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PUBLIC HEALTH SERVICE ACT
[As Amended Through P.L. 118–35, Enacted January 19, 2024]
øCurrency: This publication is a compilation of the text of title III of Chapter 373
of the 78th Congress. It was last amended by the public law listed in the As
Amended Through note above and below at the bottom of each page of the pdf
version and reflects current law through the date of the enactment of the public
law listed at https://www.govinfo.gov/app/collection/comps/¿
øNote: While this publication does not represent an official version of any Federal
statute, substantial efforts have been made to ensure the accuracy of its contents.
The official version of Federal law is found in the United States Statutes at Large
and in the United States Code. The legal effect to be given to the Statutes at
Large and the United States Code is established by statute (1 U.S.C. 112, 204).¿
TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC
HEALTH SERVICE
PART A—RESEARCH
AND INVESTIGATION
IN GENERAL
SEC. 301. ø241¿ (a) The Secretary shall conduct in the Service,
and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in
the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the
causes, diagnosis, treatment, control, and prevention of physical
and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In
carrying out the foregoing the Secretary is authorized to—
(1) collect and make available through publications and
other appropriate means, information as to, and the practical
application of, such research and other activities;
(2) make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such
projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid
to public or nonprofit universities, hospitals, laboratories, and
other institutions for the general support of their research;
(4) secure from time to time and for such periods as he
deems advisable, the assistance and advice of experts, scholars,
and consultants from the United States or abroad;
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(5) for purposes of study, admit and treat at institutions,
hospitals, and stations of the Service, persons not otherwise eligible for such treatment;
(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health
and medical fields;
(7) enter into contracts, including contracts for research in
accordance with and subject to the provisions of law applicable
to contracts entered into by the military departments under
title 10, United States Code, sections 3861 and 4141, except
that determination, approval, and certification required thereby shall be by the Secretary of Health, Education, and Welfare;
and
(8) adopt, upon recommendations of the advisory councils
to the appropriate entities of the Department or, with respect
to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary
or appropriate to carry out the purposes of this section.
(b)(1) The Secretary shall conduct and may support through
grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological
effects. In carrying out this paragraph, the Secretary shall consult
with entities of the Federal Government, outside of the Department
of Health, Education, and Welfare, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct
for such entity studies and testing of substances for carcinogenicity,
teratogenicity, mutagenicity, and other harmful biological effects.
(2)(A) The Secretary shall establish a comprehensive program
of research into the biological effects of low-level ionizing radiation
under which program the Secretary shall conduct such research
and may support such research by others through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of
Federal programs of research on the biological effects of ionizing
radiation.
(3) The Secretary shall conduct and may support through
grants and contracts research and studies on human nutrition,
with particular emphasis on the role of nutrition in the prevention
and treatment of disease and on the maintenance and promotion
of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In
carrying out activities under this paragraph, the Secretary shall
provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health,
Education, and Welfare and shall consult with entities of the Federal Government, outside of the Department of Health, Education,
and Welfare, engaged in comparable activities. The Secretary, upon
request of such an entity and under appropriate arrangements for
the payment of expenses, may conduct and support such activities
for such entity.
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(4) The Secretary shall publish a biennial report which contains—
(A) a list of all substances (i) which either are known to
be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing
in the United States are exposed;
(B) information concerning the nature of such exposure
and the estimated number of persons exposed to such substances;
(C) a statement identifying (i) each substance contained in
the list under subparagraph (A) for which no effluent, ambient,
or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which,
on the basis of available medical, scientific, or other data, such
standard, and the implementation of such standard by the
agency, decreases the risk to public health from exposure to
the substance; and
(D) a description of (i) each request received during the
year involved—
(I) from a Federal agency outside the Department of
Health, Education, and Welfare for the Secretary, or
(II) from an entity within the Department of Health,
Education, and Welfare to any other entity within the Department,
to conduct research into, or testing for, the carcinogenicity of
substances or to provide information described in clause (ii) of
subparagraph (C), and (ii) how the Secretary and each such
other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any contract for
the conduct of any study, testing, program, research, or review, or
assessment under this subsection shall be effective for any fiscal
year only to such extent or in such amounts as are provided in advance in Appropriation Acts.
(c) The Secretary may conduct biomedical research, directly or
through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases)
which do not occur to a significant extent in the United States.
(d)(1)(A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information
is collected (including research on mental health and research on
the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—
(i) shall issue to such person a certificate of confidentiality
to protect the privacy of individuals who are the subjects of
such research if the research is funded wholly or in part by the
Federal Government; and
(ii) may, upon application by a person engaged in research,
issue to such person a certificate of confidentiality to protect
the privacy of such individuals if the research is not so funded.
(B) Except as provided in subparagraph (C), any person to
whom a certificate is issued under subparagraph (A) to protect the
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privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for
purposes of the research.
(C) The disclosure prohibition in subparagraph (B) shall not
apply to disclosure or use that is—
(i) required by Federal, State, or local laws, excluding instances described in subparagraph (D);
(ii) necessary for the medical treatment of the individual
to whom the information, document, or biospecimen pertains
and made with the consent of such individual;
(iii) made with the consent of the individual to whom the
information, document, or biospecimen pertains; or
(iv) made for the purposes of other scientific research that
is in compliance with applicable Federal regulations governing
the protection of human subjects in research.
(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such
subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii).
(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal
process, and shall not, without the consent of the individual to
whom the information pertains, be admissible as evidence or used
for any purpose in any action, suit, or other judicial, legislative, or
administrative proceeding.
(F) Identifiable, sensitive information collected by a person to
whom a certificate has been issued under subparagraph (A), and all
copies thereof, shall be subject to the protections afforded by this
section for perpetuity.
(G) The Secretary shall take steps to minimize the burden to
researchers, streamline the process, and reduce the time it takes
to comply with the requirements of this subsection.
(2) The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have
policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of
this subsection.
(3) Nothing in this subsection shall be construed to limit the
access of an individual who is a subject of research to information
about himself or herself collected during such individual’s participation in the research.
(4) For purposes of this subsection, the term ‘‘identifiable, sensitive information’’ means information that is about an individual
and that is gathered or used during the course of research described in paragraph (1)(A) and—
(A) through which an individual is identified; or
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(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods,
that some combination of the information, a request for the information, and other available data sources could be used to
deduce the identity of an individual.
(e) The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall expand, intensify, and coordinate the activities of the Centers for Disease Control and Prevention with respect to preterm labor and delivery, preventable
maternal mortality and severe maternal morbidity, and infant mortality.
(f)(1) The Secretary may exempt from disclosure under section
552(b)(3) of title 5, United States Code, biomedical information that
is about an individual and that is gathered or used during the
course of biomedical research if—
(A) an individual is identified; or
(B) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that some
combination of the information, the request, and other available data sources could be used to deduce the identity of an individual.
(2)(A) Each determination of the Secretary under paragraph (1)
to exempt information from disclosure shall be made in writing and
accompanied by a statement of the basis for the determination.
(B) Each such determination and statement of basis shall be
available to the public, upon request, through the Office of the
Chief FOIA Officer of the Department of Health and Human Services.
(3) Nothing in this subsection shall be construed to limit a research participant’s access to information about such participant
collected during the participant’s participation in the research.
(g) Subchapter I of chapter 35 of title 44, United States Code,
shall not apply to the voluntary collection of information during the
conduct of research by the National Institutes of Health.
(h)(1) The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made
available under such terms and conditions (including payment for
them) as the Secretary determines appropriate.
(2) Where research substances and living organisms are made
available under paragraph (1) through contractors, the Secretary
may direct such contractors to collect payments on behalf of the
Secretary for the costs incurred to make available such substances
and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary.
(3) Amounts collected under paragraph (2) shall be credited to
the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and
shall remain available until expended for carrying out activities
under such accounts.
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Sec. 302
PUBLIC HEALTH SERVICE ACT
6
NARCOTICS
SEC. 302. ø242¿ (a) In carrying out the purposes of section 301
with respect to drugs the use or misuse of which might result in
drug abuse or dependency, the studies and investigations authorized therein shall include the use and misuse of narcotic drugs and
other drugs. Such studies and investigations shall further include
the quantities of crude opium, coca leaves, and their salts, derivatives, and preparations, and other drugs subject to control under
the Controlled Substances Act and Controlled Substances Import
and Export Act, together with reserves thereof, necessary to supply
the normal and emergency medicinal and scientific requirements of
the United States. The results of studies and investigations of the
quantities of narcotic drugs or other drugs subject to control under
such Acts, together with reserves of such drugs, that are necessary
to supply the normal and emergency medicinal and scientific requirements of the United States, shall be reported not later than
the first day of April of each year to the Attorney General, to be
used at his discretion in determining manufacturing quotas or importation requirements under such Acts.
(b) The Surgeon General shall cooperate with States for the
purpose of aiding them to solve their narcotic drug problems and
shall give authorized representatives of the States the benefit of his
experience in the care, treatment, and rehabilitation of narcotic addicts to the end that each State may be encouraged to provide adequate facilities and methods for the care and treatment of its narcotic addicts.
GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND
DEMONSTRATIONS IN HEALTH STATISTICS, HEALTH SERVICES, AND
HEALTH CARE TECHNOLOGY ASSESSMENT
SEC. 304. 1 ø242b¿ (a) The Secretary may, through the Agency
for Health Care Policy and Research or the National Center for
Health Statistics or using National Research Service Awards or
other appropriate authorities, undertake and support training programs to provide for an expanded and continuing supply of individuals qualified to perform the research, evaluation, and demonstration projects set forth in section 306 and in title IX.
(b) To implement subsection (a) and section 306, the Secretary
may, in addition to any other authority which under other provisions of this Act or any other law may be used by him to implement such subsection, do the following:
(1) Utilize personnel and equipment, facilities, and other
physical resources of the Department of Health and Human
Services, permit appropriate (as determined by the Secretary)
entities and individuals to utilize the physical resources of
such Department, provide technical assistance and advice,
make grants to public and nonprofit private entities and individuals, and, when appropriate, enter into contracts with public and private entities and individuals.
1 Former section 303 was repealed by section 3201(b)(1) of Public Law 106–310 (114 Stat.
1190).
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PUBLIC HEALTH SERVICE ACT
Sec. 305
(2) Admit and treat at hospitals and other facilities of the
Service persons not otherwise eligible for admission and treatment at such facilities.
(3) Secure, from time to time and for such periods as the
Secretary deems advisable but in accordance with section 3109
of title 5, United States Code, the assistance and advice of consultants from the United States or abroad. The Secretary may
for the purpose of carrying out the functions set forth in sections 305, 2 306, and 309, obtain (in accordance with section
3109 of title 5 of the United States Code, but without regard
to the limitation in such section on the number of days or the
period of service) for each of the centers the services of not
more than fifteen experts who have appropriate scientific or
professional qualifications.
(4) Acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and
equipment, and such other real or personal property (including
patents) as the Secretary deems necessary; and acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease
or otherwise, through the Administrator of General Services,
buildings or parts of buildings in the District of Columbia or
communities located adjacent to the District of Columbia.
(c)(1) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and
epidemiological activities, and all research, evaluations, and demonstrations respecting the assessment of health care technology undertaken and supported through units of the Department of Health
and Human Services. To the maximum extent feasible such coordination shall be carried out through the Agency for Health Care Policy and Research and the National Center for Health Statistics.
(2) The Secretary shall coordinate the health services research,
evaluations, and demonstrations, the health statistical and (where
appropriate) epidemiological activities, and the research, evaluations, and demonstrations respecting the assessment of health care
technology authorized by this Act through the Agency for Health
Care Policy and Research and the National Center for Health Statistics.
SEC. 305. ø 242c ¿ APPOINTMENT AND AUTHORITY OF THE DIRECTOR
OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
(a) IN GENERAL.—The Centers for Disease Control and Preven-
tion (referred to in this section as the ‘‘CDC’’) shall be headed by
the Director of the Centers for Disease Control and Prevention (referred to in this section as the ‘‘Director’’), who shall be appointed
by the President, by and with the advice and consent of the Senate. 3 Such individual shall also serve as the Administrator of the
Agency for Toxic Substances and Disease Registry consistent with
section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act. The Director shall perform functions
2 See
footnote for section 306.
3 Section 2101(b) of division FF of Public Law 117-328 states: ‘‘The first sentence of section
305(a) of the Public Health Service Act, as added by subsection (a), shall take effect on January
20, 2025.’’.
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provided for in subsection (b) and such other functions as the Secretary may prescribe.
(b) FUNCTIONS.—The Secretary, acting through the Director,
shall—
(1) implement and exercise applicable authorities and responsibilities provided for in this Act or other applicable law
related to the investigation, detection, identification, prevention, or control of diseases or conditions to preserve and improve public health domestically and globally and address injuries and occupational and environmental hazards, as appropriate;
(2) be responsible for the overall direction of the CDC and
for the establishment and implementation of policies related to
the management and operation of programs and activities
within the CDC;
(3) coordinate and oversee the operation of centers, institutes, and offices within the CDC;
(4) support, in consultation with the heads of such centers,
institutes, and offices, program coordination across such centers, institutes, and offices, including through priority setting
reviews and the development of strategic plans, to reduce unnecessary duplication and encourage collaboration between
programs;
(5) oversee the development, implementation, and updating of the strategic plan established pursuant to subsection (c);
(6) ensure that appropriate strategic planning, including
the use of performance metrics, is conducted by such centers,
institutes, and offices to facilitate and improve CDC programs
and activities;
(7) communicate, including through convening annual
meetings, with public and private entities regarding relevant
public health programs and activities, and, as applicable, the
strategic plan established pursuant to subsection (c).
(c) STRATEGIC PLAN.—
(1) IN GENERAL.—Not later than 1 year after the date of
enactment of the PREVENT Pandemics Act, and at least every
4 years thereafter, the Director shall develop and submit to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and post on the website
of the CDC, a coordinated strategy to provide strategic direction and facilitate collaboration across the centers, institutes,
and offices within the CDC. Such strategy shall be known as
the ‘‘CDC Strategic Plan’’.
(2) REQUIREMENTS.—The CDC Strategic Plan shall—
(A) identify strategic priorities and objectives related
to—
(i) preventing, reducing, and eliminating the
spread of communicable and noncommunicable diseases or conditions, and addressing injuries, and occupational and environmental hazards;
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(ii) supporting the efforts of State, local, and Tribal health departments to prevent and reduce the prevalence of the diseases or conditions under clause (i);
(iii) containing, mitigating, and ending disease
outbreaks;
(iv) enhancing global and domestic public health
capacity, capabilities, and preparedness, including
public health data, surveillance, workforce, and laboratory capacity and safety; and
(v) other priorities, as established by the Director;
(B) describe the capacity and capabilities necessary to
achieve the priorities and objectives under subparagraph
(A), and progress towards achieving such capacity and capabilities, as appropriate; and
(C) include a description of how the CDC Strategic
Plan incorporates—
(i) strategic communications;
(ii) partnerships with private sector entities, and
State, local, and Tribal health departments, and other
public sector entities, as appropriate; and
(iii) coordination with other agencies and offices of
the Department of Health and Human Services and
other Federal departments and agencies, as appropriate.
(3) USE OF PLANS.—Strategic plans developed and updated
by the centers, institutes, and offices of the CDC shall be prepared regularly and in such a manner that such plans will be
informed by the CDC Strategic Plan developed and updated
under this subsection.
(d) APPEARANCES BEFORE CONGRESS.—
(1) IN GENERAL.—Each fiscal year, the Director shall appear before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives at hearings on topics such as—
(A) support for State, local, and Tribal public health
preparedness and responses to any recent or ongoing public health emergency, including—
(i) any objectives, activities, or initiatives that
have been carried out, or are planned, by the Director
to prepare for, or respond to, the public health emergency, including relevant strategic communications or
partnerships and any gaps or challenges identified in
such objectives, activities, or initiatives;
(ii) any objectives and planned activities for the
upcoming fiscal year to address gaps in, or otherwise
improve, State, local, and Tribal public health preparedness; and
(iii) other potential all-hazard threats that the Director is preparing to address;
(B) activities related to public health and functions of
the Director described in subsection (b); and
(C) updates on other relevant activities supported or
conducted by the CDC, or in collaboration or coordination
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Sec. 305A
PUBLIC HEALTH SERVICE ACT
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with the heads of other Federal departments, agencies, or
stakeholders, as appropriate.
(2) CLARIFICATIONS.—
(A) WAIVER AUTHORITY.—The Chair of the Committee
on Health, Education, Labor, and Pensions of the Senate
or the Chair of the Committee on Energy and Commerce
of the House of Representatives may waive the requirements of paragraph (1) for the applicable fiscal year with
respect to the applicable Committee.
(B) SCOPE OF REQUIREMENTS.—The requirements of
this subsection shall not be construed to impact the appearance of other Federal officials or the Director at hearings of either Committee described in paragraph (1) at
other times and for purposes other than the times and
purposes described in paragraph (1).
(3) CLOSED HEARINGS.—Information that is not appropriate
for disclosure during an open hearing under paragraph (1) in
order to protect national security may instead be discussed in
a closed hearing that immediately follows the open hearing.
(e) OTHER TRANSACTIONS.—
(1) IN GENERAL.—In carrying out activities of the Centers
for Disease Control and Prevention, the Director may enter
into transactions other than a contract, grant, or cooperative
agreement for purposes of infectious disease research, biosurveillance, infectious disease modeling, and public health
preparedness and response.
(2) WRITTEN DETERMINATION.—With respect to a project
that is expected to cost the Centers for Disease Control and
Prevention more than $40,000,000, the Director may exercise
the authority under paragraph (1) only upon a written determination by the Assistant Secretary for Financial Resources of
the Department of Health and Human Services, that the use
of such authority is essential to promoting the success of the
project. The authority of the Assistant Secretary for Financial
Resources under this paragraph may not be delegated.
(3) GUIDELINES.—The Director, in consultation with the
Secretary, shall establish guidelines regarding the use of the
authority under paragraph (1). Such guidelines shall include
auditing requirements.
SEC. 305A. ø 242c-1 ¿ ADVISORY COMMITTEE TO THE DIRECTOR.
(a) IN GENERAL.—Not later than 60 days after the date
of the
enactment of the PREVENT Pandemics Act, the Secretary, acting
through the Director of the Centers for Disease Control and Prevention (referred to in this section as the ‘‘Director’’), shall maintain or establish an advisory committee within the Centers for Disease Control and Prevention to advise the Director on policy and
strategies that enable the agency to fulfill its mission.
(b) FUNCTIONS AND ACTIVITIES.—The Advisory Committee
may—
(1) make recommendations to the Director regarding ways
to prioritize the activities of the agency in alignment with the
CDC Strategic Plan required under section 305(c);
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PUBLIC HEALTH SERVICE ACT
Sec. 305A
(2) advise on ways to achieve or improve performance
metrics in relation to the CDC Strategic Plan, and other relevant metrics, as appropriate;
(3) provide advice and recommendations on the development of the CDC Strategic Plan, and any subsequent updates,
as appropriate;
(4) advise on grants, cooperative agreements, contracts, or
other transactions, as applicable;
(5) provide other advice to the Director, as requested, to
fulfill duties under sections 301 and 311; and
(6) appoint subcommittees.
(c) MEMBERSHIP.—
(1) IN GENERAL.—The Advisory Committee shall consist of
not more than 15 non-Federal members, including the Chair,
to be appointed by the Secretary under paragraph (3).
(2) EX OFFICIO MEMBERS.—Any ex officio members of the
Advisory Council may consist of—
(A) the Secretary;
(B) the Assistant Secretary for Health;
(C) the Director; and
(D) such additional officers or employees of the United
States as the Secretary determines necessary for the advisory committee to effectively carry out its functions.
(3) APPOINTED MEMBERS.—Individuals shall be appointed
to the Advisory Committee under paragraph (1) as follows:
(A) Twelve of the members shall be appointed by the
Director from among the leading representatives of the
health disciplines (including public health, global health,
health disparities, biomedical research, public health preparedness, and other fields, as applicable) relevant to the
activities of the agency or center, as applicable.
(B) Three of the members may be appointed by the
Secretary from the general public and may include leaders
in fields of innovation, public policy, public relations, law,
economics, or management.
(4) COMPENSATION.—Ex officio members of the Advisory
Council who are officers or employees of the United States
shall not receive any compensation for service on the advisory
committee. The remaining members of the advisory committee
may receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory committee, compensation at rates not to exceed the daily equivalent to the annual rate of basic pay for level III of the Executive Schedule under section 5314 of title 5, United States Code.
(5) TERMS OF OFFICE.—
(A) IN GENERAL.—The term of office of a member of
the advisory committee appointed under paragraph (3)
shall be 4 years, except that any member appointed to fill
a vacancy for an unexpired term shall serve for the remainder of such term. The Secretary shall make appointments to the advisory committee in such a manner as to
ensure that the terms of the members not all expire in the
same year. A member of the advisory committee may serve
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12
after the expiration of such member’s term until a successor has been appointed and taken office.
(B) REAPPOINTMENTS.—A member who has been appointed to the advisory committee for a term of 4 years
may not be reappointed to the advisory committee during
the 2-year period beginning on the date on which such 4year term expired.
(C) TIME FOR APPOINTMENT.—If a vacancy occurs in
the advisory committee among the members appointed
under paragraph (3), the Secretary shall make an appointment to fill such vacancy within 90 days from the date the
vacancy occurs.
(d) CHAIR.—The Secretary shall select a member of the advisory committee to serve as the Chair of the committee. The Secretary may so select an individual from among the appointed members. The term of office of the chair shall be 2 years.
(e) MEETINGS.—The advisory committee shall meet at the call
of the Chair or upon request of the Director, but in no event less
than 2 times during each fiscal year.
(f) EXECUTIVE SECRETARY AND STAFF.—The Director shall designate a member of the staff of the agency to serve as the executive
secretary of the advisory committee. The Director shall make available to the advisory committee such staff, information, and other
assistance as it may require to carry out its functions. The Director
shall provide orientation and training for new members of the advisory committee to provide for their effective participation in the
functions of the advisory committee.
NATIONAL CENTER FOR HEALTH STATISTICS
SEC. 306. 4 ø242k¿ (a) There is established in the Department
of Health and Human Services the National Center for Health Statistics (hereinafter in this section referred to as the ‘‘Center’’) which
shall be under the direction of a Director who shall be appointed
by the Secretary. The Secretary, acting through the Center, shall
conduct and support statistical and epidemiological activities for
the purpose of improving the effectiveness, efficiency, and quality
of health services in the United States.
(b) In carrying out subsection (a), the Secretary, acting through
the Center—
(1) shall collect statistics on—
(A) the extent and nature of illness and disability of
the population of the United States (or of any groupings of
the people included in the population), including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality,
(B) the impact of illness and disability of the population on the economy of the United States and on other
aspects of the well-being of its population (or of such
groupings),
(C) environmental, social, and other health hazards,
(D) determinants of health,
4 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat.
2205). Title IX now applies to the matter with which former section 305 was concerned.
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PUBLIC HEALTH SERVICE ACT
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(E) health resources, including physicians, dentists,
nurses, and other health professionals by specialty and
type of practice and the supply of services by hospitals, extended care facilities, home health agencies, and other
health institutions,
(F) utilization of health care, including utilization of (i)
ambulatory health services by specialties and types of
practice of the health professionals providing such services, and (ii) services of hospitals, extended care facilities,
home health agencies, and other institutions,
(G) health care costs and financing, including the
trends in health care prices and cost, the sources of payments for health care services, and Federal, State, and
local governmental expenditures for health care services,
and
(H) family formation, growth, and dissolution;
(2) shall undertake and support (by grant or contract) research, demonstrations, and evaluations respecting new or improved methods for obtaining current data on the matters referred to in paragraph (1);
(3) may undertake and support (by grant or contract) epidemiological research, demonstrations, and evaluations on the
matters referred to in paragraph (1); and
(4) may collect, furnish, tabulate, and analyze statistics,
and prepare studies, on matters referred to in paragraph (1)
upon request of public and nonprofit private entities under arrangements under which the entities will pay the cost of the
service provided.
Amounts appropriated to the Secretary from payments made under
arrangements made under paragraph (4) shall be available to the
Secretary for obligation until expended.
(c) The Center shall furnish such special statistical and epidemiological compilations and surveys as the Committee on Labor
and Human Resources and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives may request. Such statistical and epidemiological compilations and surveys shall not be made subject to the payment of the actual or estimated cost of the preparation of such compilations and surveys.
(d) To insure comparability and reliability of health statistics,
the Secretary shall, through the Center, provide adequate technical
assistance to assist State and local jurisdictions in the development
of model laws dealing with issues of confidentiality and comparability of data.
(e) For the purpose of producing comparable and uniform
health information and statistics, there is established the Cooperative Health Statistics System. The Secretary, acting through the
Center, shall—
(1) coordinate the activities of Federal agencies involved in
the design and implementation of the System;
(2) undertake and support (by grant or contract) research,
development, demonstrations, and evaluations respecting the
System;
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14
(3) make grants to and enter into contracts with State and
local health agencies to assist them in meeting the costs of
data collection and other activities carried out under the System; and
(4) review the statistical activities of the Department of
Health and Human Services to assure that they are consistent
with the System.
States participating in the System shall designate a State agency
to administer or be responsible for the administration of the statistical activities within the State under the System. The Secretary,
acting through the Center, shall prescribe guidelines to assure that
statistical activities within States participating in the system 5
produce uniform and timely data and assure appropriate access to
such data.
(f) To assist in carrying out this section, the Secretary, acting
through the Center, shall cooperate and consult with the Departments of Commerce and Labor and any other interested Federal
departments or agencies and with State and local health departments and agencies. For such purpose he shall utilize insofar as
possible the services or facilities of any agency of the Federal Government and, without regard to section 3709 of the Revised Statutes (41 U.S.C. 5), of any appropriate State or other public agency,
and may, without regard to such section, utilize the services or facilities of any private agency, organization, group, or individual, in
accordance with written agreements between the head of such
agency, organization, or group and the Secretary or between such
individual and the Secretary. Payment, if any, for such services or
facilities shall be made in such amounts as may be provided in
such agreement.
(g) To secure uniformity in the registration and collection of
mortality, morbidity, and other health data, the Secretary shall
prepare and distribute suitable and necessary forms for the collection and compilation of such data.
(h)(1) There shall be an annual collection of data from the
records of births, deaths, marriages, and divorces in registration
areas. The data shall be obtained only from and restricted to such
records of the States and municipalities which the Secretary, in his
discretion, determines possess records affording satisfactory data in
necessary detail and form. The Secretary shall encourage States
and registration areas to obtain detailed data on ethnic and racial
populations, including subpopulations of Hispanics, Asian Americans, and Pacific Islanders with significant representation in the
State or registration area. Each State or registration area shall be
paid by the Secretary the Federal share of its reasonable costs (as
determined by the Secretary) for collecting and transcribing (at the
request of the Secretary and by whatever method authorized by
him) its records for such data.
(2) There shall be an annual collection of data from a statistically valid sample concerning the general health, illness, and disability status of the civilian noninstitutionalized population. Specific topics to be addressed under this paragraph, on an annual or
periodic basis, shall include the incidence of illness and accidental
5 So
in law. Probably should be capitalized.
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PUBLIC HEALTH SERVICE ACT
Sec. 306
injuries, prevalence of chronic diseases and impairments, disability,
physician visits, hospitalizations, and the relationship between demographic and socioeconomic characteristics and health characteristics.
(i) The Center may provide to public and nonprofit private entities technical assistance in the effective use in such activities of
statistics collected or compiled by the Center.
(j) In carrying out the requirements of section 304(c) and paragraph (1) of subsection (e) of this section, the Secretary shall coordinate health statistical and epidemiological activities of the Department of Health and Human Services by—
(1) establishing standardized means for the collection of
health information and statistics under laws administered by
the Secretary;
(2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the
minimum sets of data needed on a continuing basis to fulfill
the collection requirements of subsection (b)(1);
(3) after consultation with the National Committee on
Vital and Health Statistics, establishing standards to assure
the quality of health statistical and epidemiological data collection, processing, and analysis;
(4) in the case of proposed health data collections of the
Department which are required to be reviewed by the Director
of the Office of Management and Budget under section 3509 of
title 44, United States Code, reviewing such proposed collections to determine whether they conform with the minimum
sets of data and the standards promulgated pursuant to paragraphs (2) and (3), and if any such proposed collection is found
not to be in conformance, by taking such action as may be necessary to assure that it will conform to such sets of data and
standards, and
(5) periodically reviewing ongoing health data collections of
the Department, subject to review under such section 3509, to
determine if the collections are being conducted in accordance
with the minimum sets of data and the standards promulgated
pursuant to paragraphs (2) and (3) and, if any such collection
is found not to be in conformance, by taking such action as
may be necessary to assure that the collection will conform to
such sets of data and standards not later than the nineteenth
day after the date of the completion of the review of the collection.
(k)(1) There is established in the Office of the Secretary a committee to be known as the National Committee on Vital and Health
Statistics (hereinafter in this subsection, referred to as the ‘‘Committee’’) which shall consist of 18 members.
(2) The members of the Committee shall be appointed from
among persons who have distinguished themselves in the fields of
health statistics, electronic interchange of health care information,
privacy and security of electronic information, population-based
public health, purchasing or financing health care services, integrated computerized health information systems, health services
research, consumer interests in health information, health data
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PUBLIC HEALTH SERVICE ACT
16
standards, epidemiology, and the provision of health services.
Members of the Committee shall be appointed for terms of 4 years.
(3) Of the members of the Committee—
(A) 1 shall be appointed, not later than 60 days after the
date of the enactment of the Health Insurance Portability and
Accountability Act of 1996, by the Speaker of the House of
Representatives after consultation with the Minority Leader of
the House of Representatives;
(B) 1 shall be appointed, not later than 60 days after the
date of the enactment of the Health Insurance Portability and
Accountability Act of 1996, by the President pro tempore of the
Senate after consultation with the Minority Leader of the Senate; and
(C) 16 shall be appointed by the Secretary.
(4) Members of the Committee shall be compensated in accordance with section 208(c).
(5) The Committee—
(A) shall assist and advise the Secretary—
(i) to delineate statistical problems bearing on health
and health services which are of national or international
interest;
(ii) to stimulate studies of such problems by other organizations and agencies whenever possible or to make investigations of such problems through subcommittees;
(iii) to determine, approve, and revise the terms, definitions, classifications, and guidelines for assessing health
status and health services, their distribution and costs, for
use (I) within the Department of Health and Human Services, (II) by all programs administered or funded by the
Secretary, including the Federal-State-local cooperative
health statistics system referred to in subsection (e), and
(III) to the extent possible as determined by the head of
the agency involved, by the Department of Veterans Affairs, the Department of Defense, and other Federal agencies concerned with health and health services;
(iv) with respect to the design of and approval of
health statistical and health information systems concerned with the collection, processing, and tabulation of
health statistics within the Department of Health and
Human Services, with respect to the Cooperative Health
Statistics System established under subsection (e), and
with respect to the standardized means for the collection
of health information and statistics to be established by
the Secretary under subsection (j)(1);
(v) to review and comment on findings and proposals
developed by other organizations and agencies and to
make recommendations for their adoption or implementation by local, State, national, or international agencies;
(vi) to cooperate with national committees of other
countries and with the World Health Organization and
other national agencies in the studies of problems of mutual interest;
(vii) to issue an annual report on the state of the Nation’s health, its health services, their costs and distribuFebruary 1, 2024
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17
PUBLIC HEALTH SERVICE ACT
Sec. 306
tions, and to make proposals for improvement of the Nation’s health statistics and health information systems;
and
(viii) in complying with the requirements imposed on
the Secretary under part C of title XI of the Social Security Act;
(B) shall study the issues related to the adoption of uniform data standards for patient medical record information
and the electronic exchange of such information;
(C) shall report to the Secretary not later than 4 years
after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations and
legislative proposals for such standards and electronic exchange; and
(D) shall be responsible generally for advising the Secretary and the Congress on the status of the implementation
of part C of title XI of the Social Security Act.
(6) In carrying out health statistical activities under this part,
the Secretary shall consult with, and seek the advice of, the Committee and other appropriate professional advisory groups.
(7) Not later than 1 year after the date of the enactment of the
Health Insurance Portability and Accountability Act of 1996, and
annually thereafter, the Committee shall submit to the Congress,
and make public, a report regarding the implementation of part C
of title XI of the Social Security Act. Such report shall address the
following subjects, to the extent that the Committee determines appropriate:
(A) The extent to which persons required to comply with
part C of title XI of the Social Security Act are cooperating in
implementing the standards adopted under such part.
(B) The extent to which such entities are meeting the security standards adopted under such part and the types of penalties assessed for noncompliance with such standards.
(C) Whether the Federal and State Governments are receiving information of sufficient quality to meet their responsibilities under such part.
(D) Any problems that exist with respect to implementation of such part.
(E) The extent to which timetables under such part are
being met.
(l) In carrying out this section, the Secretary, acting through
the Center, shall collect and analyze adequate health data that is
specific to particular ethnic and racial populations, including data
collected under national health surveys. Activities carried out
under this subsection shall be in addition to any activities carried
out under subsection (m).
(m)(1) The Secretary, acting through the Center, may make
grants to public and nonprofit private entities for—
(A) the conduct of special surveys or studies on the health
of ethnic and racial populations or subpopulations;
(B) analysis of data on ethnic and racial populations and
subpopulations; and
(C) research on improving methods for developing statistics on ethnic and racial populations and subpopulations.
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Sec. 307
PUBLIC HEALTH SERVICE ACT
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(2) The Secretary, acting through the Center, may provide
technical assistance, standards, and methodologies to grantees supported by this subsection in order to maximize the data quality and
comparability with other studies.
(3) Provisions of section 308(d) do not apply to surveys or studies conducted by grantees under this subsection unless the Secretary, in accordance with regulations the Secretary may issue, determines that such provisions are necessary for the conduct of the
survey or study and receives adequate assurance that the grantee
will enforce such provisions.
(4)(A) Subject to subparagraph (B), the Secretary, acting
through the Center, shall collect data on Hispanics and major Hispanic subpopulation groups and American Indians, and for developing special area population studies on major Asian American and
Pacific Islander populations.
(B) The provisions of subparagraph (A) shall be effective with
respect to a fiscal year only to the extent that funds are appropriated pursuant to paragraph (3) of subsection (n), and only if the
amounts appropriated for such fiscal year pursuant to each of paragraphs (1) and (2) of subsection (n) equal or exceed the amounts
so appropriated for fiscal year 1997.
(n)(1) For health statistical and epidemiological activities undertaken or supported under subsections (a) through (l), there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 1991 through 2003.
(2) For activities authorized in paragraphs (1) through (3) of
subsection (m), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1999 through 2003.
Of such amounts, the Secretary shall use not more than 10 percent
for administration and for activities described in subsection (m)(2).
(3) For activities authorized in subsection (m)(4), there are authorized to be appropriated $1,000,000 for fiscal year 1998, and
such sums as may be necessary for each of the fiscal years 1999
through 2002.
INTERNATIONAL COOPERATION
SEC. 307. ø242l¿ (a) The Secretary may participate with other
countries in cooperative endeavors in—
(1) biomedical research, health care technology, and the
health services research and statistical analysis authorized
under section 306 and title IX; and
(2) biomedical research, health care services, health care
research, or other related activities in furtherance of the activities, objectives or goals authorized under the Tom Lantos and
Henry J. Hyde United States Global Leadership Against HIV/
AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.
(b) In connection with the cooperative endeavors authorized by
subsection (a), the Secretary may—
(1) make such use of resources offered by participating foreign countries as he may find necessary and appropriate;
(2) establish and maintain fellowships in the United States
and in participating foreign countries;
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PUBLIC HEALTH SERVICE ACT
Sec. 307
(3) make grants to public institutions or agencies and to
nonprofit private institutions or agencies in the United States
and in participating foreign countries for the purpose of establishing and maintaining the fellowships authorized by paragraph (2);
(4) make grants or loans of equipment and materials, for
use by public or nonprofit private institutions or agencies, or
by individuals, in participating foreign countries;
(5) participate and otherwise cooperate in any international meetings, conferences, or other activities concerned
with biomedical research, health services research, health statistics, or health care technology;
(6) facilitate the interchange between the United States
and participating foreign countries, and among participating
foreign countries, of research scientists and experts who are
engaged in experiments or programs of biomedical research,
health services research, health statistical activities, or health
care technology activities, and in carrying out such purpose
may pay per diem compensation, subsistence, and travel for
such scientists and experts when away from their places of residence at rates not to exceed those provided in section 5703(b)
of title 5, United States Code, for persons in the Government
service employed intermittently;
(7) procure, in accordance with section 3109 of title 5,
United States Code, the temporary or intermittent services of
experts or consultants;
(8) enter into contracts with individuals for the provision
of services (as defined in section 104 of part 37 of title 48, Code
of Federal Regulations (48 CFR 37.104)) in participating foreign countries, which individuals may not be deemed employees of the United States for the purpose of any law administered by the Office of Personnel Management;
(9) provide such funds by advance or reimbursement to the
Secretary of State, as may be necessary, to pay the costs of acquisition, lease, construction, alteration, equipping, furnishing
or management of facilities outside of the United States; and
(10) in consultation with the Secretary of State, through
grant or cooperative agreement, make funds available to public
or nonprofit private institutions or agencies in foreign countries in which the Secretary is participating in activities described under subsection (a) to acquire, lease, construct, alter,
or renovate facilities in those countries.
(c) The Secretary may provide to personnel appointed or assigned by the Secretary to serve abroad, allowances and benefits
similar to those provided under chapter 9 of title I of the Foreign
Service Act of 1980 (22 U.S.C. 4081 et seq.). Leaves of absence for
personnel under this subsection shall be on the same basis as that
provided under subchapter I of chapter 63 of title 5, United States
Code or section 903 of the Foreign Service Act of 1980 (22 U.S.C.
4083), to individuals serving in the Foreign Service.
(d) In carrying out immunization programs and other programs
in developing countries for the prevention, treatment, and control
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Sec. 308
PUBLIC HEALTH SERVICE ACT
20
tion, in coordination with the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, the National Institutes of Health, national and local government, and other organizations, such as the World Health Organization and the United Nations Children’s Fund, shall develop and implement effective strategies to improve injection safety, including eliminating unnecessary
injections, promoting sterile injection practices and technologies,
strengthening the procedures for proper needle and syringe disposal, and improving the education and information provided to the
public and to health professionals.
GENERAL PROVISIONS RESPECTING EFFECTIVENESS, EFFICIENCY, AND
QUALITY OF HEALTH SERVICES
SEC. 308. ø242m¿ (a)(1) Not later than March 15 of each year,
the Secretary shall submit to the President and Congress the following reports:
(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics
collected under section 306(b)(1)(G).
(B) A report on health resources. Such report shall include
a description and analysis, by geographical area, of the statistics collected under section 306(b)(1)(E).
(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under section 306(b)(1)(F).
(D) A report on the health of the Nation’s people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under section 306(b)(1)(A).
(2) The reports required in paragraph (1) shall be prepared
through the National Center for Health Statistics.
(3) The Office of Management and Budget may review any report required by paragraph (1) of this subsection before its submission to Congress, but the Office may not revise any such report or
delay its submission beyond the date prescribed for its submission,
and may submit to Congress its comments respecting any such report.
(b)(1) No grant or contract may be made under section 304,
306, or 307 unless an application therefor has been submitted to
the Secretary in such form and manner, and containing such information, as the Secretary may by regulation prescribe and unless a
peer review group referred to in paragraph (2) has recommended
the application for approval.
(2)(A) Each application submitted for a grant or contract under
section 306 in an amount exceeding $50,000 of direct costs and for
a health services research, evaluation, or demonstration project, or
for a grant under section 306(m), shall be submitted to a peer review group for an evaluation of the technical and scientific merits
of the proposals made in each such application. The Director of the
National Center for Health Statistics shall establish such peer review groups as may be necessary to provide for such an evaluation
of each such application.
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PUBLIC HEALTH SERVICE ACT
Sec. 308
(B) A peer review group to which an application is submitted
pursuant to subparagraph (A) shall report its finding and recommendations respecting the application to the Secretary, acting
through the Director of the National Center for Health Statistics,
in such form and manner as the Secretary shall by regulation prescribe. The Secretary may not approve an application described in
such subparagraph unless a peer review group has recommended
the application for approval.
(C) The Secretary, acting through the Director of the National
Center for Health Statistics, shall make appointments to the peer
review groups required in subparagraph (A) from among persons
who are not officers or employees of the United States and who
possess appropriate technical and scientific qualifications, except
that peer review groups regarding grants under section 306(m)
may include appropriately qualified such officers and employees.
(c) The Secretary shall take such action as may be necessary
to assure that statistics developed under sections 304 and 306 are
of high quality, timely, comprehensive as well as specific, standardized, and adequately analyzed and indexed, and shall publish,
make available, and disseminate such statistics on as wide a basis
as is practicable.
(d) No information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the course
of activities undertaken or supported under section 304, 306, or 307
may be used for any purpose other than the purpose for which it
was supplied unless such establishment or person has consented
(as determined under regulations of the Secretary) to its use for
such other purpose and in the case of information obtained in the
course of health statistical or epidemiological activities under section 304 or 306, such information may not be published or released
in other form if the particular establishment or person supplying
the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations
of the Secretary) to its publication or release in other form.
(e)(1) Payments of any grant or under any contract under section 304, 306, or 307 may be made in advance or by way of reimbursement, and in such installments and on such conditions, as the
Secretary deems necessary to carry out the purposes of such section.
(2) The amounts otherwise payable to any person under a
grant or contract made under section 304, 306, or 307 shall be reduced by—
(A) amounts equal to the fair market value of any equipment or supplies furnished to such person by the Secretary for
the purpose of carrying out the project with respect to which
such grant or contract is made, and
(B) amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the Government in connection with such project, if such officer or employee was assigned or detailed by the Secretary to perform
such services,
but only if such person requested the Secretary to furnish such
equipment or supplies, or such services, as the case may be.
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Sec. 310
PUBLIC HEALTH SERVICE ACT
22
(f) Contracts may be entered into under section 304 or 306
without regard to section 3324 of title 31, United States Code, and
section 3709 of the Revised Statutes (41 U.S.C. 5).
HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION
SEC. 310. 6 ø242o¿ (a) A conference of the health authorities in
and among the several States shall be called annually by the Secretary. Whenever in his opinion the interests of the public health
would be promoted by a conference, the Secretary may invite as
many of such health authorities and officials of other State or local
public or private agencies, institutions, or organizations to confer
as he deems necessary or proper. Upon the application of health
authorities of five or more States it shall be the duty of the Secretary to call a conference of all State health authorities joining in
the request. Each State represented at any conference shall be entitled to a single vote. Whenever at any such conference matters relating to mental health are to be discussed, the mental health authorities of the respective States shall be invited to attend.
(b) From time to time the Secretary shall issue information related to public health, in the form of publications or otherwise, for
the use of the public, and shall publish weekly reports of health
conditions in the United States and other countries and other pertinent health information for the use of persons and institutions concerned with health services.
SEC. 310A. ø242s¿ CENTERS FOR DISEASE CONTROL AND PREVENTION
OFFICE OF WOMEN’S HEALTH.
(a) ESTABLISHMENT.—There is established within the Office of
the Director of the Centers for Disease Control and Prevention, an
office to be known as the Office of Women’s Health (referred to in
this section as the ‘‘Office’’). The Office shall be headed by a director who shall be appointed by the Director of such Centers.
(b) PURPOSE.—The Director of the Office shall—
(1) report to the Director of the Centers for Disease Control and Prevention on the current level of the Centers’ activity
regarding women’s health conditions across, where appropriate, age, biological, sociocultural (including among American
Indians, Native Hawaiians, and Alaska Natives), and geographical contexts, in all aspects of the Centers’ work, including prevention programs, public and professional education,
services, and treatment;
(2) establish short-range and long-range goals and objectives within the Centers for women’s health and, as relevant
and appropriate, coordinate with other appropriate offices on
activities within the Centers that relate to prevention, research, education and training, service delivery, and policy development, for issues of particular concern to women;
(3) identify projects in women’s health that should be conducted or supported by the Centers;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health profes6 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat.
2205).
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PUBLIC HEALTH SERVICE ACT
Sec. 310B
sionals, and other individuals and groups, as appropriate, on
the policy of the Centers with regard to women; and
(5) serve as a member of the Department of Health and
Human Services Coordinating Committee on Women’s Health
(established under section 229(b)(4)).
(c) DEFINITION.—As used in this section, the term ‘‘women’s
health conditions’’, with respect to women of all age, ethnic, and racial groups, means diseases, disorders, and conditions—
(1) unique to, significantly more serious for, or significantly more prevalent in women; and
(2) for which the factors of medical risk or type of medical
intervention are different for women, or for which there is reasonable evidence that indicates that such factors or types may
be different for women.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2010
through 2014.
SEC. 310B. ø 242u ¿ IMPROVING STATE, LOCAL, AND TRIBAL INFORMATION SHARING.
(a) IN GENERAL.—The Secretary may, in consultation with
State, local, and Tribal public health officials, carry out activities
to improve the availability of appropriate and applicable public
health data related to communicable diseases, and information
sharing between, the Director of the Centers for Disease Control
and Prevention, the Assistant Secretary for Preparedness and Response, and such State, local, and Tribal public health officials,
which may include such data from—
(1) health care providers and facilities;
(2) public health and clinical laboratories;
(3) health information exchanges and health information
networks; and
(4) State, local, and Tribal health departments.
(b) CONTENT, FORM, AND MANNER.—The Secretary shall, consistent with the requirements of this section, work with such officials and relevant stakeholders to provide information on the content, form, and manner in which such data, deidentified as applicable, may most effectively support the ability of State, local, and
Tribal health departments to respond to such communicable diseases, including related to the collection and reporting of demographic and other relevant data elements. Such form and manner
requirements shall align with the standards and implementation
specifications adopted by the Secretary under section 3004, as applicable.
(c) DECREASED BURDEN.—In facilitating the coordination of efforts under subsection (a), the Secretary shall make reasonable efforts to limit reported public health data to the minimum necessary
information needed to accomplish the intended public health purpose.
(d) EXEMPTION OF CERTAIN PUBLIC HEALTH DATA FROM DISCLOSURE.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may exempt from disclosure under section 552(b)(3) of title 5, United States Code, public
health data that are gathered under this section if—
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Sec. 311
PUBLIC HEALTH SERVICE ACT
24
(1) an individual is identified through such data; or
(2) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that some
combination of the information, the request, and other available data sources or the application of technology could be used
to deduce the identity of an individual.
PART B—FEDERAL-STATE COOPERATION
IN GENERAL
SEC. 311. ø243¿ (a) The Secretary is authorized to accept from
State and local authorities any assistance in the enforcement of
quarantine regulations made pursuant to this Act which such authorities may be able and willing to provide. The Secretary shall
also assist States and their political subdivisions in the prevention
and suppression of communicable diseases and with respect to
other public health matters, shall cooperate with and aid State and
local authorities in the enforcement of their quarantine and other
health regulations, and shall advise the several States on matters
relating to the preservation and improvement of the public health.
(b) The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing
planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out the public health activities. The Secretary is
also authorized to train personnel for State and local health work.
The Secretary may charge only private entities reasonable fees for
the training of their personnel under the preceding sentence.
(c)(1) The Secretary is authorized to develop (and may take
such action as may be necessary to implement) a plan under which
personnel, equipment, medical supplies, and other resources of the
Service and other agencies under the jurisdiction of the Secretary
may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative
planning between the Service and public and private community
health programs and agencies to cope with health problems (including epidemics and health emergencies).
(2) The Secretary may, at the request of the appropriate State
or local authority, extend temporary (not in excess of six months)
assistance to States or localities in meeting health emergencies of
such a nature as to warrant Federal assistance. The Secretary may
require such reimbursement of the United States for assistance
provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be
credited to the applicable appropriation for the Service for the year
in which such reimbursement is received.
SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
(a) IN GENERAL.—The Secretary shall award grants to
States,
political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs—
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PUBLIC HEALTH SERVICE ACT
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(1) by training and equipping local emergency medical
services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders,
to
administer
immediate
care,
including
cardiopulmonary resuscitation and automated external
defibrillation, to cardiac arrest victims;
(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are
likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external
defibrillation to cardiac arrest victims;
(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;
(4) by providing training to members of the public in
cardiopulmonary resuscitation and automated external
defibrillation;
(5) by integrating the emergency medical services system
with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators
in their community; and
(6) by encouraging private companies, including small
businesses, to purchase automated external defibrillators and
provide training for their employees to administer
cardiopulmonary resuscitation and external automated
defibrillation to cardiac arrest victims in their community.
(b) PREFERENCE.—In awarding grants under subsection (a), the
Secretary shall give a preference to a State, political subdivision of
a State, Indian tribe, or tribal organization that—
(1) has a particularly low local survival rate for cardiac arrests, or a particularly low local response rate for cardiac arrest victims; or
(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access
defibrillation program.
(c) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to—
(1) purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration;
(2) provide automated external defibrillation and basic life
support training in automated external defibrillator usage
through nationally recognized courses;
(3) provide information to community members about the
public access defibrillation program to be funded with the
grant;
(4) provide information to the local emergency medical
services system regarding the placement of automated external
defibrillators in public places;
(5) produce materials to encourage private companies, including small businesses, to purchase automated external
defibrillators;
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Sec. 313
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26
(6) establish an information clearinghouse, that shall be
administered by an organization that has substantial expertise
in
pediatric
education,
pediatric
medicine,
and
electrophysiology and sudden death, that provides information
to increase public access to defibrillation in schools; and
(7) further develop strategies to improve access to automated external defibrillators in public places.
(d) APPLICATION.—
(1) IN GENERAL.—To be eligible to receive a grant under
subsection (a), a State, political subdivision of a State, Indian
tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
(2) CONTENTS.—An application submitted under paragraph
(1) shall—
(A) describe the comprehensive public access
defibrillation program to be funded with the grant and
demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community;
(B) contain procedures for implementing appropriate
nationally recognized training courses in performing
cardiopulmonary resuscitation and the use of automated
external defibrillators;
(C) contain procedures for ensuring direct involvement
of a licensed medical professional and coordination with
the local emergency medical services system in the oversight of training and notification of incidents of the use of
the automated external defibrillators;
(D) contain procedures for proper maintenance and
testing of the automated external defibrillators, according
to the labeling of the manufacturer;
(E) contain procedures for ensuring notification of local
emergency medical services system personnel, including
dispatchers, of the location and type of devices used in the
public access defibrillation program; and
(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be
funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$25,000,000 for for 7 each of fiscal years 2003 through 2014. Not
more than 10 percent of amounts received under a grant awarded
under this section may be used for administrative expenses.
SEC. 313. ø245¿ PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE
OF VACCINATIONS.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination
with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities
7 The
words ‘‘for for’’ so in law.
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PUBLIC HEALTH SERVICE ACT
Sec. 313
to carry out a national, evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for
the prevention and control of diseases, combat misinformation
about vaccines, and disseminate scientific and evidence-based vaccine-related information, with the goal of increasing rates of vaccination across all ages, as applicable, particularly in communities
with low rates of vaccination, to reduce and eliminate vaccine-preventable diseases.
(b) CONSULTATION.—In carrying out the campaign under this
section, the Secretary shall consult with appropriate public health
and medical experts, including the National Academy of Medicine
and medical and public health associations and nonprofit organizations, in the development, implementation, and evaluation of the
evidence-based public awareness campaign.
(c) REQUIREMENTS.—The campaign under this section shall—
(1) be a nationwide, evidence-based media and public engagement initiative;
(2) include the development of resources for communities
with low rates of vaccination, including culturally and linguistically appropriate resources, as applicable;
(3) include the dissemination of vaccine information and
communication resources to public health departments, health
care providers, and health care facilities, including such providers and facilities that provide prenatal and pediatric care;
(4) be complementary to, and coordinated with, any other
Federal, State, local, or Tribal efforts, as appropriate; and
(5) assess the effectiveness of communication strategies to
increase rates of vaccination.
(d) ADDITIONAL ACTIVITIES.—The campaign under this section
may—
(1) include the use of television, radio, the internet, and
other media and telecommunications technologies;
(2) include the use of in-person activities;
(3) be focused to address specific needs of communities and
populations with low rates of vaccination; and
(4) include the dissemination of scientific and evidencebased vaccine-related information, such as—
(A) advancements in evidence-based research related
to diseases that may be prevented by vaccines and vaccine
development;
(B) information on vaccinations for individuals and
communities, including individuals for whom vaccines are
not recommended by the Advisory Committee for Immunization Practices, and the effects of low vaccination rates
within a community on such individuals;
(C) information on diseases that may be prevented by
vaccines; and
(D) information on vaccine safety and the systems in
place to monitor vaccine safety.
(e) EVALUATION.—The Secretary shall—
(1) establish benchmarks and metrics to quantitatively
measure and evaluate the awareness campaign under this section;
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(2) conduct qualitative assessments regarding the awareness campaign under this section; and
(3) prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on
Energy and Commerce of the House of Representatives an
evaluation of the awareness campaign under this section.
(f) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under
this section shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities described in this section.
(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section and subsections (k) and
(n) of section 317, $15,000,000 for each of fiscal years 2021 through
2025.
GRANTS FOR COMPREHENSIVE HEALTH PLANNING AND PUBLIC HEALTH
SERVICES
Grants to States for Comprehensive State Health Planning
SEC. 314. ø246¿ (a)(1) AUTHORIZATION.—In order to assist the
States in comprehensive and continuing planning for their current
and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make
grants to States which have submitted, and had approved by the
Secretary, State plans for comprehensive State health planning.
For the purposes of carrying out this subsection, there are hereby
authorized to be appropriated $2,500,000 for the fiscal year ending
June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968,
$10,000,000 for the fiscal year ending June 30, 1969, $15,000,000
for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal
year ending June 30, 1971, $17,000,000 for the fiscal year ending
June 30, 1972, $20,000,000 for the fiscal year ending June 30,
1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) STATE PLANS FOR COMPREHENSIVE STATE HEALTH PLANNING.—In order to be approved for purposes of this subsection, a
State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single
State agency, which may be an interdepartmental agency, as
the sole agency for administering or supervising the administration of the State’s health planning functions under the plan;
(B) provide for the establishment of a State health planning council, which shall include representatives of Federal,
State, and local agencies (including as an ex officio member, if
there is located in such State one or more hospitals or other
health care facilities of the Department of Veterans Affairs, the
individual whom the Secretary of Veterans Affairs shall have
designated to serve on such council as the representative of the
hospitals or other health care facilities of such Department
which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in
whole or in part within the State) and of consumers of health
services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such
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PUBLIC HEALTH SERVICE ACT
Sec. 314
council shall consist of representatives of consumers of health
services;
(C) set forth policies and procedures for the expenditure of
funds under the plan, which, in the judgment of the Secretary,
are designed to provide for comprehensive State planning for
health services (both public and private and including home
health care), including the facilities and persons required for
the provision of such services, to meet the health needs of the
people of the State and including environmental considerations
as they relate to public health;
(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and
groups concerned with health services, facilities, or manpower,
and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and
groups in the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances satisfactory to
the Secretary that the funds paid under this subsection will be
used to supplement and, to the extent practicable, to increase
the level of funds that would otherwise be made available by
the State for the purpose of comprehensive health planning
and not to supplant such non-Federal funds;
(F) 8 provide such methods of administration (including
methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary
shall exercise no authority with respect to the selection, tenure
of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to
be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make such reports,
in such form and containing such information, as the Secretary
may from time to time reasonably require, and will keep such
records and afford such access thereto as the Secretary finds
necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from time to time,
but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each
health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed
in accordance with criteria established by the Secretary after
consultation with the State which will meet the needs of the
State for health care facilities, equipment, and services without
duplication and otherwise in the most efficient and economical
manner, and (ii) provide that the State agency furnishing such
8 Section 208(a)(3) of Public Law 91–648 (42 U.S.C. 4728) transferred to the United States
Civil Service Commission all functions, powers, and duties of the Secretary under any law applicable to a grant program which requires the establishment and maintenance of personnel standards on a merit basis with respect to the program. Reorganization Plan No. 2 of 1978 (42 U.S.C.
1101 note) transferred to the Office of Personnel Management all functions of the United States
Civil Service Commission.
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Sec. 314
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30
assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and
recommended appropriate modification thereof;
(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of
and accounting for funds paid to the State under this subsection; and
(K) contain such additional information and assurances as
the Secretary may find necessary to carry out the purposes of
this subsection.
(3)(A) STATE ALLOTMENTS.—From the sums appropriated for
such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on
the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated
for such fiscal year pursuant to paragraph (1). Any such allotment
to a State for a fiscal year shall remain available for obligation by
the State, in accordance with the provisions of this subsection and
the State’s plan approved thereunder, until the close of the succeeding fiscal year.
(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will
not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates
as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year,
but with such proportionate amount for any of such other States
being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period;
and the total of such reductions shall be similarly reallotted among
the States whose proportionate amounts were not so reduced. Any
amount so reallotted to a State from funds appropriated pursuant
to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.
(4) PAYMENTS TO STATES.—From each State’s allotment for a
fiscal year under this subsection, the State shall from time to time
be paid the Federal share of the expenditures incurred during that
year or the succeeding year pursuant to its State plan approved
under this subsection. Such payments shall be made on the basis
of estimates by the Secretary of the sums the State will need in
order to perform the planning under its approved State plan under
this subsection, but with such adjustments as may be necessary to
take account of previously made underpayments or overpayments.
The ‘‘Federal share’’ for any State for purposes of this subsection
shall be all, or such part as the Secretary may determine, of the
cost of such planning, except that in the case of the allotments for
the fiscal year ending June 30, 1970, it shall not exceed 75 per centum, of such cost.
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PUBLIC HEALTH SERVICE ACT
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Project Grants for Areawide Health Planning
(b)(1)(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a), project
grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local
government where the recipient of the grant is not a local government or combination thereof or an agency of such government or
combination) to cover not to exceed 75 per centum of the costs of
projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care;
except that in the case of project grants made in any State prior
to July 1, 1968, approval of such State agency shall be required
only if such State has such a State plan in effect at the time of
such grants. No grant may be made under this subsection after
June 30, 1970, to any agency or organization to develop or revise
health plans for an area unless the Secretary determines that such
agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities,
and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30,
1968, $10,000,000 for the fiscal year ending June 30, 1969,
$15,000,000 for the fiscal year ending June 30, 1970, $20,000,000
for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal
year ending June 30, 1972, $40,000,000 for the fiscal year ending
June 30, 1973, and $25,100,000 for the fiscal year ending June 30,
1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the
administration of the State plan approved under subsection (a)
with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been
filed by any other agency or organization qualified to receive such
a grant, and (ii) such State agency certifies, and the Secretary
finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the
foresee-able future, any agency or organization which is qualified
for such a grant will file application therefor.
(2)(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is
sought, an areawide health planning council. The membership of
such council shall include representatives of public, voluntary, and
non-profit private agencies, institutions, and organizations concerned with health (including representatives of the interests of
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local government of the regional medical program for such area,
and of consumers of health services). A majority of the members of
such council shall consist of representatives of consumers of health
services.
(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that
the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital
expenditures for replacement, modernization, and expansion, which
is consistent with an overall State plan which will meet the needs
of the State and the area for health care facilities, equipment, and
services without duplication and otherwise in the most efficient
and economical manner.
Project Grants for Training, Studies, and Demonstrations
(c) The Secretary is also authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make grants to any
public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of projects for training,
studies, or demonstrations looking toward the development of improved or more effective comprehensive health planning throughout
the Nation. For the purposes of carrying out this subsection, there
are hereby authorized to be appropriated $1,500,000 for the fiscal
year ending June 30, 1967, $2,500,000 for the fiscal year ending
June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969,
$7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for
the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year
ending June 30, 1972, $12,000,000 for the fiscal year ending June
30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974.
SEC. 315. ø42 U.S.C. 247¿ ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING TO MEET REQUIREMENTS
FOR BECOMING CIVILIAN HEALTH CARE PROFESSIONALS.
(a) PROGRAM.—
(1) IN GENERAL.—The Secretary may establish a program,
in consultation with the Secretary of Labor, consisting of
awarding demonstration grants to States to streamline State
requirements and procedures in order to assist veterans who
held certain military occupational specialties related to medical
care or who have completed certain medical training while
serving in the Armed Forces of the United States to meet certification, licensure, and other requirements applicable to civilian health care professions (such as emergency medical technician, paramedic, licensed practical nurse, registered nurse,
physical therapy assistant, or physician assistant professions)
in the State.
(2) CONSULTATION AND COLLABORATION.—In determining
the eligible military occupational specialties or training courses
and the assistance required as described in paragraph (1), the
Secretary shall consult with the Secretary of Defense, the Secretary of Veterans Affairs, and the Assistant Secretary of
Labor for Veterans’ Employment and Training, and shall collaborate with the initiatives carried out under section 4114 of
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title 38, United States Code, and sections 1142 through 1144
of title 10, United States Code.
(b) USE OF FUNDS.—Amounts received as a demonstration
grant under this section shall be used to—
(1) prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—
(A) determining the extent to which the requirements
for the education, training, and skill level of civilian health
care professions (such as emergency medical technicians,
paramedics, licensed practical nurses, registered nurses,
physical therapy assistants, or physician assistants) in the
State are equivalent to requirements for the education,
training, and skill level of veterans who served in medical
related fields while a member of the Armed Forces of the
United States; and
(B) identifying methods, such as waivers, for veterans
who served in medical related fields while a member of the
Armed Forces of the United States to forgo or meet any
such equivalent State requirements; and
(2) if necessary to meet workforce shortages or address
gaps in education, training, or skill level to meet certification,
licensure or other requirements applicable to becoming a civilian health care professional (such as an emergency medical
technician, paramedic, licensed practical nurse, registered
nurse, physical therapy assistant, or physician assistant professions) in the State, develop or expand career pathways at institutions of higher education to support veterans in meeting
such requirements.
(c) REPORT.—Upon the completion of the demonstration program under this section, the Secretary shall submit to Congress a
report on the program.
(d) FUNDING.—No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section
shall be carried out using amounts otherwise available for such
purpose.
(e) SUNSET.—The demonstration program under this section
shall not exceed 5 years.
FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
SEC. 316. 9 ø247a¿ (a) Subject to available appropriations, the
Secretary, acting through the National Institute of Mental Health,
the National Institutes of Health, and the Administration on
Aging, shall promote the establishment of family support groups to
provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer’s disease or a related
memory disorder and members of the families of such individuals.
In promoting the establishment of such groups, the Secretary shall
give priority to—
(1) university medical centers and other appropriate health
care facilities which receive Federal funds from the Secretary
9 With respect to section 315, subsection (d) of such section provided as follows: ‘‘This section
shall cease to exist on March 31, 1989.’’. See section 1 of Public Law 100–471 (102 Stat. 2284).
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and which conduct research on Alzheimer’s disease or provide
services to individuals with such disease; and
(2) community-based programs which receive funds from
the Secretary, acting through the Administration on Aging.
(b) The Secretary shall promote the establishment of a national
network to coordinate the family support groups described in subsection (a).
PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES
SEC. 317. ø247b¿ (a) The Secretary may make grants to States,
and in consultation with State health authorities, to political subdivisions of States and to other public entities to assist them in
meeting the costs of establishing and maintaining preventive
health service programs.
(b) No grant may be made under subsection (a) unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted
in such manner as the Secretary shall by regulation prescribe and
shall provide—
(1) a complete description of the type and extent of the
program for which the applicant is seeking a grant under subsection (a);
(2) with respect to each such program (A) the amount of
Federal, State, and other funds obligated by the applicant in
its latest annual accounting period for the provision of such
program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such
services in such program, and (D) if the applicant proposes
changes in the provision of the services in such program, the
priorities of such proposed changes, reasons for such changes,
and the amount of Federal funds needed by the applicant to
make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under
subsection (a) will be provided in a manner consistent with the
State health plan in effect under section 1524(c) and in those
cases where the applicant is a State, that such program will
be provided, where appropriate, in a manner consistent with
any plans in effect under an application approved under section 315;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting
procedures as the Secretary by regulation prescribes to assure
the proper disbursement of and accounting for funds received
under grants under subsection (a);
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such
information as the Secretary may by regulation prescribe) as
the Secretary may reasonably require and keep such records
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and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c)(1) The Secretary shall not approve an application submitted
under subsection (b) for a grant for a program for which a grant
was previously made under subsection (a) unless the Secretary determines—
(A) the program for which the application was submitted
is operating effectively to achieve its stated purpose,
(B) the applicant complied with the assurances provided
the Secretary when applying for such previous grant, and
(C) the applicant will comply with the assurances provided
with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) to determine if the program assisted by such grant is operating effectively
to achieve its stated purposes and if the recipient is in compliance
with the assurances provided the Secretary when applying for such
grant.
(d) The amount of a grant under subsection (a) shall be determined by the Secretary. Payments under such grants may be made
in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments on account of underpayments or
overpayments, and in such installments and on such terms and
conditions as the Secretary finds necessary to carry out the purposes of such grants.
(e) The Secretary, at the request of a recipient of a grant under
subsection (a), may reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the
grant recipient, and
(2) the amount of the pay, allowances, and travel expenses
of any officer or employee of the Government when detailed to
the grant recipient and the amount of any other costs incurred
in connection with the detail of such officer or employee.
When the furnishing of such supplies or equipment or the detail of
such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out
a program with respect to which the grant under subsection (a) is
made. The amount by which any such grant is so reduced shall be
available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on
which the reduction of such grant is based, and such amount shall
be deemed as part of the grant and shall be deemed to have been
paid to the grant recipient.
(f)(1) Each recipient of a grant under subsection (a) shall keep
such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such
recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the
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amount of that portion of the cost of the undertaking supplied by
other sources, and such other records as will facilitate an effective
audit.
(2) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall have
access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) that are pertinent to such grants.
(g)(1) Nothing in this section shall limit or otherwise restrict
the use of funds which are granted to a State or to an agency or
a political subdivision of a State under provisions of Federal law
(other than this section) and which are available for the conduct of
preventive health service programs from being used on connection
with programs assisted through grants under subsection (a).
(2) Nothing in this section shall be construed to require any
State or any agency or political subdivision of a State to have a
preventive health service program which would require any person,
who objects to any treatment provided under such a program, to be
treated or to have any child or ward treated under such program.
(h) The Secretary shall include, as part of the report required
by section 1705, a report on the extent of the problems presented
by the diseases and conditions referred to in subsection (j) on the
amount of funds obligated under grants under subsection (a) in the
preceding fiscal year for each of the programs listed in subsection
(j); and on the effectiveness of the activities assisted under grants
under subsection (a) in controlling such diseases and conditions.
(i) The Secretary may provide technical assistance to States,
State health authorities, and other public entities in connection
with the operation of their preventive health service programs.
(j)(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph
(2), for grants under subsections (a) and (k)(1) for preventive health
service programs to immunize without charge children, adolescents,
and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary. Not more
than 10 percent ot the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants
under subsection (k)(1) for such fiscal year.
(2) For grants under subsection (a) for preventive health service programs for the provision without charge of immunizations
with vaccines approved for use, and recommended for routine use,
there are authorized to be appropriated such sums as may be necessary.
(k)(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities
for—
(A) research into the prevention and control of diseases
that may be prevented through vaccination;
(B) demonstration projects for the prevention and control
of such diseases;
(C) public information and education programs for the prevention and control of such diseases;
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(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for
health professionals (including allied health personnel);
(E) planning, implementation, and evaluation of activities
to address vaccine-preventable diseases, including activities
to—
(i) identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through
improved data collection and analysis;
(ii) pilot innovative approaches to improve vaccination
rates in communities and among populations with low
rates of vaccination;
(iii) reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;
(iv) partner with community organizations and health
care providers to develop and deliver evidence-based interventions, including culturally and linguistically appropriate interventions, to increase vaccination rates;
(v) improve delivery of evidence-based vaccine-related
information to parents and others; and
(vi) improve the ability of State, local, Tribal, and territorial public health departments to engage communities
at high risk for outbreaks related to vaccine-preventable
diseases, including, as appropriate, with local educational
agencies, as defined in section 8101 of the Elementary and
Secondary Education Act of 1965; and
(F) research related to strategies for improving awareness
of scientific and evidence-based vaccine-related information, including for communities with low rates of vaccination, in order
to understand barriers to vaccination, improve vaccination
rates, and assess the public health outcomes of such strategies.
(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases
and conditions;
(B) demonstration projects for the prevention and control
of such diseases and conditions;
(C) public information and education programs for the prevention and control of such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at
such time, and containing such information as the Secretary may
by regulation prescribe.
(4) Subsections (d), (e), and (f) shall apply to grants under this
subsection in the same manner as such subsections apply to grants
under subsection (a).
(l) AUTHORITY TO PURCHASE RECOMMENDED VACCINES FOR
ADULTS.—
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(1) IN GENERAL.—The Secretary may negotiate and enter
into contracts with manufacturers of vaccines for the purchase
and delivery of vaccines for adults as provided for under subsection (e).
(2) STATE PURCHASE.—A State may obtain additional quantities of such adult vaccines (subject to amounts specified to
the Secretary by the State in advance of negotiations) through
the purchase of vaccines from manufacturers at the applicable
price negotiated by the Secretary under this subsection.
(m) DEMONSTRATION PROGRAM TO IMPROVE IMMUNIZATION
COVERAGE.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to States to
improve the provision of recommended immunizations for children, adolescents, and adults through the use of evidencebased, population-based interventions for high-risk populations.
(2) STATE PLAN.—To be eligible for a grant under paragraph (1), a State shall submit to the Secretary an application
at such time, in such manner, and containing such information
as the Secretary may require, including a State plan that describes the interventions to be implemented under the grant
and how such interventions match with local needs and capabilities, as determined through consultation with local authorities.
(3) USE OF FUNDS.—Funds received under a grant under
this subsection shall be used to implement interventions that
are recommended by the Task Force on Community Preventive
Services (as established by the Secretary, acting through the
Director of the Centers for Disease Control and Prevention) or
other evidence-based interventions, including—
(A) providing immunization reminders or recalls for
target populations of clients, patients, and consumers;
(B) educating targeted populations and health care
providers concerning immunizations in combination with
one or more other interventions;
(C) reducing out-of-pocket costs for families for vaccines and their administration;
(D) carrying out immunization-promoting strategies
for participants or clients of public programs, including assessments of immunization status, referrals to health care
providers, education, provision of on-site immunizations, or
incentives for immunization;
(E) providing for home visits that promote immunization through education, assessments of need, referrals, provision of immunizations, or other services;
(F) providing reminders or recalls for immunization
providers;
(G) conducting assessments of, and providing feedback
to, immunization providers;
(H) any combination of one or more interventions described in this paragraph; or
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PUBLIC HEALTH SERVICE ACT
Sec. 317A
(I) immunization information systems to allow all
States to have electronic databases for immunization
records.
(4) CONSIDERATION.—In awarding grants under this subsection, the Secretary shall consider any reviews or recommendations of the Task Force on Community Preventive
Services.
(5) EVALUATION.—Not later than 3 years after the date on
which a State receives a grant under this subsection, the State
shall submit to the Secretary an evaluation of progress made
toward improving immunization coverage rates among highrisk populations within the State.
(6) REPORT TO CONGRESS.—Not later than 4 years after the
date of enactment of the Affordable Health Choices Act, the
Secretary shall submit to Congress a report concerning the effectiveness of the demonstration program established under
this subsection together with recommendations on whether to
continue and expand such program.
(7) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this subsection, such sums
as may be necessary for each of fiscal years 2010 through 2014.
(n) VACCINATION DATA.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and enhance, and, as appropriate, establish and improve, programs and conduct activities to collect, monitor, and analyze vaccination coverage data to assess levels of protection from vaccinepreventable diseases, including by assessing factors contributing to
underutilization of vaccines and variations of such factors, and
identifying communities at high risk of outbreaks associated with
vaccine-preventable diseases.
SCREENINGS, REFERRALS, AND EDUCATION REGARDING LEAD
POISONING
SEC. 317A. ø247b–1¿ (a) AUTHORITY FOR GRANTS.—
(1) IN GENERAL.—Subject to paragraph (2), the Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels; and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood lead poisoning.
(2) AUTHORITY REGARDING CERTAIN ENTITIES.—With respect to a geographic area with a need for activities authorized
in paragraph (1), in any case in which neither the State nor
the political subdivision in which such area is located has applied for a grant under paragraph (1), the Secretary may make
a grant under such paragraph to any grantee under section
329, 330, or 340A for carrying out such activities in the area.
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(3) PROVISION OF ALL SERVICES AND ACTIVITIES THROUGH
EACH GRANTEE.—In making grants under paragraph (1), the
Secretary shall ensure that each of the activities described in
such paragraph is provided through each grantee under such
paragraph. The Secretary may authorize such a grantee to provide the services and activities directly, or through arrangements with other providers.
(b) STATUS AS MEDICAID PROVIDER.—
(1) IN GENERAL.—Subject to paragraph (2), the Secretary
may not make a grant under subsection (a) unless, in the case
of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the
Social Security Act for the State involved—
(A) the applicant for the grant will provide the service
directly, and the applicant has entered into a participation
agreement under the State plan and is qualified to receive
payments under such plan; or
(B) the applicant will enter into an agreement with a
provider under which the provider will provide the service,
and the provider has entered into such a participation
agreement and is qualified to receive such payments.
(2) WAIVER REGARDING CERTAIN SECONDARY AGREEMENTS.—
(A) In the case of a provider making an agreement
pursuant to paragraph (1)(B) regarding the provision of
services, the requirement established in such paragraph
regarding a participation agreement shall be waived by the
Secretary if the provider does not, in providing health care
services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement
under any insurance policy or under any Federal or State
health benefits plan.
(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for
a waiver under such subparagraph shall be made without
regard to whether the provider accepts voluntary donations regarding the provision of services to the public.
(c) PRIORITY IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give priority to applications for programs that will serve areas with a high incidence of elevated blood
lead levels in infants and children.
(d) GRANT APPLICATION.—No grant may be made under subsection (a), unless an application therefor has been submitted to,
and approved by, the Secretary. Such an application shall be in
such form and shall be submitted in such manner as the Secretary
shall prescribe and shall include each of the following:
(1) A complete description of the program which is to be
provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include
educational programs designed to—
(A) communicate to parents, educators, and local
health officials the significance and prevalence of lead poisoning in infants and children (including the sources of
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lead exposure, the importance of screening young children
for lead, and the preventive steps that parents can take in
reducing the risk of lead poisoning) which the program is
designed to detect and prevent; and
(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning
and research (including the health consequences, if any, of
low-level lead burden; the prevalence of lead poisoning
among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other
interventions available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and
children screened for elevated blood lead levels, the number of
infants and children who were found to have elevated blood
lead levels, the number and type of medical referrals made for
such infants and children, the outcome of such referrals, and
other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as
the Secretary may require.
(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) with related activities and services carried out in
the State by grantees under title V or XIX of the Social Security Act.
(6) Assurances satisfactory to the Secretary that Federal
funds made available under such a grant for any period will
be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds
that would, in the absence of such Federal funds, be made
available for the program for which the grant is to be made
and will in no event supplant such State, local, and other nonFederal funds.
(7) Assurances satisfactory to the Secretary that the applicant will ensure complete and consistent reporting of all blood
lead test results from laboratories and health care providers to
State and local health departments in accordance with guidelines of the Centers for Disease Control and Prevention for
standardized reporting as described in subsection (m).
(8) Such other information as the Secretary may prescribe.
(e) RELATIONSHIP TO SERVICES AND ACTIVITIES UNDER OTHER
PROGRAMS.—
(1) IN GENERAL.—A recipient of a grant under subsection
(a) may not make payments from the grant for any service or
activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service
or activity—
(A) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(B) by an entity that provides health services on a prepaid basis.
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(2) APPLICABILITY TO CERTAIN SECONDARY AGREEMENTS
FOR PROVISION OF SERVICES.—Paragraph (1) shall not apply in
the case of a provider through which a grantee under subsection (a) provides services under such subsection if the Secretary has provided a waiver under subsection (b)(2) regarding
the provider.
(f) METHOD AND AMOUNT OF PAYMENT.—The Secretary shall
determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of
estimates or by way of reimbursement, with necessary adjustments
on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. Not more than 10
percent of any grant may be obligated for administrative costs.
(g) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The Secretary, at the request of a recipient of a grant under subsection (a),
may reduce the amount of such grant by—
(1) the fair market value of any supplies or equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel expenses
of any officer or employee of the Government when detailed to
the grant recipient and the amount of any other costs incurred
in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of
such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out
a program with respect to which the grant under subsection (a) is
made. The amount by which any such grant is so reduced shall be
available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on
which the reduction of such grant is based, and such amount shall
be deemed as part of the grant and shall be deemed to have been
paid to the grant recipient.
(h) RECORDS.—Each recipient of a grant under subsection (a)
shall keep such records as the Secretary shall prescribe, including
records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the
amount of that portion of the cost of the undertaking supplied by
other sources, and such other records as will facilitate an effective
audit.
(i) AUDIT AND EXAMINATION OF RECORDS.—The Secretary and
the Comptroller General of the United States, or any of their duly
authorized representatives, shall have access for the purpose of
audit and examination to any books, documents, papers, and
records of the recipient of a grant under subsection (a), that are
pertinent to such grant.
(j) ANNUAL REPORT.—
(1) IN GENERAL.—Not later than May 1 of each year, the
Secretary shall submit to the Congress a report on the effectiveness during the preceding fiscal year of programs carried
out with grants under subsection (a) and of any programs that
are carried out by the Secretary pursuant to subsection (l)(2).
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(2) CERTAIN REQUIREMENTS.—Each report under paragraph (1) shall include, in addition to any other information
that the Secretary may require, the following information:
(A) The number of infants and children screened.
(B) Demographic information on the population of infants and children screened, including the age and racial
or ethnic status of such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the
blood lead levels of the infants and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests
from laboratories and health care providers to State and
local health departments.
(G) A comparison of the data provided pursuant to
subparagraphs (A) through (F) with the equivalent data, if
any, provided in the report under paragraph (1) preceding
the report involved.
(k) INDIAN TRIBES.—For purposes of this section, the term ‘‘political subdivision’’ includes Indian tribes.
(l) FUNDING.—
(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose
of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may
be necessary for each of the fiscal years 1994 through 2005.
(2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts
appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out
programs regarding the activities described in subsection (a) in
addition to the program of grants established in such subsection.
(m) GUIDELINES FOR STANDARDIZED REPORTING.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop national guidelines for the uniform reporting of all blood lead test results to State and local
health departments.
EDUCATION, TECHNOLOGY ASSESSMENT, AND EPIDEMIOLOGY
REGARDING LEAD POISONING
SEC. 317B. ø247b–3¿ (a) PREVENTION.—
(1) PUBLIC EDUCATION.—The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall carry out a program to educate health professionals and
paraprofessionals and the general public on the prevention of
lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information concerning the health effects of low-level lead toxicity, the causes
of lead poisoning, and the primary and secondary preventive
measures that may be taken to prevent such poisoning.
(2) INTERAGENCY TASK FORCE.—
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44
(A) Not later than 6 months after the date of the enactment of the Preventive Health Amendments of 1992 10,
the Secretary shall establish a council to be known as the
Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the ‘‘Task Force’’).
The Task Force shall coordinate the efforts of Federal
agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the chair of
the Task Force;
(ii) the Secretary of Housing and Urban Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials specified in
clauses (i) through (iii), as selected by the officials respectively.
(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as
members of the Task Force, including—
(I) the plan of the Secretary of Health and
Human Services entitled ‘‘Strategic Plan for the
Elimination of Lead Poisoning’’, dated February
21, 1991;
(II) the plan of the Secretary of Housing and
Urban Development entitled ‘‘Comprehensive and
Workable Plan for the Abatement of Lead-Based
Paint in Privately Owned Housing’’, dated December 7, 1990; and
(III) the strategy of the Administrator of the
Environmental Protection Agency entitled ‘‘Strategy for Reducing Lead Exposures’’, dated February 21, 1991;
(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of research
and education concerning lead poisoning;
(v) identify the practical and technological constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive review of
Federal programs providing assistance to prevent lead
poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources
of the Senate and the Committee on the Environment
and Public Works of the Senate, and to the Committee
on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as
10 Enacted
October 27, 1992.
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PUBLIC HEALTH SERVICE ACT
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a result of such review and that contains the recommendations of the Task Force on the programs and
policies with respect to which the Task Force is established, including related budgetary recommendations;
and
(vii) annually review and coordinate departmental
and agency budgetary requests with respect to all lead
poisoning prevention activities of the Federal Government.
(b) TECHNOLOGY ASSESSMENT AND EPIDEMIOLOGY.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—
(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for
each State;
(3) provide for the collection of data on the incidence and
prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such
poisoning (including racial and ethnic status), and on the
source of payment for treatment for such poisoning (including
the extent to which insurance has paid for such treatment);
and
(4) provide for any applied research necessary to improve
the effectiveness of programs for the prevention of lead poisoning in infants and children.
NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL
DISABILITIES
SEC. 317C. ø247b–4¿ (a) IN GENERAL.—
(1) NATIONAL CENTER.—There is established within the
Centers for Disease Control and Prevention a center to be
known as the National Center on Birth Defects and Developmental Disabilities (referred to in this section as the ‘‘Center’’),
which shall be headed by a director appointed by the Director
of the Centers for Disease Control and Prevention.
(2) GENERAL DUTIES.—The Secretary shall carry out programs—
(A) to collect, analyze, and make available data on
birth defects, developmental disabilities, and disabilities
and health (in a manner that facilitates compliance with
subsection (c)(2)), including data on the causes of such defects and disabilities and on the incidence and prevalence
of such defects and disabilities;
(B) to operate regional centers for the conduct of applied epidemiological research on the prevention of such
defects and disabilities;
(C) to provide information and education to the public
on the prevention of such defects and disabilities;
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46
(D) to conduct research on and to promote the prevention of such defects and disabilities, and secondary health
conditions among individuals with disabilities; and
(E) to support a National Spina Bifida Program to prevent and reduce suffering from the Nation’s most common
permanently disabling birth defect.
(3) FOLIC ACID.—The Secretary shall carry out section
317J through the Center.
(4) CERTAIN PROGRAMS.—
(A) TRANSFERS.—All programs and functions described
in subparagraph (B) are transferred to the Center, effective upon the expiration of the 180-day period beginning
on the date of the enactment of the Children’s Health Act
of 2000 11.
(B) RELEVANT PROGRAMS.—The programs and functions described in this subparagraph are all programs and
functions that—
(i) relate to birth defects; folic acid; cerebral palsy;
intellectual disabilities; child development; newborn
screening; autism; fragile X syndrome; fetal alcohol
syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases, disorders, or conditions as determined the Secretary; and
(ii) were carried out through the National Center
for Environmental Health as of the day before the
date of the enactment of the Act referred to in subparagraph (A).
(C) RELATED TRANSFERS.—Personnel employed in connection with the programs and functions specified in subparagraph (B), and amounts available for carrying out the
programs and functions, are transferred to the Center, effective upon the expiration of the 180-day period beginning
on the date of the enactment of the Act referred to in subparagraph (A). Such transfer of amounts does not affect
the period of availability of the amounts, or the availability of the amounts with respect to the purposes for
which the amounts may be expended.
(b) GRANTS AND CONTRACTS.—
(1) IN GENERAL.—In carrying out subsection (a), the Secretary may make grants to and enter into contracts with public
and nonprofit private entities.
(2) SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.—
(A) Upon the request of a recipient of an award of a
grant or contract under paragraph (1), the Secretary may,
subject to subparagraph (B), provide supplies, equipment,
and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and,
for such purposes, may detail to the recipient any officer
or employee of the Department of Health and Human
Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of pay11 Public
Law 106–310, enacted October 17, 2000.
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Sec. 317C
ments under the award involved by an amount equal to
the costs of detailing personnel and the fair market value
of any supplies, equipment, or services provided by the
Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend
the amounts withheld.
(3) APPLICATION FOR AWARD.—The Secretary may make an
award of a grant or contract under paragraph (1) only if an application for the award is submitted to the Secretary and the
application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the purposes for
which the award is to be made.
(c) BIENNIAL REPORT.—Not later than February 1 of fiscal year
1999 and of every second such year thereafter, the Secretary shall
submit to the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the
Senate, a report that, with respect to the preceding 2 fiscal years—
(1) contains information regarding the incidence and prevalence of birth defects, developmental disabilities, and the
health status of individuals with disabilities and the extent to
which these conditions have contributed to the incidence and
prevalence of infant mortality and affected quality of life;
(2) contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics,
non-Hispanic whites, Blacks, Native Americans, and Asian
Americans);
(3) contains an assessment of the extent to which various
approaches of preventing birth defects, developmental disabilities, and secondary health conditions among individuals with
disabilities have been effective;
(4) describes the activities carried out under this section;
(5) contains information on the incidence and prevalence of
individuals living with birth defects and disabilities or developmental disabilities, information on the health status of individuals with disabilities, information on any health disparities experienced by such individuals, and recommendations for improving the health and wellness and quality of life of such individuals;
(6) contains a summary of recommendations from all birth
defects research conferences sponsored by the Centers for Disease Control and Prevention, including conferences related to
spina bifida; and
(7) contains any recommendations of the Secretary regarding this section.
(d) APPLICABILITY OF PRIVACY LAWS.—The provisions of this
section shall be subject to the requirements of section 552a of title
5, United States Code. All Federal laws relating to the privacy of
information shall apply to the data and information that is collected under this section.
(e) ADVISORY COMMITTEE.—Notwithstanding any other provision of law, the members of the advisory committee appointed by
the Director of the National Center for Environmental Health that
have expertise in birth defects, developmental disabilities, and disFebruary 1, 2024
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48
abilities and health shall be transferred to and shall advise the National Center on Birth Defects and Developmental Disabilities effective on the date of enactment of the Birth Defects and Developmental Disabilities Prevention Act of 2003.
(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of fiscal years 2003
through 2007.
PREVENTIVE HEALTH MEASURES WITH RESPECT TO PROSTATE CANCER
SEC. 317D. ø247b–5¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments
for the purpose of enabling such States and departments to carry
out programs that may include the following:
(1) To identify factors that influence the attitudes or levels
of awareness of men and health care practitioners regarding
screening for prostate cancer.
(2) To evaluate, in consultation with the Agency for Health
Care Policy and Research and the National Institutes of
Health, the effectiveness of screening strategies for prostate
cancer.
(3) To identify, in consultation with the Agency for Health
Care Policy and Research, issues related to the quality of life
for men after prostrate cancer screening and followup.
(4) To develop and disseminate public information and
education programs for prostate cancer, including appropriate
messages about the risks and benefits of prostate cancer
screening for the general public, health care providers, policy
makers and other appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary, who shall take
into consideration recommendations by the United States Preventive Services Task Force and shall seek input, where appropriate, from professional societies and other private and public
entities, that there is sufficient consensus on the effectiveness
of prostate cancer screening—
(A) to screen men for prostate cancer as a preventive
health measure;
(B) to provide appropriate referrals for the medical
treatment of men who have been screened under subparagraph (A) and to ensure, to the extent practicable, the provision of appropriate followup services and support services such as case management;
(C) to establish mechanisms through which State and
local health departments can monitor the quality of
screening procedures for prostate cancer, including the interpretation of such procedures; and
(D) to improve, in consultation with the Health Resources and Services Administration, the education, training, and skills of health practitioners (including approFebruary 1, 2024
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PUBLIC HEALTH SERVICE ACT
Sec. 317D
priate allied health professionals) in the detection and control of prostate cancer.
(8) To evaluate activities conducted under paragraphs (1)
through (7) through appropriate surveillance or program monitoring activities.
(b) REQUIREMENT OF MATCHING FUNDS.—
(1) IN GENERAL.—The Secretary may not make a grant
under subsection (a) unless the applicant involved agrees, with
respect to the costs to be incurred by the applicant in carrying
out the purpose described in such section, to make available
non-Federal contributions (in cash or in kind under paragraph
(2)) toward such costs in an amount equal to not less than $1
for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from
public or private entities.
(2) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—
(A) Non-Federal contributions required in paragraph
(1) may be in cash or in kind, fairly evaluated, including
equipment or services (and excluding indirect or overhead
costs). Amounts provided by the Federal Government, or
services assisted or subsidized to any significant extent by
the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) In making a determination of the amount of nonFederal contributions for purposes of paragraph (1), the
Secretary may include only non-Federal contributions in
excess of the average amount of non-Federal contributions
made by the applicant involved toward the purpose described in subsection (a) for the 2-year period preceding
the fiscal year for which the applicant involved is applying
to receive a grant under such subsection.
(C) In making a determination of the amount of nonFederal contributions for purposes of paragraph (1), the
Secretary shall, subject to subparagraphs (A) and (B) of
this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act by
the applicant involved toward the purpose described in
paragraphs (1) and (2) of subsection (a).
(c) EDUCATION ON SIGNIFICANCE OF EARLY DETECTION.—The
Secretary may not make a grant under subsection (a) unless the
applicant involved agrees that, in carrying out subsection (a)(3),
the applicant will carry out education programs to communicate to
men, and to local health officials, the significance of the early detection of prostate cancer.
(d) REQUIREMENT OF PROVISION OF ALL SERVICES BY DATE
CERTAIN.—The Secretary may not make a grant under subsection
(a) unless the applicant involved agrees—
(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less
than 60 percent of the grant is expended to provide each of the
services or activities described in paragraphs (1) and (2) of
such subsection;
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50
(2) to ensure that, by the end of any second fiscal year of
payments pursuant to the grant, each of the services or activities described in such subsection is provided; and
(3) to ensure that not more than 40 percent of the grant
is expended to provide the services or activities described in
paragraphs (3) through (6) of such section 12.
(e) ADDITIONAL REQUIRED AGREEMENTS.—
(1) PRIORITY FOR LOW-INCOME MEN.—The Secretary may
not make a grant under subsection (a) unless the applicant involved agrees that low-income men, and men at risk of prostate cancer, will be given priority in the provision of services
and activities pursuant to paragraphs (1) and (2) of such subsection.
(2) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The
Secretary may not make a grant under subsection (a) unless
the applicant involved agrees that, if a charge is imposed for
the provision of services or activities under the grant, such
charge—
(A) will be made according to a schedule of charges
that is made available to the public;
(B) will be adjusted to reflect the income of the man
involved; and
(C) will not be imposed on any man with an income
of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and
Budget and revised by the Secretary in accordance with
section 673(2) of the Omnibus Budget Reconciliation Act of
1981.
(3) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER
PROGRAMS.—The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant
will not be expended to make payment for any item or service
to the extent that payment has been made, or can reasonably
be expected to be made, with respect to such item or service—
(A) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) COORDINATION WITH OTHER PROSTATE CANCER PROGRAMS.—The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the services and activities funded through the grant will be coordinated
with other Federal, State, and local prostate cancer programs.
(5) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make a grant under subsection (a) unless the
applicant involved agrees that not more than 10 percent of the
grant will be expended for administrative expenses with respect to the grant.
(6) RESTRICTIONS ON USE OF GRANT.—The Secretary may
not make a grant under subsection (a) unless the applicant in12 So
in law. Probably should be ‘‘subsection’’.
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PUBLIC HEALTH SERVICE ACT
Sec. 317D
volved agrees that the grant will not be expended to provide
inpatient hospital services for any individual.
(7) RECORDS AND AUDITS.—The Secretary may not make a
grant under subsection (a) unless the applicant involved agrees
that—
(A) the applicant will establish such fiscal control and
fund accounting procedures as may be necessary to ensure
the proper disbursal of, and accounting for, amounts received by the applicant under such section; and
(B) upon request, the applicant will provide records
maintained pursuant to paragraph (1) to the Secretary or
the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.
(f) REPORTS TO SECRETARY.—The Secretary may not make a
grant under subsection (a) unless the applicant involved agrees to
submit to the Secretary such reports as the Secretary may require
with respect to the grant.
(g) DESCRIPTION OF INTENDED USES OF GRANT.—The Secretary
may not make a grant under subsection (a) unless—
(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the applicant 13 with a need for the services or activities described in subsection (a);
(3) the description provides information relating to the
services and activities to be provided, including a description
of the manner in which the services and activities will be coordinated with any similar services or activities of public or
nonprivate entities; and
(4) the description provides assurances that the grant
funds will be used in the most cost-effective manner.
(h) REQUIREMENT OF SUBMISSION OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an application for the grant is submitted to the Secretary, the application
contains the description of intended uses required in subsection (g),
and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) METHOD AND AMOUNT OF PAYMENT.—The Secretary shall
determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of
estimates or by way of reimbursement, with necessary adjustments
on account of the underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds
necessary to carry out the purposes of such grants.
(j) TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND
SERVICES IN LIEU OF GRANT FUNDS.—
(1) TECHNICAL ASSISTANCE.—The Secretary may provide
training and technical assistance with respect to the planning,
development, and operation of any program or service carried
out pursuant to subsection (a). The Secretary may provide such
13 So
in law.
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technical assistance directly or through grants to, or contracts
with, public and private entities.
(2) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT
FUNDS.—
(A) Upon the request of an applicant receiving a grant
under subsection (a), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services
for the purpose of aiding the applicant in carrying out such
section and, for such purpose, may detail to the applicant
any officer or employee of the Department of Health and
Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) to the applicant involved by an amount equal to the costs of detailing
personnel (including pay, allowances, and travel expenses)
and the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary shall, for
the payment of expenses incurred in complying with such
request, expend the amounts withheld.
(k) DEFINITION.—For purposes of this section, the term ‘‘units
of local government’’ includes Indian tribes.
(l) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for
fiscal year 1993, and such sums as may be necessary for each
of the fiscal years 1994 through 2004.
(2) ALLOCATION FOR TECHNICAL ASSISTANCE.—Of the
amounts appropriated under paragraph (1) for a fiscal year,
the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1).
NATIONAL STRATEGY FOR COMBATING AND ELIMINATING
TUBERCULOSIS
SEC. 317E. ø247b–6¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions, and
other public entities for preventive health service programs for the
prevention, control, and elimination of tuberculosis.
(b) RESEARCH AND DEVELOPMENT; DEMONSTRATION PROJECTS;
EDUCATION AND TRAINING.—With respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may,
directly or through grants to public or nonprofit private entities,
carry out the following:
(1) Research, with priority given to research and development concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and research concerning cases of tuberculosis that affect certain populations at risk for tuberculosis.
(2) Research and development and related activities to develop new tools for the elimination of tuberculosis, including
drugs, diagnostics, vaccines, and public health interventions,
such as directly observed therapy and non-pharmaceutical
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Sec. 317E
intervention, and methods to enhance detection and response
to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice.
(3) Demonstration projects for—
(A) the development of regional capabilities to prevent,
control, and eliminate tuberculosis and prevent multidrug
resistant and extensively drug resistant strains of tuberculosis;
(B) the intensification of efforts to reduce health disparities in the incidence of tuberculosis;
(C) the intensification of efforts to control tuberculosis
along the United States-Mexico border and among United
States-Mexico binational populations, including through
expansion of the scope and number of programs that—
(i) detect and treat binational cases of tuberculosis; and
(ii) treat high-risk cases of tuberculosis referred
from Mexican health departments;
(D) the intensification of efforts to prevent, detect, and
treat tuberculosis among foreign-born persons who are in
the United States;
(E) the intensification of efforts to prevent, detect, and
treat tuberculosis among populations and settings documented as having a high risk for tuberculosis; and
(F) tuberculosis detection, control, and prevention.
(4) Public information and education activities.
(5) Education, training, clinical skills improvement activities, and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees.
(6) Support of Centers to carry out activities under paragraphs (1) through (4).
(7) Collaboration with international organizations and foreign countries in carrying out such activities.
(8) Develop, enhance, and expand information technologies
that support tuberculosis control including surveillance and
database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary.
(c) COOPERATION WITH PROVIDERS OF PRIMARY HEALTH SERVICES.—The Secretary may make a grant under subsection (a) or (b)
only if the applicant for the grant agrees that, in carrying out activities under the grant, the applicant will cooperate with public
and nonprofit private providers of primary health services or substance abuse services, including entities receiving assistance under
section 329, 330, or 340A or under title V or XIX.
(d) APPLICATION FOR GRANT.—
(1) IN GENERAL.—The Secretary may make a grant under
subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application, subject to paragraph (2), is in such form, is made in such manner, and conFebruary 1, 2024
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54
tains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection
involved.
(2) PLAN FOR PREVENTION, CONTROL, AND ELIMINATION.—
The Secretary may make a grant under subsection (a) only if
the application under paragraph (1) contains a plan regarding
the prevention, control, and elimination of tuberculosis in the
geographic area with respect to which the grant is sought.
(3) DETERMINATION OF AMOUNT OF NONFEDERAL CONTRIBUTIONS.—
(A) PRIORITY.—In awarding grants under subsection
(a) or (b), the Secretary shall give highest priority to an
applicant that provides assurances that the applicant will
contribute non-Federal funds to carry out activities under
this section, which may be provided directly or through donations from public or private entities and may be in cash
or in kind, including equipment or services.
(B) FEDERAL AMOUNTS NOT TO BE INCLUDED AS CONTRIBUTIONS.—Amounts provided by the Federal Government, or services assisted or subsidized to any significant
extent by the Federal Government, may not be included in
determining the amount of non-Federal contributions as
described in subparagraph (A).
(e) SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
(1) IN GENERAL.—Upon the request of a grantee under subsection (a) or (b), the Secretary may, subject to paragraph (2),
provide supplies, equipment, and services for the purpose of
aiding the grantee in carrying out the subsection involved and,
for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services.
(2) CORRESPONDING REDUCTION IN PAYMENTS.—With respect to a request described in paragraph (1), the Secretary
shall reduce the amount of payments under the grant involved
by an amount equal to the costs of detailing personnel and the
fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment
of expenses incurred in complying with such request, expend
the amounts withheld.
(f) ADVISORY COUNCIL.—
(1) IN GENERAL.—The Secretary shall establish an advisory
council to be known as the Advisory Council for the Elimination of Tuberculosis (in this subsection referred to as the
‘‘Council’’).
(2) DUTIES.—The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the
Secretary. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—
(A) coordinating the activities of the Department of
Health and Human Services and other Federal agencies
that relate to the disease, including activities under subsection (b);
(B) responding rapidly and effectively to emerging
issues in tuberculosis; and
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(C) efficiently utilizing the Federal resources involved.
(3) COMPREHENSIVE PLAN.—
(A) IN GENERAL.—In carrying out paragraph (2), the
Council shall make or update recommendations on the development, revision, and implementation of a comprehensive plan to eliminate tuberculosis in the United States.
(B) CONSULTATION.—In carrying out subparagraph
(A), the Council may consult with appropriate public and
private entities, which may, subject to the direction or discretion of the Secretary, include—
(i) individuals who are scientists, physicians,
laboratorians, and other health professionals, who are
not officers or employees of the Federal Government
and who represent the disciplines relevant to tuberculosis elimination;
(ii) members of public-private partnerships or private entities established to address the elimination of
tuberculosis;
(iii) members of national and international nongovernmental organizations whose purpose is to eliminate tuberculosis;
(iv) members from the general public who are
knowledgeable with respect to tuberculosis elimination
including individuals who have or have had tuberculosis; and
(v) scientists, physicians, laboratorians, and other
health professionals who reside in a foreign country
with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
(C) CERTAIN COMPONENTS OF PLAN.—In carrying out
subparagraph (A), the Council shall, subject to the direction or discretion of the Secretary—
(i) consider recommendations for the involvement
of the United States in continuing global and crossborder tuberculosis control activities in countries
where a high incidence of tuberculosis directly affects
the United States; and
(ii) review the extent to which progress has been
made toward eliminating tuberculosis.
(4) BIENNIAL REPORT.—
(A) IN GENERAL.—The Council shall submit a biennial
report to the Secretary, as determined necessary by the
Secretary, on the activities carried under this section.
Each such report shall include the opinion of the Council
on the extent to which its recommendations regarding the
elimination of tuberculosis have been implemented, including with respect to—
(i) activities under subsection (b); and
(ii) the national plan referred to in paragraph (3).
(B) PUBLIC.—The Secretary shall make a report submitted under subparagraph (A) public.
(5) COMPOSITION.—The Council shall be composed of—
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(A) ex officio representatives from the Centers for Disease Control and Prevention, the National Institutes of
Health, the United States Agency for International Development, the Agency for Healthcare Research and Quality,
the Health Resources and Services Administration, the
United States-Mexico Border Health Commission, and
other Federal departments and agencies that carry out significant activities related to tuberculosis;
(B) State and local tuberculosis control and public
health officials;
(C) individuals who are scientists, physicians,
laboratorians, and other health professionals who represent disciplines relevant to tuberculosis elimination; and
(D) members of national and international nongovernmental organizations established to address the elimination of tuberculosis.
(6) STAFF, INFORMATION, AND OTHER ASSISTANCE.—The
Secretary shall provide to the Council such staff, information,
and other assistance as may be necessary to carry out the duties of the Council.
(g) FEDERAL TUBERCULOSIS TASK FORCE.—
(1) DUTIES.—The Federal Tuberculosis Task Force (in this
subsection referred to as the ‘‘Task Force’’) shall provide to the
Secretary and other appropriate Federal officials advice on research into new tools under subsection (b)(2), including advice
regarding the efficient utilization of the Federal resources involved.
(2) COMPREHENSIVE PLAN FOR NEW TOOLS DEVELOPMENT.—
In carrying out paragraph (1), the Task Force shall make recommendations on the development of a comprehensive plan for
the creation of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.
(3) CONSULTATION.—In developing the comprehensive plan
under paragraph (1), the Task Force shall consult with external parties including representatives from groups such as—
(A) scientists, physicians, laboratorians, and other
health professionals who represent the specialties and disciplines relevant to the research under consideration;
(B) members from public-private partnerships, private
entities, or foundations (or both) engaged in activities relevant to research under consideration;
(C) members of national and international nongovernmental organizations established to address tuberculosis
elimination;
(D) members from the general public who are knowledgeable with respect to tuberculosis including individuals
who have or have had tuberculosis; and
(E) scientists, physicians, laboratorians, and other
health professionals who reside in a foreign country with
a substantial incidence or prevalence of tuberculosis, and
who represent the specialties and disciplines relevant to
the research under consideration.
(h) AUTHORIZATION OF APPROPRIATIONS.—
(1) GENERAL PROGRAM.—
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PUBLIC HEALTH SERVICE ACT
Sec. 317F
(A) IN GENERAL.—For the purpose of carrying out this
section, there are authorized to be appropriated
$200,000,000 for fiscal year 2009, $210,000,000 for fiscal
year 2010, $220,500,000 for fiscal year 2011, $231,525,000
for fiscal year 2012, and $243,101,250 for fiscal year 2013.
(B) RESERVATION FOR EMERGENCY GRANTS.—Of the
amounts appropriated under subparagraph (A) for a fiscal
year, the Secretary may reserve not more than 25 percent
for emergency grants under subsection (a) for any geographic area, State, political subdivision of a State, or
other public entity in which there is, relative to other
areas, a substantial number of cases of tuberculosis,
multidrug resistant tuberculosis, or extensively drug resistant tuberculosis or a substantial rate of increase in
such cases.
(C) PRIORITY.—In allocating amounts appropriated
under subparagraph (A), the Secretary shall give priority
to allocating such amounts for grants under subsection (a).
(D) ALLOCATION OF FUNDS.—
(i) REQUIREMENT OF FORMULA.—Of the amounts
appropriated under subparagraph (A), not reserved
under subparagraph (B), and allocated by the Secretary for grants under subsection (a), the Secretary
shall distribute a portion of such amounts to grantees
under subsection (a) on the basis of a formula.
(ii) RELEVANT FACTORS.—The formula developed
by the Secretary under clause (i) shall take into account the level of tuberculosis morbidity and case complexity in the respective geographic area and may consider other factors relevant to tuberculosis in such
area.
(iii) NO CHANGE TO FORMULA REQUIRED.—This
subparagraph does not require the Secretary to modify
the formula that was used by the Secretary to distribute funds to grantees under subsection (a) for fiscal year 2009.
(2) LIMITATION.—The authorization of appropriations established in paragraph (1) for a fiscal year is effective only if
the amount appropriated under such paragraph for such year
equals or exceeds the amount appropriated to carry out this
section for fiscal year 2009.
LOAN REPAYMENT PROGRAM
SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
(1) AUTHORITY.—Subject to paragraph (2), the Secretary
may carry out a program of entering into contracts with appropriately qualified health professionals under which such health
professionals agree to conduct prevention activities or preparedness and response activities, including rapid response to
public health emergencies and significant public health
threats, as employees of the Centers for Disease Control and
Prevention and the Agency for Toxic Substances and Disease
Registry, in consideration of the Federal Government agreeing
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58
to repay, for each year of such service, not more than $50,000
of the principal and interest of the educational loans of such
health professionals.
(2) LIMITATION.—The Secretary may not enter into an
agreement with a health professional pursuant to paragraph
(1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Centers for
Disease Control and Prevention or the Agency for Toxic
Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 2 years.
(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to
the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of this Act, the provisions of such subpart shall, except as inconsistent with subsection
(a), apply to the program established in this section in the same
manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(c) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—For the purpose of carrying out this section, except as described in paragraph (2), there are authorized
to be appropriated $500,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years 1995
through 2002.
(2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For purposes of carrying out this section with respect to qualified
health professionals serving in the Epidemic Intelligence Service, as authorized under section 317G, there is authorized to be
appropriated $1,000,000 for each of fiscal years 2019 through
2023.
(d) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated
for a fiscal year for contracts under subsection (a) shall remain
available until the expiration of the second fiscal year beginning
after the fiscal year for which the amounts were appropriated.
SEC. 317G. ø247b–8¿ FELLOWSHIP AND TRAINING PROGRAMS.
The Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall establish fellowship and
training programs to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods. Such
programs shall be designed to enable health professionals and
health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and
disabilities. Such fellowships and training may be administered
through the use of either appointment or nonappointment procedures.
DIABETES IN CHILDREN AND YOUTH
SEC. 317H. ø247b–9¿ (a) SURVEILLANCE ON
TES.—The Secretary, acting through the Director
JUVENILE DIABEof the Centers for
Disease Control and Prevention, shall develop a sentinel system to
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PUBLIC HEALTH SERVICE ACT
Sec. 317J
collect data on juvenile diabetes, including with respect to incidence and prevalence, and shall establish a national database for
such data.
(b) TYPE 2 DIABETES IN YOUTH.—The Secretary shall implement a national public health effort to address type 2 diabetes in
youth, including—
(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2
diabetes in youth and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and
(2) developing and improving laboratory methods to assist
in diagnosis, treatment, and prevention of diabetes including,
but not limited to, developing noninvasive ways to monitor
blood glucose to prevent hypoglycemia and improving existing
glucometers that measure blood glucose.
(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
COMPILATION OF DATA ON ASTHMA
SEC. 317I. ø247b–10¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct local asthma surveillance activities to collect
data on the prevalence and severity of asthma and the quality
of asthma management;
(2) compile and annually publish data on the prevalence of
children suffering from asthma in each State; and
(3) to the extent practicable, compile and publish data on
the childhood mortality rate associated with asthma nationally.
(b) SURVEILLANCE ACTIVITIES.—The Director of the Centers for
Disease Control and Prevention, acting through the representative
of the Director on the National Asthma Education Prevention Program Coordinating Committee, shall, in carrying out subsection (a),
provide an update on surveillance activities at each Committee
meeting.
(c) COLLABORATIVE EFFORTS.—The activities described in subsection (a)(1) may be conducted in collaboration with eligible entities awarded a grant under section 399L.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
EFFECTS OF FOLIC ACID IN PREVENTION OF BIRTH DEFECTS
SEC. 317J. ø247b–11¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through
grants or contracts) for the following purposes:
(1) To provide education and training for health professionals and the general public for purposes of explaining the
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effects of folic acid in preventing birth defects and for purposes
of encouraging each woman of reproductive capacity (whether
or not planning a pregnancy) to consume on a daily basis a dietary supplement that provides an appropriate level of folic
acid.
(2) To conduct research with respect to such education and
training, including identifying effective strategies for increasing the rate of consumption of folic acid by women of reproductive capacity.
(3) To conduct research to increase the understanding of
the effects of folic acid in preventing birth defects, including
understanding with respect to cleft lip, cleft palate, and heart
defects.
(4) To provide for appropriate epidemiological activities regarding folic acid and birth defects, including epidemiological
activities regarding neural tube defects.
(b) CONSULTATIONS WITH STATES AND PRIVATE ENTITIES.—In
carrying out subsection (a), the Secretary shall consult with the
States and with other appropriate public or private entities, including national nonprofit private organizations, health professionals,
and providers of health insurance and health plans.
(c) TECHNICAL ASSISTANCE.—The Secretary may (directly or
through grants or contracts) provide technical assistance to public
and nonprofit private entities in carrying out the activities described in subsection (a).
(d) EVALUATIONS.—The Secretary shall (directly or through
grants or contracts) provide for the evaluation of activities under
subsection (a) in order to determine the extent to which such activities have been effective in carrying out the purposes of the program
under such subsection, including the effects on various demographic populations. Methods of evaluation under the preceding
sentence may include surveys of knowledge and attitudes on the
consumption of folic acid and on blood folate levels. Such methods
may include complete and timely monitoring of infants who are
born with neural tube defects.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SAFE MOTHERHOOD
SEC. 317K. ø247b–12¿ (a) SURVEILLANCE.—
(1) PURPOSE.—The purposes of this subsection are to establish or continue a Federal initiative to support State and
tribal maternal mortality review committees, to improve data
collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, State, and
national level to better understand the burden of maternal
complications and mortality and to decrease the disparities
among populations at risk of death and severe complications
from pregnancy.
(2) ACTIVITIES.—For the purpose described in paragraph
(1), the Secretary, acting through the Director of the Centers
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for Disease Control and Prevention, may carry out the following activities:
(A) The Secretary may continue and improve activities
related to a national maternal mortality data collection
and surveillance program to identify and support the review of pregnancy-associated deaths and pregnancy-related
deaths that occur during, or within 1 year following, pregnancy, including improving disaggregation of data (in a
manner consistent with applicable State and Federal privacy laws).
(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System to provide surveillance and
collect data in each State.
(C) The Secretary may expand the Maternal and Child
Health Epidemiology Program to provide technical support, financial assistance, or the time-limited assignment
of senior epidemiologists to maternal and child health programs in each State.
(D) The Secretary may, in cooperation with States, Indian tribes, and tribal organizations, develop a program to
support States, Indian tribes, and tribal organizations in
establishing or operating maternal mortality review committees, in accordance with subsection (d).
(b) PREVENTION RESEARCH.—
(1) PURPOSE.—The purpose of this subsection is to provide
the Secretary with the authority to further expand research
concerning risk factors, prevention strategies, and the roles of
the family, health care providers and the community in safe
motherhood.
(2) RESEARCH.—The Secretary may carry out activities to
expand research relating to—
(A) prepregnancy counseling, especially for at risk populations such as women with diabetes and women with
substance use disorder;
(B) the identification of critical components of prenatal
delivery and postpartum care;
(C) the identification of outreach and support services,
such as folic acid education, that are available for pregnant women;
(D) the identification of women who are at high risk
for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean sections;
(H) the identification of the determinants of disparities
in maternal care, health risks, and health outcomes, including an examination of the higher rates of maternal
mortality among African American women and other
groups of women with disproportionately high rates of maternal mortality;
(I) activities to reduce disparities in maternity services
and outcomes;
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(J) an examination of the relationship between interpersonal violence and maternal complications and mortality;
(K) preventing and reducing adverse health consequences that may result from smokingand substance
abuse and misuse before, during and after pregnancy;
(L) preventing infections that cause maternal and infant complications;
(M) an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care; and
(N) other areas determined appropriate by the Secretary.
(c) PREVENTION PROGRAMS.—The Secretary may carry out activities to promote safe motherhood, including—
(1) public education campaigns on healthy pregnancies;
(2) education programs for physicians, nurses and other
health care providers;
(3) activities to promote community support services for
pregnant women; and
(4) activities to promote physical, mental, and behavioral
health during, and up to 1 year following, pregnancy, with an
emphasis on prevention of, and treatment for, mental health
disorders and substance use disorder.
(d) MATERNAL MORTALITY REVIEW COMMITTEES.—
(1) IN GENERAL.—In order to participate in the program
under subsection (a)(2)(D), the applicable maternal mortality
review committee of the State, Indian tribe, or tribal organization shall—
(A) include multidisciplinary and diverse membership
that represents a variety of clinical specialties, State, tribal, or local public health officials, epidemiologists, statisticians, community organizations, geographic regions within
the area covered by such committee, and individuals or organizations that represent the populations in the area covered by such committee that are most affected by pregnancy-related deaths or pregnancy-associated deaths and
lack of access to maternal health care services; and
(B) demonstrate to the Centers for Disease Control
and Prevention that such maternal mortality review committee’s methods and processes for data collection and review, as required under paragraph (3), use best practices
to reliably determine and include all pregnancy-associated
deaths and pregnancy-related deaths, regardless of the
outcome of the pregnancy.
(2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian
tribes, and tribal organizations that participate in the program
described in this subsection shall, through the State maternal
mortality review committee, develop a process that—
(A) provides for confidential case reporting of pregnancy-associated and pregnancy-related deaths to the appropriate State or tribal health agency, including such reporting by—
(i) health care professionals;
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(ii) health care facilities;
(iii) any individual responsible for completing
death records, including medical examiners and medical coroners; and
(iv) other appropriate individuals or entities; and
(B) provides for voluntary and confidential case reporting of pregnancy-associated deaths and pregnancy-related
deaths to the appropriate State or tribal health agency by
family members of the deceased, and other appropriate individuals, for purposes of review by the applicable maternal mortality review committee; and
(C) shall include—
(i) making publicly available contact information
of the committee for use in such reporting; and
(ii) conducting outreach to local professional organizations, community organizations, and social services agencies regarding the availability of the review
committee.
(3) DATA COLLECTION AND REVIEW.—States, Indian tribes,
and tribal organizations that participate in the program described in this subsection shall—
(A) annually identify pregnancy-associated deaths and
pregnancy-related deaths—
(i) through the appropriate vital statistics unit
by—
(I) matching each death record related to a
pregnancy-associated death or pregnancy-related
death in the State or tribal area in the applicable
year to a birth certificate of an infant or fetal
death record, as applicable;
(II) to the extent practicable, identifying an
underlying or contributing cause of each pregnancy-associated death and each pregnancy-related death in the State or tribal area in the applicable year; and
(III) collecting data from medical examiner
and coroner reports, as appropriate;
(ii) using other appropriate methods or information to identify pregnancy-associated deaths and pregnancy-related deaths, including deaths from pregnancy
outcomes not identified through clause (i)(I);
(B) through the maternal mortality review committee,
review data and information to identify adverse outcomes
that may contribute to pregnancy-associated death and
pregnancy-related death, and to identify trends, patterns,
and disparities in such adverse outcomes to allow the
State, Indian tribe, or tribal organization to make recommendations to individuals and entities described in
paragraph (2)(A), as appropriate, to improve maternal care
and reduce pregnancy-associated death and pregnancy-related death;
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fication and reporting of pregnancy-associated and pregnancy-related deaths;
(D) ensure that, to the extent practicable, the data collected and reported under this paragraph is in a format
that allows for analysis by the Centers for Disease Control
and Prevention; and
(E) publicly identify the methods used to identify pregnancy-associated deaths and pregnancy-related deaths in
accordance with this section.
(4) CONFIDENTIALITY.—States, Indian tribes, and tribal organizations participating in the program described in this subsection shall establish confidentiality protections to ensure, at
a minimum, that—
(A) there is no disclosure by the maternal mortality review committee, including any individual members of the
committee, to any person, including any government official, of any identifying information about any specific maternal mortality case; and
(B) no information from committee proceedings, including deliberation or records, is made public unless specifically authorized under State and Federal law.
(5) REPORTS TO CDC.—For fiscal year 2019, and each subsequent fiscal year, each maternal mortality review committee
participating in the program described in this subsection shall
submit to the Director of the Centers for Disease Control and
Prevention a report that includes—
(A) data, findings, and any recommendations of such
committee; and
(B) as applicable, information on the implementation
during such year of any recommendations submitted by
the committee in a previous year.
(6) STATE PARTNERSHIPS.—States may partner with one or
more neighboring States to carry out the activities under this
subparagraph. With respect to the States in such a partnership, any requirement under this subparagraph relating to the
reporting of information related to such activities shall be
deemed to be fulfilled by each such State if a single such report
is submitted for the partnership.
(7) APPROPRIATE MECHANISMS FOR INDIAN TRIBES AND TRIBAL ORGANIZATIONS.—The Secretary, in consultation with Indian
tribes, shall identify and establish appropriate mechanisms for
Indian tribes and tribal organizations to demonstrate, report
data, and conduct the activities as required for participation in
the program described in this subsection. Such mechanisms
may include technical assistance with respect to grant application and submission procedures, and award management activities.
(8) RESEARCH AVAILABILITY.—The Secretary shall develop
a process to ensure that data collected under paragraph (5) is
made available, as appropriate and practicable, for research
purposes, in a manner that protects individually identifiable or
potentially identifiable information and that is consistent with
State and Federal privacy law.
(e) DEFINITIONS.—In this section—
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(1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have
the meanings given such terms in section 4 of the Indian SelfDetermination and Education Assistance Act;
(2) the term ‘‘pregnancy-associated death’’ means a death
of a woman, by any cause, that occurs during, or within 1 year
following, her pregnancy, regardless of the outcome, duration,
or site of the pregnancy; and
(3) the term ‘‘pregnancy-related death’’ means a death of
a woman that occurs during, or within 1 year following, her
pregnancy, regardless of the outcome, duration, or site of the
pregnancy—
(A) from any cause related to, or aggravated by, the
pregnancy or its management; and
(B) not from accidental or incidental causes.
(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$58,000,000 for each of fiscal years 2019 through 2023.
PRENATAL AND POSTNATAL HEALTH
SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, shall carry out programs—
(1) to collect, analyze, and make available data on prenatal
smoking and alcohol and other substance abuse and misuse,
including—
(A) data on—
(i) the incidence, prevalence, and implications of
such activities; and
(ii) the incidence and prevalence of implications
and outcomes, including neonatal abstinence syndrome
and other maternal and child health outcomes associated with such activities; and
(B) additional information or data, as appropriate, on
family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity,
geographic location, and family history, and other relevant
information, to inform such analysis;
(2) to conduct applied epidemiological research on the prevention and long-term outcomes associated with prenatal and
postnatal smoking, alcohol and other substance abuse and misuse;
(3) to support, conduct, and evaluate the effectiveness of
educational, treatment, and cessation programs;
(4) to provide information and education to the public on
the prevention and implications of prenatal and postnatal
smoking, alcohol and other substance abuse and misuse; and
(5) to issue public reports on the analysis of data described
in paragraph (1), including analysis of—
(A) long-term outcomes of children affected by neonatal abstinence syndrome;
(B) health outcomes associated with prenatal smoking,
alcohol, and substance abuse and misuse; and
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(C) relevant studies, evaluations, or information the
Secretary determines to be appropriate.
(b) GRANTS.—In carrying out subsection (a), the Secretary may
award grants to and enter into contracts with States, local governments, tribal entities, scientific and academic institutions, federally
qualified health centers, and other public and nonprofit entities,
and may provide technical and consultative assistance to such entities.
(c) COORDINATING ACTIVITIES.—To carry out this section, the
Secretary may—
(1) provide technical and consultative assistance to entities
receiving grants under subsection (b);
(2) ensure a pathway for data sharing between States,
tribal entities, and the Centers for Disease Control and Prevention;
(3) ensure data collection under this section is consistent
with applicable State, Federal, and Tribal privacy laws; and
(4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and
Tribes in implementing systems that use standards recognized
by such National Coordinator, as such recognized standards
are available, in order to facilitate interoperability between
such systems and health information technology systems, including certified health information technology.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2019
through 2023.
SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL
MENTAL HEALTH AND SUBSTANCE USE DISORDERS.
(a) GRANTS.—The Secretary shall make grants to States, In-
dian Tribes and Tribal organizations (as such terms are defined in
section 4 of the Indian Self-Determination and Education Assistance Act) to establish, improve, or maintain programs for screening, assessment, and treatment services, including culturally and
linguistically appropriate services, as appropriate, for women who
are postpartum, pregnant, or have given birth within the preceding
12 months, for maternal mental health and substance use disorders.
(b) APPLICATION.—To seek a grant under this section, an entity
listed in subsection (a) shall submit an application to the Secretary
at such time, in such manner, and containing such information as
the Secretary may require. At a minimum, any such application
shall include explanations of—
(1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for maternal mental health and substance use disorders in 1 or more
communities; and
(2) how a program, or programs, if expanded, would increase access to screening and treatment services for maternal
mental health and substance use disorders.
(c) PRIORITY.—In awarding grants under this section, the Secretary shall, as appropriate, give priority to entities listed in subsection (a) that—
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(1) are proposing to create, improve, or enhance screening,
prevention, and treatment services for maternal mental health
and substance use disorders in primary care settings;
(2) are currently partnered with, or will partner with, one
or more community-based organizations to address maternal
mental health and substance use disorders;
(3) are located in, or provide services under this section in,
an area with disproportionately high rates of maternal mental
health or substance use disorders or other related disparities;
and
(4) operate in a health professional shortage area designated under section 332, including maternity care health professional target areas.
(d) USE OF FUNDS.—The activities eligible for funding through
a grant under subsection (a)—
(1) shall include—
(A) providing appropriate training on maternal mental
health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers), and referrals for treatment to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals;
(B) providing information on maternal mental health
and substance use disorder screening, brief intervention,
treatment (as applicable for health care providers) and referrals for treatment, follow-up support services, and linkages to community-based resources to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals; and
(C) to the extent practicable and appropriate, enabling
health care providers (such as obstetrician-gynecologists,
nurse practitioners, nurse midwives, pediatricians, psychiatrists, mental and other behavioral health care providers,
and adult primary care clinicians) to provide or receive
real-time psychiatric consultation (in-person or remotely),
including through the use of technology-enabled collaborative learning and capacity building models (as defined in
section 330N), to aid in the treatment of pregnant and
postpartum women; and
(2) may include—
(A) establishing linkages with and among communitybased resources, including mental health resources, primary care resources, and support groups;
(B) utilizing telehealth services, including for rural
areas and medically underserved areas (as defined in section 330I(a));
(C) providing assistance to pregnant and postpartum
women to receive maternal mental health and substance
use disorder treatment, including patient consultation,
care coordination, and navigation for such treatment;
(D) coordinating, as appropriate, with maternal and
child health programs of State, local, and Tribal governments, including child psychiatric access programs;
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68
(E) conducting public outreach and awareness regarding grants under subsection (a);
(F) creating multistate consortia to carry out the activities required or authorized under this subsection; and
(G) training health care providers in the primary care
setting and relevant health paraprofessionals on traumainformed care, culturally and linguistically appropriate
services, and best practices related to training to improve
the provision of maternal mental health and substance use
disorder care for racial and ethnic minority populations
and reduce related disparities in the delivery of such care.
(e) TECHNICAL ASSISTANCE.—The Secretary shall provide technical assistance to grantees and entities listed in subsection (a) for
carrying out activities pursuant to this section.
(f) DISSEMINATION OF BEST PRACTICES.—The Secretary, based
on evaluation of the activities funded pursuant to this section, shall
identify and disseminate evidence-based or evidence-informed practices for screening, assessment, treatment, and referral to treatment services for maternal mental health and substance use disorders, including culturally and linguistically appropriate services,
for women during pregnancy and 12 months following pregnancy.
(g) MATCHING REQUIREMENT.—The Federal share of the cost of
the activities for which a grant is made to an entity under subsection (a) shall not exceed 90 percent of the total cost of such activities.
(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $24,000,000 for each
of fiscal years 2023 through 2027.
ORAL HEALTH PROMOTION AND DISEASE PREVENTION
FOR
SEC. 317M. ø247b–14¿ (a) GRANTS TO INCREASE RESOURCES
COMMUNITY WATER FLUORIDATION.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may
make grants to States and Indian tribes for the purpose of increasing the resources available for community water fluoridation.
(2) USE OF FUNDS.—A State shall use amounts provided
under a grant under paragraph (1)—
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on the benefits of
fluoridation; or
(D) to support the infrastructure necessary to monitor
and maintain the quality of water fluoridation.
(b) COMMUNITY WATER FLUORIDATION.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in
collaboration with the Director of the Indian Health Service,
shall establish a demonstration project that is designed to assist rural water systems in successfully implementing the
water fluoridation guidelines of the Centers for Disease Control
and Prevention that are entitled ‘‘Engineering and Administra-
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tive Recommendations for Water Fluoridation, 1995’’ (referred
to in this subsection as the ‘‘EARWF’’).
(2) REQUIREMENTS.—
(A) COLLABORATION.—In collaborating under paragraph (1), the Directors referred to in such paragraph shall
ensure that technical assistance and training are provided
to tribal programs located in each of the 12 areas of the
Indian Health Service. The Director of the Indian Health
Service shall provide coordination and administrative support to tribes under this section.
(B) GENERAL USE OF FUNDS.—Amounts made available
under paragraph (1) shall be used to assist small water
systems in improving the effectiveness of water fluoridation and to meet the recommendations of the EARWF.
(C) FLUORIDATION SPECIALISTS.—
(i) IN GENERAL.—In carrying out this subsection,
the Secretary shall provide for the establishment of
fluoridation specialist engineering positions in each of
the Dental Clinical and Preventive Support Centers
through which technical assistance and training will
be provided to tribal water operators, tribal utility operators and other Indian Health Service personnel
working directly with fluoridation projects.
(ii) LIAISON.—A fluoridation specialist shall serve
as the principal technical liaison between the Indian
Health Service and the Centers for Disease Control
and Prevention with respect to engineering and fluoridation issues.
(iii) CDC.—The Director of the Centers for Disease Control and Prevention shall appoint individuals
to serve as the fluoridation specialists.
(D) IMPLEMENTATION.—The project established under
this subsection shall be planned, implemented and evaluated over the 5-year period beginning on the date on which
funds are appropriated under this section and shall be designed to serve as a model for improving the effectiveness
of water fluoridation systems of small rural communities.
(3) EVALUATION.—In conducting the ongoing evaluation as
provided for in paragraph (2)(D), the Secretary shall ensure
that such evaluation includes—
(A) the measurement of changes in water fluoridation
compliance levels resulting from assistance provided under
this section;
(B) the identification of the administrative, technical
and operational challenges that are unique to the fluoridation of small water systems;
(C) the development of a practical model that may be
easily utilized by other tribal, State, county or local governments in improving the quality of water fluoridation
with emphasis on small water systems; and
(D) the measurement of any increased percentage of
Native Americans or Alaskan Natives who receive the benefits of optimally fluoridated water.
(c) SCHOOL-BASED DENTAL SEALANT PROGRAM.—
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70
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in
collaboration with the Administrator of the Health Resources
and Services Administration, shall award a grant to each of
the 50 States and territories and to Indians, Indian tribes, tribal organizations and urban Indian organizations (as such
terms are defined in section 4 of the Indian Health Care Improvement Act) to provide for the development of school-based
dental sealant programs to improve the access of children to
sealants.
(2) USE OF FUNDS.—A State shall use amounts received
under a grant under paragraph (1) to provide funds to eligible
school-based entities or to public elementary or secondary
schools to enable such entities or schools to provide children
with access to dental care and dental sealant services. Such
services shall be provided by licensed dental health professionals in accordance with State practice licensing laws.
(3) ELIGIBILITY.—To be eligible to receive funds under
paragraph (1), an entity shall—
(A) prepare and submit to the State an application at
such time, in such manner and containing such information as the State may require; and
(B) be a public elementary or secondary school—
(i) that is located in an urban area in which and
more than 50 percent of the student population is participating in Federal or State free or reduced meal programs; or
(ii) that is located in a rural area and, with respect to the school district in which the school is located, the district involved has a median income that
is at or below 235 percent of the poverty line, as defined in section 673(2) of the Community Services
Block Grant Act (42 U.S.C. 9902(2)).
(d) ORAL HEALTH INFRASTRUCTURE.—
(1) COOPERATIVE AGREEMENTS.—The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall enter into cooperative agreements with State,
territorial, and Indian tribes or tribal organizations (as those
terms are defined in section 4 of the Indian Health Care Improvement Act) to establish oral health leadership and program guidance, oral health data collection and interpretation,
(including determinants of poor oral health among vulnerable
populations), a multi-dimensional delivery system for oral
health, and to implement science-based programs (including
dental sealants and community water fluoridation) to improve
oral health.
(2) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as necessary to carry out
this subsection for fiscal years 2010 through 2014.
(e) DEFINITIONS.—For purposes of this section, the term ‘‘Indian tribe’’ means an Indian tribe or tribal organization as defined
in section 4(b) and section 4(c) of the Indian Self-Determination
and Education Assistance Act.
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PUBLIC HEALTH SERVICE ACT
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(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SEC. 317N. ø247b–15¿ SURVEILLANCE AND EDUCATION REGARDING INFECTIONS ASSOCIATED WITH ILLICIT DRUG USE AND
OTHER RISK FACTORS.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may (directly or
through grants to public and nonprofit private entities) provide for
programs for the following:
(1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use,
such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the
prevalence of such infections, which may include the reporting
of cases of such infections.
(2) To identify, counsel, and offer testing to individuals
who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to
July 1992, or other risk factors.
(3) To provide appropriate referrals for counseling, testing,
and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision
of appropriate follow-up services.
(4) To develop and disseminate public information and
education programs for the detection and control of infections
described in paragraph (1), with priority given to high-risk
populations as determined by the Secretary.
(5) To improve the education, training, and skills of health
professionals in the detection and control of infections described in paragraph (1), including to improve coordination of
treatment of substance use disorders and infectious diseases,
with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians.
(b) LABORATORY PROCEDURES.—The Secretary may (directly or
through grants to public and nonprofit private entities) carry out
programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection
(a)(1).
(c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has
the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$40,000,000 for each of the fiscal years 2019 through 2023.
GRANTS FOR LEAD POISONING RELATED ACTIVITIES
SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
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(1) IN GENERAL.—The Secretary shall make grants to
States to support public health activities in States and localities where data suggests that at least 5 percent of preschoolage children have an elevated blood lead level through—
(A) effective, ongoing outreach and community education targeted to families most likely to be at risk for lead
poisoning;
(B) individual family education activities that are designed to reduce ongoing exposures to lead for children
with elevated blood lead levels, including through home
visits and coordination with other programs designed to
identify and treat children at risk for lead poisoning; and
(C) the development, coordination and implementation
of community-based approaches for comprehensive lead
poisoning prevention from surveillance to lead hazard control.
(2) STATE MATCH.—A State is not eligible for a grant under
this section unless the State agrees to expend (through State
or local funds) $1 for every $2 provided under the grant to
carry out the activities described in paragraph (1).
(3) APPLICATION.—To be eligible to receive a grant under
this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require.
(b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A
State shall identify in the application for a grant under this section
how the State will coordinate operations and activities under the
grant with—
(1) other programs operated in the State that serve children with elevated blood lead levels, including any such programs operated under title V, XIX, or XXI of the Social Security Act; and
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such
Act;
(B) the head start program established under the
Head Start Act (42 U.S.C. 9831 et seq.);
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under section 17 of the Child Nutrition Act of
1966 (42 U.S.C. 1786);
(D) local public and private elementary or secondary
schools; or
(E) public housing agencies, as defined in section 3 of
the United States Housing Act of 1937 (42 U.S.C. 1437a).
(c) PERFORMANCE MEASURES.—The Secretary shall establish
needs indicators and performance measures to evaluate the activities carried out under grants awarded under this section. Such indicators shall be commensurate with national measures of maternal and child health programs and shall be developed in consultation with the Director of the Centers for Disease Control and Prevention.
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(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2001 through 2005.
HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 14)
SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
(1) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention, shall—
(A) enter into cooperative agreements with States and
other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human
papillomavirus (referred to in this section as ‘‘HPV’’) in different sites in various regions of the United States,
through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and
(B) develop and analyze data from the HPV sentinel
surveillance system described in subparagraph (A).
(2) REPORT.—The Secretary shall make a progress report
to the Congress with respect to paragraph (1) no later than 1
year after the effective date of this section.
(b) PREVENTION ACTIVITIES; EDUCATION PROGRAM.—
(1) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV, including—
(A) behavioral and other research on the impact of
HPV-related diagnosis on individuals;
(B) formative research to assist with the development
of educational messages and information for the public, for
patients, and for their partners about HPV;
(C) surveys of physician and public knowledge, attitudes, and practices about genital HPV infection; and
(D) upon the completion of and based on the findings
under subparagraphs (A) through (C), develop and disseminate educational materials for the public and health
care providers regarding HPV and its impact and prevention.
(2) REPORT; FINAL PROPOSAL.—The Secretary shall make a
progress report to the Congress with respect to paragraph (1)
not later than 1 year after the effective date of this section,
and shall develop a final report not later than 3 years after
such effective date, including a detailed summary of the significant findings and problems and the best strategies to prevent
future infections, based on available science.
(c) HPV EDUCATION AND PREVENTION.—
(1) IN GENERAL.—The Secretary shall prepare and distribute educational materials for health care providers and the
public that include information on HPV. Such materials shall
address—
(A) modes of transmission;
14 The typeface and casing of the parenthetical matter in the section heading appears in law
with all letter cased in lowercase and in bold face type; however, it is reflect here as it should
appear in light face and all small caps.
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(B) consequences of infection, including the link between HPV and cervical cancer;
(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears, and other
diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.
(2) MEDICALLY ACCURATE INFORMATION.—Educational material under paragraph (1), and all other relevant educational
and prevention materials prepared and printed from this date
forward for the public and health care providers by the Secretary (including materials prepared through the Food and
Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), or by contractors, grantees, or subgrantees thereof, that
are specifically designed to address STDs including HPV shall
contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD
the materials are designed to address. Such requirement only
applies to materials mass produced for the public and health
care providers, and not to routine communications.
(d) JOHANNA’S LAW.—
(1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
(A) IN GENERAL.—The Secretary shall carry out a national campaign to increase the awareness and knowledge
of health care providers and women with respect to
gynecologic cancers.
(B) WRITTEN MATERIALS.—Activities under the national campaign under subparagraph (A) shall include—
(i) maintaining a supply of written materials that
provide information to the public on gynecologic cancers; and
(ii) distributing the materials to members of the
public upon request.
(C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities
under the national campaign under subparagraph (A)
shall, in accordance with applicable law and regulations,
include developing and placing, in telecommunications
media, public service announcements intended to encourage women to discuss with their physicians their risks of
gynecologic cancers. Such announcements shall inform the
public on the manner in which the written materials referred to in subparagraph (B) can be obtained upon request, and shall call attention to early warning signs and
risk factors based on the best available medical information.
(2) REPORT AND STRATEGY.—
(A) REPORT.—Not later than 6 months after the date
of the enactment of this subsection, the Secretary shall
submit to the Congress a report including the following:
(i) A description of the past and present activities
of the Department of Health and Human Services to
increase awareness and knowledge of the public with
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PUBLIC HEALTH SERVICE ACT
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respect to different types of cancer, including
gynecologic cancers.
(ii) A description of the past and present activities
of the Department of Health and Human Services to
increase awareness and knowledge of health care providers with respect to different types of cancer, including gynecologic cancers.
(iii) For each activity described pursuant to clause
(i) or (ii), a description of the following:
(I) The funding for such activity for fiscal year
2006 and the cumulative funding for such activity
for previous fiscal years.
(II) The background and history of such activity, including—
(aa) the goals of such activity;
(bb) the communications objectives of
such activity;
(cc) the identity of each agency within the
Department of Health and Human Services
responsible for any aspect of the activity; and
(dd) how such activity is or was expected
to result in change.
(III) How long the activity lasted or is expected to last.
(IV) The outcomes observed and the evaluation methods, if any, that have been, are being, or
will be used with respect to such activity.
(V) For each such outcome or evaluation
method, a description of the associated results,
analyses, and conclusions.
(B) STRATEGY.—
(i) DEVELOPMENT; SUBMISSION TO CONGRESS.—Not
later than 3 months after submitting the report required by subparagraph (A), the Secretary shall develop and submit to the Congress a strategy for improving efforts to increase awareness and knowledge
of the public and health care providers with respect to
different types of cancer, including gynecological cancers.
(ii) CONSULTATION.—In developing the strategy
under clause (i), the Secretary should consult with
qualified private sector groups, including nonprofit organizations.
(3) FULL COMPLIANCE.—
(A) IN GENERAL.—Not later than March 1, 2008, the
Secretary shall ensure that all provisions of this section,
including activities directed to be carried out by the Centers for Disease Control and Prevention and the Food and
Drug Administration, are fully implemented and being
complied with. Not later than April 30, 2008, the Secretary
shall submit to Congress a report that certifies compliance
with the preceding sentence and that contains a description of all activities undertaken to achieve such compliance.
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(B) If the Secretary fails to submit the certification as
provided for under subparagraph (A), the Secretary shall,
not later than 3 months after the date on which the report
is to be submitted under subparagraph (A), and every 3
months thereafter, submit to Congress an explanation as
to why the Secretary has not yet complied with the first
sentence of subparagraph (A), a detailed description of all
actions undertaken within the month for which the report
is being submitted to bring the Secretary into compliance
with such sentence, and the anticipated date the Secretary
expects to be in full compliance with such sentence.
(4) CONSULTATION WITH NONPROFIT GYNECOLOGIC CANCER
ORGANIZATIONS.—In carrying out the national campaign under
this subsection, the Secretary shall consult with nonprofit
gynecologic cancer organizations, with a mission both to conquer ovarian or other gynecologic cancer and to provide outreach to State and local governments and communities, for the
purpose of determining the best practices for providing
gynecologic cancer information and outreach services to varied
populations.
(6) 15 AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subsection, there is authorized to be
appropriated $16,500,000 for the period of fiscal years 2007
through 2009 and $18,000,000 for the period of fiscal years
2012 through 2014.
SEC. 317Q. ø247b–18¿ SURVEILLANCE AND RESEARCH REGARDING
MUSCULAR DYSTROPHY.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may award grants
and cooperative agreements to public or nonprofit private entities
(including health departments of States and political subdivisions
of States, and including universities and other educational entities)
for the collection, analysis, and reporting of data on Duchenne and
other forms of muscular dystrophy. In making such awards, the
Secretary may provide direct technical assistance in lieu of cash.
(b) NATIONAL MUSCULAR DYSTROPHY EPIDEMIOLOGY PROGRAM.—The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, may award grants to public or
nonprofit private entities (including health departments of States
and political subdivisions of States, and including universities and
other educational entities) for the purpose of carrying out epidemiological activities regarding Duchenne and other forms of muscular
dystrophies, including collecting and analyzing information on the
number, incidence, correlates, and symptoms of cases. In carrying
out the preceding sentence, the Secretary shall provide for a national surveillance program and, to the extent possible, ensure that
data be representative of all affected populations and shared in a
timely manner. In making awards under this subsection, the Secretary may provide direct technical assistance in lieu of cash.
(c) COORDINATION WITH CENTERS OF EXCELLENCE.—The Secretary shall ensure that epidemiological information under subsections (a) and (b) is made available to centers of excellence sup15 So
in law. There is no paragraph (5).
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ported under section 404E(b) by the Director of the National Institutes of Health.
(d) DATA.—In carrying out this section, the Secretary may ensure that any data on patients that is collected as part of the Muscular Dystrophy STARnet (under a grant under this section) is regularly updated to reflect changes in patient condition over time.
(e) REPORTS AND STUDY.—
(1) ANNUAL REPORT.—Not later than 18 months after the
date of the enactment of the Paul D. Wellstone Muscular Dystrophy Community Assistance, Research, and Education
Amendments of 2008, and annually thereafter, the Director of
the Centers for Disease Control and Prevention shall submit to
the appropriate committees of the Congress a report—
(A) concerning the activities carried out by MD
STARnet site 16 funded under this section during the year
for which the report is prepared;
(B) containing the data collected and findings derived
from the MD STARnet sites each fiscal year (as funded
under a grant under this section during fiscal years 2008
through 2012); and
(C) that every 2 years outlines prospective data collection objectives and strategies.
(2) TRACKING HEALTH OUTCOMES.—The Secretary may provide health outcome data on the health and survival of people
with muscular dystrophy.
(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated such sums as may be necessary to carry out this
section.
SEC. 317R. ø247b–20¿ FOOD SAFETY GRANTS.
(a) IN GENERAL.—The Secretary may
award grants to States
and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) to
expand participation in networks to enhance Federal, State, and
local food safety efforts, including meeting the costs of establishing
and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.
(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$19,500,000 for fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2015.
SEC. 317S. ø247b–21¿ MOSQUITO-BORNE DISEASES; COORDINATION
GRANTS TO STATES; ASSESSMENT AND CONTROL GRANTS
TO POLITICAL SUBDIVISIONS.
(a) COORDINATION GRANTS TO STATES; ASSESSMENT GRANTS TO
POLITICAL SUBDIVISIONS.—
(1) IN GENERAL.—With respect to mosquito control pro-
grams to prevent and control mosquito-borne diseases (referred
to in this section as ‘‘control programs’’), the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may make grants to States for the purpose of—
(A) coordinating control programs in the State involved; and
16 So
in law. The term ‘‘site’’ probably should be ‘‘sites’’.
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(B) assisting such State in making grants to political
subdivisions of the State to conduct assessments to determine the immediate needs in such subdivisions for control
programs, including programs to address emerging infectious mosquito-borne diseases, and to develop, on the basis
of such assessments, plans for carrying out control programs in the subdivisions or improving existing control
programs.
(2) PREFERENCE IN MAKING GRANTS.—In making grants
under paragraph (1), the Secretary shall give preference to
States that have one or more political subdivisions with an incidence, prevalence, or high risk of mosquito-borne disease, or
a population of infected mosquitoes, that is substantial relative
to political subdivisions in other States.
(3) CERTAIN REQUIREMENTS.—A grant may be made under
paragraph (1) only if—
(A) the State involved has developed, or agrees to develop, a plan for coordinating control programs in the
State, and the plan takes into account any assessments or
plans described in subsection (b)(3) that have been conducted or developed, respectively, by political subdivisions
in the State;
(B) in developing such plan, the State consulted or will
consult (as the case may be under subparagraph (A)) with
political subdivisions in the State that are carrying out or
planning to carry out control programs;
(C) the State agrees to monitor control programs in
the State in order to ensure that the programs are carried
out in accordance with such plan, with priority given to coordination of control programs in political subdivisions described in paragraph (2) that are contiguous;
(D) the State agrees that the State will make grants
to political subdivisions as described in paragraph (1)(B),
and that such a grant will not exceed $10,000; and
(E) the State agrees that the grant will be used to supplement, and not supplant, State and local funds available
for the purpose described in paragraph (1).
(4) REPORTS TO SECRETARY.—A grant may be made under
paragraph (1) only if the State involved agrees that, promptly
after the end of the fiscal year for which the grant is made, the
State will submit to the Secretary a report that—
(A) describes the activities of the State under the
grant; and
(B) contains an evaluation of whether the control programs of political subdivisions in the State were effectively
coordinated with each other, which evaluation takes into
account any reports that the State received under subsection (b)(5) from such subdivisions.
(5) NUMBER OF GRANTS.—A State may not receive more
than one grant under paragraph (1).
(b) PREVENTION AND CONTROL GRANTS TO POLITICAL SUBDIVISIONS.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may
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make grants to political subdivisions of States or consortia of
political subdivisions of States, for the operation, including improvement, of control programs.
(2) PREFERENCE IN MAKING GRANTS.—In making grants
under paragraph (1), the Secretary shall give preference to a
political subdivision or consortium of political subdivisions
that—
(A) has—
(i) a history of elevated incidence or prevalence of
mosquito-borne disease;
(ii) a population of infected mosquitoes;
(iii) met criteria determined by the Secretary to
suggest an increased risk of elevated incidence or
prevalence of mosquito-borne disease in the pending
fiscal year, including an emerging infectious mosquitoborne disease that presents a serious public health
threat; or
(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that
presents a serious public health threat;
(B) demonstrates to the Secretary that such political
subdivision or consortium of political subdivisions will, if
appropriate to the mosquito circumstances involved, effectively coordinate the activities of the control programs
with contiguous political subdivisions;
(C) demonstrates to the Secretary (directly or through
State officials) that the State in which such a political subdivision or consortium of political subdivisions is located
has identified or will identify geographic areas in such
State that have a significant need for control programs
and will effectively coordinate such programs in such
areas; and
(D)(i) is located in a State that has received a grant
under subsection (a); or
(ii) that demonstrates to the Secretary that the control
program is consistent with existing State mosquito control
plans or policies, or other applicable State preparedness
plans.
(3) REQUIREMENT OF ASSESSMENT AND PLAN.—A grant may
be made under paragraph (1) only if the political subdivision
or consortium of political subdivisions involved—
(A) has conducted an assessment to determine the immediate needs in such subdivision or consortium for a control program, including an entomological survey of potential mosquito breeding areas; and
(B) has, on the basis of such assessment, developed a
plan for carrying out such a program.
(4) REQUIREMENT OF MATCHING FUNDS.—
(A) IN GENERAL.—With respect to the costs of a control
program to be carried out under paragraph (1) by a political subdivision or consortium of political subdivisions, a
grant under such paragraph may be made only if the subdivision or consortium agrees to make available (directly
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Federal contributions toward such costs in an amount that
is not less than 1⁄3 of such costs ($1 for each $2 of Federal
funds provided in the grant).
(B) DETERMINATION OF AMOUNT CONTRIBUTED.—NonFederal contributions required in subparagraph (A) may be
in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(C) WAIVER.—The Secretary may waive the requirement established in subparagraph (A) if the Secretary determines that—
(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions
involved justify the waiver; or
(ii) the geographical area covered by a political
subdivision or consortium for a grant under paragraph
(1) has an extreme mosquito control need due to—
(I) the size or density of the potentially impacted human population;
(II) the size or density of a mosquito population that requires heightened control; or
(III) the severity of the mosquito-borne disease, such that expected serious adverse health
outcomes for the human population justify the
waiver.
(5) REPORTS TO SECRETARY.—A grant may be made under
paragraph (1) only if the political subdivision or consortium of
political subdivisions involved agrees that, promptly after the
end of the fiscal year for which the grant is made, the subdivision or consortium will submit to the Secretary, and to the
State within which the subdivision or consortium is located, a
report that describes the control program and contains an evaluation of whether the program was effective.
(6) NUMBER OF GRANTS.—A political subdivision or a consortium of political subdivisions may not receive more than one
grant under paragraph (1).
(c) APPLICATIONS FOR GRANTS.—A grant may be made under
subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application is in such form, is
made in such manner, and contains such agreements, assurances,
and information as the Secretary determines to be necessary to
carry out this section.
(d) TECHNICAL ASSISTANCE.—Amounts appropriated under subsection (f) may be used by the Secretary to provide training and
technical assistance with respect to the planning, development, and
operation of assessments and plans under subsection (a) and control programs under subsection (b). The Secretary may provide
such technical assistance directly or through awards of grants or
contracts to public and private entities.
(e) DEFINITION OF POLITICAL SUBDIVISION.—In this section, the
term ‘‘political subdivision’’ means the local political jurisdiction
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immediately below the level of State government, including counties, parishes, and boroughs. If State law recognizes an entity of
general government that functions in lieu of, and is not within, a
county, parish, or borough, the Secretary may recognize an area
under the jurisdiction of such other entities of general government
as a political subdivision for purposes of this section.
(f) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—For the purpose of carrying out this section, there are authorized to be appropriated $100,000,000 for
each of fiscal years 2019 through 2023.
(2) PUBLIC HEALTH EMERGENCIES.—In the case of control
programs carried out in response to a mosquito-borne disease
that constitutes a public health emergency, the authorization
of appropriations under paragraph (1) is in addition to applicable authorizations of appropriations under this Act and other
medical and public health preparedness and response laws.
(3) FISCAL YEAR 2019 APPROPRIATIONS.—For fiscal year
2019, 50 percent or more of the funds appropriated under paragraph (1) shall be used to award grants to political subdivisions or consortia of political subdivisions under subsection (b).
SEC. 317T. ø247b–22¿ MICROBICIDE RESEARCH.
(a) IN GENERAL.—The Director of the Centers
for Disease Control and Prevention is strongly encouraged to fully implement the
Centers’ microbicide agenda to support research and development
of microbicides for use to prevent the transmission of the human
immunodeficiency virus.
(b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated such sums as may be necessary for each of fiscal
years 2009 through 2013 to carry out this section.
SEC. 317U. ø247b-23¿ NATIONAL STRATEGY AND REGIONAL CENTERS
OF EXCELLENCE IN VECTOR-BORNE DISEASES.
(a) IN GENERAL.—The Secretary shall—
(1)(A) ensure the development and implementation of a national strategy to address vector-borne diseases, including tickborne diseases, that—
(i) identifies and assesses gaps and any unnecessary
duplication in federally-funded programs; and
(ii) identifies strategic goals to address such diseases
and appropriate benchmarks to measure progress toward
achieving such goals; and
(B) update such strategy, as appropriate; and
(2) coordinate programs and activities, including related to
data collection, research, and the development of diagnostics,
treatments, vaccines, and other related activities, to address
vector-borne diseases, including tick-borne diseases, across the
Department of Health and Human Services and with other
Federal agencies or departments, as appropriate.
(b) CONSULTATION.—In carrying out subsection (a)(1), the Secretary shall consult with the Tick-Borne Disease Working Group
established under section 2062 of the 21st Century Cures Act (42
U.S.C. 284s) and other individuals, as appropriate, such as—
(1) epidemiologists with experience in vector-borne diseases;
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(2) representatives of patient advocacy and research organizations that focus on vector-borne diseases, including such
organizations that have demonstrated experience in related research, public health, data collection, or patient access to care;
(3) health information technology experts or other information management specialists;
(4) clinicians, entomologists, vector management professionals, public health professionals, and others with expertise
in vector-borne diseases; and
(5) researchers, including researchers with experience conducting translational research.
(c) CENTERS OF EXCELLENCE.—The Secretary, in coordination
with the Director of the Centers for Disease Control and Prevention, shall award grants, contracts, or cooperative agreements to institutions of higher education for the establishment or continued
support of regional centers of excellence in vector-borne diseases to
address vector-borne diseases, including tick-borne diseases, by—
(1) facilitating collaboration between academia and public
health organizations for public health surveillance, prevention,
and response activities related to vector-borne diseases, including tick-borne diseases;
(2) providing training for public health entomologists and
other health care professionals, as appropriate, to address vector-borne diseases, including tick-borne diseases;
(3) conducting research to develop and validate prevention
and control tools and methods, including evidence-based and
innovative, evidence-informed tools and methods to anticipate
and respond to disease outbreaks; or
(4) preparing for and responding to outbreaks of vectorborne diseases, including tick-borne diseases.
(d) ELIGIBILITY.—To be eligible to receive a grant, contract, or
cooperative agreement under subsection (c), an entity shall submit
to the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require, including a description of how the entity will conduct the activities described in such subsection.
(e) REPORTS.—
(1) PROGRAM SUMMARY.—An entity receiving an award
under subsection (c) shall, not later than one year after receiving such award, and annually thereafter, submit to the Secretary a summary of programs and activities funded under the
award.
(2) PROGRESS REPORT.—Not later than 4 years after the
date of enactment of this section, the Secretary shall submit to
the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the
House of Representatives, a report on the progress made in addressing vector-borne diseases, including tick-borne diseases,
through activities carried out under this section.
(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$10,000,000 for each of fiscal years 2021 through 2025.
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SEC. 317V. ø 247b-24 ¿ ADDRESSING FACTORS RELATED TO IMPROVING
HEALTH OUTCOMES.
(a) IN GENERAL.—The Secretary may, as appropriate, award
grants, contracts, or cooperative agreements to eligible entities for
the conduct of evidence-based or evidence-informed projects, which
may include the development of networks to improve health outcomes by improving the capacity of such entities to address factors
that contribute to negative health outcomes in communities.
(b) ELIGIBLE ENTITIES.—To be eligible to receive an award
under this section, an entity shall—
(1)(A) be a State, local, or Tribal health department, community-based organization, Indian Tribe or Tribal organization
(as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), or other public or private entity, as the Secretary determines appropriate; or
(B) be a consortia of entities described in subparagraph (A)
or a public-private partnership, including a community partnership;
(2) submit to the Secretary an application at such time, in
such manner, and containing such information as the Secretary shall require;
(3) in the case of an entity other than a community-based
organization, demonstrate a history of successfully working
with an established community-based organization to address
health outcomes; and
(4) submit a plan to conduct activities described in subsection (a) based on a community needs assessment that takes
into account community input.
(c) USE OF FUNDS.—An entity described in subsection (b) shall
use funds received under subsection (a), in consultation with State,
local, and Tribal health departments, community-based organizations, entities serving medically underserved communities, and
other entities, as applicable, for one or more of the following purposes:
(1) Supporting the implementation, evaluation, and dissemination of strategies, through evidence-informed or evidence-based programs and through the support and use of public health and health care professionals to address factors related to health outcomes.
(2) Establishing, maintaining, or improving, in consultation with State, local, or Tribal health departments, technology
platforms or networks to support, in a manner that is consistent with applicable Federal and State privacy law—
(A) coordination among appropriate entities, and, as
applicable and appropriate, activities to improve such coordination;
(B) information sharing on health and related social
services; and
(C) technical assistance and related support for entities participating in the platforms or networks.
(3) Implementing best practices for improving health outcomes and reducing disease among underserved populations.
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(4) Supporting consideration of factors related to health
outcomes in preparing for, and responding to, public health
emergencies, through outreach, education, research, and other
relevant activities.
(d) BEST PRACTICES AND TECHNICAL ASSISTANCE.—The Secretary, in consultation with the Director of the Office of Minority
Health, the National Coordinator for Health Information Technology, and the Administrator of the Administration for Community Living, may award grants, contracts, and cooperative agreements to public or nonprofit private entities, including minority
serving institutions (defined, for purposes of this subsection, as institutions and programs described in section 326(e)(1) of the Higher
Education Act of 1965 and institutions described in section 371(a)
of such Act of 1965), to—
(1) identify or facilitate the development of best practices
to support improved health outcomes for underserved populations;
(2) provide technical assistance, training, and evaluation
assistance to award recipients under subsection (a);
(3) disseminate best practices, including to award recipients under subsection (a); and
(4) leverage, establish, or operate regional centers to develop, evaluate, and disseminate effective strategies on factors
related to health outcomes, including supporting research and
training related to such strategies.
(e) AWARD PERIODS.—The Secretary shall issue awards under
this section for periods of not more than 5 years and may issue extensions of such award periods for an additional period of up to 3
years.
(f) REPORT.—Not later than September 30, 2026, the Secretary
shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes information on activities funded under this section. Such report shall include a description of—
(1) changes in the capacity of public health entities to address factors related to health outcomes in communities, including any applicable platforms or networks developed or utilized to coordinate health and related social services and any
changes in workforce capacity or capabilities;
(2) improvements in health outcomes and in reducing
health disparities in medically underserved communities;
(3) activities conducted to support consideration of factors
related to health outcomes in preparing for, and responding to,
public health emergencies, through outreach, education, and
other relevant activities;
(4) communities and populations served by recipients of
awards under subsection (a);
(5) activities supported under subsection (e); and
(6) other relevant activities and outcomes, as determined
by the Secretary.
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $35,000,000 for each
of fiscal years 2023 through 2027. Of the amounts appropriated
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under this subsection for a fiscal year, 5 percent shall be reserved
for awards under subsection (a) to Indian Tribes and Tribal organizations (as such terms are defined in section 4 of the Indian SelfDetermination and Education Assistance Act), urban Indian organizations (as defined in section 4 of the Indian Health Care Improvement Act), and Tribal health departments.
PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF
SEXUALLY TRANSMITTED DISEASES 17
SEC. 318. ø247c¿ (a) The Secretary may provide technical assistance to appropriate public and non-profit private entities and to
scientific institutions for their research in, and training and public
health programs for the prevention and control of sexually transmitted diseases.
(b) The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity
for—
(1) research into the prevention and control of sexually
transmitted diseases;
(2) demonstration projects for the prevention and control of
sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such diseases; and
(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for
health professionals (including allied health personnel).
(c) The Secretary is also authorized to make project grants to
States and, in consultation with the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic
tests for, and diagnosed cases of, sexually transmitted diseases;
(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities
respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to evaluate or
test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.
(d) The Secretary may make grants to States and political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention
and control of sexually transmitted diseases.
17 Title II of Public Law 103–333, an appropriations Act, provides (under the heading relating
to the Centers for Disease Control and Prevention; see 108 Stat. 2550) in part as follows: ‘‘That
funds appropriated under this heading for fiscal year 1995 and subsequent fiscal years shall be
available for payment of the costs of medical care, related expenses, and burial expenses hereafter incurred by or on behalf of any person who had participated in the study of untreated
syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts and subject to such terms
and conditions as prescribed by the Secretary of Health and Human Services and for payment,
in such amounts and subject to such terms and conditions, of such costs and expenses hereafter
incurred by or on behalf of such person’s wife or offspring determined by the Secretary to have
suffered injury or disease from syphilis contracted from such person’’.
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86
(e)(1) For the purpose of making grants under subsections (b)
through (d), there are authorized to be appropriated $85,000,000
for fiscal year 1994, and such sums as may be necessary for each
of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep such
records as the Secretary shall prescribe including records which
fully disclose the amount and disposition by such recipient of the
proceeds of such grant, the total cost of the project or undertaking
in connection with which such grant was given or used and the
amount of that portion of the cost of the project or undertaking
supplied by other sources, and such other records as will facilitate
an effective audit.
(3) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall have
access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this
section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant under
this section, may reduce such grant by the fair market value of any
supplies or equipment furnished to such recipient and by the
amount of pay, allowances, travel expenses, and any other costs in
connection with the detail of an officer or employee of the United
States to the recipient when the furnishing of such supplies or
equipment or the detail of such an officer or employee is for the
convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant
under this section is made. The amount by which any such grant
is so reduced shall be available for payment by the Secretary of the
costs incurred in furnishing the supplies, equipment, or personal
services on which the reduction of such grant is based.
(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which
is being carried out with a grant made under this section shall not,
without such individual’s consent, be disclosed except as may be
necessary to provide service to him or as may be required by a law
of a State or political subdivision of a State. Information derived
from any such program may be disclosed—
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided
care or treatment under such program is not disclosed.
(f) Nothing in this section shall be construed to require any
State or any political subdivision of a State to have a sexually
transmitted diseases program which would require any person,
who objects to any treatment provided under such a program, to be
treated under such a program.
INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
SEC. 318A. ø247c–1¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions of
States, and other public or nonprofit private entities for the purpose of carrying out the activities described in subsection (c) reFebruary 1, 2024
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garding any treatable sexually transmitted disease that can cause
infertility in women if treatment is not received for the disease.
(b) AUTHORITY REGARDING INDIVIDUAL DISEASES.—With respect to diseases described in subsection (a), the Secretary shall, in
making a grant under such subsection, specify the particular disease or diseases with respect to which the grant is to be made. The
Secretary may not make the grant unless the applicant involved
agrees to carry out this section only with respect to the disease or
diseases so specified.
(c) AUTHORIZED ACTIVITIES.—With respect to any sexually
transmitted disease described in subsection (a), the activities referred to in such subsection are—
(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with
criteria issued under subsection (f);
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention and
control of the disease (including, in the case of a woman with
the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the
woman may have contracted the disease and any individual
whom the woman may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for women
screened pursuant to paragraph (1), including referrals for
evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant
to any of paragraphs (1) through (5), providing to the partner
of the woman the services described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of the
availability of the services described in paragraphs (1) through
(6);
(8) providing to the public information and education on
the prevention and control of the disease, including disseminating such information; and
(9) providing training to health care providers in carrying
out the screenings and counseling described in paragraphs (1)
and (3).
(d) REQUIREMENT OF AVAILABILITY OF ALL SERVICES THROUGH
EACH GRANTEE.—The Secretary may make a grant under subsection (a) only if the applicant involved agrees that each activity
authorized in subsection (c) will be available through the applicant.
With respect to compliance with such agreement, the applicant
may expend the grant to carry out any of the activities directly,
and may expend the grant to enter into agreements with other
public or nonprofit private entities under which the entities carry
out the activities.
(e) REQUIRED PROVIDERS REGARDING CERTAIN SERVICES.—The
Secretary may make a grant under subsection (a) only if the applicant involved agrees that, in expending the grant to carry out activities authorized in subsection (c), the services described in paragraphs (1) through (7) of such subsection will be provided only
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88
through entities that are State or local health departments, grantees under section 329, 330, 340A, or 1001, or are other public or
nonprofit private entities that provide health services to a significant number of low-income women.
(f) QUALITY ASSURANCE REGARDING SCREENING FOR DISEASES.—For purposes of this section, the Secretary shall establish
criteria for ensuring the quality of screening procedures for diseases described in subsection (a).
(g) CONFIDENTIALITY.—The Secretary may make a grant under
subsection (a) only if the applicant involved agrees, subject to applicable law, to maintain the confidentiality of information on individuals with respect to activities carried out under subsection (c).
(h) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The
Secretary may make a grant under subsection (a) only if the applicant involved agrees that, if a charge is imposed for the provision
of services or activities under the grant, such charge—
(1) will be made according to a schedule of charges that is
made available to the public;
(2) will be adjusted to reflect the income of the individual
involved; and
(3) will not be imposed on any individual with an income
of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget
and revised by the Secretary in accordance with section 673(2)
of the Omnibus Budget Reconciliation Act of 1981.
(i) LIMITATIONS ON CERTAIN EXPENDITURES.—The Secretary
may make a grant under subsection (a) only if the applicant involved agrees that not less than 80 percent of the grant will be expended for the purpose of carrying out paragraphs (1) through (7)
of subsection (c).
(j) REPORTS TO SECRETARY.—
(1) COLLECTION OF DATA.—The Secretary may make a
grant under subsection (a) only if the applicant involved
agrees, with respect to any disease selected under subsection
(b) for the applicant, to submit to the Secretary, for each fiscal
year for which the applicant receives such a grant, a report
providing—
(A) the incidence of the disease among the population
of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided
by the applicant, and the health conditions with respect to
which referrals have been made pursuant to subsection
(c)(5);
(D) an assessment of the extent to which the activities
carried pursuant to subsection (a) have reduced the incidence of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the project carried out with the
grant.
(2) UTILITY AND COMPARABILITY OF DATA.—The Secretary
shall carry out activities for the purpose of ensuring the utility
and comparability of data collected pursuant to paragraph (1).
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(k) MAINTENANCE OF EFFORT.—With respect to activities for
which a grant under subsection (a) is authorized to be expended,
the Secretary may make such a grant only if the applicant involved
agrees to maintain expenditures of non-Federal amounts for such
activities at a level that is not less than the average level of such
expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is applying to receive
such a grant.
(l) REQUIREMENT OF APPLICATION.—
(1) IN GENERAL.—The Secretary may make a grant under
subsection (a) only if an application for the grant is submitted
to the Secretary, the application contains the plan required in
paragraph (2), and the application is in such form, is made in
such manner, and contains such agreements, assurances, and
information as the Secretary determines to be necessary to
carry out this section.
(2) SUBMISSION OF PLAN FOR PROGRAM OF GRANTEE.—
(A) IN GENERAL.—The Secretary may make a grant
under subsection (a) only if the applicant involved submits
to the Secretary a plan describing the manner in which the
applicant will comply with the agreements required as a
condition of receiving such a grant, including a specification of the entities through which activities authorized in
subsection (c) will be provided.
(B) PARTICIPATION OF CERTAIN ENTITIES.—The Secretary may make a grant under subsection (a) only if the
applicant provides assurances satisfactory to the Secretary
that the plan submitted under subparagraph (A) has been
prepared in consultation with an appropriate number and
variety of—
(i) representatives of entities in the geographic
area involved that provide services for the prevention
and control of sexually transmitted diseases, including
programs to provide to the public information and education regarding such diseases; and
(ii) representatives of entities in such area that
provide family planning services.
(m) DURATION OF GRANT.—The period during which payments
are made to an entity from a grant under subsection (a) may not
exceed 3 years. The provision of such payments shall be subject to
annual approval by the Secretary of the payments and subject to
the availability of appropriations for the fiscal year involved to
make the payments in such year. The preceding sentence may not
be construed to establish a limitation on the number of grants
under such subsection that may be made to an entity.
(n) TECHNICAL ASSISTANCE, AND SUPPLIES AND SERVICES IN
LIEU OF GRANT FUNDS.—
(1) TECHNICAL ASSISTANCE.—The Secretary may provide
training and technical assistance to grantees under subsection
(a) with respect to the planning, development, and operation of
any program or service carried out under such subsection. The
Secretary may provide such technical assistance directly or
through grants or contracts.
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90
(2) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The
Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(A) the fair market value of any supplies or equipment
furnished the grant recipient; and
(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when
detailed to the grant recipient and the amount of any
other costs incurred in connection with the detail of such
officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and
at the request of such grant recipient and for the purpose of
carrying out a program with respect to which the grant under
subsection (a) is made. The amount by which any such grant
is so reduced shall be available for payment by the Secretary
of the costs incurred in furnishing the supplies or equipment,
or in detailing the personnel, on which the reduction of such
grant is based, and such amount shall be deemed as part of the
grant and shall be deemed to have been paid to the grant recipient.
(o) EVALUATIONS AND REPORTS BY SECRETARY.—
(1) EVALUATIONS.—The Secretary shall, directly or through
contracts with public or private entities, provide for annual
evaluations of programs carried out pursuant to subsection (a)
in order to determine the quality and effectiveness of the programs.
(2) REPORT TO CONGRESS.—Not later than 1 year after the
date on which amounts are first appropriated pursuant to subsection (q), and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House
of Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report—
(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1), including information on the incidence of sexually transmitted diseases described in subsection (a); and
(B) summarizing evaluations carried out pursuant to
paragraph (1) during the preceding fiscal year.
(p) COORDINATION OF FEDERAL PROGRAMS.—The Secretary
shall coordinate the program carried out under this section with
any similar programs administered by the Secretary (including coordination between the Director of the Centers for Disease Control
and Prevention and the Director of the National Institutes of
Health).
(q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, other than subsections (o) and (r), there
are authorized to be appropriated $25,000,000 for fiscal year 1993,
and such sums as may be necessary for each of the fiscal years
1994 through 1998.
(r) SEPARATE GRANTS FOR RESEARCH ON DELIVERY OF SERVICES.—
(1) IN GENERAL.—The Secretary may make grants for the
purpose of conducting research on the manner in which the deFebruary 1, 2024
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livery of services under subsection (a) may be improved. The
Secretary may make such grants only to grantees under such
subsection and to public and nonprofit private entities that are
carrying out programs substantially similar to programs carried out under such subsection.
(2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose
of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal
years 1993 through 1998.
DATA COLLECTION REGARDING PROGRAMS UNDER TITLE XXVI
SEC. 318B. ø247c–2¿ For the purpose of collecting and providing data for program planning and evaluation activities under
title XXVI, there are authorized to be appropriated to the Secretary
(acting through the Director of the Centers for Disease Control and
Prevention) such sums as may be necessary for each of the fiscal
years 2001 through 2005. Such authorization of appropriations is
in addition to other authorizations of appropriations that are available for such purpose.
SEC. 319. ø247d¿ PUBLIC HEALTH EMERGENCIES.
(a) EMERGENCIES.—If the Secretary determines,
after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise
exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants,
providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or
prevention of a disease or disorder as described in paragraphs (1)
and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer
exists, or upon the expiration of the 90-day period beginning on the
date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of
the same or additional facts), and the preceding sentence applies
to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress
written notification of the determination.
(b) PUBLIC HEALTH EMERGENCY FUND.—
(1) IN GENERAL.—There is established in the Treasury a
fund to be designated as the ‘‘Public Health Emergency Fund’’
to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant
potential for a public health emergency, to allow the Secretary
to rapidly respond to the immediate needs resulting from such
public health emergency or potential public health emergency.
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The Secretary shall plan for the expedited distribution of funds
to appropriate agencies and entities. There is authorized to be
appropriated to the Fund such sums as may be necessary.
(2) USES.—The Secretary may use amounts in the Fund
established under paragraph (1), to—
(A) facilitate coordination between and among Federal,
State, local, Tribal, and territorial entities and public and
private health care entities that the Secretary determines
may be affected by a public health emergency or potential
public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);
(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to
a public health emergency or potential public health emergency, including further supporting programs under section 319C–1, 319C–2, or 319C–3;
(C) facilitate and accelerate, as applicable, advanced
research and development of security countermeasures (as
defined in section 319F–2), qualified countermeasures (as
defined in section 319F–1), or qualified pandemic or epidemic products (as defined in section 319F–3), that are applicable to the public health emergency or potential public
health emergency under paragraph (1);
(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information
regarding such public health emergency or potential public
health emergency, including the systems under section
319D;
(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 2812 and the Medical Reserve Corps under section 2813;
(F) support the initial deployment and distribution of
contents of the Strategic National Stockpile, as appropriate; and
(G) carry out other activities, as the Secretary determines applicable and appropriate.
(3) REPORT.—Not later than 90 days after the end of each
fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Commerce and the Committee on Appropriations of the
House of Representatives a report describing—
(A) the expenditures made from the Public Health
Emergency Fund in such fiscal year, including—
(i) the amount obligated;
(ii) the recipient or recipients of such obligated
funds;
(iii) the specific response activities such obligated
funds will support; and
(iv) the declared or potential public health emergency for which such funds were obligated; and
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(B) each public health emergency for which the expenditures were made and the activities undertaken with
respect to each emergency which was conducted or supported by expenditures from the Fund.
(4) REVIEW.—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section
and provide recommendations to the Committee on Health,
Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House
of Representatives on policies to improve such Fund for the
uses described in paragraph (2).
(5) GAO REPORT.—Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Comptroller General of
the United States shall—
(A) conduct a review of the Fund under this section,
including its uses and the resources available in the Fund;
and
(B) submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a
report on such review, including recommendations related
to such review, as applicable.
(c) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under
this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and
not supplant other Federal, State, and local public funds provided
for activities under this Act or funds otherwise provided for emergency response.
(d) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case
in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are
unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by
the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially,
any sanctions otherwise applicable to such failure to comply. Before
or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the
Federal Register a notice of the extension or waiver.
(e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.—
(1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PERSONNEL.—Notwithstanding any other provision of law, and
subject to paragraph (2), upon request by the Governor of a
State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting
State or Indian tribe to temporarily reassign, for purposes of
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immediately addressing a public health emergency in the State
or Indian tribe, State and local public health department or
agency personnel funded in whole or in part through programs
authorized under this Act, as appropriate.
(2) ACTIVATION OF EMERGENCY REASSIGNMENT.—
(A) PUBLIC HEALTH EMERGENCY.—The Secretary may
authorize a temporary reassignment of personnel under
paragraph (1) only during the period of a public health
emergency determined pursuant to subsection (a).
(B) CONTENTS OF REQUEST.—To seek authority for a
temporary reassignment of personnel under paragraph (1),
the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:
(i) An assurance that the public health emergency
in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise
available.
(ii) An assurance that the public health emergency
would be addressed more efficiently and effectively
through the requested temporary reassignment of
State and local personnel described in paragraph (1).
(iii) An assurance that the requested temporary
reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 319C–1.
(iv) An identification of—
(I) each Federal program from which personnel would be temporarily reassigned pursuant
to the requested authority; and
(II) the number of personnel who would be so
reassigned from each such program.
(v) Such other information and assurances upon
which the Secretary and Governor of a State or tribal
organization agree.
(C) CONSIDERATION.—In reviewing a request for temporary reassignment under paragraph (1), the Secretary
shall consider the degree to which the program or programs funded in whole or in part by programs authorized
under this Act would be adversely affected by the reassignment.
(D) TERMINATION AND EXTENSION.—
(i) TERMINATION.—A State or Indian tribe’s temporary reassignment of personnel under paragraph (1)
shall terminate upon the earlier of the following:
(I) The Secretary’s determination that the
public health emergency no longer exists.
(II) Subject to clause (ii), the expiration of the
30-day period following the date on which the Secretary approved the State or Indian tribe’s request
for such reassignment flexibility.
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(ii) EXTENSION OF REASSIGNMENT FLEXIBILITY.—
The Secretary may extend reassignment flexibility of
personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health
emergency still exists as of such date, but only if—
(I) the State or Indian tribe that submitted
the initial request for a temporary reassignment
of personnel submits a request for an extension of
such temporary reassignment; and
(II) the request for an extension contains the
same information and assurances necessary for
the approval of an initial request for such temporary reassignment pursuant to subparagraph
(B).
(3) VOLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF
STATE AND LOCAL PERSONNEL.—
(A) IN GENERAL.—Unless otherwise provided under the
law or regulation of the State or Indian tribe that receives
authorization for temporary reassignment of personnel
under paragraph (1), personnel eligible for reassignment
pursuant to such authorization—
(i) shall have the opportunity to volunteer for temporary reassignment; and
(ii) shall not be required to agree to a temporary
reassignment.
(B) PROHIBITION ON CONDITIONING FEDERAL AWARDS.—
The Secretary may not condition the award of a grant, contract, or cooperative agreement under this Act on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.
(4) NOTICE TO CONGRESS.—The Secretary shall give notice
to the Congress in conjunction with the approval under this
subsection of—
(A) any initial request for temporary reassignment of
personnel; and
(B) any request for an extension of such temporary reassignment.
(5) GUIDANCE.—The Secretary shall—
(A) not later than 6 months after the enactment of this
subsection, issue proposed guidance on the temporary reassignment of personnel under this subsection; and
(B) after providing notice and a 60-day period for public comment, finalize such guidance.
(6) REPORT TO CONGRESS.—Not later than 4 years after the
date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Comptroller General of
the United States shall conduct an independent evaluation,
and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—
(A) a description of how, and under what circumstances, such temporary reassignment has been used
by States and Indian tribes;
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(B) an analysis of how such temporary reassignment
has assisted States and Indian tribes in responding to public health emergencies;
(C) an evaluation of how such temporary reassignment
has improved operational efficiencies in responding to public health emergencies;
(D) an analysis of the extent to which, if any, Federal
programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and
(E) recommendations on how medical surge capacity
could be improved in responding to public health emergencies and the impact of the reassignment flexibility
under this section on such surge capacity.
(7) DEFINITIONS.—In this subsection—
(A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’
have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act;
and
(B) the term ‘‘State’’ includes, in addition to the entities listed in the definition of such term in section 2, the
Freely Associated States.
(8) SUNSET.—This subsection shall terminate on March 8,
2024.
(f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION
ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.—
(1) DETERMINATION.—If the Secretary determines, after
consultation with such public health officials as may be necessary, that—
(A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been
met; or
(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a
public health emergency; and
(B) the circumstances of such public health emergency,
or potential for such significantly likely public health
emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of
chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act),
then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during
the immediate investigation of, and response to, such public
health emergency during the period of such public health
emergency or the period of time necessary to determine if a
disease or disorder, including a novel and emerging public
health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information
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diate postresponse review does not exceed a reasonable length
of time.
(2) TRANSPARENCY.—If the Secretary determines that a
waiver is necessary under paragraph (1), the Secretary shall
promptly post on the Internet website of the Department of
Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect,
and the agencies and offices within the Department of Health
and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the
Department of Health and Human Services, as applicable.
(3) EFFECTIVENESS OF WAIVER.—Any waiver under this
subsection shall take effect on the date on which the Secretary
posts information on the Internet website as provided for in
this subsection.
(4) TERMINATION OF WAIVER.—Upon determining that the
circumstances necessitating a waiver under paragraph (1) no
longer exist, the Secretary shall promptly update the Internet
website of the Department of Health and Human Services to
reflect the termination of such waiver.
(5) LIMITATIONS.—
(A) PERIOD OF WAIVER.—The period of a waiver under
paragraph (1) shall not exceed the period of time for the
related public health emergency, including a public health
emergency declared pursuant to subsection (a), and any
immediate postresponse review regarding the public health
emergency consistent with the requirements of this subsection.
(B) SUBSEQUENT COMPLIANCE.—An initiative subject to
a waiver under paragraph (1) that is ongoing after the
date on which the waiver expires, shall be subject to the
requirements of subchapter I of chapter 35 of title 44,
United States Code, and the Secretary shall ensure that
compliance with such requirements occurs in as timely a
manner as possible based on the applicable circumstances,
but not to exceed 30 calendar days after the expiration of
the applicable waiver.
(g) CERTAIN APPOINTMENTS TO SUPPORT PUBLIC HEALTH EMERGENCY RESPONSES.—
(1) IN GENERAL.—In order to support the initial response
to a public health emergency declared by the Secretary under
this section, the Secretary may, subject to paragraph (2) and
without regard to sections 3309 through 3318 of title 5, United
States Code, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to—
(A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or
(B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health
and Human Services to respond in the event of a public
health emergency declared by the Secretary under this section.
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(2) NUMBER OF APPOINTMENTS.—Each fiscal year in which
the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—
(A) 400 individuals under paragraph (1)(A); and
(B) 100 individuals under paragraph (1)(B).
(3) COMPENSATION.—The annual rate of basic pay of an individual appointed under this subsection shall be determined
in accordance with chapter 51 and subchapter III of chapter 53
of title 5, United States Code.
(4) REPORTING.—The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—
(A) the number of positions filled through such authority;
(B) the types of appointments of such positions;
(C) the titles, occupational series, and grades of such
positions;
(D) the number of positions publicly noticed to be filled
under such authority;
(E) the number of qualified applicants who apply for
such positions;
(F) the qualification criteria for such positions; and
(G) the demographic information of individuals appointed to such positions.
(5) NOTIFICATION TO CONGRESS.—In the event the Secretary, within a single fiscal year, directly appoints more than
50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later
than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House
of Representatives. Such notification shall, in a manner that
protects personal privacy, to the extent required by applicable
Federal and State privacy law, at a minimum, include—
(A) information on each such appointment within such
fiscal year;
(B) a description of how each such position relates to
the requirements of subparagraph (A) or (B) of paragraph
(1); and
(C) the additional number of personnel, if any, the
Secretary anticipates to be necessary to adequately support a response to a public health emergency declared
under this section using the authorities described in paragraph (1) within such fiscal year.
(6) REPORTS TO CONGRESS.—Not later than September 30,
2023, and annually thereafter for each fiscal year in which the
authority under this subsection is used, the Secretary shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report describing
the total number of appointments filled under this subsection
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late to the requirements of subparagraph (A) or (B) of paragraph (1).
(7) SUNSET.—The authority under this subsection shall expire on September 30, 2028.
(h) STOCKPILE DEPLETION REPORTING.—The Secretary shall,
not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 319F–2(a) to respond to a
public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President
under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on—
(1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests;
(2) the amount of such products that remain within the
stockpile following such deployment; and
(3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to
replenishment.
SEC. 319A. ø247d–1¿ VACCINE TRACKING AND DISTRIBUTION.
(a) TRACKING.—The Secretary, together with relevant
manufacturers, wholesalers, and distributors as may agree to cooperate,
may track the initial distribution of federally purchased influenza
vaccine in an influenza pandemic, or other federally purchased vaccine to address another pandemic. Such tracking information shall
be used to inform Federal, State, local, and tribal decision makers
during an influenza pandemic or other pandemic.
(b) DISTRIBUTION.—The Secretary shall promote communication between State, local, and tribal public health officials and such
manufacturers, wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include estimates of high priority
populations, as determined by the Secretary, in State, local, and
tribal jurisdictions in order to inform Federal, State, local, and tribal decision makers during vaccine shortages and supply disruptions.
(c) CONFIDENTIALITY.—The information submitted to the Secretary or its contractors, if any, under this section or under any
other section of this Act related to vaccine distribution information
shall remain confidential in accordance with the exception from the
public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged
and confidential, as provided for in section 552(b)(4) of title 5,
United States Code, and subject to the penalties and exceptions
under sections 1832 and 1833 of title 18, United States Code, relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996. None of such information provided by
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a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor,
or shall be used in any manner to give a manufacturer, wholesaler,
or distributor a proprietary advantage.
(d) GUIDELINES.—The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high
priority populations, during times of influenza pandemics or other
pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local,
and tribal health departments, shall develop guidelines for subsections (a) and (b).
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, $30,800,000 for each
of fiscal years 2019 through 2023.
(f) REPORT TO CONGRESS.—As part of the National Health Security Strategy described in section 2802, the Secretary shall provide an update on the implementation of subsections (a) through
(d).
SEC. 319B. ø 247d-2 ¿ EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.
The Secretary may contract with public and private entities, as
appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to
address an emerging infectious disease with respect to which a
public health emergency is declared under section 319, or that has
significant potential to cause such a public health emergency.
SEC. 319C–1. ø247d–3a¿ IMPROVING STATE AND LOCAL PUBLIC HEALTH
SECURITY. 18
(a) IN GENERAL.—To enhance the security of the United States
with respect to public health emergencies, the Secretary, acting
through the Director of the Centers for Disease Control and Prevention, shall award cooperative agreements to eligible entities to
enable such entities to conduct the activities described in subsection (d).
(b) ELIGIBLE ENTITIES.—To be eligible to receive an award
under subsection (a), an entity shall—
(1)(A) be a State;
(B) be a political subdivision determined by the Secretary
to be eligible for an award under this section (based on criteria
described in subsection (h)(4)); or
(C) be a consortium of States; and
(2) prepare and submit to the Secretary an application at
such time, and in such manner, and containing such information as the Secretary may require, including—
(A) an All-Hazards Public Health Emergency Preparedness and Response Plan which shall include—
18 Former sections 319B and 319C were repealed by section 204(b)(1) of Public Law 109–417
(120 Stat. 2951).
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(i) a description of the activities such entity will
carry out under the agreement to meet the goals identified under section 2802, including with respect to
chemical, biological, radiological, or nuclear threats,
whether naturally occurring, unintentional, or deliberate;
(ii) a description of the activities such entity will
carry out with respect to pandemic influenza, as a
component of the activities carried out under clause
(i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);
(iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of
a public health emergency;
(iv) 19 a description of the mechanism the entity will
implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical
and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to section
319I to improve enrollment and coordination of volunteer
health care professionals seeking to provide medical services during a public health emergency, which may include—
(I) providing a public method of communication
for purposes of volunteer coordination (such as a
phone number);
(II) providing for optional registration to participate in volunteer services during processes related to
State medical licensing, registration, or certification or
renewal of such licensing, registration, or certification;
or
(III) other mechanisms as the State determines
appropriate;
(v) a description of how the entity will include the
State Unit on Aging in public health emergency preparedness;
(vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders, including public health agencies with specific
expertise that may be relevant to public health security, such as environmental health agencies, in public
health emergency preparedness and response;
(vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs during and following a public health emergency;
(viii) a description of how the entity, as applicable
and appropriate, will coordinate with State emergency
preparedness and response plans in public health
emergency preparedness, including State education
agencies (as defined in section 8101 of the Elementary
19 Margin
for clause (iv) is so in law.
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102
and Secondary Education Act of 1965), State child care
lead agencies (designated under section 658D of the
Child Care and Development Block Grant Act of
1990), and other relevant State agencies
(ix) in the case of entities that operate on the
United States-Mexico border or the United StatesCanada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection,
identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring
or due to bioterrorism, consistent with the requirements of this section;
(x) a description of any activities that such entity
will use to analyze real-time clinical specimens for
pathogens of public health or bioterrorism significance,
including any utilization of poison control centers;
(xi) a description of how the entity will partner
with health care facilities, including hospitals and
nursing homes and other long-term care facilities, to
promote and improve public health preparedness and
response;
(xii) a description of how the entity will provide
technical assistance to improve public health preparedness and response, as appropriate, to agencies or
other entities that operate facilities within the entity’s
jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public
health emergency declared under section 319, such as
residential care facilities, group homes, and other
similar settings; and
(xiii) a description of how, as appropriate and
practicable, the entity will include critical infrastructure partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure
will remain functioning during, or return to function
as soon as practicable after, a public health emergency;
(B) an assurance that the entity will report to the Secretary on an annual basis (or more frequently as determined by the Secretary) on the evidence-based benchmarks and objective standards established by the Secretary to evaluate the preparedness and response capabilities of such entity under subsection (g);
(C) an assurance that the entity will conduct, on at
least an annual basis, an exercise or drill that meets any
criteria established by the Secretary to test the preparedness and response capabilities of such entity, including addressing the needs of at-risk individuals, and that the entity will report back to the Secretary within the application
of the following year on the strengths and weaknesses
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identified through such exercise or drill, and corrective actions taken to address material weaknesses;
(D) an assurance that the entity will require relevant
staff to complete relevant preparedness and response
trainings, including trainings related to efficient and effective operation during an incident or event within an Incident Command System;
(E) an assurance that the entity will provide to the
Secretary the data described under section 319D(c)(3) as
determined feasible by the Secretary;
(F) an assurance that the entity will conduct activities
to inform and educate the hospitals within the jurisdiction
of such entity on the role of such hospitals in the plan required under subparagraph (A);
(G) an assurance that the entity, with respect to the
plan described under subparagraph (A), has developed and
will implement an accountability system to ensure that
such entity makes satisfactory annual improvement and
describes such system in the plan under subparagraph (A);
(H) a description of the means by which to obtain public comment and input on the plan described in subparagraph (A) and on the implementation of such plan, that
shall include an advisory committee or other similar mechanism for obtaining comment from the public and from
other State, local, and tribal stakeholders; and
(I) as relevant, a description of the process used by the
entity to consult with local departments of public health to
reach consensus, approval, or concurrence on the relative
distribution of amounts received under this section.
(c) LIMITATION.—Beginning in fiscal year 2009, the Secretary
may not award a cooperative agreement to a State unless such
State is a participant in the Emergency System for Advance Registration of Volunteer Health Professionals described in section
319I.
(d) USE OF FUNDS.—
(1) IN GENERAL.—An award under subsection (a) shall be
expended for activities to achieve the preparedness goals described under paragraphs (1), (2), (4), (5), and (6) of section
2802(b).
(2) EFFECT OF SECTION.—Nothing in this subsection may
be construed as establishing new regulatory authority or as
modifying any existing regulatory authority.
(e) COORDINATION WITH LOCAL RESPONSE CAPABILITIES.—An
entity shall, to the extent practicable, ensure that activities carried
out under an award under subsection (a) are coordinated with activities of relevant Metropolitan Medical Response Systems, local
public health departments, the Cities Readiness Initiative, local
emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section 319C–3.
(f) CONSULTATION WITH HOMELAND SECURITY.—In making
awards under subsection (a), the Secretary shall consult with the
Secretary of Homeland Security to—
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(1) ensure maximum coordination of public health and
medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;
(2) minimize duplicative funding of programs and activities; and
(3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and
guidance on best practices for such activities.
(g) ACHIEVEMENT OF MEASURABLE EVIDENCE-BASED BENCHMARKS AND OBJECTIVE STANDARDS.—
(1) IN GENERAL.—Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness Act,
the Secretary shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in section 319C–
2. In developing such benchmarks and standards, the Secretary shall consult with and seek comments from State, local,
and tribal officials and private entities, as appropriate. Where
appropriate, the Secretary shall incorporate existing objective
standards. Such benchmarks and standards shall—
(A) include outcome goals representing operational
achievements of the National Preparedness Goals developed under section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear
threats; and
(B) at a minimum, require entities to—
(i) measure progress toward achieving the outcome goals; and
(ii) at least annually, test, exercise, and rigorously
evaluate the public health and medical emergency preparedness and response capabilities of the entity, and
report to the Secretary on such measured and tested
capabilities and measured and tested progress toward
achieving outcome goals, based on criteria established
by the Secretary.
(2) CRITERIA FOR PANDEMIC INFLUENZA PLANS.—
(A) IN GENERAL.—Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall develop and disseminate to the chief executive officer of each State criteria for
an effective State plan for responding to pandemic influenza. The Secretary shall periodically update, as necessary
and appropriate, such pandemic influenza plan criteria
and shall require the integration of such criteria into the
benchmarks and standards described in paragraph (1).
(B) RULE OF CONSTRUCTION.—Nothing in this section
shall be construed to require the duplication of Federal efforts with respect to the development of criteria or standards, without regard to whether such efforts were carried
out prior to or after the date of enactment of this section.
(3) TECHNICAL ASSISTANCE.—The Secretary shall, as determined appropriate by the Secretary, provide to a State, upon
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request, technical assistance in meeting the requirements of
this section, including the provision of advice by experts in the
development of high-quality assessments, the setting of State
objectives and assessment methods, the development of measures of satisfactory annual improvement that are valid and reliable, and other relevant areas.
(4) NOTIFICATION OF FAILURES.—The Secretary shall develop and implement a process to notify entities that are determined by the Secretary to have failed to meet the requirements
of paragraph (1) or (2). Such process shall provide such entities
with the opportunity to correct such noncompliance. An entity
that fails to correct such noncompliance shall be subject to
paragraph (5).
(5) WITHHOLDING OF AMOUNTS FROM ENTITIES THAT FAIL
TO ACHIEVE BENCHMARKS OR SUBMIT INFLUENZA PLAN.—Beginning with fiscal year 2019, and in each succeeding fiscal year,
the Secretary shall—
(A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures
described in paragraph (1) for either of the 2 immediately
preceding fiscal years (beginning with fiscal year 2018),
pursuant to the process developed under paragraph (4),
the amount described in paragraph (6); and
(B) withhold from each entity that has failed to submit
to the Secretary a plan for responding to pandemic influenza that meets the criteria developed under paragraph
(2), the amount described in paragraph (6).
(6) AMOUNTS DESCRIBED.—
(A) IN GENERAL.—The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section 319C–
2:
(i) For no more than one of each of the first 2 fiscal years immediately following a fiscal year in which
an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5), an amount equal to
10 percent of the amount the entity was eligible to receive for the respective fiscal year.
(ii) For no more than one of the first 2 fiscal years
immediately following the third consecutive fiscal year
in which an entity experienced such a failure, in lieu
of applying clause (i), an amount equal to 15 percent
of the amount the entity was eligible to receive for the
respective fiscal year.
(B) SEPARATE ACCOUNTING.—Each failure described in
subparagraph (A) or (B) of paragraph (5) shall be treated
as a separate failure for purposes of calculating amounts
withheld under subparagraph (A).
(7) REALLOCATION OF AMOUNTS WITHHELD.—
(A) IN GENERAL.—The Secretary shall make amounts
withheld under paragraph (6) available for making awards
under section 319C–2 to entities described in subsection
(b)(1) of such section.
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(B) PREFERENCE IN REALLOCATION.—In making awards
under section 319C–2 with amounts described in subparagraph (A), the Secretary shall give preference to eligible
entities (as described in section 319C–2(b)(1)) that are located in whole or in part in States from which amounts
have been withheld under paragraph (6).
(8) WAIVE OR REDUCE WITHHOLDING.—The Secretary may
waive or reduce the withholding described in paragraph (6), for
a single entity or for all entities in a fiscal year, if the Secretary determines that mitigating conditions exist that justify
the waiver or reduction.
(h) FUNDING.—
(1) AUTHORIZATION OF APPROPRIATIONS.—
(A) IN GENERAL.—For the purpose of carrying out this
section, there is authorized to be appropriated
$685,000,000 for each of fiscal years 2019 through 2023 for
awards pursuant to paragraph (3) (subject to the authority
of the Secretary to make awards pursuant to paragraphs
(4) and (5)).
(B) REQUIREMENT FOR STATE MATCHING FUNDS.—Beginning in fiscal year 2009, in the case of any State or consortium of two or more States, the Secretary may not
award a cooperative agreement under this section unless
the State or consortium of States agree that, with respect
to the amount of the cooperative agreement awarded by
the Secretary, the State or consortium of States will make
available (directly or through donations from public or private entities) non-Federal contributions in an amount
equal to—
(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of such costs ($1 for each
$20 of Federal funds provided in the cooperative
agreement); and
(ii) for any second fiscal year of the cooperative
agreement, and for any subsequent fiscal year of such
cooperative agreement, not less than 10 percent of
such costs ($1 for each $10 of Federal funds provided
in the cooperative agreement).
(C) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTIONS.—As determined by the Secretary, non-Federal
contributions required in subparagraph (B) may be provided directly or through donations from public or private
entities and may be in cash or in kind, fairly evaluated, including plant, equipment or services. Amounts provided by
the Federal government, or services assisted or subsidized
to any significant extent by the Federal government, may
not be included in determining the amount of such nonFederal contributions.
(2) MAINTAINING STATE FUNDING.—
(A) IN GENERAL.—An entity that receives an award
under this section shall maintain expenditures for public
health security at a level that is not less than the average
level of such expenditures maintained by the entity for the
preceding 2 year period.
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(B) RULE OF CONSTRUCTION.—Nothing in this section
shall be construed to prohibit the use of awards under this
section to pay salary and related expenses of public health
and other professionals employed by State, local, or tribal
public health agencies who are carrying out activities supported by such awards (regardless of whether the primary
assignment of such personnel is to carry out such activities).
(3) DETERMINATION OF AMOUNT.—
(A) IN GENERAL.—The Secretary shall award cooperative agreements under subsection (a) to each State or consortium of 2 or more States that submits to the Secretary
an application that meets the criteria of the Secretary for
the receipt of such an award and that meets other implementation conditions established by the Secretary for such
awards
(B) BASE AMOUNT.—In determining the amount of an
award pursuant to subparagraph (A) for a State, the Secretary shall first determine an amount the Secretary considers appropriate for the State (referred to in this paragraph as the ‘‘base amount’’), except that such amount
may not be greater than the minimum amount determined
under subparagraph (D).
(C) INCREASE ON BASIS OF POPULATION.—After determining the base amount for a State under subparagraph
(B), the Secretary shall increase the base amount by an
amount equal to the product of—
(i) the amount appropriated under paragraph
(1)(A) for the fiscal year, less an amount equal to the
sum of all base amounts determined for the States
under subparagraph (B), and less the amount, if any,
reserved by the Secretary under paragraphs (4) and
(5); and
(ii) subject to paragraph (4)(C), the percentage
constituted by the ratio of an amount equal to the population of the State over an amount equal to the total
population of the States (as indicated by the most recent data collected by the Bureau of the Census).
(D) MINIMUM AMOUNT.—Subject to the amount appropriated under paragraph (1)(A), an award pursuant to subparagraph (A) for a State shall be the greater of the base
amount as increased under subparagraph (C), or the minimum amount under this subparagraph. The minimum
amount under this subparagraph is—
(i) in the case of each of the several States, the
District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of—
(I) $5,000,000; or
(II) if the amount appropriated under paragraph (1)(A) is less than $667,000,000, an amount
equal to 0.75 percent of the amount appropriated
under such paragraph, less the amount, if any, reserved by the Secretary under paragraphs (4) and
(5); or
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PUBLIC HEALTH SERVICE ACT
108
(ii) in the case of each of American Samoa, Guam,
the Commonwealth of the Northern Mariana Islands,
and the Virgin Islands, an amount determined by the
Secretary to be appropriate, except that such amount
may not exceed the amount determined under clause
(i).
(4) CERTAIN POLITICAL SUBDIVISIONS.—
(A) IN GENERAL.—For fiscal year 2007, the Secretary
may, before making awards pursuant to paragraph (3) for
such year, reserve from the amount appropriated under
paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection
(a) to political subdivisions that have a substantial number
of residents, have a substantial local infrastructure for responding to public health emergencies, and face a high degree of risk from bioterrorist attacks or other public health
emergencies. Not more than three political subdivisions
may receive awards pursuant to this subparagraph.
(B) COORDINATION WITH STATEWIDE PLANS.—An award
pursuant to subparagraph (A) may not be made unless the
application of the political subdivision involved is in coordination with, and consistent with, applicable Statewide
plans described in subsection (b).
(C) RELATIONSHIP TO FORMULA GRANTS.—In the case of
a State that will receive an award pursuant to paragraph
(3), and in which there is located a political subdivision
that will receive an award pursuant to subparagraph (A),
the Secretary shall, in determining the amount under
paragraph (3)(C) for the State, subtract from the population of the State an amount equal to the population of
such political subdivision.
(D) CONTINUITY OF FUNDING.—In determining whether
to make an award pursuant to subparagraph (A) to a political subdivision, the Secretary may consider, as a factor indicating that the award should be made, that the political
subdivision received public health funding from the Secretary for fiscal year 2006.
(5) SIGNIFICANT UNMET NEEDS; DEGREE OF RISK.—
(A) IN GENERAL.—For fiscal year 2007, the Secretary
may, before making awards pursuant to paragraph (3) for
such year, reserve from the amount appropriated under
paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection
(a) to eligible entities that—
(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a
bioterrorist or other threat to the public health, which
need will not be met by awards pursuant to paragraph
(3); and
(ii) face a particularly high degree of risk of such
a threat.
(B) RECIPIENTS OF GRANTS.—Awards pursuant to subparagraph (A) may be supplemental awards to States that
receive awards pursuant to paragraph (3), or may be
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109
PUBLIC HEALTH SERVICE ACT
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awards to eligible entities described in subsection (b)(1)(B)
within such States.
(C) FINDING WITH RESPECT TO DISTRICT OF COLUMBIA.—The Secretary shall consider the District of Columbia
to have a significant unmet need for purposes of subparagraph (A), and to face a particularly high degree of risk for
such purposes, on the basis of the concentration of entities
of national significance located within the District.
(6) FUNDING OF LOCAL ENTITIES.—The Secretary shall, in
making awards under this section, ensure that with respect to
the cooperative agreement awarded, the entity make available
appropriate portions of such award to political subdivisions
and local departments of public health through a process involving the consensus, approval or concurrence with such local
entities.
(7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
(A) IN GENERAL.—Amounts provided to an eligible entity under a cooperative agreement under subsection (a)
for a fiscal year and remaining unobligated at the end of
such year shall remain available to such entity for the
next fiscal year for the purposes for which such funds were
provided.
(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.—
The continued availability of funds under subparagraph
(A) with respect to an entity shall be contingent upon such
entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection (g).
(i) ADMINISTRATIVE AND FISCAL RESPONSIBILITY.—
(1) ANNUAL REPORTING REQUIREMENTS.—Each entity shall
prepare and submit to the Secretary annual reports on its activities under this section and section 319C–2. Each such report shall be prepared by, or in consultation with, the health
department. In order to properly evaluate and compare the
performance of different entities assisted under this section
and section 319C–2 and to assure the proper expenditure of
funds under this section and section 319C–2, such reports shall
be in such standardized form and contain such information as
the Secretary determines and describes within 180 days of the
date of enactment of the Pandemic and All-Hazards Preparedness Act (after consultation with the States) to be necessary
to—
(A) secure an accurate description of those activities;
(B) secure a complete record of the purposes for which
funds were spent, and of the recipients of such funds;
(C) describe the extent to which the entity has met the
goals and objectives it set forth under this section or section 319C–2;
(D) determine the extent to which funds were expended consistent with the entity’s application transmitted
under this section or section 319C–2; and
(E) publish such information on a Federal Internet
website consistent with subsection (j).
(2) AUDITS; IMPLEMENTATION.—
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110
(A) IN GENERAL.—Each entity receiving funds under
this section or section 319C–2 shall, not less often than
once every 2 years, audit its expenditures from amounts
received under this section or section 319C–2. Such audits
shall be conducted by an entity independent of the agency
administering a program funded under this section or section 319C–2 in accordance with the Comptroller General’s
standards for auditing governmental organizations, programs, activities, and functions and generally accepted auditing standards. Within 30 days following the completion
of each audit report, the entity shall submit a copy of that
audit report to the Secretary.
(B) REPAYMENT.—Each entity shall repay to the
United States amounts found by the Secretary, after notice
and opportunity for a hearing to the entity, not to have
been expended in accordance with this section or section
319C–2 and, if such repayment is not made, the Secretary
may offset such amounts against the amount of any allotment to which the entity is or may become entitled under
this section or section 319C–2 or may otherwise recover
such amounts.
(C) WITHHOLDING OF PAYMENT.—The Secretary may,
after notice and opportunity for a hearing, withhold payment of funds to any entity which is not using its allotment under this section or section 319C–2 in accordance
with such section. The Secretary may withhold such funds
until the Secretary finds that the reason for the withholding has been removed and there is reasonable assurance that it will not recur.
(j) COMPILATION AND AVAILABILITY OF DATA.—The Secretary
shall compile the data submitted under this section and make such
data available in a timely manner on an appropriate Internet
website in a format that is useful to the public and to other entities
and that provides information on what activities are best contributing to the achievement of the outcome goals described in subsection (g).
(k) EVALUATION.—
(1) IN GENERAL.—Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 and every 2 years thereafter,
the Secretary shall conduct an evaluation of the evidence-based
benchmarks and objective standards required under subsection
(g). Such evaluation shall be submitted to the congressional
committees of jurisdiction together with the National Health
Security Strategy under section 2802, at such time as such
strategy is submitted.
(2) CONTENT.—The evaluation under this paragraph shall
include—
(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;
(B) a discussion of changes to any evidence-based
benchmarks and objective standards, and the effect of such
changes on the ability to track whether entities are meeting or making progress toward the goals under this section
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111
PUBLIC HEALTH SERVICE ACT
Sec. 319C–2
and, to the extent practicable, the applicable goals of the
National Health Security Strategy under section 2802;
(C) a description of amounts received by eligible entities described in subsection (b) and section 319C–2(b), and
amounts received by subrecipients and the effect of such
funding on meeting evidence-based benchmarks and objective standards; and
(D) recommendations, as applicable and appropriate,
to improve evidence-based benchmarks and objective
standards to more accurately assess the ability of entities
receiving awards under this section to better achieve the
goals under this section and section 2802.
SEC. 319C–2. ø247d–3b¿ PARTNERSHIPS FOR STATE AND REGIONAL
HOSPITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.
(a) IN GENERAL.—The Secretary, acting through the Assistant
Secretary for Preparedness and Response, shall award competitive
grants or cooperative agreements to eligible entities to enable such
entities to improve surge capacity and enhance community and
hospital preparedness for, and response to, public health emergencies in accordance with subsection (c), including, as appropriate,
capacity and preparedness to address the needs of children and
other at-risk individuals.
(b) ELIGIBILITY.—To be eligible for an award under subsection
(a), an entity shall—
(1)(A) be a coalition that includes—
(i) one or more hospitals, at least one of which shall
be a designated trauma center, consistent with section
1213(c);
(ii) one or more other local health care facilities, including clinics, health centers, community health centers,
primary care facilities, mental health centers, mobile medical assets, or nursing homes;
(iii)(I) one or more political subdivisions;
(II) one or more States; or
(III) one or more States and one or more political subdivisions; and
(iv) one or more emergency medical service organizations or emergency management organizations; and
(B) prepare, in consultation with the Chief Executive Officer and the lead health officials of the State, District, or territory in which the hospital and health care facilities described
in subparagraph (A) are located, and submit to the Secretary,
an application at such time, in such manner, and containing
such information as the Secretary may require; or
(2)(A) be an entity described in section 319C–1(b)(1); and
(B) submit an application at such time, in such manner,
and containing such information as the Secretary may require,
including the information or assurances required under section
319C–1(b)(2) and an assurance that the State will adhere to
any applicable guidelines established by the Secretary.
(c) USE OF FUNDS.—An award under subsection (a) shall be expended for activities to achieve the preparedness goals described
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with
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PUBLIC HEALTH SERVICE ACT
112
respect to all-hazards, including chemical, biological, radiological,
or nuclear threats.
(d) PREFERENCES.—
(1) REGIONAL COORDINATION.—In making awards under
subsection (a), the Secretary shall give preference to eligible
entities that submit applications that, in the determination of
the Secretary—
(A) will enhance coordination—
(i) among the entities described in subsection
(b)(1)(A)(i);
(ii) among one or more facilities in a regional
health care emergency system under section 319C–3;
and
(iii) between such entities and the entities described in subsection (b)(1)(A)(ii); and
(B) include, in the coalition described in subsection
(b)(1)(A), a significant percentage of the hospitals and
health care facilities within the geographic area served by
such coalition.
(2) OTHER PREFERENCES.—In making awards under subsection (a), the Secretary shall give preference to eligible entities that, in the determination of the Secretary—
(A) include one or more hospitals that are participants
in the National Disaster Medical System;
(B) are located in a geographic area that faces a high
degree of risk, as determined by the Secretary in consultation with the Secretary of Homeland Security; or
(C) have a significant need for funds to achieve the
preparedness and response goals described in section
2802(b)(3).
(e) CONSISTENCY OF PLANNED ACTIVITIES.—The Secretary may
not award a cooperative agreement to an eligible entity described
in subsection (b)(1) unless the application submitted by the entity
is coordinated and consistent with an applicable State All-Hazards
Public Health Emergency Preparedness and Response Plan and relevant local plans, as determined by the Secretary in consultation
with relevant State health officials.
(f) LIMITATION ON AWARDS.—A political subdivision shall not
participate in more than one coalition described in subsection
(b)(1).
(g) COORDINATION.—
(1) LOCAL RESPONSE CAPABILITIES.—An eligible entity
shall, to the extent practicable, ensure that activities carried
out under an award under subsection (a) are coordinated with
activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness
Initiative, and local emergency plans.
(2) NATIONAL COLLABORATION.—Coalitions consisting of
one or more eligible entities under this section may, to the extent practicable, collaborate with other coalitions consisting of
one or more eligible entities under this section for purposes of
national coordination and collaboration with respect to activities to achieve the preparedness and response goals described
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).
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Sec. 319C–2
(h) MAINTENANCE OF FUNDING.—
(1) IN GENERAL.—An entity that receives an award under
this section shall maintain expenditures for health care preparedness at a level that is not less than the average level of
such expenditures maintained by the entity for the preceding
2 year period.
(2) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to prohibit the use of awards under this section
to pay salary and related expenses of public health and other
professionals employed by State, local, or tribal agencies who
are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to
carry out such activities).
(i) PERFORMANCE AND ACCOUNTABILITY.—
(1) IN GENERAL.—The requirements of section 319C–1(g),
(i), (j), and (k) shall apply to entities receiving awards under
this section (regardless of whether such entities are described
under subsection (b)(1)(A) or (b)(2)(A)) in the same manner as
such requirements apply to entities under section 319C–1. In
submitting reports under this paragraph, a coalition shall include information on the progress that the coalition has made
toward the implementation of section 319C–3 (or barriers to
progress, if any).A coalition described in subsection (b)(1)(A)
shall make such reports available to the lead health official of
the State in which such coalition is located.
(2) MEETING GOALS OF NATIONAL HEALTH SECURITY STRATEGY.—The Secretary shall implement objective, evidence-based
metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals
of the National Health Security Strategy under section 2802.
(j) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—
(A) AUTHORIZATION OF APPROPRIATIONS.—For purposes
of carrying out this section and section 319C–3, in accordance with subparagraph (B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019
through 2023.
(B) RESERVATION OF AMOUNTS FOR REGIONAL SYSTEMS.—
(i) IN GENERAL.—Subject to clause (ii), of the
amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for
the purpose of carrying out section 319C–3.
(ii) RESERVATION CONTINGENT ON CONTINUED APPROPRIATIONS FOR THIS SECTION.—If for fiscal year
2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after application of clause (i), the amount remaining for the
purpose of carrying out this section would be less than
the amount available for such purpose for the previous
fiscal year, the amount that may be reserved under
clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is
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PUBLIC HEALTH SERVICE ACT
114
not less than the amount available for such purpose
for the previous fiscal year.
(iii) SUNSET.—The authority to reserve amounts
under clause (i) shall expire on September 30, 2023.
(2) RESERVATION OF AMOUNTS FOR PARTNERSHIPS.—Prior to
making awards described in paragraph (3), the Secretary may
reserve from the amount appropriated under paragraph (1)(A)
for a fiscal year and not reserved for the purpose described in
paragraph (1)(B)(i), an amount determined appropriate by the
Secretary for making awards to entities described in subsection
(b)(1)(A).
(3) AWARDS TO STATES AND POLITICAL SUBDIVISIONS.—
(A) IN GENERAL.—From amounts appropriated for a
fiscal year under paragraph (1)(A) and not reserved under
paragraph (1)(B)(i) or (2), the Secretary shall make awards
to entities described in subsection (b)(2)(A) that have completed an application as described in subsection (b)(2)(B).
(B) AMOUNT.—The Secretary shall determine the
amount of an award to each entity described in subparagraph (A) in the same manner as such amounts are determined under section 319C–1(h).
(4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
(A) IN GENERAL.—Amounts provided to an eligible entity under a cooperative agreement under subsection (a)
for a fiscal year and remaining unobligated at the end of
such year shall remain available to such entity for the
next fiscal year for the purposes for which such funds were
provided.
(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.—
The continued availability of funds under subparagraph
(A) with respect to an entity shall be contingent upon such
entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i).
SEC. 319C–3. ø247d-3c¿ GUIDELINES FOR REGIONAL HEALTH CARE
EMERGENCY PREPAREDNESS AND RESPONSE SYSTEMS.
(a) PURPOSE.—It is the purpose of this section to identify and
provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying
levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public
health emergency, including threats posed by one or more chemical, biological, radiological, or nuclear agents, including emerging
infectious diseases.
(b) GUIDELINES.—The Assistant Secretary for Preparedness
and Response, in consultation with the Director of the Centers for
Disease Control and Prevention, the Administrator of the Centers
for Medicare & Medicaid Services, the Administrator of the Health
Resources and Services Administration, the Commissioner of Food
and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the heads of such
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Sec. 319C–3
cials, shall, not later than 2 years after the date of enactment of
this section—
(1) identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities
to provide appropriate patient care during, in advance of, or
immediately following, a public health emergency, resulting
from one or more chemical, biological, radiological, or nuclear
agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical
surge capacity and capabilities), with respect to—
(A) a regional approach to identifying hospitals and
health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including—
(i) the manner in which the system will coordinate
with and integrate the partnerships and health care
coalitions established under section 319C–2(b); and
(ii) informing and educating appropriate first responders and health care supply chain partners of the
regional emergency preparedness and response capabilities and medical surge capacity of such hospitals
and health care facilities in the community;
(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply
chain needs, taking into account resiliency, geographic considerations, and rural considerations;
(C) protocols or best practices for the safety and personal protection of workers who handle human remains
and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health,
psychological resilience, and training of the workforce, as
applicable;
(D) in a manner that allows for disease containment
(within the meaning of section 2802(b)(2)(B)), coordinated
medical triage, treatment, and transportation of patients,
based on patient medical need (including patients in rural
areas), to the appropriate hospitals or health care facilities
within the regional system or, as applicable and appropriate, between systems in different States or regions; and
(E) the needs of children and other at-risk individuals;
(2) make such guidelines available on the internet website
of the Department of Health and Human Services in a manner
that does not compromise national security; and
(3) update such guidelines as appropriate, including based
on input received pursuant to subsections (c) and (e) and information resulting from applicable reports required under the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such
Act), to address new and emerging public health threats.
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(c) CONSIDERATIONS.—In identifying, developing, and updating
guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—
(1) include input from hospitals and health care facilities
(including health care coalitions under section 319C–2), State,
local, Tribal, and territorial public health departments, and
health care or subject matter experts (including experts with
relevant expertise in chemical, biological, radiological, or nuclear threats, including emerging infectious diseases), as the
Assistant Secretary determines appropriate, to meet the goals
under section 2802(b)(3);
(2) consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary
care clinics, community health centers, mental health facilities,
ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers,
environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts that the Assistant Secretary determines appropriate, to
meet the goals under section 2802(b)(3);
(3) consider feedback related to financial implications for
hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged in
regional preparedness planning to implement and follow such
guidelines, as applicable; and
(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health
emergencies as part of the regional health care emergency preparedness and response system.
(d) TECHNICAL ASSISTANCE.—The Assistant Secretary for Preparedness and Response, in consultation with the Director of the
Centers for Disease Control and Prevention and the Assistant Secretary of Labor for Occupational Safety and Health, may provide
technical assistance and consultation toward meeting the guidelines described in subsection (b).
(e) DEMONSTRATION PROJECT FOR REGIONAL HEALTH CARE
PREPAREDNESS AND RESPONSE SYSTEMS.—
(1) IN GENERAL.—The Assistant Secretary for Preparedness and Response may establish a demonstration project pursuant to the development and implementation of guidelines
under subsection (b) to award grants to improve medical surge
capacity for all hazards, build and integrate regional medical
response capabilities, improve specialty care expertise for allhazards response, and coordinate medical preparedness and response across State, local, Tribal, territorial, and regional jurisdictions.
(2) SUNSET.—The authority under this subsection shall expire on September 30, 2023.
SEC. 319D. ø247d–4¿ FACILITIES AND CAPACITIES OF THE CENTERS
FOR DISEASE CONTROL AND PREVENTION.
(a) IN GENERAL.—
(1) FINDINGS.—Congress finds that the Centers for Disease
Control and Prevention has an essential role in defending
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against and combatting public health threats domestically and
abroad and requires secure and modern facilities, and expanded, improved, and appropriately maintained capabilities
related to bioterrorism and other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
(2) FACILITIES.—
(A) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may design, construct, and
equip new facilities, renovate existing facilities (including
laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured
and isolated parking structures, office buildings, and other
facilities and infrastructure), and upgrade security of such
facilities, in order to better conduct the capacities described in section 319A, and for supporting public health
activities.
(B) MULTIYEAR CONTRACTING AUTHORITY.—For any
project of designing, constructing, equipping, or renovating
any facility under subparagraph (A), the Director of the
Centers for Disease Control and Prevention may enter into
a single contract or related contracts that collectively include the full scope of the project, and the solicitation and
contract shall contain the clause ‘‘availability of funds’’
found at section 52.232–18 of title 48, Code of Federal Regulations.
(3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.—The Secretary shall expand,
improve, enhance, and appropriately maintain the capabilities
of the Centers for Disease Control and Prevention relating to
preparedness for and responding effectively to bioterrorism and
other public health emergencies, by—
(A) expanding or enhancing the training of personnel;
(B) improving communications facilities and networks,
including delivery of necessary information to rural areas;
(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b);
and
(D) improving laboratory facilities related to bioterrorism, infectious disease outbreaks, and other public
health emergencies, including increasing the security of
such facilities.
(4) STUDY OF RESOURCES FOR FACILITIES AND CAPACITIES.—
Not later than June 1, 2022, the Comptroller General of the
United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under
this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each
activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and
security upgrades of facilities and associated contracts under
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this subsection, and the obligations and expenditures incurred
to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify
the agency or agencies incurring such obligations and expenditures.
(b) ESTABLISHMENT OF SYSTEMS OF PUBLIC HEALTH COMMUNICATIONS AND SURVEILLANCE NETWORKS.—
(1) IN GENERAL.—The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the establishment of an integrated system or systems of public health alert communications and surveillance
networks between and among—
(A) Federal, State, local, and Tribal public health officials; and
(B) public and private health-related laboratories, hospitals, poison control centers, immunization information
systems, and other health care facilities;
(2) REQUIREMENTS.—The Secretary shall develop a plan to,
and ensure that networks under paragraph (1) allow for the
timely sharing and discussion, in a secure manner and in a
form readily usable for analytical approaches, of essential,
deidentified information concerning bioterrorism or another
public health emergency, or recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort.
The Secretary shall ensure that the activities carried out pursuant to the previous sentence are conducted in a manner that
protects personal privacy, to the extent required by applicable
Federal and State information privacy or security law, at a
minimum.
(3) STANDARDS.—
(A) IN GENERAL.—Not later than 1 year after the date
of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in cooperation with health care providers, State,
local, Tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and
the National Institute of Standards and Technology), shall,
as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section
3000, for networks under paragraph (1) and update such
standards as necessary. Such standards shall be made
available on the internet website of the Department of
Health and Human Services, in a manner that does not
compromise national security.
(B) DEFERENCE TO STANDARDS DEVELOPMENT ORGANIZATIONS.—In adopting and implementing standards under
this subsection and subsection (c), the Secretary shall give
deference to standards published by standards development organizations and voluntary consensus-based standards entities.
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AND
PUBLIC HEALTH SERVICE ACT
(c) MODERNIZING PUBLIC HEALTH SITUATIONAL AWARENESS
BIOSURVEILLANCE.—
(1) IN GENERAL.—The Secretary, in collaboration with
State, local, and Tribal public health officials, shall establish,
modernize, and improve as applicable and appropriate, a near
real-time electronic nationwide public health situational
awareness capability through an interoperable network of systems to share data and information that is deidentified, as applicable, to enhance early detection of, rapid response to, and
management of, potentially catastrophic infectious disease outbreaks, novel emerging threats, and other public health emergencies that originate domestically or abroad. Such network
shall be built on existing State situational awareness systems
or enhanced systems that enable such interoperability, to the
extent practicable. The Secretary shall ensure that the activities carried out pursuant to this paragraph are conducted in a
manner that protects personal privacy, to the extent required
by applicable Federal and State information privacy or security
law, at a minimum.
(2) COORDINATION AND CONSULTATION.—In establishing
and improving the network under paragraph (1), the Secretary
shall—
(A) facilitate coordination among agencies within the
Department of Health and Human Services that provide,
or have the potential to provide, information and data to,
and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination
among relevant agencies related to health care services,
the facilitation of health information exchange (including
the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and
(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary
of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.
(3) ELEMENTS.—
(A) IN GENERAL.—The network described in paragraph
(1) shall include data and information transmitted in a
standardized format from—
(i) State, local, and Tribal public health entities,
including public health laboratories;
(ii) Federal health agencies;
(iii) zoonotic disease monitoring systems; and
(iv) public and private sector health care entities,
hospitals, pharmacies, poison control centers or professional organizations in the field of poison control, immunization information systems, community health
centers, health centers, clinical laboratories, and public environmental health agencies, to the extent practicable and provided that such data are voluntarily
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provided simultaneously to the Secretary and appropriate State, local, and Tribal public health agencies.
(B) REVIEW.—Not later than 2 years after the date of
the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and every 6
years thereafter, the Secretary shall conduct a review of
the elements described in subparagraph (A). Such review
shall include a discussion of the addition of any elements
pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in
the incorporation of elements under subparagraph (A), and
make recommendations to improve the quality of data collected pursuant to subparagraph (A) to ensure complete,
accurate, and timely sharing of such data, as appropriate,
across such elements as described in subparagraph (A).
The Secretary shall provide such review to the congressional committees of jurisdiction.
(4) RULE OF CONSTRUCTION.—Paragraph (3) shall not be
construed as requiring separate reporting of data and information from each source listed.
(5) REQUIRED ACTIVITIES.—
(A) IN GENERAL.—In establishing, operating, and updating, as appropriate, the network described in paragraph
(1), the Secretary shall—
(i) utilize applicable interoperability standards as
adopted by the Secretary, and in consultation with the
Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology, through a joint public and private sector process;
(ii) define minimal data elements for such network;
(iii) in collaboration with State, local, and Tribal
public health officials, integrate and build upon existing State, local, and Tribal capabilities, ensuring simultaneous sharing of data, information, and analyses
that is deidentified, as applicable, from the network
described in paragraph (1) with State, local, and Tribal public health agencies in accordance with applicable
Federal and State privacy and security law;
(iv) in collaboration with State, local, and Tribal
public health officials, develop procedures and standards for the collection, analysis, and interpretation of
data that States, regions, or other entities collect and
report to the network described in paragraph (1);
(v) pilot test standards and implementation specifications, consistent with the process described in section 3002(b)(3)(C), which State, local, Tribal, and territorial public health entities may utilize, on a voluntary
basis, as a part of the network; and
(vi) in collaboration with State, local, and Tribal
public health officials, integrate and update applicable
existing public health data systems and networks of
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flect technological advancements, consistent with section 2823, as applicable.
(B) PUBLIC MEETING.—
(i) IN GENERAL.—Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019,
and 180 days after the date of enactment of the PREVENT Pandemics Act, the Secretary shall convene a
public meeting for purposes of discussing and providing input on the potential goals, functions, and uses
of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).
(ii) EXPERTS.—The public meeting shall include
representatives of relevant Federal agencies (including
representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology); State,
local, Tribal, and territorial public health officials;
stakeholders with expertise in biosurveillance and situational awareness; stakeholders with expertise in capabilities relevant to biosurveillance and situational
awareness, such as experts in informatics and data
analytics (including experts in prediction, modeling, or
forecasting); experts in State-based public health data
systems; experts in standards and implementation
specifications, including transaction standards; and experts in privacy and data security.
(iii) TOPICS.—Such public meeting shall include a
discussion of—
(I) data elements, including minimal or essential data elements, that are voluntarily provided
for such network, which may include elements
from public health and public and private health
care entities, to the extent practicable;
(II) standards and implementation specifications that may improve the collection, analysis,
and interpretation of data during a public health
emergency;
(III) strategies to encourage the access, exchange, and use of information;
(IV) considerations for State, local, Tribal, and
territorial capabilities and infrastructure related
to data exchange and interoperability, including
existing public health data systems;
(V) privacy and security protections provided
at the Federal, State, local, Tribal, and territorial
levels, and by nongovernmental stakeholders;
(VI) opportunities for the incorporation of innovative technologies to improve the network;
(VII) strategies to integrate laboratory and
public health data systems and capabilities to support rapid and accurate reporting of laboratory
test results and associated relevant data;
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(VIII) strategies to improve the collection, reporting, and dissemination of relevant, aggregated, deidentified demographic data to inform responses to public health emergencies, including
identification of at-risk populations and to address
potential health disparities; and
(IX) strategies to improve the electronic exchange of health information, as appropriate, between State and local health departments and
health care providers and facilities to improve the
detection of, and responses to, potentially catastrophic infectious disease outbreaks.
(6) STRATEGY AND IMPLEMENTATION PLAN.—
(A) IN GENERAL.—Not later than 18 months after the
date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and
every 5 years thereafter, the Secretary shall submit to the
congressional committees of jurisdiction a coordinated
strategy and an accompanying implementation plan that—
(i) is informed by the public meeting under paragraph (5)(B);
(ii) includes a review and assessment of existing
capabilities of the network and related infrastructure,
including input provided by the public meeting under
paragraph (5)(B);
(iii) identifies and demonstrates the measurable
steps the Secretary will carry out to—
(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);
(II) modernize and enhance biosurveillance
activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics
and all-hazards) from public and private entities;
(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including
the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies
within and across agencies;
(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;
(V) improve coordination and collaboration, as
appropriate, with other Federal departments to
improve the capabilities of the network and reduce administrative burden on State, local, and
Tribal entities; and
(VI) implement applicable lessons learned
from recent public health emergencies to address
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gaps in situational awareness and biosurveillance
capabilities;
(iv) includes performance measures and the
metrics by which performance measures will be assessed with respect to the measurable steps under
clause (iii);
(v) establishes dates by which each measurable
step under clause (iii) will be implemented, including
a description of how such steps will further the goals
of the network, consistent with paragraph (1); and
(vi) identifies and demonstrates measurable steps
the Secretary will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of laboratory test results,
deidentified as appropriate, during a public health
emergency, and improve coordination and collaboration with State, local, and Tribal public health officials, clinical laboratories, and other entities with expertise in public health surveillance.
(B) ANNUAL BUDGET PLAN.—Not later than 2 years
after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
and on an annual basis thereafter, in accordance with the
strategy and implementation plan under this paragraph,
the Secretary shall, taking into account recommendations
provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—
(i) a summary of resources previously expended to
establish, improve, and utilize the nationwide public
health situational awareness and biosurveillance network under paragraph (1);
(ii) estimates of costs and resources needed to establish and improve the network under paragraph (1)
according to the strategy and implementation plan
under subparagraph (A);
(iii) the identification of gaps and inefficiencies in
nationwide public health situational awareness and
biosurveillance capabilities, resources, and authorities
needed to address such gaps; and
(iv) a strategy to minimize and address such gaps
and improve inefficiencies.
(7) CONSULTATION WITH THE NATIONAL BIODEFENSE
SCIENCE BOARD.—In carrying out this section and consistent
with section 319M, the National Biodefense Science Board
shall provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary
should take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and
Human Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall—
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(A) identify the steps necessary to achieve a national
biosurveillance system for human health (taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and
environmental health), with international connectivity,
where appropriate, that is predicated on State, regional,
and community level capabilities and creates a networked
system to allow for two-way information flow between and
among Federal, State, and local government public health
authorities and clinical health care providers;
(B) identify any duplicative surveillance programs and
gaps in surveillance programs under the authority of the
Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities,
minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve
real-time and appropriate data that relate to disease activity, both human and zoonotic;
(C) coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control
and Prevention, including such advisory committees consisting of representatives from State, local, and Tribal public health authorities and appropriate public and private
sector health care entities, animal health organizations related to zoonotic disease, and academic institutions, in
order to provide guidance on public health surveillance activities; and
(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in this
paragraph in a manner that is consistent with section
2802.
(8) SITUATIONAL AWARENESS AND BIOSURVEILLANCE AS A
NATIONAL SECURITY PRIORITY.—The Secretary, on a periodic
basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness
and biosurveillance network.
(9) RULES OF CONSTRUCTION.—
(A) Nothing in this subsection shall be construed to
supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to public health surveillance.
(B) Nothing in this subsection shall be construed to
alter the authority of the Secretary with respect to the
types of data the Secretary may receive through systems
supported or established under this section.
(d) STATE AND REGIONAL SYSTEMS TO ENHANCE SITUATIONAL
AWARENESS IN PUBLIC HEALTH EMERGENCIES.—
(1) IN GENERAL.—To implement the network described in
subsection (c), the Secretary may award grants to States or
consortia of States to enhance the ability of such States or consortia of States to establish or operate a coordinated public
health situational awareness system for regional or Statewide
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tentially catastrophic infectious disease outbreaks and public
health emergencies, in collaboration with appropriate public
health agencies, environmental health agencies, sentinel hospitals, clinical laboratories, pharmacies, poison control centers,
immunization programs, other health care organizations, and
animal health organizations within such States.
(2) ELIGIBILITY.—To be eligible to receive a grant under
paragraph (1), the State or consortium of States shall submit
to the Secretary an application at such time, in such manner,
and containing such information as the Secretary may require,
including an assurance that the State or consortium of States
will submit to the Secretary—
(A) reports of such deidentified data, information, and
metrics as the Secretary may require, in consultation with
such State or consortium of States;
(B) a report on the effectiveness of the systems funded
under the grant;
(C) a description of the manner in which grant funds
will be used to enhance the timelines and comprehensiveness of efforts to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public
health emergencies, including any public-private partnerships or other partnerships entered into to improve such
capacity; and
(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph
(1).
(3) USE OF FUNDS.—A State or consortium of States that
receives an award under this subsection—
(A) shall establish, enhance, or operate a coordinated
public health situational awareness system for regional or
Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies;
(B) may award grants or contracts to entities described in paragraph (1) within or serving such State to assist such entities in improving the operation of information
technology systems, facilitating the secure exchange of
data and information, and training personnel to enhance
the operation of the system described in subparagraph (A);
and
(C) may conduct a pilot program for the development
of multi-State telehealth network test beds that build on,
enhance, and securely link existing State and local telehealth programs to prepare for, monitor, respond to, and
manage the events of public health emergencies, facilitate
coordination and communication among medical, public
health, and emergency response agencies, and provide
medical services through telehealth initiatives within the
States that are involved in such a multi-State telehealth
network test bed.
(4) LIMITATION.—Information technology systems acquired
or implemented using grants awarded under this section must
be compliant with—
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(A) interoperability and other technological standards,
as determined by the Secretary; and
(B) data collection and reporting requirements for the
network described in subsection (c).
(5) TECHNICAL ASSISTANCE.—The Secretary may provide
technical assistance to States, localities, Tribes, and territories
or a consortium of States, localities, Tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.
(6) NON-DUPLICATION OF EFFORT.—The Secretary shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies
and offices within the Department of Health and Human Services.
(e) PERSONNEL AUTHORITIES.—
(1) SPECIALLY QUALIFIED PERSONNEL.—In addition to any
other personnel authorities, to carry out subsections (b) and (c),
the Secretary may—
(A) appoint highly qualified individuals to scientific or
professional positions at the Centers for Disease Control
and Prevention, not to exceed 30 such employees at any
time (specific to positions authorized by this subsection),
with expertise in capabilities relevant to biosurveillance
and situational awareness, such as experts in informatics
and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and
(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same
terms and conditions in which individuals appointed under
9903 of title 5, United States Code, are compensated, without regard to the provisions of chapter 51 and subchapter
III of chapter 53 of such title relating to classification and
General Schedule pay rates.
(2) LIMITATIONS.—The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the
limitations described in section 319F–1(e)(2).
(f) TIMELINE.—The Secretary shall accomplish the purposes
under subsections (b) and (c) no later than September 30, 2023,
and shall provide a justification to the congressional committees of
jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).
(g) INDEPENDENT EVALUATION.—Not later than 3 years after
the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Comptroller General of the United States shall conduct an independent evaluation
and submit to the Secretary and the congressional committees of
jurisdiction a report concerning the activities conducted under subsections (b) and (c), and provide recommendations, as applicable
and appropriate, on necessary improvements to the biosurveillance
and situational awareness network.
(h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated—
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(1) to carry out subsection (a), $25,000,000 for each of fiscal years 2022 and 2023; and
(2) to carry out subsections (b), (c), and (d), $136,800,000
for each of fiscal years 2022 and 2023.
(i) DEFINITION.—For purposes of this section the term ‘‘biosurveillance’’ means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and
threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and
prompt ongoing tracking of health events, and overall situational
awareness of disease activity.
SEC. 319D–1. ø247d-4b¿ CHILDREN’S PREPAREDNESS UNIT.
(a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.—
The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the
‘‘Director’’), shall maintain an internal team of experts, to be
known as the Children’s Preparedness Unit (referred to in this subsection as the ‘‘Unit’’), to work collaboratively to provide guidance
on the considerations for, and the specific needs of, children before,
during, and after public health emergencies. The Unit shall inform
the Director regarding emergency preparedness and response efforts pertaining to children at the Centers for Disease Control and
Prevention.
(b) EXPERTISE.—The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-behavioral pediatrician, and may also include behavioral scientists,
child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the
Secretary determines appropriate.
(c) DUTIES.—The team described in subsection (a) may—
(1) assist State, local, Tribal, and territorial emergency
planning and response activities related to children, which may
include developing, identifying, and sharing best practices;
(2) provide technical assistance, training, and consultation
to Federal, State, local, Tribal, and territorial public health officials to improve preparedness and response capabilities with
respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities
in order to support the achievement of measurable evidencebased benchmarks and objective standards applicable to sections 319C–1 and 319C–2;
(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public
health emergency, including public awareness of such methods;
(4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections
319C–2 and 319C–3, to address gaps and inefficiencies in
emergency preparedness and response efforts for children;
(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies, including pursuant to section 319C–3; and
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(6) carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.
SEC. 319E. ø247d–5¿ COMBATING ANTIMICROBIAL RESISTANCE.
(a) TASK FORCE.—
(1) IN GENERAL.—The Secretary shall establish an
Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may
appoint or select a committee, or other organization in existence as of the date of the enactment of this section, to serve
as such a task force, if such committee, or other organization
meets the requirements of this section.
(2) MEMBERS OF TASK FORCE.—The task force described in
paragraph (1) shall be composed of representatives from such
Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional
societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
(3) AGENDA.—
(A) IN GENERAL.—The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to increasing
antimicrobial resistance;
(ii) public health needs to detect and monitor antimicrobial resistance;
(iii) detection, prevention, and control strategies
for resistant pathogens;
(iv) the need for improved information and data
collection;
(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance.
(B) DETECTION AND CONTROL.—The Secretary, in consultation with the task force described in paragraph (1)
and State and local public health officials, shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor
emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.
(4) MEETINGS.—The task force described under paragraph
(1) shall convene not less than twice a year, or more frequently
as the Secretary determines to be appropriate.
(b) RESEARCH AND DEVELOPMENT OF NEW ANTIMICROBIAL
DRUGS AND DIAGNOSTICS.—The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of
the task force established under subsection (a), shall directly or
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through awards of grants or cooperative agreements to public or
private entities provide for the conduct of research, investigations,
experiments, demonstrations, and studies in the health sciences
that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
(3) the epidemiology, mechanisms, and pathogenesis of
antimicrobial resistance;
(4) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in
consultation with the task force established under subsection
(a)), in collaboration and coordination with the activities of the
Department of Defense and the Joint Genome Institute of the
Department of Energy; and
(5) other relevant research areas.
(c) EDUCATION OF MEDICAL AND PUBLIC HEALTH PERSONNEL.—
The Secretary, after consultation with the Assistant Secretary for
Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for
Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies,
and such other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general public with respect to the
public health threat of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and
(3) develop and implement programs to train laboratory
personnel in the recognition or identification of resistance in
pathogens.
(d) GRANTS.—
(1) IN GENERAL.—The Secretary shall award competitive
grants to eligible entities to enable such entities to increase the
capacity to detect, monitor, and combat antimicrobial resistance.
(2) ELIGIBLE ENTITIES.—Eligible entities for grants under
paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private
nonprofit entities.
(3) USE OF FUNDS.—An eligible entity receiving a grant
under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task
force under subsection (a)(3), which may include activities
that—
(A) provide training to enable such entity to identify
patterns of resistance rapidly and accurately;
(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant inFebruary 1, 2024
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fections can be shared rapidly among relevant national,
State, and local health agencies and health care providers;
and
(C) develop and implement policies to control the
spread of antimicrobial resistance.
(e) GRANTS FOR DEMONSTRATION PROGRAMS.—
(1) IN GENERAL.—The Secretary shall award competitive
grants to eligible entities to establish demonstration programs
to promote judicious use of antimicrobial drugs or control the
spread of antimicrobial-resistant pathogens.
(2) ELIGIBLE ENTITIES.—Eligible entities for grants under
paragraph (1) may include hospitals, clinics, institutions of
long-term care, professional medical societies, schools or programs that train medical laboratory personnel, or other public
or private nonprofit entities.
(3) TECHNICAL ASSISTANCE.—The Secretary shall provide
appropriate technical assistance to eligible entities that receive
grants under paragraph (1).
(f) MONITORING AT FEDERAL HEALTH CARE FACILITIES.—The
Secretary shall encourage reporting on aggregate antimicrobial
drug use and antimicrobial resistance to antimicrobial drugs and
the implementation of antimicrobial stewardship programs by
health care facilities of the Department of Defense, the Department
of Veterans Affairs, and the Indian Health Service and shall provide technical assistance to the Secretary of Defense and the Secretary of Veterans Affairs, as appropriate and upon request.
(g) REPORT ON ANTIMICROBIAL RESISTANCE IN HUMANS AND
USE OF ANTIMICROBIAL DRUGS.—Not later than 1 year after the
date of enactment of the 21st Century Cures Act, and annually
thereafter, the Secretary shall prepare and make publicly available
data and information concerning—
(1) aggregate national and regional trends of antimicrobial
resistance in humans to antimicrobial drugs, including such
drugs approved under section 506(h) of the Federal Food,
Drug, and Cosmetic Act;
(2) antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in
humans to antimicrobial drugs and antimicrobial stewardship;
and
(3) coordination between the Director of the Centers for
Disease Control and Prevention and the Commissioner of Food
and Drugs with respect to the monitoring of—
(A) any applicable resistance under paragraph (1); and
(B) drugs approved under section 506(h) of the Federal
Food, Drug, and Cosmetic Act.
(h) INFORMATION RELATED TO ANTIMICROBIAL STEWARDSHIP
PROGRAMS.—The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related
to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and
hospitals, including community and rural hospitals.
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PUBLIC HEALTH SERVICE ACT
Sec. 319E
(i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTIMICROBIAL RESISTANCE.—The Secretary shall continue to work with
State and local public health departments on statewide or regional
programs related to antimicrobial resistance. Such efforts may include activities to related to—
(1) identifying patterns of bacterial and fungal resistance
in humans to antimicrobial drugs;
(2) preventing the spread of bacterial and fungal infections
that are resistant to antimicrobial drugs; and
(3) promoting antimicrobial stewardship.
(j) ANTIMICROBIAL RESISTANCE AND STEWARDSHIP ACTIVITIES.—
(1) IN GENERAL.—For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance,
and evaluating the effectiveness of section 506(h) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall—
(A) provide a mechanism for facilities to report data
related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and
(B) evaluate—
(i) antimicrobial resistance data using a standardized approach; and
(ii) trends in the utilization of drugs approved
under such section 506(h) with respect to patient populations.
(2) USE OF SYSTEMS.—The Secretary shall use available
systems, including the National Healthcare Safety Network or
other systems identified by the Secretary, to fulfill the requirements or conduct activities under this section.
(k) NETWORK OF ANTIBIOTIC RESISTANCE REGIONAL LABORATORIES.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as
appropriate, maintain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capabilities, within existing laboratory capacity maintained or supported by the Centers for Disease Control and Prevention, to—
(A) identify and monitor the emergence and changes
in the patterns of antimicrobial-resistant pathogens;
(B) detect, identify, confirm, and isolate such resistant
pathogens, including, as appropriate, performing such activities upon the request of another laboratory and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of
such resistant pathogens; and
(C) perform activities to support the diagnosis of such
resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.
(2) GEOGRAPHIC DISTRIBUTION.—The Secretary shall ensure that such capacity and capabilities are appropriately distributed among the geographical regions of the United States.
(3) PARTNERSHIPS AND NONDUPLICATION OF CURRENT DOMESTIC CAPACITY.—Activities supported under this subsection
may be based in an academic center, a State health department, or other facility operated by a public or private entity
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that carries out relevant laboratory or public health surveillance activities.
(l) INTERNATIONAL COLLABORATION.—
(1) IN GENERAL.—The Secretary, in coordination with
heads of other relevant Federal departments and agencies,
shall support activities related to addressing antimicrobial resistance internationally, including by—
(A) supporting basic, translational, epidemiological,
and clinical research related to antimicrobial-resistant
pathogens, including such pathogens that have not yet
been detected in the United States, and improving related
public health surveillance systems, and laboratory and
other response capacity; and
(B) providing technical assistance related to antimicrobial resistant infection and control activities.
(2) AWARDS.—In carrying out paragraph (1), the Secretary
may award grants, contracts, or cooperative agreements to
public and private entities, including nongovernmental organizations, with applicable expertise, for purposes of supporting
new and innovative approaches to the prevention, detection,
and mitigation of antimicrobial-resistant pathogens.
(m) ANTIMICROBIAL.—For purposes of subsections (f) through
(j), the term ‘‘antimicrobial’’ includes any antibacterial or
antifungal drugs, and may include drugs that eliminate or inhibit
the growth of other microorganisms, as appropriate.
(n) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under
this section shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities under
this section.
(o) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, $40,000,000 for fiscal
year 2001, $25,000,000 for each of the fiscal years 2002 and 2003,
and such sums as may be necessary for each of the fiscal years
2004 through 2006.
SEC. 319F. ø247d–6¿ PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST ATTACK.
(a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE
CURRICULA AND TRAINING.—
(1) IN GENERAL.—The Secretary, in collaboration with the
Secretary of Defense, and in consultation with relevant public
and private entities, shall develop core health and medical response curricula and trainings by adapting applicable existing
curricula and training programs to improve responses to public
health emergencies.
(2) CURRICULUM.—The public health and medical response
training program may include course work related to—
(A) medical management of casualties, taking into account the needs of at-risk individuals;
(B) public health aspects of public health emergencies;
(C) mental health aspects of public health emergencies;
(D) national incident management, including coordination among Federal, State, local, tribal, international agencies, and other entities; and
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PUBLIC HEALTH SERVICE ACT
Sec. 319F
(E) protecting health care workers and health care
first responders from workplace exposures during a public
health emergency.
(3) PEER REVIEW.—On a periodic basis, products prepared
as part of the program shall be rigorously tested and peer-reviewed by experts in the relevant fields.
(4) CREDIT.—The Secretary and the Secretary of Defense
shall—
(A) take into account continuing professional education
requirements of public health and healthcare professions;
and
(B) cooperate with State, local, and tribal accrediting
agencies and with professional associations in arranging
for students enrolled in the program to obtain continuing
professional education credit for program courses.
(5) DISSEMINATION AND TRAINING.—
(A) IN GENERAL.—The Secretary may provide for the
dissemination and teaching of the materials described in
paragraphs (1) and (2) by appropriate means, as determined by the Secretary.
(B) CERTAIN ENTITIES.—The education and training activities described in subparagraph (A) may be carried out
by Federal public health, medical, or dental entities, appropriate educational entities, professional organizations
and societies, private accrediting organizations, and other
nonprofit institutions or entities meeting criteria established by the Secretary.
(C) GRANTS AND CONTRACTS.—In carrying out this subsection, the Secretary may carry out activities directly or
through the award of grants and contracts, and may enter
into interagency agreements with other Federal agencies.
(b) ADVICE TO THE FEDERAL GOVERNMENT.—
(1) REQUIRED ADVISORY COMMITTEES.—In coordination
with the working group under subsection (a), the Secretary
shall establish advisory committees in accordance with paragraphs (2) and (3) to provide expert recommendations to assist
such working groups in carrying out their respective responsibilities under subsections (a) and (b) 20.
(2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TERRORISM 21.—
(A) IN GENERAL.—For purposes of paragraph (1), the
Secretary shall establish an advisory committee to be
known as the National Advisory Committee on At-Risk Individuals and Public Health Emergencies (referred to in
this paragraph as the ‘‘Advisory Committee’’).
20 Probably should be ‘‘to assist such working group in carrying out its responsibilities under
subsection (a)’’. Formerly there were two working groups, one under subsection (a) and one
under subsection (b). Now there is only the working group under subsection (a). See the amendments made by sections 104(a) and 108 of Public Law 107–188 (116 Stat. 605, 609).
21 The heading for subsection (b)(2) probably should read ‘‘NATIONAL ADVISORY COMMITTEE ON
AT-RISK INDIVIDUALS AND PUBLIC HEALTH EMERGENCIES’’. The amendment made by section
301(d)(1) of Public Law 109–417 (120 Stat. 2854) to strike ‘‘CHILDREN AND TERRORISM’’ and insert ‘‘AT-RISK INDIVIDUALS AND PUBLIC HEALTH EMERGENCIES’’ could not be executed due to incorrect capitalization of the word ‘‘Children’’ in the matter to be struck. Also the letter ‘‘A’’ in the
word ‘‘At-risk’’ in the inserted text probably should be lowercase type.
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(B) DUTIES.—The Advisory Committee shall provide
recommendations regarding—
(i) the preparedness of the health care (including
mental health care) system to respond to public health
emergencies as they relate to at-risk individuals;
(ii) needed changes to the health care and emergency medical service systems and emergency medical
services protocols to meet the special needs of at-risk
individuals; and
(iii) changes, if necessary, to the national stockpile
under section 121 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
to meet the emergency health security of at-risk individuals.
(C) COMPOSITION.—The Advisory Committee shall be
composed of such Federal officials as may be appropriate
to address the special needs of the diverse population
groups of at-risk populations.
(D) TERMINATION.—The Advisory Committee terminates six years after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
(3) EMERGENCY PUBLIC INFORMATION AND COMMUNICATIONS ADVISORY COMMITTEE.—
(A) IN GENERAL.—For purposes of paragraph (1), the
Secretary shall establish an advisory committee to be
known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the ‘‘EPIC Advisory Committee’’).
(B) DUTIES.—The EPIC Advisory Committee shall
make recommendations to the Secretary and report on appropriate ways to communicate public health information
regarding bioterrorism and other public health emergencies to the public.
(C) COMPOSITION.—The EPIC Advisory Committee
shall be composed of individuals representing a diverse
group of experts in public health, medicine, communications, behavioral psychology, and other areas determined
appropriate by the Secretary.
(D) DISSEMINATION.—The Secretary shall review the
recommendations of the EPIC Advisory Committee and ensure that appropriate information is disseminated to the
public.
(E) TERMINATION.—The EPIC Advisory Committee terminates one year after the date of the enactment of Public
Health Security and Bioterrorism Preparedness and Response Act of 2002.
(c) EXPANSION OF EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—The Secretary may establish 20 officer positions in the Epidemic Intelligence Service Program, in addition to the number of
the officer positions offered under such Program in 2006, for individuals who agree to participate, for a period of not less than 2
years, in the Career Epidemiology Field Officer program in a State,
local, or tribal health department that serves a health professional
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Sec. 319F
shortage area (as defined under section 332(a)), a medically underserved population (as defined under section 330(b)(3)), or a medically underserved area or area at high risk of a public health emergency as designated by the Secretary.
(d) CENTERS FOR PUBLIC HEALTH PREPAREDNESS AND RESPONSE.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may
award grants, contracts, or cooperative agreements to institutions of higher education, including accredited schools of public
health, or other nonprofit private entities to establish or maintain a network of Centers for Public Health Preparedness and
Response (referred to in this subsection as ‘‘Centers’’).
(2) ELIGIBILITY.—To be eligible to receive an award under
this subsection, an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will—
(A) coordinate relevant activities with applicable
State, local, and Tribal health departments and officials,
health care facilities, and health care coalitions to improve
public health preparedness and response, as informed by
the public health preparedness and response needs of the
community, or communities, involved;
(B) prioritize efforts to implement evidence-informed
or evidence-based practices to improve public health preparedness and response, including by helping to reduce the
transmission of emerging infectious diseases; and
(C) use funds awarded under this subsection, including by carrying out any activities described in paragraph
(3).
(3) USE OF FUNDS.—The Centers established or maintained
under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include—
(A) identifying, translating, and disseminating promising research findings or strategies into evidence-informed
or evidence-based practices to inform preparedness for,
and responses to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and
other public health emergencies, which may include conducting research related to public health preparedness and
response systems;
(B) improving awareness of such evidence-informed or
evidence-based practices and other relevant scientific or
public health information among health care professionals,
public health professionals, other stakeholders, and the
public, including through the development, evaluation, and
dissemination of trainings and training materials, consistent with section 2802(b)(2), as applicable and appropriate, and with consideration given to existing training
materials, to support preparedness for, and responses to,
such threats;
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(C) utilizing and expanding relevant technological and
analytical capabilities to inform public health and medical
preparedness and response efforts;
(D) expanding activities, including through public-private partnerships, related to public health preparedness
and response, including participation in drills and exercises and training public health experts, as appropriate;
and
(E) providing technical assistance and expertise that
relies on evidence-based practices, as applicable, related to
responses to public health emergencies, as appropriate, to
State, local, and Tribal health departments and other entities pursuant to paragraph (2)(A).
(4) DISTRIBUTION OF AWARDS.—In awarding grants, contracts, or cooperative agreements under this subsection, the
Secretary shall support not fewer than 10 Centers, subject to
the availability of appropriations, and ensure that such awards
are equitably distributed among the geographical regions of the
United States.
(e) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY
PATHOGENS AND COUNTERMEASURES.—
(1) IN GENERAL.—With respect to pathogens of potential
use in a bioterrorist attack, and other agents that may cause
a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments,
demonstrations, and studies in the health sciences relating
to—
(A) the epidemiology and pathogenesis of such pathogens;
(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens
(as determined by the Director of the National Institutes
of Health in consultation with the working group established in subsection (a)), in collaboration and coordination
with the activities of the Department of Defense and the
Joint Genome Institute of the Department of Energy;
(C) the development of priority countermeasures; and
(D) other relevant areas of research;
with consideration given to the needs of children and other vulnerable populations.
(2) PRIORITY.—The Secretary shall give priority under this
section to the funding of research and other studies related to
priority countermeasures.
(3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In carrying out paragraph (1), the Secretary shall consider using the
biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department’s affiliations with health-professions universities. When
advantageous to the Government in furtherance of the purposes of such paragraph, the Secretary may enter into cooperative agreements with the Secretary of Veterans Affairs to
achieve such purposes.
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(4) PRIORITY COUNTERMEASURES.—For purposes of this section, the term ‘‘priority countermeasure’’ means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be—
(A) a priority to treat, identify, or prevent infection by
a biological agent or toxin listed pursuant to section
351A(a)(1), or harm from any other agent that may cause
a public health emergency; or
(B) a priority to treat, identify, or prevent conditions
that may result in adverse health consequences or death
and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or
diagnostic test that is a priority under subparagraph (A).
(f) AUTHORIZATION OF APPROPRIATIONS.—
(1) FISCAL YEAR 2007.—There are authorized to be appropriated to carry out this section for fiscal year 2007—
(A) to carry out subsection (a)—
(i) $5,000,000 to carry out paragraphs (1) through
(4); and
(ii) $7,000,000 to carry out paragraph (5);
(B) to carry out subsection (c), $3,000,000; and
(C) to carry out subsection (d), $31,000,000.
(2) SUBSEQUENT FISCAL YEARS.—There are authorized to be
appropriated such sums as may be necessary to carry out this
section for fiscal year 2008 and each subsequent fiscal year.
SEC. 319F–1. ø247d–6a¿ AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT ACTIVITIES. 22
(a) IN GENERAL.—
(1) AUTHORITY.—In conducting and supporting research
and development activities regarding countermeasures under
section 319F(e), the Secretary may conduct and support such
activities in accordance with this section and, in consultation
with the Director of the National Institutes of Health, as part
of the program under section 446, if the activities concern
qualified countermeasures.
(2) DEFINITIONS.—In this section:
(A) QUALIFIED COUNTERMEASURE.—The term ‘‘qualified countermeasure’’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as
that term is defined by section 351(i) of this Act (42 U.S.C.
262(i))), or device (as that term is defined by section 201(h)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h))), that the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002)—
(i) to diagnose, mitigate, prevent, or treat harm
from any biological agent (including organisms that
cause an infectious disease) or toxin, chemical, radio22 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section
319F–1 and related provisions of law. Section 5 is included in the appendix to this compilation.
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logical, or nuclear agent that may cause a public
health emergency affecting national security;
(ii) to diagnose, mitigate, prevent, or treat harm
from a condition that may result in adverse health
consequences or death and may be caused by administering a drug, biological product, or device that is
used as described in this subparagraph; or
(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or
device described in clause (i) or (ii).
(B) INFECTIOUS DISEASE.—The term ‘‘infectious disease’’ means a disease potentially caused by a pathogenic
organism (including a bacteria, virus, fungus, or parasite)
that is acquired by a person and that reproduces in that
person.
(3) INTERAGENCY COOPERATION.—
(A) IN GENERAL.—In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the
United States Government.
(B) LIMITATION.—An agreement or undertaking under
this paragraph shall not authorize another agency to exercise the authorities provided by this section.
(4) AVAILABILITY OF FACILITIES TO THE SECRETARY.—In any
grant, contract, or cooperative agreement entered into under
the authority provided in this section with respect to a biocontainment laboratory or other related or ancillary specialized
research facility that the Secretary determines necessary for
the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary
may provide that the facility that is the object of such grant,
contract, or cooperative agreement shall be available as needed
to the Secretary to respond to public health emergencies affecting national security.
(5) TRANSFERS OF QUALIFIED COUNTERMEASURES.—Each
agreement for an award of a grant, contract, or cooperative
agreement under section 319F(e) for the development of a
qualified countermeasure shall provide that the recipient of the
award will comply with all applicable export-related controls
with respect to such countermeasure.
(b) EXPEDITED PROCUREMENT AUTHORITY.—
(1) INCREASED SIMPLIFIED ACQUISITION THRESHOLD FOR
QUALIFIED COUNTERMEASURE PROCUREMENTS.—
(A) IN GENERAL.—For any procurement by the Secretary of property or services for use (as determined by the
Secretary) in performing, administering, or supporting
qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development
needs under this section, the amount specified in section
4(11) of the Office of Federal Procurement Policy Act (41
U.S.C. 403(11)), as applicable pursuant to section 302A(a)
of the Federal Property and Administrative Services Act of
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PUBLIC HEALTH SERVICE ACT
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1949 (41 U.S.C. 252a(a)), shall be deemed to be
$25,000,000 in the administration, with respect to such
procurement, of—
(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its implementing regulations; and
(ii) section 302A(b) of such Act (41 U.S.C. 252a(b))
and its implementing regulations.
(B) APPLICATION OF CERTAIN PROVISIONS.—Notwithstanding subparagraph (A) and the provision of law and
regulations referred to in such subparagraph, each of the
following provisions shall apply to procurements described
in this paragraph to the same extent that such provisions
would apply to such procurements in the absence of subparagraph (A):
(i) Chapter 37 of title 40, United States Code (relating to contract work hours and safety standards).
(ii) Subsections (a) and (b) of section 7 of the AntiKickback Act of 1986 (41 U.S.C. 57(a) and (b)).
(iii) Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d) (relating to the examination of contractor records).
(iv) Section 3131 of title 40, United States Code
(relating to bonds of contractors of public buildings or
works).
(v) Subsection (a) of section 304 of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 254(a)) (relating to contingent fees to middlemen).
(vi) Section 6002 of the Solid Waste Disposal Act
(42 U.S.C. 6962).
(vii) Section 1354 of title 31, United States Code
(relating to the limitation on the use of appropriated
funds for contracts with entities not meeting veterans
employment reporting requirements).
(C) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for procurements that are under this paragraph, including requirements with regard to documenting the justification
for use of the authority in this paragraph with respect to
the procurement involved.
(D) AUTHORITY TO LIMIT COMPETITION.—In conducting
a procurement under this paragraph, the Secretary may
not use the authority provided for under subparagraph (A)
to conduct a procurement on a basis other than full and
open competition unless the Secretary determines that the
mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without
such a limitation.
(2) PROCEDURES OTHER THAN FULL AND OPEN COMPETITION.—
(A) IN GENERAL.—In using the authority provided in
section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to
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use procedures other than competitive procedures in the
case of a procurement described in paragraph (1) of this
subsection, the phrase ‘‘available from only one responsible
source’’ in such section 303(c)(1) shall be deemed to mean
‘‘available from only one responsible source or only from a
limited number of responsible sources’’.
(B) RELATION TO OTHER AUTHORITIES.—The authority
under subparagraph (A) is in addition to any other authority to use procedures other than competitive procedures.
(C) APPLICABLE GOVERNMENT-WIDE REGULATIONS.—
The Secretary shall implement this paragraph in accordance with government-wide regulations implementing such
section 303(c)(1) (including requirements that offers be solicited from as many potential sources as is practicable
under the circumstances, that required notices be published, and that submitted offers be considered), as such
regulations apply to procurements for which an agency has
authority to use procedures other than competitive procedures when the property or services needed by the agency
are available from only one responsible source or only from
a limited number of responsible sources and no other type
of property or services will satisfy the needs of the agency.
(3) INCREASED MICROPURCHASE THRESHOLD.—
(A) IN GENERAL.—For a procurement described by
paragraph (1), the amount specified in subsections (c), (d),
and (f) of section 32 of the Office of Federal Procurement
Policy Act (41 U.S.C. 428) shall be deemed to be $15,000
in the administration of that section with respect to such
procurement.
(B) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for purchases that are under this paragraph and that are greater
than $2,500.
(C) EXCEPTION TO PREFERENCE FOR PURCHASE CARD
MECHANISM.—No provision of law establishing a preference
for using a Government purchase card method for purchases shall apply to purchases that are under this paragraph and that are greater than $2,500.
(4) REVIEW.—
(A) REVIEW ALLOWED.—Notwithstanding subsection (f),
section 1491 of title 28, United States Code, and section
3556 of title 31 of such Code, review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest—
(i) with a contracting agency; or
(ii) with the Comptroller General under subchapter V of chapter 35 of title 31, United States
Code.
(B) OVERRIDE OF STAY OF CONTRACT AWARD OR PERFORMANCE COMMITTED TO AGENCY DISCRETION.—Notwithstanding section 1491 of title 28, United States Code, and
section 3553 of title 31 of such Code, the following authorizations by the head of a procuring activity are committed
to agency discretion:
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141
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(i) An authorization under section 3553(c)(2) of
title 31, United States Code, to award a contract for
a procurement described in paragraph (1) of this subsection.
(ii) An authorization under section 3553(d)(3)(C) of
such title to perform a contract for a procurement described in paragraph (1) of this subsection.
(c) AUTHORITY TO EXPEDITE PEER REVIEW.—
(1) IN GENERAL.—The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section,
employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary,
in consultation with the Director of NIH, deems appropriate to
obtain assessment of scientific and technical merit and likely
contribution to the field of qualified countermeasure research,
in place of the peer review and advisory council review procedures that would be required under sections 301(a)(3),
405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494, as applicable
to a grant, contract, or cooperative agreement—
(A) that is for performing, administering, or supporting qualified countermeasure research and development activities; and
(B) the amount of which is not greater than
$1,500,000.
(2) SUBSEQUENT PHASES OF RESEARCH.—The Secretary’s
determination of whether to employ expedited peer review with
respect to any subsequent phases of a research grant, contract,
or cooperative agreement under this section shall be determined without regard to the peer review procedures used for
any prior peer review of that same grant, contract, or cooperative agreement. Nothing in the preceding sentence may be construed to impose any requirement with respect to peer review
not otherwise required under any other law or regulation.
(d) AUTHORITY FOR PERSONAL SERVICES CONTRACTS.—
(1) IN GENERAL.—For the purpose of performing, administering, or supporting qualified countermeasure research and
development activities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section,
obtain by contract (in accordance with section 3109 of title 5,
United States Code, but without regard to the limitations in
such section on the period of service and on pay) the personal
services of experts or consultants who have scientific or other
professional qualifications, except that in no case shall the
compensation provided to any such expert or consultant exceed
the daily equivalent of the annual rate of compensation for the
President.
(2) FEDERAL TORT CLAIMS ACT COVERAGE.—
(A) IN GENERAL.—A person carrying out a contract
under paragraph (1), and an officer, employee, or governing board member of such person, shall, subject to a determination by the Secretary, be deemed to be an employee of the Department of Health and Human Services
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for purposes of claims under sections 1346(b) and 2672 of
title 28, United States Code, for money damages for personal injury, including death, resulting from performance
of functions under such contract.
(B) EXCLUSIVITY OF REMEDY.—The remedy provided by
subparagraph (A) shall be exclusive of any other civil action or proceeding by reason of the same subject matter
against the entity involved (person, officer, employee, or
governing board member) for any act or omission within
the scope of the Federal Tort Claims Act.
(C) RECOURSE IN CASE OF GROSS MISCONDUCT OR CONTRACT VIOLATION.—
(i) IN GENERAL.—Should payment be made by the
United States to any claimant bringing a claim under
this paragraph, either by way of administrative determination, settlement, or court judgment, the United
States shall have, notwithstanding any provision of
State law, the right to recover against any entity identified in subparagraph (B) for that portion of the damages so awarded or paid, as well as interest and any
costs of litigation, resulting from the failure of any
such entity to carry out any obligation or responsibility assumed by such entity under a contract with
the United States or from any grossly negligent or
reckless conduct or intentional or willful misconduct
on the part of such entity.
(ii) VENUE.—The United States may maintain an
action under this subparagraph against such entity in
the district court of the United States in which such
entity resides or has its principal place of business.
(3) INTERNAL CONTROLS TO BE INSTITUTED.—
(A) IN GENERAL.—The Secretary shall institute appropriate internal controls for contracts under this subsection,
including procedures for the Secretary to make a determination of whether a person, or an officer, employee, or
governing board member of a person, is deemed to be an
employee of the Department of Health and Human Services pursuant to paragraph (2).
(B) DETERMINATION OF EMPLOYEE STATUS TO BE
FINAL.—A determination by the Secretary under subparagraph (A) that a person, or an officer, employee, or governing board member of a person, is or is not deemed to
be an employee of the Department of Health and Human
Services shall be final and binding on the Secretary and
the Attorney General and other parties to any civil action
or proceeding.
(4) NUMBER OF PERSONAL SERVICES CONTRACTS LIMITED.—
The number of experts and consultants whose personal services are obtained under paragraph (1) shall not exceed 30 at
any time.
(e) STREAMLINED PERSONNEL AUTHORITY.—
(1) IN GENERAL.—In addition to any other personnel authorities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure reFebruary 1, 2024
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search and development needs under this section, without regard to those provisions of title 5, United States Code, governing appointments in the competitive service, and without
regard to the provisions of chapter 51 and subchapter III of
chapter 53 of such title relating to classification and General
Schedule pay rates, appoint professional and technical employees, not to exceed 30 such employees at any time, to positions
in the National Institutes of Health to perform, administer, or
support qualified countermeasure research and development
activities in carrying out this section.
(2) LIMITATIONS.—The authority provided for under paragraph (1) shall be exercised in a manner that—
(A) recruits and appoints individuals based solely on
their abilities, knowledge, and skills;
(B) does not discriminate for or against any applicant
for employment on any basis described in section
2302(b)(1) of title 5, United States Code;
(C) does not allow an official to appoint an individual
who is a relative (as defined in section 3110(a)(3) of such
title) of such official;
(D) does not discriminate for or against an individual
because of the exercise of any activity described in paragraph (9) or (10) of section 2302(b) of such title; and
(E) accords a preference, among equally qualified persons, to persons who are preference eligibles (as defined in
section 2108(3) of such title).
(3) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary
shall institute appropriate internal controls for appointments
under this subsection.
(f) ACTIONS COMMITTED TO AGENCY DISCRETION.—Actions by
the Secretary under the authority of this section are committed to
agency discretion.
SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE PROCUREMENTS. 23
(a) STRATEGIC NATIONAL STOCKPILE.—
(1) IN GENERAL.—The Secretary, in collaboration with the
Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and
in coordination with the Secretary of Homeland Security (referred to in this section as the ‘‘Homeland Security Secretary’’),
shall maintain a stockpile or stockpiles of drugs, vaccines and
other biological products, medical devices, and other supplies
(including personal protective equipment, ancillary medical
supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile) in such numbers, types, and amounts as are determined consistent with
section 2811 by the Secretary to be appropriate and practicable, taking into account other available sources, to provide
for and optimize the emergency health security of the United
States, including the emergency health security of children and
23 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section
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other vulnerable populations, in the event of a bioterrorist attack or other public health emergency and, as informed by existing recommendations of, or consultations with, the Public
Health Emergency Medical Countermeasure Enterprise established under section 2811–1, make necessary additions or
modifications to the contents of such stockpile or stockpiles
based on the review conducted under paragraph (2).
(2) THREAT-BASED REVIEW.—
(A) IN GENERAL.—The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph
(1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1,
review contents within the stockpile and assess whether
such contents are consistent with the recommendations
made pursuant to section 2811–1(c)(1)(A). Such review
shall be submitted on June 15, 2019, and on March 15 of
each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the
House of Representatives, in a manner that does not compromise national security.
(B) ADDITIONS, MODIFICATIONS, AND REPLENISHMENTS.—Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure
procurement or replenishment, provide—
(i) information regarding—
(I) the quantities of the additional or modified
countermeasure procured for, or contracted to be
procured for, the stockpile;
(II) planning considerations for appropriate
manufacturing capacity and capability to meet the
goals of such additions or modifications (without
disclosing proprietary information), including—
(aa) consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical
supplies on the health care system; and
(bb) an assessment of the current supply
chain for such products, including information
on supply chain redundancies, any known domestic manufacturing capacity for such products, and any related vulnerabilities;
(III) the presence or lack of a commercial
market for the countermeasure at the time of procurement;
(IV) the emergency health security threat or
threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency
health security needs associated with such threat
or threats;
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(V) an assessment of whether the emergency
health security threat or threats described in subclause (IV) could be addressed in a manner that
better utilizes the resources of the stockpile and
permits the greatest possible increase in the level
of emergency preparedness to address such
threats;
(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a
different countermeasure with the same indication
that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;
(VII) a description of how such additions or
modifications align with projected investments
under previous countermeasures budget plans
under section 2811(b)(7), including expected lifecycle costs, expenditures related to countermeasure procurement to address the threat or
threats described in subclause (IV), replenishment
dates (including the ability to extend the maximum shelf life of a countermeasure), and the
manufacturing capacity required to replenish such
countermeasure; and
(VIII) appropriate protocols and processes for
the deployment, distribution, or dispensing of the
countermeasure at the State and local level, including plans for relevant capabilities of State and
local entities to dispense, distribute, and administer the countermeasure; and
(ii) an assurance, which need not be provided in
advance of procurement, that for each countermeasure
procured or replenished under this subsection, the
Secretary completed a review addressing each item
listed under this subsection in advance of such procurement or replenishment.
(3) PROCEDURES.—The Secretary, in managing the stockpile under paragraph (1), shall—
(A) consult with the working group under section
319F(a) and the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1;
(B) ensure that adequate procedures are followed, regularly reviewed, and updated with respect to such stockpile for inventory management and accounting, and for the
physical security of the stockpile;
(C) in consultation with Federal, State, local, and Tribal officials, take into consideration the timing and location
of special events, and the availability, deployment, dispensing, and administration of countermeasures;
(D) review and revise, as appropriate, the contents of
the stockpile on a regular basis to ensure that—
(i) emerging threats, advanced technologies, and
new countermeasures are adequately considered;
(ii) the potential depletion of countermeasures currently in the stockpile is identified and appropriately
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addressed, including through necessary replenishment;
and
(iii) such contents are in working condition or usable, as applicable, and are ready for deployment,
which may include conducting maintenance services
on such contents of the stockpile and disposing of such
contents that are no longer in working condition, or
usable, as applicable;
(E) devise plans for effective and timely supply-chain
management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention,
the Assistant Secretary for Preparedness and Response,
the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the
heads of other appropriate Federal agencies; State, local,
Tribal, and territorial agencies; and the public and private
health care infrastructure, as applicable, taking into account the manufacturing capacity and other available
sources of products and appropriate alternatives to supplies in the stockpile;
(F) deploy the stockpile at the discretion of the Secretary, in consultation with, or at the request of, the Secretary of Homeland Security, to respond to an actual or potential emergency;
(G) deploy the stockpile at the discretion of the Secretary to respond to an actual or potential public health
emergency or other situation in which deployment is necessary to protect the public health or safety;
(H) ensure the adequate physical security of the stockpile;
(I) ensure that each countermeasure or product under
consideration for procurement pursuant to this subsection
receives the same consideration regardless of whether such
countermeasure or product receives or had received funding under section 319L, including with respect to whether
the countermeasure or product is most appropriate to meet
the emergency health security needs of the United States;
(J) provide assistance, including technical assistance,
to maintain and improve State local, and Tribal public
health preparedness capabilities to distribute and dispense
medical countermeasures and products from the stockpile,
as appropriate; and
(K) convene meetings, not less than once per year,
with representatives from State, local, and Tribal health
departments or officials, relevant industries, other Federal
agencies, and other appropriate stakeholders, in a manner
that does not compromise national security, to coordinate
and share information related to maintenance and use of
the stockpile, including a description of future countermeasure needs and additions, modifications, and replenishments of the contents of the stockpile, and considerations
related to the manufacturing and procurement of products
consistent with the requirements of the with the requirements of chapter 83 of title 41, United States Code (comFebruary 1, 2024
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monly referred to as the ‘‘Buy American Act’’), as appropriate.
(4) UTILIZATION GUIDELINES.—The Secretary shall ensure
timely and accurate recommended utilization guidelines for
qualified countermeasures (as defined in section 319F–1),
qualified pandemic and epidemic products (as defined in section 319F–3), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.
(5) VENDOR-MANAGED INVENTORY AND WARM-BASE SURGE
CAPACITY.—
(A) IN GENERAL.—For the purposes of maintaining the
stockpile under paragraph (1) and carrying out procedures
under paragraph (3), the Secretary may enter into contracts or cooperative agreements with vendors, which may
include manufacturers or distributors of medical products,
with respect to medical products intended to be delivered
to the ownership of the Federal Government. Each such
contract or cooperative agreement shall be subject to such
terms and conditions as the Secretary may specify, including terms and conditions with respect to—
(i) procurement, maintenance, storage, and delivery of products, in alignment with inventory management and other applicable best practices, under such
contract or cooperative agreement, which may consider, as appropriate, costs of transporting and handling such products; or
(ii) maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities
are available, and that such capacity and capabilities
are able to support the rapid manufacture, purchase,
storage, and delivery of such products, as required by
the Secretary to prepare for, or respond to, an existing
or potential public health emergency.
(B) REPORT.—Not later than 2 years after the date of
enactment of the PREVENT Pandemics Act, and annually
thereafter, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on any
contracts or cooperative agreements entered into under
subparagraph (A) for purposes of establishing and maintaining vendor-managed inventory or reserve manufacturing capacity and capabilities for products intended for
the stockpile, including a description of—
(i) the amount of each award;
(ii) the recipient of each award;
(iii) the product or products covered through each
award; and
(iv) how the Secretary works with each recipient
to ensure situational awareness related to the manufacturing capacity for, or inventory of, such products
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and coordinates the distribution and deployment of
such products, as appropriate and applicable.
(6) GAO REPORT.—
(A) IN GENERAL.—Not later than 3 years after the date
of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and every 5
years thereafter, the Comptroller General of the United
States shall conduct a review of any changes to the contents or management of the stockpile since January 1,
2015. Such review shall include—
(i) an assessment of the comprehensiveness and
completeness of each annual threat-based review
under paragraph (2), including whether all newly procured or replenished countermeasures within the
stockpile were described in each annual review, and
whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;
(ii) an assessment of whether the Secretary established health security and science-based justifications,
and a description of such justifications for procurement decisions related to health security needs with
respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;
(iii) an assessment of the plans developed by the
Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether
such plans were developed prior to procurement, modification, or replenishment;
(iv) an accounting of countermeasures procured,
modified, or replenished under paragraph (1) that received advanced research and development funding
from the Biomedical Advanced Research and Development Authority;
(v) an analysis of how such procurement decisions
made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);
(vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in
the stockpile, and how such expenditures relate to the
ability of the stockpile to meet emergency health security needs;
(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed
under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller
General;
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(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such
change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions,
use of stockpiled countermeasures, and use of resources for such activities;
(ix) an assessment of whether the processes and
procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are
sufficient to ensure countermeasures and products
under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of
whether such countermeasures and products receive or
had received funding under section 319L, including
with respect to whether such countermeasures and
products are most appropriate to meet the emergency
health security needs of the United States; and
(x) with respect to reports issued in 2027 or any
subsequent year, an assessment of selected contracts
or cooperative agreements entered into pursuant to
paragraph (5).
(B) SUBMISSION.—Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.
(7) REIMBURSEMENT FOR CERTAIN SUPPLIES.—
(A) IN GENERAL.—The Secretary may, at appropriate
intervals, make available for purchase excess contents procured for, and maintained within, the stockpile under
paragraph (1) to any Federal agency or State, local, or
Tribal government. The Secretary shall make such contents available for purchase only if—
(i) such contents are in excess of what is required
for appropriate maintenance of such stockpile;
(ii) the Secretary determines that the costs for
maintaining such excess contents are not appropriate
to expend to meet the needs of the stockpile; and
(iii) the Secretary determines that such action
does not compromise national security and is in the
national interest.
(B) REIMBURSEMENT AND COLLECTION.—The Secretary
may require reimbursement for contents that are made
available under subparagraph (A), in an amount that reflects the cost of acquiring and maintaining such contents
and the costs incurred to make available such contents in
the time and manner specified by the Secretary. Amounts
collected under this subsection shall be credited to the appropriations account or fund that incurred the costs to procure such contents, and shall remain available, without
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further appropriation, until expended, for the purposes of
the appropriation account or fund so credited.
(C) RULE OF CONSTRUCTION.—This paragraph shall not
be construed to preclude transfers of contents in the stockpile under other authorities.
(D) REPORT.—Not later than 2 years after the date of
enactment of the PREVENT Pandemics Act, and annually
thereafter, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the
use of the authority provided under this paragraph, including details of each action taken pursuant to this paragraph, the account or fund to which any collected amounts
have been credited, and how the Secretary has used such
amounts.
(E) SUNSET.—The authority under this paragraph
shall terminate on September 30, 2028.
(b) SMALLPOX VACCINE DEVELOPMENT.—
(1) IN GENERAL.—The Secretary shall award contracts,
enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that
the stockpile under subsection (a) includes an amount of vaccine against smallpox as determined by such Secretary to be
sufficient to meet the health security needs of the United
States.
(2) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to limit the private distribution, purchase, or sale
of vaccines from sources other than the stockpile described in
subsection (a).
(c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CERTAIN COUNTERMEASURES; AVAILABILITY OF SPECIAL RESERVE
FUND.—
(1) IN GENERAL.—
(A) USE OF FUND.—A security countermeasure may, in
accordance with this subsection, be procured with amounts
in the special reserve fund as defined in subsection (h).
(B) SECURITY COUNTERMEASURE.—For purposes of this
subsection, the term ‘‘security countermeasure’’ means a
drug (as that term is defined by section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1))), biological product (as that term is defined by
section 351(i) of this Act (42 U.S.C. 262(i))), or device (as
that term is defined by section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h))) that—
(i)(I) the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the
Homeland Security Act of 2002) to diagnose, mitigate,
prevent, or treat harm from any biological, chemical,
radiological, or nuclear agent identified as a material
threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may
result in adverse health consequences or death and
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may be caused by administering a drug, biological
product, or device against such an agent;
(II) the Secretary determines under paragraph
(2)(B)(ii) to be a necessary countermeasure; and
(III)(aa) is approved or cleared under chapter V of
the Federal Food, Drug, and Cosmetic Act or licensed
under section 351 of this Act; or
(bb) is a countermeasure for which the Secretary
determines that sufficient and satisfactory clinical experience or research data (including data, if available,
from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify
for approval or licensing within 10 years after the date
of a determination under paragraph (5); or
(ii) is authorized for emergency use under section
564 of the Federal Food, Drug, and Cosmetic Act.
(2) DETERMINATION OF MATERIAL THREATS.—
(A) MATERIAL THREAT.—The Homeland Security Secretary, in consultation with the Secretary and the heads of
other agencies as appropriate, shall on an ongoing basis—
(i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security.
(B) PUBLIC HEALTH IMPACT; NECESSARY COUNTERMEASURES.—The Secretary shall on an ongoing basis—
(i) assess the potential public health consequences
for the United States population of exposure to agents
identified under subparagraph (A)(ii); and
(ii) determine, on the basis of such assessment,
the agents identified under subparagraph (A)(ii) for
which countermeasures are necessary to protect the
public health.
(C) NOTICE TO CONGRESS.—The Secretary and the Secretary of Homeland Security shall send to Congress, not
later than March 15 of each year, all current material
threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the
Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and
Commerce and the Committee on Homeland Security of
the House of Representatives that a determination has
been made pursuant to subparagraph (A) or (B).
(D) ASSURING ACCESS TO THREAT INFORMATION.—In
making the assessment and determination required under
subparagraph (A), the Homeland Security Secretary shall
use all relevant information to which such Secretary is entitled under section 202 of the Homeland Security Act of
2002, including but not limited to information, regardless
of its level of classification, relating to current and emerging threats of chemical, biological, radiological, and nuclear agents.
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(3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF
COUNTERMEASURES.—
(A) IN GENERAL.—The Secretary, in consultation with
the Homeland Security Secretary, shall assess on an ongoing basis the availability and appropriateness of specific
countermeasures to address specific threats identified
under paragraph (2).
(B) INFORMATION.—The Secretary shall institute a
process for making publicly available the results of assessments under subparagraph (A) while withholding such information as—
(i) would, in the judgment of the Secretary, tend
to reveal public health vulnerabilities; or
(ii) would otherwise be exempt from disclosure
under section 552 of title 5, United States Code.
(4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COMMITMENT FOR RECOMMENDATION FOR PROCUREMENT.—
(A) PROPOSAL TO THE PRESIDENT.—If, pursuant to an
assessment under paragraph (3), the Homeland Security
Secretary and the Secretary make a determination that a
countermeasure would be appropriate but is either
currently not developed or unavailable for procurement as
a security countermeasure or is approved, licensed, or
cleared only for alternative uses, such Secretaries may
jointly submit to the President a proposal to—
(i) issue a call for the development of such countermeasure; and
(ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under paragraph (5), the Secretaries will, based in part on information obtained pursuant to such call, and subject to the availability of appropriations, make available the special reserve fund
as defined in subsection (h) for procurement of such
countermeasure, as applicable.
(B) COUNTERMEASURE SPECIFICATIONS.—The Homeland Security Secretary and the Secretary shall, to the extent practicable, include in the proposal under subparagraph (A)—
(i) estimated quantity of purchase (in the form of
number of doses or number of effective courses of
treatments regardless of dosage form);
(ii) necessary measures of minimum safety and effectiveness;
(iii) estimated price for each dose or effective
course of treatment regardless of dosage form; and
(iv) other information that may be necessary to
encourage and facilitate research, development, and
manufacture of the countermeasure or to provide specifications for the countermeasure.
(C) PRESIDENTIAL APPROVAL.—If the President approves a proposal under subparagraph (A), the Homeland
Security Secretary and the Secretary shall make known to
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persons who may respond to a call for the countermeasure
involved—
(i) the call for the countermeasure;
(ii) specifications for the countermeasure under
subparagraph (B); and
(iii) the commitment described in subparagraph
(A)(ii).
(5) SECRETARY’S DETERMINATION OF COUNTERMEASURES APPROPRIATE FOR FUNDING FROM SPECIAL RESERVE FUND.—
(A) IN GENERAL.—The Secretary, in accordance with
the provisions of this paragraph, shall identify specific security countermeasures that the Secretary determines, in
consultation with the Homeland Security Secretary, to be
appropriate for inclusion in the stockpile under subsection
(a) pursuant to procurements made with amounts in the
special reserve fund as defined in subsection (h) (referred
to in this subsection individually as a ‘‘procurement under
this subsection’’).
(B) REQUIREMENTS.—In making a determination under
subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and consider the
following:
(i) The quantities of the product that will be needed to meet the stockpile needs.
(ii) The feasibility of production and delivery within 10 years of sufficient quantities of the product.
(iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.
(6) RECOMMENDATIONS FOR PROCUREMENT.—
(A) NOTICE TO APPROPRIATE CONGRESSIONAL COMMITTEES.—The Secretary shall notify the Committee on Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of
the House of Representatives of each decision to make
available the special reserve fund as defined in subsection
(h) for procurement of a security countermeasure, including, where available, the number of, the nature of, and
other information concerning potential suppliers of such
countermeasure, and whether other potential suppliers of
the same or similar countermeasures were considered and
rejected for procurement under this section and the reasons for each such rejection.
(B) SUBSEQUENT SPECIFIC COUNTERMEASURES.—Procurement under this subsection of a security countermeasure for a particular purpose does not preclude the
subsequent procurement under this subsection of any
other security countermeasure for such purpose if the Secretary has determined under paragraph (5)(A) that such
countermeasure is appropriate for inclusion in the stockpile and if, as determined by the Secretary, such countermeasure provides improved safety or effectiveness, or for
other reasons enhances preparedness to respond to threats
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of use of a biological, chemical, radiological, or nuclear
agent. Such a determination by the Secretary is committed
to agency discretion.
(7) PROCUREMENT.—
(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The special reserve fund as defined in subsection (h) shall be
available for payments made by the Secretary to a vendor
for procurement of a security countermeasure in accordance with the provisions of this paragraph.
(B) PROCUREMENT.—
(i) IN GENERAL.—The Secretary shall be responsible for—
(I) arranging for procurement of a security
countermeasure, including negotiating terms (including quantity, production schedule, and price)
of, and entering into, contracts and cooperative
agreements, and for carrying out such other activities as may reasonably be required, including
advanced research and development, in accordance with the provisions of this subparagraph;
and
(II) promulgating such regulations as the Secretary determines necessary to implement the provisions of this subsection.
(ii) CONTRACT TERMS.—A contract for procurements under this subsection shall (or, as specified
below, may) include the following terms:
(I) PAYMENT CONDITIONED ON DELIVERY.—The
contract shall provide that no payment may be
made until delivery of a portion, acceptable to the
Secretary, of the total number of units contracted
for, except that, notwithstanding any other provision of law, the contract may provide that, if the
Secretary determines (in the Secretary’s discretion) that an advance payment, partial payment
for significant milestones, or payment to increase
manufacturing capacity is necessary to ensure
success of a project, the Secretary shall pay an
amount, not to exceed 10 percent of the contract
amount, in advance of delivery. The Secretary
shall, to the extent practicable, make the determination of advance payment at the same time as
the issuance of a solicitation. The contract shall
provide that such advance payment is required to
be repaid if there is a failure to perform by the
vendor under the contract. The contract may also
provide for additional advance payments of 5 percent each for meeting the milestones specified in
such contract, except that such payments shall not
exceed 50 percent of the total contract amount. If
the specified milestones are reached, the advanced
payments of 5 percent shall not be required to be
repaid. Nothing in this subclause shall be construed as affecting the rights of vendors under
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provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.
(II) DISCOUNTED PAYMENT.—The contract may
provide for a discounted price per unit of a product that is not licensed, cleared, or approved as
described in paragraph (1)(B)(i)(III)(aa) at the
time of delivery, and may provide for payment of
an additional amount per unit if the product becomes so licensed, cleared, or approved before the
expiration date of the contract (including an additional amount per unit of product delivered before
the effective date of such licensing, clearance, or
approval).
(III) CONTRACT DURATION.—The contract shall
be for a period not to exceed five years, except
that, in first awarding the contract, the Secretary
may provide for a longer duration, not exceeding
10 years, if the Secretary determines that complexities or other difficulties in performance under
the contract justify such a period. The contract
shall be renewable for additional periods, none of
which shall exceed five years. The Secretary shall
notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.
(IV) STORAGE BY VENDOR.—The contract may
provide that the vendor will provide storage for
stocks of a product delivered to the ownership of
the Federal Government under the contract, for
such period and under such terms and conditions
as the Secretary may specify, and in such case
amounts from the special reserve fund as defined
in subsection (h) shall be available for costs of
shipping, handling, storage, and related costs for
such product.
(V) PRODUCT APPROVAL.—The contract shall
provide that the vendor seek approval, clearance,
or licensing of the product from the Secretary; for
a timetable for the development of data and other
information to support such approval, clearance,
or licensing; and that the Secretary may waive
part or all of this contract term on request of the
vendor or on the initiative of the Secretary.
(VI) NON-STOCKPILE TRANSFERS OF SECURITY
COUNTERMEASURES.—The contract shall provide
that the vendor will comply with all applicable export-related controls with respect to such countermeasure.
(VII) SALES EXCLUSIVITY.—The contract may
provide that the vendor is the exclusive supplier
of the product to the Federal Government for a
specified period of time, not to exceed the term of
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the contract, on the condition that the vendor is
able to satisfy the needs of the Government. During the agreed period of sales exclusivity, the vendor shall not assign its rights of sales exclusivity
to another entity or entities without approval by
the Secretary. Such a sales exclusivity provision
in such a contract shall constitute a valid basis for
a sole source procurement under section 303(c)(1)
of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)).
(VIII) WARM BASED SURGE CAPACITY.—The
contract may provide that the vendor establish domestic manufacturing capacity of the product to
ensure that additional production of the product is
available in the event that the Secretary determines that there is a need to quickly purchase additional quantities of the product. Such contract
may provide a fee to the vendor for establishing
and maintaining such capacity in excess of the initial requirement for the purchase of the product.
Additionally, the cost of maintaining the domestic
manufacturing capacity shall be an allowable and
allocable direct cost of the contract.
(IX) CONTRACT TERMS.—The Secretary, in any
contract for procurement under this section—
(aa) may specify—
(AA) the dosing and administration
requirements for the countermeasure to
be developed and procured;
(BB) the amount of funding that will
be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; and
(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and
(bb) shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined
in paragraph (1)(B).
(iii) AVAILABILITY OF SIMPLIFIED ACQUISITION PROCEDURES.—
(I) IN GENERAL.—If the Secretary determines
that there is a pressing need for a procurement of
a specific countermeasure, the amount of the procurement under this subsection shall be deemed
to be below the threshold amount specified in section 4(11) of the Office of Federal Procurement
Policy Act (41 U.S.C. 403(11)), for purposes of application to such procurement, pursuant to section
302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a)), of—
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(aa) section 303(g)(1)(A) of the Federal
Property and Administrative Services Act of
1949 (41 U.S.C. 253(g)(1)(A)) and its implementing regulations; and
(bb) section 302A(b) of such Act (41
U.S.C. 252a(b)) and its implementing regulations.
(II) APPLICATION OF CERTAIN PROVISIONS.—
Notwithstanding subclause (I) and the provision of
law and regulations referred to in such clause,
each of the following provisions shall apply to procurements described in this clause to the same extent that such provisions would apply to such procurements in the absence of subclause (I):
(aa) Chapter 37 of title 40, United States
Code (relating to contract work hours and
safety standards).
(bb) Subsections (a) and (b) of section 7 of
the Anti-Kickback Act of 1986 (41 U.S.C.
57(a) and (b)).
(cc) Section 304C of the Federal Property
and Administrative Services Act of 1949 (41
U.S.C. 254d) (relating to the examination of
contractor records).
(dd) Section 3131 of title 40, United
States Code (relating to bonds of contractors
of public buildings or works).
(ee) Subsection (a) of section 304 of the
Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 254(a)) (relating to contingent fees to middlemen).
(ff) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962).
(gg) Section 1354 of title 31, United
States Code (relating to the limitation on the
use of appropriated funds for contracts with
entities not meeting veterans employment reporting requirements).
(III) INTERNAL CONTROLS TO BE ESTABLISHED.—The Secretary shall establish appropriate internal controls for procurements made
under this clause, including requirements with respect to documentation of the justification for the
use of the authority provided under this paragraph with respect to the procurement involved.
(IV) AUTHORITY TO LIMIT COMPETITION.—In
conducting a procurement under this subparagraph, the Secretary may not use the authority
provided for under subclause (I) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the
mission of the BioShield Program under the
Project BioShield Act of 2004 would be seriously
impaired without such a limitation.
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(iv) PROCEDURES OTHER THAN FULL AND OPEN
COMPETITION.—
(I) IN GENERAL.—In using the authority provided in section 303(c)(1) of title III of the Federal
Property and Administrative Services Act of 1949
(41 U.S.C. 253(c)(1)) to use procedures other than
competitive procedures in the case of a procurement under this subsection, the phrase ‘‘available
from only one responsible source’’ in such section
303(c)(1) shall be deemed to mean ‘‘available from
only one responsible source or only from a limited
number of responsible sources’’.
(II) RELATION TO OTHER AUTHORITIES.—The
authority under subclause (I) is in addition to any
other authority to use procedures other than competitive procedures.
(III) APPLICABLE GOVERNMENT-WIDE REGULATIONS.—The Secretary shall implement this clause
in accordance with government-wide regulations
implementing such section 303(c)(1) (including requirements that offers be solicited from as many
potential sources as is practicable under the circumstances, that required notices be published,
and that submitted offers be considered), as such
regulations apply to procurements for which an
agency has authority to use procedures other than
competitive procedures when the property or services needed by the agency are available from only
one responsible source or only from a limited
number of responsible sources and no other type
of property or services will satisfy the needs of the
agency.
(v) PREMIUM PROVISION IN MULTIPLE AWARD CONTRACTS.—
(I) IN GENERAL.—If, under this subsection, the
Secretary enters into contracts with more than
one vendor to procure a security countermeasure,
such Secretary may, notwithstanding any other
provision of law, include in each of such contracts
a provision that—
(aa) identifies an increment of the total
quantity of security countermeasure required,
whether by percentage or by numbers of
units; and
(bb) promises to pay one or more specified
premiums based on the priority of such vendors’ production and delivery of the increment
identified under item (aa), in accordance with
the terms and conditions of the contract.
(II) DETERMINATION OF GOVERNMENT’S REQUIREMENT NOT REVIEWABLE.—If the Secretary includes in each of a set of contracts a provision as
described in subclause (I), such Secretary’s determination of the total quantity of security counterFebruary 1, 2024
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measure required, and any amendment of such
determination, is committed to agency discretion.
(vi) EXTENSION OF CLOSING DATE FOR RECEIPT OF
PROPOSALS NOT REVIEWABLE.—A decision by the Secretary to extend the closing date for receipt of proposals for a procurement under this subsection is committed to agency discretion.
(vii) LIMITING COMPETITION TO SOURCES RESPONDING TO REQUEST FOR INFORMATION.—In conducting a
procurement under this subsection, the Secretary may
exclude a source that has not responded to a request
for information under section 303A(a)(1)(B) of the Federal Property and Administrative Services Act of 1949
(41 U.S.C. 253a(a)(1)(B)) if such request has given notice that the Secretary may so exclude such a source.
(viii) FLEXIBILITY.—In carrying out this section,
the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other
agreements that are in the best interest of the Government in meeting identified security countermeasure
needs, including with respect to reimbursement of the
cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.
(8) INTERAGENCY COOPERATION.—
(A) IN GENERAL.—In carrying out activities under this
section, the Homeland Security Secretary and the Secretary are authorized, subject to subparagraph (B), to
enter into interagency agreements and other collaborative
undertakings with other agencies of the United States
Government. Such agreements may allow other executive
agencies to order qualified and security countermeasures
under procurement contracts or other agreements established by the Secretary. Such ordering process (including
transfers of appropriated funds between an agency and the
Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31,
United States Code, except that all such orders shall be
processed under the terms established under this subsection for the procurement of countermeasures.
(B) LIMITATION.—An agreement or undertaking under
this paragraph shall not authorize another agency to exercise the authorities provided by this section to the Homeland Security Secretary or to the Secretary.
(d) DISCLOSURES.—No Federal agency may disclose under section 552 of title 5, United States Code any information identifying
the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents
or deployment capability of the stockpile that could compromise national security.
(e) DEFINITION.—For purposes of subsection (a), the term
‘‘stockpile’’ includes—
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(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree
to provide to such Secretary supplies described in subsection
(a).
(f) AUTHORIZATION OF APPROPRIATIONS.—
(1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of
carrying out subsection (a), there are authorized to be appropriated $610,000,000 for each of fiscal years 2019 through
2021, and $750,000,000 for each of fiscal years 2022 and 2023,
to remain available until expended. Such authorization is in
addition to amounts in the special reserve fund referred to in
subsection (h).
(2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of
carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
(g) SPECIAL RESERVE FUND.—
(1) AUTHORIZATION OF APPROPRIATIONS.—In addition to
amounts appropriated to the special reserve fund prior to the
date of the enactment of this subsection, there is authorized to
be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section
319L (relating to the Biomedical Advanced Research and Development Authority), $7,100,000,000 for the period of fiscal
years 2019 through 2028, to remain available until expended.
(2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RESEARCH AND DEVELOPMENT.—The Secretary may utilize not
more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related
to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this
subsection to carry out section 319L are in addition to amounts
otherwise authorized to be appropriated to carry out such section.
(3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 319L) or for procurement of a security
countermeasure under subsection (c)(7).
(4) REPORT ON SECURITY COUNTERMEASURE PROCUREMENT.—Not later than March 1 of each year in which the Secretary determines that the amount of funds available for procurement of security countermeasures is less than
$1,500,000,000, the Secretary shall submit to the Committee
on Appropriations and the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of
the House of Representatives a report detailing the amount of
such funds available for procurement and the impact such
amount of funding will have—
(A) in meeting the security countermeasure needs
identified under this section; and
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(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).
(5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Secretary, acting through the Director of the Biomedical Advanced
Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement
of security countermeasures under subsection (c) and for carrying out section 319L), including the execution of procurement
contracts, grants, and cooperative agreements pursuant to this
section and section 319L.
(h) DEFINITIONS.—In this section:
(1) The term ‘‘advanced research and development’’ has the
meaning given such term in section 319L(a).
(2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense
Countermeasures’’ appropriations account, any appropriation
made available pursuant to section 521(a) of the Homeland Security Act of 2002, and any appropriation made available pursuant to subsection (g)(1).
(i) PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.—
(1) IN GENERAL.—The Secretary, in consultation with the
Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, shall
award grants or cooperative agreements to not fewer than 5
States, or consortia of States, with consideration given to distribution among the geographical regions of the United States,
to establish, expand, or maintain a stockpile of appropriate
drugs, vaccines and other biological products, medical devices,
and other medical supplies determined by the State to be necessary to respond to a public health emergency declared by the
Governor of a State or by the Secretary under section 319, or
a major disaster or emergency declared by the President under
section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, in order to support
the preparedness goals described in paragraphs (2) through (6)
and (8) of section 2802(b). A recipient of such an award may
not use award funds to support the stockpiling of security
countermeasures (as defined in subsection (c)(1), unless the eligible entity provides justification for maintaining such countermeasures and the Secretary determines such justification is
appropriate and applicable.
(2) REQUIREMENTS.—
(A) APPLICATION.—To be eligible to receive an award
under paragraph (1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such State or States, and
submit to the Secretary an application that contains such
information as the Secretary may require, including—
(i) a plan for such stockpile, consistent with paragraph (4), including—
(I) a description of the activities such entity
will carry out under the agreement;
(II) an assurance that such entity will use
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quirements of chapter 83 of title 41, United States
Code (commonly referred to as the ‘‘Buy American
Act’’); and
(III) an outline of proposed expenses; and
(ii) a description of how such entity will coordinate
with relevant entities in receipt of an award under
section 319C–1 or 319C–2 pursuant to paragraph (4),
including through promoting alignment between the
stockpile plan established pursuant to clause (i) and
applicable plans that are established by such entity
pursuant to section 319C–1 or 319C–2.
(B) MATCHING FUNDS.—
(i) Subject to clause (ii), the Secretary may not
make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by
the applicant in carrying out the purpose described in
this subsection, to make available non-Federal contributions toward such costs in an amount equal to—
(I) for each of fiscal years 2023 and 2024, not
less than $1 for each $20 of Federal funds provided in the award; and
(II) for fiscal year 2025 and each fiscal year
thereafter, not less than $1 for each $10 of Federal funds provided in the award.
(ii) WAIVER.—The Secretary may, upon the request of a State, waive the requirement under clause
(i), in whole or in part, if the Secretary determines
that extraordinary economic conditions in the State in
the fiscal year involved or in the previous fiscal year
justify the waiver. A waiver provided by the Secretary
under this subparagraph shall apply only to the fiscal
year involved.
(C) ADMINISTRATIVE EXPENSES.—Not more than 10
percent of amounts received by an entity pursuant to an
award under this subsection may be used for administrative expenses.
(3) LEAD ENTITY.—An entity in receipt of an award under
paragraph (1) may designate a lead entity, which may be a
public or private entity, as appropriate, to manage the stockpile at the direction of the State or consortium of States.
(4) USE OF FUNDS.—An entity in receipt of an award under
paragraph (1) shall use such funds to—
(A) purchase, store, and maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies to be used during
a public health emergency, major disaster, or emergency
described in paragraph (1), in such numbers, types, and
amounts as the entity determines necessary, consistent
with such entity’s stockpile plan established pursuant to
paragraph (2)(A)(i);
(B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency,
major disaster, or other emergency described in paragraph
(1);
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(C) replenish and make necessary additions or modifications to the contents of such stockpile, including to address potential depletion;
(D) in consultation with Federal, State, and local officials, take into consideration the availability, deployment,
dispensing, and administration requirements of medical
products within the stockpile;
(E) ensure that procedures are followed for inventory
management and accounting, and for the physical security
of the stockpile, as appropriate;
(F) review and revise, as appropriate, the contents of
the stockpile on a regular basis to ensure that, to the extent practicable, new technologies and medical products
are considered;
(G) carry out exercises, drills, and other training for
purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing
the capability of such stockpile to address the medical supply needs of public health emergencies, major disasters, or
other emergencies described in paragraph (1) of varying
types and scales, which may be conducted in accordance
with requirements related to exercises, drills, and other
training for recipients of awards under section 319C–1 or
319C–2, as applicable; and
(H) carry out other activities related to the State strategic stockpile as the entity determines appropriate, to
support State efforts to prepare for, and respond to, public
health threats.
(5) SUPPLEMENT NOT SUPPLANT.—Awards under paragraph
(1) shall supplement, not supplant, the maintenance and use
of the Strategic National Stockpile by the Secretary under subsection (a).
(6) GUIDANCE FOR STATES.—Not later than 180 days after
the date of enactment of this subsection, the Secretary, in consultation with States, health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such
guidance as appropriate, for States related to maintaining and
replenishing a stockpile of medical products, which may include strategies and best practices related to—
(A) types of medical products and medical supplies
that are critical to respond to public health emergencies,
and may be appropriate for inclusion in a stockpile by
States, with consideration of threats that require the
large-scale and simultaneous deployment of stockpiles, including the stockpile maintained by the Secretary pursuant to subsection (a), and long-term public health and
medical response needs;
(B) appropriate management of the contents of a
stockpile, including management by vendors of reserve
amounts of medical products and supplies intended to be
delivered to the ownership of the State and appropriate
disposition of excess products, as applicable; and
(C) the procurement of medical products and medical
supplies consistent with the requirements of chapter 83 of
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title 41, United States Code (commonly referred to as the
‘‘Buy American Act’’).
(7) TECHNICAL ASSISTANCE.—The Secretary shall provide
assistance to States, including technical assistance, as appropriate, in establishing, maintaining, improving, and utilizing a
medical stockpile, including appropriate inventory management and disposition of products.
(8) REPORTING.—
(A) STATE REPORTS.—Each entity receiving an award
under paragraph (1) shall update, as appropriate, the plan
established pursuant to paragraph (2)(A)(i) and submit to
the Secretary an annual report on implementation of such
plan, including any changes to the contents of the stockpile
supported under such award. The Secretary shall use information obtained from such reports to inform the maintenance and management of the Strategic National Stockpile pursuant to subsection (a).
(B) REPORTS TO CONGRESS.—Not later than 1 year
after the initial issuance of awards pursuant to paragraph
(1), and annually thereafter for the duration of the program established under this subsection, the Secretary
shall submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House
of Representatives a report on such program, including—
(i) Federal and State expenditures to support
stockpiles under such program;
(ii) activities conducted pursuant to paragraph (4);
and
(iii) any additional information from the States
that the Secretary determines relevant.
(9) AUTHORIZATION OF APPROPRIATIONS.—To carry out this
subsection, there is authorized to be appropriated
$3,500,000,000 for each of fiscal years 2023 and 2024, to remain available until expended.
SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PANDEMIC AND EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.
(a) LIABILITY PROTECTIONS.—
(1) IN GENERAL.—Subject to the other provisions of this
section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for
loss caused by, arising out of, relating to, or resulting from the
administration to or the use by an individual of a covered
countermeasure if a declaration under subsection (b) has been
issued with respect to such countermeasure.
(2) SCOPE OF CLAIMS FOR LOSS.—
(A) LOSS.—For purposes of this section, the term ‘‘loss’’
means any type of loss, including—
(i) death;
(ii) physical, mental, or emotional injury, illness,
disability, or condition;
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(iii) fear of physical, mental, or emotional injury,
illness, disability, or condition, including any need for
medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.
Each of clauses (i) through (iv) applies without regard to
the date of the occurrence, presentation, or discovery of the
loss described in the clause.
(B) SCOPE.—The immunity under paragraph (1) applies to any claim for loss that has a causal relationship
with the administration to or use by an individual of a covered countermeasure, including a causal relationship with
the design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of
such countermeasure.
(3) CERTAIN CONDITIONS.—Subject to the other provisions
of this section, immunity under paragraph (1) with respect to
a covered countermeasure applies only if—
(A) the countermeasure was administered or used during the effective period of the declaration that was issued
under subsection (b) with respect to the countermeasure;
(B) the countermeasure was administered or used for
the category or categories of diseases, health conditions, or
threats to health specified in the declaration; and
(C) in addition, in the case of a covered person who is
a program planner or qualified person with respect to the
administration or use of the countermeasure, the countermeasure was administered to or used by an individual
who—
(i) was in a population specified by the declaration; and
(ii) was at the time of administration physically
present in a geographic area specified by the declaration or had a connection to such area specified in the
declaration.
(4) APPLICABILITY OF CERTAIN CONDITIONS.—With respect
to immunity under paragraph (1) and subject to the other provisions of this section:
(A) In the case of a covered person who is a manufacturer or distributor of the covered countermeasure involved, the immunity applies without regard to whether
such countermeasure was administered to or used by an
individual in accordance with the conditions described in
paragraph (3)(C).
(B) In the case of a covered person who is a program
planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in
circumstances in which the covered person reasonably
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tered or used in accordance with the conditions described
in paragraph (3)(C).
(5) EFFECT OF DISTRIBUTION METHOD.—The provisions of
this section apply to a covered countermeasure regardless of
whether such countermeasure is obtained by donation, commercial sale, or any other means of distribution, except to the
extent that, under paragraph (2)(E) of subsection (b), the declaration under such subsection provides that subsection (a) applies only to covered countermeasures obtained through a particular means of distribution.
(6) REBUTTABLE PRESUMPTION.—For purposes of paragraph
(1), there shall be a rebuttable presumption that any administration or use, during the effective period of the emergency declaration by the Secretary under subsection (b), of a covered
countermeasure shall have been for the category or categories
of diseases, health conditions, or threats to health with respect
to which such declaration was issued.
(b) DECLARATION BY SECRETARY.—
(1) AUTHORITY TO ISSUE DECLARATION.—Subject to paragraph (2), if the Secretary makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible
risk that the disease, condition, or threat may in the future
constitute such an emergency, the Secretary may make a declaration, through publication in the Federal Register, recommending, under conditions as the Secretary may specify, the
manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, and stating that subsection (a) is in effect with respect to the activities
so recommended.
(2) CONTENTS.—In issuing a declaration under paragraph
(1), the Secretary shall identify, for each covered countermeasure specified in the declaration—
(A) the category or categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure;
(B) the period or periods during which, including as
modified by paragraph (3), subsection (a) is in effect, which
period or periods may be designated by dates, or by milestones or other description of events, including factors
specified in paragraph (6);
(C) the population or populations of individuals for
which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a
specification that such subsection applies without geographic limitation to all individuals);
(D) the geographic area or areas for which subsection
(a) is in effect with respect to the administration or use of
the countermeasure (which may be a specification that
such subsection applies without geographic limitation), including, with respect to individuals in the populations
identified under subparagraph (C), a specification, as determined appropriate by the Secretary, of whether the declaration applies only to individuals physically present in
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such areas or whether in addition the declaration applies
to individuals who have a connection to such areas, which
connection is described in the declaration; and
(E) whether subsection (a) is effective only to a particular means of distribution as provided in subsection
(a)(5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
(3) EFFECTIVE PERIOD OF DECLARATION.—
(A) FLEXIBILITY OF PERIOD.—The Secretary may, in describing periods under paragraph (2)(B), have different periods for different covered persons to address different
logistical, practical or other differences in responsibilities.
(B) ADDITIONAL TIME TO BE SPECIFIED.—In each declaration under paragraph (1), the Secretary, after consulting, to the extent the Secretary deems appropriate,
with the manufacturer of the covered countermeasure,
shall also specify a date that is after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
(i) a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure,
including the return of such product to the manufacturer; and
(ii) a reasonable period for covered persons to take
such other actions as may be appropriate to limit administration or use of the covered countermeasure.
(C) ADDITIONAL PERIOD FOR CERTAIN STRATEGIC NATIONAL STOCKPILE COUNTERMEASURES.—With respect to a
covered countermeasure that is in the stockpile under section 319F-2, if such countermeasure was the subject of a
declaration under paragraph (1) at the time that it was obtained for the stockpile, the effective period of such declaration shall include a period when the countermeasure is
administered or used pursuant to a distribution or release
from the stockpile.
(4) AMENDMENTS TO DECLARATION.—The Secretary may
through publication in the Federal Register amend any portion
of a declaration under paragraph (1). Such an amendment
shall not retroactively limit the applicability of subsection (a)
with respect to the administration or use of the covered countermeasure involved.
(5) CERTAIN DISCLOSURES.—In publishing a declaration
under paragraph (1) in the Federal Register, the Secretary is
not required to disclose any matter described in section 552(b)
of title 5, United States Code.
(6) FACTORS TO BE CONSIDERED.—In deciding whether and
under what circumstances or conditions to issue a declaration
under paragraph (1) with respect to a covered countermeasure,
the Secretary shall consider the desirability of encouraging the
design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing,
promotion, sale, purchase, donation, dispensing, prescribing,
administration, licensing, and use of such countermeasure.
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(7) JUDICIAL REVIEW.—No court of the United States, or of
any State, shall have subject matter jurisdiction to review,
whether by mandamus or otherwise, any action by the Secretary under this subsection.
(8) PREEMPTION OF STATE LAW.—During the effective period of a declaration under subsection (b), or at any time with
respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish,
enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
(A) is different from, or is in conflict with, any requirement applicable under this section; and
(B) relates to the design, development, clinical testing
or investigation, formulation, manufacture, distribution,
sale, donation, purchase, marketing, promotion, packaging,
labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by
qualified persons of the covered countermeasure, or to any
matter included in a requirement applicable to the covered
countermeasure under this section or any other provision
of this Act, or under the Federal Food, Drug, and Cosmetic
Act.
(9) REPORT TO CONGRESS.—Within 30 days after making a
declaration under paragraph (1), the Secretary shall submit to
the appropriate committees of the Congress a report that provides an explanation of the reasons for issuing the declaration
and the reasons underlying the determinations of the Secretary with respect to paragraph (2). Within 30 days after
making an amendment under paragraph (4), the Secretary
shall submit to such committees a report that provides the reasons underlying the determination of the Secretary to make
the amendment.
(c) DEFINITION OF WILLFUL MISCONDUCT.—
(1) DEFINITION.—
(A) IN GENERAL.—Except as the meaning of such term
is further restricted pursuant to paragraph (2), the term
‘‘willful misconduct’’ shall, for purposes of subsection (d),
denote an act or omission that is taken—
(i) intentionally to achieve a wrongful purpose;
(ii) knowingly without legal or factual justification; and
(iii) in disregard of a known or obvious risk that
is so great as to make it highly probable that the
harm will outweigh the benefit.
(B) RULE OF CONSTRUCTION.—The criterion stated in
subparagraph (A) shall be construed as establishing a
standard for liability that is more stringent than a standard of negligence in any form or recklessness.
(2) AUTHORITY TO PROMULGATE REGULATORY DEFINITION.—
(A) IN GENERAL.—The Secretary, in consultation with
the Attorney General, shall promulgate regulations, which
may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a covered
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person that may qualify as ‘‘willful misconduct’’ for purposes of subsection (d).
(B) FACTORS TO BE CONSIDERED.—In promulgating the
regulations under this paragraph, the Secretary, in consultation with the Attorney General, shall consider the
need to define the scope of permissible civil actions under
subsection (d) in a way that will not adversely affect the
public health.
(C) TEMPORAL SCOPE OF REGULATIONS.—The regulations under this paragraph may specify the temporal effect
that they shall be given for purposes of subsection (d).
(D) INITIAL RULEMAKING.—Within 180 days after the
enactment of the Public Readiness and Emergency Preparedness Act, the Secretary, in consultation with the Attorney General, shall commence and complete an initial
rulemaking process under this paragraph.
(3) PROOF OF WILLFUL MISCONDUCT.—In an action under
subsection (d), the plaintiff shall have the burden of proving by
clear and convincing evidence willful misconduct by each covered person sued and that such willful misconduct caused
death or serious physical injury.
(4) DEFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO
SECRETARY’S DECLARATION.—Notwithstanding any other provision of law, a program planner or qualified person shall not
have engaged in ‘‘willful misconduct’’ as a matter of law where
such program planner or qualified person acted consistent with
applicable directions, guidelines, or recommendations by the
Secretary regarding the administration or use of a covered
countermeasure that is specified in the declaration under subsection (b), provided either the Secretary, or a State or local
health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the
plaintiff’s alleged loss within 7 days of the actual discovery of
such information by such program planner or qualified person.
(5) EXCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER
OR DISTRIBUTOR.—
(A) IN GENERAL.—If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection
(e)(3)(A) to constitute willful misconduct, is subject to regulation by this Act or by the Federal Food, Drug, and Cosmetic Act, such act or omission shall not constitute ‘‘willful
misconduct’’ for purposes of subsection (d) if—
(i) neither the Secretary nor the Attorney General
has initiated an enforcement action with respect to
such act or omission; or
(ii) such an enforcement action has been initiated
and the action has been terminated or finally resolved
without a covered remedy.
Any action or proceeding under subsection (d) shall be
stayed during the pendency of such an enforcement action.
(B) DEFINITIONS.—For purposes of this paragraph, the
following terms have the following meanings:
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(i) ENFORCEMENT ACTION.—The term ‘‘enforcement
action’’ means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary
proceeding based on willful misconduct, a mandatory
recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of
a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and
Cosmetic Act, a debarment proceeding, an investigator
disqualification proceeding where an investigator is an
employee or agent of the manufacturer, a revocation,
based on willful misconduct, of an authorization under
section 564 of such Act, or a suspension or withdrawal,
based on willful misconduct, of an approval or clearance under chapter V of such Act or of a licensure
under section 351 of this Act.
(ii) COVERED REMEDY.—The term ‘‘covered remedy’’ means an outcome—
(I) that is a criminal conviction, an injunction,
or a condemnation, a civil monetary payment, a
product recall, a repair or replacement of a product, a termination of an exemption under section
505(i) or 520(g) of the Federal Food, Drug, and
Cosmetic Act, a debarment, an investigator disqualification, a revocation of an authorization
under section 564 of such Act, or a suspension or
withdrawal of an approval or clearance under
chapter 5 of such Act or of a licensure under section 351 of this Act; and
(II) that results from a final determination by
a court or from a final agency action.
(iii) FINAL.—The terms ‘‘final’’ and ‘‘finally’’—
(I) with respect to a court determination, or to
a final resolution of an enforcement action that is
a court determination, mean a judgment from
which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and
(II) with respect to an agency action, or to a
final resolution of an enforcement action that is
an agency action, mean an order that is not subject to further review within the agency and that
has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a
voluntary or stipulated dismissal.
(C) RULES OF CONSTRUCTION.—
(i) IN GENERAL.—Nothing in this paragraph shall
be construed—
(I) to affect the interpretation of any provision
of the Federal Food, Drug, and Cosmetic Act, of
this Act, or of any other applicable statute or regulation; or
(II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of
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ney General, or of any other official with respect
to any administrative or court proceeding under
this Act, under the Federal Food, Drug, and Cosmetic Act, under title 18 of the United States
Code, or under any other applicable statute or
regulation.
(ii) MANDATORY RECALLS.—A mandatory recall
called for in the declaration is not a Food and Drug
Administration enforcement action.
(d) EXCEPTION TO IMMUNITY OF COVERED PERSONS.—
(1) IN GENERAL.—Subject to subsection (f), the sole exception to the immunity from suit and liability of covered persons
set forth in subsection (a) shall be for an exclusive Federal
cause of action against a covered person for death or serious
physical injury proximately caused by willful misconduct, as
defined pursuant to subsection (c), by such covered person. For
purposes of section 2679(b)(2)(B) of title 28, United States
Code, such a cause of action is not an action brought for violation of a statute of the United States under which an action
against an individual is otherwise authorized.
(2) PERSONS WHO CAN SUE.—An action under this subsection may be brought for wrongful death or serious physical
injury by any person who suffers such injury or by any representative of such a person.
(e) PROCEDURES FOR SUIT.—
(1) EXCLUSIVE FEDERAL JURISDICTION.—Any action under
subsection (d) shall be filed and maintained only in the United
States District Court for the District of Columbia.
(2) GOVERNING LAW.—The substantive law for decision in
an action under subsection (d) shall be derived from the law,
including choice of law principles, of the State in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions
of this section.
(3) PLEADING WITH PARTICULARITY.—In an action under
subsection (d), the complaint shall plead with particularity
each element of the plaintiff’s claim, including—
(A) each act or omission, by each covered person sued,
that is alleged to constitute willful misconduct relating to
the covered countermeasure administered to or used by
the person on whose behalf the complaint was filed;
(B) facts supporting the allegation that such alleged
willful misconduct proximately caused the injury claimed;
and
(C) facts supporting the allegation that the person on
whose behalf the complaint was filed suffered death or serious physical injury.
(4) VERIFICATION, CERTIFICATION, AND MEDICAL RECORDS.—
(A) IN GENERAL.—In an action under subsection (d),
the plaintiff shall verify the complaint in the manner stated in subparagraph (B) and shall file with the complaint
the materials described in subparagraph (C). A complaint
that does not substantially comply with subparagraphs (B)
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and (C) shall not be accepted for filing and shall not stop
the running of the statute of limitations.
(B) VERIFICATION REQUIREMENT.—
(i) IN GENERAL.—The complaint shall include a
verification, made by affidavit of the plaintiff under
oath, stating that the pleading is true to the knowledge of the deponent, except as to matters specifically
identified as being alleged on information and belief,
and that as to those matters the plaintiff believes it to
be true.
(ii) IDENTIFICATION OF MATTERS ALLEGED UPON INFORMATION AND BELIEF.—Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all
purposes, including a criminal prosecution, as having
been made upon the knowledge of the plaintiff.
(C) MATERIALS REQUIRED.—In an action under subsection (d), the plaintiff shall file with the complaint—
(i) an affidavit, by a physician who did not treat
the person on whose behalf the complaint was filed,
certifying, and explaining the basis for such physician’s belief, that such person suffered the serious
physical injury or death alleged in the complaint and
that such injury or death was proximately caused by
the administration or use of a covered countermeasure; and
(ii) certified medical records documenting such injury or death and such proximate causal connection.
(5) THREE-JUDGE COURT.—Any action under subsection (d)
shall be assigned initially to a panel of three judges. Such
panel shall have jurisdiction over such action for purposes of
considering motions to dismiss, motions for summary judgment, and matters related thereto. If such panel has denied
such motions, or if the time for filing such motions has expired,
such panel shall refer the action to the chief judge for assignment for further proceedings, including any trial. Section 1253
of title 28, United States Code, and paragraph (3) of subsection
(b) of section 2284 of title 28, United States Code, shall not
apply to actions under subsection (d).
(6) CIVIL DISCOVERY.—
(A) TIMING.—In an action under subsection (d), no discovery shall be allowed—
(i) before each covered person sued has had a reasonable opportunity to file a motion to dismiss;
(ii) in the event such a motion is filed, before the
court has ruled on such motion; and
(iii) in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
(B) STANDARD.—Notwithstanding any other provision
of law, the court in an action under subsection (d) shall
permit discovery only with respect to matters directly related to material issues contested in such action, and the
court shall compel a response to a discovery request (inFebruary 1, 2024
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cluding a request for admission, an interrogatory, a request for production of documents, or any other form of
discovery request) under Rule 37, Federal Rules of Civil
Procedure, only if the court finds that the requesting party
needs the information sought to prove or defend as to a
material issue contested in such action and that the likely
benefits of a response to such request equal or exceed the
burden or cost for the responding party of providing such
response.
(7) REDUCTION IN AWARD OF DAMAGES FOR COLLATERAL
SOURCE BENEFITS.—
(A) IN GENERAL.—In an action under subsection (d),
the amount of an award of damages that would otherwise
be made to a plaintiff shall be reduced by the amount of
collateral source benefits to such plaintiff.
(B) PROVIDER OF COLLATERAL SOURCE BENEFITS NOT
TO HAVE LIEN OR SUBROGATION.—No provider of collateral
source benefits shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of
the plaintiff in an action under subsection (d).
(C) COLLATERAL SOURCE BENEFIT DEFINED.—For purposes of this paragraph, the term ‘‘collateral source benefit’’ means any amount paid or to be paid in the future
to or on behalf of the plaintiff, or any service, product, or
other benefit provided or to be provided in the future to or
on behalf of the plaintiff, as a result of the injury or
wrongful death, pursuant to—
(i) any State or Federal health, sickness, incomedisability, accident, or workers’ compensation law;
(ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;
(iii) any contract or agreement of any group, organization, partnership, or corporation to provide, pay
for, or reimburse the cost of medical, hospital, dental,
or income disability benefits; or
(iv) any other publicly or privately funded program.
(8) NONECONOMIC DAMAGES.—In an action under subsection (d), any noneconomic damages may be awarded only in
an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes
of this paragraph, the term ‘‘noneconomic damages’’ means
damages for losses for physical and emotional pain, suffering,
inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, hedonic damages, injury to reputation,
and any other nonpecuniary losses.
(9) RULE 11 SANCTIONS.—Whenever a district court of the
United States determines that there has been a violation of
Rule 11 of the Federal Rules of Civil Procedure in an action
under subsection (d), the court shall impose upon the attorney,
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sible for the violation, an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the
pleading, motion, or other paper that is the subject of the violation, including a reasonable attorney’s fee. Such sanction shall
be sufficient to deter repetition of such conduct or comparable
conduct by others similarly situated, and to compensate the
party or parties injured by such conduct.
(10) INTERLOCUTORY APPEAL.—The United States Court of
Appeals for the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered person taken within 30 days of an order denying a motion to dismiss or a motion
for summary judgment based on an assertion of the immunity
from suit conferred by subsection (a) or based on an assertion
of the exclusion under subsection (c)(5).
(f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in
this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any agency thereof may
possess under any other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available
to the United States or its agencies, instrumentalities, officers, or
employees under any other law, including any provision of chapter
171 of title 28, United States Code (relating to tort claims procedure).
(g) SEVERABILITY.—If any provision of this section, or the application of such provision to any person or circumstance, is held to
be unconstitutional, the remainder of this section and the application of such remainder to any person or circumstance shall not be
affected thereby.
(h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE
INJURY COMPENSATION PROGRAM.—Nothing in this section, or any
amendment made by the Public Readiness and Emergency Preparedness Act, shall be construed to affect the National Vaccine Injury Compensation Program under title XXI of this Act.
(i) DEFINITIONS.—In this section:
(1) COVERED COUNTERMEASURE.—The term ‘‘covered countermeasure’’ means—
(A) a qualified pandemic or epidemic product (as defined in paragraph (7));
(B) a security countermeasure (as defined in section
319F–2(c)(1)(B));
(C) a drug (as such term is defined in section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)), biological product (as such term is defined by
section 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B
of the Federal Food, Drug, and Cosmetic Act; or
(D) a respiratory protective device that is approved by
the National Institute for Occupational Safety and Health
under part 84 of title 42, Code of Federal Regulations (or
any successor regulations), and that the Secretary deterFebruary 1, 2024
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175
PUBLIC HEALTH SERVICE ACT
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mines to be a priority for use during a public health emergency declared under section 319.
(2) COVERED PERSON.—The term ‘‘covered person’’, when
used with respect to the administration or use of a covered
countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
(v) an official, agent, or employee of a person or
entity described in clause (i), (ii), (iii), or (iv).
(3) DISTRIBUTOR.—The term ‘‘distributor’’ means a person
or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to manufacturers; repackers;
common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
(4) MANUFACTURER.—The term ‘‘manufacturer’’ includes—
(A) a contractor or subcontractor of a manufacturer;
(B) a supplier or licenser of any product, intellectual
property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure;
and
(C) any or all of the parents, subsidiaries, affiliates,
successors, and assigns of a manufacturer.
(5) PERSON.—The term ‘‘person’’ includes an individual,
partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department.
(6) PROGRAM PLANNER.—The term ‘‘program planner’’
means a State or local government, including an Indian tribe,
a person employed by the State or local government, or other
person who supervised or administered a program with respect
to the administration, dispensing, distribution, provision, or
use of a security countermeasure or a qualified pandemic or
epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or
scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a
declaration under subsection (b).
(7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term
‘‘qualified pandemic or epidemic product’’ means a drug (as
such term is defined in section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or
device (as such term is defined by section 201(h) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is—
(A)(i) a product manufactured, used, designed, developed, modified, licensed, or procured—
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(I) to diagnose, mitigate, prevent, treat, or cure a
pandemic or epidemic; or
(II) to limit the harm such pandemic or epidemic
might otherwise cause;
(ii) a product manufactured, used, designed, developed,
modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or
condition caused by a product described in clause (i); or
(iii) 24 a product or technology intended to enhance
the use or effect of a drug, biological product, or device
described in clause (i) or (ii); and
(B)(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act;
(ii) the object of research for possible use as described
by subparagraph (A) and is the subject of an exemption
under section 505(i) or 520(g) of the Federal Food, Drug,
and Cosmetic Act; or
(iii) authorized for emergency use in accordance with
section 564, 564A, or 564B of the Federal Food, Drug, and
Cosmetic Act.
(8) QUALIFIED PERSON.—The term ‘‘qualified person’’, when
used with respect to the administration or use of a covered
countermeasure, means—
(A) a licensed health professional or other individual
who is authorized to prescribe, administer, or dispense
such countermeasures under the law of the State in which
the countermeasure was prescribed, administered, or dispensed; or
(B) a person within a category of persons so identified
in a declaration by the Secretary under subsection (b).
(9) SECURITY COUNTERMEASURE.—The term ‘‘security countermeasure’’ has the meaning given such term in section 319F–
2(c)(1)(B).
(10) SERIOUS PHYSICAL INJURY.—The term ‘‘serious physical injury’’ means an injury that—
(A) is life threatening;
(B) results in permanent impairment of a body function or permanent damage to a body structure; or
(C) necessitates medical or surgical intervention to
preclude permanent impairment of a body function or permanent damage to a body structure.
SEC. 319F–4. ø247d–6e¿ COVERED COUNTERMEASURE PROCESS.
(a) ESTABLISHMENT OF FUND.—Upon the issuance by the
Secretary of a declaration under section 319F–3(b), there is hereby established in the Treasury an emergency fund designated as the
‘‘Covered Countermeasure Process Fund’’ for purposes of providing
timely, uniform, and adequate compensation to eligible individuals
for covered injuries directly caused by the administration or use of
a covered countermeasure pursuant to such declaration, which
Fund shall consist of such amounts designated as emergency appropriations under section 402 of H. Con. Res. 95 of the 109th Con24 Margin
of clause (iii) so in law.
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gress, this emergency designation shall remain in effect through
October 1, 2006.
(b) PAYMENT OF COMPENSATION.—
(1) IN GENERAL.—If the Secretary issues a declaration
under 319F–3(b), the Secretary shall, after amounts have by
law been provided for the Fund under subsection (a), provide
compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to such declaration.
(2) ELEMENTS OF COMPENSATION.—The compensation that
shall be provided pursuant to paragraph (1) shall have the
same elements, and be in the same amount, as is prescribed
by sections 264, 265, and 266 in the case of certain individuals
injured as a result of administration of certain countermeasures against smallpox, except that section 266(a)(2)(B)
shall not apply.
(3) RULE OF CONSTRUCTION.—Neither reasonable and necessary medical benefits nor lifetime total benefits for lost employment income due to permanent and total disability shall be
limited by section 266.
(4) DETERMINATION OF ELIGIBILITY AND COMPENSATION.—
Except as provided in this section, the procedures for determining, and for reviewing a determination of, whether an individual is an eligible individual, whether such individual has
sustained a covered injury, whether compensation may be
available under this section, and the amount of such compensation shall be those stated in section 262 (other than in
subsection (d)(2) of such section), in regulations issued pursuant to that section, and in such additional or alternate regulations as the Secretary may promulgate for purposes of this section. In making determinations under this section, other than
those described in paragraph (5)(A) as to the direct causation
of a covered injury, the Secretary may only make such determination based on compelling, reliable, valid, medical and scientific evidence.
(5) COVERED COUNTERMEASURE INJURY TABLE.—
(A) IN GENERAL.—The Secretary shall by regulation
establish a table identifying covered injuries that shall be
presumed to be directly caused by the administration or
use of a covered countermeasure and the time period in
which the first symptom or manifestation of onset of each
such adverse effect must manifest in order for such presumption to apply. The Secretary may only identify such
covered injuries, for purpose of inclusion on the table,
where the Secretary determines, based on compelling, reliable, valid, medical and scientific evidence that administration or use of the covered countermeasure directly
caused such covered injury.
(B) AMENDMENTS.—The provisions of section 263
(other than a provision of subsection (a)(2) of such section
that relates to accidental vaccinia inoculation) shall apply
to the table established under this section.
(C) JUDICIAL REVIEW.—No court of the United States,
or of any State, shall have subject matter jurisdiction to
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review, whether by mandamus or otherwise, any action by
the Secretary under this paragraph.
(6) MEANINGS OF TERMS.—In applying sections 262, 263,
264, 265, and 266 for purposes of this section—
(A) the terms ‘‘vaccine’’ and ‘‘smallpox vaccine’’ shall
be deemed to mean a covered countermeasure;
(B) the terms ‘‘smallpox vaccine injury table’’ and
‘‘table established under section 263’’ shall be deemed to
refer to the table established under paragraph (4); and
(C) other terms used in those sections shall have the
meanings given to such terms by this section.
(c) VOLUNTARY PROGRAM.—The Secretary shall ensure that a
State, local, or Department of Health and Human Services plan to
administer or use a covered countermeasure is consistent with any
declaration under 319F–3 and any applicable guidelines of the Centers for Disease Control and Prevention and that potential participants are educated with respect to contraindications, the voluntary
nature of the program, and the availability of potential benefits
and compensation under this part.
(d) EXHAUSTION; EXCLUSIVITY; ELECTION.—
(1) EXHAUSTION.—Subject to paragraph (5), a covered individual may not bring a civil action under section 319F–3(d)
against a covered person (as such term is defined in section
319F–3(i)(2)) unless such individual has exhausted such remedies as are available under subsection (a), except that if
amounts have not by law been provided for the Fund under
subsection (a), or if the Secretary fails to make a final determination on a request for benefits or compensation filed in accordance with the requirements of this section within 240 days
after such request was filed, the individual may seek any remedy that may be available under section 319F–3(d).
(2) TOLLING OF STATUTE OF LIMITATIONS.—The time limit
for filing a civil action under section 319F–3(d) for an injury
or death shall be tolled during the pendency of a claim for compensation under subsection (a).
(3) RULE OF CONSTRUCTION.—This section shall not be construed as superseding or otherwise affecting the application of
a requirement, under chapter 171 of title 28, United States
Code, to exhaust administrative remedies.
(4) EXCLUSIVITY.—The remedy provided by subsection (a)
shall be exclusive of any other civil action or proceeding for
any claim or suit this section encompasses, except for a proceeding under section 319F–3.
(5) ELECTION.—If under subsection (a) the Secretary determines that a covered individual qualifies for compensation, the
individual has an election to accept the compensation or to
bring an action under section 319F–3(d). If such individual
elects to accept the compensation, the individual may not bring
such an action.
(e) DEFINITIONS.—For purposes of this section, the following
terms shall have the following meanings:
(1) COVERED COUNTERMEASURE.—The term ‘‘covered countermeasure’’ has the meaning given such term in section 319F–
3.
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(2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’,
with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual—
(A) who is in a population specified in such declaration, and with respect to whom the administration or use
of the covered countermeasure satisfies the other specifications of such declaration; or
(B) who uses the covered countermeasure, or to whom
the covered countermeasure is administered, in a good
faith belief that the individual is in the category described
by subparagraph (A).
(3) COVERED INJURY.—The term ‘‘covered injury’’ means serious physical injury or death.
(4) DECLARATION.—The term ‘‘declaration’’ means a declaration under section 319F–3(b).
(5) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’
means an individual who is determined, in accordance with
subsection (b), to be a covered individual who sustains a covered injury.
SEC. 319F–5. ø 247d-6f ¿ PROVISION OF MEDICAL COUNTERMEASURES
TO INDIAN PROGRAMS AND FACILITIES.
In the event that the Secretary deploys the contents of the
Strategic National Stockpile under section 319F–2(a), or otherwise
distributes medical countermeasures to States to respond to a public health emergency declared by the Secretary under section 319,
the Secretary shall, in consultation with the applicable States,
make such contents or countermeasures directly available to Indian
Tribes and Tribal organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance
Act (25 U.S.C. 5304), which may include through health programs
or facilities operated by the Indian Health Service, that are affected by such public health emergency.
SEC. 319H. ø247d–7a¿ GRANTS REGARDING TRAINING AND EDUCATION
OF CERTAIN HEALTH PROFESSIONALS.
(a) IN GENERAL.—The Secretary may make awards of grants
and cooperative agreements to appropriate public and nonprofit
private health or educational entities, including health professions
schools and programs as defined in section 799B, for the purpose
of providing low-interest loans, partial scholarships, partial fellowships, revolving loan funds, or other cost-sharing forms of assistance for the education and training of individuals in any category
of health professions for which there is a shortage that the Secretary determines should be alleviated in order to prepare for or respond effectively to bioterrorism and other public health emergencies.
(b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.—
The Secretary may require as a condition of an award under subsection (a) that a grantee under such subsection provide non-Federal contributions toward the purpose described in such subsection.
(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2002
through 2006.
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SEC. 319I. ø247d–7b¿ EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH PROFESSIONAL.
(a) IN GENERAL.—Not later than 12 months after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary shall link existing State verification systems to maintain
a single national interoperable network of systems, each system
being maintained by a State or group of States, for the purpose of
verifying the credentials and licenses of health care professionals
who volunteer to provide health services during a public health
emergency. Such health care professionals may include members of
the National Disaster Medical System, members of the Medical Reserve Corps, and individual health care professionals.
(b) REQUIREMENTS.—The interoperable network of systems established under subsection (a) (referred to in this section as the
‘‘verification network’’) shall include—
(1) with respect to each volunteer health professional included in the verification network—
(A) information necessary for the rapid identification
of, and communication with, such professionals; and
(B) the credentials, certifications, licenses, and relevant training of such individuals; and
(2) the name of each member of the Medical Reserve
Corps, the National Disaster Medical System, and any other
relevant federally-sponsored or administered programs determined necessary by the Secretary.
(c) OTHER ASSISTANCE.—The Secretary may make grants and
provide technical assistance to States and other public or nonprofit
private entities for activities relating to the verification network developed under subsection (a).
(d) ACCESSIBILITY.—The Secretary shall ensure that the
verification network is electronically accessible by State, local, and
tribal health departments and can be linked with the identification
cards under section 2813.
(e) CONFIDENTIALITY.—The Secretary shall establish and require the application of and compliance with measures to ensure
the effective security of, integrity of, and access to the data included in the verification network.
(f) COORDINATION.—The Secretary shall coordinate with the
Secretary of Veterans Affairs and the Secretary of Homeland Security to assess the feasibility of integrating the verification network
under this section with the VetPro system of the Department of
Veterans Affairs and the National Emergency Responder
Credentialing System of the Department of Homeland Security.
The Secretary shall, if feasible, integrate the verification network
under this section with such VetPro system and the National
Emergency Responder Credentialing System.
(g) UPDATING OF INFORMATION.—The States that are participants in the verification network shall, on at least a quarterly
basis, work with the Director to provide for the updating of the information contained in the verification network.
(h) CLARIFICATION.—Inclusion of a health professional in the
verification network shall not constitute appointment of such individual as a Federal employee for any purpose, either under section
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2812(c) or otherwise. Such appointment may only be made under
section 2812 or 2813.
(i) HEALTH CARE PROVIDER LICENSES.—The Secretary shall encourage States to establish and implement mechanisms to waive
the application of licensing requirements applicable to health professionals, who are seeking to provide medical services (within
their scope of practice), during a national, State, local, or tribal
public health emergency upon verification that such health professionals are licensed and in good standing in another State and
have not been disciplined by any State health licensing or disciplinary board. In order to inform the development of such mechanisms by States, the Secretary shall make available information
and material provided by States that have developed mechanisms
to waive the application of licensing requirements to applicable
health professionals seeking to provide medical services during a
public health emergency. Such information shall be made publicly
available in a manner that does not compromise national security.
(j) RULE OF CONSTRUCTION.—This section may not be construed as authorizing the Secretary to issue requirements regarding the provision by the States of credentials, licenses, accreditations, or hospital privileges.
(k) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$5,000,000 for each of fiscal years 2019 through 2023.
SEC. 319J. ø247d–7c¿ SUPPLIES AND SERVICES IN LIEU OF AWARD
FUNDS.
(a) IN GENERAL.—Upon the request of a recipient of an award
under any of sections 319 through 319I or section 319K, the Secretary may, subject to subsection (b), provide supplies, equipment,
and services for the purpose of aiding the recipient in carrying out
the purposes for which the award is made and, for such purposes,
may detail to the recipient any officer or employee of the Department of Health and Human Services.
(b) CORRESPONDING REDUCTION IN PAYMENTS.—With respect to
a request described in subsection (a), the Secretary shall reduce the
amount of payments under the award involved by an amount equal
to the costs of detailing personnel and the fair market value of any
supplies, equipment, or services provided by the Secretary. The
Secretary shall, for the payment of expenses incurred in complying
with such request, expend the amounts withheld.
SEC. 319K. ø247d–7d¿ SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
(a) IN GENERAL.—The Secretary, in consultation with the At-
torney General and the Secretary of Defense, may provide technical
or other assistance to provide security to persons or facilities that
conduct development, production, distribution, or storage of priority
countermeasures (as defined in section 319F(e)(4)).
(b) GUIDELINES.—The Secretary may develop guidelines to enable entities eligible to receive assistance under subsection (a) to
secure their facilities against potential terrorist attack.
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SEC. 319L. ø247d–7e¿ BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) DEFINITIONS.—In this section:
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(1) BARDA.—The term ‘‘BARDA’’ means the Biomedical
Advanced Research and Development Authority.
(2) FUND.—The term ‘‘Fund’’ means the Biodefense Medical Countermeasure Development Fund established under
subsection (d).
(3) OTHER TRANSACTIONS.—The term ‘‘other transactions’’
means transactions, other than procurement contracts, grants,
and cooperative agreements.
(4) QUALIFIED COUNTERMEASURE.—The term ‘‘qualified
countermeasure’’ has the meaning given such term in section
319F–1.
(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term
‘‘qualified pandemic or epidemic product’’ has the meaning
given the term in section 319F–3.
(6) ADVANCED RESEARCH AND DEVELOPMENT.—
(A) IN GENERAL.—The term ‘‘advanced research and
development’’ means, with respect to a product that is or
may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
(i) are conducted after basic research and preclinical development of the product; and
(ii) are related to manufacturing the product on a
commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug,
and Cosmetic Act or under section 351 of this Act.
(B) ACTIVITIES INCLUDED.—The term under subparagraph (A) includes—
(i) testing of the product to determine whether the
product may be approved, cleared, or licensed under
the Federal Food, Drug, and Cosmetic Act or under
section 351 of this Act for a use that is or may be the
basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or
to help obtain such approval, clearance, or license;
(ii) design and development of tests or models, including animal models, for such testing;
(iii) activities to facilitate manufacture of the
product on a commercial scale with consistently high
quality, as well as to improve and make available new
technologies to increase manufacturing surge capacity;
(iv) activities to support, maintain, and improve
domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization
of advanced manufacturing and platform technologies,
to increase the availability of products that are or may
become qualified countermeasures or qualified pandemic or epidemic products;
(v) activities to improve the shelf-life of the product or technologies for administering the product; and
(vi) such other activities as are part of the advanced stages of testing, refinement, improvement,
manufacturing, or preparation of the product for such
use and as are specified by the Secretary.
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(7) SECURITY COUNTERMEASURE.—The term ‘‘security countermeasure’’ has the meaning given such term in section 319F–
2.
(8) RESEARCH TOOL.—The term ‘‘research tool’’ means a device, technology, biological material (including a cell line or an
antibody), reagent, animal model, computer system, computer
software, or analytical technique that is developed to assist in
the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products.
(9) PROGRAM MANAGER.—The term ‘‘program manager’’
means an individual appointed to carry out functions under
this section and authorized to provide project oversight and
management of strategic initiatives.
(10) PERSON.—The term ‘‘person’’ includes an individual,
partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government
agency or department.
(b) STRATEGIC PLAN FOR COUNTERMEASURE RESEARCH, DEVELOPMENT, AND PROCUREMENT.—
(1) IN GENERAL.—Not later than 6 months after the date
of enactment of the Pandemic and All-Hazards Preparedness
Act, the Secretary shall develop and make public a strategic
plan to integrate biodefense and emerging infectious disease
requirements with the advanced research and development,
strategic initiatives for innovation, support for domestic manufacturing surge capacity and capabilities, and the procurement
of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as
may be practicable to disseminate the information contained in
such plan to persons who may have the capacity to substantially contribute to the activities described in such strategic
plan. The Secretary shall update and incorporate such plan as
part of the National Health Security Strategy described in section 2802.
(2) CONTENT.—The strategic plan under paragraph (1)
shall guide—
(A) research and development, conducted or supported
by the Department of Health and Human Services, of
qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases;
(B) innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products
(such research and development referred to in this section
as ‘‘countermeasure and product advanced research and
development’’);
(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as
appropriate, including through the utilization of advanced
manufacturing and platform technologies, to increase the
availability of products that are or may become qualified
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countermeasures or qualified pandemic or epidemic products; and
(D) procurement of such qualified countermeasures
and qualified pandemic or epidemic products by such Department.
(c) BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.—
(1) ESTABLISHMENT.—There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority.
(2) IN GENERAL.—Based upon the strategic plan described
in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
(A) facilitating collaboration between the Department
of Health and Human Services and other Federal agencies,
relevant industries, academia, and other persons, with respect to such advanced research and development;
(B) promoting countermeasure and product advanced
research and development, including through the establishment and maintenance of domestic manufacturing
surge capacity and capabilities, consistent with subsection
(a)(6)(B)(iv);
(C) facilitating contacts between interested persons
and the offices or employees authorized by the Secretary
to advise such persons regarding requirements under the
Federal Food, Drug, and Cosmetic Act and under section
351 of this Act; and
(D) promoting innovation to reduce the time and cost
of countermeasure and product advanced research and development.
(3) DIRECTOR.—The BARDA shall be headed by a Director
(referred to in this section as the ‘‘Director’’) who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement
this section, including the execution of procurement contracts,
grants, and cooperative agreements pursuant to this section.
(4) DUTIES.—
(A) COLLABORATION.—To carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i) facilitate and increase the expeditious and direct communication between the Department of
Health and Human Services and relevant persons
with respect to countermeasure and product advanced
research and development, including by—
(I) facilitating such communication regarding
the processes for procuring such advanced research and development with respect to qualified
countermeasures and qualified pandemic or epidemic products of interest;
(II) soliciting information about and data from
research on potential qualified countermeasures
and qualified pandemic or epidemic products and
related technologies;
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(III) facilitating such communication, as appropriate, regarding manufacturing surge capacity
and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic
products to prepare for, or respond to, a public
health emergency or potential public health emergency; and
(IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical
countermeasure priority review voucher program
under section 565A of the Federal Food, Drug, and
Cosmetic Act;
(ii) at least annually—
(I) convene meetings with representatives
from relevant industries, academia, other Federal
agencies, international agencies as appropriate,
and other interested persons;
(II) sponsor opportunities to demonstrate the
operation and effectiveness of relevant biodefense
countermeasure technologies; and
(III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are
necessary to carry out this section;
(iii) communicate regularly with entities in receipt
of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and
other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including
any planned uses of such capacity and capabilities in
the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and
(iv) carry out the activities described in section
319L–1.
(B) SUPPORT ADVANCED RESEARCH AND DEVELOPMENT.—To carry out the purpose described in paragraph
(2)(B), the Secretary shall—
(i) conduct ongoing searches for, and support calls
for, potential qualified countermeasures and qualified
pandemic or epidemic products;
(ii) direct and coordinate the countermeasure and
product advanced research and development activities
of the Department of Health and Human Services;
(iii) establish strategic initiatives to accelerate
countermeasure and product advanced research and
development (which may include advanced research
and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic
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Act or section 351 of this Act) and innovation in such
areas as the Secretary may identify as priority unmet
need areas;
(iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development; and
(v) award contracts, grants, and cooperative agreements and enter into other transactions to support,
maintain, and improve domestic manufacturing surge
capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure
that additional capacity is available to rapidly manufacture products that are or may become qualified
countermeasures or qualified pandemic or epidemic
products in the event of a public health emergency
declaration or significant potential for a public health
emergency.
(C) FACILITATING ADVICE.—To carry out the purpose
described in paragraph (2)(C) the Secretary shall—
(i) connect interested persons with the offices or
employees authorized by the Secretary to advise such
persons regarding the regulatory requirements under
the Federal Food, Drug, and Cosmetic Act and under
section 351 of this Act related to the approval, clearance, or licensure of qualified countermeasures or
qualified pandemic or epidemic products;
(ii) with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or
employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise
designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure; and
(iii) consult with the Commissioner of Food and
Drugs, pursuant to section 565(b)(2) of the Federal
Food, Drug, and Cosmetic Act, to ensure that facilities
performing manufacturing, pursuant to an award
under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this Act, as
appropriate, including current good manufacturing
practice pursuant to section 501(a)(2)(B) of the Food,
Drug, and Cosmetic Act; and
(D) SUPPORTING INNOVATION.—To carry out the purpose described in paragraph (2)(D), the Secretary may
award contracts, grants, and cooperative agreements, or
enter into other transactions, such as prize payments, to
promote—
(i) innovation in technologies that may assist
countermeasure and product advanced research and
development, including to improve manufacturing capacities and capabilities for medical countermeasures;
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(ii) research on and development of research tools
and other devices and technologies; and
(iii) research to promote strategic initiatives, such
as rapid diagnostics, broad spectrum antimicrobials,
vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform
technologies, technologies to administer countermeasures, and technologies to improve storage and
transportation of countermeasures.
(E) MEDICAL COUNTERMEASURES INNOVATION PARTNER.—
(i) IN GENERAL.—To support the purposes described in paragraph (2), the Secretary, acting through
the Director of BARDA, may enter into an agreement
(including through the use of grants, contracts, cooperative agreements, or other transactions as described in
paragraph (5)) with an independent, nonprofit entity
to—
(I) foster and accelerate the development and
innovation of medical countermeasures and technologies that may assist advanced research and
the development of qualified countermeasures and
qualified pandemic or epidemic products, including through the use of strategic venture capital
practices and methods;
(II) promote the development of new and
promising technologies that address urgent medical countermeasure needs, as identified by the
Secretary;
(III) address unmet public health needs that
are directly related to medical countermeasure requirements, such as novel antimicrobials for
multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and
(IV) provide expert consultation and advice to
foster viable medical countermeasure innovators,
including helping qualified countermeasure
innovators navigate unique industry challenges
with respect to developing chemical, biological, radiological, and nuclear countermeasure products.
(ii) ELIGIBILITY.—
(I) IN GENERAL.—To be eligible to enter into
an agreement under clause (i) an entity shall—
(aa) be an independent, nonprofit entity;
(bb) have a demonstrated record of being
able to create linkages between innovators
and investors and leverage such partnerships
and resources for the purpose of addressing
identified strategic needs of the Federal Government;
(cc) have experience in promoting novel
technology innovation;
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(dd) be problem-driven and solution-focused based on the needs, requirements, and
problems identified by the Secretary under
clause (iv);
(ee) demonstrate the ability, or the potential ability, to promote the development of
medical countermeasure products;
(ff) demonstrate expertise, or the capacity
to develop or acquire expertise, related to
technical and regulatory considerations with
respect to medical countermeasures; and
(gg) not be within the Department of
Health and Human Services.
(II) PARTNERING EXPERIENCE.—In selecting an
entity with which to enter into an agreement
under clause (i), the Secretary shall place a high
value on the demonstrated experience of the entity in partnering with the Federal Government to
meet identified strategic needs.
(iii) NOT AGENCY.—An entity that enters into an
agreement under clause (i) shall not be deemed to be
a Federal agency for any purpose, including for any
purpose under title 5, United States Code.
(iv) DIRECTION.—Pursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement
under clause (i). As part of this agreement the Director of BARDA shall—
(I) communicate the medical countermeasure
needs, requirements, and problems to be addressed by the entity under the agreement;
(II) develop a description of work to be performed by the entity under the agreement;
(III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the
needs and requirements set forth in this subparagraph;
(IV) ensure fair consideration of products developed under the agreement in order to maintain
competition to the maximum practical extent, as
applicable and appropriate under applicable provisions of this section; and
(V) ensure, as a condition of the agreement
that the entity—
(aa) has in place a comprehensive set of
policies that demonstrate a commitment to
transparency and accountability;
(bb) protects against conflicts of interest
through a comprehensive set of policies that
address potential conflicts of interest, ethics,
disclosure, and reporting requirements;
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(cc) provides monthly accounting on the
use of funds provided under such agreement;
and
(dd) provides on a quarterly basis, reports
regarding the progress made toward meeting
the identified needs set forth in the agreement.
(v) SUPPLEMENT NOT SUPPLANT.—Activities carried
out under this subparagraph shall supplement, and
not supplant, other activities carried out under this
section.
(vi) NO ESTABLISHMENT OF ENTITY.—To prevent
unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed
to authorize the Secretary to establish within the Department of Health and Human Services an entity for
the purposes of carrying out this subparagraph.
(vii) TRANSPARENCY AND OVERSIGHT.—Upon request, the Secretary shall provide to Congress the information provided to the Secretary under clause
(iv)(V)(dd).
(viii) INDEPENDENT EVALUATION.—Not later than 4
years after the date of enactment of the 21st Century
Cures Act, the Comptroller General of the United
States shall conduct an independent evaluation, and
submit to the Secretary and the appropriate committees of Congress a report, concerning the activities
conducted under this subparagraph. Such report shall
include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph.
(ix) SUNSET.—This subparagraph shall have no
force or effect after September 30, 2028.
(F) STRATEGIC INITIATIVES.—The Secretary, acting
through the Director of BARDA, may implement strategic
initiatives, including by building on existing programs and
by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and
man-made threats that, as determined by the Secretary,
pose a significant level of risk to national security based
on the characteristics of a chemical, biological, radiological
or nuclear threat, or existing capabilities to respond to
such a threat (including medical response and treatment
capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures
and products, as applicable, to address areas including—
(i) chemical, biological, radiological, or nuclear
threats, including emerging infectious diseases, for
which insufficient approved, licensed, or authorized
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sistant to countermeasures or existing countermeasures may be rendered ineffective;
(ii) threats that consistently exist or continually
circulate and have a significant potential to become a
pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics,
vaccines, and therapeutics; virus seeds; clinical trial
lots; novel virus strains; and antigen and adjuvant
material); and
(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and
which may present increased treatment complications
such as the occurrence of resistance to available countermeasures or potential countermeasures, including
antimicrobial resistant pathogens.
(G) ANNUAL REPORTS BY AWARD RECIPIENTS.—As a
condition of receiving an award under subparagraph (B)(v),
a recipient shall develop and submit to the Secretary annual reports related to the maintenance of such capacity
and capabilities, including ensuring that such capacity and
capabilities are able to support the rapid manufacture of
countermeasures as required by the Secretary.
(5) TRANSACTION AUTHORITIES.—
(A) OTHER TRANSACTIONS.—
(i) IN GENERAL.—The Secretary shall have the authority to enter into other transactions (as defined in
subsection (a)(3)) under this subsection.
(ii) LIMITATIONS ON AUTHORITY.—
(I) IN GENERAL.—To the maximum extent
practicable, competitive procedures shall be used
when entering into transactions to carry out
projects under this subsection.
(II) WRITTEN DETERMINATIONS REQUIRED.—
The authority of this subparagraph may be exercised for a project that is expected to cost the Department of Health and Human Services in excess
of $100,000,000 only upon a written determination
by the Assistant Secretary for Financial Resources, that the use of such authority is essential
to promoting the success of the project. The authority of the Assistant Secretary for Financial
Resources under this subclause may not be delegated.
(iii) AUTHORITY DURING A PUBLIC HEALTH EMERGENCY.—
(I) IN GENERAL.—Notwithstanding clause (ii),
the Secretary, shall, to the maximum extent practicable, use competitive procedures when entering
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into transactions to carry out projects under this
subsection for purposes of a public health emergency declared by the Secretary under section 319.
Any such transactions entered into during such
public health emergency shall not be terminated
solely due to the expiration of such public health
emergency, if such public health emergency ends
before the completion of the terms of such agreement.
(II) REPORT.—After the expiration of the public health emergency declared by the Secretary
under section 319, the Secretary shall provide a
report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
Representatives regarding the use of any funds
pursuant to the authority under subclause (I), including any outcomes, benefits, and risks associated with the use of such funds, and a description
of the reasons for the use of such authority for the
project or projects.
(iv) GUIDELINES.—The Secretary shall establish
guidelines regarding the use of the authority under
clause (i). Such guidelines shall include auditing requirements.
(B) EXPEDITED AUTHORITIES.—
(i) IN GENERAL.—In awarding contracts, grants,
and cooperative agreements, and in entering into
other transactions under subparagraph (B) or (D) of
paragraph (4), the Secretary shall have the expedited
procurement authorities, the authority to expedite
peer review, and the authority for personal services
contracts, supplied by subsections (b), (c), and (d) of
section 319F–1.
(ii) APPLICATION OF PROVISIONS.—Provisions in
such section 319F–1 that apply to such authorities and
that require institution of internal controls, limit review, provide for Federal Tort Claims Act coverage of
personal services contractors, and commit decisions to
the discretion of the Secretary shall apply to the authorities as exercised pursuant to this paragraph.
(iii) AUTHORITY TO LIMIT COMPETITION.—For purposes of applying section 319F–1(b)(1)(D) to this paragraph, the phrase ‘‘BioShield Program under the
Project BioShield Act of 2004’’ shall be deemed to
mean the countermeasure and product advanced research and development program under this section.
(iv) AVAILABILITY OF DATA.—The Secretary shall
require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph (4),
a person make available to the Secretary on an ongoing basis, and submit upon request to the Secretary,
all data related to or resulting from countermeasure
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and product advanced research and development carried out pursuant to this section.
(C) ADVANCE PAYMENTS; ADVERTISING.—The Secretary
may waive the requirements of section 3324(a) of title 31,
United States Code, or section 3709 of the Revised Statutes of the United States (41 U.S.C. 5) upon the determination by the Secretary that such waiver is necessary to
obtain countermeasures or products under this section.
(D) MILESTONE-BASED PAYMENTS ALLOWED.—In awarding contracts, grants, and cooperative agreements, and in
entering into other transactions, under this section, the
Secretary may use milestone-based awards and payments.
(E) FOREIGN NATIONALS ELIGIBLE.—The Secretary may
under this section award contracts, grants, and cooperative
agreements to, and may enter into other transactions with,
highly qualified foreign national persons outside the
United States, alone or in collaboration with American
participants, when such transactions may inure to the benefit of the American people.
(F) ESTABLISHMENT OF RESEARCH CENTERS.—The Secretary may assess the feasibility and appropriateness of
establishing, through contract, grant, cooperative agreement, or other transaction, an arrangement with an existing research center in order to achieve the goals of this
section. If such an agreement is not feasible and appropriate, the Secretary may establish one or more federallyfunded research and development centers, or university-affiliated research centers, in accordance with section
303(c)(3) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(3)).
(G) GOVERNMENT PURPOSE.—In awarding contracts,
grants, and cooperative agreements under this section, the
Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified
pandemic or epidemic product.
(H) SUPPORTING WARM-BASE AND SURGE CAPACITY AND
CAPABILITIES.—Pursuant to an award under subparagraph
(B)(v), the Secretary may make payments for activities
necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support
the rapid manufacture of countermeasures as required by
the Secretary to prepare for, or respond to, an existing or
potential public health emergency or otherwise address
threats that pose a significant level of risk to national security. The Secretary may support the utilization of such
capacity and capabilities under awards for countermeasure
and product advanced research and development, as appropriate, to provide for the maintenance of such capacity
and capabilities.
(6) AT-RISK INDIVIDUALS.—In carrying out the functions
under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures
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and qualified pandemic or epidemic products that are likely to
be safe and effective with respect to children, pregnant women,
older adults, and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products.
(7) PERSONNEL AUTHORITIES.—
(A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFESSIONAL PERSONNEL.—
(i) IN GENERAL.—In addition to any other personnel authorities, the Secretary may—
(I) without regard to those provisions of title
5, United States Code, governing appointments in
the competitive service, appoint highly qualified
individuals to scientific or professional positions in
BARDA, such as program managers, to carry out
this section; and
(II) compensate them in the same manner and
subject to the same terms and conditions in which
individuals appointed under section 9903 of such
title are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter
53 of such title relating to classification and General Schedule pay rates.
(ii) MANNER OF EXERCISE OF AUTHORITY.—The authority provided for in this subparagraph shall be exercised subject to the same limitations described in
section 319F–1(e)(2).
(iii) TERM OF APPOINTMENT.—The term limitations
described in section 9903(c) of title 5, United States
Code, shall apply to appointments under this subparagraph, except that the references to the ‘‘Secretary’’
and to the ‘‘Department of Defense’s national security
missions’’ shall be deemed to be to the Secretary of
Health and Human Services and to the mission of the
Department of Health and Human Services under this
section.
(B) SPECIAL CONSULTANTS.—In carrying out this section, the Secretary may appoint special consultants pursuant to section 207(f).
(C) LIMITATION.—
(i) IN GENERAL.—The Secretary may hire up to
100 highly qualified individuals, or up to 50 percent of
the total number of employees, whichever is less,
under the authorities provided for in subparagraphs
(A) and (B).
(ii) REPORT.—The Secretary shall report to Congress on a biennial basis on the implementation of this
subparagraph.
(d) FUND.—
(1) ESTABLISHMENT.—There is established the Biodefense
Medical Countermeasure Development Fund, which shall be
available to carry out this section in addition to such amounts
as are otherwise available for this purpose.
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(2) FUNDING.—To carry out the purposes of this section,
there is authorized to be appropriated to the Fund
$611,700,000 for each of fiscal years 2019 through 2023, such
amounts to remain available until expended.
(e) INAPPLICABILITY OF CERTAIN PROVISIONS.—
(1) DISCLOSURE.—
(A) NONDISCLOSURE OF INFORMATION.—
(i) IN GENERAL.—Information described in clause
(ii) shall be deemed to be information described in section 552(b)(3) of title 5, United States Code.
(ii) INFORMATION DESCRIBED.—The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known
vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of—
(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and
development carried out under subsection (c);
(II) information pertaining to the location security, personnel, and research materials and
methods of high-containment laboratories conducting research with select agents, toxins, or
other agents with a material threat determination
under section 319F–2(c)(2); or
(III) security and vulnerability assessments.
(B) REVIEW.—Information subject to nondisclosure
under subparagraph (A) shall be reviewed by the Secretary
every 5 years, or more frequently as determined necessary
by the Secretary, to determine the relevance or necessity
of continued nondisclosure.
(C) REPORTING.—One year after the date of enactment
of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and annually thereafter,
the Secretary shall report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to
withhold information from disclosure, as well as the nature of any request under section 552 of title 5, United
States Code that was denied using such authority.
(D) SUNSET.—This paragraph shall cease to have force
or effect after March 8, 2024.
(2) REVIEW.—Notwithstanding section 1013 of title 5,
United States Code, a working group of BARDA under this section and the National Biodefense Science Board under section
319M shall each terminate on the date that is 5 years after the
date on which each such group or Board, as applicable, was established. Such 5-year period may be extended by the SecFebruary 1, 2024
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retary for one or more additional 5-year periods if the Secretary determines that any such extension is appropriate.
(f) INDEPENDENT EVALUATION.—
(1) IN GENERAL.—Not later than 180 days after the date of
enactment of the PREVENT Pandemics Act, the Comptroller
General of the United States shall conduct an independent
evaluation of the activities carried out to facilitate flexible
manufacturing capacity pursuant to this section.
(2) REPORT.—Not later than 1 year after the date of enactment of the PREVENT Pandemics Act, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—
(A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological,
radiological, and nuclear threats;
(B) the activities supported by flexible manufacturing
initiatives;
(C) the ability of flexible manufacturing activities carried out under this section to—
(i) secure and leverage leading technical expertise
with respect to countermeasure advanced research, development, and manufacturing processes; and
(ii) meet the surge manufacturing capacity needs
presented by novel and emerging threats, including
chemical, biological, radiological, and nuclear agents;
and
(D) plans for the near-, mid-, and long-term
sustainment of manufacturing activities carried out under
this section, including such activities pursuant to subsection (c)(5)(H), specific actions to regularly assess the
ability of recipients of an award under subsection
(c)(4)(B)(v) to rapidly manufacture countermeasures as required by the Secretary, and recommendations to address
challenges, if any, related to such activities.
SEC. 319L–1. ø247d–7f¿ COLLABORATION AND COORDINATION
(a) LIMITED ANTITRUST EXEMPTION.—
(1) MEETINGS AND CONSULTATIONS TO DISCUSS SECURITY
COUNTERMEASURES, QUALIFIED COUNTERMEASURES, OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT DEVELOPMENT.—
(A) AUTHORITY TO CONDUCT MEETINGS AND CONSULTATIONS.—The Secretary, in coordination with the Attorney
General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in
the development of a security countermeasure (as defined
in section 319F-2), a qualified countermeasure (as defined
in section 319F-1), or a qualified pandemic or epidemic
product (as defined in section 319F-3) for the purpose of
the development, manufacture, distribution, purchase, or
storage of a countermeasure or product. The Secretary
may convene such meeting or consultation at the request
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196
eral, the Chairman of the Federal Trade Commission (referred to in this section as the ‘‘Chairman’’), or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney
General, the Chairman, and the Secretary of Homeland
Security.
(B) MEETING AND CONSULTATION CONDITIONS.—A
meeting or consultation conducted under subparagraph (A)
shall—
(i) be chaired or, in the case of a consultation, facilitated by the Secretary;
(ii) be open to persons involved in the development, manufacture, distribution, purchase, or storage
of a countermeasure or product, as determined by the
Secretary;
(iii) be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;
(iv) be limited to discussions involving covered activities; and
(v) be conducted in such manner as to ensure that
no national security, confidential commercial, or proprietary information is disclosed outside the meeting
or consultation.
(C) LIMITATION.—The Secretary may not require participants to disclose confidential commercial or proprietary
information.
(D) TRANSCRIPT.—The Secretary shall maintain a complete verbatim transcript of each meeting or consultation
conducted under this subsection. Such transcript (or a portion thereof) shall not be disclosed under section 552 of
title 5, United States Code, to the extent that the Secretary, in consultation with the Attorney General and the
Secretary of Homeland Security, determines that disclosure of such transcript (or portion thereof) would pose a
threat to national security. The transcript (or portion
thereof) with respect to which the Secretary has made
such a determination shall be deemed to be information
described in subsection (b)(3) of such section 552.
(E) EXEMPTION.—
(i) IN GENERAL.—Subject to clause (ii), it shall not
be a violation of the antitrust laws for any person to
participate in a meeting or consultation conducted in
accordance with this paragraph.
(ii) LIMITATION.—Clause (i) shall not apply to any
agreement or conduct that results from a meeting or
consultation and that is not covered by an exemption
granted under paragraph (4).
(2) SUBMISSION OF WRITTEN AGREEMENTS.—The Secretary
shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the
Chairman for consideration. In addition to the proposed agreement itself, any submission shall include—
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(A) an explanation of the intended purpose of the
agreement;
(B) a specific statement of the substance of the agreement;
(C) a description of the methods that will be utilized
to achieve the objectives of the agreement;
(D) an explanation of the necessity for a cooperative
effort among the particular participating persons to
achieve the objectives of the agreement; and
(E) any other relevant information determined necessary by the Attorney General, in consultation with the
Chairman and the Secretary.
(3) EXEMPTION FOR CONDUCT UNDER APPROVED AGREEMENT.—It shall not be a violation of the antitrust laws for a
person to engage in conduct in accordance with a written
agreement to the extent that such agreement has been granted
an exemption under paragraph (4), during the period for which
the exemption is in effect.
(4) ACTION ON WRITTEN AGREEMENTS.—
(A) IN GENERAL.—The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part
and deny in part, or propose modifications to an exemption
request regarding a written agreement submitted under
paragraph (2), in a written statement to the Secretary,
within 15 business days of the receipt of such request. An
exemption granted under this paragraph shall take effect
immediately.
(B) EXTENSION.—The Attorney General may extend
the 15-day period referred to in subparagraph (A) for an
additional period of not to exceed 10 business days.
(C) DETERMINATION.—An exemption shall be granted
regarding a written agreement submitted in accordance
with paragraph (2) only to the extent that the Attorney
General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will
not have any substantial anticompetitive effect that is not
reasonably necessary for ensuring the availability of the
countermeasure or product involved.
(5) LIMITATION ON AND RENEWAL OF EXEMPTIONS.—An exemption granted under paragraph (4) shall be limited to covered activities, and such exemption shall be renewed (with
modifications, as appropriate, consistent with the finding described in paragraph (4)(C)), on the date that is 3 years after
the date on which the exemption is granted unless the Attorney General in consultation with the Chairman determines
that the exemption should not be renewed (with modifications,
as appropriate) considering the factors described in paragraph
(4).
(6) AUTHORITY TO OBTAIN INFORMATION.—Consideration by
the Attorney General for granting or renewing an exemption
submitted under this section shall be considered an antitrust
investigation for purposes of the Antitrust Civil Process Act (15
U.S.C. 1311 et seq.).
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(7) LIMITATION ON PARTIES.—The use of any information
acquired under an agreement for which an exemption has been
granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws
and any other applicable laws.
(8) REPORT.—Not later than one year after the date of enactment of this Act and biannually thereafter, the Attorney
General and the Chairman shall report to Congress on the use
of the exemption from the antitrust laws provided by this subsection.
(b) SUNSET.—The applicability of this section shall expire after
March 8, 2024.
(c) DEFINITIONS.—In this section:
(1) ANTITRUST LAWS.—The term ‘‘antitrust laws’’—
(A) has the meaning given such term in subsection (a)
of the first section of the Clayton Act (15 U.S.C. 12(a)), except that such term includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent such section
5 applies to unfair methods of competition; and
(B) includes any State law similar to the laws referred
to in subparagraph (A).
(2) COUNTERMEASURE OR PRODUCT.—The term ‘‘countermeasure or product’’ refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)).
(3) COVERED ACTIVITIES.—
(A) IN GENERAL.—Except as provided in subparagraph
(B), the term ‘‘covered activities’’ includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product.
(B) EXCEPTION.—The term ‘‘covered activities’’ shall
not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which
an exemption has been granted under subsection (a)(4),
the following activities involving 2 or more persons:
(i) Exchanging information among competitors relating to costs, profitability, or distribution of any
product, process, or service if such information is not
reasonably necessary to carry out covered activities—
(I) with respect to a countermeasure or product regarding which such meeting or consultation
is being conducted; or
(II) that are described in the agreement as exempted.
(ii) Entering into any agreement or engaging in
any other conduct—
(I) to restrict or require the sale, licensing, or
sharing of inventions, developments, products,
processes, or services not developed through, produced by, or distributed or sold through such covered activities; or
(II) to restrict or require participation, by any
person participating in such covered activities, in
other research and development activities, except
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as reasonably necessary to prevent the misappropriation of proprietary information contributed by
any person participating in such covered activities
or of the results of such covered activities.
(iii) Entering into any agreement or engaging in
any other conduct allocating a market with a competitor that is not expressly exempted from the antitrust
laws under subsection (a)(4).
(iv) Exchanging information among competitors
relating to production (other than production by such
covered activities) of a product, process, or service if
such information is not reasonably necessary to carry
out such covered activities.
(v) Entering into any agreement or engaging in
any other conduct restricting, requiring, or otherwise
involving the production of a product, process, or service that is not expressly exempted from the antitrust
laws under subsection (a)(4).
(vi) Except as otherwise provided in this subsection, entering into any agreement or engaging in
any other conduct to restrict or require participation
by any person participating in such covered activities,
in any unilateral or joint activity that is not reasonably necessary to carry out such covered activities.
(vii) Entering into any agreement or engaging in
any other conduct restricting or setting the price at
which a countermeasure or product is offered for sale,
whether by bid or otherwise.
SEC. 319M. ø247d–f¿ NATIONAL BIODEFENSE SCIENCE BOARD AND
WORKING GROUPS.
(a) IN GENERAL.—
(1) ESTABLISHMENT AND FUNCTION.—The Secretary shall
establish the National Biodefense Science Board (referred to in
this section as the ‘‘Board’’) to provide expert advice and guidance to the Secretary on scientific, technical and other matters
of special interest to the Department of Health and Human
Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
(2) MEMBERSHIP.—The membership of the Board shall be
comprised of individuals who represent the Nation’s preeminent scientific, public health, and medical experts, as follows—
(A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;
(B) four individuals representing the pharmaceutical,
biotechnology, and device industries;
(C) four individuals representing academia; and
(D) five other members as determined appropriate by
the Secretary, of whom—
(i) one such member shall be a practicing
healthcare professional;
(ii) one such member shall be an individual from
an organization representing healthcare consumers;
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(iii) one such member shall be an individual with
pediatric subject matter expertise; and
(iv) one such member shall be a State, tribal, territorial, or local public health official.
Nothing in this paragraph shall preclude a member of the
Board from satisfying two or more of the requirements described in subparagraph (D).
(3) TERM OF APPOINTMENT.—A member of the Board described in subparagraph (B), (C), or (D) of paragraph (2) shall
serve for a term of 3 years, except that the Secretary may adjust the terms of the initial Board appointees in order to provide for a staggered term of appointment for all members.
(4) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A
member may be appointed to serve not more than 3 terms on
the Board and may serve not more than 2 consecutive terms.
(5) DUTIES.—The Board shall—
(A) advise the Secretary on current and future trends,
challenges, and opportunities presented by advances in biological and life sciences, biotechnology, and genetic engineering with respect to threats posed by naturally occurring infectious diseases and chemical, biological, radiological, and nuclear agents;
(B) at the request of the Secretary, review and consider any information and findings received from the working groups established under subsection (b);
(C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and
coordinated biodefense research and development activities; and
(D) provide any recommendation, finding, or report
provided to the Secretary under this paragraph to the appropriate committees of Congress.
(6) MEETINGS.—
(A) INITIAL MEETING.—Not later than one year after
the date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall hold the first meeting of the Board.
(B) SUBSEQUENT MEETINGS.—The Board shall meet at
the call of the Secretary, but in no case less than twice annually.
(7) VACANCIES.—Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the original appointment.
(8) CHAIRPERSON.—The Secretary shall appoint a chairperson from among the members of the Board.
(9) POWERS.—
(A) HEARINGS.—The Board may hold such hearings,
sit and act at such times and places, take such testimony,
and receive such evidence as the Board considers advisable
to carry out this subsection.
(B) POSTAL SERVICES.—The Board may use the United
States mails in the same manner and under the same conditions as other departments and agencies of the Federal
Government.
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(10) PERSONNEL.—
(A) EMPLOYEES OF THE FEDERAL GOVERNMENT.—A
member of the Board that is an employee of the Federal
Government may not receive additional pay, allowances, or
benefits by reason of the member’s service on the Board.
(B) OTHER MEMBERS.—A member of the Board that is
not an employee of the Federal Government may be compensated at a rate not to exceed the daily equivalent of the
annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5, United
States Code, for each day (including travel time) during
which the member is engaged in the actual performance of
duties as a member of the Board.
(C) TRAVEL EXPENSES.—Each member of the Board
shall receive travel expenses, including per diem in lieu of
subsistence, in accordance with applicable provisions
under subchapter I of chapter 57 of title 5, United States
Code.
(D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal
Government employee may be detailed to the Board with
the approval for the contributing agency without reimbursement, and such detail shall be without interruption
or loss of civil service status or privilege.
(b) OTHER WORKING GROUPS.—The Secretary may establish a
working group of experts, or may use an existing working group or
advisory committee, to—
(1) identify innovative research with the potential to be developed as a qualified countermeasure or a qualified pandemic
or epidemic product;
(2) identify accepted animal models for particular diseases
and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic
infectious disease, and identify strategies to accelerate animal
model and research tool development and validation; and
(3) obtain advice regarding supporting and facilitating advanced research and development related to qualified countermeasures and qualified pandemic or epidemic products that
are likely to be safe and effective with respect to children,
pregnant women, and other vulnerable populations, and other
issues regarding activities under this section that affect such
populations.
(c) DEFINITIONS.—Any term that is defined in section 319L and
that is used in this section shall have the same meaning in this
section as such term is given in section 319L.
(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated $1,000,000 to carry out this section for fiscal
year 2007 and each fiscal year thereafter.
HANSEN’S DISEASE PROGRAM
SEC. 320. ø247e¿ (a)(1) At or through the National Hansen’s
Disease Programs Center (located in the State of Louisiana), the
Secretary shall without charge provide short-term care and treatment, including outpatient care, for Hansen’s disease and related
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complications to any person determined by the Secretary to be in
need of such care and treatment. The Secretary may not at or
through such Center provide long-term care for any such disease
or complication.
(2) The Center referred to in paragraph (1) shall conduct training in the diagnosis and management of Hansen’s disease and related complications, and shall conduct and promote the coordination of research (including clinical research), investigations, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen’s disease and other
mycobacterial diseases and complications related to such diseases.
(3) Paragraph (1) is subject to section 211 of the Department
of Health and Human Services Appropriations Act, 1998. 25
(b) In addition to the Center referred to in subsection (a), the
Secretary may establish sites regarding persons with Hansen’s disease. Each such site shall provide for the outpatient care and treatment for Hansen’s disease and related complications to any person
determined by the Secretary to be in need of such care and treatment.
(c) The Secretary shall carry out subsections (a) and (b) acting
through an agency of the Service. For purposes of the preceding
sentence, the agency designated by the Secretary shall carry out
both activities relating to the provision of health services and activities relating to the conduct of research.
(d) The Secretary shall make payments to the Board of Health
of the State of Hawaii for the care and treatment (including outpatient care) in its facilities of persons suffering from Hansen’s disease at a rate determined by the Secretary. The rate shall be approximately equal to the operating cost per patient of such facilities, except that the rate may not exceed the comparable costs per
patient with Hansen’s disease for care and treatment provided by
the Center referred to in subsection (a). Payments under this subsection are subject to the availability of appropriations for such
purpose.
COORDINATED PROGRAM TO IMPROVE PEDIATRIC ORAL HEALTH
SEC. 320A. 26 ø247d–8¿ (a) IN GENERAL.—The Secretary, acting
through the Administrator of the Health Resources and Services
Administration, shall establish a program to fund innovative oral
health activities that improve the oral health of children under 6
years of age who are eligible for services provided under a Federal
health program, to increase the utilization of dental services by
such children, and to decrease the incidence of early childhood and
baby bottle tooth decay.
(b) GRANTS.—The Secretary shall award grants to or enter into
contracts with public or private nonprofit schools of dentistry or accredited dental training institutions or programs, community dental programs, and programs operated by the Indian Health Service
(including federally recognized Indian tribes that receive medical
25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489.
26 The placement of this section in title III was carried out to reflect the probable intent of
Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to
‘‘Part B of the Public Health Service Act’’, without specifying which title of this Act was the
subject of the amendment.
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PUBLIC HEALTH SERVICE ACT
Sec. 320B
services from the Indian Health Service, urban Indian health programs funded under title V of the Indian Health Care Improvement Act, and tribes that contract with the Indian Health Service
pursuant to the Indian Self-Determination and Education Assistance Act) to enable such schools, institutions, and programs to develop programs of oral health promotion, to increase training of
oral health services providers in accordance with State practice
laws, or to increase the utilization of dental services by eligible
children.
(c) DISTRIBUTION.—In awarding grants under this section, the
Secretary shall, to the extent practicable, ensure an equitable national geographic distribution of the grants, including areas of the
United States where the incidence of early childhood caries is highest.
(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated to carry out this section $10,000,000 for each
the fiscal years 2001 through 2005.
SEC. 320B. ø247d–11¿ STATE ALL PAYER CLAIMS DATABASES.
(a) IN GENERAL.—The Secretary shall make one-time
grants to
eligible States for the purposes described in subsection (b).
(b) USES.—A State may use a grant received under subsection
(a) for one of the following purposes:
(1) To establish a State All Payer Claims Database.
(2) To improve an existing State All Payer Claims Databases.
(c) ELIGIBILITY.—To be eligible to receive a grant under subsection (a), a State shall submit to the Secretary an application at
such time, in such manner, and containing such information as the
Secretary specifies, including, with respect to a State All Payer
Claims Database, at least specifics on how the State will ensure
uniform data collection and the privacy and security of such data.
(d) GRANT PERIOD AND AMOUNT.—Grants awarded under this
section shall be for a period of 3-years, and in an amount of
$2,500,000, of which $1,000,000 shall be made available to the
State for each of the first 2 years of the grant period, and $500,000
shall be made available to the State for the third year of the grant
period.
(e) AUTHORIZED USERS.—
(1) APPLICATION.—An entity desiring authorization for access to a State All Payer Claims Database that has received a
grant under this section shall submit to the State All Payer
Claims Database an application for such access, which shall include—
(A) in the case of an entity requesting access for research purposes—
(i) a description of the uses and methodologies for
evaluating health system performance using such
data; and
(ii) documentation of approval of the research by
an institutional review board, if applicable for a particular plan of research; or
(B) in the case of an entity such as an employer,
health insurance issuer, third-party administrator, or
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health care provider, requesting access for the purpose of
quality improvement or cost-containment, a description of
the intended uses for such data.
(2) REQUIREMENTS.—
(A) ACCESS FOR RESEARCH PURPOSES.—Upon approval
of an application for research purposes under paragraph
(1)(A), the authorized user shall enter into a data use and
confidentiality agreement with the State All Payer Claims
Database that has received a grant under this subsection,
which shall include a prohibition on attempts to reidentify
and disclose individually identifiable health information
and proprietary financial information.
(B) CUSTOMIZED REPORTS.—Employers and employer
organizations may request customized reports from a State
All Payer Claims Database that has received a grant
under this section, at cost, subject to the requirements of
this section with respect to privacy, security, and proprietary financial information.
(C) NON-CUSTOMIZED REPORTS.—A State All Payer
Claims Database that has received a grant under this section shall make available to all authorized users aggregate
data sets available through the State All Payer Claims
Database, free of charge.
(3) WAIVERS.—The Secretary may waive the requirements
of this subsection of a State All Payer Claims Database to provide access of entities to such database if such State All Payer
Claims Database is substantially in compliance with this subsection.
(f) EXPANDED ACCESS.—
(1) MULTI-STATE APPLICATIONS.—The Secretary may
prioritize applications submitted by a State whose application
demonstrates that the State will work with other State All
Payer Claims Databases to establish a single application for
access to data by authorized users across multiple States.
(2) EXPANSION OF DATA SETS.—The Secretary may
prioritize applications submitted by a State whose application
demonstrates that the State will implement the reporting format for self-insured group health plans described in section
735 of the Employee Retirement Income Security Act of 1974.
(g) DEFINITIONS.—In this section—
(1) the term ‘‘individually identifiable health information’’
has the meaning given such term in section 1171(6) of the Social Security Act;
(2) the term ‘‘proprietary financial information’’ means
data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan, managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act) or other managed
care organization, or health insurance issuer offering group or
individual health insurance coverage; and
(3) the term ‘‘State All Payer Claims Database’’ means,
with respect to a State, a database that may include medical
claims, pharmacy claims, dental claims, and eligibility and provider files, which are collected from private and public payers.
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PUBLIC HEALTH SERVICE ACT
Sec. 322
(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appropriated $50,000,000 for each of
fiscal years 2022 and 2023, and $25,000,000 for fiscal year 2024,
to remain available until expended.
PART C—HOSPITALS, MEDICAL EXAMINATIONS,
AND
MEDICAL CARE
HOSPITALS
SEC. 321. ø248¿ The Surgeon General, pursuant to regulations,
shall—
(a) Control, manage, and operate all institutions, hospitals,
and stations of the Service, including minor repairs and maintenance, and provide for the care, treatment, and hospitalization of patients, including the furnishing of prosthetic and orthopedic devices; and from time to time with the approval of
the President, select suitable sites for and establish such additional institutions, hospitals, and stations in the States and
possessions of the United States as in his judgment are necessary to enable the Service to discharge its functions and duties;
(b) Provide for the transfer of Public Health Service patients, in the care of attendants where necessary, between hospitals and stations operated by the Service or between such
hospitals and stations and other hospitals and stations in
which Public Health Service patients may be received, and the
payment of expenses of such transfer;
(c) Provide for the disposal of articles produced by patients
in the course of their curative treatment, either by allowing the
patient to retain such articles or by selling them and depositing the money received therefor to the credit of the appropriation from which the materials for making the articles were
purchased;
(d) Provide for the disposal of money and effects, in the
custody of the hospitals or stations, of deceased patients; and
(e) Provide, to the extent the Surgeon General determines
that other public or private funds are not available therefor,
for the payment of expenses of preparing and transporting the
remains of, or the payment of reasonable burial expenses for,
any patient dying in a hospital or station.
CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN
OTHER PERSONS
SEC. 322. ø249¿ (a) Any person when detained in accordance
with quarantine laws, or, at the request of the Immigration and
Naturalization Service, any person detained by that Service, may
be treated and cared for by the Public Health Service.
(b) Persons not entitled to treatment and care at institutions,
hospitals, and stations of the Service may, in accordance with regulations of the Surgeon General, be admitted thereto for temporary
treatment and care in case of emergency.
(c) Persons whose care and treatment is authorized by subsection (a) may, in accordance with regulations, receive such care
and treatment at the expense of the Service from public or private
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medical or hospital facilities other than those of the Service, when
authorized by the officer in charge of the station at which the application is made.
CARE AND TREATMENT OF FEDERAL PRISONERS 27
SEC. 323. ø250¿ The Service shall supervise and furnish medical treatment and other necessary medical, psychiatric, and related technical and scientific services, authorized by the Act of May
13, 1930, as amended (U.S.C., 1940 edition, title 18, secs. 751,
752), 28 in penal and correctional institutions of the United States.
EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES
SEC. 324. ø251¿ (a) The Surgeon General is authorized to provide at institutions, hospitals, and stations of the Service medical,
surgical, and hospital services and supplies for persons entitled to
treatment under the United States Employees’ Compensation Act 29
and extensions thereof. The Surgeon General may also provide for
making medical examinations of—
(1) employees of the Federal Government for retirement
purposes;
(2) employees in Federal classified service, and applicants
for appointment, as requested by the Civil Service Commission
for the purpose of promoting health and efficiency;
(3) seamen for purposes of qualifying for certificates of
service; and
(4) employees eligible for benefits under the Longshoremen’s and Harbor Workers’ Compensation Act, as amended
(U.S.C. 1940 edition, title 33, chapter 18), 30 as requested by
any deputy commissioner thereunder.
(b) The Secretary is authorized to provide medical, surgical,
and dental treatment and hospitalization and optometric care for
Federal employees (as defined in section 8901(1) of title 5 of the
United States Code) and their dependents at remote medical facilities of the Public Health Service where such care and treatment
are not otherwise available. Such employees and their dependents
who are not entitled to this care and treatment under any other
provision of law shall be charged for it at rates established by the
Secretary to reflect the reasonable cost of providing the care and
treatment. Any payments pursuant to the preceding sentence shall
be credited to the applicable appropriation to the Public Health
Service for the year in which such payments are received.
27 Title I of the Departments of Commerce, Justice, and State, the Judiciary, and Related
Agencies Appropriations Act, 2005 (as contained in division B of Public Law 108–447) provided
that of the amounts appropriated for salaries and expenses regarding the Federal Prison System
‘‘the Attorney General may transfer to the Health Resources and Services Administration such
amounts as may be necessary for direct expenditures by that Administration for medical relief
for inmates of Federal penal and correctional institutions’’. (See 118 Stat. 2860.) Similar provisions have appeared in the analogous appropriations Act of many prior years. See section 250a
of title 42, United States Code, and the notes following such section.
28 Now codified to section 4005 of title 18, United States Code.
29 Codified to chapter 81 of title 5, United States Code.
30 Codification remains chapter 18 of title 33, United States Code.
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PUBLIC HEALTH SERVICE ACT
Sec. 327
EXAMINATION OF ALIENS
SEC. 325. ø252¿ The Surgeon General shall provide for making, at places within the United States or in other countries, such
physical and mental examinations of aliens as are required by the
immigration laws, subject to administrative regulations prescribed
by the Attorney General and medical regulations prescribed by the
Surgeon General with the approval of the Secretary.
SERVICES TO COAST GUARD, COAST AND GEODETIC SURVEY, AND
PUBLIC HEALTH SERVICE
SEC. 326. ø253¿ (a) Subject to regulations of the President—
(1) commissioned officers, chief warrant officers, warrant
officers, cadets, and enlisted personnel of the Regular Coast
Guard on active duty, including those on shore duty and those
on detached duty; and Regular and temporary members of the
United States Coast Guard Reserve when on active duty;
(2) commissioned officers, ships’ officers, and members of
the crews of vessels of the United States Coast and Geodetic
Survey on active duty including those on shore duty and those
on detached duty; and
(3) commissioned officers of the Regular or Reserve Corps
of the Public Health Service on active duty;
shall be entitled to medical, surgical, and dental treatment and
hospitalization by the Service. The Surgeon General may detail
commissioned officers for duty aboard vessels of the Coast Guard
or the Coast and Geodetic Survey.
(b)(1) The Secretary may provide health care for an officer of
the Regular or Reserve Corps involuntarily separated from the
Service, and for any dependent of such officer, if—
(A) the officer or dependent was receiving health care at
the expense of the Service at the time of the separation; and
(B) the Secretary finds that the officer or dependent is unable to obtain appropriate insurance for the conditions for
which the officer or dependent was receiving health care.
(2) Health care may be provided under paragraph (1) for a period of not more than one year from the date of separation of the
officer from the Service.
(c) The Service shall provide all services referred to in subsection (a) required by the Coast Guard or Coast and Geodetic Survey and shall perform all duties prescribed by statute in connection
with the examinations to determine physical or mental condition
for purposes of appointment, enlistment, and reenlistment, promotion and retirement, and officers of the Service assigned to duty
on Coast Guard or Coast and Geodetic Survey vessels may extend
aid to the crews of American vessels engaged in deep-sea fishing.
INTERDEPARTMENTAL WORK
SEC. 327. ø254¿ Nothing contained in this part shall affect the
authority of the Service to furnish any materials, supplies, or
equipment, or perform any work or services, requested in accordance with section 7 of the Act of May 21, 1920, as amended (U.S.C.,
1940 edition, title 31, sec. 686), or the authority of any other execuFebruary 1, 2024
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208
tive department to furnish any materials, supplies, or equipment,
or perform any work or services, requested by the Department of
Health, Education, and Welfare for the Service in accordance with
that section.
SHARING OF MEDICAL CARE FACILITIES AND RESOURCES
SEC. 327A. ø254a¿ (a) For purposes of this section—
(1) the term ‘‘specialized health resources’’ means health
care resources (whether equipment, space, or personnel) which,
because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to
maximum utilization only through mutual use;
(2) the term ‘‘hospital’’, unless otherwise specified, includes
(in addition to other hospitals) any Federal hospital.
(b) For the purpose of maintaining or improving the quality of
care in Public Health Service facilities and to provide a professional
environment therein which will help to attract and retain highly
qualified and talented health personnel, to encourage mutually
beneficial relationships between Public Health Service facilities
and hospitals and other health facilities in the health care community, and to promote the full utilization of hospitals and other
health facilities and resources, the Secretary may—
(1) enter into agreements or arrangements with schools of
medicine, schools of osteopathic medicine, and with other
health professions schools, agencies, or institutions, for such
interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the
training or research programs of the participating agencies;
and
(2) enter into agreement or arrangements with hospitals
and other health care facilities for the mutual use or the exchange of use of specialized health resources, and providing for
reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement shall be based on charges covering the reasonable cost of such
utilization, including normal depreciation and amortization costs of
equipment. Any proceeds to the Government under this subsection
shall be credited to the applicable appropriation of the Public
Health Service for the year in which such proceeds are received.
PART D—PRIMARY HEALTH CARE
Subpart I—Health Centers
SEC. 330. ø254b¿ HEALTH CENTERS.
(a) DEFINITION OF HEALTH CENTER.—
(1) IN GENERAL.—For purposes of
this section, the term
‘‘health center’’ means an entity that serves a population that
is medically underserved, or a special medically underserved
population comprised of migratory and seasonal agricultural
workers, the homeless, and residents of public housing, by providing, either through the staff and supporting resources of the
center or through contracts or cooperative arrangements—
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PUBLIC HEALTH SERVICE ACT
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(A) required primary health services (as defined in
subsection (b)(1)); and
(B) as may be appropriate for particular centers, additional health services (as defined in subsection (b)(2)) necessary for the adequate support of the primary health
services required under subparagraph (A);
for all residents of the area served by the center (hereafter referred to in this section as the ‘‘catchment area’’).
(2) LIMITATION.—The requirement in paragraph (1) to provide services for all residents within a catchment area shall
not apply in the case of a health center receiving a grant only
under subsection (g), (h), or (i).
(b) DEFINITIONS.—For purposes of this section:
(1) REQUIRED PRIMARY HEALTH SERVICES.—
(A) IN GENERAL.—The term ‘‘required primary health
services’’ means—
(i) basic health services which, for purposes of this
section, shall consist of—
(I) health services related to family medicine,
internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians and where
appropriate, physician assistants, nurse practitioners, and nurse midwives;
(II) diagnostic laboratory and radiologic services;
(III) preventive health services, including—
(aa) prenatal and perinatal services;
(bb) appropriate cancer screening;
(cc) well-child services;
(dd) immunizations against vaccine-preventable diseases;
(ee) screenings for elevated blood lead levels, communicable diseases, and cholesterol;
(ff) pediatric eye, ear, and dental
screenings to determine the need for vision
and hearing correction and dental care;
(gg) voluntary family planning services;
and
(hh) preventive dental services;
(IV) emergency medical services; and
(V) pharmaceutical services as may be appropriate for particular centers;
(ii) referrals to providers of medical services (including specialty referral when medically indicated)
and other health-related services (including substance
use disorder and mental health services);
(iii) patient case management services (including
counseling, referral, and follow-up services) and other
services designed to assist health center patients in
establishing eligibility for and gaining access to Federal, State, and local programs that provide or financially support the provision of medical, social, housing,
educational, or other related services;
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(iv) services that enable individuals to use the
services of the health center (including outreach and
transportation services and, if a substantial number of
the individuals in the population served by a center
are of limited English-speaking ability, the services of
appropriate personnel fluent in the language spoken
by a predominant number of such individuals); and
(v) education of patients and the general population served by the health center regarding the availability and proper use of health services.
(B) EXCEPTION.—With respect to a health center that
receives a grant only under subsection (g), the Secretary,
upon a showing of good cause, shall—
(i) waive the requirement that the center provide
all required primary health services under this paragraph; and
(ii) approve, as appropriate, the provision of certain required primary health services only during certain periods of the year.
(2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional
health services’’ means services that are not included as required primary health services and that are appropriate to
meet the health needs of the population served by the health
center involved. Such term may include—
(A) behavioral and mental health and substance use
disorder services;
(B) recuperative care services;
(C) environmental health services, including—
(i) the detection and alleviation of unhealthful
conditions associated with—
(I) water supply;
(II) chemical and pesticide exposures;
(III) air quality; or
(IV) exposure to lead;
(ii) sewage treatment;
(iii) solid waste disposal;
(iv) rodent and parasitic infestation;
(v) field sanitation;
(vi) housing; and
(vii) other environmental factors related to health;
and
(D) in the case of health centers receiving grants
under subsection (g), special occupation-related health
services for migratory and seasonal agricultural workers,
including—
(i) screening for and control of infectious diseases,
including parasitic diseases; and
(ii) injury prevention programs, including prevention of exposure to unsafe levels of agricultural chemicals including pesticides.
(3) MEDICALLY UNDERSERVED POPULATIONS.—
(A) IN GENERAL.—The term ‘‘medically underserved
population’’ means the population of an urban or rural
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age of personal health services or a population group designated by the Secretary as having a shortage of such services.
(B) CRITERIA.—In carrying out subparagraph (A), the
Secretary shall prescribe criteria for determining the specific shortages of personal health services of an area or
population group. Such criteria shall—
(i) take into account comments received by the
Secretary from the chief executive officer of a State
and local officials in a State; and
(ii) include factors indicative of the health status
of a population group or residents of an area, the ability of the residents of an area or of a population group
to pay for health services and their accessibility to
them, and the availability of health professionals to
residents of an area or to a population group.
(C) LIMITATION.—The Secretary may not designate a
medically underserved population in a State or terminate
the designation of such a population unless, prior to such
designation or termination, the Secretary provides reasonable notice and opportunity for comment and consults
with—
(i) the chief executive officer of such State;
(ii) local officials in such State; and
(iii) the organization, if any, which represents a
majority of health centers in such State.
(D) PERMISSIBLE DESIGNATION.—The Secretary may
designate a medically underserved population that does
not meet the criteria established under subparagraph (B)
if the chief executive officer of the State in which such population is located and local officials of such State recommend the designation of such population based on unusual local conditions which are a barrier to access to or
the availability of personal health services.
(c) PLANNING GRANTS.—
(1) CENTERS.—The Secretary may make grants to public
and nonprofit private entities for projects to plan and develop
health centers which will serve medically underserved populations. A project for which a grant may be made under this
subsection may include the cost of the acquisition and lease of
buildings and equipment (including the costs of amortizing the
principal of, and paying the interest on, loans) and shall include—
(A) an assessment of the need that the population proposed to be served by the health center for which the
project is undertaken has for required primary health
services and additional health services;
(B) the design of a health center program for such population based on such assessment;
(C) efforts to secure, within the proposed catchment
area of such center, financial and professional assistance
and support for the project;
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(D) initiation and encouragement of continuing community involvement in the development and operation of
the project; and
(E) proposed linkages between the center and other
appropriate provider entities, such as health departments,
local hospitals, and rural health clinics, to provide better
coordinated, higher quality, and more cost-effective health
care services.
(2) LIMITATION.—Not more than two grants may be made
under this subsection for the same project, except that upon a
showing of good cause, the Secretary may make additional
grant awards.
(3) RECOGNITION OF HIGH POVERTY.—
(A) IN GENERAL.—In making grants under this subsection, the Secretary may recognize the unique needs of
high poverty areas.
(B) HIGH POVERTY AREA DEFINED.—For purposes of
subparagraph (A), the term ‘‘high poverty area’’ means a
catchment area which is established in a manner that is
consistent with the factors in subsection (k)(3)(J), and the
poverty rate of which is greater than the national average
poverty rate as determined by the Bureau of the Census.
(d) IMPROVING QUALITY OF CARE.—
(1) SUPPLEMENTAL AWARDS.—The Secretary may award
supplemental grant funds to health centers funded under this
section to implement evidence-based models for increasing access to high-quality primary care services, which may include
models related to—
(A) improving the delivery of care for individuals with
multiple chronic conditions;
(B) workforce configuration;
(C) reducing the cost of care;
(D) enhancing care coordination;
(E) expanding the use of telehealth and technology-enabled collaborative learning and capacity building models;
(F) care integration, including integration of behavioral health, mental health, or substance use disorder services;
(G) addressing emerging public health or substance
use disorder issues to meet the health needs of the population served by the health center; and
(H) improving access to recommended immunizations.
(2) SUSTAINABILITY.—In making supplemental awards
under this subsection, the Secretary may consider whether the
health center involved has submitted a plan for continuing the
activities funded under this subsection after supplemental
funding is expended.
(3) SPECIAL CONSIDERATION.—The Secretary may give special consideration to applications for supplemental funding
under this subsection that seek to address significant barriers
to access to care in areas with a greater shortage of health care
providers and health services relative to the national average.
(e) OPERATING GRANTS.—
(1) AUTHORITY.—
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(A) IN GENERAL.—The Secretary may make grants for
the costs of the operation of public and nonprofit private
health centers that provide health services to medically
underserved populations.
(B) ENTITIES THAT FAIL TO MEET CERTAIN REQUIREMENTS.—The Secretary may make grants, for a period of
not to exceed 1 year, for the costs of the operation of public
and nonprofit private entities which provide health services to medically underserved populations but with respect
to which the Secretary is unable to make each of the determinations required by subsection (k)(3). The Secretary
shall not make a grant under this paragraph unless the
applicant provides assurances to the Secretary that within
120 days of receiving grant funding for the operation of the
health center, the applicant will submit, for approval by
the Secretary, an implementation plan to meet the requirements of subsection (k)(3). The Secretary may extend
such 120-day period for achieving compliance upon a demonstration of good cause by the health center.
(C) OPERATION OF NETWORKS.—The Secretary may
make grants to health centers that receive assistance
under this section, or at the request of the health centers,
directly to a network that is at least majority controlled
and, as applicable, at least majority owned by such health
centers receiving assistance under this section, for the
costs associated with the operation of such network including—
(i) the purchase or lease of equipment, which may
include data and information systems (including the
costs of amortizing the principal of, and paying the interest on, loans for equipment);
(ii) the provision of training and technical assistance; and
(iii) other activities that—
(I) reduce costs associated with the provision
of health services;
(II) improve access to, and availability of,
health services provided to individuals served by
the centers;
(III) enhance the quality and coordination of
health services; or
(IV) improve the health status of communities.
(2) USE OF FUNDS.—The costs for which a grant may be
made under subparagraph (A) or (B) of paragraph (1) may include the costs of acquiring and leasing buildings and equipment (including the costs of amortizing the principal of, and
paying interest on, loans), and the costs of providing training
related to the provision of required primary health services
and additional health services and to the management of
health center programs.
(3) CONSTRUCTION.—The Secretary may award grants
which may be used to pay the costs associated with expanding
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214
ings (including the costs of amortizing the principal of, and
paying the interest on, loans) for projects approved prior to October 1, 1996.
(4) LIMITATION.—Not more than two grants may be made
under subparagraph (B) of paragraph (1) for the same entity.
(5) AMOUNT.—
(A) IN GENERAL.—The amount of any grant made in
any fiscal year under subparagraphs (A) and (B) of paragraph (1) to a health center shall be determined by the
Secretary, but may not exceed the amount by which the
costs of operation of the center in such fiscal year exceed
the total of—
(i) State, local, and other operational funding provided to the center; and
(ii) the fees, premiums, and third-party reimbursements, which the center may reasonably be expected
to receive for its operations in such fiscal year.
(B) NETWORKS.—The total amount of grant funds
made available for any fiscal year under paragraph (1)(C)
to a health center or to a network shall be determined by
the Secretary, but may not exceed 2 percent of the total
amount appropriated under this section for such fiscal
year.
(C) PAYMENTS.—Payments under grants under subparagraph (A) or (B) of paragraph (1) shall be made in advance or by way of reimbursement and in such installments as the Secretary finds necessary and adjustments
may be made for overpayments or underpayments.
(D) USE OF NONGRANT FUNDS.—Nongrant funds described in clauses (i) and (ii) of subparagraph (A), including any such funds in excess of those originally expected,
shall be used as permitted under this section, and may be
used for such other purposes as are not specifically prohibited under this section if such use furthers the objectives
of the project.
(6) NEW ACCESS POINTS AND EXPANDED SERVICES.—
(A) APPROVAL OF NEW ACCESS POINTS.—
(i) IN GENERAL.—The Secretary may approve applications for grants under subparagraph (A) or (B) of
paragraph (1) to establish new delivery sites.
(ii) SPECIAL CONSIDERATION.—In carrying out
clause (i), the Secretary may give special consideration
to applicants that have demonstrated the new delivery
site will be located within a sparsely populated area,
or an area which has a level of unmet need that is
higher relative to other applicants.
(iii) CONSIDERATION OF APPLICATIONS.—In carrying out clause (i), the Secretary shall approve applications for grants in such a manner that the ratio of
the medically underserved populations in rural areas
which may be expected to use the services provided by
the applicants involved to the medically underserved
populations in urban areas which may be expected to
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use the services provided by the applicants is not less
than two to three or greater than three to two.
(iv) SERVICE AREA OVERLAP.—If in carrying out
clause (i) the applicant proposes to serve an area that
is currently served by another health center funded
under this section, the Secretary may consider whether the award of funding to an additional health center
in the area can be justified based on the unmet need
for additional services within the catchment area.
(v) 31 MOBILE UNITS.—An existing health center
may be awarded funds under clause (i) to establish a
new delivery site that is a mobile unit, regardless of
whether the applicant additionally proposes to establish a permanent, full-time site. In the case of a health
center that is not currently receiving funds under this
section, such health center may be awarded funds
under clause (i) to establish a new delivery site that is
a mobile unit only if such health center uses a portion
of such funds to also establish a permanent, full-time
site.
(B) APPROVAL OF EXPANDED SERVICE APPLICATIONS.—
(i) IN GENERAL.—The Secretary may approve applications for grants under subparagraph (A) or (B) of
paragraph (1) to expand the capacity of the applicant
to provide required primary health services described
in subsection (b)(1) or additional health services described in subsection (b)(2).
(ii) PRIORITY EXPANSION PROJECTS.—In carrying
out clause (i), the Secretary may give special consideration to expanded service applications that seek to address emerging public health or behavioral health,
mental health, or substance abuse issues through increasing the availability of additional health services
described in subsection (b)(2) in an area in which
there are significant barriers to accessing care.
(iii) CONSIDERATION OF APPLICATIONS.—In carrying out clause (i), the Secretary shall approve applications for grants in such a manner that the ratio of
the medically underserved populations in rural areas
which may be expected to use the services provided by
the applicants involved to the medically underserved
populations in urban areas which may be expected to
use the services provided by such applicants is not less
than two to three or greater than three to two.
(f) INFANT MORTALITY GRANTS.—
(1) IN GENERAL.—The Secretary may make grants to
health centers for the purpose of assisting such centers in—
(A) providing comprehensive health care and support
services for the reduction of—
31 Section 2(a) of Public Law 117-204 provides for an amendment to add at the end of section
330(e)(6)(A) a new clause (v). Section 2(b) of such Public Law states ‘‘[t]he amendment made
by subsection (a) shall take effect on January 1, 2024.’’.
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(i) the incidence of infant mortality; and
(ii) morbidity among children who are less than 3
years of age; and
(B) developing and coordinating service and referral
arrangements between health centers and other entities
for the health management of pregnant women and children described in subparagraph (A).
(2) PRIORITY.—In making grants under this subsection the
Secretary shall give priority to health centers providing services to any medically underserved population among which
there is a substantial incidence of infant mortality or among
which there is a significant increase in the incidence of infant
mortality.
(3) REQUIREMENTS.—The Secretary may make a grant
under this subsection only if the health center involved agrees
that—
(A) the center will coordinate the provision of services
under the grant to each of the recipients of the services;
(B) such services will be continuous for each such recipient;
(C) the center will provide follow-up services for individuals who are referred by the center for services described in paragraph (1);
(D) the grant will be expended to supplement, and not
supplant, the expenditures of the center for primary health
services (including prenatal care) with respect to the purpose described in this subsection; and
(E) the center will coordinate the provision of services
with other maternal and child health providers operating
in the catchment area.
(g) MIGRATORY AND SEASONAL AGRICULTURAL WORKERS.—
(1) IN GENERAL.—The Secretary may award grants for the
purposes described in subsections (c), (e), and (f) for the planning and delivery of services to a special medically underserved population comprised of—
(A) migratory agricultural workers, seasonal agricultural workers, and members of the families of such migratory and seasonal agricultural workers who are within a
designated catchment area; and
(B) individuals who have previously been migratory
agricultural workers but who no longer meet the requirements of subparagraph (A) of paragraph (3) because of age
or disability and members of the families of such individuals who are within such catchment area.
(2) ENVIRONMENTAL CONCERNS.—The Secretary may enter
into grants or contracts under this subsection with public and
private entities to—
(A) assist the States in the implementation and enforcement of acceptable environmental health standards,
including enforcement of standards for sanitation in migratory agricultural worker and seasonal agricultural
worker labor camps, and applicable Federal and State pesticide control standards; and
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(B) conduct projects and studies to assist the several
States and entities which have received grants or contracts
under this section in the assessment of problems related to
camp and field sanitation, exposure to unsafe levels of agricultural chemicals including pesticides, and other environmental health hazards to which migratory agricultural
workers and seasonal agricultural workers, and members
of their families, are exposed.
(3) DEFINITIONS.—For purposes of this subsection:
(A) MIGRATORY AGRICULTURAL WORKER.—The term
‘‘migratory agricultural worker’’ means an individual
whose principal employment is in agriculture, who has
been so employed within the last 24 months, and who establishes for the purposes of such employment a temporary
abode.
(B) SEASONAL AGRICULTURAL WORKER.—The term ‘‘seasonal agricultural worker’’ means an individual whose
principal employment is in agriculture on a seasonal basis
and who is not a migratory agricultural worker.
(C) AGRICULTURE.—The term ‘‘agriculture’’ means
farming in all its branches, including—
(i) cultivation and tillage of the soil;
(ii) the production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in or on, the
land; and
(iii) any practice (including preparation and processing for market and delivery to storage or to market
or to carriers for transportation to market) performed
by a farmer or on a farm incident to or in conjunction
with an activity described in clause (ii).
(h) HOMELESS POPULATION.—
(1) IN GENERAL.—The Secretary may award grants for the
purposes described in subsections (c), (e), and (f) for the planning and delivery of services to a special medically underserved population comprised of homeless individuals, including
grants for innovative programs that provide outreach and comprehensive primary health services to homeless children and
youth, children and youth at risk of homelessness, homeless
veterans, and veterans at risk of homelessness.
(2) REQUIRED SERVICES.—In addition to required primary
health services (as defined in subsection (b)(1)), an entity that
receives a grant under this subsection shall be required to provide substance abuse services as a condition of such grant.
(3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant
awarded under this subsection shall be expended to supplement, and not supplant, the expenditures of the health center
and the value of in kind contributions for the delivery of services to the population described in paragraph (1).
(4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CERTAIN FORMER HOMELESS INDIVIDUALS.—If any grantee under
this subsection has provided services described in this section
under the grant to a homeless individual, such grantee may,
notwithstanding that the individual is no longer homeless as
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a result of becoming a resident in permanent housing, expend
the grant to continue to provide such services to the individual
for not more than 12 months.
(5) DEFINITIONS.—For purposes of this section:
(A) HOMELESS INDIVIDUAL.—The term ‘‘homeless individual’’ means an individual who lacks housing (without
regard to whether the individual is a member of a family),
including an individual whose primary residence during
the night is a supervised public or private facility that provides temporary living accommodations and an individual
who is a resident in transitional housing.
(B) SUBSTANCE USE DISORDER SERVICES.—The term
‘‘substance abuse 32services’’ includes detoxification, risk
reduction, outpatient treatment, residential treatment, and
rehabilitation for substance abuse 32 provided in settings
other than hospitals.
(i) RESIDENTS OF PUBLIC HOUSING.—
(1) IN GENERAL.—The Secretary may award grants for the
purposes described in subsections (c), (e), and (f) for the planning and delivery of services to a special medically underserved population comprised of residents of public housing
(such term, for purposes of this subsection, shall have the same
meaning given such term in section 3(b)(1) of the United States
Housing Act of 1937) and individuals living in areas immediately accessible to such public housing.
(2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under
this subsection shall be expended to supplement, and not supplant, the expenditures of the health center and the value of
in kind contributions for the delivery of services to the population described in paragraph (1).
(3) CONSULTATION WITH RESIDENTS.—The Secretary may
not make a grant under paragraph (1) unless, with respect to
the residents of the public housing involved, the applicant for
the grant—
(A) has consulted with the residents in the preparation of the application for the grant; and
(B) agrees to provide for ongoing consultation with the
residents regarding the planning and administration of the
program carried out with the grant.
(j) ACCESS GRANTS.—
(1) IN GENERAL.—The Secretary may award grants to eligible health centers with a substantial number of clients with
limited English speaking proficiency to provide translation, interpretation, and other such services for such clients with limited English speaking proficiency.
(2) ELIGIBLE HEALTH CENTER.—In this subsection, the term
‘‘eligible health center’’ means an entity that—
(A) is a health center as defined under subsection (a);
(B) provides health care services for clients for whom
English is a second language; and
32 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amendment to strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such,
the amendment has not been carried out above.
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(C) has exceptional needs with respect to linguistic access or faces exceptional challenges with respect to linguistic access.
(3) GRANT AMOUNT.—The amount of a grant awarded to a
center under this subsection shall be determined by the Administrator. Such determination of such amount shall be based
on the number of clients for whom English is a second language that is served by such center, and larger grant amounts
shall be awarded to centers serving larger numbers of such clients.
(4) USE OF FUNDS.—An eligible health center that receives
a grant under this subsection may use funds received through
such grant to—
(A) provide translation, interpretation, and other such
services for clients for whom English is a second language,
including hiring professional translation and interpretation services; and
(B) compensate bilingual or multilingual staff for language assistance services provided by the staff for such clients.
(5) APPLICATION.—An eligible health center desiring a
grant under this subsection shall submit an application to the
Secretary at such time, in such manner, and containing such
information as the Secretary may reasonably require, including—
(A) an estimate of the number of clients that the center serves for whom English is a second language;
(B) the ratio of the number of clients for whom
English is a second language to the total number of clients
served by the center;
(C) a description of any language assistance services
that the center proposes to provide to aid clients for whom
English is a second language; and
(D) a description of the exceptional needs of such center with respect to linguistic access or a description of the
exceptional challenges faced by such center with respect to
linguistic access.
(6) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, in addition
to any funds authorized to be appropriated or appropriated for
health centers under any other subsection of this section, such
sums as may be necessary for each of fiscal years 2002 through
2006.
(k) APPLICATIONS.—
(1) SUBMISSION.—No grant may be made under this section unless an application therefore is submitted to, and approved by, the Secretary. Such an application shall be submitted in such form and manner and shall contain such information as the Secretary shall prescribe.
(2) DESCRIPTION OF UNMET NEED.—An application for a
grant under subparagraph (A) or (B) of subsection (e)(1) or subsection (e)(6) for a health center shall include—
(A) a description of the unmet need for health services
in the catchment area of the center;
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(B) a demonstration by the applicant that the area or
the population group to be served by the applicant has a
shortage of personal health services;
(C) a demonstration that the center will be located so
that it will provide services to the greatest number of individuals residing in the catchment area or included in such
population group; and
(D) in the case of an application for a grant pursuant
to subsection (e)(6), a demonstration that the applicant has
consulted with appropriate State and local government
agencies, and health care providers regarding the need for
the health services to be provided at the proposed delivery
site.
Such a demonstration shall be made on the basis of the criteria
prescribed by the Secretary under subsection (b)(3) or on any
other criteria which the Secretary may prescribe to determine
if the area or population group to be served by the applicant
has a shortage of personal health services. In considering an
application for a grant under subparagraph (A) or (B) of subsection (e)(1), the Secretary may require as a condition to the
approval of such application an assurance that the applicant
will provide any health service defined under paragraphs (1)
and (2) of subsection (b) that the Secretary finds is needed to
meet specific health needs of the area to be served by the applicant. Such a finding shall be made in writing and a copy
shall be provided to the applicant.
(3) REQUIREMENTS.—Except as provided in subsection
(e)(1)(B) or subsection (e)(6), the Secretary may not approve an
application for a grant under subparagraph (A) or (B) of subsection (e)(1) unless the Secretary determines that the entity
for which the application is submitted is a health center (within the meaning of subsection (a)) and that—
(A) the required primary health services of the center
will be available and accessible in the catchment area of
the center promptly, as appropriate, and in a manner
which assures continuity;
(B) the center has made and will continue to make
every reasonable effort to establish and maintain collaborative relationships with other health care providers, including other health care providers that provide care within the catchment area, local hospitals, and specialty providers in the catchment area of the center, to provide access to services not available through the health center
and to reduce the non-urgent use of hospital emergency
departments;
(C) the center will have an ongoing quality improvement system that includes clinical services and management, and that maintains the confidentiality of patient
records;
(D) the center will demonstrate its financial responsibility by the use of such accounting procedures and other
requirements as may be prescribed by the Secretary;
(E) the center—
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(i)(I) has or will have a contractual or other arrangement with the agency of the State, in which it
provides services, which administers or supervises the
administration of a State plan approved under title
XIX of the Social Security Act for the payment of all
or a part of the center’s costs in providing health services to persons who are eligible for medical assistance
under such a State plan; and
(II) 33 has or will have a contractual or other
arrangement with the State agency administering
the program under title XXI of such Act (42
U.S.C. 1397aa et seq.) with respect to individuals
who are State children’s health insurance program
beneficiaries; or
(ii) has made or will make every reasonable effort
to enter into arrangements described in subclauses (I)
and (II) of clause (i);
(F) the center has made or will make and will continue to make every reasonable effort to collect appropriate
reimbursement for its costs in providing health services to
persons who are entitled to insurance benefits under title
XVIII of the Social Security Act, to medical assistance
under a State plan approved under title XIX of such Act,
or to assistance for medical expenses under any other public assistance program or private health insurance program;
(G) the center—
(i) has prepared a schedule of fees or payments for
the provision of its services consistent with locally prevailing rates or charges and designed to cover its reasonable costs of operation and has prepared a corresponding schedule of discounts to be applied to the
payment of such fees or payments, which discounts
are adjusted on the basis of the patient’s ability to
pay;
(ii) has made and will continue to make every reasonable effort—
(I) to secure from patients payment for services in accordance with such schedules; and
(II) to collect reimbursement for health services to persons described in subparagraph (F) on
the basis of the full amount of fees and payments
for such services without application of any discount;
(iii)(I) will assure that no patient will be denied
health care services due to an individual’s inability to
pay for such services; and
(II) will assure that any fees or payments required
by the center for such services will be reduced or
waived to enable the center to fulfill the assurance described in subclause (I); and
33 Indentation
is so in law. See section 101(7)(A)(i)(III) of Public Law 107–251 (116 Stat. 225).
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(iv) has submitted to the Secretary such reports as
the Secretary may require to determine compliance
with this subparagraph;
(H) the center has established a governing board
which except in the case of an entity operated by an Indian tribe or tribal or Indian organization under the Indian Self-Determination Act or an urban Indian organization under the Indian Health Care Improvement Act (25
U.S.C. 1651 et seq.)—
(i) is composed of individuals, a majority of whom
are being served by the center and who, as a group,
represent the individuals being served by the center;
(ii) meets at least once a month, selects the services to be provided by the center, schedules the hours
during which such services will be provided, approves
the center’s annual budget, approves the selection of a
director for the center who shall be directly employed
by the center, and, except in the case of a governing
board of a public center (as defined in the second sentence of this paragraph), establishes general policies
for the center; and
(iii) in the case of an application for a second or
subsequent grant for a public center, has approved the
application or if the governing body has not approved
the application, the failure of the governing body to
approve the application was unreasonable;
except that, upon a showing of good cause the Secretary
shall waive, for the length of the project period, all or part
of the requirements of this subparagraph in the case of a
health center that receives a grant pursuant to subsection
(g), (h), (i), or (p);
(I) the center has developed—
(i) an overall plan and budget that meets the requirements of the Secretary; and
(ii) an effective procedure for compiling and reporting to the Secretary such statistics and other information as the Secretary may require relating to—
(I) the costs of its operations;
(II) the patterns of use of its services;
(III) the availability, accessibility, and acceptability of its services; and
(IV) such other matters relating to operations
of the applicant as the Secretary may require;
(J) the center will review periodically its catchment
area to—
(i) ensure that the size of such area is such that
the services to be provided through the center (including any satellite) are available and accessible to the
residents of the area promptly and as appropriate;
(ii) ensure that the boundaries of such area conform, to the extent practicable, to relevant boundaries
of political subdivisions, school districts, and Federal
and State health and social service programs; and
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(iii) ensure that the boundaries of such area eliminate, to the extent possible, barriers to access to the
services of the center, including barriers resulting
from the area’s physical characteristics, its residential
patterns, its economic and social grouping, and available transportation;
(K) in the case of a center which serves a population
including a substantial proportion of individuals of limited
English-speaking ability, the center has—
(i) developed a plan and made arrangements responsive to the needs of such population for providing
services to the extent practicable in the language and
cultural context most appropriate to such individuals;
and
(ii) identified an individual on its staff who is fluent in both that language and in English and whose
responsibilities shall include providing guidance to
such individuals and to appropriate staff members
with respect to cultural sensitivities and bridging linguistic and cultural differences;
(L) the center, has developed an ongoing referral relationship with one or more hospitals;
(M) the center encourages persons receiving or seeking
health services from the center to participate in any public
or private (including employer-offered) health programs or
plans for which the persons are eligible, so long as the center, in complying with this subparagraph, does not violate
the requirements of subparagraph (G)(iii)(I); and
(N) the center has written policies and procedures in
place to ensure the appropriate use of Federal funds in
compliance with applicable Federal statutes, regulations,
and the terms and conditions of the Federal award.
For purposes of subparagraph (H), the term ‘‘public center’’
means a health center funded (or to be funded) through a
grant under this section to a public agency.
(l) TECHNICAL ASSISTANCE.—The Secretary shall establish a
program through which the Secretary shall provide (either through
the Department of Health and Human Services or by grant or contract) technical and other assistance to eligible entities to assist
such entities to meet the requirements of subsection (k)(3). Services
provided through the program may include necessary technical and
nonfinancial assistance, including fiscal and program management
assistance, training in fiscal and program management, operational
and administrative support, and the provision of information to the
entities of the variety of resources available under this title and
how those resources can be best used to meet the health needs of
the communities served by the entities. Funds expended to carry
out activities under this subsection and operational support activities under subsection (m) shall not exceed 3 percent of the amount
appropriated for this section for the fiscal year involved.
(m) MEMORANDUM OF AGREEMENT.—In carrying out this section, the Secretary may enter into a memorandum of agreement
with a State. Such memorandum may include, where appropriate,
provisions permitting such State to—
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(1) analyze the need for primary health services for medically underserved populations within such State;
(2) assist in the planning and development of new health
centers;
(3) review and comment upon annual program plans and
budgets of health centers, including comments upon allocations
of health care resources in the State;
(4) assist health centers in the development of clinical
practices and fiscal and administrative systems through a technical assistance plan which is responsive to the requests of
health centers; and
(5) share information and data relevant to the operation of
new and existing health centers.
(n) RECORDS.—
(1) IN GENERAL.—Each entity which receives a grant under
subsection (e) shall establish and maintain such records as the
Secretary shall require.
(2) AVAILABILITY.—Each entity which is required to establish and maintain records under this subsection shall make
such books, documents, papers, and records available to the
Secretary or the Comptroller General of the United States, or
any of their duly authorized representatives, for examination,
copying or mechanical reproduction on or off the premises of
such entity upon a reasonable request therefore. The Secretary
and the Comptroller General of the United States, or any of
their duly authorized representatives, shall have the authority
to conduct such examination, copying, and reproduction.
(o) DELEGATION OF AUTHORITY.—The Secretary may delegate
the authority to administer the programs authorized by this section
to any office, except that the authority to enter into, modify, or
issue approvals with respect to grants or contracts may be delegated only within the central office of the Health Resources and
Services Administration.
(p) SPECIAL CONSIDERATION.—In making grants under this section, the Secretary shall give special consideration to the unique
needs of sparsely populated rural areas, including giving priority in
the awarding of grants for new health centers under subsections (c)
and (e), and the granting of waivers as appropriate and permitted
under subsections (b)(1)(B)(i) and (k)(3)(G).
(q) AUDITS.—
(1) IN GENERAL.—Each entity which receives a grant under
this section shall provide for an independent annual financial
audit of any books, accounts, financial records, files, and other
papers and property which relate to the disposition or use of
the funds received under such grant and such other funds received by or allocated to the project for which such grant was
made. For purposes of assuring accurate, current, and complete
disclosure of the disposition or use of the funds received, each
such audit shall be conducted in accordance with generally accepted accounting principles. Each audit shall evaluate—
(A) the entity’s implementation of the guidelines established by the Secretary respecting cost accounting,
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(B) the processes used by the entity to meet the financial and program reporting requirements of the Secretary,
and
(C) the billing and collection procedures of the entity
and the relation of the procedures to its fee schedule and
schedule of discounts and to the availability of health insurance and public programs to pay for the health services
it provides.
A report of each such audit shall be filed with the Secretary
at such time and in such manner as the Secretary may require.
(2) RECORDS.—Each entity which receives a grant under
this section shall establish and maintain such records as the
Secretary shall by regulation require to facilitate the audit required by paragraph (1). The Secretary may specify by regulation the form and manner in which such records shall be established and maintained.
(3) AVAILABILITY OF RECORDS.—Each entity which is required to establish and maintain records or to provide for and
audit under this subsection shall make such books, documents,
papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying or mechanical reproduction on or off the premises of such entity upon a
reasonable request therefore. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct
such examination, copying, and reproduction.
(4) WAIVER.—The Secretary may, under appropriate circumstances, waive the application of all or part of the requirements of this subsection with respect to an entity. A waiver
provided by the Secretary under this paragraph may not remain in effect for more than 1 year and may not be extended
after such period. An entity may not receive more than one
waiver under this paragraph in consecutive years.
(r) AUTHORIZATION OF APPROPRIATIONS.—
(1) GENERAL AMOUNTS FOR GRANTS.—For the purpose of
carrying out this section, in addition to the amounts authorized
to be appropriated under subsection (d), there is authorized to
be appropriated the following:
(A) For fiscal year 2010, $2,988,821,592.
(B) For fiscal year 2011, $3,862,107,440.
(C) For fiscal year 2012, $4,990,553,440.
(D) For fiscal year 2013, $6,448,713,307.
(E) For fiscal year 2014, $7,332,924,155.
(F) For fiscal year 2015, $8,332,924,155.
(G) For fiscal year 2016, and each subsequent fiscal
year, the amount appropriated for the preceding fiscal year
adjusted by the product of—
(i) one plus the average percentage increase in
costs incurred per patient served; and
(ii) one plus the average percentage increase in
the total number of patients served.
(2) SPECIAL PROVISIONS.—
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(A) PUBLIC CENTERS.—The Secretary may not expend
in any fiscal year, for grants under this section to public
centers (as defined in the second sentence of subsection
(k)(3)) the governing boards of which (as described in subsection (k)(3)(H)) do not establish general policies for such
centers, an amount which exceeds 5 percent of the
amounts appropriated under this section for that fiscal
year. For purposes of applying the preceding sentence, the
term ‘‘public centers’’ shall not include health centers that
receive grants pursuant to subsection (h) or (i).
(B) DISTRIBUTION OF GRANTS.—For fiscal year 2002
and each of the following fiscal years, the Secretary, in
awarding grants under this section, shall ensure that the
proportion of the amount made available under each of
subsections (g), (h), and (i), relative to the total amount appropriated to carry out this section for that fiscal year, is
equal to the proportion of the amount made available
under that subsection for fiscal year 2001, relative to the
total amount appropriated to carry out this section for fiscal year 2001.
(3) FUNDING REPORT.—The Secretary shall annually prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report
including, at a minimum—
(A) the distribution of funds for carrying out this section that are provided to meet the health care needs of
medically underserved populations, including the homeless, residents of public housing, and migratory and seasonal agricultural workers, and the appropriateness of the
delivery systems involved in responding to the needs of the
particular populations;
(B) an assessment of the relative health care access
needs of the targeted populations;
(C) the distribution of awards and funding for new or
expanded services in each of rural areas and urban areas;
(D) the distribution of awards and funding for establishing new access points, and the number of new access
points created;
(E) the amount of unexpended funding for loan guarantees and loan guarantee authority under title XVI;
(F) the rationale for any substantial changes in the
distribution of funds;
(G) the rate of closures for health centers and access
points;
(H) the number and reason for any grants awarded
pursuant to subsection (e)(1)(B); and
(I) the number and reason for any waivers provided
pursuant to subsection (q)(4).
(4) RULE OF CONSTRUCTION WITH RESPECT TO RURAL
HEALTH CLINICS.—
(A) IN GENERAL.—Nothing in this section shall be construed to prevent a community health center from contracting with a Federally certified rural health clinic (as
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defined in section 1861(aa)(2) of the Social Security Act),
a low-volume hospital (as defined for purposes of section
1886 of such Act), a critical access hospital, a sole community hospital (as defined for purposes of section
1886(d)(5)(D)(iii) of such Act), or a medicare-dependent
share hospital (as defined for purposes of section
1886(d)(5)(G)(iv) of such Act) for the delivery of primary
health care services that are available at the clinic or hospital to individuals who would otherwise be eligible for
free or reduced cost care if that individual were able to obtain that care at the community health center. Such services may be limited in scope to those primary health care
services available in that clinic or hospitals.
(B) ASSURANCES.—In order for a clinic or hospital to
receive funds under this section through a contract with a
community health center under subparagraph (A), such
clinic or hospital shall establish policies to ensure—
(i) nondiscrimination based on the ability of a patient to pay; and
(ii) the establishment of a sliding fee scale for lowincome patients.
(5) FUNDING FOR PARTICIPATION OF HEALTH CENTERS IN
ALL OF US RESEARCH PROGRAM.—In addition to any amounts
made available pursuant to paragraph (1) of this subsection,
section 402A of this Act, or section 10503 of the Patient Protection and Affordable Care Act, there is authorized to be appropriated, and there is appropriated, out of any monies in the
Treasury not otherwise appropriated, to the Secretary
$25,000,000 for fiscal year 2018 to support the participation of
health centers in the All of Us Research Program under the
Precision Medicine Initiative under section 498E of this Act.
(6) ADDITIONAL AMOUNTS FOR SUPPLEMENTAL AWARDS.—In
addition to any amounts made available pursuant to this subsection, section 402A of this Act, or section 10503 of the Patient Protection and Affordable Care Act, there is authorized to
be appropriated, and there is appropriated, out of any monies
in the Treasury not otherwise appropriated, $1,320,000,000 for
fiscal year 2020 for supplemental awards under subsection (d)
for the detection of SARS–CoV–2 or the prevention, diagnosis,
and treatment of COVID–19.
SEC. 330A. ø254c¿ RURAL HEALTH CARE SERVICES OUTREACH, RURAL
HEALTH NETWORK DEVELOPMENT, AND SMALL HEALTH
CARE PROVIDER QUALITY IMPROVEMENT GRANT PROGRAMS.
(a) PURPOSE.—The purpose of this section is to provide grants
for expanded delivery of health care services in rural areas, for the
planning and implementation of integrated health care networks in
rural areas, and for the planning and implementation of small
health care provider quality improvement activities.
(b) DEFINITIONS.—
(1) DIRECTOR.—The term ‘‘Director’’ means the Director
specified in subsection (d).
(2) FEDERALLY QUALIFIED HEALTH CENTER; RURAL HEALTH
CLINIC.—The terms ‘‘Federally qualified health center’’ and
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228
‘‘rural health clinic’’ have the meanings given the terms in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
(3) HEALTH PROFESSIONAL SHORTAGE AREA.—The term
‘‘health professional shortage area’’ means a health professional shortage area designated under section 332.
(4) MEDICALLY UNDERSERVED COMMUNITY.—The term
‘‘medically underserved community’’ has the meaning given the
term in section 799B(6).
(5) MEDICALLY UNDERSERVED POPULATION.—The term
‘‘medically underserved population’’ has the meaning given the
term in section 330(b)(3).
(c) PROGRAM.—The Secretary shall establish, under section
301, a small health care provider quality improvement grant program.
(d) ADMINISTRATION.—
(1) PROGRAMS.—The rural health care services outreach,
rural health network development, and small health care provider quality improvement grant programs established under
section 301 shall be administered by the Director of the Office
of Rural Health Policy of the Health Resources and Services
Administration, in consultation with State offices of rural
health or other appropriate State government entities.
(2) GRANTS.—
(A) IN GENERAL.—In carrying out the programs described in paragraph (1), the Director may award grants
under subsections (e), (f), and (g) to expand access to, coordinate, and improve the quality of basic health care services, and enhance the delivery of health care, in rural
areas.
(B) TYPES OF GRANTS.—The Director may award the
grants to—
(i) promote expanded delivery of health care services in rural areas under subsection (e);
(ii) provide for the planning and implementation
of integrated health care networks in rural areas
under subsection (f); and
(iii) provide for the planning and implementation
of small health care provider quality improvement activities under subsection (g).
(e) RURAL HEALTH CARE SERVICES OUTREACH GRANTS.—
(1) GRANTS.—The Director may award grants to eligible
entities to promote rural health care services outreach by improving and expanding the delivery of health care services to
include new and enhanced services in rural areas, through
community engagement and evidence-based or innovative, evidence-informed models. The Director may award the grants for
periods of not more than 5 years.
(2) ELIGIBILITY.—To be eligible to receive a grant under
this subsection for a project, an entity shall—
(A) be an entity with demonstrated experience serving,
or the capacity to serve, rural underserved populations;
(B) represent a consortium composed of members
that—
(i) include 3 or more health care providers; and
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(ii) may be nonprofit or for-profit entities; and
(C) not previously have received a grant under this
subsection for the same or a similar project, unless the entity is proposing to expand the scope of the project or the
area that will be served through the project.
(3) APPLICATIONS.—To be eligible to receive a grant under
this subsection, an eligible entity, in consultation with the appropriate State office of rural health or another appropriate
State entity, shall prepare and submit to the Secretary an application, at such time, in such manner, and containing such
information as the Secretary may require, including—
(A) a description of the project that the eligible entity
will carry out using the funds provided under the grant;
(B) a description of the manner in which the project
funded under the grant will meet the health care needs of
rural underserved populations in the local community or
region to be served;
(C) a description of how the rural underserved populations in the local community or region to be served will
be involved in the development and ongoing operations of
the project;
(D) a plan for sustaining the project after Federal support for the project has ended;
(E) a description of how the project will be evaluated;
and
(F) other such information as the Secretary determines to be appropriate.
(f) RURAL HEALTH NETWORK DEVELOPMENT GRANTS.—
(1) GRANTS.—
(A) IN GENERAL.—The Director may award rural
health network development grants to eligible entities to
plan, develop, and implement integrated health care networks that collaborate in order to—
(i) achieve efficiencies;
(ii) expand access to, coordinate, and improve the
quality of basic health care services and associated
health outcomes; and
(iii) strengthen the rural health care system as a
whole.
(B) GRANT PERIODS.—The Director may award grants
under this subsection for periods of not more than 5 years.
(2) ELIGIBILITY.—To be eligible to receive a grant under
this subsection, an entity shall—
(A) be an entity with demonstrated experience serving,
or the capacity to serve, rural underserved populations;
(B) represent a network composed of participants
that—
(i) include 3 or more health care providers; and
(ii) may be nonprofit or for-profit entities; and
(C) not previously have received a grant under this
subsection (other than a grant for planning activities) for
the same or a similar project.
(3) APPLICATIONS.—To be eligible to receive a grant under
this subsection, an eligible entity, in consultation with the apFebruary 1, 2024
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propriate State office of rural health or another appropriate
State entity, shall prepare and submit to the Secretary an application, at such time, in such manner, and containing such
information as the Secretary may require, including—
(A) a description of the project that the eligible entity
will carry out using the funds provided under the grant;
(B) an explanation of the reasons why Federal assistance is required to carry out the project;
(C) a description of—
(i) the history of collaborative activities carried
out by the participants in the network;
(ii) the degree to which the participants are ready
to integrate their functions; and
(iii) how the rural underserved populations in the
local community or region to be served will benefit
from and be involved in the development and ongoing
operations of the network;
(D) a description of how the rural underserved populations in the local community or region to be served will
experience increased access to quality health care services
across the continuum of care as a result of the integration
activities carried out by the network;
(E) a plan for sustaining the project after Federal support for the project has ended;
(F) a description of how the project will be evaluated;
and
(G) other such information as the Secretary determines to be appropriate.
(g) SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT
GRANTS.—
(1) GRANTS.—The Director may award grants to provide
for the planning and implementation of small health care provider quality improvement activities, including activities related to increasing care coordination, enhancing chronic disease management, and improving patient health outcomes. The
Director may award the grants for periods of 1 to 5 years.
(2) ELIGIBILITY.—To be eligible for a grant under this subsection, an entity shall—
(A)(i) be a rural public or rural nonprofit private
health care provider or provider of health care services,
such as a critical access hospital or a rural health clinic;
or
(ii) be another rural provider or network of small rural
providers identified by the Secretary as a key source of
local or regional care; and
(B) not previously have received a grant under this
subsection for the same or a similar project.
(3) APPLICATIONS.—To be eligible to receive a grant under
this subsection, an eligible entity, in consultation with the appropriate State office of rural health or another appropriate
State entity shall prepare and submit to the Secretary an application, at such time, in such manner, and containing such
information as the Secretary may require, including—
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(A) a description of the project that the eligible entity
will carry out using the funds provided under the grant;
(B) an explanation of the reasons why Federal assistance is required to carry out the project;
(C) a description of the manner in which the project
funded under the grant will assure continuous quality improvement in the provision of services by the entity;
(D) a description of how the rural underserved populations in the local community or region to be served will
experience increased access to quality health care services
across the continuum of care as a result of the activities
carried out by the entity;
(E) a plan for sustaining the project after Federal support for the project has ended;
(F) a description of how the project will be evaluated;
and
(G) other such information as the Secretary determines to be appropriate.
(4) EXPENDITURES FOR SMALL HEALTH CARE PROVIDER
QUALITY IMPROVEMENT GRANTS.—In awarding a grant under
this subsection, the Director shall ensure that the funds made
available through the grant will be used to provide services to
residents of rural areas. The Director shall award not less than
50 percent of the funds made available under this subsection
to providers located in and serving rural areas.
(h) GENERAL REQUIREMENTS.—
(1) PROHIBITED USES OF FUNDS.—An entity that receives a
grant under this section may not use funds provided through
the grant—
(A) to build or acquire real property; or
(B) for construction.
(2) COORDINATION WITH OTHER AGENCIES.—The Secretary
shall coordinate activities carried out under grant programs
described in this section, to the extent practicable, with Federal and State agencies and nonprofit organizations that are
operating similar grant programs, to maximize the effect of
public dollars in funding meritorious proposals.
(3) PREFERENCE.—In awarding grants under this section,
the Secretary, as appropriate, shall give preference to entities
that—
(A) are located in health professional shortage areas or
medically underserved communities, or serve medically underserved populations; or
(B) propose to develop projects with a focus on primary
care, and wellness and prevention strategies.
(i) REPORT.—Not later than 4 years after the date of enactment
of the Coronavirus Aid, Relief, and Economic Security Act, and
every 5 years thereafter, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report on the activities and outcomes of the
grant programs under subsections (e), (f), and (g), including the impact of projects funded under such programs on the health status
of rural residents with chronic conditions.
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(j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $79,500,000 for each of
fiscal years 2021 through 2025.
SEC. 330A–1. ø254c–1a¿ GRANTS TO NURSE–MANAGED HEALTH CLINICS.
(a) DEFINITIONS.—
(1) COMPREHENSIVE PRIMARY HEALTH CARE SERVICES.—In
this section, the term ‘‘comprehensive primary health care
services’’ means the primary health services described in section 330(b)(1).
(2) NURSE-MANAGED HEALTH CLINIC.—The term ‘‘nursemanaged health clinic’’ means a nurse-practice arrangement,
managed by advanced practice nurses, that provides primary
care or wellness services to underserved or vulnerable populations and that is associated with a school, college, university
or department of nursing, federally qualified health center, or
independent nonprofit health or social services agency.
(b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award
grants for the cost of the operation of nurse-managed health clinics
that meet the requirements of this section.
(c) APPLICATIONS.—To be eligible to receive a grant under this
section, an entity shall—
(1) be an NMHC; and
(2) submit to the Secretary an application at such time, in
such manner, and containing—
(A) assurances that nurses are the major providers of
services at the NMHC and that at least 1 advanced practice nurse holds an executive management position within
the organizational structure of the NMHC;
(B) an assurance that the NMHC will continue providing comprehensive primary health care services or
wellness services without regard to income or insurance
status of the patient for the duration of the grant period;
and
(C) an assurance that, not later than 90 days of receiving a grant under this section, the NMHC will establish a
community advisory committee, for which a majority of the
members shall be individuals who are served by the
NMHC.
(d) GRANT AMOUNT.—The amount of any grant made under
this section for any fiscal year shall be determined by the Secretary, taking into account—
(1) the financial need of the NMHC, considering State,
local, and other operational funding provided to the NMHC;
and
(2) other factors, as the Secretary determines appropriate.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purposes of
carrying out this section, there are authorized to be appropriated
$50,000,000 for the fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011 through 2014.
SEC. 330A–2. ø254c-1b¿ RURAL OBSTETRIC NETWORK GRANTS.
(a) PROGRAM ESTABLISHED.—The Secretary shall award
grants
or cooperative agreements to eligible entities to establish collaborative improvement and innovation networks (referred to in this
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PUBLIC HEALTH SERVICE ACT
Sec. 330A–2
section as ‘‘rural obstetric networks’’) to improve maternal and infant health outcomes and reduce preventable maternal mortality
and severe maternal morbidity by improving maternity care and
access to care in rural areas, frontier areas, maternity care health
professional target areas, or jurisdictions of Indian Tribes and Tribal organizations.
(b) USE OF FUNDS.—Grants or cooperative agreements awarded
pursuant to this section shall be used for the establishment or continuation of collaborative improvement and innovation networks to
improve maternal and infant health outcomes and reduce preventable maternal mortality and severe maternal morbidity by improving prenatal care, labor care, birthing, and postpartum care services in rural areas. Rural obstetric networks established in accordance with this section may—
(1) develop a network to improve coordination and increase
access to maternal health care and assist pregnant women in
the areas described in subsection (a) with accessing and utilizing prenatal care, labor care, birthing, and postpartum care
services to improve outcomes in birth and maternal mortality
and morbidity;
(2) identify and implement evidence-based and sustainable
delivery models for providing prenatal care, labor care, birthing, and postpartum care services, including home visiting programs and culturally appropriate care models that reduce
health disparities;
(3) develop a model for maternal health care collaboration
between health care settings to improve access to care in areas
described in subsection (a), which may include the use of telehealth;
(4) provide training for professionals in health care settings that do not have specialty maternity care;
(5) collaborate with academic institutions that can provide
regional expertise and help identify barriers to providing maternal health care, including strategies for addressing such
barriers; and
(6) assess and address disparities in infant and maternal
health outcomes, including among racial and ethnic minority
populations and underserved populations in such areas described in subsection (a).
(c) DEFINITIONS.—In this section:
(1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means
entities providing prenatal care, labor care, birthing, and
postpartum care services in rural areas, frontier areas, or
medically underserved areas, or to medically underserved populations or Indian Tribes or Tribal organizations.
(2) FRONTIER AREA.—The term ‘‘frontier area’’ means a
frontier county, as defined in section 1886(d)(3)(E)(iii)(III) of
the Social Security Act.
(3) INDIAN TRIBES; TRIBAL ORGANIZATION.—The terms ‘‘Indian Tribe’’ and ‘‘Tribal organization’’ have the meanings given
the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ in section 4
of the Indian Self-Determination and Education Assistance
Act.
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234
(4) MATERNITY CARE HEALTH PROFESSIONAL TARGET
AREA.—The term ‘‘maternity care health professional target
area’’ has the meaning described in section 332(k)(2).
(d) REPORT TO CONGRESS.—Not later than September 30, 2026,
the Secretary shall submit to Congress a report on activities supported by grants awarded under this section, including—
(1) a description of activities conducted pursuant to paragraphs (1) through (6) of subsection (b); and
(2) an analysis of the effects of rural obstetric networks on
improving maternal and infant health outcomes.
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $3,000,000 for each of
fiscal years 2023 through 2027.
SEC. 330B. ø254c–2¿ SPECIAL DIABETES PROGRAMS FOR TYPE I DIABETES. 34
(a) IN GENERAL.—The Secretary, directly or through grants,
shall provide for research into the prevention and cure of Type I
diabetes.
(b) FUNDING.—
(1) TRANSFERRED FUNDS.—Notwithstanding section 2104(a)
of the Social Security Act, from the amounts appropriated in
such section for each of fiscal years 1998 through 2002,
$30,000,000 is hereby transferred and made available in such
fiscal year for grants under this section.
(2) APPROPRIATIONS.—For the purpose of making grants
under this section, there is appropriated, out of any funds in
the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001 and 2002
(which shall be combined with amounts transferred under
paragraph (1) for each such fiscal years);
(B) $100,000,000 for fiscal year 2003;
(C) $150,000,000 for each of fiscal years 2004 through
2017;
(D) $150,000,000 for each of fiscal years 2018 through
2023, to remain available until expended; and
(E) $19,726,027 for the period beginning on October 1,
2023, and ending on November 17, 2023, $25,890,411 for
the period beginning on November 18, 2023, and ending on
January 19, 2024, and $20,136,986 for the period beginning on January 20, 2024, and ending on March 8, 2024,
to remain available until expended.
SEC. 330C. ø254c–3¿ SPECIAL DIABETES PROGRAMS FOR INDIANS. 35
(a) IN GENERAL.—The Secretary shall make grants for pro-
viding services for the prevention and treatment of diabetes in accordance with subsection (b).
(b) SERVICES THROUGH INDIAN HEALTH FACILITIES.—For purposes of subsection (a), services under such subsection are provided
34 Section 4923 of Public Law 105–33 (111 Stat. 574, as amended by section 1(c) of Public Law
107–360 (116 Stat. 3019),) requires the Secretary of Health and Human Services to conduct
evaluations regarding programs under sections 330B and 330C. An interim report is required
to be submitted to the appropriate committees of Congress not later than January 1, 2000, and
a final report is required to be submitted not later than January 1, 2007.
35 See footnote to section 330B.
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PUBLIC HEALTH SERVICE ACT
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in accordance with this subsection if the services are provided
through any of the following entities:
(1) The Indian Health Service.
(2) An Indian health program operated by an Indian tribe
or tribal organization pursuant to a contract, grant, cooperative
agreement, or compact with the Indian Health Service pursuant to the Indian Self-Determination Act.
(3) An urban Indian health program operated by an urban
Indian organization pursuant to a grant or contract with the
Indian Health Service pursuant to title V of the Indian Health
Care Improvement Act.
(c) FUNDING.—
(1) TRANSFERRED FUNDS.—Notwithstanding section 2104(a)
of the Social Security Act, from the amounts appropriated in
such section for each of fiscal years 1998 through 2002,
$30,000,000, to remain available until expended, is hereby
transferred and made available in such fiscal year for grants
under this section.
(2) APPROPRIATIONS.—For the purpose of making grants
under this section, there is appropriated, out of any money in
the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001 and 2002
(which shall be combined with amounts transferred under
paragraph (1) for each such fiscal years);
(B) $100,000,000 for fiscal year 2003;
(C) $150,000,000 for each of fiscal years 2004 through
2017;
(D) $150,000,000 for each of fiscal years 2018 through
2023, to remain available until expended; and
(E) $19,726,027 for the period beginning on October 1,
2023, and ending on November 17, 2023, $25,890,411 for
the period beginning on November 18, 2023, and ending on
January 19, 2024, and $20,136,986 for the period beginning on January 20, 2024, and ending on March 8, 2024,
to remain available until expended.
SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
(a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
(1) IN GENERAL.—The Secretary shall develop
and implement public health surveillance, education, research, and intervention strategies to improve the lives of persons with epilepsy,
with a particular emphasis on children. Such projects may be
carried out by the Secretary directly and through awards of
grants or contracts to public or nonprofit private entities. The
Secretary may directly or through such awards provide technical assistance with respect to the planning, development, and
operation of such projects.
(2) CERTAIN ACTIVITIES.—Activities under paragraph (1)
shall include—
(A) expanding current surveillance activities through
existing monitoring systems and improving registries that
maintain data on individuals with epilepsy, including children;
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(B) enhancing research activities on the diagnosis,
treatment, and management of epilepsy;
(C) implementing public and professional information
and education programs regarding epilepsy, including initiatives which promote effective management of the disease through children’s programs which are targeted to
parents, schools, daycare providers, patients;
(D) undertaking educational efforts with the media,
providers of health care, schools and others regarding stigmas and secondary disabilities related to epilepsy and seizures, and its effects on youth;
(E) utilizing and expanding partnerships with organizations with experience addressing the health and related
needs of people with disabilities; and
(F) other activities the Secretary deems appropriate.
(3) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this subsection are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding epilepsy and seizure.
(b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDICALLY UNDERSERVED AREAS.—
(1) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants for the purpose of carrying out demonstration projects to improve access to health and other services regarding seizures to encourage early detection and treatment in children and others residing in medically underserved
areas.
(2) APPLICATION FOR GRANT.—A grant may not be awarded
under paragraph (1) unless an application therefore is submitted to the Secretary and the Secretary approves such application. Such application shall be submitted in such form and
manner and shall contain such information as the Secretary
may prescribe.
(c) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘epilepsy’’ refers to a chronic and serious neurological condition characterized by excessive electrical discharges in the brain causing recurring seizures affecting all life
activities. The Secretary may revise the definition of such term
to the extent the Secretary determines necessary.
(2) The term ‘‘medically underserved’’ has the meaning applicable under section 799B(6).
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
(a) INFANT ADOPTION AWARENESS.—
(1) IN GENERAL.—The Secretary shall make grants to
national, regional, or local adoption organizations for the purpose
of developing and implementing programs to train the designated staff of eligible health centers in providing adoption information and referrals to pregnant women on an equal basis
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with all other courses of action included in nondirective counseling to pregnant women.
(2) BEST-PRACTICES GUIDELINES.—
(A) IN GENERAL.—A condition for the receipt of a grant
under paragraph (1) is that the adoption organization involved agree that, in providing training under such paragraph, the organization will follow the guidelines developed under subparagraph (B).
(B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
(i) IN GENERAL.—The Secretary shall establish
and supervise a process described in clause (ii) in
which the participants are—
(I) an appropriate number and variety of
adoption organizations that, as a group, have expertise in all models of adoption practice and that
represent all members of the adoption triad (birth
mother, infant, and adoptive parent); and
(II) affected public health entities.
(ii) DESCRIPTION OF PROCESS.—The process referred to in clause (i) is a process in which the participants described in such clause collaborate to develop
best-practices guidelines on the provision of adoption
information and referrals to pregnant women on an
equal basis with all other courses of action included in
nondirective counseling to pregnant women.
(iii) DATE CERTAIN FOR DEVELOPMENT.—The Secretary shall ensure that the guidelines described in
clause (ii) are developed not later than 180 days after
the date of the enactment of the Children’s Health Act
of 2000 36.
(C) RELATION TO AUTHORITY FOR GRANTS.—The Secretary may not make any grant under paragraph (1) before
the date on which the guidelines under subparagraph (B)
are developed.
(3) USE OF GRANT.—
(A) IN GENERAL.—With respect to a grant under paragraph (1)—
(i) an adoption organization may expend the grant
to carry out the programs directly or through grants
to or contracts with other adoption organizations;
(ii) the purposes for which the adoption organization expends the grant may include the development
of a training curriculum, consistent with the guidelines developed under paragraph (2)(B); and
(iii) a condition for the receipt of the grant is that
the adoption organization agree that, in providing
training for the designated staff of eligible health centers, such organization will make reasonable efforts to
ensure that the individuals who provide the training
are individuals who are knowledgeable in all elements
of the adoption process and are experienced in providing adoption information and referrals in the geo36 Public
Law 106–310, enacted October 17, 2000.
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graphic areas in which the eligible health centers are
located, and that the designated staff receive the
training in such areas.
(B) RULE OF CONSTRUCTION REGARDING TRAINING OF
TRAINERS.—With respect to individuals who under a grant
under paragraph (1) provide training for the designated
staff of eligible health centers (referred to in this subparagraph as ‘‘trainers’’), subparagraph (A)(iii) may not be construed as establishing any limitation regarding the geographic area in which the trainers receive instruction in
being such trainers. A trainer may receive such instruction
in a different geographic area than the area in which the
trainer trains (or will train) the designated staff of eligible
health centers.
(4) ADOPTION ORGANIZATIONS; ELIGIBLE HEALTH CENTERS;
OTHER DEFINITIONS.—For purposes of this section:
(A) The term ‘‘adoption organization’’ means a national, regional, or local organization—
(i) among whose primary purposes are adoption;
(ii) that is knowledgeable in all elements of the
adoption process and on providing adoption information and referrals to pregnant women; and
(iii) that is a nonprofit private entity.
(B) The term ‘‘designated staff’’, with respect to an eligible health center, means staff of the center who provide
pregnancy or adoption information and referrals (or will
provide such information and referrals after receiving
training under a grant under paragraph (1)).
(C) The term ‘‘eligible health centers’’ means public
and nonprofit private entities that provide health services
to pregnant women.
(5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A
condition for the receipt of a grant under paragraph (1) is that
the adoption organization involved agree to make reasonable
efforts to ensure that the eligible health centers with respect
to which training under the grant is provided include—
(A) eligible health centers that receive grants under
section 1001 (relating to voluntary family planning
projects);
(B) eligible health centers that receive grants under
section 330 (relating to community health centers, migrant
health centers, and centers regarding homeless individuals
and residents of public housing); and
(C) eligible health centers that receive grants under
this Act for the provision of services in schools.
(6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.—
In the case of eligible health centers that receive grants under
section 330 or 1001:
(A) Within a reasonable period after the Secretary begins making grants under paragraph (1), the Secretary
shall provide eligible health centers with complete information about the training available from organizations receiving grants under such paragraph. The Secretary shall
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ters to arrange for designated staff to participate in such
training. Such efforts shall affirm Federal requirements, if
any, that the eligible health center provide nondirective
counseling to pregnant women.
(B) All costs of such centers in obtaining the training
shall be reimbursed by the organization that provides the
training, using grants under paragraph (1).
(C) Not later than 1 year after the date of the enactment of the Children’s Health Act of 2000 37, the Secretary
shall submit to the appropriate committees of the Congress
a report evaluating the extent to which adoption information and referral, upon request, are provided by eligible
health centers. Within a reasonable time after training
under this section is initiated, the Secretary shall submit
to the appropriate committees of the Congress a report
evaluating the extent to which adoption information and
referral, upon request, are provided by eligible health centers in order to determine the effectiveness of such training and the extent to which such training complies with
subsection (a)(1). In preparing the reports required by this
subparagraph, the Secretary shall in no respect interpret
the provisions of this section to allow any interference in
the provider-patient relationship, any breach of patient
confidentiality, or any monitoring or auditing of the counseling process or patient records which breaches patient
confidentiality or reveals patient identity. The reports required by this subparagraph shall be conducted by the Secretary acting through the Administrator of the Health Resources and Services Administration and in collaboration
with the Director of the Agency for Healthcare Research
and Quality.
(b) APPLICATION FOR GRANT.—The Secretary may make a grant
under subsection (a) only if an application for the grant is submitted to the Secretary and the application is in such form, is
made in such manner, and contains such agreements, assurances,
and information as the Secretary determines to be necessary to
carry out this section.
(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SEC. 330G. ø254c–7¿ SPECIAL NEEDS ADOPTION PROGRAMS; PUBLIC
AWARENESS CAMPAIGN AND OTHER ACTIVITIES.
(a) SPECIAL NEEDS ADOPTION AWARENESS CAMPAIGN.—
(1) IN GENERAL.—The Secretary shall, through making
grants to nonprofit private entities, provide for the planning,
development, and carrying out of a national campaign to provide information to the public regarding the adoption of children with special needs.
(2) INPUT ON PLANNING AND DEVELOPMENT.—In providing
for the planning and development of the national campaign
under paragraph (1), the Secretary shall provide for input from
37 Public
Law 106–310, enacted October 17, 2000.
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a number and variety of adoption organizations throughout the
States in order that the full national diversity of interests
among adoption organizations is represented in the planning
and development of the campaign.
(3) CERTAIN FEATURES.—With respect to the national campaign under paragraph (1):
(A) The campaign shall be directed at various populations, taking into account as appropriate differences
among geographic regions, and shall be carried out in the
language and cultural context that is most appropriate to
the population involved.
(B) The means through which the campaign may be
carried out include—
(i) placing public service announcements on television, radio, and billboards; and
(ii) providing information through means that the
Secretary determines will reach individuals who are
most likely to adopt children with special needs.
(C) The campaign shall provide information on the
subsidies and supports that are available to individuals regarding the adoption of children with special needs.
(D) The Secretary may provide that the placement of
public service announcements, and the dissemination of
brochures and other materials, is subject to review by the
Secretary.
(4) MATCHING REQUIREMENT.—
(A) IN GENERAL.—With respect to the costs of the activities to be carried out by an entity pursuant to paragraph (1), a condition for the receipt of a grant under such
paragraph is that the entity agree to make available (directly or through donations from public or private entities)
non-Federal contributions toward such costs in an amount
that is not less than 25 percent of such costs.
(B) DETERMINATION OF AMOUNT CONTRIBUTED.—NonFederal contributions under subparagraph (A) may be in
cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions.
(b) NATIONAL RESOURCES PROGRAM.—The Secretary shall (directly or through grant or contract) carry out a program that,
through toll-free telecommunications, makes available to the public
information regarding the adoption of children with special needs.
Such information shall include the following:
(1) A list of national, State, and regional organizations
that provide services regarding such adoptions, including exchanges and other information on communicating with the organizations. The list shall represent the full national diversity
of adoption organizations.
(2) Information beneficial to individuals who adopt such
children, including lists of support groups for adoptive parents
and other postadoptive services.
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(c) OTHER PROGRAMS.—With respect to the adoption of children
with special needs, the Secretary shall make grants—
(1) to provide assistance to support groups for adoptive
parents, adopted children, and siblings of adopted children;
and
(2) to carry out studies to identify—
(A) the barriers to completion of the adoption process;
and
(B) those components that lead to favorable long-term
outcomes for families that adopt children with special
needs.
(d) APPLICATION FOR GRANT.—The Secretary may make an
award of a grant or contract under this section only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(e) FUNDING.—For the purpose of carrying out this section,
there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
(a) IN GENERAL.—
(1) CONTINUATION AND EXPANSION OF PROGRAM.—The
Secretary, acting through the Administrator of the Health Resources and Services Administration, Maternal and Child
Health Bureau, shall under authority of this section continue
in effect the Healthy Start Initiative and may carry out such
program on a national basis.
(2) DEFINITION.—For purposes of paragraph (1), the term
‘‘Healthy Start Initiative’’ is a reference to the program that,
as an initiative to reduce the rate of infant mortality and improve perinatal outcomes, makes grants for project areas with
high or increasing above the national average annual rates of
infant mortality and that, prior to the effective date of this section, was a demonstration program carried out under section
301.
(b) CONSIDERATIONS IN MAKING GRANTS.—
(1) REQUIREMENTS.—In making grants under subsection
(a), the Secretary shall require that applicants (in addition to
meeting all eligibility criteria established by the Secretary) establish, for project areas under such subsection, communitybased consortia of individuals and organizations (including
agencies responsible for administering block grant programs
under title V of the Social Security Act, participants and
former participants of project services, public health departments, hospitals, health centers under section 330, State substance abuse agencies, and other significant sources of health
care services) that are appropriate for participation in projects
under subsection (a).
(2) OTHER CONSIDERATIONS.—In making grants under subsection (a), the Secretary shall take into consideration the following:
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(A) Factors that contribute to infant mortality, including poor birth outcomes (such as low birthweight and
preterm birth) and social determinants of health.
(B) Communities with—
(i) high rates of infant mortality or poor perinatal
outcomes; or
(ii) high rates of infant mortality or poor perinatal
outcomes in specific subpopulations within the community.
(C) The extent to which applicants for such grants facilitate—
(i) collaboration with the local community in the
development of the project;
(ii) a community-based approach to the delivery of
services;
(iii) a comprehensive approach to women’s health
care to improve perinatal outcomes; and
(iv) the use and collection of data demonstrating
the effectiveness of such program in decreasing infant
mortality rates and improving perinatal outcomes, as
applicable, or the process by which new applicants
plan to collect this data.
(3) SPECIAL PROJECTS.—Nothing in paragraph (2) shall be
construed to prevent the Secretary from awarding grants
under subsection (a) for special projects that are intended to
address significant disparities in perinatal health indicators in
communities along the United States-Mexico border or in Alaska or Hawaii.
(c) COORDINATION.—
(1) IN GENERAL.—Recipients of grants under subsection (a)
shall coordinate their services and activities with the State
agency or agencies that administer block grant programs under
title V of the Social Security Act in order to promote cooperation, integration, and dissemination of information with Statewide systems and with other community services funded under
the Maternal and Child Health Block Grant.
(2) OTHER PROGRAMS.—The Secretary shall ensure coordination of the program carried out pursuant to this section with
other programs and activities related to the reduction of the
rate of infant mortality and improved perinatal and infant
health outcomes supported by the Department.
(d) RULE OF CONSTRUCTION.—Except to the extent inconsistent
with this section, this section may not be construed as affecting the
authority of the Secretary to make modifications in the program
carried out under subsection (a).
(e) FUNDING.—
(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose
of carrying out this section, there are authorized to be appropriated $125,500,000 for each of fiscal years 2021 through
2025.
(2) ALLOCATION.—
(A) PROGRAM ADMINISTRATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve up to 5 percent for coordination, disFebruary 1, 2024
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semination, technical assistance, and data activities that
are determined by the Secretary to be appropriate for carrying out the program under this section.
(B) EVALUATION.—Of the amounts appropriated under
paragraph (1) for a fiscal year, the Secretary may reserve
up to 1 percent for evaluations of projects carried out
under subsection (a). Each such evaluation shall include a
determination of whether such projects have been effective
in reducing the disparity in health status between the general population and individuals who are members of racial
or ethnic minority groups. Evaluations may also include, to
the extent practicable, information related to—
(i) progress toward achieving any grant metrics or
outcomes related to reducing infant mortality rates,
improving perinatal outcomes, or reducing the disparity in health status;
(ii) recommendations on potential improvements
that may assist with addressing gaps, as applicable
and appropriate; and
(iii) the extent to which the grantee coordinated
with the community in which the grantee is located in
the development of the project and delivery of services,
including with respect to technical assistance and
mentorship programs.
(f) GAO REPORT.—
(1) IN GENERAL.—Not later than 4 years after the date of
the enactment of this subsection, the Comptroller General of
the United States shall conduct an independent evaluation,
and submit to the appropriate Committees of Congress a report, concerning the Healthy Start program under this section.
(2) EVALUATION.—In conducting the evaluation under
paragraph (1), the Comptroller General shall consider, as applicable and appropriate, information from the evaluations
under subsection (e)(2)(B).
(3) REPORT.—The report described in paragraph (1) shall
review, assess, and provide recommendations, as appropriate,
on the following:
(A) The allocation of Healthy Start program grants by
the Health Resources and Services Administration, including considerations made by such Administration regarding
disparities in infant mortality or perinatal outcomes
among urban and rural areas in making such awards.
(B) Trends in the progress made toward meeting the
evaluation criteria pursuant to subsection (e)(2)(B), including programs which decrease infant mortality rates and
improve perinatal outcomes, programs that have not decreased infant mortality rates or improved perinatal outcomes, and programs that have made an impact on disparities in infant mortality or perinatal outcomes.
(C) The ability of grantees to improve health outcomes
for project participants, promote the awareness of the
Healthy Start program services, incorporate and promote
family participation, facilitate coordination with the community in which the grantee is located, and increase
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grantee accountability through quality improvement, performance monitoring, evaluation, and the effect such
metrics may have toward decreasing the rate of infant
mortality and improving perinatal outcomes.
(D) The extent to which such Federal programs are coordinated across agencies and the identification of opportunities for improved coordination in such Federal programs
and activities.
SEC. 330I. ø254c–14¿ TELEHEALTH NETWORK AND TELEHEALTH RESOURCE CENTERS GRANT PROGRAMS.
(a) DEFINITIONS.—In this section:
(1) DIRECTOR; OFFICE.—The terms ‘‘Director’’ and ‘‘Office’’
mean the Director and Office specified in subsection (c).
(2) FEDERALLY QUALIFIED HEALTH CENTER AND RURAL
HEALTH CLINIC.—The term ‘‘Federally qualified health center’’
and ‘‘rural health clinic’’ have the meanings given the terms in
section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa)).
(3) FRONTIER COMMUNITY.—The term ‘‘frontier community’’
shall have the meaning given the term in regulations issued
under subsection (r).
(4) MEDICALLY UNDERSERVED AREA.—The term ‘‘medically
underserved area’’ has the meaning given the term ‘‘medically
underserved community’’ in section 799B(6).
(5) MEDICALLY UNDERSERVED POPULATION.—The term
‘‘medically underserved population’’ has the meaning given the
term in section 330(b)(3).
(6) TELEHEALTH SERVICES.—The term ‘‘telehealth services’’
means services provided through telehealth technologies.
(7) TELEHEALTH TECHNOLOGIES.—The term ‘‘telehealth
technologies’’ means technologies relating to the use of electronic information, and telecommunications technologies, to
support and promote, at a distance, health care, patient and
professional health-related education, health administration,
and public health.
(b) PROGRAMS.—The Secretary shall establish, under section
301, telehealth network and telehealth resource centers grant programs.
(c) ADMINISTRATION.—
(1) ESTABLISHMENT.—There is established in the Health
Resources and Services Administration an Office for the Advancement of Telehealth. The Office shall be headed by a Director.
(2) DUTIES.—The telehealth network and telehealth resource centers grant programs established under section 301
shall be administered by the Director, in consultation with the
State offices of rural health, State offices concerning primary
care, or other appropriate State government entities.
(d) GRANTS.—
(1) TELEHEALTH NETWORK GRANTS.—The Director may, in
carrying out the telehealth network grant program referred to
in subsection (b), award grants to eligible entities for evidencebased projects that utilize telehealth technologies through telehealth networks in rural areas, frontier communities, and
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medically underserved areas, and for medically underserved
populations, to—
(A) expand access to, coordinate, and improve access
to, and the quality of, health care services; and
(B) expand and improve the quality of health information available to health care providers,, patients, and their
families.
(2) TELEHEALTH RESOURCE CENTERS GRANTS.—The Director
may, in carrying out the telehealth resource centers grant program referred to in subsection (b), award grants to eligible entities for projects to support initiatives that utilize telehealth
technologies in the areas and communities, and for the populations, described in paragraph (1).
(e) GRANT PERIODS.—The Director may award grants under
this section for periods of not more than 5 years.
(f) ELIGIBLE ENTITIES.—
(1) IN GENERAL.—To be eligible to receive a grant under
subsection (d)(1), an entity shall demonstrate that the entity
will provide services through a telehealth network.
(2) NATURE OF ENTITIES.—Each entity participating in the
telehealth network may be a nonprofit or for-profit entity
(3) COMPOSITION OF NETWORK.—The telehealth network
shall include at least 2 of the following entities (at least 1 of
which shall be a community-based health care provider):
(A) Community or migrant health centers or other
Federally qualified health centers.
(B) Health care providers, including pharmacists, in
private practice.
(C) Entities operating clinics, including rural health
clinics.
(D) Local health departments.
(E) Nonprofit hospitals, including community access
hospitals.
(F) Other publicly funded health or social service
agencies.
(G) Long-term care providers.
(H) Providers of health care services in the home.
(I) Providers of outpatient mental health and substance disorder services and entities operating outpatient
mental health and substance disorder facilities.
(J) Local or regional emergency health care providers.
(K) Institutions of higher education.
(L) Entities operating dental clinics.
(M) Providers of prenatal, labor care, birthing, and
postpartum care services, including hospitals that operate
obstetric care units.
(g) APPLICATIONS.—To be eligible to receive a grant under subsection (d), an eligible entity, in consultation with the appropriate
State office of rural health or another appropriate State entity,
shall prepare and submit to the Secretary an application, at such
time, in such manner, and containing such information as the Secretary may require, including—
(1) a description of the project that the eligible entity will
carry out using the funds provided under the grant;
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(2) a description of the manner in which the project funded
under the grant will meet the health care needs of rural or
other populations to be served through the project, and improve the access to services of, and the quality of the services
received by, those populations;
(3) evidence of local support for the project, and a description of how the areas, communities, or populations to be served
will be involved in the development and ongoing operations of
the project;
(4) a plan for sustaining the project after Federal support
for the project has ended;
(5) information on the source and amount of non-Federal
funds that the entity will provide for the project;
(6) information demonstrating the long-term viability of
the project, and other evidence of institutional commitment of
the entity to the project;
(7) in the case of an application for a project involving a
telehealth network, information demonstrating how the project
will promote the integration of telehealth technologies into the
operations of health care providers, to avoid redundancy, and
improve access to and the quality of care; and
(8) other such information as the Secretary determines to
be appropriate.
(h) PREFERENCES.—
(1) TELEHEALTH NETWORKS.—In awarding grants under
subsection (d)(1) for projects involving telehealth networks, the
Secretary shall give preference to an eligible entity that meets
at least 1 of the following requirements:
(A) ORGANIZATION.—The eligible entity is a rural community-based organization or another community-based organization.
(B) SERVICES.—The eligible entity proposes to use Federal funds made available through such a grant to develop
plans for, or to establish, telehealth networks that provide
mental health care, public health services, long-term care,
home care, preventive care, case management services,
prenatal care, labor care, birthing care, or postpartum
care.
(C) COORDINATION.—The eligible entity demonstrates
how the project to be carried out under the grant will be
coordinated with other relevant federally funded projects
in the areas, communities, and populations to be served
through the grant.
(D) NETWORK.—The eligible entity demonstrates that
the project involves a telehealth network that includes an
entity that—
(i) provides clinical health care services, or educational services for health care providers and for patients or their families; and
(ii) is—
(I) a public library;
(II) an institution of higher education; or
(III) a local government entity.
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(E) CONNECTIVITY.—The eligible entity proposes a
project that promotes local and regional connectivity within areas, communities, or populations to be served through
the project.
(2) TELEHEALTH RESOURCE CENTERS.—In awarding grants
under subsection (d)(2) for projects involving telehealth resource centers, the Secretary shall give preference to an eligible entity that meets at least 1 of the following requirements:
(A) PROVISION OF SERVICES.—The eligible entity has a
record of success in the provision of telehealth services to
rural areas, medically underserved areas, or medically underserved populations.
(B) COLLABORATION AND SHARING OF EXPERTISE.—The
eligible entity has a demonstrated record of collaborating
and sharing expertise with providers of telehealth services
at the national, regional, State, and local levels.
(C) BROAD RANGE OF TELEHEALTH SERVICES.—The eligible entity has a record of providing a broad range of telehealth services, which may include—
(i) a variety of clinical specialty services;
(ii) patient or family education;
(iii) health care professional education; and
(iv) rural residency support programs.
(i) DISTRIBUTION OF FUNDS.—
(1) IN GENERAL.—In awarding grants under this section,
the Director shall ensure, to the greatest extent possible, that
such grants are equitably distributed among the geographical
regions of the United States.
(2) TELEHEALTH NETWORKS.—In awarding grants under
subsection (d)(1) for a fiscal year, the Director shall ensure
that not less than 50 percent of the funds awarded shall be
awarded for projects in rural areas.
(j) USE OF FUNDS.—
(1) TELEHEALTH NETWORK PROGRAM.—The recipient of a
grant under subsection (d)(1) may use funds received through
such grant for salaries, equipment, and operating or other
costs, including the cost of—
(A) developing and delivering clinical telehealth services that enhance access to community-based health care
services in rural areas, frontier communities, or medically
underserved areas, or for medically underserved populations;
(B) developing and acquiring, through lease or purchase, equipment that furthers the objectives of the telehealth network grant program;
(C)(i) developing and providing distance education, in
a manner that enhances access to care in rural areas, frontier communities, or medically underserved areas, or for
medically underserved populations; or
(ii) mentoring, precepting, or supervising health care
providers and students seeking to become health care providers, in a manner that enhances access to care in the
areas and communities, or for the populations, described
in clause (i);
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(D) developing and acquiring instructional programming;
(E)(i) providing for transmission of medical data, and
maintenance of equipment; and
(ii) providing for compensation (including travel expenses) of specialists, and referring health care providers,
who are providing telehealth services through the telehealth network, if no third party payment is available for
the telehealth services delivered through the telehealth
network;
(F) developing projects to use telehealth technology to
facilitate collaboration between health care providers;
(G) collecting and analyzing usage statistics and data
to document the cost-effectiveness of the telehealth services; and
(H) carrying out such other activities as are consistent
with achieving the objectives of this section, as determined
by the Secretary.
(2) TELEHEALTH RESOURCE CENTERS.—The recipient of a
grant under subsection (d)(2) may use funds received through
such grant for salaries, equipment, and operating or other
costs for—
(A) providing technical assistance, training, and support, and providing for travel expenses, for health care providers and a range of health care entities that provide or
will provide telehealth services;
(B) disseminating information and research findings
related to telehealth services;
(C) promoting effective collaboration among telehealth
resource centers and the Office;
(D) conducting evaluations to determine the best utilization of telehealth technologies to meet health care needs;
(E) promoting the integration of the technologies used
in clinical information systems with other telehealth technologies;
(F) fostering the use of telehealth technologies to provide health care information and education for consumers
in a more effective manner; and
(G) implementing special projects or studies under the
direction of the Office.
(k) PROHIBITED USES OF FUNDS.—An entity that receives a
grant under this section may not use funds made available through
the grant—
(1) to acquire real property;
(2) for expenditures to purchase or lease equipment, to the
extent that the expenditures would exceed 20 percent of the
total grant funds;
(3) in the case of a project involving a telehealth network,
to purchase or install transmission equipment;
(4) to pay for any equipment or transmission costs not directly related to the purposes for which the grant is awarded;
(5) to purchase or install general purpose voice telephone
systems;
(6) for construction; or
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PUBLIC HEALTH SERVICE ACT
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(7) for expenditures for indirect costs (as determined by
the Secretary), to the extent that the expenditures would exceed 15 percent of the total grant funds.
(l) COLLABORATION.—In providing services under this section,
an eligible entity shall collaborate, if feasible, with entities that—
(1)(A) are private or public organizations, that receive Federal or State assistance; or
(B) are public or private entities that operate centers, or
carry out programs, that receive Federal or State assistance;
and
(2) provide telehealth services or related activities.
(m) COORDINATION WITH OTHER AGENCIES.—The Secretary
shall coordinate activities carried out under grant programs described in subsection (b), to the extent practicable, with Federal
and State agencies and nonprofit organizations that are operating
similar programs, to maximize the effect of public dollars in funding meritorious proposals.
(n) OUTREACH ACTIVITIES.—The Secretary shall establish and
implement procedures to carry out outreach activities to advise potential end users of telehealth services in rural areas, frontier communities, medically underserved areas, and medically underserved
populations in each State about the grant programs described in
subsection (b).
(o) TELEHEALTH.—It is the sense of Congress that, for purposes
of this section, States should develop reciprocity agreements so that
a provider of services under this section who is a licensed or otherwise authorized health care provider under the law of 1 or more
States, and who, through telehealth technology, consults with a licensed or otherwise authorized health care provider in another
State, is exempt, with respect to such consultation, from any State
law of the other State that prohibits such consultation on the basis
that the first health care provider is not a licensed or authorized
health care provider under the law of that State.
(p) REPORT.—Not later than 4 years after the date of enactment of the Coronavirus Aid, Relief, and Economic Security Act,
and every 5 years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the
House of Representatives a report on the activities and outcomes
of the grant programs under subsection (b).
(q) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $29,000,000 for each of
fiscal years 2021 through 2025.
SEC. 330J. ø254c–15¿ RURAL EMERGENCY MEDICAL SERVICE TRAINING
AND EQUIPMENT ASSISTANCE PROGRAM.
(a) GRANTS.—The Secretary, acting through the Administrator
of the Health Resources and Services Administration (referred to in
this section as the ‘‘Secretary’’) shall award grants to eligible entities to enable such entities to provide for improved emergency medical services in rural areas or to residents of rural areas.
(b) ELIGIBILITY; APPLICATION.—To be eligible to receive grant
under this section, an entity shall—
(1) be—
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(A) an emergency medical services agency operated by
a local or tribal government (including fire-based and nonfire based); or
(B) an emergency medical services agency that is described in section 501(c) of the Internal Revenue Code of
1986 and exempt from tax under section 501(a) of such
Code; and
(2) submit an application to the Secretary at such time, in
such manner, and containing such information as the Secretary may require.
(c) USE OF FUNDS.—An entity—
(1) shall use amounts received through a grant under subsection (a) to—
(A) train emergency medical services personnel as appropriate to obtain and maintain licenses and certifications
relevant to service in an emergency medical services agency described in subsection (b)(1);
(B) conduct courses that qualify graduates to serve in
an emergency medical services agency described in subsection (b)(1) in accordance with State and local requirements;
(C) fund specific training to meet Federal or State licensing or certification requirements; and
(D) acquire emergency medical services equipment;
and
(2) may use amounts received through a grant under subsection (a) to—
(A) recruit and retain emergency medical services personnel, which may include volunteer personnel;
(B) develop new ways to educate emergency health
care providers through the use of technology-enhanced
educational methods; or
(C) acquire personal protective equipment for emergency medical services personnel as required by the Occupational Safety and Health Administration.
(d) GRANT AMOUNTS.—Each grant awarded under this section
shall be in an amount not to exceed $200,000.
(e) DEFINITIONS.—In this section:
(1) The term ‘‘emergency medical services’’—
(A) means resources used by a public or private nonprofit licensed entity to deliver medical care outside of a
medical facility under emergency conditions that occur as
a result of the condition of the patient; and
(B) includes services delivered (either on a compensated or volunteer basis) by an emergency medical
services provider or other provider that is licensed or certified by the State involved as an emergency medical technician, a paramedic, or an equivalent professional (as determined by the State).
(2) The term ‘‘rural area’’ means—
(A) a nonmetropolitan statistical area;
(B) an area designated as a rural area by any law or
regulation of a State; or
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Sec. 330K
(C) a rural census tract of a metropolitan statistical
area (as determined under the most recent rural urban
commuting area code as set forth by the Office of Management and Budget).
(f) MATCHING REQUIREMENT.—The Secretary may not award a
grant under this section to an entity unless the entity agrees that
the entity will make available (directly or through contributions
from other public or private entities) non-Federal contributions toward the activities to be carried out under the grant in an amount
equal to 10 percent of the amount received under the grant.
(g) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—There are authorized to be appropriated
to carry out this section such sums as may be necessary for
each of fiscal years 2019 through 2023.
(2) ADMINISTRATIVE COSTS.—The Secretary may use not
more than 10 percent of the amount appropriated under paragraph (1) for a fiscal year for the administrative expenses of
carrying out this section.
SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA
TELEHEALTH.
(a) DEFINITIONS.—In this section:
(1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a
public or nonprofit private telehealth provider network that offers services that include mental health services provided by
qualified mental health providers.
(2) QUALIFIED MENTAL HEALTH PROFESSIONALS.—The term
‘‘qualified mental health professionals’’ refers to providers of
mental health services reimbursed under the medicare program carried out under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.) who have additional training in the
treatment of mental illness in children and adolescents or who
have additional training in the treatment of mental illness in
the elderly.
(3) SPECIAL POPULATIONS.—The term ‘‘special populations’’
refers to the following 2 distinct groups:
(A) Children and adolescents in mental health underserved rural areas or in mental health underserved urban
areas.
(B) Elderly individuals located in long-term care facilities in mental health underserved rural or urban areas.
(4) TELEHEALTH.—The term ‘‘telehealth’’ means the use of
electronic information and telecommunications technologies to
support long distance clinical health care, patient and professional health-related education, public health, and health administration.
(b) PROGRAM AUTHORIZED.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Office for the Advancement of Telehealth of the
Health Resources and Services Administration, shall award
grants to eligible entities to establish demonstration projects
for the provision of mental health services to special populations as delivered remotely by qualified mental health professionals using telehealth and for the provision of education reFebruary 1, 2024
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garding mental illness as delivered remotely by qualified mental health professionals using telehealth.
(2) POPULATIONS SERVED.—The Secretary shall award the
grants under paragraph (1) in a manner that distributes the
grants so as to serve equitably the populations described in
subparagraphs (A) and (B) of subsection (a)(3).
(c) USE OF FUNDS.—
(1) IN GENERAL.—An eligible entity that receives a grant
under this section shall use the grant funds—
(A) for the populations described in subsection
(a)(3)(A)—
(i) to provide mental health services, including diagnosis and treatment of mental illness, as delivered
remotely by qualified mental health professionals
using telehealth; and
(ii) to collaborate with local public health entities
to provide the mental health services; and
(B) for the populations described in subsection
(a)(3)(B)—
(i) to provide mental health services, including diagnosis and treatment of mental illness, in long-term
care facilities as delivered remotely by qualified mental health professionals using telehealth; and
(ii) to collaborate with local public health entities
to provide the mental health services.
(2) OTHER USES.—An eligible entity that receives a grant
under this section may also use the grant funds to—
(A) pay telecommunications costs; and
(B) pay qualified mental health professionals on a reasonable cost basis as determined by the Secretary for services rendered.
(3) PROHIBITED USES.—An eligible entity that receives a
grant under this section shall not use the grant funds to—
(A) purchase or install transmission equipment (other
than such equipment used by qualified mental health professionals to deliver mental health services using telehealth under the project involved); or
(B) build upon or acquire real property.
(d) EQUITABLE DISTRIBUTION.—In awarding grants under this
section, the Secretary shall ensure, to the greatest extent possible,
that such grants are equitably distributed among geographical regions of the United States.
(e) APPLICATION.—An entity that desires a grant under this
section shall submit an application to the Secretary at such time,
in such manner, and containing such information as the Secretary
determines to be reasonable.
(f) REPORT.—Not later than 4 years after the date of enactment
of the Health Care Safety Net Amendments of 2002, the Secretary
shall prepare and submit to the appropriate committees of Congress a report that shall evaluate activities funded with grants
under this section.
(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, $20,000,000 for fiscal
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year 2002 and such sums as may be necessary for fiscal years 2003
through 2006.
SEC. 330L. ø254c–18¿ TELEMEDICINE; INCENTIVE GRANTS REGARDING
COORDINATION AMONG STATES.
(a) IN GENERAL.—The Secretary may make grants to State pro-
fessional licensing boards to carry out programs under which such
licensing boards of various States cooperate to develop and implement State policies that will reduce statutory and regulatory barriers to telemedicine.
(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out subsection (a), there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2002
through 2006.
SEC. 330M. ø254c–19¿ PEDIATRIC MENTAL HEALTH CARE ACCESS
GRANTS.
(a) IN GENERAL.—The Secretary, acting through the Adminis-
trator of the Health Resources and Services Administration and in
coordination with other relevant Federal agencies, shall award
grants or cooperative agreements to States, political subdivisions of
States, and Indian Tribes and Tribal organizations (for purposes of
this section, as such terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act (25 U.S.C. 450b))
to promote behavioral health integration in pediatric primary care
by—
(1) supporting the development of statewide or regional pediatric mental health care telehealth access programs; and
(2) supporting the improvement of existing statewide or regional pediatric mental health care telehealth access programs.
(b) PROGRAM REQUIREMENTS.—
(1) IN GENERAL.—A pediatric mental health care telehealth
access program referred to in subsection (a), with respect to
which an award under such subsection may be used, shall—
(A) be a statewide or regional network of pediatric
mental health teams that provide support to pediatric primary care sites as an integrated team;
(B) support and further develop organized State or regional networks of pediatric mental health teams to provide consultative support to pediatric primary care sites;
(C) conduct an assessment of critical behavioral consultation needs among pediatric providers and such providers’ preferred mechanisms for receiving consultation,
training, and technical assistance;
(D) develop an online database and communication
mechanisms, including telehealth, to facilitate consultation
support to pediatric practices;
(E) provide rapid statewide or regional clinical telephone or telehealth consultations when requested between
the pediatric mental health teams and pediatric primary
care providers;
(F) conduct training and provide technical assistance
to pediatric primary care providers to support the early
identification, diagnosis, treatment, and referral of children with behavioral health conditions;
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(G) provide information to pediatric providers about,
and assist pediatric providers in accessing, pediatric mental health care providers, including child and adolescent
psychiatrists, developmental-behavioral pediatricians, and
licensed mental health professionals, such as psychologists,
social workers, or mental health counselors and in scheduling and conducting technical assistance;
(H) provide information to pediatric health care providers about available mental health services for children
in the community and assist with referrals to specialty
care and community or behavioral health resources; and
(I) establish mechanisms for measuring and monitoring increased access to pediatric mental health care
services by pediatric primary care providers and expanded
capacity of pediatric primary care providers to identify,
treat, and refer children with mental health conditions.
(2) SUPPORT TO SCHOOLS AND EMERGENCY DEPARTMENTS.—
(A) IN GENERAL.—In addition to the activities required
under paragraph (1), a pediatric mental health care access
program referred to in subsection (a), with respect to
which an award under such subsection may be used, may
provide information, consultative support, training, and
technical assistance to—
(i) emergency departments; and
(ii) State educational agencies, local educational
agencies, Tribal educational agencies, and elementary
and secondary schools.
(B) REQUIREMENTS FOR CERTAIN RECIPIENTS.—An entity receiving information, consultative support, training,
and technical assistance under subparagraph (A)(ii) shall
operate in a manner consistent with, and shall ensure consistency with, the requirements of subsections (a) and (c)
of section 4001 of the Elementary and Secondary Education Act with respect to such information, consultative
support, training, and technical assistance.
(3) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection,
the term ‘‘pediatric mental health team’’ means a team consisting of at least one case coordinator, at least one child and
adolescent psychiatrist, and at least one licensed clinical mental health professional, such as a psychologist, social worker,
or mental health counselor, and which may include a developmental-behavioral pediatrician, and which may include a developmental-behavioral pediatrician. Such a team may be regionally based.
(c) APPLICATION.—A State, political subdivision of a State, Indian Tribe, or Tribal organization seeking an award under this section shall submit an application to the Secretary at such time, in
such manner, and containing such information as the Secretary
may require, including a plan for the comprehensive evaluation of
activities that are carried out with funds received under such
award.
(d) EVALUATION.—A State, political subdivision of a State, Indian Tribe, or Tribal organization that receives an award under
this section shall prepare and submit an evaluation of activities
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PUBLIC HEALTH SERVICE ACT
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that are carried out with funds received under such award to the
Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including a process and outcome evaluation.
(e) ACCESS TO BROADBAND.—In administering awards under
this section, the Secretary may coordinate with other agencies to
ensure that funding opportunities are available to support access
to reliable, high-speed Internet for providers.
(f) MATCHING REQUIREMENT.—The Secretary may not make an
award under this section unless the State, political subdivision of
a State, Indian Tribe, or Tribal organization involved agrees, with
respect to the costs to be incurred by the State, political subdivision
of a State, Indian Tribe, or Tribal organization in carrying out the
purpose described in this section, to make available non-Federal
contributions (in cash or in kind) toward such costs in an amount
that is not less than 20 percent of Federal funds provided in the
award.
(g) TECHNICAL ASSISTANCE.—The Secretary may—
(1) provide, or continue to provide, technical assistance to
recipients of awards under subsection (a); and
(2) award a grant or contract to an eligible public or nonprofit private entity (as determined by the Secretary) for the
purpose of providing such technical assistance pursuant to this
subsection.
(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated, $31,000,000 for each
of fiscal years 2023 through 2027.
SEC. 330N. ø254c–20¿ EXPANDING CAPACITY FOR HEALTH OUTCOMES.
(a) DEFINITIONS.—In this section:
(1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an
entity that provides, or supports the provision of, health care
services in rural areas, frontier areas, health professional
shortage areas, or medically underserved areas, or to medically
underserved populations or Native Americans, including Indian Tribes, Tribal organizations, and urban Indian organizations, and which may include entities leading, or capable of
leading, a technology-enabled collaborative learning and capacity building model or engaging in technology-enabled collaborative training of participants in such model.
(2) HEALTH PROFESSIONAL SHORTAGE AREA.—The term
‘‘health professional shortage area’’ means a health professional shortage area designated under section 332.
(3) INDIAN TRIBE.—The terms ‘‘Indian Tribe’’ and ‘‘Tribal
organization’’ have the meanings given the terms ‘‘Indian
tribe’’ and ‘‘tribal organization’’ in section 4 of the Indian SelfDetermination and Education Assistance Act.
(4) MEDICALLY UNDERSERVED POPULATION.—The term
‘‘medically underserved population’’ has the meaning given the
term in section 330(b)(3).
(5) NATIVE AMERICANS.—The term ‘‘Native Americans’’ has
the meaning given the term in section 736 and includes Indian
Tribes and Tribal organizations.
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256
(6) TECHNOLOGY-ENABLED COLLABORATIVE LEARNING AND
CAPACITY BUILDING MODEL.—The term ‘‘technology-enabled collaborative learning and capacity building model’’ means a distance health education model that connects health care professionals, and particularly specialists, with multiple other health
care
professionals
through
simultaneous
interactive
videoconferencing for the purpose of facilitating case-based
learning, disseminating best practices, and evaluating outcomes.
(7) URBAN INDIAN ORGANIZATION.—The term ‘‘urban Indian
organization’’ has the meaning given the term in section 4 of
the Indian Health Care Improvement Act.
(b) PROGRAM ESTABLISHED.—The Secretary shall, as appropriate, award grants to evaluate, develop, and, as appropriate, expand the use of technology-enabled collaborative learning and capacity building models, to improve retention of health care providers and increase access to health care services, such as those to
address chronic diseases and conditions, infectious diseases, mental
health, substance use disorders, prenatal and maternal health, pediatric care, pain management, palliative care, and other specialty
care in rural areas, frontier areas, health professional shortage
areas, or medically underserved areas and for medically underserved populations or Native Americans.
(c) USE OF FUNDS.—
(1) IN GENERAL.—Grants awarded under subsection (b)
shall be used for—
(A) the development and acquisition of instructional
programming, and the training of health care providers
and other professionals that provide or assist in the provision of services through models described in subsection (b),
such as training on best practices for data collection and
leading or participating in such technology-enabled activities consistent with technology-enabled collaborative learning and capacity-building models;
(B) information collection and evaluation activities to
study the impact of such models on patient outcomes and
health care providers, and to identify best practices for the
expansion and use of such models; or
(C) other activities consistent with achieving the objectives of the grants awarded under this section, as determined by the Secretary.
(2) OTHER USES.—In addition to any of the uses under
paragraph (1), grants awarded under subsection (b) may be
used for—
(A) equipment to support the use and expansion of
technology-enabled collaborative learning and capacity
building models, including for hardware and software that
enables distance learning, health care provider support,
and the secure exchange of electronic health information;
or
(B) support for health care providers and other professionals that provide or assist in the provision of services
through such models.
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PUBLIC HEALTH SERVICE ACT
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(d) LENGTH OF GRANTS.—Grants awarded under subsection (b)
shall be for a period of up to 5 years.
(e) GRANT REQUIREMENTS.—The Secretary may require entities
awarded a grant under this section to collect information on the effect of the use of technology-enabled collaborative learning and capacity building models, such as on health outcomes, access to
health care services, quality of care, and provider retention in
areas and populations described in subsection (b). The Secretary
may award a grant or contract to assist in the coordination of such
models, including to assess outcomes associated with the use of
such models in grants awarded under subsection (b), including for
the purpose described in subsection (c)(1)(B).
(f) APPLICATION.—An eligible entity that seeks to receive a
grant under subsection (b) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. Such application shall include
plans to assess the effect of technology-enabled collaborative learning and capacity building models on patient outcomes and health
care providers.
(g) ACCESS TO BROADBAND.—In administering grants under
this section, the Secretary may coordinate with other agencies to
ensure that funding opportunities are available to support access
to reliable, high-speed internet for grantees.
(h) TECHNICAL ASSISTANCE.—The Secretary shall provide (either directly through the Department of Health and Human Services or by contract) technical assistance to eligible entities, including recipients of grants under subsection (b), on the development,
use, and evaluation of technology-enabled collaborative learning
and capacity building models in order to expand access to health
care services provided by such entities, including for medically underserved areas and to medically underserved populations or Native Americans.
(i) RESEARCH AND EVALUATION.—The Secretary, in consultation
with stakeholders with appropriate expertise in such models, shall
develop a strategic plan to research and evaluate the evidence for
such models. The Secretary shall use such plan to inform the activities carried out under this section.
(j) REPORT BY SECRETARY.—Not later than 4 years after the
date of enactment of this section, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives, and post on the internet website
of the Department of Health and Human Services, a report including, at minimum—
(1) a description of any new and continuing grants awarded to entities under subsection (b) and the specific purpose and
amounts of such grants;
(2) an overview of—
(A) the evaluations conducted under subsections (b);
(B) technical assistance provided under subsection (h);
and
(C) activities conducted by entities awarded grants
under subsection (b); and
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258
(3) a description of any significant findings or developments related to patient outcomes or health care providers and
best practices for eligible entities expanding, using, or evaluating technology-enabled collaborative learning and capacity
building models, including through the activities described in
subsection (h).
(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $10,000,000 for each of
fiscal years 2022 through 2026.
SEC. 330O. ø254c-21¿ INNOVATION FOR MATERNAL HEALTH.
(a) IN GENERAL.—The Secretary, in consultation with
experts
representing a variety of clinical specialties, State, Tribal, or local
public health officials, researchers, epidemiologists, statisticians,
and community organizations, shall establish or continue a program to award competitive grants to eligible entities for the purpose of—
(1) identifying, developing, or disseminating best practices
to improve maternal health care quality and outcomes, improve maternal and infant health, and eliminate preventable
maternal mortality and severe maternal morbidity, which may
include—
(A) information on evidence-based practices to improve
the quality and safety of maternal health care in hospitals
and other health care settings of a State or health care
system by addressing topics commonly associated with
health complications or risks related to prenatal care,
labor care, birthing, and postpartum care;
(B) best practices for improving maternal health care
based on data findings and reviews conducted by a State
maternal mortality review committee that address topics
of relevance to common complications or health risks related to prenatal care, labor care, birthing, and
postpartum care; and
(C) information on addressing determinants of health
that impact maternal health outcomes for women before,
during, and after pregnancy;
(2) collaborating with State maternal mortality review
committees to identify issues for the development and implementation of evidence-based practices to improve maternal
health outcomes and reduce preventable maternal mortality
and severe maternal morbidity, consistent with section 317K;
(3) providing technical assistance and supporting the implementation of best practices identified in paragraph (1) to entities providing health care services to pregnant and
postpartum women; and
(4) identifying, developing, and evaluating new models of
care that improve maternal and infant health outcomes, which
may include the integration of community-based services and
clinical care.
(b) ELIGIBLE ENTITIES.—To be eligible for a grant under subsection (a), an entity shall—
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PUBLIC HEALTH SERVICE ACT
Sec. 330P
(1) submit to the Secretary an application at such time, in
such manner, and containing such information as the Secretary may require; and
(2) demonstrate in such application that the entity is capable of carrying out data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology
or maternal health.
(c) REPORT.—Not later than September 30, 2025, and every 2
years thereafter, the Secretary shall submit a report to Congress
on the practices described in paragraphs (1) and (2) of subsection
(a). Such report shall include a description of the extent to which
such practices reduced preventable maternal mortality and severe
maternal morbidity, and whether such practices improved maternal
and infant health. The Secretary shall disseminate information on
such practices, as appropriate.
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $9,000,000 for each of
fiscal years 2023 through 2027.
SEC. 330P. ø254c-22¿ INTEGRATED SERVICES FOR PREGNANT AND
POSTPARTUM WOMEN.
(a) IN GENERAL.—The Secretary may award grants for the pur-
pose of establishing or operating evidence-based or innovative, evidence-informed programs to deliver integrated health care services
to pregnant and postpartum women to optimize the health of
women and their infants, including to reduce adverse maternal
health outcomes, pregnancy-related deaths, and related health disparities (including such disparities associated with racial and ethnic minority populations), and, as appropriate, by addressing issues
researched under subsection (b)(2) of section 317K.
(b) INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM
WOMEN.—
(1) ELIGIBILITY.—To be eligible to receive a grant under
subsection (a), a State, Indian Tribe, or Tribal organization (as
such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act) shall work with relevant stakeholders that coordinate care to develop and carry
out the program, including—
(A) State, Tribal, and local agencies responsible for
Medicaid, public health, social services, mental health, and
substance use disorder treatment and services;
(B) health care providers who serve pregnant and
postpartum women; and
(C) community-based health organizations and health
workers, including providers of home visiting services and
individuals representing communities with disproportionately high rates of maternal mortality and severe maternal
morbidity, and including those representing racial and ethnic minority populations.
(2) TERMS.—
(A) PERIOD.—A grant awarded under subsection (a)
shall be made for a period of 5 years. Any supplemental
award made to a grantee under subsection (a) may be
made for a period of less than 5 years.
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PUBLIC HEALTH SERVICE ACT
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(B) PRIORITIES.—In awarding grants under subsection
(a), the Secretary shall—
(i) give priority to States, Indian Tribes, and Tribal organizations that have the highest rates of maternal mortality and severe maternal morbidity relative
to other such States, Indian Tribes, or Tribal organizations, respectively; and
(ii) shall consider health disparities related to maternal mortality and severe maternal morbidity, including such disparities associated with racial and
ethnic minority populations.
(C) EVALUATION.—The Secretary shall require grantees to evaluate the outcomes of the programs supported
under the grant.
(c) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $10,000,000 for each of
fiscal years 2023 through 2027.
Subpart II—National Health Service Corps Program
NATIONAL HEALTH SERVICE CORPS
SEC. 331. ø254d¿ (a)(1) For the purpose of eliminating health
manpower 38 shortages in health professional shortage areas, there
is established, within the Service, the National Health Service
Corps, which shall consist of—
(A) such officers of the Regular and Reserve Corps of the
Service as the Secretary may designate,
(B) such civilian employees of the United States as the
Secretary may appoint, and
(C) such other individuals who are not employees of the
United States.
(2) The Corps shall be utilized by the Secretary to provide primary health services in health professional shortage areas.
(3) For purposes of this subpart and subpart III:
(A) The term ‘‘Corps’’ means the National Health Service
Corps.
(B) The term ‘‘Corps member’’ means each of the officers,
employees, and individuals of which the Corps consists pursuant to paragraph (1).
(C) The term ‘‘health professional shortage area’’ has the
meaning given such term in section 332(a).
(D) The term ‘‘primary health services’’ means health services regarding family medicine, internal medicine, pediatrics,
obstetrics and gynecology, dentistry, or mental health, that are
provided by physicians or other health professionals.
(E)(i) The term ‘‘behavioral and mental health professionals’’ means health service psychologists, licensed clinical
social workers, licensed professional counselors, marriage and
family therapists, psychiatric nurse specialists, and psychiatrists.
38 So in law. Probably should be ‘‘health professional shortages’’. See section 401 of Public Law
101–597 (104 Stat. 3035).
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(ii) The term ‘‘graduate program of behavioral and mental
health’’ means a program that trains behavioral and mental
health professionals.
(b)(1) The Secretary may conduct at schools of medicine, osteopathic medicine, dentistry, and, as appropriate, nursing and other
schools of the health professions, including schools at which graduate programs of behavioral and mental health are offered, and at
entities which train allied health personnel, recruiting programs
for the Corps, the Scholarship Program, and the Loan Repayment
Program. Such recruiting programs shall include efforts to recruit
individuals who will serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program.
(2) In the case of physicians, dentists, behavioral and mental
health professionals, certified nurse midwives, certified nurse practitioners, and physician assistants who have an interest and a commitment to providing primary health care, the Secretary may establish fellowship programs to enable such health professionals to
gain exposure to and expertise in the delivery of primary health
services in health professional shortage areas. To the maximum extent practicable, the Secretary shall ensure that any such programs
are established in conjunction with accredited residency programs,
and other training programs, regarding such health professions.
(c)(1) The Secretary may reimburse an applicant for a position
in the Corps (including an individual considering entering into a
written agreement pursuant to section 338D) for the actual and
reasonable expenses incurred in traveling to and from the applicant’s place of residence to an eligible site to which the applicant
may be assigned under section 333 for the purpose of evaluating
such site with regard to being assigned at such site. The Secretary
may establish a maximum total amount that may be paid to an individual as reimbursement for such expenses.
(2) The Secretary may also reimburse the applicant for the actual and reasonable expenses incurred for the travel of 1 family
member to accompany the applicant to such site. The Secretary
may establish a maximum total amount that may be paid to an individual as reimbursement for such expenses.
(3) In the case of an individual who has entered into a contract
for obligated service under the Scholarship Program or under the
Loan Repayment Program, the Secretary may reimburse such individual for all or part of the actual and reasonable expenses incurred in transporting the individual, the individual’s family, and
the family’s possessions to the site of the individual’s assignment
under section 333. The Secretary may establish a maximum total
amount that may be paid to an individual as reimbursement for
such expenses.
(d)(1) The Secretary may, under regulations promulgated by
the Secretary, adjust the monthly pay of each member of the Corps
(other than a member described in subsection (a)(1)(C)) who is directly engaged in the delivery of health services in a health professional shortage area as follows:
(A) During the first 36 months in which such a member is
so engaged in the delivery of health services, his monthly pay
may be increased by an amount which when added to the
member’s monthly pay and allowances will provide a monthly
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262
income competitive with the average monthly income from a
practice of an individual who is a member of the profession of
the Corps member, who has equivalent training, and who has
been in practice for a period equivalent to the period during
which the Corps member has been in practice.
(B) During the period beginning upon the expiration of the
36 months referred to in subparagraph (A) and ending with the
month in which the member’s monthly pay and allowances are
equal to or exceed the monthly income he received for the last
of such 36 months, the member may receive in addition to his
monthly pay and allowances an amount which when added to
such monthly pay and allowances equals the monthly income
he received for such last month.
(C) For each month in which a member is directly engaged
in the delivery of health services in a health professional shortage area in accordance with an agreement with the Secretary
entered into under section 741(f)(1)(C), under which the Secretary is obligated to make payments in accordance with section 741(f)(2), the amount of any monthly increase under subparagraph (A) or (B) with respect to such member shall be decreased by an amount equal to one-twelfth of the amount
which the Secretary is obligated to pay upon the completion of
the year of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the term ‘‘monthly pay’’
includes special pay received under chapter 5 of title 37 of the
United States Code.
(2) In the case of a member of the Corps who is directly engaged in the delivery of health services in a health professional
shortage area in accordance with a service obligation incurred
under the Scholarship Program or the Loan Repayment Program,
the adjustment in pay authorized by paragraph (1) may be made
for such a member only upon satisfactory completion of such service obligation, and the first 36 months of such member’s being so
engaged in the delivery of health services shall, for purposes of
paragraph (1)(A), be deemed to begin upon such satisfactory completion.
(3) A member of the Corps described in subparagraph (C) of
subsection (a)(1) shall when assigned to an entity under section 333
be subject to the personnel system of such entity, except that such
member shall receive during the period of assignment the income
that the member would receive if the member was a member of the
Corps described in subparagraph (B) of such subsection.
(e) Corps members assigned under section 333 to provide
health services in health professional shortage areas shall not be
counted against any employment ceiling affecting the Department.
(f) Sections 214 and 216 shall not apply to members of the National Health Service Corps during their period of obligated service
under the Scholarship Program or the Loan Repayment Program,
except when such members are Commissioned Corps officers who
entered into a contract with Secretary under section 338A or 338B
after December 31, 2006 and when the Secretary determines that
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tion to health care services provided in the community in which
such officer is providing health care services.
(g)(1) The Secretary shall, by rule, prescribe conversion provisions applicable to any individual who, within a year after completion of service as a member of the Corps described in subsection
(a)(1)(C), becomes a commissioned officer in the Regular or Reserve
Corps of the Service.
(2) The rules prescribed under paragraph (1) shall provide that
in applying the appropriate provisions of this Act which relate to
retirement, any individual who becomes such an officer shall be entitled to have credit for any period of service as a member of the
Corps described in subsection (a)(1)(C).
(h) The Secretary shall ensure that adequate staff is provided
to the Service with respect to effectively administering the program
for the Corps.
(i)(1) In carrying out subpart III, the Secretary may, in accordance with this subsection, issue waivers to individuals who have
entered into a contract for obligated service under the Scholarship
Program or the Loan Repayment Program under which the individuals are authorized to satisfy the requirement of obligated service
through providing clinical practice that is half time.
(2) A waiver described in paragraph (1) may be provided by the
Secretary only if—
(A) the entity for which the service is to be performed—
(i) has been approved under section 333A for assignment of a Corps member; and
(ii) has requested in writing assignment of a health
professional who would serve half time;
(B) the Secretary has determined that assignment of a
health professional who would serve half time would be appropriate for the area where the entity is located;
(C) a Corps member who is required to perform obligated
service has agreed in writing to be assigned for half-time service to an entity described in subparagraph (A);
(D) the entity and the Corps member agree in writing that
the Corps member will perform half-time clinical practice;
(E) the Corps member agrees in writing to fulfill all of the
service obligations under section 338C through half-time clinical practice and either—
(i) double the period of obligated service that would
otherwise be required; or
(ii) in the case of contracts entered into under section
338B, accept a minimum service obligation of 2 years with
an award amount equal to 50 percent of the amount that
would otherwise be payable for full-time service; and
(F) the Corps member agrees in writing that if the Corps
member begins providing half-time service but fails to begin or
complete the period of obligated service, the method stated in
338E(c) for determining the damages for breach of the individual’s written contract will be used after converting periods of
obligated service or of service performed into their full-time
equivalents.
(3) In evaluating waivers issued under paragraph (1), the Secretary shall examine the effect of multidisciplinary teams.
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(j) For the purposes of this subpart and subpart III:
(1) The term ‘‘Department’’ means the Department of
Health and Human Services.
(2) The term ‘‘Loan Repayment Program’’ means the National Health Service Corps Loan Repayment Program established under section 338B.
(3) The term ‘‘Scholarship Program’’ means the National
Health Service Corps Scholarship Program established under
section 338A.
(4) The term ‘‘State’’ includes, in addition to the several
States, only the District of Columbia, the Commonwealth of
Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the
Trust Territory of the Pacific Islands.
(5) The terms ‘‘full time’’ and ‘‘full-time’’ mean a minimum
of 40 hours per week in a clinical practice, for a minimum of
45 weeks per year.
(6) The terms ‘‘half time’’ and ‘‘half-time’’ mean a minimum of 20 hours per week (not to exceed 39 hours per week)
in a clinical practice, for a minimum of 45 weeks per year.
DESIGNATION OF HEALTH PROFESSIONAL SHORTAGE AREAS
SEC. 332. ø254e¿ (a)(1) For purposes of this subpart the term
‘‘health professional shortage area’’ means (A) an area in an urban
or rural area (which need not conform to the geographic boundaries
of a political subdivision and which is a rational area for the delivery of health services) which the Secretary determines has a health
manpower shortage, (B) a population group which the Secretary determines has such a shortage, or (C) a public or nonprofit private
medical facility or other public facility which the Secretary determines has such a shortage. All Federally qualified health centers
and rural health clinics, as defined in section 1861(aa) of the Social
Security Act (42 U.S.C. 1395x(aa)), that meet the requirements of
section 334 shall be automatically designated as having such a
shortage. The Secretary shall not remove an area from the areas
determined to be health professional shortage areas under subparagraph (A) of the preceding sentence until the Secretary has afforded interested persons and groups in such area an opportunity
to provide data and information in support of the designation as a
health professional shortage area or a population group described
in subparagraph (B) of such sentence or a facility described in subparagraph (C) of such sentence, and has made a determination on
the basis of the data and information submitted by such persons
and groups and other data and information available to the Secretary.
(2) For purposes of this subsection, the term ‘‘medical facility’’
means a facility for the delivery of health services and includes—
(A) a hospital, State mental hospital, public health center,
outpatient medical facility, rehabilitation facility, facility for
long-term care, community mental health center, migrant
health center, facility operated by a city or county health department, and community health center and which is not reasonably accessible to an adequately served area;
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(B) such a facility of a State correctional institution or of
the Indian Health Service, and a health program or facility operated by a tribe or tribal organization under the Indian SelfDetermination Act;
(C) such a facility used in connection with the delivery of
health services under section 321 (relating to hospitals), 322
(relating to care and treatment of persons under quarantine
and others), 323 (relating to care and treatment of Federal
prisoners), 324 (relating to examination and treatment of certain Federal employees), 325 (relating to examination of
aliens), 326 (relating to services to certain Federal employees),
320 (relating to services for persons with Hansen’s disease), or
330(h) (relating to the provision of health services to homeless
individuals); and
(D) a Federal medical facility.
(3) Homeless individuals (as defined in section 330(h)(5)), seasonal agricultural workers (as defined in section 330(g)(3)) and migratory agricultural workers (as so defined)), and residents of public housing (as defined in section 3(b)(1) of the United States Housing Act of 1937 (42 U.S.C. 1437a(b)(1))) may be population groups
under paragraph (1).
(b) The Secretary shall establish by regulation criteria for the
designation of areas, population groups, medical facilities, and
other public facilities, in the States, as health professional shortage
areas. In establishing such criteria, the Secretary shall take into
consideration the following:
(1) The ratio of available health manpower to the number
of individuals in an area or population group, or served by a
medical facility or other public facility under consideration for
designation.
(2) Indicators of a need, notwithstanding the supply of
health manpower, for health services for the individuals in an
area or population group or served by a medical facility or
other public facility under consideration for designation.
(3) The percentage of physicians serving an area, population group, medical facility, or other public facility under consideration for designation who are employed by hospitals and
who are graduates of foreign medical schools.
(c) In determining whether to make a designation, the Secretary shall take into consideration the following:
(1) The recommendations of the Governor of each State in
which the area, population group, medical facility, or other
public facility under consideration for designation is in whole
or part located.
(2) The extent to which individuals who are (A) residents
of the area, members of the population group, or patients in
the medical facility or other public facility under consideration
for designation, and (B) entitled to have payment made for
medical services under title XVIII, XIX, or XXI of the Social
Security Act, cannot obtain such services because of suspension
of physicians from the programs under such titles.
(d)(1) In accordance with the criteria established under subsection (b) and the considerations listed in subsection (c), the Secretary shall designate health professional shortage areas in the
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States, publish a descriptive list of the areas, population groups,
medical facilities, and other public facilities so designated, and at
least annually review and, as necessary, revise such designations.
(2) For purposes of paragraph (1), a complete descriptive list
shall be published in the Federal Register not later than July 1 of
1991 and each subsequent year.
(e)(1) Prior to the designation of a public facility, including a
Federal medical facility, as a health professional shortage area, the
Secretary shall give written notice of such proposed designation to
the chief administrative officer of such facility and request comments within 30 days with respect to such designation.
(2) Prior to the designation of a health professional shortage
area under this section, the Secretary shall, to the extent practicable, give written notice of the proposed designation of such area
to appropriate public or private nonprofit entities which are located
or have a demonstrated interest in such area and request comments from such entities with respect to the proposed designation
of such area.
(f) The Secretary shall give written notice of the designation of
a health professional shortage area, not later than 60 days from
the date of such designation, to—
(1) the Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or part located; and
(2) appropriate public or nonprofit private entities which
are located or which have a demonstrated interest in the area
so designated.
(g) Any person may recommend to the Secretary the designation of an area, population group, medical facility, or other public
facility as a health professional shortage area.
(h) The Secretary may conduct such information programs in
areas, among population groups, and in medical facilities and other
public facilities designated under this section as health professional
shortage areas as may be necessary to inform public and nonprofit
private entities which are located or have a demonstrated interest
in such areas of the assistance available under this title by virtue
of the designation of such areas.
(i) DISSEMINATION.—The Administrator of the Health Resources and Services Administration shall disseminate information
concerning the designation criteria described in subsection (b) to—
(1) the Governor of each State;
(2) the representative of any area, population group, or facility selected by any such Governor to receive such information;
(3) the representative of any area, population group, or facility that requests such information; and
(4) the representative of any area, population group, or facility determined by the Administrator to be likely to meet the
criteria described in subsection (b).
(j)(1) The Secretary shall submit the report described in paragraph (2) if the Secretary, acting through the Administrator of the
Health Resources and Services Administration, issues—
(A) a regulation that revises the definition of a health professional shortage area for purposes of this section; or
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(B) a regulation that revises the standards concerning priority of such an area under section 333A.
(2) On issuing a regulation described in paragraph (1), the Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report that
describes the regulation.
(3) Each regulation described in paragraph (1) shall take effect
180 days after the committees described in paragraph (2) receive
a report referred to in such paragraph describing the regulation.
(k)(1) The Secretary, acting through the Administrator of the
Health Resources and Services Administration, shall identify,
based on the data collected under paragraph (3), maternity care
health professional target areas that satisfy the criteria described
in paragraph (2) for purposes of, in connection with receipt of assistance under this title, assigning to such identified areas maternity care health professionals who, without application of this subsection, would otherwise be eligible for such assistance. The Secretary shall distribute maternity care health professionals within
health professional shortage areas using the maternity care health
professional target areas so identified.
(2) For purposes of paragraph (1), the Secretary shall establish
criteria for maternity care health professional target areas that
identify geographic areas within health professional shortage areas
that have a shortage of maternity care health professionals.
(3) For purposes of this subsection, the Secretary shall collect
and publish in the Federal Register data comparing the availability
and need of maternity care health services in health professional
shortage areas and in areas within such health professional shortage areas.
(4) In carrying out paragraph (1), the Secretary shall seek
input from relevant provider organizations, including medical societies, organizations representing medical facilities, and other organizations with expertise in maternity care.
(5) For purposes of this subsection, the term ‘‘full scope maternity care health services’’ includes during labor care, birthing, prenatal care, and postpartum care.
(6) Nothing in this subsection shall be construed as—
(A) requiring the identification of a maternity care health
professional target area in an area not otherwise already designated as a health professional shortage area; or
(B) affecting the types of health professionals, without application of this subsection, otherwise eligible for assistance,
including a loan repayment or scholarship, pursuant to the application of this section.
ASSIGNMENT OF CORPS PERSONNEL
SEC. 333. ø254f¿ (a)(1) The Secretary may assign members of
the Corps to provide, under regulations promulgated by the Secretary, health services in or to a health professional shortage area
during the assignment period only if—
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(A) a public or private entity, which is located or has a
demonstrated interest in such area, makes application to the
Secretary for such assignment;
(B) such application has been approved by the Secretary;
(C) the entity agrees to comply with the requirements of
section 334; and
(D) the Secretary has (i) conducted an evaluation of the
need and demand for health professional shortage area, the intended use of Corps members to be assigned to the area, community support for the assignment of Corps members to the
area, the area’s efforts to secure health professional shortage
area, and the fiscal management capability of the entity to
which Corps members would be assigned and (ii) on the basis
of such evaluation has determined that—
(I) there is a need and demand for health manpower
for the area;
(II) there has been appropriate and efficient use of any
Corps members previously assigned to the entity for the
area;
(III) there is general community support for the assignment of Corps members to the entity;
(IV) the area has made unsuccessful efforts to secure
health manpower for the area;
(V) there is a reasonable prospect of sound fiscal management, including efficient collection of fee-for-service,
third-party, and other appropriate funds, by the entity
with respect to Corps members assigned to such entity;
and
(VI) 39 the entity demonstrates willingness to
support or facilitate mentorship, professional development, and training opportunities for Corps
members.
An application for assignment of a Corps member to a health professional shortage area shall include a demonstration by the applicant that the area or population group to be served by the applicant has a shortage of personal health services and that the Corps
member will be located so that the member will provide services to
the greatest number of persons residing in such area or included
in such population group. Such a demonstration shall be made on
the basis of the criteria prescribed by the Secretary under section
332(b) and on additional criteria which the Secretary shall prescribe to determine if the area or population group to be served by
the applicant has a shortage of personal health services.
(2) Corps members may be assigned to a Federal health care
facility, but only upon the request of the head of the department
or agency of which such facility is a part.
(3) In approving applications for assignment of members of the
Corps the Secretary shall not discriminate against applications
from entities which are not receiving Federal financial assistance
under this Act. In approving such applications, the Secretary shall
give preference to applications in which a nonprofit entity or public
39 Margin
so in law.
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entity shall provide a site to which Corps members may be assigned.
(b)(1) The Secretary may not approve an application for the assignment of a member of the Corps described in subparagraph (C)
of section 331(a)(1) to an entity unless the application of the entity
contains assurances satisfactory to the Secretary that the entity (A)
has sufficient financial resources to provide the member of the
Corps with an income of not less than the income to which the
member would be entitled if the member was a member described
in subparagraph (B) of section 331(a)(1), or (B) would have such financial resources if a grant was made to the entity under paragraph (2).
(2)(A) If in approving an application of an entity for the assignment of a member of the Corps described in subparagraph (C) of
section 331(a)(1) the Secretary determines that the entity does not
have sufficient financial resources to provide the member of the
Corps with an income of not less than the income to which the
member would be entitled if the member was a member described
in subparagraph (B) of section 331(a)(1), the Secretary may make
a grant to the entity to assure that the member of the Corps assigned to it will receive during the period of assignment to the entity such an income.
(B) The amount of any grant under subparagraph (A) shall be
determined by the Secretary. Payments under such a grant may be
made in advance or by way of reimbursement, and at such intervals and on such conditions, as the Secretary finds necessary. No
grant may be made unless an application therefor is submitted to
and approved by the Secretary. Such an application shall be in
such form, submitted in such manner, and contain such information, as the Secretary shall by regulation prescribe.
(c) The Secretary shall assign Corps members to entities in
health professional shortage areas without regard to the ability of
the individuals in such areas, population groups, medical facilities,
or other public facilities to pay for such services.
(d)(1) The Secretary may provide technical assistance to a public or private entity which is located in a health professional shortage area and which desires to make an application under this section for assignment of a Corps member to such area. Assistance
provided under this paragraph may include assistance to an entity
in (A) analyzing the potential use of health professions personnel
in defined health services delivery areas by the residents of such
areas, (B) determining the need for such personnel in such areas,
(C) determining the extent to which such areas will have a financial base to support the practice of such personnel and the extent
to which additional financial resources are needed to adequately
support the practice, (D) determining the types of inpatient and
other health services that should be provided by such personnel in
such areas, and (E) developing long-term plans for addressing
health professional shortages and improving access to health care.
The Secretary shall encourage entities that receive technical assistance under this paragraph to communicate with other communities, State Offices of Rural Health, State Primary Care Associations and Offices, and other entities concerned with site development and community needs assessment.
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(2) The Secretary may provide, to public and private entities
which are located in a health professional shortage area to which
area a Corps member has been assigned, technical assistance to assist in the retention of such member in such area after the completion of such member’s assignment to the area.
(3) The Secretary may provide, to health professional shortage
areas to which no Corps member has been assigned, (A) technical
assistance to assist in the recruitment of health manpower for such
areas, and (B) current information on public and private programs
which provide assistance in the securing of health manpower.
(4)(A) The Secretary shall undertake to demonstrate the improvements that can be made in the assignment of members of the
Corps to health professional shortage areas and in the delivery of
health care by Corps members in such areas through coordination
with States, political subdivisions of States, agencies of States and
political subdivisions, and other public and private entities which
have expertise in the planning, development, and operation of centers for the delivery of primary health care. In carrying out this
subparagraph, the Secretary shall enter into agreements with
qualified entities which provide that if—
(i) the entity places in effect a program for the planning,
development, and operation of centers for the delivery of primary health care in health professional shortage areas which
reasonably addresses the need for such care in such areas, and
(ii) under the program the entity will perform the functions described in subparagraph (B),
the Secretary will assign under this section members of the Corps
in accordance with the program.
(B) For purposes of subparagraph (A), the term ‘‘qualified entity’’ means a State, political subdivision of a State, an agency of a
State or political subdivision, or other public or private entity operating solely within one State, which the Secretary determines is
able—
(i) to analyze the potential use of health professions personnel in defined health services delivery areas by the residents of such areas;
(ii) to determine the need for such personnel in such areas
and to recruit, select, and retain health professions personnel
(including members of the National Health Service Corps) to
meet such need;
(iii) to determine the extent to which such areas will have
a financial base to support the practice of such personnel and
the extent to which additional financial resources are needed
to adequately support the practice;
(iv) to determine the types of inpatient and other health
services that should be provided by such personnel in such
areas;
(v) to assist such personnel in the development of their
clinical practice and fee schedules and in the management of
their practice;
(vi) to assist in the planning and development of facilities
for the delivery of primary health care; and
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Sec. 333A
(vii) to assist in establishing the governing bodies of centers for the delivery of such care and to assist such bodies in
defining and carrying out their responsibilities.
(e) Notwithstanding any other law, any member of the Corps
licensed to practice medicine, osteopathic medicine, dentistry, or
any other health profession in any State shall, while serving in the
Corps, be allowed to practice such profession in any State.
SEC. 333A. ø254f–1¿ PRIORITIES IN ASSIGNMENT OF CORPS PERSONNEL.
(a) IN GENERAL.—In approving applications made under sec-
tion 333 for the assignment of Corps members, the Secretary
shall—
(1) give priority to any such application that—
(A) is made regarding the provision of primary health
services to a health professional shortage area with the
greatest such shortage; and
(B) is made by an entity that—
(i) serves a health professional shortage area described in subparagraph (A);
(ii) coordinates the delivery of primary health
services with related health and social services;
(iii) has a documented record of sound fiscal management; and
(iv) will experience a negative impact on its capacity to provide primary health services if a Corps member is not assigned to the entity;
(2) with respect to the geographic area in which the health
professional shortage area is located, take into consideration
the willingness of individuals in the geographic area, and of
the appropriate governmental agencies or health entities in the
area, to assist and cooperate with the Corps in providing effective primary health services; and
(3) take into consideration comments of medical, osteopathic, dental, or other health professional societies whose
members deliver services to the health professional shortage
area, or if no such societies exist, comments of physicians, dentists, or other health professionals delivering services to the
area.
(b) ESTABLISHMENT OF CRITERIA FOR DETERMINING PRIORITIES.—
(1) IN GENERAL.—The Secretary shall establish criteria
specifying the manner in which the Secretary makes a determination under subsection (a)(1)(A) of the health professional
shortage areas with the greatest such shortages.
(2) PUBLICATION OF CRITERIA.—The criteria required in
paragraph (1) shall be published in the Federal Register not
later than July 1, 1991. Any revisions made in the criteria by
the Secretary shall be effective upon publication in the Federal
Register.
(c) NOTIFICATIONS REGARDING PRIORITIES.—
(1) PROPOSED LIST.—The Secretary shall prepare and publish a proposed list of health professional shortage areas and
entities that would receive priority under subsection (a)(1) in
the assignment of Corps members. The list shall contain the
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information described in paragraph (2), and the relative scores
and relative priorities of the entities submitting applications
under section 333, in a proposed format. All such entities shall
have 30 days after the date of publication of the list to provide
additional data and information in support of inclusion on the
list or in support of a higher priority determination and the
Secretary shall reasonably consider such data and information
in preparing the final list under paragraph (2).
(2) PREPARATION OF LIST FOR APPLICABLE PERIOD.—For the
purpose of carrying out paragraph (3), the Secretary shall prepare and, as appropriate, update a list of health professional
shortage areas and entities that are receiving priority under
subsection (a)(1) in the assignment of Corps members. Such
list—
(A) shall include a specification, for each such health
professional shortage area, of the entities for which the
Secretary has provided an authorization to receive assignments of Corps members in the event that Corps members
are available for the assignments; and
(B) shall, of the entities for which an authorization described in subparagraph (A) has been provided, specify—
(i) the entities provided such an authorization for
the assignment of Corps members who are participating in the Scholarship Program;
(ii) the entities provided such an authorization for
the assignment of Corps members who are participating in the Loan Repayment Program; and
(iii) the entities provided such an authorization for
the assignment of Corps members who have become
Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment
Programs.
The Secretary may set forth such specifications by medical
specialty.
(3) NOTIFICATION OF AFFECTED PARTIES.—
(A) ENTITIES.—Not later than 30 days after the Secretary has added to a list under paragraph (2) an entity
specified as described in subparagraph (A) of such paragraph, the Secretary shall notify such entity that the entity has been provided an authorization to receive assignments of Corps members in the event that Corps members
are available for the assignments.
(B) INDIVIDUALS.—In the case of an individual obligated to provide service under the Scholarship Program,
not later than 3 months before the date described in section 338C(b)(5), the Secretary shall provide to such individual the names of each of the entities specified as described in paragraph (2)(B)(i) that is appropriate for the
individual’s medical specialty and discipline.
(4) REVISIONS.—If the Secretary proposes to make a revision in the list under paragraph (2), and the revision would adversely alter the status of an entity with respect to the list, the
Secretary shall notify the entity of the revision. Any entity adversely affected by such a revision shall be notified in writing
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Sec. 334
by the Secretary of the reasons for the revision and shall have
30 days from such notification to file a written appeal of the
determination involved which shall be reasonably considered
by the Secretary before the revision to the list becomes final.
The revision to the list shall be effective with respect to assignment of Corps members beginning on the date that the revision becomes final.
(d) LIMITATION ON NUMBER OF ENTITIES OFFERED AS ASSIGNMENT CHOICES IN SCHOLARSHIP PROGRAM.—
(1) DETERMINATION OF AVAILABLE CORPS MEMBERS.—By
April 1 of each calendar year, the Secretary shall determine
the number of participants in the Scholarship Program who
will be available for assignments under section 333 during the
program year beginning on July 1 of that calendar year.
(2) DETERMINATION OF NUMBER OF ENTITIES.—At all times
during a program year, the number of entities specified under
subsection (c)(2)(B)(i) shall be—
(A) not less than the number of participants determined with respect to that program year under paragraph
(1); and
(B) not greater than twice the number of participants
determined with respect to that program year under paragraph (1).
SEC. 334. ø254g¿ CHARGES FOR SERVICES BY ENTITIES USING CORPS
MEMBERS.
(a) AVAILABILITY OF SERVICES REGARDLESS OF ABILITY TO PAY
OR PAYMENT SOURCE.—An entity to which a Corps member is as-
signed shall not deny requested health care services, and shall not
discriminate in the provision of services to an individual—
(1) because the individual is unable to pay for the services;
or
(2) because payment for the services would be made
under—
(A) the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.);
(B) the medicaid program under title XIX of such Act
(42 U.S.C. 1396 et seq.); or
(C) the State children’s health insurance program
under title XXI of such Act (42 U.S.C. 1397aa et seq.).
(b) CHARGES FOR SERVICES.—The following rules shall apply to
charges for health care services provided by an entity to which a
Corps member is assigned:
(1) IN GENERAL.—
(A) SCHEDULE OF FEES OR PAYMENTS.—Except as provided in paragraph (2), the entity shall prepare a schedule
of fees or payments for the entity’s services, consistent
with locally prevailing rates or charges and designed to
cover the entity’s reasonable cost of operation.
(B) SCHEDULE OF DISCOUNTS.—Except as provided in
paragraph (2), the entity shall prepare a corresponding
schedule of discounts (including, in appropriate cases,
waivers) to be applied to the payment of such fees or payments. In preparing the schedule, the entity shall adjust
the discounts on the basis of a patient’s ability to pay.
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(C) USE OF SCHEDULES.—The entity shall make every
reasonable effort to secure from patients fees and payments for services in accordance with such schedules, and
fees or payments shall be sufficiently discounted in accordance with the schedule described in subparagraph (B).
(2) SERVICES TO BENEFICIARIES OF FEDERAL AND FEDERALLY ASSISTED PROGRAMS.—In the case of health care services
furnished to an individual who is a beneficiary of a program
listed in subsection (a)(2), the entity—
(A) shall accept an assignment pursuant to section
1842(b)(3)(B)(ii) of the Social Security Act (42 U.S.C.
1395u(b)(3)(B)(ii)) with respect to an individual who is a
beneficiary under the medicare program; and
(B) shall enter into an appropriate agreement with—
(i) the State agency administering the program
under title XIX of such Act with respect to an individual who is a beneficiary under the medicaid program; and
(ii) the State agency administering the program
under title XXI of such Act with respect to an individual who is a beneficiary under the State children’s
health insurance program.
(3) COLLECTION OF PAYMENTS.—The entity shall take reasonable and appropriate steps to collect all payments due for
health care services provided by the entity, including payments
from any third party (including a Federal, State, or local government agency and any other third party) that is responsible
for part or all of the charge for such services.
PROVISION OF HEALTH SERVICES BY CORPS MEMBERS
SEC. 335. ø254h¿ (a) In providing health services in a health
professional shortage area, Corps members shall utilize the techniques, facilities, and organizational forms most appropriate for the
area, population group, medical facility, or other public facility, and
shall, to the maximum extent feasible, provide such services (1) to
all individuals in, or served by, such health professional shortage
area regardless of their ability to pay for the services, and (2) in
a manner which is cooperative with other health care providers
serving such health professional shortage area.
(b)(1) Notwithstanding any other provision of law, the Secretary may (A) to the maximum extent feasible make such arrangements as he determines necessary to enable Corps members to utilize the health facilities in or serving the health professional shortage area in providing health services; (B) make such arrangements
as he determines are necessary for the use of equipment and supplies of the Service and for the lease or acquisition of other equipment and supplies; and (C) secure the permanent or temporary
services of physicians, dentists, nurses, administrators, and other
health personnel. If there are no health facilities in or serving such
area, the Secretary may arrange to have Corps members provide
health services in the nearest health facilities of the Service or may
lease or otherwise provide facilities in or serving such area for the
provision of health services.
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(2) If the individuals in or served by a health professional
shortage area are being served (as determined under regulations of
the Secretary) by a hospital or other health care delivery facility
of the Service, the Secretary may, in addition to such other arrangements as he may make under paragraph (1), arrange for the
utilization of such hospital or facility by Corps members in providing health services, but only to the extent that such utilization
will not impair the delivery of health services and treatment
through such hospital or facility to individuals who are entitled to
health services and treatment through such hospital or facility.
(c) The Secretary may make one loan to any entity with an approved application under section 333 to assist such entity in meeting the costs of (1) establishing medical, dental, or other health
profession practices, including the development of medical practice
management systems; (2) acquiring equipment for use in providing
health services; and (3) renovating buildings to establish health facilities. No loan may be made under this subsection unless an application therefor is submitted to, and approved by, the Secretary.
The amount of any such loan shall be determined by the Secretary,
except that no such loan may exceed $50,000.
(d) Upon the expiration of the assignment of all Corps members to a health professional shortage area, the Secretary may (notwithstanding any other provision of law) sell, to any appropriate
local entity, equipment and other property of the United States utilized by such members in providing health services. Sales made
under this subsection shall be made at the fair market value (as
determined by the Secretary) of the equipment or such other property; except that the Secretary may make such sales for a lesser
value to an appropriate local entity, if he determines that the entity is financially unable to pay the full market value.
(e)(1)(A) It shall be unlawful for any hospital to deny an authorized Corps member admitting privileges when such Corps
member otherwise meets the professional qualifications established
by the hospital for granting such privileges and agrees to abide by
the published bylaws of the hospital and the published bylaws,
rules, and regulations of its medical staff.
(B) Any hospital which is found by the Secretary, after notice
and an opportunity for a hearing on the record, to have violated
this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to be eligible to receive
any Federal funds under this Act or under titles XVIII, XIX, or XXI
of the Social Security Act.
(2) For purposes of this subsection, the term ‘‘hospital’’ includes
a State or local public hospital, a private profit hospital, a private
nonprofit hospital, a general or special hospital, and any other type
of hospital (excluding a hospital owned or operated by an agency
of the Federal Government), and any related facilities.
SEC. 336. ø254h–1¿ FACILITATION OF EFFECTIVE PROVISION OF CORPS
SERVICES.
(a) CONSIDERATION OF INDIVIDUAL CHARACTERISTICS OF MEMBERS IN MAKING ASSIGNMENTS.—In making an assignment of a
Corps member to an entity that has had an application approved
under section 333, the Secretary shall, subject to making the assignment in accordance with section 333A, seek to assign to the enFebruary 1, 2024
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tity a Corps member who has (and whose spouse, if any, has) characteristics that increase the probability that the member will remain in the health professional shortage area involved after the
completion of the period of service in the Corps.
(b) COUNSELING ON SERVICE IN CORPS.—
(1) IN GENERAL.—The Secretary shall, subject to paragraph
(3), offer appropriate counseling on service in the Corps to individuals during the period of membership in the Corps, particularly during the initial period of each assignment.
(2) CAREER ADVISOR REGARDING OBLIGATED SERVICE.—
(A) In the case of individuals who have entered into
contracts for obligated service under the Scholarship or
Loan Repayment Program, counseling under paragraph (1)
shall include appropriate counseling on matters particular
to such obligated service. The Secretary shall ensure that
career advisors for providing such counseling are available
to such individuals throughout the period of participation
in the Scholarship or Loan Repayment Program.
(B) With respect to the Scholarship Program, counseling under paragraph (1) shall include counseling individuals during the period in which the individuals are pursuing an educational degree in the health profession involved, including counseling to prepare the individual for
service in the Corps.
(3) EXTENT OF COUNSELING SERVICES.—With respect to individuals who have entered into contracts for obligated service
under the Scholarship or Loan Repayment Program, this subsection shall be carried out regarding such individuals
throughout the period of obligated service (and, additionally,
throughout the period specified in paragraph (2)(B), in the case
of the Scholarship Program). With respect to Corps members
generally, this subsection shall be carried out to the extent
practicable.
(c) GRANTS REGARDING PREPARATION OF STUDENTS FOR PRACTICE.—With respect to individuals who have entered into contracts
for obligated service under the Scholarship or Loan Repayment
Program, the Secretary may make grants to, and enter into contracts with, public and nonprofit private entities (including health
professions schools) for the conduct of programs designed to prepare such individuals for the effective provision of primary health
services in the health professional shortage areas to which the individuals are assigned.
(d) PROFESSIONAL DEVELOPMENT AND TRAINING.—
(1) IN GENERAL.—The Secretary shall assist Corps members in establishing and maintaining professional relationships
and development opportunities, including by—
(A) establishing appropriate professional relationships
between the Corps member involved and the health professions community of the geographic area with respect to
which the member is assigned;
(B) establishing professional development, training,
and mentorship linkages between the Corps member involved and the larger health professions community, including through distance learning, direct mentorship, and
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development and implementation of training modules designed to meet the educational needs of offsite Corps members;
(C) establishing professional networks among Corps
members; or
(D) engaging in other professional development,
mentorship, and training activities for Corps members, at
the discretion of the Secretary.
(2) ASSISTANCE IN ESTABLISHING PROFESSIONAL RELATIONSHIPS.—In providing such assistance under paragraph (1), the
Secretary shall focus on establishing relationships with hospitals, with academic medical centers and health professions
schools, with area health education centers under section 751,
with health education and training centers under section 752,
and with border health education and training centers under
such section 752. Such assistance shall include assistance in
obtaining faculty appointments at health professions schools.
(3) SUPPLEMENT NOT SUPPLANT.—Such efforts under this
subsection shall supplement, not supplant, non-government efforts by professional health provider societies to establish and
maintain professional relationships and development opportunities.
(e) TEMPORARY RELIEF FROM CORPS DUTIES.—
(1) IN GENERAL.—The Secretary shall, subject to paragraph
(4), provide assistance to Corps members in establishing arrangements through which Corps members may, as appropriate, be provided temporary relief from duties in the Corps
in order to pursue continuing education in the health professions, to participate in exchange programs with teaching centers, to attend professional conferences, or to pursue other interests, including vacations.
(2) ASSUMPTION OF DUTIES OF MEMBER.—
(A) Temporary relief under paragraph (1) may be provided only if the duties of the Corps member involved are
assumed by another health professional. With respect to
such temporary relief, the duties may be assumed by
Corps members or by health professionals who are not
Corps members, if the Secretary approves the professionals for such purpose. Any health professional so approved by the Secretary shall, during the period of providing such temporary relief, be deemed to be a Corps
member for purposes of section 224 (including for purposes
of the remedy described in such section), section 333(f) 40,
and section 335(e).
(B) In carrying out paragraph (1), the Secretary shall
provide for the formation and continued existence of a
group of health professionals to provide temporary relief
under such paragraph.
(3) RECRUITMENT FROM GENERAL HEALTH PROFESSIONS
COMMUNITY.—In carrying out paragraph (1), the Secretary
shall—
40 So in law. As a result of the amendments made by section 103(b) of Public Law 101–597
(104 Stat. 3015), there is no subsection (f) in section 333. (Subsection (e) of section 333, like
sections 224 and 335(e), establishes a right for Corps members.)
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(A) encourage health professionals who are not Corps
members to enter into arrangements under which the
health professionals temporarily assume the duties of
Corps members for purposes of paragraph (1); and
(B) with respect to the entities to which Corps members have been assigned under section 333, encourage the
entities to facilitate the development of arrangements described in subparagraph (A).
(4) LIMITATION.—In carrying out paragraph (1), the Secretary may not, except as provided in paragraph (5), obligate
any amounts (other than for incidental expenses) for the purpose of—
(A) compensating a health professional who is not a
Corps member for assuming the duties of a Corps member;
or
(B) paying the costs of a vacation, or other interests
that a Corps member may pursue during the period of
temporary relief under such paragraph.
(5) SOLE PROVIDERS OF HEALTH SERVICES.—In the case of
any Corps member who is the sole provider of health services
in the geographic area involved, the Secretary may, from
amounts appropriated under section 338, obligate on behalf of
the member such sums as the Secretary determines to be necessary for purposes of providing temporary relief under paragraph (1).
(f) DETERMINATIONS REGARDING EFFECTIVE SERVICE.—In carrying out subsection (a) and sections 338A(d) and 338B(d), the Secretary shall carry out activities to determine—
(1) the characteristics of physicians, dentists, and other
health professionals who are more likely to remain in practice
in health professional shortage areas after the completion of
the period of service in the Corps;
(2) the characteristics of health manpower shortage
areas 41, and of entities seeking assignments of Corps members, that are more likely to retain Corps members after the
members have completed the period of service in the Corps;
and
(3) the appropriate conditions for the assignment and utilization in health manpower shortage areas 41 of certified nurse
practitioners, certified nurse midwives, and physician assistants.
ANNUAL REPORTS
SEC. 336A. ø254i¿ The Secretary shall submit an annual report
to Congress, and shall include in such report with respect to the
previous calendar year—
(1) the number, identity, and priority of all health professional shortage areas designated in such year and the number
of health professional shortage areas which the Secretary estimates will be designated in the subsequent year;
41 So in law. Probably should be ‘‘health professional shortage areas’’. See section 401 of Public
Law 101–597 (104 Stat. 3035).
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(2) the number of applications filed under section 333 in
such year for assignment of Corps members and the action
taken on each such application;
(3) the number and types of Corps members assigned in
such year to health professional shortage areas, the number
and types of additional Corps members which the Secretary estimates will be assigned to such areas in the subsequent year,
and the need for additional members for the Corps;
(4) the recruitment efforts engaged in for the Corps in such
year and the number of qualified individuals who applied for
service in the Corps in such year;
(5) the number of patients seen and the number of patient
visits recorded during such year with respect to each health
professional shortage area to which a Corps member was assigned during such year;
(6) the number of Corps members who elected, and the
number of Corps members who did not elect, to continue to
provide health services in health professional shortage areas
after termination of their service in the Corps and the reasons
(as reported to the Secretary) of members who did not elect for
not making such election;
(7) the results of evaluations and determinations made
under section 333(a)(1)(D) during such year; and
(8) the amount charged during such year for health services provided by Corps members, the amount which was collected in such year by entities in accordance with section 334,
and the amount which was paid to the Secretary in such year
under such agreements 42.
NATIONAL ADVISORY COUNCIL
SEC. 337. ø254j¿ (a) There is established a council to be known
as the National Advisory Council on the National Health Service
Corps (hereinafter in this section referred to as the ‘‘Council’’). The
Council shall be composed of fifteen members appointed by the Secretary. The Council shall consult with, advise, and make recommendations to, the Secretary with respect to his responsibilities
in carrying out this subpart (other than section 338G), and shall
review and comment upon regulations promulgated by the Secretary under this subpart.
(b)(1) Members of the Council shall be appointed for a term of
three years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member’s
predecessor was appointed shall be appointed for the remainder of
such term. No member shall be removed, except for cause.
(2) Members of the Council (other than members who are officers or employees of the United States), while attending meetings
or conferences thereof or otherwise serving on the business of the
Council, shall be entitled to receive for each day (including traveltime) in which they are so serving compensation at a rate fixed by
42 There is no antecedent reference to ‘‘agreements’’. Formerly, paragraph (8) contained the
clause ‘‘, the amount which was collected in such year by entities in accordance with agreements
under section 334,’’. Section 307(b) of Public Law 107–251 (116 Stat. 1649) struck ‘‘agreements
under’’ in that clause.
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the Secretary (but not to exceed the daily equivalent of the annual
rate of basic pay in effect for grade GS–18 of the General Schedule); and while so serving away from their homes or regular places
of business all members may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by section 5703 of
title 5 of the United States Code for persons in the Government
service employed intermittently.
(c) Section 1013 of title 5, United States Code, shall not apply
with respect to the Council.
AUTHORIZATION OF APPROPRIATION
SEC. 338. ø254k¿ (a) For the purpose of carrying out this subpart, there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2008 through 2012.
(b) An appropriation under an authorization under subsection
(a) for any fiscal year may be made at any time before that fiscal
year and may be included in an Act making an appropriation under
an authorization under subsection (a) for another fiscal year; but
no funds may be made available from any appropriation under
such authorization for obligation under sections 331 through 335,
section 336A, and section 337 before the fiscal year for which such
appropriation is authorized.
Subpart III—Scholarship Program and Loan
Repayment Program
NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP PROGRAM
SEC. 338A. ø254l¿ (a) The Secretary shall establish the National Health Service Corps Scholarship Program to assure, with
respect to the provision of primary health services pursuant to section 331(a)(2)—
(1) an adequate supply of physicians, dentists, behavioral
and mental health professionals, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other
health professionals.
(b) To be eligible to participate in the Scholarship Program, an
individual must—
(1) be accepted for enrollment, or be enrolled, as a full-time
student (A) in an accredited (as determined by the Secretary)
educational institution in a State and (B) in a course of study
or program, offered by such institution and approved by the
Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession, or an appropriate
degree from a graduate program of behavioral and mental
health;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service
or be eligible for selection for civilian service in the Corps;
(3) submit an application to participate in the Scholarship
Program; and
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(4) sign and submit to the Secretary, at the time of submittal of such application, a written contract (described in subsection (f)) to accept payment of a scholarship and to serve (in
accordance with this subpart) for the applicable period of obligated service in a health professional shortage area.
(c)(1) In disseminating application forms and contract forms to
individuals desiring to participate in the Scholarship Program, the
Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the United States is entitled
under section 338E in the case of the individual’s breach of the
contract; and
(B) information respecting meeting a service obligation
through private practice under an agreement under section
338D and such other information as may be necessary for the
individual to understand the individual’s prospective participation in the Scholarship Program and service in the Corps, including a statement of all factors considered in approving applications for participation in the Program and in making assignments for participants in the Program.
(2) The application form, contract form, and all other information furnished by the Secretary under this subpart shall be written
in a manner calculated to be understood by the average individual
applying to participate in the Scholarship Program. The Secretary
shall make such application forms, contract forms, and other information available to individuals desiring to participate in the Scholarship Program on a date sufficiently early to insure that such individuals have adequate time to carefully review and evaluate such
forms and information.
(3)(A) The Secretary shall distribute to health professions
schools materials providing information on the Scholarship Program and shall encourage the schools to disseminate the materials
to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Scholarship Program is nearing completion, the Secretary shall encourage the individual to remain in a
health professional shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated
service under the Scholarship Program, the Secretary may provide
assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and
is continuing to provide primary health services.
(C) In the case of entities to which participants in the Scholarship Program are assigned under section 333, the Secretary shall
encourage the entities to provide options with respect to assisting
the participants in remaining in the health professional shortage
areas involved, and in continuing to provide primary health services, after the period of obligated service under the Scholarship
Program is completed. The options with respect to which the Secretary provides such encouragement may include options regarding
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the sharing of a single employment position in the health professions by 2 or more health professionals, and options regarding the
recruitment of couples where both of the individuals are health
professionals.
(d)(1) Subject to section 333A, in providing contracts under the
Scholarship Program—
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services;
(B) the Secretary, in considering applications from individuals accepted for enrollment or enrolled in dental school, shall
consider applications from all individuals accepted for enrollment or enrolled in any accredited dental school in a State;
and
(C) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting
qualified individuals to participate in such Program.
(2) In providing contracts under the Scholarship Program, the
Secretary shall give priority—
(A) first, to any application for such a contract submitted
by an individual who has previously received a scholarship
under this section or under section 758;
(B) second, to any application for such a contract submitted by an individual who has characteristics that increase
the probability that the individual will continue to serve in a
health professional shortage area after the period of obligated
service pursuant to subsection (f) is completed; and
(C) third, subject to subparagraph (B), to any application
for such a contract submitted by an individual who is from a
disadvantaged background.
(e)(1) An individual becomes a participant in the Scholarship
Program only upon the Secretary’s approval of the individual’s application submitted under subsection (b)(3) and the Secretary’s acceptance of the contract submitted by the individual under subsection (b)(4).
(2) The Secretary shall provide written notice to an individual
promptly upon the Secretary’s approving, under paragraph (1), of
the individual’s participation in the Scholarship Program.
(f) The written contract (referred to in this subpart) between
the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (2), the Secretary agrees (i) to
provide the individual with a scholarship (described in
subsection (g)) in each such school year or years for a period of years (not to exceed four school years) determined
by the individual, during which period the individual is
pursuing a course of study described in subsection
(b)(1)(B), and (ii) to accept (subject to the availability of appropriated funds for carrying out sections 331 through 335
and section 337) the individual into the Corps (or for
equivalent service as otherwise provided in this subpart);
and
(B) subject to paragraph (2), the individual agrees—
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Sec. 338A
(i) to accept provision of such a scholarship to the
individual;
(ii) to maintain enrollment in a course of study described in subsection (b)(1)(B) until the individual
completes the course of study;
(iii) while enrolled in such course of study, to
maintain an acceptable level of academic standing (as
determined under regulations of the Secretary by the
educational institution offering such course of study);
(iv) if pursuing a degree from a school of medicine
or osteopathic medicine, to complete a residency in a
specialty that the Secretary determines is consistent
with the needs of the Corps; and
(v) to serve for a time period (hereinafter in the
subpart referred to as the ‘‘period of obligated service’’)
equal to—
(I) one year for each school year for which the
individual was provided a scholarship under the
Scholarship Program, or
(II) two years,
whichever is greater, as a provider of primary health
services in a health professional shortage area (designated under section 332) to which he is assigned by
the Secretary as a member of the Corps, or as otherwise provided in this subpart;
(2) a provision that any financial obligation of the United
States arising out of a contract entered into under this subpart
and any obligation of the individual which is conditioned thereon, is contingent upon funds being appropriated for scholarships under this subpart and to carry out the purposes of sections 331 through 335 and sections 337 and 338;
(3) a statement of the damages to which the United States
is entitled, under section 338E for the individual’s breach of
the contract; and
(4) such other statements of the rights and liabilities of the
Secretary and of the individual, not inconsistent with the provisions of this subpart.
(g)(1) A scholarship provided to a student for a school year
under a written contract under the Scholarship Program shall consist of—
(A) payment to, or (in accordance with paragraph (2)) on
behalf of, the student of the amount (except as provided in section 711) of—
(i) the tuition of the student in such school year; and
(ii) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the
student in such school year; and
(B) payment to the student of a stipend of $400 per month
(adjusted in accordance with paragraph (3)) for each of the 12
consecutive months beginning with the first month of such
school year.
(2) The Secretary may contract with an educational institution,
in which a participant in the Scholarship Program is enrolled, for
the payment to the educational institution of the amounts of tuiFebruary 1, 2024
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tion and other reasonable educational expenses described in paragraph (1)(A). Payment to such an educational institution may be
made without regard to section 3648 of the Revised Statutes (31
U.S.C. 529).
(3) The amount of the monthly stipend, specified in paragraph
(1)(B) and as previously adjusted (if at all) in accordance with this
paragraph, shall be increased by the Secretary for each school year
ending in a fiscal year beginning after September 30, 1978, by an
amount (rounded to the next highest multiple of $1) equal to the
amount of such stipend multiplied by the overall percentage (under
section 5303 of title 5, United States Code) of the adjustment (if
such adjustment is an increase) in the rates of pay under the General Schedule made effective in the fiscal year in which such school
year ends.
(h) Notwithstanding any other provision of law, individuals
who have entered into written contracts with the Secretary under
this section, while undergoing academic training, shall not be
counted against any employment ceiling affecting the Department.
SEC. 338B. ø254l–1¿ NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM.
(a) ESTABLISHMENT.—The Secretary shall establish a program
to be known as the National Health Service Corps Loan Repayment
Program to assure, with respect to the provision of primary health
services pursuant to section 331(a)(2)—
(1) an adequate supply of physicians, dentists, behavioral
and mental health professionals, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other
health professionals.
(b) ELIGIBILITY.—To be eligible to participate in the Loan Repayment Program, an individual must—
(1)(A) have a degree in medicine, osteopathic medicine,
dentistry, or another health profession, or an appropriate degree from a graduate program of behavioral and mental health,
or be certified as a nurse midwife, nurse practitioner, or physician assistant;
(B) be enrolled in an approved graduate training program
in medicine, osteopathic medicine, dentistry, behavioral and
mental health, or other health profession; or
(C) be enrolled as a full-time student—
(i) in an accredited (as determined by the Secretary)
educational institution in a State; and
(ii) in the final year of a course of a study or program,
offered by such institution and approved by the Secretary,
leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service
or be eligible for selection for civilian service in the Corps; and
(3) submit to the Secretary an application for a contract
described in subsection (f) (relating to the payment by the Secretary of the educational loans of the individual in consideration of the individual serving for a period of obligated service).
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(c) APPLICATION, CONTRACT,
AND
Sec. 338B
INFORMATION REQUIRE-
MENTS.—
(1) SUMMARY AND INFORMATION.—In disseminating application forms and contract forms to individuals desiring to participate in the Loan Repayment Program, the Secretary shall
include with such forms—
(A) a fair summary of the rights and liabilities of an
individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the
United States is entitled under section 338E in the case of
the individual’s breach of the contract; and
(B) information respecting meeting a service obligation
through private practice under an agreement under section
338D and such other information as may be necessary for
the individual to understand the individual’s prospective
participation in the Loan Repayment Program and service
in the Corps.
(2) UNDERSTANDABILITY.—The application form, contract
form, and all other information furnished by the Secretary
under this subpart shall be written in a manner calculated to
be understood by the average individual applying to participate
in the Loan Repayment Program.
(3) AVAILABILITY.—The Secretary shall make such application forms, contract forms, and other information available to
individuals desiring to participate in the Loan Repayment Program on a date sufficiently early to ensure that such individuals have adequate time to carefully review and evaluate such
forms and information.
(4) RECRUITMENT AND RETENTION.—
(A) The Secretary shall distribute to health professions
schools materials providing information on the Loan Repayment Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Loan Repayment Program is nearing completion, the Secretary shall encourage
the individual to remain in a health professional shortage
area and to continue providing primary health services.
(ii) During the period in which a health professional is
planning and making the transition to private practice
from obligated service under the Loan Repayment Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the
Loan Repayment Program are assigned under section 333,
the Secretary shall encourage the entities to provide options with respect to assisting the participants in remaining in the health professional shortage areas involved, and
in continuing to provide primary health services, after the
period of obligated service under the Loan Repayment Program is completed. The options with respect to which the
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286
Secretary provides such encouragement may include options regarding the sharing of a single employment position in the health professions by 2 or more health professionals, and options regarding the recruitment of couples
where both of the individuals are health professionals.
(d)(1) Subject to section 333A, in providing contracts under the
Loan Repayment Program—
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services; and
(B) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting
qualified individuals to participate in such Program.
(2) In providing contracts under the Loan Repayment Program,
the Secretary shall give priority—
(A) to any application for such a contract submitted by an
individual whose training is in a health profession or specialty
determined by the Secretary to be needed by the Corps;
(B) to any application for such a contract submitted by an
individual who has (and whose spouse, if any, has) characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the
period of obligated service pursuant to subsection (f) is completed; and
(C) subject to subparagraph (B), to any application for such
a contract submitted by an individual who is from a disadvantaged background.
(e) APPROVAL REQUIRED FOR PARTICIPATION.—An individual becomes a participant in the Loan Repayment Program only upon the
Secretary and the individual entering into a written contract described in subsection (f).
(f) CONTENTS OF CONTRACTS.—The written contract (referred to
in this subpart) between the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (3), the Secretary agrees—
(i) to pay on behalf of the individual loans in accordance with subsection (g); and
(ii) to accept (subject to the availability of appropriated funds for carrying out sections 331 through
335 and section 337) the individual into the Corps (or
for equivalent service as otherwise provided in this
subpart); and
(B) subject to paragraph (3), the individual agrees—
(i) to accept loan payments on behalf of the individual;
(ii) in the case of an individual described in subsection (b)(1)(C), to maintain enrollment in a course of
study or training described in such subsection until
the individual completes the course of study or training;
(iii) in the case of an individual described in subsection (b)(1)(C), while enrolled in such course of study
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Sec. 338B
demic standing (as determined under regulations of
the Secretary by the educational institution offering
such course of study or training); and
(iv) to serve for a time period (hereinafter in this
subpart referred to as the ‘‘period of obligated service’’)
equal to 2 years or such longer period as the individual may agree to, as a provider of primary health
services in a health professional shortage area (designated under section 332) to which such individual is
assigned by the Secretary as a member of the Corps
or released under section 338D;
(2) a provision permitting the Secretary to extend for such
longer additional periods, as the individual may agree to, the
period of obligated service agreed to by the individual under
paragraph (1)(B)(iv), including extensions resulting in an aggregate period of obligated service in excess of 4 years;
(3) a provision that any financial obligation of the United
States arising out of a contract entered into under this subpart
and any obligation of the individual that is conditioned thereon, is contingent on funds being appropriated for loan repayments under this subpart and to carry out the purposes of sections 331 through 335 and sections 337 and 338;
(4) a statement of the damages to which the United States
is entitled, under section 338E for the individual’s breach of
the contract; and
(5) such other statements of the rights and liabilities of the
Secretary and of the individual, not inconsistent with this subpart.
(g) PAYMENTS.—
(1) IN GENERAL.—A loan repayment provided for an individual under a written contract under the Loan Repayment
Program shall consist of payment, in accordance with paragraph (2), on behalf of the individual of the principal, interest,
and related expenses on government and commercial loans received by the individual regarding the undergraduate or graduate education of the individual (or both), which loans were
made for—
(A) tuition expenses;
(B) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the
individual; or
(C) reasonable living expenses as determined by the
Secretary.
(2) PAYMENTS FOR YEARS SERVED.—
(A) IN GENERAL.—For each year of obligated service
that an individual contracts to serve under subsection (f)
the Secretary may pay up to $50,000, plus, beginning with
fiscal year 2012, an amount determined by the Secretary
on an annual basis to reflect inflation, on behalf of the individual for loans described in paragraph (1). In making a
determination of the amount to pay for a year of such service by an individual, the Secretary shall consider the extent to which each such determination—
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Sec. 338C
PUBLIC HEALTH SERVICE ACT
288
(i) affects the ability of the Secretary to maximize
the number of contracts that can be provided under
the Loan Repayment Program from the amounts appropriated for such contracts;
(ii) provides an incentive to serve in health professional shortage areas with the greatest such shortages; and
(iii) provides an incentive with respect to the
health professional involved remaining in a health
professional shortage area, and continuing to provide
primary health services, after the completion of the
period of obligated service under the Loan Repayment
Program.
(B) REPAYMENT SCHEDULE.—Any arrangement made
by the Secretary for the making of loan repayments in accordance with this subsection shall provide that any repayments for a year of obligated service shall be made no later
than the end of the fiscal year in which the individual
completes such year of service.
(3) TAX LIABILITY.—For the purpose of providing reimbursements for tax liability resulting from payments under
paragraph (2) on behalf of an individual—
(A) the Secretary shall, in addition to such payments,
make payments to the individual in an amount equal to 39
percent of the total amount of loan repayments made for
the taxable year involved; and
(B) may make such additional payments as the Secretary determines to be appropriate with respect to such
purpose.
(4) PAYMENT SCHEDULE.—The Secretary may enter into an
agreement with the holder of any loan for which payments are
made under the Loan Repayment Program to establish a
schedule for the making of such payments.
(h) EMPLOYMENT CEILING.—Notwithstanding any other provision of law, individuals who have entered into written contracts
with the Secretary under this section, while undergoing academic
or other training, shall not be counted against any employment
ceiling affecting the Department.
OBLIGATED SERVICE
SEC. 338C. ø254m¿ (a) SERVICE IN FULL-TIME CLINICAL PRACTICE.—Except as provided in section 338D, each individual who has
entered into a written contract with the Secretary under section
338A or 338B shall provide service in the full-time clinical practice
of such individual’s profession as a member of the Corps for the period of obligated service provided in such contract. The Secretary
may treat teaching as clinical practice for up to 20 percent of such
period of obligated service. Notwithstanding the preceding sentence, with respect to a member of the Corps participating in the
teaching health centers graduate medical education program under
section 340H, for the purpose of calculating time spent in full-time
clinical practice under this section, up to 50 percent of time spent
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Sec. 338C
teaching by such member may be counted toward his or her service
obligation.
(b)(1) If an individual is required under subsection (a) to provide service as specified in section 338A(f)(1)(B)(v) or
338B(f)(1)(B)(iv) (hereinafter in this subsection referred to as ‘‘obligated service’’), the Secretary shall, not later than ninety days before the date described in paragraph (5), determine if the individual shall provide such service—
(A) as a member of the Corps who is a commissioned officer in the Regular or Reserve Corps of the Service or who is
a civilian employee of the United States, or
(B) as a member of the Corps who is not such an officer
or employee,
and shall notify such individual of such determination.
(2) If the Secretary determines that an individual shall provide
obligated service as a member of the Corps who is a commissioned
officer in the Service or a civilian employee of the United States,
the Secretary shall, not later than sixty days before the date described in paragraph (5), provide such individual with sufficient information regarding the advantages and disadvantages of service
as such a commissioned officer or civilian employee to enable the
individual to make a decision on an informed basis. To be eligible
to provide obligated service as a commissioned officer in the Service, an individual shall notify the Secretary, not later than thirty
days before the date described in paragraph (5), of the individual’s
desire to provide such service as such an officer. If an individual
qualifies for an appointment as such an officer, the Secretary shall,
as soon as possible after the date described in paragraph (5), appoint the individual as a commissioned officer of the Regular or Reserve Corps of the Service and shall designate the individual as a
member of the Corps.
(3) If an individual provided notice by the Secretary under
paragraph (2) does not qualify for appointment as a commissioned
officer in the Service, the Secretary shall, as soon as possible after
the date described in paragraph (5), appoint such individual as a
civilian employee of the United States and designate the individual
as a member of the Corps.
(4) If the Secretary determines that an individual shall provide
obligated service as a member of the Corps who is not an employee
of the United States, the Secretary shall, as soon as possible after
the date described in paragraph (5), designate such individual as
a member of the Corps to provide such service.
(5)(A) In the case of the Scholarship Program, the date referred
to in paragraphs (1) through (4) shall be the date on which the individual completes the training required for the degree for which
the individual receives the scholarship, except that—
(i) for an individual receiving such a degree after September 30, 2000, from a school of medicine or osteopathic medicine, such date shall be the date the individual completes a
residency in a specialty that the Secretary determines is consistent with the needs of the Corps; and
(ii) at the request of an individual, the Secretary may, consistent with the needs of the Corps, defer such date until the
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Sec. 338D
PUBLIC HEALTH SERVICE ACT
290
end of a period of time required for the individual to complete
advanced training (including an internship or residency).
(B) No period of internship, residency, or other advanced clinical training shall be counted toward satisfying a period of obligated service under this subpart.
(C) In the case of the Loan Repayment Program, if an individual is required to provide obligated service under such Program,
the date referred to in paragraphs (1) through (4)—
(i) shall be the date determined under subparagraph (A) in
the case of an individual who is enrolled in the final year of
a course of study;
(ii) shall, in the case of an individual who is enrolled in an
approved graduate training program in medicine, osteopathic
medicine, dentistry, or other health profession, be the date the
individual completes such training program; and
(iii) shall, in the case of an individual who has a degree
in medicine, osteopathic medicine, dentistry, or other health
profession and who has completed graduate training, be the
date the individual enters into an agreement with the Secretary under section 338B.
(c) An individual shall be considered to have begun serving a
period of obligated service—
(1) on the date such individual is appointed as an officer
in a Regular or Reserve Corps of the Service or is designated
as a member of the Corps under subsection (b)(3) or (b)(4), or
(2) in the case of an individual who has entered into an
agreement with the Secretary under section 338D, on the date
specified in such agreement,
whichever is earlier.
(d) The Secretary shall assign individuals performing obligated
service in accordance with a written contract under the Scholarship
Program to health professional shortage areas in accordance with
sections 331 through 335 and sections 337 and 338. If the Secretary determines that there is no need in a health professional
shortage area (designated under section 332) for a member of the
profession in which an individual is obligated to provide service
under a written contract and if such individual is an officer in the
Service or a civilian employee of the United States, the Secretary
may detail such individual to serve his period of obligated service
as a full-time member of such profession in such unit of the Department as the Secretary may determine.
PRIVATE PRACTICE
SEC. 338D. ø254n¿ (a) The Secretary shall, to the extent permitted by, and consistent with, the requirements of applicable
State law, release an individual from all or part of his service obligation under section 338C(a) or under section 225 (as in effect on
September 30, 1977) if the individual applies for such a release
under this section and enters into a written agreement with the
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Sec. 338D
ployee in an entity directly providing health services) of his health
profession—
(1) in the case of an individual who received a scholarship
under the Scholarship Program or a loan repayment under the
Loan Repayment Program and who is performing obligated
service as a member of the Corps in a health professional
shortage area on the date of his application for such a release,
in the health professional shortage area in which such individual is serving on such date or in the case of an individual
for whom a loan payment was made under the Loan Repayment Program and who is performing obligated service as a
member of the Corps in a health professional shortage area on
the date of the application of the individual for such a release,
in the health professional shortage area selected by the Secretary; or
(2) in the case of any other individual, in a health professional shortage area (designated under section 332) selected by
the Secretary.
(b)(1) The written agreement described in subsection (a)
shall—
(A) provide that, during the period of private practice by
an individual pursuant to the agreement, the individual shall
comply with the requirements of section 334 that apply to entities; and
(B) contain such additional provisions as the Secretary
may require to carry out the objectives of this section.
(2) The Secretary shall take such action as may be appropriate
to ensure that the conditions of the written agreement prescribed
by this subsection are adhered to.
(c) If an individual breaches the contract entered into under
section 338A or 338B by failing (for any reason) to begin his service
obligation in accordance with an agreement entered into under subsection (a) or to complete such service obligation, the Secretary
may permit such individual to perform such service obligation as
a member of the Corps.
(d) The Secretary may pay an individual who has entered into
an agreement with the Secretary under subsection (a) an amount
to cover all or part of the individual’s expenses reasonably incurred
in transporting himself, his family, and his possessions to the location of his private clinical practice.
(e) Upon the expiration of the written agreement under subsection (a), the Secretary may (notwithstanding any other provision
of law) sell to the individual who has entered into an agreement
with the Secretary under subsection (a), equipment and other property of the United States utilized by such individual in providing
health services. Sales made under this subsection shall be made at
the fair market value (as determined by the Secretary) of the
equipment or such other property, except that the Secretary may
make such sales for a lesser value to the individual if he determines that the individual is financially unable to pay the full market value.
(f) The Secretary may, out of appropriations authorized under
section 338, pay to individuals participating in private practice
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under this section the cost of such individual’s malpractice insurance and the lesser of—
(1)(A) $10,000 in the first year of obligated service;
(B) $7,500 in the second year of obligated service;
(C) $5,000 in the third year of obligated service; and
(D) $2,500 in the fourth year of obligated service; or
(2) an amount determined by subtracting such individual’s
net income before taxes from the income the individual would
have received as a member of the Corps for each such year of
obligated service.
(g) The Secretary shall, upon request, provide to each individual released from service obligation under this section technical
assistance to assist such individual in fulfilling his or her agreement under this section.
BREACH OF SCHOLARSHIP CONTRACT OR LOAN REPAYMENT CONTRACT
SEC. 338E. ø254o¿ (a)(1) An individual who has entered into a
written contract with the Secretary under section 338A and who—
(A) fails to maintain an acceptable level of academic standing in the educational institution in which he is enrolled (such
level determined by the educational institution under regulations of the Secretary);
(B) is dismissed from such educational institution for disciplinary reasons; or
(C) voluntarily terminates the training in such an educational institution for which he is provided a scholarship
under such contract, before the completion of such training,
in lieu of any service obligation arising under such contract, shall
be liable to the United States for the amount which has been paid
to him, or on his behalf, under the contract.
(2) An individual who has entered into a written contract with
the Secretary under section 338B and who—
(A) in the case of an individual who is enrolled in the final
year of a course of study, fails to maintain an acceptable level
of academic standing in the educational institution in which
such individual is enrolled (such level determined by the educational institution under regulations of the Secretary) or voluntarily terminates such enrollment or is dismissed from such
educational institution before completion of such course of
study; or
(B) in the case of an individual who is enrolled in a graduate training program, fails to complete such training program
and does not receive a waiver from the Secretary under section
338B(b)(1)(B)(ii),
in lieu of any service obligation arising under such contract shall
be liable to the United States for the amount that has been paid
on behalf of the individual under the contract.
(b)(1)(A) Except as provided in paragraph (2), if (for any reason
not specified in subsection (a) or section 338G(d)) an individual
breaches his written contract by failing to begin such individual’s
service obligation under section 338A in accordance with section
338C or 338D, to complete such service obligation, or to complete
a required residency as specified in section 338A(f)(1)(B)(iv), the
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Sec. 338E
United States shall be entitled to recover from the individual an
amount determined in accordance with the formula
A=3ϕ(t¥s/t)
in which ‘‘A’’ is the amount the United States is entitled to recover,
‘‘ϕ’’ is the sum of the amounts paid under this subpart to or on behalf of the individual and the interest on such amounts which
would be payable if at the time the amounts were paid they were
loans bearing interest at the maximum legal prevailing rate, as determined by the Treasurer of the United States; ‘‘t’’ is the total
number of months in the individual’s period of obligated service;
and ‘‘s’’ is the number of months of such period served by him in
accordance with section 338C or a written agreement under section
338D.
(B)(i) Any amount of damages that the United States is entitled to recover under this subsection or under subsection (c) shall,
within the 1-year period beginning on the date of the breach of the
written contract (or such longer period beginning on such date as
specified by the Secretary), be paid to the United States. Amounts
not paid within such period shall be subject to collection through
deductions in Medicare payments pursuant to section 1892 of the
Social Security Act.
(ii) If damages described in clause (i) are delinquent for 3
months, the Secretary shall, for the purpose of recovering such
damages—
(I) utilize collection agencies contracted with by the Administrator of the General Services Administration; or
(II) enter into contracts for the recovery of such damages
with collection agencies selected by the Secretary.
(iii) Each contract for recovering damages pursuant to this subsection shall provide that the contractor will, not less than once
each 6 months, submit to the Secretary a status report on the success of the contractor in collecting such damages. Section 3718 of
title 31, United States Code, shall apply to any such contract to the
extent not inconsistent with this subsection.
(iv) To the extent not otherwise prohibited by law, the Secretary shall disclose to all appropriate credit reporting agencies information relating to damages of more than $100 that are entitled
to be recovered by the United States under this subsection and that
are delinquent by more than 60 days or such longer period as is
determined by the Secretary.
(2) If an individual is released under section 753 from a service
obligation under section 225 (as in effect on September 30, 1977)
and if the individual does not meet the service obligation incurred
under section 753, subsection (f) of such section 225 shall apply to
such individual in lieu of paragraph (1) of this subsection.
(3) The Secretary may terminate a contract with an individual
under section 338A if, not later than 30 days before the end of the
school year to which the contract pertains, the individual—
(A) submits a written request for such termination; and
(B) repays all amounts paid to, or on behalf of, the individual under section 338A(g).
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(c)(1) If (for any reason not specified in subsection (a) or section
338G(d)) an individual breaches the written contract of the individual under section 338B by failing either to begin such individual’s service obligation in accordance with section 338C or 338D or
to complete such service obligation, the United States shall be entitled to recover from the individual an amount equal to the sum
of—
(A) the total of the amounts paid by the United States
under section 338B(g) on behalf of the individual for any period
of obligated service not served;
(B) an amount equal to the product of the number of
months of obligated service that were not completed by the individual, multiplied by $7,500; and
(C) the interest on the amounts described in subparagraphs (A) and (B), at the maximum legal prevailing rate, as
determined by the Treasurer of the United States, from the
date of the breach;
except that the amount the United States is entitled to recover
under this paragraph shall not be less than $31,000.
(2) The Secretary may terminate a contract with an individual
under section 338B if, not later than 45 days before the end of the
fiscal year in which the contract was entered into, the individual—
(A) submits a written request for such termination; and
(B) repays all amounts paid on behalf of the individual
under section 338B(g).
(3) Damages that the United States is entitled to recover shall
be paid in accordance with subsection (b)(1)(B).
(d)(1) Any obligation of an individual under the Scholarship
Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for service or payment of damages
shall be canceled upon the death of the individual.
(2) The Secretary shall by regulation provide for the partial or
total waiver or suspension of any obligation of service or payment
by an individual under the Scholarship Program (or a contract
thereunder) or the Loan Repayment Program (or a contract thereunder) whenever compliance by the individual is impossible or
would involve extreme hardship to the individual and if enforcement of such obligation with respect to any individual would be unconscionable.
(3)(A) Any obligation of an individual under the Scholarship
Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for payment of damages may be released by a discharge in bankruptcy under title 11 of the United
States Code only if such discharge is granted after the expiration
of the 7-year period beginning on the first date that payment of
such damages is required, and only if the bankruptcy court finds
that nondischarge of the obligation would be unconscionable.
(B)(i) Subparagraph (A) shall apply to any financial obligation
of an individual under the provision of law specified in clause (ii)
to the same extent and in the same manner as such subparagraph
applies to any obligation of an individual under the Scholarship or
Loan Repayment Program (or contract thereunder) for payment of
damages.
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(ii) The provision of law referred to in clause (i) is subsection
(f) of section 225 of this Act, as in effect prior to the repeal of such
section by section 408(b)(1) of Public Law 94–484.
(e) Notwithstanding any other provision of Federal or State
law, there shall be no limitation on the period within which suit
may be filed, a judgment may be enforced, or an action relating to
an offset or garnishment, or other action, may be initiated or taken
by the Secretary, the Attorney General, or the head of another Federal agency, as the case may be, for the repayment of the amount
due from an individual under this section.
(f) The amendment made by section 313(a)(4) of the Health
Care Safety Net Amendments of 2002 (Public Law 107–251) shall
apply to any obligation for which a discharge in bankruptcy has not
been granted before the date that is 31 days after the date of enactment of such Act.
SEC. 338F. ø254o–1¿ FUND REGARDING USE OF AMOUNTS RECOVERED
FOR CONTRACT BREACH TO REPLACE SERVICES LOST AS
RESULT OF BREACH.
(a) ESTABLISHMENT OF FUND.—There is established in the
Treasury of the United States a fund to be known as the National
Health Service Corps Member Replacement Fund (hereafter in this
section referred to as the ‘‘Fund’’). The Fund shall consist of such
amounts as may be appropriated under subsection (b) to the Fund.
Amounts appropriated for the Fund shall remain available until expended.
(b) AUTHORIZATION OF APPROPRIATIONS TO FUND.—For each
fiscal year, there is authorized to be appropriated to the Fund an
amount equal to the sum of—
(1) the amount collected during the preceding fiscal year
by the Federal Government pursuant to the liability of individuals under section 338E for the breach of contracts entered
into under section 338A or 338B;
(2) the amount by which grants under section 338I have,
for such preceding fiscal year, been reduced under subsection
(g)(2)(B) of such section; and
(3) the aggregate of the amount of interest accruing during
the preceding fiscal year on obligations held in the Fund pursuant to subsection (d) and the amount of proceeds from the
sale or redemption of such obligations during such fiscal year.
(c) USE OF FUND.—
(1) PAYMENTS TO CERTAIN HEALTH FACILITIES.—Amounts in
the Fund and available pursuant to appropriations Act may,
subject to paragraph (2), be expended by the Secretary to make
payments to any entity—
(A) to which a Corps member has been assigned under
section 333; and
(B) that has a need for a health professional to provide
primary health services as a result of the Corps member
having breached the contract entered into under section
338A or 338B by the individual.
(2) PURPOSE OF PAYMENTS.—An entity receiving payments
pursuant to paragraph (1) may expend the payments to recruit
and employ a health professional to provide primary health
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services to patients of the entity, or to enter into a contract
with such a professional to provide the services to the patients.
(d) INVESTMENT.—
(1) IN GENERAL.—The Secretary of the Treasury shall invest such amounts of the Fund as such Secretary determines
are not required to meet current withdrawals from the Fund.
Such investments may be made only in interest-bearing obligations of the United States. For such purpose, such obligations
may be acquired on original issue at the issue price, or by purchase of outstanding obligations at the market price.
(2) SALE OF OBLIGATIONS.—Any obligation acquired by the
Fund may be sold by the Secretary of the Treasury at the market price.
SPECIAL LOANS FOR FORMER CORPS MEMBERS TO ENTER PRIVATE
PRACTICE
SEC. 338G. ø254p¿ (a) The Secretary may, out of appropriations authorized under section 338, make one loan to a Corps member who has agreed in writing—
(1) to engage in the private full-time clinical practice of the
profession of the member in a health professional shortage
area (designated under section 332) for a period of not less
than 2 years which—
(A) in the case of a Corps member who is required to
complete a period of obligated service under this subpart,
begins not later than 1 year after the date on which such
individual completes such period of obligated service; and
(B) in the case of an individual who is not required to
complete a period of obligated service under this subpart,
begins at such time as the Secretary considers appropriate;
(2) to conduct such practice in accordance with section
338D(b)(1); and
(3) to such additional conditions as the Secretary may require to carry out this section.
Such a loan shall be used to assist such individual in meeting the
costs of beginning the practice of such individual’s profession in accordance with such agreement, including the costs of acquiring
equipment and renovating facilities for use in providing health
services, and of hiring nurses and other personnel to assist in providing health services. Such loan may not be used for the purchase
or construction of any building.
(b)(1) The amount of a loan under subsection (a) to an individual shall not exceed $25,000.
(2) The interest rate for any such loan shall not exceed an annual rate of 5 percent.
(c) The Secretary may not make a loan under this section unless an application therefor has been submitted to, and approved
by, the Secretary. The Secretary shall, by regulation, set interest
rates and repayment terms for loans under this section.
(d) If the Secretary determines that an individual has breached
a written agreement entered into under subsection (a), he shall, as
soon as practicable after making such determination notify the individual of such determination. If within 60 days after the date of
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giving such notice, such individual is not practicing his profession
in accordance with the agreement under such subsection and has
not provided assurances satisfactory to the Secretary that he will
not knowingly violate such agreement again, the United States
shall be entitled to recover from such individual—
(1) in the case of an individual who has received a grant
under this section (as in effect prior to October 1, 1984), an
amount determined under section 338E(b), except that in applying the formula contained in such section ‘‘ϕ’’ shall be the
sum of the amount of the grant made under subsection (a) to
such individual and the interest on such amount which would
be payable if at the time it was paid it was a loan bearing interest at the maximum legal prevailing rate, ‘‘t’’ shall be the
number of months that such individual agreed to practice his
profession under agreement, and ‘‘s’’ shall be the number of
months that such individual practices his profession in accordance with such agreement; and
(2) in the case of an individual who has received a loan
under this section, the full amount of the principal and interest
owed by such individual under this section.
SEC. 338H. ø254q¿ AUTHORIZATION OF APPROPRIATIONS.
(a) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of
carrying out this section 43, there is authorized to be appropriated,
out of any funds in the Treasury not otherwise appropriated, the
following:
(1) For fiscal year 2010, $320,461,632.
(2) For fiscal year 2011, $414,095,394.
(3) For fiscal year 2012, $535,087,442.
(4) For fiscal year 2013, $691,431,432.
(5) For fiscal year 2014, $893,456,433.
(6) For fiscal year 2015, $1,154,510,336.
(7) For fiscal year 2016, and each subsequent fiscal year,
the amount appropriated for the preceding fiscal year adjusted
by the product of—
(A) one plus the average percentage increase in the
costs of health professions education during the prior fiscal
year; and
(B) one plus the average percentage change in the
number of individuals residing in health professions shortage areas designated under section 333 during the prior
fiscal year, relative to the number of individuals residing
in such areas during the previous fiscal year.
(b) SCHOLARSHIPS FOR NEW PARTICIPANTS.—Of the amounts
appropriated under subsection (a) for a fiscal year, the Secretary
shall obligate not less than 10 percent for the purpose of providing
contracts for—
(1) scholarships under this subpart to individuals who
have not previously received such scholarships; or
(2) scholarships or loan repayments under the Loan Repayment Program under section 338B to individuals from disadvantaged backgrounds.
43 The reference to ‘‘this section’’ in section 338H(a) probably should be a reference to ‘‘this
subpart’’.
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(c) SCHOLARSHIPS AND LOAN REPAYMENTS.—With respect to
certification as a nurse practitioner, nurse midwife, or physician
assistant, the Secretary shall, from amounts appropriated under
subsection (a) for a fiscal year, obligate not less than a total of 10
percent for contracts for both scholarships under the Scholarship
Program under section 338A and loan repayments under the Loan
Repayment Program under section 338B to individuals who are entering the first year of a course of study or program described in
section 338A(b)(1)(B) that leads to such a certification or individuals who are eligible for the loan repayment program as specified
in section 338B(b) for a loan related to such certification.
SEC. 338I. ø254q–1¿ GRANTS TO STATES FOR LOAN REPAYMENT PROGRAMS.
(a) IN GENERAL.—
(1) AUTHORITY FOR GRANTS.—The Secretary, acting
through the Administrator of the Health Resources and Services Administration, may make grants to States for the purpose of assisting the States in operating programs described in
paragraph (2) in order to provide for the increased availability
of primary health care services in health professional shortage
areas. The National Advisory Council established under section
337 shall advise the Administrator regarding the program
under this section.
(2) LOAN REPAYMENT PROGRAMS.—The programs referred
to in paragraph (1) are, subject to subsection (c), programs of
entering into contracts under which the State involved agrees
to pay all or part of the principal, interest, and related expenses of the educational loans of health professionals in consideration of the professionals agreeing to provide primary
health services in health professional shortage areas.
(3) DIRECT ADMINISTRATION BY STATE AGENCY.—The Secretary may not make a grant under paragraph (1) unless the
State involved agrees that the program operated with the
grant will be administered directly by a State agency.
(b) REQUIREMENT OF MATCHING FUNDS.—
(1) IN GENERAL.—The Secretary may not make a grant
under subsection (a) unless the State agrees that, with respect
to the costs of making payments on behalf of individuals under
contracts made pursuant to paragraph (2) of such subsection,
the State will make available (directly or through donations
from public or private entities) non-Federal contributions in
cash toward such costs in an amount equal to not less than $1
for each $1 of Federal funds provided in the grant.
(2) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—In determining the amount of non-Federal contributions in cash that a State has provided pursuant to paragraph (1), the Secretary may not include any amounts provided
to the State by the Federal Government.
(c) COORDINATION WITH FEDERAL PROGRAM.—
(1) ASSIGNMENTS FOR HEALTH PROFESSIONAL SHORTAGE
AREAS UNDER FEDERAL PROGRAM.—The Secretary may not
make a grant under subsection (a) unless the State involved
agrees that, in carrying out the program operated with the
grant, the State will assign health professionals participating
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in the program only to public and nonprofit private entities located in and providing health services in health professional
shortage areas.
(2) REMEDIES FOR BREACH OF CONTRACTS.—The Secretary
may not make a grant under subsection (a) unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will provide remedies
for any breach of the contracts by the health professionals involved.
(3) LIMITATION REGARDING CONTRACT INDUCEMENTS.—
(A) Except as provided in subparagraph (B), the Secretary may not make a grant under subsection (a) unless
the State involved agrees that the contracts provided by
the State pursuant to paragraph (2) of such subsection will
not be provided on terms that are more favorable to health
professionals than the most favorable terms that the Secretary is authorized to provide for contracts under the
Loan Repayment Program under section 338B, including
terms regarding—
(i) the annual amount of payments provided on
behalf of the professionals regarding educational
loans; and
(ii) the availability of remedies for any breach of
the contracts by the health professionals involved.
(B) With respect to the limitation established in subparagraph (A) regarding the annual amount of payments
that may be provided to a health professional under a contract provided by a State pursuant to subsection (a)(2),
such limitation shall not apply with respect to a contract
if—
(i) the excess of such annual payments above the
maximum amount authorized in section 338B(g)(2)(A)
for annual payments regarding contracts is paid solely
from non-Federal contributions under subsection (b);
and
(ii) the contract provides that the health professional involved will satisfy the requirement of obligated service under the contract solely through the
provision of primary health services in a health professional shortage area that is receiving priority for purposes of section 333A(a)(1) and that is authorized to
receive assignments under section 333 of individuals
who are participating in the Scholarship Program
under section 338A.
(d) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not
make a grant under subsection (a) unless the State involved agrees
that the grant will not be expended—
(1) to conduct activities for which Federal funds are expended—
(A) within the State to provide technical or other nonfinancial assistance under subsection (f) of section 330;
(B) under a memorandum of agreement entered into
with the State under subsection (h) of such section; or
(C) under a grant under section 338J; or
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(2) for any purpose other than making payments on behalf
of health professionals under contracts entered into pursuant
to subsection (a)(2).
(e) REPORTS.—The Secretary may not make a grant under subsection (a) unless the State involved agrees—
(1) to submit to the Secretary such reports regarding the
States loan repayment program, as are determined to be appropriate by the Secretary; and
(2) to submit such a report not later than January 10 of
each fiscal year immediately following any fiscal year for which
the State has received such a grant.
(f) REQUIREMENT OF APPLICATION.—The Secretary may not
make a grant under subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in such
form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(g) NONCOMPLIANCE.—
(1) IN GENERAL.—The Secretary may not make payments
under subsection (a) to a State for any fiscal year subsequent
to the first fiscal year of such payments unless the Secretary
determines that, for the immediately preceding fiscal year, the
State has complied with each of the agreements made by the
State under this section.
(2) REDUCTION IN GRANT RELATIVE TO NUMBER OF
BREACHED CONTRACTS.—
(A) Before making a grant under subsection (a) to a
State for a fiscal year, the Secretary shall determine the
number of contracts provided by the State under paragraph (2) of such subsection with respect to which there
has been an initial breach by the health professionals involved during the fiscal year preceding the fiscal year for
which the State is applying to receive the grant.
(B) Subject to paragraph (3), in the case of a State
with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall reduce the amount of a
grant under subsection (a) to the State for the fiscal year
involved by an amount equal to the sum of the expenditures of Federal funds made regarding the contracts involved and an amount representing interest on the amount
of such expenditures, determined with respect to each contract on the basis of the maximum legal rate prevailing for
loans made during the time amounts were paid under the
contract, as determined by the Treasurer of the United
States.
(3) WAIVER REGARDING REDUCTION IN GRANT.—The Secretary may waive the requirement established in paragraph
(2)(B) with respect to the initial breach of a contract if the Secretary determines that such breach by the health professional
involved was attributable solely to the professional having a
serious illness.
(h) DEFINITIONS.—For purposes of this section, the term
‘‘State’’ means each of the 50 States, the District of Columbia, the
Commonwealth of Puerto Rico, the United States Virgin Islands,
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Guam, American Samoa, Palau, the Marshall Islands, and the
Commonwealth of the Northern Mariana Islands.
(i) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—For the purpose of making grants under
subsection (a), there are authorized to be appropriated
$12,000,000 for fiscal year 2008, and such sums as may be necessary for each of fiscal years 2009 through 2012.
(2) AVAILABILITY.—Amounts appropriated under paragraph
(1) shall remain available until expended.
(j) PUBLIC HEALTH LOAN REPAYMENT.—
(1) IN GENERAL.—The Secretary may award grants to
States for the purpose of assisting such States in operating
loan repayment programs under which such States enter into
contracts to repay all or part of the eligible loans borrowed by,
or on behalf of, individuals who agree to serve in State, local,
or tribal health departments that serve health professional
shortage areas or other areas at risk of a public health emergency, as designated by the Secretary.
(2) LOANS ELIGIBLE FOR REPAYMENT.—To be eligible for repayment under this subsection, a loan shall be a loan made,
insured, or guaranteed by the Federal Government that is borrowed by, or on behalf of, an individual to pay the cost of attendance for a program of education leading to a degree appropriate for serving in a State, local, or tribal health department
as determined by the Secretary and the chief executive officer
of the State in which the grant is administered, at an institution of higher education (as defined in section 102 of the Higher Education Act of 1965), including principal, interest, and related expenses on such loan.
(3) APPLICABILITY OF EXISTING REQUIREMENTS.—With respect to awards made under paragraph (1)—
(A) the requirements of subsections (b), (f), and (g)
shall apply to such awards; and
(B) the requirements of subsection (c) shall apply to
such awards except that with respect to paragraph (1) of
such subsection, the State involved may assign an individual only to public and nonprofit private entities that
serve health professional shortage areas or areas at risk of
a public health emergency, as determined by the Secretary.
(4) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, such sums
as may be necessary for each of fiscal years 2007 through 2010.
SEC. 338J. ø254r¿ GRANTS TO STATE OFFICES OF RURAL HEALTH.
(a) IN GENERAL.—The Secretary, acting through the Director
of
the Federal Office of Rural Health Policy (established under section
711 of the Social Security Act), shall make grants to each State Office of Rural Health for the purpose of improving health care in
rural areas.
(b) REQUIREMENT OF MATCHING FUNDS.—
(1) IN GENERAL.—Subject to paragraph (2), the Secretary
may not make a grant under subsection (a) unless the State office of rural health involved agrees, with respect to the costs
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to be incurred in carrying out the purpose described in such
subsection, to provide non-Federal contributions toward such
costs in an amount equal to $3 for each $1 of Federal funds
provided in the grant.
(2) WAIVER OR REDUCTION.—The Secretary may waive or
reduce the non-Federal contribution if the Secretary determines that requiring matching funds would limit the State office of rural health’s ability to carry out the purpose described
in subsection (a).
(3) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—Non-Federal contributions required in paragraph
(1) may be in cash or in kind, fairly evaluated, including plant,
equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(c) CERTAIN REQUIRED ACTIVITIES.—Recipients of a grant
under subsection (a) shall use the grant funds for purposes of—
(1) maintaining within the State office of rural health a
clearinghouse for collecting and disseminating information
on—
(A) rural health care issues;
(B) research findings relating to rural health care; and
(C) innovative approaches to the delivery of health
care in rural areas;
(2) coordinating the activities carried out in the State that
relate to rural health care, including providing coordination for
the purpose of avoiding redundancy in such activities; and
(3) identifying Federal and State programs regarding rural
health, and providing technical assistance to public and nonprofit private entities regarding participation in such programs.
(d) REQUIREMENT REGARDING ANNUAL BUDGET FOR OFFICE.—
The Secretary may not make a grant under subsection (a) unless
the State involved agrees that, for any fiscal year for which the
State office of rural health receives such a grant, the office operated pursuant to subsection (a) of this section will be provided with
an annual budget of not less than $150,000.
(e) CERTAIN USES OF FUNDS.—
(1) RESTRICTIONS.—The Secretary may not make a grant
under subsection (a) unless the State office of rural health involved agrees that the grant will not be expended—
(A) to provide health care (including providing cash
payments regarding such care);
(B) to conduct activities for which Federal funds are
expended—
(i) within the State to provide technical and other
nonfinancial assistance under section 330A(f);
(ii) under a memorandum of agreement entered
into with the State office of rural health under section
330A(h); or
(iii) under a grant under section 338I;
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(C) to purchase medical equipment, to purchase ambulances, aircraft, or other vehicles, or to purchase major
communications equipment;
(D) to purchase or improve real property; or
(E) to carry out any activity regarding a certificate of
need.
(2) AUTHORITIES.—Activities for which a State office of
rural health may expend a grant under subsection (a) include—
(A) paying the costs of maintaining an office of rural
health for purposes of subsection (a);
(B) subject to paragraph (1)(B)(iii), paying the costs of
any activity carried out with respect to recruiting and retaining health professionals to serve in rural areas of the
State; and
(C) providing grants and contracts to public and nonprofit private entities to carry out activities authorized in
this section.
(3) LIMIT ON INDIRECT COSTS.—The Secretary may impose
a limit of no more than 15 percent on indirect costs claimed by
the recipient of the grant.
(f) REPORTS.—The Secretary may not make a grant under subsection (a) unless the State office of rural health involved agrees—
(1) to submit to the Secretary reports or performance data
containing such information as the Secretary may require regarding activities carried out under this section; and
(2) to submit such a report or performance data not later
than September 30 of each fiscal year immediately following
any fiscal year for which the State office of rural health has
received such a grant.
(g) REQUIREMENT OF APPLICATION.—The Secretary may not
make a grant under subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in such
form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(h) NONCOMPLIANCE.—The Secretary may not make payments
under subsection (a) to a State office of rural health for any fiscal
year subsequent to the first fiscal year of such payments unless the
Secretary determines that, for the immediately preceding fiscal
year, the State office of rural health has complied with each of the
agreements made by the State office of rural health under this section.
(i) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—For the purpose of making grants under
subsection (a), there are authorized to be appropriated
$12,500,000 for each of fiscal years 2023 through 2027.
(2) AVAILABILITY.—Amounts appropriated under paragraph
(1) shall remain available until expended.
SEC. 338K. ø254s¿ NATIVE HAWAIIAN HEALTH SCHOLARSHIPS.
(a) Subject to the availability of funds appropriated under the
authority of subsection (d), the Secretary shall provide scholarship
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assistance, pursuant to a contract with the Papa Ola Lokahi, to
students who—
(1) meet the requirements of section 338A(b), and
(2) are Native Hawaiians.
(b)(1) The scholarship assistance provided under subsection (a)
shall be provided under the same terms and subject to the same
conditions, regulations, and rules that apply to scholarship assistance provided under section 338A.
(2) The Native Hawaiian Health Scholarship program shall not
be administered by or through the Indian Health Service.
(c) For purposes of this section, the term ‘‘Native Hawaiian’’
means any individual who is—
(1) a citizen of the United States,
(2) a resident of the State of Hawaii, and
(3) a descendant of the aboriginal people, who prior to
1778, occupied and exercised sovereignty in the area that now
constitutes the State of Hawaii, as evidenced by—
(A) genealogical records,
(B) Kupuna (elders) or Kama’aina (long-term community residents) verification, or
(C) birth records of the State of Hawaii.
(d) There are authorized to be appropriated $1,800,000 for each
of the fiscal years 1990, 1991, and 1992 for the purpose of funding
the scholarship assistance provided under subsection (a).
SEC. 338L. ø254t¿ DEMONSTRATION PROJECT.
(a) PROGRAM AUTHORIZED.—The Secretary
shall establish a
demonstration project to provide for the participation of individuals
who are chiropractic doctors or pharmacists in the Loan Repayment Program described in section 338B.
(b) PROCEDURE.—An individual that receives assistance under
this section with regard to the program described in section 338B
shall comply with all rules and requirements described in such section (other than subparagraphs (A) and (B) of section 338B(b)(1))
in order to receive assistance under this section.
(c) LIMITATIONS.—
(1) IN GENERAL.—The demonstration project described in
this section shall provide for the participation of individuals
who shall provide services in rural and urban areas.
(2) AVAILABILITY OF OTHER HEALTH PROFESSIONALS.—The
Secretary may not assign an individual receiving assistance
under this section to provide obligated service at a site unless—
(A) the Secretary has assigned a physician (as defined
in section 1861(r) of the Social Security Act) or other
health professional licensed to prescribe drugs to provide
obligated service at such site under section 338C or 338D;
and
(B) such physician or other health professional will
provide obligated service at such site concurrently with the
individual receiving assistance under this section.
(3) RULES OF CONSTRUCTION.—
(A) SUPERVISION OF INDIVIDUALS.—Nothing in this section shall be construed to require or imply that a physician
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or other health professional licensed to prescribe drugs
must supervise an individual receiving assistance under
the demonstration project under this section, with respect
to such project.
(B) LICENSURE OF HEALTH PROFESSIONALS.—Nothing
in this section shall be construed to supersede State law
regarding licensure of health professionals.
(d) DESIGNATIONS.—The demonstration project described in
this section, and any providers who are selected to participate in
such project, shall not be considered by the Secretary in the designation of a health professional shortage area under section 332
during fiscal years 2002 through 2004.
(e) RULE OF CONSTRUCTION.—This section shall not be construed to require any State to participate in the project described
in this section.
(f) REPORT.—
(1) IN GENERAL.—The Secretary shall evaluate the participation of individuals in the demonstration projects under this
section and prepare and submit a report containing the information described in paragraph (2) to—
(A) the Committee on Health, Education, Labor, and
Pensions of the Senate;
(B) the Subcommittee on Labor, Health and Human
Services, and Education of the Committee on Appropriations of the Senate;
(C) the Committee on Energy and Commerce of the
House of Representatives; and
(D) the Subcommittee on Labor, Health and Human
Services, and Education of the Committee on Appropriations of the House of Representatives.
(2) CONTENT.—The report described in paragraph (1) shall
detail—
(A) the manner in which the demonstration project described in this section has affected access to primary care
services, patient satisfaction, quality of care, and health
care services provided for traditionally underserved populations;
(B) how the participation of chiropractic doctors and
pharmacists in the Loan Repayment Program might affect
the designation of health professional shortage areas; and
(C) whether adding chiropractic doctors and pharmacists as permanent members of the National Health
Service Corps would be feasible and would enhance the effectiveness of the National Health Service Corps.
(g) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—There are authorized to be appropriated
to carry out this section, such sums as may be necessary for
fiscal years 2002 through 2004.
(2) FISCAL YEAR 2005 44.—If the Secretary determines and
certifies to Congress by not later than September 30, 2004,
44 So in law. The figure in the heading for paragraph (2) was erroneously enacted so that
‘‘2005’’ appears in full figures. However, the version represented here in the pdf reflects this
Continued
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306
that the number of individuals participating in the demonstration project established under this section is insufficient for
purposes of performing the evaluation described in subsection
(f)(1), the authorization of appropriations under paragraph (1)
shall be extended to include fiscal year 2005.
SEC. 338M. ø254u¿ PUBLIC HEALTH DEPARTMENTS.
(a) IN GENERAL.—To the extent that funds
are appropriated
under subsection (e), the Secretary shall establish a demonstration
project to provide for the participation of individuals who are eligible for the Loan Repayment Program described in section 338B and
who agree to complete their service obligation in a State health department that provides a significant amount of service to health
professional shortage areas or areas at risk of a public health emergency, as determined by the Secretary, or in a local or tribal health
department that serves a health professional shortage area or an
area at risk of a public health emergency.
(b) PROCEDURE.—To be eligible to receive assistance under subsection (a), with respect to the program described in section 338B,
an individual shall—
(1) comply with all rules and requirements described in
such section (other than section 338B(f)(1)(B)(iv)); and
(2) agree to serve for a time period equal to 2 years, or
such longer period as the individual may agree to, in a State,
local, or tribal health department, described in subsection (a).
(c) DESIGNATIONS.—The demonstration project described in
subsection (a), and any healthcare providers who are selected to
participate in such project, shall not be considered by the Secretary
in the designation of health professional shortage areas under section 332 during fiscal years 2007 through 2010.
(d) REPORT.—Not later than 3 years after the date of enactment of this section, the Secretary shall submit a report to the relevant committees of Congress that evaluates the participation of
individuals in the demonstration project under subsection (a), the
impact of such participation on State, local, and tribal health departments, and the benefit and feasibility of permanently allowing
such placements in the Loan Repayment Program.
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, such sums as may be
necessary for each of fiscal years 2007 through 2010.
SEC. 338N. ø254v¿ CLARIFICATION REGARDING SERVICE IN SCHOOLS
AND OTHER COMMUNITY-BASED SETTINGS.
(a) SCHOOLS AND COMMUNITY-BASED SETTINGS.—An entity to
which a participant in the Scholarship Program or the Loan Repayment Program (referred to in this section as a ‘‘participant’’) is assigned under section 333 may direct such participant to provide
service as a behavioral or mental health professional at a school or
other community-based setting located in a health professional
shortage area.
(b) OBLIGATED SERVICE.—
(1) IN GENERAL.—Any service described in subsection (a)
that a participant provides may count towards such particifigure so that it conforms to the proper size for figures that appear in a paragraph or below
header.
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pant’s completion of any obligated service requirements under
the Scholarship Program or the Loan Repayment Program,
subject to any limitation imposed under paragraph (2).
(2) LIMITATION.—The Secretary may impose a limitation
on the number of hours of service described in subsection (a)
that a participant may credit towards completing obligated
service requirements, provided that the limitation allows a
member to credit service described in subsection (a) for not less
than 50 percent of the total hours required to complete such
obligated service requirements.
(c) RULE OF CONSTRUCTION.—The authorization under subsection (a) shall be notwithstanding any other provision of this subpart or subpart II.
Subpart IV—Home Health Services
HOME HEALTH SERVICES
SEC. 339. ø255¿ (a)(1) For the purpose of encouraging the establishment and initial operation of home health programs to provide home health services in areas in which such services are inadequate or not readily accessible, the Secretary may, in accordance
with the provisions of this section, make grants to public and nonprofit private entities and loans to proprietary entities to meet the
initial costs of establishing and operating such home health programs. Such grants and loans may include funds to provide training for paraprofessionals (including homemaker home health aides)
to provide home health services.
(2) In making grants and loans under this subsection, the Secretary shall—
(A) consider the relative needs of the several States for
home health services;
(B) give preference to areas in which a high percentage of
the population proposed to be served is composed of individuals
who are elderly, medically indigent, or disabled; and
(C) give special consideration to areas with inadequate
means of transportation to obtain necessary health services.
(3)(A) No loan may be made to a proprietary entity under this
section unless the application of such entity for such loan contains
assurances satisfactory to the Secretary that—
(i) at the time the application is made the entity is fiscally
sound;
(ii) the entity is unable to secure a loan for the project for
which the application is submitted from non-Federal lenders at
the rate of interest prevailing in the area in which the entity
is located; and
(iii) during the period of the loan, such entity will remain
fiscally sound.
(B) Loans under this section shall be made at an interest rate
comparable to the rate of interest prevailing on the date the loan
is made with respect to the marketable obligations of the United
States of comparable maturities, adjusted to provide for administrative costs.
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(4) Applications for grants and loans under this subsection
shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and
loans under this subsection $5,000,000 for each of the fiscal years
ending on September 30, 1983, September 30, 1984, September 30,
1985, September 30, 1986, and September 30, 1987.
(b)(1) The Secretary may make grants to and enter into contracts with public and private entities to assist them in developing
appropriate training programs for paraprofessionals (including
homemaker home health aides) to provide home health services.
(2) Any program established with a grant or contract under
this subsection to train homemaker home health aides shall—
(A) extend for at least forty hours, and consist of classroom
instruction and at least twenty hours (in the aggregate) of supervised clinical instruction directed toward preparing students to deliver home health services;
(B) be carried out under appropriate professional supervision and be designed to train students to maintain or enhance the personal care of an individual in his home in a manner which promotes the functional independence of the individual; and
(C) include training in—
(i) personal care services designed to assist an individual in the activities of daily living such as bathing, exercising, personal grooming, and getting in and out of bed;
and
(ii) household care services such as maintaining a safe
living environment, light housekeeping, and assisting in
providing good nutrition (by the purchasing and preparation of food).
(3) In making grants and entering into contracts under this
subsection, special consideration shall be given to entities which establish or will establish programs to provide training for persons
fifty years of age and older who wish to become paraprofessionals
(including homemaker home health aides) to provide home health
services.
(4) Applications for grants and contracts under this subsection
shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and contracts under this subsection $2,000,000 for each of the fiscal years
ending September 30, 1983, September 30, 1984, September 30,
1985, September 30, 1986, and September 30, 1987.
(c) The Secretary shall report to the Committee on Labor and
Human Resources of the Senate and the Committee on Energy and
Commerce of the House of Representatives on or before January 1,
1984, with respect to—
(1) the impact of grants made and contracts entered into
under subsections (a) and (b) (as such subsections were in effect prior to October 1, 1981);
(2) the need to continue grants and loans under subsections (a) and (b) (as such subsections are in effect on the
day after the date of enactment of the Orphan Drug Act); and
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(3) the extent to which standards have been applied to the
training of personnel who provide home health services.
(d) For purposes of this section, the term ‘‘home health services’’ has the meaning prescribed for the term by section 1861(m)
of the Social Security Act.
Subpart V—Healthy Communities Access Program
SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFICIENCY, AND COORDINATION OF SERVICES FOR THE UNINSURED AND UNDERINSURED.
(a) IN GENERAL.—The Secretary may award grants to eligible
entities to assist in the development of integrated health care delivery systems to serve communities of individuals who are uninsured
and individuals who are underinsured—
(1) to improve the efficiency of, and coordination among,
the providers providing services through such systems;
(2) to assist communities in developing programs targeted
toward preventing and managing chronic diseases; and
(3) to expand and enhance the services provided through
such systems.
(b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under
this section, an entity shall be an entity that—
(1) represents a consortium—
(A) whose principal purpose is to provide a broad
range of coordinated health care services for a community
defined in the entity’s grant application as described in
paragraph (2); and
(B) that includes at least one of each of the following
providers that serve the community (unless such provider
does not exist within the community, declines or refuses to
participate, or places unreasonable conditions on their participation)—
(i) a Federally qualified health center (as defined
in section 1861(aa) of the Social Security Act (42
U.S.C. 1395x(aa)));
(ii) a hospital with a low-income utilization rate
(as defined in section 1923(b)(3) of the Social Security
Act (42 U.S.C. 1396r–4(b)(3)), that is greater than 25
percent;
(iii) a public health department; and
(iv) an interested public or private sector health
care provider or an organization that has traditionally
served the medically uninsured and underserved; and
(2) submits to the Secretary an application, in such form
and manner as the Secretary shall prescribe, that—
(A) defines a community or geographic area of uninsured and underinsured individuals;
(B) identifies the providers who will participate in the
consortium’s program under the grant, and specifies each
provider’s contribution to the care of uninsured and underinsured individuals in the community, including the volume of care the provider provides to beneficiaries under
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the medicare, medicaid, and State child health insurance
programs and to patients who pay privately for services;
(C) describes the activities that the applicant and the
consortium propose to perform under the grant to further
the objectives of this section;
(D) demonstrates the consortium’s ability to build on
the current system (as of the date of submission of the application) for serving a community or geographic area of
uninsured and underinsured individuals by involving providers who have traditionally provided a significant volume of care for that community;
(E) demonstrates the consortium’s ability to develop
coordinated systems of care that either directly provide or
ensure the prompt provision of a broad range of high-quality, accessible services, including, as appropriate, primary,
secondary, and tertiary services, as well as substance
abuse treatment and mental health services in a manner
that assures continuity of care in the community or geographic area;
(F) provides evidence of community involvement in the
development, implementation, and direction of the program that the entity proposes to operate;
(G) demonstrates the consortium’s ability to ensure
that individuals participating in the program are enrolled
in public insurance programs for which the individuals are
eligible or know of private insurance programs where
available;
(H) presents a plan for leveraging other sources of revenue, which may include State and local sources and private grant funds, and integrating current and proposed
new funding sources in a way to assure long-term sustainability of the program;
(I) describes a plan for evaluation of the activities carried out under the grant, including measurement of
progress toward the goals and objectives of the program
and the use of evaluation findings to improve program performance;
(J) demonstrates fiscal responsibility through the use
of appropriate accounting procedures and appropriate
management systems;
(K) demonstrates the consortium’s commitment to
serve the community without regard to the ability of an individual or family to pay by arranging for or providing free
or reduced charge care for the poor; and
(L) includes such other information as the Secretary
may prescribe.
(c) LIMITATIONS.—
(1) NUMBER OF AWARDS.—
(A) IN GENERAL.—For each of fiscal years 2003, 2004,
2005, and 2006, the Secretary may not make more than 35
new awards under subsection (a) (excluding renewals of
such awards).
(B) RULE OF CONSTRUCTION.—This paragraph shall not
be construed to affect awards made before fiscal year 2003.
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(2) IN GENERAL.—An eligible entity may not receive a
grant under this section (including with respect to any such
grant made before fiscal year 2003) for more than 3 consecutive fiscal years, except that such entity may receive such a
grant award for not more than 1 additional fiscal year if—
(A) the eligible entity submits to the Secretary a request for a grant for such an additional fiscal year;
(B) the Secretary determines that extraordinary circumstances (as defined in paragraph (3)) justify the granting of such request; and
(C) the Secretary determines that granting such request is necessary to further the objectives described in
subsection (a).
(3) EXTRAORDINARY CIRCUMSTANCES.—
(A) IN GENERAL.—In paragraph (2), the term ‘‘extraordinary circumstances’’ means an event (or events) that is
outside of the control of the eligible entity that has prevented the eligible entity from fulfilling the objectives described by such entity in the application submitted under
subsection (b)(2).
(B) EXAMPLES.—Extraordinary circumstances include—
(i) natural disasters or other major disruptions to
the security or health of the community or geographic
area served by the eligible entity; or
(ii) a significant economic deterioration in the
community or geographic area served by such eligible
entity, that directly and adversely affects the entity
receiving an award under subsection (a).
(d) PRIORITIES.—In awarding grants under this section, the
Secretary—
(1) shall accord priority to applicants that demonstrate the
extent of unmet need in the community involved for a more coordinated system of care; and
(2) may accord priority to applicants that best promote the
objectives of this section, taking into consideration the extent
to which the application involved—
(A) identifies a community whose geographical area
has a high or increasing percentage of individuals who are
uninsured;
(B) demonstrates that the applicant has included in its
consortium providers, support systems, and programs that
have a tradition of serving uninsured individuals and
underinsured individuals in the community;
(C) shows evidence that the program would expand
utilization of preventive and primary care services for uninsured and underinsured individuals and families in the
community, including behavioral and mental health services, oral health services, or substance abuse services;
(D) proposes a program that would improve coordination between health care providers and appropriate social
service providers;
(E) demonstrates collaboration with State and local
governments;
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(F) demonstrates that the applicant makes use of nonFederal contributions to the greatest extent possible; or
(G) demonstrates a likelihood that the proposed program will continue after support under this section ceases.
(e) USE OF FUNDS.—
(1) USE BY GRANTEES.—
(A) IN GENERAL.—Except as provided in paragraphs
(2) and (3), a grantee may use amounts provided under
this section only for—
(i) direct expenses associated with achieving the
greater integration of a health care delivery system so
that the system either directly provides or ensures the
provision of a broad range of culturally competent
services, as appropriate, including primary, secondary,
and tertiary services, as well as substance abuse treatment and mental health services; and
(ii) direct patient care and service expansions to
fill identified or documented gaps within an integrated
delivery system.
(B) SPECIFIC USES.—The following are examples of
purposes for which a grantee may use grant funds under
this section, when such use meets the conditions stated in
subparagraph (A):
(i) Increases in outreach activities and closing
gaps in health care service.
(ii) Improvements to case management.
(iii) Improvements to coordination of transportation to health care facilities.
(iv) Development of provider networks and other
innovative models to engage physicians in voluntary
efforts to serve the medically underserved within a
community.
(v) Recruitment, training, and compensation of
necessary personnel.
(vi) Acquisition of technology for the purpose of coordinating care.
(vii) Improvements to provider communication, including implementation of shared information systems
or shared clinical systems.
(viii) Development of common processes for determining eligibility for the programs provided through
the system, including creating common identification
cards and single sliding scale discounts.
(ix) Development of specific prevention and disease management tools and processes.
(x) Translation services.
(xi) Carrying out other activities that may be appropriate to a community and that would increase access by the uninsured to health care, such as access
initiatives for which private entities provide non-Federal contributions to supplement the Federal funds
provided through the grants for the initiatives.
(2) DIRECT PATIENT CARE LIMITATION.—Not more than 15
percent of the funds provided under a grant awarded under
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this section may be used for providing direct patient care and
services.
(3) RESERVATION OF FUNDS FOR NATIONAL PROGRAM PURPOSES.—The Secretary may use not more than 3 percent of
funds appropriated to carry out this section for providing technical assistance to grantees, obtaining assistance of experts
and consultants, holding meetings, developing of tools, disseminating of information, evaluation, and carrying out activities
that will extend the benefits of programs funded under this
section to communities other than the community served by
the program funded.
(f) GRANTEE REQUIREMENTS.—
(1) EVALUATION OF EFFECTIVENESS.—A grantee under this
section shall—
(A) report to the Secretary annually regarding—
(i) progress in meeting the goals and measurable
objectives set forth in the grant application submitted
by the grantee under subsection (b); and
(ii) the extent to which activities conducted by
such grantee have—
(I) improved the effectiveness, efficiency, and
coordination of services for uninsured and underinsured individuals in the communities or geographic areas served by such grantee;
(II) resulted in the provision of better quality
health care for such individuals; and
(III) resulted in the provision of health care to
such individuals at lower cost than would have
been possible in the absence of the activities conducted by such grantee; and
(B) provide for an independent annual financial audit
of all records that relate to the disposition of funds received through the grant.
(2) PROGRESS.—The Secretary may not renew an annual
grant under this section for an entity for a fiscal year unless
the Secretary is satisfied that the consortium represented by
the entity has made reasonable and demonstrable progress in
meeting the goals and measurable objectives set forth in the
entity’s grant application for the preceding fiscal year.
(g) MAINTENANCE OF EFFORT.—With respect to activities for
which a grant under this section is authorized, the Secretary may
award such a grant only if the applicant for the grant, and each
of the participating providers, agree that the grantee and each such
provider will maintain its expenditures of non-Federal funds for
such activities at a level that is not less than the level of such expenditures during the fiscal year immediately preceding the fiscal
year for which the applicant is applying to receive such grant.
(h) TECHNICAL ASSISTANCE.—The Secretary may, either directly or by grant or contract, provide any entity that receives a
grant under this section with technical and other nonfinancial assistance necessary to meet the requirements of this section.
(i) EVALUATION OF PROGRAM.—Not later than September 30,
2005, the Secretary shall prepare and submit to the appropriate
committees of Congress a report that describes the extent to which
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projects funded under this section have been successful in improving the effectiveness, efficiency, and coordination of services for uninsured and underinsured individuals in the communities or geographic areas served by such projects, including whether the
projects resulted in the provision of better quality health care for
such individuals, and whether such care was provided at lower
costs, than would have been provided in the absence of such
projects.
(j) DEMONSTRATION AUTHORITY.—The Secretary may make
demonstration awards under this section to historically black
health professions schools for the purposes of—
(1) developing patient-based research infrastructure at historically black health professions schools, which have an affiliation, or affiliations, with any of the providers identified in
subsection (b)(1)(B);
(2) establishment of joint and collaborative programs of
medical research and data collection between historically black
health professions schools and such providers, whose goal is to
improve the health status of medically underserved populations; or
(3) supporting the research-related costs of patient care,
data collection, and academic training resulting from such affiliations.
(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of fiscal years 2002 through 2006.
(l) DATE CERTAIN FOR TERMINATION OF PROGRAM.—Funds may
not be appropriated to carry out this section after September 30,
2006.
SEC. 340A. ø256a¿ PATIENT NAVIGATOR GRANTS.
(a) GRANTS.—The Secretary, acting through
the Administrator
of the Health Resources and Services Administration, may make
grants to eligible entities for the development and operation of
demonstration programs to provide patient navigator services to
improve health care outcomes. The Secretary shall coordinate with,
and ensure the participation of, the Indian Health Service, the National Cancer Institute, the Office of Rural Health Policy, and such
other offices and agencies as deemed appropriate by the Secretary,
regarding the design and evaluation of the demonstration programs.
(b) USE OF FUNDS.—The Secretary shall require each recipient
of a grant under this section to use the grant to recruit, assign,
train, and employ patient navigators who have direct knowledge of
the communities they serve to facilitate the care of individuals, including by performing each of the following duties:
(1) Acting as contacts, including by assisting in the coordination of health care services and provider referrals, for individuals who are seeking prevention or early detection services
for, or who following a screening or early detection service are
found to have a symptom, abnormal finding, or diagnosis of,
cancer or other chronic disease.
(2) Facilitating the involvement of community organizations in assisting individuals who are at risk for or who have
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cancer or other chronic diseases to receive better access to
high-quality health care services (such as by creating partnerships with patient advocacy groups, charities, health care centers, community hospice centers, other health care providers,
or other organizations in the targeted community).
(3) Notifying individuals of clinical trials and, on request,
facilitating enrollment of eligible individuals in these trials.
(4) Anticipating, identifying, and helping patients to overcome barriers within the health care system to ensure prompt
diagnostic and treatment resolution of an abnormal finding of
cancer or other chronic disease.
(5) Coordinating with the relevant health insurance ombudsman programs to provide information to individuals who
are at risk for or who have cancer or other chronic diseases
about health coverage, including private insurance, health care
savings accounts, and other publicly funded programs (such as
Medicare, Medicaid, health programs operated by the Department of Veterans Affairs or the Department of Defense, the
State children’s health insurance program, and any private or
governmental prescription assistance programs).
(6) Conducting ongoing outreach to health disparity populations, including the uninsured, rural populations, and other
medically underserved populations, in addition to assisting
other individuals who are at risk for or who have cancer or
other chronic diseases to seek preventative care.
(c) PROHIBITIONS.—
(1) REFERRAL FEES.—The Secretary shall require each recipient of a grant under this section to prohibit any patient
navigator providing services under the grant from accepting
any referral fee, kickback, or other thing of value in return for
referring an individual to a particular health care provider.
(2) LEGAL FEES AND COSTS.—The Secretary shall prohibit
the use of any grant funds received under this section to pay
any fees or costs resulting from any litigation, arbitration, mediation, or other proceeding to resolve a legal dispute.
(d) GRANT PERIOD.—
(1) IN GENERAL.—Subject to paragraphs (2) and (3), the
Secretary may award grants under this section for periods of
not more than 3 years.
(2) EXTENSIONS.—Subject to paragraph (3), the Secretary
may extend the period of a grant under this section. Each such
extension shall be for a period of not more than 1 year.
(3) LIMITATIONS ON GRANT PERIOD.—In carrying out this
section, the Secretary shall ensure that the total period of a
grant does not exceed 4 years.
(e) APPLICATION.—
(1) IN GENERAL.—To seek a grant under this section, an eligible entity shall submit an application to the Secretary in
such form, in such manner, and containing such information as
the Secretary may require.
(2) CONTENTS.—At a minimum, the Secretary shall require
each such application to outline how the eligible entity will establish baseline measures and benchmarks that meet the Secretary’s requirements to evaluate program outcomes.
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(3) MINIMUM CORE PROFICIENCIES.—The Secretary shall
not award a grant to an entity under this section unless such
entity provides assurances that patient navigators recruited,
assigned, trained, or employed using grant funds meet minimum core proficiencies, as defined by the entity that submits
the application, that are tailored for the main focus or intervention of the navigator involved.
(f) UNIFORM BASELINE MEASURES.—The Secretary shall establish uniform baseline measures in order to properly evaluate the
impact of the demonstration projects under this section.
(g) PREFERENCE.—In making grants under this section, the
Secretary shall give preference to eligible entities that demonstrate
in their applications plans to utilize patient navigator services to
overcome significant barriers in order to improve health care outcomes in their respective communities.
(h) DUPLICATION OF SERVICES.—An eligible entity that is receiving Federal funds for activities described in subsection (b) on
the date on which the entity submits an application under subsection (e) may not receive a grant under this section unless the
entity can demonstrate that amounts received under the grant will
be utilized to expand services or provide new services to individuals
who would not otherwise be served.
(i) COORDINATION WITH OTHER PROGRAMS.—The Secretary
shall ensure coordination of the demonstration grant program
under this section with existing authorized programs in order to facilitate access to high-quality health care services.
(j) STUDY; REPORTS.—
(1) FINAL REPORT BY SECRETARY.—Not later than 6 months
after the completion of the demonstration grant program under
this section, the Secretary shall conduct a study of the results
of the program and submit to the Congress a report on such
results that includes the following:
(A) An evaluation of the program outcomes, including—
(i) quantitative analysis of baseline and benchmark measures; and
(ii) aggregate information about the patients
served and program activities.
(B) Recommendations on whether patient navigator
programs could be used to improve patient outcomes in
other public health areas.
(2) INTERIM REPORTS BY SECRETARY.—The Secretary may
provide interim reports to the Congress on the demonstration
grant program under this section at such intervals as the Secretary determines to be appropriate.
(3) REPORTS BY GRANTEES.—The Secretary may require
grant recipients under this section to submit interim and final
reports on grant program outcomes.
(k) RULE OF CONSTRUCTION.—This section shall not be construed to authorize funding for the delivery of health care services
(other than the patient navigator duties listed in subsection (b)).
(l) DEFINITIONS.—In this section:
(1) The term ‘‘eligible entity’’ means a public or nonprofit
private health center (including a Federally qualified health
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center (as that term is defined in section 1861(aa)(4) of the Social Security Act)), a health facility operated by or pursuant to
a contract with the Indian Health Service, a hospital, a cancer
center, a rural health clinic, an academic health center, or a
nonprofit entity that enters into a partnership or coordinates
referrals with such a center, clinic, facility, or hospital to provide patient navigator services.
(2) The term ‘‘health disparity population’’ means a population that, as determined by the Secretary, has a significant
disparity in the overall rate of disease incidence, prevalence,
morbidity, mortality, or survival rates as compared to the
health status of the general population.
(3) The term ‘‘patient navigator’’ means an individual who
has completed a training program approved by the Secretary
to perform the duties listed in subsection (b).
(m) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—To carry out this section, there are authorized to be appropriated $2,000,000 for fiscal year 2006,
$5,000,000 for fiscal year 2007, $8,000,000 for fiscal year 2008,
$6,500,000 for fiscal year 2009, $3,500,000 for fiscal year 2010,
and such sums as may be necessary for each of fiscal years
2011 through 2015.
(2) AVAILABILITY.—The amounts appropriated pursuant to
paragraph (1) shall remain available for obligation through the
end of fiscal year 2015.
Subpart VII—Drug Pricing Agreements 45
LIMITATION ON PRICES OF DRUGS PURCHASED BY COVERED ENTITIES
SEC. 340B. ø256b¿ (a) REQUIREMENTS FOR AGREEMENT WITH
SECRETARY.—
(1) IN GENERAL.—The Secretary shall enter into an agreement with each manufacturer of covered outpatient drugs
under which the amount required to be paid (taking into account any rebate or discount, as provided by the Secretary) to
the manufacturer for covered outpatient drugs (other than
drugs described in paragraph (3)) purchased by a covered entity on or after the first day of the first month that begins after
the date of the enactment of this section, does not exceed an
amount equal to the average manufacturer price for the drug
under title XIX of the Social Security Act in the preceding calendar quarter, reduced by the rebate percentage described in
paragraph (2). Each such agreement shall require that the
manufacturer furnish the Secretary with reports, on a quarterly basis, of the price for each covered outpatient drug subject to the agreement that, according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug (referred to in this section
as the ‘‘ceiling price’’), and shall require that the manufacturer
offer each covered entity covered outpatient drugs for purchase
45 So in law. Former subpart VI was repealed by section 4(a)(3) of Public Law 104–299 (110
Stat. 3645).
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at or below the applicable ceiling price if such drug is made
available to any other purchaser at any price.
(2) REBATE PERCENTAGE DEFINED.—
(A) IN GENERAL.—For a covered outpatient drug purchased in a calendar quarter, the ‘‘rebate percentage’’ is
the amount (expressed as a percentage) equal to—
(i) the average total rebate required under section
1927(c) of the Social Security Act with respect to the
drug (for a unit of the dosage form and strength involved) during the preceding calendar quarter; divided
by
(ii) the average manufacturer price for such a unit
of the drug during such quarter.
(B) OVER THE COUNTER DRUGS.—
(i) IN GENERAL.—For purposes of subparagraph
(A), in the case of over the counter drugs, the ‘‘rebate
percentage’’ shall be determined as if the rebate required under section 1927(c) of the Social Security Act
is based on the applicable percentage provided under
section 1927(c)(3) of such Act.
(ii) DEFINITION.—The term ‘‘over the counter
drug’’ means a drug that may be sold without a prescription and which is prescribed by a physician (or
other persons authorized to prescribe such drug under
State law).
(3) DRUGS PROVIDED UNDER STATE MEDICAID PLANS.—
Drugs described in this paragraph are drugs purchased by the
entity for which payment is made by the State under the State
plan for medical assistance under title XIX of the Social Security Act.
(4) COVERED ENTITY DEFINED.—In this section, the term
‘‘covered entity’’ means an entity that meets the requirements
described in paragraph (5) and is one of the following:
(A) A Federally-qualified health center (as defined in
section 1905(l)(2)(B) of the Social Security Act).
(B) An entity receiving a grant under section 340A 46.
(C) A family planning project receiving a grant or contract under section 1001.
(D) An entity receiving a grant under subpart II of
part C of title XXVI (relating to categorical grants for outpatient early intervention services for HIV disease).
(E) A State-operated AIDS drug purchasing assistance
program receiving financial assistance under title XXVI.
(F) A black lung clinic receiving funds under section
427(a) of the Black Lung Benefits Act.
(G) A comprehensive hemophilia diagnostic treatment
center receiving a grant under section 501(a)(2) of the Social Security Act.
(H) A Native Hawaiian Health Center receiving funds
under the Native Hawaiian Health Care Act of 1988.
(I) An urban Indian organization receiving funds
under title V of the Indian Health Care Improvement Act.
46 See
footnote on preceding page. See also footnote for section 217(a).
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(J) Any entity receiving assistance under title XXVI
(other than a State or unit of local government or an entity
described in subparagraph (D)), but only if the entity is
certified by the Secretary pursuant to paragraph (7).
(K) An entity receiving funds under section 318 (relating to treatment of sexually transmitted diseases) or section 317(j)(2) (relating to treatment of tuberculosis)
through a State or unit of local government, but only if the
entity is certified by the Secretary pursuant to paragraph
(7).
(L) A subsection (d) hospital (as defined in section
1886(d)(1)(B) of the Social Security Act) that—
(i) is owned or operated by a unit of State or local
government, is a public or private non-profit corporation which is formally granted governmental powers
by a unit of State or local government, or is a private
non-profit hospital which has a contract with a State
or local government to provide health care services to
low income individuals who are not entitled to benefits
under title XVIII of the Social Security Act or eligible
for assistance under the State plan under this title;
(ii) for the most recent cost reporting period that
ended before the calendar quarter involved, had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Social Security Act) greater than 11.75 percent or was described
in section 1886(d)(5)(F)(i)(II) of such Act; and
(iii) does not obtain covered outpatient drugs
through a group purchasing organization or other
group purchasing arrangement.
(M) A children’s hospital excluded from the Medicare
prospective payment system pursuant to section
1886(d)(1)(B)(iii) of the Social Security Act, or a free-standing cancer hospital excluded from the Medicare prospective
payment system pursuant to section 1886(d)(1)(B)(v) of the
Social Security Act, that would meet the requirements of
subparagraph (L), including the disproportionate share adjustment percentage requirement under clause (ii) of such
subparagraph, if the hospital were a subsection (d) hospital as defined by section 1886(d)(1)(B) of the Social Security Act.
(N) An entity that is a critical access hospital (as determined under section 1820(c)(2) of the Social Security
Act), and that meets the requirements of subparagraph
(L)(i).
(O) An entity that is a rural referral center, as defined
by section 1886(d)(5)(C)(i) of the Social Security Act, or a
sole community hospital, as defined by section
1886(d)(5)(C)(iii) of such Act, and that both meets the requirements of subparagraph (L)(i) and has a disproportionate share adjustment percentage equal to or greater
than 8 percent.
(5) REQUIREMENTS FOR COVERED ENTITIES.—
(A) PROHIBITING DUPLICATE DISCOUNTS OR REBATES.—
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(i) IN GENERAL.—A covered entity shall not request payment under title XIX of the Social Security
Act for medical assistance described in section
1905(a)(12) of such Act with respect to a drug that is
subject to an agreement under this section if the drug
is subject to the payment of a rebate to the State
under section 1927 of such Act.
(ii) ESTABLISHMENT OF MECHANISM.—The Secretary shall establish a mechanism to ensure that covered entities comply with clause (i). If the Secretary
does not establish a mechanism within 12 months
under the previous sentence, the requirements of section 1927(a)(5)(C) of the Social Security Act shall
apply.
(B) PROHIBITING RESALE OF DRUGS.—With respect to
any covered outpatient drug that is subject to an agreement under this subsection, a covered entity shall not resell or otherwise transfer the drug to a person who is not
a patient of the entity.
(C) AUDITING.—A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug
that is subject to an agreement under this subsection with
the entity (acting in accordance with procedures established by the Secretary relating to the number, duration,
and scope of audits) to audit at the Secretary’s or the manufacturer’s expense the records of the entity that directly
pertain to the entity’s compliance with the requirements
described in subparagraphs (A) or (B) with respect to
drugs of the manufacturer.
(D) ADDITIONAL SANCTION FOR NONCOMPLIANCE.—If
the Secretary finds, after audit as described in subparagraph (C) and after notice and hearing, that a covered entity is in violation of a requirement described in subparagraphs 47 (A) or (B), the covered entity shall be liable to
the manufacturer of the covered outpatient drug that is
the subject of the violation in an amount equal to the reduction in the price of the drug (as described in subparagraph (A)) provided under the agreement between the entity and the manufacturer under this paragraph.
(6) TREATMENT OF DISTINCT UNITS OF HOSPITALS.—In the
case of a covered entity that is a distinct part of a hospital, the
hospital shall not be considered a covered entity under this
paragraph unless the hospital is otherwise a covered entity
under this subsection.
(7) CERTIFICATION OF CERTAIN COVERED ENTITIES.—
(A) DEVELOPMENT OF PROCESS.—Not later than 60
days after the date of enactment of this subsection, the
Secretary shall develop and implement a process for the
certification of entities described in subparagraphs (J) and
(K) of paragraph (4).
47 So in law. See section 602(a) of Public Law 102–585 (106 Stat. 4967). Probably should be
‘‘subparagraph’’.
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(B) INCLUSION OF PURCHASE INFORMATION.—The process developed under subparagraph (A) shall include a requirement that an entity applying for certification under
this paragraph submit information to the Secretary concerning the amount such entity expended for covered outpatient drugs in the preceding year so as to assist the Secretary in evaluating the validity of the entity’s subsequent
purchases of covered outpatient drugs at discounted prices.
(C) CRITERIA.—The Secretary shall make available to
all manufacturers of covered outpatient drugs a description of the criteria for certification under this paragraph.
(D) LIST OF PURCHASERS AND DISPENSERS.—The certification process developed by the Secretary under subparagraph (A) shall include procedures under which each State
shall, not later than 30 days after the submission of the
descriptions under subparagraph (C), prepare and submit
a report to the Secretary that contains a list of entities described in subparagraphs (J) and (K) of paragraph (4) that
are located in the State.
(E) RECERTIFICATION.—The Secretary shall require the
recertification of entities certified pursuant to this paragraph on a not more frequent than annual basis, and shall
require that such entities submit information to the Secretary to permit the Secretary to evaluate the validity of
subsequent purchases by such entities in the same manner
as that required under subparagraph (B).
(8) DEVELOPMENT OF PRIME VENDOR PROGRAM.—The Secretary shall establish a prime vendor program under which
covered entities may enter into contracts with prime vendors
for the distribution of covered outpatient drugs. If a covered
entity obtains drugs directly from a manufacturer, the manufacturer shall be responsible for the costs of distribution.
(9) NOTICE TO MANUFACTURERS.—The Secretary shall notify manufacturers of covered outpatient drugs and single State
agencies under section 1902(a)(5) of the Social Security Act of
the identities of covered entities under this paragraph, and of
entities that no longer meet the requirements of paragraph (5)
or that are no longer certified pursuant to paragraph (7).
(10) NO PROHIBITION ON LARGER DISCOUNT.—Nothing in
this subsection shall prohibit a manufacturer from charging a
price for a drug that is lower than the maximum price that
may be charged under paragraph (1).
(b) OTHER DEFINITIONS 48.—
(1) IN GENERAL.—In this section, the terms ‘‘average manufacturer price’’, ‘‘covered outpatient drug’’, and ‘‘manufacturer’’ have the meaning given such terms in section 1927(k)
of the Social Security Act.
48 The
amendment made by section 7101(b)(2)(A) of Public Law 111–148 strikes ‘‘OTHER DEFIand all that follows through ‘‘In this section’’ and inserts ‘‘OTHER DEFINITIONS.—
(1) IN GENERAL.—In this section’’.
The heading of such amendment should have been to strike ‘‘OTHER DEFINITIONS’’. The
amendment made by such section has been carried out to reflect the probable intent of Congress.
NITION’’
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(2) 49 COVERED DRUG.—In this section, the term ‘‘covered
drug’’—
(A) means a covered outpatient drug (as defined in
section 1927(k)(2) of the Social Security Act); and
(B) includes, notwithstanding paragraph (3)(A) of section 1927(k) of such Act, a drug used in connection with
an inpatient or outpatient service provided by a hospital
described in subparagraph (L), (M), (N), or (O) of subsection (a)(4) that is enrolled to participate in the drug discount program under this section.
(d) 50 IMPROVEMENTS IN PROGRAM INTEGRITY.—
(1) MANUFACTURER COMPLIANCE.—
(A) IN GENERAL.—From amounts appropriated under
paragraph (4), the Secretary shall provide for improvements in compliance by manufacturers with the requirements of this section in order to prevent overcharges and
other violations of the discounted pricing requirements
specified in this section.
(B) IMPROVEMENTS.—The improvements described in
subparagraph (A) shall include the following:
(i) The development of a system to enable the Secretary to verify the accuracy of ceiling prices calculated by manufacturers under subsection (a)(1) and
charged to covered entities, which shall include the
following:
(I) Developing and publishing through an appropriate policy or regulatory issuance, precisely
defined standards and methodology for the calculation of ceiling prices under such subsection.
(II) Comparing regularly the ceiling prices calculated by the Secretary with the quarterly pricing data that is reported by manufacturers to the
Secretary.
(III) Performing spot checks of sales transactions by covered entities.
(IV) Inquiring into the cause of any pricing
discrepancies that may be identified and either
taking, or requiring manufacturers to take, such
corrective action as is appropriate in response to
such price discrepancies.
(ii) The establishment of procedures for manufacturers to issue refunds to covered entities in the event
that there is an overcharge by the manufacturers, including the following:
(I) Providing the Secretary with an explanation of why and how the overcharge occurred,
49 There
are no references to the term ‘‘covered drug’’ in this section.
law, there is no subsection (c) in section 340B of the Public Health Service Act. Subsection (d) of section 340B of the Public Health Service, as in effect before the enactment of Public Law 111–148, was redesignated as subsection (c) by section 2501(f)(1)(C) of Public Law 111–
148, amended to read by section 7101(d) of Public Law 111–148, and stricken by section 2302(2)
of Public Law 111–152. Subsection (d) of section 340B of the Public Health Service, as currently
in effect, is shown according to the probable intent of the Congress. Section 7102(a) of Public
Law 111–148 does not execute because it amends to read a nonexistent subsection (d). Notably,
section 2302(3) of Public Law 111–152 assumes that section 7102(a) of Public Law 111–148 executed properly and makes amendments to subsection (d).
50 In
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how the refunds will be calculated, and to whom
the refunds will be issued.
(II) Oversight by the Secretary to ensure that
the refunds are issued accurately and within a
reasonable period of time, both in routine instances of retroactive adjustment to relevant pricing data and exceptional circumstances such as
erroneous or intentional overcharging for covered
outpatient drugs.
(iii) The provision of access through the Internet
website of the Department of Health and Human
Services to the applicable ceiling prices for covered
outpatient drugs as calculated and verified by the Secretary in accordance with this section, in a manner
(such as through the use of password protection) that
limits such access to covered entities and adequately
assures security and protection of privileged pricing
data from unauthorized re-disclosure.
(iv) The development of a mechanism by which—
(I) rebates and other discounts provided by
manufacturers to other purchasers subsequent to
the sale of covered outpatient drugs to covered entities are reported to the Secretary; and
(II) appropriate credits and refunds are issued
to covered entities if such discounts or rebates
have the effect of lowering the applicable ceiling
price for the relevant quarter for the drugs involved.
(v) Selective auditing of manufacturers and wholesalers to ensure the integrity of the drug discount program under this section.
(vi) The imposition of sanctions in the form of civil
monetary penalties, which—
(I) shall be assessed according to standards
established in regulations to be promulgated by
the Secretary not later than 180 days after the
date of enactment of the Patient Protection and
Affordable Care Act;
(II) shall not exceed $5,000 for each instance
of overcharging a covered entity that may have occurred; and
(III) shall apply to any manufacturer with an
agreement under this section that knowingly and
intentionally charges a covered entity a price for
purchase of a drug that exceeds the maximum applicable price under subsection (a)(1).
(2) COVERED ENTITY COMPLIANCE.—
(A) IN GENERAL.—From amounts appropriated under
paragraph (4), the Secretary shall provide for improvements in compliance by covered entities with the requirements of this section in order to prevent diversion and violations of the duplicate discount provision and other requirements specified under subsection (a)(5).
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(B) IMPROVEMENTS.—The improvements described in
subparagraph (A) shall include the following:
(i) The development of procedures to enable and
require covered entities to regularly update (at least
annually) the information on the Internet website of
the Department of Health and Human Services relating to this section.
(ii) The development of a system for the Secretary
to verify the accuracy of information regarding covered
entities that is listed on the website described in
clause (i).
(iii) The development of more detailed guidance
describing methodologies and options available to covered entities for billing covered outpatient drugs to
State Medicaid agencies in a manner that avoids duplicate discounts pursuant to subsection (a)(5)(A).
(iv) The establishment of a single, universal, and
standardized identification system by which each covered entity site can be identified by manufacturers,
distributors, covered entities, and the Secretary for
purposes of facilitating the ordering, purchasing, and
delivery of covered outpatient drugs under this section, including the processing of chargebacks for such
drugs.
(v) The imposition of sanctions, in appropriate
cases as determined by the Secretary, additional to
those to which covered entities are subject under subsection (a)(5)(D), through one or more of the following
actions:
(I) Where a covered entity knowingly and intentionally violates subsection (a)(5)(B), the covered entity shall be required to pay a monetary
penalty to a manufacturer or manufacturers in
the form of interest on sums for which the covered
entity is found liable under subsection (a)(5)(D),
such interest to be compounded monthly and
equal to the current short term interest rate as
determined by the Federal Reserve for the time
period for which the covered entity is liable.
(II) Where the Secretary determines a violation of subsection (a)(5)(B) was systematic and
egregious as well as knowing and intentional, removing the covered entity from the drug discount
program under this section and disqualifying the
entity from re-entry into such program for a reasonable period of time to be determined by the
Secretary.
(III) Referring matters to appropriate Federal
authorities within the Food and Drug Administration, the Office of Inspector General of Department of Health and Human Services, or other
Federal agencies for consideration of appropriate
action under other Federal statutes, such as the
Prescription Drug Marketing Act (21 U.S.C. 353).
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(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.—
(A) IN GENERAL.—Not later than 180 days after the
date of enactment of the Patient Protection and Affordable
Care Act, the Secretary shall promulgate regulations to establish and implement an administrative process for the
resolution of claims by covered entities that they have
been overcharged for drugs purchased under this section,
and claims by manufacturers, after the conduct of audits
as authorized by subsection (a)(5)(C), of violations of subsections (a)(5)(A) or (a)(5)(B), including appropriate procedures for the provision of remedies and enforcement of determinations made pursuant to such process through
mechanisms and sanctions described in paragraphs (1)(B)
and (2)(B).
(B) DEADLINES AND PROCEDURES.—Regulations promulgated by the Secretary under subparagraph (A) shall—
(i) designate or establish a decision-making official
or decision-making body within the Department of
Health and Human Services to be responsible for reviewing and finally resolving claims by covered entities that they have been charged prices for covered
outpatient drugs in excess of the ceiling price described in subsection (a)(1), and claims by manufacturers that violations of subsection (a)(5)(A) or (a)(5)(B)
have occurred;
(ii) establish such deadlines and procedures as
may be necessary to ensure that claims shall be resolved fairly, efficiently, and expeditiously;
(iii) establish procedures by which a covered entity
may discover and obtain such information and documents from manufacturers and third parties as may
be relevant to demonstrate the merits of a claim that
charges for a manufacturer’s product have exceeded
the applicable ceiling price under this section, and
may submit such documents and information to the
administrative official or body responsible for adjudicating such claim;
(iv) require that a manufacturer conduct an audit
of a covered entity pursuant to subsection (a)(5)(C) as
a prerequisite to initiating administrative dispute resolution proceedings against a covered entity;
(v) permit the official or body designated under
clause (i), at the request of a manufacturer or manufacturers, to consolidate claims brought by more than
one manufacturer against the same covered entity
where, in the judgment of such official or body, consolidation is appropriate and consistent with the goals
of fairness and economy of resources; and
(vi) include provisions and procedures to permit
multiple covered entities to jointly assert claims of
overcharges by the same manufacturer for the same
drug or drugs in one administrative proceeding, and
permit such claims to be asserted on behalf of covered
entities by associations or organizations representing
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the interests of such covered entities and of which the
covered entities are members.
(C) FINALITY OF ADMINISTRATIVE RESOLUTION.—The
administrative resolution of a claim or claims under the
regulations promulgated under subparagraph (A) shall be
a final agency decision and shall be binding upon the parties involved, unless invalidated by an order of a court of
competent jurisdiction.
(4) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, such sums
as may be necessary for fiscal year 2010 and each succeeding
fiscal year.
(e) 51 EXCLUSION OF ORPHAN DRUGS FOR CERTAIN COVERED ENTITIES.—For covered entities described in subparagraph (M) (other
than a children’s hospital described in subparagraph (M)), (N), or
(O) of subsection (a)(4), the term ‘‘covered outpatient drug’’ shall
not include a drug designated by the Secretary under section 526
of the Federal Food, Drug, and Cosmetic Act for a rare disease or
condition.
Subpart VIII—Bulk Purchases of Vaccines for Certain Programs
BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS
SEC. 340C. ø256c¿ (a) AGREEMENTS FOR PURCHASES.—
(1) IN GENERAL.—Not later than 180 days after the date of
the enactment of the Preventive Health Amendments of
1992 52, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation
with the Administrator of the Health Resources and Services
Administration, shall enter into negotiations with manufacturers of vaccines for the purpose of establishing and maintaining
agreements under which entities described in paragraph (2)
may purchase vaccines from the manufacturers at the prices
specified in the agreements.
(2) RELEVANT ENTITIES.—The entities referred to in paragraph (1) are entities that provide immunizations against vaccine-preventable diseases with assistance provided under section 330.
(b) NEGOTIATION OF PRICES.—In carrying out subsection (a),
the Secretary shall, to the extent practicable, ensure that the prices
provided for in agreements under such subsection are comparable
to the prices provided for in agreements negotiated by the Secretary on behalf of grantees under section 317(j)(1).
(c) AUTHORITY OF SECRETARY.—In carrying out subsection (a),
the Secretary, in the discretion of the Secretary, may enter into the
agreements described in such subsection (and may decline to enter
51 Subsection (e) is shown according to the probable intent of Congress. Section 2302(4) of Public Law 111–152 inserts subsection (e) ‘‘after subsection (d)’’. See note in section 340B(d) of the
Public Health Service Act regarding the inclusion of subsection (d) to reflect the probable intent
of Congress.
Section 204(a)(1) of Public Law 111–309 amends subsection (e) of section 340B (effective on
the enactment of such Public Law).
52 Enacted October 27, 1992.
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into such agreements), may modify such agreements, may extend
such agreements, and may terminate such agreements.
(d) RULE OF CONSTRUCTION.—This section may not be construed as requiring any State to reduce or terminate the supply of
vaccines provided by the State to any of the entities described in
subsection (a)(2).
BREAST AND CERVICAL CANCER INFORMATION
SEC. 340D. ø256d¿ (a) IN GENERAL.—As a condition of receiving grants, cooperative agreements, or contracts under this Act,
each of the entities specified in subsection (c) shall, to the extent
determined to be appropriate by the Secretary, make available information concerning breast and cervical cancer.
(b) CERTAIN AUTHORITIES.—In carrying out subsection (a), an
entity specified in subsection (c)—
(1) may make the information involved available to such
individuals as the entity determines appropriate;
(2) may, as appropriate, provide information under subsection (a) on the need for self-examination of the breasts and
on the skills for such self-examinations;
(3) shall provide information under subsection (a) in the
language and cultural context most appropriate to the individuals to whom the information is provided; and
(4) shall refer such clients as the entities determine appropriate for breast and cervical cancer screening, treatment, or
other appropriate services.
(c) RELEVANT ENTITIES.—The entities specified in this subsection are the following:
(1) Entities receiving assistance under section 317F (relating to tuberculosis) 53.
(2) Entities receiving assistance under section 318 (relating to sexually transmitted diseases).
(3) Migrant health centers receiving assistance under section 329 54.
(4) Community health centers receiving assistance under
section 330 54.
(5) Entities receiving assistance under section 330(h) (relating to homeless individuals).
(6) Entities receiving assistance under section 340A 54 (relating to health services for residents of public housing).
(7) Entities providing services with assistance under title
V or title XIX.
(8) Entities receiving assistance under section 1001 (relating to family planning).
(9) Entities receiving assistance under title XXVI (relating
to services with respect to acquired immune deficiency syndrome).
(10) Non-Federal entities authorized under the Indian SelfDetermination Act.
53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114
Stat. 1163). Section 317E relates to tuberculosis, not section 317F.
54 See footnote for section 217(a).
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Subpart IX—Support of Graduate Medical Education Programs in
Children’s Hospitals
SEC. 340E. ø256e¿ PROGRAM OF PAYMENTS TO CHILDREN’S HOSPITALS THAT OPERATE GRADUATE MEDICAL EDUCATION
PROGRAMS.
(a) PAYMENTS.—The Secretary shall make two payments under
this section to each children’s hospital for each of fiscal years 2000
through 2005, each of fiscal years 2007 through 2011, each of fiscal
years 2014 through 2018, and each of fiscal years 2019 through
2023, one for the direct expenses and the other for indirect expenses associated with operating approved graduate medical residency training programs. The Secretary shall promulgate regulations pursuant to the rulemaking requirements of title 5, United
States Code, which shall govern payments made under this subpart.
(b) AMOUNT OF PAYMENTS.—
(1) IN GENERAL.—Subject to paragraphs (2) and (3), the
amounts payable under this section to a children’s hospital for
an approved graduate medical residency training program for
a fiscal year are each of the following amounts:
(A) DIRECT EXPENSE AMOUNT.—The amount determined under subsection (c) for direct expenses associated
with operating approved graduate medical residency training programs.
(B) INDIRECT EXPENSE AMOUNT.—The amount determined under subsection (d) for indirect expenses associated with the treatment of more severely ill patients and
the additional costs relating to teaching residents in such
programs.
(2) CAPPED AMOUNT.—
(A) IN GENERAL.—The total of the payments made to
children’s hospitals under paragraph (1)(A) or paragraph
(1)(B) in a fiscal year shall not exceed the funds appropriated under paragraph (1) or (2), respectively, of subsection (f) for such payments for that fiscal year.
(B) PRO RATA REDUCTIONS OF PAYMENTS FOR DIRECT
EXPENSES.—If the Secretary determines that the amount of
funds appropriated under subsection (f)(1) for a fiscal year
is insufficient to provide the total amount of payments otherwise due for such periods under paragraph (1)(A), the
Secretary shall reduce the amounts so payable on a pro
rata basis to reflect such shortfall.
(3) ANNUAL REPORTING REQUIRED.—
(A) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
(i) IN GENERAL.—The amount payable under this
section to a children’s hospital for a fiscal year (beginning with fiscal year 2008 and after taking into account paragraph (2)) shall be reduced by 25 percent if
the Secretary determines that—
(I) the hospital has failed to provide the Secretary, as an addendum to the hospital’s application under this section for such fiscal year, the report required under subparagraph (B) for the previous fiscal year; or
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(II) such report fails to provide the information required under any clause of such subparagraph.
(ii) NOTICE AND OPPORTUNITY TO PROVIDE MISSING
INFORMATION.—Before imposing a reduction under
clause (i) on the basis of a hospital’s failure to provide
information described in clause (i)(II), the Secretary
shall provide notice to the hospital of such failure and
the Secretary’s intention to impose such reduction and
shall provide the hospital with the opportunity to provide the required information within a period of 30
days beginning on the date of such notice. If the hospital provides such information within such period, no
reduction shall be made under clause (i) on the basis
of the previous failure to provide such information.
(B) ANNUAL REPORT.—The report required under this
subparagraph for a children’s hospital for a fiscal year is
a report that includes (in a form and manner specified by
the Secretary) the following information for the residency
academic year completed immediately prior to such fiscal
year:
(i) The types of resident training programs that
the hospital provided for residents described in subparagraph (C), such as general pediatrics, internal
medicine/pediatrics, and pediatric subspecialties, including both medical subspecialties certified by the
American Board of Pediatrics (such as pediatric gastroenterology) and non-medical subspecialties approved by other medical certification boards (such as
pediatric surgery).
(ii) The number of training positions for residents
described in subparagraph (C), the number of such positions recruited to fill, and the number of such positions filled.
(iii) The types of training that the hospital provided for residents described in subparagraph (C) related to the health care needs of different populations,
such as children who are underserved for reasons of
family income or geographic location, including rural
and urban areas.
(iv) The changes in residency training for residents described in subparagraph (C) which the hospital has made during such residency academic year
(except that the first report submitted by the hospital
under this subparagraph shall be for such changes
since the first year in which the hospital received payment under this section), including—
(I) changes in curricula, training experiences,
and types of training programs, and benefits that
have resulted from such changes; and
(II) changes for purposes of training the residents in the measurement and improvement of
the quality and safety of patient care.
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(v) The numbers of residents described in subparagraph (C) who completed their residency training
at the end of such residency academic year and care
for children within the borders of the service area of
the hospital or within the borders of the State in
which the hospital is located. Such numbers shall be
disaggregated with respect to residents who completed
residencies in general pediatrics or internal medicine/
pediatrics, subspecialty residencies, and dental
residencies.
(C) RESIDENTS.—The residents described in this subparagraph are those who—
(i) are in full-time equivalent resident training positions in any training program sponsored by the hospital; or
(ii) are in a training program sponsored by an entity other than the hospital, but who spend more than
75 percent of their training time at the hospital.
(D) REPORT TO CONGRESS.—Not later than the end of
fiscal year 2018, and the end of fiscal year 2022, the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit a report
to the Congress—
(i) summarizing the information submitted in reports to the Secretary under subparagraph (B);
(ii) describing the results of the program carried
out under this section; and
(iii) making recommendations for improvements to
the program.
(c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDUCATION.—
(1) IN GENERAL.—The amount determined under this subsection for payments to a children’s hospital for direct graduate
expenses relating to approved graduate medical residency
training programs for a fiscal year is equal to the product of—
(A) the updated per resident amount for direct graduate medical education, as determined under paragraph
(2); and
(B) the average number of full-time equivalent residents in the hospital’s graduate approved medical residency training programs (as determined under section
1886(h)(4) of the Social Security Act during the fiscal year.
(2) UPDATED PER RESIDENT AMOUNT FOR DIRECT GRADUATE
MEDICAL EDUCATION.—The updated per resident amount for direct graduate medical education for a hospital for a fiscal year
is an amount determined as follows:
(A) DETERMINATION OF HOSPITAL SINGLE PER RESIDENT
AMOUNT.—The Secretary shall compute for each hospital
operating an approved graduate medical education program (regardless of whether or not it is a children’s hospital) a single per resident amount equal to the average
(weighted by number of full-time equivalent residents) of
the primary care per resident amount and the non-primary
care per resident amount computed under section
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1886(h)(2) of the Social Security Act for cost reporting periods ending during fiscal year 1997.
(B) DETERMINATION OF WAGE AND NON-WAGE-RELATED
PROPORTION OF THE SINGLE PER RESIDENT AMOUNT.—The
Secretary shall estimate the average proportion of the single per resident amounts computed under subparagraph
(A) that is attributable to wages and wage-related costs.
(C) STANDARDIZING PER RESIDENT AMOUNTS.—The Secretary shall establish a standardized per resident amount
for each such hospital—
(i) by dividing the single per resident amount computed under subparagraph (A) into a wage-related portion and a non-wage-related portion by applying the
proportion determined under subparagraph (B);
(ii) by dividing the wage-related portion by the
factor applied under section 1886(d)(3)(E) of the Social
Security Act for discharges occurring during fiscal
year 1999 for the hospital’s area; and
(iii) by adding the non-wage-related portion to the
amount computed under clause (ii).
(D) DETERMINATION OF NATIONAL AVERAGE.—The Secretary shall compute a national average per resident
amount equal to the average of the standardized per resident amounts computed under subparagraph (C) for such
hospitals, with the amount for each hospital weighted by
the average number of full-time equivalent residents at
such hospital.
(E) APPLICATION TO INDIVIDUAL HOSPITALS.—The Secretary shall compute for each such hospital that is a children’s hospital a per resident amount—
(i) by dividing the national average per resident
amount computed under subparagraph (D) into a
wage-related portion and a non-wage-related portion
by applying the proportion determined under subparagraph (B);
(ii) by multiplying the wage-related portion by the
factor applied under section 1886(d)(3)(E) of the Social
Security Act for discharges occurring during the preceding fiscal year for the hospital’s area; and
(iii) by adding the non-wage-related portion to the
amount computed under clause (ii).
(F) UPDATING RATE.—The Secretary shall update such
per resident amount for each such children’s hospital by
the estimated percentage increase in the consumer price
index for all urban consumers during the period beginning
October 1997 and ending with the midpoint of the Federal
fiscal year for which payments are made.
(d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
(1) IN GENERAL.—The amount determined under this subsection for payments to a children’s hospital for indirect expenses associated with the treatment of more severely ill patients and the additional costs associated with the teaching of
residents for a fiscal year is equal to an amount determined
appropriate by the Secretary.
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(2) FACTORS.—In determining the amount under paragraph (1), the Secretary shall—
(A) take into account variations in case mix among
children’s hospitals and the ratio of the number of fulltime equivalent residents in the hospitals’ approved graduate medical residency training programs to beds (but excluding beds or bassinets assigned to healthy newborn infants); and
(B) assure that the aggregate of the payments for indirect expenses associated with the treatment of more severely ill patients and the additional costs related to the
teaching of residents under this section in a fiscal year are
equal to the amount appropriated for such expenses for the
fiscal year involved under subsection (f)(2).
(e) MAKING OF PAYMENTS.—
(1) INTERIM PAYMENTS.—The Secretary shall determine,
before the beginning of each fiscal year involved for which payments may be made for a hospital under this section, the
amounts of the payments for direct graduate medical education
and indirect medical education for such fiscal year and shall
(subject to paragraph (2)) make the payments of such amounts
in 12 equal interim installments during such period. Such interim payments to each individual hospital shall be based on
the number of residents reported in the hospital’s most recently filed Medicare cost report prior to the application date
for the Federal fiscal year for which the interim payment
amounts are established. In the case of a hospital that does not
report residents on a Medicare cost report, such interim payments shall be based on the number of residents trained during the hospital’s most recently completed Medicare cost report
filing period.
(2) WITHHOLDING.—The Secretary shall withhold up to 25
percent from each interim installment for direct and indirect
graduate medical education paid under paragraph (1) as necessary to ensure a hospital will not be overpaid on an interim
basis.
(3) RECONCILIATION.—Prior to the end of each fiscal year,
the Secretary shall determine any changes to the number of
residents reported by a hospital in the application of the hospital for the current fiscal year to determine the final amount
payable to the hospital for the current fiscal year for both direct expense and indirect expense amounts. Based on such determination, the Secretary shall recoup any overpayments
made and pay any balance due to the extent possible. The final
amount so determined shall be considered a final intermediary
determination for the purposes of section 1878 of the Social Security Act and shall be subject to administrative and judicial
review under that section in the same manner as the amount
of payment under section 1186(d) of such Act is subject to review under such section.
(f) AUTHORIZATION OF APPROPRIATIONS.—
(1) DIRECT GRADUATE MEDICAL EDUCATION.—
(A) IN GENERAL.—There are hereby authorized to be
appropriated, out of any money in the Treasury not otherFebruary 1, 2024
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wise appropriated, for payments under subsection
(b)(1)(A)—
(i) for fiscal year 2000, $90,000,000;
(ii) for fiscal year 2001, $95,000,000;
(iii) for each of the fiscal years 2002 through 2005,
such sums as may be necessary;
(iv) for each of fiscal years 2007 through 2011,
$110,000,000;
(v) for each of fiscal years 2014 through 2018,
$100,000,000; and
(vi) for each of fiscal years 2019 through 2023,
$105,000,000.
(B) CARRYOVER OF EXCESS.—The amounts appropriated under subparagraph (A) for fiscal year 2000 shall
remain available for obligation through the end of fiscal
year 2001.
(2) INDIRECT MEDICAL EDUCATION.—There are hereby authorized to be appropriated, out of any money in the Treasury
not otherwise appropriated, for payments under subsection
(b)(1)(B)—
(A) for fiscal year 2000, $190,000,000;
(B) for fiscal year 2001, $190,000,000;
(C) for each of the fiscal years 2002 through 2005,
such sums as may be necessary;
(D) for each of fiscal years 2007 through 2011,
$220,000,000;
(E) for each of fiscal years 2014 through 2018,
$200,000,000; and
(F) for each of fiscal years 2019 through 2023,
$220,000,000.
(g) DEFINITIONS.—In this section:
(1) APPROVED GRADUATE MEDICAL RESIDENCY TRAINING
PROGRAM.—The term ‘‘approved graduate medical residency
training program’’ has the meaning given the term ‘‘approved
medical residency training program’’ in section 1886(h)(5)(A) of
the Social Security Act.
(2) CHILDREN’S HOSPITAL.—The term ‘‘children’s hospital’’
means a hospital with a Medicare payment agreement and
which is excluded from the Medicare inpatient prospective payment system pursuant to section 1886(d)(1)(B)(iii) of the Social
Security Act and its accompanying regulations.
(3) DIRECT GRADUATE MEDICAL EDUCATION COSTS.—The
term ‘‘direct graduate medical education costs’’ has the meaning given such term in section 1886(h)(5)(C) of the Social Security Act.
(h) ADDITIONAL PROVISIONS.—
(1) IN GENERAL.—The Secretary is authorized to make
available up to 25 percent of the total amounts in excess of
$245,000,000 appropriated under paragraphs (1) and (2) of subsection (f), but not to exceed $7,000,000, for payments to hospitals qualified as described in paragraph (2), for the direct
and indirect expenses associated with operating approved graduate medical residency training programs, as described in subsection (a).
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334
(2) QUALIFIED HOSPITALS.—
(A) IN GENERAL.—To qualify to receive payments
under paragraph (1), a hospital shall be a free-standing
hospital—
(i) with a Medicare payment agreement and that
is excluded from the Medicare inpatient hospital prospective payment system pursuant to section
1886(d)(1)(B) of the Social Security Act and its accompanying regulations;
(ii) whose inpatients are predominantly individuals under 18 years of age;
(iii) that has an approved medical residency training program as defined in section 1886(h)(5)(A) of the
Social Security Act; and
(iv) that is not otherwise qualified to receive payments under this section or section 1886(h) of the Social Security Act.
(B) ESTABLISHMENT OF RESIDENCY CAP.—In the case of
a freestanding children’s hospital that, on the date of enactment of this subsection, meets the requirements of subparagraph (A) but for which the Secretary has not determined an average number of full-time equivalent residents
under section 1886(h)(4) of the Social Security Act, the
Secretary may establish such number of full-time equivalent residents for the purposes of calculating payments
under this subsection.
(3) PAYMENTS.—Payments to hospitals made under this
subsection shall be made in the same manner as payments are
made to children’s hospitals, as described in subsections (b)
through (e).
(4) PAYMENT AMOUNTS.—The direct and indirect payment
amounts under this subsection shall be determined using per
resident amounts that are no greater than the per resident
amounts used for determining direct and indirect payment
amounts under subsection (a).
(5) REPORTING.—A hospital receiving payments under this
subsection shall be subject to the reporting requirements under
subsection (b)(3).
(6) REMAINING FUNDS.—
(A) IN GENERAL.—If the payments to qualified hospitals under paragraph (1) for a fiscal year are less than
the total amount made available under such paragraph for
that fiscal year, any remaining amounts for such fiscal
year may be made available to all hospitals participating
in the program under this subsection or subsection (a).
(B) QUALITY BONUS SYSTEM.—For purposes of distributing the remaining amounts described in subparagraph
(A), the Secretary may establish a quality bonus system,
whereby the Secretary distributes bonus payments to hospitals participating in the program under this subsection
or subsection (a) that meet standards specified by the Secretary, which may include a focus on quality measurement
and improvement, interpersonal and communications
skills, delivering patient-centered care, and practicing in
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integrated health systems, including training in community-based settings. In developing such standards, the Secretary shall collaborate with relevant stakeholders, including program accrediting bodies, certifying boards, training
programs, health care organizations, health care purchasers, and patient and consumer groups.
Subpart X—Primary Dental Programs
SEC. 340F. ø256f¿ DESIGNATED DENTAL HEALTH PROFESSIONAL
SHORTAGE AREA.
In this subpart, the term ‘‘designated dental health professional shortage area’’ means an area, population group, or facility
that is designated by the Secretary as a dental health professional
shortage area under section 332 or designated by the applicable
State as having a dental health professional shortage.
SEC. 340G. ø256g¿ GRANTS FOR INNOVATIVE PROGRAMS.
(a) GRANT PROGRAM AUTHORIZED.—The Secretary,
acting
through the Administrator of the Health Resources and Services
Administration, is authorized to award grants to States for the purpose of helping States develop and implement innovative programs
to address the dental workforce needs of designated dental health
professional shortage areas in a manner that is appropriate to the
States’ individual needs.
(b) STATE ACTIVITIES.—A State receiving a grant under subsection (a) may use funds received under the grant for—
(1) loan forgiveness and repayment programs for dentists
who—
(A) agree to practice in designated dental health professional shortage areas;
(B) are dental school graduates who agree to serve as
public health dentists for the Federal, State, or local government; and
(C) agree to—
(i) provide services to patients regardless of such
patients’ ability to pay; and
(ii) use a sliding payment scale for patients who
are unable to pay the total cost of services;
(2) dental recruitment and retention efforts;
(3) grants and low-interest or no-interest loans to help
dentists who participate in the medicaid program under title
XIX of the Social Security Act (42 U.S.C. 1396 et seq.) to establish or expand practices in designated dental health professional shortage areas by equipping dental offices or sharing in
the overhead costs of such practices;
(4) the establishment or expansion of dental residency programs in coordination with accredited dental training institutions in States without dental schools;
(5) programs developed in consultation with State and
local dental societies to expand or establish oral health services
and facilities in designated dental health professional shortage
areas, including services and facilities for children with special
needs, such as—
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(A) the expansion or establishment of a communitybased dental facility, free-standing dental clinic, consolidated health center dental facility, school-linked dental facility, or United States dental school-based facility;
(B) the establishment of a mobile or portable dental
clinic;
(C) the establishment or expansion of private dental
services to enhance capacity through additional equipment
or additional hours of operation;
(D) the establishment or development of models for
the provision of dental services to children and adults,
such as dental homes, including for the elderly, blind, individuals with disabilities, and individuals living in longterm care facilities; and
(E) the establishment of initiatives to reduce the use
of emergency departments by individuals who seek dental
services more appropriately delivered in a dental primary
care setting;
(6) placement and support of dental students, dental residents, and advanced dentistry trainees;
(7) continuing dental education, including distance-based
education;
(8) practice support through teledentistry conducted in accordance with State laws;
(9) community-based prevention services such as water
fluoridation and dental sealant programs;
(10) coordination with local educational agencies within
the State to foster programs that promote children going into
oral health or science professions;
(11) the establishment of faculty recruitment programs at
accredited dental training institutions whose mission includes
community outreach and service and that have a demonstrated
record of serving underserved States;
(12) the development of a State dental officer position or
the augmentation of a State dental office to coordinate oral
health and access issues in the State; and
(13) any other activities determined to be appropriate by
the Secretary.
(c) APPLICATION.—
(1) IN GENERAL.—Each State desiring a grant under this
section shall submit an application to the Secretary at such
time, in such manner, and containing such information as the
Secretary may reasonably require.
(2) ASSURANCES.—The application shall include assurances
that the State will meet the requirements of subsection (d) and
that the State possesses sufficient infrastructure to manage
the activities to be funded through the grant and to evaluate
and report on the outcomes resulting from such activities.
(d) MATCHING REQUIREMENT.—The Secretary may not make a
grant to a State under this section unless that State agrees that,
with respect to the costs to be incurred by the State in carrying out
the activities for which the grant was awarded, the State will provide non-Federal contributions in an amount equal to not less than
40 percent of Federal funds provided under the grant. The State
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may provide the contributions in cash or in kind, fairly evaluated,
including plant, equipment, and services and may provide the contributions from State, local, or private sources.
(e) REPORT.—Not later than 5 years after the date of enactment of the Health Care Safety Net Amendments of 2002, the Secretary shall prepare and submit to the appropriate committees of
Congress a report containing data relating to whether grants provided under this section have increased access to dental services in
designated dental health professional shortage areas.
(f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to
be appropriated to carry out this section, $13,903,000 for each of
fiscal years 2019 through 2023.
SEC. 340G–1. ø256g–1¿ DEMONSTRATION PROGRAM.
(a) IN GENERAL.—
(1) AUTHORIZATION.—The Secretary is authorized
to award
grants to 15 eligible entities to enable such entities to establish
a demonstration program to establish training programs to
train, or to employ, alternative dental health care providers in
order to increase access to dental health care services in rural
and other underserved communities.
(2) DEFINITION.—The term ‘‘alternative dental health care
providers’’ includes community dental health coordinators, advance practice dental hygienists, independent dental hygienists, supervised dental hygienists, primary care physicians,
dental therapists, dental health aides, and any other health
professional that the Secretary determines appropriate.
(b) TIMEFRAME.—The demonstration projects funded under this
section shall begin not later than 2 years after the date of enactment of this section, and shall conclude not later than 7 years after
such date of enactment.
(c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under
subsection (a), an entity shall—
(1) be—
(A) an institution of higher education, including a community college;
(B) a public-private partnership;
(C) a federally qualified health center;
(D) an Indian Health Service facility or a tribe or tribal organization (as such terms are defined in section 4 of
the Indian Self-Determination and Education Assistance
Act);
(E) a State or county public health clinic, a health facility operated by an Indian tribe or tribal organization, or
urban Indian organization providing dental services; or
(F) a public hospital or health system;
(2) be within a program accredited by the Commission on
Dental Accreditation or within a dental education program in
an accredited institution; and
(3) shall submit an application to the Secretary at such
time, in such manner, and containing such information as the
Secretary may require.
(d) ADMINISTRATIVE PROVISIONS.—
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(1) AMOUNT OF GRANT.—Each grant under this section
shall be in an amount that is not less than $4,000,000 for the
5-year period during which the demonstration project being
conducted.
(2) DISBURSEMENT OF FUNDS.—
(A) PRELIMINARY DISBURSEMENTS.—Beginning 1 year
after the enactment of this section, the Secretary may disperse to any entity receiving a grant under this section not
more than 20 percent of the total funding awarded to such
entity under such grant, for the purpose of enabling the
entity to plan the demonstration project to be conducted
under such grant.
(B) SUBSEQUENT DISBURSEMENTS.—The remaining
amount of grant funds not dispersed under subparagraph
(A) shall be dispersed such that not less than 15 percent
of such remaining amount is dispersed each subsequent
year.
(e) COMPLIANCE WITH STATE REQUIREMENTS.—Each entity receiving a grant under this section shall certify that it is in compliance with all applicable State licensing requirements.
(f) EVALUATION.—The Secretary shall contract with the Director of the Institute of Medicine to conduct a study of the demonstration programs conducted under this section that shall provide analysis, based upon quantitative and qualitative data, regarding access to dental health care in the United States.
(g) CLARIFICATION REGARDING DENTAL HEALTH AIDE PROGRAM.—Nothing in this section shall prohibit a dental health aide
training program approved by the Indian Health Service from
being eligible for a grant under this section.
(h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated such sums as may be necessary to carry out this
section.
Subpart XI—Support of Graduate Medical
Education in Qualified Teaching Health Centers
SEC. 340H. ø256h¿ PROGRAM OF PAYMENTS TO TEACHING HEALTH
CENTERS THAT OPERATE GRADUATE MEDICAL EDUCATION PROGRAMS.
(a) PAYMENTS.—
(1) IN GENERAL.—Subject to subsection (h)(2), the Sec-
retary shall make payments under this section for direct expenses and indirect expenses to qualified teaching health centers that are listed as sponsoring institutions by the relevant
accrediting body for, as appropriate—
(A) maintenance of filled positions at existing approved graduate medical residency training programs;
(B) expansion of existing approved graduate medical
residency training programs; and
(C) establishment of new approved graduate medical
residency training programs.
(2) PER RESIDENT AMOUNT.—In making payments under
paragraph (1), the Secretary shall consider the cost of training
residents at teaching health centers and the implications of the
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per resident amount on approved graduate medical residency
training programs at teaching health centers.
(3) PRIORITY.—In making payments under paragraph
(1)(C), the Secretary shall give priority to qualified teaching
health centers that—
(A) serve a health professional shortage area with a
designation in effect under section 332 or a medically underserved community (as defined in section 799B); or
(B) are located in a rural area (as defined in section
1886(d)(2)(D) of the Social Security Act).
(b) AMOUNT OF PAYMENTS.—
(1) IN GENERAL.—Subject to paragraph (2), the amounts
payable under this section to qualified teaching health centers
for an approved graduate medical residency training program
for a fiscal year are each of the following amounts:
(A) DIRECT EXPENSE AMOUNT.—The amount determined under subsection (c) for direct expenses associated
with sponsoring approved graduate medical residency
training programs.
(B) INDIRECT EXPENSE AMOUNT.—The amount determined under subsection (d) for indirect expenses associated with the additional costs relating to teaching residents in such programs.
(2) CAPPED AMOUNT.—
(A) IN GENERAL.—The total of the payments made to
qualified teaching health centers under paragraph (1)(A)
or paragraph (1)(B) in a fiscal year shall not exceed the
amount of funds appropriated under subsection (g) for
such payments for that fiscal year.
(B) LIMITATION.—The Secretary shall limit the funding
of full-time equivalent residents in order to ensure the direct and indirect payments as determined under subsection (c) and (d) do not exceed the total amount of funds
appropriated in a fiscal year under subsection (g).
(c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDUCATION.—
(1) IN GENERAL.—The amount determined under this subsection for payments to qualified teaching health centers for direct graduate expenses relating to approved graduate medical
residency training programs for a fiscal year is equal to the
product of—
(A) the updated national per resident amount for direct graduate medical education, as determined under
paragraph (2); and
(B) the average number of full-time equivalent residents in the teaching health center’s graduate approved
medical residency training programs as determined under
section 1886(h)(4) of the Social Security Act (without regard to the limitation under subparagraph (F) of such section) during the fiscal year.
(2) UPDATED NATIONAL PER RESIDENT AMOUNT FOR DIRECT
GRADUATE MEDICAL EDUCATION.—The updated per resident
amount for direct graduate medical education for a qualified
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teaching health center for a fiscal year is an amount determined as follows:
(A) DETERMINATION OF QUALIFIED TEACHING HEALTH
CENTER PER RESIDENT AMOUNT.—The Secretary shall compute for each individual qualified teaching health center a
per resident amount—
(i) by dividing the national average per resident
amount computed under section 340E(c)(2)(D) into a
wage-related portion and a non-wage related portion
by applying the proportion determined under subparagraph (B);
(ii) by multiplying the wage-related portion by the
factor applied under section 1886(d)(3)(E) of the Social
Security Act (but without application of section 4410
of the Balanced Budget Act of 1997 (42 U.S.C. 1395ww
note)) during the preceding fiscal year for the teaching
health center’s area; and
(iii) by adding the non-wage-related portion to the
amount computed under clause (ii).
(B) UPDATING RATE.—The Secretary shall update such
per resident amount for each such qualified teaching
health center as determined appropriate by the Secretary.
(d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
(1) IN GENERAL.—The amount determined under this subsection for payments to qualified teaching health centers for indirect expenses associated with the additional costs of teaching
residents for a fiscal year is equal to an amount determined
appropriate by the Secretary.
(2) FACTORS.—In determining the amount under paragraph (1), the Secretary shall—
(A) evaluate indirect training costs relative to supporting a primary care residency program in qualified
teaching health centers; and
(B) based on this evaluation, assure that the aggregate
of the payments for indirect expenses under this section
and the payments for direct graduate medical education as
determined under subsection (c) in a fiscal year do not exceed the amount appropriated for such expenses as determined in subsection (g).
(3) INTERIM PAYMENT.—Before the Secretary makes a payment under this subsection pursuant to a determination of indirect expenses under paragraph (1), the Secretary may provide to qualified teaching health centers a payment, in addition to any payment made under subsection (c), for expected
indirect expenses associated with the additional costs of teaching residents for a fiscal year, based on an estimate by the Secretary.
(e) CLARIFICATION REGARDING RELATIONSHIP TO OTHER PAYMENTS FOR GRADUATE MEDICAL EDUCATION.—Payments under this
section—
(1) shall be in addition to any payments—
(A) for the indirect costs of medical education under
section 1886(d)(5)(B) of the Social Security Act;
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(B) for direct graduate medical education costs under
section 1886(h) of such Act; and
(C) for direct costs of medical education under section
1886(k) of such Act;
(2) shall not be taken into account in applying the limitation on the number of total full-time equivalent residents
under subparagraphs (F) and (G) of section 1886(h)(4) of such
Act and clauses (v), (vi)(I), and (vi)(II) of section 1886(d)(5)(B)
of such Act for the portion of time that a resident rotates to
a hospital; and
(3) shall not include the time in which a resident is counted toward full-time equivalency by a hospital under paragraph
(2) or under section 1886(d)(5)(B)(iv) of the Social Security Act,
section 1886(h)(4)(E) of such Act, or section 340E of this Act.
(f) RECONCILIATION.—The Secretary shall determine any
changes to the number of residents reported by a teaching health
center in the application of the teaching health center for the current fiscal year to determine the final amount payable to the teaching health center for the current fiscal year for both direct expense
and indirect expense amounts. Based on such determination, the
Secretary shall recoup any overpayments made to pay any balance
due to the extent possible. The final amount so determined shall
be considered a final intermediary determination for the purposes
of section 1878 of the Social Security Act and shall be subject to
administrative and judicial review under that section in the same
manner as the amount of payment under section 1186(d) of such
Act is subject to review under such section.
(g) FUNDING.—
(1) IN GENERAL.—To carry out this section, there are appropriated such sums as may be necessary, not to exceed
$230,000,000, for the period of fiscal years 2011 through 2015,
$60,000,000 for each of fiscal years 2016 and 2017,
$126,500,000 for each of fiscal years 2018 through 2023,
$16,635,616 for the period beginning on October 1, 2023, and
ending on November 17, 2023, $21,834,247 for the period beginning on November 18, 2023, and ending on January 19,
2024, and $16,982,192 for the period beginning on January 20,
2024, and ending on March 8, 2024, to remain available until
expended.
(2) ADMINISTRATIVE EXPENSES.—Of the amount made
available to carry out this section for any fiscal year, the Secretary may not use more than 5 percent of such amount for the
expenses of administering this section.
(h) ANNUAL REPORTING REQUIRED.—
(1) ANNUAL REPORT.—The report required under this paragraph for a qualified teaching health center for a fiscal year is
a report that includes (in a form and manner specified by the
Secretary) the following information for the residency academic
year completed immediately prior to such fiscal year:
(A) The types of primary care resident approved training programs that the qualified teaching health center provided for residents.
(B) The number of approved training positions for residents described in paragraph (4).
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(C) The number of residents described in paragraph
(4) who completed their residency training at the end of
such residency academic year and care for vulnerable populations living in underserved areas.
(D) The number of patients treated by residents described in paragraph (4).
(E) The number of visits by patients treated by residents described in paragraph (4).
(F) Of the number of residents described in paragraph
(4) who completed their residency training at the end of
such residency academic year, the number and percentage
of such residents entering primary care practice (meaning
any of the areas of practice listed in the definition of a primary care residency program in section 749A).
(G) Of the number of residents described in paragraph
(4) who completed their residency training at the end of
such residency academic year, the number and percentage
of such residents who entered practice at a health care facility—
(i) primarily serving a health professional shortage area with a designation in effect under section 332
or a medically underserved community (as defined in
section 799B); or
(ii) located in a rural area (as defined in section
1886(d)(2)(D) of the Social Security Act).
(H) Other information as deemed appropriate by the
Secretary.
(2) AUDIT AUTHORITY; LIMITATION ON PAYMENT.—
(A) AUDIT AUTHORITY.—The Secretary may audit a
qualified teaching health center to ensure the accuracy
and completeness of the information submitted in a report
under paragraph (1).
(B) LIMITATION ON PAYMENT.—A teaching health center may only receive payment in a cost reporting period for
a number of such resident positions that is greater than
the base level of primary care resident positions, as determined by the Secretary. For purposes of this subparagraph, the ‘‘base level of primary care residents’’ for a
teaching health center is the level of such residents as of
a base period.
(3) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
(A) IN GENERAL.—The amount payable under this section to a qualified teaching health center for a fiscal year
shall be reduced by at least 25 percent if the Secretary determines that—
(i) the qualified teaching health center has failed
to provide the Secretary, as an addendum to the qualified teaching health center’s application under this
section for such fiscal year, the report required under
paragraph (1) for the previous fiscal year; or
(ii) such report fails to provide complete and accurate information required under any subparagraph of
such paragraph.
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(B) NOTICE AND OPPORTUNITY TO PROVIDE ACCURATE
AND MISSING INFORMATION.—Before imposing a reduction
under subparagraph (A) on the basis of a qualified teaching health center’s failure to provide complete and accurate information described in subparagraph (A)(ii), the
Secretary shall provide notice to the teaching health center
of such failure and the Secretary’s intention to impose
such reduction and shall provide the teaching health center with the opportunity to provide the required information within the period of 30 days beginning on the date of
such notice. If the teaching health center provides such information within such period, no reduction shall be made
under subparagraph (A) on the basis of the previous failure to provide such information.
(4) RESIDENTS.—The residents described in this paragraph
are those who are in part-time or full-time equivalent resident
training positions at a qualified teaching health center in any
approved graduate medical residency training program.
(i) REGULATIONS.—The Secretary shall promulgate regulations
to carry out this section.
(j) DEFINITIONS.—In this section:
(1) APPROVED GRADUATE MEDICAL RESIDENCY TRAINING
PROGRAM.—The term ‘‘approved graduate medical residency
training program’’ means a residency or other postgraduate
medical training program—
(A) participation in which may be counted toward certification in a specialty or subspecialty and includes formal
postgraduate training programs in geriatric medicine approved by the Secretary; and
(B) that meets criteria for accreditation (as established
by the Accreditation Council for Graduate Medical Education, the American Osteopathic Association, or the American Dental Association).
(2) NEW APPROVED GRADUATE MEDICAL RESIDENCY TRAINING PROGRAM.—The term ‘‘new approved graduate medical
residency training program’’ means an approved graduate medical residency training program for which the sponsoring qualified teaching health center has not received a payment under
this section for a previous fiscal year (other than pursuant to
subsection (a)(1)(C)).
(3) PRIMARY CARE RESIDENCY PROGRAM.—The term ‘‘primary care residency program’’ has the meaning given that
term in section 749A.
(4) QUALIFIED TEACHING HEALTH CENTER.—The term
‘‘qualified teaching health center’’ has the meaning given the
term ‘‘teaching health center’’ in section 749A.
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Subpart XII—Community-Based Collaborative
Care Network Program
SEC. 340I. ø256i¿ COMMUNITY-BASED COLLABORATIVE CARE NETWORK PROGRAM. 55
(a) IN GENERAL.—The Secretary may award grants to eligible
entities to support community-based collaborative care networks
that meet the requirements of subsection (b).
(b) COMMUNITY-BASED COLLABORATIVE CARE NETWORKS.—
(1) DESCRIPTION.—A community-based collaborative care
network (referred to in this section as a ‘‘network’’) shall be a
consortium of health care providers with a joint governance
structure (including providers within a single entity) that provides comprehensive coordinated and integrated health care
services (as defined by the Secretary) for low-income populations.
(2) REQUIRED INCLUSION.—A network shall include the following providers (unless such provider does not exist within
the community, declines or refuses to participate, or places unreasonable conditions on their participation):
(A) A hospital that meets the criteria in section
1923(b)(1) of the Social Security Act; and
(B) All Federally qualified health centers (as defined
in section 1861(aa) of the Social Security Act located in the
community.
(3) PRIORITY.—In awarding grants, the Secretary shall give
priority to networks that include—
(A) the capability to provide the broadest range of
services to low-income individuals;
(B) the broadest range of providers that currently
serve a high volume of low-income individuals; and
(C) a county or municipal department of health.
(c) APPLICATION.—
(1) APPLICATION.—A network described in subsection (b)
shall submit an application to the Secretary.
(2) RENEWAL.—In subsequent years, based on the performance of grantees, the Secretary may provide renewal grants to
prior year grant recipients.
(d) USE OF FUNDS.—
(1) USE BY GRANTEES.—Grant funds may be used for the
following activities:
(A) Assist low-income individuals to—
(i) access and appropriately use health services;
(ii) enroll in health coverage programs; and
(iii) obtain a regular primary care provider or a
medical home.
(B) Provide case management and care management.
(C) Perform health outreach using neighborhood
health workers or through other means.
55 Section 301(c) of Public Law 115–63 provides for amendments to part D of the Public Health
Service Act by redesignating the second subpart XI and the second section 340H as subpart XII
and section 340I, respectively. Such amendment probably should have included a reference to
title III in the amendment instruction; however, such amendments were carried out to reflect
the probable intent of Congress.
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Sec. 351
(D) Provide transportation.
(E) Expand capacity, including through telehealth,
after-hours services or urgent care.
(F) Provide direct patient care services.
(2) GRANT FUNDS TO HRSA GRANTEES.—The Secretary may
limit the percent of grant funding that may be spent on direct
care services provided by grantees of programs administered
by the Health Resources and Services Administration or impose other requirements on such grantees deemed necessary.
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of fiscal years 2011 through 2015.
øPart E (secs. 341–347) repealed by section 3405(a) of Public
Law 106–310 (as amended by section 110(b) of Public Law 114–
198).¿
PART F—LICENSING—BIOLOGICAL PRODUCTS
LABORATORIES 56
AND
CLINICAL
Subpart 1—Biological Products
REGULATION OF BIOLOGICAL PRODUCTS 57
SEC. 351. ø262¿ (a)(1) No person shall introduce or deliver for
introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection
(k) is in effect for the biological product; and
(B) each package of the biological product is plainly
marked with—
(i) the proper name of the biological product contained
in the package;
(ii) the name, address, and applicable license number
of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) PEDIATRIC STUDIES.—A person that submits an application for a license under this paragraph shall submit
to the Secretary as part of the application any assessments
required under section 505B of the Federal Food, Drug,
and Cosmetic Act.
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
56 Section 511(d) of Public Law 104–132 (110 Stat. 1284) relates to the regulatory control of
biological agents and includes a requirement that the Secretary ‘‘establish and maintain a list
of each biological agent that has the potential to pose a severe threat to public health and safety’’.
57 Section 123(f) of Public Law 105–115 (111 Stat. 2324) provides as follows:
‘‘(f) SPECIAL RULE.—The Secretary of Health and Human Services shall take measures to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).’’.
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(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be
safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents
to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING;
RISK EVALUATION AND MITIGATION STRATEGY.—A person that submits an application for a license under this paragraph is subject to
sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and
Cosmetic Act.
(E)(i) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with respect
to a qualified indication for a drug, submitted under this subsection, if such supplemental application complies with the requirements of subparagraph (B) of section 505(c)(5) of the Federal Food,
Drug, and Cosmetic Act.
(ii) In this subparagraph, the terms ‘‘qualified indication’’ and
‘‘qualified data summary’’ have the meanings given such terms in
section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.
(3) The Secretary shall prescribe requirements under which a
biological product undergoing investigation shall be exempt from
the requirements of paragraph (1).
(b) No person shall falsely label or mark any package or container of any biological product or alter any label or mark on the
package or container of the biological product so as to falsify the
label or mark.
(c) Any officer, agent, or employee of the Department of Health
and Human Services, authorized by the Secretary for the purpose,
may during all reasonable hours enter and inspect any establishment for the propagation or manufacture and preparation of any
biological product.
(d)(1) Upon a determination that a batch, lot, or other quantity
of a product licensed under this section presents an imminent or
substantial hazard to the public health, the Secretary shall issue
an order immediately ordering the recall of such batch, lot, or other
quantity of such product. An order under this paragraph shall be
issued in accordance with section 554 of title 5, United States
Code.
(2) Any violation of paragraph (1) shall subject the violator to
a civil penalty of up to $100,000 per day of violation. The amount
of a civil penalty under this paragraph shall, effective December 1
of each year beginning 1 year after the effective date of this paragraph, be increased by the percent change in the Consumer Price
Index for the base quarter of such year over the Consumer Price
Index for the base quarter of the preceding year, adjusted to the
nearest 1⁄10 of 1 percent. For purposes of this paragraph, the term
‘‘base quarter’’, as used with respect to a year, means the calendar
quarter ending on September 30 of such year and the price index
for a base quarter is the arithmetical mean of such index for the
3 months comprising such quarter.
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(e) No person shall interfere with any officer, agent, or employee of the Service in the performance of any duty imposed upon
him by this section or by regulations made by authority thereof.
(f) Any person who shall violate, or aid or abet in violating, any
of the provisions of this section shall be punished upon conviction
by a fine not exceeding $500 or by imprisonment not exceeding one
year, or by both such fine and imprisonment, in the discretion of
the court.
(g) Nothing contained in this Act shall be construed as in any
way affecting, modifying, repealing, or superseding the provisions
of the Federal Food, Drug, and Cosmetic Act (U.S.C., 1940 edition,
title 21, ch. 9). 58
(h) 59 A partially processed biological product which—
(1) is not in a form applicable to the prevention, treatment,
or cure of diseases or injuries of man;
(2) is not intended for sale in the United States; and
(3) is intended for further manufacture into final dosage
form outside the United States,
shall be subject to no restriction on the export of the product under
this Act or the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321 et. seq.) if the product is manufactured, processed, packaged,
and held in conformity with current good manufacturing practice
requirements or meets international manufacturing standards as
certified by an international standards organization recognized by
the Secretary and meets the requirements of section 801(e)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).
(i) In this section:
(1) The term ‘‘biological product’’ means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component
or derivative, allergenic product, protein, or analogous product,
or arsphenamine or derivative of arsphenamine (or any other
trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human
beings.
(2) The term ‘‘biosimilar’’ or ‘‘biosimilarity’’, in reference to
a biological product that is the subject of an application under
subsection (k), means—
(A) that the biological product is highly similar to the
reference product notwithstanding minor differences in
clinically inactive components; and
(B) there are no clinically meaningful differences between the biological product and the reference product in
terms of the safety, purity, and potency of the product.
(3) The term ‘‘interchangeable’’ or ‘‘interchangeability’’, in
reference to a biological product that is shown to meet the
standards described in subsection (k)(4), means that the biological product may be substituted for the reference product
without the intervention of the health care provider who prescribed the reference product.
58 Codification
remains chapter 9 of title 21, United States Code (§ 301 et seq.).
59 Section 2102(d)(2) of title II of Public Law 104–134 (110 Stat. 1321-319) amended certain
provisions in subsection (h). Subsequently, section 2104 of such Public Law (110 Stat. 1321-320)
amended subsection (h) in its entirety. The above reflects only the latter amendment.
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(4) The term ‘‘reference product’’ means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under
subsection (k).
(j) The Federal Food, Drug, and Cosmetic Act, including the requirements under sections 505(o), 505(p), and 505–1 of such Act,
applies to a biological product subject to regulation under this section, except that a product for which a license has been approved
under subsection (a) shall not be required to have an approved application under section 505 of such Act.
(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
INTERCHANGEABLE.—
(1) IN GENERAL.—Any person may submit an application
for licensure of a biological product under this subsection.
(2) CONTENT.—
(A) IN GENERAL.—
(i) REQUIRED INFORMATION.—An application submitted under this subsection shall include information
demonstrating that—
(I) the biological product is biosimilar to a reference product based upon data derived from—
(aa) analytical studies that demonstrate
that the biological product is highly similar to
the reference product notwithstanding minor
differences in clinically inactive components;
(bb) an assessment of toxicity (which may
rely on, or consist of, a study or studies described in item (aa) or (cc)); and
(cc) a clinical study or studies (including
the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are
sufficient to demonstrate safety, purity, and
potency in 1 or more appropriate conditions of
use for which the reference product is licensed
and intended to be used and for which licensure is sought for the biological product;
(II) the biological product and reference product utilize the same mechanism or mechanisms of
action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the
reference product;
(III) the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been
previously approved for the reference product;
(IV) the route of administration, the dosage
form, and the strength of the biological product
are the same as those of the reference product;
and
(V) the facility in which the biological product
is manufactured, processed, packed, or held meets
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standards designed to assure that the biological
product continues to be safe, pure, and potent.
(ii) DETERMINATION BY SECRETARY.—The Secretary may determine, in the Secretary’s discretion,
that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection.
(iii) ADDITIONAL INFORMATION.—An application
submitted under this subsection—
(I) shall include publicly-available information
regarding the Secretary’s previous determination
that the reference product is safe, pure, and potent;
(II) may include any additional information in
support of the application, including publiclyavailable information with respect to the reference
product or another biological product; and
(III) may include information to show that the
conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological
product have been previously approved for the reference product.
(B) INTERCHANGEABILITY.—An application (or a supplement to an application) submitted under this subsection
may include information demonstrating that the biological
product meets the standards described in paragraph (4).
(3) EVALUATION BY SECRETARY.—Upon review of an application (or a supplement to an application) submitted under this
subsection, the Secretary shall license the biological product
under this subsection if—
(A) the Secretary determines that the information submitted in the application (or the supplement) is sufficient
to show that the biological product—
(i) is biosimilar to the reference product; or
(ii) meets the standards described in paragraph
(4), and therefore is interchangeable with the reference product; and
(B) the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of
the application, in accordance with subsection (c).
(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.—Upon review of an application submitted under this
subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines
that the information submitted in the application (or a supplement to such application) is sufficient to show that—
(A) the biological product—
(i) is biosimilar to the reference product; and
(ii) can be expected to produce the same clinical
result as the reference product in any given patient;
and
(B) for a biological product that is administered more
than once to an individual, the risk in terms of safety or
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diminished efficacy of alternating or switching between
use of the biological product and the reference product is
not greater than the risk of using the reference product
without such alternation or switch.
(5) GENERAL RULES.—
(A) ONE REFERENCE PRODUCT PER APPLICATION.—A biological product, in an application submitted under this
subsection, may not be evaluated against more than 1 reference product.
(B) REVIEW.—An application submitted under this
subsection shall be reviewed by the division within the
Food and Drug Administration that is responsible for the
review and approval of the application under which the
reference product is licensed.
(C) RISK EVALUATION AND MITIGATION STRATEGIES.—
The authority of the Secretary with respect to risk evaluation and mitigation strategies under the Federal Food,
Drug, and Cosmetic Act shall apply to biological products
licensed under this subsection in the same manner as such
authority applies to biological products licensed under subsection (a).
(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL
PRODUCT.—The Secretary shall not make approval as an interchangeable biological product effective with respect to an application submitted under this subsection that relies on the same
reference product for which a prior biological product has received a determination of interchangeability for any condition
of use, until the earlier of—
(A) 1 year after the first commercial marketing of the
first interchangeable biosimilar biological product to be approved as interchangeable for that reference product;
(B) 18 months after—
(i) a final court decision on all patents in suit in
an action instituted under subsection (l)(6) against the
applicant that submitted the application for the first
approved interchangeable biosimilar biological product; or
(ii) the dismissal with or without prejudice of an
action instituted under subsection (l)(6) against the
applicant that submitted the application for the first
approved interchangeable biosimilar biological product; or
(C)(i) 42 months after approval of the first interchangeable biosimilar biological product if the applicant
that submitted such application has been sued under subsection (l)(6) and such litigation is still ongoing within
such 42-month period; or
(ii) 18 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection (l)(6).
For purposes of this paragraph, the term ‘‘final court decision’’
means a final decision of a court from which no appeal (other
than a petition to the United States Supreme Court for a writ
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of certiorari) has been or can be taken, and the term ‘‘first
interchangeable biosimilar biological product’’ means any interchangeable biosimilar biological product that is approved on
the first day on which such a product is approved as interchangeable with the reference product.
(7) EXCLUSIVITY FOR REFERENCE PRODUCT.—
(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection
may not be made effective by the Secretary until the date
that is 12 years after the date on which the reference product was first licensed under subsection (a).
(B) FILING PERIOD.—An application under this subsection may not be submitted to the Secretary until the
date that is 4 years after the date on which the reference
product was first licensed under subsection (a).
(C) FIRST LICENSURE.—Subparagraphs (A) and (B)
shall not apply to a license for or approval of—
(i) a supplement for the biological product that is
the reference product; or
(ii) a subsequent application filed by the same
sponsor or manufacturer of the biological product that
is the reference product (or a licensor, predecessor in
interest, or other related entity) for—
(I) a change (not including a modification to
the structure of the biological product) that results
in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
(II) a modification to the structure of the biological product that does not result in a change in
safety, purity, or potency.
(D) DEEMED LICENSES.—
(i) NO ADDITIONAL EXCLUSIVITY THROUGH DEEMING.—An approved application that is deemed to be a
license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a)
for purposes of subparagraphs (A) and (B).
(ii) APPLICATION OF LIMITATIONS ON EXCLUSIVITY.—Subparagraph (C) shall apply with respect to
a reference product referred to in such subparagraph
that was the subject of an approved application that
was deemed to be a license pursuant to section
7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.
(iii) APPLICABILITY.—The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and
section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and
Cosmetic Act shall continue to apply to a biological
product after an approved application for the biological
product is deemed to be a license for the biological
product under subsection (a) pursuant to section
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7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.
(8) GUIDANCE DOCUMENTS.—
(A) IN GENERAL.—The Secretary may, after opportunity for public comment, issue guidance in accordance,
except as provided in subparagraph (B)(i), with section
701(h) of the Federal Food, Drug, and Cosmetic Act with
respect to the licensure of a biological product under this
subsection. Any such guidance may be general or specific.
(B) PUBLIC COMMENT.—
(i) IN GENERAL.—The Secretary shall provide the
public an opportunity to comment on any proposed
guidance issued under subparagraph (A) before
issuing final guidance.
(ii) INPUT REGARDING MOST VALUABLE GUIDANCE.—
The Secretary shall establish a process through which
the public may provide the Secretary with input regarding priorities for issuing guidance.
(C) NO REQUIREMENT FOR APPLICATION CONSIDERATION.—The issuance (or non-issuance) of guidance under
subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection.
(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.—If the Secretary issues product class-specific guidance under subparagraph (A), such guidance shall include
a description of—
(i) the criteria that the Secretary will use to determine whether a biological product is highly similar to
a reference product in such product class; and
(ii) the criteria, if available, that the Secretary
will use to determine whether a biological product
meets the standards described in paragraph (4).
(E) CERTAIN PRODUCT CLASSES.—
(i) GUIDANCE.—The Secretary may indicate in a
guidance document that the science and experience, as
of the date of such guidance, with respect to a product
or product class (not including any recombinant protein) does not allow approval of an application for a license as provided under this subsection for such product or product class.
(ii) MODIFICATION OR REVERSAL.—The Secretary
may issue a subsequent guidance document under
subparagraph (A) to modify or reverse a guidance document under clause (i).
(iii) NO EFFECT ON ABILITY TO DENY LICENSE.—
Clause (i) shall not be construed to require the Secretary to approve a product with respect to which the
Secretary has not indicated in a guidance document
that the science and experience, as described in clause
(i), does not allow approval of such an application.
(9) PUBLIC LISTING.—
(A) IN GENERAL.—
(i) INITIAL PUBLICATION.—Not later than 180 days
after the date of enactment of this paragraph, the SecFebruary 1, 2024
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retary shall publish and make available to the public
in a searchable, electronic format—
(I) a list of each biological product, by nonproprietary name (proper name), for which, as of
such date of enactment, a biologics license under
subsection (a) or this subsection is in effect, or
that, as of such date of enactment, is deemed to
be licensed under this section pursuant to section
7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009;
(II) the date of licensure of the marketing application and the application number; and
(III) with respect to each biological product
described in subclause (I), the licensure status,
and, as available, the marketing status.
(ii) REVISIONS.—Every 30 days after the publication of the first list under clause (i), the Secretary
shall revise the list to include each biological product
which has been licensed under subsection (a) or this
subsection during the 30-day period or deemed licensed under this section pursuant to section
7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.
(iii) PATENT INFORMATION.—Not later than 30
days after a list of patents under subsection (l)(3)(A),
or a supplement to such list under subsection (l)(7),
has been provided by the reference product sponsor to
the subsection (k) applicant respecting a biological
product included on the list published under this subparagraph, the reference product sponsor shall provide
such list of patents (or supplement thereto) and their
corresponding expiry dates to the Secretary, and the
Secretary shall, in revisions made under clause (ii), include such information for such biological product.
Within 30 days of providing any subsequent or supplemental list of patents to any subsequent subsection (k)
applicant under subsection (l)(3)(A) or (l)(7), the reference product sponsor shall update the information
provided to the Secretary under this clause with any
additional patents from such subsequent or supplemental list and their corresponding expiry dates.
(iv) LISTING OF EXCLUSIVITIES.—For each biological product included on the list published under this
subparagraph, the Secretary shall specify each exclusivity period under paragraph (6) or paragraph (7) for
which the Secretary has determined such biological
product to be eligible and that has not concluded.
(B) REVOCATION OR SUSPENSION OF LICENSE.—If the license of a biological product is determined by the Secretary to have been revoked or suspended for safety, purity, or potency reasons, it may not be published in the list
under subparagraph (A). If such revocation or suspension
occurred after inclusion of such biological product in the
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list published under subparagraph (A), the reference product sponsor shall notify the Secretary that—
(i) the biological product shall be immediately removed from such list for the same period as the revocation or suspension; and
(ii) a notice of the removal shall be published in
the Federal Register.
(l) PATENTS.—
(1) CONFIDENTIAL ACCESS TO SUBSECTION (k) APPLICATION.—
(A) APPLICATION OF PARAGRAPH.—Unless otherwise
agreed to by a person that submits an application under
subsection (k) (referred to in this subsection as the ‘‘subsection (k) applicant’’) and the sponsor of the application
for the reference product (referred to in this subsection as
the ‘‘reference product sponsor’’), the provisions of this
paragraph shall apply to the exchange of information described in this subsection.
(B) IN GENERAL.—
(i) PROVISION OF CONFIDENTIAL INFORMATION.—
When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide
to the persons described in clause (ii), subject to the
terms of this paragraph, confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion,
to be appropriate (referred to in this subsection as the
‘‘confidential information’’).
(ii) RECIPIENTS OF INFORMATION.—The persons described in this clause are the following:
(I) OUTSIDE COUNSEL.—One or more attorneys
designated by the reference product sponsor who
are employees of an entity other than the reference product sponsor (referred to in this paragraph as the ‘‘outside counsel’’), provided that
such attorneys do not engage, formally or informally, in patent prosecution relevant or related to
the reference product.
(II) IN-HOUSE COUNSEL.—One attorney that
represents the reference product sponsor who is
an employee of the reference product sponsor, provided that such attorney does not engage, formally
or informally, in patent prosecution relevant or related to the reference product.
(iii) PATENT OWNER ACCESS.—A representative of
the owner of a patent exclusively licensed to a reference product sponsor with respect to the reference
product and who has retained a right to assert the
patent or participate in litigation concerning the patent may be provided the confidential information, provided that the representative informs the reference
product sponsor and the subsection (k) applicant of his
or her agreement to be subject to the confidentiality
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provisions set forth in this paragraph, including those
under clause (ii).
(C) LIMITATION ON DISCLOSURE.—No person that receives confidential information pursuant to subparagraph
(B) shall disclose any confidential information to any other
person or entity, including the reference product sponsor
employees, outside scientific consultants, or other outside
counsel retained by the reference product sponsor, without
the prior written consent of the subsection (k) applicant,
which shall not be unreasonably withheld.
(D) USE OF CONFIDENTIAL INFORMATION.—Confidential
information shall be used for the sole and exclusive purpose of determining, with respect to each patent assigned
to or exclusively licensed by the reference product sponsor,
whether a claim of patent infringement could reasonably
be asserted if the subsection (k) applicant engaged in the
manufacture, use, offering for sale, sale, or importation
into the United States of the biological product that is the
subject of the application under subsection (k).
(E) OWNERSHIP OF CONFIDENTIAL INFORMATION.—The
confidential information disclosed under this paragraph is,
and shall remain, the property of the subsection (k) applicant. By providing the confidential information pursuant
to this paragraph, the subsection (k) applicant does not
provide the reference product sponsor or the outside counsel any interest in or license to use the confidential information, for purposes other than those specified in subparagraph (D).
(F) EFFECT OF INFRINGEMENT ACTION.—In the event
that the reference product sponsor files a patent infringement suit, the use of confidential information shall continue to be governed by the terms of this paragraph until
such time as a court enters a protective order regarding
the information. Upon entry of such order, the subsection
(k) applicant may redesignate confidential information in
accordance with the terms of that order. No confidential
information shall be included in any publicly-available
complaint or other pleading. In the event that the reference product sponsor does not file an infringement action
by the date specified in paragraph (6), the reference product sponsor shall return or destroy all confidential information received under this paragraph, provided that if the
reference product sponsor opts to destroy such information,
it will confirm destruction in writing to the subsection (k)
applicant.
(G) RULE OF CONSTRUCTION.—Nothing in this paragraph shall be construed—
(i) as an admission by the subsection (k) applicant
regarding the validity, enforceability, or infringement
of any patent; or
(ii) as an agreement or admission by the subsection (k) applicant with respect to the competency,
relevance, or materiality of any confidential information.
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(H) EFFECT OF VIOLATION.—The disclosure of any confidential information in violation of this paragraph shall be
deemed to cause the subsection (k) applicant to suffer irreparable harm for which there is no adequate legal remedy and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation of this paragraph.
(2) SUBSECTION (k) APPLICATION INFORMATION.—Not later
than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the
subsection (k) applicant—
(A) shall provide to the reference product sponsor a
copy of the application submitted to the Secretary under
subsection (k), and such other information that describes
the process or processes used to manufacture the biological
product that is the subject of such application; and
(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.
(3) LIST AND DESCRIPTION OF PATENTS.—
(A) LIST BY REFERENCE PRODUCT SPONSOR.—Not later
than 60 days after the receipt of the application and information under paragraph (2), the reference product sponsor
shall provide to the subsection (k) applicant—
(i) a list of patents for which the reference product
sponsor believes a claim of patent infringement could
reasonably be asserted by the reference product sponsor, or by a patent owner that has granted an exclusive license to the reference product sponsor with respect to the reference product, if a person not licensed
by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into
the United States of the biological product that is the
subject of the subsection (k) application; and
(ii) an identification of the patents on such list
that the reference product sponsor would be prepared
to license to the subsection (k) applicant.
(B) LIST AND DESCRIPTION BY SUBSECTION (k) APPLICANT.—Not later than 60 days after receipt of the list
under subparagraph (A), the subsection (k) applicant—
(i) may provide to the reference product sponsor a
list of patents to which the subsection (k) applicant believes a claim of patent infringement could reasonably
be asserted by the reference product sponsor if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or
importing into the United States of the biological product that is the subject of the subsection (k) application;
(ii) shall provide to the reference product sponsor,
with respect to each patent listed by the reference
product sponsor under subparagraph (A) or listed by
the subsection (k) applicant under clause (i)—
(I) a detailed statement that describes, on a
claim by claim basis, the factual and legal basis of
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the opinion of the subsection (k) applicant that
such patent is invalid, unenforceable, or will not
be infringed by the commercial marketing of the
biological product that is the subject of the subsection (k) application; or
(II) a statement that the subsection (k) applicant does not intend to begin commercial marketing of the biological product before the date
that such patent expires; and
(iii) shall provide to the reference product sponsor
a response regarding each patent identified by the reference product sponsor under subparagraph (A)(ii).
(C) DESCRIPTION BY REFERENCE PRODUCT SPONSOR.—
Not later than 60 days after receipt of the list and statement under subparagraph (B), the reference product sponsor shall provide to the subsection (k) applicant a detailed
statement that describes, with respect to each patent described in subparagraph (B)(ii)(I), on a claim by claim
basis, the factual and legal basis of the opinion of the reference product sponsor that such patent will be infringed
by the commercial marketing of the biological product that
is the subject of the subsection (k) application and a response to the statement concerning validity and enforceability provided under subparagraph (B)(ii)(I).
(4) PATENT RESOLUTION NEGOTIATIONS.—
(A) IN GENERAL.—After receipt by the subsection (k)
applicant of the statement under paragraph (3)(C), the reference product sponsor and the subsection (k) applicant
shall engage in good faith negotiations to agree on which,
if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor shall
be the subject of an action for patent infringement under
paragraph (6).
(B) FAILURE TO REACH AGREEMENT.—If, within 15 days
of beginning negotiations under subparagraph (A), the subsection (k) applicant and the reference product sponsor fail
to agree on a final and complete list of which, if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor shall be the subject
of an action for patent infringement under paragraph (6),
the provisions of paragraph (5) shall apply to the parties.
(5) PATENT RESOLUTION IF NO AGREEMENT.—
(A) NUMBER OF PATENTS.—The subsection (k) applicant shall notify the reference product sponsor of the number of patents that such applicant will provide to the reference product sponsor under subparagraph (B)(i)(I).
(B) EXCHANGE OF PATENT LISTS.—
(i) IN GENERAL.—On a date agreed to by the subsection (k) applicant and the reference product sponsor, but in no case later than 5 days after the subsection (k) applicant notifies the reference product
sponsor under subparagraph (A), the subsection (k)
applicant and the reference product sponsor shall simultaneously exchange—
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(I) the list of patents that the subsection (k)
applicant believes should be the subject of an action for patent infringement under paragraph (6);
and
(II) the list of patents, in accordance with
clause (ii), that the reference product sponsor believes should be the subject of an action for patent
infringement under paragraph (6).
(ii) NUMBER OF PATENTS LISTED BY REFERENCE
PRODUCT SPONSOR.—
(I) IN GENERAL.—Subject to subclause (II), the
number of patents listed by the reference product
sponsor under clause (i)(II) may not exceed the
number of patents listed by the subsection (k) applicant under clause (i)(I).
(II) EXCEPTION.—If a subsection (k) applicant
does not list any patent under clause (i)(I), the reference product sponsor may list 1 patent under
clause (i)(II).
(6) IMMEDIATE PATENT INFRINGEMENT ACTION.—
(A) ACTION IF AGREEMENT ON PATENT LIST.—If the
subsection (k) applicant and the reference product sponsor
agree on patents as described in paragraph (4), not later
than 30 days after such agreement, the reference product
sponsor shall bring an action for patent infringement with
respect to each such patent.
(B) ACTION IF NO AGREEMENT ON PATENT LIST.—If the
provisions of paragraph (5) apply to the parties as described in paragraph (4)(B), not later than 30 days after
the exchange of lists under paragraph (5)(B), the reference
product sponsor shall bring an action for patent infringement with respect to each patent that is included on such
lists.
(C) NOTIFICATION AND PUBLICATION OF COMPLAINT.—
(i) NOTIFICATION TO SECRETARY.—Not later than
30 days after a complaint is served to a subsection (k)
applicant in an action for patent infringement described under this paragraph, the subsection (k) applicant shall provide the Secretary with notice and a
copy of such complaint.
(ii) PUBLICATION BY SECRETARY.—The Secretary
shall publish in the Federal Register notice of a complaint received under clause (i).
(7) NEWLY ISSUED OR LICENSED PATENTS.—In the case of a
patent that—
(A) is issued to, or exclusively licensed by, the reference product sponsor after the date that the reference
product sponsor provided the list to the subsection (k) applicant under paragraph (3)(A); and
(B) the reference product sponsor reasonably believes
that, due to the issuance of such patent, a claim of patent
infringement could reasonably be asserted by the reference
product sponsor if a person not licensed by the reference
product sponsor engaged in the making, using, offering to
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sell, selling, or importing into the United States of the biological product that is the subject of the subsection (k) application,
not later than 30 days after such issuance or licensing, the reference product sponsor shall provide to the subsection (k) applicant a supplement to the list provided by the reference product sponsor under paragraph (3)(A) that includes such patent,
not later than 30 days after such supplement is provided, the
subsection (k) applicant shall provide a statement to the reference product sponsor in accordance with paragraph (3)(B),
and such patent shall be subject to paragraph (8).
(8) NOTICE OF COMMERCIAL MARKETING AND PRELIMINARY
INJUNCTION.—
(A) NOTICE OF COMMERCIAL MARKETING.—The subsection (k) applicant shall provide notice to the reference
product sponsor not later than 180 days before the date of
the first commercial marketing of the biological product licensed under subsection (k).
(B) PRELIMINARY INJUNCTION.—After receiving the notice under subparagraph (A) and before such date of the
first commercial marketing of such biological product, the
reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging
in the commercial manufacture or sale of such biological
product until the court decides the issue of patent validity,
enforcement, and infringement with respect to any patent
that is—
(i) included in the list provided by the reference
product sponsor under paragraph (3)(A) or in the list
provided by the subsection (k) applicant under paragraph (3)(B); and
(ii) not included, as applicable, on—
(I) the list of patents described in paragraph
(4); or
(II) the lists of patents described in paragraph
(5)(B).
(C) REASONABLE COOPERATION.—If the reference product sponsor has sought a preliminary injunction under
subparagraph (B), the reference product sponsor and the
subsection (k) applicant shall reasonably cooperate to expedite such further discovery as is needed in connection with
the preliminary injunction motion.
(9) LIMITATION ON DECLARATORY JUDGMENT ACTION.—
(A) SUBSECTION (k) APPLICATION PROVIDED.—If a subsection (k) applicant provides the application and information required under paragraph (2)(A), neither the reference
product sponsor nor the subsection (k) applicant may, prior
to the date notice is received under paragraph (8)(A), bring
any action under section 2201 of title 28, United States
Code, for a declaration of infringement, validity, or enforceability of any patent that is described in clauses (i)
and (ii) of paragraph (8)(B).
(B) SUBSEQUENT FAILURE TO ACT BY SUBSECTION (k)
APPLICANT.—If a subsection (k) applicant fails to complete
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an action required of the subsection (k) applicant under
paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i),
paragraph (7), or paragraph (8)(A), the reference product
sponsor, but not the subsection (k) applicant, may bring an
action under section 2201 of title 28, United States Code,
for a declaration of infringement, validity, or enforceability
of any patent included in the list described in paragraph
(3)(A), including as provided under paragraph (7).
(C) SUBSECTION (k) APPLICATION NOT PROVIDED.—If a
subsection (k) applicant fails to provide the application and
information required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k) applicant, may
bring an action under section 2201 of title 28, United
States Code, for a declaration of infringement, validity, or
enforceability of any patent that claims the biological product or a use of the biological product.
(m) PEDIATRIC STUDIES.—
(1) APPLICATION OF CERTAIN PROVISIONS.—The provisions
of subsections (a), (d), (e), (f), (h), (i), (j), (k), (l), (n), and (p) of
section 505A of the Federal Food, Drug, and Cosmetic Act shall
apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner
as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act.
(2) MARKET EXCLUSIVITY FOR NEW BIOLOGICAL PRODUCTS.—
If, prior to approval of an application that is submitted under
subsection (a), the Secretary determines that information relating to the use of a new biological product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which
shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using
appropriate formulations for each age group for which the
study is requested within any such timeframe, and the reports
thereof are submitted and accepted in accordance with section
505A(d)(4) of the Federal Food, Drug, and Cosmetic Act—
(A) the periods for such biological product referred to
in subsection (k)(7) are deemed to be 4 years and 6 months
rather than 4 years and 12 years and 6 months rather
than 12 years; and
(B) if the biological product is designated under section 526 for a rare disease or condition, the period for such
biological product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(3) MARKET EXCLUSIVITY FOR ALREADY-MARKETED BIOLOGICAL PRODUCTS.—If the Secretary determines that information
relating to the use of a licensed biological product in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under subsection (a) for pediatric studies
(which shall include a timeframe for completing such studies),
the holder agrees to the request, such studies are completed
using appropriate formulations for each age group for which
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the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with
section 505A(d)(4) of the Federal Food, Drug, and Cosmetic
Act—
(A) the periods for such biological product referred to
in subsection (k)(7) are deemed to be 4 years and 6 months
rather than 4 years and 12 years and 6 months rather
than 12 years; and
(B) if the biological product is designated under section 526 for a rare disease or condition, the period for such
biological product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(4) EXCEPTION.—The Secretary shall not extend a period
referred to in paragraph (2)(A), (2)(B), (3)(A), or (3)(B) if the
determination under section 505A(d)(4) is made later than 9
months prior to the expiration of such period.
(n) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CONTROLS UNDER THE CSA.—
(1) IN GENERAL.—In the case of an application under subsection (a) with respect to a biological product for which the
Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, approval of such application shall not take effect until the interim final rule controlling the biological product is issued in
accordance with section 201(j) of the Controlled Substances
Act.
(2) DATE OF APPROVAL.—For purposes of this section, with
respect to an application described in paragraph (1), references
to the date of approval of such application, or licensure of the
product subject to such application, shall mean the later of—
(A) the date an application is approved under subsection (a); or
(B) the date of issuance of the interim final rule controlling the biological product.
SEC. 351A. ø262a¿ ENHANCED CONTROL OF DANGEROUS BIOLOGICAL
AGENTS AND TOXINS. 60
(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS
AND TOXINS.—
(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
(A) IN GENERAL.—The Secretary shall by regulation
establish and maintain a list of each biological agent and
each toxin that has the potential to pose a severe threat
to public health and safety.
(B) CRITERIA.—In determining whether to include an
agent or toxin on the list under subparagraph (A), the Secretary shall—
(i) consider—
60 A program is carried out by the Secretary of Agriculture with respect to each biological
agent and each toxin that the Secretary determines has the potential to pose a severe threat
to animal or plant health, or to animal or plant products. Such program has requirements and
authorities similar to those established in section 351A above. See subtitle B of title II of Public
Law 107–188 (section 211 et seq.; 116 Stat. 647). Subtitle C of such title (section 221 et seq.;
116 Stat. 657) relates to interagency coordination of the two programs.
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(I) the effect on human health of exposure to
the agent or toxin;
(II) the degree of contagiousness of the agent
or toxin and the methods by which the agent or
toxin is transferred to humans;
(III) the availability and effectiveness of
pharmacotherapies and immunizations to treat
and prevent any illness resulting from infection by
the agent or toxin; and
(IV) any other criteria, including the needs of
children and other vulnerable populations, that
the Secretary considers appropriate; and
(ii) consult with appropriate Federal departments
and agencies and with scientific experts representing
appropriate professional groups, including groups with
pediatric expertise.
(2) BIENNIAL REVIEW.—The Secretary shall review and republish the list under paragraph (1) biennially, or more often
as needed, and shall by regulation revise the list as necessary
in accordance with such paragraph.
(b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOXINS.—The Secretary shall by regulation provide for—
(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, including measures
to ensure—
(A) proper training, including with respect to notification requirements under this section, of—
(i) individuals who are involved in the handling
and use of such agents and toxins, including appropriate skills to handle such agents and toxins;
(ii) individuals whose responsibilities routinely
place them in close proximity to laboratory facilities in
which such agents and toxins are being transferred,
possessed, or used; and
(iii) individuals who perform administrative or
oversight functions of the facility related to the transfer, possession, or use of such agents and toxins on behalf of registered persons;
(B) proper laboratory facilities to contain and dispose
of such agents and toxins;
(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any other
criminal purpose;
(3) the establishment of procedures to protect the public
safety in the event of a transfer or potential transfer of such
an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and
(4) appropriate availability of biological agents and toxins
for research, education, and other legitimate purposes.
(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—The
Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession
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and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to
protect the public health and safety.
(d) REGISTRATION; IDENTIFICATION; DATABASE.—
(1) REGISTRATION.—Regulations under subsections (b) and
(c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register
under such regulations have a lawful purpose to possess, use,
or transfer such agents and toxins, including provisions in accordance with subsection (e)(6).
(2) IDENTIFICATION; DATABASE.—Regulations under subsections (b) and (c) shall require that registration include (if
available to the person registering) information regarding the
characterization of listed agents and toxins to facilitate their
identification, including their source. The Secretary shall maintain a national database that includes the names and locations
of registered persons, the listed agents and toxins such persons
are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.
(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED
PERSONS.—
(1) IN GENERAL.—Regulations under subsections (b) and (c)
shall include appropriate safeguard and security requirements
for persons possessing, using, or transferring a listed agent or
toxin commensurate with the risk such agent or toxin poses to
public health and safety (including risks posed by the release,
theft, or loss of such agent or toxin, or use in domestic or international terrorism). The Secretary shall establish such requirements in collaboration with the Secretary of Homeland Security and the Attorney General, and shall ensure compliance
with such requirements as part of the registration system
under such regulations.
(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.—Requirements under paragraph (1) shall include provisions to ensure that registered persons—
(A) provide access to listed agents and toxins to only
those individuals whom the registered person involved determines have a legitimate need to handle or use such
agents and toxins;
(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney
General, promptly after first determining that the individuals need access under subparagraph (A), and periodically
thereafter while the individuals have such access, not less
frequently than once every five years;
(C) deny access to such agents and toxins by individuals whom the Attorney General has identified as restricted persons; and
(D) limit or deny access to such agents and toxins by
individuals whom the Attorney General has identified as
within any category under paragraph (3)(B)(ii), if limiting
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mined appropriate by the Secretary, in consultation with
the Attorney General.
(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY
GENERAL.—
(A) IN GENERAL.—Upon the receipt of names and other
identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying
whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic
databases that are available to the Federal Government
and are appropriate for such purpose.
(B) CERTAIN INDIVIDUALS.—For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—
(i) the individual is a restricted person; or
(ii) the individual is reasonably suspected by any
Federal law enforcement or intelligence agency of—
(I) committing a crime set forth in section
2332b(g)(5) of title 18, United States Code;
(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18)
or with any other organization that engages in intentional crimes of violence; or
(III) being an agent of a foreign power (as defined in section 1801 of title 50, United States
Code).
(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING
SUBMITTED NAMES.—After the receipt of a name and other
identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether
the individual is within any of the categories specified in
subparagraph (B).
(4) NOTIFICATIONS BY SECRETARY.—The Secretary, after receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of whether
the individual is granted or denied access under paragraph (2).
If the individual is denied such access, the Secretary shall
promptly notify the individual of the denial.
(5) EXPEDITED REVIEW.—Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits
names and other identifying information under paragraph
(2)(B) and who demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary—
(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and
(B) expedite the notification of the registered person
by the Secretary under paragraph (4).
(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
(A) INDIVIDUALS.—Regulations under subsections (b)
and (c) shall provide that an individual who seeks to regFebruary 1, 2024
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ister under either of such subsections is subject to the
same processes described in paragraphs (2) through (4) as
apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B).
Paragraph (5) does not apply for purposes of this subparagraph.
(B) OTHER PERSONS.—Regulations under subsections
(b) and (c) shall provide that, in determining whether to
deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person
to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases
available to the Federal Government, as appropriate for
the purpose of promptly notifying the Secretary whether
the person, or, where relevant, the individual who owns or
controls such person, is a restricted person or is reasonably
suspected by any Federal law enforcement or intelligence
agency of being within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including individuals).
Such regulations shall provide that a person who seeks to
register under either of such subsections is subject to the
same processes described in paragraphs (2) and (4) as
apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B).
Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local
governmental agencies from the requirements of this subparagraph.
(7) REVIEW.—
(A) ADMINISTRATIVE REVIEW.—
(i) IN GENERAL.—Regulations under subsections
(b) and (c) shall provide for an opportunity for a review by the Secretary—
(I) when requested by the individual involved,
of a determination under paragraph (2) to deny
the individual access to listed agents and toxins;
and
(II) when requested by the person involved, of
a determination under paragraph (6) to deny or
revoke registration for such person.
(ii) EX PARTE REVIEW.—During a review under
clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement
agency.
(iii) FINAL AGENCY ACTION.—The decision of the
Secretary in a review under clause (i) constitutes final
agency action for purposes of section 702 of title 5,
United States Code.
(B) CERTAIN PROCEDURES.—
(i) SUBMISSION OF EX PARTE MATERIALS IN JUDICIAL PROCEEDINGS.—When reviewing a decision of the
Secretary under subparagraph (A), and upon request
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made ex parte and in writing by the United States, a
court, upon a sufficient showing, may review and consider ex parte documents containing information the
disclosure of which could compromise national security
or an investigation by any law enforcement agency. If
the court determines that portions of the documents
considered ex parte should be disclosed to the person
involved to allow a response, the court shall authorize
the United States to delete from such documents specified items of information the disclosure of which could
compromise national security or an investigation by
any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes
could compromise national security or an investigation
by any law enforcement agency shall be subject to the
processes set forth in subparagraphs (A) and (B)(i) of
section 2339B(f)(5) of title 18, United States Code (relating to interlocutory appeal and expedited consideration).
(ii) DISCLOSURE OF INFORMATION.—In a review
under subparagraph (A), and in any judical proceeding
conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to
disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of
title 5, United States Code.
(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.—
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of listed
agents and toxins.
(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The
Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.
(f) INSPECTIONS.—The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to
ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of subsection (e).
(g) EXEMPTIONS.—
(1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations
under subsections (b) and (c) shall exempt clinical or diagnostic
laboratories and other persons who possess, use, or transfer
listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—
(A) the identification of such agents or toxins is reported to the Secretary, and when required under Federal,
State, or local law, to other appropriate authorities; and
(B) such agents or toxins are transferred or destroyed
in a manner set forth by the Secretary by regulation.
(2) PRODUCTS.—
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(A) IN GENERAL.—Regulations under subsections (b)
and (c) shall exempt products that are, bear, or contain
listed agents or toxins and are cleared, approved, licensed,
or registered under any of the Acts specified in subparagraph (B), unless the Secretary by order determines that
applying additional regulation under subsection (b) or (c)
to a specific product is necessary to protect public health
and safety.
(B) RELEVANT LAWS.—For purposes of subparagraph
(A), the Acts specified in this subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act.
(ii) Section 351 of this Act.
(iii) The Act commonly known as the VirusSerum-Toxin Act (the eighth paragraph under the
heading ‘‘Bureau of Animal Industry’’ in the Act of
March 4, 1913; 21 U.S.C. 151–159).
(iv) The Federal Insecticide, Fungicide, and
Rodenticide Act.
(C) INVESTIGATIONAL USE.—
(i) IN GENERAL.—The Secretary may exempt an investigational product that is, bears, or contains a listed agent or toxin from the applicability of provisions
of regulations under subsection (b) or (c) when such
product is being used in an investigation authorized
under any Federal Act and the Secretary determines
that applying additional regulation under subsection
(b) or (c) to such product is not necessary to protect
public health and safety.
(ii) CERTAIN PROCESSES.—Regulations under subsections (b) and (c) shall set forth the procedures for
applying for an exemption under clause (i). In the case
of investigational products authorized under any of
the Acts specified in subparagraph (B), the Secretary
shall make a determination regarding a request for an
exemption not later than 14 days after the first date
on which both of the following conditions have been
met by the person requesting the exemption:
(I) The person has submitted to the Secretary
an application for the exemption meeting the requirements established by the Secretary.
(II) The person has notified the Secretary that
the investigation has been authorized under such
an Act.
(3) PUBLIC HEALTH EMERGENCIES.—The Secretary may
temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary
determines that such exemption is necessary to provide for the
timely participation of the person in a response to a domestic
or foreign public health emergency (whether determined under
section 319(a) or otherwise) that involves a listed agent or
toxin. With respect to the emergency involved, such exemption
for a person may not exceed 30 days, except that the Secretary,
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after review of whether such exemption remains necessary,
may provide one extension of an additional 30 days.
(4) AGRICULTURAL EMERGENCIES.—Upon request of the
Secretary of Agriculture, after the granting by such Secretary
of an exemption under section 212(g)(1)(D) of the Agricultural
Bioterrorism Protection Act of 2002 pursuant to a finding that
there is an agricultural emergency, the Secretary of Health
and Human Services may temporarily exempt a person from
the applicability of the requirements of this section, in whole
or in part, to provide for the timely participation of the person
in a response to the agricultural emergency. With respect to
the emergency involved, the exemption under this paragraph
for a person may not exceed 30 days, except that upon request
of the Secretary of Agriculture, the Secretary of Health and
Human Services may, after review of whether such exemption
remains necessary, provide one extension of an additional 30
days.
(h) DISCLOSURE OF INFORMATION.—
(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal
agency specified in paragraph (2) shall disclose under section
552 of title 5, United States Code, any of the following:
(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession,
use, or transfer of a listed agent or toxin; or information
derived therefrom to the extent that it identifies the listed
agent or toxin possessed, used, or transferred by a specific
registered person or discloses the identity or location of a
specific registered person.
(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or
transfer information submitted under subsections (b) and
(c) to the extent that such compilation discloses site-specific registration or transfer information.
(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures
used by a registered person to prevent unauthorized access
to listed agents and toxins.
(D) Any notification of a release of a listed agent or
toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under
subsection (f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the
identity or location of a specific registered person if the
agency determines that public disclosure of the information would endanger public health or safety.
(2) COVERED AGENCIES.—For purposes of paragraph (1)
only, the Federal agencies specified in this paragraph are the
following:
(A) The Department of Health and Human Services,
the Department of Justice, the Department of Agriculture,
and the Department of Transportation.
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(B) Any Federal agency to which information specified
in paragraph (1) is transferred by any agency specified in
subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person, or
has a sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters
into contracts or cooperative agreements involving listed
agents and toxins to or with a registered person, and to
which information specified in paragraph (1) is transferred
by any such registered person.
(3) OTHER EXEMPTIONS.—This subsection may not be construed as altering the application of any exemptions to public
disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1).
(4) RULE OF CONSTRUCTION.—Except as specifically provided in paragraph (1), this subsection may not be construed
as altering the authority of any Federal agency to withhold
under section 552 of title 5, United States Code, or the obligation of any Federal agency to disclose under section 552 of title
5, United States Code, any information, including information
relating to—
(A) listed agents and toxins, or individuals seeking access to such agents and toxins;
(B) registered persons, or persons seeking to register
their possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and requirements under regulations under subsections (b) and
(c); or
(D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and
reports, or individuals seeking access to such agents and
toxins.
(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This
subsection may not be construed as providing any authority—
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under
any other Federal law or treaty.
(i) CIVIL MONEY PENALTY.— 61
(1) IN GENERAL.—In addition to any other penalties that
may apply under law, any person who violates any provision
of regulations under subsection (b) or (c) shall be subject to the
United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in
the case of any other person.
(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions
of section 1128A of the Social Security Act (other than subsections (a), (b), (h), and (i), the first sentence of subsection (c),
61 Section 175b of title 18, United States Code, establishes criminal penalties relating to biological agents or toxins that are listed as select agents in Appendix A of part 72 of title 42,
Code of Federal Regulations, pursuant to section 351A above, and are not exempted under subsection (h) of section 72.6, or Appendix A of part 72, of title 42, Code of Federal Regulations.
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and paragraphs (1) and (2) of subsection (f)) shall apply to a
civil money penalty under paragraph (1) in the same manner
as such provisions apply to a penalty or proceeding under section 1128A(a) of such Act. The Secretary may delegate authority under this subsection in the same manner as provided in
section 1128A(j)(2) of the Social Security Act, and such authority shall include all powers as contained in section 406 of title
5, United States Code.
(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under
subsections (b) and (c) shall require the prompt notification of the
Secretary by a registered person whenever a release, meeting criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by
the Secretary that the release poses a threat to public health or
safety, the Secretary shall take appropriate action to notify relevant State and local public health authorities, other relevant Federal authorities, and, if necessary, other appropriate persons (including the public). If the released listed agent or toxin is an overlap agent or toxin (as defined in subsection (l)), the Secretary shall
promptly notify the Secretary of Agriculture upon notification by
the registered person.
(k) REPORTS.—
(1) NOTIFICATION WITH RESPECT TO FEDERAL FACILITIES.—
In the event of the release, loss, or theft of an agent or toxin
listed by the Secretary pursuant to subsection (a)(1), or by the
Secretary of Agriculture pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002, from or within a laboratory facility owned or operated by the Department
of Health and Human Services, or other Federal laboratory facility subject to the requirements of this section, the Secretary,
in a manner that does not compromise national security,
shall—
(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives of such event, including—
(i) the Federal laboratory facility in which such release, loss, or theft occurred; and
(ii) the circumstances of such release, loss, or
theft; and
(B) not later than 14 days after such notification, update such Committees on—
(i) any actions taken or planned by the Secretary
to mitigate any potential threat such release, loss, or
theft may pose to public health and safety; and
(ii) any actions taken or planned by the Secretary
to review the circumstances of such release, loss, or
theft, and prevent similar events.
(2) ANNUAL REPORT.—The Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the
House of Representatives on an annual basis a report—
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(A) summarizing the number and nature of notifications received under subsection (e)(8) (relating to theft or
loss) and subsection (j) (relating to releases), during the
preceding fiscal year;
(B) describing actions taken by the Secretary to address such incidents, such as any corrective action plans
required and steps taken to promote adherence to, and
compliance with, safety and security best practices, standards, and regulations; and
(C) describing any gaps, challenges, or limitations with
respect to ensuring that such safety and security practices
are consistently applied and adhered to, and actions taken
to address such gaps, challenges, or limitations.
(3) IMPLEMENTATION OF RECOMMENDATIONS OF THE FEDERAL EXPERTS SECURITY ADVISORY PANEL AND THE FAST TRACK
ACTION COMMITTEE ON SELECT AGENT REGULATIONS.—
(A) IN GENERAL.—Not later than 1 year after the date
of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of
the Federal Experts Security Advisory Panel concerning
the select agent program.
(B) CONTINUED UPDATES.—The Secretary shall report
to the congressional committees of jurisdiction annually
following the submission of the report under subparagraph
(A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided
for the delay in, or lack of, implementation.
(l) DEFINITIONS.—For purposes of this section:
(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the
meanings given such terms in section 178 of title 18, United
States Code.
(2) The term ‘‘listed agents and toxins’’ means biological
agents and toxins listed pursuant to subsection (a)(1).
(3) The term ‘‘listed agents or toxins’’ means biological
agents or toxins listed pursuant to subsection (a)(1).
(4) The term ‘‘overlap agents and toxins’’ means biological
agents and toxins that—
(A) are listed pursuant to subsection (a)(1); and
(B) are listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.
(5) The term ‘‘overlap agent or toxin’’ means a biological
agent or toxin that—
(A) is listed pursuant to subsection (a)(1); and
(B) is listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.
(6) The term ‘‘person’’ includes Federal, State, and local
governmental entities.
(7) The term ‘‘registered person’’ means a person registered
under regulations under subsection (b) or (c).
(8) The term ‘‘restricted person’’ has the meaning given
such term in section 175b of title 18, United States Code.
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(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2023
through 2027.
PREPARATION OF BIOLOGICAL PRODUCTS
SEC. 352. ø263¿ (a) The Service may prepare for its own use
any product described in section 351 and any product necessary to
carrying out any of the purposes of section 301.
(b) The Service may prepare any product described in section
351 for the use of other Federal departments or agencies, and public or private agencies and individuals engaged in work in the field
of medicine when such product is not available from establishments
licensed under such section.
SEC. 352A. ø263-1¿ EDUCATION ON BIOLOGICAL PRODUCTS.
(a) INTERNET WEBSITE.—
(1) IN GENERAL.—The Secretary may maintain and
operate
an internet website to provide educational materials for health
care providers, patients, and caregivers, regarding the meaning
of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and
interchangeable biosimilar biological products.
(2) CONTENT.—Educational materials provided under paragraph (1) may include—
(A) explanations of key statutory and regulatory
terms, including ‘‘biosimilar’’ and ‘‘interchangeable’’, and
clarification regarding the use of interchangeable biosimilar biological products;
(B) information related to development programs for
biological products, including biosimilar biological products
and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related
to the comparability of such biological products;
(C) an explanation of the process for reporting adverse
events for biological products, including biosimilar biological products and interchangeable biosimilar biological
products; and
(D) an explanation of the relationship between biosimilar biological products and interchangeable biosimilar
biological products licensed under section 351(k) and reference products (as defined in section 351(i)), including the
standards for review and licensing of each such type of biological product.
(3) FORMAT.—The educational materials provided under
paragraph (1) may be—
(A) in formats such as webinars, continuing education
modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and
(B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the
Secretary determines appropriate.
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(4) OTHER INFORMATION.—In addition to the information
described in paragraph (2), the Secretary shall continue to publish—
(A) the action package of each biological product licensed under subsection (a) or (k) of section 351; or
(B) the summary review of each biological product licensed under subsection (a) or (k) of section 351.
(5) CONFIDENTIAL AND TRADE SECRET INFORMATION.—This
subsection does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other
matter described in section 552(b) of title 5.
(b) CONTINUING EDUCATION.—The Secretary shall advance
education and awareness among health care providers regarding
biological products, including biosimilar biological products and
interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing education programs
that advance the education of such providers on the prescribing of,
and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable
biosimilar biological products.
Subpart 2—Clinical Laboratories
CERTIFICATION OF LABORATORIES
SEC. 353. ø263a¿ (a) DEFINITION.—As used in this section, the
term ‘‘laboratory’’ or ‘‘clinical laboratory’’ means a facility for the biological,
microbiological,
serological,
chemical,
immunohematological, hematological, biophysical, cytological, pathological,
or other examination of materials derived from the human body for
the purpose of providing information for the diagnosis, prevention,
or treatment of any disease or impairment of, or the assessment of
the health of, human beings.
(b) CERTIFICATE REQUIREMENT.—No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes
such examination or procedure.
(c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
(1) IN GENERAL.—The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d).
(2) TERM.—A certificate issued under this section shall be
valid for a period of 2 years or such shorter period as the Secretary may establish.
(d) REQUIREMENTS FOR CERTIFICATES.—
(1) IN GENERAL.—A laboratory may be issued a certificate
or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which
accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall
prescribe,
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(ii) that describes the characteristics of the laboratory examinations and other procedures performed by
the laboratory including—
(I) the number and types of laboratory examinations and other procedures performed,
(II) the methodologies for laboratory examinations and other procedures employed, and
(III) the qualifications (educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the laboratory examinations and other
procedures, and
(iii) that contains such other information as the
Secretary may require to determine compliance with
this section, and
the laboratory agrees to provide to the Secretary (or if the
laboratory is accredited, to the accreditation body which
accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months
after the change was put into effect,
(B) the laboratory provides the Secretary—
(i) with satisfactory assurances that the laboratory
will be operated in accordance with standards issued
by the Secretary under subsection (f), or
(ii) with proof of accreditation under subsection
(e),
(C) the laboratory agrees to permit inspections by the
Secretary under subsection (g),
(D) the laboratory agrees to make records available
and submit reports to the Secretary as the Secretary may
reasonably require, and
(E) the laboratory agrees to treat proficiency testing
samples in the same manner as it treats materials derived
from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited
under subsection (i)(4).
(2) REQUIREMENTS FOR CERTIFICATES OF WAIVER.—
(A) IN GENERAL.—A laboratory which only performs
laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its
certificate of waiver renewed if—
(i) the laboratory submits an application—
(I) in such form and manner as the Secretary
shall prescribe,
(II) that describes the characteristics of the
laboratory examinations and other procedures performed by the laboratory, including the number
and types of laboratory examinations and other
procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel
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directing and supervising the laboratory and performing the laboratory examinations and other
procedures, and
(III) that contains such other information as
the Secretary may reasonably require to determine compliance with this section, and
(ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require.
(B) CHANGES.—If a laboratory makes changes in the
examinations and other procedures performed by it only
with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such
changes to the Secretary not later than 6 months after the
change has been put into effect. If a laboratory proposes to
make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the
laboratory shall report such change to the Secretary before
the change takes effect.
(C) EFFECT.—Subsections (f) and (g) shall not apply to
a laboratory to which has been issued a certificate of waiver.
(3) EXAMINATIONS AND PROCEDURES.—The examinations
and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the
Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations
and procedures that have an insignificant risk of an erroneous
result, including those that—
(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the
user negligible, or
(B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.
(4) DEFINITION.—As used in this section, the term ‘‘certificate’’ includes a certificate of waiver issued under paragraph
(2).
(e) ACCREDITATION.—
(1) IN GENERAL.—A laboratory may be accredited for purposes of obtaining a certificate if the laboratory—
(A) meets the standards of an approved accreditation
body, and
(B) authorizes the accreditation body to submit to the
Secretary (or such State agency as the Secretary may designate) such records or other information as the Secretary
may require.
(2) APPROVAL OF ACCREDITATION BODIES.—
(A) IN GENERAL.—The Secretary may approve a private nonprofit organization to be an accreditation body for
the accreditation of laboratories if—
(i) using inspectors qualified to evaluate the methodologies used by the laboratories in performing laboratory examinations and other procedures, the acFebruary 1, 2024
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creditation body agrees to inspect a laboratory for purposes of accreditation with such frequency as determined by Secretary, 62
(ii) the standards applied by the body in determining whether or not to accredit a laboratory are
equal to or more stringent than the standards issued
by the Secretary under subsection (f),
(iii) there is adequate provision for assuring that
the standards of the accreditation body continue to be
met by the laboratory,
(iv) in the case of any laboratory accredited by the
body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any
other action taken against it by the accrediting body,
the accrediting body agrees to submit to the Secretary
the name of such laboratory within 30 days of the action taken,
(v) the accreditation body agrees to notify the Secretary at least 30 days before it changes its standards,
and
(vi) if the accreditation body has its approval withdrawn by the Secretary, the body agrees to notify each
laboratory accredited by the body of the withdrawal
within 10 days of the withdrawal.
(B) CRITERIA AND PROCEDURES.—The Secretary shall
promulgate criteria and procedures for approving an accreditation body and for withdrawing such approval if the
Secretary determines that the accreditation body does not
meet the requirements of subparagraph (A).
(C) EFFECT OF WITHDRAWAL OF APPROVAL.—If the Secretary withdraws the approval of an accreditation body
under subparagraph (B), the certificate of any laboratory
accredited by the body shall continue in effect for 60 days
after the laboratory receives notification of the withdrawal
of the approval, except that the Secretary may extend such
period for a laboratory if it 62 determines that the laboratory submitted an application for accreditation or a certificate in a timely manner after receipt of the notification of
the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the laboratory shall continue in effect—
(i) for 45 days after the laboratory receives notice
of the withdrawal or revocation of the accreditation, or
(ii) until the effective date of any action taken by
the Secretary under subsection (i).
(D) EVALUATIONS.—The Secretary shall evaluate annually the performance of each approved accreditation
body by—
(i) inspecting under subsection (g) a sufficient
number of the laboratories accredited by such body to
allow a reasonable estimate of the performance of such
body, and
62 So
in law. Probably should be ‘‘the Secretary’’.
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(ii) such other means as the Secretary determines
appropriate.
(3) REPORT.—The Secretary shall annually prepare and
submit, to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Labor and
Human Resources of the Senate, a report that describes the results of the evaluation conducted under paragraph (2)(D).
(f) 63 STANDARDS.—
(1) IN GENERAL.—The Secretary shall issue standards to
assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures. Such standards shall require
each laboratory issued a certificate under this section—
(A) to maintain a quality assurance and quality control program adequate and appropriate for the validity and
reliability of the laboratory examinations and other procedures of the laboratory and to meet requirements relating
to the proper collection, transportation, and storage of
specimens and the reporting of results,
(B) to maintain records, equipment, and facilities necessary for the proper and effective operation of the laboratory,
(C) in performing and carrying out its laboratory examinations and other procedures, to use only personnel
meeting such qualifications as the Secretary may establish
for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which
qualifications shall, as appropriate, be different on the
basis of the type of examinations and procedures being
performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures,
(D) to qualify under a proficiency testing program
meeting the standards established by the Secretary under
paragraph (3), and
(E) to meet such other requirements as the Secretary
determines necessary to assure consistent performance by
such laboratories of accurate and reliable laboratory examinations and procedures.
(2) CONSIDERATIONS.—In developing the standards to be
issued under paragraph (1), the Secretary shall, within the
flexibility provided under subparagraphs (A) through (E) of
paragraph (1), take into consideration—
(A) the examinations and procedures performed and
the methodologies employed,
(B) the degree of independent judgment involved,
(C) the amount of interpretation involved,
(D) the difficulty of the calculations involved,
63 Section 3 of Public Law 100–578 provides that, with respect to subsection (g)(1) and subsections (h) through (m), any reference made in any of such subsections to the standards established under subsection (f) ‘‘shall be considered a reference to the standards established under
subsection (d) [of section 353], as in effect on December 31, 1988.’’.
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(E) the calibration and quality control requirements of
the instruments used,
(F) the type of training required to operate the instruments used in the methodology, and
(G) such other factors as the Secretary considers relevant.
(3) PROFICIENCY TESTING PROGRAM.—
(A) IN GENERAL.—The Secretary shall establish standards for the proficiency testing programs for laboratories
issued a certificate under this section which are conducted
by the Secretary, conducted by an organization approved
under subparagraph (C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for
each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the Secretary has determined that a proficiency test cannot reasonably be developed. The testing
shall be conducted on a quarterly basis, except where the
Secretary determines for technical and scientific reasons
that a particular examination or procedure may be tested
less frequently (but not less often than twice per year).
(B) CRITERIA.—The standards established under subparagraph (A) shall include uniform criteria for acceptable
performance under a proficiency testing program, based on
the available technology and the clinical relevance of the
laboratory examination or other procedure subject to such
program. The criteria shall be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall also include a
system for grading proficiency testing performance to determine whether a laboratory has performed acceptably for
a particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.
(C) APPROVED PROFICIENCY TESTING PROGRAMS.—For
the purpose of administering proficiency testing programs
which meet the standards established under subparagraph
(A), the Secretary shall approve a proficiency testing program offered by a private nonprofit organization or a State
if the program meets the standards established under subparagraph (A) and the organization or State provides technical assistance to laboratories seeking to qualify under
the program. The Secretary shall evaluate each program
approved under this subparagraph annually to determine
if the program continues to meet the standards established
under subparagraph (A) and shall withdraw the approval
of any program that no longer meets such standards.
(D) ON-SITE 64 TESTING.—The Secretary shall perform,
or shall direct a program approved under subparagraph
(C) to perform, onsite proficiency testing to assure compli64 So
in law. Probably should not be hyphenated. Compare with text of subparagraph (D).
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ance with the requirements of subsection (d)(5) 65. The Secretary shall perform, on an onsite or other basis, proficiency testing to evaluate the performance of a proficiency testing program approved under subparagraph (C)
and to assure quality performance by a laboratory.
(E) TRAINING, TECHNICAL ASSISTANCE, AND ENHANCED
PROFICIENCY TESTING.—The Secretary may, in lieu of or in
addition to actions authorized under subsection (h), (i), or
(j), require any laboratory which fails to perform acceptably on an individual examination and procedure or a category of examination and procedures—
(i) to undertake training and to obtain the necessary technical assistance to meet the requirements
of the proficency 66 testing program,
(ii) to enroll in a program of enhanced proficiency
testing, or
(iii) to undertake any combination of the training,
technical assistance, or testing described in clauses (i)
and (ii).
(F) TESTING RESULTS.—The Secretary shall establish a
system to make the results of the proficiency testing programs subject to the standards established by the Secretary under subparagraph (A) available, on a reasonable
basis, upon request of any person. The Secretary shall include with results made available under this subparagraph
such explanatory information as may be appropriate to assist in the interpretation of such results.
(4) NATIONAL STANDARDS FOR QUALITY ASSURANCE IN CYTOLOGY SERVICES.—
(A) ESTABLISHMENT.—The Secretary shall establish
national standards for quality assurance in cytology services designed to assure consistent performance by laboratories of valid and reliable cytological services.
(B) STANDARDS.—The standards established under
subparagraph (A) shall include—
(i) the maximum number of cytology slides that
any individual may screen in a 24-hour period,
(ii) requirements that a clinical laboratory maintain a record of (I) the number of cytology slides
screened during each 24-hour period by each individual who examines cytology slides for the laboratory,
and (II) the number of hours devoted during each 24hour period to screening cytology slides by such individual,
(iii) criteria for requiring rescreening of cytological
preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in
high risk groups, and (III) for each abnormal
cytological result, rescreening of all prior cytological
specimens for the patient, if available,
65 So
66 So
in law. Probably should be ‘‘(d)(1)(E)’’.
in law. Probably should be ‘‘proficiency’’.
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(iv) periodic confirmation and evaluation of the
proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site 67 proficiency testing of such individuals, with such testing to take
place, to the extent practicable, under normal working
conditions,
(v) procedures for detecting inadequately prepared
slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides,
(vi) requirements that all cytological screening be
done on the premises of a laboratory that is certified
under this section,
(vii) requirements for the retention of cytology
slides by laboratories for such periods of time as the
Secretary considers appropriate, and
(viii) standards requiring periodic inspection of cytology services by persons capable of evaluating the
quality of cytology services.
(g) INSPECTIONS.—
(1) IN GENERAL.—The Secretary may, on an announced or
unannounced basis, enter and inspect, during regular hours of
operation, laboratories which have been issued a certificate
under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials,
records, and information that the Secretary determines have a
bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it be 68 submitted to the Secretary. An inspection under this paragraph
may be made only upon presenting identification to the owner,
operator, or agent in charge of the laboratory being inspected.
(2) COMPLIANCE WITH REQUIREMENTS AND STANDARDS.—
The Secretary shall conduct inspections of laboratories under
paragraph (1) to determine their compliance with the requirements of subsection (d) and the standards issued under subsection (f). Inspections of laboratories not accredited under subsection (e) shall be conducted on a biennial basis or with such
other frequency as the Secretary determines to be necessary to
assure compliance with such requirements and standards. Inspections of laboratories accredited under subsection (e) shall
be conducted on such basis as the Secretary determines is necessary to assure compliance with such requirements and standards.
(h) INTERMEDIATE SANCTIONS.—
(1) IN GENERAL.—If the Secretary determines that a laboratory which has been issued a certificate under this section
no longer substantially meets the requirements for the
issuance of a certificate, the Secretary may impose inter67 See
68 So
footnote 1 for paragraph (3)(D).
in law. Probably should be ‘‘require it to be’’.
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mediate sanctions in lieu of the actions authorized by subsection (i).
(2) TYPES OF SANCTIONS.—The intermediate sanctions
which may be imposed under paragraph (1) shall consist of—
(A) directed plans of correction,
(B) civil money penalties in an amount not to exceed
$10,000 for each violation listed in subsection (i)(1) or for
each day of substantial noncompliance with the requirements of this section,
(C) payment for the costs of onsite monitoring, or
(D) any combination of the actions described in subparagraphs (A), (B), and (C).
(3) PROCEDURES.—The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1).
Such procedures shall provide for notice to the laboratory and
a reasonable opportunity to respond to the proposed sanction
and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions 69
(i) SUSPENSION, REVOCATION, AND LIMITATION.—
(1) IN GENERAL.—Except as provided in paragraph (2), the
certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory—
(A) has been guilty of misrepresentation in obtaining
the certificate,
(B) has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate,
(C) has failed to comply with the requirements of subsection (d) or the standards prescribed by the Secretary
under subsection (f),
(D) has failed to comply with reasonable requests of
the Secretary for—
(i) any information or materials, or
(ii) work on materials,
that the Secretary concludes is necessary to determine the
laboratory’s continued eligibility for its certificate or continued compliance with the Secretary’s standards under
subsection (f),
(E) has refused a reasonable request of the Secretary,
or any Federal officer or employee duly designated by the
Secretary, for permission to inspect the laboratory and its
operations and pertinent records during the hours the laboratory is in operation,
(F) has violated or aided and abetted in the violation
of any provisions of this section or of any regulation promulgated thereunder, or
69 So
in law. The sentence lacks a period.
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(G) has not complied with an intermediate sanction
imposed under subsection (h).
(2) ACTION BEFORE A HEARING.—If the Secretary determines that—
(A) the failure of a laboratory to comply with the
standards of the Secretary under subsection (f) presents an
imminent and serious risk to human health, or
(B) a laboratory has engaged in an action described in
subparagraph (D) or (E) of paragraph (1),
the Secretary may suspend or limit the certificate of the laboratory before holding a hearing under paragraph (1) regarding
such failure or refusal. The opportunity for a hearing shall be
provided no later than 60 days from the effective date of the
suspension or limitation. A suspension or limitation under this
paragraph shall stay in effect until the decision of the Secretary made after the hearing under paragraph (1).
(3) INELIGIBILITY TO OWN OR OPERATE LABORATORIES AFTER
REVOCATION.—No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years
of the revocation of the certificate, own or operate a laboratory
for which a certificate has been issued under this section, except that if the revocation occurs pursuant to paragraph (4) the
Secretary may substitute intermediate sanctions under subsection (h) instead of the 2-year prohibition against ownership
or operation which would otherwise apply under this paragraph. The certificate of a laboratory which has been excluded
from participation under the medicare program under title
XVIII of the Social Security Act because of actions relating to
the quality of the laboratory shall be suspended for the period
the laboratory is so excluded.
(4) IMPROPER REFERRALS.—Any laboratory that the Secretary determines intentionally refers its proficiency testing
samples to another laboratory for analysis may have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h).
(j) INJUNCTIONS.—Whenever the Secretary has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the Secretary may
bring suit in the district court of the United States for the district
in which such laboratory is situated to enjoin continuation of such
activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of
a final order under this subsection shall be granted without bond
by such court.
(k) JUDICIAL REVIEW.—
(1) PETITION.—Any laboratory which has had an intermediate sanction imposed under subsection (h) or has had its
certificate suspended, revoked, or limited under subsection (i)
may, at any time within 60 days after the date the action of
the Secretary under subsection (i) or (h) becomes final, file a
petition with the United States court of appeals for the circuit
wherein the laboratory has its principal place of business for
judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a
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copy of the petition to the Secretary or other officer designated
by the Secretary for that purpose. As soon as practicable after
receipt of the copy, the Secretary shall file in the court the
record on which the action of the Secretary is based, as provided in section 2112 of title 28, United States Code.
(2) ADDITIONAL EVIDENCE.—If the petitioner applies to the
court for leave to adduce additional evidence, and shows to the
satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to
adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence (and evidence in
rebuttal of such additional evidence) to be taken before the
Secretary, and to be adduced upon the hearing in such manner
and upon such terms and conditions as the court may deem
proper. The Secretary may modify the findings of the Secretary
as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file such
modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of his original action, with the return of such additional evidence.
(3) JUDGMENT OF COURT.—Upon the filing of the petition
referred to in paragraph (1), the court shall have jurisdiction
to affirm the action, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to
the facts, if supported by substantial evidence, shall be conclusive.
(4) FINALITY OF JUDGMENT.—The judgment of the court affirming or setting aside, in whole or in part, any such action
of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28, United States
Code.
(l) SANCTIONS.—Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder
shall be imprisoned for not more than one year or fined under title
18, United States Code or both, except that if the conviction is for
a second or subsequent violation of such a requirement such person
shall be imprisoned for not more than 3 years or fined in accordance with title 18, United States Code or both.
(m) FEES.—
(1) CERTIFICATE FEES.—The Secretary shall require payment of fees for the issuance and renewal of certificates, except
that the Secretary shall only require a nominal fee for the
issuance and renewal of certificates of waiver.
(2) ADDITIONAL FEES.—The Secretary shall require the
payment of fees for inspections of laboratories which are not
accredited and for the cost of performing proficiency testing on
laboratories which do not participate in proficiency testing programs approved under subsection (f)(3)(C).
(3) CRITERIA.—
(A) FEES UNDER PARAGRAPH (1).—Fees imposed under
paragraph (1) shall be sufficient to cover the general costs
of administering this section, including evaluating and
monitoring proficiency testing programs approved under
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subsection (f) and accrediting bodies and implementing
and monitoring compliance with the requirements of this
section.
(B) FEES UNDER PARAGRAPH (2).—Fees imposed under
paragraph (2) shall be sufficient to cover the cost of the
Secretary in carrying out the inspections and proficiency
testing described in paragraph (2).
(C) FEES IMPOSED UNDER PARAGRAPHS (1) AND (2).—
Fees imposed under paragraphs (1) and (2) shall vary by
group or classification of laboratory, based on such considerations as the Secretary determines are relevant, which
may include the dollar volume and scope of the testing
being performed by the laboratories.
(n) INFORMATION.—On April 1, 1990 and annually thereafter,
the Secretary shall compile and make available to physicians and
the general public information, based on the previous calendar
year, which the Secretary determines is useful in evaluating the
performance of a laboratory, including—
(1) a list of laboratories which have been convicted under
Federal or State laws relating to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories—
(A) which have had their certificates revoked, suspended, or limited under subsection (i), or
(B) which have been the subject of a sanction under
subsection (l),
together with a statement of the reasons for the revocation,
suspension, limitation, or sanction,
(3) a list of laboratories subject to intermediate sanctions
under subsection (h) together with a statement of the reasons
for the sanctions,
(4) a list of laboratories whose accreditation has been withdrawn or revoked together with a statement of the reasons for
the withdrawal or revocation,
(5) a list of laboratories against which the Secretary has
taken action under subsection (j) together with a statement of
the reasons for such action, and
(6) a list of laboratories which have been excluded from
participation under title XVIII or XIX of the Social Security
Act.
The information to be compiled under paragraphs (1) through (6)
shall be information for the calendar year preceding the date the
information is to be made available to the public and shall be accompanied by such explanatory information as may be appropriate
to assist in the interpretation of the information compiled under
such paragraphs.
(o) DELEGATION.—In carrying out this section, the Secretary
may, pursuant to agreement, use the services or facilities of any
Federal or State or local public agency or nonprofit private organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as the Secretary may determine.
(p) STATE LAWS.—
(1) Except as provided in paragraph (2), nothing in this
section shall be construed as affecting the power of any State
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to enact and enforce laws relating to the matters covered by
this section to the extent that such laws are not inconsistent
with this section or with the regulations issued under this section.
(2) If a State enacts laws relating to matters covered by
this section which provide for requirements equal to or more
stringent than the requirements of this section or than the regulations issued under this section, the Secretary may exempt
clinical laboratories in that State from compliance with this
section.
(q) CONSULTATIONS.—In carrying out this section, the Secretary shall consult with appropriate private organizations and
public agencies.
Subpart 3—Mammography Facilities
SEC. 354. ø263b¿ CERTIFICATION OF MAMMOGRAPHY FACILITIES.
(a) DEFINITIONS.—As used in this section:
(1) ACCREDITATION BODY.—The term ‘‘accreditation body’’
means a body that has been approved by the Secretary under
subsection (e)(1)(A) to accredit mammography facilities.
(2) CERTIFICATE.—The term ‘‘certificate’’ means the certificate described in subsection (b)(1).
(3) FACILITY.—
(A) IN GENERAL.—The term ‘‘facility’’ means a hospital,
outpatient department, clinic, radiology practice, or mobile
unit, an office of a physician, or other facility as determined by the Secretary, that conducts breast cancer
screening or diagnosis through mammography activities.
Such term does not include a facility of the Department of
Veterans Affairs.
(B) ACTIVITIES.—For the purposes of this section, the
activities of a facility include the operation of equipment
to produce the mammogram, the processing of the film, the
initial interpretation of the mammogram and the viewing
conditions for that interpretation. Where procedures such
as the film processing, or the interpretation of the mammogram are performed in a location different from where
the mammogram is performed, the facility performing the
mammogram shall be responsible for meeting the quality
standards described in subsection (f).
(4) INSPECTION.—The term ‘‘inspection’’ means an onsite
evaluation of the facility by the Secretary, or State or local
agency on behalf of the Secretary.
(5) MAMMOGRAM.—The term ‘‘mammogram’’ means a radiographic image produced through mammography.
(6) MAMMOGRAPHY.—The term ‘‘mammography’’ means radiography of the breast.
(7) SURVEY.—The term ‘‘survey’’ means an onsite physics
consultation and evaluation performed by a medical physicist
as described in subsection (f)(1)(E).
(8) REVIEW PHYSICIAN.—The term ‘‘review physician’’
means a physician as prescribed by the Secretary under subsection (f)(1)(D) who meets such additional requirements as
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may be established by an accreditation body under subsection
(e) and approved by the Secretary to review clinical images
under subsection (e)(1)(B)(i) on behalf of the accreditation body.
(b) CERTIFICATE REQUIREMENT.—
(1) CERTIFICATE.—No facility may conduct an examination
or procedure described in paragraph (2) involving mammography after October 1, 1994, unless the facility obtains—
(A) a certificate or a temporary renewal certificate—
(i) that is issued, and, if applicable, renewed, by
the Secretary in accordance with paragraphs 70 (1) or
(2) of subsection (c);
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility;
or
(B) a provisional certificate or a limited provisional
certificate—
(i) that is issued by the Secretary in accordance
with paragraphs (3) and (4) of subsection (c);
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility.
The reference to a certificate in this section includes a temporary renewal certificate, provisional certificate, or a 71 limited provisional certificate.
(2) EXAMINATION OR PROCEDURE.—A facility shall obtain a
certificate in order to—
(A) operate radiological equipment that is used to
image the breast;
(B) provide for the interpretation of a mammogram
produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed; and
(C) provide for the processing of film produced by such
equipment at the facility or under arrangements with a
qualified individual at a facility different from where the
mammography examination is performed.
(c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
(1) IN GENERAL.—The Secretary may issue or renew a certificate for a facility if the person or agent described in subsection (d)(1)(A) meets the applicable requirements of subsection (d)(1) with respect to the facility. The Secretary may
issue or renew a certificate under this paragraph for not more
than 3 years.
(2) TEMPORARY RENEWAL CERTIFICATE.—The Secretary
may issue a temporary renewal certificate, for a period of not
to exceed 45 days, to a facility seeking reaccreditation if the accreditation body has issued an accreditation extension, for a
period of not to exceed 45 days, for any of the following:
70 So in law. Probably should be ‘‘paragraph’’. See section 2(1)(A)(ii) of Public Law 108–365
(118 Stat. 1738).
71 So in law. The article ‘‘a’’ appears before both ‘‘temporary renewal certificate’’ and ‘‘limited
provisional certificate’’. See section 2(1)(C) of Public Law 108–365 (118 Stat. 1738).
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(A) The facility has submitted the required materials
to the accreditation body within the established time
frames for the submission of such materials but the accreditation body is unable to complete the reaccreditation
process before the certification expires.
(B) The facility has acquired additional or replacement
equipment, or has had significant personnel changes or
other unforeseen situations that have caused the facility to
be unable to meet reaccreditation timeframes, but in the
opinion of the accreditation body have not compromised
the quality of mammography.
(3) LIMITED PROVISIONAL CERTIFICATE.—The Secretary
may, upon the request of an accreditation body, issue a limited
provisional certificate to an entity to enable the entity to conduct examinations for educational purposes while an onsite
visit from an accreditation body is in progress. Such certificate
shall be valid only during the time the site visit team from the
accreditation body is physically in the facility, and in no case
shall be valid for longer than 72 hours. The issuance of a certificate under this paragraph, shall not preclude the entity
from qualifying for a provisional certificate under paragraph
(4).
(4) PROVISIONAL CERTIFICATE.—The Secretary may issue a
provisional certificate for an entity to enable the entity to qualify as a facility. The applicant for a provisional certificate shall
meet the requirements of subsection (d)(1), except providing information required by clauses (iii) and (iv) of subsection
(d)(1)(A). A provisional certificate may be in effect no longer
than 6 months from the date it is issued, except that it may
be extended once for a period of not more than 90 days if the
owner, lessor, or agent of the facility demonstrates to the Secretary that without such extension access to mammography in
the geographic area served by the facility would be significantly reduced and if the owner, lessor, or agent of the facility
will describe in a report to the Secretary steps that will be
taken to qualify the facility for certification under subsection
(b)(1).
(d) APPLICATION FOR CERTIFICATE.—
(1) SUBMISSION.—The Secretary may issue or renew a certificate for a facility if—
(A) the person who owns or leases the facility or an
authorized agent of the person, submits to the Secretary,
in such form and manner as the Secretary shall prescribe,
an application that contains at a minimum—
(i) a description of the manufacturer, model, and
type of each x-ray machine, image receptor, and processor operated in the performance of mammography
by the facility;
(ii) a description of the procedures currently used
to provide mammography at the facility, including—
(I) the types of procedures performed and the
number of such procedures performed in the prior
12 months;
(II) the methodologies for mammography; and
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(III) the names and qualifications (educational
background, training, and experience) of the personnel performing mammography and the physicians reading and interpreting the results from
the procedures;
(iii) proof of on-site survey by a qualified medical
physicist as described in subsection (f)(1)(E); and
(iv) proof of accreditation in such manner as the
Secretary shall prescribe; and
(B) the person or agent submits to the Secretary—
(i) a satisfactory assurance that the facility will be
operated in accordance with standards established by
the Secretary under subsection (f) to assure the safety
and accuracy of mammography;
(ii) a satisfactory assurance that the facility will—
(I) permit inspections under subsection (g);
(II) make such records and information available, and submit such reports, to the Secretary as
the Secretary may require; and
(III) update the information submitted under
subparagraph (A) or assurances submitted under
this subparagraph on a timely basis as required
by the Secretary; and
(iii) such other information as the Secretary may
require.
An applicant shall not be required to provide in an application
under subparagraph (A) any information which the applicant
has supplied to the accreditation body which accredited the applicant, except as required by the Secretary.
(2) APPEAL.—If the Secretary denies an application for the
certification of a facility submitted under paragraph (1)(A), the
Secretary shall provide the owner or lessor of the facility or the
agent of the owner or lessor who submitted such application—
(A) a statement of the grounds on which the denial is
based, and
(B) an opportunity for an appeal in accordance with
the procedures set forth in regulations of the Secretary
published at part 498 of title 42, Code of Federal Regulations.
(3) EFFECT OF DENIAL.—If the application for the certification of a facility is denied, the facility may not operate unless
the denial of the application is overturned at the conclusion of
the administrative appeals process provided in the regulations
referred to in paragraph (2)(B).
(e) ACCREDITATION.—
(1) APPROVAL OF ACCREDITATION BODIES.—
(A) IN GENERAL.—The Secretary may approve a private nonprofit organization or State agency to accredit facilities for purposes of subsection (d)(1)(A)(iv) if the accreditation body meets the standards for accreditation established by the Secretary as described in subparagraph (B)
and provides the assurances required by subparagraph (C).
(B) STANDARDS.—The Secretary shall establish standards for accreditation bodies, including—
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(i) standards that require an accreditation body to
perform—
(I) a review of clinical images from each facility accredited by such body not less often than
every 3 years which review will be made by qualified review physicians; and
(II) a review of a random sample of clinical
images from such facilities in each 3-year period
beginning October 1, 1994, which review will be
made by qualified review physicians;
(ii) standards that prohibit individuals conducting
the reviews described in clause (i) from maintaining
any relationship to the facility undergoing review
which would constitute a conflict of interest;
(iii) standards that limit the imposition of fees for
accreditation to reasonable amounts;
(iv) standards that require as a condition of accreditation that each facility undergo a survey at least
annually by a medical physicist as described in subsection (f)(1)(E) to ensure that the facility meets the
standards described in subparagraphs (A) and (B) of
subsection (f)(1);
(v) standards that require monitoring and evaluation of such survey, as prescribed by the Secretary;
(vi) standards that are equal to standards established under subsection (f) which are relevant to accreditation as determined by the Secretary; and
(vii) such additional standards as the Secretary
may require.
(C) ASSURANCES.—The accrediting body shall provide
the Secretary satisfactory assurances that the body will—
(i) comply with the standards as described in subparagraph (B);
(ii) comply with the requirements described in
paragraph (4);
(iii) submit to the Secretary the name of any facility for which the accreditation body denies, suspends,
or revokes accreditation;
(iv) notify the Secretary in a timely manner before
the accreditation body changes the standards of the
body;
(v) notify each facility accredited by the accreditation body if the Secretary withdraws approval of the
accreditation body under paragraph (2) in a timely
manner; and
(vi) provide such other additional information as
the Secretary may require.
(D) REGULATIONS.—Not later than 9 months after the
date of the enactment of this section, the Secretary shall
promulgate regulations under which the Secretary may approve an accreditation body.
(2) WITHDRAWAL OF APPROVAL.—
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proval of an accreditation body if the Secretary determines
that the accreditation body does not meet the standards
under subparagraph (B) of paragraph (1), the requirements of clauses (i) through (vi) of subparagraph (C) of
paragraph (1), or the requirements of paragraph (4).
(B) EFFECT OF WITHDRAWAL.—If the Secretary withdraws the approval of an accreditation body under subparagraph (A), the certificate of any facility accredited by
the body shall continue in effect until the expiration of a
reasonable period, as determined by the Secretary, for
such facility to obtain another accreditation.
(3) ACCREDITATION.—To be accredited by an approved accreditation body a facility shall meet—
(A) the standards described in paragraph (1)(B) which
the Secretary determines are applicable to the facility, and
(B) such other standards which the accreditation body
may require.
(4) COMPLIANCE.—To ensure that facilities accredited by
an accreditation body will continue to meet the standards of
the accreditation body, the accreditation body shall—
(A) make onsite visits on an annual basis of a sufficient number of the facilities accredited by the body to
allow a reasonable estimate of the performance of the
body; and
(B) take such additional measures as the Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made after providing such notice as the Secretary may require.
(5) REVOCATION OF ACCREDITATION.—If an accreditation
body revokes the accreditation of a facility, the certificate of
the facility shall continue in effect until such time as may be
determined by the Secretary.
(6) EVALUATION AND REPORT.—
(A) EVALUATION.—The Secretary shall evaluate annually the performance of each approved accreditation body
by—
(i) inspecting under subsection (g)(2) a sufficient
number of the facilities accredited by the body to allow
a reasonable estimate of the performance of the body;
and
(ii) such additional means as the Secretary determines to be appropriate.
(B) REPORT.—The Secretary shall annually prepare
and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report that
describes the results of the evaluation conducted in accordance with subparagraph (A).
(f) QUALITY STANDARDS.—
(1) IN GENERAL.—The standards referred to in subsection
(d)(1)(B)(i) are standards established by the Secretary which
include—
(A) standards that require establishment and maintenance of a quality assurance and quality control program
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at each facility that is adequate and appropriate to ensure
the reliability, clarity, and accuracy of interpretation of
mammograms and standards for appropriate radiation
dose;
(B) standards that require use of radiological equipment specifically designed for mammography, including
radiologic standards and standards for other equipment
and materials used in conjunction with such equipment;
(C) a requirement that personnel who perform mammography—
(i)(I) be licensed by a State to perform radiological
procedures; or
(II) be certified as qualified to perform radiological
procedures by an organization described in paragraph
(2)(A); and
(ii) during the 2-year period beginning October 1,
1994, meet training standards for personnel who perform mammography or meet experience requirements
which shall at a minimum include 1 year of experience
in the performance of mammography; and
(iii) upon the expiration of such 2-year period
meet minimum training standards for personnel who
perform mammograms;
(D) a requirement that mammograms be interpreted
by a physician who is certified as qualified to interpret radiological procedures, including mammography—
(i)(I) by a board described in paragraph (2)(B); or
(II) by a program that complies with the standards described in paragraph (2)(C); and
(ii) who meets training and continuing medical
education requirements as established by the Secretary;
(E) a requirement that individuals who survey mammography facilities be medical physicists—
(i) licensed or approved by a State to perform such
surveys, reviews, or inspections for mammography facilities;
(ii) certified in diagnostic radiological physics or
certified as qualified to perform such surveys by a
board as described in paragraph (2)(D); or
(iii) in the first 5 years after the date of the enactment of this section, who meet other criteria established by the Secretary which are comparable to the
criteria described in clause (i) or (ii);
(F) a requirement that a medical physicist who is
qualified in mammography as described in subparagraph
(E) survey mammography equipment and oversee quality
assurance practices at each facility;
(G) a requirement that—
(i) a facility that performs any mammogram—
(I) except as provided in subclause (II), maintain the mammogram in the permanent medical
records of the patient for a period of not less than
5 years, or not less than 10 years if no subsequent
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mammograms of such patient are performed at
the facility, or longer if mandated by State law;
and
(II) upon the request of or on behalf of the patient, transfer the mammogram to a medical institution, to a physician of the patient, or to the patient directly; and
(ii)(I) a facility must assure the preparation of a
written report of the results of any mammography examination signed by the interpreting physician;
(II) such written report shall be provided to the
patient’s physicians (if any);
(III) if such a physician is not available or if there
is no such physician, the written report shall be sent
directly to the patient; and
(IV) whether or not such a physician is available
or there is no such physician, a summary of the written report shall be sent directly to the patient in terms
easily understood by a lay person; and
(H) standards relating to special techniques for mammography of patients with breast implants.
Subparagraph (G) shall not be construed to limit a patient’s access to the patient’s medical records.
(2) CERTIFICATION OF PERSONNEL.—The Secretary shall by
regulation—
(A) specify organizations eligible to certify individuals
to perform radiological procedures as required by paragraph (1)(C);
(B) specify boards eligible to certify physicians to interpret radiological procedures, including mammography,
as required by paragraph (1)(D);
(C) establish standards for a program to certify physicians described in paragraph (1)(D); and
(D) specify boards eligible to certify medical physicists
who are qualified to survey mammography equipment and
to oversee quality assurance practices at mammography
facilities.
(g) INSPECTIONS.—
(1) ANNUAL INSPECTIONS.—
(A) IN GENERAL.—The Secretary may enter and inspect facilities to determine compliance with the certification requirements under subsection (b) and the standards established under subsection (f). The Secretary shall,
if feasible, delegate to a State or local agency the authority
to make such inspections.
(B) IDENTIFICATION.—The Secretary, or State or local
agency acting on behalf of the Secretary, may conduct inspections only on presenting identification to the owner,
operator, or agent in charge of the facility to be inspected.
(C) SCOPE OF INSPECTION.—In conducting inspections,
the Secretary or State or local agency acting on behalf of
the Secretary—
(i) shall have access to all equipment, materials,
records, and information that the Secretary or State or
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local agency considers necessary to determine whether
the facility is being operated in accordance with this
section; and
(ii) may copy, or require the facility to submit to
the Secretary or the State or local agency, any of the
materials, records, or information.
(D) QUALIFICATIONS OF INSPECTORS.—Qualified individuals, as determined by the Secretary, shall conduct all
inspections. The Secretary may request that a State or
local agency acting on behalf of the Secretary designate a
qualified officer or employee to conduct the inspections, or
designate a qualified Federal officer or employee to conduct inspections. The Secretary shall establish minimum
qualifications and appropriate training for inspectors and
criteria for certification of inspectors in order to inspect facilities for compliance with subsection (f).
(E) FREQUENCY.—The Secretary or State or local agency acting on behalf of the Secretary shall conduct inspections under this paragraph of each facility not less often
than annually, subject to paragraph (6).
(F) RECORDS AND ANNUAL REPORTS.—The Secretary or
a State or local agency acting on behalf of the Secretary
which is responsible for inspecting mammography facilities
shall maintain records of annual inspections required
under this paragraph for a period as prescribed by the Secretary. Such a State or local agency shall annually prepare
and submit to the Secretary a report concerning the inspections carried out under this paragraph. Such reports
shall include a description of the facilities inspected and
the results of such inspections.
(2) INSPECTION OF ACCREDITED FACILITIES.—The Secretary
shall inspect annually a sufficient number of the facilities accredited by an accreditation body to provide the Secretary with
a reasonable estimate of the performance of such body.
(3) INSPECTION OF FACILITIES INSPECTED BY STATE OR
LOCAL AGENCIES.—The Secretary shall inspect annually facilities inspected by State or local agencies acting on behalf of the
Secretary to assure a reasonable performance by such State or
local agencies.
(4) TIMING.—The Secretary, or State or local agency, may
conduct inspections under paragraphs (1), (2), and (3), during
regular business hours or at a mutually agreeable time and
after providing such notice as the Secretary may prescribe, except that the Secretary may waive such requirements if the
continued performance of mammography at such facility
threatens the public health.
(5) LIMITED REINSPECTION.—Nothing in this section limits
the authority of the Secretary to conduct limited reinspections
of facilities found not to be in compliance with this section.
(6) DEMONSTRATION PROGRAM.—
(A) IN GENERAL.—The Secretary may establish a demonstration program under which inspections under paragraph (1) of selected facilities are conducted less frequently
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cies acting on behalf of the Secretary) than the interval
specified in subparagraph (E) of such paragraph.
(B) REQUIREMENTS.—Any demonstration program
under subparagraph (A) shall be carried out in accordance
with the following:
(i) The program may not be implemented before
April 1, 2001. Preparations for the program may be
carried out prior to such date.
(ii) In carrying out the program, the Secretary
may not select a facility for inclusion in the program
unless the facility is substantially free of incidents of
noncompliance with the standards under subsection
(f). The Secretary may at any time provide that a facility will no longer be included in the program.
(iii) The number of facilities selected for inclusion
in the program shall be sufficient to provide a statistically significant sample, subject to compliance with
clause (ii).
(iv) Facilities that are selected for inclusion in the
program shall be inspected at such intervals as the
Secretary determines will reasonably ensure that the
facilities are maintaining compliance with such standards.
(h) SANCTIONS.—
(1) IN GENERAL.—In order to promote voluntary compliance
with this section, the Secretary may, in lieu of taking the actions authorized by subsection (i), impose one or more of the
following sanctions:
(A) Directed plans of correction which afford a facility
an opportunity to correct violations in a timely manner.
(B) Payment for the cost of onsite monitoring.
(2) PATIENT INFORMATION.—If the Secretary determines
that the quality of mammography performed by a facility
(whether or not certified pursuant to subsection (c)) was so inconsistent with the quality standards established pursuant to
subsection (f) as to present a significant risk to individual or
public health, the Secretary may require such facility to notify
patients who received mammograms at such facility, and their
referring physicians, of the deficiencies presenting such risk,
the potential harm resulting, appropriate remedial measures,
and such other relevant information as the Secretary may require.
(3) CIVIL MONEY PENALTIES.—The Secretary may assess
civil money penalties in an amount not to exceed $10,000 for—
(A) failure to obtain a certificate as required by subsection (b),
(B) each failure by a facility to substantially comply
with, or each day on which a facility fails to substantially
comply with, the standards established under subsection
(f) or the requirements described in subclauses (I) through
(III) of subsection (d)(1)(B)(ii),
(C) each failure to notify a patient of risk as required
by the Secretary pursuant to paragraph (2), and
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(D) each violation, or for each aiding and abetting in
a violation of, any provision of, or regulation promulgated
under, this section by an owner, operator, or any employee
of a facility required to have a certificate.
(4) PROCEDURES.—The Secretary shall develop and implement procedures with respect to when and how each of the
sanctions is to be imposed under paragraphs (1) through (3).
Such procedures shall provide for notice to the owner or operator of the facility and a reasonable opportunity for the owner
or operator to respond to the proposed sanctions and appropriate procedures for appealing determinations relating to the
imposition of sanctions.
(i) SUSPENSION AND REVOCATION.—
(1) IN GENERAL.—The certificate of a facility issued under
subsection (c) may be suspended or revoked if the Secretary
finds, after providing, except as provided in paragraph (2), reasonable notice and an opportunity for a hearing to the owner
or operator of the facility, that the owner, operator, or any employee of the facility—
(A) has been guilty of misrepresentation in obtaining
the certificate;
(B) has failed to comply with the requirements of subsection (d)(1)(B)(ii)(III) or the standards established by the
Secretary under subsection (f);
(C) has failed to comply with reasonable requests of
the Secretary (or of an accreditation body approved pursuant to subsection (e)) for any record, information, report, or
material that the Secretary (or such accreditation body or
State carrying out certification program requirements pursuant to subsection (q)) concludes is necessary to determine the continued eligibility of the facility for a certificate
or continued compliance with the standards established
under subsection (f);
(D) has refused a reasonable request of the Secretary,
any Federal officer or employee duly designated by the
Secretary, or any State or local officer or employee duly
designated by the State or local agency, for permission to
inspect the facility or the operations and pertinent records
of the facility in accordance with subsection (g);
(E) has violated or aided and abetted in the violation
of any provision of, or regulation promulgated under, this
section; or
(F) has failed to comply with a sanction imposed under
subsection (h).
(2) ACTION BEFORE A HEARING.—
(A) IN GENERAL.—The Secretary may suspend the certificate of the facility before holding a hearing required by
paragraph (1) if the Secretary has reason to believe that
the circumstance of the case will support one or more of
the findings described in paragraph (1) and that—
(i) the failure or violation was intentional; or
(ii) the failure or violation presents a serious risk
to human health.
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(B) HEARING.—If the Secretary suspends a certificate
under subparagraph (A), the Secretary shall provide an opportunity for a hearing to the owner or operator of the facility not later than 60 days from the effective date of the
suspension. The suspension shall remain in effect until the
decision of the Secretary made after the hearing.
(3) INELIGIBILITY TO OWN OR OPERATE FACILITIES AFTER
REVOCATION.—If the Secretary revokes the certificate of a facility on the basis of an act described in paragraph (1), no person
who owned or operated the facility at the time of the act may,
within 2 years of the revocation of the certificate, own or operate a facility that requires a certificate under this section.
(j) INJUNCTIONS.—If the Secretary determines that—
(1) continuation of any activity related to the provision of
mammography by a facility would constitute a serious risk to
human health, the Secretary may bring suit in the district
court of the United States for the district in which the facility
is situated to enjoin continuation of the activity; and
(2) a facility is operating without a certificate as required
by subsection (b), the Secretary may bring suit in the district
court of the United States for the district in which the facility
is situated to enjoin the operation of the facility.
Upon a proper showing, the district court shall grant a temporary
injunction or restraining order against continuation of the activity
or against operation of a facility, as the case may be, without requiring the Secretary to post a bond, pending issuance of a final
order under this subsection.
(k) JUDICIAL REVIEW.—
(1) PETITION.—If the Secretary imposes a sanction on a facility under subsection (h) or suspends or revokes the certificate of a facility under subsection (i), the owner or operator of
the facility may, not later than 60 days after the date the action of the Secretary becomes final, file a petition with the
United States court of appeals for the circuit in which the facility is situated for judicial review of the action. As soon as practicable after receipt of the petition, the clerk of the court shall
transmit a copy of the petition to the Secretary or other officer
designated by the Secretary. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record
on which the action of the Secretary is based, as provided in
section 2112 of title 28, United States Code.
(2) ADDITIONAL EVIDENCE.—If the petitioner applies to the
court for leave to adduce additional evidence, and shows to the
satisfaction of the court that the additional evidence is material and that there were reasonable grounds for the failure to
adduce such evidence in the proceeding before the Secretary,
the court may order the additional evidence (and evidence in
rebuttal of the additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner
and upon such terms and conditions as the court may determine to be proper. The Secretary may modify the findings of
the Secretary as to the facts, or make new findings, by reason
of the additional evidence so taken, and the Secretary shall file
the modified or new findings, and the recommendations of the
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Secretary, if any, for the modification or setting aside of the
original action of the Secretary with the return of the additional evidence.
(3) JUDGMENT OF COURT.—Upon the filing of the petition
referred to in paragraph (1), the court shall have jurisdiction
to affirm the action, or to set the action aside in whole or in
part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence,
shall be conclusive.
(4) FINALITY OF JUDGMENT.—The judgment of the court affirming or setting aside, in whole or in part, any action of the
Secretary shall be final, subject to review by the Supreme
Court of the United States upon certiorari or certification, as
provided in section 1254 of title 28, United States Code.
(l) INFORMATION.—
(1) IN GENERAL.—Not later than October 1, 1996, and annually thereafter, the Secretary shall compile and make available to physicians and the general public information that the
Secretary determines is useful in evaluating the performance
of facilities, including a list of facilities—
(A) that have been convicted under Federal or State
laws relating to fraud and abuse, false billings, or kickbacks;
(B) that have been subject to sanctions under subsection (h), together with a statement of the reasons for
the sanctions;
(C) that have had certificates revoked or suspended
under subsection (i), together with a statement of the reasons for the revocation or suspension;
(D) against which the Secretary has taken action
under subsection (j), together with a statement of the reasons for the action;
(E) whose accreditation has been revoked, together
with a statement of the reasons of the revocation;
(F) against which a State has taken adverse action;
and
(G) that meets such other measures of performance as
the Secretary may develop.
(2) DATE.—The information to be compiled under paragraph (1) shall be information for the calendar year preceding
the date the information is to be made available to the public.
(3) EXPLANATORY INFORMATION.—The information to be
compiled under paragraph (1) shall be accompanied by such explanatory information as may be appropriate to assist in the
interpretation of the information compiled under such paragraph.
(m) STATE LAWS.—Nothing in this section shall be construed to
limit the authority of any State to enact and enforce laws relating
to the matters covered by this section that are at least as stringent
as this section or the regulations issued under this section.
(n) NATIONAL ADVISORY COMMITTEE.—
(1) ESTABLISHMENT.—In carrying out this section, the Secretary shall establish an advisory committee to be known as
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mittee (hereafter in this subsection referred to as the ‘‘Advisory
Committee’’).
(2) COMPOSITION.—The Advisory Committee shall be composed of not fewer than 13, nor more than 19 individuals, who
are not officers or employees of the Federal Government. The
Secretary shall make appointments to the Advisory Committee
from among—
(A) physicians,
(B) practitioners, and
(C) other health professionals,
whose clinical practice, research specialization, or professional
expertise include a significant focus on mammography. The
Secretary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography, at least 2 industry representatives
with expertise in mammography equipment, and at least 2
practicing physicians who provide mammography services.
(3) FUNCTIONS AND DUTIES.—The Advisory Committee
shall—
(A) advise the Secretary on appropriate quality standards and regulations for mammography facilities;
(B) advise the Secretary on appropriate standards and
regulations for accreditation bodies;
(C) advise the Secretary in the development of regulations with respect to sanctions;
(D) assist in developing procedures for monitoring
compliance with standards under subsection (f);
(E) make recommendations and assist in the establishment of a mechanism to investigate consumer complaints;
(F) report on new developments concerning breast imaging that should be considered in the oversight of mammography facilities;
(G) determine whether there exists a shortage of
mammography facilities in rural and health professional
shortage areas and determine the effects of personnel or
other requirements of subsection (f) on access to the services of such facilities in such areas;
(H) determine whether there will exist a sufficient
number of medical physicists after October 1, 1999, to assure compliance with the requirements of subsection
(f)(1)(E);
(I) determine the costs and benefits of compliance with
the requirements of this section (including the requirements of regulations promulgated under this section); and
(J) perform other activities that the Secretary may require.
The Advisory Committee shall report the findings made under
subparagraphs (G) and (I) to the Secretary and the Congress
no later than October 1, 1993.
(4) MEETINGS.—The Advisory Committee shall meet not
less than quarterly for the first 3 years of the program and
thereafter, at least annually.
(5) CHAIRPERSON.—The Secretary shall appoint a chairperson of the Advisory Committee.
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(o) CONSULTATIONS.—In carrying out this section, the Secretary shall consult with appropriate Federal agencies within the
Department of Health and Human Services for the purposes of developing standards, regulations, evaluations, and procedures for
compliance and oversight.
(p) BREAST CANCER SCREENING SURVEILLANCE RESEARCH
GRANTS.—
(1) RESEARCH.—
(A) GRANTS.—The Secretary shall award grants to
such entities as the Secretary may determine to be appropriate to establish surveillance systems in selected geographic areas to provide data to evaluate the functioning
and effectiveness of breast cancer screening programs in
the United States, including assessments of participation
rates in screening mammography, diagnostic procedures,
incidence of breast cancer, mode of detection (mammography screening or other methods), outcome and follow up
information, and such related epidemiologic analyses that
may improve early cancer detection and contribute to reduction in breast cancer mortality. Grants may be awarded
for further research on breast cancer surveillance systems
upon the Secretary’s review of the evaluation of the program.
(B) USE OF FUNDS.—Grants awarded under subparagraph (A) may be used—
(i) to study—
(I) methods to link mammography and clinical
breast examination records with population-based
cancer registry data;
(II) methods to provide diagnostic outcome
data, or facilitate the communication of diagnostic
outcome data, to radiology facilities for purposes
of evaluating patterns of mammography interpretation; and
(III) mechanisms for limiting access and
maintaining confidentiality of all stored data; and
(ii) to conduct pilot testing of the methods and
mechanisms described in subclauses (I), (II), and (III)
of clause (i) on a limited basis.
(C) GRANT APPLICATION.—To be eligible to receive
funds under this paragraph, an entity shall submit an application to the Secretary at such time, in such manner,
and containing such information as the Secretary may require.
(D) REPORT.—A recipient of a grant under this paragraph shall submit a report to the Secretary containing the
results of the study and testing conducted under clauses (i)
and (ii) of subparagraph (B), along with recommendations
for methods of establishing a breast cancer screening surveillance system.
(2) ESTABLISHMENT.—The Secretary shall establish a
breast cancer screening surveillance system based on the recommendations contained in the report described in paragraph
(1)(D).
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Sec. 354
PUBLIC HEALTH SERVICE ACT
400
(3) STANDARDS AND PROCEDURES.—The Secretary shall establish standards and procedures for the operation of the
breast cancer screening surveillance system, including procedures to maintain confidentiality of patient records.
(4) INFORMATION.—The Secretary shall recruit facilities to
provide to the breast cancer screening surveillance system relevant data that could help in the research of the causes, characteristics, and prevalence of, and potential treatments for,
breast cancer and benign breast conditions, if the information
may be disclosed under section 552 of title 5, United States
Code.
(q) STATE PROGRAM.—
(1) IN GENERAL.—The Secretary may, upon application, authorize a State—
(A) to carry out, subject to paragraph (2), the certification program requirements under subsections (b), (c), (d),
(g)(1), (h), (i), and (j) (including the requirements under
regulations promulgated pursuant to such subsections),
and
(B) to implement the standards established by the Secretary under subsection (f),
with respect to mammography facilities operating within the
State.
(2) APPROVAL.—The Secretary may approve an application
under paragraph (1) if the Secretary determines that—
(A) the State has enacted laws and issued regulations
relating to mammography facilities which are the requirements of this section (including the requirements under
regulations promulgated pursuant to such subsections),
and
(B) the State has provided satisfactory assurances that
the State—
(i) has the legal authority and qualified personnel
necessary to enforce the requirements of and the regulations promulgated pursuant to this section (including the requirements under regulations promulgated
pursuant to such subsections),
(ii) will devote adequate funds to the administration and enforcement of such requirements, and
(iii) will provide the Secretary with such information and reports as the Secretary may require.
(3) AUTHORITY OF SECRETARY.—In a State with an approved application—
(A) the Secretary shall carry out the Secretary’s functions under subsections (e) and (f);
(B) the Secretary may take action under subsections
(h), (i), and (j); and
(C) the Secretary shall conduct oversight functions
under subsections (g)(2) and (g)(3).
(4) WITHDRAWAL OF APPROVAL.—
(A) IN GENERAL.—The Secretary may, after providing
notice and opportunity for corrective action, withdraw the
approval of a State’s authority under paragraph (1) if the
Secretary determines that the State does not meet the reFebruary 1, 2024
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401
PUBLIC HEALTH SERVICE ACT
Sec. 361
quirements of such paragraph. The Secretary shall promulgate regulations for the implementation of this subparagraph.
(B) EFFECT OF WITHDRAWAL.—If the Secretary withdraws the approval of a State under subparagraph (A), the
certificate of any facility certified by the State shall continue in effect until the expiration of a reasonable period,
as determined by the Secretary, for such facility to obtain
certification by the Secretary.
(r) FUNDING.—
(1) FEES.—
(A) IN GENERAL.—The Secretary shall, in accordance
with this paragraph assess and collect fees from persons
described in subsection (d)(1)(A) (other than persons who
are governmental entities, as determined by the Secretary)
to cover the costs of inspections conducted under subsection (g)(1) by the Secretary or a State acting under a
delegation under subparagraph (A) of such subsection.
Fees may be assessed and collected under this paragraph
only in such manner as would result in an aggregate
amount of fees collected during any fiscal year which
equals the aggregate amount of costs for such fiscal year
for inspections of facilities of such persons under subsection (g)(1). A person’s liability for fees shall be reasonably based on the proportion of the inspection costs which
relate to such person.
(B) DEPOSIT AND APPROPRIATIONS.—
(i) DEPOSIT AND AVAILABILITY.—Fees collected
under subparagraph (A) shall be deposited as an offsetting collection to the appropriations for the Department of Health and Human Services as provided in
appropriation Acts and shall remain available without
fiscal year limitation.
(ii) APPROPRIATIONS.—Fees collected under subparagraph (A) shall be collected and available only to
the extent provided in advance in appropriation Acts.
(2) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section—
(A) to award research grants under subsection (p),
such sums as may be necessary for each of the fiscal years
1993 through 2007; and
(B) for the Secretary to carry out other activities
which are not supported by fees authorized and collected
under paragraph (1), such sums as may be necessary for
fiscal years 1993 through 2007.
PART G—QUARANTINE
AND INSPECTION
CONTROL OF COMMUNICABLE DISEASES
SEC. 361. ø264¿ (a) The Surgeon General, with the approval of
the Secretary is authorized to make and enforce such regulations
as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries
into the States or possessions, or from one State or possession into
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Sec. 362
PUBLIC HEALTH SERVICE ACT
402
any other State or possession. For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such
inspection, fumigation, disinfection, sanitation, pest extermination,
destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings,
and other measures, as in his judgment may be necessary.
(b) Regulations prescribed under this section shall not provide
for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon
the recommendation of the Secretary, in consultation with the Surgeon General, 72.
(c) Except as provided in subsection (d), regulations prescribed
under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be
applicable only to individuals coming into a State or possession
from a foreign country or a possession.
(d)(1) Regulations prescribed under this section may provide
for the apprehension and examination of any individual reasonably
believed to be infected with a communicable disease in a qualifying
stage and (A) to be moving or about to move from a State to another State; or (B) to be a probable source of infection to individuals who, while infected with such disease in a qualifying stage,
will be moving from a State to another State. Such regulations may
provide that if upon examination any such individual is found to
be infected, he may be detained for such time and in such manner
as may be reasonably necessary. For purposes of this subsection,
the term ‘‘State’’ includes, in addition to the several States, only
the District of Columbia.
(2) For purposes of this subsection, the term ‘‘qualifying stage’’,
with respect to a communicable disease, means that such disease—
(A) is in a communicable stage; or
(B) is in a precommunicable stage, if the disease would be
likely to cause a public health emergency if transmitted to
other individuals.
(e) Nothing in this section or section 363, or the regulations
promulgated under such sections, may be construed as superseding
any provision under State law (including regulations and including
provisions established by political subdivisions of States), except to
the extent that such a provision conflicts with an exercise of Federal authority under this section or section 363.
SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
SEC. 362. ø265¿ Whenever the Surgeon General determines
that by reason of the existence of any communicable disease in a
foreign country there is serious danger of the introduction of such
disease into the United States, and that this danger is so increased
by the introduction of persons or property from such country that
a suspension of the right to introduce such persons and property
is required in the interest of the public health, the Surgeon Gen72 The comma is so in law. See the amendment made by section 142(a)(1) of Public Law 107–
188 (116 Stat. 626).
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403
PUBLIC HEALTH SERVICE ACT
Sec. 364
eral, in accordance with regulations approved by the President,
shall have the power to prohibit, in whole or in part, the introduction of persons and property from such countries or places as he
shall designate in order to avert such danger, and for such period
of time as he may deem necessary for such purpose.
SPECIAL POWERS IN TIME OF WAR
SEC. 363. 73
ø266¿ To protect the military and naval forces and
war workers of the United States, in time of war, against any communicable disease specified in Executive orders as provided in subsection (b) of section 361, the Secretary, in consultation with the
Surgeon General, is authorized to provide by regulations for the apprehension and examination, in time of war, of any individual reasonably believed (1) to be infected with such disease and (2) to be
a probable source of infection to members of the armed forces of the
United States or to individuals engaged in the production or transportation of arms, munitions, ships, food, clothing, or other supplies
for the armed forces. Such regulations may provide that if upon examination any such individual is found to be so infected, he may
be detained for such time and in such manner as may be reasonably necessary.
QUARANTINE STATIONS
SEC. 364. ø267¿ (a) Except as provided in title II of the Act of
June 15, 1917, as amended (U.S.C., 1940 edition, title 50, secs.
191–194), 74 the Surgeon General shall control, direct, and manage
all United States quarantine stations, grounds, and anchorages,
designate their boundaries, and designate the quarantine officers
to be in charge thereof. With the approval of the President he shall
from time to time select suitable sites for and establish such additional stations, grounds, and anchorages in the States and possessions of the United States as in his judgment are necessary to prevent the introduction of communicable diseases into the States and
possessions of the United States.
(b) The Surgeon General shall establish the hours during
which quarantine service shall be performed at each quarantine
station, and, upon application by any interested party, may establish quarantine inspection during the twenty-four hours of the day,
or any fraction thereof, at such quarantine stations as, in his opinion, require such extended service. He may restrict the performance of quarantine inspection to hours of daylight for such arriving
vessels as cannot, in his opinion, be satisfactorily inspected during
hours of darkness. No vessel shall be required to undergo quarantine inspection during the hours of darkness, unless the quarantine officer at such quarantine station shall deem an immediate
inspection necessary to protect the public health. Uniformity shall
not be required in the hours during which quarantine inspection
may be obtained at the various ports of the United States.
73 Under section 3 of Public Law 239, 80th Congress, the date of July 25, 1947, is deemed,
for purposes of this section, to be the date of termination of ‘‘any state of war heretofore declared
by the Congress’’.
74 Now codified to sections 191, 192, 194, and 195 of title 50, United States Code.
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Sec. 364
PUBLIC HEALTH SERVICE ACT
404
(c) The Surgeon General shall fix a reasonable rate of extra
compensation for overtime services of employees of the United
States Public Health Service, Foreign Quarantine Division, performing overtime duties including the operation of vessels, in connection with the inspection or quarantine treatment of persons
(passengers and crews), conveyances, or goods arriving by land,
water, or air in the United States or any place subject to the jurisdiction thereof, hereinafter referred to as ‘‘employees of the Public
Health Service’’, when required to be on duty between the hours of
6 o’clock postmeridian and 6 o’clock antemeridian (or between the
hours of 7 o’clock postmeridian and 7 o’clock antemeridian at stations which have a declared workday of from 7 o’clock antemeridian
to 7 o’clock postmeridian), or on Sundays or holidays, such rate, in
lieu of compensation under any other provision of law, to be fixed
at two times the basic hourly rate for each hour that the overtime
extends beyond 6 o’clock (or 7 o’clock as the case may be)
postmeridian, and two times the basic hourly rate for each overtime hour worked on Sundays or holidays. As used in this subsection, the term ‘‘basic hourly rate’’ shall mean the regular basic
rate of pay which is applicable to such employees for work performed within their regular scheduled tour of duty.
(d)(1) The said extra compensation shall be paid to the United
States by the owner, agent, consignee, operator, or master or other
person in charge of any conveyance, for whom, at his request, services as described in this subsection (hereinafter referred to as overtime service) are performed. If such employees have been ordered
to report for duty and have so reported, and the requested services
are not performed by reason of circumstances beyond the control of
the employees concerned, such extra compensation shall be paid on
the same basis as though the overtime services had actually been
performed during the period between the time the employees were
ordered to report for duty and did so report, and the time they
were notified that their services would not be required, and in any
case as though their services had continued for not less than one
hour. The Surgeon General with the approval of the Secretary of
Health, Education, and Welfare may prescribe regulations requiring the owner, agent, consignee, operator, or master or other person for whom the overtime services are performed to file a bond in
such amounts and containing such conditions and with such sureties, or in lieu of a bond, to deposit money or obligations of the
United States in such amount, as will assure the payment of
charges under this subsection, which bond or deposit may cover one
or more transactions or all transactions during a specified period:
Provided, That no charges shall be made for services performed in
connection with the inspection of (1) persons arriving by international highways, ferries, bridges, or tunnels, or the conveyances
in which they arrive, or (2) persons arriving by aircraft or railroad
trains, the operations of which are covered by published schedules,
or the aircraft or trains in which they arrive, or (3) persons arriving by vessels operated between Canadian ports and ports on Puget
Sound or operated on the Great Lakes and connecting waterways,
the operations of which are covered by published schedules, or the
vessels in which they arrive.
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405
PUBLIC HEALTH SERVICE ACT
Sec. 366
(2) Moneys collected under this subsection shall be deposited in
the Treasury of the United States to the credit of the appropriation
charged with the expense of the services, and the appropriations so
credited shall be available for the payment of such compensation
to the said employees for services so rendered.
CERTAIN DUTIES OF CONSULAR AND OTHER OFFICERS
SEC. 365. ø268¿ (a) Any consular or medical officer of the
United States, designated for such purpose by the Secretary, shall
make reports to the Surgeon General, on such forms and at such
intervals as the Surgeon General may prescribe, of the health conditions at the port or place at which such officer is stationed.
(b) It shall be the duty of the customs officers and of Coast
Guard officers to aid in the enforcement of quarantine rules and
regulations; but no additional compensation, except actual and necessary traveling expenses, shall be allowed any such officer by reason of such services.
BILLS OF HEALTH
SEC. 366. ø269¿ (a) Except as otherwise prescribed in regulations, any vessel at any foreign port or place clearing or departing
for any port or place in a State or possession shall be required to
obtain from the consular officer of the United States or from the
Public Health Service officer, or other medical officer of the United
States designated by the Surgeon General, at the port or place of
departure, a bill of health in duplicate, in the form prescribed by
the Surgeon General. The President, from time to time, shall specify the ports at which a medical officer shall be stationed for this
purpose. Such bill of health shall set forth the sanitary history and
condition of said vessel, and shall state that it has in all respects
complied with the regulations prescribed pursuant to subsection (c).
Before granting such duplicate bill of health, such consular or medical officer shall be satisfied that the matters and things therein
stated are true. The consular officer shall be entitled to demand
and receive the fees for bills of health and such fees shall be established by regulation.
(b) Original bills of health shall be delivered to the collectors
of customs at the port of entry. Duplicate copies of such bills of
health shall be delivered at the time of inspection to quarantine officers at such port. The bills of health herein prescribed shall be
considered as part of the ship’s papers, and when duly certified to
by the proper consular or other officer of the United States, over
his official signature and seal, shall be accepted as evidence of the
statements therein contained in any court of the United States.
(c) The Surgeon General shall from time to time prescribe regulations, applicable to vessels referred to in subsection (a) of this
section for the purpose of preventing the introduction into the
States or possessions of the United States of any communicable disease by securing the best sanitary condition of such vessels, their
cargoes, passengers, and crews. Such regulations shall be observed
by such vessels prior to departure, during the course of the voyage,
and also during inspection, disinfection, or other quarantine procedure upon arrival at any United States quarantine station.
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Sec. 367
PUBLIC HEALTH SERVICE ACT
406
(d) The provisions of subsections (a) and (b) of this section shall
not apply to vessels plying between such foreign ports on or near
the frontiers of the United States and ports of the United States
as are designated by treaty.
(e) It shall be unlawful for any vessel to enter any port in any
State or possession of the United States to discharge its cargo, or
land its passengers, except upon a certificate of the quarantine officer that regulations prescribed under subsection (c) have in all respects been complied with by such officer, the vessel, and its master. The master of every such vessel shall deliver such certificate
to the collector of customs at the port of entry, together with the
original bill of health and other papers of the vessel. The certificate
required by this subsection shall be procurable from the quarantine
officer, upon arrival of the vessel at the quarantine station and satisfactory inspection thereof, at any time within which quarantine
services are performed at such station.
CIVIL AIR NAVIGATION AND CIVIL AIRCRAFT
SEC. 367. ø270¿ The Surgeon General is authorized to provide
by regulations for the application to air navigation and aircraft of
any of the provisions of sections 364, 365, and 366 and regulations
prescribed thereunder (including penalties and forfeitures for violations of such sections and regulations), to such extent and upon
such conditions as he deems necessary for the safeguarding of the
public health.
PENALTIES
SEC. 368. ø271¿ (a) Any person who violates any regulation
prescribed under section 361, 362, or 363, or any provision of section 366 or any regulation prescribed thereunder, or who enters or
departs from the limits of any quarantine station, ground, or anchorage in disregard of quarantine rules and regulations or without
permission of the quarantine officer in charge, shall be punished by
a fine of not more than $1,000 or by imprisonment for not more
than one year, or both.
(b) Any vessel which violates section 366, or any regulations
thereunder or under section 364, or which enters within or departs
from the limits of any quarantine station, ground, or anchorage in
disregard of the quarantine rules and regulations or without permission of the officer in charge, shall forfeit to the United States
not more than $5,000, the amount to be determined by the court,
which shall be a lien on such vessel, to be recovered by proceedings
in the proper district court of the United States. In all such proceedings the United States attorney shall appear on behalf of the
United States; and all such proceedings shall be conducted in accordance with the rules and laws governing cases of seizure of vessels for violation of the revenue laws of the United States.
(c) With the approval of the Secretary, the Surgeon General
may, upon application therefor, remit or mitigate any forfeiture
provided for under subsection (b) of this section, and he shall have
authority to ascertain the facts upon all such applications.
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407
PUBLIC HEALTH SERVICE ACT
Sec. 371
ADMINISTRATION OF OATHS
SEC. 369. ø272¿ Medical officers of the United States, when
performing duties as quarantine officers at any port or place within
the United States, are authorized to take declarations and administer oaths in matters pertaining to the administration of the quarantine laws and regulations of the United States.
PART H—ORGAN TRANSPLANTS 75
ORGAN PROCUREMENT ORGANIZATIONS
SEC. 371. ø273¿ (a)(1) The Secretary may make grants for the
planning of qualified organ procurement organizations described in
subsection (b).
(2) The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b).
(b)(1) 76 A qualified organ procurement organization for which
grants may be made under subsection (a) is an organization which,
as determined by the Secretary, will carry out the functions described in paragraph (2) 77 and—
(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as specified
by the Secretary) necessary to assure the fiscal stability of the
organization,
(C) has an agreement with the Secretary to be reimbursed
under title XVIII of the Social Security Act for the procurement
of kidneys,
(D) notwithstanding any other provision of law, has met
the other requirements of this section and has been certified or
recertified by the Secretary within the previous 4-year period
as meeting the performance standards to be a qualified organ
procurement organization through a process that either—
(i) granted certification or recertification within such
4-year period with such certification or recertification in effect as of January 1, 2000, and remaining in effect through
the earlier of—
(I) January 1, 2002; or
(II) the completion of recertification under the requirements of clause (ii); or
75 See section 301 of the National Organ Transplant Act (Public Law 98-507; 42 U.S.C. 274e)
for the prohibition against acquiring, receiving, or transferring a human organ for valuable consideration for use in human transplantation.
76 So in law. Subparagraphs (D) and (E) have the same text, and there are two subparagraphs
(H). This results from the same set of amendments to section 371(b)(1) being enacted twice. The
first set of amendments was made by section 701(c) of Public Law 106–505 (114 Stat. 2347).
These amendments redesignated subparagraphs (D) through (G) as subparagraphs (E) through
(H), respectively, and then added a new subparagraph (D). The second set was made by section
219(b) of the Departments of Labor, Health and Human Services, and Education, and Related
Agencies Appropriations Act, 2001 (as enacted into law by section 1(a)(1) of Public Law 106–
554; 114 Stat. 2763A–29). Per the second set of amendments, the subparagraph (D) added by
the first set was redesignated as (E), and the same text was again added as a subparagraph
(D). Per the second set, subparagraphs (F) and (G), as redesignated by the first set, were redesignated as (G) and (H), which resulted in there being two subparagraphs (H).
77 So in law. Probably should be ‘‘paragraph (3)’’.
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Sec. 371
PUBLIC HEALTH SERVICE ACT
408
(ii) is defined through regulations that are promulgated by the Secretary by not later than January 1, 2002,
that—
(I) require recertifications of qualified organ procurement organizations not more frequently than once
every 4 years;
(II) rely on outcome and process performance
measures that are based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area
of qualified organ procurement organizations;
(III) use multiple outcome measures as part of the
certification process; and
(IV) provide for a qualified organ procurement organization to appeal a decertification to the Secretary
on substantive and procedural grounds;
(E) has procedures to obtain payment for non-renal organs
provided to transplant centers,
(F) has a defined service area that is of sufficient size to
assure maximum effectiveness in the procurement and equitable distribution of organs, and that either includes an entire
metropolitan statistical area (as specified by the Director of the
Office of Management and Budget) or does not include any
part of the area,
(G) has a director and such other staff, including the organ
donation coordinators and organ procurement specialists necessary to effectively obtain organs from donors in its service
area, and
(H) has a board of directors or an advisory board which—
(i) is composed of—
(I) members who represent hospital administrators, intensive care or emergency room personnel, tissue banks, and voluntary health associations in its
service area,
(II) members who represent the public residing in
such area,
(III) a physician with knowledge, experience, or
skill in the field of histocompatibility or an individual
with a doctorate degree in a biological science with
knowledge, experience, or skill in the field of
histocompatibility,
(IV) a physician with knowledge or skill in the
field of neurology, and
(V) from each transplant center in its service area
which has arrangements described in paragraph (3)(G)
with the organization, a member who is a surgeon who
has practicing privileges in such center and who performs organ transplant surgery,
(ii) has the authority to recommend policies for the
procurement of organs and the other functions described in
paragraph (3), and
(iii) has no authority over any other activity of the organization.
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409
PUBLIC HEALTH SERVICE ACT
Sec. 371A
(2)(A) Not later than 90 days after the date of the enactment
of this paragraph, 78 the Secretary shall publish in the Federal Register a notice of proposed rulemaking to establish criteria for determining whether an entity meets the requirement established in
paragraph (1)(E).
(B) Not later than 1 year after the date of enactment of this
paragraph, 78 the Secretary shall publish in the Federal Register a
final rule to establish the criteria described in subparagraph (A).
(3) An organ procurement organization shall—
(A) have effective agreements, to identify potential organ
donors, with a substantial majority of the hospitals and other
health care entities in its service area which have facilities for
organ donations,
(B) conduct and participate in systematic efforts, including
professional education, to acquire all usable organs from potential donors,
(C) arrange for the acquisition and preservation of donated
organs and provide quality standards for the acquisition of organs which are consistent with the standards adopted by the
Organ Procurement and Transplantation Network under section 372(b)(2)(E), including arranging for testing with respect
to identifying organs that are infected with human immunodeficiency virus (HIV),
(D) arrange for the appropriate tissue typing of donated organs,
(E) have a system to allocate donated organs equitably
among transplant patients according to established medical criteria,
(F) provide or arrange for the transportation of donated organs to transplant centers,
(G) have arrangements to coordinate its activities with
transplant centers in its service area,
(H) participate in the Organ Procurement Transplantation
Network established under section 372,
(I) have arrangements to cooperate with tissue banks for
the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all usable
tissues are obtained from potential donors,
(J) evaluate annually the effectiveness of the organization
in acquiring potentially available organs, and
(K) assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by
potential donors.
(c) Pancreata procured by an organ procurement organization
and used for islet cell transplantation or research shall be counted
for purposes of certification or recertification under subsection (b).
SEC. 371A. ø273a¿ NATIONAL LIVING DONOR MECHANISMS.
The Secretary may establish and maintain mechanisms to
evaluate the long-term effects associated with living organ donations by individuals who have served as living donors.
78 Enacted
November 16, 1990. See section 201(d) of Public Law 101–616.
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Sec. 372
PUBLIC HEALTH SERVICE ACT
410
ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
SEC. 372. ø274¿ (a) IN GENERAL—The Secretary shall provide
for the continued operation of an Organ Procurement and Transplantation Network which meets the requirements of subsection
(b). The Secretary may award grants, contracts, or cooperative
agreements, as the Secretary determines appropriate, for purposes
of carrying out this section.
(b) COMPOSITION.—
(1) IN GENERAL.—The Organ Procurement and Transplantation Network shall—
(A) be operated through awards to public or private
entities made by the Secretary that are distinct from the
awards made to support the organization tasked with supporting the board of directors described in subparagraph
(B); and
(B) 79 have a board of directors—
(i) that includes representatives of organ procurement
organizations (including organizations that have received
grants under section 371), transplant centers, voluntary
health associations, and the general public; and
(ii) that shall establish an executive committee and
other committees, whose chairpersons shall be selected to
ensure continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network
shall—
(A) establish in one location or through regional centers—
(i) a national list of individuals who need organs, and
(ii) a national system, through the use of computers
and in accordance with established medical criteria, to
match organs and individuals included in the list, especially individuals whose immune system makes it difficult
for them to receive organs,
(B) establish membership criteria and medical criteria for
allocating organs and provide to members of the public an opportunity to comment with respect to such criteria,
(C) maintain a twenty-four-hour telephone service to facilitate matching organs with individuals included in the list,
(D) assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients,
(E) adopt and use standards of quality for the acquisition
and transportation of donated organs,
(F) prepare and distribute, on a regionalized basis (and, to
the extent practicable, among regions or on a national basis),
samples of blood sera from individuals who are included on the
list and whose immune system makes it difficult for them to
receive organs, in order to facilitate matching the compatibility
of such individuals with organ donors,
(G) coordinate, as appropriate, the transportation of organs
from organ procurement organizations to transplant centers,
79 The margin of subparagraph (B) of section 372(b)(1) is so in law. Should be moved to the
right to align with subparagraph (A) (as so amended by section 2(2) of Public Law 118–14).
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(H) provide information to physicians and other health
professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donation and transplants,
(J) carry out studies and demonstration projects for the
purpose of improving procedures for organ procurement and allocation,
(K) work actively to increase the supply of donated organs,
(L) submit to the Secretary an annual report containing information on the comparative costs and patient outcomes at
each transplant center affiliated with the organ procurement
and transplantation network,
(M) 80 recognize the differences in health and in organ
transplantation issues between children and adults
throughout the system and adopt criteria, polices, and procedures that address the unique health care needs of children,
(N) 80 carry out studies and demonstration projects for
the purpose of improving procedures for organ donation
procurement and allocation, including but not limited to
projects to examine and attempt to increase transplantation among populations with special needs, including
children and individuals who are members of racial or ethnic minority groups, and among populations with limited
access to transportation, and
(O) 80 provide that for purposes of this paragraph, the
term ‘‘children’’ refers to individuals who are under the age
of 18.
(3) CLARIFICATION.—In adopting and using standards of
quality under paragraph (2)(E), the Organ Procurement and
Transplantation Network may adopt and use such standards
with respect to organs infected with human immunodeficiency
virus (in this paragraph referred to as ‘‘HIV’’), provided that
any such standards ensure that organs infected with HIV may
be transplanted only into individuals who—
(A) are infected with HIV before receiving such organ;
and
(B)(i) are participating in clinical research approved by
an institutional review board under the criteria, standards,
and regulations described in subsections (a) and (b) of section 377E; or
(ii) if the Secretary has determined under section
377E(c) that participation in such clinical research, as a
requirement for such transplants, is no longer warranted,
are receiving a transplant under the standards and regulations under section 377E(c).
(c) The Secretary shall establish procedures for—
(1) receiving from interested persons critical comments relating to the manner in which the Organ Procurement and
Transplantation Network is carrying out the duties of the Network under subsection (b); and
80 Indentation
is so in law. See section 2101(a)(3) of Public Law 106–310 (114 Stat. 1156).
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Sec. 373
PUBLIC HEALTH SERVICE ACT
412
(2) the consideration by the Secretary of such critical comments.
SCIENTIFIC REGISTRY
SEC. 373. ø274a¿ The Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ
transplants. The registry shall include such information respecting
patients and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status
of organ transplantation. The Secretary shall prepare for inclusion
in the report under section 376 an analysis of information derived
from the registry.
GENERAL PROVISIONS RESPECTING GRANTS AND CONTRACTS
SEC. 374. ø274b¿ (a) No grant may be made under this part
or contract entered into under section 372 or 373 unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall by regulation prescribe.
(b)(1) A grant for planning under section 371(a)(1) may be
made for one year with respect to any organ procurement organization and may not exceed $100,000.
(2) Grants under section 371(a)(2) may be made for two years.
No such grant may exceed $500,000 for any year and no organ procurement organization may receive more than $800,000 for initial
operation or expansion.
(3) Grants or contracts under section 371(a)(3) may be made
for not more than 3 years.
(c)(1) The Secretary shall determine the amount of a grant or
contract made under section 371 or 373. Payments under such
grants and contracts may be made in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments
on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants and contracts.
(2)(A) Each recipient of a grant or contract under section 371,
372, or 373 shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant or contract,
the total cost of the undertaking in connection with which such
grant or contract was made, and the amount of that portion of the
cost of the undertaking supplied by other sources, and such other
records as will facilitate an effective audit.
(B) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall have
access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant or contract
under section 371, 372, or 373 that are pertinent to such grant or
contract.
(d) For purposes of this part:
(1) The term ‘‘transplant center’’ means a health care facility in which transplants of organs are performed.
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413
PUBLIC HEALTH SERVICE ACT
Sec. 377
(2) The term ‘‘organ’’ means the human kidney, liver,
heart, lung, pancreas, and any other human organ (other than
corneas and eyes) specified by the Secretary by regulation and
for purposes of section 373, such term includes bone marrow.
ADMINISTRATION
SEC. 375. ø274c¿ The Secretary shall designate and maintain
an identifiable administrative unit in the Public Health Service
to—
(1) administer this part and coordinate with the organ procurement activities under title XVIII of the Social Security Act;
(2) conduct a program of public information to inform the
public of the need for organ donations;
(3) provide technical assistance to organ procurement organizations, the Organ Procurement and Transplantation Network established under section 372, and other entities in the
health care system involved in organ donations, procurement,
and transplants; and
(4) provide information—
(A) to patients, their families, and their physicians
about transplantation; and
(B) to patients and their families about the resources
available nationally and in each State, and the comparative costs and patient outcomes at each transplant center
affiliated with the organ procurement and transplantation
network, in order to assist the patients and families with
the costs associated with transplantation.
REPORT
SEC. 376. ø274d¿ Not later than 2 years after the date of enactment of the Securing the U.S. Organ Procurement and Transplantation Network Act and every second year thereafter, the Secretary shall publish, and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate, a report on
the scientific and clinical status of organ transplantation. The Secretary shall consult with the Director of the National Institutes of
Health and the Commissioner of the Food and Drug Administration
in the preparation of the report.
SEC. 377. ø274f¿ REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES INCURRED TOWARD LIVING ORGAN DONATION.
(a) IN GENERAL.—The Secretary may award grants to States,
transplant centers, qualified organ procurement organizations
under section 371, or other public or private entities for the purpose of—
(1) providing for the reimbursement of travel and subsistence expenses incurred by individuals toward making living
donations of their organs (in this section referred to as ‘‘donating individuals’’); and
(2) providing for the reimbursement of such incidental nonmedical expenses that are so incurred as the Secretary determines by regulation to be appropriate.
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Sec. 377A
PUBLIC HEALTH SERVICE ACT
414
(b) PREFERENCE.—The Secretary shall, in carrying out subsection (a), give preference to those individuals that the Secretary
determines are more likely to be otherwise unable to meet such expenses.
(c) CERTAIN CIRCUMSTANCES.—The Secretary may, in carrying
out subsection (a), consider—
(1) the term ‘‘donating individuals’’ as including individuals who in good faith incur qualifying expenses toward the intended donation of an organ but with respect to whom, for such
reasons as the Secretary determines to be appropriate, no donation of the organ occurs; and
(2) the term ‘‘qualifying expenses’’ as including the expenses of having relatives or other individuals, not to exceed
2, accompany or assist the donating individual for purposes of
subsection (a) (subject to making payment for only those types
of expenses that are paid for a donating individual).
(d) RELATIONSHIP TO PAYMENTS UNDER OTHER PROGRAMS.—An
award may be made under subsection (a) only if the applicant involved agrees that the award will not be expended to pay the qualifying expenses of a donating individual to the extent that payment
has been made, or can reasonably be expected to be made, with respect to such expenses—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits
program;
(2) by an entity that provides health services on a prepaid
basis; or
(3) by the recipient of the organ.
(e) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘donating individuals’’ has the meaning indicated for such term in subsection (a)(1), subject to subsection
(c)(1).
(2) The term ‘‘qualifying expenses’’ means the expenses authorized for purposes of subsection (a), subject to subsection
(c)(2).
(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there is authorized to be appropriated
$5,000,000 for each of the fiscal years 2005 through 2009.
SEC. 377A. ø274f–1¿ PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.
(a) ORGAN DONATION PUBLIC AWARENESS PROGRAM.—The Sec-
retary shall, directly or through grants or contracts, establish a
public education program in cooperation with existing national
public awareness campaigns to increase awareness about organ donation and the need to provide for an adequate rate of such donations.
(b) STUDIES AND DEMONSTRATIONS.—The Secretary may make
peer-reviewed grants to, or enter into peer-reviewed contracts with,
public and nonprofit private entities for the purpose of carrying out
studies and demonstration projects to increase organ donation and
recovery rates, including living donation.
(c) GRANTS TO STATES.—
(1) IN GENERAL.—The Secretary may make grants to
States for the purpose of assisting States in carrying out organ
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Sec. 377B
donor awareness, public education, and outreach activities and
programs designed to increase the number of organ donors
within the State, including living donors.
(2) ELIGIBILITY.—To be eligible to receive a grant under
this subsection, a State shall—
(A) submit an application to the Department in the
form prescribed;
(B) establish yearly benchmarks for improvement in
organ donation rates in the State; and
(C) report to the Secretary on an annual basis a description and assessment of the State’s use of funds received under this subsection, accompanied by an assessment of initiatives for potential replication in other States.
(3) USE OF FUNDS.—Funds received under this subsection
may be used by the State, or in partnership with other public
agencies or private sector institutions, for education and
awareness efforts, information dissemination, activities pertaining to the State donor registry, and other innovative donation specific initiatives, including living donation.
(d) EDUCATIONAL ACTIVITIES.—The Secretary, in coordination
with the Organ Procurement and Transplantation Network and
other appropriate organizations, shall support the development and
dissemination of educational materials to inform health care professionals and other appropriate professionals in issues surrounding organ, tissue, and eye donation including evidence-based
proven methods to approach patients and their families, cultural
sensitivities, and other relevant issues.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$15,000,000 for fiscal year 2005, and such sums as may be necessary for each of the fiscal years 2006 through 2009. Such authorization of appropriations is in addition to any other authorizations
of appropriations that are available for such purpose.
SEC. 377B. ø274f–2¿ GRANTS REGARDING HOSPITAL ORGAN DONATION
COORDINATORS.
(a) AUTHORITY.—
(1) IN GENERAL.—The Secretary may award grants to
qualified organ procurement organizations and hospitals under
section 371 to establish programs coordinating organ donation
activities of eligible hospitals and qualified organ procurement
organizations under section 371. Such activities shall be coordinated to increase the rate of organ donations for such hospitals.
(2) ELIGIBLE HOSPITAL.—For purposes of this section, the
term ‘‘eligible hospital’’ means a hospital that performs significant trauma care, or a hospital or consortium of hospitals that
serves a population base of not fewer than 200,000 individuals.
(b) ADMINISTRATION OF COORDINATION PROGRAM.—A condition
for the receipt of a grant under subsection (a) is that the applicant
involved agree that the program under such subsection will be carried out jointly—
(1) by representatives from the eligible hospital and the
qualified organ procurement organization with respect to
which the grant is made; and
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Sec. 377C
PUBLIC HEALTH SERVICE ACT
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(2) by such other entities as the representatives referred to
in paragraph (1) may designate.
(c) REQUIREMENTS.—Each entity receiving a grant under subsection (a) shall—
(1) establish joint organ procurement organization and
hospital designated leadership responsibility and accountability for the project;
(2) develop mutually agreed upon overall project performance goals and outcome measures, including interim outcome
targets; and
(3) collaboratively design and implement an appropriate
data collection process to provide ongoing feedback to hospital
and organ procurement organization leadership on project
progress and results.
(d) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed to interfere with regulations in force on the date of enactment of the Organ Donation and Recovery Improvement Act.
(e) EVALUATIONS.—Within 3 years after the award of grants
under this section, the Secretary shall ensure an evaluation of programs carried out pursuant to subsection (a) in order to determine
the extent to which the programs have increased the rate of organ
donation for the eligible hospitals involved.
(f) MATCHING REQUIREMENT.—The Secretary may not award a
grant to a qualifying organ donation entity under this section unless such entity agrees that, with respect to costs to be incurred by
the entity in carrying out activities for which the grant was awarded, the entity shall contribute (directly or through donations from
public or private entities) non-Federal contributions in cash or in
kind, in an amount equal to not less than 30 percent of the amount
of the grant awarded to such entity.
(g) FUNDING.—For the purpose of carrying out this section,
there are authorized to be appropriated $3,000,000 for fiscal year
2005, and such sums as may be necessary for each of fiscal years
2006 through 2009.
SEC. 377C. ø274f–3¿ STUDIES RELATING TO ORGAN DONATION AND
THE RECOVERY, PRESERVATION, AND TRANSPORTATION
OF ORGANS.
(a) DEVELOPMENT OF SUPPORTIVE INFORMATION.—The Sec-
retary, acting through the Director of the Agency for Healthcare
Research and Quality, shall develop scientific evidence in support
of efforts to increase organ donation and improve the recovery,
preservation, and transportation of organs.
(b) ACTIVITIES.—In carrying out subsection (a), the Secretary
shall—
(1) conduct or support evaluation research to determine
whether interventions, technologies, or other activities improve
the effectiveness, efficiency, or quality of existing organ donation practice;
(2) undertake or support periodic reviews of the scientific
literature to assist efforts of professional societies to ensure
that the clinical practice guidelines that they develop reflect
the latest scientific findings;
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PUBLIC HEALTH SERVICE ACT
Sec. 377D
(3) ensure that scientific evidence of the research and
other activities undertaken under this section is readily accessible by the organ procurement workforce; and
(4) work in coordination with the appropriate professional
societies as well as the Organ Procurement and Transplantation Network and other organ procurement and transplantation organizations to develop evidence and promote the adoption of such proven practices.
(c) RESEARCH AND DISSEMINATION.—The Secretary, acting
through the Director of the Agency for Healthcare Research and
Quality, as appropriate, shall provide support for research and dissemination of findings, to—
(1) develop a uniform clinical vocabulary for organ recovery;
(2) apply information technology and telecommunications
to support the clinical operations of organ procurement organizations;
(3) enhance the skill levels of the organ procurement workforce in undertaking quality improvement activities; and
(4) assess specific organ recovery, preservation, and transportation technologies.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$2,000,000 for fiscal year 2005, and such sums as may be necessary
for each of fiscal years 2006 through 2009.
SEC. 377D. ø274f–4¿ REPORT RELATING TO ORGAN DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
(a) IN GENERAL.—Not later than December 31, 2005, and every
2 years thereafter, the Secretary shall report to the appropriate
committees of Congress on the activities of the Department carried
out pursuant to this part, including an evaluation describing the
extent to which the activities have affected the rate of organ donation and recovery.
(b) REQUIREMENTS.—To the extent practicable, each report submitted under subsection (a) shall—
(1) evaluate the effectiveness of activities, identify effective
activities, and disseminate such findings with respect to organ
donation and recovery;
(2) assess organ donation and recovery activities that are
recently completed, ongoing, or planned; and
(3) evaluate progress on the implementation of the plan required under subsection (c)(5).
(c) INITIAL REPORT REQUIREMENTS.—The initial report under
subsection (a) shall include the following:
(1) An evaluation of the organ donation practices of organ
procurement organizations, States, other countries, and other
appropriate organizations including an examination across all
populations, including those with low organ donation rates,
of—
(A) existing barriers to organ donation; and
(B) the most effective donation and recovery practices.
(2) An evaluation of living donation practices and procedures. Such evaluation shall include an assessment of issues
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Sec. 377E
PUBLIC HEALTH SERVICE ACT
418
relating to informed consent and the health risks associated
with living donation (including possible reduction of long-term
effects).
(3) An evaluation of—
(A) federally supported or conducted organ donation
efforts and policies, as well as federally supported or conducted basic, clinical, and health services research (including research on preservation techniques and organ rejection and compatibility); and
(B) the coordination of such efforts across relevant
agencies within the Department and throughout the Federal Government.
(4) An evaluation of the costs and benefits of State donor
registries, including the status of existing State donor registries, the effect of State donor registries on organ donation
rates, issues relating to consent, and recommendations regarding improving the effectiveness of State donor registries in increasing overall organ donation rates.
(5) A plan to improve federally supported or conducted
organ donation and recovery activities, including, when appropriate, the establishment of baselines and benchmarks to
measure overall outcomes of these programs. Such plan shall
provide for the ongoing coordination of federally supported or
conducted organ donation and research activities.
SEC. 377E. ø274f–5¿ CRITERIA, STANDARDS, AND REGULATIONS WITH
RESPECT TO ORGANS INFECTED WITH HIV.
(a) IN GENERAL.—Not later than 2 years after the date of the
enactment of the HIV Organ Policy Equity Act, the Secretary shall
develop and publish criteria for the conduct of research relating to
transplantation of organs from donors infected with human immunodeficiency virus (in this section referred to as ‘‘HIV’’) into individuals who are infected with HIV before receiving such organ.
(b) CORRESPONDING CHANGES TO STANDARDS AND REGULATIONS
APPLICABLE TO RESEARCH.—Not later than 2 years after the date
of the enactment of the HIV Organ Policy Equity Act, to the extent
determined by the Secretary to be necessary to allow the conduct
of research in accordance with the criteria developed under subsection (a)—
(1) the Organ Procurement and Transplantation Network
shall revise the standards of quality adopted under section
372(b)(2)(E); and
(2) the Secretary shall revise section 121.6 of title 42, Code
of Federal Regulations (or any successor regulations).
(c) REVISION OF STANDARDS AND REGULATIONS GENERALLY.—
Not later than 4 years after the date of the enactment of the HIV
Organ Policy Equity Act, and annually thereafter, the Secretary,
shall—
(1) review the results of scientific research in conjunction
with the Organ Procurement and Transplantation Network to
determine whether the results warrant revision of the standards of quality adopted under section 372(b)(2)(E) with respect
to donated organs infected with HIV and with respect to the
safety of transplanting an organ with a particular strain of
HIV into a recipient with a different strain of HIV;
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Sec. 379
(2) if the Secretary determines under paragraph (1) that
such results warrant revision of the standards of quality adopted under section 372(b)(2)(E) with respect to donated organs
infected with HIV and with respect to transplanting an organ
with a particular strain of HIV into a recipient with a different
strain of HIV, direct the Organ Procurement and Transplantation Network to revise such standards, consistent with section 372 and in a way that ensures the changes will not reduce
the safety of organ transplantation; and
(3) in conjunction with any revision of such standards
under paragraph (2), revise section 121.6 of title 42, Code of
Federal Regulations (or any successor regulations).
SEC. 378. ø274g¿ AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are authorized
to be appropriated $8,000,000 for fiscal year 1991, and such sums
as may be necessary for each of the fiscal years 1992 and 1993.
PART I—C.W. BILL YOUNG CELL
TRANSPLANTATION PROGRAM
SEC. 379. ø274k¿ NATIONAL PROGRAM.
(a) ESTABLISHMENT.—The Secretary,
acting through the Administrator of the Health Resources and Services Administration,
shall by one or more contracts establish and maintain a C.W. Bill
Young Cell Transplantation Program (referred to in this section as
the ‘‘Program’’), successor to the National Bone Marrow Donor Registry, that has the purpose of increasing the number of transplants
for recipients suitably matched to biologically unrelated donors of
bone marrow and cord blood, and that meets the requirements of
this section. The Secretary may award a separate contract to perform each of the major functions of the Program described in paragraphs (1) and (2) of subsection (d) if deemed necessary by the Secretary to operate an effective and efficient system that is in the
best interest of patients. The Secretary shall conduct a separate
competition for the initial establishment of the cord blood functions
of the Program. The Program shall be under the general supervision of the Secretary. The Secretary shall establish an Advisory
Council to advise, assist, consult with, and make recommendations
to the Secretary on matters related to the activities carried out by
the Program. The members of the Advisory Council shall be appointed in accordance with the following:
(1) Each member of the Advisory Council shall serve for a
term of 2 years, and each such member may serve as many as
3 consecutive 2-year terms, except that—
(A) such limitations shall not apply to the Chair of the
Advisory Council (or the Chair-elect) or to the member of
the Advisory Council who most recently served as the
Chair; and
(B) one additional consecutive 2-year term may be
served by any member of the Advisory Council who has no
employment, governance, or financial affiliation with any
donor center, recruitment organization, transplant center,
or cord blood bank.
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(2) A member of the Advisory Council may continue to
serve after the expiration of the term of such member until a
successor is appointed.
(3) In order to ensure the continuity of the Advisory Council, the Advisory Council shall be appointed so that each year
the terms of approximately one-third of the members of the
Advisory Council expire.
(4) The membership of the Advisory Council—
(A) shall include as voting members a balanced number of representatives including representatives of marrow
donor centers and marrow transplant centers, representatives of cord blood banks and participating birthing hospitals, recipients of a bone marrow transplant, recipients
of a cord blood transplant, persons who require such transplants, family members of such a recipient or family members of a patient who has requested the assistance of the
Program in searching for an unrelated donor of bone marrow or cord blood, persons with expertise in bone marrow
and cord blood transplantation, persons with expertise in
typing, matching, and transplant outcome data analysis,
persons with expertise in the social sciences, basic scientists with expertise in the biology of adult stem cells,
and members of the general public; and
(B) shall include as nonvoting members representatives from the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, the Division of Transplantation of the
Health Resources and Services Administration, the Food
and Drug Administration, and the National Institutes of
Health.
(5) Members of the Advisory Council shall be chosen so as
to ensure objectivity and balance and reduce the potential for
conflicts of interest. The Secretary shall establish bylaws and
procedures—
(A) to prohibit any member of the Advisory Council
who has an employment, governance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank from participating in any
decision that materially affects the center, recruitment organization, transplant center, or cord blood bank; and
(B) to limit the number of members of the Advisory
Council with any such affiliation.
(6) The Secretary, acting through the Administrator of the
Health Resources and Services Administration, shall submit to
Congress an annual report on the activities carried out under
this section.
(7) The Secretary shall convene the Advisory Council at
least two times each calendar year.
(b) ACCREDITATION.—The Secretary shall, through a public
process, recognize one or more accreditation entities for the accreditation of cord blood banks.
(c) INFORMED CONSENT.—The Secretary shall, through a public
process, examine issues of informed consent, including—
(1) the appropriate timing of such consent; and
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(2) the information provided to the maternal donor regarding all of her medically appropriate cord blood options.
Based on such examination, the Secretary shall require that the
standards used by the accreditation entities recognized under subsection (b) ensure that a cord blood unit is acquired with the informed consent of the maternal donor.
(d) FUNCTIONS.— 81
(1) BONE MARROW FUNCTIONS.—With respect to bone marrow, the Program shall—
(A) operate a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably
matched to candidate patients;
(B) consistent with paragraph (3), permit transplant
physicians, other appropriate health care professionals,
and patients to search by means of electronic access all
available bone marrow donors listed in the Program;
(C) carry out a program for the recruitment of bone
marrow donors in accordance with subsection (e), including
with respect to increasing the representation of racial and
ethnic minority groups (including persons of mixed ancestry) in the enrollment of the Program;
(D) maintain and expand medical contingency response capabilities, in coordination with Federal programs,
to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of
supporting patients with marrow damage from disease can
be used to support casualties with marrow damage;
(E) carry out informational and educational activities
in accordance with subsection (e);
(F) at least annually update information to account for
changes in the status of individuals as potential donors of
bone marrow;
81 Section
5 of Public Law 105–196 (112 Stat. 636) provides as follows:
‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller
General of the United States shall conduct a study of the National Bone Marrow Donor Registry
under section 379 of the Public Health Service Act for purposes of making determinations of
the following:
‘‘(1) The extent to which, relative to the effective date of this Act, such Registry has increased the representation of racial and ethnic minority groups (including persons of mixed
ancestry) among potential donors of bone marrow who are enrolled with the Registry, and
whether the extent of increase results in a level of representation that meets the standard
established in subsection (c)(1)(A) of such section 379 (as added by section 2(c) of this Act).
‘‘(2) The extent to which patients in need of a transplant of bone marrow from a biologically unrelated donor, and the physicians of such patients, have been utilizing the Registry in the search for such a donor.
‘‘(3) The number of such patients for whom the Registry began a preliminary search but
for whom the full search process was not completed, and the reasons underlying such circumstances.
‘‘(4) The extent to which the plan required in section 2(b)(2) of this Act (relating to the
relationship between the Registry and donor centers) has been implemented.
‘‘(5) The extent to which the Registry, donor centers, donor registries, collection centers,
transplant centers, and other appropriate entities have been complying with the standards,
criteria, and procedures under subsection (e) of such section 379 (as redesignated by section
2(c) of this Act).
‘‘(b) REPORT.—A report describing the findings of the study under subsection (a) shall be submitted to the Congress not later than October 1, 2001. The report may not be submitted before
January 1, 2001.’’.
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(G) provide for a system of patient advocacy through
the office established under subsection (h);
(H) provide case management services for any potential donor of bone marrow to whom the Program has provided a notice that the potential donor may be suitably
matched to a particular patient through the office established under subsection (h);
(I) with respect to searches for unrelated donors of
bone marrow that are conducted through the system under
subparagraph (A), collect, analyze, and publish data in a
standardized electronic format on the number and percentage of patients at each of the various stages of the search
process, including data regarding the furthest stage
reached, the number and percentage of patients who are
unable to complete the search process, and the reasons underlying such circumstances;
(J) support studies and demonstration and outreach
projects for the purpose of increasing the number of individuals who are willing to be marrow donors to ensure a
genetically diverse donor pool; and
(K) facilitate research with the appropriate Federal
agencies to improve the availability, efficiency, safety, and
cost of transplants from unrelated donors and the effectiveness of Program operations.
(2) CORD BLOOD FUNCTIONS.—
(A) IN GENERAL.—With respect to cord blood, the Program shall—
(i) 82 operate a system for identifying, matching, and
facilitating the distribution of donated cord blood units
that are suitably matched to candidate patients and meet
all applicable Federal and State regulations (including informed consent and Food and Drug Administration regulations) from a qualified cord blood bank;
(ii) 82 consistent with paragraph (3), allow transplant
physicians, other appropriate health care professionals,
and patients to search by means of electronic access all
available cord blood units made available through the Program;
(iii) 82 allow transplant physicians and other appropriate health care professionals to reserve, as defined by
the Secretary, a cord blood unit for transplantation;
(iv) support and expand new and existing studies
and demonstration and outreach projects for the purpose of increasing cord blood unit donation and collection from a genetically diverse population and expanding the number of cord blood unit collection sites
partnering with cord blood banks receiving a contract
under the National Cord Blood Inventory program
under section 2 of the Stem Cell Therapeutic and Re82 Margin so in law. The amendment by section 2(b)(2)(A)(ii) of Public Law 111–264 redesignates subpargraphs (A)–(H) as clauses (i)–(viii); however, the amendment did not move the margins of such clauses to the right so that it appears indented 6 ems from the left margin (except
for clause (iv) which was amended in its entirety by section 2(b)(2)(A)(iii) of such Public Law
and as rewritten appears on the correct margin).
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search Act of 2005, including such studies and projects
that focus on—
(I) remote collection of cord blood units, consistent with the requirements under the Program
and the National Cord Blood Inventory program
goal described in section 2(a) of the Stem Cell
Therapeutic and Research Act of 2005; and
(II) exploring novel approaches or incentives
to encourage innovative technological advances
that could be used to collect cord blood units, consistent with the requirements under the Program
and such National Cord Blood Inventory program
goal;
(v) 82 provide for a system of patient advocacy through
the office established under subsection (h);
(vi) 82 coordinate with the qualified cord blood banks to
support informational and educational activities in accordance with subsection (g);
(vii) 82 maintain and expand medical contingency response capabilities, in coordination with Federal programs,
to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of
supporting patients with marrow damage from disease can
be used to support casualties with marrow damage; and
(viii) 82 with respect to the system under subparagraph
(A), collect, analyze, and publish data in a standardized
electronic format, as required by the Secretary, on the
number and percentage of patients at each of the various
stages of the search process, including data regarding the
furthest stage reached, the number and percentage of patients who are unable to complete the search process, and
the reasons underlying such circumstances.
(B) EFFORTS TO INCREASE COLLECTION OF HIGH QUALITY CORD BLOOD UNITS.—In carrying out subparagraph
(A)(iv), not later than 1 year after the date of enactment
of the Stem Cell Therapeutic and Research Reauthorization Act of 2010 and annually thereafter, the Secretary
shall set an annual goal of increasing collections of high
quality cord blood units, including remote collection, consistent with the inventory goal described in section 2(a) of
the Stem Cell Therapeutic and Research Act of 2005 (referred to in this subparagraph as the ‘‘inventory goal’’),
and shall identify at least one project under subparagraph
(A)(iv) to replicate and expand nationwide, as appropriate.
(C) DEFINITION.—In this paragraph, the term ‘‘remote
collection’’ means the collection of cord blood units at locations that do not have written contracts with cord blood
banks for collection support.
(3) SINGLE POINT OF ACCESS; STANDARD DATA.—
(A) SINGLE POINT OF ACCESS.—The Secretary shall ensure that health care professionals and patients are able
to search electronically for and facilitate access to, in the
manner and to the extent defined by the Secretary and
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consistent with the functions described in paragraphs
(1)(A) and (2)(A)(i), cells from bone marrow donors and
cord blood units through a single point of access.
(B) STANDARD DATA.—The Secretary shall require all
recipients of contracts under this section to make available
a standard dataset for purposes of subparagraph (A) in a
standardized electronic format that enables transplant
physicians to compare among and between bone marrow
donors and cord blood units to ensure the best possible
match for the patient.
(4) DEFINITION.—The term ‘‘qualified cord blood bank’’
means a cord blood bank that—
(A) has obtained all applicable Federal and State licenses, certifications, registrations (including pursuant to
the regulations of the Food and Drug Administration), and
other authorizations required to operate and maintain a
cord blood bank;
(B) has implemented donor screening, cord blood collection practices, and processing methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes, including with respect to the transmission of potentially harmful infections
and other diseases;
(C) is accredited by an accreditation entity recognized
by the Secretary under subsection (b);
(D) has established a system of strict confidentiality to
protect the identity and privacy of patients and donors in
accordance with existing Federal and State law;
(E) has established a system for encouraging donation
by a genetically diverse group of donors; and
(F) has established a system to confidentially maintain
linkage between a cord blood unit and a maternal donor.
(e) BONE MARROW RECRUITMENT; PRIORITIES; INFORMATION
AND EDUCATION.—
(1) RECRUITMENT; PRIORITIES.—The Program shall carry
out activities for the recruitment of bone marrow donors. Such
recruitment program shall identify populations that are underrepresented among potential donors enrolled with the Program. In the case of populations that are identified under the
preceding sentence:
(A) The Program shall give priority to carrying out activities under this part to increase representation for such
populations in order to enable a member of such a population, to the extent practicable, to have a probability of
finding a suitable unrelated donor that is comparable to
the probability that an individual who is not a member of
an underrepresented population would have.
(B) The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be
populations that have been identified for purposes of this
paragraph, and shall carry out subparagraph (A) with respect to such populations.
(2) INFORMATION AND EDUCATION REGARDING RECRUITMENT; TESTING AND ENROLLMENT.—
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(A) IN GENERAL.—The Program shall carry out informational and educational activities, in coordination with
organ donation public awareness campaigns operated
through the Department of Health and Human Services,
for purposes of recruiting individuals to serve as donors of
bone marrow, and shall test and enroll with the Program
potential bone marrow donors. Such information and educational activities shall include the following:
(i) Making information available to the general
public, including information describing the needs of
patients with respect to donors of bone marrow.
(ii) Educating and providing information to individuals who are willing to serve as potential bone marrow donors.
(iii) Training individuals in requesting individuals
to serve as potential bone marrow donors.
(B) PRIORITIES.—In carrying out informational and
educational activities under subparagraph (A), the Program shall give priority to recruiting individuals to serve
as donors of bone marrow for populations that are identified under paragraph (1).
(3) TRANSPLANTATION AS TREATMENT OPTION.—In addition
to activities regarding recruitment, the recruitment program
under paragraph (1) shall provide information to physicians,
other health care professionals, and the public regarding bone
marrow transplants from unrelated donors as a treatment option.
(4) IMPLEMENTATION OF SUBSECTION.—The requirements of
this subsection shall be carried out by the entity that has been
awarded a contract by the Secretary under subsection (a) to
carry out the functions described in subsection (d)(1).
(f) BONE MARROW CRITERIA, STANDARDS, AND PROCEDURES.—
The Secretary shall enforce, for participating entities, including the
Program, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers—
(1) quality standards and standards for tissue typing, obtaining the informed consent of donors, and providing patient
advocacy;
(2) donor selection criteria, based on established medical
criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases
such as the viruses that cause hepatitis and the etiologic agent
for Acquired Immune Deficiency Syndrome;
(3) procedures to ensure the proper collection and transportation of the marrow;
(4) standards for the system for patient advocacy operated
under subsection (h), including standards requiring the provision of appropriate information (at the start of the search process and throughout the process) to patients and their families
and physicians;
(5) standards that—
(A) require the establishment of a system of strict confidentiality to protect the identity and privacy of patients
and donors in accordance with Federal and State law; and
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(B) prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and extent of the disclosure; and
(6) in the case of a marrow donor center or marrow donor
registry participating in the program, procedures to ensure the
establishment of a method for integrating donor files, searches,
and general procedures of the center or registry with the Program.
(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
EDUCATION.—
(1) RECRUITMENT; PRIORITIES.—The Program shall support
activities, in cooperation with qualified cord blood banks, for
the recruitment of cord blood donors. Such recruitment program shall identify populations that are underrepresented
among cord blood donors. In the case of populations that are
identified under the preceding sentence:
(A) The Program shall give priority to supporting activities under this part to increase representation for such
populations in order to enable a member of such a population, to the extent practicable, to have a probability of
finding a suitable cord blood unit that is comparable to the
probability that an individual who is not a member of an
underrepresented population would have.
(B) The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be
populations that have been identified for purposes of this
paragraph, and shall support activities under subparagraph (A) with respect to such populations.
(2) INFORMATION AND EDUCATION REGARDING RECRUITMENT; TESTING AND DONATION.—
(A) IN GENERAL.—In carrying out the recruitment program under paragraph (1), the Program shall support informational and educational activities in coordination with
qualified cord blood banks and organ donation public
awareness campaigns operated through the Department of
Health and Human Services, for purposes of recruiting
pregnant women to serve as donors of cord blood. Such information and educational activities shall include the following:
(i) Making information available to the general
public, including information describing the needs of
patients with respect to cord blood units.
(ii) Educating and providing information to pregnant women who are willing to donate cord blood
units.
(iii) Training individuals in requesting pregnant
women to serve as cord blood donors.
(B) PRIORITIES.—In carrying out informational and
educational activities under subparagraph (A), the Program shall give priority to supporting the recruitment of
pregnant women to serve as donors of cord blood for populations that are identified under paragraph (1).
(3) TRANSPLANTATION AS TREATMENT OPTION.—In addition
to activities regarding recruitment, the recruitment program
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under paragraph (1) shall provide information to physicians,
other health care professionals, and the public regarding cord
blood transplants from donors as a treatment option.
(4) IMPLEMENTATION OF SUBSECTION.—The requirements of
this subsection shall be carried out by the entity that has been
awarded a contract by the Secretary under subsection (a) to
carry out the functions described in subsection (d)(2).
(h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE
MARROW AND CORD BLOOD.—
(1) IN GENERAL.—The Secretary shall establish and maintain, through a contract or other means determined appropriate by the Secretary, an office of patient advocacy (in this
subsection referred to as the ‘‘Office’’).
(2) GENERAL FUNCTIONS.—The Office shall meet the following requirements:
(A) The Office shall be headed by a director.
(B) The Office shall be staffed by individuals with expertise in bone marrow and cord blood therapy covered
under the Program.
(C) The Office shall operate a system for patient advocacy, which shall be separate from mechanisms for donor
advocacy, and which shall serve patients for whom the
Program is conducting, or has been requested to conduct,
a search for a bone marrow donor or cord blood unit.
(D) In the case of such a patient, the Office shall serve
as an advocate for the patient by directly providing to the
patient (or family members, physicians, or other individuals acting on behalf of the patient) individualized services
with respect to efficiently utilizing the system under paragraphs (1) and (2) of subsection (d) to conduct an ongoing
search for a bone marrow donor or cord blood unit and assist with information regarding third party payor matters.
(E) In carrying out subparagraph (D), the Office shall
monitor the system under paragraphs (1) and (2) of subsection (d) to determine whether the search needs of the
patient involved are being met, including with respect to
the following:
(i) Periodically providing to the patient (or an individual acting on behalf of the patient) information
regarding bone marrow donors or cord blood units that
are suitably matched to the patient, and other information regarding the progress being made in the
search.
(ii) Informing the patient (or such other individual) if the search has been interrupted or discontinued.
(iii) Identifying and resolving problems in the
search, to the extent practicable.
(F) The Office shall ensure that the following data are
made available to patients:
(i) The resources available through the Program.
(ii) A comparison of transplant centers regarding
search and other costs that prior to transplantation
are charged to patients by transplant centers.
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(iii) The post-transplant outcomes for individual
transplant centers.
(iv) Information concerning issues that patients
may face after a transplant.
(v) Such other information as the Program determines to be appropriate.
(G) The Office shall conduct surveys of patients (or
family members, physicians, or other individuals acting on
behalf of patients) to determine the extent of satisfaction
with the system for patient advocacy under this subsection, and to identify ways in which the system can be
improved to best meet the needs of patients.
(3) CASE MANAGEMENT.—
(A) IN GENERAL.—In serving as an advocate for a patient under paragraph (2), the Office shall provide individualized case management services directly to the patient
(or family members, physicians, or other individuals acting
on behalf of the patient), including—
(i) individualized case assessment; and
(ii) the functions described in paragraph (2)(D)
(relating to progress in the search process).
(B) POSTSEARCH FUNCTIONS.—In addition to the case
management services described in paragraph (1) for patients, the Office shall, on behalf of patients who have
completed the search for a bone marrow donor or cord
blood unit, provide information and education on the process of receiving a transplant, including the post-transplant
process.
(i) COMMENT PROCEDURES.—The Secretary shall establish and
provide information to the public on procedures under which the
Secretary shall receive and consider comments from interested persons relating to the manner in which the Program is carrying out
the duties of the Program. The Secretary may promulgate regulations under this section.
(j) CONSULTATION.—In developing policies affecting the Program, the Secretary shall consult with the Advisory Council, the
Department of Defense Marrow Donor Recruitment and Research
Program operated by the Department of the Navy, and the board
of directors of each entity awarded a contract under this section.
(k) CONTRACTS.—
(1) APPLICATION.—To be eligible to enter into a contract
under this section, an entity shall submit to the Secretary and
obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by
regulation prescribe.
(2) CONSIDERATIONS.—In awarding contracts under this
section, the Secretary shall give consideration to the continued
safety of donors and patients and other factors deemed appropriate by the Secretary.
(l) ELIGIBILITY.—Entities eligible to receive a contract under
this section shall include private nonprofit entities.
(m) RECORDS.—
(1) RECORDKEEPING.—Each recipient of a contract or subcontract under subsection (a) shall keep such records as the
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Secretary shall prescribe, including records that fully disclose
the amount and disposition by the recipient of the proceeds of
the contract, the total cost of the undertaking in connection
with which the contract was made, and the amount of the portion of the cost of the undertaking supplied by other sources,
and such other records as will facilitate an effective audit.
(2) EXAMINATION OF RECORDS.—The Secretary and the
Comptroller General of the United States shall have access to
any books, documents, papers, and records of the recipient of
a contract or subcontract entered into under this section that
are pertinent to the contract, for the purpose of conducting audits and examinations.
(n) PENALTIES FOR DISCLOSURE.—Any person who discloses the
content of any record referred to in subsection (d)(4)(D) or (f)(5)(A)
without the prior written consent of the donor or potential donor
with respect to whom the record is maintained, or in violation of
the standards described in subsection (f)(5)(B), shall be imprisoned
for not more than 2 years or fined in accordance with title 18,
United States Code, or both.
(o) PERIODIC REVIEW OF STATE OF SCIENCE.—
(1) REVIEW.—Not less frequently than every 2 years, the
Secretary, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the
Administrator of the Health Resources and Services Administration, the Advisory Council, and other stakeholders, where
appropriate given relevant expertise, shall conduct a review of
the state of the science of using adult stem cells and birthing
tissues to develop new types of therapies for patients, for the
purpose of considering the potential inclusion of such new
types of therapies in the Program.
(2) RECOMMENDATIONS.—Not later than June 30, 2025, the
Secretary shall—
(A) complete the second review required by paragraph
(1); and
(B) informed by such review, submit to the Committee
on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House
of Representatives recommendations on the appropriateness of the inclusion of new types of therapies in the Program.
SEC. 379A. ø274l¿ STEM CELL THERAPEUTIC OUTCOMES DATABASE.
(a) ESTABLISHMENT.—The Secretary shall by contract establish
and maintain a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product
(including bone marrow, cord blood, or other such product) from a
donor.
(b) INFORMATION.—The outcomes database shall include information in a standardized electronic format with respect to patients
described in subsection (a), diagnosis, transplant procedures, results, long-term follow-up, and such other information as the Secretary determines to be appropriate, to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving
recipients of a stem cell therapeutics product from a donor.
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(c) ANNUAL REPORT ON PATIENT OUTCOMES.—The Secretary
shall require the entity awarded a contract under this section to
submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center, based on data collected and maintained by the entity pursuant to this section.
(d) PUBLICLY AVAILABLE DATA.—The outcomes database shall
make relevant scientific information not containing individually
identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide
information to transplant programs, physicians, patients, entities
awarded a contract under section 379 donor registries, and cord
blood banks.
SEC. 379A–1. ø274l–1¿ DEFINITIONS.
In this part:
(1) The term ‘‘Advisory Council’’ means the advisory council established by the Secretary under section 379(a)(1).
(2) The term ‘‘bone marrow’’ means the cells found in adult
bone marrow and peripheral blood.
(3) The term ‘‘outcomes database’’ means the database established by the Secretary under section 379A.
(4) The term ‘‘Program’’ means the C.W. Bill Young Cell
Transplantation Program established under section 379.
SEC. 379B. ø274m¿ AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are authorized
to be appropriated $31,009,000 for each of fiscal years 2022
through 2026.
PART J—PREVENTION
AND
CONTROL
OF INJURIES
RESEARCH
SEC. 391. ø280b¿ (a) The Secretary, through the Director of the
Centers for Disease Control and Prevention, shall—
(1) conduct, and give assistance to public and nonprofit
private entities, scientific institutions, and individuals engaged
in the conduct of, research relating to the causes, mechanisms,
prevention, diagnosis, treatment 83 of injuries, and rehabilitation from injuries;
(2) make grants to, or enter into cooperative agreements or
contracts with, public and nonprofit private entities (including
academic institutions, hospitals, and laboratories) and individuals for the conduct of such research; and
(3) make grants to, or enter into cooperative agreements or
contracts with, academic institutions for the purpose of providing training on the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall collect and disseminate, through
publications and other appropriate means, information concerning
the practical applications of research conducted or assisted under
subsection (a). In carrying out the preceding sentence, the Sec83 So
in law. Probably should read ‘‘...diagnosis, and treatment...’’.
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retary shall disseminate such information to the public, including
through elementary and secondary schools.
PREVENTION AND CONTROL ACTIVITIES
SEC. 392. ø280b–0¿ (a) The Secretary, through the Director of
the Centers for Disease Control and Prevention, shall—
(1) assist States and political subdivisions of States in activities for the prevention and control of injuries; and
(2) encourage regional activities between States designed
to reduce injury rates.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, may—
(1) enter into agreements between the Service and public
and private community health agencies which provide for cooperative planning of activities to deal with problems relating to
the prevention and control of injuries;
(2) work in cooperation with other Federal agencies, and
with public and nonprofit private entities, to promote activities
regarding the prevention and control of injuries; and
(3) make grants to States and, after consultation with
State health agencies, to other public or nonprofit private entities for the purpose of carrying out demonstration projects for
the prevention and control of injuries at sites that are not subject to the Occupational Safety and Health Act of 1970, including homes, elementary and secondary schools, and public buildings.
SEC. 392A. ø280b–1¿ PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
(a) EVIDENCE-BASED PREVENTION GRANTS.—
(1) IN GENERAL.—The Director of the Centers for Disease
Control and Prevention may—
(A) to the extent practicable, carry out and expand any
evidence-based prevention activities described in paragraph (2);
(B) provide training and technical assistance to States,
localities, and Indian Tribes for purposes of carrying out
such activity; and
(C) award grants to States, localities, and Indian
Tribes for purposes of carrying out such activity.
(2) EVIDENCE-BASED PREVENTION ACTIVITIES.—An evidencebased prevention activity described in this paragraph is any of
the following activities:
(A) Improving the efficiency and use of a new or currently operating prescription drug monitoring program, including by—
(i) encouraging all authorized users (as specified
by the State or other entity) to register with and use
the program;
(ii) enabling such users to access any updates to
information collected by the program in as close to
real-time as possible;
(iii) improving the ease of use of such program;
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(iv) providing for a mechanism for the program to
notify authorized users of any potential misuse or
abuse of controlled substances and any detection of inappropriate prescribing or dispensing practices relating to such substances;
(v) encouraging the analysis of prescription drug
monitoring data for purposes of providing de-identified, aggregate reports based on such analysis to State
public health agencies, State substance abuse agencies, State licensing boards, and other appropriate
State agencies, as permitted under applicable Federal
and State law and the policies of the prescription drug
monitoring program and not containing any protected
health information, to prevent inappropriate prescribing, drug diversion, or abuse and misuse of controlled substances, and to facilitate better coordination
among agencies;
(vi) enhancing interoperability between the program and any health information technology (including certified health information technology), including
by integrating program data into such technology;
(vii) updating program capabilities to respond to
technological innovation for purposes of appropriately
addressing the occurrence and evolution of controlled
substance overdoses;
(viii) facilitating and encouraging data exchange
between the program and the prescription drug monitoring programs of other States;
(ix) enhancing data collection and quality, including improving patient matching and proactively monitoring data quality;
(x) providing prescriber and dispenser practice
tools, including prescriber practice insight reports for
practitioners to review their prescribing patterns in
comparison to such patterns of other practitioners in
the specialty; and
(xi) meeting the purpose of the program established under section 399O, as described in section
399O(a).
(B) Promoting community or health system interventions.
(C) Evaluating interventions to prevent controlled substance overdoses.
(D) Implementing projects to advance an innovative
prevention approach with respect to new and emerging
public health crises and opportunities to address such crises, such as enhancing public education and awareness on
the risks associated with opioids.
(3) ADDITIONAL GRANTS.—The Director may award grants
to States, localities, and Indian Tribes—
(A) to carry out innovative projects for grantees to rapidly respond to controlled substance misuse, abuse, and
overdoses, including changes in patterns of controlled substance use; and
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(B) for any other evidence-based activity for preventing controlled substance misuse, abuse, and overdoses
as the Director determines appropriate.
(4) RESEARCH.—The Director, in coordination with the Assistant Secretary for Mental Health and Substance Use and
the National Mental Health and Substance Use Policy Laboratory established under section 501A, as appropriate and applicable, may conduct studies and evaluations to address substance use disorders, including preventing substance use disorders or other related topics the Director determines appropriate.
(b) ENHANCED CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION, ANALYSIS, AND DISSEMINATION GRANTS.—
(1) IN GENERAL.—The Director of the Centers for Disease
Control and Prevention may—
(A) to the extent practicable, carry out any controlled
substance overdose data collection activities described in
paragraph (2);
(B) provide training and technical assistance to States,
localities, and Indian Tribes for purposes of carrying out
such activity;
(C) award grants to States, localities, and Indian
Tribes for purposes of carrying out such activity; and
(D) coordinate with the Assistant Secretary for Mental
Health and Substance Use to collect data pursuant to section 505(d)(1)(A) (relating to the number of individuals admitted to emergency departments as a result of the abuse
of alcohol or other drugs).
(2) CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION
AND ANALYSIS ACTIVITIES.—A controlled substance overdose
data collection, analysis, and dissemination activity described
in this paragraph is any of the following activities:
(A) Improving the timeliness of reporting data to the
public, including data on fatal and nonfatal overdoses of
controlled substances.
(B) Enhancing the comprehensiveness of controlled
substance overdose data by collecting information on such
overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and
emergency departments.
(C) Modernizing the system for coding causes of death
related to controlled substance overdoses to use an electronic-based system.
(D) Using data to help identify risk factors associated
with controlled substance overdoses.
(E) Supporting entities involved in providing information on controlled substance overdoses, such as coroners,
medical examiners, and public health laboratories to improve accurate testing and standardized reporting of
causes and contributing factors to controlled substances
overdoses and analysis of various opioid analogues to controlled substance overdoses.
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(F) Working to enable and encourage the access, exchange, and use of information regarding controlled substance overdoses among data sources and entities.
(c) PRIORITY.—In awarding grants to States under subsections
(a) and (b), the Director of the Centers for Disease Control and Prevention may give priority to jurisdictions with a disproportionately
high rate of drug overdoses or drug overdose deaths, as applicable.
(d) DEFINITIONS.—In this section:
(1) CONTROLLED SUBSTANCE.—The term ‘‘controlled substance’’ has the meaning given that term in section 102 of the
Controlled Substances Act.
(2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act.
(e) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section, section 399O of this Act, and section 102 of
the Comprehensive Addiction and Recovery Act of 2016 (Public
Law 114–198), there is authorized to be appropriated $496,000,000
for each of fiscal years 2019 through 2023.
INTERPERSONAL VIOLENCE WITHIN FAMILIES AND AMONG
ACQUAINTANCES
SEC. 393. ø280b–1a¿ (a) With respect to activities that are authorized in sections 391 and 392, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall
carry out such activities with respect to interpersonal violence
within families and among acquaintances. Activities authorized in
the preceding sentence include the following:
(1) Collecting data relating to the incidence of such violence.
(2) Making grants to public and nonprofit private entities
for the evaluation of programs whose purpose is to prevent
such violence, including the evaluation of demonstration
projects under paragraph (6).
(3) Making grants to public and nonprofit private entities
for the conduct of research on identifying effective strategies
for preventing such violence.
(4) Providing to the public information and education on
such violence, including information and education to increase
awareness of the public health consequences of such violence.
(5) Training health care providers as follows:
(A) To identify individuals whose medical conditions or
statements indicate that the individuals are victims of
such violence.
(B) To routinely determine, in examining patients,
whether the medical conditions or statements of the patients so indicate.
(C) To refer individuals so identified to entities that
provide services regarding such violence, including referrals for counseling, housing, legal services, and services of
community organizations.
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(6) Making grants to public and nonprofit private entities
for demonstration projects with respect to such violence, including with respect to prevention.
(b) For purposes of this part, the term ‘‘interpersonal violence
within families and among acquaintances’’ includes behavior commonly referred to as domestic violence, sexual assault, spousal
abuse, woman battering, partner abuse, elder abuse, and acquaintance rape.
SEC. 393A. ø280b–1b¿ USE OF ALLOTMENTS FOR RAPE PREVENTION
EDUCATION.
(a) PERMITTED USE.—The Secretary, acting through the Na-
tional Center for Injury Prevention and Control at the Centers for
Disease Control and Prevention, shall award targeted grants to
States to be used for rape prevention and education programs conducted by rape crisis centers, State, territorial or tribal sexual assault coalitions, and other public and private nonprofit entities
for—
(1) educational seminars;
(2) the operation of hotlines or utilization of other communication technologies for purposes related to such a hotline;
(3) training programs for professionals, including schoolbased professionals, to identify and refer students who may
have experienced or are at risk of experiencing sexual violence;
(4) the preparation of informational material;
(5) education and training programs for students and campus personnel designed to reduce the incidence of sexual assault at colleges and universities;
(6) education to increase awareness about drugs and alcohol used to facilitate rapes or sexual assaults; and
(7) other efforts to increase awareness of the facts about,
or to help prevent, sexual violence, sexual assault, and sexual
harassment, including efforts to increase awareness in underserved communities and awareness among individuals with
disabilities (as defined in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102)) and Deaf 84 individuals.
(b) COLLECTION AND DISSEMINATION OF INFORMATION ON SEXUAL ASSAULT.—The Secretary shall, through the National Resource
Center on Sexual Assault established under the National Center
for Injury Prevention and Control at the Centers for Disease Control and Prevention, provide resource information, policy, training,
and technical assistance to Federal, State, local, and Indian Tribal
agencies, as well as to State sexual assault coalitions and local sexual assault programs and to other professionals and interested parties on issues relating to sexual assault, including maintenance of
a central resource library in order to collect, prepare, analyze, and
disseminate information and statistics and analyses thereof relating to the incidence and prevention of sexual assault.
(c) MEANINGFUL INVOLVEMENT OF STATE SEXUAL ASSAULT COALITIONS, CULTURALLY SPECIFIC ORGANIZATIONS, AND UNDERSERVED
COMMUNITIES.—In awarding funds to States under this section, the
Secretary shall set forth procedures designed to ensure meaningful
involvement of sexual assault coalitions, culturally specific organi84 So
in law. Probably should read ‘‘deaf’’.
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zations, and representatives from underserved communities of the
State or territory in the application for, and implementation of,
funding.
(d) AUTHORIZATION OF APPROPRIATIONS.—
(1) IN GENERAL.—There is authorized to be appropriated to
carry out this section $100,000,000 for each of fiscal years 2023
through 2027.
(2) NATIONAL SEXUAL VIOLENCE RESOURCE CENTER ALLOTMENT.—Of the total amount made available under this subsection in each fiscal year, not less than $1,500,000 shall be
available for allotment under subsection (b).
(3) BASELINE FUNDING FOR STATES, THE DISTRICT OF COLUMBIA, AND PUERTO RICO.—A minimum allocation of $150,000
shall be awarded in each fiscal year for each of the States, the
District of Columbia, and Puerto Rico. A minimum allocation
of $35,000 shall be awarded in each fiscal year for each Territory. Any unused or remaining funds shall be allotted to each
State, the District of Columbia, and Puerto Rico on the basis
of population. Not less than 80 percent of the total amount
made available under this subsection in each fiscal year shall
be awarded in accordance with this paragraph.
(4) STATE, TERRITORIAL, AND TRIBAL SEXUAL ASSAULT COALITION ALLOTMENT.—
(A) IN GENERAL.—Of the total amount appropriated
under this subsection for a fiscal year, not less than 15
percent shall be allocated to State, territorial, and Tribal
sexual assault coalitions for the purposes of coordinating
and providing prevention activities, providing assistance to
prevention programs, and collaborating and coordinating
with applicable Federal, State, Tribal, and local entities
engaged in sexual violence prevention, in accordance with
this paragraph.
(B) ALLOCATIONS.—Of the total amount appropriated
under this subsection and allocated to making awards to
sexual assault coalitions, as described in subparagraph (A),
for a fiscal year—
(i) not less than 10 percent shall be made available to Tribal sexual assault coalitions; and
(ii) any remaining amounts shall be made available, in equal amounts, to each State coalition and
each territorial coalition.
(C) CLARIFICATION.—Receipt of an award under this
subsection by a sexual assault coalition shall not preclude
the coalition from receiving additional grants or administering funds to carry out the purposes described in subsection (a).
(e) LIMITATIONS.—
(1) SUPPLEMENT NOT SUPPLANT.—Amounts provided to
States under this section shall be used to supplement and not
supplant other Federal, State, and local public funds expended
to provide services of the type described in subsection (a).
(2) STUDIES.—A State may not use more than 2 percent of
the amount received by the State under this section for each
fiscal year for surveillance studies or prevalence studies.
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(3) ADMINISTRATION.—A State may not use more than 5
percent of the amount received by the State under this section
for each fiscal year for administrative expenses.
(f) REPORT.—Not later than 1 year after the date of the enactment of the Violence Against Women Act Reauthorization Act of
2022, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall submit to the Committee on
Appropriations, the Committee on Energy and Commerce, and the
Committee on the Judiciary of the House of Representatives and
the Committee on Appropriations, the Committee on Health, Education, Labor, and Pensions, and the Committee on the Judiciary
of the Senate a report on the activities funded by grants awarded
under this section and best practices relating to rape prevention
and education.
PREVENTION OF TRAUMATIC BRAIN INJURY
SEC. 393B. ø280b–1c¿ (a) IN GENERAL.—The Secretary, acting
through the Director of the Centers for Disease Control and Prevention, may carry out projects to reduce the incidence of traumatic
brain injury. Such projects may be carried out by the Secretary directly or through awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such
awards provide technical assistance with respect to the planning,
development, and operation of such projects.
(b) CERTAIN ACTIVITIES.—Activities under subsection (a) may
include—
(1) the conduct of research into identifying effective strategies for the prevention of traumatic brain injury;
(2) the implementation of public information and education
programs for the prevention of such injury and for broadening
the awareness of the public concerning the public health consequences of such injury; and
(3) the implementation of a national education and awareness campaign regarding such injury (in conjunction with the
program of the Secretary regarding health-status goals for
2020, commonly referred to as Healthy People 2020), including—
(A) the national dissemination of information on—
(i) incidence and prevalence; and
(ii) information relating to traumatic brain injury
and the sequelae of secondary conditions arising from
traumatic brain injury upon discharge from hospitals
and emergency departments; and
(B) the provision of information in primary care settings, including emergency rooms and trauma centers, concerning the availability of State level services and resources.
(c) COORDINATION OF ACTIVITIES.—The Secretary shall ensure
that activities under this section are coordinated as appropriate
with other agencies of the Public Health Service that carry out activities regarding traumatic brain injury.
(d) DEFINITION.—For purposes of this section, the term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such
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term does not include brain dysfunction caused by congenital or degenerative disorders, nor birth trauma, but may include brain injuries caused by anoxia due to trauma. The Secretary may revise the
definition of such term as the Secretary determines necessary, after
consultation with States and other appropriate public or nonprofit
private entities.
NATIONAL PROGRAM FOR TRAUMATIC BRAIN INJURY SURVEILLANCE
AND REGISTRIES
SEC. 393C. 85 ø280b–1d¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and
Prevention, may make grants to States or their designees to develop or operate the State’s traumatic brain injury surveillance system or registry to determine the incidence and prevalence of traumatic brain injury and related disability, to ensure the uniformity
of reporting under such system or registry, to link individuals with
traumatic brain injury to services and supports, and to link such
individuals with academic institutions to conduct applied research
that will support the development of such surveillance systems and
registries as may be necessary. A surveillance system or registry
under this section shall provide for the collection of data concerning—
(1) demographic information about each traumatic brain
injury;
(2) information about the circumstances surrounding the
injury event associated with each traumatic brain injury;
(3) administrative information about the source of the collected information, dates of hospitalization and treatment, and
the date of injury; and
(4) information characterizing the clinical aspects of the
traumatic brain injury, including the severity of the injury,
outcomes of the injury, the types of treatments received, and
the types of services utilized.
(b) Not later than 18 months after the date of enactment of the
Traumatic Brain Injury Act of 2008, the Secretary, acting through
the Director of the Centers for Disease Control and Prevention and
the Director of the National Institutes of Health and in consultation with the Secretary of Defense and the Secretary of Veterans
Affairs, shall submit to the relevant committees of Congress a report that contains the findings derived from an evaluation concerning activities and procedures that can be implemented by the
Centers for Disease Control and Prevention to improve the collection and dissemination of compatible epidemiological studies on the
incidence and prevalence of traumatic brain injury in individuals
who were formerly in the military. The report shall include recommendations on the manner in which such agencies can further
collaborate on the development and improvement of traumatic
brain injury diagnostic tools and treatments.
(c) NATIONAL CONCUSSION DATA COLLECTION AND ANALYSIS.—
The Secretary, acting through the Director of the Centers for Dis85 The amendment by section 2(3) of Public Law 110–206 to redesignate section 393B (relating
to traumatic brain injury registeries) as section 393C could not be executed because such section
had already been redesignated as section 393C by section 2(1) of Public Law 110–202.
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Sec. 393D
ease Control and Prevention, may implement concussion data collection and analysis to determine the prevalence and incidence of
concussion.
SEC. 393D. ø28b–1f¿ PREVENTION OF FALLS AMONG OLDER ADULTS.
(a) PUBLIC EDUCATION.—The Secretary may—
(1) oversee and support a national education campaign to
be carried out by a nonprofit organization with experience in
designing and implementing national injury prevention programs, that is directed principally to older adults, their families, and health care providers, and that focuses on reducing
falls among older adults and preventing repeat falls; and
(2) award grants, contracts, or cooperative agreements to
qualified organizations, institutions, or consortia of qualified
organizations and institutions, specializing, or demonstrating
expertise, in falls or fall prevention, for the purpose of organizing State-level coalitions of appropriate State and local
agencies, safety, health, senior citizen, and other organizations
to design and carry out local education campaigns, focusing on
reducing falls among older adults and preventing repeat falls.
(b) RESEARCH.—
(1) IN GENERAL.—The Secretary may—
(A) conduct and support research to—
(i) improve the identification of older adults who
have a high risk of falling;
(ii) improve data collection and analysis to identify
fall risk and protective factors;
(iii) design, implement, and evaluate the most effective fall prevention interventions;
(iv) improve strategies that are proven to be effective in reducing falls by tailoring these strategies to
specific populations of older adults;
(v) conduct research in order to maximize the dissemination of proven, effective fall prevention interventions;
(vi) intensify proven interventions to prevent falls
among older adults;
(vii) improve the diagnosis, treatment, and rehabilitation of elderly fall victims and older adults at
high risk for falls; and
(viii) assess the risk of falls occurring in various
settings;
(B) conduct research concerning barriers to the adoption of proven interventions with respect to the prevention
of falls among older adults;
(C) conduct research to develop, implement, and evaluate the most effective approaches to reducing falls among
high-risk older adults living in communities and long-term
care and assisted living facilities; and
(D) evaluate the effectiveness of community programs
designed to prevent falls among older adults.
(2) EDUCATIONAL SUPPORT.—The Secretary, either directly
or through awarding grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of
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440
qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, may provide
professional education for physicians and allied health professionals, and aging service providers in fall prevention, evaluation, and management.
(c) DEMONSTRATION PROJECTS.—The Secretary may carry out
the following:
(1) Oversee and support demonstration and research
projects to be carried out by qualified organizations, institutions, or consortia of qualified organizations and institutions,
specializing, or demonstrating expertise, in falls or fall prevention, in the following areas:
(A) A multistate demonstration project assessing the
utility of targeted fall risk screening and referral programs.
(B) Programs designed for community-dwelling older
adults that utilize multicomponent fall intervention approaches, including physical activity, medication assessment and reduction when possible, vision enhancement,
and home modification strategies.
(C) Programs that are targeted to new fall victims who
are at a high risk for second falls and which are designed
to maximize independence and quality of life for older
adults, particularly those older adults with functional limitations.
(D) Private sector and public-private partnerships to
develop technologies to prevent falls among older adults
and prevent or reduce injuries if falls occur.
(2)(A) Award grants, contracts, or cooperative agreements
to qualified organizations, institutions, or consortia of qualified
organizations and institutions, specializing, or demonstrating
expertise, in falls or fall prevention, to design, implement, and
evaluate fall prevention programs using proven intervention
strategies in residential and institutional settings.
(B) Award 1 or more grants, contracts, or cooperative
agreements to 1 or more qualified organizations, institutions,
or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, in
order to carry out a multistate demonstration project to implement and evaluate fall prevention programs using proven
intervention strategies designed for single and multifamily residential settings with high concentrations of older adults, including—
(i) identifying high-risk populations;
(ii) evaluating residential facilities;
(iii) conducting screening to identify high-risk individuals;
(iv) providing fall assessment and risk reduction interventions and counseling;
(v) coordinating services with health care and social
service providers; and
(vi) coordinating post-fall treatment and rehabilitation.
(3) Award 1 or more grants, contracts, or cooperative
agreements to qualified organizations, institutions, or consortia
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of qualified organizations and institutions, specializing, or
demonstrating expertise, in falls or fall prevention, to conduct
evaluations of the effectiveness of the demonstration projects
described in this subsection.
(d) PRIORITY.—In awarding grants, contracts, or cooperative
agreements under this section, the Secretary may give priority to
entities that explore the use of cost-sharing with respect to activities funded under the grant, contract, or agreement to ensure the
institutional commitment of the recipients of such assistance to the
projects funded under the grant, contract, or agreement. Such nonFederal cost sharing contributions may be provided directly or
through donations from public or private entities and may be in
cash or in-kind, fairly evaluated, including plant, equipment, or
services.
(e) STUDY OF EFFECTS OF FALLS ON HEALTH CARE COSTS.—
(1) IN GENERAL.—The Secretary may conduct a review of
the effects of falls on health care costs, the potential for reducing falls, and the most effective strategies for reducing health
care costs associated with falls.
(2) REPORT.—If the Secretary conducts the review under
paragraph (1), the Secretary shall, not later than 36 months
after the date of enactment of the Safety of Seniors Act of
2007, submit to Congress a report describing the findings of
the Secretary in conducting such review.
GENERAL PROVISIONS
SEC. 394. ø280b–2¿ (a) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an advisory committee to advise the Secretary and such Director with respect to the prevention and control of injuries.
(b) The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, may provide technical assistance to public and nonprofit private entities with respect to the
planning, development, and operation of any program or service
carried out pursuant to this part. The Secretary may provide such
technical assistance directly or through grants or contracts.
(c) Not later than February 1 of 1995 and of every second year
thereafter, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Energy and Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources of the Senate, a report describing the activities carried out under this part
during the preceding 2 fiscal years. Such report shall include a description of such activities that were carried out with respect to
interpersonal violence within families and among acquaintances
and with respect to rural areas.
SEC. 394A. ø280b–3¿ AUTHORIZATIONS OF APPROPRIATIONS.
(a) IN GENERAL.—For the purpose of carrying out
this part,
there are authorized to be appropriated $50,000,000 for fiscal year
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1994, and 86 such sums as may be necessary for each of the fiscal
years 1995 through 1998, and such sums as may be necessary for
each of the fiscal years 2001 through 2005.
(b) TRAUMATIC BRAIN INJURY.—To carry out sections 393B and
393C, there are authorized to be appropriated $11,750,000 for each
of fiscal years 2020 through 2024.
PART K—HEALTH CARE SERVICES IN THE HOME AND PUBLIC
HEALTH PROGRAMS FOR DEMENTIA 87
Subpart I—Grants for Demonstration Projects
SEC. 395. ø280c¿ ESTABLISHMENT OF PROGRAM.
(a) IN GENERAL.—The Secretary, acting through
the Administrator of the Health Resources and Services Administration, shall
make not less than 5, and not more than 20, grants to States for
the purpose of assisting grantees in carrying out demonstration
projects—
(1) to identify low-income individuals who can avoid institutionalization or prolonged hospitalization if 88 skilled nursing
care services, homemaker or home health aide services, or personal care services are provided in the homes of the individuals;
(2) to pay the costs of the provision of such services in the
homes of such individuals; and
(3) to coordinate the provision by public and private entities of such services, and other long-term care services, in the
homes of such individuals.
(b) REQUIREMENT WITH RESPECT TO AGE OF RECIPIENTS OF
SERVICES.—The Secretary may not make a grant under subsection
(a) to a State unless the State agrees to ensure that—
(1) not less than 25 percent of the grant is expended to
provide services under such subsection to individuals who are
not less than 65 years of age; and
(2) of the portion of the grant reserved by the State for
purposes of complying with paragraph (1), not less than 10 percent is expended to provide such services to individuals who
are not less than 85 years of age.
(c) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PROGRAMS.—A State may not make payments from a grant under subsection (a) for any item or service to the extent that payment has
been made, or can reasonably be expected to be made, with respect
to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits
program; or
86 So in law. Section 1306 of Public Law 106–310 (114 Stat. 1143) attempts to strike ‘‘and’’,
but the amendment cannot be executed because the instructions were to strike ‘‘and’’ after
‘‘1994’’. (The word ‘‘and’’ appears after ‘‘1994,’’, not ‘‘1994’’.)
87 The style or formatting of the heading of Park K, as amended by section 2(1) of Public Law
115–406 and carried out above, reflects the original traditional style of such part heading.
88 Section 2(f) of Public Law 102–108 (105 Stat. 550) provides as follows: ‘‘(f) PUBLIC HEALTH
SERVICE ACT TECHNICAL AMENDMENTS.—Section 395. [280c](a)(1) after the word ‘if’ insert the
words ‘skilled medical services,’ ’’. The text of such section 2(f) does not provide sufficient amendatory instructions to execute an amendment. The apparent intent of the Congress was to amend
section 395(a)(1) of the Public Health Service Act (42 U.S.C. 280c(a)(1)).
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(2) by an entity that provides health services on a prepaid
basis.
SEC. 396. ø280c–1¿ LIMITATION ON DURATION OF GRANT AND REQUIREMENT OF MATCHING FUNDS.
(a) LIMITATION ON DURATION OF GRANT.—The period during
which payments are made to a State from a grant under section
395(a) may not exceed 3 years. Such payments shall be subject to
annual evaluation by the Secretary.
(b) REQUIREMENT OF MATCHING FUNDS.—
(1)(A) For the first year of payments to a State from a
grant under section 395(a), the Secretary may not make such
payments in an amount exceeding 75 percent of the costs of
services to be provided by the State pursuant to such section.
(B) For the second year of such payments to a State, the
Secretary may not make such payments in an amount exceeding 65 percent of the costs of such services.
(C) For the third year of such payments to a State, the
Secretary may not make such payments in an amount exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under section
395(a) to a State unless the State agrees to make available, directly or through donations from public or private entities,
non-Federal contributions toward the costs of services to be
provided pursuant to such section in an amount equal to—
(A) for the first year of payments to the State from the
grant, not less than $25 (in cash or in kind under subsection (c)) for each $75 of Federal funds provided in the
grant;
(B) for the second year of such payments to the State,
not less than $35 (in cash or in kind under subsection (c))
for each $65 of such Federal funds; and
(C) for the third year of such payments to the State,
not less than $45 (in cash or in kind under subsection (c))
for each $55 of such Federal funds.
(c) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—Non-Federal contributions required in subsection (b) may be
in cash or in kind, fairly evaluated, including plant, equipment, or
services. Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such
non-Federal contributions.
SEC. 397. ø280c–2¿ GENERAL PROVISIONS.
(a) LIMITATION ON ADMINISTRATIVE
EXPENSES.—The Secretary
may not make a grant under section 395(a) to a State unless the
State agrees that not more than 10 percent of the grant will be expended for administrative expenses with respect to the grant.
(b) DESCRIPTION OF INTENDED USE OF GRANT.—The Secretary
may not make a grant under section 395(a) to a State unless—
(1) the State submits to the Secretary a description of the
purposes for which the State intends to expend the grant; and
(2) such description provides information relating to the
programs and activities to be supported and services to be provided, including—
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(A) the number of individuals who will receive services
pursuant to section 395(a) and the average costs of providing such services to each such individual; and
(B) a description of the manner in which such programs and activities will be coordinated with any similar
programs and activities of public and private entities.
(c) REQUIREMENT OF APPLICATION.—The Secretary may not
make a grant under section 395(a) to a State unless the State has
submitted to the Secretary an application for the grant. The application shall—
(1) contain the description of intended expenditures required in subsection (b);
(2) with respect to carrying out the purpose for which the
grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner,
and contain such information and agreements as the Secretary
determines to be necessary to carry out this subpart.
(d) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary
shall—
(1) provide for an evaluation of each demonstration project
for which a grant is made under section 395(a); and
(2) not later than 6 months after the completion of such
evaluations, submit to the Congress a report describing the
findings made as a result of the evaluations.
(e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of
carrying out this subpart, there are authorized to be appropriated
$5,000,000 for each of the fiscal years 1988 through 1990,
$7,500,000 for fiscal year 1991, and such sums as may be necessary
for each of the fiscal years 1992 and 1993.
Subpart II—Programs With Respect to
Alzheimer’s Disease and Related Dementias
SEC. 398. ø280c–3¿ COOPERATIVE AGREEMENTS TO STATES AND PUBLIC HEALTH DEPARTMENTS FOR ALZHEIMER’S DISEASE
AND RELATED DEMENTIAS.
(a) IN GENERAL.—The Secretary, in coordination with the Di-
rector of the Centers for Disease Control and Prevention and the
heads of other agencies, as appropriate, shall award cooperative
agreements to health departments of States, political subdivisions
of States, and Indian tribes and tribal organizations, to address
Alzheimer’s disease and related dementias, including by reducing
cognitive decline, helping meet the needs of caregivers, and addressing unique aspects of Alzheimer’s disease and related dementias to support the development and implementation of evidencebased interventions with respect to—
(1) educating and informing the public, based on evidencebased public health research and data, about Alzheimer’s disease and related dementias;
(2) supporting early detection and diagnosis;
(3) reducing the risk of potentially avoidable hospitalizations for individuals with Alzheimer’s disease and related dementias;
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(4) reducing the risk of cognitive decline and cognitive impairment associated with Alzheimer’s disease and related dementias;
(5) improving support to meet the needs of caregivers of individuals with Alzheimer’s disease and related dementias;
(6) supporting care planning and management for individuals with Alzheimer’s disease and related dementias.
(7) supporting other relevant activities identified by the
Secretary or the Director of the Centers for Disease Control
and Prevention, as appropriate
(b) PREFERENCE.—In awarding cooperative agreements under
this section, the Secretary shall give preference to applications that
focus on addressing health disparities, including populations and
geographic areas that have the highest prevalence of Alzheimer’s
disease and related dementias.
(c) ELIGIBILITY.—To be eligible to receive a cooperative agreement under this section, an eligible entity (pursuant to subsection
(a)) shall prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as the
Secretary may require, including a plan that describes—
(1) how the applicant proposes to develop or expand, programs to educate individuals through partnership engagement,
workforce development, guidance and support for programmatic efforts, and evaluation with respect to Alzheimer’s
disease and related dementias, and in the case of a cooperative
agreement under this section, how the applicant proposes to
support other relevant activities identified by the Secretary or
Director of the Centers for Disease Control and Prevention, as
appropriate.
(2) the manner in which the applicant will coordinate with
Federal, tribal, and State programs related to Alzheimer’s disease and related dementias, and appropriate State, tribal, and
local agencies, as well as other relevant public and private organizations or agencies; and
(3) the manner in which the applicant will evaluate the effectiveness of any program carried out under the cooperative
agreement.
(d) MATCHING REQUIREMENT.—Each health department that is
awarded a cooperative agreement under subsection (a) shall provide, from non-Federal sources, an amount equal to 30 percent of
the amount provided under such agreement (which may be provided in cash or in-kind) to carry out the activities supported by
the cooperative agreement.
(e) WAIVER AUTHORITY.—The Secretary may waive all or part
of the matching requirement described in subsection (d) for any fiscal year for a health department of a State, political subdivision of
a State, or Indian tribe and tribal organization (including those located in a rural area or frontier area), if the Secretary determines
that applying such matching requirement would result in serious
hardship or an inability to carry out the purposes of the cooperative agreement awarded to such health department of a State, political subdivision of a State, or Indian tribe and tribal organization.
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(g) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PROGRAMS.—A State may not make payments from a grant 89 under
subsection (a) for any item or service to the extent that payment
has been made, or can reasonably be expected to be made, with respect to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits
program; or
(2) by an entity that provides health services on a prepaid
basis.
(f) 90 NON-DUPLICATION OF EFFORT.—The Secretary shall ensure that activities under any cooperative agreement awarded
under this subpart do not unnecessarily duplicate efforts of other
agencies and offices within the Department of Health and Human
Services related to—
(1) activities of centers of excellence with respect to Alzheimer’s disease and related dementias described in section
398A; and
(2) activities of public health departments with respect to
Alzheimer’s disease and related dementias described in this
section.
SEC. 398A. ø280c–4¿ PROMOTION OF PUBLIC HEALTH KNOWLEDGE AND
AWARENESS OF ALZHEIMER’S DISEASE AND RELATED DEMENTIAS.
(a) ALZHEIMER’S DISEASE AND RELATED DEMENTIAS PUBLIC
HEALTH CENTERS OF EXCELLENCE.—
(1) IN GENERAL.—The Secretary, in coordination with the
Director of the Centers for Disease Control and Prevention and
the heads of other agencies as appropriate, shall award grants,
contracts, or cooperative agreements to eligible entities, such
as institutions of higher education, State, tribal, and local
health departments, Indian tribes, tribal organizations, associations, or other appropriate entities for the establishment or
support of regional centers to address Alzheimer’s disease and
related dementias by—
(A) advancing the awareness of public health officials,
health care professionals, and the public, on the most current information and research related to Alzheimer’s disease and related dementias, including cognitive decline,
brain health, and associated health disparities;
(B) identifying and translating promising research
findings, such as findings from research and activities conducted or supported by the National Institutes of Health,
including Alzheimer’s Disease Research Centers authorized by section 445, into evidence-based programmatic
interventions for populations with Alzheimer’s disease and
related dementias and caregivers for such populations; and
89 Section 3(6) of Public Law 115–406 provides as follows: ‘‘(6) in subsection (f) (as so redesignated), by striking ‘grant’ and inserting ‘cooperative agreement’ ’’. The amendment was not carried out because it probably should have been made to subsection (g) (as so redesignated).
90 The placement of subsection (f) (as added to the end of the section by section 3(7) of Public
Law 115–406) is so in law. The amendment probably should have been made to insert this new
subsection before subsection (g) (as redesignated).
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(C) expanding activities, including through public-private partnerships related to Alzheimer’s disease and related dementias and associated health disparities.
(2) REQUIREMENTS.—To be eligible to receive a grant, contract, or cooperative agreement under this subsection, an entity shall submit to the Secretary an application containing such
agreements and information as the Secretary may require, including a description of how the entity will—
(A) coordinate, as applicable, with existing Federal,
State, and tribal programs related to Alzheimer’s disease
and related dementias;
(B) examine, evaluate, and promote evidence-based
interventions for individuals with Alzheimer’s disease and
related dementias, including underserved populations with
such conditions, and those who provide care for such individuals; and
(C) prioritize activities relating to—
(i) expanding efforts, as appropriate, to implement
evidence-based practices to address Alzheimer’s disease and related dementias, including through the
training of State, local, and tribal public health officials and other health professionals on such practices;
(ii) supporting early detection and diagnosis of
Alzheimer’s disease and related dementias;
(iii) reducing the risk of potentially avoidable hospitalizations of individuals with Alzheimer’s disease
and related dementias;
(iv) reducing the risk of cognitive decline and cognitive impairment associated with Alzheimer’s disease
and related dementias;
(v) enhancing support to meet the needs of caregivers of individuals with Alzheimer’s disease and related dementias;
(vi) reducing health disparities related to the care
and support of individuals with Alzheimer’s disease
and related dementias;
(vii) supporting care planning and management
for individuals with Alzheimer’s disease and related
dementias; and
(viii) supporting other relevant activities identified
by the Secretary or the Director of the Centers for Disease Control and Prevention, as appropriate.
(3) CONSIDERATIONS.—In awarding grants, contracts, and
cooperative agreements under this subsection, the Secretary
shall consider, among other factors, whether the entity—
(A) provides services to rural areas or other underserved populations;
(B) is able to build on an existing infrastructure of
services and public health research; and
(C) has experience with providing care or caregiver
support, or has experience conducting research related to
Alzheimer’s disease and related dementias.
(4) DISTRIBUTION OF AWARDS.—In awarding grants, contracts, or cooperative agreements under this subsection, the
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448
Secretary, to the extent practicable, shall ensure equitable distribution of awards based on geographic area, including consideration of rural areas, and the burden of the disease within
sub-populations.
(5) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant, contract, or cooperative agreement awarded
under this subsection, not later than 90 days after the end of
the first year of the period of assistance, and annually thereafter for the duration of the grant, contract, or agreement (including the duration of any renewal period as provided for
under paragraph (5)), the entity shall submit data, as appropriate, to the Secretary regarding—
(A) the programs and activities funded under the
grant, contract, or agreement; and
(B) outcomes related to such programs and activities.
(b) IMPROVING DATA ON STATE AND NATIONAL PREVALENCE OF
ALZHEIMER’S DISEASE AND RELATED DEMENTIAS.—
(1) IN GENERAL.—The Secretary shall, as appropriate, improve the analysis and timely reporting of data on the incidence and prevalence of Alzheimer’s disease and related dementias. Such data may include, as appropriate, information
on cognitive decline, caregiving, and health disparities experienced by individuals with cognitive decline and their caregivers. The Secretary may award grants, contracts, or cooperative agreements to eligible entities for activities under this
paragraph.
(2) ELIGIBILITY.—To be eligible to receive a grant, contract,
or cooperative agreement under this subsection, an entity shall
be a public or nonprofit private entity, including institutions of
higher education, State, local, and tribal health departments,
and Indian tribes and tribal organizations, and submit to the
Secretary an application at such time, in such manner, and
containing such information as the Secretary may require.
(3) DATA SOURCES.—The analysis, timely public reporting,
and dissemination of data under this subsection may be carried
out using data sources such as the following:
(A) The Behavioral Risk Factor Surveillance System.
(B) The National Health and Nutrition Examination
Survey.
(C) The National Health Interview Survey.
(c) IMPROVED COORDINATION.—The Secretary shall ensure that
activities and programs related to dementia under this section do
not unnecessarily duplicate activities and programs of other agencies and offices within the Department of Health and Human Services.
SEC. 398B. ø280c–5¿ GENERAL PROVISIONS.
(a) LIMITATION ON ADMINISTRATIVE EXPENSES.—The
Secretary
may not make a grant or cooperative agreement under sections 398
or 398A to an entity unless the entity agrees that not more than
5 percent of the grant or cooperative agreement will be expended
for administrative expenses with respect to the grant or cooperative
agreement.
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(b) REQUIREMENT OF APPLICATION.—The Secretary may not
make a grant under sections 398 or 398A to an entity unless the
entity has submitted to the Secretary an application for the grant.
The application shall—
(1) contain the description of intended expenditures;
(2) with respect to carrying out the purpose for which the
grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner,
and contain such information and agreements as the Secretary
determines to be necessary to carry out this subpart.
(c) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary
shall—
(1) provide for an evaluation of the activities for which an
award is made under sections 398 or 398A; and
(2) not later than 1 year after the completion of such evaluations, submit to the Congress a report describing the findings made as a result of the evaluations.
(d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and
‘‘tribal organization’’ have the meanings given such terms in section 4 of the Indian Health Care Improvement Act.
(e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of
carrying out this subpart, there are authorized to be appropriated
$20,000,000 for each of fiscal years 2020 through 2024.
Subpart III—Grants for Home Visiting Services for At-Risk
Families
SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND
CHILD HEALTH.
(a) IN GENERAL.—
(1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting
through the Administrator of the Health Resources and Services Administration, shall make grants to eligible entities to
pay the Federal share of the cost of providing the services specified in subsection (b) to families in which a member is—
(A) a pregnant woman at risk of delivering an infant
with a health or developmental complication; or
(B) a child less than 3 years of age—
(i) who is experiencing or is at risk of a health or
developmental complication, or of child abuse or neglect; or
(ii) who has been prenatally exposed to maternal
substance abuse.
(2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CONSULTATIONS.—
(A) The Secretary shall award grants under paragraph
(1) for periods of at least three years.
(B) The Administrator of the Administration for Children, Youth, and Families and the Director of the National
Commission to Prevent Infant Mortality shall be consulted
regarding the promulgation of program guidelines and
funding priorities under this section.
(3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
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(A) Subject to subparagraph (B), the Secretary may
make a grant under paragraph (1) only if, in the case of
any service under such paragraph that is covered in the
State plan approved under title XIX of the Social Security
Act for the State involved—
(i) the entity involved will provide the service directly, and the entity has entered into a participation
agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement with
an organization under which the organization will provide the service, and the organization has entered into
such a participation agreement and is qualified to receive such payments.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of
services under paragraph (1), the requirement established
in such subparagraph regarding a participation agreement
shall be waived by the Secretary if the organization does
not, in providing health or mental health services, impose
a charge or accept reimbursement available from any
third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a
waiver under such clause shall be made without regard to
whether the organization accepts voluntary donations regarding the provision of services to the public.
(b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With respect to an eligible family, each of the following services shall, directly or through arrangement with other public or nonprofit private entities, be available (as applicable to the family member involved) in each project operated with a grant under subsection (a):
(1) Prenatal and postnatal health care.
(2) Primary health care for the children, including developmental assessments.
(3) Education for the parents concerning infant care and
child development, including the development and utilization
of parent and teacher resource networks and other family resource and support networks where such networks are available.
(4) Upon the request of a parent, providing the education
described in paragraph (3) to other individuals who have responsibility for caring for the children.
(5) Education for the parents concerning behaviors that adversely affect health.
(6) Assistance in obtaining necessary health, mental
health, developmental, social, housing, and nutrition services
and other assistance, including services and other assistance
under maternal and child health programs; the special supplemental nutrition program for women, infants, and children;
section 17 of the Child Nutrition Act of 1966; title V of the Social Security Act; title XIX of such Act (including the program
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for early and periodic screening, diagnostic, and treatment
services described in section 1905(r) of such Act); titles IV and
XIX of the Social Security Act; housing programs; other food
assistance programs; and appropriate alcohol and drug dependency treatment programs, according to need.
(c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants
under subsection (a), the Secretary shall take into consideration—
(1) the ability of the entity involved to provide, either directly or through linkages, a broad range of preventive and primary health care services and related social, family support,
and developmental services;
(2) different combinations of professional and lay home
visitors utilized within programs that are reflective of the identified service needs and characteristics of target populations;
(3) the extent to which the population to be targeted has
limited access to health care, and related social, family support, and developmental services; and
(4) whether such grants are equitably distributed among
urban and rural settings and whether entities serving Native
American communities are represented among the grantees.
(d) FEDERAL SHARE.—With respect to the costs of carrying out
a project under subsection (a), a grant under such subsection for
the project may not exceed 90 percent of such costs. To be eligible
to receive such a grant, an applicant must provide assurances that
the applicant will obtain at least 10 percent of such costs from nonFederal funds (and such contributions to such costs may be in cash
or in-kind, including facilities and personnel).
(e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For
purposes of subsection (a)(1), a pregnant woman shall be considered to be at risk of delivering an infant with a health or developmental complication if during the pregnancy the woman—
(1) lacks appropriate access to, or information concerning,
early and routine prenatal care;
(2) lacks the transportation necessary to gain access to the
services described in subsection (b);
(3) lacks appropriate child care assistance, which results in
impeding the ability of such woman to utilize health and related social services;
(4) is fearful of accessing substance abuse services or child
and family support services; or
(5) is a minor with a low income.
(f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
(1) CASE MANAGEMENT MODEL.—Home visiting services
provided under this section shall be delivered according to a
case management model, and a registered nurse, licensed social worker, or other licensed health care professional with experience and expertise in providing health and related social
services in home and community settings shall be assigned as
the case manager for individual cases under such model.
(2) CASE MANAGER.—A case manager assigned under paragraph (1) shall have primary responsibility for coordinating
and overseeing the development of a plan for each family that
is to receive home visiting services under this section, and for
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coordinating the delivery of such services provided through appropriate personnel.
(3) APPROPRIATE PERSONNEL.—In determining which personnel shall be utilized in the delivery of services, the case
manager shall consider—
(A) the stated objective of the project to be operated
with the grant, as determined after considering identified
gaps in the current service delivery system; and
(B) the nature of the needs of the family to be served,
as determined at the initial assessment of the family that
is conducted by the case manager, and through follow-up
contacts by other providers of home visiting services.
(4) FAMILY SERVICE PLAN.—A case manager, in consultation with a team established in accordance with paragraph (5)
for the family involved, shall develop a plan for the family following the initial visit to the home of the family. Such plan
shall reflect—
(A) an assessment of the health and related social
service needs of the family;
(B) a structured plan for the delivery of home visiting
services to meet the identified needs of the family;
(C) the frequency with which such services are to be
provided to the family;
(D) ongoing revisions made as the needs of family
members change; and
(E) the continuing voluntary participation of the family in the plan.
(5) HOME VISITING SERVICES TEAM.—The team to be consulted under paragraph (4) on behalf of a family shall include,
as appropriate, other nursing professionals, physician assistants, social workers, child welfare professionals, infant and
early childhood specialists, nutritionists, and laypersons
trained as home visitors. The case manager shall ensure that
the plan is coordinated with those physician services that may
be required by the mother or child.
(g) OUTREACH.—Each grantee under subsection (a) shall provide outreach and casefinding services to inform eligible families of
the availability of home visiting services from the project.
(h) CONFIDENTIALITY.—In accordance with applicable State
law, an entity receiving a grant under subsection (a) shall maintain
confidentiality with respect to services provided to families under
this section.
(i) CERTAIN ASSURANCES.—The Secretary may award a grant
under subsection (a) only if the entity involved provides assurances
satisfactory to the Secretary that—
(1) the entity will provide home visiting services with reasonable frequency—
(A) to families with pregnant women, as early in the
pregnancy as is practicable, and until the infant reaches at
least 2 years of age; and
(B) to other eligible families, for at least 2 years; and
(2) the entity will coordinate with public health and related social service agencies to prevent duplication of effort and
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improve the delivery of comprehensive health and related social services.
(j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The
Secretary may award a grant under subsection (a) only if the entity
involved submits to the Secretary—
(1) a description of the population to be targeted for home
visiting services and methods of outreach and casefinding for
identifying eligible families, including the use of lay home visitors where appropriate;
(2) a description of the types and qualifications of home
visitors used by the entity and the process by which the entity
will provide continuing training and sufficient support to the
home visitors; and
(3) such other information as the Secretary determines to
be appropriate.
(k) LIMITATION REGARDING ADMINISTRATIVE EXPENSES.—Not
more than 10 percent of a grant under subsection (a) may be expended for administrative expenses with respect to the grant. The
costs of training individuals to serve in the project involved are not
subject to the preceding sentence.
(l) RESTRICTIONS ON USE OF GRANT.—To be eligible to receive
a grant under this section, an entity must agree that the grant will
not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or
permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of nonFederal funds as a condition for the receipt of Federal funds;
or
(5) to provide financial assistance to any entity other than
a public or nonprofit private entity.
(m) REPORTS TO SECRETARY.—To be eligible to receive a grant
under this section, an entity must agree to submit an annual report on the services provided under this section to the Secretary in
such manner and containing such information as the Secretary by
regulation requires. At a minimum, the entity shall report information concerning eligible families, including—
(1) the characteristics of the families and children receiving services under this section;
(2) the usage, nature, and location of the provider, of preventive health services, including prenatal, primary infant, and
child health care;
(3) the incidence of low birthweight and premature infants;
(4) the length of hospital stays for pre- and post-partum
women and their children;
(5) the incidence of substantiated child abuse and neglect
for all children within participating families;
(6) the number of emergency room visits for routine health
care;
(7) the source of payment for health care services and the
extent to which the utilization of health care services, other
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than routine screening and medical care, available to the individuals under the program established under title XIX of the
Social Security Act, and under other Federal, State, and local
programs, is reduced;
(8) the number and type of referrals made for health and
related social services, including alcohol and drug treatment
services, and the utilization of such services provided by the
grantee; and
(9) the incidence of developmental disabilities.
(n) REQUIREMENT OF APPLICATION.—The Secretary may make
a grant under subsection (a) only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements and assurances required in this section, and the information required in
subsection (j);
(3) the application contains evidence that the preparation
of the application has been coordinated with the State agencies
responsible for maternal and child health and child welfare,
and coordinated with services provided under part C of the Individuals with Disabilities Education Act; and
(4) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out
this section.
(o) PEER REVIEW.—
(1) REQUIREMENT.—In making determinations for awarding grants under subsection (a), the Secretary shall rely on the
recommendations of the peer review panel established under
paragraph (2).
(2) COMPOSITION.—The Secretary shall establish a review
panel to make recommendations under paragraph (1) that
shall be composed of—
(A) national experts in the fields of maternal and child
health, child abuse and neglect, and the provision of community-based primary health services; and
(B) representatives of relevant Federal agencies, including the Health Resources and Services Administration,
the Substance Abuse and Mental Health Services Administration, the Administration for Children, Youth, and Families, the U.S. Advisory Board on Child Abuse and Neglect,
and the National Commission to Prevent Infant Mortality.
(p) EVALUATIONS.—
(1) IN GENERAL.—The Secretary shall, directly or through
contracts with public or private entities—
(A) conduct evaluations to determine the effectiveness
of projects under subsection (a) in reducing the incidence
of children born with health or developmental complications, the incidence among children less than 3 years of
age of such complications, and the incidence of child abuse
and neglect; and
(B) not less than once during each 3-year period, prepare and submit to the appropriate committees of Congress a report concerning the results of such evaluations.
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(2) CONTENTS.—The evaluations conducted under paragraph (1) shall—
(A) include a summary of the data contained in the
annual reports submitted under subsection (m);
(B) assess the relative effectiveness of projects under
subsection (a) in urban and rural areas, and among programs utilizing differing combinations of professionals and
trained home visitors recruited from the community to
meet the needs of defined target service populations; and
(C) make further recommendations necessary or desirable to increase the effectiveness of such projects.
(q) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘eligible entity’’ includes public and nonprofit
private entities that provide health or related social services,
including community-based organizations, visiting nurse organizations, hospitals, local health departments, community
health centers, Native Hawaiian health centers, nurse managed clinics, family service agencies, child welfare agencies, developmental service providers, family resource and support
programs, and resource mothers projects.
(2) The term ‘‘eligible family’’ means a family described in
subsection (a).
(3) The term ‘‘health or developmental complication’’, with
respect to a child, means—
(A) being born in an unhealthy or potentially
unhealthy condition, including premature birth, low birthweight, and prenatal exposure to maternal substance
abuse;
(B) a condition arising from a condition described in
subparagraph (A);
(C) a physical disability or delay; and
(D) a developmental disability or delay.
(4) The term ‘‘home visiting services’’ means the services
specified in subsection (b), provided at the residence of the eligible family involved or provided pursuant to arrangements
made for the family (including arrangements for services in
community settings).
(5) The term ‘‘home visitors’’ means providers of home visiting services.
(r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there is authorized to be appropriated
$30,000,000 for each of the fiscal years 1993 and 1994.
øPart L 91—¿
91 The content of section 399A above, and the placement of the section in this Act, probably
do not reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106
of Public Law 106–310 (114 Stat. 1175) attempts to make various amendments to section 399D,
but the amendments cannot be executed because section 399D was redesignated as section 399A
by section 502(1) of such Public Law (114 Stat. 1115). (Section 399D now relates to technical
assistance in operations of Statewide cancer registries.)
Further, section 3106(m) of the Public Law (114 Stat. 1179) attempts to transfer section 399D
to title V of this Act as a section 519, but this transfer has not been executed because it applied
to section 399D ‘‘as amended by this section’’ (section 3106), and no amendments described in
section 3106 have been made to section 399D.
As a conforming amendment, section 3106(n) of the Public Law provided that title III of this
Act ‘‘is amended by striking the heading for part L’’. This amendment has been executed, but
Continued
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SEC. 399A. ø280d¿ GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS. 91
(a) ESTABLISHMENT.—
(1) IN GENERAL.—The Secretary, acting through the Ad-
ministrator of the Health Resources and Services Administration, shall make grants to public and nonprofit private entities
for the purpose of carrying out programs—
(A) to provide the services described in subsection (b)
to children of substance abusers;
(B) to provide the applicable services described in subsection (c) to families in which a member is a substance
abuser; and
(C) to identify such children and such families.
(2) ADMINISTRATIVE CONSULTATIONS.—The Administrator
of the Administration for Children, Youth, and Families and
the Administrator of the Substance Abuse and Mental Health
Services Administration shall be consulted regarding the promulgation of program guidelines and funding priorities under
this section.
(3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
(A) Subject to subparagraph (B), the Secretary may
make a grant under paragraph (1) only if, in the case of
any service under such paragraph that is covered in the
State plan approved under title XIX of the Social Security
Act for the State involved—
(i) the entity involved will provide the service directly, and the entity has entered into a participation
agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement with
an organization under which the organization will provide the service, and the organization has entered into
such a participation agreement and is qualified to receive such payments.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of
services under paragraph (1), the requirement established
in such subparagraph regarding a participation agreement
shall be waived by the Secretary if the organization does
not, in providing health or mental health services, impose
a charge or accept reimbursement available from any
third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a
waiver under such clause shall be made without regard to
whether the organization accepts voluntary donations regarding the provision of services to the public.
for the convenience of the reader, a designation for a part L is shown above in brackets to indicate the probable intent of the Congress that section 399A is not included in part K of title III.
For the convenience of the reader, an italicized note follows section 399A above showing the
section as it would appear if the amendments described in section 3106 of the Public Law were
executed to section 399A.
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(b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The
Secretary may make a grant under subsection (a) only if the applicant involved agrees to make available (directly or through agreements with other entities) to children of substance abusers each of
the following services:
(1) Periodic evaluation of children for developmental, psychological, and medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental health services.
(4) Therapeutic intervention services for children, including provision of therapeutic child care.
(5) Preventive counseling services.
(6) Counseling related to the witnessing of chronic violence.
(7) Referrals for, and assistance in establishing eligibility
for, services provided under—
(A) education and special education programs;
(B) Head Start programs established under the Head
Start Act;
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by Federal,
State, or local governments; and
(F) programs offered by vocational rehabilitation agencies, recreation departments, and housing agencies.
(8) Additional developmental services that are consistent
with the provision of early intervention services, as such term
is defined in part C of the Individuals with Disabilities Education Act.
(c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may
make a grant under subsection (a) only if, in the case of families
in which a member is a substance abuser, the applicant involved
agrees to make available (directly or through agreements with
other entities) each of the following services, as applicable to the
family member involved:
(1) Services as follows, to be provided by a public health
nurse, social worker, or similar professional, or by a trained
worker from the community who is supervised by a professional:
(A) Counseling to substance abusers on the benefits
and availability of substance abuse treatment services and
services for children of substance abusers.
(B) Assistance to substance abusers in obtaining and
using substance abuse treatment services and in obtaining
the services described in subsection (b) for their children.
(C) Visiting and providing support to substance abusers, especially pregnant women, who are receiving substance abuse treatment services or whose children are receiving services under subsection (b).
(2) In the case of substance abusers:
(A) Encouragement and, where necessary, referrals to
participate in appropriate substance abuse treatment.
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(B) Primary health care and mental health services,
including prenatal and post partum care for pregnant
women.
(C) Consultation and referral regarding subsequent
pregnancies and life options, including education and career planning.
(D) Where appropriate, counseling regarding family
conflict and violence.
(E) Remedial education services.
(F) Referrals for, and assistance in establishing eligibility for, services described in subsection (b)(7).
(3) In the case of substance abusers, spouses of substance
abusers, extended family members of substance abusers, caretakers of children of substance abusers, and other people significantly involved in the lives of substance abusers or the children of substance abusers:
(A) An assessment of the strengths and service needs
of the family and the assignment of a case manager who
will coordinate services for the family.
(B) Therapeutic intervention services, such as parental
counseling, joint counseling sessions for families and children, and family therapy.
(C) Child care or other care for the child to enable the
parent to attend treatment or other activities and respite
care services.
(D) Parenting education services and parent support
groups.
(E) Support services, including, where appropriate,
transportation services.
(F) Where appropriate, referral of other family members to related services such as job training.
(G) Aftercare services, including continued support
through parent groups and home visits.
(d) CONSIDERATIONS IN MAKING GRANTS.—In making grants
under subsection (a), the Secretary shall ensure that the grants are
reasonably distributed among the following types of entities:
(1) Alcohol and drug treatment programs, especially those
providing treatment to pregnant women and mothers and their
children.
(2) Public or nonprofit private entities that provide health
or social services to disadvantaged populations, and that
have—
(A) expertise in applying the services to the particular
problems of substance abusers and the children of substance abusers; and
(B) an affiliation or contractual relationship with one
or more substance abuse treatment programs.
(3) Consortia of public or nonprofit private entities that include at least one substance abuse treatment program.
(4) Indian tribes.
(e) FEDERAL SHARE.—The Federal share of a program carried
out under subsection (a) shall be 90 percent. The Secretary shall
accept the value of in-kind contributions, including facilities and
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personnel, made by the grant recipient as a part or all of the nonFederal share of grants.
(f) COORDINATION WITH OTHER PROVIDERS.—The Secretary
may make a grant under subsection (a) only if the applicant involved agrees to coordinate its activities with those of the State
lead agency, and the State Interagency Coordinating Council,
under part C of the Individuals with Disabilities Education Act.
(g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make
a grant under subsection (a) only if the applicant involved agrees
that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or
permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of nonFederal funds as a condition for the receipt of Federal funds;
or
(5) to provide financial assistance to any entity other than
a public or nonprofit private entity.
(h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The
Secretary may make a grant under subsection (a) only if the applicant involved submits to the Secretary—
(1) a description of the population that is to receive services under this section and a description of such services that
are to be provided and measurable goals and objectives;
(2) a description of the mechanism that will be used to involve the local public agencies responsible for health, mental
health, child welfare, education, juvenile justice, developmental
disabilities, and substance abuse treatment programs in planning and providing services under this section, as well as evidence that the proposal has been coordinated with the State
agencies responsible for administering those programs and the
State agency responsible for administering public maternal
and child health services;
(3) information demonstrating that the applicant has established a collaborative relationship with child welfare agencies and child protective services that will enable the applicant,
where appropriate, to—
(A) provide advocacy on behalf of substance abusers
and the children of substance abusers in child protective
services cases;
(B) provide services to help prevent the unnecessary
placement of children in substitute care; and
(C) promote reunification of families or permanent
plans for the placement of the child; and
(4) such other information as the Secretary determines to
be appropriate.
(i) REPORTS TO SECRETARY.—The Secretary may make a grant
under subsection (a) only if the applicant involved agrees that for
each fiscal year for which the applicant receives such a grant the
applicant, in accordance with uniform standards developed by the
Secretary, will submit to the Secretary a report containing—
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(1) a description of specific services and activities provided
under the grant;
(2) information regarding progress toward meeting the program’s stated goals and objectives;
(3) information concerning the extent of use of services
provided under the grant, including the number of referrals to
related services and information on other programs or services
accessed by children, parents, and other caretakers;
(4) information concerning the extent to which parents
were able to access and receive treatment for alcohol and drug
abuse and sustain participation in treatment over time until
the provider and the individual receiving treatment agree to
end such treatment, and the extent to which parents re-enter
treatment after the successful or unsuccessful termination of
treatment;
(5) information concerning the costs of the services provided and the source of financing for health care services;
(6) information concerning—
(A) the number and characteristics of families, parents, and children served, including a description of the
type and severity of childhood disabilities, and an analysis
of the number of children served by age;
(B) the number of children served who remained with
their parents during the period in which entities provided
services under this section;
(C) the number of children served who were placed in
out-of-home care during the period in which entities provided services under this section;
(D) the number of children described in subparagraph
(C) who were reunited with their families; and
(E) the number of children described in subparagraph
(C) for whom a permanent plan has not been made or for
whom the permanent plan is other than family reunification;
(7) information on hospitalization or emergency room use
by the family members participating in the program; and
(8) such other information as the Secretary determines to
be appropriate.
(j) REQUIREMENT OF APPLICATION.—The Secretary may make
any grant under subsection (a) only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements required in
this section and the information required in subsection (h); and
(3) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out
this section.
(k) PEER REVIEW.—
(1) REQUIREMENT.—In making determinations for awarding grants under subsection (a), the Secretary shall rely on the
recommendations of the peer review panel established under
paragraph (2).
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(2) COMPOSITION.—The Secretary shall establish a review
panel to make recommendations under paragraph (1) that
shall be composed of—
(A) national experts in the fields of maternal and child
health, substance abuse treatment, and child welfare; and
(B) representatives of relevant Federal agencies, including the Health Resources and Services Administration,
the Substance Abuse and Mental Health Services Administration, and the Administration for Children, Youth, and
Families.
(l) EVALUATIONS.—The Secretary shall periodically conduct
evaluations to determine the effectiveness of programs supported
under subsection (a)—
(1) in reducing the incidence of alcohol and drug abuse
among substance abusers participating in the programs;
(2) in preventing adverse health conditions in children of
substance abusers;
(3) in promoting better utilization of health and developmental services and improving the health, developmental, and
psychological status of children receiving services under the
program;
(4) in improving parental and family functioning;
(5) in reducing the incidence of out-of-home placement for
children whose parents receive services under the program;
and
(6) in facilitating the reunification of families after children have been placed in out-of-home care.
(m) REPORT TO CONGRESS.—Not later than 2 years after the
date on which amounts are first appropriated under subjection (o),
the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, a report
that contains a description of programs carried out under this section. At a minimum, the report shall contain—
(1) information concerning the number and type of programs receiving grants;
(2) information concerning the type and use of services offered;
(3) information concerning—
(A) the number and characteristics of families, parents, and children served;
(B) the number of children served who remained with
their parents during or after the period in which entities
provided services under this section;
(C) the number of children served who were placed in
out-of-home care during the period in which entities provided services under this section;
(D) the number of children described in subparagraph
(C) who were reunited with their families; and
(E) the number of children described in subparagraph
(C) who were permanently placed in out-of-home care;
analyzed by the type of entity described in subsection (d) that
provided services;
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(4) an analysis of the access provided to, and use of, related services and alcohol and drug treatment through programs carried out under this section; and
(5) a comparison of the costs of providing services through
each of the types of entities described in subsection (d).
(n) DATA COLLECTION.—The Secretary shall periodically collect
and report on information concerning the numbers of children in
substance abusing families, including information on the age, gender and ethnicity of the children, the composition and income of the
family, and the source of health care finances.
(o) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘caretaker’’, with respect to a child of a substance abuser, means any individual acting in a parental role
regarding the child (including any birth parent, foster parent,
adoptive parent, relative of such a child, or other individual
acting in such a role).
(2) The term ‘‘children of substance abusers’’ means—
(A) children who have lived or are living in a household with a substance abuser who is acting in a parental
role regarding the children; and
(B) children who have been prenatally exposed to alcohol or other dangerous drugs.
(3) The term ‘‘Indian tribe’’ means any tribe, band, nation,
or other organized group or community of Indians, including
any Alaska Native village (as defined in, or established pursuant to, the Alaska Native Claims Settlement Act), that is recognized as eligible for the special programs and services provided by the United States to Indians because of their status
as Indians.
(4) The term ‘‘public or nonprofit private entities that provide health or social services to disadvantaged populations’’ includes community-based organizations, local public health departments, community action agencies, hospitals, community
health centers, child welfare agencies, developmental disabilities service providers, and family resource and support programs.
(5) The term ‘‘substance abuse’’ means the abuse of alcohol
or other drugs.
NOTE: ƒFor the convenience of the reader, the following indicates
the probable intent of the Congress by showing section 399A as the
section would appear if the amendments described in section 3106
of Public Law 106–310 (114 Stat. 1175) were executed to section
399A, rather than to section 399D as instructed by such section
3106, including the amendment that redesignates the section as section 519 (toward the purpose of transferring the section to title V of
this Act). See footnote on page 619.≈
SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.
(a) ESTABLISHMENT.—
(1) IN GENERAL.—The Secretary, acting through the Admin-
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ministration, shall make grants to public and nonprofit private
entities for the purpose of carrying out programs—
(A) to provide the services described in subsection (b) to
children of substance abusers;
(B) to provide the applicable services described in subsection (c) to families in which a member is a substance
abuser;
(C) to identify such children and such families through
youth service agencies, family social services, child care
providers, Head Start, schools and after-school programs,
early childhood development programs, community-based
family resource and support centers, the criminal justice
system, health, substance abuse and mental health providers through screenings conducted during regular childhood examinations and other examinations, self and family
member referrals, substance abuse treatment services, and
other providers of services to children and families; and
(D) to provide education and training to health, substance abuse and mental health professionals, and other
providers of services to children and families through youth
service agencies, family social services, child care, Head
Start, schools and after-school programs, early childhood
development programs, community-based family resource
and support centers, the criminal justice system, and other
providers of services to children and families.
(2) ADMINISTRATIVE CONSULTATIONS.—The Administrator
of the Administration for Children, Youth, and Families and
the Administrator of the Health Resources and Services Administration shall be consulted regarding the promulgation of program guidelines and funding priorities under this section.
(3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
(A) Subject to subparagraph (B), the Secretary may
make a grant under paragraph (1) only if, in the case of
any service under such paragraph that is covered in the
State plan approved under title XIX of the Social Security
Act for the State involved—
(i)(I) the entity involved will provide the service directly, and the entity has entered into a participation
agreement under the State plan and is qualified to receive payments under such plan; or
(II) the entity will enter into an agreement with an
organization under which the organization will provide
the service, and the organization has entered into such
a participation agreement and is qualified to receive
such payments; and
(ii) the entity will identify children who may be eligible for medical assistance under a State program
under title XIX or XXI of the Social Security Act.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of
services under paragraph (1), the requirement established
in such subparagraph regarding a participation agreement
shall be waived by the Secretary if the organization does
not, in providing health or mental health services, impose
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a charge or accept reimbursement available from any thirdparty payor, including reimbursement under any insurance
policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a
waiver under such clause shall be made without regard to
whether the organization accepts voluntary donations regarding the provision of services to the public.
(b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The
Secretary may make a grant under subsection (a) only if the applicant involved agrees to make available (directly or through agreements with other entities) to children of substance abusers each of
the following services:
(1) Periodic evaluation of children for developmental, psychological, alcohol and drug, and medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental health services.
(4) Therapeutic intervention services for children, including
provision of therapeutic child care.
(5) Developmentally and age-appropriate drug and alcohol
early intervention, treatment and prevention services.
(6) Counseling related to the witnessing of chronic violence.
(7) Referrals for, and assistance in establishing eligibility
for, services provided under—
(A) education and special education programs;
(B) Head Start programs established under the Head
Start Act;
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by Federal,
State, or local governments; and
(F) programs offered by vocational rehabilitation agencies, recreation departments, and housing agencies.
(8) Additional developmental services that are consistent
with the provision of early intervention services, as such term
is defined in part H of the Individuals with Disabilities Education Act.
Services shall be provided under paragraphs (2) through (8) by a
public health nurse, social worker, or similar professional, or by a
trained worker from the community who is supervised by a professional, or by an entity, where the professional or entity provides assurances that the professional or entity is licensed or certified by the
State if required and is complying with applicable licensure or certification requirements.
(c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may
make a grant under subsection (a) only if, in the case of families
in which a member is a substance abuser, the applicant involved
agrees to make available (directly or through agreements with other
entities) each of the following services, as applicable to the family
member involved:
(1) Services as follows, to be provided by a public health
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sional, or by an entity, where the professional or entity provides
assurances that the professional or entity is licensed or certified
by the State if required and is complying with applicable licensure or certification requirements:
(A) Counseling to substance abusers on the benefits
and availability of substance abuse treatment services and
services for children of substance abusers.
(B) Assistance to substance abusers in obtaining and
using substance abuse treatment services and in obtaining
the services described in subsection (b) for their children.
(C) Visiting and providing support to substance abusers, especially pregnant women, who are receiving substance abuse treatment services or whose children are receiving services under subsection (b).
(D) Aggressive outreach to family members with substance abuse problems.
(E) Inclusion of consumer in the development, implementation, and monitoring of Family Services Plan.
(2) In the case of substance abusers:
(A) Alcohol and drug treatment services, including
screening and assessment, diagnosis, detoxification, individual, group and family counseling, relapse prevention,
pharmacotherapy treatment, after-care services, and case
management.
(B) Primary health care and mental health services, including prenatal and post partum care for pregnant
women.
(C) Consultation and referral regarding subsequent
pregnancies and life options and counseling on the human
immunodeficiency virus and acquired immune deficiency
syndrome.
(D) Where appropriate, counseling regarding family violence.
(E) Career planning and education services.
(F) Referrals for, and assistance in establishing eligibility for, services described in subsection (b)(7).
(3) In the case of substance abusers, spouses of substance
abusers, extended family members of substance abusers, caretakers of children of substance abusers, and other people significantly involved in the lives of substance abusers or the children of substance abusers:
(A) An assessment of the strengths and service needs of
the family and the assignment of a case manager who will
coordinate services for the family.
(B) Therapeutic intervention services, such as parental
counseling, joint counseling sessions for families and children, and family therapy.
(C) Child care or other care for the child to enable the
parent to attend treatment or other activities and respite
care services.
(D) Parenting education services and parent support
groups which include child abuse and neglect prevention
techniques.
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(E) Support services, including, where appropriate,
transportation services.
(F) Where appropriate, referral of other family members to related services such as job training.
(G) Aftercare services, including continued support
through parent groups and home visits.
(d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
FAMILIES.—The Secretary may make a grant under subsection (a)
for the training of health, substance abuse and mental health professionals and other providers of services to children and families
through youth service agencies, family social services, child care
providers, Head Start, schools and after-school programs, early
childhood development programs, community-based family resource
centers, the criminal justice system, and other providers of services
to children and families. Such training shall be to assist professionals in recognizing the drug and alcohol problems of their clients
and to enhance their skills in identifying and understanding the nature of substance abuse, and obtaining substance abuse early intervention, prevention and treatment resources.
(e) ELIGIBLE ENTITIES.—The Secretary shall distribute the
grants through the following types of entities:
(1) Alcohol and drug early intervention, prevention or treatment programs, especially those providing treatment to pregnant women and mothers and their children.
(2) Public or nonprofit private entities that provide health
or social services to disadvantaged populations, and that
have—
(A) expertise in applying the services to the particular
problems of substance abusers and the children of substance abusers; or
(B) an affiliation or contractual relationship with one
or more substance abuse treatment programs or pediatric
health or mental health providers and family mental
health providers.
(3) Consortia of public or nonprofit private entities that include at least one substance abuse treatment program.
(4) Indian tribes.
(f) FEDERAL SHARE.—The Federal share of a program carried
out under subsection (a) shall be 90 percent. The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by the grant recipient as a part or all of the non-Federal share of grants.
(g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make
a grant under subsection (a) only if the applicant involved agrees
that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or
permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of nonFederal funds as a condition for the receipt of Federal funds;
or
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(5) to provide financial assistance to any entity other than
a public or nonprofit private entity.
(h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The
Secretary may make a grant under subsection (a) only if the applicant involved submits to the Secretary—
(1) a description of the population that is to receive services
under this section and a description of such services that are to
be provided and measurable goals and objectives;
(2) a description of the mechanism that will be used to involve the local public agencies responsible for health, including
maternal and child health 92 mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse in planning and providing services under this section, as well as evidence that the proposal has been coordinated
with the State agencies responsible for administering those programs, the State agency responsible for administering alcohol
and drug programs, the State lead agency, and the State Interagency Coordinating Council under part H of the Individuals
with Disabilities Education Act; and; 93
(3) such other information as the Secretary determines to be
appropriate.
(i) REPORTS TO SECRETARY.—The Secretary may make a grant
under subsection (a) only if the applicant involved agrees that for
each fiscal year for which the applicant receives such a grant the
applicant, in accordance with uniform standards developed by the
Secretary, will submit to the Secretary a report containing—
(1) a description of specific services and activities provided
under the grant;
(2) information regarding progress toward meeting the program’s stated goals and objectives;
(3) information concerning the extent of use of services provided under the grant, including the number of referrals to related services and information on other programs or services
accessed by children, parents, and other caretakers;
(4) information concerning the extent to which parents were
able to access and receive treatment for alcohol and drug abuse
and sustain participation in treatment over time until the provider and the individual receiving treatment agree to end such
treatment, and the extent to which parents re-enter treatment
after the successful or unsuccessful termination of treatment;
(5) information concerning the costs of the services provided
and the source of financing for health care services;
(6) information concerning—
(A) the number and characteristics of families, parents,
and children served, including a description of the type and
severity of childhood disabilities, and an analysis of the
number of children served by age;
(B) the number of children served who remained with
their parents during the period in which entities provided
services under this section; and
92 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310
(114 Stat. 1177).
93 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106–
310 (114 Stat. 1177).
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(C) the number of case workers or other professionals
trained to identify and address substance abuse issues.
(7) information on hospitalization or emergency room use
by the family members participating in the program; and
(8) such other information as the Secretary determines to be
appropriate.
(j) REQUIREMENT OF APPLICATION.—The Secretary may make
any grant under subsection (a) only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements required in this
section and the information required in subsection (h); and
(3) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out
this section.
(k) EVALUATIONS.—The Secretary shall periodically conduct
evaluations to determine the effectiveness of programs supported
under subsection (a)—
(1) in reducing the incidence of alcohol and drug abuse
among substance abusers participating in the programs;
(2) in preventing adverse health conditions in children of
substance abusers;
(3) in promoting better utilization of health and developmental services and improving the health, developmental, and
psychological status of children receiving services under the
program; and
(4) in improving parental and family functioning, including increased participation in work or employment-related activities and decreased participation in welfare programs.
(l) REPORT TO CONGRESS.—Not later than 2 years after the date
on which amounts are first appropriated under subjection (o), the
Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives, and to the Committee on
Labor and Human Resources of the Senate, a report that contains
a description of programs carried out under this section. At a minimum, the report shall contain—
(1) information concerning the number and type of programs receiving grants;
(2) information concerning the type and use of services offered; and
(3) information concerning—
(A) the number and characteristics of families, parents,
and children served; and
(B) the number of children served who remained with
their parents during or after the period in which entities
provided services under this section. 94
94 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3),
would be so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period probably should be a semicolon, and the semicolon probably should be a period.
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PUBLIC HEALTH SERVICE ACT
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analyzed by the type of entity described in subsection (d) 95 that provided services; 96
(m) DATA COLLECTION.—The Secretary shall periodically collect
and report on information concerning the numbers of children in
substance abusing families, including information on the age, gender and ethnicity of the children, the composition and income of the
family, and the source of health care finances. The periodic report
shall include a quantitative estimate of the prevalence of alcohol
and drug problems in families involved in the child welfare system,
the barriers to treatment and prevention services facing these families, and policy recommendations for removing the identified barriers, including training for child welfare workers.
(n) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘caretaker’’, with respect to a child of a substance abuser, means any individual acting in a parental role
regarding the child (including any birth parent, foster parent,
adoptive parent, relative of such a child, or other individual
acting in such a role).
(2) The term ‘‘children of substance abusers’’ means—
(A) children who have lived or are living in a household with a substance abuser who is acting in a parental
role regarding the children; and
(B) children who have been prenatally exposed to alcohol or other drugs.
(3) The term ‘‘Indian tribe’’ means any tribe, band, nation,
or other organized group or community of Indians, including
any Alaska Native village (as defined in, or established pursuant to, the Alaska Native Claims Settlement Act), that is recognized as eligible for the special programs and services provided
by the United States to Indians because of their status as Indians.
(4) The term ‘‘public or nonprofit private entities that provide health or social services to disadvantaged populations’’ includes community-based organizations, local public health departments, community action agencies, hospitals, community
health centers, child welfare agencies, developmental disabilities service providers, and family resource and support programs.
(5) The term ‘‘substance abuse’’ means the abuse of alcohol
or other drugs.
(o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$50,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and 2003.
95 The reference to subsection (d) probably should be a reference to subsection (e). Section
3106(l) of Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
(e) and make conforming changes in cross-references. One of the conforming changes would be
to subsection (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears
in subsection (l), however, not subsection (m).
96 See footnote for subsection (l)(3)(B).
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Sec. 399B
PUBLIC HEALTH SERVICE ACT
PART M—NATIONAL PROGRAM
OF
470
CANCER REGISTRIES
SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
(a) IN GENERAL.—
(1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting
through the Director of the Centers for Disease Control, may
make grants to States, or may make grants or enter into contracts with academic or nonprofit organizations designated by
the State to operate the State’s cancer registry in lieu of making a grant directly to the State, to support the operation of
population-based, statewide registries to collect, for each condition specified in paragraph (2)(A), data concerning—
(A) demographic information about each case of cancer;
(B) information on the industrial or occupational history of the individuals with the cancers, to the extent such
information is available from the same record;
(C) administrative information, including date of diagnosis and source of information;
(D) pathological data characterizing the cancer, including the cancer site, stage of disease (pursuant to Staging
Guide), incidence, and type of treatment; and
(E) other elements determined appropriate by the Secretary.
(2) CANCER; BENIGN BRAIN-RELATED TUMORS.—
(A) IN GENERAL.—For purposes of paragraph (1), the
conditions referred to in this paragraph are the following:
(i) Each form of in-situ and invasive cancer (with
the exception of basal cell and squamous cell carcinoma of the skin), including malignant brain-related
tumors.
(ii) Benign brain-related tumors.
(B) BRAIN-RELATED TUMOR.—For purposes of subparagraph (A):
(i) The term ‘‘brain-related tumor’’ means a listed
primary tumor (whether malignant or benign) occurring in any of the following sites:
(I) The brain, meninges, spinal cord, cauda
equina, a cranial nerve or nerves, or any other
part of the central nervous system.
(II) The pituitary gland, pineal gland, or
craniopharyngeal duct.
(ii) The term ‘‘listed’’, with respect to a primary
tumor, means a primary tumor that is listed in the
International Classification of Diseases for Oncology
(commonly referred to as the ICD–O).
(iii) The term ‘‘International Classification of Diseases for Oncology’’ means a classification system that
includes topography (site) information and histology
(cell type information) developed by the World Health
Organization, in collaboration with international centers, to promote international comparability in the collection, classification, processing, and presentation of
cancer statistics. The ICD–O system is a supplement
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to the International Statistical Classification of Diseases and Related Health Problems (commonly known
as the ICD) and is the standard coding system used by
cancer registries worldwide. Such term includes any
modification made to such system for purposes of the
United States. Such term further includes any published classification system that is internationally recognized as a successor to the classification system referred to in the first sentence of this clause.
(C) STATEWIDE CANCER REGISTRY.—References in this
section to cancer registries shall be considered to be references to registries described in this subsection.
(b) MATCHING FUNDS.—
(1) IN GENERAL.—The Secretary may make a grant under
subsection (a) only if the State, or the academic or nonprofit
private organization designated by the State to operate the
cancer registry of the State, involved agrees, with respect to
the costs of the program, to make available (directly or through
donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 25
percent of such costs or $1 for every $3 of Federal funds provided in the grant.
(2) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION; MAINTENANCE OF EFFORT.—
(A) Non-Federal contributions required in paragraph
(1) may be in cash or in kind, fairly evaluated, including
plant, equipment, or services. Amounts provided by the
Federal Government, or services assisted or subsidized to
any significant extent by the Federal Government, may
not be included in determining the amount of such nonFederal contributions.
(B) With respect to a State in which the purpose described in subsection (a) is to be carried out, the Secretary,
in making a determination of the amount of non-Federal
contributions provided under paragraph (1), may include
only such contributions as are in excess of the amount of
such contributions made by the State toward the collection
of data on cancer for the fiscal year preceding the first
year for which a grant under subsection (a) is made with
respect to the State. The Secretary may decrease the
amount of non-Federal contributions that otherwise would
have been required by this subsection in those cases in
which the State can demonstrate that decreasing such
amount is appropriate because of financial hardship.
(c) ELIGIBILITY FOR GRANTS.—
(1) IN GENERAL.—No grant shall be made by the Secretary
under subsection (a) unless an application has been submitted
to, and approved by, the Secretary. Such application shall be
in such form, submitted in such a manner, and be accompanied
by such information, as the Secretary may specify. No such application may be approved unless it contains assurances that
the applicant will use the funds provided only for the purposes
specified in the approved application and in accordance with
the requirements of this section, that the application will esFebruary 1, 2024
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472
tablish such fiscal control and fund accounting procedures as
may be necessary to assure proper disbursement and accounting of Federal funds paid to the applicant under subsection (a)
of this section, and that the applicant will comply with the
peer review requirements under sections 491 and 492.
(2) ASSURANCES.—Each applicant, prior to receiving Federal funds under subsection (a), shall provide assurances satisfactory to the Secretary that the applicant will—
(A) provide for the establishment of a registry in accordance with subsection (a);
(B) comply with appropriate standards of completeness, timeliness, and quality of population-based cancer
registry data;
(C) provide for the annual publication of reports of
cancer data under subsection (a); and
(D) provide for the authorization under State law of
the statewide cancer registry, including promulgation of
regulations providing—
(i) a means to assure complete reporting of cancer
cases (as described in subsection (a)) to the statewide
cancer registry by hospitals or other facilities providing screening, diagnostic or therapeutic services to
patients with respect to cancer;
(ii) a means to assure the complete reporting of
cancer cases (as defined in subsection (a)) to the statewide cancer registry by physicians, surgeons, and all
other health care practitioners diagnosing or providing
treatment for cancer patients, except for cases directly
referred to or previously admitted to a hospital or
other facility providing screening, diagnostic or therapeutic services to patients in that State and reported
by those facilities;
(iii) a means for the statewide cancer registry to
access all records of physicians and surgeons, hospitals, outpatient clinics, nursing homes, and all other
facilities, individuals, or agencies providing such services to patients which would identify cases of cancer or
would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified
patient;
(iv) for the reporting of cancer case data to the
statewide cancer registry in such a format, with such
data elements, and in accordance with such standards
of quality timeliness and completeness, as may be established by the Secretary;
(v) for the protection of the confidentiality of all
cancer case data reported to the statewide cancer registry, including a prohibition on disclosure to any person of information reported to the statewide cancer
registry that identifies, or could lead to the identification of, an individual cancer patient, except for disclosure to other State cancer registries and local and
State health officers;
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(vi) for a means by which confidential case data
may in accordance with State law be disclosed to cancer researchers for the purposes of cancer prevention,
control and research;
(vii) for the authorization or the conduct, by the
statewide cancer registry or other persons and organizations, of studies utilizing statewide cancer registry
data, including studies of the sources and causes of
cancer, evaluations of the cost, quality, efficacy, and
appropriateness of diagnostic, therapeutic, rehabilitative, and preventative services and programs relating
to cancer, and any other clinical, epidemiological, or
other cancer research; and
(viii) for protection for individuals complying with
the law, including provisions specifying that no person
shall be held liable in any civil action with respect to
a cancer case report provided to the statewide cancer
registry, or with respect to access to cancer case information provided to the statewide cancer registry.
(d) RELATIONSHIP TO CERTAIN PROGRAMS.—
(1) IN GENERAL.—This section may not be construed to act
as a replacement for or diminishment of the program carried
out by the Director of the National Cancer Institute and designated by such Director as the Surveillance, Epidemiology,
and End Results Program (SEER).
(2) SUPPLANTING OF ACTIVITIES.—In areas where both such
programs exist, the Secretary shall ensure that SEER support
is not supplanted and that any additional activities are consistent with the guidelines provided for in subsection (c)(2) (C)
and (D) and are appropriately coordinated with the existing
SEER program.
(3) TRANSFER OF RESPONSIBILITY.—The Secretary may not
transfer administration responsibility for such SEER program
from such Director.
(4) COORDINATION.—To encourage the greatest possible efficiency and effectiveness of Federally supported efforts with
respect to the activities described in this subsection, the Secretary shall take steps to assure the appropriate coordination
of programs supported under this part with existing Federally
supported cancer registry programs.
(e) REQUIREMENT REGARDING CERTAIN STUDY ON BREAST CANCER.—In the case of a grant under subsection (a) to any State specified in subsection (b) of section 399E, the Secretary may establish
such conditions regarding the receipt of the grant as the Secretary
determines are necessary to facilitate the collection of data for the
study carried out under such section.
SEC. 399C. ø280e–1¿ PLANNING GRANTS REGARDING REGISTRIES.
(a) IN GENERAL.—
(1) STATES.—The Secretary, acting through the Director
of
the Centers for Disease Control, may make grants to States for
the purpose of developing plans that meet the assurances required by the Secretary under section 399B(c)(2).
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Sec. 399D
PUBLIC HEALTH SERVICE ACT
474
(2) OTHER ENTITIES.—For the purpose described in paragraph (1), the Secretary may make grants to public entities
other than States and to nonprofit private entities. Such a
grant may be made to an entity only if the State in which the
purpose is to be carried out has certified that the State approves the entity as qualified to carry out the purpose.
(b) APPLICATION.—The Secretary may make a grant under subsection (a) only if an application for the grant is submitted to the
Secretary, the application contains the certification required in subsection (a)(2) (if the application is for a grant under such subsection), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as
the Secretary determines to be necessary to carry out this section.
SEC. 399D. ø280e–2¿ TECHNICAL ASSISTANCE IN OPERATIONS OF
STATEWIDE CANCER REGISTRIES.
The Secretary, acting through the Director of the Centers for
Disease Control, may, directly or through grants and contracts, or
both, provide technical assistance to the States in the establishment and operation of statewide registries, including assistance in
the development of model legislation for statewide cancer registries
and assistance in establishing a computerized reporting and data
processing system.
SEC. 399E. ø280e–3¿ STUDY IN CERTAIN STATES TO DETERMINE THE
FACTORS CONTRIBUTING TO THE ELEVATED BREAST
CANCER MORTALITY RATES.
(a) IN GENERAL.—Subject to subsections (c) and (d), the Sec-
retary, acting through the Director of the National Cancer Institute, shall conduct a study for the purpose of determining the factors contributing to the fact that breast cancer mortality rates in
the States specified in subsection (b) are elevated compared to
rates in other States.
(b) RELEVANT STATES.—The States referred to in subsection (a)
are Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and the District of Columbia.
(c) COOPERATION OF STATE.—The Secretary may conduct the
study required in subsection (a) in a State only if the State agrees
to cooperate with the Secretary in the conduct of the study, including providing information from any registry operated by the State
pursuant to section 399B(a).
(d) PLANNING, COMMENCEMENT, AND DURATION.—The Secretary shall, during each of the fiscal years 1993 and 1994, develop
a plan for conducting the study required in subsection (a). The
study shall be initiated by the Secretary not later than fiscal year
1994, and the collection of data under the study may continue
through fiscal year 1998.
SEC. 399E–1. ø280e–3a¿ NATIONAL CHILDHOOD CANCER REGISTRY.
(a) IN GENERAL.—The Secretary, acting through the Director
of
the Centers for Disease Control and Prevention, may make awards
to State cancer registries to enhance and expand infrastructure to
collect information to better understand the epidemiology of cancer
in children, adolescents, and young adults. Such registries may be
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475
PUBLIC HEALTH SERVICE ACT
Sec. 399F
updated to include each occurrence of such cancers within a period
of time designated by the Secretary.
(b) ACTIVITIES.—The grants described in subsection (a) may be
used for—
(1) identifying, recruiting, and training potential sources
for reporting childhood, adolescent, and young adult cancer
cases;
(2) developing practices to ensure early inclusion of childhood, adolescent, and young adult cancer cases in State cancer
registries through the use of electronic reporting;
(3) collecting and submitting deidentified data to the Centers for Disease Control and Prevention for inclusion in a national database that includes information on childhood, adolescent, and young adult cancers; and
(4) improving State cancer registries and the database described in paragraph (3), as appropriate, including to support
the early inclusion of childhood, adolescent, and young adult
cancer cases.
(c) COORDINATION.—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect
to the activities described in this section, the Secretary shall ensure the appropriate coordination of programs supported under this
section with other federally supported cancer registry programs
and the activities under section 417E(a), as appropriate.
(d) INFORMED CONSENT AND PRIVACY REQUIREMENTS AND COORDINATION WITH EXISTING PROGRAMS.—The activities described in
this section shall be subject to section 552a of title 5, United States
Code, the regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996, applicable Federal and State informed consent regulations, any other
applicable Federal and State laws relating to the privacy of patient
information, and section 399B(d)(4) of this Act.
SEC. 399F. ø280e–4¿ AUTHORIZATION OF APPROPRIATIONS.
(a) REGISTRIES.—For the purpose of carrying out
this part
(other than section 399E–1), there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 through 2003. Of the
amounts appropriated under the preceding sentence for any such
fiscal year, the Secretary may obligate not more than 25 percent
for carrying out section 399C, and not more than 10 percent may
be expended for assessing the accuracy, completeness and quality
of data collected, and not more than 10 percent of which is to be
expended under section 399D.
(b) BREAST CANCER STUDY.—Of the amounts appropriated for
the National Cancer Institute under subpart 1 of part C of title IV
for any fiscal year in which the study required in section 399K 97
is being carried out, the Secretary shall expend not less than
$1,000,000 for the study.
97 Probably should be a reference to section 399E. Section 502(2)(D)(iii) of Public Law 106–
310 (114 Stat. 1115) provides that subsection (b) above is amended by striking ‘‘subsection
399K’’ and inserting ‘‘section 399E’’. The amendment cannot be executed because the term to
be struck does not appear in subsection (b). (Compare ‘‘subsection 399K’’ and ‘‘section 399K’’.)
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Sec. 399G
PUBLIC HEALTH SERVICE ACT
PART N—NATIONAL FOUNDATION FOR THE CENTERS
CONTROL AND PREVENTION
476
FOR
DISEASE
SEC. 399G. ø280e–11¿ ESTABLISHMENT AND DUTIES OF FOUNDATION.
(a) IN GENERAL.—There shall be established in accordance
with this section a nonprofit private corporation to be known as the
National Foundation for the Centers for Disease Control and Prevention (in this part referred to as the ‘‘Foundation’’). The Foundation shall not be an agency or instrumentality of the Federal Government, and officers, employees, and members of the board of the
Foundation shall not be officers or employees of the Federal Government.
(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation
shall be to support and carry out activities for the prevention and
control of diseases, disorders, injuries, and disabilities, and for promotion of public health.
(c) ENDOWMENT FUND.—
(1) IN GENERAL.—In carrying out subsection (b), the Foundation shall establish a fund for providing endowments for positions that are associated with the Centers for Disease Control
and Prevention and dedicated to the purpose described in such
subsection. Subject to subsection (f)(1)(B), the fund shall consist of such donations as may be provided by non-Federal entities and such non-Federal assets of the Foundation (including
earnings of the Foundation and the fund) as the Foundation
may elect to transfer to the fund.
(2) AUTHORIZED EXPENDITURES OF FUND.—The provision of
endowments under paragraph (1) shall be the exclusive function of the fund established under such paragraph. Such endowments may be expended only for the compensation of individuals holding the positions, for staff, equipment, quarters,
travel, and other expenditures that are appropriate in supporting the positions, and for recruiting individuals to hold the
positions endowed by the fund.
(d) CERTAIN ACTIVITIES OF FOUNDATION.—In carrying out subsection (b), the Foundation may provide for the following with respect to the purpose described in such subsection:
(1) Programs of fellowships for State and local public
health officials to work and study in association with the Centers for Disease Control and Prevention.
(2) Programs of international arrangements to provide opportunities for public health officials of other countries to serve
in public health capacities in the United States in association
with the Centers for Disease Control and Prevention or elsewhere, or opportunities for employees of such Centers (or other
public health officials in the United States) to serve in such capacities in other countries, or both.
(3) Studies, projects, and research (which may include applied research on the effectiveness of prevention activities,
demonstration projects, and programs and projects involving
international, Federal, State, and local governments).
(4) Forums for government officials and appropriate private entities to exchange information. Participants in such foFebruary 1, 2024
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477
PUBLIC HEALTH SERVICE ACT
Sec. 399G
rums may include institutions of higher education and appropriate international organizations.
(5) Meetings, conferences, courses, and training workshops.
(6) Programs to improve the collection and analysis of data
on the health status of various populations.
(7) Programs for writing, editing, printing, and publishing
of books and other materials.
(8) Other activities to carry out the purpose described in
subsection (b).
(e) GENERAL STRUCTURE OF FOUNDATION; NONPROFIT STATUS.—
(1) BOARD OF DIRECTORS.—The Foundation shall have a
board of directors (in this part referred to as the ‘‘Board’’),
which shall be established and conducted in accordance with
subsection (f). The Board shall establish the general policies of
the Foundation for carrying out subsection (b), including the
establishment of the bylaws of the Foundation.
(2) EXECUTIVE DIRECTOR.—The Foundation shall have an
executive director (in this part referred to as the ‘‘Director’’),
who shall be appointed by the Board, who shall serve at the
pleasure of the Board, and for whom the Board shall establish
the rate of compensation. Subject to compliance with the policies and bylaws established by the Board pursuant to paragraph (1), the Director shall be responsible for the daily operations of the Foundation in carrying out subsection (b).
(3) NONPROFIT STATUS.—In carrying out subsection (b), the
Board shall establish such policies and bylaws under paragraph (1), and the Director shall carry out such activities
under paragraph (2), as may be necessary to ensure that the
Foundation maintains status as an organization that—
(A) is described in subsection (c)(3) of section 501 of
the Internal Revenue Code of 1986; and
(B) is, under subsection (a) of such section, exempt
from taxation.
(f) BOARD OF DIRECTORS.—
(1) CERTAIN BYLAWS.—
(A) In establishing bylaws under subsection (e)(1), the
Board shall ensure that the bylaws of the Foundation include bylaws for the following:
(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation.
(ii) Policies, including ethical standards, for the
acceptance and disposition of donations to the Foundation and for the disposition of the assets of the Foundation.
(iii) Policies for the conduct of the general operations of the Foundation.
(iv) Policies for writing, editing, printing, and publishing of books and other materials, and the acquisition of patents and licenses for devices and procedures
developed by the Foundation.
(B) In establishing bylaws under subsection (e)(1), the
Board shall ensure that the bylaws of the Foundation (and
activities carried out under the bylaws) do not—
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Sec. 399G
PUBLIC HEALTH SERVICE ACT
478
(i) reflect unfavorably upon the ability of the
Foundation, or the Centers for Disease Control and
Prevention, to carry out its responsibilities or official
duties in a fair and objective manner; or
(ii) compromise, or appear to compromise, the integrity of any governmental program or any officer or
employee involved in such program.
(2) COMPOSITION.—
(A) Subject to subparagraph (B), the Board shall be
composed of 7 individuals, appointed in accordance with
paragraph (4), who collectively possess education or experience appropriate for representing the general field of public health, the general field of international health, and the
general public. Each such individual shall be a voting
member of the Board.
(B) The Board may, through amendments to the bylaws of the Foundation, provide that the number of members of the Board shall be a greater number than the number specified in subparagraph (A).
(3) CHAIR.—The Board shall, from among the members of
the Board, designate an individual to serve as the chair of the
Board (in this subsection referred to as the ‘‘Chair’’).
(4) APPOINTMENTS, VACANCIES, AND TERMS.—Subject to
subsection (j) (regarding the initial membership of the Board),
the following shall apply to the Board:
(A) Any vacancy in the membership of the Board shall
be filled by appointment by the Board, after consideration
of suggestions made by the Chair and the Director regarding the appointments. Any such vacancy shall be filled not
later than the expiration of the 180-day period beginning
on the date on which the vacancy occurs.
(B) The term of office of each member of the Board appointed under subparagraph (A) shall be 5 years. A member of the Board may continue to serve after the expiration
of the term of the member until the expiration of the 180day period beginning on the date on which the term of the
member expires.
(C) A vacancy in the membership of the Board shall
not affect the power of the Board to carry out the duties
of the Board. If a member of the Board does not serve the
full term applicable under subparagraph (B), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor
of the individual.
(5) COMPENSATION.—Members of the Board may not receive compensation for service on the Board. The members may
be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board.
(g) CERTAIN RESPONSIBILITIES OF EXECUTIVE DIRECTOR.—In
carrying out subsection (e)(2), the Director shall carry out the following functions:
(1) Hire, promote, compensate, and discharge officers and
employees of the Foundation, and define the duties of the officers and employees.
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PUBLIC HEALTH SERVICE ACT
Sec. 399G
(2) Accept and administer donations to the Foundation,
and administer the assets of the Foundation.
(3) Establish a process for the selection of candidates for
holding endowed positions under subsection (c).
(4) Enter into such financial agreements as are appropriate in carrying out the activities of the Foundation.
(5) Take such action as may be necessary to acquire patents and licenses for devices and procedures developed by the
Foundation and the employees of the Foundation.
(6) Adopt, alter, and use a corporate seal, which shall be
judicially noticed.
(7) Commence and respond to judicial proceedings in the
name of the Foundation.
(8) Other functions that are appropriate in the determination of the Director.
(h) GENERAL PROVISIONS.—
(1) AUTHORITY FOR ACCEPTING FUNDS.—The Director of the
Centers for Disease Control and Prevention may accept and
utilize, on behalf of the Federal Government, any gift, donation, bequest, or devise of real or personal property from the
Foundation for the purpose of aiding or facilitating the work of
such Centers. Funds may be accepted and utilized by such Director under the preceding sentence without regard to whether
the funds are designated as general-purpose funds or specialpurpose funds.
(2) AUTHORITY FOR ACCEPTANCE OF VOLUNTARY SERVICES.—
(A) The Director of the Centers for Disease Control
and Prevention may accept, on behalf of the Federal Government, any voluntary services provided to such Centers
by the Foundation for the purpose of aiding or facilitating
the work of such Centers. In the case of an individual,
such Director may accept the services provided under the
preceding sentence by the individual until such time as the
private funding for such individual ends.
(B) The limitation established in subparagraph (A) regarding the period of time in which services may be accepted applies to each individual who is not an employee
of the Federal Government and who serves in association
with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation.
(3) ADMINISTRATIVE CONTROL.—No officer, employee, or
member of the Board of the Foundation may exercise any administrative or managerial control over any Federal employee.
(4) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL
EMPLOYEES.—In the case of any individual who is not an employee of the Federal Government and who serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation, the Foundation shall negotiate a memorandum of understanding with the
individual and the Director of the Centers for Disease Control
and Prevention specifying that the individual—
(A) shall be subject to the ethical and procedural
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PUBLIC HEALTH SERVICE ACT
480
tigation, and research findings (including publications and
patents) that are required of individuals employed by the
Centers for Disease Control and Prevention, including
standards under this Act, chapter 131 of title 5, United
States Code, and the Technology Transfer Act; and
(B) shall be subject to such ethical and procedural
standards under chapter 11 of title 18, United States Code
(relating to conflicts of interest), as the Director of such
Centers determines is appropriate, except such memorandum may not provide that the individual shall be subject to the standards of section 209 of such chapter.
(5) FINANCIAL CONFLICTS OF INTEREST.—Any individual
who is an officer, employee, or member of the Board of the
Foundation may not directly or indirectly participate in the
consideration or determination by the Foundation of any question affecting—
(A) any direct or indirect financial interest of the individual; or
(B) any direct or indirect financial interest of any business organization or other entity of which the individual is
an officer or employee or in which the individual has a direct or indirect financial interest.
(6) AUDITS; AVAILABILITY OF RECORDS.—The Foundation
shall—
(A) provide for biennial audits of the financial condition of the Foundation; and
(B) make such audits, and all other records, documents, and other papers of the Foundation, available to
the Secretary and the Comptroller General of the United
States for examination or audit.
(7) REPORTS.—
(A) Not later than February 1 of each fiscal year, the
Foundation shall publish a report describing the activities
of the Foundation during the preceding fiscal year. Each
such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial
condition, and accomplishments of the Foundation, including an accounting of the use of amounts provided for under
subsection (i).
(B) With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include
the source, and a description of, all gifts to the Foundation
of real or personal property, and the source and amount of
all gifts to the Foundation of money. Each such report
shall include a specification of any restrictions on the purposes for which gifts to the Foundation may be used.
(C) The Foundation shall make copies of each report
submitted under subparagraph (A) available—
(i) for public inspection, and shall upon request
provide a copy of the report to any individual for a
charge not to exceed the cost of providing the copy;
and
(ii) to the appropriate committees of Congress.
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PUBLIC HEALTH SERVICE ACT
Sec. 399G
(8) LIAISON FROM CENTERS FOR DISEASE CONTROL AND PREVENTION.—The Director of the Centers for Disease Control and
Prevention shall serve as the liaison representative of such
Centers to the Board and the Foundation.
(i) FEDERAL FUNDING.—
(1) AUTHORITY FOR ANNUAL GRANTS.—
(A) The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall—
(i) for fiscal year 1993, make a grant to an entity
described in subsection (j)(9) (relating to the establishment of a committee to establish the Foundation);
(ii) for fiscal year 1994, make a grant to the committee established under such subsection, or if the
Foundation has been established, to the Foundation;
and
(iii) for fiscal year 1995 and each subsequent fiscal
year, make a grant to the Foundation.
(B) A grant under subparagraph (A) may be expended—
(i) in the case of an entity receiving the grant
under subparagraph (A)(i), only for the purpose of carrying out the duties established in subsection (j)(9) for
the entity;
(ii) in the case of the committee established under
such subsection, only for the purpose of carrying out
the duties established in subsection (j) for the committee; and
(iii) in the case of the Foundation, only for the
purpose of the administrative expenses of the Foundation.
(C) A grant under subparagraph (A) may not be expended to provide amounts for the fund established under
subsection (c).
(D) For the purposes described in subparagraph (B)—
(i) any portion of the grant made under subparagraph (A)(i) for fiscal year 1993 that remains unobligated after the entity receiving the grant completes
the duties established in subsection (j)(9) for the entity
shall be available to the committee established under
such subsection; and
(ii) any portion of a grant under subparagraph (A)
made for fiscal year 1993 or 1994 that remains unobligated after such committee completes the duties established in such subsection for the committee shall be
available to the Foundation.
(2) FUNDING FOR GRANTS.—
(A) For the purpose of grants under paragraph (1),
there is authorized to be appropriated $1,250,000 for each
fiscal year.
(B) For the purpose of grants under paragraph (1), the
Secretary may for each fiscal year make available not less
than $500,000, and not more than $1,250,000 from the
amounts appropriated for the fiscal year for the programs
of the Department of Health and Human Services. Such
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Sec. 399G
PUBLIC HEALTH SERVICE ACT
482
amounts may be made available without regard to whether
amounts have been appropriated under subparagraph (A).
(3) CERTAIN RESTRICTION.—If the Foundation receives Federal funds for the purpose of serving as a fiscal intermediary
between Federal agencies, the Foundation may not receive
such funds for the indirect costs of carrying out such purpose
in an amount exceeding 10 percent of the direct costs of carrying out such purpose. The preceding sentence may not be
construed as authorizing the expenditure of any grant under
paragraph (1) for such purpose.
(4) SUPPORT SERVICES.—The Director of the Centers for
Disease Control and Prevention may provide facilities, utilities,
and support services to the Foundation if it is determined by
the Director to be advantageous to the programs of such Centers.
(j) COMMITTEE FOR ESTABLISHMENT OF FOUNDATION.—
(1) IN GENERAL.—There shall be established in accordance
with this subsection a committee to carry out the functions described in paragraph (2) (which committee is referred to in this
subsection as the ‘‘Committee’’).
(2) FUNCTIONS.—The functions referred to in paragraph (1)
for the Committee are as follows:
(A) To carry out such activities as may be necessary
to incorporate the Foundation under the laws of the State
involved, including serving as incorporators for the Foundation. Such activities shall include ensuring that the articles of incorporation for the Foundation require that the
Foundation be established and operated in accordance
with the applicable provisions of this part (or any successor to this part), including such provisions as may be in
effect pursuant to amendments enacted after the date of
the enactment of the Preventive Health Amendments of
1992 98.
(B) To ensure that the Foundation qualifies for and
maintains the status described in subsection (e)(3) (regarding taxation).
(C) To establish the general policies and initial bylaws
of the Foundation, which bylaws shall include the bylaws
described in subsections (e)(3) and (f)(1).
(D) To provide for the initial operation of the Foundation, including providing for quarters, equipment, and
staff.
(E) To appoint the initial members of the Board in accordance with the requirements established in subsection
(f)(2)(A) for the composition of the Board, and in accordance with such other qualifications as the Committee may
determine to be appropriate regarding such composition.
Of the members so appointed—
(i) 2 shall be appointed to serve for a term of 3
years;
(ii) 2 shall be appointed to serve for a term of 4
years; and
98 Enacted
October 27, 1992.
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(iii) 3 shall be appointed to serve for a term of 5
years.
(3) COMPLETION OF FUNCTIONS OF COMMITTEE; INITIAL
MEETING OF BOARD.—
(A) The Committee shall complete the functions required in paragraph (1) not later than September 30, 1994.
The Committee shall terminate upon the expiration of the
30-day period beginning on the date on which the Secretary determines that the functions have been completed.
(B) The initial meeting of the Board shall be held not
later than November 1, 1994.
(4) COMPOSITION.—The Committee shall be composed of 5
members, each of whom shall be a voting member. Of the
members of the Committee—
(A) no fewer than 2 shall have broad, general experience in public health; and
(B) no fewer than 2 shall have broad, general experience in nonprofit private organizations (without regard to
whether the individuals have experience in public health).
(5) CHAIR.—The Committee shall, from among the members of the Committee, designate an individual to serve as the
chair of the Committee.
(6) TERMS; VACANCIES.—The term of members of the Committee shall be for the duration of the Committee. A vacancy
in the membership of the Committee shall not affect the power
of the Committee to carry out the duties of the Committee. If
a member of the Committee does not serve the full term, the
individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the
individual.
(7) COMPENSATION.—Members of the Committee may not
receive compensation for service on the Committee. Members
of the Committee may be reimbursed for travel, subsistence,
and other necessary expenses incurred in carrying out the duties of the Committee.
(8) COMMITTEE SUPPORT.—The Director of the Centers for
Disease Control and Prevention may, from amounts available
to the Director for the general administration of such Centers,
provide staff and financial support to assist the Committee
with carrying out the functions described in paragraph (2). In
providing such staff and support, the Director may both detail
employees and contract for assistance.
(9) GRANT FOR ESTABLISHMENT OF COMMITTEE.—
(A) With respect to a grant under paragraph (1)(A)(i)
of subsection (i) for fiscal year 1993, an entity described in
this paragraph is a private nonprofit entity with significant experience in domestic and international issues of
public health. Not later than 180 days after the date of the
enactment of the Preventive Health Amendments of
1992 99, the Secretary shall make the grant to such an en99 Enacted
October 27, 1992.
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tity (subject to the availability of funds under paragraph
(2) of such subsection).
(B) The grant referred to in subparagraph (A) may be
made to an entity only if the entity agrees that—
(i) the entity will establish a committee that is
composed in accordance with paragraph (4); and
(ii) the entity will not select an individual for
membership on the Committee unless the individual
agrees that the Committee will operate in accordance
with each of the provisions of this subsection that relate to the operation of the Committee.
(C) The Secretary may make a grant referred to in
subparagraph (A) only if the applicant for the grant makes
an agreement that the grant will not be expended for any
purpose other than carrying out subparagraph (B). Such a
grant may be made only if an application for the grant is
submitted to the Secretary containing such agreement, and
the application is in such form, is made in such manner,
and contains such other agreements and such assurances
and information as the Secretary determines to be necessary to carry out this paragraph.
PART O—FETAL ALCOHOL SYNDROME
PREVENTION AND SERVICES PROGRAM
SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME
PREVENTION AND SERVICES PROGRAM.
(a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION
AND SERVICES DELIVERY PROGRAM.—The Secretary shall establish
a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect
prevention, intervention and services delivery program that shall
include—
(1) an education and public awareness program to support,
conduct, and evaluate the effectiveness of—
(A) educational programs targeting medical schools,
social and other supportive services, educators and counselors and other service providers in all phases of childhood development, and other relevant service providers,
concerning the prevention, identification, and provision of
services for children, adolescents and adults with Fetal Alcohol Syndrome and Fetal Alcohol Effect;
(B) strategies to educate school-age children, including
pregnant and high risk youth, concerning Fetal Alcohol
Syndrome and Fetal Alcohol Effect;
(C) public and community awareness programs concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
and
(D) strategies to coordinate information and services
across affected community agencies, including agencies
providing social services such as foster care, adoption, and
social work, medical and mental health services, and agencies involved in education, vocational training and civil
and criminal justice;
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(2) a prevention and diagnosis program to support clinical
studies, demonstrations and other research as appropriate to—
(A) develop appropriate medical diagnostic methods for
identifying Fetal Alcohol Syndrome and Fetal Alcohol Effect; and
(B) develop effective prevention services and interventions for pregnant, alcohol-dependent women; and
(3) an applied research program concerning intervention
and prevention to support and conduct service demonstration
projects, clinical studies and other research models providing
advocacy, educational and vocational training, counseling, medical and mental health, and other supportive services, as well
as models that integrate and coordinate such services, that are
aimed at the unique challenges facing individuals with Fetal
Alcohol Syndrome or Fetal Alcohol Effect and their families.
(b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may
award grants, cooperative agreements and contracts and provide
technical assistance to eligible entities described in section 399I to
carry out subsection (a).
(c) DISSEMINATION OF CRITERIA.—In carrying out this section,
the Secretary shall develop a procedure for disseminating the Fetal
Alcohol Syndrome and Fetal Alcohol Effect diagnostic criteria developed pursuant to section 705 of the ADAMHA Reorganization
Act (42 U.S.C. 485n note) to health care providers, educators, social
workers, child welfare workers, and other individuals.
(d) NATIONAL TASK FORCE.—
(1) IN GENERAL.—The Secretary shall establish a task force
to be known as the National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (referred to in this subsection
as the ‘‘Task Force’’) to foster coordination among all governmental agencies, academic bodies and community groups that
conduct or support Fetal Alcohol Syndrome and Fetal Alcohol
Effect research, programs, and surveillance, and otherwise
meet the general needs of populations actually or potentially
impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect.
(2) MEMBERSHIP.—The Task Force established pursuant to
paragraph (1) shall—
(A) be chaired by an individual to be appointed by the
Secretary and staffed by the Administration; and
(B) include the Chairperson of the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services, individuals with
Fetal Alcohol Syndrome and Fetal Alcohol Effect, and representatives from advocacy and research organizations
such as the Research Society on Alcoholism, the FAS Family Resource Institute, the National Organization of Fetal
Alcohol Syndrome, the Arc, the academic community, and
Federal, State and local government agencies and offices.
(3) FUNCTIONS.—The Task Force shall—
(A) advise Federal, State and local programs and research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect, including programs and research concerning
education and public awareness for relevant service providers, school-age children, women at-risk, and the general
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public, medical diagnosis, interventions for women at-risk
of giving birth to children with Fetal Alcohol Syndrome
and Fetal Alcohol Effect, and beneficial services for individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect and their families;
(B) coordinate its efforts with the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services; and
(C) report on a biennial basis to the Secretary and relevant committees of Congress on the current and planned
activities of the participating agencies.
(4) TIME FOR APPOINTMENT.—The members of the Task
Force shall be appointed by the Secretary not later than 6
months after the date of enactment of this part.
SEC. 399I. ø280f–1¿ ELIGIBILITY.
To be eligible to receive a grant, or enter into a cooperative
agreement or contract under this part, an entity shall—
(1) be a State, Indian tribal government, local government,
scientific or academic institution, or nonprofit organization;
and
(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may prescribe, including a description of the activities that the entity intends to carry out using amounts received under this part.
SEC. 399J. ø280f–2¿ AUTHORIZATION OF APPROPRIATIONS.
(a) IN GENERAL.—There are authorized to be appropriated
to
carry out this part, $27,000,000 for each of the fiscal years 1999
through 2003.
(b) TASK FORCE.—From amounts appropriated for a fiscal year
under subsection (a), the Secretary may use not to exceed
$2,000,000 of such amounts for the operations of the National Task
Force under section 399H(d).
SEC. 399K. ø280f–3¿ SUNSET PROVISION.
This part shall not apply on the date that is 7 years after the
date on which all members of the National Task Force have been
appointed under section 399H(d)(1).
PART P—ADDITIONAL PROGRAMS
SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PROGRAM.
(a) AUTHORITY TO MAKE GRANTS.—
(1) IN GENERAL.—In addition to any other payments made
under this Act or title V of the Social Security Act, the Secretary shall award grants to eligible entities to carry out the
following purposes:
(A) To provide access to quality medical care for children who live in areas that have a high prevalence of asthma and who lack access to medical care.
(B) To provide on-site education to parents, children,
health care providers, and medical teams to recognize the
signs and symptoms of asthma, and to train them in the
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use of medications to treat asthma and prevent its exacerbations.
(C) To decrease preventable trips to the emergency
room by making medication available to individuals who
have not previously had access to treatment or education
in the management of asthma.
(D) To provide other services, such as smoking cessation programs, home modification, and other direct and
support services that ameliorate conditions that exacerbate
or induce asthma.
(2) CERTAIN PROJECTS.—In making grants under paragraph (1), the Secretary may make grants designed to develop
and expand the following projects:
(A) Projects to provide comprehensive asthma services
to children in accordance with the guidelines of the National Asthma Education and Prevention Program
(through the National Heart, Lung and Blood Institute),
including access to care and treatment for asthma in a
community-based setting.
(B) Projects to fully equip mobile health care clinics
that provide preventive asthma care including diagnosis,
physical examinations, pharmacological therapy, skin testing, peak flow meter testing, and other asthma-related
health care services.
(C) Projects to conduct validated asthma management
education programs for patients with asthma and their
families, including patient education regarding asthma
management, family education on asthma management,
and the distribution of materials, including displays and
videos, to reinforce concepts presented by medical teams.
(2) 100 AWARD OF GRANTS.—
(A) APPLICATION.—
(i) IN GENERAL.—An eligible entity shall submit
an application to the Secretary for a grant under this
section in such form and manner as the Secretary may
require.
(ii) REQUIRED INFORMATION.—An application submitted under this subparagraph shall include a plan
for the use of funds awarded under the grant and such
other information as the Secretary may require.
(B) REQUIREMENT.—In awarding grants under this
section, the Secretary shall give preference to eligible entities that demonstrate that the activities to be carried out
under this section shall be in localities within areas of
known or suspected high prevalence of childhood asthma
or high asthma-related mortality or high rate of hospitalization or emergency room visits for asthma (relative
to the average asthma prevalence rates and associated
mortality rates in the United States). Acceptable data sets
to demonstrate a high prevalence of childhood asthma or
high asthma-related mortality may include data from Fed100 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and
paragraph (3) probably should be redesignated as paragraphs (3) and (4), respectively. See section 501 of Public Law 106–310 (114 Stat. 1113).
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eral, State, or local vital statistics, claims data under title
XIX or XXI of the Social Security Act, other public health
statistics or surveys, or other data that the Secretary, in
consultation with the Director of the Centers for Disease
Control and Prevention, deems appropriate.
(3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this
section, the term ‘‘eligible entity’’ means a public or nonprofit
private entity (including a State or political subdivision of a
State), or a consortium of any of such entities.
(b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—An eligible entity shall identify in the plan submitted as part of an application for a grant under this section how the entity will coordinate operations and activities under the grant with—
(1) other programs operated in the State that serve children with asthma, including any such programs operated
under title V, XIX, or XXI of the Social Security Act; and
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such
Act;
(B) the head start program established under the
Head Start Act (42 U.S.C. 9831 et seq.);
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under section 17 of the Child Nutrition Act of
1966 (42 U.S.C. 1786);
(D) local public and private elementary or secondary
schools; or
(E) public housing agencies, as defined in section 3 of
the United States Housing Act of 1937 (42 U.S.C. 1437a).
(c) EVALUATION.—An eligible entity that receives a grant under
this section shall submit to the Secretary an evaluation of the operations and activities carried out under the grant that includes—
(1) a description of the health status outcomes of children
assisted under the grant;
(2) an assessment of the utilization of asthma-related
health care services as a result of activities carried out under
the grant;
(3) the collection, analysis, and reporting of asthma data
according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention; and
(4) such other information as the Secretary may require.
(d) PREFERENCE FOR STATES THAT ALLOW STUDENTS TO SELFADMINISTER MEDICATION TO TREAT ASTHMA AND ANAPHYLAXIS.—
101
(1) PREFERENCE.—The Secretary, in making any grant
under this section or any other grant that is asthma-related
(as determined by the Secretary) to a State, shall give preference to any State that satisfies the following:
101 Subsection (d) was added by section 3(a) of Public Law 108–377 (118 Stat. 2203), which
was enacted October 30, 2004. Section 3(b) of such Public Law provides as follows: ‘‘The amendments made by this section shall apply only with respect to grants made on or after the date
that is 9 months after the date of the enactment of this Act.’’.
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(A) IN GENERAL.—The State must require that each
public elementary school and secondary school in that
State will grant to any student in the school an authorization for the self-administration of medication to treat that
student’s asthma or anaphylaxis, if—
(i) a health care practitioner prescribed the medication for use by the student during school hours and
instructed the student in the correct and responsible
use of the medication;
(ii) the student has demonstrated to the health
care practitioner (or such practitioner’s designee) and
the school nurse (if available) the skill level necessary
to use the medication and any device that is necessary
to administer such medication as prescribed;
(iii) the health care practitioner formulates a written treatment plan for managing asthma or anaphylaxis episodes of the student and for medication use by
the student during school hours; and
(iv) the student’s parent or guardian has completed and submitted to the school any written documentation required by the school, including the treatment plan formulated under clause (iii) and other documents related to liability.
(B) SCOPE.—An authorization granted under subparagraph (A) must allow the student involved to possess and
use his or her medication—
(i) while in school;
(ii) while at a school-sponsored activity, such as a
sporting event; and
(iii) in transit to or from school or school-sponsored activities.
(C) DURATION OF AUTHORIZATION.—An authorization
granted under subparagraph (A)—
(i) must be effective only for the same school and
school year for which it is granted; and
(ii) must be renewed by the parent or guardian
each subsequent school year in accordance with this
subsection.
(D) BACKUP MEDICATION.—The State must require
that backup medication, if provided by a student’s parent
or guardian, be kept at a student’s school in a location to
which the student has immediate access in the event of an
asthma or anaphylaxis emergency.
(E) MAINTENANCE OF INFORMATION.—The State must
require that information described in subparagraphs
(A)(iii) and (A)(iv) be kept on file at the student’s school in
a location easily accessible in the event of an asthma or
anaphylaxis emergency.
(F) SCHOOL PERSONNEL ADMINISTRATION OF EPINEPHRINE OR SCHOOL COMPREHENSIVE ALLERGIES AND ASTHMA
MANAGEMENT PROGRAM.—
(i) IN GENERAL.—In determining the preference (if
any) to be given to a State under this subsection, the
Secretary shall give additional preference to a State
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that provides to the Secretary the certification described in subparagraph (G) and that requires that
each public elementary school and secondary schoolin
the State satisfy the criteria described in clause (ii) or
clause (iii).
(ii) CRITERIA FOR SCHOOL PERSONNEL ADMINISTRATION OF EPINEPHRINE.—For purposes of clause (i), the
criteria described in this clause, with respect to each
public elementary school and secondary school in the
State, are that each such school—
(I) permits trained personnel of the school to
administer epinephrine to any student of the
school reasonably believed to be having an
anaphylactic reaction;
(II) maintains a supply of epinephrine in a secure location that is easily accessible to trained
personnel of the school for the purpose of administration to any student of the school reasonably believed to be having an anaphylactic reaction; and
(III) has in place a plan for having on the
premises of the school during all operating hours
of the school one or more individuals who are
trained personnel of the school.
(iii) CRITERIA FOR SCHOOL COMPREHENSIVE ALLERGIES AND ASTHMA MANAGEMENT PROGRAM.—For purposes of clause (i), the criteria described in this clause,
with respect to each public elementary school and secondary school in the State, are that each such school—
(I) has in place a plan for having on the premises of the school during all operating hours of the
school a school nurse or one or more other individuals who are designated by the principal (or other
appropriate administrative staff) of the school to
direct and apply the program described in subclause (II) on a voluntary basis outside their scope
of employment; and
(II) has in place, under the direction of a
school nurse or other individual designated under
subclause (I), a comprehensive school-based allergies and asthma management program that includes—
(aa) a method to identify all students of
such school with a diagnosis of allergies and
asthma;
(bb) an individual student allergies and
asthma action plan for each student of such
school with a diagnosis of allergies and asthma;
(cc) allergies and asthma education for
school staff who are directly responsible for
students who have been identified as having
allergies or asthma, such as education regarding basics, management, trigger management,
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and comprehensive emergency responses with
respect to allergies and asthma;
(dd) efforts to reduce the presence of environmental triggers of allergies and asthma;
and
(ee) a system to support students with a
diagnosis of allergies or asthma through coordination with family members of such students, primary care providers of such students, primary asthma or allergy care providers of such students, and others as necessary.
(G) CIVIL LIABILITY PROTECTION LAW.—The certification required in subparagraph (F) shall be a certification
made by the State attorney general that the State has reviewed any applicable civil liability protection law to determine the application of such law with regard to elementary and secondary school trained personnel who may administer epinephrine to a student reasonably believed to
be having an anaphylactic reaction and has concluded that
such law provides adequate civil liability protection applicable to such trained personnel. For purposes of the previous sentence, the term ‘‘civil liability protection law’’
means a State law offering legal protection to individuals
who give aid on a voluntary basis in an emergency to an
individual who is ill, in peril, or otherwise incapacitated.
(2) RULE OF CONSTRUCTION.—Nothing in this subsection
creates a cause of action or in any other way increases or diminishes the liability of any person under any other law.
(3) DEFINITIONS.—For purposes of this subsection:
(A) The terms ‘‘elementary school’’ and ‘‘secondary
school’’ have the meaning given to those terms in section
8101 of the Elementary and Secondary Education Act of
1965.
(B) The term ‘‘health care practitioner’’ means a person authorized under law to prescribe drugs subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act.
(C) The term ‘‘medication’’ means a drug as that term
is defined in section 201 of the Federal Food, Drug, and
Cosmetic Act and includes inhaled bronchodilators and
auto-injectable epinephrine.
(D) The term ‘‘self-administration’’ means a student’s
discretionary use of his or her prescribed asthma or anaphylaxis medication, pursuant to a prescription or written
direction from a health care practitioner.
(E) The term ‘‘trained personnel’’ means, with respect
to an elementary or secondary school, an individual, such
as the school nurse—
(i) who has been designated by the school nurse or
principal (or other appropriate administrative staff) of
the school to administer epinephrine on a voluntary
basis outside their scope of employment;
(ii) who has received training in the administration of epinephrine; and
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(iii) whose training in the administration of epinephrine meets appropriate medical standards and
has been documented by appropriate administrative
staff of the school.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT
REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
INFANTS, AND YOUNG CHILDREN.
(a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING
SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—The Secretary, acting through the Administrator of the
Health Resources and Services Administration, shall make awards
of grants or cooperative agreements to develop statewide newborn,
infant, and young child hearing screening, evaluation, diagnosis,
and intervention programs and systems, and to assist in the recruitment, retention, education, and training of qualified personnel
and health care providers (including, as appropriate, education and
training of family members), for the following purposes:
(1) To develop and monitor the efficacy of statewide programs and systems for hearing screening of newborns, infants,
and young children (referred to in this section as ‘‘children’’);
prompt evaluation and diagnosis of children referred from
screening programs; and appropriate educational, audiological,
medical, and communication (or language acquisition) interventions (including family support), for children identified as
deaf or hard-of-hearing, consistent with the following:
(A) Early intervention includes referral to, and delivery of, information and services by organizations such as
schools and agencies (including community, consumer, and
family-based agencies), in health care settings (including
medical homes for children), and in programs mandated by
part C of the Individuals with Disabilities Education Act,
which offer programs specifically designed to meet the
unique language and communication needs of deaf and
hard-of-hearing children.
(B) Information provided to families should be accurate, comprehensive, up-to-date, and evidence-based, as
appropriate, to allow families to make important decisions
for their children in a timely manner, including decisions
with respect to the full range of assistive hearing technologies and communications modalities, as appropriate.
(C) Programs and systems under this paragraph shall
offer mechanisms that foster family-to-family and deaf and
hard-of-hearing consumer-to-family supports.
(2) To continue to provide technical support to States,
through one or more technical resource centers, to assist in further developing and enhancing State early hearing detection
and intervention programs.
(3) To identify or develop efficient models (educational and
medical) to ensure that children who are identified as deaf or
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fied early intervention providers or qualified health care providers (including those at medical homes for children), and referrals, as appropriate, including to early intervention services
under part C of the Individuals with Disabilities Education
Act. State agencies shall be encouraged to effectively increase
the rate of such follow-up and referral.
(b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED
RESEARCH.—
(1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
(A) IN GENERAL.—The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies or
designated entities of States—
(i) to develop, maintain, and improve data collection systems related to newborn, infant, and young
child hearing screening, evaluation (including
audiologic, medical, and language acquisition evaluations), diagnosis, and intervention services;
(ii) to conduct applied research related to newborn, infant, and young child hearing screening, evaluation, and intervention programs and outcomes;
(iii) to ensure quality monitoring of hearing
screening, evaluation, and intervention programs and
systems for newborns, infants, and young children;
and
(iv) to support newborn, infant, and young child
hearing screening, evaluation, and intervention programs, and information systems.
(B) USE OF AWARDS.—The awards made under subparagraph (A) may be used—
(i) to provide technical assistance on data collection and management, including to coordinate and develop standardized procedures for data management;
(ii) to assess and report on the cost and program
effectiveness of newborn, infant, and young child hearing screening, evaluation, and intervention programs
and systems;
(iii) to collect data and report on newborn, infant,
and young child hearing screening, evaluation, diagnosis, and intervention programs and systems for applied research, program evaluation, and policy improvement;
(iv) to identify the causes and risk factors for congenital hearing loss;
(v) to study the effectiveness of newborn, infant,
and young child hearing screening, audiologic and
medical evaluations and intervention programs and
systems by assessing the health, intellectual and social developmental, cognitive, and hearing status of
these children at school age; and
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tween clinical care and public health settings, including the ability of States and territories to exchange
and share data.
(2) NATIONAL INSTITUTES OF HEALTH.—The Director of the
National Institutes of Health, acting through the Director of
the National Institute on Deafness and Other Communication
Disorders, shall for purposes of this section, continue a program of research and development on the efficacy of new
screening techniques and technology, including clinical studies
of screening methods, studies on efficacy of intervention, and
related research.
(c) COORDINATION AND COLLABORATION.—
(1) IN GENERAL.—In carrying out programs under this section, the Administrator of the Health Resources and Services
Administration, the Director of the Centers for Disease Control
and Prevention, and the Director of the National Institutes of
Health shall collaborate and consult with—
(A) other Federal agencies;
(B) State and local agencies, including agencies responsible for early intervention services pursuant to title
XIX of the Social Security Act (Medicaid Early and Periodic Screening, Diagnosis and Treatment Program); title
XXI of the Social Security Act (State Children’s Health Insurance Program); title V of the Social Security Act (Maternal and Child Health Block Grant Program); and part
C of the Individuals with Disabilities Education Act;
(C) consumer groups of, and that serve, individuals
who are deaf and hard-of-hearing and their families;
(D) appropriate national medical and other health and
education specialty organizations;
(E) individuals who are deaf or hard-of-hearing and
their families;
(F) other qualified professional personnel who are proficient in deaf or hard-of-hearing children’s language and
who possess the specialized knowledge, skills, and attributes needed to serve deaf and hard-of-hearing children,
and their families;
(G) third-party payers and managed care organizations; and
(H) related commercial industries.
(2) POLICY DEVELOPMENT.—The Administrator of the
Health Resources and Services Administration, the Director of
the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and
collaborate on recommendations for policy development at the
Federal and State levels and with the private sector, including
consumer, medical and other health and education professional-based organizations, with respect to newborn and infant
hearing screening, evaluation, diagnosis, and intervention programs and systems.
(3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION
PROGRAMS AND SYSTEMS; DATA COLLECTION.—The Administrator of the Health Resources and Services Administration
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and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States—
(A) to establish newborn, infant, and young child hearing screening, evaluation, diagnosis, and intervention programs and systems under subsection (a); and
(B) to develop a data collection system under subsection (b).
(d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.—
Nothing in this section shall be construed to preempt or prohibit
any State law, including State laws that do not require the screening for hearing loss of children of parents who object to the screening on the grounds that such screening conflicts with the parent’s
religious beliefs.
(e) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘audiologic’’, when used in connection with
evaluation, means procedures—
(A) to assess the status of the auditory system;
(B) to establish the site of the auditory disorder, the
type and degree of hearing loss, and the potential effects
of hearing loss on communication; and
(C) to identify appropriate treatment and referral options, including—
(i) linkage to State coordinating agencies under
part C of the Individuals with Disabilities Education
Act or other appropriate agencies;
(ii) medical evaluation;
(iii) assessment for the full range of assistive
hearing technologies appropriate for newborns, infants, and young children;
(iv) audiologic rehabilitation treatment; and
(v) referral to national and local consumer, selfhelp, parent, family, and education organizations, and
other family-centered services.
(2) The term ‘‘early intervention’’means—
(A) providing appropriate services for the child who is
deaf or hard-of-hearing, including nonmedical services; and
(B) ensuring that the family of the child is—
(i) provided comprehensive, consumer-oriented information about the full range of family support, training, information services, and language acquisition in
oral and visual modalities; and
(ii) given the opportunity to consider and obtain
the full range of such appropriate services, educational
and program placements, and other options for the
child from highly qualified providers.
(3) The term ‘‘medical evaluation’’ means key components
performed by a physician including history, examination, and
medical decisionmaking focused on symptomatic and related
body systems for the purpose of diagnosing the etiology of
hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.
(4) The term ‘‘medical intervention’’means the process by
which a physician provides medical diagnosis and direction for
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medical or surgical treatment options for hearing loss or other
medical disorders associated with hearing loss.
(5) The term ‘‘newborn, infant, and young child hearing
screening’’ means objective physiologic procedures to detect
possible hearing loss and to identify newborns, infants, and
young children under 3 years of age who require further
audiologic and medical evaluations.
(f) AUTHORIZATION OF APPROPRIATIONS.—
(1) STATEWIDE NEWBORN AND INFANT HEARING SCREENING,
EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—For
the purpose of carrying out subsection (a), there are authorized
to be appropriated to the Health Resources and Services Administration $17,818,000 for each of fiscal years 2023 through
2027.
(2) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH; CENTERS FOR DISEASE CONTROL AND PREVENTION.—For the purpose of carrying out subsection (b)(1), there
are authorized to be appropriated to the Centers for Disease
Control and Prevention $10,760,000 for each of fiscal years
2023 through 2027.
(3) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH; NATIONAL INSTITUTE ON DEAFNESS AND OTHER
COMMUNICATION DISORDERS.—For the purpose of carrying out
subsection (b)(2), there are authorized to be appropriated to the
National Institute on Deafness and Other Communication Disorders such sums as may be necessary for fiscal years 2011
through 2015.
SEC. 399N. ø280g–2¿ CHILDHOOD MALIGNANCIES.
(a) IN GENERAL.—The Secretary, acting as
appropriate through
the Director of the Centers for Disease Control and Prevention and
the Director of the National Institutes of Health, shall study environmental and other risk factors for childhood cancers (including
skeletal malignancies, leukemias, malignant tumors of the central
nervous system, lymphomas, soft tissue sarcomas, and other malignant neoplasms) and carry out projects to improve outcomes among
children with childhood cancers and resultant secondary conditions,
including limb loss, anemia, rehabilitation, and palliative care.
Such projects shall be carried out by the Secretary directly and
through awards of grants or contracts.
(b) CERTAIN ACTIVITIES.—Activities under subsection (a) include—
(1) the expansion of current demographic data collection
and population surveillance efforts to include childhood cancers
nationally;
(2) the development of a uniform reporting system under
which treating physicians, hospitals, clinics, and States report
the diagnosis of childhood cancers, including relevant associated epidemiological data; and
(3) support for the National Limb Loss Information Center
to address, in part, the primary and secondary needs of persons who experience childhood cancers in order to prevent or
minimize the disabling nature of these cancers.
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(c) COORDINATION OF ACTIVITIES.—The Secretary shall assure
that activities under this section are coordinated as appropriate
with other agencies of the Public Health Service that carry out activities focused on childhood cancers and limb loss.
(d) DEFINITION.—For purposes of this section, the term ‘‘childhood cancer’’ refers to a spectrum of different malignancies that
vary by histology, site of disease, origin, race, sex, and age. The
Secretary may for purposes of this section revise the definition of
such term to the extent determined by the Secretary to be appropriate.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2001
through 2005.
SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
(a) PROGRAM.—
(1) IN GENERAL.—Each fiscal year, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, in coordination with the heads of other departments and agencies as appropriate, shall support States or localities for the purpose of improving the efficiency and use of
PDMPs, including—
(A) establishment and implementation of a PDMP;
(B) maintenance of a PDMP;
(C) improvements to a PDMP by—
(i) enhancing functional components to work toward—
(I) universal use of PDMPs among providers
and their delegates, to the extent that State laws
allow;
(II) more timely inclusion of data within a
PDMP;
(III) active management of the PDMP, in part
by sending proactive or unsolicited reports to providers to inform prescribing; and
(IV) ensuring the highest level of ease in use
of and access to PDMPs by providers and their
delegates, to the extent that State laws allow;
(ii) in consultation with the Office of the National
Coordinator for Health Information Technology, improving the intrastate interoperability of PDMPs by—
(I) making PDMPs more actionable by integrating PDMPs within electronic health records
and health information technology infrastructure;
and
(II) linking PDMP data to other data systems
within the State, including—
(aa) the data of pharmacy benefit managers, medical examiners and coroners, and
the State’s Medicaid program;
(bb) worker’s compensation data; and
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(cc) prescribing data of providers of the
Department of Veterans Affairs and the Indian Health Service within the State;
(iii) in consultation with the Office of the National
Coordinator for Health Information Technology, improving the interstate interoperability of PDMPs
through—
(I) sharing of dispensing data in near-real
time across State lines; and
(II) integration of automated queries for
multistate PDMP data and analytics into clinical
workflow to improve the use of such data and analytics by practitioners and dispensers; or
(iv) improving the ability to include treatment
availability resources and referral capabilities within
the PDMP.
(2) LEGISLATION.—As a condition on the receipt of support
under this section, the Secretary shall require a State or locality to demonstrate that it has enacted legislation or regulations—
(A) to provide for the implementation of the PDMP;
and
(B) to permit the imposition of appropriate penalties
for the unauthorized use and disclosure of information
maintained by the PDMP.
(b) PDMP STRATEGIES.—The Secretary shall encourage a State
or locality, in establishing, improving, or maintaining a PDMP, to
implement strategies that improve—
(1) the reporting of dispensing in the State or locality of
a controlled substance to an ultimate user so the reporting occurs not later than 24 hours after the dispensing event;
(2) the consultation of the PDMP by each prescribing practitioner, or their designee, in the State or locality before initiating treatment with a controlled substance, or any substance
as required by the State to be reported to the PDMP, and over
the course of ongoing treatment for each prescribing event;
(3) the consultation of the PDMP before dispensing a controlled substance, or any substance as required by the State to
be reported to the PDMP;
(4) the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient, including opioid misuse, are detected;
(5) the availability of data in the PDMP to other States,
as allowable under State law; and
(6) the availability of nonidentifiable information to the
Centers for Disease Control and Prevention for surveillance,
epidemiology, statistical research, or educational purposes.
(c) DRUG MISUSE AND ABUSE.—In consultation with practitioners, dispensers, and other relevant and interested stakeholders,
a State receiving support under this section—
(1) shall establish a program to notify practitioners and
dispensers of information that will help to identify and prevent
the unlawful diversion or misuse of controlled substances;
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(2) may, to the extent permitted under State law, notify
the appropriate authorities responsible for carrying out drug
diversion investigations if the State determines that information in the PDMP maintained by the State indicates an unlawful diversion or abuse of a controlled substance;
(3) may conduct analyses of controlled substance program
data for purposes of providing appropriate State agencies with
aggregate reports based on such analyses in as close to realtime as practicable, regarding prescription patterns flagged as
potentially presenting a risk of misuse, abuse, addiction, overdose, and other aggregate information, as appropriate and in
compliance with applicable Federal and State laws and provided that such reports shall not include protected health information; and
(4) may access information about prescriptions, such as
claims data, to ensure that such prescribing and dispensing
history is updated in as close to real-time as practicable, in
compliance with applicable Federal and State laws and provided that such information shall not include protected health
information.
(d) EVALUATION AND REPORTING.—As a condition on receipt of
support under this section, the State shall report on interoperability with PDMPs of other States and Federal agencies, where
appropriate, intrastate interoperability with health information
technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and
whether or not the State provides automatic, up-to-date, or daily
information about a patient when a practitioner (or the designee of
a practitioner, where permitted) requests information about such
patient.
(e) EVALUATION AND REPORTING.—A State receiving support
under this section shall provide the Secretary with aggregate nonidentifiable information, as permitted by State law, to enable the
Secretary—
(1) to evaluate the success of the State’s program in
achieving the purpose described in subsection (a); or
(2) to prepare and submit to the Congress the report required by subsection (i)(2).
(f) EDUCATION AND ACCESS TO THE MONITORING SYSTEM.—A
State receiving support under this section shall take steps to—
(1) facilitate prescribers and dispensers, and their delegates, as permitted by State law, to use the PDMP, to the extent practicable; and
(2) educate prescribers and dispensers, and their delegates
on the benefits of the use of PDMPs.
(g) ELECTRONIC FORMAT.—The Secretary may issue guidelines
specifying a uniform electronic format for the reporting, sharing,
and disclosure of information pursuant to PDMPs. To the extent
possible, such guidelines shall be consistent with standards recognized by the Office of the National Coordinator for Health Information Technology.
(h) RULES OF CONSTRUCTION.—
(1) FUNCTIONS OTHERWISE AUTHORIZED BY LAW.—Nothing
in this section shall be construed to restrict the ability of any
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authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law.
(2) ADDITIONAL PRIVACY PROTECTIONS.—Nothing in this
section shall be construed as preempting any State from imposing any additional privacy protections.
(3) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this section shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104–191; 110 Stat.
2033) and section 543 of this Act.
(4) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in
this section shall be construed to create a Federal private
cause of action.
(i) PROGRESS REPORT.—Not later than 3 years after the date of
enactment of this section, the Secretary shall—
(1) complete a study that—
(A) determines the progress of grantees in establishing
and implementing PDMPs consistent with this section;
(B) provides an analysis of the extent to which the operation of PDMPs has—
(i) reduced inappropriate use, abuse, diversion of,
and overdose with, controlled substances;
(ii) established or strengthened initiatives to ensure linkages to substance use disorder treatment
services; or
(iii) affected patient access to appropriate care in
States operating PDMPs;
(C) determine the progress of grantees in achieving
interstate interoperability and intrastate interoperability
of PDMPs, including an assessment of technical, legal, and
financial barriers to such progress and recommendations
for addressing these barriers;
(D) determines the progress of grantees in implementing near real-time electronic PDMPs;
(E) provides an analysis of the privacy protections in
place for the information reported to the PDMP in each
State or locality receiving support under this section and
any recommendations of the Secretary for additional Federal or State requirements for protection of this information;
(F) determines the progress of States or localities in
implementing technological alternatives to centralized data
storage, such as peer-to-peer file sharing or data pointer
systems, in PDMPs and the potential for such alternatives
to enhance the privacy and security of individually identifiable data; and
(G) evaluates the penalties that States or localities
have enacted for the unauthorized use and disclosure of information maintained in PDMPs, and the criteria used by
the Secretary to determine whether such penalties qualify
as appropriate for purposes of subsection (a)(2); and
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(2) submit a report to the Congress on the results of the
study.
(j) ADVISORY COUNCIL.—
(1) ESTABLISHMENT.—A State or locality may establish an
advisory council to assist in the establishment, improvement,
or maintenance of a PDMP consistent with this section.
(2) LIMITATION.—A State or locality may not use Federal
funds for the operations of an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP.
(3) SENSE OF CONGRESS.—It is the sense of the Congress
that, in establishing an advisory council to assist in the establishment, improvement, or maintenance of a PDMP, a State or
locality should consult with appropriate professional boards
and other interested parties.
(k) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘controlled substance’’ means a controlled
substance (as defined in section 102 of the Controlled Substances Act) in schedule II, III, or IV of section 202 of such Act.
(2) The term ‘‘dispense’’ means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order
of, a practitioner, irrespective of whether the dispenser uses
the Internet or other means to effect such delivery.
(3) The term ‘‘dispenser’’ means a physician, pharmacist,
or other person that dispenses a controlled substance to an ultimate user.
(4) The term ‘‘interstate interoperability’’ with respect to a
PDMP means the ability of the PDMP to electronically share
reported information with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing
of a controlled substance prescribed by a practitioner whose
principal place of business is located in such other State.
(5) The term ‘‘intrastate interoperability’’ with respect to a
PDMP means the integration of PDMP data within electronic
health records and health information technology infrastructure or linking of a PDMP to other data systems within the
State, including the State’s Medicaid program, workers’ compensation programs, and medical examiners or coroners.
(6) The term ‘‘nonidentifiable information’’ means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable
basis to believe that the information can be used to identify a
practitioner, dispenser, or an ultimate user.
(7) The term ‘‘PDMP’’ means a prescription drug monitoring program that is State-controlled.
(8) The term ‘‘practitioner’’ means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which the individual practices or does research, to distribute, dispense, conduct research
with respect to, administer, or use in teaching or chemical
analysis, a controlled substance in the course of professional
practice or research.
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(9) The term ‘‘State’’ means each of the 50 States, the District of Columbia, and any commonwealth or territory of the
United States.
(10) The term ‘‘ultimate user’’ means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the
person’s household, or for the use of an animal owned by the
person or by a member of the person’s household.
(11) The term ‘‘clinical workflow’’ means the integration of
automated queries for prescription drug monitoring programs
data and analytics into health information technologies such as
electronic health record systems, health information exchanges,
and/or pharmacy dispensing software systems, thus streamlining provider access through automated queries.
SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYSTEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING VIOLENCE, SEXUAL ASSAULT, AND STALKING.
(a) IN GENERAL.—The Secretary shall award grants for—
(1) the development or enhancement and implementation
of interdisciplinary training for health professionals, public
health staff, community health workers, violence prevention
advocates working with health providers, and allied health professionals;
(2) the development or enhancement and implementation
of education programs for medical, psychology, dental, social
work, nursing, and other health profession students, interns,
residents, fellows, or current health care providers (including
midwives and doulas);
(3) the development or enhancement and implementation
of comprehensive statewide strategies to improve the capacity
of clinics, public health facilities, hospitals, and other health
settings (including behavioral and mental health programs) to
prevent and respond to domestic violence, dating violence, sexual assault, and stalking;
(4) the development or enhancement and implementation
of training programs to improve the capacity of early childhood
programs to address domestic violence, dating violence, sexual
assault, and stalking among families they serve; and
(5) the development or enhancement and implementation
of comprehensive statewide strategies for health and violence
prevention programs to work together to promote primary prevention of domestic violence, dating violence, sexual assault,
and stalking.
(b) USE OF FUNDS.—
(1) REQUIRED USES.—Amounts provided under a grant
under this section shall be used to—
(A) fund interdisciplinary training and education programs under paragraphs (1) and (2) of subsection (a)
that—
(i) are designed to train medical, psychology, dental, social work, nursing, and other health profession
students, interns, residents, fellows, or current health
care providers to provide universal education on
healthy relationships and provide trauma-informed
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health care services (including mental or behavioral
health care services and referrals to appropriate community services) to individuals who are or who have
been victims of domestic violence, dating violence, sexual assault, or stalking;
(ii) plan and develop training components that
center the experiences of, and are developed in collaboration with, culturally specific individuals and American Indians and Alaska Natives, and include community-defined practices such as the use of doulas, midwives, and traditional healers, for integration into approved internship, residency, and fellowship training
or continuing medical or other health education training that address physical, mental, and behavioral
health issues, including protective factors, related to
domestic violence, dating violence, sexual assault,
stalking, and other forms of violence and abuse (including labor and sex trafficking), focus on reducing
health inequities and preventing violence and abuse,
and include the primacy of victim safety and confidentiality;
(iii) are designed to be inclusive of the experiences
of all individuals, including LGBT individuals, and include training on improving equity and reducing disparities in access to health care services and prevention resources; and
(iv) include training on the use of a universal prevention education approach to both prevent and respond to domestic violence, dating violence, sexual assault, or stalking in health care settings;
(B) design and implement comprehensive strategies to
improve the capacity of the health care system to prevent
and respond to domestic or sexual violence in clinical and
public health settings, hospitals, clinics, and other health
settings (including behavioral and mental health), under
subsection (a)(3) through—
(i) the implementation, dissemination, and evaluation of policies and procedures to guide health professionals and public health staff in identifying, responding to, and promoting prevention of domestic violence,
dating violence, sexual assault, and stalking during inperson or virtual visits, including strategies to ensure
that health information is maintained in a manner
that protects the patient’s privacy and safety, and
safely uses health information technology to improve
documentation, identification, assessment, treatment,
and follow-up care and to maximize victim choice on
the use and sharing of their health information;
(ii) the development of services to address the
safety, medical, and mental health needs of patients
by—
(I) increasing the capacity of existing health
care professionals (including professionals who
specialize in trauma or in substance use disorders)
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in behavioral and mental health care, community
health workers, and public health staff to address
domestic violence, dating violence, sexual assault,
stalking, and children exposed to violence;
(II) contracting with or hiring advocates for
victims of domestic violence or sexual assault to
provide such services; or
(III) providing funding to State domestic and
sexual violence coalitions to improve the capacity
of such coalitions to coordinate and support health
advocates and other health system partnerships;
(iii) the development of measures and methods for
the evaluation of the practice of prevention, intervention, and documentation regarding victims of domestic
violence, dating violence, sexual assault, and stalking
during in-person or virtual visits, including the development and testing of quality improvement measurements, in accordance with the multi-stakeholder and
quality measurement processes established under
paragraphs (7) and (8) of section 1890(b) and section
1890A of the Social Security Act (42 U.S.C.
1395aaa(b)(7) and (8); 42 U.S.C. 1890A);
(iv) the provision of training and follow-up technical assistance to health care professionals, and public health staff, and allied health professionals to identify, assess, treat, and refer clients who are victims of
domestic violence, dating violence, sexual assault, or
stalking, and promote prevention during in-person or
virtual visits, including using tools and training materials already developed;
(v) the development, implementation, dissemination, and evaluation of best practices, tools, and training materials, including culturally relevant tools, for
mental health, behavioral health, and substance use
disorder professionals to identify and respond to domestic violence, sexual violence, stalking, and dating
violence; and
(vi) the development and provision of culturally
relevant training and follow-up technical assistance to
health care professionals, and public health staff, and
allied health professionals to identify, assess, treat,
and refer clients who are victims of domestic violence,
dating violence, sexual assault, or stalking from culturally specific communities and promote prevention,
using tools and training materials, developed by and
for culturally specific communities, with priority given
to trainings provided by culturally specific organizations; and
(C) design and implement comprehensive strategies to
prevent domestic or sexual violence including through the
use of universal education in clinical and public health settings, hospitals, clinics and other health settings.
(2) PERMISSIBLE USES.—
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(A) CHILD ABUSE AND ABUSE IN LATER LIFE.—To the
extent consistent with the purpose of this section, a grantee may use amounts received under this section to address, as part of a comprehensive programmatic approach
implemented under the grant, issues relating to child
abuse or abuse in later life.
(B) RURAL AREAS.—Grants funded under paragraphs
(1) and (2) of subsection (a) may be used to offer to rural
areas community-based training opportunities, which may
include the use of distance learning networks and other
available technologies needed to reach isolated rural areas,
for medical, nursing, and other health profession students
and residents on domestic violence, dating violence, sexual
assault, stalking, and, as appropriate, other forms of violence and abuse.
(C) OTHER USES.—Grants funded under subsection
(a)(3) may be used for—
(i) the development of training modules and policies that address the overlap of child abuse, domestic
violence, dating violence, sexual assault, and stalking
and abuse in later life, as well as childhood exposure
to domestic and sexual violence;
(ii) the development, expansion, and implementation of programs that promote the prevention of sexual
assault as well as sexual assault forensic medical examination or sexual assault nurse examiner programs;
(iii) the inclusion of the health effects of lifetime
exposure to violence and abuse and exposure to violence across generations as well as related protective
factors and behavioral risk factors in health professional training schools including medical, dental, nursing, social work, and mental and behavioral health
curricula, and allied health service training courses;
(iv) the integration of knowledge of domestic violence, dating violence, sexual assault, and stalking
into health care accreditation and professional licensing examinations, such as medical, dental, mental
health, social work, and nursing boards, and where
appropriate, other allied health exams and certifications;
(v) providing funding to culturally specific organizations to improve the capacity of such organizations
to engage and partner with health care providers to
support victims and meet increased referrals from
health systems;
(vi) developing a State-level pilot program to—
(I) improve the response of substance use disorder treatment programs, harm reduction programs for people who use substances, and systems
to domestic violence, dating violence, sexual assault, and stalking;
(II) improve the capacity of substance use disorder treatment programs, harm reduction programs for people who use substances, and systems
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to serve survivors of domestic violence, dating violence, sexual assault, and stalking dealing with
substance use disorder; and
(III) improve the capacity of domestic violence, dating violence, sexual assault, and stalking
programs to serve survivors who have substance
use history; or
(vii) developing and utilizing existing technical assistance and training resources to improve the capacity of substance use disorder treatment programs and
harm reduction programs for people who use substances to address domestic violence, dating violence,
sexual assault, and stalking among patients the programs serve.
(c) REQUIREMENTS FOR GRANTEES.—
(1) CONFIDENTIALITY AND SAFETY.—
(A) IN GENERAL.—Grantees under this section shall
ensure that all programs developed with grant funds address issues of confidentiality and patient safety and comply with applicable confidentiality and nondisclosure requirements under section 40002(b)(2) of the Violence
Against Women Act of 1994 and the Family Violence Prevention and Services Act, and that faculty and staff associated with delivering educational components are fully
trained in procedures that will protect the immediate and
ongoing security and confidentiality of the patients, patient records, and staff. Such grantees shall consult entities with demonstrated expertise in the confidentiality and
safety needs of victims of domestic violence, dating violence, sexual assault, and stalking on the development and
adequacy of confidentially and security procedures, and
provide documentation of such consultation.
(B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.—
Grantees under this section shall provide to patients advance notice about any circumstances under which information may be disclosed, such as mandatory reporting
laws, and shall give patients the option to receive information and referrals without affirmatively disclosing abuse.
(2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee
shall use not more than 10 percent of the amounts received
under a grant under this section for administrative expenses.
(3) APPLICATION.—
(A) PREFERENCE.—In selecting grant recipients under
this section, the Secretary shall give preference to applicants based on the strength of their evaluation strategies,
with priority given to—
(i) outcome based evaluations;
(ii) culturally specific and population specific organizations; and
(iii) programs developing and implementing community-driven solutions to address domestic violence,
dating violence, sexual assault, or stalking.
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(B) SUBSECTION (A)(1) AND (2) GRANTEES.—Applications
for grants under paragraphs (1) and (2) of subsection (a)
shall include—
(i) documentation that the applicant represents a
team of entities working collaboratively to strengthen
the response of the health care system to domestic violence, dating violence, sexual assault, or stalking, and
which includes at least one of each of—
(I) an accredited school of allopathic or osteopathic medicine, psychology, nursing, dentistry,
social work, or other health field;
(II) a health care facility or system; or
(III) a government or nonprofit entity, including a culturally specific organization or community-based organization working to address the social determinants of health, with a history of effective work in the fields of domestic violence, dating
violence, sexual assault, or stalking; and
(ii) strategies for the dissemination and sharing of
curricula and other educational materials developed
under the grant, if any, with other interested health
professions schools and national resource repositories
for materials on domestic violence, dating violence,
sexual assault, and stalking.
(C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a
grant under subsection (a)(3) shall submit an application
to the Secretary at such time, in such a manner, and containing such information and assurances as the Secretary
may require, including—
(i) documentation that all training, education,
screening, assessment, services, treatment, and any
other approach to patient care will be informed by an
understanding of violence and abuse victimization and
trauma-specific approaches that will be integrated into
prevention, intervention, and treatment activities;
(ii) strategies—
(I) for the development and implementation of
policies to prevent and address domestic violence,
dating violence, sexual assault, and stalking over
the lifespan and generations in health care settings; and
(II) to address primary prevention of domestic
violence, dating violence, sexual assault, and
stalking over the lifespan and generations, including strategies that address related social determinants of health, economic justice, and equity
issues, and that are inclusive of LGBT individuals;
(iii) a plan for consulting with State and tribal domestic violence or sexual assault coalitions, national
nonprofit victim advocacy organizations, culturally
specific organizations, and population specific organizations with demonstrated expertise in domestic violence, dating violence, sexual assault, or stalking;
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(iv) with respect to an application for a grant
under which the grantee will have contact with patients, a plan, developed in collaboration with local
victim service providers (including culturally specific
organizations), to respond appropriately to and make
correct referrals for individuals who disclose that they
are victims of domestic violence, dating violence, sexual assault, stalking, or other types of violence, and
documentation provided by the grantee of an ongoing
collaborative relationship with a local victim service
provider; and
(v) with respect to an application for a grant proposing to fund a program described in subsection
(b)(2)(C)(ii), a certification that any sexual assault forensic medical examination and sexual assault nurse
examiner programs supported with such grant funds
will adhere to the guidelines set forth by the Attorney
General.
(d) ELIGIBLE ENTITIES.—
(1) IN GENERAL.—To be eligible to receive funding under
paragraph (1) or (2) of subsection (a), an entity shall be—
(A) a nonprofit organization with a history of effective
work in the field of training health professionals with an
understanding of, and clinical skills pertinent to, domestic
violence, dating violence, sexual assault, or stalking, and
lifetime exposure to violence and abuse;
(B) an accredited school of allopathic or osteopathic
medicine, psychology, nursing, dentistry, social work, or allied health;
(C) a health care provider membership or professional
organization, or a health care system; or
(D) a State, tribal, territorial, or local entity.
(2) SUBSECTION (A)(3) GRANTEES.—To be eligible to receive
funding under subsection (a)(3), an entity shall be—
(A) a State department (or other division) of health
(including mental health or substance abuse agencies), a
State, tribal, or territorial domestic violence or sexual assault coalition or victim service provider, or any other nonprofit, nongovernmental organization with a history of effective work in the fields of domestic violence, dating violence, sexual assault, or stalking, and health care, including physical or behavioral health care and substance use
disorder prevention and treatment; or
(B) a local victim service provider, a local department
(or other division) of health, a local health clinic, hospital,
behavioral health treatment system, or health system, a
community-based organization with a history of effective
work in the field of domestic violence, dating violence, sexual assault, or stalking and health care, including physical
or mental health care or substance use disorder prevention
and treatment, or a community-based organization with a
history of partnership with programs in the field of domestic violence, dating violence, sexual assault, or stalking
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and health care, including physical or mental health care
or substance use disorder prevention and treatment.
(e) TECHNICAL ASSISTANCE.—
(1) IN GENERAL.—Of the funds made available to carry out
this section for any fiscal year, the Secretary may make grants
or enter into contracts to provide technical assistance with respect to the planning, development, and operation of any program, activity or service carried out pursuant to this section.
Not more than 8 percent of the funds appropriated under this
section in each fiscal year may be used to fund technical assistance under this subsection.
(2) AVAILABILITY OF MATERIALS.—The Secretary shall make
publicly available materials developed by grantees under this
section, including materials on training, best practices, and research and evaluation.
(3) REPORTING.—The Secretary shall publish a biennial report on—
(A) the distribution of funds under this section; and
(B) the programs and activities supported by such
funds.
(f) RESEARCH AND EVALUATION.—
(1) IN GENERAL.—Of the funds made available to carry out
this section for any fiscal year, the Secretary may use not more
than 20 percent to make a grant or enter into a contract for
research and evaluation of—
(A) grants awarded under this section; and
(B) other training for health professionals and effective interventions in the health care setting that prevent
domestic violence, dating violence, and sexual assault
across the lifespan, prevent the health effects of such violence, and improve the safety and health of individuals
who are currently being victimized.
(2) RESEARCH.—Research authorized in paragraph (1) may
include—
(A) research on the effects of domestic violence, dating
violence, sexual assault, and childhood exposure to domestic, dating or sexual violence on health behaviors, health
conditions, and health status of individuals, families, and
populations, including underserved populations;
(B) research to determine effective health care interventions to respond to and prevent domestic violence, dating violence, sexual assault, and stalking;
(C) research on the impact of domestic, dating and
sexual violence, childhood exposure to such violence, and
stalking on the health care system, health care utilization,
health care costs, and health status; and
(D) research on the impact of adverse childhood experiences on adult experience with domestic violence, dating
violence, sexual assault, stalking, and adult health outcomes, including how to reduce or prevent the impact of
adverse childhood experiences through the health care setting.
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(g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated to carry out this section, $20,000,000 for each
of fiscal years 2023 through 2027.
(h) DEFINITIONS.—Except as otherwise provided, the definitions
in section 40002 of the Violence Against Women Act of 1994 shall
apply to this section.
SEC. 399Q. ø280g–5¿ PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND SUPPORT SERVICES.
(a) IN GENERAL.—The Secretary, directly or through the
awarding of grants to public or private nonprofit entities, may conduct activities, which may include demonstration projects for the
purpose of improving the provision of information on prematurity
to health professionals and other health care providers and the
public and improving the treatment and outcomes mothers of infants born preterm, and infants born preterm, as appropriate.
(b) ACTIVITIES.—Activities to be carried out under subsection
(a) may include the establishment of—
(1) programs, including those to test and evaluate strategies, which, in collaboration with States, localities, tribes, and
community organizations, support the provision of information
and education to health professionals, other health care providers, and the public concerning—
(A) the core risk factors for preterm labor and delivery;
(B) evidence-based strategies to prevent preterm birth
and associated outcomes;
(C) medically indicated deliveries before full term, and
the risks of non-medically indicated deliveries before full
term;
(D) the importance of preconception and prenatal care,
including—
(i) smoking cessation;
(ii) weight maintenance and good nutrition, including folic acid intake;
(iii) the screening for and the treatment of infections;
(iv) screening for and treatment of substance use
disorders;
(v) screening for and treatment of maternal depression;
(vi) maternal immunization; and
(vii) stress management;
(E) treatments and outcomes for premature infants,
including late preterm infants; and
(F) the informational needs of families during the stay
of an infant in a neonatal intensive care unit.
(2) programs to increase the availability, awareness, and
use of pregnancy and post-term information services that provide evidence-based, clinical information through counselors,
community outreach efforts, electronic or telephonic communication, or other appropriate means regarding causes associated with prematurity, birth defects, or health risks to a postterm infant, as well as prevention of a future preterm birth;
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(3) programs to respond to the informational needs of families during the stay of an infant in a neonatal intensive care
unit, during the transition of the infant to the home, and in
the event of a newborn death; and
(4) such other programs as the Secretary determines appropriate to achieve the purpose specified in subsection (a).
(c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated to carry out this section $1,900,000 for each of
fiscal years 2014 through 2018.
SEC. 399R. ø280g–6¿ CHRONIC KIDNEY DISEASE INITIATIVES.
(a) IN GENERAL.—The Secretary shall establish pilot
projects
to—
(1) increase public and medical community awareness
(particularly of those who treat patients with diabetes and hypertension) regarding chronic kidney disease, focusing on prevention;
(2) increase screening for chronic kidney disease, focusing
on Medicare beneficiaries at risk of chronic kidney disease; and
(3) enhance surveillance systems to better assess the prevalence and incidence of chronic kidney disease.
(b) SCOPE AND DURATION.—
(1) SCOPE.—The Secretary shall select at least 3 States in
which to conduct pilot projects under this section.
(2) DURATION.—The pilot projects under this section shall
be conducted for a period that is not longer than 5 years and
shall begin on January 1, 2009.
(c) EVALUATION AND REPORT.—The Comptroller General of the
United States shall conduct an evaluation of the pilot projects conducted under this section. Not later than 12 months after the date
on which the pilot projects are completed, the Comptroller General
shall submit to Congress a report on the evaluation.
(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated such sums as may be necessary for the purpose
of carrying out this section.
SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
(a) ESTABLISHMENT.—
(1) IN GENERAL.—Not later than 1 year after the receipt
of
the report described in subsection (b)(2)(A), the Secretary, acting through the Director of the Centers for Disease Control
and Prevention, may, if scientifically advisable—
(A) develop a system to collect data on amyotrophic
lateral sclerosis (referred to in this section as ‘‘ALS’’) and
other motor neuron disorders that can be confused with
ALS, misdiagnosed as ALS, and in some cases progress to
ALS, including information with respect to the incidence
and prevalence of the disease in the United States; and
(B) establish a national registry for the collection and
storage of such data to develop a population-based registry
of cases in the United States of ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed
as ALS, and in some cases progress to ALS.
(2) PURPOSE.—It is the purpose of the registry established
under paragraph (1)(B) to—
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(A) better describe the incidence and prevalence of
ALS in the United States;
(B) examine appropriate factors, such as environmental and occupational, that may be associated with the
disease;
(C) better outline key demographic factors (such as
age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated
with the disease;
(D) better examine the connection between ALS and
other motor neuron disorders that can be confused with
ALS, misdiagnosed as ALS, and in some cases progress to
ALS; and
(E) other matters as recommended by the Advisory
Committee established under subsection (b).
(b) ADVISORY COMMITTEE.—
(1) ESTABLISHMENT.—Not later than 180 days after the
date of the enactment of this section, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may establish a committee to be known as the Advisory Committee on the National ALS Registry (referred to in
this section as the ‘‘Advisory Committee’’). The Advisory Committee shall be composed of not more than 27 members to be
appointed by the Secretary, acting through the Centers for Disease Control and Prevention, of which—
(A) two-thirds of such members shall represent governmental agencies—
(i) including at least one member representing—
(I) the National Institutes of Health, to include, upon the recommendation of the Director of
the National Institutes of Health, representatives
from the National Institute of Neurological Disorders and Stroke and the National Institute of
Environmental Health Sciences;
(II) the Department of Veterans Affairs;
(III) the Agency for Toxic Substances and Disease Registry; and
(IV) the Centers for Disease Control and Prevention; and
(ii) of which at least one such member shall be a
clinician with expertise on ALS and related diseases,
an epidemiologist with experience in data registries, a
statistician, an ethicist, and a privacy expert (relating
to the privacy regulations under the Health Insurance
Portability and Accountability Act of 1996); and
(B) one-third of such members shall be public members, including at least one member representing—
(i) national and voluntary health associations;
(ii) patients with ALS or their family members;
(iii) clinicians with expertise on ALS and related
diseases;
(iv) epidemiologists with experience in data registries;
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(v) geneticists or experts in genetics who have experience with the genetics of ALS or other neurological
diseases and
(vi) other individuals with an interest in developing and maintaining the National ALS Registry.
(2) DUTIES.—The Advisory Committee may review information and make recommendations to the Secretary concerning—
(A) the development and maintenance of the National
ALS Registry;
(B) the type of information to be collected and stored
in the Registry;
(C) the manner in which such data is to be collected;
(D) the use and availability of such data including
guidelines for such use; and
(E) the collection of information about diseases and
disorders that primarily affect motor neurons that are considered essential to furthering the study and cure of ALS.
(3) REPORT.—Not later than 270 days after the date on
which the Advisory Committee is established, the Advisory
Committee may submit a report to the Secretary concerning
the review conducted under paragraph (2) that contains the
recommendations of the Advisory Committee with respect to
the results of such review.
(c) GRANTS.—The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may award grants to,
and enter into contracts and cooperative agreements with, public or
private nonprofit entities for the collection, analysis, and reporting
of data on ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress
to ALS after receiving the report under subsection (b)(3).
(d) COORDINATION WITH STATE, LOCAL, AND FEDERAL REGISTRIES.—
(1) 102 IN GENERAL.—In establishing the National ALS Registry under subsection (a), the Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
may—
(A) identify, build upon, expand, and coordinate among
existing data and surveillance systems, surveys, registries,
and other Federal public health and environmental infrastructure wherever possible, which may include—
(i) any registry pilot projects previously supported
by the Centers for Disease Control and Prevention;
(ii) the Department of Veterans Affairs ALS Registry;
(iii) the DNA and Cell Line Repository of the National Institute of Neurological Disorders and Stroke
Human Genetics Resource Center at the National Institutes of Health;
(iv) Agency for Toxic Substances and Disease Registry studies, including studies conducted in Illinois,
102 So in law. Subsection (d) (as added by section 2 of Public Law 110–373) does not include
a paragraph (2).
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Missouri, El Paso and San Antonio, Texas, and Massachusetts;
(v) State-based ALS registries;
(vi) the National Vital Statistics System; and
(vii) any other existing or relevant databases that
collect or maintain information on those motor neuron
diseases recommended by the Advisory Committee established in subsection (b); and
(B) provide for research access to ALS data as recommended by the Advisory Committee established in subsection (b) to the extent permitted by applicable statutes
and regulations and in a manner that protects personal
privacy consistent with applicable privacy statutes and
regulations.
(C) COORDINATION WITH NIH AND DEPARTMENT OF VETERANS AFFAIRS.—Consistent with applicable privacy statutes and regulations, the Secretary may ensure that epidemiological and other types of information obtained under
subsection (a) is made available to the National Institutes
of Health and the Department of Veterans Affairs.
(e) DEFINITION.—For the purposes of this section, the term ‘‘national voluntary health association’’ means a national non-profit organization with chapters or other affiliated organizations in States
throughout the United States with experience serving the population of individuals with ALS and have demonstrated experience
in ALS research, care, and patient services.
SEC. 399S–1. ø280g–7a¿ SURVEILLANCE OF NEUROLOGICAL DISEASES.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination
with other agencies as the Secretary determines, shall, as appropriate—
(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases; and
(2) incorporate information obtained through such activities into an integrated surveillance system, which may consist
of or include a registry, to be known as the National Neurological Conditions Surveillance System.
(b) RESEARCH.—The Secretary shall ensure that the National
Neurological Conditions Surveillance System is designed in a manner that facilitates further research on neurological diseases.
(c) CONTENT.—In carrying out subsection (a), the Secretary—
(1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in
the United States;
(2) to the extent practicable, shall provide for the collection
and storage of other available information on neurological diseases, including information related to persons living with neurological diseases who choose to participate, such as—
(A) demographics, such as age, race, ethnicity, sex, geographic location, family history, and other information, as
appropriate;
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(B) risk factors that may be associated with neurological diseases, such as genetic and environmental risk
factors and other information, as appropriate; and
(C) diagnosis and progression markers;
(3) may provide for the collection and storage of information relevant to analysis on neurological diseases, such as information concerning—
(A) the natural history of the diseases;
(B) the prevention of the diseases;
(C) the detection, management, and treatment approaches for the diseases; and
(D) the development of outcomes measures;
(4) may address issues identified during the consultation
process under subsection (d); and
(5) initially may address a limited number of neurological
diseases.
(d) CONSULTATION.—In carrying out this section, the Secretary
shall consult with individuals with appropriate expertise, which
may include—
(1) epidemiologists with experience in disease surveillance
or registries;
(2) representatives of national voluntary health associations that—
(A) focus on neurological diseases; and
(B) have demonstrated experience in research, care, or
patient services;
(3) health information technology experts or other information management specialists;
(4) clinicians with expertise in neurological diseases; and
(5) research scientists with experience conducting
translational research or utilizing surveillance systems for scientific research purposes.
(e) GRANTS.—The Secretary may award grants to, or enter into
contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section.
(f) COORDINATION WITH OTHER FEDERAL, STATE, AND LOCAL
AGENCIES.—Subject to subsection (h), the Secretary shall—
(1) make information and analysis in the National Neurological Conditions Surveillance System available, as appropriate—
(A) to Federal departments and agencies, such as the
National Institutes of Health and the Department of Veterans Affairs; and
(B) to State and local agencies; and
(2) identify, build upon, leverage, and coordinate among
existing data and surveillance systems, surveys, registries, and
other Federal public health infrastructure, wherever practicable.
(g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary
shall ensure that information and analysis in the National Neurological Conditions Surveillance System are available, as appropriate, to the public, including researchers.
(h) PRIVACY.—The Secretary shall ensure that information and
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tem are made available only to the extent permitted by applicable
Federal and State law, and in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum.
(i) REPORTS.—
(1) REPORT ON INFORMATION AND ANALYSES.—Not later
than 1 year after the date on which any system is established
under this section, the Secretary shall submit an interim report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding aggregate information collected pursuant to this section and epidemiological analyses, as appropriate. Such report shall be posted on
the Internet website of the Department of Health and Human
Services and shall be updated biennially.
(2) IMPLEMENTATION REPORT.—Not later than 4 years after
the date of the enactment of this section, the Secretary shall
submit a report to the Congress concerning the implementation
of this section. Such report shall include information on—
(A) the development and maintenance of the National
Neurological Conditions Surveillance System;
(B) the type of information collected and stored in the
surveillance system;
(C) the use and availability of such information, including guidelines for such use; and
(D) the use and coordination of databases that collect
or maintain information on neurological diseases.
(j) DEFINITION.—In this section, the term ‘‘national voluntary
health association’’ means a national nonprofit organization with
chapters, other affiliated organizations, or networks in States
throughout the United States with experience serving the population of individuals with neurological disease and have demonstrated experience in neurological disease research, care, and patient services.
(k) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appropriated $5,000,000 for each of
fiscal years 2018 through 2022.
SEC. 399T. ø280g–8¿ SUPPORT FOR PATIENTS RECEIVING A POSITIVE
DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY
OR POSTNATALLY DIAGNOSED CONDITIONS.
(a) DEFINITIONS.—In this section:
(1) DOWN SYNDROME.—The term ‘‘Down syndrome’’ refers
to a chromosomal disorder caused by an error in cell division
that results in the presence of an extra whole or partial copy
of chromosome 21.
(2) HEALTH CARE PROVIDER.—The term ‘‘health care provider’’ means any person or entity required by State or Federal
law or regulation to be licensed, registered, or certified to provide health care services, and who is so licensed, registered, or
certified.
(3) POSTNATALLY DIAGNOSED CONDITION.—The term
‘‘postnatally diagnosed condition’’ means any health condition
identified during the 12-month period beginning at birth.
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(4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘prenatally diagnosed condition’’ means any fetal health condition
identified by prenatal genetic testing or prenatal screening procedures.
(5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diagnostic or screening tests offered to pregnant women seeking
routine prenatal care that are administered on a required or
recommended basis by a health care provider based on medical
history, family background, ethnic background, previous test
results, or other risk factors.
(b) INFORMATION AND SUPPORT SERVICES.—
(1) IN GENERAL.—The Secretary, acting through the Director of the National Institutes of Health, the Director of the
Centers for Disease Control and Prevention, or the Administrator of the Health Resources and Services Administration,
may authorize and oversee certain activities, including the
awarding of grants, contracts or cooperative agreements to eligible entities, to—
(A) collect, synthesize, and disseminate current evidence-based information relating to Down syndrome or
other prenatally or postnatally diagnosed conditions; and
(B) coordinate the provision of, and access to, new or
existing supportive services for patients receiving a positive diagnosis for Down syndrome or other prenatally or
postnatally diagnosed conditions, including—
(i) the establishment of a resource telephone hotline accessible to patients receiving a positive test result or to the parents of newly diagnosed infants with
Down syndrome and other diagnosed conditions;
(ii) the expansion and further development of the
National Dissemination Center for Children with Disabilities, so that such Center can more effectively conduct outreach to new and expecting parents and provide them with up-to-date information on the range of
outcomes for individuals living with the diagnosed
condition, including physical, developmental, educational, and psychosocial outcomes;
(iii) the expansion and further development of national and local peer-support programs, so that such
programs can more effectively serve women who receive a positive diagnosis for Down syndrome or other
prenatal conditions or parents of infants with a
postnatally diagnosed condition;
(iv) the establishment of a national registry, or
network of local registries, of families willing to adopt
newborns with Down syndrome or other prenatally or
postnatally diagnosed conditions, and links to adoption
agencies willing to place babies with Down syndrome
or other prenatally or postnatally diagnosed conditions, with families willing to adopt; and
(v) the establishment of awareness and education
programs for health care providers who provide, interpret, or inform parents of the results of prenatal tests
for Down syndrome or other prenatally or postnatally
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518
diagnosed conditions, to patients, consistent with the
purpose described in section 2(b)(1) 103 of the Prenatally and Postnatally Diagnosed Conditions Awareness Act.
(2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible
entity’’ means—
(A) a State or a political subdivision of a State;
(B) a consortium of 2 or more States or political subdivisions of States;
(C) a territory;
(D) a health facility or program operated by or pursuant to a contract with or grant from the Indian Health
Service; or
(E) any other entity with appropriate expertise in prenatally and postnatally diagnosed conditions (including nationally recognized disability groups), as determined by the
Secretary.
(3) DISTRIBUTION.—In distributing funds under this subsection, the Secretary shall place an emphasis on funding partnerships between health care professional groups and disability advocacy organizations.
(c) PROVISION OF INFORMATION TO PROVIDERS.—
(1) IN GENERAL.—A grantee under this section shall make
available to health care providers of parents who receive a prenatal or postnatal diagnosis the following:
(A) Up-to-date, evidence-based, written information
concerning the range of outcomes for individuals living
with the diagnosed condition, including physical, developmental, educational, and psychosocial outcomes.
(B) Contact information regarding support services, including information hotlines specific to Down syndrome or
other prenatally or postnatally diagnosed conditions, resource centers or clearinghouses, national and local peer
support groups, and other education and support programs
as described in subsection (b)(2).
(2) INFORMATIONAL REQUIREMENTS.—Information provided
under this subsection shall be—
(A) culturally and linguistically appropriate as needed
by women receiving a positive prenatal diagnosis or the
family of infants receiving a postnatal diagnosis; and
(B) approved by the Secretary.
(d) REPORT.—Not later than 2 years after the date of enactment of this section, the Government Accountability Office shall
submit a report to Congress concerning the effectiveness of current
healthcare and family support programs serving as resources for
the families of children with disabilities.
SEC.
399U.
ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK
FORCE.
ESTABLISHMENT AND PURPOSE.—The Director of the Cen-
(a)
ters for Disease Control and Prevention shall convene an independent Community Preventive Services Task Force (referred to in
this subsection as the ‘‘Task Force’’) to be composed of individuals
103 So
in law. Probably should read ‘‘section 2(1)’’.
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with appropriate expertise. Such Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and
cost-effectiveness of community preventive interventions for the
purpose of developing recommendations, to be published in the
Guide to Community Preventive Services (referred to in this section as the ‘‘Guide’’), for individuals and organizations delivering
population-based services, including primary care professionals,
health care systems, professional societies, employers, community
organizations, non-profit organizations, schools, governmental public health agencies, Indian tribes, tribal organizations and urban
Indian organizations, medical groups, Congress and other policymakers. Community preventive services include any policies, programs, processes or activities designed to affect or otherwise affecting health at the population level.
(b) DUTIES.—The duties of the Task Force shall include—
(1) the development of additional topic areas for new recommendations and interventions related to those topic areas,
including those related to specific populations and age groups,
as well as the social, economic and physical environments that
can have broad effects on the health and disease of populations
and health disparities among sub-populations and age groups;
(2) at least once during every 5-year period, review interventions and update recommendations related to existing topic
areas, including new or improved techniques to assess the
health effects of interventions, including health impact assessment and population health modeling;
(3) improved integration with Federal Government health
objectives and related target setting for health improvement;
(4) the enhanced dissemination of recommendations;
(5) the provision of technical assistance to those health
care professionals, agencies, and organizations that request
help in implementing the Guide recommendations; and
(6) providing yearly reports to Congress and related agencies identifying gaps in research and recommending priority
areas that deserve further examination, including areas related to populations and age groups not adequately addressed
by current recommendations.
(c) ROLE OF AGENCY.—The Director shall provide ongoing administrative, research, and technical support for the operations of
the Task Force, including coordinating and supporting the dissemination of the recommendations of the Task Force, ensuring adequate staff resources, and assistance to those organizations requesting it for implementation of Guide recommendations.
(d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE.—
The Task Force shall take appropriate steps to coordinate its work
with the U.S. Preventive Services Task Force and the Advisory
Committee on Immunization Practices, including the examination
of how each task force’s recommendations interact at the nexus of
clinic and community.
(e) OPERATION.—In carrying out the duties under subsection
(b), the Task Force shall not be subject to the provisions of chapter
10 of title 5, United States Code.
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520
(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated such sums as may be necessary for each fiscal
year to carry out the activities of the Task Force.
SEC. 399V. ø280g–11¿ AWARDS TO SUPPORT COMMUNITY HEALTH
WORKERS AND COMMUNITY HEALTH.
(a) IN GENERAL.—The Secretary shall award grants, contracts,
or cooperative agreements to eligible entities to promote positive
health behaviors and outcomes for populations in medically underserved communities by leveraging community health workers, including by addressing ongoing and longer-term community health
needs, and by building the capacity of the community health worker workforce. Such grants, contracts, and cooperative agreements
shall be awarded in alignment and coordination with existing funding arrangements supporting community health workers.
(b) USE OF FUNDS.—Subject to any requirements for the scope
of licensure, registration, or certification of a community health
worker under applicable State law, grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to —
(1) recruit, hire, train, and retain community health workers that reflect the needs of the community;
(2) support community health workers in providing education and outreach, in a community setting, regarding—
(A) health conditions prevalent in—
(i) medically underserved communities (as defined
in section 799B), particularly racial and ethnic minority populations; and
(ii) other such at-risk populations or geographic
areas that may require additional support during public health emergencies, which may include counties
identified by the Secretary using applicable measures
developed by the Centers for Disease Control and Prevention or other Federal agencies; and
(B) addressing health disparities, including by—
(i) promoting awareness of services and resources
to increase access to health care, mental health and
substance use disorder services, child services, technology, housing services, educational services, nutrition services, employment services, and other services;
and
(ii) assisting in conducting individual and community needs assessments;
(3) educate community members, including regarding effective strategies to promote healthy behaviors;
(4) educate and provide outreach regarding enrollment in
health insurance including the Children’s Health Insurance
Program under title XXI of the Social Security Act, Medicare
under title XVIII of such Act and Medicaid under title XIX of
such Act;
(5) identify and refer underserved populations to appropriate health care agencies and community-based programs
and organizations in order to increase access to quality health
care services and to streamline care, including serving as a liaison between communities and health care agencies; and
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(6) support community health workers in educating, guiding, or providing home visitation services regarding chronic
diseases, maternal health, prenatal, and postpartum care in
order to improve maternal and infant health outcomes.
(c) APPLICATION.—To be eligible to receive an award under subsection (a), an entity shall prepare and submit to the Secretary an
application at such time, in such manner, and containing such information as the Secretary may require.
(d) PRIORITY.—In making awards under subsection (a), the Secretary shall give priority to applicants that—
(1) propose to serve—
(A) areas with populations that have a high rate of
chronic disease, infant mortality, or maternal morbidity
and mortality;
(B) low-income populations, including medically underserved populations (as defined in section 330(b)(3));
(C) populations residing in health professional shortage areas (as defined in section 332(a));
(D) populations residing in maternity care health professional target areas identified under section 332(k); or
(E) rural or traditionally underserved populations, including racial and ethnic minority populations or low-income populations;
(2) have experience in providing health or health-related
social services to individuals who are underserved with respect
to such services, including rural populations and racial and
ethnic minority populations;
(3) have documented community activity and experience
and established relationships with community health workers
in the communities expected to be served by the program;
(4) develop a plan for providing services to the extent practicable, in the language and cultural context most appropriate
to individuals expected to be served by the program; and
(5) propose to use evidence-informed or evidence-based
practices, as applicable and appropriate.
(e) COLLABORATION WITH ACADEMIC INSTITUTIONS AND THE
ONE-STOP DELIVERY SYSTEM.—The Secretary shall encourage eligible entities receiving funds under this section to collaborate with
academic institutions, health professions schools, minority-serving
institutions (defined, for purposes of this subsection, as institutions
and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institutions described in section 371(a) of
such Act), area health education centers under section 751 of this
Act, and one-stop delivery systems under section 121 of the Workforce Innovation and Opportunity Act. Nothing in this section shall
be construed to require such collaboration.
(f) TECHNICAL ASSISTANCE.—The Secretary may provide to eligible entities that receive awards under subsection (a) technical assistance with respect to planning, development, and operation of
community health worker programs authorized or supported under
this section.
(g) DISSEMINATION OF BEST PRACTICES.—Not later than 4 years
after the date of enactment of the PREVENT Pandemics Act, the
Secretary shall, based on activities carried out under this section
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PUBLIC HEALTH SERVICE ACT
522
and in consultation with relevant stakeholders, identify and disseminate evidence-based or evidence-informed practices regarding
recruitment and retention of community health workers and paraprofessionals to address ongoing public health and community
health needs, and to prepare for, and respond to, future public
health emergencies.
(h) REPORT TO CONGRESS.—Not later than 4 years after the
date of enactment of the PREVENT Pandemics Act, the Secretary
shall submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate and
the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives a report concerning
the effectiveness of the program under this section in addressing
ongoing public health and community health needs. Such report
shall include recommendations regarding any improvements to
such program, including recommendations for how to improve recruitment, training, and retention of the community health workforce.
(i) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section, there are authorized to be appropriated
$50,000,000 for each of fiscal years 2023 through 2027.
(j) DEFINITIONS.—In this section:
(1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a
public or nonprofit private entity, including a State or political
subdivision of a State, an Indian Tribe or Tribal organization,
an urban Indian organization, a community-based organization, a public health department, a free health clinic, a hospital, or a Federally-qualified health center ( 104(as defined in
section 1861(aa)(4) of the Social Security Act), or a consortium
of any such entities.
(2) INDIAN TRIBE; TRIBAL ORGANIZATION.—The terms ‘‘Indian Tribe’’ and ‘‘Tribal organization’’ have the meanings given
the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’, respectively,
in section 4 of the Indian Self-Determination and Education
Assistance Act.
(3) URBAN INDIAN ORGANIZATION.—The term ‘‘urban Indian
organization’’ has the meaning given such term in section 4 of
the Indian Health Care Improvement Act.
SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
(a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
(1) IN GENERAL.—The Secretary, acting through the
Director of the Agency for Healthcare Research and Quality, shall
establish a Primary Care Extension Program.
(2) PURPOSE.—The Primary Care Extension Program shall
provide support and assistance to primary care providers to
educate providers about preventive medicine, health promotion, chronic disease management, mental and behavioral
health services (including substance abuse prevention and
treatment services), and evidence-based and evidence-informed
therapies and techniques, in order to enable providers to incorporate such matters into their practice and to improve commu-
104 Double parenthesis so in law. See the amendment made by section 2222(a)(9)(C)(ii) of division FF of Public Law 117-328.
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PUBLIC HEALTH SERVICE ACT
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nity health by working with community-based health connectors (referred to in this section as ‘‘Health Extension Agents’’).
(3) DEFINITIONS.—In this section:
(A) HEALTH EXTENSION AGENT.—The term ‘‘Health Extension Agent’’ means any local, community-based health
worker who facilitates and provides assistance to primary
care practices by implementing quality improvement or
system redesign, incorporating the principles of the patient-centered medical home to provide high-quality, effective, efficient, and safe primary care and to provide guidance to patients in culturally and linguistically appropriate
ways, and linking practices to diverse health system resources.
(B) PRIMARY CARE PROVIDER.—The term ‘‘primary care
provider’’ means a clinician who provides integrated, accessible health care services and who is accountable for addressing a large majority of personal health care needs, including providing preventive and health promotion services for men, women, and children of all ages, developing
a sustained partnership with patients, and practicing in
the context of family and community, as recognized by a
State licensing or regulatory authority, unless otherwise
specified in this section.
(b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY
CARE EXTENSION AGENCIES.—
(1) GRANTS.—The Secretary shall award competitive
grants to States for the establishment of State- or multistatelevel primary care Primary Care Extension Program State
Hubs (referred to in this section as ‘‘Hubs’’).
(2) COMPOSITION OF HUBS.—A Hub established by a State
pursuant to paragraph (1)—
(A) shall consist of, at a minimum, the State health
department, the entity responsible for administering the
State Medicaid program (if other than the State health department), the State-level entity administering the Medicare program, and the departments that train providers in
primary care in 1 or more health professions schools in the
State; and
(B) may include entities such as hospital associations,
primary care practice-based research networks, health professional societies, State primary care associations, State
licensing boards, organizations with a contract with the
Secretary under section 1153 of the Social Security Act,
consumer groups, and other appropriate entities.
(c) STATE AND LOCAL ACTIVITIES.—
(1) HUB ACTIVITIES.—Hubs established under a grant
under subsection (b) shall—
(A) submit to the Secretary a plan to coordinate functions with quality improvement organizations and area
health education centers if such entities are members of
the Hub not described in subsection (b)(2)(A);
(B) contract with a county- or local-level entity that
shall serve as the Primary Care Extension Agency to administer the services described in paragraph (2);
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524
(C) organize and administer grant funds to county- or
local-level Primary Care Extension Agencies that serve a
catchment area, as determined by the State; and
(D) organize State-wide or multistate networks of
local-level Primary Care Extension Agencies to share and
disseminate information and practices.
(2) LOCAL PRIMARY CARE EXTENSION AGENCY ACTIVITIES.—
(A) REQUIRED ACTIVITIES.—Primary Care Extension
Agencies established by a Hub under paragraph (1) shall—
(i) assist primary care providers to implement a
patient-centered medical home to improve the accessibility, quality, and efficiency of primary care services,
including health homes;
(ii) develop and support primary care learning
communities to enhance the dissemination of research
findings for evidence-based practice, assess implementation of practice improvement, share best practices,
and involve community clinicians in the generation of
new knowledge and identification of important questions for research;
(iii) participate in a national network of Primary
Care Extension Hubs and propose how the Primary
Care Extension Agency will share and disseminate lessons learned and best practices; and
(iv) develop a plan for financial sustainability involving State, local, and private contributions, to provide for the reduction in Federal funds that is expected after an initial 6-year period of program establishment, infrastructure development, and planning.
(B) DISCRETIONARY ACTIVITIES.—Primary Care Extension Agencies established by a Hub under paragraph (1)
may—
(i) provide technical assistance, training, and organizational support for community health teams established under section 3602 of the Patient Protection
and Affordable Care Act;
(ii) collect data and provision of primary care provider feedback from standardized measurements of
processes and outcomes to aid in continuous performance improvement;
(iii) collaborate with local health departments,
community health centers, tribes and tribal entities,
and other community agencies to identify community
health priorities and local health workforce needs, and
participate in community-based efforts to address the
social and primary determinants of health, strengthen
the local primary care workforce, and eliminate health
disparities;
(iv) develop measures to monitor the impact of the
proposed program on the health of practice enrollees
and of the wider community served; and
(v) participate in other activities, as determined
appropriate by the Secretary.
(d) FEDERAL PROGRAM ADMINISTRATION.—
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(1) GRANTS; TYPES.—Grants awarded under subsection (b)
shall be—
(A) program grants, that are awarded to State or
multistate entities that submit fully-developed plans for
the implementation of a Hub, for a period of 6 years; or
(B) planning grants, that are awarded to State or
multistate entities with the goal of developing a plan for
a Hub, for a period of 2 years.
(2) APPLICATIONS.—To be eligible for a grant under subsection (b), a State or multistate entity shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require.
(3) EVALUATION.—A State that receives a grant under subsection (b) shall be evaluated at the end of the grant period by
an evaluation panel appointed by the Secretary.
(4) CONTINUING SUPPORT.—After the sixth year in which
assistance is provided to a State under a grant awarded under
subsection (b), the State may receive additional support under
this section if the State program has received satisfactory evaluations with respect to program performance and the merits of
the State sustainability plan, as determined by the Secretary.
(5) LIMITATION.—A State shall not use in excess of 10 percent of the amount received under a grant to carry out administrative activities under this section. Funds awarded pursuant
to this section shall not be used for funding direct patient care.
(e) REQUIREMENTS ON THE SECRETARY.—In carrying out this
section, the Secretary shall consult with the heads of other Federal
agencies with demonstrated experience and expertise in health care
and preventive medicine, such as the Centers for Disease Control
and Prevention, the Substance Abuse and Mental Health Administration, the Health Resources and Services Administration, the National Institutes of Health, the Office of the National Coordinator
for Health Information Technology, the Indian Health Service, the
Agricultural Cooperative Extension Service of the Department of
Agriculture, and other entities, as the Secretary determines appropriate.
(f) AUTHORIZATION OF APPROPRIATIONS.—To awards grants as
provided in subsection (d), there are authorized to be appropriated
$120,000,000 for each of fiscal years 2011 and 2012, and such sums
as may be necessary to carry out this section for each of fiscal
years 2013 through 2014.
SEC. 399V–2. ø280g–13¿ NATIONAL CONGENITAL HEART DISEASE RESEARCH, SURVEILLANCE, AND AWARENESS.
(a) IN GENERAL.—The Secretary shall, as appropriate—
(1) enhance and expand research and data collection efforts related to congenital heart disease, including to study and
track the epidemiology of congenital heart disease to understand health outcomes for individuals with congenital heart
disease across all ages;
(2) conduct activities to improve public awareness of, and
education related to, congenital heart disease, including care of
individuals with such disease; and
(3) award grants to entities to undertake the activities described in this section.
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(b) ACTIVITIES.—
(1) IN GENERAL.—The Secretary shall carry out activities,
including, as appropriate, through a national cohort study and
a nationally-representative, population-based surveillance system, to improve the understanding of the epidemiology of congenital heart disease in all age groups, with particular attention to—
(A) the incidence and prevalence of congenital heart
disease in the United States;
(B) causation and risk factors associated with, and
natural history of, congenital heart disease;
(C) health care utilization by individuals with congenital heart disease;
(D) demographic factors associated with congenital
heart disease, such as age, race, ethnicity, sex, and family
history of individuals who are diagnosed with the disease;
and
(E) evidence-based practices related to care and treatment for individuals with congenital heart disease.
(2) PERMISSIBLE CONSIDERATIONS.—In carrying out the activities under this section, the Secretary may, as appropriate—
(A) collect data on the health outcomes, including behavioral and mental health outcomes, of a diverse population of individuals of all ages with congenital heart disease, such that analysis of the outcomes will inform evidence-based practices for individuals with congenital heart
disease; and
(B) consider health disparities among individuals with
congenital heart disease, which may include the consideration of prenatal exposures.
(c) AWARENESS CAMPAIGN.—The Secretary may carry out
awareness and educational activities related to congenital heart
disease in individuals of all ages, which may include information
for patients, family members, and health care providers, on topics
such as the prevalence of such disease, the effect of such disease
on individuals of all ages, and the importance of long-term, specialized care for individuals with such disease.
(d) PUBLIC ACCESS.—The Secretary shall ensure that, subject
to subsection (e), information collected under this section is made
available, as appropriate, to the public, including researchers.
(e) PATIENT PRIVACY.—The Secretary shall ensure that the
data and information collected under this section are made available in a manner that, at a minimum, protects personal privacy to
the extent required by applicable Federal and State law.
(f) ELIGIBILITY FOR GRANTS.—To be eligible to receive a grant
under subsection (a)(3), an entity shall—
(1) be a public or private nonprofit entity with specialized
experience in congenital heart disease; and
(2) submit to the Secretary an application at such time, in
such manner, and containing such information as the Secretary may require.
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $10,000,000 for each
of fiscal years 2020 through 2024.
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SEC. 399V–3. ø280g–14¿ NATIONAL DIABETES PREVENTION PROGRAM.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall establish a
national diabetes prevention program (referred to in this section as
the ‘‘program’’) targeted at adults at high risk for diabetes in order
to eliminate the preventable burden of diabetes.
(b) PROGRAM ACTIVITIES.—The program described in subsection
(a) shall include—
(1) a grant program for community-based diabetes prevention program model sites;
(2) a program within the Centers for Disease Control and
Prevention to determine eligibility of entities to deliver community-based diabetes prevention services;
(3) a training and outreach program for lifestyle intervention instructors; and
(4) evaluation, monitoring and technical assistance, and
applied research carried out by the Centers for Disease Control
and Prevention.
(c) ELIGIBLE ENTITIES.—To be eligible for a grant under subsection (b)(1), an entity shall be a State or local health department,
a tribal organization, a national network of community-based nonprofits focused on health and wellbeing, an academic institution, or
other entity, as the Secretary determines.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of fiscal years 2010
through 2014.
SEC. 399V–4. ø280g–15¿ STATE DEMONSTRATION PROGRAMS TO EVALUATE ALTERNATIVES TO CURRENT MEDICAL TORT LITIGATION.
(a) IN GENERAL.—The Secretary is authorized to award dem-
onstration grants to States for the development, implementation,
and evaluation of alternatives to current tort litigation for resolving
disputes over injuries allegedly caused by health care providers or
health care organizations. In awarding such grants, the Secretary
shall ensure the diversity of the alternatives so funded.
(b) DURATION.—The Secretary may award grants under subsection (a) for a period not to exceed 5 years.
(c) CONDITIONS FOR DEMONSTRATION GRANTS.—
(1) REQUIREMENTS.—Each State desiring a grant under
subsection (a) shall develop an alternative to current tort litigation that—
(A) allows for the resolution of disputes over injuries
allegedly caused by health care providers or health care organizations; and
(B) promotes a reduction of health care errors by encouraging the collection and analysis of patient safety data
related to disputes resolved under subparagraph (A) by organizations that engage in efforts to improve patient safety and the quality of health care.
(2) ALTERNATIVE TO CURRENT TORT LITIGATION.—Each
State desiring a grant under subsection (a) shall demonstrate
how the proposed alternative described in paragraph (1)(A)—
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(A) makes the medical liability system more reliable
by increasing the availability of prompt and fair resolution
of disputes;
(B) encourages the efficient resolution of disputes;
(C) encourages the disclosure of health care errors;
(D) enhances patient safety by detecting, analyzing,
and helping to reduce medical errors and adverse events;
(E) improves access to liability insurance;
(F) fully informs patients about the differences in the
alternative and current tort litigation;
(G) provides patients the ability to opt out of or voluntarily withdraw from participating in the alternative at
any time and to pursue other options, including litigation,
outside the alternative;
(H) would not conflict with State law at the time of
the application in a way that would prohibit the adoption
of an alternative to current tort litigation; and
(I) would not limit or curtail a patient’s existing legal
rights, ability to file a claim in or access a State’s legal
system, or otherwise abrogate a patient’s ability to file a
medical malpractice claim.
(3) SOURCES OF COMPENSATION.—Each State desiring a
grant under subsection (a) shall identify the sources from and
methods by which compensation would be paid for claims resolved under the proposed alternative to current tort litigation,
which may include public or private funding sources, or a combination of such sources. Funding methods shall to the extent
practicable provide financial incentives for activities that improve patient safety.
(4) SCOPE.—
(A) IN GENERAL.—Each State desiring a grant under
subsection (a) shall establish a scope of jurisdiction (such
as Statewide, designated geographic region, a designated
area of health care practice, or a designated group of
health care providers or health care organizations) for the
proposed alternative to current tort litigation that is sufficient to evaluate the effects of the alternative. No scope of
jurisdiction shall be established under this paragraph that
is based on a health care payer or patient population.
(B) NOTIFICATION OF PATIENTS.—A State shall demonstrate how patients would be notified that they are receiving health care services that fall within such scope,
and the process by which they may opt out of or voluntarily withdraw from participating in the alternative. The
decision of the patient whether to participate or continue
participating in the alternative process shall be made at
any time and shall not be limited in any way.
(5) PREFERENCE IN AWARDING DEMONSTRATION GRANTS.—
In awarding grants under subsection (a), the Secretary shall
give preference to States—
(A) that have developed the proposed alternative
through substantive consultation with relevant stakeholders, including patient advocates, health care providers
and health care organizations, attorneys with expertise in
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representing patients and health care providers, medical
malpractice insurers, and patient safety experts;
(B) that make proposals that are likely to enhance patient safety by detecting, analyzing, and helping to reduce
medical errors and adverse events; and
(C) that make proposals that are likely to improve access to liability insurance.
(d) APPLICATION.—
(1) IN GENERAL.—Each State desiring a grant under subsection (a) shall submit to the Secretary an application, at such
time, in such manner, and containing such information as the
Secretary may require.
(2) REVIEW PANEL.—
(A) IN GENERAL.—In reviewing applications under
paragraph (1), the Secretary shall consult with a review
panel composed of relevant experts appointed by the
Comptroller General.
(B) COMPOSITION.—
(i) NOMINATIONS.—The Comptroller General shall
solicit nominations from the public for individuals to
serve on the review panel.
(ii) APPOINTMENT.—The Comptroller General shall
appoint, at least 9 but not more than 13, highly qualified and knowledgeable individuals to serve on the review panel and shall ensure that the following entities
receive fair representation on such panel:
(I) Patient advocates.
(II) Health care providers and health care organizations.
(III) Attorneys with expertise in representing
patients and health care providers.
(IV) Medical malpractice insurers.
(V) State officials.
(VI) Patient safety experts.
(C) CHAIRPERSON.—The Comptroller General shall
designate a member of the review panel to be the chairperson of the review panel.
(D) AVAILABILITY OF INFORMATION.—The Secretary
shall make available to the review panel such information,
personnel, and administrative services and assistance as
the review panel may reasonably require to carry out its
duties.
(E) INFORMATION FROM AGENCIES.—The review panel
may request directly from any department or agency of the
United States any information that such panel considers
necessary to carry out its duties. To the extent consistent
with applicable laws and regulations, the head of such department or agency shall furnish the requested information to the review panel.
(e) REPORTS.—
(1) BY STATE.—Each State receiving a grant under subsection (a) shall submit to the Secretary an annual report evaluating the effectiveness of activities funded with grants awarded under such subsection. Such report shall, at a minimum, inFebruary 1, 2024
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clude the impact of the activities funded on patient safety and
on the availability and price of medical liability insurance.
(2) BY SECRETARY.—The Secretary shall submit to Congress an annual compendium of the reports submitted under
paragraph (1) and an analysis of the activities funded under
subsection (a) that examines any differences that result from
such activities in terms of the quality of care, number and nature of medical errors, medical resources used, length of time
for dispute resolution, and the availability and price of liability
insurance.
(f) TECHNICAL ASSISTANCE.—
(1) IN GENERAL.—The Secretary shall provide technical assistance to the States applying for or awarded grants under
subsection (a).
(2) REQUIREMENTS.—Technical assistance under paragraph
(1) shall include—
(A) guidance on non-economic damages, including the
consideration of individual facts and circumstances in determining appropriate payment, guidance on identifying
avoidable injuries, and guidance on disclosure to patients
of health care errors and adverse events; and
(B) the development, in consultation with States, of
common definitions, formats, and data collection infrastructure for States receiving grants under this section to
use in reporting to facilitate aggregation and analysis of
data both within and between States.
(3) USE OF COMMON DEFINITIONS, FORMATS, AND DATA COLLECTION INFRASTRUCTURE.—States not receiving grants under
this section may also use the common definitions, formats, and
data collection infrastructure developed under paragraph
(2)(B).
(g) EVALUATION.—
(1) IN GENERAL.—The Secretary, in consultation with the
review panel established under subsection (d)(2), shall enter
into a contract with an appropriate research organization to
conduct an overall evaluation of the effectiveness of grants
awarded under subsection (a) and to annually prepare and submit a report to Congress. Such an evaluation shall begin not
later than 18 months following the date of implementation of
the first program funded by a grant under subsection (a).
(2) CONTENTS.—The evaluation under paragraph (1) shall
include—
(A) an analysis of the effects of the grants awarded
under subsection (a) with regard to the measures described
in paragraph (3);
(B) for each State, an analysis of the extent to which
the alternative developed under subsection (c)(1) is effective in meeting the elements described in subsection (c)(2);
(C) a comparison among the States receiving grants
under subsection (a) of the effectiveness of the various alternatives developed by such States under subsection
(c)(1);
(D) a comparison, considering the measures described
in paragraph (3), of States receiving grants approved
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under subsection (a) and similar States not receiving such
grants; and
(E) a comparison, with regard to the measures described in paragraph (3), of—
(i) States receiving grants under subsection (a);
(ii) States that enacted, prior to the date of enactment of the Patient Protection and Affordable Care
Act, any cap on non-economic damages; and
(iii) States that have enacted, prior to the date of
enactment of the Patient Protection and Affordable
Care Act, a requirement that the complainant obtain
an opinion regarding the merit of the claim, although
the substance of such opinion may have no bearing on
whether the complainant may proceed with a case.
(3) MEASURES.—The evaluations under paragraph (2) shall
analyze and make comparisons on the basis of—
(A) the nature and number of disputes over injuries allegedly caused by health care providers or health care organizations;
(B) the nature and number of claims in which tort litigation was pursued despite the existence of an alternative
under subsection (a);
(C) the disposition of disputes and claims, including
the length of time and estimated costs to all parties;
(D) the medical liability environment;
(E) health care quality;
(F) patient safety in terms of detecting, analyzing, and
helping to reduce medical errors and adverse events;
(G) patient and health care provider and organization
satisfaction with the alternative under subsection (a) and
with the medical liability environment; and
(H) impact on utilization of medical services, appropriately adjusted for risk.
(4) FUNDING.—The Secretary shall reserve 5 percent of the
amount appropriated in each fiscal year under subsection (k)
to carry out this subsection.
(h) MEDPAC AND MACPAC REPORTS.—
(1) MEDPAC.—The Medicare Payment Advisory Commission shall conduct an independent review of the alternatives to
current tort litigation that are implemented under grants
under subsection (a) to determine the impact of such alternatives on the Medicare program under title XVIII of the Social Security Act, and its beneficiaries.
(2) MACPAC.—The Medicaid and CHIP Payment and Access Commission shall conduct an independent review of the
alternatives to current tort litigation that are implemented
under grants under subsection (a) to determine the impact of
such alternatives on the Medicaid or CHIP programs under titles XIX and XXI of the Social Security Act, and their beneficiaries.
(3) REPORTS.—Not later than December 31, 2016, the
Medicare Payment Advisory Commission and the Medicaid and
CHIP Payment and Access Commission shall each submit to
Congress a report that includes the findings and recommendaFebruary 1, 2024
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tions of each respective Commission based on independent reviews conducted under paragraphs (1) and (2), including an
analysis of the impact of the alternatives reviewed on the efficiency and effectiveness of the respective programs.
(i) OPTION TO PROVIDE FOR INITIAL PLANNING GRANTS.—Of the
funds appropriated pursuant to subsection (k), the Secretary may
use a portion not to exceed $500,000 per State to provide planning
grants to such States for the development of demonstration project
applications meeting the criteria described in subsection (c). In selecting States to receive such planning grants, the Secretary shall
give preference to those States in which State law at the time of
the application would not prohibit the adoption of an alternative to
current tort litigation.
(j) DEFINITIONS.—In this section:
(1) HEALTH CARE SERVICES.—The term ‘‘health care services’’ means any services provided by a health care provider, or
by any individual working under the supervision of a health
care provider, that relate to—
(A) the diagnosis, prevention, or treatment of any
human disease or impairment; or
(B) the assessment of the health of human beings.
(2) HEALTH CARE ORGANIZATION.—The term ‘‘health care
organization’’ means any individual or entity which is obligated
to provide, pay for, or administer health benefits under any
health plan.
(3) HEALTH CARE PROVIDER.—The term ‘‘health care provider’’ means any individual or entity—
(A) licensed, registered, or certified under Federal or
State laws or regulations to provide health care services;
or
(B) required to be so licensed, registered, or certified
but that is exempted by other statute or regulation.
(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, $50,000,000 for the 5fiscal year period beginning with fiscal year 2011.
(l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO
TORT LITIGATION.—Nothing in this section shall be construed to
limit any prior, current, or future efforts of any State to establish
any alternative to tort litigation.
(m) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed as limiting states’ authority over or responsibility for
their state justice systems.
SEC. 399V–5. ø280g–16¿ FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE.
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of the FDA Food Safety Modernization Act, the Secretary,
acting through the Director of the Centers for Disease Control and
Prevention and in consultation with the working group described
in subsection (b)(2), shall designate 5 Integrated Food Safety Centers of Excellence (referred to in this section as the ‘‘Centers of Excellence’’) to serve as resources for Federal, State, and local public
health professionals to respond to foodborne illness outbreaks. The
Centers of Excellence shall be headquartered at selected State
health departments.
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(b) SELECTION OF CENTERS OF EXCELLENCE.—
(1) ELIGIBLE ENTITIES.—To be eligible to be designated as
a Center of Excellence under subsection (a), an entity shall—
(A) be a State health department;
(B) partner with 1 or more institutions of higher education that have demonstrated knowledge, expertise, and
meaningful experience with regional or national food production, processing, and distribution, as well as leadership
in the laboratory, epidemiological, and environmental detection and investigation of foodborne illness; and
(C) provide to the Secretary such information, at such
time, and in such manner, as the Secretary may require.
(2) WORKING GROUP.—Not later than 180 days after the
date of enactment of the FDA Food Safety Modernization Act,
the Secretary shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, including food retailers and food manufacturers, consumer organizations, and academia to make recommendations to the Secretary regarding
designations of the Centers of Excellence.
(3) ADDITIONAL CENTERS OF EXCELLENCE.—The Secretary
may designate eligible entities to be regional Food Safety Centers of Excellence, in addition to the 5 Centers designated
under subsection (a).
(c) ACTIVITIES.—Under the leadership of the Director of the
Centers for Disease Control and Prevention, each Center of Excellence shall be based out of a selected State health department,
which shall provide assistance to other regional, State, and local
departments of health through activities that include—
(1) providing resources, including timely information concerning symptoms and tests, for frontline health professionals
interviewing individuals as part of routine surveillance and
outbreak investigations;
(2) providing analysis of the timeliness and effectiveness of
foodborne disease surveillance and outbreak response activities;
(3) providing training for epidemiological and environmental investigation of foodborne illness, including suggestions
for streamlining and standardizing the investigation process;
(4) establishing fellowships, stipends, and scholarships to
train future epidemiological and food-safety leaders and to address critical workforce shortages;
(5) training and coordinating State and local personnel;
(6) strengthening capacity to participate in existing or new
foodborne illness surveillance and environmental assessment
information systems; and
(7) conducting research and outreach activities focused on
increasing prevention, communication, and education regarding food safety.
(d) REPORT TO CONGRESS.—Not later than 2 years after the
date of enactment of the FDA Food Safety Modernization Act, the
Secretary shall submit to Congress a report that—
(1) describes the effectiveness of the Centers of Excellence;
and
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(2) provides legislative recommendations or describes additional resources required by the Centers of Excellence.
(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated such sums as may be necessary to carry out this
section.
(f) NO DUPLICATION OF EFFORT.—In carrying out activities of
the Centers of Excellence or other programs under this section, the
Secretary shall not duplicate other Federal foodborne illness response efforts.
SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTENTIAL CANCER CLUSTERS.
(a) DEFINITIONS.—In this section:
(1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means
the incidence of a particular cancer within a population group,
a geographical area, and a period of time that is greater than
expected for such group, area, and period.
(2) PARTICULAR CANCER.—The term ‘‘particular cancer’’
means one specific type of cancer or a type of cancers scientifically proven to have the same cause.
(3) POPULATION GROUP.—The term ‘‘population group’’
means a group, for purposes of calculating cancer rates, defined by factors such as race, ethnicity, age, or gender.
(b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUSTERS.—
(1) DEVELOPMENT OF CRITERIA.—The Secretary shall develop criteria for the designation of potential cancer clusters.
(2) REQUIREMENTS.—The criteria developed under paragraph (1) shall consider, as appropriate—
(A) a standard for cancer cluster identification and reporting protocols used to determine when cancer incidence
is greater than would be typically observed;
(B) scientific screening standards that ensure that a
cluster of a particular cancer involves the same type of
cancer, or types of cancers;
(C) the population in which the cluster of a particular
cancer occurs by factors such as race, ethnicity, age, and
gender, for purposes of calculating cancer rates;
(D) the boundaries of a geographic area in which a
cluster of a particular cancer occurs so as not to create or
obscure a potential cluster by selection of a specific area;
and
(E) the time period over which the number of cases of
a particular cancer, or the calculation of an expected number of cases, occurs.
(c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER
CLUSTERS.—The Secretary, in consultation with the Council of
State and Territorial Epidemiologists and representatives of State
and local health departments, shall develop, publish, and periodically update guidelines for investigating potential cancer clusters.
The guidelines shall—
(1) recommend that investigations of cancer clusters—
(A) use the criteria developed under subsection (b);
(B) use the best available science; and
(C) rely on a weight of the scientific evidence;
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(2) provide standardized methods of reviewing and categorizing data, including from health surveillance systems and reports of potential cancer clusters; and
(3) provide guidance for using appropriate epidemiological
and other approaches for investigations.
(d) INVESTIGATION OF CANCER CLUSTERS.—
(1) SECRETARY DISCRETION.—The Secretary—
(A) in consultation with representatives of the relevant
State and local health departments, shall consider whether
it is appropriate to conduct an investigation of a potential
cancer cluster; and
(B) in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based on
the availability of resources.
(2) COORDINATION.—In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the
Department of Health and Human Services and other Federal
agencies, such as the Environmental Protection Agency.
(3) BIOMONITORING.—In investigating potential cancer
clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs,
such as the National Health and Nutrition Examination Survey. The Secretary may provide technical assistance for relevant biomonitoring studies of other Federal agencies.
(e) DUTIES.—The Secretary shall—
(1) ensure that appropriate staff of agencies within the Department of Health and Human Services are prepared to provide timely assistance, to the extent practicable, upon receiving
a request to investigate a potential cancer cluster from a State
or local health authority;
(2) maintain staff expertise in epidemiology, toxicology,
data analysis, environmental health and cancer surveillance,
exposure assessment, pediatric health, pollution control, community outreach, health education, laboratory sampling and
analysis, spatial mapping, and informatics;
(3) consult with community members as investigations into
potential cancer clusters are conducted, as the Secretary determines appropriate;
(4) collect, store, and disseminate reports on investigations
of potential cancer clusters, the possible causes of such clusters, and the actions taken to address such clusters; and
(5) provide technical assistance for investigating cancer
clusters to State and local health departments through existing
programs, such as the Epi-Aids program of the Centers for Disease Control and Prevention and the Assessments of Chemical
Exposures Program of the Agency for Toxic Substances and
Disease Registry.
SEC. 399V–7. ø 280g-18 ¿ MATERNAL MENTAL HEALTH HOTLINE.
(a) IN GENERAL.—The Secretary shall maintain, by grant
or
contract, a national maternal mental health hotline to provide emotional support, information, brief intervention, and mental health
and substance use disorder resources to pregnant and postpartum
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women at risk of, or affected by, maternal mental health and substance use disorders, and to their families or household members.
(b) REQUIREMENTS FOR HOTLINE.—The hotline under subsection (a) shall—
(1) be a 24/7 real-time hotline;
(2) provide voice and text support;
(3) be staffed by certified peer specialists, licensed health
care professionals, or licensed mental health professionals who
are trained on—
(A) maternal mental health and substance use disorder prevention, identification, and intervention; and
(B) providing culturally and linguistically appropriate
support; and
(4) provide maternal mental health and substance use disorder assistance and referral services to meet the needs of underserved populations, individuals with disabilities, and family
and household members of pregnant or postpartum women at
risk of experiencing maternal mental health and substance use
disorders.
(c) ADDITIONAL REQUIREMENTS.—In maintaining the hotline
under subsection (a), the Secretary shall—
(1) consult with the Domestic Violence Hotline, National
Suicide Prevention Lifeline, and Veterans Crisis Line to ensure
that pregnant and postpartum women are connected in realtime to the appropriate specialized hotline service, when applicable;
(2) conduct a public awareness campaign for the hotline;
(3) consult with Federal departments and agencies, including the Substance Abuse and Mental Health Services Administration and the Department of Veterans Affairs, to increase
awareness regarding the hotline; and
(4) consult with appropriate State, local, and Tribal public
health officials, including officials who administer programs
that serve low-income pregnant and postpartum individuals.
(d) ANNUAL REPORT.—The Secretary shall submit an annual
report to the Congress on the hotline under subsection (a) and implementation of this section, including—
(1) an evaluation of the effectiveness of activities conducted or supported under subsection (a);
(2) a directory of entities or organizations to which staff
maintaining the hotline funded under this section may make
referrals; and
(3) such additional information as the Secretary determines appropriate.
(e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $10,000,000 for each
of fiscal years 2023 through 2027.
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Sec. 399W
PART Q—PROGRAMS TO IMPROVE THE
HEALTH OF CHILDREN
SEC. 399W. ø280h¿ GRANTS TO PROMOTE CHILDHOOD NUTRITION AND
PHYSICAL ACTIVITY.
(a) IN GENERAL.—The Secretary, acting though the Director of
the Centers for Disease Control and Prevention, shall award competitive grants to States and political subdivisions of States for the
development and implementation of State and community-based
intervention programs to promote good nutrition and physical activity in children and adolescents.
(b) ELIGIBILITY.—To be eligible to receive a grant under this
section a State or political subdivision of a State shall prepare and
submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require,
including a plan that describes—
(1) how the applicant proposes to develop a comprehensive
program of school- and community-based approaches to encourage and promote good nutrition and appropriate levels of physical activity with respect to children or adolescents in local
communities;
(2) the manner in which the applicant shall coordinate
with appropriate State and local authorities, such as State and
local school departments, State departments of health, chronic
disease directors, State directors of programs under section 17
of the Child Nutrition Act of 1966, 5-a-day coordinators, governors councils for physical activity and good nutrition, and
State and local parks and recreation departments; and
(3) the manner in which the applicant will evaluate the effectiveness of the program carried out under this section.
(c) USE OF FUNDS.—A State or political subdivision of a State
shall use amount received under a grant under this section to—
(1) develop, implement, disseminate, and evaluate schooland community-based strategies in States to reduce inactivity
and improve dietary choices among children and adolescents;
(2) expand opportunities for physical activity programs in
school- and community-based settings; and
(3) develop, implement, and evaluate programs that promote good eating habits and physical activity including opportunities for children with cognitive and physical disabilities.
(d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an
amount not to exceed 10 percent of the amount appropriated for a
fiscal year under subsection (h) to permit the Director of the Centers for Disease Control and Prevention to—
(1) provide States and political subdivisions of States with
technical support in the development and implementation of
programs under this section; and
(2) disseminate information about effective strategies and
interventions in preventing and treating obesity through the
promotion of good nutrition and physical activity.
(e) LIMITATION ON ADMINISTRATIVE COSTS.—Not to exceed 10
percent of the amount of a grant awarded to the State or political
subdivision under subsection (a) for a fiscal year may be used by
the State or political subdivision for administrative expenses.
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(f) TERM.—A grant awarded under subsection (a) shall be for
a term of 3 years.
(g) DEFINITION.—In this section, the term ‘‘children and adolescents’’ means individuals who do not exceed 18 years of age.
(h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2001 through 2005.
SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
(a) IN GENERAL.—The Secretary, acting through
the Centers
for Disease Control and Prevention and in consultation with the
Director of the National Institutes of Health, shall—
(1) conduct research to better understand the relationship
between physical activity, diet, and health and factors that influence health-related behaviors;
(2) develop and evaluate strategies for the prevention and
treatment of obesity to be used in community-based interventions and by health professionals;
(3) develop and evaluate strategies for the prevention and
treatment of eating disorders, such as anorexia and bulimia;
(4) conduct research to establish the prevalence, consequences, and costs of childhood obesity and its effects in
adulthood;
(5) identify behaviors and risk factors that contribute to
obesity;
(6) evaluate materials and programs to provide nutrition
education to parents and teachers of children in child care or
pre-school and the food service staff of such child care and preschool entities; and
(7) evaluate materials and programs that are designed to
educate and encourage physical activity in child care and preschool facilities.
(b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2001 through 2005.
SEC. 399Y. ø280h–2¿ EDUCATION CAMPAIGN.
(a) IN GENERAL.—The Secretary, acting
through the Director of
the Centers for Disease Control and Prevention, and in collaboration with national, State, and local partners, physical activity organizations, nutrition experts, and health professional organizations,
shall develop a national public campaign to promote and educate
children and their parents concerning—
(1) the health risks associated with obesity, inactivity, and
poor nutrition;
(2) ways in which to incorporate physical activity into daily
living; and
(3) the benefits of good nutrition and strategies to improve
eating habits.
(b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2001 through 2005.
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Sec. 399Z–1
SEC. 399Z. ø280h–3¿ HEALTH PROFESSIONAL EDUCATION AND TRAINING.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, in collaboration
with the Administrator of the Health Resources and Services Administration and the heads of other agencies, and in consultation
with appropriate health professional associations, shall develop and
carry out a program to educate and train health professionals in
effective strategies to—
(1) better identify and assess patients with obesity or an
eating disorder or patients at-risk of becoming obese or developing an eating disorder;
(2) counsel, refer, or treat patients with obesity or an eating disorder; and
(3) educate patients and their families about effective
strategies to improve dietary habits and establish appropriate
levels of physical activity.
(b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2001 through 2005.
SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
(a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
(1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term
‘‘comprehensive primary health services’’ means the core services offered by school-based health centers, which shall include
the following:
(A) PHYSICAL.—Comprehensive health assessments,
diagnosis, and treatment of minor, acute, and chronic medical conditions, and referrals to, and follow-up for, specialty care and oral and vision health services.
(B) MENTAL HEALTH.—Mental health and substance
use disorder assessments, crisis intervention, counseling,
treatment, and referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs.
(2) MEDICALLY UNDERSERVED CHILDREN AND ADOLESCENTS.—
(A) IN GENERAL.—The term ‘‘medically underserved
children and adolescents’’ means a population of children
and adolescents who are residents of an area designated as
a medically underserved area or a health professional
shortage area by the Secretary.
(B) CRITERIA.—The Secretary shall prescribe criteria
for determining the specific shortages of personal health
services for medically underserved children and adolescents under subparagraph (A) that shall—
(i) take into account any comments received by
the Secretary from the chief executive officer of a
State and local officials in a State; and
(ii) include factors indicative of the health status
of such children and adolescents of an area, including
the ability of the residents of such area to pay for
health services, the accessibility of such services, the
availability of health professionals to such children
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540
and adolescents, and other factors as determined appropriate by the Secretary.
(3) SCHOOL-BASED HEALTH CENTER.—The term ‘‘schoolbased health center’’ means a health clinic that—
(A) meets the definition of a school-based health center under section 2110(c)(9)(A) of the Social Security Act
and is administered by a sponsoring facility (as defined in
section 2110(c)(9)(B) of the Social Security Act);
(B) provides, at a minimum, comprehensive primary
health services during school hours to children and adolescents by health professionals in accordance with established standards, community practice, reporting laws, and
other State laws, including parental consent and notification laws that are not inconsistent with Federal law; and
(C) does not perform abortion services.
(b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award
grants for the costs of the operation of school-based health centers
(referred to in this section as ‘‘SBHCs’’) that meet the requirements
of this section.
(c) APPLICATIONS.—To be eligible to receive a grant under this
section, an entity shall—
(1) be an SBHC (as defined in subsection (a)(3)); and
(2) submit to the Secretary an application at such time, in
such manner, and containing—
(A) evidence that the applicant meets all criteria necessary to be designated an SBHC;
(B) evidence of local need for the services to be provided by the SBHC;
(C) an assurance that—
(i) SBHC services will be provided to those children and adolescents for whom parental or guardian
consent has been obtained in cooperation with Federal, State, and local laws governing health care service provision to children and adolescents;
(ii) the SBHC has made and will continue to make
every reasonable effort to establish and maintain collaborative relationships with other health care providers in the catchment area of the SBHC;
(iii) the SBHC will provide on-site access during
the academic day when school is in session and 24hour coverage through an on-call system and through
its backup health providers to ensure access to services on a year-round basis when the school or the
SBHC is closed;
(iv) the SBHC will be integrated into the school
environment and will coordinate health services with
school personnel, such as administrators, teachers,
nurses, counselors, and support personnel, as well as
with other community providers co-located at the
school;
(v) the SBHC sponsoring facility assumes all responsibility for the SBHC administration, operations,
and oversight; and
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(vi) the SBHC will comply with Federal, State,
and local laws concerning patient privacy and student
records, including regulations promulgated under the
Health Insurance Portability and Accountability Act of
1996 and section 444 of the General Education Provisions Act; and
(D) such other information as the Secretary may require.
(d) PREFERENCES AND CONSIDERATION.—In reviewing applications:
(1) The Secretary may give preference to applicants who
demonstrate an ability to serve the following:
(A) Communities that have evidenced barriers to primary health care and mental health and substance use
disorder prevention services for children and adolescents.
(B) Communities with high per capita numbers of children and adolescents who are uninsured, underinsured, or
enrolled in public health insurance programs.
(C) Populations of children and adolescents that have
historically demonstrated difficulty in accessing health and
mental health and substance use disorder prevention services.
(2) The Secretary may give consideration to whether an
applicant has received a grant under subsection (a) of section
4101 of the Patient Protection and Affordable Care Act.
(e) WAIVER OF REQUIREMENTS.—The Secretary may—
(1) under appropriate circumstances, waive the application
of all or part of the requirements of this subsection with respect to an SBHC for not to exceed 2 years; and
(2) upon a showing of good cause, waive the requirement
that the SBHC provide all required comprehensive primary
health services for a designated period of time to be determined by the Secretary.
(f) USE OF FUNDS.—
(1) FUNDS.—Funds awarded under a grant under this section—
(A) may be used for—
(i) acquiring and leasing equipment (including the
costs of amortizing the principle of, and paying interest on, loans for such equipment);
(ii) providing training related to the provision of
required comprehensive primary health services and
additional health services;
(iii) the management and operation of health center programs;
(iv) the payment of salaries for physicians, nurses,
and other personnel of the SBHC; and
(B) may not be used to provide abortions.
(2) CONSTRUCTION.—The Secretary may award grants
which may be used to pay the costs associated with expanding
and modernizing existing buildings for use as an SBHC, including the purchase of trailers or manufactured buildings to
install on the school property.
(3) LIMITATIONS.—
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PUBLIC HEALTH SERVICE ACT
542
(A) IN GENERAL.—Any provider of services that is determined by a State to be in violation of a State law described in subsection (a)(3)(B) with respect to activities
carried out at a SBHC shall not be eligible to receive additional funding under this section.
(B) NO OVERLAPPING GRANT PERIOD.—No entity that
has received funding under section 330 for a grant period
shall be eligible for a grant under this section for with respect to the same grant period.
(g) MATCHING REQUIREMENT.—
(1) IN GENERAL.—Each eligible entity that receives a grant
under this section shall provide, from non-Federal sources, an
amount equal to 20 percent of the amount of the grant (which
may be provided in cash or in-kind) to carry out the activities
supported by the grant.
(2) WAIVER.—The Secretary may waive all or part of the
matching requirement described in paragraph (1) for any fiscal
year for the SBHC if the Secretary determines that applying
the matching requirement to the SBHC would result in serious
hardship or an inability to carry out the purposes of this section.
(h) SUPPLEMENT, NOT SUPPLANT.—Grant funds provided under
this section shall be used to supplement, not supplant, other Federal or State funds.
(i) EVALUATION.—The Secretary shall develop and implement a
plan for evaluating SBHCs and monitoring quality performance
under the awards made under this section.
(j) AGE APPROPRIATE SERVICES.—An eligible entity receiving
funds under this section shall only provide age appropriate services
through a SBHC funded under this section to an individual.
(k) PARENTAL CONSENT.—An eligible entity receiving funds
under this section shall not provide services through a SBHC funded under this section to an individual without the consent of the
parent or guardian of such individual if such individual is considered a minor under applicable State law.
(l) TECHNICAL ASSISTANCE.—The Secretary shall provide technical assistance by grants or contracts awarded to private, nonprofit entities with demonstrated expertise related to school-based
health centers. Such technical assistance, taking into account local
and regional differences among school based health centers, shall
support such entities in providing services described in subsection
(a)(1) pursuant to this section, including mental health and substance use disorder services, and may include technical assistance
relating to program operations and support for the implementation
of evidence-based or evidence-informed best practices related to the
provision of high quality health care services to children and adolescents.
(m) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2022 through
2026.
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SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL
HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
(a) GRANTS.—The Secretary shall—
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PUBLIC HEALTH SERVICE ACT
Sec. 399Z–2
(1) award grants to eligible entities to develop, maintain,
or enhance infant and early childhood mental health promotion, intervention, and treatment programs, including—
(A) programs for infants and children at significant
risk of developing, showing early signs of, or having been
diagnosed with mental illness, including a serious emotional disturbance; and
(B) multigenerational therapy and other services that
support the caregiving relationship; and
(2) ensure that programs funded through grants under this
section are evidence-informed or evidence-based models, practices, and methods that are, as appropriate, culturally and linguistically appropriate, and can be replicated in other appropriate settings.
(b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
(1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a
child from birth to not more than 12 years of age who—
(A) is at risk for, shows early signs of, or has been diagnosed with a mental illness, including a serious emotional disturbance; and
(B) may benefit from infant and early childhood intervention or treatment programs or specialized preschool or
elementary school programs that are evidence-based or
that have been scientifically demonstrated to show promise
but would benefit from further applied development.
(2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a
human services agency or nonprofit institution that—
(A) employs licensed mental health professionals who
have specialized training and experience in infant and
early childhood mental health assessment, diagnosis, and
treatment, or is accredited or approved by the appropriate
State agency, as applicable, to provide for children from infancy to 12 years of age mental health promotion, intervention, or treatment services; and
(B) provides services or programs described in subsection (a) that are evidence-based or that have been scientifically demonstrated to show promise but would benefit
from further applied development.
(c) APPLICATION.—An eligible entity seeking a grant under subsection (a) shall submit to the Secretary an application at such
time, in such manner, and containing such information as the Secretary may require.
(d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT
PROGRAMS.—An eligible entity may use amounts awarded under a
grant under subsection (a)(1) to carry out the following:
(1) Provide age-appropriate mental health promotion and
early intervention services or mental illness treatment services, which may include specialized programs, for eligible children at significant risk of developing, showing early signs of,
or having been diagnosed with a mental illness, including a serious emotional disturbance. Such services may include social
and behavioral services as well as multigenerational therapy
and other services that support the caregiving relationship.
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(2) Provide training for health care professionals with expertise in infant and early childhood mental health care with
respect to appropriate and relevant integration with other disciplines such as primary care clinicians, early intervention specialists, child welfare staff, home visitors, early care and education providers, and others who work with young children and
families.
(3) Provide mental health consultation to personnel of
early care and education programs (including licensed or regulated center-based and home-based child care, home visiting,
preschool special education, and early intervention programs)
who work with children and families.
(4) Provide training for mental health clinicians in infant
and early childhood in promising and evidence-based practices
and models for infant and early childhood mental health treatment and early intervention, including with regard to practices
for identifying and treating mental illness and behavioral disorders of infants and children resulting from exposure or repeated exposure to adverse childhood experiences or childhood
trauma.
(5) Provide age-appropriate assessment, diagnostic, and
intervention services for eligible children, including early mental health promotion, intervention, and treatment services.
(e) MATCHING FUNDS.—The Secretary may not award a grant
under this section to an eligible entity unless the eligible entity
agrees, with respect to the costs to be incurred by the eligible entity in carrying out the activities described in subsection (d), to make
available non-Federal contributions (in cash or in kind) toward
such costs in an amount that is not less than 10 percent of the
total amount of Federal funds provided in the grant.
(f) TECHNICAL ASSISTANCE.—The Secretary may, directly or by
awarding grants or contracts to public and private nonprofit entities, provide training and technical assistance to eligible entities to
carry out activities described in subsection (d).
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $50,000,000 for the
period of fiscal years 2023 through 2027.
PART R—PROGRAMS RELATING TO AUTISM
SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE
AND RESEARCH PROGRAM.
(a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL
DISABILITIES.—
(1) IN GENERAL.—The Secretary, acting through the Direc-
tor of the Centers for Disease Control and Prevention, may
award grants or cooperative agreements to eligible entities for
the collection, analysis, and reporting of State epidemiological
data for children and adults with autism spectrum disorder
and other developmental disabilities. An eligible entity shall
assist with the development and coordination of State autism
spectrum disorder and other developmental disability surveillance efforts within a region. In making such awards, the Secretary may provide direct technical assistance in lieu of cash.
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Sec. 399AA
(2) DATA STANDARDS.—In submitting epidemiological data
to the Secretary pursuant to paragraph (1), an eligible entity
shall report data according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention, after
consultation with relevant State, local, and Tribal public
health officials, private sector developmental disability researchers, and advocates for individuals with autism spectrum
disorder and other developmental disabilities.
(3) ELIGIBILITY.—To be eligible to receive an award under
paragraph (1), an entity shall be a public or nonprofit private
entity (including a health department of a State or a political
subdivision of a State, a university, any other educational institution, an Indian tribe, or a tribal organization), and submit
to the Secretary an application at such time, in such manner,
and containing such information as the Secretary may require.
(b) CENTERS OF EXCELLENCE IN AUTISM SPECTRUM DISORDER
EPIDEMIOLOGY.—
(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall,
subject to the availability of appropriations, award grants or
cooperative agreements for the establishment or support of regional centers of excellence in autism spectrum disorder and
other developmental disabilities epidemiology for the purpose
of collecting and analyzing information on the number, incidence, correlates, and causes of autism spectrum disorder and
other developmental disabilities for children and adults.
(2) REQUIREMENTS.—To be eligible to receive a grant or cooperative agreement under paragraph (1), an entity shall submit to the Secretary an application containing such agreements
and information as the Secretary may require, including an
agreement that the center to be established or supported under
the grant or cooperative agreement shall operate in accordance
with the following:
(A) The center will collect, analyze, and report autism
spectrum disorder and other developmental disability data
according to guidelines prescribed by the Director of the
Centers for Disease Control and Prevention, after consultation with State, local, and Tribal public health officials, private sector developmental disability researchers,
advocates for individuals with autism spectrum disorder,
and advocates for individuals with other developmental
disabilities.
(B) The center will develop or extend an area of special research expertise (including genetics, epigenetics, and
epidemiological research related to environmental exposures), immunology, and other relevant research specialty
areas.
(C) The center will identify eligible cases and controls
through its surveillance system and conduct research into
factors which may cause or increase the risk of autism
spectrum disorder and other developmental disabilities.
(c) FEDERAL RESPONSE.—The Secretary shall coordinate the
Federal response to requests for assistance from State health, mental health, and education department officials regarding potential
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or alleged autism spectrum disorder or developmental disability
clusters.
(d) DEFINITIONS.—In this part:
(1) INDIAN TRIBE; TRIBAL ORGANIZATION.—The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
such terms in section 4 of the Indian Health Care Improvement Act.
(2) OTHER DEVELOPMENTAL DISABILITIES.—The term ‘‘other
developmental disabilities’’ has the meaning given the term
‘‘developmental disability’’ in section 102(8) of the Developmental Disabilities Assistance and Bill of Rights Act of 2000
(42 U.S.C. 15002(8)).
(3) STATE.—The term ‘‘State’’ means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, American Samoa, Guam, the Commonwealth of the
Northern Mariana Islands, the Virgin Islands, and the Trust
Territory of the Pacific Islands.
(e) SUNSET.—This section shall not apply after September 30,
2024.
SEC. 399BB. ø280i–1¿ AUTISM EDUCATION, EARLY DETECTION, AND
INTERVENTION.
(a) PURPOSE.—It is the purpose of this section—
(1) to increase awareness, reduce barriers to screening and
diagnosis, promote evidence-based interventions for individuals
with autism spectrum disorder and other developmental disabilities, and train professionals to utilize valid and reliable
screening tools to diagnose or rule out and provide evidencebased interventions for individuals with autism spectrum disorder and other developmental disabilities across their lifespan; and
(2) to conduct activities under this section with a focus on
an interdisciplinary approach (as defined in programs developed under section 501(a)(2) of the Social Security Act) that
will also focus on specific issues for children who are not receiving an early diagnosis and subsequent interventions.
(b) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, establish and evaluate activities to—
(1) provide culturally competent information and education
on autism spectrum disorder and other developmental disabilities to increase public awareness of developmental milestones;
(2) promote research into the development and validation
of reliable screening tools for individuals with autism spectrum
disorder and other developmental disabilities and disseminate
information regarding those screening tools;
(3) promote early screening of individuals at higher risk
for autism spectrum disorder and other developmental disabilities as early as practicable, given evidence-based screening
techniques and interventions;
(4) promote evidence-based screening techniques and interventions for individuals with autism spectrum disorder and
other developmental disabilities across their lifespan;
(5) increase the number of individuals who are able to confirm or rule out a diagnosis of autism spectrum disorder and
other developmental disabilities;
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(6) increase the number of individuals able to provide evidence-based interventions for individuals diagnosed with autism spectrum disorder or other developmental disabilities; and
(7) promote the use of evidence-based interventions for individuals at higher risk for autism spectrum disorder and
other developmental disabilities as early as practicable.
(c) INFORMATION AND EDUCATION.—
(1) IN GENERAL.—In carrying out subsection (b)(1), the Secretary, in collaboration with the Secretary of Education and
the Secretary of Agriculture, shall, subject to the availability of
appropriations, provide culturally competent information regarding autism spectrum disorder and other developmental
disabilities, risk factors, characteristics, identification, diagnosis or rule out, and evidence-based interventions to meet the
needs of individuals with autism spectrum disorder and other
developmental disabilities across their lifespan and the needs
of their families through—
(A) Federal programs, including—
(i) the Head Start program;
(ii) the Early Start program;
(iii) the Healthy Start program;
(iv) programs under the Child Care and Development Block Grant Act of 1990;
(v) programs under title XIX of the Social Security
Act (particularly the Medicaid Early and Periodic
Screening, Diagnosis and Treatment Program);
(vi) the program under title XXI of the Social Security Act (the State Children’s Health Insurance Program);
(vii) the program under title V of the Social Security Act (the Maternal and Child Health Block Grant
Program);
(viii) the program under parts B and C of the Individuals with Disabilities Education Act;
(ix) the special supplemental nutrition program
for women, infants, and children established under
section 17 of the Child Nutrition Act of 1966 (42
U.S.C. 1786); and
(x) the State grant program under the Rehabilitation Act of 1973.
(B) State licensed child care facilities; and
(C) other community-based organizations or points of
entry for individuals with autism spectrum disorder and
other developmental disabilities to receive services.
(2) LEAD AGENCY.—
(A) DESIGNATION.—As a condition on the provision of
assistance or the conduct of activities under this section
with respect to a State, the Secretary may require the
Governor of the State—
(i) to designate a public agency as a lead agency
to coordinate the activities provided for under paragraph (1) in the State at the State level; and
(ii) acting through such lead agency, to make
available to individuals and their family members,
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guardians, advocates, or authorized representatives;
providers; and other appropriate individuals in the
State, comprehensive culturally competent information
about State and local resources regarding autism spectrum disorder and other developmental disabilities,
risk factors, characteristics, identification, diagnosis or
rule out, available services and supports (which may
include respite care for caregivers of individuals with
autism spectrum disorder or other developmental disabilities), and evidence-based interventions.
(B) REQUIREMENTS OF AGENCY.—In designating the
lead agency under subparagraph (A)(i), the Governor
shall—
(i) select an agency that has demonstrated experience and expertise in—
(I) autism spectrum disorder and other developmental disability issues; and
(II) developing, implementing, conducting,
and administering programs and delivering education, information, and referral services (including
technology-based
curriculum-development
services) to individuals with autism spectrum disorder and developmental disabilities and their
family members, guardians, advocates or authorized representatives, providers, and other appropriate individuals locally and across the State;
and
(ii) consider input from individuals with autism
spectrum disorder and developmental disabilities and
their family members, guardians, advocates or authorized representatives, providers, and other appropriate
individuals.
(C) INFORMATION.—Information under subparagraph
(A)(ii) shall be provided through—
(i) toll-free telephone numbers;
(ii) Internet websites;
(iii) mailings; or
(iv) such other means as the Governor may require.
(d) TOOLS.—
(1) IN GENERAL.—To promote the use of valid and reliable
screening tools for autism spectrum disorder and other developmental disabilities, the Secretary shall develop a curriculum
for continuing education to assist individuals in recognizing
the need for valid and reliable screening tools and the use of
such tools.
(2) COLLECTION, STORAGE, COORDINATION, AND AVAILABILITY.—The Secretary, in collaboration with the Secretary of
Education, shall provide for the collection, storage, coordination, and public availability of tools described in paragraph (1),
educational materials and other products that are used by the
Federal programs referred to in subsection (c)(1)(A), as well
as—
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(A) programs authorized under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000;
(B) early intervention programs or interagency coordinating councils authorized under part C of the Individuals
with Disabilities Education Act; and
(C) children with special health care needs programs
authorized under title V of the Social Security Act.
(3) REQUIRED SHARING.—In establishing mechanisms and
entities under this subsection, the Secretary, and the Secretary
of Education, shall ensure the sharing of tools, materials, and
products developed under this subsection among entities receiving funding under this section.
(e) DIAGNOSIS.—
(1) TRAINING.—The Secretary, in coordination with activities conducted under title V of the Social Security Act, shall,
subject to the availability of appropriations, expand existing
interdisciplinary training opportunities or opportunities to increase the number of sites able to diagnose or rule out individuals with autism spectrum disorder or other developmental
disabilities across their lifespan and ensure that—
(A) competitive grants or cooperative agreements are
awarded to public or nonprofit agencies, including institutions of higher education, to expand existing or develop
new maternal and child health interdisciplinary leadership
education in neurodevelopmental and related disabilities
programs (similar to the programs developed under section
501(a)(2) of the Social Security Act) in States that do not
have such a program;
(B) trainees under such training programs—
(i) receive an appropriate balance of academic,
clinical, and community opportunities;
(ii) are culturally competent;
(iii) are ethnically diverse;
(iv) demonstrate a capacity to evaluate, diagnose
or rule out, develop, and provide evidence-based interventions to individuals with autism spectrum disorder
and other developmental disabilities across their lifespan; and
(v) demonstrate an ability to use a family-centered
approach, which may include collaborating with research centers or networks to provide training for providers of respite care (as defined in section 2901); and
(C) program sites provide culturally competent services.
(2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING
PROGRAMS.—
(A) IN GENERAL.—In making awards under this subsection, the Secretary may prioritize awards to applicants
that are developmental-behavioral pediatrician training
programs located in rural or underserved areas.
(B) DEFINITION OF UNDERSERVED AREA.—In this paragraph, the term ‘‘underserved area’’ means—
(i) a health professional shortage area (as defined
in section 332(a)(1)(A)); and
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(ii) an urban or rural area designated by the Secretary as an area with a shortage of personal health
services (as described in section 330(b)(3)(A)).
(3) TECHNICAL ASSISTANCE.—The Secretary may award one
or more grants under this section to provide technical assistance to the network of interdisciplinary training programs.
(4) BEST PRACTICES.—The Secretary shall promote research into additional valid and reliable tools for shortening
the time required to confirm or rule out a diagnosis of autism
spectrum disorder or other developmental disabilities and detecting individuals with autism spectrum disorder or other developmental disabilities at an earlier age.
(f) INTERVENTION.—The Secretary shall promote research,
through grants or contracts, which may include grants or contracts
to research centers or networks, to determine the evidence-based
practices for interventions to improve the physical and behavioral
health of individuals with autism spectrum disorder or other developmental disabilities across the lifespan of such individuals, develop guidelines for those interventions, and disseminate information related to such research and guidelines.
(g) SUNSET.—This section shall not apply after September 30,
2024.
SEC. 399CC. ø280i–2¿ INTERAGENCY AUTISM COORDINATING COMMITTEE.
(a) ESTABLISHMENT.—The Secretary shall establish a com-
mittee, to be known as the ‘‘Interagency Autism Coordinating Committee’’ (in this section referred to as the ‘‘Committee’’), to coordinate all efforts within the Department of Health and Human Services concerning autism spectrum disorder.
(b) RESPONSIBILITIES.—In carrying out its duties under this
section, the Committee shall—
(1) monitor autism spectrum disorder research, and to the
extent practicable services and support activities, across all relevant Federal departments and agencies, including coordination of Federal activities with respect to autism spectrum disorder;
(2) develop a summary of advances in autism spectrum
disorder research related to causes, prevention, treatment,
early screening, diagnosis or rule out, interventions, including
school and community-based interventions, and access to services and supports for individuals with autism spectrum disorder across the lifespan of such individuals;
(3) make recommendations to the Secretary regarding any
appropriate changes to such activities, including with respect
to the strategic plan developed under paragraph (5);
(4) make recommendations to the Secretary regarding public participation in decisions relating to autism spectrum disorder, and the process by which public feedback can be better
integrated into such decisions;
(5) develop a strategic plan for the conduct of, and support
for, autism spectrum disorder research, including as practicable for services and supports, for individuals with an autism spectrum disorder across the lifespan of such individuals
and the families of such individuals, which shall include—
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(A) proposed budgetary requirements; and
(B) recommendations to ensure that autism spectrum
disorder research, and services and support activities to
the extent practicable, of the Department of Health and
Human Services and of other Federal departments and
agencies are not unnecessarily duplicative; and
(6) submit to Congress and the President—
(A) an annual update on the summary of advances described in paragraph (2); and
(B) an annual update to the strategic plan described
in paragraph (5), including any progress made in achieving
the goals outlined in such strategic plan.
(c) MEMBERSHIP.—
(1) FEDERAL MEMBERSHIP.—The Committee shall be composed of the following Federal members—
(A) the Director of the Centers for Disease Control and
Prevention;
(B) the Director of the National Institutes of Health,
and the Directors of such national research institutes of
the National Institutes of Health as the Secretary determines appropriate;
(C) the heads of such other agencies as the Secretary
determines appropriate, such as the Administration for
Community Living, Administration for Children and Families, the Centers for Medicare & Medicaid Services, the
Food and Drug Administration, and the Health Resources
and Services Administration; and
(D) representatives of other Federal Governmental
agencies that serve individuals with autism spectrum disorder such as the Department of Education, the Department of Labor, the Department of Justice, the Department
of Veterans Affairs, the Department of Housing and Urban
Development, and the Department of Defense.
(2) NON-FEDERAL MEMBERS.—Not more than 1⁄2, but not
fewer than 1⁄3, of the total membership of the Committee, shall
be composed of non-Federal public members to be appointed by
the Secretary, of which—
(A) at least three such members shall be individuals
with a diagnosis of autism spectrum disorder;
(B) at least three such members shall be parents or
legal guardians of an individual with an autism spectrum
disorder; and
(C) at least three such members shall be representatives of leading research, advocacy, and service organizations for individuals with autism spectrum disorder.
(3) PERIOD OF APPOINTMENT; VACANCIES.—
(A) PERIOD OF APPOINTMENT FOR NON-FEDERAL MEMBERS.—Non-Federal members shall serve for a term of 4
years, and may be reappointed for one additional 4-year
term.
(B) VACANCIES.—A vacancy on the Committee shall be
filled in the manner in which the original appointment
was made and shall not affect the powers or duties of the
Committee. Any member appointed to fill a vacancy for an
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unexpired term shall be appointed for the remainder of
such term. A member may serve after the expiration of the
member’s term until a successor has been appointed.
(d) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PROVISIONS.—The following provisions shall apply with respect to the
Committee:
(1) The Committee shall receive necessary and appropriate
administrative support from the Secretary.
(2) The Committee shall meet at the call of the chairperson
or upon the request of the Secretary. The Committee shall
meet not fewer than 2 times each year.
(3) All meetings of the Committee shall be public and shall
include appropriate time periods for questions and presentations by the public.
(e) SUBCOMMITTEES; ESTABLISHMENT AND MEMBERSHIP.—In
carrying out its functions, the Committee may establish subcommittees and convene workshops and conferences. Such subcommittees shall be composed of Committee members and may
hold such meetings as are necessary to enable the subcommittees
to carry out their duties.
(f) SUNSET.—This section shall not apply after September 30,
2024, and the Committee shall be terminated on such date.
SEC. 399DD. ø280i–3¿ REPORTS TO CONGRESS.
(a) PROGRESS REPORT.—
(1) IN GENERAL.— 105Not later than
4 years after the date
of enactment of the Autism CARES Act of 2019, the Secretary,
in coordination with the Secretary of Education and the Secretary of Defense, shall prepare and submit to the Health,
Education, Labor, and Pensions Committee of the Senate and
the Energy and Commerce Committee of the House of Representatives, and make publicly available, including through
posting on the Internet Web site of the Department of Health
and Human Services, a progress report on activities related to
autism spectrum disorder and other developmental disabilities.
(2) CONTENTS.—The report submitted under subsection (a)
shall contain—
(A) a description of the progress made in implementing the provisions of the Autism CARES Act of 2019;
(B) a description of the amounts expended on the implementation of the amendments made by the Autism
CARES Act of 2019;
(C) information on the incidence and prevalence of autism spectrum disorder, including available information on
the prevalence of autism spectrum disorder among children and adults, and identification of any changes over
time with respect to the incidence and prevalence of autism spectrum disorder;
(D) information on the average age of diagnosis for
children with autism spectrum disorder and other disabilities, including how that age may have changed over the
4-year period beginning on the date of enactment of the
105 Casing
of heading for paragraph (1) so in law.
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Autism CARES Act of 2019 and, as appropriate, how this
age varies across population subgroups;
(E) information on the average age for intervention for
individuals diagnosed with autism spectrum disorder and
other developmental disabilities, including how that age
may have changed over the 4-year period beginning on the
date of enactment of the Autism CARES Act of 2019 and,
as appropriate, how this age varies across population subgroups;
(F) information on the average time between initial
screening and then diagnosis or rule out for individuals
with autism spectrum disorder or other developmental disabilities, as well as information on the average time between diagnosis and evidence-based intervention for individuals with autism spectrum disorder or other developmental disabilities and, as appropriate, on how such average time varies across population subgroups;
(G) information on the effectiveness and outcomes of
interventions for individuals diagnosed with autism spectrum disorder, including by severity level as practicable,
and other developmental disabilities and how the age of
the individual or other factors, such as demographic characteristics, may affect such effectiveness;
(H) information on the effectiveness and outcomes of
innovative and newly developed intervention strategies for
individuals with autism spectrum disorder or other developmental disabilities;
(I) a description of the actions taken to implement and
the progress made on implementation of the strategic plan
developed by the Interagency Autism Coordinating Committee under section 399CC(b); and
(J) information on how States use home- and community-based services and other supports to ensure that individuals with autism spectrum disorder and other developmental disabilities are living, working, and participating in
their community.
(b) REPORT ON THE HEALTH AND WELL-BEING OF INDIVIDUALS
WITH AUTISM SPECTRUM DISORDER ACROSS THEIR LIFESPAN.—
(1) IN GENERAL.—Not later than 2 years after the date of
enactment of the Autism CARES Act of 2019, the Secretary
shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, a
report concerning the health and well-being of individuals with
autism spectrum disorder.
(2) CONTENTS.—The report submitted under paragraph (1)
shall contain—
(A) demographic factors associated with the health
and well-being of individuals with autism spectrum disorder;
(B) an overview of policies and programs relevant to
the health and well-being of individuals with autism spectrum disorder, including an identification of existing Federal laws, regulations, policies, research, and programs;
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(C) recommendations on establishing best practices
guidelines to ensure interdisciplinary coordination between
all relevant service providers receiving Federal funding;
(D) comprehensive approaches to improving health
outcomes and well-being for individuals with autism spectrum disorder, including—
(i) community-based behavioral supports and
interventions;
(ii) nutrition, recreational, and social activities;
and
(iii) personal safety services related to public safety agencies or the criminal justice system for such individuals; and
(E) recommendations that seek to improve health outcomes for such individuals, including across their lifespan,
by addressing—
(i) screening and diagnosis of children and adults;
(ii) behavioral and other therapeutic approaches;
(iii) primary and preventative care;
(iv) communication challenges;
(v) aggression, self-injury, elopement, and other
behavioral issues;
(vi) emergency room visits and acute care hospitalization;
(vii) treatment for co-occurring physical and mental health conditions;
(viii) premature mortality;
(ix) medical practitioner training; and
(x) caregiver mental health.
SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
(a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.—To carry out section 399AA, there is authorized
to be appropriated $23,100,000 for each of fiscal years 2020
through 2024.
(b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION.—To carry out section 399BB, there is authorized to be appropriated $50,599,000 for each of fiscal years 2020 through 2024.
(c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN
OTHER PROGRAMS.—To carry out sections 399CC and 409C, there
are authorized to be appropriated $296,000,000 for each of fiscal
years 2020 through 2024.
PART S—HEALTH CARE QUALITY PROGRAMS
Subpart I—National Strategy for Quality
Improvement in Health Care
SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT
IN HEALTH CARE.
(a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
(1) NATIONAL STRATEGY.—The Secretary, through a trans-
parent collaborative process, shall establish a national strategy
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to improve the delivery of health care services, patient health
outcomes, and population health.
(2) IDENTIFICATION OF PRIORITIES.—
(A) IN GENERAL.—The Secretary shall identify national
priorities for improvement in developing the strategy
under paragraph (1).
(B) REQUIREMENTS.—The Secretary shall ensure that
priorities identified under subparagraph (A) will—
(i) have the greatest potential for improving the
health outcomes, efficiency, and patient-centeredness
of health care for all populations, including children
and vulnerable populations;
(ii) identify areas in the delivery of health care
services that have the potential for rapid improvement
in the quality and efficiency of patient care;
(iii) address gaps in quality, efficiency, comparative effectiveness information (taking into consideration the limitations set forth in subsections (c) and
(d) of section 1182 of the Social Security Act), and
health outcomes measures and data aggregation techniques;
(iv) improve Federal payment policy to emphasize
quality and efficiency;
(v) enhance the use of health care data to improve
quality, efficiency, transparency, and outcomes;
(vi) address the health care provided to patients
with high-cost chronic diseases;
(vii) improve research and dissemination of strategies and best practices to improve patient safety and
reduce medical errors, preventable admissions and readmissions, and health care-associated infections;
(viii) reduce health disparities across health disparity populations (as defined in section 485E) and geographic areas; and
(ix) address other areas as determined appropriate
by the Secretary.
(C) CONSIDERATIONS.—In identifying priorities under
subparagraph (A), the Secretary shall take into consideration the recommendations submitted by the entity with a
contract under section 1890(a) of the Social Security Act
and other stakeholders.
(D) COORDINATION WITH STATE AGENCIES.—The Secretary shall collaborate, coordinate, and consult with State
agencies responsible for administering the Medicaid program under title XIX of the Social Security Act and the
Children’s Health Insurance Program under title XXI of
such Act with respect to developing and disseminating
strategies, goals, models, and timetables that are consistent with the national priorities identified under subparagraph (A).
(b) STRATEGIC PLAN.—
(1) IN GENERAL.—The national strategy shall include a
comprehensive strategic plan to achieve the priorities described
in subsection (a).
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(2) REQUIREMENTS.—The strategic plan shall include provisions for addressing, at a minimum, the following:
(A) Coordination among agencies within the Department, which shall include steps to minimize duplication of
efforts and utilization of common quality measures, where
available. Such common quality measures shall be measures identified by the Secretary under section 1139A or
1139B of the Social Security Act or endorsed under section
1890 of such Act.
(B) Agency-specific strategic plans to achieve national
priorities.
(C) Establishment of annual benchmarks for each relevant agency to achieve national priorities.
(D) A process for regular reporting by the agencies to
the Secretary on the implementation of the strategic plan.
(E) Strategies to align public and private payers with
regard to quality and patient safety efforts.
(F) Incorporating quality improvement and measurement in the strategic plan for health information technology required by the American Recovery and Reinvestment Act of 2009 (Public Law 111–5).
(c) PERIODIC UPDATE OF NATIONAL STRATEGY.—The Secretary
shall update the national strategy not less than annually. Any such
update shall include a review of short- and long-term goals.
(d) SUBMISSION AND AVAILABILITY OF NATIONAL STRATEGY AND
UPDATES.—
(1) DEADLINE FOR INITIAL SUBMISSION OF NATIONAL STRATEGY.—Not later than January 1, 2011, the Secretary shall submit to the relevant committees of Congress the national strategy described in subsection (a).
(2) UPDATES.—
(A) IN GENERAL.—The Secretary shall submit to the
relevant committees of Congress an annual update to the
strategy described in paragraph (1).
(B) INFORMATION SUBMITTED.—Each update submitted
under subparagraph (A) shall include—
(i) a review of the short- and long-term goals of
the national strategy and any gaps in such strategy;
(ii) an analysis of the progress, or lack of progress,
in meeting such goals and any barriers to such
progress;
(iii) the information reported under section 1139A
of the Social Security Act, consistent with the reporting requirements of such section; and
(iv) in the case of an update required to be submitted on or after January 1, 2014, the information reported under section 1139B(b)(4) of the Social Security
Act, consistent with the reporting requirements of
such section.
(C) SATISFACTION OF OTHER REPORTING REQUIREMENTS.—Compliance with the requirements of clauses (iii)
and (iv) of subparagraph (B) shall satisfy the reporting requirements under sections 1139A(a)(6) and 1139B(b)(4), respectively, of the Social Security Act.
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(e) HEALTH CARE QUALITY INTERNET WEBSITE.—Not later than
January 1, 2011, the Secretary shall create an Internet website to
make public information regarding—
(1) the national priorities for health care quality improvement established under subsection (a)(2);
(2) the agency-specific strategic plans for health care quality described in subsection (b)(2)(B); and
(3) other information, as the Secretary determines to be
appropriate.
SEC. 399II. ø280j–1¿ COLLECTION AND ANALYSIS OF DATA FOR QUALITY AND RESOURCE USE MEASURES.
(a) IN GENERAL.—
(1) ESTABLISHMENT OF STRATEGIC FRAMEWORK.—The Sec-
retary shall establish and implement an overall strategic
framework to carry out the public reporting of performance information, as described in section 399JJ. Such strategic framework may include methods and related timelines for implementing nationally consistent data collection, data aggregation,
and analysis methods.
(2) COLLECTION AND AGGREGATION OF DATA.—The Secretary shall collect and aggregate consistent data on quality
and resource use measures from information systems used to
support health care delivery, and may award grants or contracts for this purpose. The Secretary shall align such collection and aggregation efforts with the requirements and assistance regarding the expansion of health information technology
systems, the interoperability of such technology systems, and
related standards that are in effect on the date of enactment
of the Patient Protection and Affordable Care Act.
(3) SCOPE.—The Secretary shall ensure that the data collection, data aggregation, and analysis systems described in
paragraph (1) involve an increasingly broad range of patient
populations, providers, and geographic areas over time.
(b) GRANTS OR CONTRACTS FOR DATA COLLECTION.—
(1) IN GENERAL.—The Secretary may award grants or contracts to eligible entities to support new, or improve existing,
efforts to collect and aggregate quality and resource use measures described under subsection (c).
(2) ELIGIBLE ENTITIES.—To be eligible for a grant or contract under this subsection, an entity shall—
(A) be—
(i) a multi-stakeholder entity that coordinates the
development of methods and implementation plans for
the consistent reporting of summary quality and cost
information;
(ii) an entity capable of submitting such summary
data for a particular population and providers, such as
a disease registry, regional collaboration, health plan
collaboration, or other population-wide source; or
(iii) a Federal Indian Health Service program or a
health program operated by an Indian tribe (as defined in section 4 of the Indian Health Care Improvement Act);
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(B) promote the use of the systems that provide data
to improve and coordinate patient care;
(C) support the provision of timely, consistent quality
and resource use information to health care providers, and
other groups and organizations as appropriate, with an opportunity for providers to correct inaccurate measures; and
(D) agree to report, as determined by the Secretary,
measures on quality and resource use to the public in accordance with the public reporting process established
under section 399JJ.
(c) CONSISTENT DATA AGGREGATION.—The Secretary may
award grants or contracts under this section only to entities that
enable summary data that can be integrated and compared across
multiple sources. The Secretary shall provide standards for the protection of the security and privacy of patient data.
(d) MATCHING FUNDS.—The Secretary may not award a grant
or contract under this section to an entity unless the entity agrees
that it will make available (directly or through contributions from
other public or private entities) non-Federal contributions toward
the activities to be carried out under the grant or contract in an
amount equal to $1 for each $5 of Federal funds provided under the
grant or contract. Such non-Federal matching funds may be provided directly or through donations from public or private entities
and may be in cash or in-kind, fairly evaluated, including plant,
equipment, or services.
(e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated such sums as may be
necessary for fiscal years 2010 through 2014.
SEC. 399JJ. ø280j–2¿ PUBLIC REPORTING OF PERFORMANCE INFORMATION.
(a) DEVELOPMENT OF PERFORMANCE WEBSITES.—The Secretary
shall make available to the public, through standardized Internet
websites, performance information summarizing data on quality
measures. Such information shall be tailored to respond to the differing needs of hospitals and other institutional health care providers, physicians and other clinicians, patients, consumers, researchers, policymakers, States, and other stakeholders, as the Secretary may specify.
(b) INFORMATION ON CONDITIONS.—The performance information made publicly available on an Internet website, as described
in subsection (a), shall include information regarding clinical conditions to the extent such information is available, and the information shall, where appropriate, be provider-specific and sufficiently
disaggregated and specific to meet the needs of patients with different clinical conditions.
(c) CONSULTATION.—
(1) IN GENERAL.—In carrying out this section, the Secretary shall consult with the entity with a contract under section 1890(a) of the Social Security Act, and other entities, as
appropriate, to determine the type of information that is useful
to stakeholders and the format that best facilitates use of the
reports and of performance reporting Internet websites.
(2) CONSULTATION WITH STAKEHOLDERS.—The entity with
a contract under section 1890(a) of the Social Security Act
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shall convene multi-stakeholder groups, as described in such
section, to review the design and format of each Internet
website made available under subsection (a) and shall transmit
to the Secretary the views of such multi-stakeholder groups
with respect to each such design and format.
(d) COORDINATION.—Where appropriate, the Secretary shall coordinate the manner in which data are presented through Internet
websites described in subsection (a) and for public reporting of
other quality measures by the Secretary, including such quality
measures under title XVIII of the Social Security Act.
(e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated such sums as may be
necessary for fiscal years 2010 through 2014.
SEC. 399KK. ø280j–3¿ QUALITY IMPROVEMENT PROGRAM FOR HOSPITALS WITH A HIGH SEVERITY ADJUSTED READMISSION
RATE.
(a) ESTABLISHMENT.—
(1) IN GENERAL.—Not later than 2 years after the date of
enactment of this section, the Secretary shall make available
a program for eligible hospitals to improve their readmission
rates through the use of patient safety organizations (as defined in section 921(4)).
(2) ELIGIBLE HOSPITAL DEFINED.—In this subsection, the
term ‘‘eligible hospital’’ means a hospital that the Secretary determines has a high rate of risk adjusted readmissions for the
conditions described in section 1886(q)(8)(A) of the Social Security Act and has not taken appropriate steps to reduce such readmissions and improve patient safety as evidenced through
historically high rates of readmissions, as determined by the
Secretary.
(3) RISK ADJUSTMENT.—The Secretary shall utilize appropriate risk adjustment measures to determine eligible hospitals.
(b) REPORT TO THE SECRETARY.—As determined appropriate by
the Secretary, eligible hospitals and patient safety organizations
working with those hospitals shall report to the Secretary on the
processes employed by the hospital to improve readmission rates
and the impact of such processes on readmission rates.
PART T—ORAL HEALTHCARE PREVENTION
ACTIVITIES
SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION
CAMPAIGN.
(a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.—
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with professional
oral health organizations, shall, subject to the availability of appropriations, establish a 5-year national, public education campaign
(referred to in this section as the ‘‘campaign’’) that is focused on
oral health education, including prevention of oral disease such as
early childhood and other caries, periodontal disease, and oral cancer.
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(b) REQUIREMENTS.—In establishing the campaign under subsection (a), the Secretary shall—
(1) ensure that activities are targeted towards specific populations such as children, pregnant women, parents, the elderly, individuals with disabilities, and ethnic and racial minority
populations, including Indians, Alaska Natives and Native Hawaiians (as defined in section 4(c) of the Indian Health Care
Improvement Act) in a culturally and linguistically appropriate
manner; and
(2) utilize science-based strategies to convey oral health
prevention messages that include, but are not limited to, community water fluoridation and dental sealants.
(c) ACTION FOR DENTAL HEALTH PROGRAM.—
(1) IN GENERAL.—The Secretary, in consultation with the
Director of the Centers for Disease Control and Prevention and
the Administrator of the Health Resources and Services Administration, may award grants, contracts, or cooperative
agreements to eligible entities to collaborate with State or local
public health officials, tribal health officials, oral health professional organizations, and others, as appropriate, to develop and
implement initiatives to improve oral health, including activities to prevent dental disease and reduce barriers to the provision of dental services, including—
(A) through community-wide dental disease prevention
programs; and
(B) by increasing public awareness and education related to oral health and dental disease prevention.
(2) ELIGIBLE ENTITIES.—To be eligible to receive a grant,
contract, or cooperative agreement under this subsection, an
entity shall be—
(A) a dental association;
(B) a State or tribal health department or State or
tribal oral health program;
(C) an accredited dental education, dental hygiene, or
postdoctoral dental education program; or
(D) a non-profit community-based organization that
partners with public and private non-profit entities, such
as an academic institution, to facilitate the provision of
dental services to underserved populations.
SEC. 399LL–1. ø280k–1¿ RESEARCH-BASED DENTAL CARIES DISEASE
MANAGEMENT.
(a) IN GENERAL.—The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall award demonstration grants to eligible entities to demonstrate the effectiveness of research-based dental caries disease management activities.
(b) ELIGIBILITY.—To be eligible for a grant under this section,
an entity shall—
(1) be a community-based provider of dental services (as
defined by the Secretary), including a Federally-qualified
health center, a clinic of a hospital owned or operated by a
State (or by an instrumentality or a unit of government within
a State), a State or local department of health, a dental program of the Indian Health Service, an Indian tribe or tribal organization, or an urban Indian organization (as such terms are
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defined in section 4 of the Indian Health Care Improvement
Act), a health system provider, a private provider of dental
services, medical, dental, public health, nursing, nutrition educational institutions, or national organizations involved in improving children’s oral health; and
(2) submit to the Secretary an application at such time, in
such manner, and containing such information as the Secretary may require.
(c) USE OF FUNDS.—A grantee shall use amounts received
under a grant under this section to demonstrate the effectiveness
of research-based dental caries disease management activities.
(d) USE OF INFORMATION.—The Secretary shall, as practicable
and appropriate, utilize information generated from grantees under
this section in planning and implementing the oral health education campaign and action for dental health program under section 399LL.
SEC. 399LL–2. ø280k–2¿ AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out this part,
such sums as may be necessary.
PART U—EMPLOYER-BASED WELLNESS
PROGRAM
SEC. 399MM. ø280l¿ TECHNICAL ASSISTANCE FOR EMPLOYER-BASED
WELLNESS PROGRAMS.
In order to expand the utilization of evidence-based prevention
and health promotion approaches in the workplace, the Director
shall—
(1) provide employers (including small, medium, and large
employers, as determined by the Director) with technical assistance, consultation, tools, and other resources in evaluating
such employers’ employer-based wellness programs, including—
(A) measuring the participation and methods to increase participation of employees in such programs;
(B) developing standardized measures that assess policy, environmental and systems changes necessary to have
a positive health impact on employees’ health behaviors,
health outcomes, and health care expenditures; and
(C) evaluating such programs as they relate to
changes in the health status of employees, the absenteeism
of employees, the productivity of employees, the rate of
workplace injury, and the medical costs incurred by employees; and
(2) build evaluation capacity among workplace staff by
training employers on how to evaluate employer-based
wellness programs and ensuring evaluation resources, technical assistance, and consultation are available to workplace
staff as needed through such mechanisms as web portals, call
centers, or other means.
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SEC. 399MM–1. ø280l–1¿ NATIONAL WORKSITE HEALTH POLICIES AND
PROGRAMS STUDY.
(a) IN GENERAL.—In order to assess, analyze, and monitor over
time data about workplace policies and programs, and to develop
instruments to assess and evaluate comprehensive workplace
chronic disease prevention and health promotion programs, policies
and practices, not later than 2 years after the date of enactment
of this part, and at regular intervals (to be determined by the Director) thereafter, the Director shall conduct a national worksite
health policies and programs survey to assess employer-based
health policies and programs.
(b) REPORT.—Upon the completion of each study under subsection (a), the Director shall submit to Congress a report that includes the recommendations of the Director for the implementation
of effective employer-based health policies and programs.
SEC. 399MM–2. ø280l–2¿ PRIORITIZATION OF EVALUATION BY SECRETARY.
The Secretary shall evaluate, in accordance with this part, all
programs funded through the Centers for Disease Control and Prevention before conducting such an evaluation of privately funded
programs unless an entity with a privately funded wellness program requests such an evaluation.
SEC.
399MM–3. ø280l–3¿ PROHIBITION OF
WELLNESS REQUIREMENTS.
FEDERAL
WORKPLACE
Notwithstanding any other provision of this part, any recommendations, data, or assessments carried out under this part
shall not be used to mandate requirements for workplace wellness
programs.
PART V—PROGRAMS RELATING TO BREAST
HEALTH AND CANCER
SEC. 399NN. ø280m¿ YOUNG WOMEN’S BREAST HEALTH AWARENESS
AND SUPPORT OF YOUNG WOMEN DIAGNOSED WITH
BREAST CANCER.
(a) PUBLIC EDUCATION CAMPAIGN.—
(1) IN GENERAL.—The Secretary, acting through the Direc-
tor of the Centers for Disease Control and Prevention, shall
conduct a national evidence-based education campaign to increase awareness of young women’s knowledge regarding—
(A) breast health in young women of all racial, ethnic,
and cultural backgrounds;
(B) breast awareness and good breast health habits;
(C) the occurrence of breast cancer and the general
and specific risk factors in women who may be at high risk
for breast cancer based on familial, racial, ethnic, and cultural backgrounds such as Ashkenazi Jewish populations;
(D) evidence-based information that would encourage
young women and their health care professional to increase early detection of breast cancers; and
(E) the availability of health information and other resources for young women diagnosed with breast cancer.
(2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The
campaign shall provide evidence-based, age-appropriate mesFebruary 1, 2024
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sages and materials as developed by the Centers for Disease
Control and Prevention and the Advisory Committee established under paragraph (4).
(3) MEDIA CAMPAIGN.—In conducting the education campaign under paragraph (1), the Secretary shall award grants to
entities to establish national multimedia campaigns oriented to
young women that may include advertising through television,
radio, print media, billboards, posters, all forms of existing and
especially emerging social networking media, other Internet
media, and any other medium determined appropriate by the
Secretary.
(4) ADVISORY COMMITTEE.—
(A) ESTABLISHMENT.—Not later than 60 days after the
date of the enactment of this section, the Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall establish an advisory committee to
assist in creating and conducting the education campaigns
under paragraph (1) and subsection (b)(1).
(B) MEMBERSHIP.—The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, shall appoint to the advisory committee under subparagraph (A) such members as deemed necessary to properly advise the Secretary, and shall include organizations
and individuals with expertise in breast cancer, disease
prevention, early detection, diagnosis, public health, social
marketing, genetic screening and counseling, treatment,
rehabilitation, palliative care, and survivorship in young
women.
(b) HEALTH CARE PROFESSIONAL EDUCATION CAMPAIGN.—The
Secretary, acting through the Director of the Centers for Disease
Control and Prevention, and in consultation with the Administrator
of the Health Resources and Services Administration, shall conduct
an education campaign among physicians and other health care
professionals to increase awareness—
(1) of breast health, symptoms, and early diagnosis and
treatment of breast cancer in young women, including specific
risk factors such as family history of cancer and women that
may be at high risk for breast cancer, such as Ashkenazi Jewish population;
(2) on how to provide counseling to young women about
their breast health, including knowledge of their family cancer
history and importance of providing regular clinical breast examinations;
(3) concerning the importance of discussing healthy behaviors, and increasing awareness of services and programs available to address overall health and wellness, and making patient referrals to address tobacco cessation, good nutrition, and
physical activity;
(4) on when to refer patients to a health care provider with
genetics expertise;
(5) on how to provide counseling that addresses long-term
survivorship and health concerns of young women diagnosed
with breast cancer; and
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(6) on when to provide referrals to organizations and institutions that provide credible health information and substantive assistance and support to young women diagnosed
with breast cancer.
(c) PREVENTION RESEARCH ACTIVITIES.—The Secretary, acting
through—
(1) the Director of the Centers for Disease Control and
Prevention, shall conduct prevention research on breast cancer
in younger women, including—
(A) behavioral, survivorship studies, and other research on the impact of breast cancer diagnosis on young
women;
(B) formative research to assist with the development
of educational messages and information for the public,
targeted populations, and their families about breast
health, breast cancer, and healthy lifestyles;
(C) testing and evaluating existing and new social
marketing strategies targeted at young women; and
(D) surveys of health care providers and the public regarding knowledge, attitudes, and practices related to
breast health and breast cancer prevention and control in
high-risk populations; and
(2) the Director of the National Institutes of Health, shall
conduct research to develop and validate new screening tests
and methods for prevention and early detection of breast cancer in young women.
(d) SUPPORT FOR YOUNG WOMEN DIAGNOSED WITH BREAST
CANCER.—
(1) IN GENERAL.—The Secretary shall award grants to organizations and institutions to provide health information from
credible sources and substantive assistance directed to young
women diagnosed with breast cancer and pre-neoplastic breast
diseases.
(2) PRIORITY.—In making grants under paragraph (1), the
Secretary shall give priority to applicants that deal specifically
with young women diagnosed with breast cancer and pre-neoplastic breast disease.
(e) NO DUPLICATION OF EFFORT.—In conducting an education
campaign or other program under subsections (a), (b), (c), or (d),
the Secretary shall avoid duplicating other existing Federal breast
cancer education efforts.
(f) MEASUREMENT; REPORTING.—The Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall—
(1) measure—
(A) young women’s awareness regarding breast health,
including knowledge of family cancer history, specific risk
factors and early warning signs, and young women’s
proactive efforts at early detection;
(B) the number or percentage of young women utilizing information regarding lifestyle interventions that
foster healthy behaviors;
(C) the number or percentage of young women receiving regular clinical breast exams; and
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(D) the number or percentage of young women who
perform breast self exams, and the frequency of such
exams, before the implementation of this section;
(2) not less than every 3 years, measure the impact of such
activities; and
(3) submit reports to the Congress on the results of such
measurements.
(g) DEFINITION.—In this section, the term ‘‘young women’’
means women 15 to 44 years of age.
(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out subsections (a), (b), (c)(1), and (d), there are authorized to be appropriated $9,000,000 for each of fiscal years 2022 through 2026.
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| File Type | application/pdf |
| File Modified | 2024-02-02 |
| File Created | 2024-02-01 |