Authorizing Legislation - Public Law

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Minimum Data Elements/System for Technical Assistance Reporting for the National Breast and Cervical Cancer Earl

Authorizing Legislation - Public Law

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ATTACHMENT 1
Public Law 101-354, The Breast and Cervical Cancer Mortality Prevention Act of 1990

Title 42. The Public Health and Welfare
Chapter 6a. The Public Health Service
Preventive Health Measures with Respect to Breast and Cervical Cancers
42 U.S.C. § 300k
Note: Amendments to 42 USC § 300k are indicated in bold and italics, followed by a reference
to the amending law in parentheses.

§ 300k. Establishment of program of grants to States
(a) In general. The Secretary, acting through the Director of the Centers for Disease
Control and Prevention, may make grants to States on the basis of an established
competitive review process for the purpose of carrying out programs—
(1) to screen women for breast and cervical cancer as a preventive health
measure;
(2) to provide appropriate referrals for medical treatment of women screened
pursuant to paragraph (1) and to ensure, to the extent practicable, the provision of
appropriate follow-up services and support services such as case management
(Women's Health Research and Prevention Amendments of 1998, Public Law
105- 340);
(3) to develop and disseminate public information and education programs for the
detection and control of breast and cervical cancer;
(4) to improve the education, training, and skills of health professionals (including
allied health professionals) in the detection and control of breast and cervical
cancer;
(5) to establish mechanisms through which the States can monitor the quality of
screening procedures for breast and cervical cancer, including the interpretation of
such procedures; and
(6) to evaluate activities conducted under paragraphs (1) through (5) through
appropriate surveillance or program-monitoring activities.
(b) Grant and contract authority of States.
(1) In general. A state receiving a grant under subsection (a) may, subject to
paragraphs (2) and (3), expend the grant to carry out the purpose described in
such subsection through grants to public and non profit private entities and

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through contracts with public and private entities (Women's Health Research
and Prevention Amendments of 1998, Public Law 105-340).
(2) CERTAIN APPLICATIONS- If a nonprofit private entity and a private
entity that is not a nonprofit entity both submit applications to a State to receive
an award of a grant or contract pursuant to paragraph (1), the State may give
priority to the application submitted by the nonprofit private entity in any case
in which the State determines that the quality of such application is equivalent
to the quality of the application submitted by the other private entity (Women’s
Health Research and Prevention Amendments of 1998, Public Law 105-340).
(3) Payments for screenings. The amount paid by a State to an entity under this
subsection for a screening procedure under subsection (a)(1) may not exceed the
amount that would be paid under part B of title XVIII of the Social Security Act
[42 U.S.C. §§ 1395j et seq.] if payment were made under such part for furnishing
the procedure to a woman enrolled under such part.
(c) Special consideration for certain States. In making grants under subsection (a) to
States whose initial grants under such subsection are made for fiscal year 1995 or any
subsequent fiscal year, the Secretary shall give special consideration to any State whose
proposal for carrying out programs under such subsection—
(1) has been approved through a process of peer review; and
(2) is made with respect to geographic areas in which there is—
(A) a substantial rate of mortality from breast or cervical cancer; or
(B) a substantial incidence of either of such cancers.
[(d)](c) Coordinating committee regarding year 2000 health objectives. The Secretary,
acting through the Director of the Centers for Disease Control and Prevention, shall
establish a committee to coordinate the activities of the agencies of the Public Health
Service (and other appropriate Federal agencies) that are carried out toward achieving the
objectives established by the Secretary for reductions in the rate of mortality from breast
and cervical cancer in the United States by the year 2000. Such committee shall be
comprised of Federal officers or employees designated by the heads of the agencies
involved to serve on the committee as representatives of the agencies, and such
representatives from other public or private entities as the Secretary determines to be
appropriate.

§ 300l. Requirement of matching funds
(a) In general. The Secretary may not make a grant under section 1501 [42 U.S.C. §
300k] unless the State involved agrees, with respect to the costs to be incurred by the
State in carrying out the purpose described in such section, to make available non-Federal
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contributions (in cash or in kind under subsection (b)) 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.
(b) Determination of amount of non-Federal contribution.
(1) In general. Non-Federal contributions required in subsection (a) 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.
(2) Maintenance of effort. In making a determination of the amount of nonFederal contributions for purposes of subsection (a), the Secretary may include
only non-Federal contributions in excess of the average amount of non-Federal
contributions made by the State involved toward the purpose described in section
1501 [42 U.S.C. § 300k] for the 2-year period preceding the first fiscal year for
which the State is applying to receive a grant under such section.
(3) Inclusion of relevant non-Federal contributions for Medicaid. In making a
determination of the amount of non-Federal contributions for purposes of
subsection (a), the Secretary shall, subject to paragraphs (1) and (2) of this
subsection, include any non-Federal amounts expended pursuant to title XIX of
the Social Security Act [42 U.S.C. § 1396 et seq.] by the State involved toward
the purpose described in paragraphs (1) and (2) of section 1501(a) [42 U.S.C. §
300k(a)].

§ 300l-1. Requirement regarding medicaid
The Secretary may not make a grant under section 1501 [42 U.S.C. § 300k] for a program in a
State unless the State plan under title XIX of the Social Security Act [42 U.S.C. §§ 1396 et seq.]
for the State includes the screening procedures specified in subparagraphs (A) and (B) of section
1503(a)(2) [42 U.S.C. § 300m(a)(2)(A), (B)] as medical assistance provided under the plan.

§ 300m. Requirements with respect to type and quality of services
(a) Requirement of provision of all services by date certain. The Secretary may not make
a grant under section 1501 [42 U.S.C. § 300k] unless the State 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
section 1501(a) [42 U.S.C. § 300k(a)], including making available screening
procedures for both breast and cervical cancers;

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(2) subject to subsection (b), to ensure that—
(A) in the case of breast cancer, both a physical examination of the breasts
and the screening procedure known as a mammography are conducted;
and
(B) in the case of cervical cancer, both a pelvic examination and the
screening procedure known as a pap smear are conducted;
(3) 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 section 1501(a) [42 U.S.C.
§ 300k(a)] is provided; and
(4) 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.
(b) Use of improved screening procedures. The Secretary may not make a grant under
section 1501 [42 U.S.C. § 300k] unless the State involved agrees that, if any screening
procedure superior to a procedure described in subsection (a)(2) becomes commonly
available and is recommended for use, any entity providing screening procedures
pursuant to the grant will utilize the superior procedure rather than the procedure
described in such subsection.
(c) Quality assurance regarding screening procedures. The Secretary may not make a
grant under section 1501 [42 U.S.C. § 300k] unless the State involved agrees that the
State will, in accordance with applicable law, assure the quality of screening procedures
conducted pursuant to such section.
(d) Waiver of Services Requirement on Division of Funds —
(1) IN GENERAL- The Secretary shall establish a demonstration project under
which the Secretary may waive the requirements of paragraphs (1) and (4) of
subsection (a) for not more than 5 States, if—
(A) the State involved will use the waiver to leverage non-Federal funds
to supplement each of the services or activities described in paragraphs
(1) and (2) of section 1501(a);
(B) the application of such requirement would result in a barrier to the
enrollment of qualifying women;
(C) the State involved—
(i) demonstrates, to the satisfaction of the Secretary, the manner
in which the State will use such waiver to expand the level of

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screening and follow-up services provided immediately prior to
the date on which the waiver is granted; and
(ii) provides assurances, satisfactory to the Secretary, that the
State will, on an annual basis, demonstrate, through such
documentation as the Secretary may require, that the State has
used such waiver as described in clause (i);
(D) the State involved submits to the Secretary—
(i) assurances, satisfactory to the Secretary, that the State will
maintain the average annual level of State fiscal year
expenditures for the services and activities described in
paragraphs (1) and (2) of section 1501(a) for the period for
which the waiver is granted, and for the period for which any
extension of such wavier is granted, at a level that is not less
than—
(I) the level of the State fiscal year expenditures for such
services and activities for the fiscal year preceding the
first fiscal year for which the waiver is granted; or
(II) at the option of the State and upon approval by the
Secretary, the average level of the State expenditures for
such services and activities for the 3-fiscal year period
preceding the first fiscal year for which the waiver is
granted; and
(ii) a plan, satisfactory to the Secretary, for maintaining the level
of activities carried out under the waiver after the expiration of
the waiver and any extension of such waiver;
(E) the Secretary finds that granting such a waiver to a State will
increase the number of women in the State that receive each of the
services or activities described in paragraphs (1) and (2) of section
1501(a), including making available screening procedures for both
breast and cervical cancers; and
(F) the Secretary finds that granting such a waiver to a State will not
adversely affect the quality of each of the services or activities described
in paragraphs (1) and (2) of section 1501(a).
(2) DURATION OF WAIVER(A) IN GENERAL- In granting waivers under paragraph (1), the
Secretary—
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(i) shall grant such waivers for a period that is not less than 1
year but not more than 2 years; and
(ii) upon request of a State, may extend a waiver for an
additional period that is not less than 1 year but not more than 2
years in accordance with subparagraph (B).
(B) ADDITIONAL PERIOD- The Secretary, upon the request of a State
that has received a waiver under paragraph (1), shall, at the end of the
waiver period described in subparagraph (A)(i), review performance
under the waiver and may extend the waiver for an additional period if
the Secretary determines that—
(i) without an extension of the waiver, there will be a barrier to
the enrollment of qualifying women;
(ii) the State requesting such extended waiver will use the waiver
to leverage non-Federal funds to supplement the services or
activities described in paragraphs (1) and (2) of section 1501(a);
(iii) the waiver has increased, and will continue to increase, the
number of women in the State that receive the services or
activities described in paragraphs (1) and (2) of section 1501(a);
(iv) the waiver has not, and will not, result in lower quality in the
State of the services or activities described in paragraphs (1) and
(2) of section 1501(a); and
(v) the State has maintained the average annual level of State
fiscal expenditures for the services and activities described in
paragraphs (1) and (2) of section 1501(a) for the period for
which the waiver was granted at a level that is not less than—
(I) the level of the State fiscal year expenditures for such
services and activities for the fiscal year preceding the
first fiscal year for which the waiver is granted; or
(II) at the option of the State and upon approval by the
Secretary, the average level of the State expenditures for
such services and activities for the 3-fiscal year period
preceding the first fiscal year for which the waiver is
granted.
3) REPORTING REQUIREMENTS- The Secretary shall include as part of the
evaluations and reports required under section 1508, the following:

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(A) A description of the total amount of dollars leveraged annually from
Non-Federal entities in States receiving a waiver under paragraph (1)
and how these amounts were used.
(B) With respect to States receiving a waiver under paragraph (1), a
description of the percentage of the grant that is expended on providing
each of the services or activities described in—
(i) paragraphs (1) and (2) of section 1501(a); and
(ii) paragraphs (3) through (6) of section 1501(a).
(C) A description of the number of States receiving waivers under
paragraph (1) annually.
(D) With respect to States receiving a waiver under paragraph (1), a
description of—
(i) the number of women receiving services under paragraphs
(1), (2), and (3) of section 1501(a) in programs before and after
the granting of such waiver; and
(ii) the average annual level of State fiscal expenditures for the
services and activities described in paragraphs (1) and (2) of
section 1501(a) for the year preceding the first year for which the
waiver was granted.
(4) LIMITATION- Amounts to which a waiver applies under this subsection
shall not be used to increase the number of salaried employees.
(5) DEFINITIONS- In this subsection:
(A) INDIAN TRIBE- The term “Indian tribe” has the meaning given
the term in section 4 of the Indian Health Care Improvement Act (25
U.S.C. 1603).
(B) TRIBAL ORGANIZATION- The term “tribal organization” has the
meaning given the term in section 4 of the Indian Health Care
Improvement Act.
(C) STATE- The term “State” means each of the several States of the
United States, the District of Columbia, the Commonwealth of Puerto
Rico, American Samoa, the Commonwealth of the Northern Mariana
Islands, the Republic of the Marshall Islands, the Federated States of
Micronesia, the Republic of Palau, an Indian tribe, and a tribal
organization.
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(6) SUNSET- The Secretary may not grant a waiver or extension under this
subsection after September 30, 2012.

§ 300n. Additional required agreements
(a) Priority for low-income women. The Secretary may not make a grant under section
1501 [42 U.S.C. § 300k] unless the State involved agrees that low-income women will be
given priority in the provision of services and activities pursuant to paragraphs (1) and (2)
of section 1501(a) [42 U.S.C. § 300k(a)].
(b) Limitation on imposition of fees for services. The Secretary may not make a grant
under section 1501 [42 U.S.C. § 300k] unless the State 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 woman involved; and
(3) will not be imposed on any woman 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 [42 U.S.C. § 9902(2)].
(c) Statewide provision of services.
(1) In general. The Secretary may not make a grant under section 1501 [42 U.S.C.
§ 300k] unless the State involved agrees that services and activities under the
grant will be made available throughout the State, including availability to
members of any Indian tribe or tribal organization (as such terms are defined in
section 4 of the Indian Self-Determination and Education Assistance Act [25
U.S.C. § 450b]).
(2) Waiver. The Secretary may waive the requirement established in paragraph (1)
for a State if the Secretary determines that compliance by the State with the
requirement would result in an inefficient allocation of resources with respect to
carrying out the purpose described in section 1501(a) [42 U.S.C. § 300k(a)].
(3) Grants to tribes and tribal organizations.
(A) The Secretary, acting through the Director of the Centers for Disease
Control and Prevention, may make grants to tribes and tribal organizations
(as such terms are used in paragraph (1)) for the purpose of carrying out
programs described in section 1501(a) [42 U.S.C. § 300k(a)]. This title
applies to such a grant (in relation to the jurisdiction of the tribe or
organization) to the same extent and in the same manner as such title
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applies to a grant to a State under section 1501 [42 U.S.C. § 300k] (in
relation to the jurisdiction of the State).
(B) If a tribe or tribal organization is receiving a grant under subparagraph
(A) and the State in which the tribe or organization is located is receiving
a grant under section 1501 [42 U.S.C. § 300k], the requirement established
in paragraph (1) for the State regarding the tribe or organization is deemed
to have been waived under paragraph (2).
(d) Relationship to items and services under other programs. The Secretary may not make
a grant under section 1501 [42 U.S.C. § 300k] unless the State 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—
(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.
(e) Coordination with other breast and cervical cancer programs. The Secretary may not
make a grant under section 1501 [42 U.S.C. § 300k] unless the State involved agrees that
the services and activities funded through the grant shall be coordinated with other
Federal, State, and local breast and cervical cancer programs.
(f) Limitation on administrative expenses. The Secretary may not make a grant under
section 1501 [42 U.S.C. § 300k] unless the State involved agrees that not more than 10
percent of the grant will be expended for administrative expenses with respect to the
grant.
(g) Restrictions on use of grant. The Secretary may not make a grant under section 1501
[42 U.S.C. § 300k] unless the State involved agrees that the grant will not be expended to
provide inpatient hospital services for any individual.
(h) Records and audits. The Secretary may not make a grant under section 1501 [42
U.S.C. § 300k] unless the State involved agrees that—
(1) the State 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 State under such section; and
(2) upon request, the State 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 State of the grant.

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(i) Reports to Secretary. The Secretary may not make a grant under section 1501 [42
U.S.C. § 300k] unless the State involved agrees to submit to the Secretary such reports as
the Secretary may require with respect to the grant.

§ 300n-1. Description of intended uses of grant
The Secretary may not make a grant under section 1501 [42 U.S.C. § 300k] unless—
(1) the State involved submits to the Secretary a description of the purposes for which the
State intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the State with a need
for the services or activities described in section 1501(a) [42 U.S.C. § 300k(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 and nonprofit private
entities; and
(4) the description provides assurances that the grant funds will be used in the most costeffective manner.

§ 300n-2. Requirement of submission of application
The Secretary may not make a grant under section 1501 [42 U.S.C. § 300k] unless an application
for the grant is submitted to the Secretary, the application contains the description of intended
uses required in section 1505 [42 U.S.C. § 300n-1], 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 title [42 U.S.C. §§ 300k et seq.].

§ 300n-3. Technical assistance and provision of supplies and services in lieu of
grant funds
(a) 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 section 1501 [42 U.S.C. § 300k]. The Secretary may provide such
technical assistance directly or through grants to, or contracts with, public and private
entities.
(b) Provision of supplies and services in lieu of grant funds.
(1) In general. Upon the request of a State receiving a grant under section 1501
[42 U.S.C. § 300k], the Secretary may, subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding the State in carrying out such
section and, for such purpose, may detail to the State any officer or employee of
the Department of Health and Human Services.
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(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
under section 1501 [42 U.S.C. § 300k] to the State 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.

§ 300n-4. Evaluations and reports
(a) Evaluations. The Secretary shall, directly or through contracts with public private
entities, provide for annual evaluations of programs carried out pursuant to section 1501
[42 U.S.C. § 300k]. Such evaluations shall include evaluations of the extent to which
States carrying out such programs are in compliance with section 1501(a)(2) [42 U.S.C. §
300k(a)(2)] and with section 1504© [42 U.S.C. § 300n(c)].
(b) Report to Congress. The Secretary shall, not later than 1 year after the date on which
amounts are first appropriated pursuant to section 1509(a) [42 U.S.C. § 300n-5(a)], and
annually thereafter, 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 summarizing evaluations carried out pursuant to subsection (a) during the
preceding fiscal year and making such recommendations for administrative and
legislative initiatives with respect to this title [42 U.S.C. §§ 300k et seq.] as the Secretary
determines to be appropriate, including recommendations regarding compliance by the
States with section 1501(a)(2) [42 U.S.C. § 300k(a)(2)] and with section 1504© [42
U.S.C. § 300n(c)].

§ 300n-4a. Supplemental grants for additional preventive health services
(a) Demonstration projects. In the case of States receiving grants under section 1501 [42
U.S.C. § 300k], the Secretary, acting through the Director of the Centers for Disease
Control and Prevention, may make grants to not more than 3 such States to carry out
demonstration projects for the purpose of—
(1) providing preventive health services in addition to the services authorized in
such section, including screenings regarding blood pressure and cholesterol, and
including health education;
(2) providing appropriate referrals for medical treatment of women receiving
services pursuant to paragraph (1) and ensuring, to the extent practicable, the
provision of appropriate follow-up services; and
(3) evaluating activities conducted under paragraphs (1) and (2) through
appropriate surveillance or program-monitoring activities.

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(b) Status as participant in program regarding breast and cervical cancer. The Secretary
may not make a grant under subsection (a) unless the State involved agrees that services
under the grant will be provided only through entities that are screening women for breast
or cervical cancer pursuant to a grant under section 1501 [42 U.S.C. § 300k].
(c) Applicability of provisions of general program. This title [42 U.S.C. §§ 300k et seq.]
applies to a grant under subsection (a) to the same extent and in the same manner as such
title applies to a grant under section 1501[42 U.S.C. § 300k].
(d) Funding.
(1) In general. Subject to paragraph (2), for the purpose of carrying out this
section, there are authorized to be appropriated $ 3,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the fiscal years 1995 through
2003 (Women’s Health Research and Prevention Amendments of 1998, Public
Law 105-340).
(2) Limitation regarding funding with respect to breast and cervical cancer. The
authorization of appropriations established in paragraph (1) is not effective for a
fiscal year unless the amount appropriated under section 1510(a) [42 U.S.C. §
300n-5(a)] for the fiscal year is equal to or greater than $ 100,000,000.

§ 300n-5. Funding for general program
(a) Authorization of appropriations. For the purpose of carrying out this title [42 U.S.C.
§§ 300k et seq.], there are authorized to be appropriated $ 50,000,000 for fiscal year
1991, such sums as may be necessary for each of the fiscal years 1992 and 1993, $
150,000,000 for fiscal year 1994, and such sums as may be necessary for each of the
fiscal years 1995 through 2003 (Women’s Health Research and Prevention
Amendments of 1998, Public Law 105-340).
(b) Set-aside for technical assistance and provision of supplies and services. Of the
amounts appropriated under subsection (a) for a fiscal year, the Secretary shall reserve
not more than 20 percent for carrying out section 1507 [42 U.S.C. § 300n-3].

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