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pdfPUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1033
Public Law 114–255
114th Congress
An Act
To accelerate the discovery, development, and delivery of 21st century cures, and
for other purposes.
Dec. 13, 2016
[H.R. 34]
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
21st Century
Cures Act.
42 USC 201 note.
(a) SHORT TITLE.—This Act may be cited as the ‘‘21st Century
Cures Act’’.
(b) TABLE OF CONTENTS.—The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
DIVISION A—21ST CENTURY CURES
Sec. 1000. Short title.
TITLE I—INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID
ABUSE
Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.
TITLE II—DISCOVERY
Subtitle A—National Institutes of Health Reauthorization
Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.
Sec.
Sec.
Sec.
Sec.
2011.
2012.
2013.
2014.
Subtitle B—Advancing Precision Medicine
Precision Medicine Initiative.
Privacy protection for human research subjects.
Protection of identifiable and sensitive information.
Data sharing.
Subtitle C—Supporting Young Emerging Scientists
Sec. 2021. Investing in the next generation of researchers.
Sec. 2022. Improvement of loan repayment program.
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Subtitle D—National Institutes of Health Planning and Administration
2031. National Institutes of Health strategic plan.
2032. Triennial reports.
2033. Increasing accountability at the National Institutes of Health.
2034. Reducing administrative burden for researchers.
2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.
2036. High-risk, high-reward research.
2037. National Center for Advancing Translational Sciences.
2038. Collaboration and coordination to enhance research.
2039. Enhancing the rigor and reproducibility of scientific research.
2040. Improving medical rehabilitation research at the National Institutes of
Health.
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2041.
2042.
2043.
2044.
Task force on research specific to pregnant women and lactating women.
Streamlining National Institutes of Health reporting requirements.
Reimbursement for research substances and living organisms.
Sense of Congress on increased inclusion of underrepresented populations in clinical trials.
Subtitle E—Advancement of the National Institutes of Health Research and Data
Access
Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.
Subtitle F—Facilitating Collaborative Research
Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research purposes.
Subtitle G—Promoting Pediatric Research
Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.
TITLE III—DEVELOPMENT
Sec.
Sec.
Sec.
Sec.
3001.
3002.
3003.
3004.
Subtitle A—Patient-Focused Drug Development
Patient experience data.
Patient-focused drug development guidance.
Streamlining patient input.
Report on patient experience drug development.
Subtitle B—Advancing New Drug Therapies
Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric
diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.
Sec.
Sec.
Sec.
Sec.
3021.
3022.
3023.
3024.
Sec.
Sec.
Sec.
Sec.
3031.
3032.
3033.
3034.
Sec. 3035.
Sec. 3036.
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Sec. 3037.
Sec. 3038.
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3041.
3042.
3043.
3044.
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3051.
3052.
3053.
3054.
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Subtitle C—Modern Trial Design and Evidence Development
Novel clinical trial designs.
Real world evidence.
Protection of human research subjects.
Informed consent waiver or alteration for clinical investigations.
Subtitle D—Patient Access to Therapies and Information
Summary level review.
Expanded access policy.
Accelerated approval for regenerative advanced therapies.
Guidance regarding devices used in the recovery, isolation, or delivery
of regenerative advanced therapies.
Report on regenerative advanced therapies.
Standards for regenerative medicine and regenerative advanced therapies.
Health care economic information.
Combination product innovation.
Subtitle E—Antimicrobial Innovation and Stewardship
Antimicrobial resistance monitoring.
Limited population pathway.
Prescribing authority.
Susceptibility test interpretive criteria for microorganisms; antimicrobial
susceptibility testing devices.
Subtitle F—Medical Device Innovations
Breakthrough devices.
Humanitarian device exemption.
Recognition of standards.
Certain class I and class II devices.
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3055.
3056.
3057.
3058.
3059.
3060.
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Classification panels.
Institutional review board flexibility.
CLIA waiver improvements.
Least burdensome device review.
Cleaning instructions and validation data requirement.
Clarifying medical software regulation.
Subtitle G—Improving Scientific Expertise and Outreach at FDA
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
Subtitle H—Medical Countermeasures Innovation
Medical countermeasure guidelines.
Clarifying BARDA contracting authority.
Countermeasure budget plan.
Medical countermeasures innovation.
Streamlining Project BioShield procurement.
Encouraging treatments for agents that present a national security
threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use authorization.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
3081.
3082.
3083.
3084.
3085.
3086.
Subtitle I—Vaccine Access, Certainty, and Innovation
Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on
Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.
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Subtitle J—Technical Corrections
Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
4001.
4002.
4003.
4004.
4005.
4006.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
4007.
4008.
4009.
4010.
4011.
4012.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
5001.
5002.
5003.
5004.
5005.
5006.
5007.
5008.
Sec.
Sec.
Sec.
Sec.
5009.
5010.
5011.
5012.
TITLE IV—DELIVERY
Assisting doctors and hospitals in improving quality of care for patients.
Transparent reporting on usability, security, and functionality.
Interoperability.
Information blocking.
Leveraging electronic health records to improve patient care.
Empowering patients and improving patient access to their electronic
health information.
GAO study on patient matching.
GAO study on patient access to health information.
Improving Medicare local coverage determinations.
Medicare pharmaceutical and technology ombudsman.
Medicare site-of-service price transparency.
Telehealth services in Medicare.
TITLE V—SAVINGS
Savings in the Medicare Improvement Fund.
Medicaid reimbursement to States for durable medical equipment.
Penalties for violations of grants, contracts, and other agreements.
Reducing overpayments of infusion drugs.
Increasing oversight of termination of Medicaid providers.
Requiring publication of fee-for-service provider directory.
Fairness in Medicaid supplemental needs trusts.
Eliminating Federal financial participation with respect to expenditures
under Medicaid for agents used for cosmetic purposes or hair growth.
Amendment to the Prevention and Public Health Fund.
Strategic Petroleum Reserve drawdown.
Rescission of portion of ACA territory funding.
Medicare coverage of home infusion therapy.
DIVISION B—HELPING FAMILIES IN MENTAL HEALTH CRISIS
Sec. 6000. Short title.
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PUBLIC LAW 114–255—DEC. 13, 2016
TITLE VI—STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A—Leadership
Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and Mental Health
Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.
Subtitle B—Oversight and Accountability
Sec. 6021. Improving oversight of mental and substance use disorders programs
through the Assistant Secretary for Planning and Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.
Subtitle C—Interdepartmental Serious Mental Illness Coordinating Committee
Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee.
TITLE VII—ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH
SCIENCE AND TECHNOLOGY
Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs and practices.
Sec. 7003. Priority mental health needs of regional and national significance.
Sec. 7004. Priority substance use disorder treatment needs of regional and national
significance.
Sec. 7005. Priority substance use disorder prevention needs of regional and national significance.
TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND
RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse prevention and
treatment block grant and the community mental health services block
grant.
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TITLE IX—PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE
USE DISORDER CARE
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
9001.
9002.
9003.
9004.
9005.
9006.
9007.
9008.
9009.
9010.
9011.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
9012.
9013.
9014.
9015.
9016.
9017.
Subtitle A—Helping Individuals and Families
Grants for treatment and recovery for homeless individuals.
Grants for jail diversion programs.
Promoting integration of primary and behavioral health care.
Projects for assistance in transition from homelessness.
National Suicide Prevention Lifeline Program.
Connecting individuals and families with care.
Strengthening community crisis response systems.
Garrett Lee Smith Memorial Act reauthorization.
Adult suicide prevention.
Mental health awareness training grants.
Sense of Congress on prioritizing American Indians and Alaska Native
youth within suicide prevention programs.
Evidence-based practices for older adults.
National violent death reporting system.
Assisted outpatient treatment.
Assertive community treatment grant program.
Sober truth on preventing underage drinking reauthorization.
Center and program repeals.
Subtitle B—Strengthening the Health Care Workforce
Sec. 9021. Mental and behavioral health education and training grants.
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9022.
9023.
9024.
9025.
Strengthening the mental and substance use disorders workforce.
Clarification on current eligibility for loan repayment programs.
Minority fellowship program.
Liability protections for health professional volunteers at community
health centers.
Sec. 9026. Reports.
Subtitle C—Mental Health on Campus Improvement
Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.
TITLE X—STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER
CARE FOR CHILDREN AND ADOLESCENTS
Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention services for
children and adolescents.
Sec. 10004. Children’s recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion, intervention, and
treatment.
TITLE XI—COMPASSIONATE COMMUNICATION ON HIPAA
Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of protected health information.
Sec. 11004. Development and dissemination of model training programs.
TITLE XII—MEDICAID MENTAL HEALTH COVERAGE
Sec. 12001. Rule of construction related to Medicaid coverage of mental health
services and primary care services furnished on the same day.
Sec. 12002. Study and report related to Medicaid managed care regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric demonstration
project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal care services
and home health care services under Medicaid.
TITLE XIII—MENTAL HEALTH PARITY
Sec. 13001. Enhanced compliance with mental health and substance use disorder
coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and substance
use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.
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TITLE XIV—MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A—Mental Health and Safe Communities
Sec. 14001. Law enforcement grants for crisis intervention teams, mental health
purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges in drug
courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
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Sec. 14012. Co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs.
Sec. 14013. Mental health and drug treatment alternatives to incarceration programs.
Sec. 14014. National criminal justice and mental health training and technical assistance.
Sec. 14015. Improving Department of Justice data collection on mental illness involved in crime.
Sec. 14016. Reports on the number of mentally ill offenders in prison.
Sec. 14017. Codification of due process for determinations by secretary of veterans
affairs of mental capacity of beneficiaries.
Sec. 14018. Reauthorization of appropriations.
Subtitle B—Comprehensive Justice and Mental Health
Sequential intercept model.
Prison and jails.
Allowable uses.
Law enforcement training.
Federal law enforcement training.
GAO report.
Evidence based practices.
Transparency, program accountability, and enhancement of local authority.
Sec. 14029. Grant accountability.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
14021.
14022.
14023.
14024.
14025.
14026.
14027.
14028.
DIVISION C—INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH
CARE FOR AMERICANS
Sec. 15000. Short title.
TITLE XV—PROVISIONS RELATING TO MEDICARE PART A
Sec. 15001. Development of Medicare HCPCS version of MS–DRG codes for similar
hospital services.
Sec. 15002. Establishing beneficiary equity in the Medicare hospital readmission
program.
Sec. 15003. Five-year extension of the rural community hospital demonstration program.
Sec. 15004. Regulatory relief for LTCHs.
Sec. 15005. Savings from IPPS MACRA pay-for through not applying documentation and coding adjustments.
Sec. 15006. Extension of certain LTCH Medicare payment rules.
Sec. 15007. Application of rules on the calculation of hospital length of stay to all
LTCHs.
Sec. 15008. Change in Medicare classification for certain hospitals.
Sec. 15009. Temporary exception to the application of the Medicare LTCH site neutral provisions for certain spinal cord specialty hospitals.
Sec. 15010. Temporary extension to the application of the Medicare LTCH site neutral provisions for certain discharges with severe wounds.
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TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B
Sec. 16001. Continuing Medicare payment under HOPD prospective payment system for services furnished by mid-build off-campus outpatient departments of providers.
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient department of
a provider policy.
Sec. 16003. Treatment of eligible professionals in ambulatory surgical centers for
meaningful use and MIPS.
Sec. 16004. Continuing Access to Hospitals Act of 2016.
Sec. 16005. Delay of implementation of Medicare fee schedule adjustments for
wheelchair accessories and seating systems when used in conjunction
with complex rehabilitation technology (CRT) wheelchairs.
Sec. 16006. Allowing physical therapists to utilize locum tenens arrangements
under Medicare.
Sec. 16007. Extension of the transition to new payment rates for durable medical
equipment under the Medicare program.
Sec. 16008. Requirements in determining adjustments using information from competitive bidding programs.
TITLE XVII—OTHER MEDICARE PROVISIONS
Sec. 17001. Delay in authority to terminate contracts for Medicare Advantage plans
failing to achieve minimum quality ratings.
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130 STAT. 1039
Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the Medicare
Shared Savings Program.
TITLE XVIII—OTHER PROVISIONS
Sec. 18001. Exception from group health plan requirements for qualified small employer health reimbursement arrangements.
DIVISION A—21ST CENTURY CURES
21st Century
Cures Act.
SEC. 1000. SHORT TITLE.
42 USC 201 note.
This Division may be cited as the ‘‘21st Century Cures Act’’.
TITLE I—INNOVATION PROJECTS AND
STATE RESPONSES TO OPIOID ABUSE
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SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION
PROJECTS.
(a) IN GENERAL.—The Director of the National Institutes of
Health (referred to in this section as the ‘‘Director of NIH’’) shall
use any funds appropriated pursuant to the authorization of appropriations in subsection (b)(3) to carry out the National Institutes
of Health innovation projects described in subsection (b)(4) (referred
to in this section as the ‘‘NIH Innovation Projects’’).
(b) NATIONAL INSTITUTES OF HEALTH INNOVATION ACCOUNT.—
(1) ESTABLISHMENT OF NIH INNOVATION ACCOUNT.—There
is established in the Treasury an account, to be known as
the ‘‘NIH Innovation Account’’ (referred to in this subsection
as the ‘‘Account’’), for purposes of carrying out the NIH Innovation Projects described in paragraph (4).
(2) TRANSFER OF DIRECT SPENDING SAVINGS.—
(A) IN GENERAL.—The following amounts shall be
transferred to the Account from the general fund of the
Treasury:
(i) For fiscal year 2017, $352,000,000.
(ii) For fiscal year 2018, $496,000,000.
(iii) For fiscal year 2019, $711,000,000.
(iv) For fiscal year 2020, $492,000,000.
(v) For fiscal year 2021, $404,000,000.
(vi) For fiscal year 2022, $496,000,000.
(vii) For fiscal year 2023, $1,085,000,000.
(viii) For fiscal year 2024, $407,000,000.
(ix) For fiscal year 2025, $127,000,000.
(x) For fiscal year 2026, $226,000,000.
(B) AMOUNTS DEPOSITED.—Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant
to paragraph (3).
(3) APPROPRIATIONS.—
(A) AUTHORIZATION OF APPROPRIATIONS.—For each of
the fiscal years 2017 through 2026, there is authorized
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130 STAT. 1040
PUBLIC LAW 114–255—DEC. 13, 2016
to be appropriated from the Account to the Director of
NIH, for the purpose of carrying out the NIH Innovation
Projects, an amount not to exceed the total amount transferred to the Account under paragraph (2)(A), to remain
available until expended.
(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of
fiscal years 2017 through 2026, for any discretionary appropriation under the heading ‘‘NIH Innovation Account’’ provided to the Director of NIH pursuant to the authorization
of appropriations under subparagraph (A) for the purpose
of carrying out the NIH Innovation Projects, the total
amount of such appropriations for the applicable fiscal
year (not to exceed the total amount remaining in the
Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any
estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and
Emergency Deficit Control Act of 1985, and the amount
transferred to the Account shall be reduced by the same
amount.
(4) NIH INNOVATION PROJECTS.—NIH Innovation Projects
authorized to be funded under this section shall consist of
the following and, of the total amounts authorized to be appropriated under paragraph (3), there are authorized to be appropriated to each such project a total amount not to exceed
the following, over the period of fiscal years 2017 through
2026:
(A) For the Precision Medicine Initiative, including
for the advancement of a cohort of individuals to support
the goals of the Precision Medicine Initiative, not to exceed
a total of $1,455,000,000, as follows:
(i) For fiscal year 2017, $40,000,000.
(ii) For fiscal year 2018, $100,000,000.
(iii) For fiscal year 2019, $186,000,000.
(iv) For fiscal year 2020, $149,000,000.
(v) For fiscal year 2021, $109,000,000.
(vi) For fiscal year 2022, $150,000,000.
(vii) For fiscal year 2023, $419,000,000.
(viii) For fiscal year 2024, $235,000,000.
(ix) For fiscal year 2025, $36,000,000.
(x) For fiscal year 2026, $31,000,000.
(B) For the Brain Research through Advancing Innovative Neurotechnologies Initiative (known as the ‘‘BRAIN
Initiative’’), not to exceed a total of $1,511,000,000, as
follows:
(i) For fiscal year 2017, $10,000,000.
(ii) For fiscal year 2018, $86,000,000.
(iii) For fiscal year 2019, $115,000,000.
(iv) For fiscal year 2020, $140,000,000.
(v) For fiscal year 2021, $100,000,000.
(vi) For fiscal year 2022, $152,000,000.
(vii) For fiscal year 2023, $450,000,000.
(viii) For fiscal year 2024, $172,000,000.
(ix) For fiscal year 2025, $91,000,000.
(x) For fiscal year 2026, $195,000,000.
(C) To support cancer research, such as the development of cancer vaccines, the development of more sensitive
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1041
diagnostic tests for cancer, immunotherapy and the
development of combination therapies, and research that
has the potential to transform the scientific field, that
has inherently higher risk, and that seeks to address major
challenges related to cancer, not to exceed a total of
$1,800,000,000, as follows:
(i) For fiscal year 2017, $300,000,000.
(ii) For fiscal year 2018, $300,000,000.
(iii) For fiscal year 2019, $400,000,000.
(iv) For fiscal year 2020, $195,000,000.
(v) For fiscal year 2021, $195,000,000.
(vi) For fiscal year 2022, $194,000,000.
(vii) For fiscal year 2023, $216,000,000.
(D) For the National Institutes of Health, in coordination with the Food and Drug Administration, to award
grants and contracts for clinical research to further the
field of regenerative medicine using adult stem cells,
including autologous stem cells, for which grants and contracts shall be contingent upon the recipient making available non-Federal contributions toward the costs of such
research in an amount not less than $1 for each $1 of
Federal funds provided in the award, not to exceed a total
of $30,000,000, as follows:
(i) For fiscal year 2017, $2,000,000.
(ii) For each of fiscal years 2018 and 2019,
$10,000,000.
(iii) For fiscal year 2020, $8,000,000.
(iv) For each of fiscal years 2021 through 2026,
$0.
(c) ACCOUNTABILITY AND OVERSIGHT.—
(1) WORK PLAN.—
(A) IN GENERAL.—Not later than 180 days after the
date of enactment of this Act, the Director of NIH 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 work plan including the proposed allocation
of funds authorized to be appropriated pursuant to subsection (b)(3) for each of fiscal years 2017 through 2026
for the NIH Innovation Projects and the contents described
in subparagraph (B).
(B) CONTENTS.—The work plan submitted under
subparagraph (A) shall include—
(i) recommendations from the Advisory Committee
described in subparagraph (C);
(ii) the amount of money to be obligated or
expended in each fiscal year for each NIH Innovation
Project;
(iii) a description and justification of each such
project; and
(iv) a description of how each such project supports
the strategic research priorities identified in the NIH
Strategic Plan under subsection (m) of section 402
of the Public Health Service Act (42 U.S.C. 282), as
added by section 2031.
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(C) RECOMMENDATIONS.—Prior to submitting the work
plan under this paragraph, the Director of NIH shall seek
recommendations from the Advisory Committee to the
Director of NIH appointed under section 222 of the Public
Health Service Act (42 U.S.C. 217a) on—
(i) the allocations of funds appropriated pursuant
to the authorization of appropriations under subsection
(b)(3) for each of fiscal years 2017 through 2026; and
(ii) on the contents of the proposed work plan.
(2) REPORTS.—
(A) ANNUAL REPORTS.—Not later than October 1 of
each of fiscal years 2018 through 2027, the Director of
NIH 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 including—
(i) the amount of money obligated or expended
in the prior fiscal year for each NIH Innovation Project;
(ii) a description of any such project using funds
provided pursuant to the authorization of appropriations under subsection (b)(3); and
(iii) whether such projects are advancing the strategic research priorities identified in the NIH Strategic
Plan under subsection (m) of section 402 of the Public
Health Service Act (42 U.S.C. 282), as added by section
2031.
(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the
Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on
Appropriations of the House of Representatives, the
Director of NIH shall provide an update in the form of
testimony and any additional reports to the respective
congressional committee regarding the allocation of funding
under this section or the description of the NIH Innovation
Projects.
(d) LIMITATIONS.—Notwithstanding any transfer authority
authorized by this Act or any appropriations Act, any funds made
available pursuant to the authorization of appropriations under
subsection (b)(3) may not be used for any purpose other than
a NIH Innovation Project.
(e) SUNSET.—This section shall expire on September 30, 2026.
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SEC. 1002. FDA INNOVATION PROJECTS.
(a) IN GENERAL.—The Commissioner of Food and Drugs
(referred to in this section as the ‘‘Commissioner’’) shall use any
funds appropriated pursuant to the authorization of appropriations
under subsection (b)(3) to carry out the activities described in
subsection (b)(4).
(b) FDA INNOVATION ACCOUNT.—
(1) ESTABLISHMENT OF FDA INNOVATION ACCOUNT.—There
is established in the Treasury an account, to be known as
the ‘‘FDA Innovation Account’’ (referred to in this subsection
as the ‘‘Account’’), for purposes of carrying out the activities
described in paragraph (4).
(2) TRANSFER OF DIRECT SPENDING SAVINGS.—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1043
(A) IN GENERAL.—For each of fiscal years 2017 through
2025, the following amounts shall be transferred to the
Account from the general fund of the Treasury:
(i) For fiscal year 2017, $20,000,000.
(ii) For fiscal year 2018, $60,000,000.
(iii) For fiscal year 2019, $70,000,000.
(iv) For fiscal year 2020, $75,000,000.
(v) For fiscal year 2021, $70,000,000.
(vi) For fiscal year 2022, $50,000,000.
(vii) For fiscal year 2023, $50,000,000.
(viii) For fiscal year 2024, $50,000,000.
(ix) For fiscal year 2025, $55,000,000.
(B) AMOUNTS DEPOSITED.—Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant
to paragraph (3).
(3) APPROPRIATIONS.—
(A) AUTHORIZATION OF APPROPRIATIONS.—For each of
the fiscal years 2017 through 2025, there is authorized
to be appropriated from the Account to the Commissioner,
for the purpose of carrying out the activities described
in paragraph (5), an amount not to exceed the total amount
transferred to the Account under paragraph (2)(A), to
remain available until expended.
(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of
fiscal years 2017 through 2025, for any discretionary appropriation under the heading ‘‘FDA Innovation Account’’ provided to the Commissioner pursuant to the authorization
of appropriations under subparagraph (A) for the purpose
of carrying out the projects activities described in paragraph (4), the total amount of such appropriations in the
applicable fiscal year (not to exceed the total amount
remaining in the Account) shall be subtracted from the
estimate of discretionary budget authority and the resulting
outlays for any estimate under the Congressional Budget
and Impoundment Control Act of 1974 or the Balanced
Budget and Emergency Deficit Control Act of 1985, and
the amount transferred to the Account shall be reduced
by the same amount.
(4) FDA ACTIVITIES.—The activities authorized to be funded
under this section are the activities under subtitles A through
F (including the amendments made by such subtitles) of title
III of this Act and section 1014 of the Federal Food, Drug,
and Cosmetic Act, as added by section 3073 of this Act.
(c) ACCOUNTABILITY AND OVERSIGHT.—
(1) WORK PLAN.—
(A) IN GENERAL.—Not later than 180 days after the
date of enactment of this Act, the Commissioner 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 work plan including the proposed allocation
of funds appropriated pursuant to the authorization of
appropriations under subsection (b)(3) for each of fiscal
years 2017 through 2025 and the contents described in
subparagraph (B).
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(B) CONTENTS.—The work plan submitted under
subparagraph (A) shall include—
(i) recommendations from the Advisory Committee
described in subparagraph (C);
(ii) the amount of money to be obligated or
expended in each fiscal year for each activity described
in subsection (b)(4); and
(iii) a description and justification of each such
project activity.
(C) RECOMMENDATIONS.—Prior to submitting the work
plan under this paragraph, the Commissioner shall seek
recommendations from the Science Board to the Food and
Drug Administration, on the proposed allocation of funds
appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017
through 2025 and on the contents of the proposed work
plan.
(2) REPORTS.—
(A) ANNUAL REPORTS.—Not later than October 1 of
each of fiscal years 2018 through 2026, the Commissioner
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 including—
(i) the amount of money obligated or expended
in the prior fiscal year for each activity described in
subsection (b)(4);
(ii) a description of all such activities using funds
provided pursuant to the authorization of appropriations under subsection (b)(3); and
(iii) how the activities are advancing public health.
(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the
Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on
Appropriations of the House of Representatives, the
Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under
this section or the description of the activities undertaken
with such funding.
(d) LIMITATIONS.—Notwithstanding any transfer authority
authorized by this Act or any appropriations Act, any funds made
available pursuant to the authorization of appropriations in subsection (b)(3) shall not be used for any purpose other than an
activity described in subsection (b)(4).
(e) SUNSET.—This section shall expire on September 30, 2025.
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42 USC 290ee–3
note.
SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE
CRISIS.
(a) IN GENERAL.—The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’) shall use any funds
appropriated pursuant to the authorization of appropriations under
subsection (b) to carry out the grant program described in subsection
(c) for purposes of addressing the opioid abuse crisis within the
States.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1045
(b) ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE
CRISIS.—
(1) ESTABLISHMENT.—There is established in the Treasury
an account, to be known as the ‘‘Account For the State Response
to the Opioid Abuse Crisis’’ (referred to in this subsection
as the ‘‘Account’’), to carry out the opioid grant program
described in subsection (c).
(2) TRANSFER OF DIRECT SPENDING SAVINGS.—
(A) IN GENERAL.—The following amounts shall be
transferred to the Account from the general fund of the
Treasury:
(i) For fiscal year 2017, $500,000,000.
(ii) For fiscal year 2018, $500,000,000.
(B) AMOUNTS DEPOSITED.—Any amounts transferred
under subparagraph (A) shall remain unavailable in the
Account until such amounts are appropriated pursuant
to paragraph (3).
(3) APPROPRIATIONS.—
(A) AUTHORIZATION OF APPROPRIATIONS.—In each of
the fiscal years 2017 and 2018, there is authorized to
be appropriated from the Account to the Secretary, for
the grant program described in subsection (c), an amount
not to exceed the total amount transferred to the Account
under paragraph (2)(A), to remain available until expended.
(B) OFFSETTING FUTURE APPROPRIATIONS.—In each of
fiscal years 2017 and 2018, for any discretionary appropriation under the heading ‘‘Account For the State Response
to the Opioid Abuse Crisis’’ for the grant program described
in subsection (c), the total amount of such appropriations
in the applicable fiscal year (not to exceed the total amount
remaining in the Account) shall be subtracted from the
estimate of discretionary budget authority and the resulting
outlays for any estimate under the Congressional Budget
and Impoundment Control Act of 1974 or the Balanced
Budget and Emergency Deficit Control Act of 1985, and
the amount transferred to the Account shall be reduced
by the same amount.
(c) OPIOID GRANT PROGRAM.—
(1) STATE RESPONSE TO THE OPIOID ABUSE CRISIS.—Subject
to the availability of appropriations, the Secretary shall award
grants to States for the purpose of addressing the opioid abuse
crisis within such States, in accordance with subparagraph
(B). In awarding such grants, the Secretary shall give preference to States with an incidence or prevalence of opioid
use disorders that is substantially higher relative to other
States.
(2) OPIOID GRANTS.—Grants awarded to a State under this
subsection shall be used for carrying out activities that supplement activities pertaining to opioids undertaken by the State
agency responsible for administering the substance abuse
prevention and treatment block grant under subpart II of part
B of title XIX of the Public Health Service Act (42 U.S.C.
300x–21 et seq.), which may include public health-related activities such as the following:
(A) Improving State prescription drug monitoring programs.
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PUBLIC LAW 114–255—DEC. 13, 2016
(B) Implementing prevention activities, and evaluating
such activities to identify effective strategies to prevent
opioid abuse.
(C) Training for health care practitioners, such as best
practices for prescribing opioids, pain management, recognizing potential cases of substance abuse, referral of
patients to treatment programs, and overdose prevention.
(D) Supporting access to health care services, including
those services provided by Federally certified opioid treatment programs or other appropriate health care providers
to treat substance use disorders.
(E) Other public health-related activities, as the State
determines appropriate, related to addressing the opioid
abuse crisis within the State.
(d) ACCOUNTABILITY AND OVERSIGHT.—A State receiving a grant
under subsection (c) shall include in a report related to substance
abuse submitted to the Secretary pursuant to section 1942 of the
Public Health Service Act (42 U.S.C. 300x–52), a description of—
(1) the purposes for which the grant funds received by
the State under such subsection for the preceding fiscal year
were expended and a description of the activities of the State
under the program; and
(2) the ultimate recipients of amounts provided to the State
in the grant.
(e) LIMITATIONS.—Any funds made available pursuant to the
authorization of appropriations under subsection (b)—
(1) notwithstanding any transfer authority in any appropriations Act, shall not be used for any purpose other than
the grant program in subsection (c); and
(2) shall be subject to the same requirements as substance
abuse prevention and treatment programs under titles V and
XIX of the Public Health Service Act (42 U.S.C. 290aa et
seq., 300w et seq.).
(f) SUNSET.—This section shall expire on September 30, 2026.
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SEC. 1004. BUDGETARY TREATMENT.
(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects of
division A of this Act shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory PayAs-You-Go Act of 2010.
(b) SENATE PAYGO SCORECARDS.—The budgetary effects of division A of this Act shall not be entered on any PAYGO scorecard
maintained for purposes of section 201 of S. Con. Res. 21 (110th
Congress).
(c) RESERVATION OF SAVINGS.—None of the funds in the NIH
Innovation Account, the FDA Innovation Account, or the Account
For the State Response to the Opioid Abuse Crisis established
by this title shall be made available except to the extent provided
in advance in appropriations Acts, and legislation or an Act that
rescinds or reduces amounts in such accounts shall not be estimated
as a reduction in direct spending under the Congressional Budget
and Impoundment Control Act of 1974 or the Balanced Budget
and Emergency Deficit Control Act of 1985.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1047
TITLE II—DISCOVERY
Subtitle A—National Institutes of Health
Reauthorization
SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
Section 402A(a)(1) of the Public Health Service Act (42 U.S.C.
282a(a)(1)) is amended—
(1) in subparagraph (B), by striking ‘‘and’’ at the end;
(2) in subparagraph (C), by striking the period at the
end and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
‘‘(D) $34,851,000,000 for fiscal year 2018;
‘‘(E) $35,585,871,000 for fiscal year 2019; and
‘‘(F) $36,472,442,775 for fiscal year 2020.’’.
SEC. 2002. EUREKA PRIZE COMPETITIONS.
42 USC 283q.
(a) IN GENERAL.—Pursuant to the authorities and processes
established under section 24 of the Stevenson-Wydler Technology
Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National
Institutes of Health shall support prize competitions for one or
both of the following goals:
(1) Identifying and funding areas of biomedical science
that could realize significant advancements through a prize
competition.
(2) Improving health outcomes, particularly with respect
to human diseases and conditions—
(A) for which public and private investment in research
is disproportionately small relative to Federal Government
expenditures on prevention and treatment activities with
respect to such diseases and conditions, such that Federal
expenditures on health programs would be reduced;
(B) that are serious and represent a significant disease
burden in the United States; or
(C) for which there is potential for significant return
on investment to the United States.
(b) TRACKING; REPORTING.—The Director of the National
Institutes of Health shall—
(1) collect information on—
(A) the effect of innovations funded through the prize
competitions under this section in advancing biomedical
science or improving health outcomes pursuant to subsection (a); and
(B) the effect of the innovations on Federal expenditures; and
(2) include the information collected under paragraph (1)
in the triennial report under section 403 of the Public Health
Service Act (42 U.S.C. 283) (as amended by section 2032).
Subtitle B—Advancing Precision Medicine
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SEC. 2011. PRECISION MEDICINE INITIATIVE.
42 USC 289g–5.
Part H of title IV of the Public Health Service Act (42 U.S.C.
289 et seq.) is amended by adding at the end the following:
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‘‘SEC. 498E. PRECISION MEDICINE INITIATIVE.
‘‘(a) IN GENERAL.—The Secretary is encouraged to establish
and carry out an initiative, to be known as the ‘Precision Medicine
Initiative’ (in this section referred to as the ‘Initiative’), to augment
efforts to address disease prevention, diagnosis, and treatment.
‘‘(b) COMPONENTS.—The Initiative described under subsection
(a) may include—
‘‘(1) developing a network of scientists to assist in carrying
out the purposes of the Initiative;
‘‘(2) developing new approaches for addressing scientific,
medical, public health, and regulatory science issues;
‘‘(3) applying genomic technologies, such as whole genomic
sequencing, to provide data on the molecular basis of disease;
‘‘(4) collecting information voluntarily provided by a diverse
cohort of individuals that can be used to better understand
health and disease; and
‘‘(5) other activities to advance the goals of the Initiative,
as the Secretary determines appropriate.
‘‘(c) AUTHORITY OF THE SECRETARY.—In carrying out this section, the Secretary may—
‘‘(1) coordinate with the Secretary of Energy, private
industry, and others, as the Secretary determines appropriate,
to identify and address the advanced supercomputing and other
advanced technology needs for the Initiative;
‘‘(2) develop and utilize public-private partnerships; and
‘‘(3) leverage existing data sources.
‘‘(d) REQUIREMENTS.—In the implementation of the Initiative
under subsection (a), the Secretary shall—
‘‘(1) ensure the collaboration of the National Institutes
of Health, the Food and Drug Administration, the Office of
the National Coordinator for Health Information Technology,
and the Office for Civil Rights of the Department of Health
and Human Services;
‘‘(2) comply with existing laws and regulations for the
protection of human subjects involved in research, including
the protection of participant privacy;
‘‘(3) implement policies and mechanisms for appropriate
secure data sharing across systems that include protections
for privacy and security of data;
‘‘(4) consider the diversity of the cohort to ensure inclusion
of a broad range of participants, including consideration of
biological, social, and other determinants of health that contribute to health disparities;
‘‘(5) ensure that only authorized individuals may access
controlled or sensitive, identifiable biological material and associated information collected or stored in connection with the
Initiative; and
‘‘(6) on the appropriate Internet website of the Department
of Health and Human Services, identify any entities with access
to such information and provide information with respect to
the purpose of such access, a summary of the research project
for which such access is granted, as applicable, and a description of the biological material and associated information to
which the entity has access.
‘‘(e) REPORT.—Not later than 1 year after the date of enactment
of the 21st Century Cures Act, the Secretary shall submit a report
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130 STAT. 1049
on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives. Such report shall include steps the Secretary has
taken to consult with experts or other heads of departments or
agencies of the Federal Government in the development of such
policies.’’.
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SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.
(a) IN GENERAL.—Subsection (d) of section 301 of the Public
Health Service Act (42 U.S.C. 241) is amended to read as follows:
‘‘(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 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
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42 USC 241 note.
PUBLIC LAW 114–255—DEC. 13, 2016
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
‘‘(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.’’.
(b) APPLICABILITY.—Beginning 180 days after the date of enactment of this Act, all persons engaged in research and authorized
by the Secretary of Health and Human Services to protect information under section 301(d) of the Public Health Service Act (42
U.S.C. 241(d)) prior to the date of enactment of this Act shall
be subject to the requirements of such section (as amended by
this Act).
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SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.
Section 301 of the Public Health Service Act (42 U.S.C. 241)
is amended by adding at the end the following:
‘‘(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.
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130 STAT. 1051
‘‘(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.’’.
SEC. 2014. DATA SHARING.
(a) IN GENERAL.—Section 402(b) of the Public Health Service
Act (42 U.S.C. 282(b)) is amended—
(1) in paragraph (23), by striking ‘‘and’’ at the end;
(2) in paragraph (24), by striking the period and inserting
‘‘; and’’; and
(3) by inserting after paragraph (24) the following:
‘‘(25) may require recipients of National Institutes of Health
awards to share scientific data, to the extent feasible, generated
from such National Institutes of Health awards in a manner
that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection
of—
‘‘(A) human research participants, including with
respect to privacy, security, informed consent, and protected
health information; and
‘‘(B) proprietary interests, confidential commercial
information, and the intellectual property rights of the
funding recipient.’’.
(b) CONFIDENTIALITY.—Nothing in the amendments made by
subsection (a) authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other
privileged or confidential information, described in section 552(b)(4)
of title 5, United States Code, or section 1905 of title 18, United
States Code, or be construed to require recipients of grants or
cooperative agreements through the National Institutes of Health
to share such information.
42 USC 282 note.
Subtitle C—Supporting Young Emerging
Scientists
SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.
(a) IN GENERAL.—Part A of title IV of the Public Health Service
Act (42 U.S.C. 281 et seq.) is amended by adding at the end
the following:
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‘‘SEC. 404M. NEXT GENERATION OF RESEARCHERS.
42 USC 283o.
‘‘(a) NEXT GENERATION OF RESEARCHERS INITIATIVE.—There
shall be established within the Office of the Director of the National
Institutes of Health, the Next Generation of Researchers Initiative
(referred to in this section as the ‘Initiative’), through which the
Director shall coordinate all policies and programs within the
National Institutes of Health that are focused on promoting and
providing opportunities for new researchers and earlier research
independence.
‘‘(b) ACTIVITIES.—The Director of the National Institutes of
Health, through the Initiative shall—
‘‘(1) promote policies and programs within the National
Institutes of Health that are focused on improving opportunities
for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;
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‘‘(2) develop, modify, or prioritize policies, as needed, within
the National Institutes of Health to promote opportunities for
new researchers and earlier research independence, such as
policies to increase opportunities for new researchers to receive
funding, enhance training and mentorship programs for
researchers, and enhance workforce diversity;
‘‘(3) coordinate, as appropriate, with relevant agencies,
professional and academic associations, academic institutions,
and others, to improve and update existing information on
the biomedical research workforce in order to inform programs
related to the training, recruitment, and retention of biomedical
researchers; and
‘‘(4) carry out other activities, including evaluation and
oversight of existing programs, as appropriate, to promote the
development of the next generation of researchers and earlier
research independence.’’.
(b) CONSIDERATION OF RECOMMENDATIONS.—In carrying out
activities under section 404M(b) of the Public Health Service Act,
the Director of the National Institutes of Health shall take into
consideration the recommendations made by the National Academies of Sciences, Engineering, and Medicine as part of the comprehensive study on policies affecting the next generation of
researchers under the Department of Health and Human Services
Appropriations Act, 2016 (Public Law 114–113), and 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, with respect to any actions taken
by the National Institutes of Health based on the recommendations
not later than 2 years after the completion of the study required
pursuant to the Department of Health and Human Services Appropriations Act, 2016.
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SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.
(a) INTRAMURAL LOAN REPAYMENT PROGRAM.—Section 487A
of the Public Health Service Act (42 U.S.C. 288–1) is amended—
(1) by amending the section heading to read as follows:
‘‘INTRAMURAL LOAN REPAYMENT PROGRAM’’;
(2) in subsection (a)—
(A) by striking ‘‘The Secretary shall carry out a program’’ and inserting ‘‘The Director of the National
Institutes of Health shall, as appropriate and based on
workforce and scientific priorities, carry out a program
through the subcategories listed in subsection (b)(1) (or
modified subcategories as provided for in subsection (b)(2))’’;
(B) by striking ‘‘conduct’’ and inserting ‘‘conduct
research’’;
(C) by striking ‘‘research with respect to acquired
immune deficiency syndrome’’; and
(D) by striking ‘‘$35,000’’ and inserting ‘‘$50,000’’;
(3) by redesignating subsection (b) as subsection (d);
(4) by inserting after subsection (a), the following:
‘‘(b) SUBCATEGORIES OF RESEARCH.—
‘‘(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health—
‘‘(A) shall continue to focus on—
‘‘(i) general research;
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130 STAT. 1053
‘‘(ii) research on acquired immune deficiency syndrome; and
‘‘(iii) clinical research conducted by appropriately
qualified health professional who are from disadvantaged backgrounds; and
‘‘(B) may focus on an area of emerging scientific or
workforce need.
‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.—
The Director of the National Institutes of Health may eliminate
one or more subcategories provided for in paragraph (1) due
to changes in workforce or scientific needs related to biomedical
research. The Director may establish other subcategory areas
based on workforce and scientific priorities if the total number
of subcategories does not exceed the number of subcategories
listed in paragraph (1).
‘‘(c) LIMITATION.—The Director of the National Institutes of
Health may not enter into a contract with a health professional
pursuant to subsection (a) unless such professional has a substantial
amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).’’; and
(5) by adding at the end the following:
‘‘(e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for
carrying out this section shall remain available until the expiration
of the second fiscal year beginning after the fiscal year for which
such amounts are made available.’’.
(b) EXTRAMURAL LOAN REPAYMENT PROGRAM.—Section 487B
of the Public Health Service Act (42 U.S.C. 288–2) is amended—
(1) by amending the section heading to read as follows:
‘‘EXTRAMURAL LOAN REPAYMENT PROGRAM’’;
(2) in subsection (a)—
(A) by striking ‘‘The Secretary, in consultation with
the Director of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, shall
establish a program’’ and inserting ‘‘IN GENERAL.—The
Director of the National Institutes of Health shall, as appropriate and based on workforce and scientific priorities,
carry out a program through the subcategories listed in
subsection (b)(1) (or modified subcategories as provided
for in subsection (b)(2)),’’;
(B) by striking ‘‘(including graduate students)’’;
(C) by striking ‘‘with respect to contraception, or with
respect to infertility,’’; and
(D) by striking ‘‘service, not more than $35,000’’ and
inserting ‘‘research, not more than $50,000’’;
(3) by redesignating subsections (b) and (c) as subsections
(d) and (e), respectively;
(4) by inserting after subsection (a), the following:
‘‘(b) SUBCATEGORIES OF RESEARCH.—
‘‘(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health—
‘‘(A) shall continue to focus on—
‘‘(i) contraception or infertility research;
‘‘(ii) pediatric research, including pediatric
pharmacological research;
‘‘(iii) minority health disparities research;
‘‘(iv) clinical research; and
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‘‘(v) clinical research conducted by appropriately
qualified health professional who are from disadvantaged backgrounds; and
‘‘(B) may focus on an area of emerging scientific or
workforce need.
‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.—
The Director of the National Institutes of Health may eliminate
one or more subcategories provided for in paragraph (1) due
to changes in workforce or scientific needs related to biomedical
research. The Director may establish other subcategory areas
based on workforce and scientific priorities if the total number
of subcategories does not exceed the number of subcategories
listed in paragraph (1).
‘‘(c) LIMITATION.—The Director of the National Institutes of
Health may not enter into a contract with a health professional
pursuant to subsection (a) unless such professional has a substantial
amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).’’;
(5) in subsection (d) (as so redesignated), by striking ‘‘The
provisions’’ and inserting ‘‘APPLICABILITY OF CERTAIN PROVISIONS REGARDING OBLIGATED SERVICE.—The provisions’’; and
(6) in subsection (e) (as so redesignated), by striking
‘‘Amounts’’ and inserting ‘‘AVAILABILITY OF APPROPRIATIONS.—
Amounts’’.
(c) TECHNICAL AND CONFORMING AMENDMENTS.—Title IV of
the Public Health Service Act is amended—
(1) by striking section 464z–5 (42 U.S.C. 285t–2);
(2) by striking section 487C (42 U.S.C. 288–3);
(3) by striking section 487E (42 U.S.C. 288–5);
(4) by striking section 487F (42 U.S.C. 288–5a), as added
by section 205 of Public Law 106–505, relating to loan repayment for clinical researchers; and
(5) by striking section 487F (42 U.S.C. 288–6), as added
by section 1002(b) of Public Law 106–310 relating to pediatric
research loan repayment.
(d) GAO REPORT.—Not later than 18 months after the date
of enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report on the efforts of the
National Institutes of Health to attract, retain, and develop
emerging scientists, including underrepresented individuals in the
sciences, such as women, racial and ethnic minorities, and other
groups. Such report shall include an analysis of the impact of
the additional authority provided to the Secretary of Health and
Human Services under this Act to address workforce shortages
and gaps in priority research areas, including which centers and
research areas offered loan repayment program participants the
increased award amount.
Subtitle D—National Institutes of Health
Planning and Administration
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SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.
(a) STRATEGIC PLAN.—Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended—
(1) in subsection (b)(5), by inserting before the semicolon
the following: ‘‘, and through the development, implementation,
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130 STAT. 1055
and updating of the strategic plan developed under subsection
(m)’’; and
(2) by adding at the end the following:
‘‘(m) NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date
of enactment of the 21st Century Cures Act, and at least
every 6 years thereafter, the Director of the National Institutes
of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the
National Institutes of Health, a coordinated strategy (to be
known as the ‘National Institutes of Health Strategic Plan’)
to provide direction to the biomedical research investments
made by the National Institutes of Health, to facilitate
collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.
‘‘(2) REQUIREMENTS.—The strategy under paragraph (1)
shall—
‘‘(A) identify strategic research priorities and objectives
across biomedical research, including—
‘‘(i) an assessment of the state of biomedical and
behavioral research, including areas of opportunity
with respect to basic, clinical, and translational
research;
‘‘(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions;
‘‘(iii) emerging scientific opportunities, rising
public health challenges, and scientific knowledge gaps;
and
‘‘(iv) the identification of near-, mid-, and longterm scientific needs;
‘‘(B) consider, in carrying out subparagraph (A)—
‘‘(i) disease burden in the United States and the
potential for return on investment to the United States;
‘‘(ii) rare diseases and conditions;
‘‘(iii) biological, social, and other determinants of
health that contribute to health disparities; and
‘‘(iv) other factors the Director of National
Institutes of Health determines appropriate;
‘‘(C) include multi-institute priorities, including
coordination of research among institutes and centers;
‘‘(D) include strategic priorities for funding research
through the Common Fund, in accordance with section
402A(c)(1)(C);
‘‘(E) address the National Institutes of Health’s proposed and ongoing activities related to training and the
biomedical workforce; and
‘‘(F) describe opportunities for collaboration with other
agencies and departments, as appropriate.
‘‘(3) USE OF PLANS.—Strategic plans developed and updated
by the national research institutes and national centers of
the National Institutes of Health shall be prepared regularly
and in such a manner that such plans will be informed by
the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national
research institutes and national centers shall have a common
template.
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‘‘(4) CONSULTATION.—The Director of National Institutes
of Health shall develop the strategic plan under paragraph
(1) in consultation with the directors of the national research
institutes and national centers, researchers, patient advocacy
groups, and industry leaders.’’.
(b) CONFORMING AMENDMENT.—Section 402A(c)(1)(C) of the
Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended
by striking ‘‘Not later than June 1, 2007, and every 2 years thereafter,’’ and inserting ‘‘As part of the National Institutes of Health
Strategic Plan required under section 402(m),’’.
(c) STRATEGIC PLAN.—Section 492B(a) of the Public Health
Service Act (42 U.S.C. 289a–2(a)) is amended by adding at the
end the following:
‘‘(3) STRATEGIC PLANNING.—
‘‘(A) IN GENERAL.—The directors of the national
institutes and national centers shall consult at least once
annually with the Director of the National Institute on
Minority Health and Health Disparities and the Director
of the Office of Research on Women’s Health regarding
objectives of the national institutes and national centers
to ensure that future activities by such institutes and centers take into account women and minorities and are
focused on reducing health disparities.
‘‘(B) STRATEGIC PLANS.—Any strategic plan issued by
a national institute or national center shall include details
on the objectives described in subparagraph (A).’’.
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SEC. 2032. TRIENNIAL REPORTS.
Section 403 of the Public Health Service Act (42 U.S.C. 283)
is amended—
(1) in the section heading, by striking ‘‘BIENNIAL’’ and
inserting ‘‘TRIENNIAL’’ ; and
(2) in subsection (a)—
(A) in the matter preceding paragraph (1), by striking
‘‘biennial’’ and inserting ‘‘triennial’’;
(B) by amending paragraph (3) to read as follows:
‘‘(3) A description of intra-National Institutes of Health
activities, including—
‘‘(A) identification of the percentage of funds made
available by each national research institute and national
center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration
between the institute or center and 1 or more other national
research institutes or national centers; and
‘‘(B) recommendations for promoting coordination of
information among the centers of excellence.’’;
(C) in paragraph (4)—
(i) in subparagraph (B), by striking ‘‘demographic
variables and other variables’’ and inserting ‘‘demographic variables, including biological and social variables and relevant age categories (such as pediatric
subgroups), and determinants of health,’’; and
(ii) in subparagraph (C)(v)—
(I) by striking ‘‘demographic variables and
such’’ and inserting ‘‘demographic variables,
including relevant age categories (such as pediatric
subgroups), information submitted by each
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130 STAT. 1057
national research institute and national center to
the Director of National Institutes of Health under
section 492B(f), and such’’; and
(II) by striking ‘‘(regarding inclusion of women
and minorities in clinical research)’’ and inserting
‘‘and other applicable requirements regarding
inclusion of demographic groups’’; and
(D) in paragraph (6)—
(i) in the matter preceding subparagraph (A), by
striking ‘‘the following:’’ and inserting ‘‘the following—
’’;
(ii) in subparagraph (A)—
(I) by striking ‘‘An evaluation’’ and inserting
‘‘an evaluation’’; and
(II) by striking the period and inserting ‘‘;
and’’;
(iii) by striking subparagraphs (B) and (D);
(iv) by redesignating subparagraph (C) as subparagraph (B); and
(v) in subparagraph (B), as redesignated by clause
(iv), by striking ‘‘Recommendations’’ and inserting ‘‘recommendations’’.
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SEC.
2033.
INCREASING ACCOUNTABILITY
INSTITUTES OF HEALTH.
AT
THE
NATIONAL
(a) APPOINTMENT AND TERMS OF DIRECTORS OF NATIONAL
RESEARCH INSTITUTES AND NATIONAL CENTERS.—Subsection (a) of
section 405 of the Public Health Service Act (42 U.S.C. 284) is
amended to read as follows:
‘‘(a) APPOINTMENT.—
‘‘(1) IN GENERAL.—The Director of the National Cancer
Institute shall be appointed by the President, and the Directors
of the other national research institutes and national centers
shall be appointed by the Secretary, acting through the Director
of National Institutes of Health. Each Director of a national
research institute or national center shall report directly to
the Director of National Institutes of Health.
‘‘(2) APPOINTMENT.—
‘‘(A) TERM.—A Director of a national research institute
or national center who is appointed by the Secretary, acting
through the Director of National Institutes of Health, shall
be appointed for 5 years.
‘‘(B) REAPPOINTMENT.—At the end of the term of a
Director of a national research institute or national center,
the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism.
There shall be no limit on the number of terms that a
Director may serve.
‘‘(C) VACANCIES.—If the office of a Director of a national
research institute or national center becomes vacant before
the end of such Director’s term, the Director appointed
to fill the vacancy shall be appointed for a 5-year term
starting on the date of such appointment.
‘‘(D) CURRENT DIRECTORS.—Each Director of a national
research institute or national center who is serving on
the date of enactment of the 21st Century Cures Act shall
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PUBLIC LAW 114–255—DEC. 13, 2016
be deemed to be appointed for a 5-year term under this
subsection beginning on such date of enactment.
‘‘(E) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to limit the authority of the
Secretary or the Director of National Institutes of Health
to terminate the appointment of a director referred to in
subparagraph (A) before the expiration of such director’s
5-year term.
‘‘(F) NATURE OF APPOINTMENT.—Appointments and reappointments under this subsection shall be made on the
basis of ability and experience as it relates to the mission
of the National Institutes of Health and its components,
including compliance with any legal requirement that the
Secretary or Director of National Institutes of Health determines relevant.
‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.—The restrictions contained in section 202 of the Departments of Labor,
Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C.
238f note) related to consultants and individual scientists
appointed for limited periods of time shall not apply to Directors
appointed under this subsection.’’.
(b) REVIEW OF CERTAIN AWARDS BY DIRECTORS.—Section 405(b)
of the Public Health Service Act (42 U.S.C. 284(b)) is amended
by adding at the end the following:
‘‘(3) Before an award is made by a national research institute
or by a national center for a grant for a research program or
project (commonly referred to as an ‘R-series grant’), other than
an award constituting a noncompetitive renewal of such a grant,
or a noncompetitive administrative supplement to such a grant,
the Director of such national research institute or national center
shall, consistent with the peer review process—
‘‘(A) review and make the final decision with respect to
making the award; and
‘‘(B) take into consideration, as appropriate—
‘‘(i) the mission of the national research institute or
national center and the scientific priorities identified in
the strategic plan under section 402(m);
‘‘(ii) programs or projects funded by other agencies
on similar research topics; and
‘‘(iii) advice by staff and the advisory council or board
of such national research institute or national center.’’.
(c) REPORT ON DUPLICATION IN FEDERAL BIOMEDICAL
RESEARCH.—The Secretary of Health and Human Services (referred
to in this subsection as the ‘‘Secretary’’), shall, not later than
2 years after the date of enactment of this Act, submit a report
to Congress on efforts to prevent and eliminate duplicative biomedical research that is not necessary for scientific purposes. Such
report shall—
(1) describe the procedures in place to identify such duplicative research, including procedures for monitoring research
applications and funded research awards to prevent unnecessary duplication;
(2) describe the steps taken to improve the procedures
described in paragraph (1), in response to relevant recommendations made by the Comptroller General of the United States;
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(3) describe how the Secretary operationally distinguishes
necessary and appropriate scientific replication from unnecessary duplication; and
(4) provide examples of instances where the Secretary has
identified unnecessarily duplicative research and the steps
taken to eliminate the unnecessary duplication.
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SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS.
(a) PLAN PREPARATION AND IMPLEMENTATION OF MEASURES TO
REDUCE ADMINISTRATIVE BURDENS.—
(1) IN GENERAL.—Not later than 2 years after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’) shall—
(A) lead a review by research funding agencies of all
regulations and policies related to the disclosure of financial
conflicts of interest, including the minimum threshold for
reporting financial conflicts of interest;
(B) make revisions, as appropriate, to harmonize
existing policies and reduce administrative burden on
researchers while maintaining the integrity and credibility
of research findings and protections of human participants;
and
(C) confer with the Office of the Inspector General
about the activities of such office related to financial conflicts of interest involving research funding agencies.
(2) CONSIDERATIONS.—In updating policies under paragraph (1)(B), the Secretary shall consider—
(A) modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by
institutions receiving grant or cooperative agreement
funding from the National Institutes of Health;
(B) ensuring that financial interest disclosure reporting
requirements are appropriate for, and relevant to, awards
that will directly fund research, which may include modification of the definition of the term ‘‘investigator’’ for purposes of the regulations and policies described in subparagraphs (A) and (B) of paragraph (1); and
(C) updating any applicable training modules of the
National Institutes of Health related to Federal financial
interest disclosure.
(b) MONITORING OF SUBRECIPIENTS OF FUNDING FROM THE
NATIONAL INSTITUTES OF HEALTH.—The Director of the National
Institutes of Health (referred to in this section as the ‘‘Director
of National Institutes of Health’’) shall implement measures to
reduce the administrative burdens related to monitoring of subrecipients of grants by primary awardees of funding from the
National Institutes of Health, which may incorporate findings and
recommendations from existing and ongoing activities. Such measures may include, as appropriate—
(1) an exemption from subrecipient monitoring requirements, upon request from the primary awardees, provided
that—
(A) the subrecipient is subject to Federal audit requirements pursuant to the Uniform Guidance of the Office
of Management and Budget;
(B) the primary awardee conducts, pursuant to guidance of the National Institutes of Health, a pre-award
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PUBLIC LAW 114–255—DEC. 13, 2016
evaluation of each subrecipient’s risk of noncompliance with
Federal statutes and regulations, the conditions of the
subaward, and any recurring audit findings; and
(C) such exemption does not absolve the primary
awardee of liability for misconduct by subrecipients; and
(2) the implementation of alternative grant structures that
obviate the need for subrecipient monitoring, which may include
collaborative grant models allowing for multiple primary
awardees.
(c) REPORTING OF FINANCIAL EXPENDITURES.—The Secretary,
in consultation with the Director of National Institutes of Health,
shall evaluate financial expenditure reporting procedures and
requirements for recipients of funding from the National Institutes
of Health and take action, as appropriate, to avoid duplication
between department and agency procedures and requirements and
minimize burden to funding recipients.
(d) ANIMAL CARE AND USE IN RESEARCH.—Not later than 2
years after the date of enactment of this Act, the Director of
National Institutes of Health, in collaboration with the Secretary
of Agriculture and the Commissioner of Food and Drugs, shall
complete a review of applicable regulations and policies for the
care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while
maintaining the integrity and credibility of research findings and
protection of research animals. In carrying out this effort, the
Director of the National Institutes of Health shall seek the input
of experts, as appropriate. The Director of the National Institutes
of Health shall—
(1) identify ways to ensure such regulations and policies
are not inconsistent, overlapping, or unnecessarily duplicative,
including with respect to inspection and review requirements
by Federal agencies and accrediting associations;
(2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
(3) take other actions, as appropriate, to improve the
coordination of regulations and policies with respect to research
with laboratory animals.
(e) DOCUMENTATION OF PERSONNEL EXPENSES.—The Secretary
shall clarify the applicability of the requirements under the Office
of Management and Budget Uniform Guidance for management
and certification systems adopted by entities receiving Federal
research grants through the Department of Health and Human
Services regarding documentation of personnel expenses, including
clarification of the extent to which any flexibility to such requirements specified in such Uniform Guidance applies to entities
receiving grants through the Department of Health and Human
Services.
(f) RESEARCH POLICY BOARD.—
(1) ESTABLISHMENT.—Not later than 1 year after the date
of enactment of this Act, the Director of the Office of Management and Budget shall establish an advisory committee, to
be known as the ‘‘Research Policy Board’’ (referred to in this
subsection as the ‘‘Board’’), to provide Federal Government
officials with information on the effects of regulations related
to Federal research requirements.
(2) MEMBERSHIP.—
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130 STAT. 1061
(A) IN GENERAL.—The Board shall include not more
than 10 Federal members, including each of the following
Federal members or their designees:
(i) The Administrator of the Office of Information
and Regulatory Affairs of the Office of Management
and Budget.
(ii) The Director of the Office of Science and Technology Policy.
(iii) The Secretary of Health and Human Services.
(iv) The Director of the National Science Foundation.
(v) The secretaries and directors of other departments and agencies that support or regulate scientific
research, as determined by the Director of the Office
of Management and Budget.
(B) NON-FEDERAL MEMBERS.—The Board shall be comprised of not less than 9 and not more than 12 representatives of academic research institutions, other private, nonprofit research institutions, or other nonprofit organizations
with relevant expertise. Such members shall be appointed
by a formal process, to be established by the Director
of the Office of Management and Budget, in consultation
with the Federal membership, and that incorporates—
(i) nomination by members of the nonprofit scientific research community, including academic
research institutions; and
(ii) procedures to fill membership positions vacated
before the end of a member’s term.
(3) PURPOSE AND RESPONSIBILITIES.—The Board shall make
recommendations regarding the modification and harmonization of regulations and policies having similar purposes across
research funding agencies to ensure that the administrative
burden of such research policy and regulation is minimized
to the greatest extent possible and consistent with maintaining
responsible oversight of federally funded research. Activities
of the Board may include—
(A) providing thorough and informed analysis of regulations and policies;
(B) identifying negative or adverse consequences of
existing policies and making actionable recommendations
regarding possible improvement of such policies;
(C) making recommendations with respect to efforts
within the Federal Government to improve coordination
of regulation and policy related to research;
(D) creating a forum for the discussion of research
policy or regulatory gaps, challenges, clarification, or
harmonization of such policies or regulation, and best practices; and
(E) conducting ongoing assessment and evaluation of
regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes.
(4) EXPERT SUBCOMMITTEES.—The Board may form temporary expert subcommittees, as appropriate, to develop timely
analysis on pressing issues and assist the Board in anticipating
future regulatory challenges, including challenges emerging
from new scientific advances.
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(5) REPORTING REQUIREMENTS.—Not later than 2 years
after the date of enactment of this Act, and once thereafter,
the Board shall submit a report to the Director of the Office
of Management and Budget, the Administrator of the Office
of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and
Technology Policy, the heads of relevant Federal departments
and agencies, the Committee on Health, Education, Labor, and
Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives containing formal
recommendations on the conceptualization, development,
harmonization, and reconsideration of scientific research policy,
including the regulatory benefits and burdens.
(6) SUNSET.—The Board shall terminate on September 30,
2021.
(7) GAO REPORT.—Not later than 4 years after the date
of enactment of this Act, the Comptroller General of the United
States shall conduct an independent evaluation of the activities
carried out by the Board pursuant to this subsection and submit
to the appropriate committees of Congress a report regarding
the results of the independent evaluation. Such report shall
review and assess the Board’s activities with respect to the
responsibilities described in paragraph (3).
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH
FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS.
Section 301 of the Public Health Service Act (42 U.S.C. 241),
as amended by section 2013, is further amended by adding at
the end the following:
‘‘(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.’’.
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SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.
(a) IN GENERAL.—Section 402 of the Public Health Service
Act (42 U.S.C. 282), as amended by section 2031, is further amended
by adding at the end the following:
‘‘(n) UNIQUE RESEARCH INITIATIVES.—
‘‘(1) IN GENERAL.—The Director of NIH may approve, after
consideration of a proposal under paragraph (2)(A), requests
by the national research institutes and centers, or program
officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement
with respect to projects that carry out—
‘‘(A) the Precision Medicine Initiative under section
498E; or
‘‘(B) section 402(b)(7), except that not more than 50
percent of the funds available for a fiscal year through
the Common Fund under section 402A(c)(1) for purposes
of carrying out such section 402(b)(7) may be used to engage
in such other transactions.
‘‘(2) REQUIREMENTS.—The authority provided under this
subsection may be used to conduct or support high impact
cutting-edge research described in paragraph (1) using the other
transactions authority described in such paragraph if the
institute, center, or office—
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‘‘(A) submits a proposal to the Director of NIH for
the use of such authority before conducting or supporting
the research, including why the use of such authority is
essential to promoting the success of the project;
‘‘(B) receives approval for the use of such authority
from the Director of NIH; and
‘‘(C) for each year in which the institute, center, or
office has used such authority in accordance with this
subsection, submits a report to the Director of NIH on
the activities of the institute, center, or office relating to
such research.’’.
(b) REPORT TO CONGRESS.—Not later than September 30, 2020,
the Secretary of Health and Human Services, acting through the
Director of the National Institutes of Health, shall conduct an
evaluation of the activities under subsection (n) of section 402
of the Public Health Service Act (42 U.S.C. 282), as added by
subsection (a), and submit 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 on the
results of such evaluation.
(c) DUTIES OF DIRECTORS OF INSTITUTES.—Section 405(b)(1)
of the Public Health Service Act (42 U.S.C. 284(b)(1)) is amended—
(1) by redesignating subparagraphs (C) through (L) as subparagraphs (D) through (M), respectively; and
(2) by inserting after subparagraph (B), the following:
‘‘(C) shall, as appropriate, conduct and support research
that has the potential to transform the scientific field, has
inherently higher risk, and that seeks to address major current
challenges;’’.
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SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL
SCIENCES.
(a) IN GENERAL.—Section 479(b) of the Public Health Service
Act (42 U.S.C. 287(b)) is amended—
(1) in paragraph (1), by striking ‘‘phase IIA’’ and inserting
‘‘phase IIB’’; and
(2) in paragraph (2)—
(A) in the matter preceding subparagraph (A), by
striking ‘‘phase IIB’’ and inserting ‘‘phase III’’;
(B) in subparagraph (A), by striking ‘‘phase IIB’’ and
inserting ‘‘phase III’’;
(C) in subparagraph (B), by striking ‘‘phase IIA’’ and
inserting ‘‘phase IIB’’; and
(D) in subparagraph (C), by striking ‘‘phase IIB’’ and
inserting ‘‘phase III’’.
(b) INCREASED TRANSPARENCY.—Section 479 of the Public
Health Service Act (42 U.S.C. 287) is amended—
(1) in subsection (c)—
(A) in paragraph (4)(D), by striking ‘‘and’’ at the end;
(B) in paragraph (5), by striking the period and
inserting a semicolon; and
(C) by adding at the end the following:
‘‘(6) the methods and tools, if any, that have been developed
since the last biennial report was prepared; and
‘‘(7) the methods and tools, if any, that have been developed
and are being utilized by the Food and Drug Administration
to support medical product reviews.’’; and
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(2) by adding at the end the following:
‘‘(d) INCLUSION OF LIST.—The first biennial report submitted
under this section after the date of enactment of the 21st Century
Cures Act shall include a complete list of all of the methods and
tools, if any, which have been developed by research supported
by the Center.
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed as authorizing the Secretary to disclose any information that is a trade secret, or other privileged or confidential
information subject to section 552(b)(4) of title 5, United States
Code, or section 1905 of title 18, United States Code.’’.
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SEC.
2038.
COLLABORATION
RESEARCH.
AND
COORDINATION
TO
ENHANCE
(a)
RESEARCH
PRIORITIES;
COLLABORATIVE
RESEARCH
PROJECTS.—Section 402(b) of the Public Health Service Act (42
U.S.C. 282(b)) is amended—
(1) by amending paragraph (4) to read as follows:
‘‘(4) shall assemble accurate data to be used to assess
research priorities, including—
‘‘(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing
health disparities; and
‘‘(B) data on study populations of clinical research,
funded by or conducted at each national research institute
and national center, which—
‘‘(i) specifies the inclusion of—
‘‘(I) women;
‘‘(II) members of minority groups;
‘‘(III) relevant age categories, including pediatric subgroups; and
‘‘(IV) other demographic variables as the
Director of the National Institutes of Health determines appropriate;
‘‘(ii) is disaggregated by research area, condition,
and disease categories; and
‘‘(iii) is to be made publicly available on the Internet website of the National Institutes of Health;’’; and
(2) in paragraph (8)—
(A) in subparagraph (A), by striking ‘‘and’’ at the end;
and
(B) by adding at the end the following:
‘‘(C) foster collaboration between clinical research
projects funded by the respective national research
institutes and national centers that—
‘‘(i) conduct research involving human subjects;
and
‘‘(ii) collect similar data; and
‘‘(D) encourage the collaboration described in subparagraph (C) to—
‘‘(i) allow for an increase in the number of subjects
studied; and
‘‘(ii) utilize diverse study populations, with special
consideration to biological, social, and other determinants of health that contribute to health disparities;’’.
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(b) REPORTING.—Section 492B(f) of the Public Health Service
Act (42 U.S.C. 289a–2(f)) is amended—
(1) by striking ‘‘biennial’’ each place such term appears
and inserting ‘‘triennial’’;
(2) by striking ‘‘The advisory council’’ and inserting the
following:
‘‘(1) IN GENERAL.—The advisory council’’; and
(3) by adding at the end the following:
‘‘(2) CONTENTS.—Each triennial report prepared by an
advisory council of each national research institute as described
in paragraph (1) shall include each of the following:
‘‘(A) The number of women included as subjects, and
the proportion of subjects that are women, in any project
of clinical research conducted during the applicable
reporting period, disaggregated by categories of research
area, condition, or disease, and accounting for single-sex
studies.
‘‘(B) The number of members of minority groups
included as subjects, and the proportion of subjects that
are members of minority groups, in any project of clinical
research conducted during the applicable reporting period,
disaggregated by categories of research area, condition,
or disease and accounting for single-race and single-ethnicity studies.
‘‘(C) For the applicable reporting period, the number
of projects of clinical research that include women and
members of minority groups and that—
‘‘(i) have been completed during such reporting
period; and
‘‘(ii) are being carried out during such reporting
period and have not been completed.
‘‘(D) The number of studies completed during the
applicable reporting period for which reporting has been
submitted in accordance with subsection (c)(2)(A).’’.
(c) COORDINATION.—Section 486(c)(2) of the Public Health
Service Act (42 U.S.C. 287d(c)(2)) is amended by striking ‘‘designees’’
and inserting ‘‘senior-level staff designees’’.
(d) IN GENERAL.—Part A of title IV of the Public Health Service
Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further
amended by adding at the end the following:
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‘‘SEC. 404N. POPULATION FOCUSED RESEARCH.
42 USC 283p.
‘‘The Director of the National Institutes of Health shall, as
appropriate, encourage efforts to improve research related to the
health of sexual and gender minority populations, including by—
‘‘(1) facilitating increased participation of sexual and gender
minority populations in clinical research supported by the
National Institutes of Health, and reporting on such participation, as applicable;
‘‘(2) facilitating the development of valid and reliable
methods for research relevant to sexual and gender minority
populations; and
‘‘(3) addressing methodological challenges.’’.
(e) REPORTING.—
(1) IN GENERAL.—The Secretary, in collaboration with the
Director of the National Institutes of Health, shall as appropriate—
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42 USC 284r.
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(A) continue to support research for the development
of appropriate measures related to reporting health
information about sexual and gender minority populations;
and
(B) not later than 2 years after the date of enactment
of this Act, disseminate and make public such measures.
(2) NATIONAL ACADEMY OF MEDICINE RECOMMENDATIONS.—
In developing the measures described in paragraph (1)(A), the
Secretary shall take into account recommendations made by
the National Academy of Medicine.
(f) IMPROVING COORDINATION RELATED TO MINORITY HEALTH
AND HEALTH DISPARITIES.—Section 464z–3 of the Public Health
Service Act (42 U.S.C. 285t) is amended—
(1) by redesignating subsection (h), relating to interagency
coordination, that follows subsection (j) as subsection (k); and
(2) in subsection (k) (as so redesignated)—
(A) in the subsection heading, by striking ‘‘INTERAGENCY’’ and inserting ‘‘INTRA-NATIONAL INSTITUTES OF
HEALTH’’;
(B) by striking ‘‘as the primary Federal officials’’ and
inserting ‘‘as the primary Federal official’’;
(C) by inserting a comma after ‘‘review’’;
(D) by striking ‘‘Institutes and Centers of the National
Institutes of Health’’ and inserting ‘‘national research
institutes and national centers’’; and
(E) by adding at the end the following: ‘‘The Director
of the Institute may foster partnerships between the
national research institutes and national centers and may
encourage the funding of collaborative research projects
to achieve the goals of the National Institutes of Health
that are related to minority health and health disparities.’’.
(g) BASIC RESEARCH.—
(1) DEVELOPING POLICIES.—Not later than 2 years after
the date of enactment of this Act, the Director of the National
Institutes of Health (referred to in this section as the ‘‘Director
of the National Institutes of Health’’), taking into consideration
the recommendations developed under section 2039, shall
develop policies for projects of basic research funded by National
Institutes of Health to assess—
(A) relevant biological variables including sex, as
appropriate; and
(B) how differences between male and female cells,
tissues, or animals may be examined and analyzed.
(2) REVISING POLICIES.—The Director of the National
Institutes of Health may update or revise the policies developed
under paragraph (1) as appropriate.
(3) CONSULTATION AND OUTREACH.—In developing,
updating, or revising the policies under this section, the
Director of the National Institutes of Health shall—
(A) consult with—
(i) the Office of Research on Women’s Health;
(ii) the Office of Laboratory Animal Welfare; and
(iii) appropriate members of the scientific and academic communities; and
(B) conduct outreach to solicit feedback from members
of the scientific and academic communities on the influence
of sex as a variable in basic research, including feedback
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130 STAT. 1067
on when it is appropriate for projects of basic research
involving cells, tissues, or animals to include both male
and female cells, tissues, or animals.
(4) ADDITIONAL REQUIREMENTS.—The Director of the
National Institutes of Health shall—
(A) ensure that projects of basic research funded by
the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under
this section, as applicable; and
(B) encourage that the results of such research, when
published or reported, be disaggregated as appropriate with
respect to the analysis of any sex differences.
(h) CLINICAL RESEARCH.—
(1) IN GENERAL.—Not later than 1 year after the date
of enactment of this Act, the Director of the National Institutes
of Health, in consultation with the Director of the Office of
Research on Women’s Health and the Director of the National
Institute on Minority Health and Health Disparities, shall
update the guidelines established under section 492B(d) of
Public Health Service Act (42 U.S.C. 289a–2(d)) in accordance
with paragraph (2).
(2) REQUIREMENTS.—The updated guidelines described in
paragraph (1) shall—
(A) reflect the science regarding sex differences;
(B) improve adherence to the requirements under section 492B of the Public Health Service Act (42 U.S.C.
289a–2), including the reporting requirements under subsection (f) of such section; and
(C) clarify the circumstances under which studies
should be designed to support the conduct of analyses
to detect significant differences in the intervention effect
due to demographic factors related to section 492B of the
Public Health Service Act, including in the absence of
prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the
effects of the absence of such analyses on the availability
of data related to demographic differences.
(i) APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.—
(1) INPUT FROM EXPERTS.—Not later than 180 days after
the date of enactment of this Act, the Director of the National
Institutes of Health shall convene a workshop of experts on
pediatric and older populations to provide input on—
(A) appropriate age groups to be included in research
studies involving human subjects; and
(B) acceptable justifications for excluding participants
from a range of age groups from human subjects research
studies.
(2) POLICY UPDATES.—Not later than 180 days after the
conclusion of the workshop under paragraph (1), the Director
of the National Institutes of Health shall make a determination
with respect to whether the policies of the National Institutes
of Health on the inclusion of relevant age groups in clinical
studies need to be updated, and shall update such policies
as appropriate. In making the determination, the Director of
the National Institutes of Health shall take into consideration
whether such policies—
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note.
42 USC 282 note.
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(A) address the consideration of age as an inclusion
variable in research involving human subjects; and
(B) identify the criteria for justification for any agerelated exclusions in such research.
(3) PUBLIC AVAILABILITY OF FINDINGS AND CONCLUSIONS.—
The Director of the National Institutes of Health shall—
(A) make the findings and conclusions resulting from
the workshop under paragraph (1) and updates to policies
in accordance with paragraph (2), as applicable, available
to the public on the Internet website of the National
Institutes of Health; and
(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service
Act (42 U.S.C. 283) (as amended by section 2032) are
made available to the public on the Internet website of
the National Institutes of Health.
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42 USC 282 note.
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH.
(a) ESTABLISHMENT.—Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Director of the National Institutes of Health,
shall convene a working group under the Advisory Committee to
the Director of the National Institutes of Health (referred to in
this section as the ‘‘Advisory Committee’’), appointed under section
222 of the Public Health Service Act (42 U.S.C. 217a), to develop
and issue recommendations through the Advisory Committee for
a formal policy, which may incorporate or be informed by relevant
existing and ongoing activities, to enhance rigor and reproducibility
of scientific research funded by the National Institutes of Health.
(b) CONSIDERATIONS.—In developing and issuing recommendations through the Advisory Committee under subsection (a), the
working group established under such subsection shall consider,
as appropriate—
(1) preclinical experiment design, including analysis of sex
as a biological variable;
(2) clinical experiment design, including—
(A) the diversity of populations studied for clinical
research, with respect to biological, social, and other determinants of health that contribute to health disparities;
(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and
(C) the circumstances under which clinical studies,
including clinical trials, should conduct an analysis of the
data collected during the study on the basis of biological,
social, and other factors that contribute to health disparities;
(3) applicable levels of rigor in statistical methods, methodology, and analysis;
(4) data and information sharing in accordance with
applicable privacy laws and regulations; and
(5) any other matter the working group determines relevant.
(c) POLICIES.—Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health
shall consider the recommendations developed by the working group
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and issued by the Advisory Committee under subsection (a) and
develop or update policies as appropriate.
(d) REPORT.—Not later than 2 years after the date of enactment
of this Act, the Director of the National Institutes of Health shall
issue a report to the Secretary of Health and Human Services,
the Committee on Health, Education, Labor, and Pensions of the
Senate, and the Committee on Energy and Commerce of the House
of Representatives regarding recommendations developed under
subsection (a) and any subsequent policy changes implemented,
to enhance rigor and reproducibility in scientific research funded
by the National Institutes of Health.
(e) CONFIDENTIALITY.—Nothing in this section authorizes the
Secretary of Health and Human Services to disclose any information
that is a trade secret, or other privileged or confidential information,
described in section 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.
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SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE
NATIONAL INSTITUTES OF HEALTH.
(a) IN GENERAL.—Section 452 of the Public Health Service
Act (42 U.S.C. 285g–4) is amended—
(1) in subsection (b), by striking ‘‘conduct and support’’
and inserting ‘‘conduct, support, and coordination’’;
(2) in subsection (c)(1)(C), by striking ‘‘of the Center’’ and
inserting ‘‘within the Center’’;
(3) in subsection (d)—
(A) by striking ‘‘(d)(1) In consultation’’ and all that
follows through the end of paragraph (1) and inserting
the following:
‘‘(d)(1) The Director of the Center, in consultation with the
Director of the Institute, the coordinating committee established
under subsection (e), and the advisory board established under
subsection (f), shall develop a comprehensive plan (referred to in
this section as the ‘Research Plan’) for the conduct, support, and
coordination of medical rehabilitation research.’’;
(B) in paragraph (2)—
(i) in subparagraph (A), by striking ‘‘; and’’ and
inserting a semicolon;
(ii) in subparagraph (B), by striking the period
and inserting ‘‘; and’’; and
(iii) by adding at the end the following:
‘‘(C) include goals and objectives for conducting, supporting,
and coordinating medical rehabilitation research, consistent
with the purpose described in subsection (b).’’;
(C) by striking paragraph (4) and inserting the following:
‘‘(4) The Director of the Center, in consultation with the Director
of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection
(f), shall revise and update the Research Plan periodically, as appropriate, or not less than every 5 years. Not later than 30 days
after the Research Plan is so revised and updated, the Director
of the Center shall transmit the revised and updated Research
Plan to the President, the Committee on Health, Education, Labor,
and Pensions of the Senate, and the Committee on Energy and
Commerce of the House of Representatives.’’; and
(D) by adding at the end the following:
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‘‘(5) The Director of the Center, in consultation with the Director
of the Institute, shall, prior to revising and updating the Research
Plan, prepare a report for the coordinating committee established
under subsection (e) and the advisory board established under
subsection (f) that describes and analyzes the progress during the
preceding fiscal year in achieving the goals and objectives described
in paragraph (2)(C) and includes expenditures for rehabilitation
research at the National Institutes of Health. The report shall
include recommendations for revising and updating the Research
Plan, and such initiatives as the Director of the Center and the
Director of the Institute determine appropriate. In preparing the
report, the Director of the Center and the Director of the Institute
shall consult with the Director of the National Institutes of Health.’’;
(4) in subsection (e)—
(A) in paragraph (2), by inserting ‘‘periodically host
a scientific conference or workshop on medical rehabilitation research and’’ after ‘‘The Coordinating Committee
shall’’; and
(B) in paragraph (3), by inserting ‘‘the Director of the
Division of Program Coordination, Planning, and Strategic
Initiatives within the Office of the Director of the National
Institutes of Health,’’ after ‘‘shall be composed of’’;
(5) in subsection (f)(3)(B)—
(A) by redesignating clauses (ix) through (xi) as clauses
(x) through (xii), respectively; and
(B) by inserting after clause (viii) the following:
‘‘(ix) The Director of the Division of Program Coordination,
Planning, and Strategic Initiatives.’’; and
(6) by adding at the end the following:
‘‘(g)(1) The Secretary and the heads of other Federal agencies
shall jointly review the programs carried out (or proposed to be
carried out) by each such official with respect to medical rehabilitation research and, as appropriate, enter into agreements preventing
duplication among such programs.
‘‘(2) The Secretary shall, as appropriate, enter into interagency
agreements relating to the coordination of medical rehabilitation
research conducted by agencies of the National Institutes of Health
and other agencies of the Federal Government.
‘‘(h) For purposes of this section, the term ‘medical rehabilitation research’ means the science of mechanisms and interventions
that prevent, improve, restore, or replace lost, underdeveloped, or
deteriorating function.’’.
(b) CONFORMING AMENDMENT.—Section 3 of the National
Institutes of Health Amendments of 1990 (42 U.S.C. 285g–4 note)
is amended—
(1) in subsection (a), by striking ‘‘IN GENERAL.—’’; and
(2) by striking subsection (b).
42 USC 289a–2
note.
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT
WOMEN AND LACTATING WOMEN.
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(a) TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN
LACTATING WOMEN.—
(1) ESTABLISHMENT.—Not later than 90 days after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’) shall
establish a task force, in accordance with the Federal Advisory
Committee Act (5 U.S.C. App.), to be known as the ‘‘Task
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1071
Force on Research Specific to Pregnant Women and Lactating
Women’’ (in this section referred to as the ‘‘Task Force’’).
(2) DUTIES.—The Task Force shall provide advice and guidance to the Secretary regarding Federal activities related to
identifying and addressing gaps in knowledge and research
regarding safe and effective therapies for pregnant women and
lactating women, including the development of such therapies
and the collaboration on and coordination of such activities.
(3) MEMBERSHIP.—
(A) FEDERAL MEMBERS.—The Task Force shall be composed of each of the following Federal members, or the
designees of such members:
(i) The Director of the Centers for Disease Control
and Prevention.
(ii) The Director of the National Institutes of
Health, the Director of the Eunice Kennedy Shriver
National Institute of Child Health and Human
Development, and the directors of such other appropriate national research institutes.
(iii) The Commissioner of Food and Drugs.
(iv) The Director of the Office on Women’s Health.
(v) The Director of the National Vaccine Program
Office.
(vi) The head of any other research-related agency
or department not described in clauses (i) through
(v) that the Secretary determines appropriate, which
may include the Department of Veterans Affairs and
the Department of Defense.
(B) NON-FEDERAL MEMBERS.—The Task Force shall be
composed of each of the following non-Federal members,
including—
(i) representatives from relevant medical societies
with subject matter expertise on pregnant women, lactating women, or children;
(ii) nonprofit organizations with expertise related
to the health of women and children;
(iii) relevant industry representatives; and
(iv) other representatives, as appropriate.
(C) LIMITATIONS.—The non-Federal members described
in subparagraph (B) shall—
(i) compose not more than one-half, and not less
than one-third, of the total membership of the Task
Force; and
(ii) be appointed by the Secretary.
(4) TERMINATION.—
(A) IN GENERAL.—Subject to subparagraph (B), the
Task Force shall terminate on the date that is 2 years
after the date on which the Task Force is established
under paragraph (1).
(B) EXTENSION.—The Secretary may extend the operation of the Task Force for one additional 2-year period
following the 2-year period described in subparagraph (A),
if the Secretary determines that the extension is appropriate for carrying out the purpose of this section.
(5) MEETINGS.—The Task Force shall meet not less than
2 times each year and shall convene public meetings, as appropriate, to fulfill its duties under paragraph (2).
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130 STAT. 1072
PUBLIC LAW 114–255—DEC. 13, 2016
(6) TASK FORCE REPORT TO CONGRESS.—Not later than 18
months after the date on which the Task Force is established
under paragraph (1), the Task Force shall prepare and submit
to the Secretary, 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 each of the following:
(A) A plan to identify and address gaps in knowledge
and research regarding safe and effective therapies for
pregnant women and lactating women, including the
development of such therapies.
(B) Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research.
(C) Effective communication strategies with health care
providers and the public on information relevant to pregnant women and lactating women.
(D) Identification of Federal activities, including—
(i) the state of research on pregnancy and lactation;
(ii) recommendations for the coordination of, and
collaboration on research related to pregnant women
and lactating women;
(iii) dissemination of research findings and
information relevant to pregnant women and lactating
women to providers and the public; and
(iv) existing Federal efforts and programs to
improve the scientific understanding of the health
impacts on pregnant women, lactating women, and
related birth and pediatric outcomes, including with
respect to pharmacokinetics, pharmacodynamics, and
toxicities.
(E) Recommendations to improve the development of
safe and effective therapies for pregnant women and lactating women.
(b) CONFIDENTIALITY.—Nothing in this section shall authorize
the Secretary of Health and Human Services to disclose any
information that is a trade secret, or other privileged or confidential
information, described in section 552(b)(4) of title 5, United States
Code, or section 1905 of title 18, United States Code.
(c) UPDATING PROTECTIONS FOR PREGNANT WOMEN AND LACTATING WOMEN IN RESEARCH.—
(1) IN GENERAL.—Not later than 2 years after the date
of enactment of this Act, the Secretary, considering any recommendations of the Task Force available at such time and
in consultation with the heads of relevant agencies of the
Department of Health and Human Services, shall, as appropriate, update regulations and guidance, as applicable,
regarding the inclusion of pregnant women and lactating
women in clinical research.
(2) CRITERIA FOR EXCLUDING PREGNANT OR LACTATING
WOMEN.—In updating any regulations or guidance described
in paragraph (1), the Secretary shall consider any appropriate
criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women
or lactating women as a study population requiring additional
protections from participating in human subject research.
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SEC.
2042.
STREAMLINING NATIONAL INSTITUTES
REPORTING REQUIREMENTS.
OF
130 STAT. 1073
HEALTH
(a) TRANS-NATIONAL INSTITUTES OF HEALTH RESEARCH
REPORTING.—Section 402A(c)(2) of the Public Health Service Act
(42 U.S.C. 282a(c)(2)) is amended—
(1) by amending subparagraph (B) to read as follows:
‘‘(B) REPORTING.—Not later than 2 years after the date
of enactment of 21st Century Cures Act, the head of each
national research institute or national center shall submit
to the Director of the National Institutes of Health a report,
to be included in the triennial report under section 403,
on the amount made available by the institute or center
for conducting or supporting research that involves
collaboration between the institute or center and 1 or more
other national research institutes or national centers.’’; and
(2) in subparagraphs (D) and (E) by striking ‘‘(B)(i)’’ each
place it appears and inserting ‘‘(B)’’.
(b) FRAUD AND ABUSE REPORTING.—Section 403B of the Public
Health Service Act (42 U.S.C. 283a–1) is amended—
(1) by striking subsection (b);
(2) by redesignating subsection (c) as subsection (b); and
(3) in subsection (b) (as so redesignated), by striking ‘‘subsections (a) and (b)’’ and inserting ‘‘subsection (a)’’.
(c) DOCTORAL DEGREES REPORTING.—Section 403C(a)(2) of the
Public Health Service Act (42 U.S.C. 283a–2(a)(2)) is amended
by striking ‘‘(not including any leaves of absence)’’.
(d) VACCINE REPORTING.—Section 404B of the Public Health
Service Act (42 U.S.C. 283d) is amended—
(1) by striking subsection (b); and
(2) by striking ‘‘(a) DEVELOPMENT OF NEW VACCINES.—
The Secretary’’ and inserting ‘‘The Secretary’’.
(e) NATIONAL CENTER FOR ADVANCING TRANSLATIONAL
SCIENCES.—Section 479(c) of the Public Health Service Act (42
U.S.C. 287(c)) is amended—
(1) in the subsection heading, by striking ‘‘ANNUAL’’ and
inserting ‘‘BIENNIAL’’; and
(2) in the matter preceding paragraph (1), by striking ‘‘an
annual report’’ and inserting ‘‘a report on a biennial basis’’.
(f) REVIEW OF CENTERS OF EXCELLENCE.—
(1) REPEAL.—Section 404H of the Public Health Service
Act (42 U.S.C. 283j) is repealed.
(2) CONFORMING AMENDMENT.—Section 399EE(c) of the
Public Health Service Act (42 U.S.C. 280–4(c)) is amended
by striking ‘‘399CC, 404H,’’ and inserting ‘‘399CC’’.
(g) RAPID HIV TEST REPORT.—Section 502(a) of the Ryan White
CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is amended—
(1) by striking paragraph (2); and
(2) by redesignating paragraph (3) as paragraph (2).
(h) NATIONAL INSTITUTE OF NURSING RESEARCH.—
(1) REPEAL.—Section 464Y of the Public Health Service
Act (42 U.S.C. 285q–3) is repealed.
(2) CONFORMING AMENDMENT.—Section 464X(g) of the
Public Health Service Act (42 U.S.C. 285q–2(g)) is amended
by striking ‘‘biennial report made under section 464Y,’’ and
inserting ‘‘triennial report made under section 403’’.
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130 STAT. 1074
PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING
ORGANISMS.
Section 301 of the Public Health Service Act (42 U.S.C. 241),
as amended by section 2035, is further amended—
(1) in the flush matter at the end of subsection (a)—
(A) by redesignating such matter as subsection (h)(1);
and
(B) by moving such matter so as to appear at the
end of such section; and
(2) in subsection (h) (as so redesignated), by adding at
the end the following:
‘‘(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.’’.
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDERREPRESENTED POPULATIONS IN CLINICAL TRIALS.
It is the sense of Congress that the National Institute on
Minority Health and Health Disparities should include within its
strategic plan under section 402(m) of the Public Health Service
Act (42 U.S.C. 282(m)) ways to increase representation of underrepresented populations in clinical trials.
Subtitle E—Advancement of the National
Institutes of Health Research and Data
Access
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SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.
Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C.
282(j)(2)(D)) is amended—
(1) in clause (ii)(I), by inserting before the semicolon ‘‘,
unless the responsible party affirmatively requests that the
Director of the National Institutes of Health publicly post such
clinical trial information for an applicable device clinical trial
prior to such date of clearance or approval’’; and
(2) by adding at the end the following:
‘‘(iii) OPTION TO MAKE CERTAIN CLINICAL TRIAL
INFORMATION AVAILABLE EARLIER.—The Director of the
National Institutes of Health shall inform responsible
parties of the option to request that clinical trial
information for an applicable device clinical trial be
publicly posted prior to the date of clearance or
approval, in accordance with clause (ii)(I).
‘‘(iv) COMBINATION PRODUCTS.—An applicable clinical trial for a product that is a combination of drug,
device, or biological product shall be considered—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1075
‘‘(I) an applicable drug clinical trial, if the
Secretary determines under section 503(g) of the
Federal Food, Drug, and Cosmetic Act that the
primary mode of action of such product is that
of a drug or biological product; or
‘‘(II) an applicable device clinical trial, if the
Secretary determines under such section that the
primary mode of action of such product is that
of a device.’’.
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SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.
(a) DEFINITIONS.—In this section:
(1) APPLICABLE CLINICAL TRIAL.—The term ‘‘applicable clinical trial’’ has the meaning given the term in section 402(j)
of the Public Health Service Act (42 U.S.C. 282(j)).
(2) SECRETARY.—The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(b) REPORT ON ACTIVITIES TO ENCOURAGE COMPLIANCE.—Not
later than 2 years after the date of enactment of this Act, the
Secretary, acting through the Director of the National Institutes
of Health and in collaboration with the Commissioner of Food
and Drugs, 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
describes education and outreach, guidance, enforcement, and other
activities undertaken to encourage compliance with section 402(j)
of the Public Health Service Act (42 U.S.C. 282(j)).
(c) REPORTS ON CLINICAL TRIALS.—
(1) IN GENERAL.—Not later than 2 years after the final
compliance date under the final rule implementing section
402(j) of the Public Health Service Act, and every 2 years
thereafter for the next 4 years, the Secretary, acting through
the Director of the National Institutes of Health and in
collaboration with the Commissioner of Food and Drugs, 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—
(A) the total number of applicable clinical trials with
complete data bank registration information registered
during the period for which the report is being prepared
(broken down by each year of such reporting period);
(B) the total number of applicable clinical trials registered during the period for which the report is being
prepared for which results have been submitted to the
data bank (broken down by each year of such reporting
period);
(C) the activities undertaken by the Secretary to educate responsible persons about data bank registration and
results submission requirements, including through
issuance of guidance documents, informational meetings,
and training sessions; and
(D) the activities described in the report submitted
under subsection (b).
(2) ACTIONS TO ENFORCE COMPLIANCE.—After the Secretary
has undertaken the educational activities described in paragraph (1)(C), the Secretary shall include in subsequent reports
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130 STAT. 1076
PUBLIC LAW 114–255—DEC. 13, 2016
submitted under paragraph (1) the number of actions taken
by the Secretary during the period for which the report is
being prepared to enforce compliance with data bank registration and results submission requirements.
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.
Section 492B(c) of the Public Health Service Act (42 U.S.C.
289a–2(c)) is amended—
(1) by striking ‘‘In the case’’ and inserting the following:
‘‘(1) IN GENERAL.—In the case’’; and
(2) by adding at the end the following:
‘‘(2) REPORTING REQUIREMENTS.—For any new and competing project of clinical research subject to the requirements
under this section that receives a grant award 1 year after
the date of enactment of the 21st Century Cures Act, or any
date thereafter, for which a valid analysis is provided under
paragraph (1)—
‘‘(A) and which is an applicable clinical trial as defined
in section 402(j), the entity conducting such clinical
research shall submit the results of such valid analysis
to the clinical trial registry data bank expanded under
section 402(j)(3), and the Director of the National Institutes
of Health shall, as appropriate, consider whether such
entity has complied with the reporting requirement
described in this subparagraph in awarding any future
grant to such entity, including pursuant to section
402(j)(5)(A)(ii) when applicable; and
‘‘(B) the Director of the National Institutes of Health
shall encourage the reporting of the results of such valid
analysis described in paragraph (1) through any additional
means determined appropriate by the Director.’’.
SEC. 2054. CONSULTATION.
Not later than 90 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall consult
with relevant Federal agencies, including the Food and Drug
Administration, the Office of the National Coordinator for Health
Information Technology, and the National Institutes of Health,
as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to
enhancements to the clinical trial registry data bank under section
402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including
with respect to usability, functionality, and search capability.
Subtitle F—Facilitating Collaborative
Research
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SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE
SYSTEM.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by inserting after section 399S the following:
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130 STAT. 1077
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‘‘SEC. 399S–1. SURVEILLANCE OF NEUROLOGICAL DISEASES.
42 USC 280g–7a.
‘‘(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;
‘‘(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.
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130 STAT. 1078
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(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 analysis in the National Neurological Conditions Surveillance
System 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.
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130 STAT. 1079
‘‘(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.’’.
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SEC. 2062. TICK-BORNE DISEASES.
42 USC 284s.
(a) IN GENERAL.—The Secretary of Health and Human Services
(referred to in this section as ‘‘the Secretary’’) shall continue to
conduct or support epidemiological, basic, translational, and clinical
research related to vector-borne diseases, including tick-borne diseases.
(b) REPORTS.—The Secretary shall ensure that each triennial
report under section 403 of the Public Health Service Act (42
U.S.C. 283) (as amended by section 2032) includes information
on actions undertaken by the National Institutes of Health to
carry out subsection (a) with respect to tick-borne diseases.
(c) TICK-BORNE DISEASES WORKING GROUP.—
(1) ESTABLISHMENT.—The Secretary shall establish a
working group, to be known as the Tick-Borne Disease Working
Group (referred to in this section as the ‘‘Working Group’’),
comprised of representatives of appropriate Federal agencies
and other non-Federal entities, to provide expertise and to
review all efforts within the Department of Health and Human
Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine
research priorities.
(2) RESPONSIBILITIES.—The working group shall—
(A) not later than 2 years after the date of enactment
of this Act, develop or update a summary of—
(i) ongoing tick-borne disease research, including
research related to causes, prevention, treatment,
surveillance, diagnosis, diagnostics, duration of illness,
and intervention for individuals with tick-borne diseases;
(ii) advances made pursuant to such research;
(iii) Federal activities related to tick-borne diseases, including—
(I) epidemiological activities related to tickborne diseases; and
(II) basic, clinical, and translational tick-borne
disease research related to the pathogenesis,
prevention, diagnosis, and treatment of tick-borne
diseases;
(iv) gaps in tick-borne disease research described
in clause (iii)(II);
(v) the Working Group’s meetings required under
paragraph (4); and
(vi) the comments received by the Working Group;
(B) make recommendations to the Secretary regarding
any appropriate changes or improvements to such activities
and research; and
(C) solicit input from States, localities, and nongovernmental entities, including organizations representing
patients, health care providers, researchers, and industry
regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.
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(3) MEMBERSHIP.—The members of the working group shall
represent a diversity of scientific disciplines and views and
shall be composed of the following members:
(A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representatives of each of the following:
(i) The Office of the Assistant Secretary for Health.
(ii) The Food and Drug Administration.
(iii) The Centers for Disease Control and Prevention.
(iv) The National Institutes of Health.
(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary
determines appropriate.
(B) NON–FEDERAL PUBLIC MEMBERS.—Seven non–Federal public members, consisting of representatives of the
following categories:
(i) Physicians and other medical providers with
experience in diagnosing and treating tick-borne diseases.
(ii) Scientists or researchers with expertise.
(iii) Patients and their family members.
(iv) Nonprofit organizations that advocate for
patients with respect to tick-borne diseases.
(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.
(4) MEETINGS.—The Working Group shall meet not less
than twice each year.
(5) REPORTING.—Not later than 2 years after the date
of enactment of this Act, and every 2 years thereafter until
termination of the Working Group pursuant to paragraph (7),
the Working Group shall—
(A) submit a report on its activities under paragraph
(2)(A) and any recommendations under paragraph (2)(B)
to the Secretary, the Committee on Energy and Commerce
of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate; and
(B) make such report publicly available on the Internet
website of the Department of Health and Human Services.
(6) APPLICABILITY OF FACA.—The Working Group shall be
treated as an advisory committee subject to the Federal
Advisory Committee Act (5 U.S.C. App.).
(7) SUNSET.—The Working Group under this section shall
terminate 6 years after the date of enactment of this Act.
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42 USC 1320d–2
note.
SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR
RESEARCH PURPOSES.
(a) GUIDANCE RELATED TO REMOTE ACCESS.—Not later than
1 year after the date of enactment of this Act, the Secretary of
Health and Human Services (referred to in this section as the
‘‘Secretary’’) shall issue guidance clarifying that subparagraph (B)
of section 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the
removal of protected health information by a researcher) does not
prohibit remote access to health information by a researcher for
such purposes as described in section 164.512(i)(1)(ii) of part 164
of the Rule so long as—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1081
(1) at a minimum, security and privacy safeguards, consistent with the requirements of the Rule, are maintained by
the covered entity and the researcher; and
(2) the protected health information is not copied or otherwise retained by the researcher.
(b) GUIDANCE RELATED TO STREAMLINING AUTHORIZATION.—
Not later than 1 year after the date of enactment of this Act,
the Secretary shall issue guidance on the following:
(1) AUTHORIZATION FOR USE AND DISCLOSURE OF HEALTH
INFORMATION.—Clarification of the circumstances under which
the authorization for the use or disclosure of protected health
information, with respect to an individual, for future research
purposes contains a sufficient description of the purpose of
the use or disclosure, such as if the authorization—
(A) sufficiently describes the purposes such that it
would be reasonable for the individual to expect that the
protected health information could be used or disclosed
for such future research;
(B) either—
(i) states that the authorization will expire on a
particular date or on the occurrence of a particular
event; or
(ii) states that the authorization will remain valid
unless and until it is revoked by the individual; and
(C) provides instruction to the individual on how to
revoke such authorization at any time.
(2) REMINDER OF THE RIGHT TO REVOKE.—Clarification of
the circumstances under which it is appropriate to provide
an individual with an annual notice or reminder that the individual has the right to revoke such authorization.
(3) REVOCATION OF AUTHORIZATION.—Clarification of appropriate mechanisms by which an individual may revoke an
authorization for future research purposes, such as described
in paragraph (1)(C).
(c) WORKING GROUP ON PROTECTED HEALTH INFORMATION FOR
RESEARCH.—
(1) ESTABLISHMENT.—Not later than 1 year after the date
of enactment of this Act, the Secretary shall convene a working
group to study and report on the uses and disclosures of protected health information for research purposes, under the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104–191).
(2) MEMBERS.—The working group shall include representatives of—
(A) relevant Federal agencies, including the National
Institutes of Health, the Centers for Disease Control and
Prevention, the Food and Drug Administration, and the
Office for Civil Rights;
(B) the research community;
(C) patients;
(D) experts in civil rights, such as privacy rights;
(E) developers of health information technology;
(F) experts in data privacy and security;
(G) health care providers;
(H) bioethicists; and
(I) other experts and entities, as the Secretary determines appropriate.
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130 STAT. 1082
PUBLIC LAW 114–255—DEC. 13, 2016
(3) REPORT.—Not later than 1 year after the date on which
the working group is convened under paragraph (1), the
working group shall conduct a review and submit a report
to the Secretary containing recommendations on whether the
uses and disclosures of protected health information for
research purposes should be modified to allow protected health
information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge,
while protecting individuals’ privacy rights. In conducting the
review and making recommendations, the working group
shall—
(A) address, at a minimum—
(i) the appropriate manner and timing of
authorization, including whether additional notification
to the individual should be required when the individual’s protected health information will be used or disclosed for such research;
(ii) opportunities for individuals to set preferences
on the manner in which their protected health information is used in research;
(iii) opportunities for patients to revoke authorization;
(iv) notification to individuals of a breach in privacy;
(v) existing gaps in statute, regulation, or policy
related to protecting the privacy of individuals, and
(vi) existing barriers to research related to the
current restrictions on the uses and disclosures of protected health information; and
(B) consider, at a minimum—
(i) expectations and preferences on how an individual’s protected health information is shared and used;
(ii) issues related to specific subgroups of people,
such as children, incarcerated individuals, and individuals with a cognitive or intellectual disability
impacting capacity to consent;
(iii) relevant Federal and State laws;
(iv) models of facilitating data access and levels
of data access, including data segmentation, where
applicable;
(v) potential impacts of disclosure and non-disclosure of protected health information on access to health
care services; and
(vi) the potential uses of such data.
(4) REPORT SUBMISSION.—The Secretary shall submit the
report under paragraph (3) 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 shall post such report on the appropriate Internet website
of the Department of Health and Human Services.
(5) TERMINATION.—The working group convened under
paragraph (1) shall terminate the day after the report under
paragraph (3) is submitted to Congress and made public in
accordance with paragraph (4).
(d) DEFINITIONS.—In this section:
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1083
(1) THE RULE.—References to ‘‘the Rule’’ refer to part 160
or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).
(2) PART 164.—References to a specified section of ‘‘part
164’’, refer to such specified section of part 164 of title 45,
Code of Federal Regulations (or any successor section).
Subtitle G—Promoting Pediatric Research
SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.
Section 409D(d) of the Public Health Service Act (42 U.S.C.
284h(d)) is amended—
(1) in paragraph (1), by striking ‘‘in consultation with the
Director of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development and in collaboration
with other appropriate national research institutes and national
centers that carry out activities involving pediatric research,
may provide for the establishment of’’ and inserting ‘‘in
collaboration with the national research institutes and national
centers that carry out activities involving pediatric research,
shall support’’; and
(2) in paragraph (2)(A) and the first sentence of paragraph
(2)(E), by striking ‘‘may’’ each place such term appears and
inserting ‘‘shall’’.
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.
It is the sense of Congress that—
(1) the National Institutes of Health should encourage a
global pediatric clinical study network by providing grants,
contracts, or cooperative agreements to support new and early
stage investigators who participate in the global pediatric clinical study network;
(2) the Secretary of Health and Human Services (referred
to in this section as the ‘‘Secretary’’) should engage with clinical
investigators and appropriate authorities outside of the United
States, including authorities in the European Union, during
the formation of the global pediatric clinical study network
to encourage the participation of such investigator and authorities; and
(3) once a global pediatric clinical study network is established and becomes operational, the Secretary should continue
to encourage and facilitate the participation of clinical investigators and appropriate authorities outside of the United
States, including in the European Union, to participate in the
network with the goal of enhancing the global reach of the
network.
TITLE III—DEVELOPMENT
Subtitle A—Patient-Focused Drug
Development
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SEC. 3001. PATIENT EXPERIENCE DATA.
Section 569C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb–8c) is amended—
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130 STAT. 1084
PUBLIC LAW 114–255—DEC. 13, 2016
(1) in subsection (a)—
(A) in the subsection heading, by striking ‘‘IN GENERAL’’
and inserting ‘‘PATIENT ENGAGEMENT IN DRUGS AND
DEVICES’’;
(B) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving such subparagraphs 2 ems to the right; and
(C) by striking ‘‘The Secretary’’ and inserting the following:
‘‘(1) IN GENERAL.—The Secretary’’;
(2) by redesignating subsections (b) through (e) as paragraphs (2) through (5), respectively, and moving such paragraphs 2 ems to the right; and
(3) by adding at the end the following:
‘‘(b) STATEMENT OF PATIENT EXPERIENCE.—
‘‘(1) IN GENERAL.—Following the approval of an application
that was submitted under section 505(b) of this Act or section
351(a) of the Public Health Service Act at least 180 days
after the date of enactment of the 21st Century Cures Act,
the Secretary shall make public a brief statement regarding
the patient experience data and related information, if any,
submitted and reviewed as part of such application.
‘‘(2) DATA AND INFORMATION.—The data and information
referred to in paragraph (1) are—
‘‘(A) patient experience data;
‘‘(B) information on patient-focused drug development
tools; and
‘‘(C) other relevant information, as determined by the
Secretary.
‘‘(c) PATIENT EXPERIENCE DATA.—For purposes of this section,
the term ‘patient experience data’ includes data that—
‘‘(1) are collected by any persons (including patients, family
members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug
manufacturers); and
‘‘(2) are intended to provide information about patients’
experiences with a disease or condition, including—
‘‘(A) the impact of such disease or condition, or a related
therapy, on patients’ lives; and
‘‘(B) patient preferences with respect to treatment of
such disease or condition.’’.
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21 USC
360bbb–8c note.
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SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUIDANCE.
(a) PUBLICATION OF GUIDANCE DOCUMENTS.—Not later than
180 days after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this section as the
‘‘Secretary’’), acting through the Commissioner of Food and Drugs,
shall develop a plan to issue draft and final versions of one or
more guidance documents, over a period of 5 years, regarding
the collection of patient experience data, and the use of such data
and related information in drug development. Not later than 18
months after the date of enactment of this Act, the Secretary
shall issue a draft version of at least one such guidance document.
Not later than 18 months after the public comment period on
the draft guidance ends, the Secretary shall issue a revised draft
guidance or final guidance.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1085
(b) PATIENT EXPERIENCE DATA.—For purposes of this section,
the term ‘‘patient experience data’’ has the meaning given such
term in section 569C of the Federal Food, Drug, and Cosmetic
Act (as added by section 3001).
(c) CONTENTS.—The guidance documents described in subsection (a) shall address—
(1) methodological approaches that a person seeking to
collect patient experience data for submission to, and proposed
use by, the Secretary in regulatory decisionmaking may use,
that are relevant and objective and ensure that such data
are accurate and representative of the intended population,
including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis;
(2) methodological approaches that may be used to develop
and identify what is most important to patients with respect
to burden of disease, burden of treatment, and the benefits
and risks in the management of the patient’s disease;
(3) approaches to identifying and developing methods to
measure impacts to patients that will help facilitate collection
of patient experience data in clinical trials;
(4) methodologies, standards, and technologies to collect
and analyze clinical outcome assessments for purposes of regulatory decisionmaking;
(5) how a person seeking to develop and submit proposed
draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance
to the Secretary;
(6) the format and content required for submissions under
this section to the Secretary, including with respect to the
information described in paragraph (1);
(7) how the Secretary intends to respond to submissions
of information described in paragraph (1), if applicable,
including any timeframe for response when such submission
is not part of a regulatory application or other submission
that has an associated timeframe for response; and
(8) how the Secretary, if appropriate, anticipates using
relevant patient experience data and related information,
including with respect to the structured risk-benefit assessment
framework described in section 505(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory
decisionmaking.
SEC. 3003. STREAMLINING PATIENT INPUT.
Chapter 35 of title 44, United States Code, shall not apply
to the collection of information to which a response is voluntary,
that is initiated by the Secretary under section 569C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended
by section 3001) or section 3002.
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SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.
21 USC
360bbb–8c note.
21 USC 355 note.
Not later than June 1 of 2021, 2026, and 2031, the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall prepare and publish on the Internet
website of the Food and Drug Administration a report assessing
the use of patient experience data in regulatory decisionmaking,
in particular with respect to the review of patient experience data
and information on patient-focused drug development tools as part
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130 STAT. 1086
PUBLIC LAW 114–255—DEC. 13, 2016
of applications approved under section 505(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of
the Public Health Service Act (42 U.S.C. 262(a)).
Subtitle B—Advancing New Drug
Therapies
SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 506F the following new section:
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21 USC 357.
‘‘SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
‘‘(a) PROCESS FOR QUALIFICATION.—
‘‘(1) IN GENERAL.—The Secretary shall establish a process
for the qualification of drug development tools for a proposed
context of use under which—
‘‘(A)(i) a requestor initiates such process by submitting
a letter of intent to the Secretary; and
‘‘(ii) the Secretary accepts or declines to accept such
letter of intent;
‘‘(B)(i) if the Secretary accepts the letter of intent,
a requestor submits a qualification plan to the Secretary;
and
‘‘(ii) the Secretary accepts or declines to accept the
qualification plan; and
‘‘(C)(i) if the Secretary accepts the qualification plan,
the requestor submits to the Secretary a full qualification
package;
‘‘(ii) the Secretary determines whether to accept such
qualification package for review; and
‘‘(iii) if the Secretary accepts such qualification package
for review, the Secretary conducts such review in accordance with this section.
‘‘(2) ACCEPTANCE AND REVIEW OF SUBMISSIONS.—
‘‘(A) IN GENERAL.—Subparagraphs (B), (C), and (D)
shall apply with respect to the treatment of a letter of
intent, a qualification plan, or a full qualification package
submitted under paragraph (1) (referred to in this paragraph as ‘qualification submissions’).
‘‘(B) ACCEPTANCE FACTORS; NONACCEPTANCE.—The Secretary shall determine whether to accept a qualification
submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall
not be construed as a final determination by the Secretary
under this section regarding the qualification of a drug
development tool for its proposed context of use.
‘‘(C) PRIORITIZATION OF QUALIFICATION REVIEW.—The
Secretary may prioritize the review of a full qualification
package submitted under paragraph (1) with respect to
a drug development tool, based on factors determined
appropriate by the Secretary, including—
‘‘(i) as applicable, the severity, rarity, or prevalence
of the disease or condition targeted by the drug
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1087
development tool and the availability or lack of alternative treatments for such disease or condition; and
‘‘(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.
‘‘(D) ENGAGEMENT OF EXTERNAL EXPERTS.—The Secretary may, for purposes of the review of qualification
submissions, through the use of cooperative agreements,
grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review
of any qualification plan submitted under paragraph (1)
or the review of any full qualification package under paragraph (3).
‘‘(3) REVIEW OF FULL QUALIFICATION PACKAGE.—The Secretary shall—
‘‘(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and
‘‘(B) determine whether the drug development tool at
issue is qualified for its proposed context of use.
‘‘(4) QUALIFICATION.—The Secretary shall determine
whether a drug development tool is qualified for a proposed
context of use based on the scientific merit of a full qualification
package reviewed under paragraph (3).
‘‘(b) EFFECT OF QUALIFICATION.—
‘‘(1) IN GENERAL.—A drug development tool determined
to be qualified under subsection (a)(4) for a proposed context
of use specified by the requestor may be used by any person
in such context of use for the purposes described in paragraph
(2).
‘‘(2) USE OF A DRUG DEVELOPMENT TOOL.—Subject to paragraph (3), a drug development tool qualified under this section
may be used for—
‘‘(A) supporting or obtaining approval or licensure (as
applicable) of a drug or biological product (including in
accordance with section 506(c)) under section 505 of this
Act or section 351 of the Public Health Service Act; or
‘‘(B) supporting the investigational use of a drug or
biological product under section 505(i) of this Act or section
351(a)(3) of the Public Health Service Act.
‘‘(3) RESCISSION OR MODIFICATION.—
‘‘(A) IN GENERAL.—The Secretary may rescind or
modify a determination under this section to qualify a
drug development tool if the Secretary determines that
the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a
determination may be based on new information that calls
into question the basis for such qualification.
‘‘(B) MEETING FOR REVIEW.—If the Secretary rescinds
or modifies under subparagraph (A) a determination to
qualify a drug development tool, the requestor involved
shall, on request, be granted a meeting with the Secretary
to discuss the basis of the Secretary’s decision to rescind
or modify the determination before the effective date of
the rescission or modification.
‘‘(c) TRANSPARENCY.—
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130 STAT. 1088
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(1) IN GENERAL.—Subject to paragraph (3), the Secretary
shall make publicly available, and update on at least a biannual
basis, on the Internet website of the Food and Drug Administration the following:
‘‘(A) Information with respect to each qualification
submission under the qualification process under subsection (a), including—
‘‘(i) the stage of the review process applicable to
the submission;
‘‘(ii) the date of the most recent change in stage
status;
‘‘(iii) whether external scientific experts were utilized in the development of a qualification plan or
the review of a full qualification package; and
‘‘(iv) submissions from requestors under the qualification process under subsection (a), including any
data and evidence contained in such submissions, and
any updates to such submissions.
‘‘(B) The Secretary’s formal written determinations in
response to such qualification submissions.
‘‘(C) Any rescissions or modifications under subsection
(b)(3) of a determination to qualify a drug development
tool.
‘‘(D) Summary reviews that document conclusions and
recommendations for determinations to qualify drug
development tools under subsection (a).
‘‘(E) A comprehensive list of—
‘‘(i) all drug development tools qualified under subsection (a); and
‘‘(ii) all surrogate endpoints which were the basis
of approval or licensure (as applicable) of a drug or
biological product (including in accordance with section
506(c)) under section 505 of this Act or section 351
of the Public Health Service Act.
‘‘(2) RELATION TO TRADE SECRETS ACT.—Information made
publicly available by the Secretary under paragraph (1) shall
be considered a disclosure authorized by law for purposes of
section 1905 of title 18, United States Code.
‘‘(3) APPLICABILITY.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information
contained in an application submitted under section 505 of
this Act or section 351 of the Public Health Service Act that
is confidential commercial or trade secret information subject
to section 552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed—
‘‘(1) to alter the standards of evidence under subsection
(c) or (d) of section 505, including the substantial evidence
standard in such subsection (d), or under section 351 of the
Public Health Service Act (as applicable); or
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act or the Public Health Service
Act, as applicable (as in effect before the date of the enactment
of the 21st Century Cures Act).
‘‘(e) DEFINITIONS.—In this section:
‘‘(1) BIOMARKER.—The term ‘biomarker’—
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130 STAT. 1089
‘‘(A) means a characteristic (such as a physiologic,
pathologic, or anatomic characteristic or measurement) that
is objectively measured and evaluated as an indicator of
normal biologic processes, pathologic processes, or biological
responses to a therapeutic intervention; and
‘‘(B) includes a surrogate endpoint.
‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The term ‘biomedical research consortia’ means collaborative groups that
may take the form of public-private partnerships and may
include government agencies, institutions of higher education
(as defined in section 101(a) of the Higher Education Act of
1965), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and
individuals.
‘‘(3) CLINICAL OUTCOME ASSESSMENT.—The term ‘clinical
outcome assessment’ means—
‘‘(A) a measurement of a patient’s symptoms, overall
mental state, or the effects of a disease or condition on
how the patient functions; and
‘‘(B) includes a patient-reported outcome.
‘‘(4) CONTEXT OF USE.—The term ‘context of use’ means,
with respect to a drug development tool, the circumstances
under which the drug development tool is to be used in drug
development and regulatory review.
‘‘(5) DRUG DEVELOPMENT TOOL.—The term ‘drug development tool’ includes—
‘‘(A) a biomarker;
‘‘(B) a clinical outcome assessment; and
‘‘(C) any other method, material, or measure that the
Secretary determines aids drug development and regulatory review for purposes of this section.
‘‘(6) PATIENT-REPORTED OUTCOME.—The term ‘patientreported outcome’ means a measurement based on a report
from a patient regarding the status of the patient’s health
condition without amendment or interpretation of the patient’s
report by a clinician or any other person.
‘‘(7) QUALIFICATION.—The terms ‘qualification’ and ‘qualified’ mean a determination by the Secretary that a drug
development tool and its proposed context of use can be relied
upon to have a specific interpretation and application in drug
development and regulatory review under this Act.
‘‘(8) REQUESTOR.—The term ‘requestor’ means an entity
or entities, including a drug sponsor or a biomedical research
consortia, seeking to qualify a drug development tool for a
proposed context of use under this section.
‘‘(9) SURROGATE ENDPOINT.—The term ‘surrogate endpoint’
means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not
itself a direct measurement of clinical benefit, and—
‘‘(A) is known to predict clinical benefit and could be
used to support traditional approval of a drug or biological
product; or
‘‘(B) is reasonably likely to predict clinical benefit and
could be used to support the accelerated approval of a
drug or biological product in accordance with section
506(c).’’.
(b) GUIDANCE.—
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21 USC 357 note.
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130 STAT. 1090
PUBLIC LAW 114–255—DEC. 13, 2016
(1) IN GENERAL.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’) shall,
in consultation with biomedical research consortia (as defined
in subsection (e) of section 507 of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a)) and other
interested parties through a collaborative public process, issue
guidance to implement such section 507 that—
(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the
development of biomarkers delineated under the taxonomy
established under paragraph (3);
(B) with respect to the qualification process under such
section 507—
(i) describes the requirements that entities seeking
to qualify a drug development tool under such section
shall observe when engaging in such process;
(ii) outlines reasonable timeframes for the Secretary’s review of letters, qualification plans, or full
qualification packages submitted under such process;
and
(iii) establishes a process by which such entities
or the Secretary may consult with biomedical research
consortia and other individuals and entities with expert
knowledge and insights that may assist the Secretary
in the review of qualification plans and full qualification submissions under such section; and
(C) includes such other information as the Secretary
determines appropriate.
(2) TIMING.—Not later than 3 years after the date of the
enactment of this Act, the Secretary shall issue draft guidance
under paragraph (1) on the implementation of section 507 of
the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). The Secretary shall issue final guidance on the
implementation of such section not later than 6 months after
the date on which the comment period for the draft guidance
closes.
(3) TAXONOMY.—
(A) IN GENERAL.—For purposes of informing guidance
under this subsection, the Secretary shall, in consultation
with biomedical research consortia and other interested
parties through a collaborative public process, establish
a taxonomy for the classification of biomarkers (and related
scientific concepts) for use in drug development.
(B) PUBLIC AVAILABILITY.—Not later than 2 years after
the date of the enactment of this Act, the Secretary shall
make such taxonomy publicly available in draft form for
public comment. The Secretary shall finalize the taxonomy
not later than 1 year after the close of the public comment
period.
(c) MEETING AND REPORT.—
(1) MEETING.—Not later than 2 years after the date of
the enactment of this Act, the Secretary shall convene a public
meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a).
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130 STAT. 1091
(2) REPORT.—Not later than 5 years after the date of the
enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the
qualification process under section 507 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), information
on—
(A) the number of requests submitted, as a letter of
intent, for qualification of a drug development tool (as
defined in subsection (e) of such section 507);
(B) the number of such requests accepted and determined to be eligible for submission of a qualification plan
or full qualification package (as such terms are defined
in subsection (e) of such section 507), respectively;
(C) the number of such requests for which external
scientific experts were utilized in the development of a
qualification plan or review of a full qualification package;
(D) the number of qualification plans and full qualification packages, respectively, submitted to the Secretary;
and
(E) the drug development tools qualified through such
qualification process, specified by type of tool, such as
a biomarker or clinical outcome assessment (as such terms
are defined in subsection (e) of such section 507).
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.
Subchapter B of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by inserting
after section 529 the following:
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‘‘SEC. 529A. TARGETED DRUGS FOR RARE DISEASES.
21 USC 360ff–1.
‘‘(a) PURPOSE.—The purpose of this section, through the
approach provided for in subsection (b), is to—
‘‘(1) facilitate the development, review, and approval of
genetically targeted drugs and variant protein targeted drugs
to address an unmet medical need in one or more patient
subgroups, including subgroups of patients with different
mutations of a gene, with respect to rare diseases or conditions
that are serious or life-threatening; and
‘‘(2) maximize the use of scientific tools or methods,
including surrogate endpoints and other biomarkers, for such
purposes.
‘‘(b) LEVERAGING OF DATA FROM PREVIOUSLY APPROVED DRUG
APPLICATION OR APPLICATIONS.—The Secretary may, consistent with
applicable standards for approval under this Act or section 351(a)
of the Public Health Service Act, allow the sponsor of an application
under section 505(b)(1) of this Act or section 351(a) of the Public
Health Service Act for a genetically targeted drug or a variant
protein targeted drug to rely upon data and information—
‘‘(1) previously developed by the same sponsor (or another
sponsor that has provided the sponsor with a contractual right
of reference to such data and information); and
‘‘(2) submitted by a sponsor described in paragraph (1)
in support of one or more previously approved applications
that were submitted under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service Act,
for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject
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of an application or applications described in paragraph (2) or
for a variant protein targeted drug that is the same or incorporates
or utilizes the same variant protein targeted drug, as the drug
or drugs that are the subject of an application or applications
described in paragraph (2).
‘‘(c) DEFINITIONS.—For purposes of this section—
‘‘(1) the term ‘genetically targeted drug’ means a drug
that—
‘‘(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act for the treatment of a rare disease or condition
(as such term is defined in section 526) that is serious
or life-threatening;
‘‘(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene
or its associated gene product; and
‘‘(C) incorporates or utilizes a genetically targeted technology;
‘‘(2) the term ‘genetically targeted technology’ means a
technology comprising non-replicating nucleic acid or analogous
compounds with a common or similar chemistry that is intended
to treat one or more patient subgroups, including subgroups
of patients with different mutations of a gene, with the same
disease or condition, including a disease or condition due to
other variants in the same gene; and
‘‘(3) the term ‘variant protein targeted drug’ means a drug
that—
‘‘(A) is the subject of an application under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act for the treatment of a rare disease or condition
(as such term is defined in section 526) that is serious
or life-threatening;
‘‘(B) modulates the function of a product of a mutated
gene where such mutation is responsible in whole or in
part for a given disease or condition; and
‘‘(C) is intended to treat one or more patient subgroups,
including subgroups of patients with different mutations
of a gene, with the same disease or condition.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to—
‘‘(1) alter the authority of the Secretary to approve drugs
pursuant to this Act or section 351 of the Public Health Service
Act (as authorized prior to the date of enactment of the 21st
Century Cures Act), including the standards of evidence, and
applicable conditions, for approval under such applicable Act;
or
‘‘(2) confer any new rights, beyond those authorized under
this Act or the Public Health Service Act prior to enactment
of this section, with respect to the permissibility of a sponsor
referencing information contained in another application submitted under section 505(b)(1) of this Act or section 351(a)
of the Public Health Service Act.’’.
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130 STAT. 1093
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) IN GENERAL.—Section 529(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) and inserting the following:
‘‘(5) TERMINATION OF AUTHORITY.—The Secretary may not
award any priority review vouchers under paragraph (1) after
September 30, 2020, unless the rare pediatric disease product
application—
‘‘(A) is for a drug that, not later than September 30,
2020, is designated under subsection (d) as a drug for
a rare pediatric disease; and
‘‘(B) is, not later than September 30, 2022, approved
under section 505(b)(1) of this Act or section 351(a) of
the Public Health Service Act.’’.
(b) REPORT.—The Advancing Hope Act of 2016 (Public Law
114–229) is amended by striking section 3.
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SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.
(a) STUDY.—The Comptroller General of the United States
(referred to in this section as the ‘‘Comptroller General’’) shall
conduct a study addressing the effectiveness and overall impact
of the following priority review voucher programs, including any
such programs amended or established by this Act:
(1) The neglected tropical disease priority review voucher
program under section 524 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n).
(2) The rare pediatric disease priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff).
(3) The medical countermeasure priority review voucher
program under section 565A of the Federal Food, Drug, and
Cosmetic Act, as added by section 3086.
(b) ISSUANCE OF REPORT.—Not later than January 31, 2020,
the Comptroller General 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
containing the results of the study under subsection (a).
(c) CONTENTS OF REPORTS.—The report submitted under subsection (b) shall address—
(1) for each drug for which a priority review voucher has
been awarded as of initiation of the study—
(A) the indications for which the drug is approved
under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application
under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C.
262(a));
(B) whether, and to what extent, the voucher impacted
the sponsor’s decision to develop the drug; and
(C) whether, and to what extent, the approval or licensure of the drug, as applicable and appropriate—
(i) addressed a global unmet need related to the
treatment or prevention of a neglected tropical disease,
including whether the sponsor of a drug coordinated
with international development organizations;
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(ii) addressed an unmet need related to the treatment of a rare pediatric disease; or
(iii) affected the Nation’s preparedness against a
chemical, biological, radiological, or nuclear threat,
including naturally occurring threats;
(2) for each drug for which a priority review voucher has
been used—
(A) the indications for which such drug is approved
under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application
under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C.
262);
(B) the value of the voucher, if transferred; and
(C) the length of time between the date on which
the voucher was awarded and the date on which the
voucher was used; and
(3) an analysis of the priority review voucher programs
described in subsection (a), including—
(A) the resources used by the Food and Drug Administration in reviewing drugs for which vouchers were used,
including the effect of the programs on the Food and Drug
Administration’s review of drugs for which priority review
vouchers were not awarded or used;
(B) whether any improvements to such programs are
necessary to appropriately target incentives for the development of drugs that would likely not otherwise be developed,
or developed in as timely a manner, and, as applicable
and appropriate—
(i) address global unmet needs related to the treatment or prevention of neglected tropical diseases,
including in countries in which neglected tropical diseases are endemic; or
(ii) address unmet needs related to the treatment
of rare pediatric diseases; and
(C) whether the sunset of the rare pediatric disease
program and medical countermeasure program has had
an impact on the program, including any potential unintended consequences.
(d) PROTECTION OF NATIONAL SECURITY.—The Comptroller General shall conduct the study and issue reports under this section
in a manner that does not compromise national security.
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SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is
amended—
(1) in subsection (a), by striking paragraph (1) and inserting
the following: ‘‘(1) defraying the costs of developing drugs for
rare diseases or conditions, including qualified testing
expenses,’’; and
(2) in subsection (b)(1)—
(A) in subparagraph (A)(ii), by striking ‘‘and’’ after
the semicolon;
(B) in subparagraph (B), by striking the period and
inserting ‘‘; and’’; and
(C) by adding at the end the following:
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130 STAT. 1095
‘‘(C) prospectively planned and designed observational
studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition
and in the development of a therapy, including studies
and analyses to—
‘‘(i) develop or validate a drug development tool
related to a rare disease or condition; or
‘‘(ii) understand the full spectrum of the disease
manifestations, including describing genotypic and
phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition.’’.
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING.
21 USC 399h.
(a) IN GENERAL.—The Secretary of Health and Human Services
may award grants to institutions of higher education and nonprofit
organizations for the purpose of studying and recommending
improvements to the process of continuous manufacturing of drugs
and biological products and similar innovative monitoring and control techniques.
(b) DEFINITIONS.—In this section—
(1) the term ‘‘drug’’ has the meaning given such term
in section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321);
(2) the term ‘‘biological product’’ has the meaning given
such term in section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)); and
(3) the term ‘‘institution of higher education’’ has the
meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)).
Subtitle C—Modern Trial Design and
Evidence Development
SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS.
21 USC 355 note.
(a) PROPOSALS FOR USE OF NOVEL CLINICAL TRIAL DESIGNS
DRUGS AND BIOLOGICAL PRODUCTS.—For purposes of assisting
sponsors in incorporating complex adaptive and other novel trial
designs into proposed clinical protocols and applications for new
drugs under section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) and biological products under section 351 of
the Public Health Service Act (42 U.S.C. 262), the Secretary of
Health and Human Services (referred to in this section as the
‘‘Secretary’’) shall conduct a public meeting and issue guidance
in accordance with subsection (b).
(b) GUIDANCE ADDRESSING USE OF NOVEL CLINICAL TRIAL
DESIGNS.—
(1) IN GENERAL.—The Secretary, acting through the
Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel
trial design in the development and regulatory review and
approval or licensure for drugs and biological products.
(2) CONTENTS.—The guidance under paragraph (1) shall
address—
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FOR
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(A) the use of complex adaptive and other novel trial
designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard
under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—
(i) completion of such modeling or simulations;
or
(ii) the submission of resulting information to the
Secretary;
(C) the types of quantitative and qualitative information that should be submitted for review; and
(D) recommended analysis methodologies.
(3) PUBLIC MEETING.—Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult
with stakeholders, including representatives of regulated
industry, academia, patient advocacy organizations, consumer
groups, and disease research foundations, through a public
meeting to be held not later than 18 months after the date
of enactment of this Act.
(4) TIMING.—The Secretary shall update or issue a draft
version of the guidance required by paragraph (1) not later
than 18 months after the date of the public meeting required
by paragraph (3) and finalize such guidance not later than
1 year after the date on which the public comment period
for the draft guidance closes.
SEC. 3022. REAL WORLD EVIDENCE.
Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 505E (21 U.S.C. 355f) the following:
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21 USC 355g.
‘‘SEC. 505F. UTILIZING REAL WORLD EVIDENCE.
‘‘(a) IN GENERAL.—The Secretary shall establish a program
to evaluate the potential use of real world evidence—
‘‘(1) to help to support the approval of a new indication
for a drug approved under section 505(c); and
‘‘(2) to help to support or satisfy postapproval study requirements.
‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this section, the term
‘real world evidence’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than
randomized clinical trials.
‘‘(c) PROGRAM FRAMEWORK.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date
of enactment of the 21st Century Cures Act, the Secretary
shall establish a draft framework for implementation of the
program under this section.
‘‘(2) CONTENTS OF FRAMEWORK.—The framework shall
include information describing—
‘‘(A) the sources of real world evidence, including
ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research
activities;
‘‘(B) the gaps in data collection activities;
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130 STAT. 1097
‘‘(C) the standards and methodologies for collection
and analysis of real world evidence; and
‘‘(D) the priority areas, remaining challenges, and
potential pilot opportunities that the program established
under this section will address.
‘‘(3) CONSULTATION.—
‘‘(A) IN GENERAL.—In developing the program framework under this subsection, the Secretary shall consult
with regulated industry, academia, medical professional
organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.
‘‘(B) PROCESS.—The consultation under subparagraph
(A) may be carried out through approaches such as—
‘‘(i) a public-private partnership with the entities
described in such subparagraph in which the Secretary
may participate;
‘‘(ii) a contract, grant, or other arrangement, as
the Secretary determines appropriate, with such a
partnership or an independent research organization;
or
‘‘(iii) public workshops with the entities described
in such subparagraph.
‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary shall, not later
than 2 years after the date of enactment of the 21st Century
Cures Act and in accordance with the framework established under
subsection (c), implement the program to evaluate the potential
use of real world evidence.
‘‘(e) GUIDANCE FOR INDUSTRY.—The Secretary shall—
‘‘(1) utilize the program established under subsection (a),
its activities, and any subsequent pilots or written reports,
to inform a guidance for industry on—
‘‘(A) the circumstances under which sponsors of drugs
and the Secretary may rely on real world evidence for
the purposes described in paragraphs (1) and (2) of subsection (a); and
‘‘(B) the appropriate standards and methodologies for
collection and analysis of real world evidence submitted
for such purposes;
‘‘(2) not later than 5 years after the date of enactment
of the 21st Century Cures Act, issue draft guidance for industry
as described in paragraph (1); and
‘‘(3) not later than 18 months after the close of the public
comment period for the draft guidance described in paragraph
(2), issue revised draft guidance or final guidance.
‘‘(f) RULE OF CONSTRUCTION.—
‘‘(1) IN GENERAL.—Subject to paragraph (2), nothing in
this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the
Secretary determines that sufficient basis exists for any such
nonspecified use.
‘‘(2)
STANDARDS
OF
EVIDENCE
AND
SECRETARY’S
AUTHORITY.—This section shall not be construed to alter—
‘‘(A) the standards of evidence under—
‘‘(i) subsection (c) or (d) of section 505, including
the substantial evidence standard in such subsection
(d); or
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‘‘(ii) section 351(a) of the Public Health Service
Act; or
‘‘(B) the Secretary’s authority to require postapproval
studies or clinical trials, or the standards of evidence under
which studies or trials are evaluated.’’.
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42 USC 289 note.
SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS.
(a) IN GENERAL.—In order to simplify and facilitate compliance
by researchers with applicable regulations for the protection of
human subjects in research, the Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’) shall, to
the extent practicable and consistent with other statutory provisions, harmonize differences between the HHS Human Subject
Regulations and the FDA Human Subject Regulations in accordance
with subsection (b).
(b) AVOIDING REGULATORY DUPLICATION AND UNNECESSARY
DELAYS.—The Secretary shall, as appropriate—
(1) make such modifications to the provisions of the HHS
Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary—
(A) to reduce regulatory duplication and unnecessary
delays;
(B) to modernize such provisions in the context of
multisite and cooperative research projects; and
(C) to protect vulnerable populations, incorporate local
considerations, and support community engagement
through mechanisms such as consultation with local
researchers and human research protection programs, in
a manner consistent with subparagraph (B); and
(2) ensure that human subject research that is subject
to the HHS Human Subject Regulations and to the FDA Human
Subject Regulations may—
(A) use joint or shared review;
(B) rely upon the review of—
(i) an independent institutional review board; or
(ii) an institutional review board of an entity other
than the sponsor of the research; or
(C) use similar arrangements to avoid duplication of
effort.
(c) CONSULTATION.—In harmonizing or modifying regulations
or guidance under this section, the Secretary shall consult with
stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology,
and medical device developers, clinical research organizations,
patient groups, and others).
(d) TIMING.—The Secretary shall complete the harmonization
described in subsection (a) not later than 3 years after the date
of enactment of this Act.
(e) PROGRESS REPORT.—Not later than 2 years after the date
of enactment of this Act, the Secretary shall submit to Congress
a report on the progress made toward completing such harmonization.
(f) DEFINITIONS.—
(1) HUMAN SUBJECT REGULATIONS.—In this section:
(A) FDA HUMAN SUBJECT REGULATIONS.—The term
‘‘FDA Human Subject Regulations’’ means the provisions
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of parts 50, 56, 312, and 812 of title 21, Code of Federal
Regulations (or any successor regulations).
(B) HHS HUMAN SUBJECT REGULATIONS.—The term
‘‘HHS Human Subject Regulations’’ means the provisions
of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).
(C) VULNERABLE POPULATION RULES.—The term
‘‘vulnerable population rules’’ means—
(i) except in the case of research described in clause
(ii), the provisions of subparts B through D of part
46, Code of Federal Regulations (or any successor regulations); and
(ii) in the case of research that is subject to FDA
Human Subject Regulations, the provisions applicable
to vulnerable populations under part 56 of title 21,
Code of Federal Regulations (or any successor regulations) and subpart D of part 50 of such title 21 (or
any successor regulations).
(2) INSTITUTIONAL REVIEW BOARD DEFINED.—In this section,
the term ‘‘institutional review board’’ has the meaning that
applies to the term ‘‘institutional review board’’ under the HHS
Human Subject Regulations.
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS.
(a) DEVICES.—Section 520(g)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended—
(1) in subparagraph (D), by striking ‘‘except where subject
to such conditions as the Secretary may prescribe, the investigator’’ and inserting the following: ‘‘except where, subject to
such conditions as the Secretary may prescribe—
‘‘(i) the proposed clinical testing poses no more than
minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare
of the human subject; or
‘‘(ii) the investigator’’; and
(2) in the matter following subparagraph (D), by striking
‘‘subparagraph (D)’’ and inserting ‘‘subparagraph (D)(ii)’’.
(b) DRUGS.—Section 505(i)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ‘‘except
where it is not feasible or it is contrary to the best interests
of such human beings’’ and inserting ‘‘except where it is not feasible,
it is contrary to the best interests of such human beings, or the
proposed clinical testing poses no more than minimal risk to such
human beings and includes appropriate safeguards as prescribed
to protect the rights, safety, and welfare of such human beings’’.
Subtitle D—Patient Access to Therapies
and Information
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SEC. 3031. SUMMARY LEVEL REVIEW.
(a) FFDCA.—Section 505(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the end
the following:
‘‘(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with respect
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to a qualified indication for a drug, submitted under subsection
(b), if such supplemental application complies with subparagraph
(B).
‘‘(B) A supplemental application is eligible for review as
described in subparagraph (A) only if—
‘‘(i) there is existing data available and acceptable to the
Secretary demonstrating the safety of the drug; and
‘‘(ii) all data used to develop the qualified data summaries
are submitted to the Secretary as part of the supplemental
application.
‘‘(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually—
‘‘(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
‘‘(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act;
‘‘(iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under
subparagraph (A) or section 351(a)(2)(E) of the Public Health
Service Act; and
‘‘(iv) the number of applications reviewed under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service
Act for which the Secretary made use of full data sets in
addition to the qualified data summary.
‘‘(D) In this paragraph—
‘‘(i) the term ‘qualified indication’ means an indication for
a drug that the Secretary determines to be appropriate for
summary level review under this paragraph; and
‘‘(ii) the term ‘qualified data summary’ means a summary
of clinical data that demonstrates the safety and effectiveness
of a drug with respect to a qualified indication.’’.
(b) PHSA.—Section 351(a)(2) of the Public Health Service Act
(42 U.S.C. 262(a)(2)) is amended by adding at the end the following:
‘‘(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.’’.
SEC. 3032. EXPANDED ACCESS POLICY.
Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 561 (21 U.S.C. 360bbb) the
following:
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21 USC
360bbb–0.
‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS.
‘‘(a) IN GENERAL.—The manufacturer or distributor of one or
more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make
available the policy of the manufacturer or distributor on evaluating
and responding to requests submitted under section 561(b) for provision of such a drug.
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‘‘(b) PUBLIC AVAILABILITY OF EXPANDED ACCESS POLICY.—The
policies under subsection (a) shall be made public and readily
available, such as by posting such policies on a publicly available
Internet website. Such policies may be generally applicable to all
investigational drugs of such manufacturer or distributor.
‘‘(c) CONTENT OF POLICY.—A policy described in subsection (a)
shall include—
‘‘(1) contact information for the manufacturer or distributor
to facilitate communication about requests described in subsection (a);
‘‘(2) procedures for making such requests;
‘‘(3) the general criteria the manufacturer or distributor
will use to evaluate such requests for individual patients, and
for responses to such requests;
‘‘(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests; and
‘‘(5) a hyperlink or other reference to the clinical trial
record containing information about the expanded access for
such drug that is required under section 402(j)(2)(A)(ii)(II)(gg)
of the Public Health Service Act.
‘‘(d) NO GUARANTEE OF ACCESS.—The posting of policies by
manufacturers and distributors under subsection (a) shall not serve
as a guarantee of access to any specific investigational drug by
any individual patient.
‘‘(e) REVISED POLICY.—Nothing in this section shall prevent
a manufacturer or distributor from revising a policy required under
this section at any time.
‘‘(f) APPLICATION.—This section shall apply to a manufacturer
or distributor with respect to an investigational drug beginning
on the later of—
‘‘(1) the date that is 60 calendar days after the date of
enactment of the 21st Century Cures Act; or
‘‘(2) the first initiation of a phase 2 or phase 3 study
(as such terms are defined in section 312.21(b) and (c) of title
21, Code of Federal Regulations (or any successor regulations))
with respect to such investigational drug.’’.
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SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
THERAPIES.
(a) IN GENERAL.—Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended—
(1) by transferring subsection (e) (relating to construction)
so that it appears before subsection (f) (relating to awareness
efforts); and
(2) by adding at the end the following:
‘‘(g) REGENERATIVE ADVANCED THERAPY.—
‘‘(1) IN GENERAL.—The Secretary, at the request of the
sponsor of a drug, shall facilitate an efficient development
program for, and expedite review of, such drug if the drug
qualifies as a regenerative advanced therapy under the criteria
described in paragraph (2).
‘‘(2) CRITERIA.—A drug is eligible for designation as a regenerative advanced therapy under this subsection if—
‘‘(A) the drug is a regenerative medicine therapy (as
defined in paragraph (8));
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(B) the drug is intended to treat, modify, reverse,
or cure a serious or life-threatening disease or condition;
and
‘‘(C) preliminary clinical evidence indicates that the
drug has the potential to address unmet medical needs
for such a disease or condition.
‘‘(3) REQUEST FOR DESIGNATION.—The sponsor of a drug
may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after,
submission of an application for the investigation of the drug
under section 505(i) of this Act or section 351(a)(3) of the
Public Health Service Act.
‘‘(4) DESIGNATION.—Not later than 60 calendar days after
the receipt of a request under paragraph (3), the Secretary
shall determine whether the drug that is the subject of the
request meets the criteria described in paragraph (2). If the
Secretary determines that the drug meets the criteria, the
Secretary shall designate the drug as a regenerative advanced
therapy and shall take such actions as are appropriate under
paragraph (1). If the Secretary determines that a drug does
not meet the criteria for such designation, the Secretary shall
include with the determination a written description of the
rationale for such determination.
‘‘(5) ACTIONS.—The sponsor of a regenerative advanced
therapy shall be eligible for the actions to expedite development
and review of such therapy under subsection (a)(3)(B), including
early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval
of an application for the product under subsection (c).
‘‘(6) ACCESS TO EXPEDITED APPROVAL PATHWAYS.—An
application for a regenerative advanced therapy under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act may be—
‘‘(A) eligible for priority review, as described in the
Manual of Policies and Procedures of the Food and Drug
Administration and goals identified in the letters described
in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and
‘‘(B) eligible for accelerated approval under subsection
(c), as agreed upon pursuant to subsection (a)(3)(B),
through, as appropriate—
‘‘(i) surrogate or intermediate endpoints reasonably
likely to predict long-term clinical benefit; or
‘‘(ii) reliance upon data obtained from a meaningful
number of sites, including through expansion to additional sites, as appropriate.
‘‘(7) POSTAPPROVAL REQUIREMENTS.—The sponsor of a
regenerative advanced therapy that is granted accelerated
approval and is subject to the postapproval requirements under
subsection (c) may, as appropriate, fulfill such requirements,
as the Secretary may require, through—
‘‘(A) the submission of clinical evidence, clinical studies,
patient registries, or other sources of real world evidence,
such as electronic health records;
‘‘(B) the collection of larger confirmatory data sets,
as agreed upon pursuant to subsection (a)(3)(B); or
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130 STAT. 1103
‘‘(C) postapproval monitoring of all patients treated
with such therapy prior to approval of the therapy.
‘‘(8) DEFINITION.—For purposes of this section, the term
‘regenerative medicine therapy’ includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or
products, except for those regulated solely under section 361
of the Public Health Service Act and part 1271 of title 21,
Code of Federal Regulations.’’.
(b) RULE OF CONSTRUCTION.—Nothing in this section and the
amendments made by this section shall be construed to alter the
authority of the Secretary of Health and Human Services—
(1) to approve drugs pursuant to the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351
of the Public Health Service Act (42 U.S.C. 262) as authorized
prior to the date of enactment of the 21st Century Cures
Act, including the standards of evidence, and applicable conditions, for approval under such Acts; or
(2) to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior
to the date of enactment of the 21st Century Cures Act.
(c) CONFORMING AMENDMENT.—Section 506(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended
by inserting ‘‘and the 21st Century Cures Act’’ after ‘‘Food and
Drug Administration Safety and Innovation Act’’.
SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY,
ISOLATION, OR DELIVERY OF REGENERATIVE ADVANCED
THERAPIES.
21 USC 356 note.
21 USC 356g
note.
(a) DRAFT GUIDANCE.—Not later than 1 year after the date
of enactment of the 21st Century Cures Act, the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs, shall issue draft guidance clarifying how, in the context
of regenerative advanced therapies, the Secretary will evaluate
devices used in the recovery, isolation, or delivery of regenerative
advanced therapies. In doing so, the Secretary shall specifically
address—
(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination
device and cell or tissue products;
(2) what, if any, intended uses or specific attributes would
result in a device used with a regenerative therapy product
to be classified as a class III device;
(3) when the Food and Drug Administration considers it
is necessary, if ever, for the intended use of a device to be
limited to a specific intended use with only one particular
type of cell; and
(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell
type.
(b) FINAL GUIDANCE.—Not later than 12 months after the close
of the period for public comment on the draft guidance under
subsection (a), the Secretary of Health and Human Services shall
finalize such guidance.
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SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES.
21 USC 356 note.
(a) REPORT TO CONGRESS.—Before March 1 of each calendar
year, the Secretary of Health and Human Services shall, with
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PUBLIC LAW 114–255—DEC. 13, 2016
respect to the previous calendar year, submit 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 on—
(1) the number and type of applications for approval of
regenerative advanced therapies filed, approved or licensed as
applicable, withdrawn, or denied; and
(2) how many of such applications or therapies, as
applicable, were granted accelerated approval or priority
review.
(b) REGENERATIVE ADVANCED THERAPY.—In this section, the
term ‘‘regenerative advanced therapy’’ has the meaning given such
term in section 506(g) of the Federal Food, Drug, and Cosmetic
Act, as added by section 3033 of this Act.
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES.
Subchapter A of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 506F the following:
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21 USC 356g.
‘‘SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES.
‘‘(a) IN GENERAL.—Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary, in consultation with the National Institute of Standards and Technology and
stakeholders (including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine and advanced therapies industry organizations, and standard
setting organizations), shall facilitate an effort to coordinate and
prioritize the development of standards and consensus definition
of terms, through a public process, to support, through regulatory
predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies,
including with respect to the manufacturing processes and controls
of such products.
‘‘(b) ACTIVITIES.—
‘‘(1) IN GENERAL.—In carrying out this section, the Secretary shall continue to—
‘‘(A) identity opportunities to help advance the development of regenerative medicine therapies and regenerative
advanced therapies;
‘‘(B) identify opportunities for the development of laboratory regulatory science research and documentary
standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and
‘‘(C) work with stakeholders, such as those described
in subsection (a), as appropriate, in the development of
such standards.
‘‘(2) REGULATIONS AND GUIDANCE.—Not later than 1 year
after the development of standards as described in subsection
(a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations
and guidance as the Secretary determines appropriate.
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‘‘(c) DEFINITIONS.—For purposes of this section, the terms
‘regenerative medicine therapy’ and ‘regenerative advanced therapy’
have the meanings given such terms in section 506(g).’’.
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.
Section 502(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(a)) is amended—
(1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) If its’’;
(2) by striking ‘‘a formulary committee, or other similar
entity, in the course of the committee or the entity carrying
out its responsibilities for the selection of drugs for managed
care or other similar organizations’’ and inserting ‘‘a payor,
formulary committee, or other similar entity with knowledge
and expertise in the area of health care economic analysis,
carrying out its responsibilities for the selection of drugs for
coverage or reimbursement’’;
(3) by striking ‘‘directly relates’’ and inserting ‘‘relates’’;
(4) by striking ‘‘and is based on competent and reliable
scientific evidence. The requirements set forth in section 505(a)
or in section 351(a) of the Public Health Service Act shall
not apply to health care economic information provided to such
a committee or entity in accordance with this paragraph’’ and
inserting ‘‘, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between
the health care economic information and the labeling approved
for the drug under section 505 or under section 351 of the
Public Health Service Act. The requirements set forth in section
505(a) or in subsections (a) and (k) of section 351 of the Public
Health Service Act shall not apply to health care economic
information provided to such a payor, committee, or entity
in accordance with this paragraph’’; and
(5) by striking ‘‘In this paragraph, the term’’ and all that
follows and inserting the following:
‘‘(2)(A) For purposes of this paragraph, the term ‘health care
economic information’ means any analysis (including the clinical
data, inputs, clinical or other assumptions, methods, results, and
other components underlying or comprising the analysis) that
identifies, measures, or describes the economic consequences, which
may be based on the separate or aggregated clinical consequences
of the represented health outcomes, of the use of a drug. Such
analysis may be comparative to the use of another drug, to another
health care intervention, or to no intervention.
‘‘(B) Such term does not include any analysis that relates only
to an indication that is not approved under section 505 or under
section 351 of the Public Health Service Act for such drug.’’.
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SEC. 3038. COMBINATION PRODUCT INNOVATION.
(a) IN GENERAL.—Section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)) is amended—
(1) by striking paragraph (3);
(2) by redesignating paragraph (2) as paragraph (7);
(3) by redesignating paragraphs (4) and (5) as paragraphs
(8) and (9), respectively;
(4) by striking ‘‘(g)(1)’’ and all that follows through the
end of paragraph (1) and inserting the following:
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(g)(1)(A) The Secretary shall, in accordance with this subsection, assign a primary agency center to regulate products that
constitute a combination of a drug, device, or biological product.
‘‘(B) The Secretary shall conduct the premarket review of any
combination product under a single application, whenever appropriate.
‘‘(C) For purposes of this subsection, the term ‘primary mode
of action’ means the single mode of action of a combination product
expected to make the greatest contribution to the overall intended
therapeutic effects of the combination product.
‘‘(D) The Secretary shall determine the primary mode of action
of the combination product. If the Secretary determines that the
primary mode of action is that of—
‘‘(i) a drug (other than a biological product), the agency
center charged with premarket review of drugs shall have
primary jurisdiction;
‘‘(ii) a device, the agency center charged with premarket
review of devices shall have primary jurisdiction; or
‘‘(iii) a biological product, the agency center charged with
premarket review of biological products shall have primary
jurisdiction.
‘‘(E) In determining the primary mode of action of a combination
product, the Secretary shall not determine that the primary mode
of action is that of a drug or biological product solely because
the combination product has any chemical action within or on
the human body.
‘‘(F) If a sponsor of a combination product disagrees with the
determination under subparagraph (D)—
‘‘(i) such sponsor may request, and the Secretary shall
provide, a substantive rationale to such sponsor that references
scientific evidence provided by the sponsor and any other scientific evidence relied upon by the Secretary to support such
determination; and
‘‘(ii)(I) the sponsor of the combination product may propose
one or more studies (which may be nonclinical, clinical, or
both) to establish the relevance, if any, of the chemical action
in achieving the primary mode of action of such product;
‘‘(II) if the sponsor proposes any such studies, the Secretary
and the sponsor of such product shall collaborate and seek
to reach agreement, within a reasonable time of such proposal,
not to exceed 90 calendar days, on the design of such studies;
and
‘‘(III) if an agreement is reached under subclause (II) and
the sponsor conducts one or more of such studies, the Secretary
shall consider the data resulting from any such study when
reevaluating the determination of the primary mode of action
of such product, and unless and until such reevaluation has
occurred and the Secretary issues a new determination, the
determination of the Secretary under subparagraph (D) shall
remain in effect.
‘‘(2)(A)(i) To establish clarity and certainty for the sponsor,
the sponsor of a combination product may request a meeting on
such combination product. If the Secretary concludes that a determination of the primary mode of action pursuant to paragraph
(1)(D) is necessary, the sponsor may request such meeting only
after the Secretary makes such determination. If the sponsor submits a written meeting request, the Secretary shall, not later than
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130 STAT. 1107
75 calendar days after receiving such request, meet with the sponsor
of such combination product.
‘‘(ii) A meeting under clause (i) may—
‘‘(I) address the standards and requirements for market
approval or clearance of the combination product;
‘‘(II) address other issues relevant to such combination
product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and
‘‘(III) identify elements under subclauses (I) and (II) that
may be more appropriate for discussion and agreement with
the Secretary at a later date given that scientific or other
information is not available, or agreement is otherwise not
feasible regarding such elements, at the time a request for
such meeting is made.
‘‘(iii) Any agreement under this subparagraph shall be in
writing and made part of the administrative record by the Secretary.
‘‘(iv) Any such agreement shall remain in effect, except—
‘‘(I) upon the written agreement of the Secretary and the
sponsor or applicant; or
‘‘(II) pursuant to a decision by the director of the reviewing
division of the primary agency center, or a person more senior
than such director, in consultation with consulting centers and
the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other
applicable standard under this Act or the Public Health Service
Act applicable to the combination product has been identified
since the agreement was reached, or that deviating from the
agreement is otherwise justifiable based on scientific evidence,
for public health reasons.
‘‘(3) For purposes of conducting the premarket review of a
combination product that contains an approved constituent part
described in paragraph (4), the Secretary may require that the
sponsor of such combination product submit to the Secretary only
data or information that the Secretary determines is necessary
to meet the standard for clearance or approval, as applicable, under
this Act or the Public Health Service Act, including any incremental
risks and benefits posed by such combination product, using a
risk-based approach and taking into account any prior finding of
safety and effectiveness or substantial equivalence for the approved
constituent part relied upon by the applicant in accordance with
paragraph (5).
‘‘(4) For purposes of paragraph (3), an approved constituent
part is—
‘‘(A) a drug constituent part of a combination product being
reviewed in a single application or request under section 515,
510(k), or 513(f)(2) (submitted in accordance with paragraph
(5)), that is an approved drug, provided such application or
request complies with paragraph (5);
‘‘(B) a device constituent part approved under section 515
that is referenced by the sponsor and that is available for
use by the Secretary under section 520(h)(4); or
‘‘(C) any constituent part that was previously approved,
cleared, or classified under section 505, 510(k), 513(f)(2), or
515 of this Act for which the sponsor has a right of reference
or any constituent part that is a nonprescription drug, as
defined in section 760(a)(2).
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(5)(A) If an application is submitted under section 515 or
510(k) or a request is submitted under section 513(f)(2), consistent
with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved
drug—
‘‘(i) the application or request shall include the certification
or statement described in section 505(b)(2); and
‘‘(ii) the applicant or requester shall provide notice as
described in section 505(b)(3).
‘‘(B) For purposes of this paragraph and paragraph (4), the
term ‘approved drug’ means an active ingredient—
‘‘(i) that was in an application previously approved under
section 505(c);
‘‘(ii) where such application is relied upon by the applicant
submitting the application or request described in subparagraph (A);
‘‘(iii) for which full reports of investigations that have been
made to show whether such drug is safe for use and whether
such drug is effective in use were not conducted by or for
the applicant submitting the application or request described
in subparagraph (A); and
‘‘(iv) for which the applicant submitting the application
or request described in subparagraph (A) has not obtained
a right of reference or use from the person by or for whom
the investigations described in clause (iii) were conducted.
‘‘(C) The following provisions shall apply with respect to an
application or request described in subparagraph (A) to the same
extent and in the same manner as if such application or request
were an application described in section 505(b)(2) that referenced
the approved drug:
‘‘(i) Subparagraphs (A), (B), (C), and (D) of section 505(c)(3).
‘‘(ii) Clauses (ii), (iii), and (iv) of section 505(c)(3)(E).
‘‘(iii) Subsections (b) and (c) of section 505A.
‘‘(iv) Section 505E(a).
‘‘(v) Section 527(a).
‘‘(D) Notwithstanding any other provision of this subsection,
an application or request for classification for a combination product
described in subparagraph (A) shall be considered an application
submitted under section 505(b)(2) for purposes of section
271(e)(2)(A) of title 35, United States Code.
‘‘(6) Nothing in this subsection shall be construed as prohibiting
a sponsor from submitting separate applications for the constituent
parts of a combination product, unless the Secretary determines
that a single application is necessary.’’;
(5) in paragraph (8) (as redesignated by paragraph (3))—
(A) in subparagraph (C)—
(i) by amending clause (i) to read as follows:
‘‘(i) In carrying out this subsection, the Office shall help to
ensure timely and effective premarket review that involves more
than one agency center by coordinating such reviews, overseeing
the timeliness of such reviews, and overseeing the alignment of
feedback regarding such reviews.’’;
(ii) in clause (ii), by inserting ‘‘and alignment’’
after ‘‘the timeliness’’ each place it appears; and
(iii) by adding at the end the following new clauses:
‘‘(iii) The Office shall ensure that, with respect to a combination
product, a designated person or persons in the primary agency
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130 STAT. 1109
center is the primary point or points of contact for the sponsor
of such combination product. The Office shall also coordinate
communications to and from any consulting center involved in
such premarket review, if requested by such primary agency center
or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and
the requirements of all affected agency centers, from the primary
agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.
‘‘(iv) The Office shall, with respect to the premarket review
of a combination product—
‘‘(I) ensure that any meeting between the Secretary and
the sponsor of such product is attended by each agency center
involved in the review, as appropriate;
‘‘(II) ensure that each consulting agency center has completed its premarket review and provided the results of such
review to the primary agency center in a timely manner; and
‘‘(III) ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on
other relevant regulations, guidances, and policies.
‘‘(v) In seeking agency action with respect to a combination
product, the sponsor of such product—
‘‘(I) shall identify the product as a combination product;
and
‘‘(II) may request in writing the participation of representatives of the Office in meetings related to such combination
product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.
‘‘(vi) Not later than 4 years after the date of enactment of
the 21st Century Cures Act, and after a public comment period
of not less than 60 calendar days, the Secretary shall issue a
final guidance that describes—
‘‘(I) the structured process for managing pre-submission
interactions with sponsors developing combination products;
‘‘(II) the best practices for ensuring that the feedback in
such pre-submission interactions represents the Agency’s best
advice based on the information provided during such presubmission interactions;
‘‘(III) the information that is required to be submitted
with a meeting request under paragraph (2), how such meetings
relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached
through a meeting under such paragraph (2);’’; and
(B) in subparagraph (G)—
(i) in the matter preceding clause (i), by inserting
‘‘(except with respect to clause (iv), beginning not later
than one year after the date of the enactment of the
21st Century Cures Act)’’ after ‘‘enactment of this paragraph’’;
(ii) in clause (ii), by striking ‘‘and’’ at the end;
(iii) in clause (iii), by striking the period at the
end and inserting ‘‘; and’’; and
(iv) by adding at the end the following new clause:
‘‘(iv) identifying the percentage of combination products
for which a dispute resolution, with respect to premarket
review, was requested by the combination product’s sponsor.’’;
and
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21 USC 355 note.
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PUBLIC LAW 114–255—DEC. 13, 2016
(6) in paragraph (9) (as redesignated by paragraph (3))—
(A) in subparagraph (C)—
(i) in clause (i), by striking the comma at the
end and inserting a semicolon;
(ii) in clause (ii), by striking ‘‘, and’’ at the end
and inserting a semicolon;
(iii) in clause (iii), by striking the period at the
end and inserting ‘‘; and’’; and
(iv) by adding at the end the following:
‘‘(iv) de novo classification under section
513(a)(1).’’; and
(B) by adding at the end the following:
‘‘(D) The terms ‘premarket review’ and ‘reviews’ include
all activities of the Food and Drug Administration conducted
prior to approval or clearance of an application, notification,
or request for classification submitted under section 505, 510(k),
513(f)(2), 515, or 520 of this Act or under section 351 of the
Public Health Service Act, including with respect to investigational use of the product.’’.
(b) INFORMATION FOR APPROVAL OF COMBINATION PRODUCTS.—
Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(h)(4)) is amended—
(1) in subparagraph (A), by striking ‘‘Any information’’
and inserting ‘‘Subject to subparagraph (C), any information’’;
and
(2) by adding at the end the following new subparagraph:
‘‘(C) No information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c) may
be used to approve or clear any application submitted under section
515 or 510(k) or to classify a product under section 513(f)(2) for
a combination product containing as a constituent part an approved
drug (as defined in section 503(g)(5)(B)) unless—
‘‘(i) the application includes the certification or statement
referenced in section 503(g)(5)(A);
‘‘(ii) the applicant provides notice as described in section
503(g)(5)(A); and
‘‘(iii) the Secretary’s approval of such application is subject
to the provisions in section 503(g)(5)(C).’’.
(c) VARIATIONS FROM CGMP STREAMLINED APPROACH.—Not
later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services (referred to in this
subsection as the ‘‘Secretary’’) shall identify types of combination
products and manufacturing processes with respect to which the
Secretary proposes that good manufacturing processes may be
adopted that vary from the requirements set forth in section 4.4
of title 21, Code of Federal Regulations (or any successor regulations) or that the Secretary proposes can satisfy the requirements
in section 4.4 through alternative or streamlined mechanisms. The
Secretary shall identify such types, variations from such requirements, and such mechanisms, in a proposed list published in the
Federal Register. After a public comment period regarding the
appropriate good manufacturing practices for such types, the Secretary shall publish a final list in the Federal Register, notwithstanding section 553 of title 5, United States Code. The Secretary
shall evaluate such types, variations, and mechanisms using a
risk-based approach. The Secretary shall periodically review such
final list.
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130 STAT. 1111
Subtitle E—Antimicrobial Innovation and
Stewardship
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SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.
(a) IN GENERAL.—Section 319E of the Public Health Service
Act (42 U.S.C. 247d–5) is amended—
(1) by redesignating subsections (f) and (g) as subsections
(l) and (m), respectively; and
(2) by inserting after subsection (e), the following:
‘‘(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.
‘‘(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.
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(j) ANTIMICROBIAL RESISTANCE
AND
STEWARDSHIP ACTIVI-
TIES.—
42 USC 247d–5
note.
‘‘(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) 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.’’.
(b) AVAILABILITY OF DATA.—The Secretary shall make the data
collected pursuant to this subsection public. Nothing in this subsection shall be construed as authorizing the Secretary to disclose
any information that is a trade secret or confidential information
subject to section 552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code.
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SEC. 3042. LIMITED POPULATION PATHWAY.
Section 506 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356), as amended by section 3033, is further amended by
adding at the end the following:
‘‘(h) LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL AND
ANTIFUNGAL DRUGS.—
‘‘(1) IN GENERAL.—The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one
or more other drugs, as a limited population drug pursuant
to this subsection only if—
‘‘(A) the drug is intended to treat a serious or lifethreatening infection in a limited population of patients
with unmet needs;
‘‘(B) the standards for approval under section 505(c)
and (d), or the standards for licensure under section 351
of the Public Health Service Act, as applicable, are met;
and
‘‘(C) the Secretary receives a written request from the
sponsor to approve the drug as a limited population drug
pursuant to this subsection.
‘‘(2) BENEFIT-RISK CONSIDERATION.—The Secretary’s determination of safety and effectiveness of an antibacterial or
antifungal drug shall reflect the benefit-risk profile of such
drug in the intended limited population, taking into account
the severity, rarity, or prevalence of the infection the drug
is intended to treat and the availability or lack of alternative
treatment in such limited population. Such drug may be
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130 STAT. 1113
approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a
population that is broader than the intended limited population.
‘‘(3) ADDITIONAL REQUIREMENTS.—A drug approved under
this subsection shall be subject to the following requirements,
in addition to any other applicable requirements of this Act:
‘‘(A) LABELING.—To indicate that the safety and
effectiveness of a drug approved under this subsection has
been demonstrated only with respect to a limited population—
‘‘(i) all labeling and advertising of an antibacterial
or antifungal drug approved under this subsection shall
contain the statement ‘Limited Population’ in a prominent manner and adjacent to, and not more prominent
than—
‘‘(I) the proprietary name of such drug, if any;
or
‘‘(II) if there is no proprietary name, the established name of the drug, if any, as defined in
section 503(e)(3), or, in the case of a drug that
is a biological product, the proper name, as defined
by regulation; and
‘‘(ii) the prescribing information for the drug
required by section 201.57 of title 21, Code of Federal
Regulations (or any successor regulation) shall also
include the following statement: ‘This drug is indicated
for use in a limited and specific population of patients.’.
‘‘(B) PROMOTIONAL MATERIAL.—The sponsor of an antibacterial or antifungal drug subject to this subsection shall
submit to the Secretary copies of all promotional materials
related to such drug at least 30 calendar days prior to
dissemination of the materials.
‘‘(4) OTHER PROGRAMS.—A sponsor of a drug that seeks
approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other
applicable sections or subsections of this Act or the Public
Health Service Act.
‘‘(5) GUIDANCE.—Not later than 18 months after the date
of enactment of the 21st Century Cures Act, the Secretary
shall issue draft guidance describing criteria, processes, and
other general considerations for demonstrating the safety and
effectiveness of limited population antibacterial and antifungal
drugs. The Secretary shall publish final guidance within 18
months of the close of the public comment period on such
draft guidance. The Secretary may approve antibacterial and
antifungal drugs under this subsection prior to issuing guidance
under this paragraph.
‘‘(6) ADVICE.—The Secretary shall provide prompt advice
to the sponsor of a drug for which the sponsor seeks approval
under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval,
and to conduct any additional studies that would be required
to gain approval of such drug for use in a broader population.
‘‘(7) TERMINATION OF LIMITATIONS.—If, after approval of
a drug under this subsection, the Secretary approves a broader
indication for such drug under section 505(b) or section 351(a)
of the Public Health Service Act, the Secretary may remove
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130 STAT. 1114
PUBLIC LAW 114–255—DEC. 13, 2016
any postmarketing conditions, including requirements with
respect to labeling and review of promotional materials under
paragraph (3), applicable to the approval of the drug under
this subsection.
‘‘(8) RULES OF CONSTRUCTION.—Nothing in this subsection
shall be construed to alter the authority of the Secretary to
approve drugs pursuant to this Act or section 351 of the Public
Health Service Act, including the standards of evidence and
applicable conditions for approval under such Acts, the standards of approval of a drug under such Acts, or to alter the
authority of the Secretary to monitor drugs pursuant to such
Acts.
‘‘(9) REPORTING AND ACCOUNTABILITY.—
‘‘(A) BIENNIAL REPORTING.—The Secretary shall report
to Congress not less often than once every 2 years on
the number of requests for approval, and the number of
approvals, of an antibacterial or antifungal drug under
this subsection.
‘‘(B) GAO REPORT.—Not later than December 2021,
the Comptroller General of the United States shall 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
coordination of activities required under section 319E of
the Public Health Service Act. Such report shall include
a review of such activities, and the extent to which the
use of the pathway established under this subsection has
streamlined premarket approval for antibacterial or
antifungal drugs for limited populations, if such pathway
has functioned as intended, if such pathway has helped
provide for safe and effective treatment for patients, if
such premarket approval would be appropriate for other
categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.’’.
21 USC 356 note.
SEC. 3043. PRESCRIBING AUTHORITY.
Nothing in this subtitle, or an amendment made by this subtitle, shall be construed to restrict the prescribing of antimicrobial
drugs or other products, including drugs approved under subsection
(h) of section 506 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356) (as added by section 3042), by health care professionals, or to limit the practice of health care.
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS;
ANTIMICROBIAL
SUSCEPTIBILITY
TESTING DEVICES.
(a) IN GENERAL.—Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended
by inserting after section 511 the following:
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21 USC 360a–2.
‘‘SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS.
‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.—
‘‘(1) PURPOSE.—The purpose of this section is to clarify
the Secretary’s authority to—
‘‘(A) efficiently update susceptibility test interpretive
criteria for antimicrobial drugs when necessary for public
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130 STAT. 1115
health, due to, among other things, the constant evolution
of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique
management of antimicrobial drugs that is inappropriate
for most other drugs in order to delay or prevent the
development of further resistance to existing therapies;
‘‘(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and
‘‘(C) clear under section 510(k), classify under section
513(f)(2), or approve under section 515, antimicrobial
susceptibility testing devices utilizing updated, recognized
susceptibility test interpretive criteria to characterize the
in vitro susceptibility of particular bacteria, fungi, or other
microorganisms, as applicable, to antimicrobial drugs.
‘‘(2) IDENTIFICATION OF CRITERIA.—The Secretary shall
identify appropriate susceptibility test interpretive criteria with
respect to antimicrobial drugs—
‘‘(A) if such criteria are available on the date of
approval of the drug under section 505 of this Act or
licensure of the drug under section 351 of the Public Health
Service Act (as applicable), upon such approval or licensure;
or
‘‘(B) if such criteria are unavailable on such date, on
the date on which such criteria are available for such
drug.
‘‘(3) BASES FOR INITIAL IDENTIFICATION.—The Secretary
shall identify appropriate susceptibility test interpretive criteria
under paragraph (2), based on the Secretary’s review of, to
the extent available and relevant—
‘‘(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;
‘‘(B) the relationship of susceptibility test interpretive
criteria to morbidity and mortality associated with the
disease or condition for which such drug is used; and
‘‘(C) such other evidence and information as the Secretary considers appropriate.
‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA WEBSITE.—
‘‘(1) IN GENERAL.—Not later than 1 year after the date
of the enactment of the 21st Century Cures Act, the Secretary
shall establish, and maintain thereafter, on the website of
the Food and Drug Administration, a dedicated website that
contains a list of any appropriate new or updated susceptibility
test interpretive criteria standards and interpretive criteria
in accordance with paragraph (2) (referred to in this section
as the ‘Interpretive Criteria Website’).
‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA
STANDARDS AND INTERPRETIVE CRITERIA.—
‘‘(A) IN GENERAL.—The list described in paragraph (1)
shall consist of any new or updated susceptibility test
interpretive criteria standards that are—
‘‘(i) established by a nationally or internationally
recognized standard development organization that—
‘‘(I) establishes and maintains procedures to
address potential conflicts of interest and ensure
transparent decisionmaking;
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130 STAT. 1116
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(II) holds open meetings to ensure that there
is an opportunity for public input by interested
parties, and establishes and maintains processes
to ensure that such input is considered in decisionmaking; and
‘‘(III) permits its standards to be made publicly
available, through the National Library of Medicine or another similar source acceptable to the
Secretary; and
‘‘(ii) recognized in whole, or in part, by the Secretary under subsection (c).
‘‘(B) OTHER LIST.—The Interpretive Criteria Website
shall, in addition to the list described in subparagraph
(A), include a list of interpretive criteria, if any, that the
Secretary has determined to be appropriate with respect
to legally marketed antimicrobial drugs, where—
‘‘(i) the Secretary does not recognize, in whole or
in part, an interpretive criteria standard described
under subparagraph (A) otherwise applicable to such
a drug;
‘‘(ii) the Secretary withdraws under subsection
(c)(1)(A) recognition of a standard, in whole or in part,
otherwise applicable to such a drug;
‘‘(iii) the Secretary approves an application under
section 505 of this Act or section 351 of the Public
Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant
interpretive criteria included in a standard recognized
by the Secretary under subsection (c); or
‘‘(iv) because the characteristics of such a drug
differ from other drugs with the same active ingredient,
the interpretive criteria with respect to such drug—
‘‘(I) differ from otherwise applicable interpretive criteria included in a standard listed under
subparagraph (A) or interpretive criteria otherwise
listed under this subparagraph; and
‘‘(II) are determined by the Secretary to be
appropriate for the drug.
‘‘(C) REQUIRED STATEMENTS.—The Interpretive Criteria
Website shall include statements conveying—
‘‘(i) that the website provides information about
the in vitro susceptibility of bacteria, fungi, or other
microorganisms, as applicable to a certain drug (or
drugs);
‘‘(ii) that—
‘‘(I) the safety and efficacy of such drugs in
treating clinical infections due to such bacteria,
fungi, or other microorganisms, as applicable, may
or may not have been established in adequate
and well-controlled clinical trials in order for the
susceptibility information described in clause (i)
to be included on the website; and
‘‘(II) the clinical significance of such susceptibility information in such instances is unknown;
‘‘(iii) that the approved product labeling for specific
drugs provides the uses for which the Secretary has
approved the product; and
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130 STAT. 1117
‘‘(iv) any other information that the Secretary
determines appropriate to adequately convey the
meaning of the data supporting the recognition or
listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included
on the website.
‘‘(3) NOTICE.—Not later than the date on which the
Interpretive Criteria Website is established, the Secretary shall
publish a notice of that establishment in the Federal Register.
‘‘(4) INAPPLICABILITY OF MISBRANDING PROVISION.—The
inclusion in the approved labeling of an antimicrobial drug
of a reference or hyperlink to the Interpretive Criteria Website,
in and of itself, shall not cause the drug to be misbranded
in violation of section 502.
‘‘(5) TRADE SECRETS AND CONFIDENTIAL INFORMATION.—
Nothing in this section shall be construed as authorizing the
Secretary to disclose any information that is a trade secret
or confidential information subject to section 552(b)(4) of title
5, United States Code.
‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA.—
‘‘(1) EVALUATION AND PUBLICATION.—
‘‘(A) IN GENERAL.—Beginning on the date of the
establishment of the Interpretive Criteria Website, and
at least every 6 months thereafter, the Secretary shall—
‘‘(i) evaluate any appropriate new or updated
susceptibility test interpretive criteria standards established by a nationally or internationally recognized
standard development organization described in subsection (b)(2)(A)(i); and
‘‘(ii) publish on the public website of the Food
and Drug Administration a notice—
‘‘(I) withdrawing recognition of any different
susceptibility test interpretive criteria standard,
in whole or in part;
‘‘(II) recognizing the new or updated standards;
‘‘(III) recognizing one or more parts of the
new or updated interpretive criteria specified in
such a standard and declining to recognize the
remainder of such standard; and
‘‘(IV) making any necessary updates to the
lists under subsection (b)(2).
‘‘(B) UPON APPROVAL OF A DRUG.—Upon the approval
of an initial or supplemental application for an antimicrobial drug under section 505 of this Act or section
351 of the Public Health Service Act, as applicable, where
such approval is based on susceptibility test interpretive
criteria which differ from those contained in a standard
recognized, or from those otherwise listed, by the Secretary
pursuant to this subsection, or for which there are no
relevant interpretive criteria standards recognized, or
interpretive criteria otherwise listed, by the Secretary
pursuant to this subsection, the Secretary shall update
the lists under subparagraphs (A) and (B) of subsection
(b)(2) to include the susceptibility test interpretive criteria
upon which such approval was based.
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‘‘(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STANDevaluating new or updated susceptibility test
interpretive criteria standards under paragraph (1)(A), the Secretary may consider—
‘‘(A) the Secretary’s determination that such a standard
is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same
active ingredient;
‘‘(B) information provided by interested third parties,
including public comment on the annual compilation of
notices published under paragraph (3);
‘‘(C) any bases used to identify susceptibility test
interpretive criteria under subsection (a)(2); and
‘‘(D) such other information or factors as the Secretary
determines appropriate.
‘‘(3) ANNUAL COMPILATION OF NOTICES.—Each year, the
Secretary shall compile the notices published under paragraph
(1)(A) and publish such compilation in the Federal Register
and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the
Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria—
‘‘(A) recognized by the Secretary under this subsection;
or
‘‘(B) otherwise listed on the Interpretive Criteria
Website under subsection (b)(2).
‘‘(4) RELATION TO SECTION 514(c).—Any susceptibility test
interpretive standard recognized under this subsection or any
criteria otherwise listed under subsection (b)(2)(B) shall be
deemed to be recognized as a standard by the Secretary under
section 514(c)(1).
‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRITERIA.—Nothing
in this section prohibits a person from seeking approval or
clearance of a drug or device, or changes to the drug or the
device, on the basis of susceptibility test interpretive criteria
which differ from those contained in a standard recognized,
or from those otherwise listed, by the Secretary pursuant to
subsection (b)(2).
‘‘(d) ANTIMICROBIAL DRUG LABELING.—
‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISHMENT OF
INTERPRETIVE CRITERIA WEBSITE.—
‘‘(A) IN GENERAL.—With respect to an antimicrobial
drug lawfully introduced or delivered for introduction into
interstate commerce for commercial distribution before the
establishment of the Interpretive Criteria Website, a holder
of an approved application under section 505 of this Act
or section 351 of the Public Health Service Act, as
applicable, for each such drug, not later than 1 year after
establishment of the Interpretive Criteria Website
described in subsection (b)(1), shall remove susceptibility
test interpretive criteria, if any, and related information
from the approved drug labeling and replace it with a
reference to the Interpretive Criteria Website.
‘‘(B) LABELING CHANGES.—The labeling changes
required by this section shall be considered a minor change
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130 STAT. 1119
under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable
annual report.
‘‘(2) DRUGS MARKETED SUBSEQUENT TO ESTABLISHMENT OF
INTERPRETIVE CRITERIA WEBSITE.—With respect to antimicrobial
drugs approved on or after the date of the establishment of
the Interpretive Criteria Website described in subsection (b)(1),
the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.
‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTIMICROBIAL
SUSCEPTIBILITY TESTING DEVICES.—
‘‘(1) IN GENERAL.—Notwithstanding sections 501, 502, 505,
510, 513, and 515, if the conditions specified in paragraph
(2) are met (in addition to other applicable provisions under
this chapter) with respect to an antimicrobial susceptibility
testing device described in subsection (f)(1), the Secretary may
authorize the marketing of such device for a use described
in such subsection.
‘‘(2) CONDITIONS APPLICABLE TO ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES.—The conditions specified in this paragraph are the following:
‘‘(A) The device is used to make a determination of
susceptibility using susceptibility test interpretive criteria
that are—
‘‘(i) included in a standard recognized by the Secretary under subsection (c); or
‘‘(ii) otherwise listed on the Interpretive Criteria
Website under subsection (b)(2).
‘‘(B) The labeling of such device includes statements
conveying—
‘‘(i) that the device provides information about the
in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs;
‘‘(ii) that—
‘‘(I) the safety and efficacy of such drugs in
treating clinical infections due to such bacteria,
fungi, or other microorganisms, as applicable, may
or may not have been established in adequate
and well-controlled clinical trials in order for the
device to report the susceptibility of such bacteria,
fungi, or other microorganisms, as applicable, to
such drugs; and
‘‘(II) the clinical significance of such susceptibility information in those instances is unknown;
‘‘(iii) that the approved labeling for drugs tested
using such a device provides the uses for which the
Secretary has approved such drugs; and
‘‘(iv) any other information the Secretary determines appropriate to adequately convey the meaning
of the data supporting the recognition or listing of
susceptibility test interpretive criteria standards or
susceptibility test interpretive criteria described in
subparagraph (A).
‘‘(C) The antimicrobial susceptibility testing device
meets all other requirements to be cleared under section
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PUBLIC LAW 114–255—DEC. 13, 2016
510(k), classified under section 513(f)(2), or approved under
section 515.
‘‘(f) DEFINITIONS.—In this section:
‘‘(1) The term ‘antimicrobial susceptibility testing device’
means a device that utilizes susceptibility test interpretive
criteria to determine and report the in vitro susceptibility of
certain microorganisms to a drug (or drugs).
‘‘(2) The term ‘qualified infectious disease product’ means
a qualified infectious disease product designated under section
505E(d).
‘‘(3) The term ‘susceptibility test interpretive criteria’
means—
‘‘(A) one or more specific numerical values which
characterize the susceptibility of bacteria or other microorganisms to the drug tested; and
‘‘(B) related categorizations of such susceptibility,
including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary
determines appropriate.
‘‘(4)(A) The term ‘antimicrobial drug’ means, subject to
subparagraph (B), a systemic antibacterial or antifungal drug
that—
‘‘(i) is intended for human use in the treatment of
a disease or condition caused by a bacterium or fungus;
‘‘(ii) may include a qualified infectious disease product
designated under section 505E(d); and
‘‘(iii) is subject to section 503(b)(1).
‘‘(B) If provided by the Secretary through regulations, such
term may include—
‘‘(i) drugs other than systemic antibacterial and
antifungal drugs; and
‘‘(ii) biological products (as such term is defined in
section 351 of the Public Health Service Act) to the extent
such products exhibit antimicrobial activity.
‘‘(5) The term ‘interpretive criteria standard’ means a compilation of susceptibility test interpretive criteria developed by
a standard development organization that meets the criteria
set forth in subsection (b)(2)(A)(i).
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to—
‘‘(1) alter the standards of evidence under subsection (c)
or (d) of section 505 (including the substantial evidence
standard under section 505(d)) or under section 351 of the
Public Health Service Act (as applicable); or
‘‘(2) with respect to clearing devices under section 510(k),
classifying devices under section 513(f)(2), or approving devices
under section 515—
‘‘(A) apply with respect to any drug, device, or biological
product, in any context other than an antimicrobial drug
and an antimicrobial susceptibility testing device that uses
susceptibility test interpretive criteria to characterize and
report the susceptibility of certain bacteria, fungi, or other
microorganisms, as applicable, to such drug to reflect
patient morbidity and mortality in accordance with this
section; or
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130 STAT. 1121
‘‘(B) unless specifically stated, have any effect on
authorities provided under other sections of this Act,
including any regulations issued under such sections.’’.
(b) CONFORMING AMENDMENTS.—
(1) REPEAL OF PRIOR RELATED AUTHORITY.—Section 1111
of the Food and Drug Administration Amendments Act of 2007
(42 U.S.C. 247d–5a), relating to identification of clinically
susceptible concentrations of antimicrobials, is repealed.
(2) ADDITION TO CATEGORIES OF MISBRANDED DRUGS.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352) is amended by adding at the end the following:
‘‘(dd) If it is an antimicrobial drug, as defined in section 511A(f),
and its labeling fails to conform with the requirements under section
511A(d).’’.
(3) RECOGNITION OF INTERPRETIVE CRITERIA STANDARD AS
DEVICE STANDARD.—Section 514(c)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended
by inserting after ‘‘the Secretary shall, by publication in the
Federal Register’’ the following: ‘‘(or, with respect to a susceptibility test interpretive criteria standard under section 511A,
by posting on the Interpretive Criteria Website in accordance
with such section)’’.
(c) REPORT TO CONGRESS.—Not later than 2 years after the
date of enactment of this Act, the Secretary of Health and Human
Services 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 implementing section 511A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360a), as added by subsection
(a).
(d) REQUESTS FOR UPDATES TO INTERPRETIVE CRITERIA
WEBSITE.—Chapter 35 of title 44, United States Code, shall not
apply to the collection of information from interested parties
regarding updating the lists established under section 511A(b) of
the Federal Food, Drug, and Cosmetic Act and posted on the
Interpretive Criteria Website established under section 511A(c) of
such Act.
21 USC 360a–2
note.
Subtitle F—Medical Device Innovations
SEC. 3051. BREAKTHROUGH DEVICES.
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 515B, as added by section 3034(b), the following:
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‘‘SEC. 515C. BREAKTHROUGH DEVICES.
21 USC 360e–3.
‘‘(a) PURPOSE.—The purpose of this section is to encourage
the Secretary, and provide the Secretary with sufficient authority,
to apply efficient and flexible approaches to expedite the development of, and prioritize the Food and Drug Administration’s review
of, devices that represent breakthrough technologies.
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary shall establish a program to expedite the development of, and provide for
the priority review for, devices, as determined by the Secretary—
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‘‘(1) that provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human disease
or conditions; and
‘‘(2)(A) that represent breakthrough technologies;
‘‘(B) for which no approved or cleared alternatives exist;
‘‘(C) that offer significant advantages over existing
approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate
the need for hospitalization, improve patient quality of life,
facilitate patients’ ability to manage their own care (such as
through self-directed personal assistance), or establish longterm clinical efficiencies; or
‘‘(D) the availability of which is in the best interest of
patients.
‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a device may
request that the Secretary designate such device for expedited
development and priority review under this section. Any such
request for designation may be made at any time prior to the
submission of an application under section 515(c), a notification
under section 510(k), or a petition for classification under section
513(f)(2).
‘‘(d) DESIGNATION PROCESS.—
‘‘(1) IN GENERAL.—Not later than 60 calendar days after
the receipt of a request under subsection (c), the Secretary
shall determine whether the device that is the subject of the
request meets the criteria described in subsection (b). If the
Secretary determines that the device meets the criteria, the
Secretary shall designate the device for expedited development
and priority review.
‘‘(2) REVIEW.—Review of a request under subsection (c)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
‘‘(3) WITHDRAWAL.—The Secretary may not withdraw a designation granted under this section on the basis of the criteria
under subsection (b) no longer applying because of the subsequent clearance or approval of another device that—
‘‘(A) was designated under this section; or
‘‘(B) was given priority review under section 515(d)(5),
as in effect prior to the date of enactment of the 21st
Century Cures Act.
‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY REVIEW.—
‘‘(1) ACTIONS.—For purposes of expediting the development
and review of devices designated under subsection (d) the Secretary shall—
‘‘(A) assign a team of staff, including a team leader
with appropriate subject matter expertise and experience,
for each device for which a request is submitted under
subsection (c);
‘‘(B) provide for oversight of the team by senior agency
personnel to facilitate the efficient development of the
device and the efficient review of any submission described
in subsection (c) for the device;
‘‘(C) adopt an efficient process for timely dispute resolution;
‘‘(D) provide for interactive and timely communication
with the sponsor of the device during the development
program and review process;
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130 STAT. 1123
‘‘(E) expedite the Secretary’s review of manufacturing
and quality systems compliance, as applicable;
‘‘(F) disclose to the sponsor, not less than 5 business
days in advance, the topics of any consultation the Secretary intends to undertake with external experts or an
advisory committee concerning the sponsor’s device and
provide the sponsor the opportunity to recommend such
external experts;
‘‘(G) provide for advisory committee input, as the Secretary determines appropriate (including in response to
the request of the sponsor) for applications submitted under
section 515(c); and
‘‘(H) assign staff to be available within a reasonable
time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device
pursuant to an exemption under section 520(g).
‘‘(2) ADDITIONAL ACTIONS.—In addition to the actions
described in paragraph (1), for purposes of expediting the
development and review of devices designated under subsection
(d), the Secretary, in collaboration with the device sponsor,
may, as appropriate—
‘‘(A) coordinate with the sponsor regarding early agreement on a data development plan;
‘‘(B) take steps to ensure that the design of clinical
trials is as efficient and flexible as practicable, when scientifically appropriate;
‘‘(C) facilitate, when scientifically appropriate, expedited and efficient development and review of the device
through utilization of timely postmarket data collection
with regard to application for approval under section 515(c);
and
‘‘(D) agree in writing to clinical protocols that the Secretary will consider binding on the Secretary and the
sponsor, subject to—
‘‘(i) changes to such protocols agreed to in writing
by the sponsor and the Secretary; or
‘‘(ii) a decision, made by the director of the office
responsible for reviewing the device submission, that
a substantial scientific issue essential to determining
the safety or effectiveness of such device exists, provided that such decision is in writing, and is made
only after the Secretary provides to the device sponsor
or applicant an opportunity for a meeting at which
the director and the sponsor or applicant are present
and at which the director documents the substantial
scientific issue.
‘‘(f) PRIORITY REVIEW GUIDANCE.—
‘‘(1) CONTENT.—Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary shall
issue guidance on the implementation of this section. Such
guidance shall—
‘‘(A) set forth the process by which a person may seek
a designation under subsection (d);
‘‘(B) provide a template for requests under subsection
(c);
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‘‘(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and
‘‘(D) identify the criteria and processes the Secretary
will use to assign a team of staff, including team leaders,
to review devices designated for expedited development
and priority review, including any training required for
such personnel to ensure effective and efficient review.
‘‘(2) PROCESS.—Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a proposed guidance.
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to affect—
‘‘(1) the criteria and standards for evaluating an application
pursuant to section 515(c), a report and request for classification
under section 513(f)(2), or a report under section 510(k),
including the recognition of valid scientific evidence as
described in section 513(a)(3)(B) and consideration and application of the least burdensome means of evaluating device
effectiveness or demonstrating substantial equivalence between
devices with differing technological characteristics, as
applicable;
‘‘(2) the authority of the Secretary with respect to clinical
holds under section 520(g)(8)(A);
‘‘(3) the authority of the Secretary to act on an application
pursuant to section 515(d) before completion of an establishment inspection, as the Secretary determines appropriate; or
‘‘(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and 522.’’.
(b) DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.—
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360g–1(a)(1)) is amended by inserting ‘‘a request for
designation under section 515C,’’ after ‘‘application under section
515,’’.
(c) TERMINATION OF PREVIOUS PROGRAM.—
(1) IN GENERAL.—Section 515(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(d)) is amended—
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph (5).
(2) CONFORMING AMENDMENT.—Section 737(5) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is
amended by striking ‘‘515(d)(6)’’ and inserting ‘‘515(d)(5)’’.
(d) REPORT.—On January 1, 2019, the Secretary of Health
and Human Services shall issue 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—
(1) on the program under section 515C of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a),
in bringing safe and effective devices included in such program
to patients as soon as possible; and
(2) that includes recommendations, if any, to strengthen
the program to better meet patient device needs in a manner
as timely as possible.
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SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.
(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j) is amended—
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(1) in paragraph (1) by striking ‘‘fewer than 4,000’’ and
inserting ‘‘not more than 8,000’’;
(2) in paragraph (2)(A) by striking ‘‘fewer than 4,000’’ and
inserting ‘‘not more than 8,000’’; and
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ and inserting
‘‘8,000’’.
(b) GUIDANCE DOCUMENT ON PROBABLE BENEFIT.—Not later
than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that
defines the criteria for establishing ‘‘probable benefit’’ as that term
is used in section 520(m)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).
21 USC 360j
note.
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SEC. 3053. RECOGNITION OF STANDARDS.
(a) IN GENERAL.—Section 514(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360d(c)) is amended—
(1) in paragraph (1), by inserting after subparagraph (B)
the following new subparagraphs:
‘‘(C)(i) Any person may submit a request for recognition under
subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard
organization.
‘‘(ii) Not later than 60 calendar days after the Secretary receives
such a request, the Secretary shall—
‘‘(I) make a determination to recognize all, part, or none
of the standard that is the subject of the request; and
‘‘(II) issue to the person who submitted such request a
response in writing that states the Secretary’s rationale for
that determination, including the scientific, technical, regulatory, or other basis for such determination.
‘‘(iii) The Secretary shall make a response issued under clause
(ii)(II) publicly available, in such a manner as the Secretary determines appropriate.
‘‘(iv) The Secretary shall take such actions as may be necessary
to implement all or part of a standard recognized under clause
(ii)(I), in accordance with subparagraph (A).
‘‘(D) The Secretary shall make publicly available, in such
manner as the Secretary determines appropriate, the rationale for
recognition under subparagraph (A) of all, part, or none of a
standard, including the scientific, technical, regulatory, or other
basis for the decision regarding such recognition.’’; and
(2) by adding at the end the following:
‘‘(4) The Secretary shall provide to all employees of the Food
and Drug Administration who review premarket submissions for
devices periodic training on the concept and use of recognized
standards for purposes of meeting a premarket submission requirement or other applicable requirement under this Act, including
standards relevant to an employee’s area of device review.’’.
(b) GUIDANCE.—The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall review
and update, if necessary, previously published guidance and
standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards,
under section 514(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360d(c)), taking into account the experience with and
reliance on a standard by foreign regulatory authorities and the
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device industry, and whether recognition of a standard will promote
harmonization among regulatory authorities in the regulation of
devices.
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SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.
(a) CLASS I DEVICES.—Section 510(l) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(l)) is amended—
(1) by striking ‘‘A report under subsection (k)’’ and inserting
‘‘(1) A report under subsection (k)’’; and
(2) by adding at the end the following new paragraph:
‘‘(2) Not later than 120 calendar days after the date of enactment of the 21st Century Cures Act and at least once every 5
years thereafter, as the Secretary determines appropriate, the Secretary shall identify, through publication in the Federal Register,
any type of class I device that the Secretary determines no longer
requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication—
‘‘(A) each type of class I device so identified shall be exempt
from the requirement for a report under subsection (k); and
‘‘(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.’’.
(b) CLASS II DEVICES.—Section 510(m) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended—
(1) by striking ‘‘(m)(1)’’ and all that follows through ‘‘by
the Secretary.’’ and inserting the following:
‘‘(m)(1) The Secretary shall—
‘‘(A) not later than 90 days after the date of enactment
of the 21st Century Cures Act and at least once every 5 years
thereafter, as the Secretary determines appropriate—
‘‘(i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary
determines no longer requires a report under subsection
(k) to provide reasonable assurance of safety and effectiveness; and
‘‘(ii) provide for a period of not less than 60 calendar
days for public comment beginning on the date of the
publication of such notice; and
‘‘(B) not later than 210 calendar days after the date of
enactment of the 21st Century Cures Act, publish in the Federal
Register a list representing the Secretary’s final determination
with respect to the devices contained in the list published
under subparagraph (A).’’; and
(2) in paragraph (2)—
(A) by striking ‘‘1 day after the date of publication
of a list under this subsection,’’ and inserting ‘‘1 calendar
day after the date of publication of the final list under
paragraph (1)(B),’’; and
(B) by striking ‘‘30-day period’’ and inserting ‘‘60-calendar-day period’’; and
(C) by adding at the end the following new paragraph:
‘‘(3) Upon the publication of the final list under paragraph
(1)(B)—
‘‘(A) each type of class II device so listed shall be exempt
from the requirement for a report under subsection (k); and
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‘‘(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.’’.
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SEC. 3055. CLASSIFICATION PANELS.
(a) CLASSIFICATION PANELS.—Paragraph (5) of section 513(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b))
is amended—
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; and
(2) by adding at the end the following:
‘‘(B) When a device is specifically the subject of review by
a classification panel, the Secretary shall—
‘‘(i) ensure that adequate expertise is represented on the
classification panel to assess—
‘‘(I) the disease or condition which the device is
intended to cure, treat, mitigate, prevent, or diagnose; and
‘‘(II) the technology of the device; and
‘‘(ii) provide an opportunity for the person whose device
is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel.
‘‘(C) For purposes of subparagraph (B)(i), the term ‘adequate
expertise’ means that the membership of the classification panel
includes—
‘‘(i) two or more voting members, with a specialty or other
expertise clinically relevant to the device under review; and
‘‘(ii) at least one voting member who is knowledgeable
about the technology of the device.
‘‘(D) The Secretary shall provide an annual opportunity for
patients, representatives of patients, and sponsors of medical device
submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification
panels.’’.
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended—
(1) in subparagraph (A)(iii), by inserting before the period
at the end ‘‘, including, subject to the discretion of the panel
chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel
for the purpose of correcting misstatements of fact or providing
clarifying information, and permitting the person or representative to call on experts within the person’s organization to
address such specific issues in the time provided’’; and
(2) by striking subparagraph (B) and inserting the following
new subparagraph:
‘‘(B)(i) Any meeting of a classification panel with respect to
the review of a device shall—
‘‘(I) provide adequate time for initial presentations by the
person whose device is specifically the subject of such review
and by the Secretary; and
‘‘(II) encourage free and open participation by all interested
persons.
‘‘(ii) Following the initial presentations described in clause (i),
the panel may—
‘‘(I) pose questions to a designated representative described
in subparagraph (A)(iii); and
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‘‘(II) consider the responses to such questions in the panel’s
review of the device.’’.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j) is amended—
(1) in subsection (g)(3)—
(A) in subparagraph (A)(i)—
(i) by striking ‘‘local’’; and
(ii) by striking ‘‘which has been’’; and
(B) in subparagraph (B), by striking ‘‘a local institutional’’ and inserting ‘‘an institutional’’; and
(2) in subsection (m)(4)—
(A) by striking subparagraph (A) and inserting the
following:
‘‘(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in
accordance with the regulations of the Secretary; and’’;
(B) in subparagraph (B), by striking ‘‘a local institutional’’ and inserting ‘‘an institutional’’; and
(C) in the matter following subparagraph (B), by
striking ‘‘local’’.
42 USC 263a
note.
SEC. 3057. CLIA WAIVER IMPROVEMENTS.
(a) DRAFT REVISED GUIDANCE.—Not later than 1 year after
the date of the enactment of this Act, the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs, shall publish a draft guidance that—
(1) revises ‘‘Section V. Demonstrating Insignificant Risk
of an Erroneous Result – Accuracy’’ of the guidance entitled
‘‘Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’ and dated January 30,
2008; and
(2) includes the appropriate use of comparable performance
between a waived user and a moderately complex laboratory
user to demonstrate accuracy.
(b) FINAL REVISED GUIDANCE.—The Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall finalize the draft guidance published under subsection
(a) not later than 1 year after the comment period for such draft
guidance closes.
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SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.
(a) IN GENERAL.—Section 513 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following:
‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDENSOME REQUIREMENTS.—
‘‘(1) The Secretary shall—
‘‘(A) ensure that each employee of the Food and Drug
Administration who is involved in the review of premarket
submissions, including supervisors, receives training
regarding the meaning and implementation of the least
burdensome requirements under subsections (a)(3)(D) and
(i)(1)(D) of this section and section 515(c)(5); and
‘‘(B) periodically assess the implementation of the least
burdensome requirements, including the employee training
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under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied.
‘‘(2) Not later than 18 months after the date of enactment
of the 21st Century Cures Act, the ombudsman for any
organizational unit of the Food and Drug Administration
responsible for the premarket review of devices shall—
‘‘(A) conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training
in implementing the least burdensome requirements;
‘‘(B) include in such audit interviews of persons who
are representatives of the device industry regarding their
experiences in the device premarket review process,
including with respect to the application of least burdensome concepts to premarket review and decisionmaking;
‘‘(C) include in such audit a list of the measurement
tools the Secretary uses to assess the implementation of
the least burdensome requirements, including under paragraph (1)(B) and section 517A(a)(3), and may also provide
feedback on the effectiveness of such tools in the
implementation of the least burdensome requirements;
‘‘(D) summarize the findings of such audit in a final
audit report; and
‘‘(E) within 30 calendar days of completion of such
final audit report, make such final audit report available—
‘‘(i) 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
‘‘(ii) on the Internet website of the Food and Drug
Administration.’’.
(b) PREMARKET APPLICATIONS.—Section 515(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by
adding at the end the following:
‘‘(5)(A) In requesting additional information with respect to
an application under this section, the Secretary shall consider the
least burdensome appropriate means necessary to demonstrate a
reasonable assurance of device safety and effectiveness.
‘‘(B) For purposes of subparagraph (A), the term ‘necessary’
means the minimum required information that would support a
determination by the Secretary that an application provides a
reasonable assurance of the safety and effectiveness of the device.
‘‘(C) For purposes of this paragraph, the Secretary shall consider
the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device
safety and effectiveness.
‘‘(D) Nothing in this paragraph alters the standards for premarket approval of a device.’’.
(c) RATIONALE FOR SIGNIFICANT DECISIONS REGARDING
DEVICES.—Section 517A(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360g–1(a)) is amended by adding at the end the
following:
‘‘(3) APPLICATION OF LEAST BURDENSOME REQUIREMENTS.—
The substantive summary required under this subsection shall
include a brief statement regarding how the least burdensome
requirements were considered and applied consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as
applicable.’’.
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130 STAT. 1130
PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT.
21 USC 360 note.
(a) IN GENERAL.—Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end
the following:
‘‘(q) REUSABLE MEDICAL DEVICES.—
‘‘(1) IN GENERAL.—Not later than 180 days after the date
of enactment of the 21st Century Cures Act, the Secretary
shall identify and publish a list of reusable device types for
which reports under subsection (k) are required to include—
‘‘(A) instructions for use, which have been validated
in a manner specified by the Secretary; and
‘‘(B) validation data, the types of which shall be specified by the Secretary;
regarding cleaning, disinfection, and sterilization, and for which
a substantial equivalence determination may be based.
‘‘(2) REVISION OF LIST.—The Secretary shall revise the list
under paragraph (2), as the Secretary determines appropriate,
with notice in the Federal Register.
‘‘(3) CONTENT OF REPORTS.—Reports under subsection (k)
that are submitted after the publication of the list described
in paragraph (1), for devices or types of devices included on
such list, shall include such instructions for use and validation
data.’’.
(b) DEVICE MODIFICATIONS.—The Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall issue final guidance regarding when a premarket
notification under section 510(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for
a modification or change to a legally marketed device. Such final
guidance shall be issued not later than 1 year after the date
on which the comment period closes for the draft guidance on
such subject.
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SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end
the following:
‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECISIONS SUPPORT
SOFTWARE.—
‘‘(1) The term device, as defined in section 201(h), shall
not include a software function that is intended—
‘‘(A) for administrative support of a health care facility,
including the processing and maintenance of financial
records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management,
analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit
eligibility, population health management, and laboratory
workflow;
‘‘(B) for maintaining or encouraging a healthy lifestyle
and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
‘‘(C) to serve as electronic patient records, including
patient-provided information, to the extent that such
records are intended to transfer, store, convert formats,
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1131
or display the equivalent of a paper medical chart, so
long as—
‘‘(i) such records were created, stored, transferred,
or reviewed by health care professionals, or by individuals working under supervision of such professionals;
‘‘(ii) such records are part of health information
technology that is certified under section 3001(c)(5)
of the Public Health Service Act; and
‘‘(iii) such function is not intended to interpret
or analyze patient records, including medical image
data, for the purpose of the diagnosis, cure, mitigation,
prevention, or treatment of a disease or condition;
‘‘(D) for transferring, storing, converting formats, or
displaying clinical laboratory test or other device data and
results, findings by a health care professional with respect
to such data and results, general information about such
findings, and general background information about such
laboratory test or other device, unless such function is
intended to interpret or analyze clinical laboratory test
or other device data, results, and findings; or
‘‘(E) unless the function is intended to acquire, process,
or analyze a medical image or a signal from an in vitro
diagnostic device or a pattern or signal from a signal
acquisition system, for the purpose of—
‘‘(i) displaying, analyzing, or printing medical
information about a patient or other medical information (such as peer-reviewed clinical studies and clinical
practice guidelines);
‘‘(ii) supporting or providing recommendations to
a health care professional about prevention, diagnosis,
or treatment of a disease or condition; and
‘‘(iii) enabling such health care professional to
independently review the basis for such recommendations that such software presents so that it is not
the intent that such health care professional rely primarily on any of such recommendations to make a
clinical diagnosis or treatment decision regarding an
individual patient.
‘‘(2) In the case of a product with multiple functions that
contains—
‘‘(A) at least one software function that meets the
criteria under paragraph (1) or that otherwise does not
meet the definition of device under section 201(h); and
‘‘(B) at least one function that does not meet the criteria
under paragraph (1) and that otherwise meets the definition of a device under section 201(h),
the Secretary shall not regulate the software function of such
product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety
and effectiveness of the device function or functions of such
product described in subparagraph (B), the Secretary may
assess the impact that the software function or functions
described in subparagraph (A) have on such device function
or functions.
‘‘(3)(A) Notwithstanding paragraph (1), a software function
described in subparagraph (C), (D), or (E) of paragraph (1)
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21 USC 360j
note.
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PUBLIC LAW 114–255—DEC. 13, 2016
shall not be excluded from the definition of device under section
201(h) if—
‘‘(i) the Secretary makes a finding that use of such
software function would be reasonably likely to have
serious adverse health consequences; and
‘‘(ii) the software function has been identified in a
final order issued by the Secretary under subparagraph
(B).
‘‘(B) Subparagraph (A) shall apply only if the Secretary—
‘‘(i) publishes a notification and proposed order in the
Federal Register;
‘‘(ii) includes in such notification the Secretary’s
finding, including the rationale and identification of the
evidence on which such finding was based, as described
in subparagraph (A)(i); and
‘‘(iii) provides for a period of not less than 30 calendar
days for public comment before issuing a final order or
withdrawing such proposed order.
‘‘(C) In making a finding under subparagraph (A)(i) with
respect to a software function, the Secretary shall consider—
‘‘(i) the likelihood and severity of patient harm if the
software function were to not perform as intended;
‘‘(ii) the extent to which the software function is
intended to support the clinical judgment of a health care
professional;
‘‘(iii) whether there is a reasonable opportunity for
a health care professional to review the basis of the
information or treatment recommendation provided by the
software function; and
‘‘(iv) the intended user and user environment, such
as whether a health care professional will use a software
function of a type described in subparagraph (E) of paragraph (1).
‘‘(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to—
‘‘(A) exercise enforcement discretion as to any device
subject to regulation under this Act;
‘‘(B) regulate software used in the manufacture and
transfusion of blood and blood components to assist in
the prevention of disease in humans; or
‘‘(C) regulate software as a device under this Act if
such software meets the criteria under section
513(a)(1)(C).’’.
(b) REPORTS.—The Secretary of Health and Human Services
(referred to in this subsection as the ‘‘Secretary’’), after consultation
with agencies and offices of the Department of Health and Human
Services involved in health information technology, shall publish
a report, not later than 2 years after the date of enactment of
this Act and every 2 years thereafter, that—
(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup
companies, health plans or other third-party payers, venture
capital investors, information technology vendors, health
information technology vendors, small businesses, purchasers,
employers, and other stakeholders with relevant expertise, as
determined by the Secretary;
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130 STAT. 1133
(2) examines information available to the Secretary on
any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j) (as amended by subsection
(a)); and
(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to
promote safety, education, and competency related to such functions.
(c) CLASSIFICATION OF ACCESSORIES.—Section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended
by adding at the end the following:
‘‘(9) The Secretary shall classify an accessory under this section
based on the intended use of the accessory, notwithstanding the
classification of any other device with which such accessory is
intended to be used.’’.
(d) CONFORMING AMENDMENT.—Section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by
adding at the end the following: ‘‘The term ‘device’ does not include
software functions excluded pursuant to section 520(o).’’.
Subtitle G—Improving Scientific Expertise
and Outreach at FDA
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SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE.
(a) HIRING AND RETENTION AUTHORITY.—Section 228 of the
Public Health Service Act (42 U.S.C. 237) is amended—
(1) in the section heading, by inserting ‘‘AND BIOMEDICAL
PRODUCT ASSESSMENT’’ after ‘‘RESEARCH’’;
(2) in subsection (a)—
(A) in paragraph (1), by striking ‘‘Silvio O. Conte Senior
Biomedical Research Service, not to exceed 500 members’’
and inserting ‘‘Silvio O. Conte Senior Biomedical Research
and Biomedical Product Assessment Service (in this section
referred to as the ‘Service’), not to exceed 2,000 members,
the purpose of which is to recruit and retain outstanding
and qualified scientific and technical experts in the fields
of biomedical research, clinical research evaluation, and
biomedical product assessment’’;
(B) by amending paragraph (2) to read as follows:
‘‘(2) The authority established in paragraph (1) may not be
construed to require the Secretary to reduce the number of
employees serving under any other employment system in order
to offset the number of members serving in the Service.’’; and
(C) by adding at the end the following:
‘‘(3) The Secretary shall assign experts under this section to
agencies within the Department of Health and Human Services
taking into account the need for the expertise of such expert.’’;
(3) in subsection (b)—
(A) in the matter preceding paragraph (1), by striking
‘‘or clinical research evaluation’’ and inserting ‘‘, clinical
research evaluation, or biomedical product assessment’’;
and
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PUBLIC LAW 114–255—DEC. 13, 2016
(B) in paragraph (1), by inserting ‘‘or a doctoral or
master’s level degree in engineering, bioinformatics, or a
related or emerging field,’’ after the comma;
(4) in subsection (d)(2), by striking ‘‘and shall not exceed
the rate payable for level I of the Executive Schedule unless
approved by the President under section 5377(d)(2) of title
5, United States Code’’ and inserting ‘‘and shall not exceed
the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code’’;
(5) by striking subsection (e); and
(6) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
(b) GAO STUDY.—
(1) IN GENERAL.—The Comptroller General of the United
States shall conduct a study of the effectiveness of the amendments to section 228 of the Public Health Service Act (42
U.S.C. 237) made by subsection (a) and the impact of such
amendments, if any, on all agencies or departments of the
Department of Health and Human Services, and, not later
than 4 years after the date of enactment of this Act, shall
submit a report based on such study to the Committee on
Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives.
(2) CONTENT OF STUDY AND REPORT.—The study and report
under paragraph (1) shall include an examination of the extent
to which recruitment and retention of outstanding and qualified
scientific, medical, or technical experts in the fields of biomedical research, clinical research evaluation, and biomedical
product assessment have improved or otherwise have been
affected by the amendments to section 228 of the Public Health
Service Act (42 U.S.C. 237) made by subsection (a), including
by determining, during the period between the date of enactment of this Act and the completion of the study—
(A) the total number of members recruited and retained
under the Senior Biomedical Research and Biomedical
Product Assessment Service under such section 228, and
the effect of increasing the number of members eligible
for such Service;
(B) the number of members of such Senior Biomedical
Research and Biomedical Product Assessment Service hired
with a doctoral level degree in biomedicine or a related
field, and the number of such members hired with a doctoral or master’s level degree in engineering, bioinformatics,
or a related or emerging field; and
(C) the number of Senior Biomedical Research and
Biomedical Product Assessment Service members that have
been hired by each agency or department of the Department
of Health and Human Services, and how such Department
assigns such members to each agency or department.
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SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
(a) IN GENERAL.—The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 714 (21 U.S.C. 379d–3) the
following:
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‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
21 USC 379d–3a.
‘‘(a) IN GENERAL.—The Secretary may, notwithstanding title
5, United States Code, governing appointments in the competitive
service, appoint outstanding and qualified candidates to scientific,
technical, or professional positions that support the development,
review, and regulation of medical products. Such positions shall
be within the competitive service.
‘‘(b) COMPENSATION.—
‘‘(1) IN GENERAL.—Notwithstanding any other provision of
law, including any requirement with respect to General
Schedule pay rates under subchapter III of chapter 53 of title
5, United States Code, and consistent with the requirements
of paragraph (2), the Commissioner of Food and Drugs may
determine and set—
‘‘(A) the annual rate of pay of any individual appointed
under subsection (a); and
‘‘(B) for purposes of retaining qualified employees, the
annual rate of pay for any qualified scientific, technical,
or professional personnel appointed to a position described
in subsection (a) before the date of enactment of the 21st
Century Cures Act.
‘‘(2) LIMITATION.—The annual rate of pay established
pursuant to paragraph (1) may not exceed the amount of annual
compensation (excluding expenses) specified in section 102 of
title 3, United States Code.
‘‘(3) PUBLIC AVAILABILITY.—The annual rate of pay provided
to an individual in accordance with this section shall be publicly
available information.
‘‘(c) RULE OF CONSTRUCTION.—The authorities under this section shall not be construed to affect the authority provided under
section 714.
‘‘(d) REPORT ON WORKFORCE PLANNING.—
‘‘(1) IN GENERAL.—Not later than 18 months after the date
of enactment of the 21st Century Cures Act, the Secretary
shall submit a report on workforce planning to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives that examines the extent to which the Food and
Drug Administration has a critical need for qualified individuals
for scientific, technical, or professional positions, including—
‘‘(A) an analysis of the workforce needs at the Food
and Drug Administration and the Secretary’s strategic plan
for addressing such needs, including through use of the
authority under this section; and
‘‘(B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which
may include the use of—
‘‘(i) recruitment through nongovernmental recruitment or placement agencies;
‘‘(ii) recruitment through academic institutions;
‘‘(iii) recruitment or hiring bonuses, if applicable;
‘‘(iv) recruitment using targeted direct hiring
authorities; and
‘‘(v) retention of qualified scientific, technical, and
professional employees using the authority under this
section, or other applicable authorities of the Secretary.
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1)
may include the recommendations of the Commissioner of Food
and Drugs that would help the Food and Drug Administration
to better recruit and retain qualified individuals for scientific,
technical, or professional positions at the agency.’’.
(b) GAO STUDY AND REPORT.—
(1) IN GENERAL.—The Comptroller General of the United
States shall conduct a study of the ability of the Food and
Drug Administration to hire, train, and retain qualified scientific, technical, and professional staff, not including contractors, necessary to fulfill the mission of the Food and Drug
Administration to protect and promote public health. Not later
than January 1, 2022, the Comptroller General shall submit
a report on such study to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives.
(2) CONTENTS OF STUDY.—The Comptroller General shall
include in the study and report under paragraph (1)—
(A) information about the progress of the Food and
Drug Administration in recruiting and retaining qualified
scientific, technical, and professional staff outstanding in
the field of biomedical research, clinical research evaluation, and biomedical product assessment;
(B) the extent to which critical staffing needs exist
at the Food and Drug Administration, and barriers to
hiring, training, and retaining qualified staff, if any;
(C) an examination of the recruitment and retention
strategies of the Food and Drug Administration, including
examining any strategic workforce plan, focused on
improving scientific, technical, and professional staff
recruitment and retention; and
(D) recommendations for potential improvements that
would address staffing needs of the Food and Drug
Administration.
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION
INTERCENTER INSTITUTES.
(a) IN GENERAL.—Chapter X of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at
the end the following:
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21 USC 399g.
‘‘SEC.
1014.
FOOD AND
INSTITUTES.
DRUG
ADMINISTRATION
INTERCENTER
‘‘(a) IN GENERAL.—The Secretary shall establish one or more
Intercenter Institutes within the Food and Drug Administration
(referred to in this section as an ‘Institute’) for a major disease
area or areas. With respect to the major disease area of focus
of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major
disease area or areas, among the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, and
the Center for Devices and Radiological Health (for the purposes
of this section, referred to as the ‘Centers’). Such activities may
include—
‘‘(1) coordination of staff from the Centers with diverse
product expertise in the diagnosis, cure, mitigation, treatment,
or prevention of the specific diseases relevant to the major
disease area of focus of the Institute;
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130 STAT. 1137
‘‘(2) streamlining, where appropriate, the review of medical
products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of
the Institute, applying relevant standards under sections 505,
510(k), 513(f)(2), and 515 of this Act and section 351 of the
Public Health Service Act, and other applicable authorities;
‘‘(3) promotion of scientific programs within the Centers
related to the major disease area of focus of the Institute;
‘‘(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education
opportunities for the personnel of the Centers with expertise
related to the major disease area of focus of the Institute;
‘‘(5) enhancement of the interactions of the Centers with
patients, sponsors, and the external biomedical community
regarding the major disease area of focus of the Institute;
and
‘‘(6) facilitation of the collaborative relationships of the
Centers with other agencies within the Department of Health
and Human Services regarding the major disease area of focus
of the Institute.
‘‘(b) PUBLIC PROCESS.—The Secretary shall provide a period
for public comment during the time that each Institute is being
implemented.
‘‘(c) TIMING.—The Secretary shall establish at least one
Institute under subsection (a) before the date that is 1 year after
the date of enactment of the 21st Century Cures Act.
‘‘(d) TERMINATION OF INSTITUTES.—The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public
health. Not less than 60 days prior to so terminating an Institute,
the Secretary shall provide public notice, including the rationale
for such termination.’’.
(b) TECHNICAL AMENDMENTS.—Chapter X of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended—
(1) by redesignating section 1012 as section 1013; and
(2) by redesignating the second section 1011 (with respect
to improving the training of State, local, territorial, and tribal
food safety officials), as added by section 209(a) of the FDA
Food Safety Modernization Act (Public Law 111–353), as section
1012.
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SEC. 3074. SCIENTIFIC ENGAGEMENT.
42 USC 3506a.
(a) IN GENERAL.—Scientific meetings that are attended by scientific or medical personnel, or other professionals, of the Department of Health and Human Services for whom attendance at such
meeting is directly related to their professional duties and the
mission of the Department—
(1) shall not be considered conferences for the purposes
of complying with Federal reporting requirements contained
in annual appropriations Acts or in this section; and
(2) shall not be considered conferences for purposes of
a restriction contained in an annual appropriations Act, based
on Office of Management and Budget Memorandum M-12-12
or any other regulation restricting travel to such meeting.
(b) LIMITATION.—Nothing in this section shall be construed
to exempt travel for scientific meetings from Federal regulations
relating to travel.
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PUBLIC LAW 114–255—DEC. 13, 2016
(c) REPORTS.—Not later than 90 days after the end of the
fiscal year, each operating division of the Department of Health
and Human Services shall prepare, and post on an Internet website
of the operating division, an annual report on scientific meeting
attendance and related travel spending for each fiscal year. Such
report shall include—
(1) general information concerning the scientific meeting
activities involved;
(2) information concerning the total amount expended for
such meetings;
(3) a description of all such meetings that were attended
by scientific or medical personnel, or other professionals, of
each such operating division where the total amount expended
by the operating division associated with each such meeting
were in excess of $30,000, including—
(A) the total amount of meeting expenses incurred
by the operating division for such meeting;
(B) the location of such meeting;
(C) the date of such meeting;
(D) a brief explanation on how such meeting advanced
the mission of the operating division; and
(E) the total number of individuals whose travel
expenses or other scientific meeting expenses were paid
by the operating division; and
(4) with respect to any such meeting where the total
expenses to the operating division exceeded $150,000, a description of the exceptional circumstances that necessitated the
expenditure of such amounts.
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SEC. 3075. DRUG SURVEILLANCE.
(a) NEW DRUGS.—Section 505(k)(5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section
2074, is further amended—
(1) in subparagraph (A), by striking ‘‘, bi-weekly screening’’
and inserting ‘‘screenings’’;
(2) in subparagraph (B), as redesignated by section
2074(1)(C), by striking the period at the end and inserting
‘‘; and’’; and
(3) by adding at the end the following:
‘‘(C) make available on the Internet website of the Food
and Drug Administration—
‘‘(i) guidelines, developed with input from experts qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, that detail best practices
for drug safety surveillance using the Adverse Event
Reporting System; and
‘‘(ii) criteria for public posting of adverse event signals.’’.
(b) FAERS REVISION.—Section 505(r)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by
striking ‘‘, by 18 months’’ and all that follows through the semicolon
at the end of the subparagraph and inserting ‘‘and making publicly
available on the Internet website established under paragraph (1)
best practices for drug safety surveillance activities for drugs
approved under this section or section 351 of the Public Health
Service Act;’’.
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(c) RISK EVALUATION AND MITIGATION STRATEGIES.—Section
505–1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355–1(f)(5)) is amended—
(1) in the matter preceding subparagraph (A), by inserting
‘‘or other advisory committee’’ after ‘‘(or successor committee)’’;
and
(2) in subparagraph (B), by striking ‘‘at least annually,’’
and inserting ‘‘periodically’’.
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SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) BOARD OF DIRECTORS.—
(1) COMPOSITION AND SIZE.—Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C))
is amended—
(A) by redesignating clause (ii) as clause (iii);
(B) by inserting after clause (i) the following:
‘‘(ii) ADDITIONAL MEMBERS.—The Board, through
amendments to the bylaws of the Foundation, may
provide that the number of voting members of the
Board shall be a number (to be specified in such
amendment) greater than 14. Any Board positions that
are established by any such amendment shall be
appointed (by majority vote) by the individuals who,
as of the date of such amendment, are voting members
of the Board and persons so appointed may represent
any of the categories specified in subclauses (I) through
(V) of clause (i), so long as no more than 30 percent
of the total voting members of the Board (including
members whose positions are established by such
amendment) are representatives of the general
pharmaceutical, device, food, cosmetic, and biotechnology industries.’’; and
(C) in clause (iii)(I), as redesignated by subparagraph
(A), by striking ‘‘The ex officio members shall ensure’’ and
inserting ‘‘The ex officio members, acting pursuant to clause
(i), and the Board, acting pursuant to clause (ii), shall
ensure’’.
(2) FEDERAL EMPLOYEES ALLOWED TO SERVE ON BOARD.—
Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated
by paragraph (1)(A), is amended by adding at the end the
following: ‘‘For purposes of this section, the term ‘employee
of the Federal Government’ does not include a special Government employee, as that term is defined in section 202(a) of
title 18, United States Code.’’.
(3) STAGGERED TERMS.—Subparagraph (A) of section
770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379dd(d)(3)) is amended to read as follows:
‘‘(A) TERM.—The term of office of each member of the
Board appointed under paragraph (1)(C)(i), and the term
of office of any member of the Board whose position is
established pursuant to paragraph (1)(C)(ii), shall be 4
years, except that—
‘‘(i) the terms of offices for the members of the
Board initially appointed under paragraph (1)(C)(i)
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shall expire on a staggered basis as determined by
the ex officio members; and
‘‘(ii) the terms of office for the persons initially
appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered
basis, as determined by the individuals who, as of
the date of the amendment establishing such positions,
are members of the Board.’’.
(b) EXECUTIVE DIRECTOR COMPENSATION.—Section 770(g)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2))
is amended by striking ‘‘but shall not be greater than the compensation of the Commissioner’’.
(c) SEPARATION OF FUNDS.—Section 770(m) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking
‘‘are held in separate accounts from funds received from entities
under subsection (i)’’ and inserting ‘‘are managed as individual
programmatic funds under subsection (i), according to best
accounting practices’’.
Subtitle H—Medical Countermeasures
Innovation
SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.
Section 319F–2 of the Public Health Service Act (42 U.S.C.
247d–6b) is amended—
(1) in subsection (a), by adding at the end the following:
‘‘(3) 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.’’; and
(2) in subsection (g)—
(A) by amending paragraph (4) to read as follows:
‘‘(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
‘‘(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).’’.
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SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.
(a) IN GENERAL.—Section 319F–2(g) of the Public Health
Service Act (42 U.S.C. 247d–6b(g)) is amended by adding at the
end the following:
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130 STAT. 1141
‘‘(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.’’.
(b) BARDA CONTRACTING AUTHORITY.—Section 319L(c)(3) of
the Public Health Service Act (42 U.S.C. 247d–7c) is amended
by inserting ‘‘, including the execution of procurement contracts,
grants, and cooperative agreements pursuant to this section’’ before
the period.
SEC. 3083. COUNTERMEASURE BUDGET PLAN.
Section 2811(b)(7) of the Public Health Service Act (42 U.S.C.
300hh–10(b)(7)) is amended—
(1) in the matter preceding subparagraph (A), by striking
the first sentence and inserting ‘‘Develop, and update not later
than March 1 of each year, a coordinated 5-year budget plan
based on the medical countermeasure priorities described in
subsection (d), including with respect to chemical, biological,
radiological, and nuclear agent or agents that may present
a threat to the Nation, including such agents that are novel
or emerging infectious diseases, and the corresponding efforts
to develop qualified countermeasures (as defined in section
319F–1), security countermeasures (as defined in section 319F–
2), and qualified pandemic or epidemic products (as defined
in section 319F–3) for each such threat.’’;
(2) in subparagraph (C), by striking ‘‘; and’’ and inserting
a semicolon;
(3) in subparagraph (D), by striking ‘‘to the appropriate
committees of Congress upon request.’’ and inserting ‘‘, not
later than March 15 of each year, 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; and’’; and
(4) by adding at the end the following:
‘‘(E) not later than March 15 of each year, be made
publicly available in a manner that does not compromise
national security.’’.
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SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.
Section 319L(c)(4) of the Public Health Service Act (42 U.S.C.
247d–7e(c)(4)) is amended by adding at the end the following:
‘‘(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
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130 STAT. 1142
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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;
‘‘(dd) be problem-driven and solutionfocused 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.
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130 STAT. 1143
‘‘(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;
‘‘(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
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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, 2022.’’.
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.
Section 319F–2(c) of the Public Health Service Act (42 U.S.C.
247d–6b(c)) is amended—
(1) in paragraph (4)(A)(ii), by striking ‘‘make a recommendation under paragraph (6) that the special reserve fund
as defined in subsection (h) be made available for the procurement of such countermeasure’’ and inserting ‘‘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’’;
(2) in paragraph (6)—
(A) by striking subparagraphs (A), (B), and (E);
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (A) and (B), respectively;
(C) by amending subparagraph (A), as so redesignated,
to read as follows:
‘‘(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.’’; and
(D) in the heading, by striking ‘‘RECOMMENDATION FOR
PRESIDENT’S APPROVAL’’ and inserting ‘‘RECOMMENDATIONS
FOR PROCUREMENT’’; and
(3) in paragraph (7)—
(A) by striking subparagraphs (A) and (B) and inserting
the following:
‘‘(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.’’; and
(B) by redesignating subparagraph (C) as subparagraph (B).
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SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT
A NATIONAL SECURITY THREAT.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting
after section 565 the following:
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130 STAT. 1145
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‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
AGENTS THAT PRESENT NATIONAL SECURITY THREATS.
21 USC
360bbb–4a.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) HUMAN DRUG APPLICATION.—The term ‘human drug
application’ has the meaning given such term in section 735(1).
‘‘(2) PRIORITY REVIEW.—The term ‘priority review’, with
respect to a human drug application, means review and action
by the Secretary on such application not later than 6 months
after receipt by the Secretary of such application, as described
in the Manual of Policies and Procedures in the Food and
Drug Administration and goals identified in the letters
described in section 101(b) of the Food and Drug Administration
Safety and Innovation Act.
‘‘(3) PRIORITY REVIEW VOUCHER.—The term ‘priority review
voucher’ means a voucher issued by the Secretary to the sponsor
of a material threat medical countermeasure application that
entitles the holder of such voucher to priority review of a
single human drug application submitted under section
505(b)(1) or section 351(a) of the Public Health Service Act
after the date of approval of the material threat medical
countermeasure application.
‘‘(4) MATERIAL THREAT MEDICAL COUNTERMEASURE APPLICATION.—The term ‘material threat medical countermeasure
application’ means an application that—
‘‘(A) is a human drug application for a drug intended
for use—
‘‘(i) to prevent, or treat harm from a biological,
chemical, radiological, or nuclear agent identified as
a material threat under section 319F–2(c)(2)(A)(ii) of
the Public Health Service Act; or
‘‘(ii) to 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, or biological product against such
agent; and
‘‘(B) the Secretary determines eligible for priority
review;
‘‘(C) is approved after the date of enactment of the
21st Century Cures Act; and
‘‘(D) is for a human drug, no active ingredient
(including any ester or salt of the active ingredient) of
which has been approved in any other application under
section 505(b)(1) or section 351(a) of the Public Health
Service Act.
‘‘(b) PRIORITY REVIEW VOUCHER.—
‘‘(1) IN GENERAL.—The Secretary shall award a priority
review voucher to the sponsor of a material threat medical
countermeasure application upon approval by the Secretary
of such material threat medical countermeasure application.
‘‘(2) TRANSFERABILITY.—The sponsor of a material threat
medical countermeasure application that receives a priority
review voucher under this section may transfer (including by
sale) the entitlement to such voucher to a sponsor of a human
drug for which an application under section 505(b)(1) or section
351(a) of the Public Health Service Act will be submitted after
the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times
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130 STAT. 1146
PUBLIC LAW 114–255—DEC. 13, 2016
a priority review voucher may be transferred before such
voucher is used.
‘‘(3) NOTIFICATION.—
‘‘(A) IN GENERAL.—The sponsor of a human drug
application shall notify the Secretary not later than 90
calendar days prior to submission of the human drug
application that is the subject of a priority review voucher
of an intent to submit the human drug application,
including the date on which the sponsor intends to submit
the application. Such notification shall be a legally binding
commitment to pay for the user fee to be assessed in
accordance with this section.
‘‘(B) TRANSFER AFTER NOTICE.—The sponsor of a human
drug application that provides notification of the intent
of such sponsor to use the voucher for the human drug
application under subparagraph (A) may transfer the
voucher after such notification is provided, if such sponsor
has not yet submitted the human drug application
described in the notification.
‘‘(c) PRIORITY REVIEW USER FEE.—
‘‘(1) IN GENERAL.—The Secretary shall establish a user
fee program under which a sponsor of a human drug application
that is the subject of a priority review voucher shall pay to
the Secretary a fee determined under paragraph (2). Such fee
shall be in addition to any fee required to be submitted by
the sponsor under chapter VII.
‘‘(2) FEE AMOUNT.—The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the review
of a human drug application subject to priority review in the
previous fiscal year.
‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish,
before the beginning of each fiscal year beginning after September 30, 2016, for that fiscal year, the amount of the priority
review user fee.
‘‘(4) PAYMENT.—
‘‘(A) IN GENERAL.—The priority review user fee
required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1)
or section 351(a) of the Public Health Service Act for which
the priority review voucher is used.
‘‘(B) COMPLETE APPLICATION.—An application described
under subparagraph (A) for which the sponsor requests
the use of a priority review voucher shall be considered
incomplete if the fee required by this subsection and all
other applicable user fees are not paid in accordance with
the Secretary’s procedures for paying such fees.
‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR
REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable
under this section.
‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to
this subsection for any fiscal year—
‘‘(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food
and Drug Administration; and
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130 STAT. 1147
‘‘(6) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.
‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary shall publish a notice in
the Federal Register and on the Internet website of the Food and
Drug Administration not later than 30 calendar days after the
occurrence of each of the following:
‘‘(1) The Secretary issues a priority review voucher under
this section.
‘‘(2) The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 351(a)
of the Public Health Service Act for which the sponsor of
the application used a priority review voucher issued under
this section.
‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section
precludes a sponsor who seeks a priority review voucher under
this section from participating in any other incentive program,
including under this Act, except that no sponsor of a material
threat medical countermeasure application may receive more than
one priority review voucher issued under any section of this Act
with respect to such drug.
‘‘(f) RELATION TO OTHER PROVISIONS.—The provisions of this
section shall supplement, not supplant, any other provisions of
this Act or the Public Health Service Act that encourage the
development of medical countermeasures.
‘‘(g) SUNSET.—The Secretary may not award any priority review
vouchers under subsection (b) after October 1, 2023.’’.
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SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC
HEALTH EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d)
is amended by adding at the end the following:
‘‘(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
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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
shall not be applicable during the immediate postresponse
review regarding such public health emergency if such immediate 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.’’.
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION.
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(a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR
GENCIES.—Section 564 of the Federal Food, Drug,
USE IN EMERand Cosmetic
Act (21 U.S.C. 360bbb–3) is amended—
(1) in subsection (a)(2)—
(A) in subparagraph (A)—
(i) by striking ‘‘or 515’’ and inserting ‘‘512, or 515’’;
and
(ii) by inserting ‘‘or conditionally approved under
section 571 of this Act’’ after ‘‘Public Health Service
Act’’; and
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130 STAT. 1149
(B) in subparagraph (B), by inserting ‘‘conditionally
approved under section 571,’’ after ‘‘approved,’’ each place
the term appears;
(2) in subsection (b)(4), by striking the second comma after
‘‘determination’’;
(3) in subsection (e)(3)(B), by striking ‘‘section 503(b)’’ and
inserting ‘‘subsection (b) or (f) of section 503 or under section
504’’;
(4) in subsection (f)(2)—
(A) by inserting ‘‘, or an animal to which,’’ after ‘‘to
a patient to whom’’; and
(B) by inserting ‘‘or by the veterinarian caring for
such animal, as applicable’’ after ‘‘attending physician’’;
(5) in subsection (g)(1), by inserting ‘‘conditional approval
under section 571,’’ after ‘‘approval,’’;
(6) in subsection (h)(1), by striking ‘‘or section 520(g)’’and
inserting ‘‘512(j), or 520(g)’’; and
(7) in subsection (k), by striking ‘‘section 520(g),’’and
inserting ‘‘512(j), or 520(g)’’.
(b) NEW ANIMAL DRUGS.—Section 512(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended—
(1) in subparagraph (B), by striking ‘‘or’’ at the end;
(2) in subparagraph (C), by striking the period and
inserting ‘‘; or’’; and
(3) by inserting after subparagraph (C) the following:
‘‘(D) there is in effect an authorization pursuant to section
564 with respect to such use or intended use of such drug,
and such drug, its labeling, and such use conform to any
conditions of such authorization.’’.
(c) EMERGENCY USE OF MEDICAL PRODUCTS.—Section 564A of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–
3a) is amended—
(1) in subsection (a)(1)(A), by inserting ‘‘, conditionally
approved under section 571,’’ after ‘‘chapter’’; and
(2) in subsection (d), by striking ‘‘sections 503(b) and 520(e)’’
and inserting ‘‘subsections (b) and (f) of section 503, section
504, and section 520(e)’’.
(d) PRODUCTS HELD FOR EMERGENCY USE.—Section 564B(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–
3b(2)) is amended—
(1) in subparagraph (A)—
(A) by inserting ‘‘or conditionally approved under section 571 of this Act’’ after ‘‘Public Health Service Act’’;
and
(B) by striking ‘‘or 515’’ and inserting ‘‘512, or 515’’;
and
(2) in subparagraph (B), by striking ‘‘or 520’’ and inserting
‘‘512, or 520’’.
Subtitle I—Vaccine Access, Certainty, and
Innovation
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SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.
21 USC
360bbb–4 note.
(a) CONSIDERATION OF NEW VACCINES.—Upon the licensure
of any vaccine or any new indication for a vaccine, the Advisory
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Committee on Immunization Practices (in this section referred to
as the ‘‘Advisory Committee’’) shall, as appropriate, consider the
use of the vaccine at its next regularly scheduled meeting.
(b) ADDITIONAL INFORMATION.—If the Advisory Committee does
not make a recommendation with respect to the use of a vaccine
at the Advisory Committee’s first regularly scheduled meeting after
the licensure of the vaccine or any new indication for the vaccine,
the Advisory Committee shall provide an update on the status
of such committee’s review.
(c) CONSIDERATION FOR BREAKTHROUGH THERAPIES AND FOR
POTENTIAL USE DURING PUBLIC HEALTH EMERGENCY.—The
Advisory Committee shall make recommendations with respect to
the use of certain vaccines in a timely manner, as appropriate,
including vaccines that—
(1) are designated as a breakthrough therapy under section
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356) and licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262); or
(2) could be used in a public health emergency.
(d) DEFINITION.—In this section, the terms ‘‘Advisory Committee on Immunization Practices’’ and ‘‘Advisory Committee’’ mean
the Advisory Committee on Immunization Practices established by
the Secretary pursuant to section 222 of the Public Health Service
Act (42 U.S.C. 217a), acting through the Director of the Centers
for Disease Control and Prevention.’’.
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SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY
COMMITTEE
ON
IMMUNIZATION
PRACTICES
RECOMMENDATIONS.
(a) REVIEW.—The Director of the Centers for Disease Control
and Prevention shall conduct a review of the processes used by
the Advisory Committee on Immunization Practices in formulating
and issuing recommendations pertaining to vaccines, including with
respect to consistency.
(b) CONSIDERATIONS.—The review under subsection (a) shall
include an assessment of—
(1) the criteria used to evaluate new and existing vaccines,
including the identification of any areas for which flexibility
in evaluating such criteria is necessary and the reason for
such flexibility;
(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and
analysis of scientific and economic data, including the scientific
basis for such approach; and
(3) the extent to which the processes used by the work
groups of the Advisory Committee on Immunization Practices
are consistent among such groups, including the identification
of reasons for any variation.
(c) STAKEHOLDERS.—In carrying out the review under subsection (a), the Director of the Centers for Disease Control and
Prevention shall solicit input from vaccine stakeholders.
(d) REPORT.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control
and Prevention shall submit to the appropriate committees of the
Congress, and make publicly available, a report on the results
of the review under subsection (a), including any recommendations
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130 STAT. 1151
on improving the consistency of the processes described in such
subsection.
(e) DEFINITION.—In this section, the term ‘‘Advisory Committee
on Immunization Practices’’ means the Advisory Committee on
Immunization Practices established by the Secretary of Health and
Human Services pursuant to section 222 of the Public Health
Service Act (42 U.S.C. 217a), acting through the Director of the
Centers for Disease Control and Prevention.
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SEC. 3093. ENCOURAGING VACCINE INNOVATION.
(a) VACCINE MEETINGS.—The Director of the Centers for Disease Control and Prevention shall ensure that appropriate staff
within the relevant centers and divisions of the Office of Infectious
Diseases, and others, as appropriate, coordinate with respect to
the public health needs, epidemiology, and program planning and
implementation considerations related to immunization, including
with regard to meetings with stakeholders related to such topics.
(b) REPORT ON VACCINE INNOVATION.—
(1) IN GENERAL.—Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’), in
collaboration with appropriate agencies or offices within the
Department of Health and Human Services, including the
National Institutes of Health, the Centers for Disease Control
and Prevention, the Food and Drug Administration, and the
Biomedical Advanced Research and Development Authority,
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, and post publicly on the Internet website of the Department of Health
and Human Services, a report on ways to promote innovation
in the development of vaccines that minimize the burden of
infectious disease.
(2) CONTENTS.—The report described in paragraph (1) shall
review the current status of vaccine development and, as appropriate—
(A) consider the optimal process to determine which
vaccines would be beneficial to public health and how
information on such vaccines is disseminated to key stakeholders;
(B) examine and identify whether obstacles exist that
inhibit the development of beneficial vaccines; and
(C) make recommendations about how best to remove
any obstacles identified under subparagraph (B) in order
to promote and incentivize vaccine innovation and development.
(3) CONSULTATION.—In preparing the report under this
subsection, the Secretary may consult with—
(A) representatives of relevant Federal agencies and
departments, including the Department of Defense and
the Department of Veterans Affairs;
(B) academic researchers;
(C) developers and manufacturers of vaccines;
(D) medical and public health practitioners;
(E) representatives of patient, policy, and advocacy
organizations; and
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PUBLIC LAW 114–255—DEC. 13, 2016
(F) representatives of other entities, as the Secretary
determines appropriate.
(c) UPDATES RELATED TO MATERNAL IMMUNIZATION.—
(1) ADDITIONAL VACCINES.—Section 2114(e) of the Public
Health Service Act (42 U.S.C. 300aa–14(e)) is amended by
adding at the end the following:
‘‘(3) VACCINES RECOMMENDED FOR USE IN PREGNANT
WOMEN.—The Secretary shall revise the Vaccine Injury Table
included in subsection (a), through the process described in
subsection (c), to include vaccines recommended by the Centers
for Disease Control and Prevention for routine administration
in pregnant women and the information described in subparagraphs (B) and (C) of paragraph (2) with respect to such vaccines.’’.
(2) PETITION CONTENT.—Section 2111 of the Public Health
Service Act (42 U.S.C. 300aa–11) is amended by adding at
the end the following:
‘‘(f) MATERNAL IMMUNIZATION.—
‘‘(1) IN GENERAL.—Notwithstanding any other provision of
law, for purposes of this subtitle, both a woman who received
a covered vaccine while pregnant and any child who was in
utero at the time such woman received the vaccine shall be
considered persons to whom the covered vaccine was administered and persons who received the covered vaccine.
‘‘(2) DEFINITION.—As used in this subsection, the term
‘child’ shall have the meaning given that term by subsections
(a) and (b) of section 8 of title 1, United States Code, except
that, for purposes of this subsection, such section 8 shall be
applied as if the term ‘include’ in subsection (a) of such section
were replaced with the term ‘mean’.’’.
(3) PETITIONERS.—Section 2111(b)(2) of the Public Health
Service Act (42 U.S.C. 300aa–11(b)(2)) is amended by adding
‘‘A covered vaccine administered to a pregnant woman shall
constitute more than one administration, one to the mother
and one to each child (as such term is defined in subsection
(f)(2)) who was in utero at the time such woman was administered the vaccine.’’ at the end.
Subtitle J—Technical Corrections
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SEC. 3101. TECHNICAL CORRECTIONS.
(a) FFDCA.—
(1) REFERENCES.—Except as otherwise expressly provided,
whenever in this subsection an amendment is expressed in
terms of an amendment to a section or other provision, the
reference shall be considered to be made to that section or
other provision of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.).
(2) AMENDMENTS.—
(A) PROHIBITED ACTS.—Section 301(r) (21 U.S.C. 331(r))
is amended by inserting ‘‘, drug,’’ after ‘‘device’’ each place
the term appears.
(B) NEW DRUGS.—Section 505 (21 U.S.C. 355) is
amended—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1153
(i) in subsection (d), in the last sentence, by
striking ‘‘premarket approval’’ and inserting ‘‘marketing approval’’; and
(ii) in subsection (q)(5)(A), by striking ‘‘subsection
(b)(2) or (j) of the Act or 351(k)’’ and inserting ‘‘subsection (b)(2) or (j) of this section or section 351(k)’’.
(C) RISK EVALUATION AND MITIGATION STRATEGIES.—
Section 505–1(h)(21 U.S.C. 355–1(h)) is amended—
(i) in paragraph (2)(A)(iii)—
(I) in the clause heading, by striking ‘‘LABEL’’
and inserting ‘‘LABELING’’;
(II) by striking ‘‘label’’ each place the term
appears and inserting ‘‘labeling’’; and
(III) by striking ‘‘sponsor’’ and inserting
‘‘responsible person’’; and
(ii) in paragraph (8), by striking ‘‘and (7).’’ and
inserting ‘‘and (7)’’.
(D) PEDIATRIC STUDY PLANS.—Section 505B (21 U.S.C.
355c) is amended—
(i) in subsection (e)—
(I) in paragraph (2)—
(aa) in subparagraph (A), by inserting
‘‘study’’ after ‘‘initial pediatric’’ each place the
term appears; and
(bb) in subparagraph (B), in the subparagraph heading, by striking ‘‘INITIAL PLAN’’ and
inserting ‘‘INITIAL PEDIATRIC STUDY PLAN’’;
(II) in paragraph (5), in the paragraph
heading, by inserting ‘‘AGREED INITIAL PEDIATRIC
STUDY’’ before ‘‘PLAN’’; and
(III) in paragraph (6), by striking ‘‘agreed initial pediatric plan’’ and inserting ‘‘agreed initial
pediatric study plan’’; and
(ii) in subsection (f)(1), by inserting ‘‘and any
significant amendments to such plans,’’ after ‘‘agreed
initial pediatric study plans,’’.
(E) DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIVE-SAVING DRUGS.—Section 506C (21 U.S.C. 356c)
is amended—
(i) in subsection (c), by striking ‘‘discontinuation’’
and inserting ‘‘discontinuance’’; and
(ii) in subsection (g)(1), by striking ‘‘section 505(j)
that could help’’ and inserting ‘‘section 505(j), that
could help’’.
(F) ANNUAL REPORTING ON DRUG SHORTAGES.—Section
506C–1(a) (21 U.S.C. 331(a)) is amended, in the matter
before paragraph (1)—
(i) by striking ‘‘Not later than the end of calendar
year 2013, and not later than the end of each calendar
year thereafter,’’ and inserting ‘‘Not later than March
31 of each calendar year,’’; and
(ii) by inserting ‘‘, with respect to the preceding
calendar year,’’ after ‘‘a report’’.
(G) DRUG SHORTAGE LIST.—Section 506E(b)(3)(E) (21
U.S.C. 356e(b)(3)(E)) is amended by striking ‘‘discontinuation’’ and inserting ‘‘discontinuance’’.
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130 STAT. 1154
PUBLIC LAW 114–255—DEC. 13, 2016
(H) INSPECTIONS OF ESTABLISHMENTS.—Section 510(h)
(21 U.S.C. 360(h)) is amended—
(i) in paragraph (4), in the matter preceding
subparagraph (A), by striking ‘‘establishing the riskbased scheduled’’ and inserting ‘‘establishing a riskbased schedule’’; and
(ii) in paragraph (6)—
(I) in subparagraph (A), by striking ‘‘fiscal’’
and inserting ‘‘calendar’’ each place the term
appears; and
(II) in subparagraph (B), by striking ‘‘an active
ingredient of a drug, a finished drug product, or
an excipient of a drug’’ and inserting ‘‘an active
ingredient of a drug or a finished drug product’’.
(I) CLASSIFICATION OF DEVICES INTENDED FOR HUMAN
USE.—Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is
amended—
(i) in clause (i), by striking ‘‘within 30 days’’; and
(ii) in clause (iv), by striking ‘‘low-moderate’’ and
inserting ‘‘low to moderate’’.
(J) PREMARKET APPROVAL.—Section 515(a)(1) (21
U.S.C. 360e(a)(1)) is amended by striking ‘‘subject to a
an order’’ and inserting ‘‘subject to an order’’.
(K) PROGRAM TO IMPROVE THE DEVICE RECALL
SYSTEM.—Section 518A (21 U.S.C. 360h–1) is amended—
(i) by striking subsection (c); and
(ii) by redesignating subsection (d) as subsection
(c).
(L) UNIQUE DEVICE IDENTIFIER.—Section 519(f) (21
U.S.C. 360i(f)) is amended by striking ‘‘and life sustaining’’
and inserting ‘‘or life sustaining’’.
(M) PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
TROPICAL DISEASES.—Section 524(c)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A))
is amended by striking ‘‘Services Act’’ and inserting
‘‘Service Act’’.
(N) PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.—Section 524A (21 U.S.C. 360n–1) is
amended—
(i) by striking ‘‘If the Secretary’’ and inserting the
following:
‘‘(a) IN GENERAL.—If the Secretary’’;
(ii) by striking ‘‘any’’ and inserting ‘‘the first’’; and
(iii) by adding at the end the following:
‘‘(b) CONSTRUCTION.—Nothing in this section shall prohibit the
Secretary from giving priority review to a human drug application
or efficacy supplement submitted for approval under section 505(b)
that otherwise meets the criteria for the Secretary to grant priority
review.’’.
(O) CONSULTATION WITH EXTERNAL EXPERTS ON RARE
DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING
OF TREATMENTS.—Section 569(a)(2)(A) (21 U.S.C. 360bbb–
8(a)(2)(A)) is amended, in the first sentence, by striking
‘‘subsection (c)’’ and inserting ‘‘subsection (b)’’.
(P) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section
569A(c) (21 U.S.C. 360bbb–8a(c)) is amended by inserting
‘‘or under the Public Health Service Act’’ after ‘‘this Act’’.
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(Q) USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED STATES.—Section 569B (21 U.S.C. 360bbb–
8b) is amended by striking ‘‘drug or device’’ and inserting
‘‘drug, biological product, or device’’ each place the term
appears.
(R) MEDICAL GASES DEFINITIONS.—Section 575(1)(H)
(21 U.S.C. 360ddd(1)(H)) is amended—
(i) by inserting ‘‘for a new drug’’ after ‘‘any period
of exclusivity’’; and
(ii) by inserting ‘‘or any period of exclusivity for
a new animal drug under section 512(c)(2)(F),’’ after
‘‘section 505A,’’.
(S) REGULATION OF MEDICAL GASES.—Section 576(a)
(21 U.S.C. 360ddd–1(a)) is amended—
(i) in the matter preceding subparagraph (A) of
paragraph (1), by inserting ‘‘who seeks to initially introduce or deliver for introduction a designated medical
gas into interstate commerce’’ after ‘‘any person’’; and
(ii) in paragraph (3)—
(I) in subparagraph (A)—
(aa) in clause (i)(VIII), by inserting ‘‘for
a new drug’’ after ‘‘any period of exclusivity’’;
and
(bb) in clause (ii), in the matter preceding
subclause (I), by inserting ‘‘the’’ before ‘‘final
use’’; and
(II) in subparagraph (B)—
(aa) in clause (i), by inserting ‘‘for a new
drug’’ after ‘‘any period of exclusivity’’; and
(bb) in clause (ii), by inserting a comma
after ‘‘drug product’’.
(T) INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL GASES.—Section 577 (21 U.S.C. 360ddd–2) is amended
by inserting ‘‘or 740(a)’’ after ‘‘section 736(a)’’.
(U) CONFLICTS OF INTEREST.—Section 712(e)(1)(B) (21
U.S.C. 379d–1(e)(1)(B)) is amended by striking ‘‘services’’
and inserting ‘‘service’’.
(V) AUTHORITY TO ASSESS AND USE BIOSIMILAR
BIOLOGICAL PRODUCT FEES.—Section 744H(a) (21 U.S.C.
379j–52(a)) is amended—
(i) in paragraph (1)(A)(v), by striking ‘‘Biosimilars
User Fee Act of 2012’’ and inserting ‘‘Biosimilar User
Fee Act of 2012’’; and
(ii) in paragraph (2)(B), by striking ‘‘Biosimilars
User Fee Act of 2012’’ and inserting ‘‘Biosimilar User
Fee Act of 2012’’.
(W) REGISTRATION OF COMMERCIAL IMPORTERS.—
(i) AMENDMENT.—Section 801(s)(2) (21 U.S.C.
381(s)(2)) is amended by adding at the end the following:
‘‘(D) EFFECTIVE DATE.—In establishing the effective
date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border
Protection, as determined appropriate by the Secretary of
Health and Human Services, provide a reasonable period
of time for an importer of a drug to comply with good
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importer practices, taking into account differences among
importers and types of imports, including based on the
level of risk posed by the imported product.’’.
(ii) CONFORMING AMENDMENT.—Section 714 of the
Food and Drug Administration Safety and Innovation
Act (Public Law 112–144; 126 Stat. 1074) is amended
by striking subsection (d).
(X) RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.—Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended
by striking ‘‘conduction’’ and inserting ‘‘conducting’’.
(b) FDASIA.—
(1) FINDINGS RELATING TO DRUG APPROVAL.—Section
901(a)(1)(A) of the Food and Drug Administration Safety and
Innovation Act (Public Law 112–144; 21 U.S.C. 356 note) is
amended by striking ‘‘serious and life-threatening diseases’’
and inserting ‘‘serious or life-threatening diseases’’.
(2) REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS.—Section 907 of the Food and Drug Administration
Safety and Innovation Act (Public Law 112–144; 126 Stat.
1092, 1093) is amended—
(A) in the section heading, by striking ‘‘BIOLOGICS’’
in the heading and inserting ‘‘BIOLOGICAL PRODUCTS’’;
and
(B) in subsection (a)(2)(B), by striking ‘‘applications
for new drug applications’’ and inserting ‘‘new drug applications’’.
(3) COMBATING PRESCRIPTION DRUG ABUSE.—Section 1122
of the Food and Drug Administration Safety and Innovation
Act (Public Law 112–144; 126 Stat. 1112, 1113) is amended—
(A) in subsection (a)(2), by striking ‘‘dependance’’ and
inserting ‘‘dependence’’; and
(B) in subsection (c), by striking ‘‘promulgate’’ and
inserting ‘‘issue’’.
SEC. 3102. COMPLETED STUDIES.
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The Federal Food, Drug, and Cosmetic Act is amended—
(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))—
(A) in subparagraph (A), by inserting ‘‘and’’ after the
semicolon;
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as subparagraph (B);
(2) in section 505A (21 U.S.C. 355a), by striking subsection
(p);
(3) in section 505B (21 U.S.C. 355c)—
(A) by striking subsection (l); and
(B) by redesignating subsection (m) as subsection (l);
and
(4) in section 523 (21 U.S.C. 360m), by striking subsection
(d).
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130 STAT. 1157
TITLE IV—DELIVERY
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING
QUALITY OF CARE FOR PATIENTS.
(a) IN GENERAL.—The Health Information Technology for Economic and Clinical Health Act (title XIII of division A of Public
Law 111–5) is amended—
(1) by adding at the end of part 1 of subtitle A the following:
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‘‘SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING
QUALITY OF CARE FOR PATIENTS.
42 USC 300jj–11
note.
‘‘(a) REDUCTION IN BURDENS GOAL.—The Secretary of Health
and Human Services (referred to in this section as the ‘Secretary’),
in consultation with providers of health services, health care suppliers of services, health care payers, health professional societies,
health information technology developers, health care quality
organizations, health care accreditation organizations, public health
entities, States, and other appropriate entities, shall, in accordance
with subsection (b)—
‘‘(1) establish a goal with respect to the reduction of regulatory or administrative burdens (such as documentation
requirements) relating to the use of electronic health records;
‘‘(2) develop a strategy for meeting the goal established
under paragraph (1); and
‘‘(3) develop recommendations for meeting the goal established under paragraph (1).
‘‘(b) STRATEGY AND RECOMMENDATIONS.—
‘‘(1) IN GENERAL.—To achieve the goal established under
subsection (a)(1), the Secretary, in consultation with the entities
described in such subsection, shall, not later than 1 year after
the date of enactment of the 21st Century Cures Act, develop
a strategy and recommendations to meet the goal in accordance
with this subsection.
‘‘(2) STRATEGY.—The strategy developed under paragraph
(1) shall address the regulatory and administrative burdens
(such as documentation requirements) relating to the use of
electronic health records. Such strategy shall include broad
public comment and shall prioritize—
‘‘(A)(i) incentives for meaningful use of certified EHR
technology for eligible professionals and hospitals under
sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of
the Social Security Act (42 U.S.C. 1395w–4(a)(7),
1395ww(b)(3)(B)(ix));
‘‘(ii) the program for making payments under section
1903(a)(3)(F) of the Social Security Act (42 U.S.C.
1396b(a)(3)(F)) to encourage the adoption and use of certified EHR technology by Medicaid providers;
‘‘(iii) the Merit-based Incentive Payment System under
section 1848(q) of the Social Security Act (42 U.S.C. 1395w–
4(q));
‘‘(iv) alternative payment models (as defined in section
1833(z)(3)(C) of the Social Security Act (42 U.S.C.
1395l(z)(3)(C));
‘‘(v) the Hospital Value-Based Purchasing Program
under section 1886(o) of the Social Security Act (42 U.S.C.
1395ww(o)); and
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‘‘(vi) other value-based payment programs, as the Secretary determines appropriate;
‘‘(B) health information technology certification;
‘‘(C) standards and implementation specifications, as
appropriate;
‘‘(D) activities that provide individuals access to their
electronic health information;
‘‘(E) activities related to protecting the privacy of electronic health information;
‘‘(F) activities related to protecting the security of electronic health information;
‘‘(G) activities related to facilitating health and clinical
research;
‘‘(H) activities related to public health;
‘‘(I) activities related to aligning and simplifying
quality measures across Federal programs and other
payers;
‘‘(J) activities related to reporting clinical data for
administrative purposes; and
‘‘(K) other areas, as the Secretary determines appropriate.
‘‘(3) RECOMMENDATIONS.—The recommendations developed
under paragraph (1) shall address—
‘‘(A) actions that improve the clinical documentation
experience;
‘‘(B) actions that improve patient care;
‘‘(C) actions to be taken by the Secretary and by other
entities; and
‘‘(D) other areas, as the Secretary determines appropriate, to reduce the reporting burden required of health
care providers.
‘‘(4) FACA.—The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the development of the goal, strategies,
or recommendations described in this section.
‘‘(c) APPLICATION OF CERTAIN REGULATORY REQUIREMENTS.—
A physician (as defined in section 1861(r)(1) of the Social Security
Act), to the extent consistent with applicable State law, may delegate electronic medical record documentation requirements specified
in regulations promulgated by the Centers for Medicare & Medicaid
Services to a person performing a scribe function who is not such
physician if such physician has signed and verified the documentation.’’; and
(2) in the table of contents in section 13001(b), by inserting
after the item relating to section 13102 the following:
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‘‘13103. Assisting doctors and hospitals in improving the quality and care for patients.’’.
(b) CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY FOR
MEDICAL SPECIALTIES AND SITES OF SERVICE.—Section 3001(c)(5)
of the Public Health Service Act (42 U.S.C. 300jj–11(c)(5)) is
amended by adding at the end the following:
‘‘(C) HEALTH INFORMATION TECHNOLOGY FOR MEDICAL
SPECIALTIES AND SITES OF SERVICE.—
‘‘(i) IN GENERAL.—The National Coordinator shall
encourage, keep, or recognize, through existing authorities, the voluntary certification of health information
technology under the program developed under
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130 STAT. 1159
subparagraph (A) for use in medical specialties and
sites of service for which no such technology is available or where more technological advancement or
integration is needed.
‘‘(ii) SPECIFIC MEDICAL SPECIALTIES.—The Secretary shall accept public comment on specific medical
specialties and sites of service, in addition to those
described in clause (i), for the purpose of selecting
additional specialties and sites of service as necessary.
‘‘(iii) HEALTH INFORMATION TECHNOLOGY FOR
PEDIATRICS.—Not later than 18 months after the date
of enactment of the 21st Century Cures Act, the Secretary, in consultation with relevant stakeholders,
shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of
children. Not later than 2 years after the date of enactment of the 21st Century Cures Act, the Secretary
shall adopt certification criteria under section 3004
to support the voluntary certification of health information technology for use by pediatric health providers
to support the health care of children.’’.
(c) MEANINGFUL USE STATISTICS.—
(1) IN GENERAL.—Not later than 6 months after the date
of enactment of this Act, the Secretary of Health and Human
Services shall submit to the HIT Advisory Committee of the
Office of the National Coordinator for Health Information Technology, a report concerning attestation statistics for the Medicare and Medicaid EHR Meaningful Use Incentive programs
to assist in informing standards adoption and related practices.
Such statistics shall include attestation information delineated
by State, including, to the extent practicable, the number of
providers who did not meet the minimum criteria necessary
to attest for the Medicare and Medicaid EHR Meaningful Use
Incentive programs for a calendar year, and shall be made
publicly available on the Internet website of the Secretary
on at least a quarterly basis.
(2) AUTHORITY TO ALTER FORMAT.—The Secretary of Health
and Human Services may alter the format of the reports on
the attestation of eligible health care professionals following
the first performance year of the Merit-based Incentive Payment System to account for changes arising from the
implementation of such payment system.
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SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND
FUNCTIONALITY.
(a) ENHANCEMENTS TO CERTIFICATION.—Section 3001(c)(5) of
the Public Health Service Act (42 U.S.C. 300jj–11), as amended
by section 4001(b), is further amended by adding at the end the
following:
‘‘(D) CONDITIONS OF CERTIFICATION.—Not later than
1 year after the date of enactment of the 21st Century
Cures Act, the Secretary, through notice and comment
rulemaking, shall require, as a condition of certification
and maintenance of certification for programs maintained
or recognized under this paragraph, consistent with other
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130 STAT. 1160
PUBLIC LAW 114–255—DEC. 13, 2016
conditions and requirements under this title, that the
health information technology developer or entity—
‘‘(i) does not take any action that constitutes
information blocking as defined in section 3022(a);
‘‘(ii) provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take
any action described in clause (i) or any other action
that may inhibit the appropriate exchange, access, and
use of electronic health information;
‘‘(iii) does not prohibit or restrict communication
regarding—
‘‘(I) the usability of the health information
technology;
‘‘(II) the interoperability of the health information technology;
‘‘(III) the security of the health information
technology;
‘‘(IV) relevant information regarding users’
experiences when using the health information
technology;
‘‘(V) the business practices of developers of
health
information
technology
related
to
exchanging electronic health information; and
‘‘(VI) the manner in which a user of the health
information technology has used such technology;
‘‘(iv) has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without
special effort through the use of application programming interfaces or successor technology or standards,
as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under
applicable privacy laws;
‘‘(v) has successfully tested the real world use of
the technology for interoperability (as defined in section 3000) in the type of setting in which such technology would be marketed;
‘‘(vi) provides to the Secretary an attestation that
the developer or entity—
‘‘(I) has not engaged in any of the conduct
described in clause (i);
‘‘(II) has provided assurances satisfactory to
the Secretary in accordance with clause (ii);
‘‘(III) does not prohibit or restrict communication as described in clause (iii);
‘‘(IV) has published information in accordance
with clause (iv);
‘‘(V) ensures that its technology allows for
health information to be exchanged, accessed, and
used, in the manner described in clause (iv); and
‘‘(VI) has undertaken real world testing as
described in clause (v); and
‘‘(vii) submits reporting criteria in accordance with
section 3009A(b).’’.
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130 STAT. 1161
‘‘(E) COMPLIANCE WITH
CATION.—The Secretary may
CONDITIONS OF CERTIFIencourage compliance with
the conditions of certification described in subparagraph
(D) and take action to discourage noncompliance, as appropriate.’’.
(b) EHR SIGNIFICANT HARDSHIP EXCEPTION.—
(1) APPLICATION TO ELIGIBLE PROFESSIONALS.—
CASE
OF
DECERTIFICATION.—Section
(A)
IN
1848(a)(7)(B) of the Social Security Act (42 U.S.C. 1395w–
4(a)(7)(B)) is amended by inserting after the first sentence
the following new sentence: ‘‘The Secretary shall exempt
an eligible professional from the application of the payment
adjustment under subparagraph (A) with respect to a year,
subject to annual renewal, if the Secretary determines that
compliance with the requirement for being a meaningful
EHR user is not possible because the certified EHR technology used by such professional has been decertified under
a program kept or recognized pursuant to section 3001(c)(5)
of the Public Health Service Act.’’.
(B) CONTINUED APPLICATION UNDER MIPS.—Section
1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w–
4(o)(2)(D)) is amended by adding at the end the following
new sentence: ‘‘The provisions of subparagraphs (B) and
(D) of subsection (a)(7), shall apply to assessments of MIPS
eligible professionals under subsection (q) with respect to
the performance category described in subsection
(q)(2)(A)(iv) in an appropriate manner which may be similar
to the manner in which such provisions apply with respect
to payment adjustments made under subsection (a)(7)(A).’’.
(2) APPLICATION TO ELIGIBLE HOSPITALS.—Section
1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first
sentence the following new sentence: ‘‘The Secretary shall
exempt an eligible hospital from the application of the payment
adjustment under subclause (I) with respect to a fiscal year,
subject to annual renewal, if the Secretary determines that
compliance with the requirement for being a meaningful EHR
user is not possible because the certified EHR technology used
by such hospital is decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service
Act.’’.
(c) ELECTRONIC HEALTH RECORD REPORTING PROGRAM.—Subtitle A of title XXX of the Public Health Service Act (42 U.S.C.
300jj–11 et seq.) is amended by adding at the end the following:
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‘‘SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM.
‘‘(a) REPORTING CRITERIA.—
‘‘(1) CONVENING OF STAKEHOLDERS.—Not later than 1 year
after the date of enactment of the 21st Century Cures Act,
the Secretary shall convene stakeholders, as described in paragraph (2), for the purpose of developing the reporting criteria
in accordance with paragraph (3).
‘‘(2) DEVELOPMENT OF REPORTING CRITERIA.—The reporting
criteria under this subsection shall be developed through a
public, transparent process that reflects input from relevant
stakeholders, including—
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(A) health care providers, including primary care and
specialty care health care professionals;
‘‘(B) hospitals and hospital systems;
‘‘(C) health information technology developers;
‘‘(D) patients, consumers, and their advocates;
‘‘(E) data sharing networks, such as health information
exchanges;
‘‘(F) authorized certification bodies and testing laboratories;
‘‘(G) security experts;
‘‘(H) relevant manufacturers of medical devices;
‘‘(I) experts in health information technology market
economics;
‘‘(J) public and private entities engaged in the evaluation of health information technology performance;
‘‘(K) quality organizations, including the consensus
based entity described in section 1890 of the Social Security
Act;
‘‘(L) experts in human factors engineering and the
measurement of user-centered design; and
‘‘(M) other entities or individuals, as the Secretary
determines appropriate.
‘‘(3) CONSIDERATIONS FOR REPORTING CRITERIA.—The
reporting criteria developed under this subsection—
‘‘(A) shall include measures that reflect categories
including—
‘‘(i) security;
‘‘(ii) usability and user-centered design;
‘‘(iii) interoperability;
‘‘(iv) conformance to certification testing; and
‘‘(v) other categories, as appropriate to measure
the performance of electronic health record technology;
‘‘(B) may include categories such as—
‘‘(i) enabling the user to order and view the results
of laboratory tests, imaging tests, and other diagnostic
tests;
‘‘(ii) submitting, editing, and retrieving data from
registries such as clinician-led clinical data registries;
‘‘(iii) accessing and exchanging information and
data from and through health information exchanges;
‘‘(iv) accessing and exchanging information and
data from medical devices;
‘‘(v) accessing and exchanging information and
data held by Federal, State, and local agencies and
other applicable entities useful to a health care provider or other applicable user in the furtherance of
patient care;
‘‘(vi) accessing and exchanging information from
other health care providers or applicable users;
‘‘(vii) accessing and exchanging patient generated
information;
‘‘(viii) providing the patient or an authorized designee with a complete copy of their health information
from an electronic record in a computable format;
‘‘(ix) providing accurate patient information for the
correct patient, including exchanging such information,
and avoiding the duplication of patients records; and
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130 STAT. 1163
‘‘(x) other categories regarding performance, accessibility, as the Secretary determines appropriate; and
‘‘(C) shall be designed to ensure that small and startup
health information technology developers are not unduly
disadvantaged by the reporting criteria.
‘‘(4) MODIFICATIONS.—After the reporting criteria have been
developed under paragraph (3), the Secretary may convene
stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such
paragraph.
‘‘(b) PARTICIPATION.—As a condition of maintaining certification
under section 3001(c)(5)(D), a developer of certified electronic health
records shall submit to an appropriate recipient of a grant, contract,
or agreement under subsection (c)(1) responses to the criteria developed under subsection (a), with respect to all certified technology
offered by such developer.
‘‘(c) REPORTING PROGRAM.—
‘‘(1) IN GENERAL.—Not later than 1 year after the date
of enactment of the 21st Century Cures Act, the Secretary
shall award grants, contracts, or agreements to independent
entities on a competitive basis to support the convening of
stakeholders as described in subsection (a)(2), collect the
information required to be reported in accordance with the
criteria established as described subsection (a)(3), and develop
and implement a process in accordance with paragraph (5)
and report such information to the Secretary.
‘‘(2) APPLICATIONS.—An independent entity that seeks a
grant, contract, or agreement 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 description of—
‘‘(A) the proposed method for reviewing and summarizing information gathered based on reporting criteria
established under subsection (a);
‘‘(B) if applicable, the intended focus on a specific
subset of certified electronic health record technology users,
such as health care providers, including primary care, specialty care, and care provided in rural settings; hospitals
and hospital systems; and patients, consumers, and
patients and consumer advocates;
‘‘(C) the plan for widely distributing reports described
in paragraph (6);
‘‘(D) the period for which the grant, contract, or agreement is requested, which may be up to 2 years; and
‘‘(E) the budget for reporting program participation,
and whether the eligible independent entity intends to
continue participation after the period of the grant, contract, or agreement.
‘‘(3) CONSIDERATIONS FOR INDEPENDENT ENTITIES.—In
awarding grants, contracts, and agreements under paragraph
(1), the Secretary shall give priority to independent entities
with appropriate expertise in health information technology
usability, interoperability, and security (especially entities with
such expertise in electronic health records) with respect to—
‘‘(A) health care providers, including primary care, specialty care, and care provided in rural settings;
‘‘(B) hospitals and hospital systems; and
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130 STAT. 1164
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(C) patients, consumers, and patient and consumer
advocates.
‘‘(4) LIMITATIONS.—
‘‘(A) ASSESSMENT AND REDETERMINATION.—Not later
than 4 years after the date of enactment of the 21st Century Cures Act and every 2 years thereafter, the Secretary,
in consultation with stakeholders, shall—
‘‘(i) assess performance of the recipients of the
grants, contracts, and agreements under paragraph
(1) based on quality and usability of reports described
in paragraph (6); and
‘‘(ii) re-determine grants, contracts, and agreements as necessary.
‘‘(B) PROHIBITIONS ON PARTICIPATION.—The Secretary
may not award a grant, contract, or cooperative agreement
under paragraph (1) to—
‘‘(i) a proprietor of certified health information
technology or a business affiliate of such a proprietor;
‘‘(ii) a developer of certified health information
technology; or
‘‘(iii) a State or local government agency.
‘‘(5) FEEDBACK.—Based on reporting criteria established
under subsection (a), the recipients of grants, contracts, and
agreements under paragraph (1) shall develop and implement
a process to collect and verify confidential feedback on such
criteria from—
‘‘(A) health care providers, patients, and other users
of certified electronic health record technology; and
‘‘(B) developers of certified electronic health record
technology.
‘‘(6) REPORTS.—
‘‘(A) DEVELOPMENT OF REPORTS.—Each recipient of a
grant, contract, or agreement under paragraph (1) shall
report on the information reported to such recipient pursuant to subsection (a) and the user feedback collected under
paragraph (5) by preparing summary reports and detailed
reports of such information.
‘‘(B) DISTRIBUTION OF REPORTS.—Each recipient of a
grant, contract, or agreement under paragraph (1) shall
submit the reports prepared under subparagraph (A) to
the Secretary for public distribution in accordance with
subsection (d).
‘‘(d) PUBLICATION.—The Secretary shall distribute widely, as
appropriate, and publish, on the Internet website of the Office
of the National Coordinator—
‘‘(1) the reporting criteria developed under subsection (a);
and
‘‘(2) the summary and detailed reports under subsection
(c)(6).
‘‘(e) REVIEW.—Each recipient of a grant, contract, or agreement
under paragraph (1) shall develop and implement a process through
which participating electronic health record technology developers
may review and recommend changes to the reports created under
subsection (c)(6) for products developed by such developer prior
to the publication of such report under subsection (d).
‘‘(f) ADDITIONAL RESOURCES.—The Secretary may provide additional resources on the Internet website of the Office of the National
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130 STAT. 1165
Coordinator to better inform consumers of health information technology. Such reports may be carried out through partnerships with
private organizations with appropriate expertise.’’.
(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated $15,000,000 for purposes of carrying out subparagraph (D) of section 3001(c)(5) of the Public Health Service Act
(42 U.S.C. 300jj–11) (as added by subsection (a)) and section 3009A
of the Public Health Service Act (as added by subsection (b)),
including for purposes of administering any contracts, grants, or
agreements, to remain available until expended.
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SEC. 4003. INTEROPERABILITY.
(a) DEFINITION.—Section 3000 of the Public Health Service
Act (42 U.S.C. 300jj) is amended—
(1) by redesignating paragraphs (10) through (14), as paragraphs (11) through (15), respectively; and
(2) by inserting after paragraph (9) the following:
‘‘(10) INTEROPERABILITY.—The term ‘interoperability’, with
respect to health information technology, means such health
information technology that—
‘‘(A) enables the secure exchange of electronic health
information with, and use of electronic health information
from, other health information technology without special
effort on the part of the user;
‘‘(B) allows for complete access, exchange, and use of
all electronically accessible health information for authorized use under applicable State or Federal law; and
‘‘(C) does not constitute information blocking as defined
in section 3022(a).’’.
(b) SUPPORT FOR INTEROPERABLE NETWORK EXCHANGE.—Section 3001(c) of the Public Health Service Act (42 U.S.C. 300jj–
11(c)) is amended by adding at the end the following:
‘‘(9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.—
‘‘(A) IN GENERAL.—The National Coordinator shall, in
collaboration with the National Institute of Standards and
Technology and other relevant agencies within the Department of Health and Human Services, for the purpose of
ensuring full network-to-network exchange of health
information, convene public-private and public-public partnerships to build consensus and develop or support a
trusted exchange framework, including a common agreement among health information networks nationally. Such
convention may occur at a frequency determined appropriate by the Secretary.
‘‘(B) ESTABLISHING A TRUSTED EXCHANGE FRAMEWORK.—
‘‘(i) IN GENERAL.—Not later than 6 months after
the date of enactment of the 21st Century Cures Act,
the National Coordinator shall convene appropriate
public and private stakeholders to develop or support
a trusted exchange framework for trust policies and
practices and for a common agreement for exchange
between health information networks. The common
agreement may include—
‘‘(I) a common method for authenticating
trusted health information network participants;
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‘‘(II) a common set of rules for trusted
exchange;
‘‘(III) organizational and operational policies
to enable the exchange of health information
among networks, including minimum conditions
for such exchange to occur; and
‘‘(IV) a process for filing and adjudicating noncompliance with the terms of the common agreement.
‘‘(ii) TECHNICAL ASSISTANCE.—The National Coordinator, in collaboration with the National Institute of
Standards and Technology, shall provide technical
assistance on how to implement the trusted exchange
framework and common agreement under this paragraph.
‘‘(iii) PILOT TESTING.—The National Coordinator,
in consultation with the National Institute of Standards and Technology, shall provide for the pilot testing
of the trusted exchange framework and common agreement established or supported under this subsection
(as authorized under section 13201 of the Health
Information Technology for Economic and Clinical
Health Act). The National Coordinator, in consultation
with the National Institute of Standards and Technology, may delegate pilot testing activities under this
clause to independent entities with appropriate expertise.
‘‘(C) PUBLICATION OF A TRUSTED EXCHANGE FRAMEWORK
AND COMMON AGREEMENT.—Not later than 1 year after
convening stakeholders under subparagraph (A), the
National Coordinator shall publish on its public Internet
website, and in the Federal register, the trusted exchange
framework and common agreement developed or supported
under subparagraph (B). Such trusted exchange framework
and common agreement shall be published in a manner
that protects proprietary and security information,
including trade secrets and any other protected intellectual
property.
‘‘(D) DIRECTORY OF PARTICIPATING HEALTH INFORMATION NETWORKS.—
‘‘(i) IN GENERAL.—Not later than 2 years after
convening stakeholders under subparagraph (A), and
annually thereafter, the National Coordinator shall
publish on its public Internet website a list of the
health information networks that have adopted the
common agreement and are capable of trusted
exchange pursuant to the common agreement developed or supported under paragraph (B).
‘‘(ii) PROCESS.—The Secretary shall, through notice
and comment rulemaking, establish a process for
health information networks that voluntarily elect to
adopt the trusted exchange framework and common
agreement to attest to such adoption of the framework
and agreement.
‘‘(E) APPLICATION OF THE TRUSTED EXCHANGE FRAMEWORK AND COMMON AGREEMENT.—As appropriate, Federal
agencies contracting or entering into agreements with
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130 STAT. 1167
health information exchange networks may require that
as each such network upgrades health information technology or trust and operational practices, such network
may adopt, where available, the trusted exchange framework and common agreement published under subparagraph (C).
‘‘(F) RULE OF CONSTRUCTION.—
‘‘(i) GENERAL ADOPTION.—Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework
or common agreement.
‘‘(ii) ADOPTION WHEN EXCHANGE OF INFORMATION
IS WITHIN NETWORK.—Nothing in this paragraph shall
be construed to require a health information network
to adopt the trusted exchange framework or common
agreement for the exchange of electronic health
information between participants of the same network.
‘‘(iii) EXISTING FRAMEWORKS AND AGREEMENTS.—
The trusted exchange framework and common agreement published under subparagraph (C) shall take into
account existing trusted exchange frameworks and
agreements used by health information networks to
avoid the disruption of existing exchanges between
participants of health information networks.
‘‘(iv) APPLICATION BY FEDERAL AGENCIES.—Notwithstanding clauses (i), (ii), and (iii), Federal agencies
may require the adoption of the trusted exchange
framework and common agreement published under
subparagraph (C) for health information exchanges
contracting with or entering into agreements pursuant
to subparagraph (E).
‘‘(v) CONSIDERATION OF ONGOING WORK.—In carrying out this paragraph, the Secretary shall ensure
the consideration of activities carried out by public
and private organizations related to exchange between
health information exchanges to avoid duplication of
efforts.’’.
(c) PROVIDER DIGITAL CONTACT INFORMATION INDEX.—
(1) IN GENERAL.—Not later than 3 years after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the ‘‘Secretary’’) shall,
directly or through a partnership with a private entity, establish a provider digital contact information index to provide
digital contact information for health professionals and health
facilities.
(2) USE OF EXISTING INDEX.—In establishing the initial
index under paragraph (1), the Secretary may utilize an existing
provider directory to make such digital contact information
available.
(3) CONTACT INFORMATION.—An index established under
this subsection shall ensure that contact information is available at the individual health care provider level and at the
health facility or practice level.
(4) RULE OF CONSTRUCTION.—
(A) IN GENERAL.—The purpose of this subsection is
to encourage the exchange of electronic health information
by providing the most useful, reliable, and comprehensive
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index of providers possible. In furthering such purpose,
the Secretary shall include all health professionals and
health facilities applicable to provide a useful, reliable,
and comprehensive index for use in the exchange of health
information.
(B) LIMITATION.—In no case shall exclusion from the
index of providers be used as a measure to achieve objectives other the objectives described in subparagraph (A).
(d) STANDARDS DEVELOPMENT ORGANIZATIONS.—Section 3004
of the Public Health Service Act (42 U.S.C. 300jj–14) is amended
by adding at the end the following:
‘‘(c) DEFERENCE TO STANDARDS DEVELOPMENT ORGANIZATIONS.—In adopting and implementing standards under this section,
the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based
standards bodies.’’.
(e) HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.—
(1) IN GENERAL.—Title XXX of the Public Health Service
Act (42 U.S.C. 300jj et seq.) is amended by striking sections
3002 (42 U.S.C. 300jj–12) and 3003 (42 U.S.C. 300jj–13) and
inserting the following:
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42 USC 300jj–12.
‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.
‘‘(a) ESTABLISHMENT.—There is established a Health Information Technology Advisory Committee (referred to in this section
as the ‘HIT Advisory Committee’) to recommend to the National
Coordinator, consistent with the implementation of the strategic
plan described in section 3001(c)(3), policies, and, for purposes
of adoption under section 3004, standards, implementation specifications, and certification criteria, relating to the implementation of
a health information technology infrastructure, nationally and
locally, that advances the electronic access, exchange, and use of
health information. Such Committee shall serve to unify the roles
of, and replace, the HIT Policy Committee and the HIT Standards
Committee, as in existence before the date of the enactment of
the 21st Century Cures Act.
‘‘(b) DUTIES.—
‘‘(1) RECOMMENDATIONS ON POLICY FRAMEWORK TO ADVANCE
AN INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRASTRUCTURE.—
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall
recommend to the National Coordinator a policy framework
for adoption by the Secretary consistent with the strategic
plan under section 3001(c)(3) for advancing the target areas
described in this subsection. Such policy framework shall
seek to prioritize achieving advancements in the target
areas specified in subparagraph (B) of paragraph (2) and
may, to the extent consistent with this section, incorporate
policy recommendations made by the HIT Policy Committee, as in existence before the date of the enactment
of the 21st Century Cures Act.
‘‘(B) UPDATES.—The HIT Advisory Committee shall
propose updates to such recommendations to the policy
framework and make new recommendations, as appropriate.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1169
‘‘(2) GENERAL DUTIES AND TARGET AREAS.—
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall
recommend to the National Coordinator for purposes of
adoption under section 3004, standards, implementation
specifications, and certification criteria and an order of
priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria. Such recommendations shall include recommended
standards, architectures, and software schemes for access
to electronic individually identifiable health information
across disparate systems including user vetting, authentication, privilege management, and access control.
‘‘(B) PRIORITY TARGET AREAS.—For purposes of this
section, the HIT Advisory Committee shall make recommendations under subparagraph (A) with respect to at
least each of the following target areas:
‘‘(i) Achieving a health information technology
infrastructure, nationally and locally, that allows for
the electronic access, exchange, and use of health
information, including through technology that provides accurate patient information for the correct
patient, including exchanging such information, and
avoids the duplication of patient records.
‘‘(ii) The promotion and protection of privacy and
security of health information in health information
technology, including technologies that allow for an
accounting of disclosures and protections against
disclosures of individually identifiable health information made by a covered entity for purposes of treatment, payment, and health care operations (as such
terms are defined for purposes of the regulation
promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996),
including for the segmentation and protection from
disclosure of specific and sensitive individually identifiable health information with the goal of minimizing
the reluctance of patients to seek care.
‘‘(iii) The facilitation of secure access by an individual to such individual’s protected health information
and access to such information by a family member,
caregiver, or guardian acting on behalf of a patient,
including due to age-related and other disability, cognitive impairment, or dementia.
‘‘(iv) Subject to subparagraph (D), any other target
area that the HIT Advisory Committee identifies as
an appropriate target area to be considered under this
subparagraph.
‘‘(C) ADDITIONAL TARGET AREAS.—For purposes of this
section, the HIT Advisory Committee may make recommendations under subparagraph (A), in addition to areas
described in subparagraph (B), with respect to any of the
following areas:
‘‘(i) The use of health information technology to
improve the quality of health care, such as by promoting the coordination of health care and improving
continuity of health care among health care providers,
reducing medical errors, improving population health,
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PUBLIC LAW 114–255—DEC. 13, 2016
reducing chronic disease, and advancing research and
education.
‘‘(ii) The use of technologies that address the needs
of children and other vulnerable populations.
‘‘(iii) The use of electronic systems to ensure the
comprehensive collection of patient demographic data,
including at a minimum, race, ethnicity, primary language, and gender information.
‘‘(iv) The use of self-service, telemedicine, home
health care, and remote monitoring technologies.
‘‘(v) The use of technologies that meet the needs
of diverse populations.
‘‘(vi) The use of technologies that support—
‘‘(I) data for use in quality and public reporting
programs;
‘‘(II) public health; or
‘‘(III) drug safety.
‘‘(vii) The use of technologies that allow individually identifiable health information to be rendered
unusable, unreadable, or indecipherable to unauthorized individuals when such information is transmitted
in a health information network or transported outside
of the secure facilities or systems where the disclosing
covered entity is responsible for security conditions.
‘‘(viii) The use of a certified health information
technology for each individual in the United States.
‘‘(D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY
TARGET AREAS.—For purposes of subparagraph (B)(iv), the
HIT Advisory Committee may identify an area to be considered for purposes of recommendations under this subsection
as a target area described in subparagraph (B) if—
‘‘(i) the area is so identified for purposes of
responding to new circumstances that have arisen in
the health information technology community that
affect the interoperability, privacy, or security of health
information, or affect patient safety; and
‘‘(ii) at least 30 days prior to treating such area
as if it were a target area described in subparagraph
(B), the National Coordinator provides adequate notice
to Congress of the intent to treat such area as so
described.
‘‘(E) FOCUS OF COMMITTEE WORK.—It is the sense of
Congress that the HIT Advisory Committee shall focus
its work on the priority areas described in subparagraph
(B) before proceeding to other work under subparagraph
(C).
‘‘(3) RULES RELATING TO RECOMMENDATIONS FOR STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA.—
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall
recommend to the National Coordinator standards,
implementation specifications, and certification criteria
described in subsection (a), which may include standards,
implementation specifications, and certification criteria
that have been developed, harmonized, or recognized by
the HIT Advisory Committee or predecessor committee.
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130 STAT. 1171
The HIT Advisory Committee shall update such recommendations and make new recommendations as appropriate, including in response to a notification sent under
section 3004(a)(2)(B). Such recommendations shall be consistent with the latest recommendations made by the Committee.
‘‘(B) HARMONIZATION.—The HIT Advisory Committee
may recognize harmonized or updated standards from an
entity or entities for the purpose of harmonizing or
updating standards and implementation specifications in
order to achieve uniform and consistent implementation
of the standards and implementation specification.
‘‘(C) PILOT TESTING OF STANDARDS AND IMPLEMENTATION SPECIFICATIONS.—In the development, harmonization,
or recognition of standards and implementation specifications, the HIT Advisory Committee for purposes of recommendations under paragraph (2)(B), shall, as appropriate, provide for the testing of such standards and specifications by the National Institute for Standards and Technology under section 13201(a) of the Health Information
Technology for Economic and Clinical Health Act.
‘‘(D) CONSISTENCY.—The standards, implementation
specifications, and certification criteria recommended under
paragraph (2)(B) shall be consistent with the standards
for information transactions and data elements adopted
pursuant to section 1173 of the Social Security Act.
‘‘(E) SPECIAL RULE RELATED TO INTEROPERABILITY.—
Any recommendation made by the HIT Advisory Committee
after the date of the enactment of this subparagraph with
respect to interoperability of health information technology
shall be consistent with interoperability as described in
section 3000.
‘‘(4) FORUM.—The HIT Advisory Committee shall serve as
a forum for the participation of a broad range of stakeholders
with specific expertise in policies, including technical expertise,
relating to the matters described in paragraphs (1), (2), and
(3) to provide input on the development, harmonization, and
recognition of standards, implementation specifications, and
certification criteria necessary for the development and adoption of health information technology infrastructure nationally
and locally that allows for the electronic access, exchange,
and use of health information.
‘‘(5) SCHEDULE.—Not later than 30 days after the date
on which the HIT Advisory Committee first meets, such HIT
Advisory Committee shall develop a schedule for the assessment
of policy recommendations developed under paragraph (1). The
HIT Advisory Committee shall update such schedule annually.
The Secretary shall publish such schedule in the Federal Register.
‘‘(6) PUBLIC INPUT.—The HIT Advisory Committee shall
conduct open public meetings and develop a process to allow
for public comment on the schedule described in paragraph
(5) and recommendations described in this subsection. Under
such process comments shall be submitted in a timely manner
after the date of publication of a recommendation under this
subsection.
‘‘(c) MEASURED PROGRESS IN ADVANCING PRIORITY AREAS.—
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130 STAT. 1172
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(1) IN GENERAL.—For purposes of this section, the National
Coordinator, in collaboration with the Secretary, shall establish,
and update as appropriate, objectives and benchmarks for
advancing and measuring the advancement of the priority target areas described in subsection (b)(2)(B).
‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING INTEROPERABILITY.—
‘‘(A) IN GENERAL.—The HIT Advisory Committee, in
consultation with the National Coordinator, shall annually
submit to the Secretary and Congress a report on the
progress made during the preceding fiscal year in—
‘‘(i) achieving a health information technology
infrastructure, nationally and locally, that allows for
the electronic access, exchange, and use of health
information; and
‘‘(ii) meeting the objectives and benchmarks
described in paragraph (1).
‘‘(B) CONTENT.—Each such report shall include, for
a fiscal year—
‘‘(i) a description of the work conducted by the
HIT Advisory Committee during the preceding fiscal
year with respect to the areas described in subsection
(b)(2)(B);
‘‘(ii) an assessment of the status of the infrastructure described in subparagraph (A), including the
extent to which electronic health information is appropriately and readily available to enhance the access,
exchange, and the use of electronic health information
between users and across technology offered by different developers;
‘‘(iii) the extent to which advancements have been
achieved with respect to areas described in subsection
(b)(2)(B);
‘‘(iv) an analysis identifying existing gaps in policies and resources for—
‘‘(I) achieving the objectives and benchmarks
established under paragraph (1); and
‘‘(II) furthering interoperability throughout the
health information technology infrastructure;
‘‘(v) recommendations for addressing the gaps
identified in clause (iii); and
‘‘(vi) a description of additional initiatives as the
HIT Advisory Committee and National Coordinator
determine appropriate.
‘‘(3) SIGNIFICANT ADVANCEMENT DETERMINATION.—The Secretary shall periodically, based on the reports submitted under
this subsection, review the target areas described in subsection
(b)(2)(B), and, based on the objectives and benchmarks established under paragraph (1), the Secretary shall determine if
significant advancement has been achieved with respect to
such an area. Such determination shall be taken into consideration by the HIT Advisory Committee when determining to
what extent the Committee makes recommendations for an
area other than an area described in subsection (b)(2)(B).
‘‘(d) MEMBERSHIP AND OPERATIONS.—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1173
‘‘(1) IN GENERAL.—The National Coordinator shall take a
leading position in the establishment and operations of the
HIT Advisory Committee.
‘‘(2) MEMBERSHIP.—The membership of the HIT Advisory
Committee shall—
‘‘(A) include at least 25 members, of which—
‘‘(i) no fewer than 2 members are advocates for
patients or consumers of health information technology;
‘‘(ii) 3 members are appointed by the Secretary,
1 of whom shall be appointed to represent the Department of Health and Human Services and 1 of whom
shall be a public health official;
‘‘(iii) 2 members are appointed by the majority
leader of the Senate;
‘‘(iv) 2 members are appointed by the minority
leader of the Senate;
‘‘(v) 2 members are appointed by the Speaker of
the House of Representatives;
‘‘(vi) 2 members are appointed by the minority
leader of the House of Representatives; and
‘‘(vii) such other members are appointed by the
Comptroller General of the United States; and
‘‘(B) at least reflect providers, ancillary health care
workers, consumers, purchasers, health plans, health
information technology developers, researchers, patients,
relevant Federal agencies, and individuals with technical
expertise on health care quality, system functions, privacy,
security, and on the electronic exchange and use of health
information, including the use standards for such activity.
‘‘(3) PARTICIPATION.—The members of the HIT Advisory
Committee shall represent a balance among various sectors
of the health care system so that no single sector unduly
influences the recommendations of the Committee.
‘‘(4) TERMS.—
‘‘(A) IN GENERAL.—The terms of the members of the
HIT Advisory Committee shall be for 3 years, except that
the Secretary shall designate staggered terms of the members first appointed.
‘‘(B) VACANCIES.—Any member appointed to fill a
vacancy in the membership of the HIT Advisory Committee
that occurs prior to the expiration of the term for which
the member’s predecessor was appointed shall be appointed
only for the remainder of that term. A member may serve
after the expiration of that member’s term until a successor
has been appointed. A vacancy in the HIT Advisory Committee shall be filled in the manner in which the original
appointment was made.
‘‘(C) LIMITS.—Members of the HIT Advisory Committee
shall be limited to two 3-year terms, for a total of not
to exceed 6 years of service on the Committee.
‘‘(5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee
shall ensure an opportunity for the participation in activities
of the Committee of outside advisors, including individuals
with expertise in the development of policies and standards
for the electronic exchange and use of health information,
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130 STAT. 1174
PUBLIC LAW 114–255—DEC. 13, 2016
including in the areas of health information privacy and security.
‘‘(6) QUORUM.—A majority of the members of the HIT
Advisory Committee shall constitute a quorum for purposes
of voting, but a lesser number of members may meet and
hold hearings.
‘‘(7) CONSIDERATION.—The National Coordinator shall
ensure that the relevant and available recommendations and
comments from the National Committee on Vital and Health
Statistics are considered in the development of policies.
‘‘(8) ASSISTANCE.—For the purposes of carrying out this
section, the Secretary may provide or ensure that financial
assistance is provided by the HIT Advisory Committee to defray
in whole or in part any membership fees or dues charged
by such Committee to those consumer advocacy groups and
not-for-profit entities that work in the public interest as a
party of their mission.
‘‘(e) APPLICATION OF FACA.—The Federal Advisory Committee
Act (5 U.S.C. App.), other than section 14 of such Act, shall apply
to the HIT Advisory Committee.
‘‘(f) PUBLICATION.—The Secretary shall provide for publication
in the Federal Register and the posting on the Internet website
of the Office of the National Coordinator for Health Information
Technology of all policy recommendations made by the HIT Advisory
Committee under this section.’’.
(2) TECHNICAL AND CONFORMING AMENDMENTS.—Title XXX
of the Public Health Service Act (42 U.S.C. 300jj et seq.) is
amended—
(A) by striking—
(i) ‘‘HIT Policy Committee’’ and ‘‘HIT Standards
Committee’’ each place that such terms appear (other
than within the term ‘‘HIT Policy Committee and the
HIT Standards Committee’’ or within the term ‘‘HIT
Policy Committee or the HIT Standards Committee’’)
and inserting ‘‘HIT Advisory Committee’’;
(ii) ‘‘HIT Policy Committee and the HIT Standards
Committee’’ each place that such term appears and
inserting ‘‘HIT Advisory Committee’’; and
(iii) ‘‘HIT Policy Committee or the HIT Standards
Committee’’ each place that such term appears and
inserting ‘‘HIT Advisory Committee’’;
(B) in section 3000 (42 U.S.C. 300jj)—
(i) by striking paragraphs (7) and (8) and redesignating paragraphs (9) through (14) as paragraphs (8)
through (13), respectively; and
(ii) by inserting after paragraph (6) the following
paragraph:
‘‘(7) HIT ADVISORY COMMITTEE.—The term ‘HIT Advisory
Committee’ means such Committee established under section
3002(a).’’;
(C) in section 3001(c) (42 U.S.C. 300jj–11(c))—
(i) in paragraph (1)(A), by striking ‘‘under section
3003’’ and inserting ‘‘under section 3002’’;
(ii) in paragraph (2), by striking subparagraph (B)
and inserting the following:
‘‘(B) HIT ADVISORY COMMITTEE.—The National Coordinator shall be a leading member in the establishment
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130 STAT. 1175
and operations of the HIT Advisory Committee and shall
serve as a liaison between that Committee and the Federal
Government.’’;
(D) in section 3004(b)(3) (42 U.S.C. 300jj–14(b)(3)), by
striking ‘‘3003(b)(2)’’ and inserting ‘‘3002(b)(4)’’;
(E) in section 3007(b) (42 U.S.C. 300jj–17(b)), by
striking ‘‘3003(a)’’ and inserting ‘‘3002(a)(2)’’; and
(F) in section 3008 (42 U.S.C. 300jj–18)—
(i) in subsection (b), by striking ‘‘or 3003’’; and
(ii) in subsection (c), by striking ‘‘3003(b)(1)(A)’’
and inserting ‘‘3002(b)(2)’’.
(3) TRANSITION TO THE HIT ADVISORY COMMITTEE.—The Secretary of Health and Human Services shall provide for an
orderly and timely transition to the HIT Advisory Committee
established under amendments made by this section.
(f) PRIORITIES FOR ADOPTION OF STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND CERTIFICATION CRITERIA.—Title XXX of the
Public Health Service Act (42 U.S.C. 300jj et seq.), as amended
by subsection (e), is further amended by inserting after section
3002 the following:
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‘‘SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION.
42 USC 300jj–12
note.
42 USC 300jj–13.
‘‘(a) IDENTIFYING PRIORITIES.—
‘‘(1) IN GENERAL.—Not later than 6 months after the date
on which the HIT Advisory Committee first meets, the National
Coordinator shall periodically convene the HIT Advisory Committee to—
‘‘(A) identify priority uses of health information technology, focusing on priorities—
‘‘(i) arising from the implementation of the incentive programs for the meaningful use of certified EHR
technology, the Merit-based Incentive Payment
System, Alternative Payment Models, the Hospital
Value-Based Purchasing Program, and any other
value-based payment program determined appropriate
by the Secretary;
‘‘(ii) related to the quality of patient care;
‘‘(iii) related to public health;
‘‘(iv) related to clinical research;
‘‘(v) related to the privacy and security of electronic
health information;
‘‘(vi) related to innovation in the field of health
information technology;
‘‘(vii) related to patient safety;
‘‘(viii) related to the usability of health information
technology;
‘‘(ix) related to individuals’ access to electronic
health information; and
‘‘(x) other priorities determined appropriate by the
Secretary;
‘‘(B) identify existing standards and implementation
specifications that support the use and exchange of electronic health information needed to meet the priorities
identified in subparagraph (A); and
‘‘(C) publish a report summarizing the findings of the
analysis conducted under subparagraphs (A) and (B) and
make appropriate recommendations.
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(2) PRIORITIZATION.—In identifying such standards and
implementation specifications under paragraph (1)(B), the HIT
Advisory Committee shall prioritize standards and implementation specifications developed by consensus-based standards
development organizations.
‘‘(3) GUIDELINES FOR REVIEW OF EXISTING STANDARDS AND
SPECIFICATIONS.—In consultation with the consensus-based
entity described in section 1890 of the Social Security Act
and other appropriate Federal agencies, the analysis of existing
standards under paragraph (1)(B) shall include an evaluation
of the need for a core set of common data elements and associated value sets to enhance the ability of certified health
information technology to capture, use, and exchange structured
electronic health information.
‘‘(b) REVIEW OF ADOPTED STANDARDS.—
‘‘(1) IN GENERAL.—Beginning 5 years after the date of enactment of the 21st Century Cures Act and every 3 years thereafter, the National Coordinator shall convene stakeholders to
review the existing set of adopted standards and implementation specifications and make recommendations with respect
to whether to—
‘‘(A) maintain the use of such standards and
implementation specifications; or
‘‘(B) phase out such standards and implementation
specifications.
‘‘(2) PRIORITIES.—The HIT Advisory Committee, in
collaboration with the National Institute for Standards and
Technology, shall annually and through the use of public input,
review and publish priorities for the use of health information
technology, standards, and implementation specifications to
support those priorities.
‘‘(c) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to prevent the use or adoption of novel standards
that improve upon the existing health information technology infrastructure and facilitate the secure exchange of health information.’’.
SEC. 4004. INFORMATION BLOCKING.
Subtitle C of title XXX of the Public Health Service Act (42
U.S.C. 300jj–51 et seq.) is amended by adding at the end the
following:
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42 USC 300jj–52.
‘‘SEC. 3022. INFORMATION BLOCKING.
‘‘(a) DEFINITION.—
‘‘(1) IN GENERAL.—In this section, the term ‘information
blocking’ means a practice that—
‘‘(A) except as required by law or specified by the
Secretary pursuant to rulemaking under paragraph (3),
is likely to interfere with, prevent, or materially discourage
access, exchange, or use of electronic health information;
and
‘‘(B)(i) if conducted by a health information technology
developer, exchange, or network, such developer, exchange,
or network knows, or should know, that such practice is
likely to interfere with, prevent, or materially discourage
the access, exchange, or use of electronic health information; or
‘‘(ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is
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130 STAT. 1177
likely to interfere with, prevent, or materially discourage
access, exchange, or use of electronic health information.
‘‘(2) PRACTICES DESCRIBED.—The information blocking practices described in paragraph (1) may include—
‘‘(A) practices that restrict authorized access, exchange,
or use under applicable State or Federal law of such
information for treatment and other permitted purposes
under such applicable law, including transitions between
certified health information technologies;
‘‘(B) implementing health information technology in
nonstandard ways that are likely to substantially increase
the complexity or burden of accessing, exchanging, or using
electronic health information; and
‘‘(C) implementing health information technology in
ways that are likely to—
‘‘(i) restrict the access, exchange, or use of electronic health information with respect to exporting
complete information sets or in transitioning between
health information technology systems; or
‘‘(ii) lead to fraud, waste, or abuse, or impede
innovations and advancements in health information
access, exchange, and use, including care delivery
enabled by health information technology.
‘‘(3) RULEMAKING.—The Secretary, through rulemaking,
shall identify reasonable and necessary activities that do not
constitute information blocking for purposes of paragraph (1).
‘‘(4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.—
The term ‘information blocking’ does not include any practice
or conduct occurring prior to the date that is 30 days after
the date of enactment of the 21st Century Cures Act.
‘‘(5) CONSULTATION.—The Secretary may consult with the
Federal Trade Commission in promulgating regulations under
this subsection, to the extent that such regulations define practices that are necessary to promote competition and consumer
welfare.
‘‘(6) APPLICATION.—The term ‘information blocking’, with
respect to an individual or entity, shall not include an act
or practice other than an act or practice committed by such
individual or entity.
‘‘(7) CLARIFICATION.—In carrying out this section, the Secretary shall ensure that health care providers are not penalized
for the failure of developers of health information technology
or other entities offering health information technology to such
providers to ensure that such technology meets the requirements to be certified under this title.
‘‘(b) INSPECTOR GENERAL AUTHORITY.—
‘‘(1) IN GENERAL.—The inspector general of the Department
of Health and Human Services (referred to in this section
as the ‘Inspector General’) may investigate any claim that—
‘‘(A) a health information technology developer of certified health information technology or other entity offering
certified health information technology—
‘‘(i) submitted a false attestation under section
3001(c)(5)(D)(vii); or
‘‘(ii) engaged in information blocking;
‘‘(B) a health care provider engaged in information
blocking; or
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‘‘(C) a health information exchange or network engaged
in information blocking.
‘‘(2) PENALTIES.—
‘‘(A) DEVELOPERS, NETWORKS, AND EXCHANGES.—Any
individual or entity described in subparagraph (A) or (C)
of paragraph (1) that the Inspector General, following an
investigation conducted under this subsection, determines
to have committed information blocking shall be subject
to a civil monetary penalty determined by the Secretary
for all such violations identified through such investigation,
which may not exceed $1,000,000 per violation. Such determination shall take into account factors such as the nature
and extent of the information blocking and harm resulting
from such information blocking, including, where
applicable, the number of patients affected, the number
of providers affected, and the number of days the information blocking persisted.
‘‘(B) PROVIDERS.—Any individual or entity described
in subparagraph (B) of paragraph (1) determined by the
Inspector General to have committed information blocking
shall be referred to the appropriate agency to be subject
to appropriate disincentives using authorities under
applicable Federal law, as the Secretary sets forth through
notice and comment rulemaking.
‘‘(C) PROCEDURE.—The provisions of section 1128A of
the Social Security Act (other than subsections (a) and
(b) of such section) shall apply to a civil money penalty
applied under this paragraph in the same manner as such
provisions apply to a civil money penalty or proceeding
under such section 1128A(a).
‘‘(D) RECOVERED PENALTY FUNDS.—The amounts recovered under this paragraph shall be allocated as follows:
‘‘(i) ANNUAL OPERATING EXPENSES.—Each year following the establishment of the authority under this
subsection, the Office of the Inspector General shall
provide to the Secretary an estimate of the costs to
carry out investigations under this section. Such estimate may include reasonable reserves to account for
variance in annual amounts recovered under this paragraph. There is authorized to be appropriated for purposes of carrying out this section an amount equal
to the amount specified in such estimate for the fiscal
year.
‘‘(ii) APPLICATION TO OTHER PROGRAMS.—The
amounts recovered under this paragraph and
remaining after amounts are made available under
clause (i) shall be transferred to the Federal Hospital
Insurance Trust Fund under section 1817 of the Social
Security Act and the Federal Supplementary Medical
Insurance Trust Fund under section 1841 of such Act,
in such proportion as the Secretary determines appropriate.
‘‘(E) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to the Office of the Inspector
General to carry out this section $10,000,000, to remain
available until expended.
‘‘(3) RESOLUTION OF CLAIMS.—
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130 STAT. 1179
‘‘(A) IN GENERAL.—The Office of the Inspector General,
if such Office determines that a consultation regarding
the health privacy and security rules promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d–2 note) will
resolve an information blocking claim, may refer such
instances of information blocking to the Office for Civil
Rights of the Department of Health and Human Services
for resolution.
‘‘(B) LIMITATION ON LIABILITY.—If a health care provider or health information technology developer makes
information available based on a good faith reliance on
consultations with the Office for Civil Rights of the Department of Health and Human Services pursuant to a referral
under subparagraph (A), with respect to such information,
the health care provider or developer shall not be liable
for such disclosure or disclosures made pursuant to
subparagraph (A).
‘‘(c) IDENTIFYING BARRIERS TO EXCHANGE OF CERTIFIED HEALTH
INFORMATION TECHNOLOGY.—
‘‘(1) TRUSTED EXCHANGE DEFINED.—In this section, the term
‘trusted exchange’ with respect to certified electronic health
records means that the certified electronic health record technology has the technical capability to enable secure health
information exchange between users and multiple certified electronic health record technology systems.
‘‘(2) GUIDANCE.—The National Coordinator, in consultation
with the Office for Civil Rights of the Department of Health
and Human Services, shall issue guidance on common legal,
governance, and security barriers that prevent the trusted
exchange of electronic health information.
‘‘(3) REFERRAL.—The National Coordinator and the Office
for Civil Rights of the Department of Health and Human Services may refer to the Inspector General instances or patterns
of refusal to exchange health information with an individual
or entity using certified electronic health record technology
that is technically capable of trusted exchange and under conditions when exchange is legally permissible.
‘‘(d) ADDITIONAL PROVISIONS.—
‘‘(1) INFORMATION SHARING PROVISIONS.—The National
Coordinator may serve as a technical consultant to the
Inspector General and the Federal Trade Commission for purposes of carrying out this section. The National Coordinator
may, notwithstanding any other provision of law, share
information related to claims or investigations under subsection
(b) with the Federal Trade Commission for purposes of such
investigations and shall share information with the Inspector
General, as required by law.
‘‘(2) PROTECTION FROM DISCLOSURE OF INFORMATION.—Any
information that is received by the National Coordinator in
connection with a claim or suggestion of possible information
blocking and that could reasonably be expected to facilitate
identification of the source of the information—
‘‘(A) shall not be disclosed by the National Coordinator
except as may be necessary to carry out the purpose of
this section;
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‘‘(B) shall be exempt from mandatory disclosure under
section 552 of title 5, United States Code, as provided
by subsection (b)(3) of such section; and
‘‘(C) may be used by the Inspector General or Federal
Trade Commission for reporting purposes to the extent
that such information could not reasonably be expected
to facilitate identification of the source of such information.
‘‘(3) STANDARDIZED PROCESS.—
‘‘(A) IN GENERAL.—The National Coordinator shall
implement a standardized process for the public to submit
reports on claims of—
‘‘(i) health information technology products or
developers of such products (or other entities offering
such products to health care providers) not being interoperable or resulting in information blocking;
‘‘(ii) actions described in subsection (b)(1) that
result in information blocking as described in subsection (a); and
‘‘(iii) any other act described in subsection (a).
‘‘(B) COLLECTION OF INFORMATION.—The standardized
process implemented under subparagraph (A) shall provide
for the collection of such information as the originating
institution, location, type of transaction, system and
version, timestamp, terminating institution, locations,
system and version, failure notice, and other related
information.
‘‘(4) NONDUPLICATION OF PENALTY STRUCTURES.—In carrying out this subsection, the Secretary shall, to the extent
possible, ensure that penalties do not duplicate penalty structures that would otherwise apply with respect to information
blocking and the type of individual or entity involved as of
the day before the date of the enactment of this section.’’.
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42 USC 300jj–14
note.
SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE
PATIENT CARE.
(a) REQUIREMENT RELATING TO REGISTRIES.—
(1) IN GENERAL.—To be certified in accordance with title
XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.),
electronic health records shall be capable of transmitting to,
and where applicable, receiving and accepting data from, registries in accordance with standards recognized by the Office
of the National Coordinator for Health Information Technology,
including clinician-led clinical data registries, that are also
certified to be technically capable of receiving and accepting
from, and where applicable, transmitting data to certified electronic health record technology in accordance with such standards.
(2) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to require the certification of registries
beyond the technical capability to exchange data in accordance
with applicable recognized standards.
(b) DEFINITION.—For purposes of this Act, the term ‘‘clinicianled clinical data registry’’ means a clinical data repository—
(1) that is established and operated by a clinician-led or
controlled, tax-exempt (pursuant to section 501(c) of the
Internal Revenue Code of 1986), professional society or other
similar clinician-led or -controlled organization, or such
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130 STAT. 1181
organization’s controlled affiliate, devoted to the care of a population defined by a particular disease, condition, exposure or
therapy;
(2) that is designed to collect detailed, standardized data
on an ongoing basis for medical procedures, services, or therapies for particular diseases, conditions, or exposures;
(3) that provides feedback to participants who submit
reports to the repository;
(4) that meets standards for data quality including—
(A) systematically collecting clinical and other health
care data, using standardized data elements and having
procedures in place to verify the completeness and validity
of those data; and
(B) being subject to regular data checks or audits to
verify completeness and validity; and
(5) that provides ongoing participant training and support.
(c) TREATMENT OF HEALTH INFORMATION TECHNOLOGY DEVELOPERS WITH RESPECT TO PATIENT SAFETY ORGANIZATIONS.—
(1) IN GENERAL.—In applying part C of title IX of the
Public Health Service Act (42 U.S.C. 299b–21 et seq.), a health
information technology developer shall be treated as a provider
(as defined in section 921 of such Act) for purposes of reporting
and conducting patient safety activities concerning improving
clinical care through the use of health information technology
that could result in improved patient safety, health care quality,
or health care outcomes.
(2) REPORT.—Not later than 4 years after the date of enactment of this Act, the Secretary of Health and Human Services
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 concerning best practices and current trends voluntarily provided,
without identifying individual providers or disclosing or using
protected health information or individually identifiable
information, by patient safety organizations to improve the
integration of health information technology into clinical practice.
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SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS
TO THEIR ELECTRONIC HEALTH INFORMATION.
(a) USE OF HEALTH INFORMATION EXCHANGES FOR PATIENT
ACCESS.—Section 3009 of the Public Health Service Act (42 U.S.C.
300jj–19) is amended by adding at the end the following:
‘‘(c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH
INFORMATION THROUGH HEALTH INFORMATION EXCHANGES .—
‘‘(1) IN GENERAL.—The Secretary shall use existing authorities to encourage partnerships between health information
exchange organizations and networks and health care providers, health plans, and other appropriate entities with the
goal of offering patients access to their electronic health
information in a single, longitudinal format that is easy to
understand, secure, and may be updated automatically.
‘‘(2) EDUCATION OF PROVIDERS.—The Secretary, in coordination with the Office for Civil Rights of the Department of
Health and Human Services, shall—
‘‘(A) educate health care providers on ways of
leveraging the capabilities of health information exchanges
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PUBLIC LAW 114–255—DEC. 13, 2016
(or other relevant platforms) to provide patients with access
to their electronic health information;
‘‘(B) clarify misunderstandings by health care providers
about using health information exchanges (or other relevant platforms) for patient access to electronic health
information; and
‘‘(C) to the extent practicable, educate providers about
health information exchanges (or other relevant platforms)
that employ some or all of the capabilities described in
paragraph (1).
‘‘(3) REQUIREMENTS.—In carrying out paragraph (1), the
Secretary, in coordination with the Office for Civil Rights, shall
issue guidance to health information exchanges related to best
practices to ensure that the electronic health information provided to patients is—
‘‘(A) private and secure;
‘‘(B) accurate;
‘‘(C) verifiable; and
‘‘(D) where a patient’s authorization to exchange
information is required by law, easily exchanged pursuant
to such authorization.
‘‘(4) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to preempt State laws applicable to patient
consent for the access of information through a health information exchange (or other relevant platform) that provide protections to patients that are greater than the protections otherwise
provided for under applicable Federal law.
‘‘(d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.—
The National Coordinator and the Office for Civil Rights of the
Department of Health and Human Services shall jointly promote
patient access to health information in a manner that would ensure
that such information is available in a form convenient for the
patient, in a reasonable manner, without burdening the health
care provider involved.
‘‘(e) ACCESSIBILITY OF PATIENT RECORDS.—
‘‘(1) ACCESSIBILITY AND UPDATING OF INFORMATION.—
‘‘(A) IN GENERAL.—The Secretary, in consultation with
the National Coordinator, shall promote policies that
ensure that a patient’s electronic health information is
accessible to that patient and the patient’s designees, in
a manner that facilitates communication with the patient’s
health care providers and other individuals, including
researchers, consistent with such patient’s consent.
‘‘(B) UPDATING EDUCATION ON ACCESSING AND
EXCHANGING PERSONAL HEALTH INFORMATION.—To promote
awareness that an individual has a right of access to
inspect, obtain a copy of, and transmit to a third party
a copy of such individual’s protected health information
pursuant to the Health Information Portability and
Accountability Act, Privacy Rule (subpart E of part 164
of title 45, Code of Federal Regulations), the Director of
the Office for Civil Rights, in consultation with the National
Coordinator, shall assist individuals and health care providers in understanding a patient’s rights to access and
protect personal health information under the Health
Insurance Portability and Accountability Act of 1996
(Public Law 104–191), including providing best practices
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130 STAT. 1183
for requesting personal health information in a computable
format, including using patient portals or third-party
applications and common cases when a provider is permitted to exchange and provide access to health information.’’.
‘‘(2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out
certification programs under section 3001(c)(5), the National
Coordinator may require that—
‘‘(A) the certification criteria support—
‘‘(i) patient access to their electronic health
information, including in a single longitudinal format
that is easy to understand, secure, and may be updated
automatically;
‘‘(ii) the patient’s ability to electronically communicate patient-reported information (such as family history and medical history); and
‘‘(iii) patient access to their personal electronic
health information for research at the option of the
patient; and
‘‘(B) the HIT Advisory Committee develop and
prioritize standards, implementation specifications, and
certification criteria required to help support patient access
to electronic health information, patient usability, and support for technologies that offer patients access to their
electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated
automatically.’’.
(b) ACCESS TO INFORMATION IN AN ELECTRONIC FORMAT.—Section 13405(e) of the Health Information Technology for Economic
and Clinical Health Act (42 U.S.C. 17935) is amended—
(1) in paragraph (1), by striking ‘‘and’’ at the end;
(2) by redesignating paragraph (2) as paragraph (3); and
(3) by inserting after paragraph (1), the following:
‘‘(2) if the individual makes a request to a business associate for access to, or a copy of, protected health information
about the individual, or if an individual makes a request to
a business associate to grant such access to, or transmit such
copy directly to, a person or entity designated by the individual,
a business associate may provide the individual with such
access or copy, which may be in an electronic form, or grant
or transmit such access or copy to such person or entity designated by the individual; and’’.
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SEC. 4007. GAO STUDY ON PATIENT MATCHING.
(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States
shall conduct a study to—
(1) review the policies and activities of the Office of the
National Coordinator for Health Information Technology and
other relevant stakeholders, which may include standards
development organizations, experts in the technical aspects
of health information technology, health information technology
developers, providers of health services, health care suppliers,
health care payers, health care quality organizations, States,
health information technology policy experts, and other appropriate entities, to ensure appropriate patient matching to protect patient privacy and security with respect to electronic
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PUBLIC LAW 114–255—DEC. 13, 2016
health records and the exchange of electronic health information; and
(2) survey ongoing efforts related to the policies and activities described in paragraph (1) and the effectiveness of such
efforts occurring in the private sector.
(b) AREAS OF CONCENTRATION.—In conducting the study under
subsection (a), the Comptroller General shall—
(1) evaluate current methods used in certified electronic
health records for patient matching based on performance
related to factors such as—
(A) the privacy of patient information;
(B) the security of patient information;
(C) improving matching rates;
(D) reducing matching errors; and
(E) reducing duplicate records; and
(2) determine whether the Office of the National Coordinator for Health Information Technology could improve patient
matching by taking steps including—
(A) defining additional data elements to assist in
patient data matching;
(B) agreeing on a required minimum set of elements
that need to be collected and exchanged;
(C) requiring electronic health records to have the
ability to make certain fields required and use specific
standards; and
(D) other options recommended by the relevant stakeholders consulted pursuant to subsection (a).
(c) REPORT.—Not later than 2 years after the date of enactment
of this Act, the Comptroller General shall submit to the appropriate
committees of Congress a report concerning the findings of the
study conducted under subsection (a).
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SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.
(a) STUDY.—
(1) IN GENERAL.—The Comptroller General of the United
States (referred to in this section as the ‘‘Comptroller General’’)
shall build on prior Government Accountability Office studies
and other literature review and conduct a study to review
patient access to their own protected health information,
including barriers to such patient access and complications
or difficulties providers experience in providing access to
patients. In conducting such study, the Comptroller General
shall consider the increase in adoption of health information
technology and the increasing prevalence of protected health
information that is maintained electronically.
(2) AREAS OF CONCENTRATION.—In conducting the review
under paragraph (1), the Comptroller General shall consider—
(A) instances when covered entities charge individuals,
including patients, third parties, and health care providers,
for record requests, including records that are requested
in an electronic format;
(B) examples of the amounts and types of fees charged
to individuals for record requests, including instances when
the record is requested to be transmitted to a third party;
(C) the extent to which covered entities are unable
to provide the access requested by individuals in the form
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130 STAT. 1185
and format requested by the individual, including examples
of such instances;
(D) instances in which third parties may request protected health information through patients’ individual right
of access, including instances where such requests may
be used to circumvent appropriate fees that may be charged
to third parties;
(E) opportunities that permit covered entities to charge
appropriate fees to third parties for patient records while
providing patients with access to their protected health
information at low or no cost;
(F) the ability of providers to distinguish between
requests originating from an individual that require limitation to a cost-based fee and requests originating from third
parties that may not be limited to cost-based fees; and
(G) other circumstances that may inhibit the ability
of providers to provide patients with access to their records,
and the ability of patients to gain access to their records.
(b) REPORT.—Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit a report
to Congress on the findings of the study conducted under subsection
(a).
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.
(a) IN GENERAL.—Section 1862(l)(5) of the Social Security Act
(42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph:
‘‘(D) LOCAL COVERAGE DETERMINATIONS.—The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to
make available on the Internet website of such contractor
and on the Medicare Internet website, at least 45 days
before the effective date of such determination, the following information:
‘‘(i) Such determination in its entirety.
‘‘(ii) Where and when the proposed determination
was first made public.
‘‘(iii) Hyperlinks to the proposed determination and
a response to comments submitted to the contractor
with respect to such proposed determination.
‘‘(iv) A summary of evidence that was considered
by the contractor during the development of such determination and a list of the sources of such evidence.
‘‘(v) An explanation of the rationale that supports
such determination.’’.
(b) EFFECTIVE DATE.—The amendment made by subsection (a)
shall apply with respect to local coverage determinations that are
proposed or revised on or after the date that is 180 days after
the date of enactment of this Act.
42 USC 1395y
note.
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SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
Section 1808 of the Social Security Act (42 U.S.C. 1395b–
9) is amended by adding at the end the following new subsection:
‘‘(d) PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.—
‘‘(1) IN GENERAL.—Not later than 12 months after the date
of enactment of this paragraph, the Secretary shall provide
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for a pharmaceutical and technology ombudsman within the
Centers for Medicare & Medicaid Services who shall receive
and respond to complaints, grievances, and requests that—
‘‘(A) are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought
under this title; and
‘‘(B) are with respect to coverage, coding, or payment
under this title for such products.
‘‘(2) APPLICATION.—The second sentence of subsection (c)(2)
shall apply to the ombudsman under subparagraph (A) in the
same manner as such sentence applies to the Medicare Beneficiary Ombudsman under subsection (c).’’.
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SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
Section 1834 of the Social Security Act (42 U.S.C. 1395m)
is amended by adding at the end the following new subsection:
‘‘(t) SITE-OF-SERVICE PRICE TRANSPARENCY.—
‘‘(1) IN GENERAL.—In order to facilitate price transparency
with respect to items and services for which payment may
be made either to a hospital outpatient department or to an
ambulatory surgical center under this title, the Secretary shall,
for 2018 and each year thereafter, make available to the public
via a searchable Internet website, with respect to an appropriate number of such items and services—
‘‘(A) the estimated payment amount for the item or
service under the outpatient department fee schedule under
subsection (t) of section 1833 and the ambulatory surgical
center payment system under subsection (i) of such section;
and
‘‘(B) the estimated amount of beneficiary liability
applicable to the item or service.
‘‘(2) CALCULATION OF ESTIMATED BENEFICIARY LIABILITY.—
For purposes of paragraph (1)(B), the estimated amount of
beneficiary liability, with respect to an item or service, is the
amount for such item or service for which an individual who
does not have coverage under a Medicare supplemental policy
certified under section 1882 or any other supplemental insurance coverage is responsible.
‘‘(3) IMPLEMENTATION.—In carrying out this subsection, the
Secretary—
‘‘(A) shall include in the notice described in section
1804(a) a notification of the availability of the estimated
amounts made available under paragraph (1); and
‘‘(B) may utilize mechanisms in existence on the date
of enactment of this subsection, such as the portion of
the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician
performance is posted (commonly referred to as the Physician Compare Internet website), to make available such
estimated amounts under such paragraph.
‘‘(4) FUNDING.—For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the
Federal Supplementary Medical Insurance Trust Fund under
section 1841 to the Centers for Medicare & Medicaid Services
Program Management Account, of $6,000,000 for fiscal year
2017, to remain available until expended.’’.
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SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.
(a) PROVISION OF INFORMATION BY CENTERS FOR MEDICARE
& MEDICAID SERVICES.—Not later than 1 year after the date of
enactment of this Act, the Administrator of the Centers for Medicare
& Medicaid Services shall provide to the committees of jurisdiction
of the House of Representatives and the Senate information on
the following:
(1) The populations of Medicare beneficiaries, such as those
who are dually eligible for the Medicare program under title
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and
the Medicaid program under title XIX of such Act (42 U.S.C.
1396 et seq.) and those with chronic conditions, whose care
may be improved most in terms of quality and efficiency by
the expansion, in a manner that meets or exceeds the existing
in-person standard of care under the Medicare program under
such title XVIII, of telehealth services under section 1834(m)(4)
of such Act (42 U.S.C. 1395m(m)(4)).
(2) Activities by the Center for Medicare and Medicaid
Innovation which examine the use of telehealth services in
models, projects, or initiatives funded through section 1115A
of such Act (42 U.S.C. 1315a).
(3) The types of high-volume services (and related
diagnoses) under such title XVIII which might be suitable
to be furnished using telehealth.
(4) Barriers that might prevent the expansion of telehealth
services under section 1834(m)(4) of the Social Security Act
(42 U.S.C. 1395m(m)(4)) beyond such services that are in effect
as of the date of enactment of this Act.
(b) PROVISION OF INFORMATION BY MEDPAC.—Not later than
March 15, 2018, the Medicare Payment Advisory Commission established under section 1805 of the Social Security Act (42 U.S.C.
1395b–6) shall, using quantitative and qualitative research
methods, provide information to the committees of jurisdiction of
the House of Representatives and the Senate that identifies—
(1) the telehealth services for which payment can be made,
as of the date of enactment of this Act, under the fee-forservice program under parts A and B of title XVIII of such
Act;
(2) the telehealth services for which payment can be made,
as of such date, under private health insurance plans; and
(3) with respect to services identified under paragraph
(2) but not under paragraph (1), ways in which payment for
such services might be incorporated into such fee-for-service
program (including any recommendations for ways to accomplish this incorporation).
(c) SENSE OF CONGRESS.—It is the sense of Congress that—
(1) eligible originating sites should be expanded beyond
those originating sites described in section 1834(m)(4)(C) of
the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
(2) any expansion of telehealth services under the Medicare
program under title XVIII of such Act should—
(A) recognize that telemedicine is the delivery of safe,
effective, quality health care services, by a health care
provider, using technology as the mode of care delivery;
(B) meet or exceed the conditions of coverage and payment with respect to the Medicare program if the service
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was furnished in person, including standards of care, unless
specifically addressed in subsequent legislation; and
(C) involve clinically appropriate means to furnish such
services.
TITLE V—SAVINGS
SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)), as amended by section 704(h) of the Comprehensive
Addiction and Recovery Act of 2016, is amended by striking
‘‘$140,000,000’’ and inserting ‘‘$270,000,000’’.
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE
MEDICAL EQUIPMENT.
Section 1903(i)(27) of the Social Security Act (42 U.S.C.
1396b(i)(27)) is amended by striking ‘‘January 1, 2019’’ and inserting
‘‘January 1, 2018’’.
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SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND
OTHER AGREEMENTS.
(a) IN GENERAL.—Section 1128A of the Social Security Act
(42 U.S.C. 1320a–7a) is amended by adding at the end the following
new subsections:
‘‘(o) Any person (including an organization, agency, or other
entity, but excluding a program beneficiary, as defined in subsection
(q)(4)) that, with respect to a grant, contract, or other agreement
for which the Secretary provides funding—
‘‘(1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant,
contract, or other agreement that the person knows or should
know is false or fraudulent;
‘‘(2) knowingly makes, uses, or causes to be made or used
any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or
other document that is required to be submitted in order to
directly or indirectly receive or retain funds provided in whole
or in part by such Secretary pursuant to such grant, contract,
or other agreement;
‘‘(3) knowingly makes, uses, or causes to be made or used,
a false record or statement material to a false or fraudulent
specified claim under such grant, contract, or other agreement;
‘‘(4) knowingly makes, uses, or causes to be made or used,
a false record or statement material to an obligation (as defined
in subsection (s)) to pay or transmit funds or property to such
Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly
avoids or decreases an obligation to pay or transmit funds
or property to such Secretary with respect to such grant, contract, or other agreement; or
‘‘(5) fails to grant timely access, upon reasonable request
(as defined by such Secretary in regulations), to the Inspector
General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector
General in matters involving such grants, contracts, or other
agreements;
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1189
shall be subject, in addition to any other penalties that may be
prescribed by law, to a civil money penalty in cases under paragraph
(1), of not more than $10,000 for each specified claim; in cases
under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases
under paragraph (3), not more than $50,000 for each false record
or statement; in cases under paragraph (4), not more than $50,000
for each false record or statement or $10,000 for each day that
the person knowingly conceals or knowingly and improperly avoids
or decreases an obligation to pay; or in cases under paragraph
(5), not more than $15,000 for each day of the failure described
in such paragraph. In addition, in cases under paragraphs (1)
and (3), such a person shall be subject to an assessment of not
more than 3 times the amount claimed in the specified claim
described in such paragraph in lieu of damages sustained by the
United States or a specified State agency because of such specified
claim, and in cases under paragraphs (2) and (4), such a person
shall be subject to an assessment of not more than 3 times the
total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to
the Secretary described in paragraph (4), of the value of the property
described in such paragraph) in lieu of damages sustained by the
United States or a specified State agency because of such case.
In addition, the Secretary may make a determination in the same
proceeding to exclude the person from participation in the Federal
health care programs (as defined in section 1128B(f)(1)) and to
direct the appropriate State agency to exclude the person from
participation in any State health care program.
‘‘(p) The provisions of subsections (c), (d), (g), and (h) shall
apply to a civil money penalty or assessment under subsection
(o) in the same manner as such provisions apply to a penalty,
assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall
be treated as including a reference to a specified claim (as defined
in subsection (r)).
‘‘(q) For purposes of this subsection and subsections (o) and
(p):
‘‘(1) The term ‘Department’ means the Department of
Health and Human Services.
‘‘(2) The term ‘material’ means having a natural tendency
to influence, or be capable of influencing, the payment or receipt
of money or property.
‘‘(3) The term ‘other agreement’ includes a cooperative
agreement, scholarship, fellowship, loan, subsidy, payment for
a specified use, donation agreement, award, or subaward
(regardless of whether one or more of the persons entering
into the agreement is a contractor or subcontractor).
‘‘(4) The term ‘program beneficiary’ means, in the case
of a grant, contract, or other agreement designed to accomplish
the objective of awarding or otherwise furnishing benefits or
assistance to individuals and for which the Secretary provides
funding, an individual who applies for, or who receives, such
benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant,
contract, or other agreement, an officer, employee, or agent
of a person or entity that receives such grant or that enters
into such contract or other agreement.
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(5) The term ‘recipient’ includes a subrecipient or subcontractor.
‘‘(6) The term ‘specified State agency’ means an agency
of a State government established or designated to administer
or supervise the administration of a grant, contract, or other
agreement funded in whole or in part by the Secretary.
‘‘(r) For purposes of this section, the term ‘specified claim’
means any application, request, or demand under a grant, contract,
or other agreement for money or property, whether or not the
United States or a specified State agency has title to the money
or property, that is not a claim (as defined in subsection (i)(2))
and that—
‘‘(1) is presented or caused to be presented to an officer,
employee, or agent of the Department or agency thereof, or
of any specified State agency; or
‘‘(2) is made to a contractor, grantee, or any other recipient
if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest,
and if the Department—
‘‘(A) provides or has provided any portion of the money
or property requested or demanded; or
‘‘(B) will reimburse such contractor, grantee, or other
recipient for any portion of the money or property which
is requested or demanded.
‘‘(s) For purposes of subsection (o), the term ‘obligation’ means
an established duty, whether or not fixed, arising from an express
or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.’’.
(b) CONFORMING AMENDMENTS.—Section 1128A of the Social
Security Act (42 U.S.C. 1320a–7a) is amended—
(1) in subsection (e), by inserting ‘‘or specified claim’’ after
‘‘claim’’ in the first sentence; and
(2) in subsection (f)—
(A) in the matter preceding paragraph (1)—
(i) by inserting ‘‘or specified claim (as defined in
subsection (r))’’ after ‘‘district where the claim’’; and
(ii) by inserting ‘‘(or, with respect to a person
described in subsection (o), the person)’’ after ‘‘claimant’’; and
(B) in the matter following paragraph (4), by inserting
‘‘(or, in the case of a penalty or assessment under subsection
(o), by a specified State agency (as defined in subsection
(q)(6)),’’ after ‘‘or a State agency’’.
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SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.
(a) TREATMENT OF INFUSION DRUGS FURNISHED THROUGH
DURABLE MEDICAL EQUIPMENT.—Section 1842(o)(1) of the Social
Security Act (42 U.S.C. 1395u(o)(1)) is amended—
(1) in subparagraph (C), by inserting ‘‘(and including a
drug or biological described in subparagraph (D)(i) furnished
on or after January 1, 2017)’’ after ‘‘2005’’; and
(2) in subparagraph (D)—
(A) by striking ‘‘infusion drugs’’ and inserting ‘‘infusion
drugs or biologicals’’ each place it appears; and
(B) in clause (i)—
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130 STAT. 1191
(i) by striking ‘‘2004’’ and inserting ‘‘2004, and
before January 1, 2017’’; and
(ii) by striking ‘‘for such drug’’.
(b) NONINCLUSION OF DME INFUSION DRUGS UNDER DME
COMPETITIVE ACQUISITION PROGRAMS.—
(1) IN GENERAL.—Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)(A)) is amended—
(A) by striking ‘‘and excluding’’ and inserting ‘‘,
excluding’’; and
(B) by inserting before the period at the end the following: ‘‘, and excluding drugs and biologicals described
in section 1842(o)(1)(D)’’.
(2) CONFORMING AMENDMENT.—Section 1842(o)(1)(D)(ii) of
the Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended
by striking ‘‘2007’’ and inserting ‘‘2007, and before the date
of the enactment of the 21st Century Cures Act.’’.
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SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID
PROVIDERS.
(a) INCREASED OVERSIGHT AND REPORTING.—
(1) STATE REPORTING REQUIREMENTS.—Section 1902(kk) of
the Social Security Act (42 U.S.C. 1396a(kk)) is amended—
(A) by redesignating paragraph (8) as paragraph (9);
and
(B) by inserting after paragraph (7) the following new
paragraph:
‘‘(8) PROVIDER TERMINATIONS.—
‘‘(A) IN GENERAL.—Beginning on July 1, 2018, in the
case of a notification under subsection (a)(41) with respect
to a termination for a reason specified in section 455.101
of title 42, Code of Federal Regulations (as in effect on
November 1, 2015) or for any other reason specified by
the Secretary, of the participation of a provider of services
or any other person under the State plan (or under a
waiver of the plan), the State, not later than 30 days
after the effective date of such termination, submits to
the Secretary with respect to any such provider or person,
as appropriate—
‘‘(i) the name of such provider or person;
‘‘(ii) the provider type of such provider or person;
‘‘(iii) the specialty of such provider’s or person’s
practice;
‘‘(iv) the date of birth, Social Security number,
national provider identifier (if applicable), Federal taxpayer identification number, and the State license or
certification number of such provider or person (if
applicable);
‘‘(v) the reason for the termination;
‘‘(vi) a copy of the notice of termination sent to
the provider or person;
‘‘(vii) the date on which such termination is effective, as specified in the notice; and
‘‘(viii) any other information required by the Secretary.
‘‘(B) EFFECTIVE DATE DEFINED.—For purposes of this
paragraph, the term ‘effective date’ means, with respect
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130 STAT. 1192
PUBLIC LAW 114–255—DEC. 13, 2016
to a termination described in subparagraph (A), the later
of—
‘‘(i) the date on which such termination is effective,
as specified in the notice of such termination; or
‘‘(ii) the date on which all appeal rights applicable
to such termination have been exhausted or the
timeline for any such appeal has expired.’’.
(2) CONTRACT REQUIREMENT FOR MANAGED CARE ENTITIES.—Section 1932(d) of the Social Security Act (42 U.S.C.
1396u–2(d)) is amended by adding at the end the following
new paragraph:
‘‘(5) CONTRACT REQUIREMENT FOR MANAGED CARE ENTITIES.—With respect to any contract with a managed care entity
under section 1903(m) or 1905(t)(3) (as applicable), no later
than July 1, 2018, such contract shall include a provision
that providers of services or persons terminated (as described
in section 1902(kk)(8)) from participation under this title, title
XVIII, or title XXI shall be terminated from participating under
this title as a provider in any network of such entity that
serves individuals eligible to receive medical assistance under
this title.’’.
(3) TERMINATION NOTIFICATION DATABASE.—Section 1902
of the Social Security Act (42 U.S.C. 1396a) is amended by
adding at the end the following new subsection:
‘‘(ll) TERMINATION NOTIFICATION DATABASE.—In the case of a
provider of services or any other person whose participation under
this title or title XXI is terminated (as described in subsection
(kk)(8)), the Secretary shall, not later than 30 days after the date
on which the Secretary is notified of such termination under subsection (a)(41) (as applicable), review such termination and, if the
Secretary determines appropriate, include such termination in any
database or similar system developed pursuant to section 6401(b)(2)
of the Patient Protection and Affordable Care Act (42 U.S.C. 1395cc
note; Public Law 111–148).’’.
(4) NO FEDERAL FUNDS FOR ITEMS AND SERVICES FURNISHED
BY TERMINATED PROVIDERS.—Section 1903 of the Social Security
Act (42 U.S.C. 1396b) is amended—
(A) in subsection (i)(2)—
(i) in subparagraph (A), by striking the comma
at the end and inserting a semicolon;
(ii) in subparagraph (B), by striking ‘‘or’’ at the
end; and
(iii) by adding at the end the following new
subparagraph:
‘‘(D) beginning on July 1, 2018, under the plan by
any provider of services or person whose participation in
the State plan is terminated (as described in section
1902(kk)(8)) after the date that is 60 days after the date
on which such termination is included in the database
or other system under section 1902(ll); or’’; and
(B) in subsection (m), by inserting after paragraph
(2) the following new paragraph:
‘‘(3) No payment shall be made under this title to a State
with respect to expenditures incurred by the State for payment
for services provided by a managed care entity (as defined under
section 1932(a)(1)) under the State plan under this title (or under
a waiver of the plan) unless the State—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1193
‘‘(A) beginning on July 1, 2018, has a contract with such
entity that complies with the requirement specified in section
1932(d)(5); and
‘‘(B) beginning on January 1, 2018, complies with the
requirement specified in section 1932(d)(6)(A).’’.
(5) DEVELOPMENT OF UNIFORM TERMINOLOGY FOR REASONS
FOR PROVIDER TERMINATION.—Not later than July 1, 2017, the
Secretary of Health and Human Services shall, in consultation
with the heads of State agencies administering State Medicaid
plans (or waivers of such plans), issue regulations establishing
uniform terminology to be used with respect to specifying reasons under subparagraph (A)(v) of paragraph (8) of section
1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)), as
added by paragraph (1), for the termination (as described in
such paragraph (8)) of the participation of certain providers
in the Medicaid program under title XIX of such Act or the
Children’s Health Insurance Program under title XXI of such
Act.
(6) CONFORMING AMENDMENT.—Section 1902(a)(41) of the
Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by
striking ‘‘provide that whenever’’ and inserting ‘‘provide, in
accordance with subsection (kk)(8) (as applicable), that whenever’’.
(b) INCREASING AVAILABILITY OF MEDICAID PROVIDER INFORMATION.—
(1) FFS PROVIDER ENROLLMENT.—Section 1902(a) of the
Social Security Act (42 U.S.C. 1396a(a)) is amended by inserting
after paragraph (77) the following new paragraph:
‘‘(78) provide that, not later than January 1, 2017, in the
case of a State that pursuant to its State plan or waiver
of the plan for medical assistance pays for medical assistance
on a fee-for-service basis, the State shall require each provider
furnishing items and services to, or ordering, prescribing, referring, or certifying eligibility for, services for individuals eligible
to receive medical assistance under such plan to enroll with
the State agency and provide to the State agency the provider’s
identifying information, including the name, specialty, date of
birth, Social Security number, national provider identifier (if
applicable), Federal taxpayer identification number, and the
State license or certification number of the provider (if
applicable);’’.
(2) MANAGED CARE PROVIDER ENROLLMENT.—Section
1932(d) of the Social Security Act (42 U.S.C. 1396u–2(d)), as
amended by subsection (a)(2), is amended by adding at the
end the following new paragraph:
‘‘(6) ENROLLMENT OF PARTICIPATING PROVIDERS.—
‘‘(A) IN GENERAL.—Beginning not later than January
1, 2018, a State shall require that, in order to participate
as a provider in the network of a managed care entity
that provides services to, or orders, prescribes, refers, or
certifies eligibility for services for, individuals who are
eligible for medical assistance under the State plan under
this title (or under a waiver of the plan) and who are
enrolled with the entity, the provider is enrolled consistent
with section 1902(kk) with the State agency administering
the State plan under this title. Such enrollment shall
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include providing to the State agency the provider’s identifying information, including the name, specialty, date of
birth, Social Security number, national provider identifier,
Federal taxpayer identification number, and the State
license or certification number of the provider.
‘‘(B) RULE OF CONSTRUCTION.—Nothing in subparagraph (A) shall be construed as requiring a provider
described in such subparagraph to provide services to
individuals who are not enrolled with a managed care
entity under this title.’’.
(c) COORDINATION WITH CHIP.—
(1) IN GENERAL.—Section 2107(e)(1) of the Social Security
Act (42 U.S.C. 1397gg(e)(1)) is amended—
(A) by redesignating subparagraphs (B), (C), (D), (E),
(F), (G), (H), (I), (J), (K), (L), (M), (N), and (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), (O),
(P), (Q), and (R), respectively;
(B) by inserting after subparagraph (A) the following
new subparagraphs:
‘‘(B) Section 1902(a)(39) (relating to termination of
participation of certain providers).
‘‘(C) Section 1902(a)(78) (relating to enrollment of providers participating in State plans providing medical assistance on a fee-for-service basis).’’;
(C) by inserting after subparagraph (K) (as redesignated by subparagraph (A)) the following new subparagraph:
‘‘(L) Section 1903(m)(3) (relating to limitation on payment with respect to managed care).’’; and
(D) in subparagraph (P) (as redesignated by subparagraph (A)), by striking ‘‘(a)(2)(C) and (h)’’ and inserting
‘‘(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating
to contract requirement for managed care entities), (d)(6)
(relating to enrollment of providers participating with a
managed care entity), and (h) (relating to special rules
with respect to Indian enrollees, Indian health care providers, and Indian managed care entities)’’.
(2) EXCLUDING FROM MEDICAID PROVIDERS EXCLUDED FROM
CHIP.—Section 1902(a)(39) of the Social Security Act (42 U.S.C.
1396a(a)(39)) is amended by striking ‘‘title XVIII or any other
State plan under this title’’ and inserting ‘‘title XVIII, any
other State plan under this title (or waiver of the plan), or
any State child health plan under title XXI (or waiver of the
plan) and such termination is included by the Secretary in
any database or similar system developed pursuant to section
6401(b)(2) of the Patient Protection and Affordable Care Act’’.
(d) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed as changing or limiting the appeal rights of providers
or the process for appeals of States under the Social Security
Act.
(e) OIG REPORT.—Not later than March 31, 2020, the Inspector
General of the Department of Health and Human Services shall
submit to Congress a report on the implementation of the amendments made by this section. Such report shall include the following:
(1) An assessment of the extent to which providers who
are included under subsection (ll) of section 1902 of the Social
Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3))
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in the database or similar system referred to in such subsection
are terminated (as described in paragraph (8) of subsection
(kk) of such section, as added by subsection (a)(1)) from participation in all State plans under title XIX of such Act (or waivers
of such plans).
(2) Information on the amount of Federal financial participation paid to States under section 1903 of such Act in violation
of the limitation on such payment specified in subparagraph
(D) of subsection (i)(2) of such section and paragraph (3) of
subsection (m) of such section, as added by subsection (a)(4).
(3) An assessment of the extent to which contracts with
managed care entities under title XIX of such Act comply
with the requirement specified in paragraph (5) of section
1932(d) of such Act, as added by subsection (a)(2).
(4) An assessment of the extent to which providers have
been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such
Act (42 U.S.C. 1396a(a)(78), 1396u–2(d)(6)(A)) with State agencies administering State plans under title XIX of such Act
(or waivers of such plans).
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SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER
DIRECTORY.
(a) IN GENERAL.—Section 1902(a) of the Social Security Act
(42 U.S.C. 1396a(a)) is amended—
(1) in paragraph (81), by striking ‘‘and’’ at the end;
(2) in paragraph (82), by striking the period at the end
and inserting ‘‘; and’’; and
(3) by inserting after paragraph (82) the following new
paragraph:
‘‘(83) provide that, not later than January 1, 2017, in the
case of a State plan (or waiver of the plan) that provides
medical assistance on a fee-for-service basis or through a primary care case-management system described in section
1915(b)(1) (other than a primary care case management entity
(as defined by the Secretary)), the State shall publish (and
update on at least an annual basis) on the public website
of the State agency administering the State plan, a directory
of the physicians described in subsection (mm) and, at State
option, other providers described in such subsection that—
‘‘(A) includes—
‘‘(i) with respect to each such physician or provider—
‘‘(I) the name of the physician or provider;
‘‘(II) the specialty of the physician or provider;
‘‘(III) the address at which the physician or
provider provides services; and
‘‘(IV) the telephone number of the physician
or provider; and
‘‘(ii) with respect to any such physician or provider
participating in such a primary care case-management
system, information regarding—
‘‘(I) whether the physician or provider is
accepting as new patients individuals who receive
medical assistance under this title; and
‘‘(II) the physician’s or provider’s cultural and
linguistic capabilities, including the languages
spoken by the physician or provider or by the
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skilled medical interpreter providing interpretation services at the physician’s or provider’s office;
and
‘‘(B) may include, at State option, with respect to each
such physician or provider—
‘‘(i) the Internet website of such physician or provider; or
‘‘(ii) whether the physician or provider is accepting
as new patients individuals who receive medical assistance under this title.’’.
(b) DIRECTORY PHYSICIAN OR PROVIDER DESCRIBED.—Section
1902 of the Social Security Act (42 U.S.C. 1396a), as amended
by section 5005(a)(3), is further amended by adding at the end
the following new subsection:
‘‘(mm) DIRECTORY PHYSICIAN OR PROVIDER DESCRIBED.—A
physician or provider described in this subsection is—
‘‘(1) in the case of a physician or provider of a provider
type for which the State agency, as a condition on receiving
payment for items and services furnished by the physician
or provider to individuals eligible to receive medical assistance
under the State plan, requires the enrollment of the physician
or provider with the State agency, a physician or a provider
that—
‘‘(A) is enrolled with the agency as of the date on
which the directory is published or updated (as applicable)
under subsection (a)(83); and
‘‘(B) received payment under the State plan in the
12-month period preceding such date; and
‘‘(2) in the case of a physician or provider of a provider
type for which the State agency does not require such enrollment, a physician or provider that received payment under
the State plan (or a waiver of the plan) in the 12-month
period preceding the date on which the directory is published
or updated (as applicable) under subsection (a)(83).’’.
(c) RULE OF CONSTRUCTION.—
(1) IN GENERAL.—The amendment made by subsection (a)
shall not be construed to apply in the case of a State (as
defined for purposes of title XIX of the Social Security Act)
in which all the individuals enrolled in the State plan under
such title (or under a waiver of such plan), other than individuals described in paragraph (2), are enrolled with a medicaid
managed care organization (as defined in section 1903(m)(1)(A)
of such Act (42 U.S.C. 1396b(m)(1)(A))), including prepaid
inpatient health plans and prepaid ambulatory health plans
(as defined by the Secretary of Health and Human Services).
(2) INDIVIDUALS DESCRIBED.—An individual described in
this paragraph is an individual who is an Indian (as defined
in section 4 of the Indian Health Care Improvement Act (25
U.S.C. 1603)) or an Alaska Native.
(d) EXCEPTION FOR STATE LEGISLATION.—In the case of a State
plan under title XIX of the Social Security Act (42 U.S.C. 1396
et seq.), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan
to meet one or more additional requirements imposed by amendments made by this section, the respective plan shall not be
regarded as failing to comply with the requirements of such title
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solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning
after the close of the first regular session of the State legislature
that begins after the date of enactment of this Act. For purposes
of the previous sentence, in the case of a State that has a 2year legislative session, each year of the session shall be considered
to be a separate regular session of the State legislature.
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.
(a) IN GENERAL.—Section 1917(d)(4)(A) of the Social Security
Act (42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ‘‘the individual,’’ after ‘‘for the benefit of such individual by’’.
(b) EFFECTIVE DATE.—The amendment made by subsection (a)
shall apply to trusts established on or after the date of the enactment of this Act.
42 USC 1396p
note.
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH
RESPECT TO EXPENDITURES UNDER MEDICAID FOR
AGENTS USED FOR COSMETIC PURPOSES OR HAIR
GROWTH.
(a) IN GENERAL.—Section 1903(i)(21) of the Social Security Act
(42 U.S.C. 1396b(i)(21)) is amended by inserting ‘‘section
1927(d)(2)(C) (relating to drugs when used for cosmetic purposes
or hair growth), except where medically necessary, and’’ after ‘‘drugs
described in’’.
(b) EFFECTIVE DATE.—The amendment made by subsection (a)
shall apply with respect to calendar quarters beginning on or after
the date of the enactment of this Act.
42 USC 1396b
note.
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH
FUND.
Section 4002(b) of the Patient Protection and Affordable Care
Act (42 U.S.C. 300u–11(b)) is amended—
(1) in paragraph (3), by striking ‘‘$1,250,000,000’’ and
inserting ‘‘$900,000,000’’;
(2) in paragraph (4), by striking ‘‘$1,500,000,000’’ and
inserting ‘‘$1,000,000,000’’; and
(3) by striking paragraph (5) and inserting the following:
‘‘(5) for fiscal year 2022, $1,500,000,000;
‘‘(6) for fiscal year 2023, $1,000,000,000;
‘‘(7) for fiscal year 2024, $1,700,000,000; and
‘‘(8) for fiscal year 2025 and each fiscal year thereafter,
$2,000,000,000.’’.
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SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.
(a) DRAWDOWN AND SALE.—
(1) IN GENERAL.—Notwithstanding section 161 of the
Energy Policy and Conservation Act (42 U.S.C. 6241), except
as provided in subsections (b) and (c), the Secretary of Energy
shall drawdown and sell from the Strategic Petroleum
Reserve—
(A) 10,000,000 barrels of crude oil during fiscal year
2017;
(B) 9,000,000 barrels of crude oil during fiscal year
2018; and
(C) 6,000,000 barrels of crude oil during fiscal year
2019.
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(2) DEPOSIT OF AMOUNTS RECEIVED FROM SALE.—Amounts
received from a sale under paragraph (1) shall be deposited
in the general fund of the Treasury during the fiscal year
in which the sale occurs.
(b) EMERGENCY PROTECTION.—The Secretary shall not draw
down and sell crude oil under this section in quantities that would
limit the authority to sell petroleum products under section 161(h)
of the Energy Policy and Conservation Act (42 U.S.C. 6241(h))
in the full quantity authorized by that subsection.
(c) STRATEGIC PETROLEUM DRAWDOWN LIMITATIONS.—Subparagraphs (C) and (D) of section 161(h)(2) of the Energy Policy and
Conservation Act (42 U.S.C. 6241(h)(2)(C) and (D)) are both
amended by striking ‘‘500,000,000’’ and inserting ‘‘450,000,000’’.
SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.
Of the unobligated amounts available under section 1323(c)(1)
of the Patient Protection and Affordable Care Act (42 U.S.C.
18043(c)(1)), $464,000,000 is rescinded immediately upon the date
of the enactment of this Act.
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SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
(a) IN GENERAL.—Section 1861 of the Social Security Act (42
U.S.C. 1395x) is amended—
(1) in subsection (s)(2)—
(A) by striking ‘‘and’’ at the end of subparagraph (EE);
(B) by inserting ‘‘and’’ at the end of subparagraph
(FF); and
(C) by inserting at the end the following new subparagraph:
‘‘(GG) home infusion therapy (as defined in subsection
(iii)(1));’’; and
(2) by adding at the end the following new subsection:
‘‘(iii) HOME INFUSION THERAPY.—(1) The term ‘home infusion
therapy’ means the items and services described in paragraph (2)
furnished by a qualified home infusion therapy supplier (as defined
in paragraph (3)(D)) which are furnished in the individual’s home
(as defined in paragraph (3)(B)) to an individual—
‘‘(A) who is under the care of an applicable provider (as
defined in paragraph (3)(A)); and
‘‘(B) with respect to whom a plan prescribing the type,
amount, and duration of infusion therapy services that are
to be furnished such individual has been established by a
physician (as defined in subsection (r)(1)) and is periodically
reviewed by a physician (as so defined) in coordination with
the furnishing of home infusion drugs (as defined in paragraph
(3)(C)) under part B.
‘‘(2) The items and services described in this paragraph are
the following:
‘‘(A) Professional services, including nursing services, furnished in accordance with the plan.
‘‘(B) Training and education (not otherwise paid for as
durable medical equipment (as defined in subsection (n)),
remote monitoring, and monitoring services for the provision
of home infusion therapy and home infusion drugs furnished
by a qualified home infusion therapy supplier.
‘‘(3) For purposes of this subsection:
‘‘(A) The term ‘applicable provider’ means—
‘‘(i) a physician;
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130 STAT. 1199
‘‘(ii) a nurse practitioner; and
‘‘(iii) a physician assistant.
‘‘(B) The term ‘home’ means a place of residence used
as the home of an individual (as defined for purposes of subsection (n)).
‘‘(C) The term ‘home infusion drug’ means a parenteral
drug
or
biological
administered
intravenously,
or
subcutaneously for an administration period of 15 minutes or
more, in the home of an individual through a pump that is
an item of durable medical equipment (as defined in subsection
(n)). Such term does not include the following:
‘‘(i) Insulin pump systems.
‘‘(ii) A self-administered drug or biological on a selfadministered drug exclusion list.
‘‘(D)(i) The term ‘qualified home infusion therapy supplier’
means a pharmacy, physician, or other provider of services
or supplier licensed by the State in which the pharmacy, physician, or provider or services or supplier furnishes items or
services and that—
‘‘(I) furnishes infusion therapy to individuals with acute
or chronic conditions requiring administration of home infusion drugs;
‘‘(II) ensures the safe and effective provision and
administration of home infusion therapy on a 7-day-a-week,
24-hour-a-day basis;
‘‘(III) is accredited by an organization designated by
the Secretary pursuant to section 1834(u)(5); and
‘‘(IV) meets such other requirements as the Secretary
determines appropriate, taking into account the standards
of care for home infusion therapy established by Medicare
Advantage plans under part C and in the private sector.
‘‘(ii) A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or
supplier to meet the requirements of this subparagraph.’’.
(b) PAYMENT AND RELATED REQUIREMENTS FOR HOME INFUSION
THERAPY.—Section 1834 of the Social Security Act (42 U.S.C.
1395m), as amended by section 4011, is further amended by adding
at the end the following new subsection:
‘‘(u) PAYMENT AND RELATED REQUIREMENTS FOR HOME INFUSION THERAPY.—
‘‘(1) PAYMENT.—
‘‘(A) SINGLE PAYMENT.—
‘‘(i) IN GENERAL.—Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement
a payment system under which a single payment is
made under this title to a qualified home infusion
therapy supplier for items and services described in
subparagraphs (A) and (B) of section 1861(iii)(2)) furnished by a qualified home infusion therapy supplier
(as defined in section 1861(iii)(3)(D)) in coordination
with the furnishing of home infusion drugs (as defined
in section 1861(iii)(3)(C)) under this part.
‘‘(ii) UNIT OF SINGLE PAYMENT.—A unit of single
payment under the payment system implemented
under this subparagraph is for each infusion drug
administration calendar day in the individual’s home.
The Secretary shall, as appropriate, establish single
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payment amounts for types of infusion therapy,
including to take into account variation in utilization
of nursing services by therapy type.
‘‘(iii) LIMITATION.—The single payment amount
determined under this subparagraph after application
of subparagraph (B) and paragraph (3) shall not exceed
the amount determined under the fee schedule under
section 1848 for infusion therapy services furnished
in a calendar day if furnished in a physician office
setting, except such single payment shall not reflect
more than 5 hours of infusion for a particular therapy
in a calendar day.
‘‘(B) REQUIRED ADJUSTMENTS.—The Secretary shall
adjust the single payment amount determined under
subparagraph (A) for home infusion therapy services under
section 1861(iii)(1) to reflect other factors such as—
‘‘(i) a geographic wage index and other costs that
may vary by region; and
‘‘(ii) patient acuity and complexity of drug administration.
‘‘(C) DISCRETIONARY ADJUSTMENTS.—
‘‘(i) IN GENERAL.—Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of
subparagraph (B)) to reflect outlier situations and
other factors as the Secretary determines appropriate.
‘‘(ii) REQUIREMENT OF BUDGET NEUTRALITY.—Any
adjustment under this subparagraph shall be made
in a budget neutral manner.
‘‘(2) CONSIDERATIONS.—In developing the payment system
under this subsection, the Secretary may consider the costs
of furnishing infusion therapy in the home, consult with home
infusion therapy suppliers, consider payment amounts for
similar items and services under this part and part A, and
consider payment amounts established by Medicare Advantage
plans under part C and in the private insurance market for
home infusion therapy (including average per treatment day
payment amounts by type of home infusion therapy).
‘‘(3) ANNUAL UPDATES.—
‘‘(A) IN GENERAL.—Subject to subparagraph (B), the
Secretary shall update the single payment amount under
this subsection from year to year beginning in 2022 by
increasing the single payment amount from the prior year
by the percentage increase in the Consumer Price Index
for all urban consumers (United States city average) for
the 12-month period ending with June of the preceding
year.
‘‘(B) ADJUSTMENT.—For each year, the Secretary shall
reduce the percentage increase described in subparagraph
(A) by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in a percentage being less than 0.0 for
a year, and may result in payment being less than such
payment rates for the preceding year.
‘‘(4) AUTHORITY TO APPLY PRIOR AUTHORIZATION.—The Secretary may, as determined appropriate by the Secretary, apply
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130 STAT. 1201
prior authorization for home infusion therapy services under
section 1861(iii)(1).
‘‘(5) ACCREDITATION OF QUALIFIED HOME INFUSION THERAPY
SUPPLIERS.—
‘‘(A) FACTORS FOR DESIGNATION OF ACCREDITATION
ORGANIZATIONS.—The Secretary shall consider the following
factors in designating accreditation organizations under
subparagraph (B) and in reviewing and modifying the list
of accreditation organizations designated pursuant to
subparagraph (C):
‘‘(i) The ability of the organization to conduct
timely reviews of accreditation applications.
‘‘(ii) The ability of the organization to take into
account the capacities of suppliers located in a rural
area (as defined in section 1886(d)(2)(D)).
‘‘(iii) Whether the organization has established
reasonable fees to be charged to suppliers applying
for accreditation.
‘‘(iv) Such other factors as the Secretary determines appropriate.
‘‘(B) DESIGNATION.—Not later than January 1, 2021,
the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).
‘‘(C) REVIEW AND MODIFICATION OF LIST OF ACCREDITATION ORGANIZATIONS.—
‘‘(i) IN GENERAL.—The Secretary shall review the
list of accreditation organizations designated under
subparagraph (B) taking into account the factors under
subparagraph (A). Taking into account the results of
such review, the Secretary may, by regulation, modify
the list of accreditation organizations designated under
subparagraph (B).
‘‘(ii) SPECIAL RULE FOR ACCREDITATIONS DONE
PRIOR TO REMOVAL FROM LIST OF DESIGNATED ACCREDITATION ORGANIZATIONS.—In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph
(B), any supplier that is accredited by the organization
during the period beginning on the date on which
the organization is designated as an accreditation
organization under subparagraph (B) and ending on
the date on which the organization is removed from
such list shall be considered to have been accredited
by an organization designated by the Secretary under
subparagraph (B) for the remaining period such
accreditation is in effect.
‘‘(D) RULE FOR ACCREDITATIONS MADE PRIOR TO DESIGNATION.—In the case of a supplier that is accredited
before January 1, 2021, by an accreditation organization
designated by the Secretary under subparagraph (B) as
of January 1, 2019, such supplier shall be considered to
have been accredited by an organization designated by
the Secretary under such paragraph as of January 1, 2023,
for the remaining period such accreditation is in effect.
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‘‘(6) NOTIFICATION OF INFUSION THERAPY OPTIONS AVAILABLE PRIOR TO FURNISHING HOME INFUSION THERAPY.—Prior
42 USC 13951
note.
to the furnishing of home infusion therapy to an individual,
the physician who establishes the plan described in section
1861(iii)(1) for the individual shall provide notification (in a
form, manner, and frequency determined appropriate by the
Secretary) of the options available (such as home, physician’s
office, hospital outpatient department) for the furnishing of
infusion therapy under this part.’’.
(c) CONFORMING AMENDMENTS.—
(1) PAYMENT REFERENCE.—Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)) is amended—
(A) by striking ‘‘and’’ before ‘‘(AA)’’; and
(B) by inserting before the semicolon at the end the
following: ‘‘, and (BB) with respect to home infusion
therapy, the amount paid shall be an amount equal to
80 percent of the lesser of the actual charge for the services
or the amount determined under section 1834(u)’’.
(2) DIRECT PAYMENT.—The first sentence of section
1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6))
is amended—
(A) by striking ‘‘and’’ before ‘‘(H)’’; and
(B) by inserting before the period at the end the following: ‘‘, and (I) in the case of home infusion therapy,
payment shall be made to the qualified home infusion
therapy supplier’’.
(3) EXCLUSION FROM HOME HEALTH SERVICES.—Section
1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is
amended, in the first sentence, by inserting the following before
the period at the end: ‘‘and home infusion therapy (as defined
in subsection (iii)(i))’’.
(d) EFFECTIVE DATE.—The amendments made by this section
shall apply to items and services furnished on or after January
1, 2021.
DIVISION B—HELPING FAMILIES IN
MENTAL HEALTH CRISIS
Helping Families
in Mental Health
Crisis Reform Act
of 2016.
42 USC 201 note.
SEC. 6000. SHORT TITLE.
This division may be cited as the ‘‘Helping Families in Mental
Health Crisis Reform Act of 2016’’.
TITLE VI—STRENGTHENING
LEADERSHIP AND ACCOUNTABILITY
Subtitle A—Leadership
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SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE USE.
(a) ASSISTANT SECRETARY.—Section 501(c) of the Public Health
Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:
‘‘(c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SECRETARY.—
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‘‘(1) ASSISTANT SECRETARY.—The Administration shall be
headed by an official to be known as the Assistant Secretary
for Mental Health and Substance Use (hereinafter in this title
referred to as the ‘Assistant Secretary’) who shall be appointed
by the President, by and with the advice and consent of the
Senate.
‘‘(2) DEPUTY ASSISTANT SECRETARY.—The Assistant Secretary, with the approval of the Secretary, may appoint a
Deputy Assistant Secretary and may employ and prescribe
the functions of such officers and employees, including attorneys, as are necessary to administer the activities to be carried
out through the Administration.’’.
(b) TRANSFER OF AUTHORITIES.—The Secretary of Health and
Human Services shall delegate to the Assistant Secretary for Mental
Health and Substance Use all duties and authorities that—
(1) as of the day before the date of enactment of this
Act, were vested in the Administrator of the Substance Abuse
and Mental Health Services Administration; and
(2) are not terminated by this Act.
(c) CONFORMING AMENDMENTS.—Title V of the Public Health
Service Act (42 U.S.C. 290aa et seq.), as amended by the previous
provisions of this section, is further amended—
(1) by striking ‘‘Administrator of the Substance Abuse and
Mental Health Services Administration’’ each place it appears
and inserting ‘‘Assistant Secretary for Mental Health and Substance Use’’; and
(2) by striking ‘‘Administrator’’ or ‘‘ADMINISTRATOR’’ each
place it appears (including in any headings) and inserting
‘‘Assistant Secretary’’ or ‘‘ASSISTANT SECRETARY’’, respectively,
except where the term ‘‘Administrator’’ appears—
(A) in each of subsections (e) and (f) of section 501
of such Act (42 U.S.C. 290aa), including the headings of
such subsections, within the term ‘‘Associate Administrator’’;
(B) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ‘‘Administrator of the Health
Resources and Services Administration’’;
(C) in section 507(b)(6) of such Act (42 U.S.C.
290bb(b)(6)), within the term ‘‘Administrator of the Centers
for Medicare & Medicaid Services’’;
(D) in section 519B(c)(1)(B) of such Act (42 U.S.C.
290bb–25b(c)(1)(B)), within the term ‘‘Administrator of the
National Highway Traffic Safety Administration’’; or
(E) in each of sections 519B(c)(1)(B), 520C(a), and
520D(a) of such Act (42 U.S.C. 290bb–25b(c)(1)(B), 290bb–
34(a), 290bb–35(a)), within the term ‘‘Administrator of the
Office of Juvenile Justice and Delinquency Prevention’’.
(d) REFERENCES.—After executing subsections (a), (b), and (c),
any reference in statute, regulation, or guidance to the Administrator of the Substance Abuse and Mental Health Services Administration shall be construed to be a reference to the Assistant Secretary for Mental Health and Substance Use.
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SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE
ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa),
as amended by section 6001, is further amended—
(1) in subsection (b)—
(A) in the subsection heading, by striking ‘‘AGENCIES’’
and inserting ‘‘CENTERS’’; and
(B) in the matter preceding paragraph (1), by striking
‘‘entities’’ and inserting ‘‘Centers’’;
(2) in subsection (d)—
(A) in paragraph (1)—
(i) by striking ‘‘agencies’’ each place the term
appears and inserting ‘‘Centers’’; and
(ii) by striking ‘‘such agency’’ and inserting ‘‘such
Center’’;
(B) in paragraph (2)—
(i) by striking ‘‘agencies’’ and inserting ‘‘Centers’’;
(ii) by striking ‘‘with respect to substance abuse’’
and inserting ‘‘with respect to substance use disorders’’;
and
(iii) by striking ‘‘and individuals who are substance
abusers’’ and inserting ‘‘and individuals with substance
use disorders’’;
(C) in paragraph (5), by striking ‘‘substance abuse’’
and inserting ‘‘substance use disorder’’;
(D) in paragraph (6)—
(i) by striking ‘‘the Centers for Disease Control’’
and inserting ‘‘the Centers for Disease Control and
Prevention,’’;
(ii) by striking ‘‘Administration develop’’ and
inserting ‘‘Administration, develop’’;
(iii) by striking ‘‘HIV or tuberculosis among substance abusers and individuals with mental illness’’
and inserting ‘‘HIV, hepatitis, tuberculosis, and other
communicable diseases among individuals with mental
or substance use disorders,’’; and
(iv) by striking ‘‘illnesses’’ at the end and inserting
‘‘diseases or disorders’’;
(E) in paragraph (7), by striking ‘‘abuse utilizing antiaddiction medications, including methadone’’ and inserting
‘‘use disorders, including services that utilize drugs or
devices approved or cleared by the Food and Drug Administration for the treatment of substance use disorders’’;
(F) in paragraph (8)—
(i) by striking ‘‘Agency for Health Care Policy
Research’’ and inserting ‘‘Agency for Healthcare
Research and Quality’’; and
(ii) by striking ‘‘treatment and prevention’’ and
inserting ‘‘prevention and treatment’’;
(G) in paragraph (9)—
(i) by inserting ‘‘and maintenance’’ after ‘‘development’’;
(ii) by striking ‘‘Agency for Health Care Policy
Research’’ and inserting ‘‘Agency for Healthcare
Research and Quality’’; and
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130 STAT. 1205
(iii) by striking ‘‘treatment and prevention services’’ and inserting ‘‘prevention, treatment, and
recovery support services and are appropriately incorporated into programs carried out by the Administration’’;
(H) in paragraph (10), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’;
(I) by striking paragraph (11) and inserting the following:
‘‘(11) work with relevant agencies of the Department of
Health and Human Services on integrating mental health promotion and substance use disorder prevention with general
health promotion and disease prevention and integrating
mental and substance use disorders treatment services with
physical health treatment services;’’;
(J) in paragraph (13)—
(i) in the matter preceding subparagraph (A), by
striking ‘‘this title, assure that’’ and inserting ‘‘this
title or part B of title XIX, or grant programs otherwise
funded by the Administration’’;
(ii) in subparagraph (A)—
(I) by inserting ‘‘require that’’ before ‘‘all
grants’’; and
(II) by striking ‘‘and’’ at the end;
(iii) by redesignating subparagraph (B) as subparagraph (C);
(iv) by inserting after subparagraph (A) the following:
‘‘(B) ensure that the director of each Center of the
Administration consistently documents the application of
criteria when awarding grants and the ongoing oversight
of grantees after such grants are awarded;’’;
(v) in subparagraph (C), as so redesignated—
(I) by inserting ‘‘require that’’ before ‘‘all
grants’’; and
(II) in clause (ii), by inserting ‘‘and’’ after the
semicolon at the end; and
(vi) by adding at the end the following:
‘‘(D) inform a State when any funds are awarded
through such a grant to any entity within such State;’’;
(K) in paragraph (16), by striking ‘‘abuse and mental
health information’’ and inserting ‘‘use disorder information, including evidence-based and promising best practices
for prevention, treatment, and recovery support services
for individuals with mental and substance use disorders,’’;
(L) in paragraph (17)—
(i) by striking ‘‘substance abuse’’ and inserting
‘‘substance use disorder’’; and
(ii) by striking ‘‘and’’ at the end;
(M) in paragraph (18), by striking the period and
inserting a semicolon; and
(N) by adding at the end the following:
‘‘(19) consult with State, local, and tribal governments,
nongovernmental entities, and individuals with mental illness,
particularly adults with a serious mental illness, children with
a serious emotional disturbance, and the family members of
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such adults and children, with respect to improving communitybased and other mental health services;
‘‘(20) collaborate with the Secretary of Defense and the
Secretary of Veterans Affairs to improve the provision of mental
and substance use disorder services provided by the Department of Defense and the Department of Veterans Affairs to
members of the Armed Forces, veterans, and the family members of such members and veterans, including through the
provision of services using the telehealth capabilities of the
Department of Defense and the Department of Veterans Affairs;
‘‘(21) collaborate with the heads of relevant Federal agencies and departments, States, communities, and nongovernmental experts to improve mental and substance use disorders
services for chronically homeless individuals, including by
designing strategies to provide such services in supportive
housing;
‘‘(22) work with States and other stakeholders to develop
and support activities to recruit and retain a workforce
addressing mental and substance use disorders;
‘‘(23) collaborate with the Attorney General and representatives of the criminal justice system to improve mental and
substance use disorders services for individuals who have been
arrested or incarcerated;
‘‘(24) after providing an opportunity for public input, set
standards for grant programs under this title for mental and
substance use disorders services and prevention programs,
which standards may address—
‘‘(A) the capacity of the grantee to implement the
award;
‘‘(B) requirements for the description of the program
implementation approach;
‘‘(C) the extent to which the grant plan submitted
by the grantee as part of its application must explain
how the grantee will reach the population of focus and
provide a statement of need, which may include information
on how the grantee will increase access to services and
a description of measurable objectives for improving outcomes;
‘‘(D) the extent to which the grantee must collect and
report on required performance measures; and
‘‘(E) the extent to which the grantee is proposing to
use evidence-based practices; and
‘‘(25) advance, through existing programs, the use of
performance metrics, including those based on the recommendations on performance metrics from the Assistant Secretary for
Planning and Evaluation under section 6021(d) of the Helping
Families in Mental Health Crisis Reform Act of 2016.’’; and
(3) in subsection (m), by adding at the end the following:
‘‘(4) EMERGENCY RESPONSE.—Amounts made available for
carrying out this subsection shall remain available through
the end of the fiscal year following the fiscal year for which
such amounts are appropriated.’’.
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SEC. 6003. CHIEF MEDICAL OFFICER.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa),
as amended by sections 6001 and 6002, is further amended—
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(1) by redesignating subsections (g) through (j) and subsections (k) through (o) as subsections (h) through (k) and
subsections (m) through (q), respectively;
(2) in subsection (e)(3)(C), by striking ‘‘subsection (k)’’ and
inserting ‘‘subsection (m)’’;
(3) in subsection (f)(2)(C)(iii), by striking ‘‘subsection (k)’’
and inserting ‘‘subsection (m)’’; and
(4) by inserting after subsection (f) the following:
‘‘(g) CHIEF MEDICAL OFFICER.—
‘‘(1) IN GENERAL.—The Assistant Secretary, with the
approval of the Secretary, shall appoint a Chief Medical Officer
to serve within the Administration.
‘‘(2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall
select the Chief Medical Officer from among individuals who—
‘‘(A) have a doctoral degree in medicine or osteopathic
medicine;
‘‘(B) have experience in the provision of mental or
substance use disorder services;
‘‘(C) have experience working with mental or substance
use disorder programs;
‘‘(D) have an understanding of biological, psychosocial,
and pharmaceutical treatments of mental or substance use
disorders; and
‘‘(E) are licensed to practice medicine in one or more
States.
‘‘(3) DUTIES.—The Chief Medical Officer shall—
‘‘(A) serve as a liaison between the Administration
and providers of mental and substance use disorders
prevention, treatment, and recovery services;
‘‘(B) assist the Assistant Secretary in the evaluation,
organization, integration, and coordination of programs
operated by the Administration;
‘‘(C) promote evidence-based and promising best practices, including culturally and linguistically appropriate
practices, as appropriate, for the prevention and treatment
of, and recovery from, mental and substance use disorders,
including serious mental illness and serious emotional
disturbances;
‘‘(D) participate in regular strategic planning with the
Administration;
‘‘(E) coordinate with the Assistant Secretary for Planning and Evaluation to assess the use of performance
metrics to evaluate activities within the Administration
related to mental and substance use disorders; and
‘‘(F) coordinate with the Assistant Secretary to ensure
mental and substance use disorders grant programs within
the Administration consistently utilize appropriate
performance metrics and evaluation designs.’’.
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SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS.
Section 505 of the Public Health Service Act (42 U.S.C. 290aa–
4), as amended by section 6001(c), is amended—
(1) by striking the section designation and heading and
inserting the following:
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‘‘SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND
QUALITY.’’;
(2) by redesignating subsections (a) through (d) as subsections (b) through (e), respectively;
(3) before subsection (b), as redesignated by paragraph
(2), by inserting the following:
‘‘(a) IN GENERAL.—The Assistant Secretary shall maintain
within the Administration a Center for Behavioral Health Statistics
and Quality (in this section referred to as the ‘Center’). The Center
shall be headed by a Director (in this section referred to as the
‘Director’) appointed by the Secretary from among individuals with
extensive experience and academic qualifications in research and
analysis in behavioral health care or related fields.’’;
(4) in subsection (b), as redesignated by paragraph (2)—
(A) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively;
(B) by striking ‘‘The Secretary, acting’’ and all that
follows through ‘‘year on—’’ and inserting ‘‘The Director
shall—
‘‘(1) coordinate the Administration’s integrated data
strategy, including by collecting data each year on—’’;
(C) in the subparagraph (B), as redesignated by
subparagraph (A), by striking ‘‘Assistant Secretary’’ and
inserting ‘‘Director’’; and
(D) by adding at the end the following new paragraphs:
‘‘(2) provide statistical and analytical support for activities
of the Administration;
‘‘(3) recommend a core set of performance metrics to
evaluate activities supported by the Administration; and
‘‘(4) coordinate with the Assistant Secretary, the Assistant
Secretary for Planning and Evaluation, and the Chief Medical
Officer appointed under section 501(g), as appropriate, to
improve the quality of services provided by programs of the
Administration and the evaluation of activities carried out by
the Administration.’’.
(5) in subsection (c), as so redesignated—
(A) by striking ‘‘With respect to the activities’’ and
inserting ‘‘MENTAL HEALTH.—With respect to the activities’’;
(B) by striking ‘‘Assistant Secretary’’ each place it
appears and inserting ‘‘Director’’; and
(C) by striking ‘‘subsection (a)’’ and inserting ‘‘subsection (b)(1)’’;
(6) in subsection (d), as so redesignated—
(A) by striking the subsection designation and all that
follows through ‘‘With respect to the activities’’ and
inserting the following:
‘‘(d) SUBSTANCE ABUSE.—
‘‘(1) IN GENERAL.—With respect to the activities’’;
(B) in paragraph (1)—
(i) in the matter before subparagraph (A)—
(I) by striking ‘‘subsection (a)’’ and inserting
‘‘subsection (b)(1)’’; and
(II) by striking ‘‘Assistant Secretary’’ each
place it appears and inserting ‘‘Director’’; and
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130 STAT. 1209
(ii) in subparagraph (B), by inserting ‘‘in coordination with the Centers for Disease Control and Prevention’’ before the semicolon at the end; and
(C) in paragraph (2), by striking ‘‘ANNUAL SURVEYS’’
and inserting ‘‘ANNUAL SURVEYS; PUBLIC AVAILABILITY OF
DATA.—Annual surveys’’; and
(7) in subsection (e), as so redesignated—
(A) by striking ‘‘After consultation’’ and inserting ‘‘CONSULTATION.—After consultation’’; and
(B) by striking ‘‘Assistant Secretary shall develop’’ and
inserting ‘‘Assistant Secretary shall use existing standards
and best practices to develop’’.
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SEC. 6005. STRATEGIC PLAN.
Section 501 of the Public Health Service Act (42 U.S.C. 290aa),
as amended by sections 6001 through 6003, is further amended
by inserting after subsection (k), as redesignated by section 6003,
the following:
‘‘(l) STRATEGIC PLAN.—
‘‘(1) IN GENERAL.—Not later than September 30, 2018, and
every 4 years thereafter, the Assistant Secretary shall develop
and carry out a strategic plan in accordance with this subsection
for the planning and operation of activities carried out by
the Administration, including evidence-based programs.
‘‘(2) COORDINATION.—In developing and carrying out the
strategic plan under this subsection, the Assistant Secretary
shall take into consideration the findings and recommendations
of the Assistant Secretary for Planning and Evaluation under
section 6021(d) of the Helping Families in Mental Health Crisis
Reform Act of 2016 and the report of the Interdepartmental
Serious Mental Illness Coordinating Committee under section
6031 of such Act.
‘‘(3) PUBLICATION OF PLAN.—Not later than September 30,
2018, and every 4 years thereafter, the Assistant Secretary
shall—
‘‘(A) submit the strategic plan developed under paragraph (1) to the Committee on Energy and Commerce and
the Committee on Appropriations of the House of Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations
of the Senate; and
‘‘(B) post such plan on the Internet website of the
Administration.
‘‘(4) CONTENTS.—The strategic plan developed under paragraph (1) shall—
‘‘(A) identify strategic priorities, goals, and measurable
objectives for mental and substance use disorders activities
and programs operated and supported by the Administration, including priorities to prevent or eliminate the burden
of mental and substance use disorders;
‘‘(B) identify ways to improve the quality of services
for individuals with mental and substance use disorders,
and to reduce homelessness, arrest, incarceration, violence,
including self-directed violence, and unnecessary hospitalization of individuals with a mental or substance use
disorder, including adults with a serious mental illness
or children with a serious emotional disturbance;
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‘‘(C) ensure that programs provide, as appropriate,
access to effective and evidence-based prevention, diagnosis, intervention, treatment, and recovery services,
including culturally and linguistically appropriate services,
as appropriate, for individuals with a mental or substance
use disorder;
‘‘(D) identify opportunities to collaborate with the
Health Resources and Services Administration to develop
or improve—
‘‘(i) initiatives to encourage individuals to pursue
careers (especially in rural and underserved areas and
with rural and underserved populations) as psychiatrists, including child and adolescent psychiatrists,
psychologists, psychiatric nurse practitioners, physician assistants, clinical social workers, certified peer
support specialists, licensed professional counselors, or
other licensed or certified mental health or substance
use disorder professionals, including such professionals
specializing in the diagnosis, evaluation, or treatment
of adults with a serious mental illness or children
with a serious emotional disturbance; and
‘‘(ii) a strategy to improve the recruitment,
training, and retention of a workforce for the treatment
of individuals with mental or substance use disorders,
or co-occurring disorders;
‘‘(E) identify opportunities to improve collaboration
with States, local governments, communities, and Indian
tribes and tribal organizations (as such terms are defined
in section 4 of the Indian Self-Determination and Education
Assistance Act); and
‘‘(F) specify a strategy to disseminate evidence-based
and promising best practices related to prevention, diagnosis, early intervention, treatment, and recovery services
related to mental illness, particularly for adults with a
serious mental illness and children with a serious emotional disturbance, and for individuals with a substance
use disorder.’’.
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SEC.
6006.
BIENNIAL
PROGRESS.
REPORT
CONCERNING
ACTIVITIES
AND
(a) IN GENERAL.—Section 501 of the Public Health Service
Act (42 U.S.C. 290aa), as so amended, is further amended by
amending subsection (m), as redesignated by section 6003, to read
as follows:
‘‘(m) BIENNIAL REPORT CONCERNING ACTIVITIES AND
PROGRESS.—Not later than September 30, 2020, and every 2 years
thereafter, the Assistant Secretary shall prepare and submit to
the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions and the Committee
on Appropriations of the Senate, and post on the Internet website
of the Administration, a report containing at a minimum—
‘‘(1) a review of activities conducted or supported by the
Administration, including progress toward strategic priorities,
goals, and objectives identified in the strategic plan developed
under subsection (l);
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130 STAT. 1211
‘‘(2) an assessment of programs and activities carried out
by the Assistant Secretary, including the extent to which programs and activities under this title and part B of title XIX
meet identified goals and performance measures developed for
the respective programs and activities;
‘‘(3) a description of the progress made in addressing gaps
in mental and substance use disorders prevention, treatment,
and recovery services and improving outcomes by the Administration, including with respect to serious mental illnesses,
serious emotional disturbances, and co-occurring disorders;
‘‘(4) a description of the manner in which the Administration coordinates and partners with other Federal agencies and
departments related to mental and substance use disorders,
including activities related to—
‘‘(A) the implementation and dissemination of research
findings into improved programs, including with respect
to how advances in serious mental illness and serious emotional disturbance research have been incorporated into
programs;
‘‘(B) the recruitment, training, and retention of a
mental and substance use disorders workforce;
‘‘(C) the integration of mental disorder services, substance use disorder services, and physical health services;
‘‘(D) homelessness; and
‘‘(E) veterans;
‘‘(5) a description of the manner in which the Administration promotes coordination by grantees under this title, and
part B of title XIX, with State or local agencies; and
‘‘(6) a description of the activities carried out under section
501A(e), with respect to mental and substance use disorders,
including—
‘‘(A) the number and a description of grants awarded;
‘‘(B) the total amount of funding for grants awarded;
‘‘(C) a description of the activities supported through
such grants, including outcomes of programs supported;
and
‘‘(D) information on how the National Mental Health
and Substance Use Policy Laboratory is consulting with
the Assistant Secretary for Planning and Evaluation and
collaborating with the Center for Substance Abuse Treatment, the Center for Substance Abuse Prevention, the
Center for Behavioral Health Statistics and Quality, and
the Center for Mental Health Services to carry out such
activities; and
‘‘(7) recommendations made by the Assistant Secretary for
Planning and Evaluation under section 6021 of the Helping
Families in Mental Health Crisis Reform Act of 2016 to improve
programs within the Administration, and actions taken in
response to such recommendations to improve programs within
the Administration.
The Assistant Secretary may meet reporting requirements established under this title by providing the contents of such reports
as an addendum to the biennial report established under this subsection, notwithstanding the timeline of other reporting requirements in this title. Nothing in this subsection shall be construed
to alter the content requirements of such reports or authorize
the Assistant Secretary to alter the timeline of any such reports
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PUBLIC LAW 114–255—DEC. 13, 2016
to be less frequent than biennially, unless as specified in this
title.’’.
(b) CONFORMING AMENDMENT.—Section 508(p) of the Public
Health Service Act (42 U.S.C. 290bb–1(p)) is amended by striking
‘‘section 501(k)’’ and inserting ‘‘section 501(m)’’.
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SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES, SUBSTANCE ABUSE PREVENTION, AND SUBSTANCE
ABUSE TREATMENT.
(a) CENTER FOR MENTAL HEALTH SERVICES.—Section 520(b)
of the Public Health Service Act (42 U.S.C. 290bb–31(b)) is
amended—
(1) by redesignating paragraphs (3) through (15) as paragraphs (4) through (16), respectively;
(2) by inserting after paragraph (2) the following:
‘‘(3) collaborate with the Director of the National Institute
of Mental Health and the Chief Medical Officer, appointed
under section 501(g), to ensure that, as appropriate, programs
related to the prevention and treatment of mental illness and
the promotion of mental health and recovery support are carried
out in a manner that reflects the best available science and
evidence-based practices, including culturally and linguistically
appropriate services, as appropriate;’’;
(3) in paragraph (5), as so redesignated, by inserting ‘‘,
including through programs that reduce risk and promote resiliency’’ before the semicolon;
(4) in paragraph (6), as so redesignated, by inserting ‘‘in
collaboration with the Director of the National Institute of
Mental Health,’’ before ‘‘develop’’;
(5) in paragraph (8), as so redesignated, by inserting ‘‘,
increase meaningful participation of individuals with mental
illness in programs and activities of the Administration,’’ before
‘‘and protect the legal’’;
(6) in paragraph (10), as so redesignated, by striking
‘‘professional and paraprofessional personnel pursuant to section 303’’ and inserting ‘‘health paraprofessional personnel and
health professionals’’;
(7) in paragraph (11), as so redesignated, by inserting
‘‘and tele-mental health’’ after ‘‘rural mental health’’;
(8) in paragraph (12), as so redesignated, by striking ‘‘establish a clearinghouse for mental health information to assure
the widespread dissemination of such information’’ and
inserting ‘‘disseminate mental health information, including
evidence-based practices,’’;
(9) in paragraph (15), as so redesignated, by striking ‘‘and’’
at the end;
(10) in paragraph (16), as so redesignated, by striking
the period and inserting ‘‘; and’’; and
(11) by adding at the end the following:
‘‘(17) ensure the consistent documentation of the application
of criteria when awarding grants and the ongoing oversight
of grantees after such grants are awarded.’’.
(b) DIRECTOR OF THE CENTER FOR SUBSTANCE ABUSE PREVENTION.—Section 515 of the Public Health Service Act (42 U.S.C.
290bb–21) is amended—
(1) in the section heading, by striking ‘‘OFFICE’’ and
inserting ‘‘CENTER’’;
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1213
(2) in subsection (a)—
(A) by striking ‘‘an Office’’ and inserting ‘‘a Center’’;
and
(B) by striking ‘‘The Office’’ and inserting ‘‘The Prevention Center’’; and
(3) in subsection (b)—
(A) in paragraph (1), by inserting ‘‘through the reduction of risk and the promotion of resiliency’’ before the
semicolon;
(B) by redesignating paragraphs (3) through (11) as
paragraphs (4) through (12), respectively;
(C) by inserting after paragraph (2) the following:
‘‘(3) collaborate with the Director of the National Institute
on Drug Abuse, the Director of the National Institute on Alcohol
Abuse and Alcoholism, and States to promote the study of
substance abuse prevention and the dissemination and
implementation of research findings that will improve the
delivery and effectiveness of substance abuse prevention activities;’’;
(D) in paragraph (4), as so redesignated, by striking
‘‘literature on the adverse effects of cocaine free base
(known as crack)’’ and inserting ‘‘educational information
on the effects of drugs abused by individuals, including
drugs that are emerging as abused drugs’’;
(E) in paragraph (6), as so redesignated—
(i) by striking ‘‘substance abuse counselors’’ and
inserting ‘‘health professionals who provide substance
use and misuse prevention and treatment services’’;
and
(ii) by striking ‘‘drug abuse education, prevention,’’
and inserting ‘‘illicit drug use education and prevention’’;
(F) by amending paragraph (7), as so redesignated,
to read as follows:
‘‘(7) in cooperation with the Director of the Centers for
Disease Control and Prevention, develop and disseminate educational materials to increase awareness for individuals at
greatest risk for substance use disorders to prevent the transmission of communicable diseases, such as HIV, hepatitis,
tuberculosis, and other communicable diseases;’’;
(G) in paragraph (9), as so redesignated—
(i) by striking ‘‘to discourage’’ and inserting ‘‘that
reduce the risk of’’; and
(ii) by inserting before the semicolon ‘‘and promote
resiliency’’;
(H) in paragraph (11), as so redesignated, by striking
‘‘and’’ after the semicolon;
(I) in paragraph (12), as so redesignated, by striking
the period and inserting a semicolon; and
(J) by adding at the end the following:
‘‘(13) ensure the consistent documentation of the application
of criteria when awarding grants and the ongoing oversight
of grantees after such grants are awarded; and
‘‘(14) assist and support States in preventing illicit drug
use, including emerging illicit drug use issues.’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
(c) DIRECTOR OF THE CENTER FOR SUBSTANCE
MENT.—Section 507 of the Public Health Service
ABUSE TREATAct (42 U.S.C.
290bb) is amended—
(1) in subsection (a)—
(A) by striking ‘‘treatment of substance abuse’’ and
inserting ‘‘treatment of substance use disorders’’; and
(B) by striking ‘‘abuse treatment systems’’ and
inserting ‘‘use disorder treatment systems’’; and
(2) in subsection (b)—
(A) in paragraph (1), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’;
(B) in paragraph (3), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’;
(C) in paragraph (4), by striking ‘‘individuals who abuse
drugs’’ and inserting ‘‘individuals who illicitly use drugs’’;
(D) in paragraph (9), by striking ‘‘carried out by the
Director’’;
(E) by striking paragraph (10);
(F) by redesignating paragraphs (11) through (14) as
paragraphs (10) through (13), respectively;
(G) in paragraph (12), as so redesignated, by striking
‘‘; and’’ and inserting a semicolon; and
(H) by striking paragraph (13), as so redesignated,
and inserting the following:
‘‘(13) ensure the consistent documentation of the application
of criteria when awarding grants and the ongoing oversight
of grantees after such grants are awarded; and
‘‘(14) work with States, providers, and individuals in
recovery, and their families, to promote the expansion of
recovery support services and systems of care oriented toward
recovery.’’.
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SEC. 6008. ADVISORY COUNCILS.
Section 502(b) of the Public Health Service Act (42 U.S.C.
290aa–1(b)) is amended—
(1) in paragraph (2)—
(A) in subparagraph (E), by striking ‘‘and’’ after the
semicolon;
(B) by redesignating subparagraph (F) as subparagraph
(J); and
(C) by inserting after subparagraph (E), the following:
‘‘(F) the Chief Medical Officer, appointed under section
501(g);
‘‘(G) the Director of the National Institute of Mental
Health for the advisory councils appointed under subsections (a)(1)(A) and (a)(1)(D);
‘‘(H) the Director of the National Institute on Drug
Abuse for the advisory councils appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
‘‘(I) the Director of the National Institute on Alcohol
Abuse and Alcoholism for the advisory councils appointed
under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and’’;
and
(2) in paragraph (3), by adding at the end the following:
‘‘(C) Not less than half of the members of the advisory
council appointed under subsection (a)(1)(D)—
‘‘(i) shall—
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‘‘(I) have a medical degree;
‘‘(II) have a doctoral degree in psychology; or
‘‘(III) have an advanced degree in nursing or
social work from an accredited graduate school
or be a certified physician assistant; and
‘‘(ii) shall specialize in the mental health field.
‘‘(D) Not less than half of the members of the advisory
councils appointed under subsections (a)(1)(B) and
(a)(1)(C)—
‘‘(i) shall—
‘‘(I) have a medical degree;
‘‘(II) have a doctoral degree; or
‘‘(III) have an advanced degree in nursing,
public health, behavioral or social sciences, or
social work from an accredited graduate school
or be a certified physician assistant; and
‘‘(ii) shall have experience in the provision of substance use disorder services or the development and
implementation of programs to prevent substance
misuse.’’.
SEC. 6009. PEER REVIEW.
Section 504(b) of the Public Health Service Act (42 U.S.C.
290aa–3(b)) is amended by adding at the end the following: ‘‘In
the case of any such peer review group that is reviewing a grant,
cooperative agreement, or contract related to mental illness treatment, not less than half of the members of such peer review group
shall be licensed and experienced professionals in the prevention,
diagnosis, or treatment of, or recovery from, mental illness or cooccurring mental illness and substance use disorders and have
a medical degree, a doctoral degree in psychology, or an advanced
degree in nursing or social work from an accredited program, and
the Secretary, in consultation with the Assistant Secretary, shall,
to the extent possible, ensure such peer review groups include
broad geographic representation, including both urban and rural
representatives.’’.
Subtitle B—Oversight and Accountability
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SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE
DISORDERS PROGRAMS THROUGH THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION.
42 USC 290aa
note.
(a) IN GENERAL.—The Secretary of Health and Human Services,
acting through the Assistant Secretary for Planning and Evaluation,
shall ensure efficient and effective planning and evaluation of
mental and substance use disorders prevention and treatment programs and related activities.
(b) EVALUATION STRATEGY.—In carrying out subsection (a), the
Assistant Secretary for Planning and Evaluation shall, not later
than 180 days after the date of enactment of this Act, develop
a strategy for conducting ongoing evaluations that identifies priority
programs to be evaluated by the Assistant Secretary for Planning
and Evaluation and priority programs to be evaluated by other
relevant offices and agencies within the Department of Health
and Human Services. The strategy shall—
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(1) include a plan for evaluating programs related to mental
and substance use disorders, including co-occurring disorders,
across agencies, as appropriate, including programs related to—
(A) prevention, intervention, treatment, and recovery
support services, including such services for adults with
a serious mental illness or children with a serious emotional disturbance;
(B) the reduction of homelessness and incarceration
among individuals with a mental or substance use disorder;
and
(C) public health and health services; and
(2) include a plan for assessing the use of performance
metrics to evaluate activities carried out by entities receiving
grants, contracts, or cooperative agreements related to mental
and substance use disorders prevention and treatment services
under title V or title XIX of the Public Health Service Act
(42 U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.).
(c) CONSULTATION.—In carrying out this section, the Assistant
Secretary for Planning and Evaluation shall consult, as appropriate,
with the Assistant Secretary for Mental Health and Substance
Use, the Chief Medical Officer of the Substance Abuse and Mental
Health Services Administration appointed under section 501(g) of
the Public Health Service Act (42 U.S.C. 290aa(g)), as amended
by section 6003, the Behavioral Health Coordinating Council of
the Department of Health and Human Services, other agencies
within the Department of Health and Human Services, and other
relevant Federal departments and agencies.
(d) RECOMMENDATIONS.—In carrying out this section, the
Assistant Secretary for Planning and Evaluation shall provide recommendations to the Secretary of Health and Human Services,
the Assistant Secretary for Mental Health and Substance Use,
and the Congress on improving the quality of prevention and treatment programs and activities related to mental and substance use
disorders, including recommendations for the use of performance
metrics. The Assistant Secretary for Mental Health and Substance
Use shall include such recommendations in the biennial report
required by subsection 501(m) of the Public Health Service Act,
as redesignated by section 6003 of this Act.
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SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS.
(a) PUBLIC AVAILABILITY OF REPORTS.—Section 105(a)(7) of the
Protection and Advocacy for Individuals with Mental Illness Act
(42 U.S.C. 10805(a)(7)) is amended by striking ‘‘is located a report’’
and inserting ‘‘is located, and make publicly available, a report’’.
(b) DETAILED ACCOUNTING.—Section 114(a) of the Protection
and Advocacy for Individuals with Mental Illness Act (42 U.S.C.
10824(a)) is amended—
(1) in paragraph (3), by striking ‘‘and’’ at the end;
(2) in paragraph (4), by striking the period at the end
and inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(5) using data from the existing required annual program
progress reports submitted by each system funded under this
title, a detailed accounting for each such system of how funds
are spent, disaggregated according to whether the funds were
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130 STAT. 1217
received from the Federal Government, the State government,
a local government, or a private entity.’’.
SEC. 6023. GAO STUDY.
(a) IN GENERAL.—Not later than 18 months after the date
of enactment of this Act, the Comptroller General of the United
States, in consultation with the Secretary of Health and Human
Services and the Assistant Secretary for Mental Health and Substance Use, shall conduct an independent evaluation, and submit
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, on programs funded by allotments
made under title I of the Protection and Advocacy for Individuals
with Mental Illness Act (42 U.S.C. 10801 et seq.).
(b) CONTENTS.—The report and evaluation required under subsection (a) shall include—
(1) a review of the programs described in such subsection
that are carried out by State agencies and such programs
that are carried out by private, nonprofit organizations; and
(2) a review of the compliance of the programs described
in subsection (a) with statutory and regulatory responsibilities,
such as—
(A) responsibilities relating to family engagement;
(B) responsibilities relating to the grievance procedure
for clients or prospective clients of the system to assure
that individuals with mental illness have full access to
the services of the system, for individuals who have
received or are receiving mental health services, and for
family members of such individuals with mental illness,
or representatives of such individuals or family members,
to assure that the eligible system is operating in compliance
with the provisions of the Protection and Advocacy for
Individuals with Mental Illness Act, as required to be established by section 105(a)(9) of such Act (42 U.S.C.
10805(a)(9));
(C) investigation of alleged abuse and neglect of persons with mental illness;
(D) availability of adequate medical and behavioral
health treatment;
(E) denial of rights for persons with mental illness;
and
(F) compliance with the Federal prohibition on lobbying.
Subtitle C—Interdepartmental Serious
Mental Illness Coordinating Committee
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SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING COMMITTEE.
(a) ESTABLISHMENT.—
(1) IN GENERAL.—Not later than 3 months after the date
of enactment of this Act, the Secretary of Health and Human
Services, or the designee of the Secretary, shall establish a
committee to be known as the Interdepartmental Serious
Mental Illness Coordinating Committee (in this section referred
to as the ‘‘Committee’’).
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130 STAT. 1218
PUBLIC LAW 114–255—DEC. 13, 2016
(2) FEDERAL ADVISORY COMMITTEE ACT.—Except as provided
in this section, the provisions of the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee.
(b) MEETINGS.—The Committee shall meet not fewer than 2
times each year.
(c) RESPONSIBILITIES.—Not later than 1 year after the date
of enactment of this Act, and 5 years after such date of enactment,
the Committee shall submit to Congress and any other relevant
Federal department or agency a report including—
(1) a summary of advances in serious mental illness and
serious emotional disturbance research related to the prevention of, diagnosis of, intervention in, and treatment and
recovery of serious mental illnesses, serious emotional disturbances, and advances in access to services and support for adults
with a serious mental illness or children with a serious emotional disturbance;
(2) an evaluation of the effect Federal programs related
to serious mental illness have on public health, including public
health outcomes such as—
(A) rates of suicide, suicide attempts, incidence and
prevalence of serious mental illnesses, serious emotional
disturbances, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room
boarding, preventable emergency room visits, interaction
with the criminal justice system, homelessness, and
unemployment;
(B) increased rates of employment and enrollment in
educational and vocational programs;
(C) quality of mental and substance use disorders treatment services; or
(D) any other criteria as may be determined by the
Secretary; and
(3) specific recommendations for actions that agencies can
take to better coordinate the administration of mental health
services for adults with a serious mental illness or children
with a serious emotional disturbance.
(d) COMMITTEE EXTENSION.—Upon the submission of the second
report under subsection (c), the Secretary shall submit a recommendation to Congress on whether to extend the operation of
the Committee.
(e) MEMBERSHIP.—
(1) FEDERAL MEMBERS.—The Committee shall be composed
of the following Federal representatives, or the designees of
such representatives—
(A) the Secretary of Health and Human Services, who
shall serve as the Chair of the Committee;
(B) the Assistant Secretary for Mental Health and
Substance Use;
(C) the Attorney General;
(D) the Secretary of Veterans Affairs;
(E) the Secretary of Defense;
(F) the Secretary of Housing and Urban Development;
(G) the Secretary of Education;
(H) the Secretary of Labor;
(I) the Administrator of the Centers for Medicare &
Medicaid Services; and
(J) the Commissioner of Social Security.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1219
(2) NON-FEDERAL MEMBERS.—The Committee shall also
include not less than 14 non-Federal public members appointed
by the Secretary of Health and Human Services, of which—
(A) at least 2 members shall be an individual who
has received treatment for a diagnosis of a serious mental
illness;
(B) at least 1 member shall be a parent or legal
guardian of an adult with a history of a serious mental
illness or a child with a history of a serious emotional
disturbance;
(C) at least 1 member shall be a representative of
a leading research, advocacy, or service organization for
adults with a serious mental illness;
(D) at least 2 members shall be—
(i) a licensed psychiatrist with experience in
treating serious mental illnesses;
(ii) a licensed psychologist with experience in
treating serious mental illnesses or serious emotional
disturbances;
(iii) a licensed clinical social worker with experience treating serious mental illnesses or serious emotional disturbances; or
(iv) a licensed psychiatric nurse, nurse practitioner, or physician assistant with experience in
treating serious mental illnesses or serious emotional
disturbances;
(E) at least 1 member shall be a licensed mental health
professional with a specialty in treating children and
adolescents with a serious emotional disturbance;
(F) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with minorities;
(G) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with medically underserved populations;
(H) at least 1 member shall be a State certified mental
health peer support specialist;
(I) at least 1 member shall be a judge with experience
in adjudicating cases related to criminal justice or serious
mental illness;
(J) at least 1 member shall be a law enforcement
officer or corrections officer with extensive experience in
interfacing with adults with a serious mental illness, children with a serious emotional disturbance, or individuals
in a mental health crisis; and
(K) at least 1 member shall have experience providing
services for homeless individuals and working with adults
with a serious mental illness, children with a serious emotional disturbance, or individuals in a mental health crisis.
(3) TERMS.—A member of the Committee appointed under
subsection (e)(2) shall serve for a term of 3 years, and may
be reappointed for 1 or more additional 3-year terms. Any
member appointed to fill a vacancy for an 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.
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PUBLIC LAW 114–255—DEC. 13, 2016
(f) WORKING GROUPS.—In carrying out its functions, the Committee may establish working groups. Such working groups shall
be composed of Committee members, or their designees, and may
hold such meetings as are necessary.
(g) SUNSET.—The Committee shall terminate on the date that
is 6 years after the date on which the Committee is established
under subsection (a)(1).
TITLE VII—ENSURING MENTAL AND
SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH
SCIENCE AND TECHNOLOGY
SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS.
Title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by inserting after section 501 (42 U.S.C. 290aa)
the following:
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42 USC 290aa–0.
‘‘SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY
LABORATORY.
‘‘(a) IN GENERAL.—There shall be established within the
Administration a National Mental Health and Substance Use Policy
Laboratory (referred to in this section as the ‘Laboratory’).
‘‘(b) RESPONSIBILITIES.—The Laboratory shall—
‘‘(1) continue to carry out the authorities and activities
that were in effect for the Office of Policy, Planning, and Innovation as such Office existed prior to the date of enactment
of the Helping Families in Mental Health Crisis Reform Act
of 2016;
‘‘(2) identify, coordinate, and facilitate the implementation
of policy changes likely to have a significant effect on mental
health, mental illness, recovery supports, and the prevention
and treatment of substance use disorder services;
‘‘(3) work with the Center for Behavioral Health Statistics
and Quality to collect, as appropriate, information from
grantees under programs operated by the Administration in
order to evaluate and disseminate information on evidencebased practices, including culturally and linguistically appropriate services, as appropriate, and service delivery models;
‘‘(4) provide leadership in identifying and coordinating policies and programs, including evidence-based programs, related
to mental and substance use disorders;
‘‘(5) periodically review programs and activities operated
by the Administration relating to the diagnosis or prevention
of, treatment for, and recovery from, mental and substance
use disorders to—
‘‘(A) identify any such programs or activities that are
duplicative;
‘‘(B) identify any such programs or activities that are
not evidence-based, effective, or efficient; and
‘‘(C) formulate recommendations for coordinating,
eliminating, or improving programs or activities identified
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1221
under subparagraph (A) or (B) and merging such programs
or activities into other successful programs or activities;
and
‘‘(6) carry out other activities as deemed necessary to continue to encourage innovation and disseminate evidence-based
programs and practices.
‘‘(c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY
MODELS.—
‘‘(1) IN GENERAL.—In carrying out subsection (b)(3), the
Laboratory—
‘‘(A) may give preference to models that improve—
‘‘(i) the coordination between mental health and
physical health providers;
‘‘(ii) the coordination among such providers and
the justice and corrections system; and
‘‘(iii) the cost effectiveness, quality, effectiveness,
and efficiency of health care services furnished to
adults with a serious mental illness, children with
a serious emotional disturbance, or individuals in a
mental health crisis; and
‘‘(B) may include clinical protocols and practices that
address the needs of individuals with early serious mental
illness.
‘‘(2) CONSULTATION.—In carrying out this section, the Laboratory shall consult with—
‘‘(A) the Chief Medical Officer appointed under section
501(g);
‘‘(B) representatives of the National Institute of Mental
Health, the National Institute on Drug Abuse, and the
National Institute on Alcohol Abuse and Alcoholism, on
an ongoing basis;
‘‘(C) other appropriate Federal agencies;
‘‘(D) clinical and analytical experts with expertise in
psychiatric medical care and clinical psychological care,
health care management, education, corrections health
care, and mental health court systems, as appropriate;
and
‘‘(E) other individuals and agencies as determined
appropriate by the Assistant Secretary.
‘‘(d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Laboratory shall begin implementation of this section not later than
January 1, 2018.
‘‘(e) PROMOTING INNOVATION.—
‘‘(1) IN GENERAL.—The Assistant Secretary, in coordination
with the Laboratory, may award grants to States, local governments, Indian tribes or tribal organizations (as such terms
are defined in section 4 of the Indian Self-Determination and
Education Assistance Act), educational institutions, and nonprofit organizations to develop evidence-based interventions,
including culturally and linguistically appropriate services, as
appropriate, for—
‘‘(A) evaluating a model that has been scientifically
demonstrated to show promise, but would benefit from
further applied development, for—
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‘‘(i) enhancing the prevention, diagnosis, intervention, and treatment of, and recovery from, mental illness, serious emotional disturbances, substance use
disorders, and co-occurring illness or disorders; or
‘‘(ii) integrating or coordinating physical health
services and mental and substance use disorders services; and
‘‘(B) expanding, replicating, or scaling evidence-based
programs across a wider area to enhance effective
screening, early diagnosis, intervention, and treatment
with respect to mental illness, serious mental illness,
serious emotional disturbances, and substance use disorders, primarily by—
‘‘(i) applying such evidence-based programs to the
delivery of care, including by training staff in effective
evidence-based treatments; or
‘‘(ii) integrating such evidence-based programs into
models of care across specialties and jurisdictions.
‘‘(2) CONSULTATION.—In awarding grants under this subsection, the Assistant Secretary shall, as appropriate, consult
with the Chief Medical Officer, appointed under section 501(g),
the advisory councils described in section 502, the National
Institute of Mental Health, the National Institute on Drug
Abuse, and the National Institute on Alcohol Abuse and Alcoholism, as appropriate.
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated—
‘‘(A) to carry out paragraph (1)(A), $7,000,000 for the
period of fiscal years 2018 through 2020; and
‘‘(B) to carry out paragraph (1)(B), $7,000,000 for the
period of fiscal years 2018 through 2020.’’.
SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCEBASED PROGRAMS AND PRACTICES.
Part D of title V of the Public Health Service Act (42 U.S.C.
290dd et seq.) is amended by inserting after section 543 of such
Act (42 U.S.C. 290dd–2) the following:
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42 USC
290dd–2a.
‘‘SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCEBASED PROGRAMS AND PRACTICES.
‘‘(a) IN GENERAL.—The Assistant Secretary shall, as appropriate, improve access to reliable and valid information on evidencebased programs and practices, including information on the strength
of evidence associated with such programs and practices, related
to mental and substance use disorders for States, local communities,
nonprofit entities, and other stakeholders, by posting on the Internet website of the Administration information on evidence-based
programs and practices that have been reviewed by the Assistant
Secretary in accordance with the requirements of this section.
‘‘(b) APPLICATIONS.—
‘‘(1) APPLICATION PERIOD.—In carrying out subsection (a),
the Assistant Secretary may establish a period for the submission of applications for evidence-based programs and practices
to be posted publicly in accordance with subsection (a).
‘‘(2) NOTICE.—In establishing the application period under
paragraph (1), the Assistant Secretary shall provide for the
public notice of such application period in the Federal Register.
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130 STAT. 1223
Such notice may solicit applications for evidence-based programs and practices to address gaps in information identified
by the Assistant Secretary, the National Mental Health and
Substance Use Policy Laboratory established under section
501A, or the Assistant Secretary for Planning and Evaluation,
including pursuant to the evaluation and recommendations
under section 6021 of the Helping Families in Mental Health
Crisis Reform Act of 2016 or priorities identified in the strategic
plan under section 501(l).
‘‘(c) REQUIREMENTS.—The Assistant Secretary may establish
minimum requirements for the applications submitted under subsection (b), including applications related to the submission of
research and evaluation.
‘‘(d) REVIEW AND RATING.—
‘‘(1) IN GENERAL.—The Assistant Secretary shall review
applications prior to public posting in accordance with subsection (a), and may prioritize the review of applications for
evidence-based programs and practices that are related to topics
included in the notice provided under subsection (b)(2).
‘‘(2) SYSTEM.—In carrying out paragraph (1), the Assistant
Secretary may utilize a rating and review system, which may
include information on the strength of evidence associated with
the evidence-based programs and practices and a rating of
the methodological rigor of the research supporting the applications.
‘‘(3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant
Secretary shall make the metrics used to evaluate applications
under this section, and any resulting ratings of such applications, publicly available.’’.
SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND
NATIONAL SIGNIFICANCE.
Section 520A of the Public Health Service Act (42 U.S.C. 290bb–
32) is amended—
(1) in subsection (a)—
(A) in paragraph (4), by inserting before the period
‘‘, which may include technical assistance centers’’; and
(B) in the flush sentence following paragraph (4)—
(i) by inserting ‘‘, contracts,’’ before ‘‘or cooperative
agreements’’; and
(ii) by striking ‘‘Indian tribes and tribal organizations’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance
Act), health facilities, or programs operated by or in
accordance with a contract or grant with the Indian
Health Service, or’’; and
(2) by amending subsection (f) to read as follows:
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $394,550,000 for each
of fiscal years 2018 through 2022.’’.
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SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS
OF REGIONAL AND NATIONAL SIGNIFICANCE.
Section 509 of the Public Health Service Act (42 U.S.C. 290bb–
2) is amended—
(1) in subsection (a)—
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(A) in the matter preceding paragraph (1), by striking
‘‘abuse’’ and inserting ‘‘use disorder’’;
(B) in paragraph (3), by inserting before the period
‘‘that permit States, local governments, communities, and
Indian tribes and tribal organizations (as the terms ‘Indian
tribes’ and ‘tribal organizations’ are defined in section 4
of the Indian Self-Determination and Education Assistance
Act) to focus on emerging trends in substance abuse and
co-occurrence of substance use disorders with mental illness
or other conditions’’; and
(C) in the flush sentence following paragraph (3)—
(i) by inserting ‘‘, contracts,’’ before ‘‘or cooperative
agreements’’; and
(ii) by striking ‘‘Indian tribes and tribal organizations,’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance
Act), health facilities, or programs operated by or in
accordance with a contract or grant with the Indian
Health Service, or’’;
(2) in subsection (b)—
(A) in paragraph (1), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’; and
(B) in paragraph (2), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’;
(3) in subsection (e), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’; and
(4) in subsection (f), by striking ‘‘$300,000,000’’ and all
that follows through the period and inserting ‘‘$333,806,000
for each of fiscal years 2018 through 2022.’’.
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SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS
OF REGIONAL AND NATIONAL SIGNIFICANCE.
Section 516 of the Public Health Service Act (42 U.S.C. 290bb–
22) is amended—
(1) in the section heading, by striking ‘‘ABUSE’’ and
inserting ‘‘USE DISORDER’’;
(2) in subsection (a)—
(A) in the matter preceding paragraph (1), by striking
‘‘abuse’’ and inserting ‘‘use disorder’’;
(B) in paragraph (3), by inserting before the period
‘‘, including such programs that focus on emerging drug
abuse issues’’; and
(C) in the flush sentence following paragraph (3)—
(i) by inserting ‘‘, contracts,’’ before ‘‘or cooperative
agreements’’; and
(ii) by striking ‘‘Indian tribes and tribal organizations,’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance
Act), health facilities, or programs operated by or in
accordance with a contract or grant with the Indian
Health Service,’’;
(3) in subsection (b)—
(A) in paragraph (1), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’; and
(B) in paragraph (2)—
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130 STAT. 1225
(i) in subparagraph (A), by striking ‘‘; and’’ at
the end and inserting ‘‘;’’;
(ii) in subparagraph (B)—
(I) by striking ‘‘abuse’’ and inserting ‘‘use disorder’’; and
(II) by striking the period and inserting ‘‘;
and’’; and
(iii) by adding at the end the following:
‘‘(C) substance use disorder prevention among highrisk groups.’’;
(4) in subsection (e), by striking ‘‘abuse’’ and inserting
‘‘use disorder’’; and
(5) in subsection (f), by striking ‘‘$300,000,000’’ and all
that follows through the period and inserting ‘‘$211,148,000
for each of fiscal years 2018 through 2022.’’.
TITLE VIII—SUPPORTING STATE PREVENTION
ACTIVITIES
AND
RESPONSES TO MENTAL HEALTH AND
SUBSTANCE USE DISORDER NEEDS
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SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.
(a) FORMULA GRANTS.—Section 1911(b) of the Public Health
Service Act (42 U.S.C. 300x(b)) is amended—
(1) by redesignating paragraphs (1) through (3) as paragraphs (2) through (4), respectively; and
(2) by inserting before paragraph (2) (as so redesignated)
the following:
‘‘(1) providing community mental health services for adults
with a serious mental illness and children with a serious emotional disturbance as defined in accordance with section
1912(c);’’.
(b) STATE PLAN.—Section 1912(b) of the Public Health Service
Act (42 U.S.C. 300x–1(b)) is amended—
(1) in paragraph (3), by redesignating subparagraphs (A)
through (C) as clauses (i) through (iii), respectively, and
realigning the margins accordingly;
(2) by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively, and realigning the margins
accordingly;
(3) in the matter preceding subparagraph (A) (as so redesignated), by striking ‘‘With respect to’’ and all that follows
through ‘‘are as follows:’’ and inserting ‘‘In accordance with
subsection (a), a State shall submit to the Secretary a plan
every two years that, at a minimum, includes each of the
following:’’;
(4) by inserting before subparagraph (A) (as so redesignated) the following:
‘‘(1) SYSTEM OF CARE.—A description of the State’s system
of care that contains the following:’’;
(5) by striking subparagraph (A) (as so redesignated) and
inserting the following:
‘‘(A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYSTEMS.—The plan shall—
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‘‘(i) identify the single State agency to be responsible for the administration of the program under the
grant, including any third party who administers
mental health services and is responsible for complying
with the requirements of this part with respect to
the grant;
‘‘(ii) provide for an organized community-based
system of care for individuals with mental illness, and
describe available services and resources in a comprehensive system of care, including services for
individuals with co-occurring disorders;
‘‘(iii) include a description of the manner in which
the State and local entities will coordinate services
to maximize the efficiency, effectiveness, quality, and
cost-effectiveness of services and programs to produce
the best possible outcomes (including health services,
rehabilitation services, employment services, housing
services, educational services, substance use disorder
services, legal services, law enforcement services, social
services, child welfare services, medical and dental
care services, and other support services to be provided
with Federal, State, and local public and private
resources) with other agencies to enable individuals
receiving services to function outside of inpatient or
residential institutions, to the maximum extent of their
capabilities, including services to be provided by local
school systems under the Individuals with Disabilities
Education Act;
‘‘(iv) include a description of how the State promotes evidence-based practices, including those evidence-based programs that address the needs of
individuals with early serious mental illness regardless
of the age of the individual at onset, provide comprehensive individualized treatment, or integrate
mental and physical health services;
‘‘(v) include a description of case management services;
‘‘(vi) include a description of activities that seek
to engage adults with a serious mental illness or children with a serious emotional disturbance and their
caregivers where appropriate in making health care
decisions, including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
‘‘(vii) as appropriate to, and reflective of, the uses
the State proposes for the block grant funds, include—
‘‘(I) a description of the activities intended to
reduce hospitalizations and hospital stays using
the block grant funds;
‘‘(II) a description of the activities intended
to reduce incidents of suicide using the block grant
funds;
‘‘(III) a description of how the State integrates
mental health and primary care using the block
grant funds, which may include providing, in the
case of individuals with co-occurring mental and
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130 STAT. 1227
substance use disorders, both mental and substance use disorders services in primary care settings or arrangements to provide primary and specialty care services in community-based mental
and substance use disorders settings; and
‘‘(IV) a description of recovery and recovery
support services for adults with a serious mental
illness and children with a serious emotional
disturbance.’’;
(6) in subparagraph (B) (as so redesignated)—
(A) by striking ‘‘The plan contains’’ and inserting ‘‘The
plan shall contain’’; and
(B) by striking ‘‘presents quantitative targets to be
achieved in the implementation of the system described
in paragraph (1)’’ and inserting ‘‘present quantitative targets and outcome measures for programs and services provided under this subpart’’;
(7) in subparagraph (C) (as so redesignated)—
(A) by striking ‘‘serious emotional disturbance’’ in the
matter preceding clause (i) (as so redesignated) and all
that follows through ‘‘substance abuse services’’ in clause
(i) (as so redesignated) and inserting the following: ‘‘a
serious emotional disturbance (as defined pursuant to subsection (c)), the plan shall provide for a system of integrated
social services, educational services, child welfare services,
juvenile justice services, law enforcement services, and substance use disorder services’’;
(B) by striking ‘‘Education Act);’’ and inserting ‘‘Education Act).’’; and
(C) by striking clauses (ii) and (iii) (as so redesignated);
(8) in subparagraph (D) (as so redesignated), by striking
‘‘plan describes’’ and inserting ‘‘plan shall describe’’;
(9) in subparagraph (E) (as so redesignated)—
(A) in the subparagraph heading by striking ‘‘SYSTEMS’’
and inserting ‘‘SERVICES’’;
(B) in the first sentence, by striking ‘‘plan describes’’
and all that follows through ‘‘and provides for’’ and
inserting ‘‘plan shall describe the financial resources available, the existing mental health workforce, and the
workforce trained in treating individuals with co-occurring
mental and substance use disorders, and shall provide for’’;
and
(C) in the second sentence—
(i) by striking ‘‘further describes’’ and inserting
‘‘shall further describe’’; and
(ii) by striking ‘‘involved.’’ and inserting ‘‘involved,
and the manner in which the State intends to comply
with each of the funding agreements in this subpart
and subpart III.’’;
(10) by striking the flush matter at the end; and
(11) by adding at the end the following:
‘‘(2) GOALS AND OBJECTIVES.—The establishment of goals
and objectives for the period of the plan, including targets
and milestones that are intended to be met, and the activities
that will be undertaken to achieve those targets.’’.
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130 STAT. 1228
PUBLIC LAW 114–255—DEC. 13, 2016
(c) EARLY SERIOUS MENTAL ILLNESS.—Section 1920 of the
Public Health Service Act (42 U.S.C. 300x–9) is amended by adding
at the end the following:
‘‘(c) EARLY SERIOUS MENTAL ILLNESS.—
‘‘(1) IN GENERAL.—Except as provided in paragraph (2),
a State shall expend not less than 10 percent of the amount
the State receives for carrying out this section for each fiscal
year to support evidence-based programs that address the needs
of individuals with early serious mental illness, including psychotic disorders, regardless of the age of the individual at
onset.
‘‘(2) STATE FLEXIBILITY.—In lieu of expending 10 percent
of the amount the State receives under this section for a fiscal
year as required under paragraph (1), a State may elect to
expend not less than 20 percent of such amount by the end
of such succeeding fiscal year.’’.
(d) ADDITIONAL PROVISIONS.—Section 1915(b) of the Public
Health Service Act (42 U.S.C. 300x–4(b)) is amended—
(1) in paragraph (3)—
(A) by striking ‘‘The Secretary’’ and inserting the following:
‘‘(A) IN GENERAL.—The Secretary’’;
(B) by striking ‘‘paragraph (1) if’’ and inserting ‘‘paragraph (1) in whole or in part if’’;
(C) by striking ‘‘State justify the waiver.’’ and inserting
‘‘State in the fiscal year involved or in the previous fiscal
year justify the waiver’’; and
(D) by adding at the end the following:
‘‘(B) DATE CERTAIN FOR ACTION UPON REQUEST.—The
Secretary shall approve or deny a request for a waiver
under this paragraph not later than 120 days after the
date on which the request is made.
‘‘(C) APPLICABILITY OF WAIVER.—A waiver provided by
the Secretary under this paragraph shall be applicable
only to the fiscal year involved.’’; and
(2) in paragraph (4)—
(A) in subparagraph (A)—
(i) by inserting after the subparagraph designation
the following: ‘‘IN GENERAL.—’’;
(ii) by striking ‘‘In making a grant’’ and inserting
the following:
‘‘(i) DETERMINATION.—In making a grant’’; and
(iii) by inserting at the end the following:
‘‘(ii) ALTERNATIVE.—A State that has failed to
comply with paragraph (1) and would otherwise be
subject to a reduction in the State’s allotment under
section 1911 may, upon request by the State, in lieu
of having the amount of the allotment under section
1911 for the State reduced for the fiscal year of the
grant, agree to comply with a negotiated agreement
that is approved by the Secretary and carried out
in accordance with guidelines issued by the Secretary.
If a State fails to enter into or comply with a negotiated
agreement, the Secretary may take action under this
paragraph or the terms of the negotiated agreement.’’;
and
(B) in subparagraph (B)—
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130 STAT. 1229
(i) by inserting after the subparagraph designation
the following: ‘‘SUBMISSION OF INFORMATION TO THE
SECRETARY.—’’; and
(ii) by striking ‘‘subparagraph (A)’’ and inserting
‘‘subparagraph (A)(i)’’.
(e) APPLICATION FOR GRANT.—Section 1917(a) of the Public
Health Service Act (42 U.S.C. 300x–6(a)) is amended—
(1) in paragraph (1), by striking ‘‘1941’’ and inserting
‘‘1942(a)’’; and
(2) in paragraph (5), by striking ‘‘1915(b)(3)(B)’’ and
inserting ‘‘1915(b)’’.
(f) FUNDING.—Section 1920 of the Public Health Service Act
(42 U.S.C. 300x–9) is amended—
(1) in subsection (a)—
(A) by striking ‘‘section 505’’ and inserting ‘‘section
505(c)’’; and
(B) by striking ‘‘$450,000,000’’ and all that follows
through the period and inserting ‘‘$532,571,000 for each
of fiscal years 2018 through 2022.’’; and
(2) in subsection (b)(2) by striking ‘‘sections 505 and’’ and
inserting ‘‘sections 505(c) and’’.
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SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK
GRANT.
(a) FORMULA GRANTS.—Section 1921(b) of the Public Health
Service Act (42 U.S.C. 300x–21(b)) is amended—
(1) by inserting ‘‘carrying out the plan developed in accordance with section 1932(b) and for’’ after ‘‘for the purpose of’’;
and
(2) by striking ‘‘abuse’’ and inserting ‘‘use disorders’’.
(b) OUTREACH TO PERSONS WHO INJECT DRUGS.—Section
1923(b) of the Public Health Service Act (42 U.S.C. 300x–23(b))
is amended—
(1) in the subsection heading, by striking ‘‘REGARDING
INTRAVENOUS SUBSTANCE ABUSE’’ and inserting ‘‘TO PERSONS
WHO INJECT DRUGS’’; and
(2) by striking ‘‘for intravenous drug abuse’’ and inserting
‘‘for persons who inject drugs’’.
(c) REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN
IMMUNODEFICIENCY VIRUS.—Section 1924 of the Public Health
Service Act (42 U.S.C. 300x–24) is amended—
(1) in subsection (a)(1)—
(A) in the matter preceding subparagraph (A), by
striking ‘‘substance abuse’’ and inserting ‘‘substance use
disorders’’; and
(B) in subparagraph (A), by striking ‘‘such abuse’’ and
inserting ‘‘such disorders’’;
(2) in subsection (b)—
(A) in paragraph (1)(A), by striking ‘‘substance abuse’’
and inserting ‘‘substance use disorders’’;
(B) in paragraph (2), by inserting ‘‘and Prevention’’
after ‘‘Disease Control’’;
(C) in paragraph (3)—
(i) in the paragraph heading, by striking ‘‘ABUSE’’
and inserting ‘‘USE DISORDERS’’; and
(ii) by striking ‘‘substance abuse’’ and inserting
‘‘substance use disorders’’; and
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130 STAT. 1230
PUBLIC LAW 114–255—DEC. 13, 2016
(D) in paragraph (6)(B), by striking ‘‘substance abuse’’
and inserting ‘‘substance use disorders’’;
(3) by striking subsection (d); and
(4) by redesignating subsection (e) as subsection (d).
(d) GROUP HOMES.—Section 1925 of the Public Health Service
Act (42 U.S.C. 300x–25) is amended—
(1) in the section heading, by striking ‘‘RECOVERING SUBSTANCE ABUSERS’’ and inserting ‘‘PERSONS IN RECOVERY FROM
SUBSTANCE USE DISORDERS’’; and
(2) in subsection (a), in the matter preceding paragraph
(1), by striking ‘‘recovering substance abusers’’ and inserting
‘‘persons in recovery from substance use disorders’’.
(e) ADDITIONAL AGREEMENTS.—Section 1928 of the Public
Health Service Act (42 U.S.C. 300x–28) is amended—
(1) in subsection (a), by striking ‘‘(relative to fiscal year
1992)’’;
(2) by striking subsection (b) and inserting the following:
‘‘(b) PROFESSIONAL DEVELOPMENT.—A funding agreement for
a grant under section 1921 is that the State involved will ensure
that prevention, treatment, and recovery personnel operating in
the State’s substance use disorder prevention, treatment, and
recovery systems have an opportunity to receive training, on an
ongoing basis, concerning—
‘‘(1) recent trends in substance use disorders in the State;
‘‘(2) improved methods and evidence-based practices for
providing substance use disorder prevention and treatment
services;
‘‘(3) performance-based accountability;
‘‘(4) data collection and reporting requirements; and
‘‘(5) any other matters that would serve to further improve
the delivery of substance use disorder prevention and treatment
services within the State.’’; and
(3) in subsection (d)(1), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorders’’.
(f) REPEAL.—Section 1929 of the Public Health Service Act
(42 U.S.C. 300x–29) is repealed.
(g) MAINTENANCE OF EFFORT.—Section 1930 of the Public
Health Service Act (42 U.S.C. 300x–30) is amended—
(1) in subsection (c)(1), by striking ‘‘in the State justify
the waiver’’ and inserting ‘‘exist in the State, or any part
of the State, to justify the waiver’’; and
(2) in subsection (d), by inserting at the end the following:
‘‘(3) ALTERNATIVE.—A State that has failed to comply with
this section and would otherwise be subject to a reduction
in the State’s allotment under section 1921, may, upon request
by the State, in lieu of having the State’s allotment under
section 1921 reduced, agree to comply with a negotiated agreement that is approved by the Secretary and carried out in
accordance with guidelines issued by the Secretary. If a State
fails to enter into or comply with a negotiated agreement,
the Secretary may take action under this paragraph or the
terms of the negotiated agreement.’’.
(h) RESTRICTIONS ON EXPENDITURES.—Section 1931(b)(1) of the
Public Health Service Act (42 U.S.C. 300x–31(b)(1)) is amended
by striking ‘‘substance abuse’’ and inserting ‘‘substance use disorders’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1231
(i) APPLICATION.—Section 1932 of the Public Health Service
Act (42 U.S.C. 300x–32) is amended—
(1) in subsection (a)—
(A) in the matter preceding paragraph (1), by striking
‘‘subsections (c) and (d)(2)’’ and inserting ‘‘subsection (c)’’;
and
(B) in paragraph (5), by striking ‘‘the information
required in section 1929, the information required in section 1930(c)(2), and’’;
(2) in subsection (b)—
(A) by striking paragraph (1) and inserting the following:
‘‘(1) IN GENERAL.—In order for a State to be in compliance
with subsection (a)(6), the State shall submit to the Secretary
a plan that, at a minimum, includes the following:
‘‘(A) A description of the State’s system of care that—
‘‘(i) identifies the single State agency responsible
for the administration of the program, including any
third party who administers substance use disorder
services and is responsible for complying with the
requirements of the grant;
‘‘(ii) provides information on the need for substance
use disorder prevention and treatment services in the
State, including estimates on the number of individuals
who need treatment, who are pregnant women, women
with dependent children, individuals with a co-occurring mental health and substance use disorder, persons
who inject drugs, and persons who are experiencing
homelessness;
‘‘(iii) provides aggregate information on the
number of individuals in treatment within the State,
including the number of such individuals who are pregnant women, women with dependent children, individuals with a co-occurring mental health and substance
use disorder, persons who inject drugs, and persons
who are experiencing homelessness;
‘‘(iv) provides a description of the system that is
available to provide services by modality, including
the provision of recovery support services;
‘‘(v) provides a description of the State’s comprehensive statewide prevention efforts, including the
number of individuals being served in the system, target populations, and priority needs, and provides a
description of the amount of funds from the prevention
set-aside expended on primary prevention;
‘‘(vi) provides a description of the financial
resources available;
‘‘(vii) describes the existing substance use disorders
workforce and workforce trained in treating co-occurring substance use and mental disorders;
‘‘(viii) includes a description of how the State promotes evidence-based practices; and
‘‘(ix) describes how the State integrates substance
use disorder services and primary health care, which
in the case of those individuals with co-occurring
mental health and substance use disorders may include
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130 STAT. 1232
PUBLIC LAW 114–255—DEC. 13, 2016
providing both mental health and substance use disorder services in primary care settings or providing
primary and specialty care services in communitybased mental health and substance use disorder service
settings.
‘‘(B) The establishment of goals and objectives for the
period of the plan, including targets and milestones that
are intended to be met, and the activities that will be
undertaken to achieve those targets.
‘‘(C) A description of how the State will comply with
each funding agreement for a grant under section 1921
that is applicable to the State, including a description
of the manner in which the State intends to expend grant
funds.’’; and
(B) in paragraph (2)—
(i) in the paragraph heading, by striking
‘‘AUTHORITY OF SECRETARY REGARDING MODIFICATIONS’’
and inserting ‘‘MODIFICATIONS’’;
(ii) by striking ‘‘As a condition’’ and inserting the
following:
‘‘(A) AUTHORITY OF SECRETARY.—As a condition;’’; and
(iii) by adding at the end the following:
‘‘(B) STATE REQUEST FOR MODIFICATION.—If the State
determines that a modification to such plan is necessary,
the State may request the Secretary to approve the modification. Any such modification shall be in accordance with
paragraph (1) and section 1941.’’; and
(C) in paragraph (3), by inserting, ‘‘, including any
modification under paragraph (2)’’ after ‘‘subsection (a)(6)’’;
and
(3) in subsection (e)(2), by striking ‘‘section 1922(c)’’ and
inserting ‘‘section 1922(b)’’.
(j) DEFINITIONS.—Section 1934 of the Public Health Service
Act (42 U.S.C. 300x–34) is amended—
(1) in paragraph (3), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorders’’; and
(2) in paragraph (7), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorders’’.
(k) FUNDING.—Section 1935 of the Public Health Service Act
(42 U.S.C. 300x–35) is amended—
(1) in subsection (a)—
(A) by striking ‘‘section 505’’ and inserting ‘‘section
505(d)’’; and
(B) by striking ‘‘$2,000,000,000 for fiscal year 2001,
and such sums as may be necessary for each of the fiscal
years 2002 and 2003’’ and inserting ‘‘$1,858,079,000 for
each of fiscal years 2018 through 2022.’’; and
(2) in subsection (b)(1)(B) by striking ‘‘sections 505 and’’
and inserting ‘‘sections 505(d) and’’.
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SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.
Subpart III of part B of title XIX of the Public Health Service
Act (42 U.S.C. 300x–51 et seq.) is amended—
(1) in section 1943(a)(3) (42 U.S.C. 300x–53(a)(3)), by
striking ‘‘section 505’’ and inserting ‘‘subsections (c) and (d)
of section 505’’;
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130 STAT. 1233
(2) in section 1953(b) (42 U.S.C. 300x–63(b)), by striking
‘‘substance abuse’’ and inserting ‘‘substance use disorder’’; and
(3) by adding at the end the following:
‘‘SEC. 1957. PUBLIC HEALTH EMERGENCIES.
42 USC 300x–67.
‘‘In the case of a public health emergency (as determined under
section 319), the Secretary, on a State by State basis, may, as
the circumstances of the emergency reasonably require and for
the period of the emergency, grant an extension, or waive application deadlines or compliance with any other requirement, of a
grant authorized under section 521, 1911, or 1921 or an allotment
authorized under Public Law 99–319 (42 U.S.C. 10801 et seq.).
‘‘SEC. 1958. JOINT APPLICATIONS.
42 USC 300x–68.
‘‘The Secretary, acting through the Assistant Secretary for
Mental Health and Substance Use, shall permit a joint application
to be submitted for grants under subpart I and subpart II upon
the request of a State. Such application may be jointly reviewed
and approved by the Secretary with respect to such subparts, consistent with the purposes and authorized activities of each such
grant program. A State submitting such a joint application shall
otherwise meet the requirements with respect to each such subpart.’’.
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SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK
GRANT AND THE COMMUNITY MENTAL HEALTH SERVICES
BLOCK GRANT.
(a) IN GENERAL.—The Secretary of Health and Human Services,
acting through the Assistant Secretary for Mental Health and Substance Use, shall through a grant or contract, or through an agreement with a third party, conduct a study on the formulas for
distribution of funds under the substance abuse prevention and
treatment block grant, and the community mental health services
block grant, under part B of title XIX of the Public Health Service
Act (42 U.S.C. 300x et seq.) and recommend changes if necessary.
Such study shall include—
(1) an analysis of whether the distributions under such
block grants accurately reflect the need for the services under
the grants in the States;
(2) an examination of whether the indices used under the
formulas for distribution of funds under such block grants
are appropriate, and if not, alternatives recommended by the
Secretary;
(3) where recommendations are included under paragraph
(2) for the use of different indices, a description of the variables
and data sources that should be used to determine the indices;
(4) an evaluation of the variables and data sources that
are being used for each of the indices involved, and whether
such variables and data sources accurately represent the need
for services, the cost of providing services, and the ability
of the States to pay for such services;
(5) the effect that the minimum allotment requirements
for each such block grant have on each State’s final allotment
and the effect of such requirements, if any, on each State’s
formula-based allotment;
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(6) recommendations for modifications to the minimum
allotment provisions to ensure an appropriate distribution of
funds; and
(7) any other information that the Secretary determines
appropriate.
(b) REPORT.—Not later than 2 years after the date of enactment
of this Act, the Secretary of Health and Human Services 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 containing the findings
and recommendations of the study conducted under subsection (a)
and the study conducted under section 9004(g).
TITLE IX—PROMOTING ACCESS TO
MENTAL HEALTH AND SUBSTANCE
USE DISORDER CARE
Subtitle A—Helping Individuals and
Families
SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS
INDIVIDUALS.
Section 506 of the Public Health Service Act (42 U.S.C. 290aa–
5) is amended—
(1) in subsection (a), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorder’’;
(2) in subsection (b)—
(A) in paragraphs (1) and (3), by striking ‘‘substance
abuse’’ each place the term appears and inserting ‘‘substance use disorder’’; and
(B) in paragraph (4), by striking ‘‘substance abuse’’
and inserting ‘‘a substance use disorder’’;
(3) in subsection (c)—
(A) in paragraph (1), by striking ‘‘substance abuse disorder’’ and inserting ‘‘substance use disorder’’; and
(B) in paragraph (2)—
(i) in subparagraph (A), by striking ‘‘substance
abuse’’ and inserting ‘‘a substance use disorder’’; and
(ii) in subparagraph (B), by striking ‘‘substance
abuse’’ and inserting ‘‘substance use disorder’’; and
(4) in subsection (e), by striking ‘‘, $50,000,000 for fiscal
year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003’’ and inserting ‘‘$41,304,000
for each of fiscal years 2018 through 2022’’.
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SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.
Section 520G of the Public Health Service Act (42 U.S.C. 290bb–
38) is amended—
(1) by striking ‘‘substance abuse’’ each place such term
appears and inserting ‘‘substance use disorder’’;
(2) in subsection (a)—
(A) by striking ‘‘Indian tribes, and tribal organizations’’
and inserting ‘‘and Indian tribes and tribal organizations
(as the terms ‘Indian tribes’ and ‘tribal organizations’ are
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130 STAT. 1235
defined in section 4 of the Indian Self-Determination and
Education Assistance Act)’’; and
(B) by inserting ‘‘or a health facility or program operated by or in accordance with a contract or grant with
the Indian Health Service,’’ after ‘‘entities,’’;
(3) in subsection (c)(2)(A)(i), by striking ‘‘the best known’’
and inserting ‘‘evidence-based’’;
(4) by redesignating subsections (d) through (i) as subsections (e) through (j), respectively;
(5) by inserting after subsection (c) the following:
‘‘(d) SPECIAL CONSIDERATION REGARDING VETERANS.—In
awarding grants under subsection (a), the Secretary shall, as appropriate, give special consideration to entities proposing to use grant
funding to support jail diversion services for veterans.’’;
(6) in subsection (e), as so redesignated—
(A) in paragraph (3), by striking ‘‘; and’’ and inserting
a semicolon;
(B) in paragraph (4), by striking the period and
inserting ‘‘; and’’; and
(C) by adding at the end the following:
‘‘(5) develop programs to divert individuals prior to booking
or arrest.’’; and
(7) in subsection (j), as so redesignated, by striking
‘‘$10,000,000 for fiscal year 2001, and such sums as may be
necessary for fiscal years 2002 through 2003’’ and inserting
‘‘$4,269,000 for each of fiscal years 2018 through 2022’’.
SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL
HEALTH CARE.
Section 520K of the Public Health Service Act (42 U.S.C. 290bb–
42) is amended to read as follows:
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‘‘SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE
AGREEMENTS.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible entity’ means a
State, or other appropriate State agency, in collaboration with
1 or more qualified community programs as described in section
1913(b)(1) or 1 or more community health centers as described
in section 330.
‘‘(2) INTEGRATED CARE.—The term ‘integrated care’ means
collaborative models or practices offering mental and physical
health services, which may include practices that share the
same space in the same facility.
‘‘(3) SPECIAL POPULATION.—The term ‘special population’
means—
‘‘(A) adults with a mental illness who have co-occurring
physical health conditions or chronic diseases;
‘‘(B) adults with a serious mental illness who have
co-occurring physical health conditions or chronic diseases;
‘‘(C) children and adolescents with a serious emotional
disturbance with co-occurring physical health conditions
or chronic diseases; or
‘‘(D) individuals with a substance use disorder.
‘‘(b) GRANTS AND COOPERATIVE AGREEMENTS.—
‘‘(1) IN GENERAL.—The Secretary may award grants and
cooperative agreements to eligible entities to support the
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130 STAT. 1236
PUBLIC LAW 114–255—DEC. 13, 2016
improvement of integrated care for primary care and behavioral
health care in accordance with paragraph (2).
‘‘(2) PURPOSES.—A grant or cooperative agreement awarded
under this section shall be designed to—
‘‘(A) promote full integration and collaboration in clinical practices between primary and behavioral health care;
‘‘(B) support the improvement of integrated care models
for primary care and behavioral health care to improve
the overall wellness and physical health status of adults
with a serious mental illness or children with a serious
emotional disturbance; and
‘‘(C) promote integrated care services related to
screening, diagnosis, prevention, and treatment of mental
and substance use disorders, and co-occurring physical
health conditions and chronic diseases.
‘‘(c) APPLICATIONS.—
‘‘(1) IN GENERAL.—An eligible entity seeking a grant or
cooperative agreement under this section shall submit an
application to the Secretary at such time, in such manner,
and accompanied by such information as the Secretary may
require, including the contents described in paragraph (2).
‘‘(2) CONTENTS.—The contents described in this paragraph
are—
‘‘(A) a description of a plan to achieve fully collaborative
agreements to provide services to special populations;
‘‘(B) a document that summarizes the policies, if any,
that serve as barriers to the provision of integrated care,
and the specific steps, if applicable, that will be taken
to address such barriers;
‘‘(C) a description of partnerships or other arrangements with local health care providers to provide services
to special populations;
‘‘(D) an agreement and plan to report to the Secretary
performance measures necessary to evaluate patient outcomes and facilitate evaluations across participating
projects; and
‘‘(E) a plan for sustainability beyond the grant or
cooperative agreement period under subsection (e).
‘‘(d) GRANT AND COOPERATIVE AGREEMENT AMOUNTS.—
‘‘(1) TARGET AMOUNT.—The target amount that an eligible
entity may receive for a year through a grant or cooperative
agreement under this section shall be $2,000,000.
‘‘(2) ADJUSTMENT PERMITTED.—The Secretary, taking into
consideration the quality of the application and the number
of eligible entities that received grants under this section prior
to the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, may adjust the target amount
that an eligible entity may receive for a year through a grant
or cooperative agreement under this section.
‘‘(3) LIMITATION.—An eligible entity receiving funding
under this section may not allocate more than 10 percent
of funds awarded under this section to administrative functions,
and the remaining amounts shall be allocated to health facilities
that provide integrated care.
‘‘(e) DURATION.—A grant or cooperative agreement under this
section shall be for a period not to exceed 5 years.
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130 STAT. 1237
‘‘(f) REPORT ON PROGRAM OUTCOMES.—An eligible entity
receiving a grant or cooperative agreement under this section shall
submit an annual report to the Secretary that includes—
‘‘(1) the progress made to reduce barriers to integrated
care as described in the entity’s application under subsection
(c); and
‘‘(2) a description of functional outcomes of special populations, including—
‘‘(A) with respect to adults with a serious mental illness, participation in supportive housing or independent
living programs, attendance in social and rehabilitative
programs, participation in job training opportunities, satisfactory performance in work settings, attendance at scheduled medical and mental health appointments, and compliance with prescribed medication regimes;
‘‘(B) with respect to individuals with co-occurring
mental illness and physical health conditions and chronic
diseases, attendance at scheduled medical and mental
health appointments, compliance with prescribed medication regimes, and participation in learning opportunities
related to improved health and lifestyle practices; and
‘‘(C) with respect to children and adolescents with a
serious emotional disturbance who have co-occurring physical health conditions and chronic diseases, attendance at
scheduled medical and mental health appointments,
compliance with prescribed medication regimes, and
participation in learning opportunities at school and extracurricular activities.
‘‘(g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH
CARE INTEGRATION.—
‘‘(1) IN GENERAL.—The Secretary may provide appropriate
information, training, and technical assistance to eligible entities that receive a grant or cooperative agreement under this
section, in order to help such entities meet the requirements
of this section, including assistance with—
‘‘(A) development and selection of integrated care
models;
‘‘(B) dissemination of evidence-based interventions in
integrated care;
‘‘(C) establishment of organizational practices to support operational and administrative success; and
‘‘(D) other activities, as the Secretary determines
appropriate.
‘‘(2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMATION.—The information and resources provided by the Secretary
under paragraph (1) shall, as appropriate, be made available
to States, political subdivisions of States, Indian tribes or tribal
organizations (as defined in section 4 of the Indian Self-Determination and Education Assistance Act), outpatient mental
health and addiction treatment centers, community mental
health centers that meet the criteria under section 1913(c),
certified community behavioral health clinics described in section 223 of the Protecting Access to Medicare Act of 2014,
primary care organizations such as Federally qualified health
centers or rural health clinics as defined in section 1861(aa)
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of the Social Security Act, other community-based organizations, or other entities engaging in integrated care activities,
as the Secretary determines appropriate.
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this
section, there are authorized to be appropriated $51,878,000 for
each of fiscal years 2018 through 2022.’’.
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SEC.
9004.
PROJECTS FOR
HOMELESSNESS.
ASSISTANCE
IN
TRANSITION
FROM
(a) FORMULA GRANTS TO STATES.—Section 521 of the Public
Health Service Act (42 U.S.C. 290cc–21) is amended by striking
‘‘1991 through 1994’’ and inserting ‘‘2018 through 2022’’.
(b) PURPOSE OF GRANTS.—Section 522 of the Public Health
Service Act (42 U.S.C. 290cc–22) is amended—
(1) in subsection (a)(1)(B), by striking ‘‘substance abuse’’
and inserting ‘‘a substance use disorder’’;
(2) in subsection (b)(6), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorder’’;
(3) in subsection (c), by striking ‘‘substance abuse’’ and
inserting ‘‘a substance use disorder’’;
(4) in subsection (e)—
(A) in paragraph (1), by striking ‘‘substance abuse’’
and inserting ‘‘a substance use disorder’’; and
(B) in paragraph (2), by striking ‘‘substance abuse’’
and inserting ‘‘substance use disorder’’;
(5) by striking subsection (g) and redesignating subsections
(h) and (i) as (g) and (h), accordingly; and
(6) in subsection (g), as redesignated by paragraph (5),
by striking ‘‘substance abuse’’ each place such term appears
and inserting ‘‘substance use disorder’’.
(c) DESCRIPTION OF INTENDED EXPENDITURES OF GRANT.—Section 527 of the Public Health Service Act (42 U.S.C. 290cc–27)
is amended by striking ‘‘substance abuse’’ each place such term
appears and inserting ‘‘substance use disorder’’.
(d) TECHNICAL ASSISTANCE.—Section 530 of the Public Health
Service Act (42 U.S.C. 290cc–30) is amended by striking ‘‘through
the National Institute of Mental Health, the National Institute
of Alcohol Abuse and Alcoholism, and the National Institute on
Drug Abuse’’ and inserting ‘‘acting through the Assistant Secretary’’.
(e) DEFINITIONS.—Section 534(4) of the Public Health Service
Act (42 U.S.C. 290cc–34(4)) is amended to read as follows:
‘‘(4) SUBSTANCE USE DISORDER SERVICES.—The term ‘substance use disorder services’ has the meaning given the term
‘substance abuse services’ in section 330(h)(5)(C).’’.
(f) FUNDING.—Section 535(a) of the Public Health Service Act
(42 U.S.C. 290cc–35(a)) is amended by striking ‘‘$75,000,000 for
each of the fiscal years 2001 through 2003’’ and inserting
‘‘$64,635,000 for each of fiscal years 2018 through 2022’’.
(g) STUDY CONCERNING FORMULA.—
(1) IN GENERAL.—Not later than 2 years after the date
of enactment of this Act, the Assistant Secretary for Mental
Health and Substance Use (referred to in this section as the
‘‘Assistant Secretary’’) shall conduct a study concerning the
formula used under section 524 of the Public Health Service
Act (42 U.S.C. 290cc–24) for making allotments to States under
section 521 of such Act (42 U.S.C. 290cc–21). Such study shall
include an evaluation of quality indicators of need for purposes
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130 STAT. 1239
of revising the formula for determining the amount of each
allotment for the fiscal years following the submission of the
study.
(2) REPORT.—In accordance with section 8004(b), the Assistant Secretary shall submit to the committees of Congress
described in such section a report concerning the results of
the study conducted under paragraph (1).
SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb–31 et seq.) is amended by inserting after
section 520E–2 (42 U.S.C. 290bb–36b) the following:
‘‘SEC. 520E–3. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
‘‘(a) IN GENERAL.—The Secretary, acting through the Assistant
Secretary, shall maintain the National Suicide Prevention Lifeline
program (referred to in this section as the ‘program’), authorized
under section 520A and in effect prior to the date of enactment
of the Helping Families in Mental Health Crisis Reform Act of
2016.
‘‘(b) ACTIVITIES.—In maintaining the program, the activities
of the Secretary shall include—
‘‘(1) coordinating a network of crisis centers across the
United States for providing suicide prevention and crisis intervention services to individuals seeking help at any time, day
or night;
‘‘(2) maintaining a suicide prevention hotline to link callers
to local emergency, mental health, and social services resources;
and
‘‘(3) consulting with the Secretary of Veterans Affairs to
ensure that veterans calling the suicide prevention hotline have
access to a specialized veterans’ suicide prevention hotline.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $7,198,000 for each
of fiscal years 2018 through 2022.’’.
42 USC
290bb–36c.
SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb–31 et seq.), as amended by section 9005,
is further amended by inserting after section 520E–3 the following:
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‘‘SEC. 520E–4. TREATMENT REFERRAL ROUTING SERVICE.
‘‘(a) IN GENERAL.—The Secretary, acting through the Assistant
Secretary, shall maintain the National Treatment Referral Routing
Service (referred to in this section as the ‘Routing Service’) to
assist individuals and families in locating mental and substance
use disorders treatment providers.
‘‘(b) ACTIVITIES OF THE SECRETARY.—To maintain the Routing
Service, the activities of the Assistant Secretary shall include
administering—
‘‘(1) a nationwide, telephone number providing year-round
access to information that is updated on a regular basis
regarding local behavioral health providers and communitybased organizations in a manner that is confidential, without
requiring individuals to identify themselves, is in languages
that include at least English and Spanish, and is at no cost
to the individual using the Routing Service; and
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‘‘(2) an Internet website to provide a searchable, online
treatment services locator of behavioral health treatment providers and community-based organizations, which shall include
information on the name, location, contact information, and
basic services provided by such providers and organizations.
‘‘(c) REMOVING PRACTITIONER CONTACT INFORMATION.—In the
event that the Internet website described in subsection (b)(2) contains information on any qualified practitioner that is certified
to prescribe medication for opioid dependency under section
303(g)(2)(B) of the Controlled Substances Act, the Assistant Secretary—
‘‘(1) shall provide an opportunity to such practitioner to
have the contact information of the practitioner removed from
the website at the request of the practitioner; and
‘‘(2) may evaluate other methods to periodically update
the information displayed on such website.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to prevent the Assistant Secretary from using any
unobligated amounts otherwise made available to the Administration to maintain the Routing Service.’’.
SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
Section 520F of the Public Health Service Act (42 U.S.C. 290bb–
37) is amended to read as follows:
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‘‘SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
‘‘(a) IN GENERAL.—The Secretary shall award competitive
grants to—
‘‘(1) State and local governments and Indian tribes and
tribal organizations, to enhance community-based crisis
response systems; or
‘‘(2) States to develop, maintain, or enhance a database
of beds at inpatient psychiatric facilities, crisis stabilization
units, and residential community mental health and residential
substance use disorder treatment facilities, for adults with a
serious mental illness, children with a serious emotional
disturbance, or individuals with a substance use disorder.
‘‘(b) APPLICATIONS.—
‘‘(1) IN GENERAL.—To receive a grant under subsection (a),
an entity shall submit to the Secretary an application, at such
time, in such manner, and containing such information as
the Secretary may require.
‘‘(2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An application for a grant under subsection (a)(1) shall include a plan
for—
‘‘(A) promoting integration and coordination between
local public and private entities engaged in crisis response,
including first responders, emergency health care providers,
primary care providers, law enforcement, court systems,
health care payers, social service providers, and behavioral
health providers;
‘‘(B) developing memoranda of understanding with
public and private entities to implement crisis response
services;
‘‘(C) addressing gaps in community resources for crisis
intervention and prevention; and
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‘‘(D) developing models for minimizing hospital readmissions, including through appropriate discharge planning.
‘‘(3) BEDS DATABASE PLAN.—An application for a grant
under subsection (a)(2) shall include a plan for developing,
maintaining, or enhancing a real-time, Internet-based bed database to collect, aggregate, and display information about beds
in inpatient psychiatric facilities and crisis stabilization units,
and residential community mental health and residential substance use disorder treatment facilities to facilitate the identification and designation of facilities for the temporary treatment of individuals in mental or substance use disorder crisis.
‘‘(c) DATABASE REQUIREMENTS.—A bed database described in
this section is a database that—
‘‘(1) includes information on inpatient psychiatric facilities,
crisis stabilization units, and residential community mental
health and residential substance use disorder facilities in the
State involved, including contact information for the facility
or unit;
‘‘(2) provides real-time information about the number of
beds available at each facility or unit and, for each available
bed, the type of patient that may be admitted, the level of
security provided, and any other information that may be necessary to allow for the proper identification of appropriate
facilities for treatment of individuals in mental or substance
use disorder crisis; and
‘‘(3) enables searches of the database to identify available
beds that are appropriate for the treatment of individuals in
mental or substance use disorder crisis.
‘‘(d) EVALUATION.—An entity receiving a grant under subsection
(a)(1) shall submit to the Secretary, at such time, in such manner,
and containing such information as the Secretary may reasonably
require, a report, including an evaluation of the effect of such
grant on—
‘‘(1) local crisis response services and measures for individuals receiving crisis planning and early intervention supports;
‘‘(2) individuals reporting improved functional outcomes;
and
‘‘(3) individuals receiving regular followup care following
a crisis.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section, $12,500,000 for the
period of fiscal years 2018 through 2022.’’.
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SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.
(a) SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.—Section 520C of the Public Health Service Act (42 U.S.C. 290bb–
34), as amended by section 6001, is further amended—
(1) in the section heading, by striking ‘‘YOUTH INTERAGENCY RESEARCH, TRAINING, AND TECHNICAL ASSISTANCE
CENTERS’’ and inserting ‘‘SUICIDE PREVENTION TECHNICAL
ASSISTANCE CENTER’’;
(2) in subsection (a), by striking ‘‘acting through the Assistant Secretary for Mental Health and Substance Use’’ and all
that follows through the period at the end of paragraph (2)
and inserting ‘‘acting through the Assistant Secretary, shall
establish a research, training, and technical assistance resource
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PUBLIC LAW 114–255—DEC. 13, 2016
center to provide appropriate information, training, and technical assistance to States, political subdivisions of States, federally recognized Indian tribes, tribal organizations, institutions
of higher education, public organizations, or private nonprofit
organizations regarding the prevention of suicide among all
ages, particularly among groups that are at a high risk for
suicide.’’;
(3) by striking subsections (b) and (c);
(4) by redesignating subsection (d) as subsection (b);
(5) in subsection (b), as so redesignated—
(A) in the subsection heading, by striking ‘‘ADDITIONAL
CENTER’’ and inserting ‘‘RESPONSIBILITIES OF THE CENTER’’;
(B) in the matter preceding paragraph (1), by striking
‘‘The additional research’’ and all that follows through ‘‘nonprofit organizations for’’ and inserting ‘‘The center established under subsection (a) shall conduct activities for the
purpose of’’;
(C) by striking ‘‘youth suicide’’ each place such term
appears and inserting ‘‘suicide’’;
(D) in paragraph (1)—
(i) by striking ‘‘the development or continuation
of’’ and inserting ‘‘developing and continuing’’; and
(ii) by inserting ‘‘for all ages, particularly among
groups that are at a high risk for suicide’’ before the
semicolon at the end;
(E) in paragraph (2), by inserting ‘‘for all ages, particularly among groups that are at a high risk for suicide’’
before the semicolon at the end;
(F) in paragraph (3), by inserting ‘‘and tribal’’ after
‘‘statewide’’;
(G) in paragraph (5), by inserting ‘‘and prevention’’
after ‘‘intervention’’;
(H) in paragraph (8), by striking ‘‘in youth’’;
(I) in paragraph (9), by striking ‘‘and behavioral health’’
and inserting ‘‘health and substance use disorder’’; and
(J) in paragraph (10), by inserting ‘‘conducting’’ before
‘‘other’’; and
(6) by striking subsection (e) and inserting the following:
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$5,988,000 for each of fiscal years 2018 through 2022.
‘‘(d) ANNUAL REPORT.—Not later than 2 years after the date
of enactment of this subsection, the Secretary shall submit to Congress a report on the activities carried out by the center established
under subsection (a) during the year involved, including the potential effects of such activities, and the States, organizations, and
institutions that have worked with the center.’’.
(b) YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION
STRATEGIES.—Section 520E of the Public Health Service Act (42
U.S.C. 290bb–36) is amended—
(1) in paragraph (1) of subsection (a) and in subsection
(c), by striking ‘‘substance abuse’’ each place such term appears
and inserting ‘‘substance use disorder’’;
(2) in subsection (b)—
(A) in paragraph (2)—
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(i) by striking ‘‘ensure that each State is awarded
only 1 grant or cooperative agreement under this section’’ and inserting ‘‘ensure that a State does not
receive more than 1 grant or cooperative agreement
under this section at any 1 time’’; and
(ii) by striking ‘‘been awarded’’ and inserting
‘‘received’’; and
(B) by adding after paragraph (2) the following:
‘‘(3) CONSIDERATION.—In awarding grants under this section, the Secretary shall take into consideration the extent
of the need of the applicant, including the incidence and prevalence of suicide in the State and among the populations of
focus, including rates of suicide determined by the Centers
for Disease Control and Prevention for the State or population
of focus.’’;
(3) in subsection (g)(2), by striking ‘‘2 years after the date
of enactment of this section,’’ and insert ‘‘2 years after the
date of enactment of Helping Families in Mental Health Crisis
Reform Act of 2016,’’; and
(4) by striking subsection (m) and inserting the following:
‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
$30,000,000 for each of fiscal years 2018 through 2022.’’.
SEC. 9009. ADULT SUICIDE PREVENTION.
Subpart 3 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb–31 et seq.) is amended by adding at the
end the following:
42 USC
290bb–43.
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‘‘SEC. 520L. ADULT SUICIDE PREVENTION.
‘‘(a) GRANTS.—
‘‘(1) IN GENERAL.—The Assistant Secretary shall award
grants to eligible entities described in paragraph (2) to implement suicide prevention and intervention programs, for individuals who are 25 years of age or older, that are designed to
raise awareness of suicide, establish referral processes, and
improve care and outcomes for such individuals who are at
risk of suicide.
‘‘(2) ELIGIBLE ENTITIES.—To be eligible to receive a grant
under this section, an entity shall be a community-based primary care or behavioral health care setting, an emergency
department, a State mental health agency (or State health
agency with mental or behavioral health functions), public
health agency, a territory of the United States, or an Indian
tribe or tribal organization (as the terms ‘Indian tribe’ and
‘tribal organization’ are defined in section 4 of the Indian SelfDetermination and Education Assistance Act).
‘‘(3) USE OF FUNDS.—The grants awarded under paragraph
(1) shall be used to implement programs, in accordance with
such paragraph, that include one or more of the following
components:
‘‘(A) Screening for suicide risk, suicide intervention
services, and services for referral for treatment for individuals at risk for suicide.
‘‘(B) Implementing evidence-based practices to provide
treatment for individuals at risk for suicide, including
appropriate followup services.
‘‘(C) Raising awareness and reducing stigma of suicide.
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‘‘(b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant
Secretary shall—
‘‘(1) evaluate the activities supported by grants awarded
under subsection (a), and disseminate, as appropriate, the
findings from the evaluation; and
‘‘(2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities that receive
a grant under this section, in order to help such entities to
meet the requirements of this section, including assistance
with selection and implementation of evidence-based interventions and frameworks to prevent suicide.
‘‘(c) DURATION.—A grant under this section shall be for a period
of not more than 5 years.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $30,000,000 for the
period of fiscal years 2018 through 2022.’’.
SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.
Section 520J of the Public Health Service Act (42 U.S.C. 290bb–
41) is amended—
(1) in the section heading, by inserting ‘‘MENTAL HEALTH
AWARENESS’’ before ‘‘TRAINING’’; and
(2) in subsection (b)—
(A) in the subsection heading, by striking ‘‘ILLNESS’’
and inserting ‘‘HEALTH’’;
(B) in paragraph (1), by inserting ‘‘veterans, law
enforcement, and other categories of individuals, as determined by the Secretary,’’ after ‘‘emergency services personnel’’;
(C) in paragraph (5)—
(i) in the matter preceding subparagraph (A), by
striking ‘‘to’’ and inserting ‘‘for evidence-based programs that provide training and education in accordance with paragraph (1) on matters including’’; and
(ii) by striking subparagraphs (A) through (C) and
inserting the following:
‘‘(A) recognizing the signs and symptoms of mental
illness; and
‘‘(B)(i) resources available in the community for individuals with a mental illness and other relevant resources;
or
‘‘(ii) safely de-escalating crisis situations involving
individuals with a mental illness.’’; and
(D) in paragraph (7), by striking ‘‘, $25,000,000’’ and
all that follows through the period at the end and inserting
‘‘$14,693,000 for each of fiscal years 2018 through 2022.’’.
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SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS
AND ALASKA NATIVE YOUTH WITHIN SUICIDE PREVENTION PROGRAMS.
(a) FINDINGS.—The Congress finds as follows:
(1) Suicide is the eighth leading cause of death among
American Indians and Alaska Natives across all ages.
(2) Among American Indians and Alaska Natives who are
10 to 34 years of age, suicide is the second leading cause
of death.
(3) The suicide rate among American Indian and Alaska
Native adolescents and young adults ages 15 to 34 (17.9 per
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100,000) is approximately 1.3 times higher than the national
average for that age group (13.3 per 100,000).
(b) SENSE OF CONGRESS.—It is the sense of Congress that
the Secretary of Health and Human Services, in carrying out suicide
prevention and intervention programs, should prioritize programs
and activities for populations with disproportionately high rates
of suicide, such as American Indians and Alaska Natives.
SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.
Section 520A(e) of the Public Health Service Act (42 U.S.C.
290bb–32(e)) is amended by adding at the end the following:
‘‘(3) GERIATRIC MENTAL DISORDERS.—The Secretary shall,
as appropriate, provide technical assistance to grantees
regarding evidence-based practices for the prevention and treatment of geriatric mental disorders and co-occurring mental
health and substance use disorders among geriatric populations, as well as disseminate information about such evidencebased practices to States and nongrantees throughout the
United States.’’.
SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.
The Secretary of Health and Human Services, acting through
the Director of the Centers for Disease Control and Prevention,
is encouraged to improve, particularly through the inclusion of
additional States, the National Violent Death Reporting System
as authorized by title III of the Public Health Service Act (42
U.S.C. 241 et seq.). Participation in the system by the States
shall be voluntary.
SEC. 9014. ASSISTED OUTPATIENT TREATMENT.
Section 224 of the Protecting Access to Medicare Act of 2014
(42 U.S.C. 290aa note) is amended—
(1) in subsection (e), by striking ‘‘and 2018,’’ and inserting
‘‘2018, 2019, 2020, 2021, and 2022,’’; and
(2) in subsection (g)—
(A) in paragraph (1), by striking ‘‘2018’’ and inserting
‘‘2022’’; and
(B) in paragraph (2), by striking ‘‘is authorized to be
appropriated to carry out this section $15,000,000 for each
of fiscal years 2015 through 2018’’ and inserting ‘‘are
authorized to be appropriated to carry out this section
$15,000,000 for each of fiscal years 2015 through 2017,
$20,000,000 for fiscal year 2018, $19,000,000 for each of
fiscal years 2019 and 2020, and $18,000,000 for each of
fiscal years 2021 and 2022’’.
SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
42 USC
290bb–44.
Part B of title V of the Public Health Service Act (42 U.S.C.
290bb et seq.), as amended by section 9009, is further amended
by adding at the end the following:
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‘‘SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
‘‘(a) IN GENERAL.—The Assistant Secretary shall award grants
to eligible entities—
‘‘(1) to establish assertive community treatment programs
for adults with a serious mental illness; or
‘‘(2) to maintain or expand such programs.
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‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under
this section, an entity shall be a State, political subdivision of
a State, Indian tribe or tribal organization (as such terms are
defined in section 4 of the Indian Self-Determination and Education
Assistance Act), mental health system, health care facility, or any
other entity the Assistant Secretary deems appropriate.
‘‘(c) SPECIAL CONSIDERATION.—In selecting among applicants
for a grant under this section, the Assistant Secretary may give
special consideration to the potential of the applicant’s program
to reduce hospitalization, homelessness, and involvement with the
criminal justice system while improving the health and social outcomes of the patient.
‘‘(d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
‘‘(1) not later than the end of fiscal year 2021, submit
a report to the appropriate congressional committees on the
grant program under this section, including an evaluation of—
‘‘(A) any cost savings and public health outcomes such
as mortality, suicide, substance use disorders, hospitalization, and use of services;
‘‘(B) rates of involvement with the criminal justice
system of patients;
‘‘(C) rates of homelessness among patients; and
‘‘(D) patient and family satisfaction with program
participation; and
‘‘(2) provide appropriate information, training, and technical assistance to grant recipients under this section to help
such recipients to establish, maintain, or expand their assertive
community treatment programs.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN GENERAL.—To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years
2018 through 2022.
‘‘(2) USE OF CERTAIN FUNDS.—Of the funds appropriated
to carry out this section in any fiscal year, not more than
5 percent shall be available to the Assistant Secretary for
carrying out subsection (d).’’.
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SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING
REAUTHORIZATION.
Section 519B of the Public Health Service Act (42 U.S.C. 290bb–
25b) is amended—
(1) in subsection (c)(3), by striking ‘‘fiscal year 2007’’ and
all that follows through the period at the end and inserting
‘‘each of the fiscal years 2018 through 2022.’’;
(2) in subsection (d)(4), by striking ‘‘fiscal year 2007’’ and
all that follows through the period at the end and inserting
‘‘each of the fiscal years 2018 through 2022.’’;
(3) in subsection (e)(1)(I), by striking ‘‘fiscal year 2007’’
and all that follows through the period at the end and inserting
‘‘each of the fiscal years 2018 through 2022.’’;
(4) in subsection (f)(2), by striking ‘‘$6,000,000 for fiscal
year 2007’’ and all that follows through the period at the
end and inserting ‘‘$3,000,000 for each of the fiscal years 2018
through 2022’’; and
(5) by adding at the end the following new subsection:
‘‘(g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
BRIEF INTERVENTION.—
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130 STAT. 1247
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‘‘(1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO
REDUCE UNDERAGE DRINKING.—The Assistant Secretary may
make grants to eligible entities to increase implementation
of practices for reducing the prevalence of alcohol use among
individuals under the age of 21, including college students.
‘‘(2) PURPOSES.—Grants under this subsection shall be
made to improve—
‘‘(A) screening children and adolescents for alcohol use;
‘‘(B) offering brief interventions to children and adolescents to discourage such use;
‘‘(C) educating parents about the dangers of, and
methods of discouraging, such use;
‘‘(D) diagnosing and treating alcohol use disorders; and
‘‘(E) referring patients, when necessary, to other appropriate care.
‘‘(3) USE OF FUNDS.—An entity receiving a grant under
this subsection may use such funding for the purposes identified
in paragraph (2) by—
‘‘(A) providing training to health care providers;
‘‘(B) disseminating best practices, including culturally
and linguistically appropriate best practices, as appropriate, and developing and distributing materials; and
‘‘(C) supporting other activities, as determined appropriate by the Assistant Secretary.
‘‘(4) APPLICATION.—To be eligible to receive a grant under
this subsection, an entity shall submit an application to the
Assistant Secretary at such time, and in such manner, and
accompanied by such information as the Assistant Secretary
may require. Each application shall include—
‘‘(A) a description of the entity;
‘‘(B) a description of activities to be completed;
‘‘(C) a description of how the services specified in paragraphs (2) and (3) will be carried out and the qualifications
for providing such services; and
‘‘(D) a timeline for the completion of such activities.
‘‘(5) DEFINITIONS.—For the purpose of this subsection:
‘‘(A) BRIEF INTERVENTION.—The term ‘brief intervention’ means, after screening a patient, providing the patient
with brief advice and other brief motivational enhancement
techniques designed to increase the insight of the patient
regarding the patient’s alcohol use, and any realized or
potential consequences of such use, to effect the desired
related behavioral change.
‘‘(B) CHILDREN AND ADOLESCENTS.—The term ‘children
and adolescents’ means any person under 21 years of age.
‘‘(C) ELIGIBLE ENTITY.—The term ‘eligible entity’ means
an entity consisting of pediatric health care providers and
that is qualified to support or provide the activities identified in paragraph (2).
‘‘(D) PEDIATRIC HEALTH CARE PROVIDER.—The term
‘pediatric health care provider’ means a provider of primary
health care to individuals under the age of 21 years.
‘‘(E) SCREENING.—The term ‘screening’ means using
validated patient interview techniques to identify and
assess the existence and extent of alcohol use in a patient.’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 9017. CENTER AND PROGRAM REPEALS.
Part B of title V of the Public Health Service Act (42 U.S.C.
290bb et seq.) is amended by striking section 506B (42 U.S.C.
290aa–5b), the second section 514 (42 U.S.C. 290bb–9) relating
to methamphetamine and amphetamine treatment initiatives, and
each of sections 514A, 517, 519A, 519C, 519E, 520B, 520D, and
520H (42 U.S.C. 290bb–8, 290bb–23, 290bb–25a, 290bb–25c, 290bb–
25e, 290bb–33, 290bb–35, and 290bb–39).
Subtitle B—Strengthening the Health Care
Workforce
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SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND
TRAINING GRANTS.
Section 756 of the Public Health Service Act (42 U.S.C. 294e–
1) is amended—
(1) in subsection (a)—
(A) in the matter preceding paragraph (1), by striking
‘‘of higher education’’; and
(B) by striking paragraphs (1) through (4) and inserting
the following:
‘‘(1) accredited institutions of higher education or accredited
professional training programs that are establishing or
expanding internships or other field placement programs in
mental health in psychiatry, psychology, school psychology,
behavioral pediatrics, psychiatric nursing (which may include
master’s and doctoral level programs), social work, school social
work, substance use disorder prevention and treatment, marriage and family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
a focus on child and adolescent mental health and transitionalage youth;
‘‘(2) accredited doctoral, internship, and post-doctoral residency programs of health service psychology (including clinical
psychology, counseling, and school psychology) for the development and implementation of interdisciplinary training of psychology graduate students for providing behavioral health services, including substance use disorder prevention and treatment
services, as well as the development of faculty in health service
psychology;
‘‘(3) accredited master’s and doctoral degree programs of
social work for the development and implementation of interdisciplinary training of social work graduate students for providing behavioral health services, including substance use disorder prevention and treatment services, and the development
of faculty in social work; and
‘‘(4) State-licensed mental health nonprofit and for-profit
organizations to enable such organizations to pay for programs
for preservice or in-service training in a behavioral healthrelated paraprofessional field with preference for preservice
or in-service training of paraprofessional child and adolescent
mental health workers.’’;
(2) in subsection (b)—
(A) by striking paragraph (5);
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130 STAT. 1249
(B) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(C) by inserting before paragraph (2), as so redesignated, the following:
‘‘(1) an ability to recruit and place the students described
in subsection (a) in areas with a high need and high demand
population;’’;
(D) in paragraph (3), as so redesignated, by striking
‘‘subsection (a)’’ and inserting ‘‘paragraph (2), especially
individuals with mental disorder symptoms or diagnoses,
particularly children and adolescents, and transitional-age
youth’’;
(E) in paragraph (4), as so redesignated, by striking
‘‘;’’ and inserting ‘‘; and’’; and
(F) in paragraph (5), as so redesignated, by striking
‘‘; and’’ and inserting a period;
(3) in subsection (c), by striking ‘‘authorized under subsection (a)(1)’’ and inserting ‘‘awarded under paragraphs (2)
and (3) of subsection (a)’’;
(4) by amending subsection (d) to read as follows:
‘‘(d) PRIORITY.—In selecting grant recipients under this section,
the Secretary shall give priority to—
‘‘(1) programs that have demonstrated the ability to train
psychology, psychiatry, and social work professionals to work
in integrated care settings for purposes of recipients under
paragraphs (1), (2), and (3) of subsection (a); and
‘‘(2) programs for paraprofessionals that emphasize the role
of the family and the lived experience of the consumer and
family-paraprofessional partnerships for purposes of recipients
under subsection (a)(4).’’; and
(5) by striking subsection (e) and inserting the following:
‘‘(e) REPORT TO CONGRESS.—Not later than 4 years after the
date of enactment of the Helping Families in Mental Health Crisis
Reform Act of 2016, the Secretary shall include in the biennial
report submitted to Congress under section 501(m) an assessment
on the effectiveness of the grants under this section in—
‘‘(1) providing graduate students support for experiential
training (internship or field placement);
‘‘(2) recruiting students interested in behavioral health
practice;
‘‘(3) recruiting students in accordance with subsection
(b)(1);
‘‘(4) developing and implementing interprofessional training
and integration within primary care;
‘‘(5) developing and implementing accredited field placements and internships; and
‘‘(6) collecting data on the number of students trained in
behavioral health care and the number of available accredited
internships and field placements.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal
years 2018 through 2022, there are authorized to be appropriated
to carry out this section $50,000,000, to be allocated as follows:
‘‘(1) For grants described in subsection (a)(1), $15,000,000.
‘‘(2) For grants described in subsection (a)(2), $15,000,000.
‘‘(3) For grants described in subsection (a)(3), $10,000,000.
‘‘(4) For grants described in subsection (a)(4), $10,000,000.’’.
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42 USC 294k.
PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE DISORDERS WORKFORCE.
Part D of title VII of the Public Health Service Act (42 U.S.C.
294 et seq.) is amended by adding at the end the following:
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‘‘SEC. 760. TRAINING DEMONSTRATION PROGRAM.
‘‘(a) IN GENERAL.—The Secretary shall establish a training
demonstration program to award grants to eligible entities to support—
‘‘(1) training for medical residents and fellows to practice
psychiatry and addiction medicine in underserved, communitybased settings that integrate primary care with mental and
substance use disorders prevention and treatment services;
‘‘(2) training for nurse practitioners, physician assistants,
health service psychologists, and social workers to provide
mental and substance use disorders services in underserved
community-based settings that integrate primary care and
mental and substance use disorders services; and
‘‘(3) establishing, maintaining, or improving academic units
or programs that—
‘‘(A) provide training for students or faculty, including
through clinical experiences and research, to improve the
ability to be able to recognize, diagnose, and treat mental
and substance use disorders, with a special focus on addiction; or
‘‘(B) develop evidence-based practices or recommendations for the design of the units or programs described
in subparagraph (A), including curriculum content standards.
‘‘(b) ACTIVITIES.—
‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.—A recipient
of a grant under subsection (a)(1)—
‘‘(A) shall use the grant funds—
‘‘(i)(I) to plan, develop, and operate a training program for medical psychiatry residents and fellows in
addiction medicine practicing in eligible entities
described in subsection (c)(1); or
‘‘(II) to train new psychiatric residents and fellows
in addiction medicine to provide and expand access
to integrated mental and substance use disorders services; and
‘‘(ii) to provide at least 1 training track that is—
‘‘(I) a virtual training track that includes an
in-person rotation at a teaching health center or
in a community-based setting, followed by a virtual
rotation in which the resident or fellow continues
to support the care of patients at the teaching
health center or in the community-based setting
through the use of health information technology
and, as appropriate, telehealth services;
‘‘(II) an in-person training track that includes
a rotation, during which the resident or fellow
practices at a teaching health center or in a
community-based setting; or
‘‘(III) an in-person training track that includes
a rotation during which the resident practices in
a community-based setting that specializes in the
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130 STAT. 1251
treatment of infants, children, adolescents, or pregnant or postpartum women; and
‘‘(B) may use the grant funds to provide additional
support for the administration of the program or to meet
the costs of projects to establish, maintain, or improve
faculty development, or departments, divisions, or other
units necessary to implement such training.
‘‘(2) TRAINING FOR OTHER PROVIDERS.—A recipient of a
grant under subsection (a)(2)—
‘‘(A) shall use the grant funds to plan, develop, or
operate a training program to provide mental and substance use disorders services in underserved, communitybased settings, as appropriate, that integrate primary care
and mental and substance use disorders prevention and
treatment services; and
‘‘(B) may use the grant funds to provide additional
support for the administration of the program or to meet
the costs of projects to establish, maintain, or improve
faculty development, or departments, divisions, or other
units necessary to implement such program.
‘‘(3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant
under subsection (a)(3) shall enter into a partnership with
organizations such as an education accrediting organization
(such as the Liaison Committee on Medical Education, the
Accreditation Council for Graduate Medical Education, the
Commission on Osteopathic College Accreditation, the Accreditation Commission for Education in Nursing, the Commission
on Collegiate Nursing Education, the Accreditation Council for
Pharmacy Education, the Council on Social Work Education,
American Psychological Association Commission on Accreditation, or the Accreditation Review Commission on Education
for the Physician Assistant) to carry out activities under subsection (a)(3).
‘‘(c) ELIGIBLE ENTITIES.—
‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.—To be eligible
to receive a grant under subsection (a)(1), an entity shall—
‘‘(A) be a consortium consisting of—
‘‘(i) at least one teaching health center; and
‘‘(ii) the sponsoring institution (or parent institution of the sponsoring institution) of—
‘‘(I) a psychiatry residency program that is
accredited by the Accreditation Council of Graduate Medical Education (or the parent institution
of such a program); or
‘‘(II) a fellowship in addiction medicine, as
determined appropriate by the Secretary; or
‘‘(B) be an entity described in subparagraph (A)(ii)
that provides opportunities for residents or fellows to train
in community-based settings that integrate primary care
with mental and substance use disorders prevention and
treatment services.
‘‘(2) TRAINING FOR OTHER PROVIDERS.—To be eligible to
receive a grant under subsection (a)(2), an entity shall be—
‘‘(A) a teaching health center (as defined in section
749A(f));
‘‘(B) a Federally qualified health center (as defined
in section 1905(l)(2)(B) of the Social Security Act);
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(C) a community mental health center (as defined
in section 1861(ff)(3)(B) of the Social Security Act);
‘‘(D) a rural health clinic (as defined in section 1861(aa)
of the Social Security Act);
‘‘(E) a health center operated by the Indian Health
Service, an Indian tribe, a tribal organization, or an urban
Indian organization (as defined in section 4 of the Indian
Health Care Improvement Act); or
‘‘(F) an entity with a demonstrated record of success
in providing training for nurse practitioners, physician
assistants, health service psychologists, and social workers.
‘‘(3) ACADEMIC UNITS OR PROGRAMS.—To be eligible to
receive a grant under subsection (a)(3), an entity shall be
a school of medicine or osteopathic medicine, a nursing school,
a physician assistant training program, a school of pharmacy,
a school of social work, an accredited public or nonprofit private
hospital, an accredited medical residency program, or a public
or private nonprofit entity which the Secretary has determined
is capable of carrying out such grant.
‘‘(d) PRIORITY.—
‘‘(1) IN GENERAL.—In awarding grants under subsection
(a)(1) or (a)(2), the Secretary shall give priority to eligible
entities that—
‘‘(A) demonstrate sufficient size, scope, and capacity
to undertake the requisite training of an appropriate
number of psychiatric residents, fellows, nurse practitioners, physician assistants, or social workers in addiction
medicine per year to meet the needs of the area served;
‘‘(B) demonstrate experience in training providers to
practice team-based care that integrates mental and substance use disorder prevention and treatment services with
primary care in community-based settings;
‘‘(C) demonstrate experience in using health information technology and, as appropriate, telehealth to support—
‘‘(i) the delivery of mental and substance use disorders services at the eligible entities described in subsections (c)(1) and (c)(2); and
‘‘(ii) community health centers in integrating primary care and mental and substance use disorders
treatment; or
‘‘(D) have the capacity to expand access to mental
and substance use disorders services in areas with demonstrated need, as determined by the Secretary, such as
tribal, rural, or other underserved communities.
‘‘(2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants
under subsection (a)(3), the Secretary shall give priority to
eligible entities that—
‘‘(A) have a record of training the greatest percentage
of mental and substance use disorders providers who enter
and remain in these fields or who enter and remain in
settings with integrated primary care and mental and substance use disorder prevention and treatment services;
‘‘(B) have a record of training individuals who are
from underrepresented minority groups, including native
populations, or from a rural or disadvantaged background;
‘‘(C) provide training in the care of vulnerable populations such as infants, children, adolescents, pregnant and
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130 STAT. 1253
postpartum women, older adults, homeless individuals, victims of abuse or trauma, individuals with disabilities, and
other groups as defined by the Secretary;
‘‘(D) teach trainees the skills to provide interprofessional, integrated care through collaboration among health
professionals; or
‘‘(E) provide training in cultural competency and health
literacy.
‘‘(e) DURATION.—Grants awarded under this section shall be
for a minimum of 5 years.
‘‘(f) STUDY AND REPORT.—
‘‘(1) STUDY.—
‘‘(A) IN GENERAL.—The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall conduct a study on the results of
the demonstration program under this section.
‘‘(B) DATA SUBMISSION.—Not later than 90 days after
the completion of the first year of the training program
and each subsequent year that the program is in effect,
each recipient of a grant under subsection (a) shall submit
to the Secretary such data as the Secretary may require
for analysis for the report described in paragraph (2).
‘‘(2) REPORT TO CONGRESS.—Not later than 1 year after
receipt of the data described in paragraph (1)(B), the Secretary
shall submit to Congress a report that includes—
‘‘(A) an analysis of the effect of the demonstration
program under this section on the quality, quantity, and
distribution of mental and substance use disorders services;
‘‘(B) an analysis of the effect of the demonstration
program on the prevalence of untreated mental and substance use disorders in the surrounding communities of
health centers participating in the demonstration; and
‘‘(C) recommendations on whether the demonstration
program should be expanded.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section $10,000,000 for each
of fiscal years 2018 through 2022.’’.
SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR LOAN
REPAYMENT PROGRAMS.
42 USC 294l–1
note.
The Administrator of the Health Resources and Services
Administration shall clarify the eligibility pursuant to section
338B(b)(1)(B) of the Public Health Service Act (42 U.S.C. 254l–
1(b)(1)(B)) of child and adolescent psychiatrists for the National
Health Service Corps Loan Repayment Program under subpart
III of part D of title III of such Act (42 U.S.C. 254l et seq.).
SEC. 9024. MINORITY FELLOWSHIP PROGRAM.
Title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by adding at the end the following:
‘‘PART K—MINORITY FELLOWSHIP PROGRAM
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‘‘SEC. 597. FELLOWSHIPS.
42 USC 290ll.
‘‘(a) IN GENERAL.—The Secretary shall maintain a program,
to be known as the Minority Fellowship Program, under which
the Secretary shall award fellowships, which may include stipends,
for the purposes of—
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‘‘(1) increasing the knowledge of mental and substance
use disorders practitioners on issues related to prevention,
treatment, and recovery support for individuals who are from
racial and ethnic minority populations and who have a mental
or substance use disorder;
‘‘(2) improving the quality of mental and substance use
disorder prevention and treatment services delivered to racial
and ethnic minority populations; and
‘‘(3) increasing the number of culturally competent mental
and substance use disorders professionals who teach, administer services, conduct research, and provide direct mental or
substance use disorder services to racial and ethnic minority
populations.
‘‘(b) TRAINING COVERED.—The fellowships awarded under subsection (a) shall be for postbaccalaureate training (including for
master’s and doctoral degrees) for mental and substance use disorder treatment professionals, including in the fields of psychiatry,
nursing, social work, psychology, marriage and family therapy,
mental health counseling, and substance use disorder and addiction
counseling.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $12,669,000 for each
of fiscal years 2018 through 2022.’’.
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SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL VOLUNTEERS AT COMMUNITY HEALTH CENTERS.
Section 224 of the Public Health Service Act (42 U.S.C. 233)
is amended by adding at the end the following:
‘‘(q)(1) For purposes of this section, a health professional volunteer at a deemed entity described in subsection (g)(4) shall, in
providing a health professional service eligible for funding under
section 330 to an individual, be deemed to be an employee of
the Public Health Service for a calendar year that begins during
a fiscal year for which a transfer was made under paragraph
(4)(C). The preceding sentence is subject to the provisions of this
subsection.
‘‘(2) In providing a health service to an individual, a health
care practitioner shall for purposes of this subsection be considered
to be a health professional volunteer at an entity described in
subsection (g)(4) if the following conditions are met:
‘‘(A) The service is provided to the individual at the facilities of an entity described in subsection (g)(4), or through
offsite programs or events carried out by the entity.
‘‘(B) The entity is sponsoring the health care practitioner
pursuant to paragraph (3)(B).
‘‘(C) The health care practitioner does not receive any compensation for the service from the individual, the entity
described in subsection (g)(4), or any third-party payer
(including reimbursement under any insurance policy or health
plan, or under any Federal or State health benefits program),
except that the health care practitioner may receive repayment
from the entity described in subsection (g)(4) for reasonable
expenses incurred by the health care practitioner in the provision of the service to the individual, which may include travel
expenses to or from the site of services.
‘‘(D) Before the service is provided, the health care practitioner or the entity described in subsection (g)(4) posts a clear
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and conspicuous notice at the site where the service is provided
of the extent to which the legal liability of the health care
practitioner is limited pursuant to this subsection.
‘‘(E) At the time the service is provided, the health care
practitioner is licensed or certified in accordance with applicable
Federal and State laws regarding the provision of the service.
‘‘(F) At the time the service is provided, the entity described
in subsection (g)(4) maintains relevant documentation certifying
that the health care practitioner meets the requirements of
this subsection.
‘‘(3) Subsection (g) (other than paragraphs (3) and (5)) and
subsections (h), (i), and (l) apply to a health care practitioner
for purposes of this subsection to the same extent and in the
same manner as such subsections apply to an officer, governing
board member, employee, or contractor of an entity described in
subsection (g)(4), subject to paragraph (4), and subject to the following:
‘‘(A) The first sentence of paragraph (1) applies in lieu
of the first sentence of subsection (g)(1)(A).
‘‘(B) With respect to an entity described in subsection (g)(4),
a health care practitioner is not a health professional volunteer
at such entity unless the entity sponsors the health care practitioner. For purposes of this subsection, the entity shall be
considered to be sponsoring the health care practitioner if—
‘‘(i) with respect to the health care practitioner, the
entity submits to the Secretary an application meeting
the requirements of subsection (g)(1)(D); and
‘‘(ii) the Secretary, pursuant to subsection (g)(1)(E),
determines that the health care practitioner is deemed
to be an employee of the Public Health Service.
‘‘(C) In the case of a health care practitioner who is determined by the Secretary pursuant to subsection (g)(1)(E) to
be a health professional volunteer at such entity, this subsection
applies to the health care practitioner (with respect to services
performed on behalf of the entity sponsoring the health care
practitioner pursuant to subparagraph (B)) for any cause of
action arising from an act or omission of the health care practitioner occurring on or after the date on which the Secretary
makes such determination.
‘‘(D) Subsection (g)(1)(F) applies to a health care practitioner for purposes of this subsection only to the extent that,
in providing health services to an individual, each of the conditions specified in paragraph (2) is met.
‘‘(4)(A) Amounts in the fund established under subsection (k)(2)
shall be available for transfer under subparagraph (C) for purposes
of carrying out this subsection.
‘‘(B)(i) Not later than May 1 of each fiscal year, the Attorney
General, in consultation with the Secretary, shall submit to the
Congress a report providing an estimate of the amount of claims
(together with related fees and expenses of witnesses) that, by
reason of the acts or omissions of health professional volunteers,
will be paid pursuant to this section during the calendar year
that begins in the following fiscal year.
‘‘(ii) Subsection (k)(1)(B) applies to the estimate under clause
(i) regarding health professional volunteers to the same extent
and in the same manner as such subsection applies to the estimate
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under such subsection regarding officers, governing board members,
employees, and contractors of entities described in subsection (g)(4).
‘‘(iii) The report shall include a summary of the data relied
upon for the estimate in clause (i), including the number of claims
filed and paid from the previous calendar year.
‘‘(C) Not later than December 31 of each fiscal year, the Secretary shall transfer from the fund under subsection (k)(2) to the
appropriate accounts in the Treasury an amount equal to the estimate made under subparagraph (B) for the calendar year beginning
in such fiscal year, subject to the extent of amounts in the fund.
‘‘(5)(A) This subsection shall take effect on October 1, 2017,
except as provided in subparagraph (B) and paragraph (6).
‘‘(B) Effective on the date of the enactment of this subsection—
‘‘(i) the Secretary may issue regulations for carrying out
this subsection, and the Secretary may accept and consider
applications submitted pursuant to paragraph (3)(B); and
‘‘(ii) reports under paragraph (4)(B) may be submitted to
Congress.
‘‘(6) Beginning on October 1, 2022, this subsection shall cease
to have any force or effect.’’.
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SEC. 9026. REPORTS.
(a) WORKFORCE DEVELOPMENT REPORT.—
(1) IN GENERAL.—Not later than 2 years after the date
of enactment of this Act, the Administrator of the Health
Resources and Services Administration, in consultation with
the Assistant Secretary for Mental Health and Substance Use,
shall conduct a study and publicly post on the appropriate
Internet website of the Department of Health and Human
Services a report on the adult and pediatric mental health
and substance use disorder workforce in order to inform Federal, State, and local efforts related to workforce enhancement.
(2) CONTENTS.—The report under this subsection shall contain—
(A) national and State-level projections of the supply
and demand of the mental health and substance use disorder health workforce, disaggregated by profession;
(B) an assessment of the mental health and substance
use disorder workforce capacity, strengths, and weaknesses
as of the date of the report, including the extent to which
primary care providers are preventing, screening, or referring for mental and substance use disorder services;
(C) information on trends within the mental health
and substance use disorder provider workforce, including
the number of individuals expected to enter the mental
health workforce over the next 5 years; and
(D) any additional information determined by the
Administrator of the Health Resources and Services
Administration, in consultation with the Assistant Secretary for Mental Health and Substance Use, to be relevant
to the mental health and substance use disorder provider
workforce.
(b) PEER-SUPPORT SPECIALIST PROGRAMS.—
(1) IN GENERAL.—The Comptroller General of the United
States shall conduct a study on peer-support specialist programs in up to 10 States that receive funding from the Substance Abuse and Mental Health Services Administration.
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(2) CONTENTS OF STUDY.—In conducting the study under
paragraph (1), the Comptroller General of the United States
shall examine and identify best practices, in the States selected
pursuant to such paragraph, related to training and credential
requirements for peer-support specialist programs, such as—
(A) hours of formal work or volunteer experience
related to mental and substance use disorders conducted
through such programs;
(B) types of peer-support specialist exams required for
such programs in the selected States;
(C) codes of ethics used by such programs in the
selected States;
(D) required or recommended skill sets for such programs in the selected States; and
(E) requirements for continuing education.
(3) REPORT.—Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States
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 study conducted under paragraph (1).
Subtitle C—Mental Health on Campus
Improvement
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SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON CAMPUS.
Section 520E–2 of the Public Health Service Act (42 U.S.C.
290bb–36b) is amended—
(1) in the section heading, by striking ‘‘AND BEHAVIORAL
HEALTH’’ and inserting ‘‘HEALTH AND SUBSTANCE USE DISORDER’’;
(2) in subsection (a)—
(A) by striking ‘‘Services,’’ and inserting ‘‘Services and’’;
(B) by striking ‘‘and behavioral health problems’’ and
inserting ‘‘health or substance use disorders’’;
(C) by striking ‘‘substance abuse’’ and inserting ‘‘substance use disorders’’; and
(D) by adding after, ‘‘suicide attempts,’’ the following:
‘‘prevent mental and substance use disorders, reduce
stigma, and improve the identification and treatment for
students at risk,’’;
(3) in subsection (b)—
(A) in the matter preceding paragraph (1), by striking
‘‘for—’’ and inserting ‘‘for one or more of the following:’’;
and
(B) by striking paragraphs (1) through (6) and inserting
the following:
‘‘(1) Educating students, families, faculty, and staff to
increase awareness of mental and substance use disorders.
‘‘(2) The operation of hotlines.
‘‘(3) Preparing informational material.
‘‘(4) Providing outreach services to notify students about
available mental and substance use disorder services.
‘‘(5) Administering voluntary mental and substance use
disorder screenings and assessments.
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‘‘(6) Supporting the training of students, faculty, and staff
to respond effectively to students with mental and substance
use disorders.
‘‘(7) Creating a network infrastructure to link institutions
of higher education with health care providers who treat mental
and substance use disorders.
‘‘(8) Providing mental and substance use disorders prevention and treatment services to students, which may include
recovery support services and programming and early intervention, treatment, and management, including through the use
of telehealth services.
‘‘(9) Conducting research through a counseling or health
center at the institution of higher education involved regarding
improving the behavioral health of students through clinical
services, outreach, prevention, or academic success, in a manner
that is in compliance with all applicable personal privacy laws.
‘‘(10) Supporting student groups on campus, including athletic teams, that engage in activities to educate students,
including activities to reduce stigma surrounding mental and
behavioral disorders, and promote mental health.
‘‘(11) Employing appropriately trained staff.
‘‘(12) Developing and supporting evidence-based and
emerging best practices, including a focus on culturally and
linguistically appropriate best practices.’’;
(4) in subsection (c)(5), by striking ‘‘substance abuse’’ and
inserting ‘‘substance use disorder’’;
(5) in subsection (d)—
(A) in the matter preceding paragraph (1), by striking
‘‘An institution of higher education desiring a grant under
this section’’ and inserting ‘‘To be eligible to receive a
grant under this section, an institution of higher education’’;
(B) by striking paragraph (1) and inserting—
‘‘(1) A description of the population to be targeted by the
program carried out under the grant, including veterans whenever possible and appropriate, and of identified mental and
substance use disorder needs of students at the institution
of higher education.’’;
(C) in paragraph (2), by inserting ‘‘, which may include,
as appropriate and in accordance with subsection (b)(7),
a plan to seek input from relevant stakeholders in the
community, including appropriate public and private entities, in order to carry out the program under the grant’’
before the period at the end; and
(D) by adding after paragraph (5) the following new
paragraphs:
‘‘(6) An outline of the objectives of the program carried
out under the grant.
‘‘(7) For an institution of higher education proposing to
use the grant for an activity described in paragraph (8) or
(9) of subsection (b), a description of the policies and procedures
of the institution of higher education that are related to
applicable laws regarding access to, and sharing of, treatment
records of students at any campus-based mental health center
or partner organization, including the policies and State laws
governing when such records can be accessed and shared for
non-treatment purposes and a description of the process used
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by the institution of higher education to notify students of
these policies and procedures, including the extent to which
written consent is required.
‘‘(8) An assurance that grant funds will be used to supplement and not supplant any other Federal, State, or local funds
available to carry out activities of the type carried out under
the grant.’’;
(6) in subsection (e)(1), by striking ‘‘and behavioral health
problems’’ and inserting ‘‘health and substance use disorders’’;
(7) in subsection (f)(2)—
(A) by striking ‘‘and behavioral health’’ and inserting
‘‘health and substance use disorder’’; and
(B) by striking ‘‘suicide and substance abuse’’ and
inserting ‘‘suicide and substance use disorders’’;
(8) by redesignating subsection (h) as subsection (i);
(9) by inserting after subsection (g) the following new subsection:
‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to grantees in carrying out this section.’’; and
(10) in subsection (i), as redesignated by paragraph (8),
by striking ‘‘$5,000,000 for fiscal year 2005’’ and all that follows
through the period at the end and inserting ‘‘$7,000,000 for
each of fiscal years 2018 through 2022.’’.
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SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE MENTAL
HEALTH.
42 USC
290bb–36b note.
(a) PURPOSE.—It is the purpose of this section to provide for
the establishment of a College Campus Task Force to discuss mental
and behavioral health concerns on campuses of institutions of higher
education.
(b) ESTABLISHMENT.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’) shall establish a College Campus Task Force (referred to in this section as
the ‘‘Task Force’’) to discuss mental and behavioral health concerns
on campuses of institutions of higher education.
(c) MEMBERSHIP.—The Task Force shall be composed of a representative from each Federal agency (as appointed by the head
of the agency) that has jurisdiction over, or is affected by, mental
health and education policies and projects, including—
(1) the Department of Education;
(2) the Department of Health and Human Services;
(3) the Department of Veterans Affairs; and
(4) such other Federal agencies as the Assistant Secretary
for Mental Health and Substance Use, in consultation with
the Secretary, determines to be appropriate.
(d) DUTIES.—The Task Force shall—
(1) serve as a centralized mechanism to coordinate a
national effort to—
(A) discuss and evaluate evidence and knowledge on
mental and behavioral health services available to, and
the prevalence of mental illness among, the age population
of students attending institutions of higher education in
the United States;
(B) determine the range of effective, feasible, and comprehensive actions to improve mental and behavioral health
on campuses of institutions of higher education;
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(C) examine and better address the needs of the age
population of students attending institutions of higher education dealing with mental illness;
(D) survey Federal agencies to determine which policies
are effective in encouraging, and how best to facilitate
outreach without duplicating, efforts relating to mental
and behavioral health promotion;
(E) establish specific goals within and across Federal
agencies for mental health promotion, including determinations of accountability for reaching those goals;
(F) develop a strategy for allocating responsibilities
and ensuring participation in mental and behavioral health
promotion, particularly in the case of competing agency
priorities;
(G) coordinate plans to communicate research results
relating to mental and behavioral health amongst the age
population of students attending institutions of higher education to enable reporting and outreach activities to produce
more useful and timely information;
(H) provide a description of evidence-based practices,
model programs, effective guidelines, and other strategies
for promoting mental and behavioral health on campuses
of institutions of higher education;
(I) make recommendations to improve Federal efforts
relating to mental and behavioral health promotion on
campuses of institutions of higher education and to ensure
Federal efforts are consistent with available standards,
evidence, and other programs in existence as of the date
of enactment of this Act;
(J) monitor Federal progress in meeting specific mental
and behavioral health promotion goals as they relate to
settings of institutions of higher education; and
(K) examine and disseminate best practices related
to intracampus sharing of treatment records;
(2) consult with national organizations with expertise in
mental and behavioral health, especially those organizations
working with the age population of students attending institutions of higher education; and
(3) consult with and seek input from mental health professionals working on campuses of institutions of higher education
as appropriate.
(e) MEETINGS.—
(1) IN GENERAL.—The Task Force shall meet not fewer
than three times each year.
(2) ANNUAL CONFERENCE.—The Secretary shall sponsor an
annual conference on mental and behavioral health in settings
of institutions of higher education to enhance coordination,
build partnerships, and share best practices in mental and
behavioral health promotion, data collection, analysis, and services.
(f) DEFINITION.—In this section, the term ‘‘institution of higher
education’’ has the meaning given such term in section 101 of
the Higher Education Act of 1965 (20 U.S.C. 1001).
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $1,000,000 for the
period of fiscal years 2018 through 2022.
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SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAMPUSES.
42 USC 290ee–4.
Part D of title V of the Public Health Service Act (42 U.S.C.
290dd et seq.) is amended by adding at the end the following:
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‘‘SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON COLLEGE CAMPUSES.
‘‘(a) PURPOSE.—It is the purpose of this section to increase
access to, and reduce the stigma associated with, mental health
services to ensure that students at institutions of higher education
have the support necessary to successfully complete their studies.
‘‘(b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary,
acting through the Assistant Secretary and in collaboration with
the Director of the Centers for Disease Control and Prevention,
shall convene an interagency, public-private sector working group
to plan, establish, and begin coordinating and evaluating a targeted
public education campaign that is designed to focus on mental
and behavioral health on the campuses of institutions of higher
education. Such campaign shall be designed to—
‘‘(1) improve the general understanding of mental health
and mental disorders;
‘‘(2) encourage help-seeking behaviors relating to the promotion of mental health, prevention of mental disorders, and
treatment of such disorders;
‘‘(3) make the connection between mental and behavioral
health and academic success; and
‘‘(4) assist the general public in identifying the early
warning signs and reducing the stigma of mental illness.
‘‘(c) COMPOSITION.—The working group convened under subsection (b) shall include—
‘‘(1) mental health consumers, including students and
family members;
‘‘(2) representatives of institutions of higher education;
‘‘(3) representatives of national mental and behavioral
health associations and associations of institutions of higher
education;
‘‘(4) representatives of health promotion and prevention
organizations at institutions of higher education;
‘‘(5) representatives of mental health providers, including
community mental health centers; and
‘‘(6) representatives of private-sector and public-sector
groups with experience in the development of effective public
health education campaigns.
‘‘(d) PLAN.—The working group under subsection (b) shall
develop a plan that—
‘‘(1) targets promotional and educational efforts to the age
population of students at institutions of higher education and
individuals who are employed in settings of institutions of
higher education, including through the use of roundtables;
‘‘(2) develops and proposes the implementation of researchbased public health messages and activities;
‘‘(3) provides support for local efforts to reduce stigma
by using the National Health Information Center as a primary
point of contact for information, publications, and service program referrals; and
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‘‘(4) develops and proposes the implementation of a social
marketing campaign that is targeted at the population of students attending institutions of higher education and individuals
who are employed in settings of institutions of higher education.
‘‘(e) DEFINITION.—In this section, the term ‘institution of higher
education’ has the meaning given such term in section 101 of
the Higher Education Act of 1965 (20 U.S.C. 1001).
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $1,000,000 for the
period of fiscal years 2018 through 2022.’’.
TITLE X—STRENGTHENING MENTAL
AND SUBSTANCE USE DISORDER
CARE FOR CHILDREN AND ADOLESCENTS
SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL
DISTURBANCE.
(a) COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR
CHILDREN WITH A SERIOUS EMOTIONAL DISTURBANCE.—Section
561(a)(1) of the Public Health Service Act (42 U.S.C. 290ff(a)(1))
is amended by inserting ‘‘, which may include efforts to identify
and serve children at risk’’ before the period.
(b) REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE
OF GRANTS.—Section 562(b) of the Public Health Service Act (42
U.S.C. 290ff–1(b)) is amended by striking ‘‘will not provide an
individual with access to the system if the individual is more
than 21 years of age’’ and inserting ‘‘will provide an individual
with access to the system through the age of 21 years’’.
(c) ADDITIONAL PROVISIONS.—Section 564(f) of the Public Health
Service Act (42 U.S.C. 290ff–3(f)) is amended by inserting ‘‘(and
provide a copy to the State involved)’’ after ‘‘to the Secretary’’.
(d) GENERAL PROVISIONS.—Section 565 of the Public Health
Service Act (42 U.S.C. 290ff–4) is amended—
(1) in subsection (b)(1)—
(A) in the matter preceding subparagraph (A), by
striking ‘‘receiving a grant under section 561(a)’’ and
inserting ‘‘, regardless of whether such public entity is
receiving a grant under section 561(a)’’; and
(B) in subparagraph (B), by striking ‘‘pursuant to’’
and inserting ‘‘described in’’;
(2) in subsection (d)(1), by striking ‘‘not more than 21
years of age’’ and inserting ‘‘through the age of 21 years’’;
and
(3) in subsection (f)(1), by striking ‘‘$100,000,000 for fiscal
year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003’’ and inserting ‘‘$119,026,000
for each of fiscal years 2018 through 2022’’.
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SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH
CARE.
Title III of the Public Health Service Act is amended by
inserting after section 330L of such Act (42 U.S.C. 254c–18) the
following new section:
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‘‘SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
42 USC 254c–19.
‘‘(a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Administration and
in coordination with other relevant Federal agencies, shall award
grants 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 a grant 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;
‘‘(G) provide information to pediatric providers about,
and assist pediatric providers in accessing, pediatric mental
health care providers, including child and adolescent
psychiatrists, and licensed mental health professionals,
such as psychologists, social workers, or mental health
counselors and in scheduling and conducting technical
assistance;
‘‘(H) 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 problems.
‘‘(2) 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
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mental health professional, such as a psychologist, social
worker, or mental health counselor. Such a team may be regionally based.
‘‘(c) APPLICATION.—A State, political subdivision of a State,
Indian tribe, or tribal organization seeking 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 require, including a plan for the comprehensive evaluation
of activities that are carried out with funds received under such
grant.
‘‘(d) EVALUATION.—A State, political subdivision of a State,
Indian tribe, or tribal organization that receives a grant under
this section shall prepare and submit an evaluation of activities
that are carried out with funds received under such grant 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 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 providers.
‘‘(f) MATCHING REQUIREMENT.—The Secretary may not award
a grant 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 grant.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this
section, there are authorized to be appropriated, $9,000,000 for
the period of fiscal years 2018 through 2022.’’.
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SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY
INTERVENTION SERVICES FOR CHILDREN AND ADOLESCENTS.
The first section 514 of the Public Health Service Act (42
U.S.C. 290bb–7), relating to substance abuse treatment services
for children and adolescents, is amended—
(1) in the section heading, by striking ‘‘ABUSE TREATMENT’’
and inserting ‘‘USE DISORDER TREATMENT AND EARLY INTERVENTION’’;
(2) by striking subsection (a) and inserting the following:
‘‘(a) IN GENERAL.—The Secretary shall award grants, contracts,
or cooperative agreements to public and private nonprofit entities,
including Indian tribes or tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination and Education
Assistance Act), or health facilities or programs operated by or
in accordance with a contract or grant with the Indian Health
Service, for the purpose of—
‘‘(1) providing early identification and services to meet the
needs of children and adolescents who are at risk of substance
use disorders;
‘‘(2) providing substance use disorder treatment services
for children, including children and adolescents with co-occurring mental illness and substance use disorders; and
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‘‘(3) providing assistance to pregnant women, and parenting
women, with substance use disorders, in obtaining treatment
services, linking mothers to community resources to support
independent family lives, and staying in recovery so that children are in safe, stable home environments and receive appropriate health care services.’’;
(3) in subsection (b)—
(A) by striking paragraph (1) and inserting the following:
‘‘(1) apply evidence-based and cost-effective methods;’’;
(B) in paragraph (2)—
(i) by striking ‘‘treatment’’; and
(ii) by inserting ‘‘substance abuse,’’ after ‘‘child welfare,’’;
(C) in paragraph (3), by striking ‘‘substance abuse disorders’’ and inserting ‘‘substance use disorders, including
children and adolescents with co-occurring mental illness
and substance use disorders,’’;
(D) in paragraph (5), by striking ‘‘treatment;’’ and
inserting ‘‘services; and’’;
(E) in paragraph (6), by striking ‘‘substance abuse
treatment; and’’ and inserting ‘‘treatment.’’; and
(F) by striking paragraph (7); and
(4) in subsection (f), by striking ‘‘$40,000,000’’ and all that
follows through the period and inserting ‘‘$29,605,000 for each
of fiscal years 2018 through 2022.’’.
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SEC. 10004. CHILDREN’S RECOVERY FROM TRAUMA.
The first section 582 of the Public Health Service Act (42
U.S.C. 290hh–1; relating to grants to address the problems of
persons who experience violence related stress) is amended—
(1) in subsection (a), by striking ‘‘developing programs’’
and all that follows through the period at the end and inserting
the following: ‘‘developing and maintaining programs that provide for—
‘‘(1) the continued operation of the National Child Traumatic Stress Initiative (referred to in this section as the
‘NCTSI’), which includes a cooperative agreement with a coordinating center, that focuses on the mental, behavioral, and
biological aspects of psychological trauma response, prevention
of the long-term consequences of child trauma, and early intervention services and treatment to address the long-term consequences of child trauma; and
‘‘(2) the development of knowledge with regard to evidencebased practices for identifying and treating mental, behavioral,
and biological disorders of children and youth resulting from
witnessing or experiencing a traumatic event.’’;
(2) in subsection (b)—
(A) by striking ‘‘subsection (a) related’’ and inserting
‘‘subsection (a)(2) (related’’;
(B) by striking ‘‘treating disorders associated with
psychological trauma’’ and inserting ‘‘treating mental,
behavioral, and biological disorders associated with psychological trauma)’’; and
(C) by striking ‘‘mental health agencies and programs
that have established clinical and basic research’’ and
inserting ‘‘universities, hospitals, mental health agencies,
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and other programs that have established clinical expertise
and research’’;
(3) by redesignating subsections (c) through (g) as subsections (g) through (k), respectively;
(4) by inserting after subsection (b), the following:
‘‘(c) CHILD OUTCOME DATA.—The NCTSI coordinating center
described in subsection (a)(1) shall collect, analyze, report, and
make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding the early identification
and delivery of evidence-based treatment and services for children
and families served by the NCTSI grantees.
‘‘(d) TRAINING.—The NCTSI coordinating center shall facilitate
the coordination of training initiatives in evidence-based and
trauma-informed treatments, interventions, and practices offered
to NCTSI grantees, providers, and partners.
‘‘(e) DISSEMINATION AND COLLABORATION.—The NCTSI coordinating center shall, as appropriate, collaborate with—
‘‘(1) the Secretary, in the dissemination of evidence-based
and trauma-informed interventions, treatments, products, and
other resources to appropriate stakeholders; and
‘‘(2) appropriate agencies that conduct or fund research
within the Department of Health and Human Services, for
purposes of sharing NCTSI expertise, evaluation data, and
other activities, as appropriate.
‘‘(f) REVIEW.—The Secretary shall, consistent with the peerreview process, ensure that NCTSI applications are reviewed by
appropriate experts in the field as part of a consensus-review
process. The Secretary shall include review criteria related to expertise and experience in child trauma and evidence-based practices.’’;
(5) in subsection (g) (as so redesignated), by striking ‘‘with
respect to centers of excellence are distributed equitably among
the regions of the country’’ and inserting ‘‘are distributed equitably among the regions of the United States’’;
(6) in subsection (i) (as so redesignated), by striking
‘‘recipient may not exceed 5 years’’ and inserting ‘‘recipient
shall not be less than 4 years, but shall not exceed 5 years’’;
and
(7) in subsection (j) (as so redesignated), by striking
‘‘$50,000,000’’ and all that follows through ‘‘2006’’ and inserting
‘‘$46,887,000 for each of fiscal years 2018 through 2022’’.
SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
Part B of title III of the Public Health Service Act (42 U.S.C.
243 et seq.) is amended by inserting after section 317L (42 U.S.C.
247b–13) the following:
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42 USC
247b–13a.
‘‘SEC. 317L–1. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
‘‘(a) GRANTS.—The Secretary shall make grants to States to
establish, improve, or maintain programs for screening, assessment,
and treatment services, including culturally and linguistically
appropriate services, as appropriate, for women who are pregnant,
or who have given birth within the preceding 12 months, for
maternal depression.
‘‘(b) APPLICATION.—To seek a grant under this section, a State
shall submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
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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 depression in 1 or more communities; and
‘‘(2) how a program, or programs, if expanded, would
increase access to screening and treatment services for
maternal depression.
‘‘(c) PRIORITY.—In awarding grants under this section, the Secretary may give priority to States proposing to improve or enhance
access to screening services for maternal depression in primary
care settings.
‘‘(d) USE OF FUNDS.—The activities eligible for funding through
a grant under subsection (a)—
‘‘(1) shall include—
‘‘(A) providing appropriate training to health care providers; and
‘‘(B) providing information to health care providers,
including information on maternal depression screening,
treatment, and followup support services, and linkages to
community-based resources; and
‘‘(2) may include—
‘‘(A) enabling health care providers (including obstetrician-gynecologists, pediatricians, psychiatrists, mental
health care providers, and adult primary care clinicians)
to provide or receive real-time psychiatric consultation (inperson or remotely) to aid in the treatment of pregnant
and parenting women;
‘‘(B) establishing linkages with and among communitybased resources, including mental health resources, primary care resources, and support groups; and
‘‘(C) utilizing telehealth services for rural areas and
medically underserved areas (as defined in section 330I(a)).
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $5,000,000 for each
of fiscal years 2018 through 2022.’’.
SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
Part Q of title III of the Public Health Service Act (42 U.S.C.
280h et seq.) is amended by adding at the end the following:
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‘‘SEC. 399Z–2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
42 USC 280h–6.
‘‘(a) GRANTS.—The Secretary shall—
‘‘(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
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PUBLIC LAW 114–255—DEC. 13, 2016
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.
‘‘(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
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130 STAT. 1269
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) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $20,000,000 for the
period of fiscal years 2018 through 2022.’’.
TITLE XI—COMPASSIONATE
COMMUNICATION ON HIPAA
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SEC. 11001. SENSE OF CONGRESS.
(a) FINDINGS.—Congress finds the following:
(1) According to the National Survey on Drug Use and
Health, in 2015, there were approximately 9,800,000 adults
in the United States with serious mental illness.
(2) The Substance Abuse and Mental Health Services
Administration defines the term ‘‘serious mental illness’’ as
an illness affecting individuals 18 years of age or older as
having, at any time in the past year, a diagnosable mental,
behavioral, or emotional disorder that results in serious functional impairment and substantially interferes with or limits
one or more major life activities.
(3) In reporting on the incidence of serious mental illness,
the Substance Abuse and Mental Health Services Administration includes major depression, schizophrenia, bipolar disorder,
and other mental disorders that cause serious impairment.
(4) Adults with a serious mental illness are at a higher
risk for chronic physical illnesses and premature death.
(5) According to the World Health Organization, adults
with a serious mental illness have lifespans that are 10 to
25 years shorter than those without serious mental illness.
The vast majority of these deaths are due to chronic physical
medical conditions, such as cardiovascular, respiratory, and
infectious diseases, as well as diabetes and hypertension.
(6) According to the World Health Organization, the
majority of deaths of adults with a serious mental illness that
are due to physical medical conditions are preventable.
(7) Supported decision making can facilitate care decisions
in areas where serious mental illness may impact the capacity
of an individual to determine a course of treatment while
still allowing the individual to make decisions independently.
(8) Help should be provided to adults with a serious mental
illness to address their acute or chronic physical illnesses,
make informed choices about treatment, and understand and
follow through with appropriate treatment.
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(9) There is confusion in the health care community
regarding permissible practices under the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (commonly known as ‘‘HIPAA’’). This confusion may hinder appropriate communication of health care
information or treatment preferences with appropriate caregivers.
(b) SENSE OF CONGRESS.—It is the sense of Congress that
clarification is needed regarding the privacy rule promulgated under
section 264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d–2 note) regarding existing permitted
uses and disclosures of health information by health care professionals to communicate with caregivers of adults with a serious
mental illness to facilitate treatment.
SEC. 11002. CONFIDENTIALITY OF RECORDS.
Not later than 1 year after the date on which the Secretary
of Health and Human Services (in this title referred to as the
‘‘Secretary’’) first finalizes regulations updating part 2 of title 42,
Code of Federal Regulations, relating to confidentiality of alcohol
and drug abuse patient records, after the date of enactment of
this Act, the Secretary shall convene relevant stakeholders to determine the effect of such regulations on patient care, health outcomes,
and patient privacy.
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42 USC 1320d–2
note.
SEC. 11003. CLARIFICATION ON PERMITTED USES AND DISCLOSURES
OF PROTECTED HEALTH INFORMATION.
(a) IN GENERAL.—The Secretary, acting through the Director
of the Office for Civil Rights, shall ensure that health care providers,
professionals, patients and their families, and others involved in
mental or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate
uses and disclosures of protected health information under the
regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–
2 note).
(b) GUIDANCE.—
(1) ISSUANCE.—In carrying out subsection (a), not later
than 1 year after the date of enactment of this section, the
Secretary shall issue guidance clarifying the circumstances
under which, consistent with regulations promulgated under
section 264(c) of the Health Insurance Portability and Accountability Act of 1996, a health care provider or covered entity
may use or disclose protected health information.
(2) CIRCUMSTANCES ADDRESSED.—The guidance issued
under this section shall address circumstances including those
that—
(A) require the consent of the patient;
(B) require providing the patient with an opportunity
to object;
(C) are based on the exercise of professional judgment
regarding whether the patient would object when the opportunity to object cannot practicably be provided because
of the incapacity of the patient or an emergency treatment
circumstance; and
(D) are determined, based on the exercise of professional judgment, to be in the best interest of the patient
when the patient is not present or otherwise incapacitated.
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(3) COMMUNICATION WITH FAMILY MEMBERS AND CAREGIVERS.—In addressing the circumstances described in paragraph (2), the guidance issued under this section shall clarify
permitted uses or disclosures of protected health information
for purposes of—
(A) communicating with a family member of the
patient, caregiver of the patient, or other individual, to
the extent that such family member, caregiver, or individual is involved in the care of the patient;
(B) in the case that the patient is an adult, communicating with a family member of the patient, caregiver
of the patient, or other individual involved in the care
of the patient;
(C) in the case that the patient is a minor, communicating with the parent or caregiver of the patient;
(D) involving the family members or caregivers of the
patient, or others involved in the patient’s care or care
plan, including facilitating treatment and medication
adherence;
(E) listening to the patient, or receiving information
with respect to the patient from the family or caregiver
of the patient;
(F) communicating with family members of the patient,
caregivers of the patient, law enforcement, or others when
the patient presents a serious and imminent threat of
harm to self or others; and
(G) communicating to law enforcement and family
members or caregivers of the patient about the admission
of the patient to receive care at, or the release of a patient
from, a facility for an emergency psychiatric hold or involuntary treatment.
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SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING
PROGRAMS.
42 USC 1320d–2
note.
(a) INITIAL PROGRAMS AND MATERIALS.—Not later than 1 year
after the date of the enactment of this Act, the Secretary, in
consultation with appropriate experts, shall identify the following
model programs and materials, or (in the case that no such programs or materials exist) recognize private or public entities to
develop and disseminate each of the following:
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, including child and adolescent psychiatrists,
psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care
managers, and hospitals, including individuals such as general
counsels or regulatory compliance staff who are responsible
for establishing provider privacy policies) regarding the permitted uses and disclosures, consistent with the standards governing the privacy and security of individually identifiable
health information promulgated by the Secretary under part
C of title XI of the Social Security Act (42 U.S.C. 1320d et
seq.) and regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996
(42 U.S.C. 1320d–2 note) and such part C, of the protected
health information of patients seeking or undergoing mental
or substance use disorder treatment.
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(2) A model program and materials for training patients
and their families regarding their rights to protect and obtain
information under the standards and regulations specified in
paragraph (1).
(b) PERIODIC UPDATES.—The Secretary shall—
(1) periodically review and update the model programs
and materials identified or developed under subsection (a);
and
(2) disseminate the updated model programs and materials
to the individuals described in subsection (a).
(c) COORDINATION.—The Secretary shall carry out this section
in coordination with the Director of the Office for Civil Rights
within the Department of Health and Human Services, the Assistant Secretary for Mental Health and Substance Use, the Administrator of the Health Resources and Services Administration, and
the heads of other relevant agencies within the Department of
Health and Human Services.
(d) INPUT OF CERTAIN ENTITIES.—In identifying, reviewing, or
updating the model programs and materials under subsections (a)
and (b), the Secretary shall solicit the input of relevant national,
State, and local associations; medical societies; licensing boards;
providers of mental and substance use disorder treatment; organizations with expertise on domestic violence, sexual assault, elder
abuse, and child abuse; and organizations representing patients
and consumers and the families of patients and consumers.
(e) FUNDING.—There are authorized to be appropriated to carry
out this section—
(1) $4,000,000 for fiscal year 2018;
(2) $2,000,000 for each of fiscal years 2019 and 2020; and
(3) $1,000,000 for each of fiscal years 2021 and 2022.
TITLE XII—MEDICAID MENTAL HEALTH
COVERAGE
42 USC 1396
note.
SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COVERAGE OF MENTAL HEALTH SERVICES AND PRIMARY
CARE SERVICES FURNISHED ON THE SAME DAY.
Nothing in title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) shall be construed as prohibiting separate payment
under the State plan under such title (or under a waiver of the
plan) for the provision of a mental health service or primary care
service under such plan, with respect to an individual, because
such service is—
(1) a primary care service furnished to the individual by
a provider at a facility on the same day a mental health
service is furnished to such individual by such provider (or
another provider) at the facility; or
(2) a mental health service furnished to the individual
by a provider at a facility on the same day a primary care
service is furnished to such individual by such provider (or
another provider) at the facility.
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SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED
CARE REGULATION.
(a) STUDY.—The Secretary of Health and Human Services,
acting through the Administrator of the Centers for Medicare &
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130 STAT. 1273
Medicaid Services, shall conduct a study on coverage under the
Medicaid program under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.) of services provided through a medicaid managed care organization (as defined in section 1903(m) of such Act
(42 U.S.C. 1396b(m)) or a prepaid inpatient health plan (as defined
in section 438.2 of title 42, Code of Federal Regulations (or any
successor regulation)) with respect to individuals over the age of
21 and under the age of 65 for the treatment of a mental health
disorder in institutions for mental diseases (as defined in section
1905(i) of such Act (42 U.S.C. 1396d(i))). Such study shall include
information on the following:
(1) The extent to which States, including the District of
Columbia and each territory or possession of the United States,
are providing capitated payments to such organizations or plans
for enrollees who are receiving services in institutions for
mental diseases.
(2) The number of individuals receiving medical assistance
under a State plan under such title XIX, or a waiver of such
plan, who receive services in institutions for mental diseases
through such organizations and plans.
(3) The range of and average number of months, and the
length of stay during such months, that such individuals are
receiving such services in such institutions.
(4) How such organizations or plans determine when to
provide for the furnishing of such services through an institution for mental diseases in lieu of other benefits (including
the full range of community-based services) under their contract
with the State agency administering the State plan under such
title XIX, or a waiver of such plan, to address psychiatric
or substance use disorder treatment.
(5) The extent to which the provision of services within
such institutions has affected the capitated payments for such
organizations or plans.
(b) REPORT.—Not later than 3 years after the date of the
enactment of this Act, the Secretary shall submit to Congress
a report on the study conducted under subsection (a).
SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVATION.
Not later than 1 year after the date of the enactment of this
Act, the Administrator of the Centers for Medicare & Medicaid
Services shall issue a State Medicaid Director letter regarding
opportunities to design innovative service delivery systems,
including systems for providing community-based services, for
adults with a serious mental illness or children with a serious
emotional disturbance who are receiving medical assistance under
title XIX of the Social Security Act (42 U.S.C. 1396 et seq.). The
letter shall include opportunities for demonstration projects under
section 1115 of such Act (42 U.S.C. 1315) to improve care for
such adults and children.
42 USC 1315
note.
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SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC DEMONSTRATION PROJECT.
(a) COLLECTION OF INFORMATION.—The Secretary of Health
and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall, to the extent practical
and data is available, with respect to each State that has participated in the demonstration project established under section 2707
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130 STAT. 1274
PUBLIC LAW 114–255—DEC. 13, 2016
of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a
note), collect from each such State information on the following:
(1) The number of institutions for mental diseases (as
defined in section 1905(i) of the Social Security Act (42 U.S.C.
1396d(i))) and beds in such institutions that received payment
for the provision of services to individuals who receive medical
assistance under a State plan under the Medicaid program
under title XIX of the Social Security Act (42 U.S.C. 1396
et seq.) (or under a waiver of such plan) through the demonstration project in each such State as compared to the total number
of institutions for mental diseases and beds in the State.
(2) The extent to which there is a reduction in expenditures
under the Medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) or other spending on
the full continuum of physical or mental health care for individuals who receive treatment in an institution for mental diseases
under the demonstration project, including outpatient,
inpatient, emergency, and ambulatory care, that is attributable
to such individuals receiving treatment in institutions for
mental diseases under the demonstration project.
(3) The number of forensic psychiatric hospitals, the
number of beds in such hospitals, and the number of forensic
psychiatric beds in other hospitals in such State, based on
the most recent data available, to the extent practical, as determined by such Administrator.
(4) The amount of any disproportionate share hospital payments under section 1923 of the Social Security Act (42 U.S.C.
1396r–4) that institutions for mental diseases in the State
received during the period beginning on July 1, 2012, and
ending on June 30, 2015, and the extent to which the demonstration project reduced the amount of such payments.
(5) The most recent data regarding all facilities or sites
in the State in which any adults with a serious mental illness
who are receiving medical assistance under a State plan under
the Medicaid program under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) (or under a waiver of such plan)
are treated during the period referred to in paragraph (4),
to the extent practical, as determined by the Administrator,
including—
(A) the types of such facilities or sites (such as an
institution for mental diseases, a hospital emergency
department, or other inpatient hospital);
(B) the average length of stay in such a facility or
site by such an individual, disaggregated by facility type;
and
(C) the payment rate under the State plan (or a waivers
of such plan) for services furnished to such an individual
for that treatment, disaggregated by facility type, during
the period in which the demonstration project is in operation.
(6) The extent to which the utilization of hospital emergency departments during the period in which the demonstration project was is in operation differed, with respect to individuals who are receiving medical assistance under a State plan
under the Medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) (or under a waiver of
such plan), between—
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130 STAT. 1275
(A) those individuals who received treatment in an
institution for mental diseases under the demonstration
project;
(B) those individuals who met the eligibility requirements for the demonstration project but who did not receive
treatment in an institution for mental diseases under the
demonstration project; and
(C) those adults with a serious mental illness who
did not meet such eligibility requirements and did not
receive treatment for such illness in an institution for
mental diseases.
(b) REPORT.—Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services
shall submit to Congress a report that summarizes and analyzes
the information collected under subsection (a). Such report may
be submitted as part of the report required under section 2707(f)
of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a
note) or separately.
SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS.
(a) IN GENERAL.—Section 1905(a)(16) of the Social Security
Act (42 U.S.C. 1396d(a)(16)) is amended—
(1) by striking ‘‘effective January 1, 1973’’ and inserting
‘‘(A) effective January 1, 1973’’; and
(2) by inserting before the semicolon at the end the following: ‘‘, and, (B) for individuals receiving services described
in subparagraph (A), early and periodic screening, diagnostic,
and treatment services (as defined in subsection (r)), whether
or not such screening, diagnostic, and treatment services are
furnished by the provider of the services described in such
subparagraph’’.
(b) EFFECTIVE DATE.—The amendments made by subsection
(a) shall apply with respect to items and services furnished in
calendar quarters beginning on or after January 1, 2019.
42 USC 1396d
note.
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SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR
PERSONAL CARE SERVICES AND HOME HEALTH CARE
SERVICES UNDER MEDICAID.
(a) IN GENERAL.—Section 1903 of the Social Security Act (42
U.S.C. 1396b) is amended by inserting after subsection (k) the
following new subsection:
‘‘(l)(1) Subject to paragraphs (3) and (4), with respect to any
amount expended for personal care services or home health care
services requiring an in-home visit by a provider that are provided
under a State plan under this title (or under a waiver of the
plan) and furnished in a calendar quarter beginning on or after
January 1, 2019 (or, in the case of home health care services,
on or after January 1, 2023), unless a State requires the use
of an electronic visit verification system for such services furnished
in such quarter under the plan or such waiver, the Federal medical
assistance percentage shall be reduced—
‘‘(A) in the case of personal care services—
‘‘(i) for calendar quarters in 2019 and 2020, by .25
percentage points;
‘‘(ii) for calendar quarters in 2021, by .5 percentage
points;
‘‘(iii) for calendar quarters in 2022, by .75 percentage
points; and
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(iv) for calendar quarters in 2023 and each year thereafter, by 1 percentage point; and
‘‘(B) in the case of home health care services—
‘‘(i) for calendar quarters in 2023 and 2024, by .25
percentage points;
‘‘(ii) for calendar quarters in 2025, by .5 percentage
points;
‘‘(iii) for calendar quarters in 2026, by .75 percentage
points; and
‘‘(iv) for calendar quarters in 2027 and each year thereafter, by 1 percentage point.
‘‘(2) Subject to paragraphs (3) and (4), in implementing the
requirement for the use of an electronic visit verification system
under paragraph (1), a State shall—
‘‘(A) consult with agencies and entities that provide personal care services, home health care services, or both under
the State plan (or under a waiver of the plan) to ensure that
such system—
‘‘(i) is minimally burdensome;
‘‘(ii) takes into account existing best practices and electronic visit verification systems in use in the State; and
‘‘(iii) is conducted in accordance with the requirements
of HIPAA privacy and security law (as defined in section
3009 of the Public Health Service Act);
‘‘(B) take into account a stakeholder process that includes
input from beneficiaries, family caregivers, individuals who furnish personal care services or home health care services, and
other stakeholders, as determined by the State in accordance
with guidance from the Secretary; and
‘‘(C) ensure that individuals who furnish personal care
services, home health care services, or both under the State
plan (or under a waiver of the plan) are provided the opportunity for training on the use of such system.
‘‘(3) Paragraphs (1) and (2) shall not apply in the case of
a State that, as of the date of the enactment of this subsection,
requires the use of any system for the electronic verification of
visits conducted as part of both personal care services and home
health care services, so long as the State continues to require
the use of such system with respect to the electronic verification
of such visits.
‘‘(4)(A) In the case of a State described in subparagraph (B),
the reduction under paragraph (1) shall not apply—
‘‘(i) in the case of personal care services, for calendar quarters in 2019; and
‘‘(ii) in the case of home health care services, for calendar
quarters in 2023.
‘‘(B) For purposes of subparagraph (A), a State described in
this subparagraph is a State that demonstrates to the Secretary
that the State—
‘‘(i) has made a good faith effort to comply with the requirements of paragraphs (1) and (2) (including by taking steps
to adopt the technology used for an electronic visit verification
system); and
‘‘(ii) in implementing such a system, has encountered
unavoidable system delays.
‘‘(5) In this subsection:
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130 STAT. 1277
‘‘(A) The term ‘electronic visit verification system’ means,
with respect to personal care services or home health care
services, a system under which visits conducted as part of
such services are electronically verified with respect to—
‘‘(i) the type of service performed;
‘‘(ii) the individual receiving the service;
‘‘(iii) the date of the service;
‘‘(iv) the location of service delivery;
‘‘(v) the individual providing the service; and
‘‘(vi) the time the service begins and ends.
‘‘(B) The term ‘home health care services’ means services
described in section 1905(a)(7) provided under a State plan
under this title (or under a waiver of the plan).
‘‘(C) The term ‘personal care services’ means personal care
services provided under a State plan under this title (or under
a waiver of the plan), including services provided under section
1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a
wavier under section 1115.
‘‘(6)(A) In the case in which a State requires personal care
service and home health care service providers to utilize an electronic visit verification system operated by the State or a contractor
on behalf of the State, the Secretary shall pay to the State, for
each quarter, an amount equal to 90 per centum of so much of
the sums expended during such quarter as are attributable to
the design, development, or installation of such system, and 75
per centum of so much of the sums for the operation and maintenance of such system.
‘‘(B) Subparagraph (A) shall not apply in the case in which
a State requires personal care service and home health care service
providers to utilize an electronic visit verification system that is
not operated by the State or a contractor on behalf of the State.’’.
(b) COLLECTION AND DISSEMINATION OF BEST PRACTICES.—Not
later than January 1, 2018, the Secretary of Health and Human
Services shall, with respect to electronic visit verification systems
(as defined in subsection (l)(5) of section 1903 of the Social Security
Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect and
disseminate best practices to State Medicaid Directors with respect
to—
(1) training individuals who furnish personal care services,
home health care services, or both under the State plan under
title XIX of such Act (or under a waiver of the plan) on such
systems and the operation of such systems and the prevention
of fraud with respect to the provision of personal care services
or home health care services (as defined in such subsection
(l)(5)); and
(2) the provision of notice and educational materials to
family caregivers and beneficiaries with respect to the use
of such electronic visit verification systems and other means
to prevent such fraud.
(c) RULES OF CONSTRUCTION.—
(1) NO EMPLOYER-EMPLOYEE RELATIONSHIP ESTABLISHED.—
Nothing in the amendment made by this section may be construed as establishing an employer-employee relationship
between the agency or entity that provides for personal care
services or home health care services and the individuals who,
under a contract with such an agency or entity, furnish such
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note.
42 USC 1396b
note.
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PUBLIC LAW 114–255—DEC. 13, 2016
services for purposes of part 552 of title 29, Code of Federal
Regulations (or any successor regulations).
(2) NO PARTICULAR OR UNIFORM ELECTRONIC VISIT
VERIFICATION SYSTEM REQUIRED.—Nothing in the amendment
made by this section shall be construed to require the use
of a particular or uniform electronic visit verification system
(as defined in subsection (l)(5) of section 1903 of the Social
Security Act (42 U.S.C. 1396b), as inserted by subsection (a))
by all agencies or entities that provide personal care services
or home health care under a State plan under title XIX of
the Social Security Act (or under a waiver of the plan) (42
U.S.C. 1396 et seq.).
(3) NO LIMITS ON PROVISION OF CARE.—Nothing in the
amendment made by this section may be construed to limit,
with respect to personal care services or home health care
services provided under a State plan under title XIX of the
Social Security Act (or under a waiver of the plan) (42 U.S.C.
1396 et seq.), provider selection, constrain beneficiaries’ selection of a caregiver, or impede the manner in which care is
delivered.
(4) NO PROHIBITION ON STATE QUALITY MEASURES REQUIREMENTS.—Nothing in the amendment made by this section shall
be construed as prohibiting a State, in implementing an electronic visit verification system (as defined in subsection (l)(5)
of section 1903 of the Social Security Act (42 U.S.C. 1396b),
as inserted by subsection (a)), from establishing requirements
related to quality measures for such system.
TITLE XIII—MENTAL HEALTH PARITY
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SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE USE DISORDER COVERAGE REQUIREMENTS.
(a) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—Section
2726(a) of the Public Health Service Act (42 U.S.C. 300gg–26(a))
is amended by adding at the end the following:
‘‘(6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—
‘‘(A) IN GENERAL.—Not later than 12 months after the
date of enactment of the Helping Families in Mental Health
Crisis Reform Act of 2016, the Secretary, the Secretary
of Labor, and the Secretary of the Treasury, in consultation
with the Inspector General of the Department of Health
and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury, shall issue a compliance program
guidance document to help improve compliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, and section 9812 of the Internal
Revenue Code of 1986, as applicable. In carrying out this
paragraph, the Secretaries may take into consideration
the 2016 publication of the Department of Health and
Human Services and the Department of Labor, entitled
‘Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance’.
‘‘(B) EXAMPLES ILLUSTRATING COMPLIANCE AND NONCOMPLIANCE.—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1279
‘‘(i) IN GENERAL.—The compliance program guidance document required under this paragraph shall
provide illustrative, de-identified examples (that do not
disclose any protected health information or individually identifiable information) of previous findings of
compliance and noncompliance with this section, section 712 of the Employee Retirement Income Security
Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable, based on investigations
of violations of such sections, including—
‘‘(I) examples illustrating requirements for
information disclosures and nonquantitative treatment limitations; and
‘‘(II) descriptions of the violations uncovered
during the course of such investigations.
‘‘(ii) NONQUANTITATIVE TREATMENT LIMITATIONS.—
To the extent that any example described in clause
(i) involves a finding of compliance or noncompliance
with regard to any requirement for nonquantitative
treatment limitations, the example shall provide sufficient detail to fully explain such finding, including
a full description of the criteria involved for approving
medical and surgical benefits and the criteria involved
for approving mental health and substance use disorder benefits.
‘‘(iii) ACCESS TO ADDITIONAL INFORMATION
REGARDING COMPLIANCE.—In developing and issuing
the compliance program guidance document required
under this paragraph, the Secretaries specified in
subparagraph (A)—
‘‘(I) shall enter into interagency agreements
with the Inspector General of the Department of
Health and Human Services, the Inspector General
of the Department of Labor, and the Inspector
General of the Department of the Treasury to
share findings of compliance and noncompliance
with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section
9812 of the Internal Revenue Code of 1986, as
applicable; and
‘‘(II) shall seek to enter into an agreement
with a State to share information on findings of
compliance and noncompliance with this section,
section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable.
‘‘(C) RECOMMENDATIONS.—The compliance program
guidance document shall include recommendations to
advance compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as
applicable, and encourage the development and use of
internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal
controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance
use disorder benefits, which may fail to comply with this
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130 STAT. 1280
PUBLIC LAW 114–255—DEC. 13, 2016
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits.
‘‘(D) UPDATING THE COMPLIANCE PROGRAM GUIDANCE
DOCUMENT.—The Secretary, the Secretary of Labor, and
the Secretary of the Treasury, in consultation with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of Labor,
and the Inspector General of the Department of the
Treasury, shall update the compliance program guidance
document every 2 years to include illustrative, de-identified
examples (that do not disclose any protected health
information or individually identifiable information) of previous findings of compliance and noncompliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable.’’.
(b) ADDITIONAL GUIDANCE.—Section 2726(a) of the Public
Health Service Act (42 U.S.C. 300gg–26(a)), as amended by subsection (a), is further amended by adding at the end the following:
‘‘(7) ADDITIONAL GUIDANCE.—
‘‘(A) IN GENERAL.—Not later than 12 months after the
date of enactment of the Helping Families in Mental Health
Crisis Reform Act of 2016, the Secretary, the Secretary
of Labor, and the Secretary of the Treasury shall issue
guidance to group health plans and health insurance
issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the
requirements of this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section 9812
of the Internal Revenue Code of 1986, as applicable.
‘‘(B) DISCLOSURE.—
‘‘(i) GUIDANCE FOR PLANS AND ISSUERS.—The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods
that group health plans and health insurance issuers
offering group or individual health insurance coverage
may use for disclosing information to ensure compliance with the requirements under this section, section
712 of the Employee Retirement Income Security Act
of 1974, or section 9812 of the Internal Revenue Code
of 1986, as applicable, (and any regulations promulgated pursuant to such sections, as applicable).
‘‘(ii) DOCUMENTS FOR PARTICIPANTS, BENEFICIARIES,
CONTRACTING PROVIDERS, OR AUTHORIZED REPRESENTATIVES.—The guidance issued under this paragraph
shall include clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or individual
health insurance coverage may use to provide any
participant, beneficiary, contracting provider, or
authorized representative, as applicable, with documents containing information that the health plans
or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section,
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1281
section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, compliance with any
regulation issued pursuant to such respective section,
or compliance with any other applicable law or regulation. Such guidance shall include information that is
comparative in nature with respect to—
‘‘(I) nonquantitative treatment limitations for
both medical and surgical benefits and mental
health and substance use disorder benefits;
‘‘(II) the processes, strategies, evidentiary
standards, and other factors used to apply the
limitations described in subclause (I); and
‘‘(III) the application of the limitations
described in subclause (I) to ensure that such
limitations are applied in parity with respect to
both medical and surgical benefits and mental
health and substance use disorder benefits.
‘‘(C) NONQUANTITATIVE TREATMENT LIMITATIONS.—The
guidance issued under this paragraph shall include clarifying information and illustrative examples of methods,
processes, strategies, evidentiary standards, and other factors that group health plans and health insurance issuers
offering group or individual health insurance coverage may
use regarding the development and application of nonquantitative treatment limitations to ensure compliance
with this section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, (and any regulations
promulgated pursuant to such respective section),
including—
‘‘(i) examples of methods of determining appropriate types of nonquantitative treatment limitations
with respect to both medical and surgical benefits and
mental health and substance use disorder benefits,
including nonquantitative treatment limitations pertaining to—
‘‘(I) medical management standards based on
medical necessity or appropriateness, or whether
a treatment is experimental or investigative;
‘‘(II) limitations with respect to prescription
drug formulary design; and
‘‘(III) use of fail-first or step therapy protocols;
‘‘(ii) examples of methods of determining—
‘‘(I) network admission standards (such as
credentialing); and
‘‘(II) factors used in provider reimbursement
methodologies (such as service type, geographic
market, demand for services, and provider supply,
practice size, training, experience, and licensure)
as such factors apply to network adequacy;
‘‘(iii) examples of sources of information that may
serve as evidentiary standards for the purposes of
making determinations regarding the development and
application of nonquantitative treatment limitations;
‘‘(iv) examples of specific factors, and the evidentiary standards used to evaluate such factors, used
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130 STAT. 1282
PUBLIC LAW 114–255—DEC. 13, 2016
by such plans or issuers in performing a nonquantitative treatment limitation analysis;
‘‘(v) examples of how specific evidentiary standards
may be used to determine whether treatments are
considered experimental or investigative;
‘‘(vi) examples of how specific evidentiary standards may be applied to each service category or classification of benefits;
‘‘(vii) examples of methods of reaching appropriate
coverage determinations for new mental health or substance use disorder treatments, such as evidence-based
early intervention programs for individuals with a
serious mental illness and types of medical management techniques;
‘‘(viii) examples of methods of reaching appropriate
coverage determinations for which there is an indirect
relationship between the covered mental health or substance use disorder benefit and a traditional covered
medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or involuntary commitment; and
‘‘(ix) additional illustrative examples of methods,
processes, strategies, evidentiary standards, and other
factors for which the Secretary determines that additional guidance is necessary to improve compliance
with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812
of the Internal Revenue Code of 1986, as applicable.
‘‘(D) PUBLIC COMMENT.—Prior to issuing any final guidance under this paragraph, the Secretary shall provide
a public comment period of not less than 60 days during
which any member of the public may provide comments
on a draft of the guidance.’’.
(c) AVAILABILITY OF PLAN INFORMATION.—
(1) SOLICITATION OF PUBLIC FEEDBACK.—Not later than
6 months after the date of enactment of this Act, the Secretary
of Health and Human Services, the Secretary of Labor, and
the Secretary of the Treasury shall solicit feedback from the
public on how the disclosure request process for documents
containing information that health plans or health insurance
issuers are required under Federal or State law to disclose
to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with existing mental
health parity and addiction equity requirements can be
improved while continuing to ensure consumers’ rights to access
all information required by Federal or State law to be disclosed.
(2) PUBLIC AVAILABILITY.—Not later than 12 months after
the date of the enactment of this Act, the Secretary of Health
and Human Services, the Secretary of Labor, and the Secretary
of the Treasury shall make such feedback publicly available.
(3) NAIC.—The Secretary of Health and Human Services,
the Secretary of Labor, and the Secretary of the Treasury
shall share feedback obtained pursuant to paragraph (1)
directly with the National Association of Insurance Commissioners to the extent such feedback includes recommendations
for the development of simplified information disclosure tools
to provide consistent information for consumers. Such feedback
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130 STAT. 1283
may be taken into consideration by the National Association
of Insurance Commissioners and other appropriate entities for
the voluntary development and voluntary use of common templates and other sample standardized forms to improve consumer access to plan information.
(d) IMPROVING COMPLIANCE.—
(1) IN GENERAL.—In the case that the Secretary of Health
and Human Services, the Secretary of Labor, or the Secretary
of the Treasury determines that a group health plan or health
insurance issuer offering group or individual health insurance
coverage has violated, at least 5 times, section 2726 of the
Public Health Service Act (42 U.S.C. 300gg–26), section 712
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185a), or section 9812 of the Internal Revenue Code
of 1986, respectively, the appropriate Secretary shall audit
plan documents for such health plan or issuer in the plan
year following the Secretary’s determination in order to help
improve compliance with such section.
(2) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to limit the authority, as in effect on the
day before the date of enactment of this Act, of the Secretary
of Health and Human Services, the Secretary of Labor, or
the Secretary of the Treasury to audit documents of health
plans or health insurance issuers.
42 USC
300gg–26 note.
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SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL
HEALTH AND SUBSTANCE USE DISORDER COVERAGE.
(a) PUBLIC MEETING.—
(1) IN GENERAL.—Not later than 6 months after the date
of enactment of this Act, the Secretary of Health and Human
Services shall convene a public meeting of stakeholders
described in paragraph (2) to produce an action plan for
improved Federal and State coordination related to the enforcement of section 2726 of the Public Health Service Act (42
U.S.C. 300gg–26), section 712 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1185a), and section
9812 of the Internal Revenue Code of 1986, and any comparable
provisions of State law (in this section such sections and provisions are collectively referred to as ‘‘mental health parity and
addiction equity requirements’’).
(2) STAKEHOLDERS.—The stakeholders described in this
paragraph shall include each of the following:
(A) The Federal Government, including representatives
from—
(i) the Department of Health and Human Services;
(ii) the Department of the Treasury;
(iii) the Department of Labor; and
(iv) the Department of Justice.
(B) State governments, including—
(i) State health insurance commissioners;
(ii) appropriate State agencies, including agencies
on public health or mental health; and
(iii) State attorneys general or other representatives of State entities involved in the enforcement of
mental health parity and addiction equity requirements.
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130 STAT. 1284
PUBLIC LAW 114–255—DEC. 13, 2016
(C) Representatives from key stakeholder groups,
including—
(i) the National Association of Insurance Commissioners;
(ii) health insurance issuers;
(iii) providers of mental health and substance use
disorder treatment;
(iv) employers; and
(v) patients or their advocates.
(b) ACTION PLAN.—Not later than 6 months after the conclusion
of the public meeting under subsection (a), the Secretary of Health
and Human Services shall finalize the action plan described in
such subsection and make it plainly available on the Internet
website of the Department of Health and Human Services.
(c) CONTENT.—The action plan under this section shall—
(1) take into consideration the recommendations of the
Mental Health and Substance Use Disorder Parity Task Force
in its final report issued in October of 2016, and any subsequent
Federal and State actions in relation to such recommendations;
(2) reflect the input of the stakeholders participating in
the public meeting under subsection (a);
(3) identify specific strategic objectives regarding how the
various Federal and State agencies charged with enforcement
of mental health parity and addiction equity requirements will
collaborate to improve enforcement of such requirements;
(4) provide a timeline for implementing the action plan;
and
(5) provide specific examples of how such objectives may
be met, which may include—
(A) providing common educational information and
documents, such as the Consumer Guide to Disclosure
Rights, to patients about their rights under mental health
parity and addiction equity requirements;
(B) facilitating the centralized collection of, monitoring
of, and response to patient complaints or inquiries relating
to mental health parity and addiction equity requirements,
which may be through the development and administration
of—
(i) a single, toll-free telephone number; and
(ii) a new parity website—
(I) to help consumers find the appropriate Federal or State agency to assist with their parity
complaints, appeals, and other actions; and
(II) that takes into consideration, but is not
duplicative of, the parity beta site being tested,
and released for public comment, by the Department of Health and Human Services as of the
date of the enactment of this Act;
(C) Federal and State law enforcement agencies
entering into memoranda of understanding to better coordinate enforcement responsibilities and information
sharing—
(i) including whether such agencies should make
the results of enforcement actions related to mental
health parity and addiction equity requirements publicly available; and
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(ii) which may include State Policy Academies on
Parity Implementation for State Officials and other
forums to bring together national experts to provide
technical assistance to teams of State officials on
strategies to advance compliance with mental health
parity and addiction equity requirements in both the
commercial market, and in the Medicaid program
under title XIX of the Social Security Act and the
State Children’s Health Insurance Program under title
XXI of such Act; and
(D) recommendations to the Congress regarding the
need for additional legal authority to improve enforcement
of mental health parity and addiction equity requirements,
including the need for additional legal authority to ensure
that nonquantitative treatment limitations are applied, and
the extent and frequency of the applications of such limitations, both to medical and surgical benefits and to mental
health and substance use disorder benefits in a comparable
manner.
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SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN
MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS.
(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, and annually thereafter for the subsequent 5
years, the Assistant Secretary of Labor of the Employee Benefits
Security Administration, in collaboration with the Administrator
of the Centers for Medicare & Medicaid Services and the Secretary
of the Treasury, shall 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
summarizing the results of all closed Federal investigations completed during the preceding 12-month period with findings of any
serious violation regarding compliance with mental health and substance use disorder coverage requirements under section 2726 of
the Public Health Service Act (42 U.S.C. 300gg–26), section 712
of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
1185a), and section 9812 of the Internal Revenue Code of 1986.
(b) CONTENTS.—Subject to subsection (c), a report under subsection (a) shall, with respect to investigations described in such
subsection, include each of the following:
(1) The number of closed Federal investigations conducted
during the covered reporting period.
(2) Each benefit classification examined by any such investigation conducted during the covered reporting period.
(3) Each subject matter, including compliance with requirements for quantitative and nonquantitative treatment limitations, of any such investigation conducted during the covered
reporting period.
(4) A summary of the basis of the final decision rendered
for each closed investigation conducted during the covered
reporting period that resulted in a finding of a serious violation.
(c) LIMITATION.—Any individually identifiable information shall
be excluded from reports under subsection (a) consistent with
protections under the health privacy and security rules promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d–2 note).
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PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS.
Not later than 3 years after the date of enactment of this
Act, the Comptroller General of the United States, in consultation
with the Secretary of Health and Human Services, the Secretary
of Labor, and the Secretary of the Treasury, shall 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 detailing the extent to which group health
plans or health insurance issuers offering group or individual health
insurance coverage that provides both medical and surgical benefits
and mental health or substance use disorder benefits, medicaid
managed care organizations with a contract under section 1903(m)
of the Social Security Act (42 U.S.C. 1396b(m)), and health plans
provided under the State Children’s Health Insurance Program
under title XXI of the Social Security Act (42 U.S.C. 1397aa et
seq.) comply with section 2726 of the Public Health Service Act
(42 U.S.C. 300gg–26), section 712 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1185a), and section 9812
of the Internal Revenue Code of 1986, including—
(1) how nonquantitative treatment limitations, including
medical necessity criteria, of such plans or issuers comply with
such sections;
(2) how the responsible Federal departments and agencies
ensure that such plans or issuers comply with such sections,
including an assessment of how the Secretary of Health and
Human Services has used its authority to conduct audits of
such plans to ensure compliance;
(3) a review of how the various Federal and State agencies
responsible for enforcing mental health parity requirements
have improved enforcement of such requirements in accordance
with the objectives and timeline described in the action plan
under section 13002; and
(4) recommendations for how additional enforcement, education, and coordination activities by responsible Federal and
State departments and agencies could better ensure compliance
with such sections, including recommendations regarding the
need for additional legal authority.
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42 USC 237a
note.
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SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS.
(a) INFORMATION.—The Secretary of Health and Human Services, acting through the Director of the Office on Women’s Health,
may—
(1) update information, related fact sheets, and resource
lists related to eating disorders that are available on the public
Internet website of the National Women’s Health Information
Center sponsored by the Office on Women’s Health, to include—
(A) updated findings and current research related to
eating disorders, as appropriate; and
(B) information about eating disorders, including
information related to males and females;
(2) incorporate, as appropriate, and in coordination with
the Secretary of Education, information from publicly available
resources into appropriate obesity prevention programs developed by the Office on Women’s Health; and
(3) make publicly available (through a public Internet
website or other method) information, related fact sheets, and
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resource lists, as updated under paragraph (1), and the information incorporated into appropriate obesity prevention programs
under paragraph (2).
(b) AWARENESS.—The Secretary of Health and Human Services
may advance public awareness on—
(1) the types of eating disorders;
(2) the seriousness of eating disorders, including prevalence, comorbidities, and physical and mental health consequences;
(3) methods to identify, intervene, refer for treatment, and
prevent behaviors that may lead to the development of eating
disorders;
(4) discrimination and bullying based on body size;
(5) the effects of media on self-esteem and body image;
and
(6) the signs and symptoms of eating disorders.
SEC. 13006. EDUCATION AND TRAINING ON EATING DISORDERS.
The Secretary of Health and Human Services may facilitate
the identification of model programs and materials for educating
and training health professionals in effective strategies to—
(1) identify individuals with eating disorders;
(2) provide early intervention services for individuals with
eating disorders;
(3) refer patients with eating disorders for appropriate
treatment;
(4) prevent the development of eating disorders; and
(5) provide appropriate treatment services for individuals
with eating disorders.
SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES.
If a group health plan or a health insurance issuer offering
group or individual health insurance coverage provides coverage
for eating disorder benefits, including residential treatment, such
group health plan or health insurance issuer shall provide such
benefits consistent with the requirements of section 2726 of the
Public Health Service Act (42 U.S.C. 300gg–26), section 712 of
the Employee Retirement Income Security Act of 1974 (29 U.S.C.
1185a), and section 9812 of the Internal Revenue Code of 1986.
42 USC 237a
note.
42 USC
300gg–26 note.
TITLE XIV—MENTAL HEALTH AND SAFE
COMMUNITIES
Subtitle A—Mental Health and Safe
Communities
SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION
TEAMS, MENTAL HEALTH PURPOSES.
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(a) EDWARD
GRAM.—Section
BYRNE MEMORIAL JUSTICE ASSISTANCE GRANT PRO501(a)(1) of title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3751(a)(1)) is amended
by adding at the end the following:
‘‘(H) Mental health programs and related law enforcement and corrections programs, including behavioral programs and crisis intervention teams.’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
(b) COMMUNITY ORIENTED POLICING SERVICES PROGRAM.—Section 1701(b) of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796dd(b)) is amended—
(1) in paragraph (17), by striking ‘‘and’’ at the end;
(2) by redesignating paragraph (18) as paragraph (22);
(3) by inserting after paragraph (17) the following:
‘‘(18) to provide specialized training to law enforcement
officers to—
‘‘(A) recognize individuals who have a mental illness;
and
‘‘(B) properly interact with individuals who have a
mental illness, including strategies for verbal de-escalation
of crises;
‘‘(19) to establish collaborative programs that enhance the
ability of law enforcement agencies to address the mental
health, behavioral, and substance abuse problems of individuals
encountered by law enforcement officers in the line of duty;
‘‘(20) to provide specialized training to corrections officers
to recognize individuals who have a mental illness;
‘‘(21) to enhance the ability of corrections officers to address
the mental health of individuals under the care and custody
of jails and prisons, including specialized training and strategies
for verbal de-escalation of crises; and’’; and
(4) in paragraph (22), as redesignated, by striking ‘‘through
(17)’’ and inserting ‘‘through (21)’’.
(c) MODIFICATIONS TO THE STAFFING FOR ADEQUATE FIRE AND
EMERGENCY RESPONSE GRANTS.—Section 34(a)(1)(B) of the Federal
Fire Prevention and Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B))
is amended by inserting before the period at the end the following:
‘‘and to provide specialized training to paramedics, emergency medical services workers, and other first responders to recognize individuals who have mental illness and how to properly intervene with
individuals with mental illness, including strategies for verbal deescalation of crises’’.
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SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.
(a) IN GENERAL.—Section 2201 of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended
in paragraph (2)(B), by inserting before the semicolon the following:
‘‘, or court-ordered assisted outpatient treatment when the court
has determined such treatment to be necessary’’.
(b) DEFINITIONS.—Section 2202 of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii—1) is
amended—
(1) in paragraph (1), by striking ‘‘and’’ at the end;
(2) in paragraph (2), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
‘‘(3) the term ‘court-ordered assisted outpatient treatment’
means a program through which a court may order a treatment
plan for an eligible patient that—
‘‘(A) requires such patient to obtain outpatient mental
health treatment while the patient is not currently residing
in a correctional facility or inpatient treatment facility;
and
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‘‘(B) is designed to improve access and adherence by
such patient to intensive behavioral health services in order
to—
‘‘(i) avert relapse, repeated hospitalizations, arrest,
incarceration, suicide, property destruction, and violent
behavior; and
‘‘(ii) provide such patient with the opportunity to
live in a less restrictive alternative to incarceration
or involuntary hospitalization; and
‘‘(4) the term ‘eligible patient’ means an adult, mentally
ill person who, as determined by a court—
‘‘(A) has a history of violence, incarceration, or medically unnecessary hospitalizations;
‘‘(B) without supervision and treatment, may be a
danger to self or others in the community;
‘‘(C) is substantially unlikely to voluntarily participate
in treatment;
‘‘(D) may be unable, for reasons other than indigence,
to provide for any of his or her basic needs, such as food,
clothing, shelter, health, or safety;
‘‘(E) has a history of mental illness or a condition
that is likely to substantially deteriorate if the person
is not provided with timely treatment; or
‘‘(F) due to mental illness, lacks capacity to fully understand or lacks judgment to make informed decisions
regarding his or her need for treatment, care, or supervision.’’.
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SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS.
(a) DEFINITIONS.—In this section—
(1) the term ‘‘eligible offender’’ means a person who—
(A)(i) previously or currently has been diagnosed by
a qualified mental health professional as having a mental
illness, mental retardation, or co-occurring mental illness
and substance abuse disorders; or
(ii) manifests obvious signs of mental illness, mental
retardation, or co-occurring mental illness and substance
abuse disorders during arrest or confinement or before
any court;
(B) comes into contact with the criminal justice system
or is arrested or charged with an offense that is not—
(i) a crime of violence, as defined under applicable
State law or in section 3156 of title 18, United States
Code; or
(ii) a serious drug offense, as defined in section
924(e)(2)(A) of title 18, United States Code; and
(C) is determined by a judge to be eligible; and
(2) the term ‘‘mental illness’’ means a diagnosable mental,
behavioral, or emotional disorder—
(A) of sufficient duration to meet diagnostic criteria
within the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association; and
(B) that has resulted in functional impairment that
substantially interferes with or limits 1 or more major
life activities.
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note.
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130 STAT. 1290
PUBLIC LAW 114–255—DEC. 13, 2016
(b) ESTABLISHMENT OF PROGRAM.—Not later than 1 year after
the date of enactment of this Act, the Attorney General shall
establish a pilot program to determine the effectiveness of diverting
eligible offenders from Federal prosecution, Federal probation, or
a Bureau of Prisons facility, and placing such eligible offenders
in drug or mental health courts.
(c) PROGRAM SPECIFICATIONS.—The pilot program established
under subsection (b) shall involve—
(1) continuing judicial supervision, including periodic
review, of program participants who have a substance abuse
problem or mental illness; and
(2) the integrated administration of services and sanctions,
which shall include—
(A) mandatory periodic testing, as appropriate, for the
use of controlled substances or other addictive substances
during any period of supervised release or probation for
each program participant;
(B) substance abuse treatment for each program
participant who requires such services;
(C) diversion, probation, or other supervised release
with the possibility of prosecution, confinement, or incarceration based on noncompliance with program requirements
or failure to show satisfactory progress toward completing
program requirements;
(D) programmatic offender management, including case
management, and aftercare services, such as relapse
prevention, health care, education, vocational training, job
placement, housing placement, and child care or other
family support services for each program participant who
requires such services;
(E) outpatient or inpatient mental health treatment,
as ordered by the court, that carries with it the possibility
of dismissal of charges or reduced sentencing upon successful completion of such treatment;
(F) centralized case management, including—
(i) the consolidation of all cases, including violations of probations, of the program participant; and
(ii) coordination of all mental health treatment
plans and social services, including life skills and vocational training, housing and job placement, education,
health care, and relapse prevention for each program
participant who requires such services; and
(G) continuing supervision of treatment plan compliance by the program participant for a term not to exceed
the maximum allowable sentence or probation period for
the charged or relevant offense and, to the extent practicable, continuity of psychiatric care at the end of the
supervised period.
(d) IMPLEMENTATION; DURATION.—The pilot program established under subsection (b) shall be conducted—
(1) in not less than 1 United States judicial district, designated by the Attorney General in consultation with the
Director of the Administrative Office of the United States
Courts, as appropriate for the pilot program; and
(2) during fiscal year 2017 through fiscal year 2021.
(e) CRITERIA FOR DESIGNATION.—Before making a designation
under subsection (d)(1), the Attorney General shall—
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(1) obtain the approval, in writing, of the United States
Attorney for the United States judicial district being designated;
(2) obtain the approval, in writing, of the chief judge for
the United States judicial district being designated; and
(3) determine that the United States judicial district being
designated has adequate behavioral health systems for treatment, including substance abuse and mental health treatment.
(f) ASSISTANCE FROM OTHER FEDERAL ENTITIES.—The Administrative Office of the United States Courts and the United States
Probation Offices shall provide such assistance and carry out such
functions as the Attorney General may request in monitoring, supervising, providing services to, and evaluating eligible offenders placed
in a drug or mental health court under this section.
(g) REPORTS.—The Attorney General, in consultation with the
Director of the Administrative Office of the United States Courts,
shall monitor the drug and mental health courts under this section,
and shall submit a report to Congress on the outcomes of the
program at the end of the period described in subsection (d)(2).
SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM.
42 USC 3796ii–8.
Part V of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796ii et seq.) is amended by inserting
at the end the following:
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‘‘SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.
‘‘(a) PRETRIAL SCREENING AND SUPERVISION.—
‘‘(1) IN GENERAL.—The Attorney General may award grants
to States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
implement, or expand pretrial services programs to improve
the identification and outcomes of individuals with mental illness.
‘‘(2) ALLOWABLE USES.—Grants awarded under this subsection may be may be used for—
‘‘(A) behavioral health needs and risk screening of
defendants, including verification of interview information,
mental health evaluation, and criminal history screening;
‘‘(B) assessment of risk of pretrial misconduct through
objective, statistically validated means, and presentation
to the court of recommendations based on such assessment,
including services that will reduce the risk of pre-trial
misconduct;
‘‘(C) followup review of defendants unable to meet the
conditions of pretrial release;
‘‘(D) evaluation of process and results of pre-trial
service programs;
‘‘(E) supervision of defendants who are on pretrial
release, including reminders to defendants of scheduled
court dates;
‘‘(F) reporting on process and results of pretrial services
programs to relevant public and private mental health
stakeholders; and
‘‘(G) data collection and analysis necessary to make
available information required for assessment of risk.
‘‘(b) BEHAVIORAL HEALTH ASSESSMENTS AND INTERVENTION.—
‘‘(1) IN GENERAL.—The Attorney General may award grants
to States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
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130 STAT. 1292
PUBLIC LAW 114–255—DEC. 13, 2016
implement, or expand a behavioral health screening and assessment program framework for State or local criminal justice
systems.
‘‘(2) ALLOWABLE USES.—Grants awarded under this subsection may be used for—
‘‘(A) promotion of the use of validated assessment tools
to gauge the criminogenic risk, substance abuse needs,
and mental health needs of individuals;
‘‘(B) initiatives to match the risk factors and needs
of individuals to programs and practices associated with
research-based, positive outcomes;
‘‘(C) implementing methods for identifying and treating
individuals who are most likely to benefit from coordinated
supervision and treatment strategies, and identifying
individuals who can do well with fewer interventions; and
‘‘(D) collaborative decision-making among the heads
of criminal justice agencies, mental health systems, judicial
systems, substance abuse systems, and other relevant systems or agencies for determining how treatment and intensive supervision services should be allocated in order to
maximize benefits, and developing and utilizing capacity
accordingly.
‘‘(c) USE OF GRANT FUNDS.—A State, unit of local government,
territory, Indian Tribe, or nonprofit agency that receives a grant
under this section shall, in accordance with subsection (b)(2), use
grant funds for the expenses of a treatment program, including—
‘‘(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program, including
costs relating to enforcement;
‘‘(2) payments for treatment providers that are approved
by the State or Indian Tribe and licensed, if necessary, to
provide needed treatment to program participants, including
aftercare supervision, vocational training, education, and job
placement; and
‘‘(3) payments to public and nonprofit private entities that
are approved by the State or Indian Tribe and licensed, if
necessary, to provide alcohol and drug addiction treatment
to offenders participating in the program.
‘‘(d) SUPPLEMENT OF NON-FEDERAL FUNDS.—
‘‘(1) IN GENERAL.—Grants awarded under this section shall
be used to supplement, and not supplant, non-Federal funds
that would otherwise be available for programs described in
this section.
‘‘(2) FEDERAL SHARE.—The Federal share of a grant made
under this section may not exceed 50 percent of the total
costs of the program described in an application under subsection (e).
‘‘(e) APPLICATIONS.—To request a grant under this section, a
State, unit of local government, territory, Indian Tribe, or nonprofit
agency shall submit an application to the Attorney General in
such form and containing such information as the Attorney General
may reasonably require.
‘‘(f) GEOGRAPHIC DISTRIBUTION.—The Attorney General shall
ensure that, to the extent practicable, the distribution of grants
under this section is equitable and includes—
‘‘(1) each State; and
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‘‘(2) a unit of local government, territory, Indian Tribe,
or nonprofit agency—
‘‘(A) in each State; and
‘‘(B) in rural, suburban, Tribal, and urban jurisdictions.
‘‘(g) REPORTS AND EVALUATIONS.—For each fiscal year, each
grantee under this section during that fiscal year shall submit
to the Attorney General a report on the effectiveness of activities
carried out using such grant. Each report shall include an evaluation in such form and containing such information as the Attorney
General may reasonably require. The Attorney General shall specify
the dates on which such reports shall be submitted.
‘‘(h) ACCOUNTABILITY.—Grants awarded under this section shall
be subject to the following accountability provisions:
‘‘(1) AUDIT REQUIREMENT.—
‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit
report of the Inspector General of the Department of Justice
under subparagraph (C) that the audited grantee has used
grant funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within 1
year after the date on which final audit report is issued.
‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this section, and in
each fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of grantees
under this section to prevent waste, fraud, and abuse of
funds by grantees. The Inspector General shall determine
the appropriate number of grantees to be audited each
year.
‘‘(C) FINAL AUDIT REPORT.—The Inspector General of
the Department of Justice shall submit to the Attorney
General a final report on each audit conducted under
subparagraph (B).
‘‘(D) MANDATORY EXCLUSION.—Grantees under this section about which there is an unresolved audit finding shall
not be eligible to receive a grant under this section during
the 2 fiscal years beginning after the end of the 1-year
period described in subparagraph (A).
‘‘(E) PRIORITY.—In making grants under this section,
the Attorney General shall give priority to applicants that
did not have an unresolved audit finding during the 3
fiscal years before submitting an application for a grant
under this section.
‘‘(F) REIMBURSEMENT.—If an entity receives a grant
under this section during the 2-fiscal-year period during
which the entity is prohibited from receiving grants under
subparagraph (D), the Attorney General shall—
‘‘(i) deposit an amount equal to the amount of
the grant that was improperly awarded to the grantee
into the General Fund of the Treasury; and
‘‘(ii) seek to recoup the costs of the repayment
under clause (i) from the grantee that was erroneously
awarded grant funds.
‘‘(2) NONPROFIT AGENCY REQUIREMENTS.—
‘‘(A) DEFINITION.—For purposes of this paragraph and
the grant program under this section, the term ‘nonprofit
agency’ means an organization that is described in section
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PUBLIC LAW 114–255—DEC. 13, 2016
501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C.
501(c)(3)) and is exempt from taxation under section 501(a)
of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
‘‘(B) PROHIBITION.—The Attorney General may not
award a grant under this section to a nonprofit agency
that holds money in an offshore account for the purpose
of avoiding paying the tax described in section 511(a) of
the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
‘‘(C) DISCLOSURE.—Each nonprofit agency that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to
the Attorney General, in the application for the grant,
the process for determining such compensation, including
the independent persons involved in reviewing and
approving such compensation, the comparability data used,
and contemporaneous substantiation of the deliberation
and decision. Upon request, the Attorney General shall
make the information disclosed under this subparagraph
available for public inspection.
‘‘(3) CONFERENCE EXPENDITURES.—
‘‘(A) LIMITATION.—Not more than $20,000 of the
amounts made available to the Department of Justice to
carry out this section may be used by the Attorney General,
or by any individual or entity awarded a grant under
this section to host, or make any expenditures relating
to, a conference unless the Deputy Attorney General provides prior written authorization that the funds may be
expended to host the conference or make such expenditure.
‘‘(B) WRITTEN APPROVAL.—Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment, honoraria
for speakers, and entertainment.
‘‘(C) REPORT.—The Deputy Attorney General shall
submit an annual report to the Committee on the Judiciary
of the Senate and the Committee on the Judiciary of the
House of Representatives on all conference expenditures
approved under this paragraph.
‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit to the Committee on the
Judiciary and the Committee on Appropriations of the Senate
and the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives an annual certification—
‘‘(A) indicating whether—
‘‘(i) all final audit reports issued by the Office
of the Inspector General under paragraph (1) have
been completed and reviewed by the appropriate
Assistant Attorney General or Director;
‘‘(ii) all mandatory exclusions required under paragraph (1)(D) have been issued; and
‘‘(iii) any reimbursements required under paragraph (1)(F) have been made; and
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‘‘(B) that includes a list of any grantees excluded under
paragraph (1)(D) from the previous year.
‘‘(i) PREVENTING DUPLICATIVE GRANTS.—
‘‘(1) IN GENERAL.—Before the Attorney General awards a
grant to an applicant under this section, the Attorney General
shall compare the possible grant with any other grants awarded
to the applicant under this Act to determine whether the grants
are for the same purpose.
‘‘(2) REPORT.—If the Attorney General awards multiple
grants to the same applicant for the same purpose, the Attorney
General shall submit to the Committee on the Judiciary of
the Senate and the Committee on the Judiciary of the House
of Representatives a report that includes—
‘‘(A) a list of all duplicate grants awarded, including
the total dollar amount of any such grants awarded; and
‘‘(B) the reason the Attorney General awarded the
duplicate grants.’’.
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SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES.
Section 2991 of the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3797aa) is amended by—
(1) redesignating subsection (j) as subsection (o); and
(2) inserting after subsection (i) the following:
‘‘(j) FORENSIC ASSERTIVE COMMUNITY TREATMENT (FACT) INITIATIVE PROGRAM.—
‘‘(1) IN GENERAL.—The Attorney General may make grants
to States, units of local government, territories, Indian Tribes,
nonprofit agencies, or any combination thereof, to develop,
implement, or expand Assertive Community Treatment initiatives to develop forensic assertive community treatment
(referred to in this subsection as ‘FACT’) programs that provide
high intensity services in the community for individuals with
mental illness with involvement in the criminal justice system
to prevent future incarcerations.
‘‘(2) ALLOWABLE USES.—Grant funds awarded under this
subsection may be used for—
‘‘(A) multidisciplinary team initiatives for individuals
with mental illnesses with criminal justice involvement
that address criminal justice involvement as part of treatment protocols;
‘‘(B) FACT programs that involve mental health professionals, criminal justice agencies, chemical dependency
specialists, nurses, psychiatrists, vocational specialists,
forensic peer specialists, forensic specialists, and dedicated
administrative support staff who work together to provide
recovery oriented, 24/7 wraparound services;
‘‘(C) services such as integrated evidence-based practices for the treatment of co-occurring mental health and
substance-related disorders, assertive outreach and engagement, community-based service provision at participants’
residence or in the community, psychiatric rehabilitation,
recovery oriented services, services to address criminogenic
risk factors, and community tenure;
‘‘(D) payments for treatment providers that are
approved by the State or Indian Tribe and licensed, if
necessary, to provide needed treatment to eligible offenders
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PUBLIC LAW 114–255—DEC. 13, 2016
participating in the program, including behavioral health
services and aftercare supervision; and
‘‘(E) training for all FACT teams to promote highfidelity practice principles and technical assistance to support effective and continuing integration with criminal justice agency partners.
‘‘(3) SUPPLEMENT AND NOT SUPPLANT.—Grants made under
this subsection shall be used to supplement, and not supplant,
non-Federal funds that would otherwise be available for programs described in this subsection.
‘‘(4) APPLICATIONS.—To request a grant under this subsection, a State, unit of local government, territory, Indian
Tribe, or nonprofit agency shall submit an application to the
Attorney General in such form and containing such information
as the Attorney General may reasonably require.’’.
SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF
SYSTEMS.
Section 2976(f) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended—
(1) in paragraph (5), by striking ‘‘and’’ at the end;
(2) in paragraph (6), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
‘‘(7) provide mental health treatment and transitional services for those with mental illnesses or with co-occurring disorders, including housing placement or assistance; and’’.
SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN DRUG COURTS.
Part EE of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797u et seq.) is amended—
(1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by
inserting ‘‘, including co-occurring substance abuse and mental
health problems,’’ after ‘‘problems’’; and
(2) in section 2959(a) (42 U.S.C. 3797u–8(a)), by inserting
‘‘, including training for drug court personnel and officials on
identifying and addressing co-occurring substance abuse and
mental health problems’’ after ‘‘part’’.
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42 USC
3797aa–1 note.
SEC. 14008. MENTAL HEALTH TRAINING FOR FEDERAL UNIFORMED
SERVICES.
(a) IN GENERAL.—Not later than 180 days after the date of
enactment of this Act, the Secretary of Defense, the Secretary
of Homeland Security, the Secretary of Health and Human Services,
and the Secretary of Commerce shall provide the following to each
of the uniformed services (as that term is defined in section 101
of title 10, United States Code) under their direction:
(1) TRAINING PROGRAMS.—Programs that offer specialized
and comprehensive training in procedures to identify and
respond appropriately to incidents in which the unique needs
of individuals with mental illnesses are involved.
(2) IMPROVED TECHNOLOGY.—Computerized information
systems or technological improvements to provide timely
information to Federal law enforcement personnel, other
branches of the uniformed services, and criminal justice system
personnel to improve the Federal response to mentally ill
individuals.
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130 STAT. 1297
(3) COOPERATIVE PROGRAMS.—The establishment and
expansion of cooperative efforts to promote public safety
through the use of effective intervention with respect to mentally ill individuals encountered by members of the uniformed
services.
SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER
REENTRY.
(a) REENTRY DEMONSTRATION PROJECTS.—Section 2976(f) of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3797w(f)), as amended by section 14006, is
amended—
(1) in paragraph (3)(C), by inserting ‘‘mental health services,’’ before ‘‘drug treatment’’; and
(2) by adding at the end the following:
‘‘(8) target offenders with histories of homelessness, substance abuse, or mental illness, including a prerelease assessment of the housing status of the offender and behavioral
health needs of the offender with clear coordination with mental
health, substance abuse, and homelessness services systems
to achieve stable and permanent housing outcomes with appropriate support service.’’.
(b) MENTORING GRANTS.—Section 211(b)(2) of the Second
Chance Act of 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting
‘‘, including mental health care’’ after ‘‘community’’.
SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS.
Section 2701(b) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended—
(1) by redesignating paragraphs (4) and (5) as paragraphs
(5) and (6), respectively; and
(2) by inserting after paragraph (3) the following:
‘‘(4) The development and operation of crisis intervention
teams that may include coordination with law enforcement
agencies and specialized training for school officials in
responding to mental health crises.’’.
SEC. 14011. ACTIVE-SHOOTER TRAINING FOR LAW ENFORCEMENT.
The Attorney General, as part of the Preventing Violence
Against Law Enforcement and Ensuring Officer Resilience and
Survivability Initiative (VALOR) of the Department of Justice, may
provide safety training and technical assistance to local law enforcement agencies, including active-shooter response training.
42 USC 3752
note.
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SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH
CHALLENGES IN RESIDENTIAL SUBSTANCE ABUSE
TREATMENT PROGRAMS.
Section 1901(a) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3796ff(a)) is amended—
(1) in paragraph (1), by striking ‘‘and’’ at the end;
(2) in paragraph (2), by striking the period at the end
and inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(3) developing and implementing specialized residential
substance abuse treatment programs that identify and provide
appropriate treatment to inmates with co-occurring mental
health and substance abuse disorders or challenges.’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES
TO INCARCERATION PROGRAMS.
Title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3711 et seq.) is amended by striking part CC
and inserting the following:
‘‘PART CC—MENTAL HEALTH AND DRUG
TREATMENT ALTERNATIVES TO INCARCERATION PROGRAMS
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42 USC 3797q.
‘‘SEC. 2901. MENTAL HEALTH AND DRUG TREATMENT ALTERNATIVES
TO INCARCERATION PROGRAMS.
‘‘(a) DEFINITIONS.—In this section—
‘‘(1) the term ‘eligible entity’ means a State, unit of local
government, Indian tribe, or nonprofit organization; and
‘‘(2) the term ‘eligible participant’ means an individual
who—
‘‘(A) comes into contact with the criminal justice system
or is arrested or charged with an offense that is not—
‘‘(i) a crime of violence, as defined under applicable
State law or in section 3156 of title 18, United States
Code; or
‘‘(ii) a serious drug offense, as defined in section
924(e)(2)(A) of title 18, United States Code;
‘‘(B) has a history of, or a current—
‘‘(i) substance use disorder;
‘‘(ii) mental illness; or
‘‘(iii) co-occurring mental illness and substance use
disorder; and
‘‘(C) has been approved for participation in a program
funded under this section by the relevant law enforcement
agency, prosecuting attorney, defense attorney, probation
official, corrections official, judge, representative of a
mental health agency, or representative of a substance
abuse agency, as required by law.
‘‘(b) PROGRAM AUTHORIZED.—The Attorney General may make
grants to eligible entities to develop, implement, or expand a treatment alternative to incarceration program for eligible participants,
including—
‘‘(1) pre-booking treatment alternative to incarceration programs, including—
‘‘(A) law enforcement training on substance use disorders, mental illness, and co-occurring mental illness and
substance use disorders;
‘‘(B) receiving centers as alternatives to incarceration
of eligible participants;
‘‘(C) specialized response units for calls related to substance use disorders, mental illness, or co-occurring mental
illness and substance use disorders; and
‘‘(D) other arrest and pre-booking treatment alternatives to incarceration models; or
‘‘(2) post-booking treatment alternative to incarceration programs, including—
‘‘(A) specialized clinical case management;
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130 STAT. 1299
‘‘(B) pre-trial services related to substances use disorders, mental illness, and co-occurring mental illness and
substance use disorders;
‘‘(C) prosecutor and defender based programs;
‘‘(D) specialized probation;
‘‘(E) treatment and rehabilitation programs; and
‘‘(F) problem-solving courts, including mental health
courts, drug courts, co-occurring mental health and substance abuse courts, DWI courts, and veterans treatment
courts.
‘‘(c) APPLICATION.—
‘‘(1) IN GENERAL.—An eligible entity desiring a grant under
this section shall submit an application to the Attorney General—
‘‘(A) that meets the criteria under paragraph (2); and
‘‘(B) at such time, in such manner, and accompanied
by such information as the Attorney General may require.
‘‘(2) CRITERIA.—An eligible entity, in submitting an application under paragraph (1), shall—
‘‘(A) provide extensive evidence of collaboration with
State and local government agencies overseeing health,
community corrections, courts, prosecution, substance
abuse, mental health, victims services, and employment
services, and with local law enforcement agencies;
‘‘(B) demonstrate consultation with the Single State
Authority for Substance Abuse of the State (as that term
is defined in section 201(e) of the Second Chance Act of
2007);
‘‘(C) demonstrate that evidence-based treatment practices will be utilized; and
‘‘(D) demonstrate that evidence-based screening and
assessment tools will be used to place participants in the
treatment alternative to incarceration program.
‘‘(d) REQUIREMENTS.—Each eligible entity awarded a grant for
a treatment alternative to incarceration program under this section
shall—
‘‘(1) determine the terms and conditions of participation
in the program by eligible participants, taking into consideration the collateral consequences of an arrest, prosecution or
criminal conviction;
‘‘(2) ensure that each substance abuse and mental health
treatment component is licensed and qualified by the relevant
jurisdiction;
‘‘(3) for programs described in subsection (b)(2), organize
an enforcement unit comprised of appropriately trained law
enforcement professionals under the supervision of the State,
Tribal, or local criminal justice agency involved, the duties
of which shall include—
‘‘(A) the verification of addresses and other contact
information of each eligible participant who participates
or desires to participate in the program; and
‘‘(B) if necessary, the location, apprehension, arrest,
and return to custody of an eligible participant in the
program who has absconded from the facility of a treatment
provider or has otherwise significantly violated the terms
and conditions of the program, consistent with Federal
and State confidentiality requirements;
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(4) notify the relevant criminal justice entity if any eligible
participant in the program absconds from the facility of the
treatment provider or otherwise violates the terms and conditions of the program, consistent with Federal and State confidentiality requirements;
‘‘(5) submit periodic reports on the progress of treatment
or other measured outcomes from participation in the program
of each eligible participant in the program to the relevant
State, Tribal, or local criminal justice agency, including mental
health courts, drug courts, co-occurring mental health and substance abuse courts, DWI courts, and veterans treatment courts;
‘‘(6) describe the evidence-based methodology and outcome
measurements that will be used to evaluate the program, and
specifically explain how such measurements will provide valid
measures of the impact of the program; and
‘‘(7) describe how the program could be broadly replicated
if demonstrated to be effective.
‘‘(e) USE OF FUNDS.—An eligible entity shall use a grant
received under this section for expenses of a treatment alternative
to incarceration program, including—
‘‘(1) salaries, personnel costs, equipment costs, and other
costs directly related to the operation of the program, including
the enforcement unit;
‘‘(2) payments for treatment providers that are approved
by the relevant State or Tribal jurisdiction and licensed, if
necessary, to provide needed treatment to eligible offenders
participating in the program, including aftercare supervision,
vocational training, education, and job placement; and
‘‘(3) payments to public and nonprofit private entities that
are approved by the State or Tribal jurisdiction and licensed,
if necessary, to provide alcohol and drug addiction treatment
to eligible offenders participating in the program.
‘‘(f) SUPPLEMENT NOT SUPPLANT.—An eligible entity shall use
Federal funds received under this section only to supplement the
funds that would, in the absence of those Federal funds, be made
available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds.
The Federal share of a grant made under this section may not
exceed 50 percent of the total costs of the program described in
an application under subsection (d).
‘‘(g) GEOGRAPHIC DISTRIBUTION.—The Attorney General shall
ensure that, to the extent practicable, the geographical distribution
of grants under this section is equitable and includes a grant
to an eligible entity in—
‘‘(1) each State;
‘‘(2) rural, suburban, and urban areas; and
‘‘(3) Tribal jurisdictions.
‘‘(h) REPORTS AND EVALUATIONS.—Each fiscal year, each
recipient of a grant under this section during that fiscal year
shall submit to the Attorney General a report on the outcomes
of activities carried out using that grant in such form, containing
such information, and on such dates as the Attorney General shall
specify.
‘‘(i) ACCOUNTABILITY.—All grants awarded by the Attorney General under this section shall be subject to the following accountability provisions:
‘‘(1) AUDIT REQUIREMENT.—
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1301
‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit
report of the Inspector General of the Department of Justice
that the audited grantee has utilized grant funds for an
unauthorized expenditure or otherwise unallowable cost
that is not closed or resolved within 12 months from the
date on which the final audit report is issued.
‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this subsection, and
in each fiscal year thereafter, the Inspector General of
the Department of Justice shall conduct audits of recipients
of grants under this section to prevent waste, fraud, and
abuse of funds by grantees. The Inspector General shall
determine the appropriate number of grantees to be audited
each year.
‘‘(C) MANDATORY EXCLUSION.—A recipient of grant
funds under this section that is found to have an unresolved
audit finding shall not be eligible to receive grant funds
under this section during the first 2 fiscal years beginning
after the end of the 12-month period described in subparagraph (A).
‘‘(D) PRIORITY.—In awarding grants under this section,
the Attorney General shall give priority to eligible
applicants that did not have an unresolved audit finding
during the 3 fiscal years before submitting an application
for a grant under this section.
‘‘(E) REIMBURSEMENT.—If an entity is awarded grant
funds under this section during the 2-fiscal-year period
during which the entity is barred from receiving grants
under subparagraph (C), the Attorney General shall—
‘‘(i) deposit an amount equal to the amount of
the grant funds that were improperly awarded to the
grantee into the General Fund of the Treasury; and
‘‘(ii) seek to recoup the costs of the repayment
to the fund from the grant recipient that was erroneously awarded grant funds.
‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.—
‘‘(A) DEFINITION.—For purposes of this paragraph and
the grant programs under this part, the term ‘nonprofit
organization’ means an organization that is described in
section 501(c)(3) of the Internal Revenue Code of 1986
and is exempt from taxation under section 501(a) of such
Code.
‘‘(B) PROHIBITION.—The Attorney General may not
award a grant under this part to a nonprofit organization
that holds money in offshore accounts for the purpose of
avoiding paying the tax described in section 511(a) of the
Internal Revenue Code of 1986.
‘‘(C) DISCLOSURE.—Each nonprofit organization that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to
the Attorney General, in the application for the grant,
the process for determining such compensation, including
the independent persons involved in reviewing and
approving such compensation, the comparability data used,
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130 STAT. 1302
PUBLIC LAW 114–255—DEC. 13, 2016
and contemporaneous substantiation of the deliberation
and decision. Upon request, the Attorney General shall
make the information disclosed under this subparagraph
available for public inspection.
‘‘(3) CONFERENCE EXPENDITURES.—
‘‘(A) LIMITATION.—No amounts made available to the
Department of Justice under this section may be used
by the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure
for conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head
of the relevant agency or department, provides prior written authorization that the funds may be expended to host
the conference.
‘‘(B) WRITTEN APPROVAL.—Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment, honoraria
for speakers, and entertainment.
‘‘(C) REPORT.—The Deputy Attorney General shall
submit an annual report to the Committee on the Judiciary
of the Senate and the Committee on the Judiciary of the
House of Representatives on all conference expenditures
approved under this paragraph.
‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit, to the Committee on the
Judiciary and the Committee on Appropriations of the Senate
and the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives, an annual
certification—
‘‘(A) indicating whether—
‘‘(i) all audits issued by the Office of the Inspector
General under paragraph (1) have been completed and
reviewed by the appropriate Assistant Attorney General or Director;
‘‘(ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and
‘‘(iii) all reimbursements required under paragraph
(1)(E) have been made; and
‘‘(B) that includes a list of any grant recipients excluded
under paragraph (1) from the previous year.
‘‘(5) PREVENTING DUPLICATIVE GRANTS.—
‘‘(A) IN GENERAL.—Before the Attorney General awards
a grant to an applicant under this section, the Attorney
General shall compare potential grant awards with other
grants awarded under this Act to determine if duplicate
grant awards are awarded for the same purpose.
‘‘(B) REPORT.—If the Attorney General awards duplicate grants to the same applicant for the same purpose
the Attorney General shall submit to the Committee on
the Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives a report that
includes—
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130 STAT. 1303
‘‘(i) a list of all duplicate grants awarded, including
the total dollar amount of any duplicate grants
awarded; and
‘‘(ii) the reason the Attorney General awarded the
duplicate grants.’’.
SEC. 14014. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH
TRAINING AND TECHNICAL ASSISTANCE.
42 USC
3797aa–1.
Part HH of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3797aa et seq.) is amended by
adding at the end the following:
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‘‘SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL HEALTH
TRAINING AND TECHNICAL ASSISTANCE.
‘‘(a) AUTHORITY.—The Attorney General may make grants to
eligible organizations to provide for the establishment of a National
Criminal Justice and Mental Health Training and Technical Assistance Center.
‘‘(b) ELIGIBLE ORGANIZATION.—For purposes of subsection (a),
the term ‘eligible organization’ means a national nonprofit organization that provides technical assistance and training to, and has
special expertise and broad, national-level experience in, mental
health, crisis intervention, criminal justice systems, law enforcement, translating evidence into practice, training, and research,
and education and support of people with mental illness and the
families of such individuals.
‘‘(c) USE OF FUNDS.—Any organization that receives a grant
under subsection (a) shall collaborate with other grant recipients
to establish and operate a National Criminal Justice and Mental
Health Training and Technical Assistance Center to—
‘‘(1) provide law enforcement officer training regarding
mental health and working with individuals with mental illnesses, with an emphasis on de-escalation of encounters
between law enforcement officers and those with mental disorders or in crisis, which shall include support the development
of in-person and technical information exchanges between systems and the individuals working in those systems in support
of the concepts identified in the training;
‘‘(2) provide education, training, and technical assistance
for States, Indian tribes, territories, units of local government,
service providers, nonprofit organizations, probation or parole
officers, prosecutors, defense attorneys, emergency response
providers, and corrections institutions to advance practice and
knowledge relating to mental health crisis and approaches to
mental health and criminal justice across systems;
‘‘(3) provide training and best practices to mental health
providers and criminal justice agencies relating to diversion
initiatives, jail and prison strategies, reentry of individuals
with mental illnesses into the community, and dispatch protocols and triage capabilities, including the establishment of
learning sites;
‘‘(4) develop suicide prevention and crisis intervention
training and technical assistance for criminal justice agencies;
‘‘(5) develop a receiving center system and pilot strategy
that provides, for a jurisdiction, a single point of entry into
the mental health and substance abuse system for assessments
and appropriate placement of individuals experiencing a crisis;
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PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(6) collect data and best practices in mental health and
criminal health and criminal justice initiatives and policies
from grantees under this part, other recipients of grants under
this section, Federal, State, and local agencies involved in the
provision of mental health services, and nongovernmental
organizations involved in the provision of mental health services;
‘‘(7) develop and disseminate to mental health providers
and criminal justice agencies evaluation tools, mechanisms,
and measures to better assess and document performance measures and outcomes relating to the provision of mental health
services;
‘‘(8) disseminate information to States, units of local government, criminal justice agencies, law enforcement agencies, and
other relevant entities about best practices, policy standards,
and research findings relating to the provision of mental health
services; and
‘‘(9) provide education and support to individuals with
mental illness involved with, or at risk of involvement with,
the criminal justice system, including the families of such
individuals.
‘‘(d) ACCOUNTABILITY.—Grants awarded under this section shall
be subject to the following accountability provisions:
‘‘(1) AUDIT REQUIREMENT.—
‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit
report of the Inspector General of the Department of Justice
under subparagraph (C) that the audited grantee has used
grant funds for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved within 1
year after the date on which the final audit report is
issued.
‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this section, and in
each fiscal year thereafter, the Inspector General of the
Department of Justice shall conduct audits of grantees
under this section to prevent waste, fraud, and abuse of
funds by grantees. The Inspector General shall determine
the appropriate number of grantees to be audited each
year.
‘‘(C) FINAL AUDIT REPORT.—The Inspector General of
the Department of Justice shall submit to the Attorney
General a final report on each audit conducted under
subparagraph (B).
‘‘(D) MANDATORY EXCLUSION.—Grantees under this section about which there is an unresolved audit finding shall
not be eligible to receive a grant under this section during
the 2 fiscal years beginning after the end of the 1-year
period described in subparagraph (A).
‘‘(E) PRIORITY.—In making grants under this section,
the Attorney General shall give priority to applicants that
did not have an unresolved audit finding during the 3
fiscal years before submitting an application for a grant
under this section.
‘‘(F) REIMBURSEMENT.—If an entity receives a grant
under this section during the 2-fiscal-year period during
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130 STAT. 1305
which the entity is prohibited from receiving grants under
subparagraph (D), the Attorney General shall—
‘‘(i) deposit an amount equal to the amount of
the grant that was improperly awarded to the grantee
into the General Fund of the Treasury; and
‘‘(ii) seek to recoup the costs of the repayment
under clause (i) from the grantee that was erroneously
awarded grant funds.
‘‘(2) NONPROFIT AGENCY REQUIREMENTS.—
‘‘(A) DEFINITION.—For purposes of this paragraph and
the grant program under this section, the term ‘nonprofit
agency’ means an organization that is described in section
501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C.
501(c)(3)) and is exempt from taxation under section 501(a)
of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
‘‘(B) PROHIBITION.—The Attorney General may not
award a grant under this section to a nonprofit agency
that holds money in an offshore account for the purpose
of avoiding paying the tax described in section 511(a) of
the Internal Revenue Code of 1986 (26 U.S.C. 511(a)).
‘‘(C) DISCLOSURE.—Each nonprofit agency that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to
the Attorney General, in the application for the grant,
the process for determining such compensation, including
the independent persons involved in reviewing and
approving such compensation, the comparability data used,
and contemporaneous substantiation of the deliberation
and decision. Upon request, the Attorney General shall
make the information disclosed under this subparagraph
available for public inspection.
‘‘(3) CONFERENCE EXPENDITURES.—
‘‘(A) LIMITATION.—No amounts made available to the
Department of Justice under this section may be used
by the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure
for conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head
of the relevant agency or department, provides prior written authorization that the funds may be expended to host
the conference.
‘‘(B) WRITTEN APPROVAL.—Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment, honoraria
for speakers, and entertainment.
‘‘(C) REPORT.—The Deputy Attorney General shall
submit an annual report to the Committee on the Judiciary
of the Senate and the Committee on the Judiciary of the
House of Representatives on all conference expenditures
approved under this paragraph.
‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit to the Committee on the
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PUBLIC LAW 114–255—DEC. 13, 2016
Judiciary and the Committee on Appropriations of the Senate
and the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives an annual certification—
‘‘(A) indicating whether—
‘‘(i) all final audit reports issued by the Office
of the Inspector General under paragraph (1) have
been completed and reviewed by the appropriate
Assistant Attorney General or Director;
‘‘(ii) all mandatory exclusions required under paragraph (1)(D) have been issued; and
‘‘(iii) any reimbursements required under paragraph (1)(F) have been made; and
‘‘(B) that includes a list of any grantees excluded under
paragraph (1)(D) from the previous year.
‘‘(5) PREVENTING DUPLICATIVE GRANTS.—
‘‘(A) IN GENERAL.—Before the Attorney General awards
a grant to an applicant under this section, the Attorney
General shall compare potential grant awards with other
grants awarded under this Act to determine if duplicate
grant awards are awarded for the same purpose.
‘‘(B) REPORT.—If the Attorney General awards duplicate grants to the same applicant for the same purpose
the Attorney General shall submit to the Committee on
the Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives a report that
includes—
‘‘(i) a list of all duplicate grants awarded, including
the total dollar amount of any duplicate grants
awarded; and
‘‘(ii) the reason the Attorney General awarded the
duplicate grants.’’.
28 USC 534 note.
SEC. 14015. IMPROVING DEPARTMENT OF JUSTICE DATA COLLECTION
ON MENTAL ILLNESS INVOLVED IN CRIME.
(a) IN GENERAL.—Notwithstanding any other provision of law,
on or after the date that is 90 days after the date on which
the Attorney General promulgates regulations under subsection
(b), any data prepared by, or submitted to, the Attorney General
or the Director of the Federal Bureau of Investigation with respect
to the incidences of homicides, law enforcement officers killed, seriously injured, and assaulted, or individuals killed or seriously
injured by law enforcement officers shall include data with respect
to the involvement of mental illness in such incidences, if any.
(b) REGULATIONS.—Not later than 90 days after the date of
the enactment of this Act, the Attorney General shall promulgate
or revise regulations as necessary to carry out subsection (a).
SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS
IN PRISON.
(a) REPORT ON THE COST OF TREATING THE MENTALLY ILL
CRIMINAL JUSTICE SYSTEM.—Not later than 12 months after
the date of enactment of this Act, the Comptroller General of
the United States shall submit to Congress a report detailing the
cost of imprisonment for individuals who have serious mental illness
by the Federal Government or a State or unit of local government,
which shall include—
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130 STAT. 1307
(1) the number and type of crimes committed by individuals
with serious mental illness each year; and
(2) detail strategies or ideas for preventing crimes by those
individuals with serious mental illness from occurring.
(b) DEFINITION.—For purposes of this section, the Attorney
General, in consultation with the Assistant Secretary of Mental
Health and Substance Use Disorders, shall define ‘‘serious mental
illness’’ based on the ‘‘Health Care Reform for Americans with
Severe Mental Illnesses: Report’’ of the National Advisory Mental
Health Council, American Journal of Psychiatry 1993; 150:1447–
1465.
SEC. 14017. CODIFICATION OF DUE PROCESS FOR DETERMINATIONS
BY SECRETARY OF VETERANS AFFAIRS OF MENTAL
CAPACITY OF BENEFICIARIES.
38 USC 5501A.
(a) IN GENERAL.—Chapter 55 of title 38, United States Code,
is amended by inserting after section 5501 the following new section:
‘‘§ 5501A. Beneficiaries’ rights in mental competence determinations
‘‘The Secretary may not make an adverse determination concerning the mental capacity of a beneficiary to manage monetary
benefits paid to or for the beneficiary by the Secretary under this
title unless such beneficiary has been provided all of the following,
subject to the procedures and timelines prescribed by the Secretary
for determinations of incompetency:
‘‘(1) Notice of the proposed adverse determination and the
supporting evidence.
‘‘(2) An opportunity to request a hearing.
‘‘(3) An opportunity to present evidence, including an
opinion from a medical professional or other person, on the
capacity of the beneficiary to manage monetary benefits paid
to or for the beneficiary by the Secretary under this title.
‘‘(4) An opportunity to be represented at no expense to
the Government (including by counsel) at any such hearing
and to bring a medical professional or other person to provide
relevant testimony at any such hearing.’’.
(b) CLERICAL AMENDMENT.—The table of sections at the beginning of such chapter 55 is amended by inserting after the item
relating to section 5501 the following new item:
38 USC
5501 prec.
‘‘5501A. Beneficiaries’ rights in mental competence determinations’’.
(c) EFFECTIVE DATE.—Section 5501A of title 38, United States
Code, as added by subsection (a), shall apply to determinations
made by the Secretary of Veterans Affairs on or after the date
of the enactment of this Act.
38 USC 5501A
note.
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SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS.
Subsection (o) of section 2991 of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3797aa), as redesignated
by section 14006, is amended—
(1) in paragraph (1)(C), by striking ‘‘2009 through 2014’’
and inserting ‘‘2017 through 2021’’; and
(2) by adding at the end the following:
‘‘(3) LIMITATION.—Not more than 20 percent of the funds
authorized to be appropriated under this section may be used for
purposes described in subsection (i) (relating to veterans).’’.
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PUBLIC LAW 114–255—DEC. 13, 2016
Subtitle B—Comprehensive Justice and
Mental Health
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SEC. 14021. SEQUENTIAL INTERCEPT MODEL.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa), as amended by section
14005, is amended by inserting after subsection (j), the following:
‘‘(k) SEQUENTIAL INTERCEPT GRANTS.—
‘‘(1) DEFINITION.—In this subsection, the term ‘eligible
entity’ means a State, unit of local government, Indian tribe,
or tribal organization.
‘‘(2) AUTHORIZATION.—The Attorney General may make
grants under this subsection to an eligible entity for sequential
intercept mapping and implementation in accordance with paragraph (3).
‘‘(3) SEQUENTIAL INTERCEPT MAPPING; IMPLEMENTATION.—
An eligible entity that receives a grant under this subsection
may use funds for—
‘‘(A) sequential intercept mapping, which—
‘‘(i) shall consist of—
‘‘(I) convening mental health and criminal justice stakeholders to—
‘‘(aa) develop a shared understanding of
the flow of justice-involved individuals with
mental illnesses through the criminal justice
system; and
‘‘(bb) identify opportunities for improved
collaborative responses to the risks and needs
of individuals described in item (aa); and
‘‘(II) developing strategies to address gaps in
services and bring innovative and effective programs to scale along multiple intercepts,
including—
‘‘(aa) emergency and crisis services;
‘‘(bb) specialized police-based responses;
‘‘(cc) court hearings and disposition alternatives;
‘‘(dd) reentry from jails and prisons; and
‘‘(ee) community supervision, treatment
and support services; and
‘‘(ii) may serve as a starting point for the development of strategic plans to achieve positive public health
and safety outcomes; and
‘‘(B) implementation, which shall—
‘‘(i) be derived from the strategic plans described
in subparagraph (A)(ii); and
‘‘(ii) consist of—
‘‘(I) hiring and training personnel;
‘‘(II) identifying the eligible entity’s target
population;
‘‘(III) providing services and supports to reduce
unnecessary penetration into the criminal justice
system;
‘‘(IV) reducing recidivism;
‘‘(V) evaluating the impact of the eligible
entity’s approach; and
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130 STAT. 1309
‘‘(VI) planning for the sustainability of effective interventions.’’.
SEC. 14022. PRISON AND JAILS.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting
after subsection (k), as added by section 14021, the following:
‘‘(l) CORRECTIONAL FACILITIES.—
‘‘(1) DEFINITIONS.—
‘‘(A) CORRECTIONAL FACILITY.—The term ‘correctional
facility’ means a jail, prison, or other detention facility
used to house people who have been arrested, detained,
held, or convicted by a criminal justice agency or a court.
‘‘(B) ELIGIBLE INMATE.—The term ‘eligible inmate’
means an individual who—
‘‘(i) is being held, detained, or incarcerated in a
correctional facility; and
‘‘(ii) manifests obvious signs of a mental illness
or has been diagnosed by a qualified mental health
professional as having a mental illness.
‘‘(2) CORRECTIONAL FACILITY GRANTS.—The Attorney General may award grants to applicants to enhance the capabilities
of a correctional facility—
‘‘(A) to identify and screen for eligible inmates;
‘‘(B) to plan and provide—
‘‘(i) initial and periodic assessments of the clinical,
medical, and social needs of inmates; and
‘‘(ii) appropriate treatment and services that
address the mental health and substance abuse needs
of inmates;
‘‘(C) to develop, implement, and enhance—
‘‘(i) post-release transition plans for eligible
inmates that, in a comprehensive manner, coordinate
health, housing, medical, employment, and other
appropriate services and public benefits;
‘‘(ii) the availability of mental health care services
and substance abuse treatment services; and
‘‘(iii) alternatives to solitary confinement and segregated housing and mental health screening and
treatment for inmates placed in solitary confinement
or segregated housing; and
‘‘(D) to train each employee of the correctional facility
to identify and appropriately respond to incidents involving
inmates with mental health or co-occurring mental health
and substance abuse disorders.’’.
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SEC. 14023. ALLOWABLE USES.
Section 2991(b)(5)(I) of title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended
by adding at the end the following:
‘‘(v) TEAMS ADDRESSING FREQUENT USERS OF CRISIS
SERVICES.—Multidisciplinary teams that—
‘‘(I) coordinate, implement, and administer
community-based crisis responses and long-term
plans for frequent users of crisis services;
‘‘(II) provide training on how to respond appropriately to the unique issues involving frequent
users of crisis services for public service personnel,
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PUBLIC LAW 114–255—DEC. 13, 2016
including criminal justice, mental health, substance abuse, emergency room, healthcare, law
enforcement, corrections, and housing personnel;
‘‘(III) develop or support alternatives to hospital and jail admissions for frequent users of crisis
services that provide treatment, stabilization, and
other appropriate supports in the least restrictive,
yet appropriate, environment; and
‘‘(IV) develop protocols and systems among law
enforcement, mental health, substance abuse,
housing, corrections, and emergency medical
service operations to provide coordinated assistance to frequent users of crisis services.’’.
SEC. 14024. LAW ENFORCEMENT TRAINING.
Section 2991(h) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended—
(1) in paragraph (1), by adding at the end the following:
‘‘(F) ACADEMY TRAINING.—To provide support for
academy curricula, law enforcement officer orientation programs, continuing education training, and other programs
that teach law enforcement personnel how to identify and
respond to incidents involving persons with mental health
disorders or co-occurring mental health and substance
abuse disorders.’’; and
(2) by adding at the end the following:
‘‘(4) PRIORITY CONSIDERATION.—The Attorney General, in
awarding grants under this subsection, shall give priority to
programs that law enforcement personnel and members of the
mental health and substance abuse professions develop and
administer cooperatively.’’.
42 USC
3797aa–1 note.
SEC. 14025. FEDERAL LAW ENFORCEMENT TRAINING.
Not later than 1 year after the date of enactment of this
Act, the Attorney General shall provide direction and guidance
for the following:
(1) TRAINING PROGRAMS.—Programs that offer specialized
and comprehensive training, in procedures to identify and
appropriately respond to incidents in which the unique needs
of individuals who have a mental illness are involved, to first
responders and tactical units of—
(A) Federal law enforcement agencies; and
(B) other Federal criminal justice agencies such as
the Bureau of Prisons, the Administrative Office of the
United States Courts, and other agencies that the Attorney
General determines appropriate.
(2) IMPROVED TECHNOLOGY.—The establishment of, or
improvement of existing, computerized information systems to
provide timely information to employees of Federal law enforcement agencies, and Federal criminal justice agencies to improve
the response of such employees to situations involving individuals who have a mental illness.
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SEC. 14026. GAO REPORT.
No later than 1 year after the date of enactment of this Act,
the Comptroller General of the United States, in coordination with
the Attorney General, shall submit to Congress a report on—
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130 STAT. 1311
(1) the practices that Federal first responders, tactical
units, and corrections officers are trained to use in responding
to individuals with mental illness;
(2) procedures to identify and appropriately respond to
incidents in which the unique needs of individuals who have
a mental illness are involved, to Federal first responders and
tactical units;
(3) the application of evidence-based practices in criminal
justice settings to better address individuals with mental illnesses; and
(4) recommendations on how the Department of Justice
can expand and improve information sharing and dissemination
of best practices.
SEC. 14027. EVIDENCE BASED PRACTICES.
Section 2991(c) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended—
(1) in paragraph (3), by striking ‘‘or’’ at the end;
(2) by redesignating paragraph (4) as paragraph (6); and
(3) by inserting after paragraph (3), the following:
‘‘(4) propose interventions that have been shown by empirical evidence to reduce recidivism;
‘‘(5) when appropriate, use validated assessment tools to
target preliminarily qualified offenders with a moderate or
high risk of recidivism and a need for treatment and services;
or’’.
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SEC.
14028.
TRANSPARENCY, PROGRAM ACCOUNTABILITY,
ENHANCEMENT OF LOCAL AUTHORITY.
AND
(a) IN GENERAL.—Section 2991(a) of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa(a))
is amended—
(1) in paragraph (7)—
(A) in the heading, by striking ‘‘MENTAL ILLNESS’’ and
inserting ‘‘MENTAL ILLNESS; MENTAL HEALTH DISORDER’’;
and
(B) by striking ‘‘term ‘mental illness’ means’’ and
inserting ‘‘terms ‘mental illness’ and ‘mental health disorder’ mean’’; and
(2) by striking paragraph (9) and inserting the following:
‘‘(9) PRELIMINARILY QUALIFIED OFFENDER.—
‘‘(A) IN GENERAL.—The term ‘preliminarily qualified
offender’ means an adult or juvenile accused of an offense
who—
‘‘(i)(I) previously or currently has been diagnosed
by a qualified mental health professional as having
a mental illness or co-occurring mental illness and
substance abuse disorders;
‘‘(II) manifests obvious signs of mental illness or
co-occurring mental illness and substance abuse disorders during arrest or confinement or before any court;
or
‘‘(III) in the case of a veterans treatment court
provided under subsection (i), has been diagnosed with,
or manifests obvious signs of, mental illness or a substance abuse disorder or co-occurring mental illness
and substance abuse disorder;
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130 STAT. 1312
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(ii) has been unanimously approved for participation in a program funded under this section by, when
appropriate—
‘‘(I) the relevant—
‘‘(aa) prosecuting attorney;
‘‘(bb) defense attorney;
‘‘(cc) probation or corrections official; and
‘‘(dd) judge; and
‘‘(II) a representative from the relevant mental
health agency described in subsection (b)(5)(B)(i);
‘‘(iii) has been determined, by each person
described in clause (ii) who is involved in approving
the adult or juvenile for participation in a program
funded under this section, to not pose a risk of violence
to any person in the program, or the public, if selected
to participate in the program; and
‘‘(iv) has not been charged with or convicted of—
‘‘(I) any sex offense (as defined in section 111
of the Sex Offender Registration and Notification
Act (42 U.S.C. 16911)) or any offense relating to
the sexual exploitation of children; or
‘‘(II) murder or assault with intent to commit
murder.
‘‘(B) DETERMINATION.—In determining whether to designate a defendant as a preliminarily qualified offender,
the relevant prosecuting attorney, defense attorney, probation or corrections official, judge, and mental health or
substance abuse agency representative shall take into
account—
‘‘(i) whether the participation of the defendant in
the program would pose a substantial risk of violence
to the community;
‘‘(ii) the criminal history of the defendant and the
nature and severity of the offense for which the defendant is charged;
‘‘(iii) the views of any relevant victims to the
offense;
‘‘(iv) the extent to which the defendant would benefit from participation in the program;
‘‘(v) the extent to which the community would
realize cost savings because of the defendant’s participation in the program; and
‘‘(vi) whether the defendant satisfies the eligibility
criteria for program participation unanimously established by the relevant prosecuting attorney, defense
attorney, probation or corrections official, judge and
mental health or substance abuse agency representative.’’.
(b) TECHNICAL AND CONFORMING AMENDMENT.—Section 2927(2)
of title I of the Omnibus Crime Control and Safe Streets Act
of 1968 (42 U.S.C. 3797s–6(2)) is amended by striking ‘‘has the
meaning given that term in section 2991(a).’’ and inserting ‘‘means
an offense that—
‘‘(A) does not have as an element the use, attempted
use, or threatened use of physical force against the person
or property of another; or
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‘‘(B) is not a felony that by its nature involves a
substantial risk that physical force against the person or
property of another may be used in the course of committing the offense.’’.
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SEC. 14029. GRANT ACCOUNTABILITY.
Section 2991 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting
after subsection (l), as added by section 14022, the following:
‘‘(m) ACCOUNTABILITY.—All grants awarded by the Attorney
General under this section shall be subject to the following accountability provisions:
‘‘(1) AUDIT REQUIREMENT.—
‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit
report of the Inspector General of the Department of Justice
that the audited grantee has utilized grant funds for an
unauthorized expenditure or otherwise unallowable cost
that is not closed or resolved within 12 months from the
date when the final audit report is issued.
‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this subsection, and
in each fiscal year thereafter, the Inspector General of
the Department of Justice shall conduct audits of recipients
of grants under this section to prevent waste, fraud, and
abuse of funds by grantees. The Inspector General shall
determine the appropriate number of grantees to be audited
each year.
‘‘(C) MANDATORY EXCLUSION.—A recipient of grant
funds under this section that is found to have an unresolved
audit finding shall not be eligible to receive grant funds
under this section during the first 2 fiscal years beginning
after the end of the 12-month period described in subparagraph (A).
‘‘(D) PRIORITY.—In awarding grants under this section,
the Attorney General shall give priority to eligible
applicants that did not have an unresolved audit finding
during the 3 fiscal years before submitting an application
for a grant under this section.
‘‘(E) REIMBURSEMENT.—If an entity is awarded grant
funds under this section during the 2-fiscal-year period
during which the entity is barred from receiving grants
under subparagraph (C), the Attorney General shall—
‘‘(i) deposit an amount equal to the amount of
the grant funds that were improperly awarded to the
grantee into the General Fund of the Treasury; and
‘‘(ii) seek to recoup the costs of the repayment
to the fund from the grant recipient that was erroneously awarded grant funds.
‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.—
‘‘(A) DEFINITION.—For purposes of this paragraph and
the grant programs under this part, the term ‘nonprofit
organization’ means an organization that is described in
section 501(c)(3) of the Internal Revenue Code of 1986
and is exempt from taxation under section 501(a) of such
Code.
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130 STAT. 1314
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(B) PROHIBITION.—The Attorney General may not
award a grant under this part to a nonprofit organization
that holds money in offshore accounts for the purpose of
avoiding paying the tax described in section 511(a) of the
Internal Revenue Code of 1986.
‘‘(C) DISCLOSURE.—Each nonprofit organization that is
awarded a grant under this section and uses the procedures
prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers,
directors, trustees, and key employees, shall disclose to
the Attorney General, in the application for the grant,
the process for determining such compensation, including
the independent persons involved in reviewing and
approving such compensation, the comparability data used,
and contemporaneous substantiation of the deliberation
and decision. Upon request, the Attorney General shall
make the information disclosed under this subparagraph
available for public inspection.
‘‘(3) CONFERENCE EXPENDITURES.—
‘‘(A) LIMITATION.—No amounts made available to the
Department of Justice under this section may be used
by the Attorney General, or by any individual or entity
awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure
for conferences that uses more than $20,000 in funds made
available by the Department of Justice, unless the head
of the relevant agency or department, provides prior written authorization that the funds may be expended to host
the conference.
‘‘(B) WRITTEN APPROVAL.—Written approval under
subparagraph (A) shall include a written estimate of all
costs associated with the conference, including the cost
of all food, beverages, audio-visual equipment, honoraria
for speakers, and entertainment.
‘‘(C) REPORT.—The Deputy Attorney General shall
submit an annual report to the Committee on the Judiciary
of the Senate and the Committee on the Judiciary of the
House of Representatives on all conference expenditures
approved under this paragraph.
‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal
year beginning after the date of enactment of this subsection,
the Attorney General shall submit, to the Committee on the
Judiciary and the Committee on Appropriations of the Senate
and the Committee on the Judiciary and the Committee on
Appropriations of the House of Representatives, an annual
certification—
‘‘(A) indicating whether—
‘‘(i) all audits issued by the Office of the Inspector
General under paragraph (1) have been completed and
reviewed by the appropriate Assistant Attorney General or Director;
‘‘(ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and
‘‘(iii) all reimbursements required under paragraph
(1)(E) have been made; and
‘‘(B) that includes a list of any grant recipients excluded
under paragraph (1) from the previous year.
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‘‘(n) PREVENTING DUPLICATIVE GRANTS.—
‘‘(1) IN GENERAL.—Before the Attorney General awards a
grant to an applicant under this section, the Attorney General
shall compare potential grant awards with other grants
awarded under this Act to determine if duplicate grant awards
are awarded for the same purpose.
‘‘(2) REPORT.—If the Attorney General awards duplicate
grants to the same applicant for the same purpose the Attorney
General shall submit to the Committee on the Judiciary of
the Senate and the Committee on the Judiciary of the House
of Representatives a report that includes—
‘‘(A) a list of all duplicate grants awarded, including
the total dollar amount of any duplicate grants awarded;
and
‘‘(B) the reason the Attorney General awarded the
duplicate grants.’’.
DIVISION C—INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE
FOR AMERICANS
SEC. 15000. SHORT TITLE.
This division may be cited as the ‘‘Increasing Choice, Access,
and Quality in Health Care for Americans Act’’.
Increasing
Choice, Access,
and Quality in
Health Care for
Americans Act.
42 USC 1305
note.
TITLE XV—PROVISIONS RELATING TO
MEDICARE PART A
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SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION OF MS–
DRG CODES FOR SIMILAR HOSPITAL SERVICES.
Section 1886 of the Social Security Act (42 U.S.C. 1395ww)
is amended by adding at the end the following new subsection:
‘‘(t) RELATING SIMILAR INPATIENT AND OUTPATIENT HOSPITAL
SERVICES.—
‘‘(1) DEVELOPMENT OF HCPCS VERSION OF MS–DRG CODES.—
Not later than January 1, 2018, the Secretary shall develop
HCPCS versions for MS–DRGs that are similar to the ICD–
10–PCS for such MS–DRGs such that, to the extent possible,
the MS–DRG assignment shall be similar for a claim coded
with the HCPCS version as an identical claim coded with
a ICD–10–PCS code.
‘‘(2) COVERAGE OF SURGICAL MS–DRGS.—In carrying out
paragraph (1), the Secretary shall develop HCPCS versions
of MS–DRG codes for not fewer than 10 surgical MS–DRGs.
‘‘(3) PUBLICATION AND DISSEMINATION OF THE HCPCS
VERSIONS OF MS–DRGS.—
‘‘(A) IN GENERAL.—The Secretary shall develop a
HCPCS MS–DRG definitions manual and software that
is similar to the definitions manual and software for ICD–
10–PCS codes for such MS–DRGs. The Secretary shall
post the HCPCS MS–DRG definitions manual and software
on the Internet website of the Centers for Medicare &
Medicaid Services. The HCPCS MS–DRG definitions
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manual and software shall be in the public domain and
available for use and redistribution without charge.
‘‘(B) USE OF PREVIOUS ANALYSIS DONE BY MEDPAC.—
In developing the HCPCS MS–DRG definitions manual
and software under subparagraph (A), the Secretary shall
consult with the Medicare Payment Advisory Commission
and shall consider the analysis done by such Commission
in translating outpatient surgical claims into inpatient surgical MS–DRGs in preparing chapter 7 (relating to hospital
short-stay policy issues) of its ‘Medicare and the Health
Care Delivery System’ report submitted to Congress in
June 2015.
‘‘(4) DEFINITION AND REFERENCE.—In this subsection:
‘‘(A) HCPCS.—The term ‘HCPCS’ means, with respect
to hospital items and services, the code under the
Healthcare Common Procedure Coding System (HCPCS)
(or a successor code) for such items and services.
‘‘(B) ICD–10–PCS.—The term ‘ICD–10–PCS’ means the
International Classification of Diseases, 10th Revision,
Procedure Coding System, and includes any subsequent
revision of such International Classification of Diseases,
Procedure Coding System.’’.
SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE
HOSPITAL READMISSION PROGRAM.
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(a) TRANSITIONAL ADJUSTMENT FOR
LATION.—Section 1886(q)(3) of the Social
DUAL ELIGIBLE POPUSecurity Act (42 U.S.C.
1395ww(q)(3)) is amended—
(1) in subparagraph (A), by inserting ‘‘subject to subparagraph (D),’’ after ‘‘purposes of paragraph (1),’’; and
(2) by adding at the end the following new subparagraph:
‘‘(D) TRANSITIONAL ADJUSTMENT FOR DUAL ELIGIBLES.—
‘‘(i) IN GENERAL.—In determining a hospital’s
adjustment factor under this paragraph for purposes
of making payments for discharges occurring during
and after fiscal year 2019, and before the application
of clause (i) of subparagraph (E), the Secretary shall
assign hospitals to groups (as defined by the Secretary
under clause (ii)) and apply the applicable provisions
of this subsection using a methodology in a manner
that allows for separate comparison of hospitals within
each such group, as determined by the Secretary.
‘‘(ii) DEFINING GROUPS.—For purposes of this
subparagraph, the Secretary shall define groups of hospitals, based on their overall proportion, of the
inpatients who are entitled to, or enrolled for, benefits
under part A, and who are full-benefit dual eligible
individuals (as defined in section 1935(c)(6)). In
defining groups, the Secretary shall consult the Medicare Payment Advisory Commission and may consider
the analysis done by such Commission in preparing
the portion of its report submitted to Congress in June
2013 relating to readmissions.
‘‘(iii) MINIMIZING REPORTING BURDEN ON HOSPITALS.—In carrying out this subparagraph, the Secretary shall not impose any additional reporting
requirements on hospitals.
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‘‘(iv) BUDGET NEUTRAL DESIGN METHODOLOGY.—
The Secretary shall design the methodology to implement this subparagraph so that the estimated total
amount of reductions in payments under this subsection equals the estimated total amount of reductions
in payments that would otherwise occur under this
subsection if this subparagraph did not apply.’’.
(b) CHANGES IN RISK ADJUSTMENT.—Section 1886(q)(3) of the
Social Security Act (42 U.S.C. 1395ww(q)(3)), as amended by subsection (a), is further amended by adding at the end the following
new subparagraph:
‘‘(E) CHANGES IN RISK ADJUSTMENT.—
‘‘(i) CONSIDERATION OF RECOMMENDATIONS IN
IMPACT REPORTS.—The Secretary may take into account
the studies conducted and the recommendations made
by the Secretary under section 2(d)(1) of the IMPACT
Act of 2014 (Public Law 113–185; 42 U.S.C. 1395lll
note) with respect to the application under this subsection of risk adjustment methodologies. Nothing in
this clause shall be construed as precluding consideration of the use of groupings of hospitals.
‘‘(ii) CONSIDERATION OF EXCLUSION OF PATIENT
CASES BASED ON V OR OTHER APPROPRIATE CODES.—
In promulgating regulations to carry out this subsection with respect to discharges occurring after fiscal
year 2018, the Secretary may consider the use of V
or other ICD-related codes for removal of a readmission. The Secretary may consider modifying measures
under this subsection to incorporate V or other ICDrelated codes at the same time as other changes are
being made under this subparagraph.
‘‘(iii) REMOVAL OF CERTAIN READMISSIONS.—In
promulgating regulations to carry out this subsection,
with respect to discharges occurring after fiscal year
2018, the Secretary may consider removal as a
readmission of an admission that is classified within
one or more of the following: transplants, end-stage
renal disease, burns, trauma, psychosis, or substance
abuse. The Secretary may consider modifying measures
under this subsection to remove readmissions at the
same time as other changes are being made under
this subparagraph.’’.
(c) MEDPAC STUDY ON READMISSIONS PROGRAM.—The Medicare
Payment Advisory Commission shall conduct a study to review
overall hospital readmissions described in section 1886(q)(5)(E) of
the Social Security Act (42 U.S.C. 1395ww(q)(5)(E)) and whether
such readmissions are related to any changes in outpatient and
emergency services furnished. The Commission shall submit to
Congress a report on such study in its report to Congress in June
2018.
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SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL DEMONSTRATION PROGRAM.
(a) EXTENSION.—Section 410A of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law
108–173; 42 U.S.C. 1395ww note) is amended—
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PUBLIC LAW 114–255—DEC. 13, 2016
(1) in subsection (a)(5), by striking ‘‘5-year extension period’’
and inserting ‘‘10-year extension period’’; and
(2) in subsection (g)—
(A) in the subsection heading, by striking ‘‘FIVE-YEAR’’
and inserting ‘‘TEN-YEAR’’;
(B) in paragraph (1), by striking ‘‘additional 5-year’’
and inserting ‘‘additional 10-year’’;
(C) by striking ‘‘5-year extension period’’ and inserting
‘‘10-year extension period’’ each place it appears;
(D) in paragraph (4)(B)—
(i) in the matter preceding clause (i), by inserting
‘‘each 5-year period in’’ after ‘‘hospital during’’; and
(ii) in clause (i), by inserting ‘‘each applicable 5year period in’’ after ‘‘the first day of’’; and
(E) by adding at the end the following new paragraphs:
‘‘(5) OTHER HOSPITALS IN DEMONSTRATION PROGRAM.—
During the second 5 years of the 10-year extension period,
the Secretary shall apply the provisions of paragraph (4) to
rural community hospitals that are not described in paragraph
(4) but are participating in the demonstration program under
this section as of December 30, 2014, in a similar manner
as such provisions apply to rural community hospitals described
in paragraph (4).
‘‘(6) EXPANSION OF DEMONSTRATION PROGRAM TO RURAL
AREAS IN ANY STATE.—
‘‘(A) IN GENERAL.—The Secretary shall, notwithstanding subsection (a)(2) or paragraph (2) of this subsection, not later than 120 days after the date of the
enactment of this paragraph, issue a solicitation for applications to select up to the maximum number of additional
rural community hospitals located in any State to participate in the demonstration program under this section for
the second 5 years of the 10-year extension period without
exceeding the limitation under paragraph (3) of this subsection.
‘‘(B) PRIORITY.—In determining which rural community
hospitals that submitted an application pursuant to the
solicitation under subparagraph (A) to select for participation in the demonstration program, the Secretary—
‘‘(i) shall give priority to rural community hospitals
located in one of the 20 States with the lowest population densities (as determined by the Secretary using
the 2015 Statistical Abstract of the United States);
and
‘‘(ii) may consider—
‘‘(I) closures of hospitals located in rural areas
in the State in which the rural community hospital
is located during the 5-year period immediately
preceding the date of the enactment of this paragraph; and
‘‘(II) the population density of the State in
which the rural community hospital is located.’’.
(b) CHANGE IN TIMING FOR REPORT.—Subsection (e) of such
section 410A is amended—
(1) by striking ‘‘Not later than 6 months after the completion of the demonstration program under this section’’ and
inserting ‘‘Not later than August 1, 2018’’; and
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(2) by striking ‘‘such program’’ and inserting ‘‘the demonstration program under this section’’.
SEC. 15004. REGULATORY RELIEF FOR LTCHS.
(a) TECHNICAL CHANGE TO THE MEDICARE LONG-TERM CARE
HOSPITAL MORATORIUM EXCEPTION.—
(1) IN GENERAL.—Section 114(d)(7) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww
note), as amended by sections 3106(b) and 10312(b) of Public
Law 111–148, section 1206(b)(2) of the Pathway for SGR Reform
Act of 2013 (division B of Public Law 113–67), and section
112 of the Protecting Access to Medicare Act of 2014 (Public
Law 113–93), is amended by striking ‘‘The moratorium under
paragraph (1)(A)’’ and inserting ‘‘Any moratorium under paragraph (1)’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph
(1) shall take effect as if included in the enactment of section
112 of the Protecting Access to Medicare Act of 2014.
(b) MODIFICATION TO MEDICARE LONG-TERM CARE HOSPITAL
HIGH COST OUTLIER PAYMENTS.—Section 1886(m) of the Social
Security Act (42 U.S.C. 1395ww(m)) is amended by adding at the
end the following new paragraph:
‘‘(7) TREATMENT OF HIGH COST OUTLIER PAYMENTS.—
‘‘(A) ADJUSTMENT TO THE STANDARD FEDERAL PAYMENT
RATE FOR ESTIMATED HIGH COST OUTLIER PAYMENTS.—
Under the system described in paragraph (1), for fiscal
years beginning on or after October 1, 2017, the Secretary
shall reduce the standard Federal payment rate as if the
estimated aggregate amount of high cost outlier payments
for standard Federal payment rate discharges for each
such fiscal year would be equal to 8 percent of estimated
aggregate payments for standard Federal payment rate
discharges for each such fiscal year.
‘‘(B) LIMITATION ON HIGH COST OUTLIER PAYMENT
AMOUNTS.—Notwithstanding subparagraph (A), the Secretary shall set the fixed loss amount for high cost outlier
payments such that the estimated aggregate amount of
high cost outlier payments made for standard Federal payment rate discharges for fiscal years beginning on or after
October 1, 2017, shall be equal to 99.6875 percent of 8
percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year.
‘‘(C) WAIVER OF BUDGET NEUTRALITY.—Any reduction
in payments resulting from the application of subparagraph
(B) shall not be taken into account in applying any budget
neutrality provision under such system.
‘‘(D) NO EFFECT ON SITE NEUTRAL HIGH COST OUTLIER
PAYMENT RATE.—This paragraph shall not apply with
respect to the computation of the applicable site neutral
payment rate under paragraph (6).’’.
42 USC 1395ww
note.
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SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT
APPLYING DOCUMENTATION AND CODING ADJUSTMENTS.
Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI
Programs Extension Act of 2007 (Public Law 110–90), as amended
by section 631(b) of the American Taxpayer Relief Act of 2012
(Public Law 112–240) and section 414(1)(B)(iii) of the Medicare
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Access and CHIP Reauthorization Act of 2015 (Public Law 114–
10), is amended in clause (iii) by striking ‘‘an increase of 0.5 percentage points for discharges occurring during each of fiscal years
2018 through 2023’’ and inserting ‘‘an increase of 0.4588 percentage
points for discharges occurring during fiscal year 2018 and 0.5
percentage points for discharges occurring during each of fiscal
years 2019 through 2023’’.
SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT
RULES.
(a) 25–PERCENT PATIENT THRESHOLD PAYMENT ADJUSTMENT.—
Section 114(c)(1)(A) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww note), as amended by section
4302(a) of division B of the American Recovery and Reinvestment
Act (Public Law 111–5), sections 3106(a) and 10312(a) of Public
Law 111–148, and section 1206(b)(1)(B) of the Pathway for SGR
Reform Act of 2013 (division B of Public Law 113–67), is amended
by striking ‘‘for a 9-year period’’ and inserting ‘‘through June 30,
2016, and for discharges occurring on or after October 1, 2016,
and before October 1, 2017’’.
(b) PAYMENT FOR HOSPITALS-WITHIN-HOSPITALS.—Section
114(c)(2) of the Medicare, Medicaid, and SCHIP Extension Act
of 2007 (42 U.S.C. 1395ww note), as amended by section 4302(a)
of division B of the American Recovery and Reinvestment Act
(Public Law 111–5), sections 3106(a) and 10312(a) of Public Law
111–148, and section 1206(b)(1)(A) of the Pathway for SGR Reform
Act of 2013 (division B of Public Law 113–67), is amended—
(1) in subparagraph (A), by inserting ‘‘or any similar provision,’’ after ‘‘Regulations,’’;
(2) in subparagraph (B)—
(A) in clause (i), by inserting ‘‘or any similar provision,’’
after ‘‘Regulations,’’; and
(B) in clause (ii), by inserting ‘‘, or any similar provision,’’ after ‘‘Regulations’’; and
(3) in subparagraph (C), by striking ‘‘for a 9-year period’’
and inserting ‘‘through June 30, 2016, and for discharges occurring on or after October 1, 2016, and before October 1, 2017’’.
SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF HOSPITAL LENGTH OF STAY TO ALL LTCHS.
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42 USC 1395ww
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(a) IN GENERAL.—Section 1206(a)(3) of the Pathway for SGR
Reform Act of 2013 (division B of Public Law 113–67; 42 U.S.C.
1395ww note) is amended—
(1) by striking subparagraph (B);
(2) by striking ‘‘SITE NEUTRAL BASIS.—’’ and all that follows
through ‘‘For discharges occurring’’ and inserting ‘‘SITE NEUTRAL
BASIS.—For discharges occurring’’;
(3) by striking ‘‘subject to subparagraph (B),’’; and
(4) by redesignating clauses (i) and (ii) as subparagraphs
(A) and (B), respectively, and moving each of such subparagraphs (as so redesignated) 2 ems to the left.
(b) EFFECTIVE DATE.—The amendments made by subsection
(a) shall be effective as if included in the enactment of section
1206(a)(3) of the Pathway for SGR Reform Act of 2013 (division
B of Public Law 113–67; 42 U.S.C. 1395ww note).
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SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN
HOSPITALS.
(a) IN GENERAL.—Subsection (d)(1)(B)(iv) of section 1886 of
the Social Security Act (42 U.S.C. 1395ww) is amended—
(1) in subclause (I), by striking ‘‘or’’ at the end;
(2) in subclause (II)—
(A) by striking ‘‘, or’’ at the end and inserting a semicolon;
(B) by redesignating such subclause as clause (vi) and
by moving it to immediately follow clause (v); and
(C) in clause (v), by striking the semicolon at the
end and inserting ‘‘, or’’; and
(3) by striking ‘‘(iv)(I) a hospital’’ and inserting ‘‘(iv) a
hospital’’.
(b) CONFORMING PAYMENT REFERENCES.—The second sentence
of subsection (d)(1)(B) of such section is amended—
(1) by inserting ‘‘(as in effect as of such date)’’ after ‘‘clause
(iv)’’; and
(2) by inserting ‘‘(or, in the case of a hospital described
in clause (iv)(II), as so in effect, shall be classified under clause
(vi) on and after the effective date of such clause (vi) and
for cost reporting periods beginning on or after January 1,
2015, shall not be subject to subsection (m) as of the date
of such classification)’’ after ‘‘so classified’’.
(c) APPLICATION.—
(1) IN GENERAL.—For cost reporting periods beginning on
or after January 1, 2015, in the case of an applicable hospital
(as defined in paragraph (3)), the following shall apply:
(A) Payment for inpatient operating costs shall be made
on a reasonable cost basis in the manner provided in section
412.526(c)(3) of title 42, Code of Federal Regulations (as
in effect on January 1, 2015) and in any subsequent modifications.
(B) Payment for capital costs shall be made in the
manner provided by section 412.526(c)(4) of title 42, Code
of Federal Regulations (as in effect on such date).
(C) Claims for payment for Medicare beneficiaries who
are discharged on or after January 1, 2017, shall be processed as claims which are paid on a reasonable cost basis
as described in section 412.526(c) of title 42, Code of Federal Regulations (as in effect on such date).
(2) APPLICABLE HOSPITAL DEFINED.—In this subsection, the
term ‘‘applicable hospital’’ means a hospital that is classified
under clause (iv)(II) of section 1886(d)(1)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(1)(B)) on the day before the
date of the enactment of this Act and which is classified under
clause (vi) of such section, as redesignated and moved by subsection (a), on or after such date of enactment.
(d) CONFORMING TECHNICAL AMENDMENTS.—
(1) Section 1899B(a)(2)(A)(iv) of the Social Security Act
(42 U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking
‘‘1886(d)(1)(B)(iv)(II)’’ and inserting ‘‘1886(d)(1)(B)(vi)’’.
(2) Section 1886(m)(5)(F) of such Act (42 U.S.C.
1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii)
by striking ‘‘(d)(1)(B)(iv)(II)’’ and inserting ‘‘(d)(1)(B)(vi)’’.
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SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CERTAIN SPINAL CORD SPECIALTY HOSPITALS.
(a) EXCEPTION.—Section 1886(m)(6) of the Social Security Act
(42 U.S.C. 1395ww(m)(6)) is amended—
(1) in subparagraph (A)(i), by striking ‘‘and (E)’’ and
inserting ‘‘, (E), and (F)’’; and
(2) by adding at the end the following new subparagraph:
‘‘(F) TEMPORARY EXCEPTION FOR CERTAIN SPINAL CORD
SPECIALTY HOSPITALS.—For discharges in cost reporting
periods beginning during fiscal years 2018 and 2019,
subparagraph (A)(i) shall not apply (and payment shall
be made to a long-term care hospital without regard to
this paragraph) if such discharge is from a long-term care
hospital that meets each of the following requirements:
‘‘(i) NOT-FOR-PROFIT.—The long-term care hospital
was a not-for-profit long-term care hospital on June
1, 2014, as determined by cost report data.
‘‘(ii) PRIMARILY PROVIDING TREATMENT FOR CATA-
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STROPHIC SPINAL CORD OR ACQUIRED BRAIN INJURIES
OR OTHER PARALYZING NEUROMUSCULAR CONDITIONS.—
Of the discharges in calendar year 2013 from the longterm care hospital for which payment was made under
this section, at least 50 percent were classified under
MS–LTCH–DRGs 28, 29, 52, 57, 551, 573, and 963.
‘‘(iii) SIGNIFICANT OUT-OF-STATE ADMISSIONS.—
‘‘(I) IN GENERAL.—The long-term care hospital
discharged inpatients (including both individuals
entitled to, or enrolled for, benefits under this
title and individuals not so entitled or enrolled)
during fiscal year 2014 who had been admitted
from at least 20 of the 50 States, determined by
the States of residency of such inpatients and
based on such data submitted by the hospital to
the Secretary as the Secretary may require.
‘‘(II) IMPLEMENTATION.—Notwithstanding any
other provision of law, the Secretary may implement subclause (I) by program instruction or otherwise.
‘‘(III) NON-APPLICATION OF PAPERWORK REDUCTION ACT.—Chapter 35 of title 44, United States
Code, shall not apply to data collected under this
clause.’’.
(b) STUDY AND REPORT ON THE STATUS AND VIABILITY OF CERTAIN SPINAL CORD SPECIALTY LONG-TERM CARE HOSPITALS.—
(1) STUDY.—The Comptroller General of the United States
shall conduct a study on long-term care hospitals described
in section 1886(m)(6)(F) of the Social Security Act, as added
by subsection (a). Such report shall include an analysis of
the following:
(A) The impact on such hospitals of the classification
and facility licensure by State agencies of such hospitals.
(B) The Medicare payment rates for such hospitals.
(C) Data on the number and health care needs of
Medicare beneficiaries who have been diagnosed with catastrophic spinal cord or acquired brain injuries or other
paralyzing neuromuscular conditions (as described within
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the discharge classifications specified in clause (ii) of such
section) who are receiving services from such hospitals.
(2) REPORT.—Not later than October 1, 2018, the Comptroller General shall submit to Congress a report on the study
conducted under paragraph (1), including recommendations for
such legislation and administrative action as the Comptroller
General determines appropriate.
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SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CERTAIN DISCHARGES WITH SEVERE WOUNDS.
(a) IN GENERAL.—Section 1886(m)(6) of the Social Security
Act (42 U.S.C. 1395ww(m)(6)), as amended by section 15009, is
further amended—
(1) in subparagraph (A)(i) by striking ‘‘and (F)’’ and
inserting ‘‘(F), and (G)’’;
(2) in subparagraph (E)(i)(I)(aa), by striking ‘‘the amendment made’’ and all that follows before the semicolon and
inserting ‘‘the last sentence of subsection (d)(1)(B)’’; and
(3) by adding at the end the following new subparagraph:
‘‘(G) ADDITIONAL TEMPORARY EXCEPTION FOR CERTAIN
SEVERE WOUND DISCHARGES FROM CERTAIN LONG-TERM CARE
HOSPITALS.—
‘‘(i) IN GENERAL.—For a discharge occurring in a
cost reporting period beginning during fiscal year 2018,
subparagraph (A)(i) shall not apply (and payment shall
be made to a long-term care hospital without regard
to this paragraph) if such discharge—
‘‘(I) is from a long-term care hospital identified
by the last sentence of subsection (d)(1)(B);
‘‘(II) is classified under MS–LTCH–DRG 602,
603, 539, or 540; and
‘‘(III) is with respect to an individual treated
by a long-term care hospital for a severe wound.
‘‘(ii) SEVERE WOUND DEFINED.—In this subparagraph, the term ‘severe wound’ means a wound which
is a stage 3 wound, stage 4 wound, unstageable wound,
non-healing surgical wound, or fistula as identified
in the claim from the long-term care hospital.
‘‘(iii) WOUND DEFINED.—In this subparagraph, the
term ‘wound’ means an injury involving division of
tissue or rupture of the integument or mucous membrane with exposure to the external environment.’’.
(c) STUDY AND REPORT TO CONGRESS.—
(1) STUDY.—The Comptroller General of the United States
shall, in consultation with relevant stakeholders, conduct a
study on the treatment needs of individuals entitled to benefits
under part A of title XVIII of the Social Security Act or enrolled
under part B of such title who require specialized wound care,
and the cost, for such individuals and the Medicare program
under such title, of treating severe wounds in rural and urban
areas. Such study shall include an assessment of—
(A) access of such individuals to appropriate levels
of care for such cases;
(B) the potential impact that section 1886(m)(6)(A)(i)
of such Act (42 U.S.C. 1395ww(m)(6)(A)(i)) will have on
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the access, quality, and cost of care for such individuals;
and
(C) how to appropriately pay for such care under the
Medicare program under such title.
(2) REPORT.—Not later than October 1, 2020, the Comptroller General shall submit to Congress a report on the study
conducted under paragraph (1), including recommendations for
such legislation and administrative action as the Comptroller
General determines appropriate.
TITLE XVI—PROVISIONS RELATING TO
MEDICARE PART B
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SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE PAYMENT SYSTEM FOR SERVICES FURNISHED BY
MID-BUILD OFF-CAMPUS OUTPATIENT DEPARTMENTS
OF PROVIDERS.
(a) IN GENERAL.—Section 1833(t)(21) of the Social Security
Act (42 U.S.C. 1395l(t)(21)) is amended—
(1) in subparagraph (B)—
(A) in clause (i), by striking ‘‘clause (ii)’’ and inserting
‘‘the subsequent provisions of this subparagraph’’; and
(B) by adding at the end the following new clauses:
‘‘(iii) DEEMED TREATMENT FOR 2017.—For purposes
of applying clause (ii) with respect to applicable items
and services furnished during 2017, a department of
a provider (as so defined) not described in such clause
is deemed to be billing under this subsection with
respect to covered OPD services furnished prior to
November 2, 2015, if the Secretary received from the
provider prior to December 2, 2015, an attestation
(pursuant to section 413.65(b)(3) of title 42 of the Code
of Federal Regulations) that such department was a
department of a provider (as so defined).
‘‘(iv) ALTERNATIVE EXCEPTION BEGINNING WITH
2018.—For purposes of paragraph (1)(B)(v) and this
paragraph with respect to applicable items and services
furnished during 2018 or a subsequent year, the term
‘off-campus outpatient department of a provider’ also
shall not include a department of a provider (as so
defined) that is not described in clause (ii) if—
‘‘(I) the Secretary receives from the provider
an attestation (pursuant to such section
413.65(b)(3)) not later than December 31, 2016
(or, if later, 60 days after the date of the enactment
of this clause), that such department met the
requirements of a department of a provider specified in section 413.65 of title 42 of the Code of
Federal Regulations;
‘‘(II) the provider includes such department
as part of the provider on its enrollment form
in accordance with the enrollment process under
section 1866(j); and
‘‘(III) the department met the mid-build
requirement of clause (v) and the Secretary
receives, not later than 60 days after the date
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130 STAT. 1325
of the enactment of this clause, from the chief
executive officer or chief operating officer of the
provider a written certification that the department met such requirement.
‘‘(v) MID-BUILD REQUIREMENT DESCRIBED.—The
mid-build requirement of this clause is, with respect
to a department of a provider, that before November
2, 2015, the provider had a binding written agreement
with an outside unrelated party for the actual construction of such department.
‘‘(vii) AUDIT.—Not later than December 31, 2018,
the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department
of a provider to which such clause applies. If the Secretary finds as a result of an audit under this clause
that the applicable requirements were not met with
respect to such department, the department shall not
be excluded from the term ‘off-campus outpatient
department of a provider’ under such clause.
‘‘(viii) IMPLEMENTATION.—For purposes of implementing clauses (iii) through (vii):
‘‘(I) Notwithstanding any other provision of
law, the Secretary may implement such clauses
by program instruction or otherwise.
‘‘(II) Subchapter I of chapter 35 of title 44,
United States Code, shall not apply.
‘‘(III) For purposes of carrying out this
subparagraph with respect to clauses (iii) and (iv)
(and clause (vii) insofar as it relates to clause
(iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund
under section 1841, to remain available until
December 31, 2018.’’; and
(2) in subparagraph (E), by adding at the end the following
new clause:
‘‘(iv) The determination of an audit under subparagraph (B)(vii).’’.
(b) EFFECTIVE DATE.—The amendments made by this section
shall be effective as if included in the enactment of section 603
of the Bipartisan Budget Act of 2015 (Public Law 114–74).
42 USC 1395l
note.
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SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER POLICY.
(a) IN GENERAL.—Section 1833(t)(21)(B) of the Social Security
Act (42 U.S.C. 1395l(t)(21)(B)), as amended by section 16001(a),
is amended—
(1) by inserting after clause (v) the following new clause:
‘‘(vi) EXCLUSION FOR CERTAIN CANCER HOSPITALS.—
For purposes of paragraph (1)(B)(v) and this paragraph
with respect to applicable items and services furnished
during 2017 or a subsequent year, the term ‘off-campus
outpatient department of a provider’ also shall not
include a department of a provider (as so defined)
that is not described in clause (ii) if the provider is
a hospital described in section 1886(d)(1)(B)(v) and—
‘‘(I) in the case of a department that met the
requirements of section 413.65 of title 42 of the
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42 USC 1395l
note.
PUBLIC LAW 114–255—DEC. 13, 2016
Code of Federal Regulations after November 1,
2015, and before the date of the enactment of
this clause, the Secretary receives from the provider an attestation that such department met
such requirements not later than 60 days after
such date of enactment; or
‘‘(II) in the case of a department that meets
such requirements after such date of enactment,
the Secretary receives from the provider an
attestation that such department meets such
requirements not later than 60 days after the date
such requirements are first met with respect to
such department.’’;
(2) in clause (vii), by inserting after the first sentence
the following: ‘‘Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to
compliance of a department of a provider with requirements
referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department.’’;
and
(3) in clause (viii)(III), by adding at the end the following:
‘‘For purposes of carrying out this subparagraph with respect
to clause (vi) (and clause (vii) insofar as it relates to such
clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841,
to remain available until expended.’’.
(b) OFFSETTING SAVINGS.—Section 1833(t)(18) of the Social
Security Act (42 U.S.C. 1395l(t)(18)) is amended—
(1) in subparagraph (B), by inserting ‘‘, subject to subparagraph (C),’’ after ‘‘shall’’; and
(2) by adding at the end the following new subparagraph:
‘‘(C) TARGET PCR ADJUSTMENT.—In applying section
419.43(i) of title 42 of the Code of Federal Regulations
to implement the appropriate adjustment under this paragraph for services furnished on or after January 1, 2018,
the Secretary shall use a target PCR that is 1.0 percentage
points less than the target PCR that would otherwise apply.
In addition to the percentage point reduction under the
previous sentence, the Secretary may consider making an
additional percentage point reduction to such target PCR
that takes into account payment rates for applicable items
and services described in paragraph (21)(C) other than
for services furnished by hospitals described in section
1886(d)(1)(B)(v). In making any budget neutrality adjustments under this subsection for 2018 or a subsequent year,
the Secretary shall not take into account the reduced
expenditures that result from the application of this
subparagraph.’’.
(c) EFFECTIVE DATE.—The amendments made by this section
shall be effective as if included in the enactment of section 603
of the Bipartisan Budget Act of 2015 (Public Law 114–74).
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SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY SURGICAL CENTERS FOR MEANINGFUL USE AND
MIPS.
Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C.
1395w–4(a)(7)(D)) is amended—
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130 STAT. 1327
(1) by striking ‘‘HOSPITAL-BASED ELIGIBLE PROFESSIONALS’’
and all that follows through ‘‘No payment’’ and inserting the
following: ‘‘HOSPITAL-BASED AND AMBULATORY SURGICAL CENTERBASED ELIGIBLE PROFESSIONALS.—
‘‘(i) HOSPITAL-BASED.—No payment’’; and
(2) by adding at the end the following new clauses:
‘‘(ii) AMBULATORY SURGICAL CENTER-BASED.—Subject to clause (iv), no payment adjustment may be
made under subparagraph (A) for 2017 and 2018 in
the case of an eligible professional with respect to
whom substantially all of the covered professional services furnished by such professional are furnished in
an ambulatory surgical center.
‘‘(iii) DETERMINATION.—The determination of
whether an eligible professional is an eligible professional described in clause (ii) may be made on the
basis of—
‘‘(I) the site of service (as defined by the Secretary); or
‘‘(II) an attestation submitted by the eligible
professional.
Determinations made under subclauses (I) and (II)
shall be made without regard to any employment or
billing arrangement between the eligible professional
and any other supplier or provider of services.
‘‘(iv) SUNSET.—Clause (ii) shall no longer apply
as of the first year that begins more than 3 years
after the date on which the Secretary determines,
through notice and comment rulemaking, that certified
EHR technology applicable to the ambulatory surgical
center setting is available.’’.
SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016.
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(a) EXTENSION OF ENFORCEMENT INSTRUCTION ON SUPERVISION
REQUIREMENTS FOR OUTPATIENT THERAPEUTIC SERVICES IN CRITICAL ACCESS AND SMALL RURAL HOSPITALS THROUGH 2016.—Section
1 of Public Law 113–198, as amended by section 1 of Public Law
114–112, is amended—
(1) in the heading, by striking ‘‘2014 AND 2015’’ and inserting
‘‘2016’’; and
(2) by striking ‘‘and 2015’’ and inserting ‘‘, 2015, and 2016’’.
(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Medicare Payment Advisory Commission
(established under section 1805 of the Social Security Act (42 U.S.C.
1395b–6)) shall submit to Congress a report analyzing the effect
of the extension of the enforcement instruction under section 1
of Public Law 113–198, as amended by section 1 of Public Law
114–112 and subsection (a) of this section, on the access to health
care by Medicare beneficiaries, on the economic impact and the
impact upon hospital staffing needs, and on the quality of health
care furnished to such beneficiaries.
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PUBLIC LAW 114–255—DEC. 13, 2016
SEC.
16005.
DELAY OF IMPLEMENTATION OF MEDICARE FEE
SCHEDULE ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES AND SEATING SYSTEMS WHEN USED IN
CONJUNCTION WITH COMPLEX REHABILITATION TECHNOLOGY (CRT) WHEELCHAIRS.
Section 2(a) of the Patient Access and Medicare Protection
Act (42 U.S.C. 1305 note) is amended by striking ‘‘January 1,
2017’’ and inserting ‘‘July 1, 2017’’.
SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM
TENENS ARRANGEMENTS UNDER MEDICARE.
42 USC 1395u
note.
(a) IN GENERAL.—The first sentence of section 1842(b)(6) of
the Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by
section 5012, is further amended—
(1) by striking ‘‘and’’ before ‘‘(I)’’; and
(2) by inserting before the period at the end the following:
‘‘, and (J) in the case of outpatient physical therapy services
furnished by physical therapists in a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health
Service Act), a medically underserved area (as designated
pursuant to section 330(b)(3)(A) of such Act), or a rural area
(as defined in section 1886(d)(2)(D)), subparagraph (D) of this
sentence shall apply to such services and therapists in the
same manner as such subparagraph applies to physicians’ services furnished by physicians’’.
(b) EFFECTIVE DATE; IMPLEMENTATION.—
(1) EFFECTIVE DATE.—The amendments made by subsection
(a) shall apply to services furnished beginning not later than
six months after the date of the enactment of this Act.
(2) IMPLEMENTATION.—The Secretary of Health and Human
Services may implement subparagraph (J) of section 1842(b)(6)
of the Social Security Act (42 U.S.C. 1395u(b)(6)), as added
by subsection (a)(2), by program instruction or otherwise.
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SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES
FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM.
(a) IN GENERAL.—The Secretary of Health and Human Services
shall extend the transition period described in clause (i) of section
414.210(g)(9) of title 42, Code of Federal Regulations, from June
30, 2016, to December 31, 2016 (with the full implementation
described in clause (ii) of such section applying to items and services
furnished with dates of service on or after January 1, 2017).
(b) STUDY AND REPORT.—
(1) STUDY.—
(A) IN GENERAL.—The Secretary of Health and Human
Services shall conduct a study that examines the impact
of applicable payment adjustments upon—
(i) the number of suppliers of durable medical
equipment that, on a date that is not before January
1, 2016, and not later than December 31, 2016, ceased
to conduct business as such suppliers; and
(ii) the availability of durable medical equipment,
during the period beginning on January 1, 2016, and
ending on December 31, 2016, to individuals entitled
to benefits under part A of title XVIII of the Social
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PUBLIC LAW 114–255—DEC. 13, 2016
130 STAT. 1329
Security Act (42 U.S.C. 1395 et seq.) or enrolled under
part B of such title.
(B) DEFINITIONS.—For purposes of this subsection, the
following definitions apply:
(i) SUPPLIER; DURABLE MEDICAL EQUIPMENT.—The
terms ‘‘supplier’’ and ‘‘durable medical equipment’’ have
the meanings given such terms by section 1861 of
the Social Security Act (42 U.S.C. 1395x).
(ii) APPLICABLE PAYMENT ADJUSTMENT.—The term
‘‘applicable payment adjustment’’ means a payment
adjustment described in section 414.210(g) of title 42,
Code of Federal Regulations, that is phased in by paragraph (9)(i) of such section. For purposes of the preceding sentence, a payment adjustment that is phased
in pursuant to the extension under subsection (a) shall
be considered a payment adjustment that is phased
in by such paragraph (9)(i).
(2) REPORT.—The Secretary of Health and Human Services
shall, not later than January 12, 2017, submit to the Committees on Ways and Means and on Energy and Commerce of
the House of Representatives, and to the Committee on Finance
of the Senate, a report on the findings of the study conducted
under paragraph (1).
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SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING
INFORMATION FROM COMPETITIVE BIDDING PROGRAMS.
(a) IN GENERAL.—Section 1834(a)(1)(G) of the Social Security
Act (42 U.S.C. 1395m(a)(1)(G)) is amended by adding at the end
the following new sentence: ‘‘In the case of items and services
furnished on or after January 1, 2019, in making any adjustments
under clause (ii) or (iii) of subparagraph (F), under subsection
(h)(1)(H)(ii), or under section 1842(s)(3)(B), the Secretary shall—
‘‘(i) solicit and take into account stakeholder input;
and
‘‘(ii) take into account the highest amount bid by
a winning supplier in a competitive acquisition area
and a comparison of each of the following with respect
to non-competitive acquisition areas and competitive
acquisition areas:
‘‘(I) The average travel distance and cost associated with furnishing items and services in the
area.
‘‘(II) The average volume of items and services
furnished by suppliers in the area.
‘‘(III) The number of suppliers in the area.’’.
(b) CONFORMING AMENDMENTS.—(1) Section 1834(h)(1)(H)(ii) of
the Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is amended
by striking ‘‘the Secretary’’ and inserting ‘‘subject to subsection
(a)(1)(G), the Secretary’’.
(2) Section 1842(s)(3)(B) of the Social Security Act (42 U.S.C.
1395m(s)(3)(B)) is amended by striking ‘‘the Secretary’’ and inserting
‘‘subject to section 1834(a)(1)(G), the Secretary’’.
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130 STAT. 1330
PUBLIC LAW 114–255—DEC. 13, 2016
TITLE XVII—OTHER MEDICARE
PROVISIONS
SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR
MEDICARE ADVANTAGE PLANS FAILING TO ACHIEVE
MINIMUM QUALITY RATINGS.
42 USC
1395w–27 note.
(a) FINDINGS.—Consistent with the studies provided under the
IMPACT Act of 2014 (Public Law 113–185), it is the intent of
Congress—
(1) to continue to study and request input on the effects
of socioeconomic status and dual-eligible populations on the
Medicare Advantage STARS rating system before reforming
such system with the input of stakeholders; and
(2) pending the results of such studies and input, to provide
for a temporary delay in authority of the Centers for Medicare
& Medicaid Services (CMS) to terminate Medicare Advantage
plan contracts solely on the basis of performance of plans
under the STARS rating system.
(b) DELAY IN MA CONTRACT TERMINATION AUTHORITY FOR
PLANS FAILING TO ACHIEVE MINIMUM QUALITY RATINGS.—Section
1857(h) of the Social Security Act (42 U.S.C. 1395w–27(h)) is
amended by adding at the end the following new paragraph:
‘‘(3) DELAY IN CONTRACT TERMINATION AUTHORITY FOR
PLANS FAILING TO ACHIEVE MINIMUM QUALITY RATING.—During
the period beginning on the date of the enactment of this
paragraph and through the end of plan year 2018, the Secretary
may not terminate a contract under this section with respect
to the offering of an MA plan by a Medicare Advantage
organization solely because the MA plan has failed to achieve
a minimum quality rating under the 5-star rating system under
section 1853(o)(4).’’.
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SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA REPORTING FOR
MEDICARE.
Section 1874 of the Social Security Act (42 U.S.C. 1395kk)
is amended by adding at the end the following new subsection:
‘‘(g) REQUIREMENT FOR ENROLLMENT DATA REPORTING.—
‘‘(1) IN GENERAL.—Each year (beginning with 2016), the
Secretary shall submit to the Committees on Ways and Means
and Energy and Commerce of the House of Representatives
and the Committee on Finance of the Senate a report on Medicare enrollment data (and, in the case of part A, on data
on individuals receiving benefits under such part) as of a date
in such year specified by the Secretary. Such data shall be
presented—
‘‘(A) by Congressional district and State; and
‘‘(B) in a manner that provides for such data based
on—
‘‘(i) fee-for-service enrollment (as defined in paragraph (2));
‘‘(ii) enrollment under part C (including separate
for aggregate enrollment in MA–PD plans and aggregate enrollment in MA plans that are not MA–PD
plans); and
‘‘(iii) enrollment under part D.
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130 STAT. 1331
‘‘(2) FEE-FOR-SERVICE ENROLLMENT DEFINED.—For purpose
of paragraph (1)(B)(i), the term ‘fee-for-service enrollment’
means aggregate enrollment (including receipt of benefits other
than through enrollment) under—
‘‘(A) part A only;
‘‘(B) part B only; and
‘‘(C) both part A and part B.’’.
SEC. 17003. UPDATING THE WELCOME TO MEDICARE PACKAGE.
(a) IN GENERAL.—Not later than 12 months after the last
day of the period for the request of information described in subsection (b), the Secretary of Health and Human Services shall,
taking into consideration information collected pursuant to subsection (b), update the information included in the Welcome to
Medicare package to include information, presented in a clear and
simple manner, about options for receiving benefits under the Medicare program under title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.), including through the original medicare fee-for-service
program under parts A and B of such title (42 U.S.C. 1395c et
seq., 42 U.S.C. 1395j et seq.), Medicare Advantage plans under
part C of such title (42 U.S.C. 1395w–21 et seq.), and prescription
drug plans under part D of such title (42 U.S.C. 1395w–101 et
seq.)). The Secretary shall make subsequent updates to the information included in the Welcome to Medicare package as appropriate.
(b) REQUEST FOR INFORMATION.—Not later than 6 months after
the date of the enactment of this Act, the Secretary of Health
and Human Services shall request information, including recommendations, from stakeholders (including patient advocates,
issuers, and employers) on information included in the Welcome
to Medicare package, including pertinent data and information
regarding enrollment and coverage for Medicare eligible individuals.
42 USC 1395a
note.
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SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY
NEWLY ENROLLED PROVIDERS OR SUPPLIERS WITHIN
A TEMPORARY MORATORIUM AREA.
(a) MEDICARE.—Section 1866(j)(7) of the Social Security Act
(42 U.S.C. 1395cc(j)(7)) is amended—
(1) in the paragraph heading, by inserting ‘‘; NONPAYMENT’’
before the period; and
(2) by adding at the end the following new subparagraph:
‘‘(C) NONPAYMENT.—
‘‘(i) IN GENERAL.—No payment may be made under
this title or under a program described in subparagraph (A) with respect to an item or service described
in clause (ii) furnished on or after October 1, 2017.
‘‘(ii) ITEM OR SERVICE DESCRIBED.—An item or
service described in this clause is an item or service
furnished—
‘‘(I) within a geographic area with respect to
which a temporary moratorium imposed under
subparagraph (A) is in effect; and
‘‘(II) by a provider of services or supplier that
meets the requirements of clause (iii).
‘‘(iii) REQUIREMENTS.—For purposes of clause (ii),
the requirements of this clause are that a provider
of services or supplier—
‘‘(I) enrolls under this title on or after the
effective date of such temporary moratorium; and
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130 STAT. 1332
PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(II) is within a category of providers of services and suppliers (as described in subparagraph
(A)) subject to such temporary moratorium.
‘‘(iv) PROHIBITION ON CHARGES FOR SPECIFIED
ITEMS OR SERVICES.—In no case shall a provider of
services or supplier described in clause (ii)(II) charge
an individual or other person for an item or service
described in clause (ii) furnished on or after October
1, 2017, to an individual entitled to benefits under
part A or enrolled under part B or an individual under
a program specified in subparagraph (A).’’.
(b) CONFORMING AMENDMENTS.—
(1) MEDICAID.—
(A) IN GENERAL.—Section 1903(i)(2) of the Social Security Act (42 U.S.C. 1396b(i)(2)), as amended by section
5005(a)(4), is further amended—
(i) in subparagraph (C), by striking ‘‘or’’ at the
end; and
(ii) by adding at the end the following new
subparagraph:
‘‘(E) with respect to any amount expended for such
an item or service furnished during calendar quarters
beginning on or after October 1, 2017, subject to section
1902(kk)(4)(A)(ii)(II), within a geographic area that is subject to a moratorium imposed under section 1866(j)(7) by
a provider or supplier that meets the requirements specified
in subparagraph (C)(iii) of such section, during the period
of such moratorium; or’’.
(B) EXCEPTION WITH RESPECT TO ACCESS.—Section
1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C.
1396a(kk)(4)(A)(ii)) is amended to read as follows:
‘‘(ii) EXCEPTIONS.—
‘‘(I) COMPLIANCE WITH MORATORIUM.—A State
shall not be required to comply with a temporary
moratorium described in clause (i) if the State
determines that the imposition of such temporary
moratorium would adversely impact beneficiaries’
access to medical assistance.
‘‘(II) FFP AVAILABLE.—Notwithstanding section 1903(i)(2)(E), payment may be made to a State
under this title with respect to amounts expended
for items and services described in such section
if the Secretary, in consultation with the State
agency administering the State plan under this
title (or a waiver of the plan), determines that
denying payment to the State pursuant to such
section would adversely impact beneficiaries’
access to medical assistance. ’’.
(C) STATE PLAN REQUIREMENT WITH RESPECT TO LIMITATION
ON
CHARGES
TO
BENEFICIARIES.—Section
1902(kk)(4)(A) of the Social Security Act (42 U.S.C.
1396a(kk)(4)(A)) is amended by adding at the end the following new clause:
‘‘(iii) LIMITATION ON CHARGES TO BENEFICIARIES.—
With respect to any amount expended for items or
services furnished during calendar quarters beginning
on or after October 1, 2017, the State prohibits, during
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130 STAT. 1333
the period of a temporary moratorium described in
clause (i), a provider meeting the requirements specified in subparagraph (C)(iii) of section 1866(j)(7) from
charging an individual or other person eligible to
receive medical assistance under the State plan under
this title (or a waiver of the plan) for an item or
service described in section 1903(i)(2)(E) furnished to
such an individual.’’.
(2) CORRECTING AMENDMENTS TO RELATED PROVISIONS.—
(A) SECTION 1866(J).—Section 1866(j) of the Social Security Act (42 U.S.C. 1395cc(j)) is amended—
(i) in paragraph (1)(A)—
(I) by striking ‘‘paragraph (4)’’ and inserting
‘‘paragraph (5)’’;
(II) by striking ‘‘moratoria in accordance with
paragraph (5)’’ and inserting ‘‘moratoria in accordance with paragraph (7)’’; and
(III) by striking ‘‘paragraph (6)’’ and inserting
‘‘paragraph (9)’’; and
(ii) by redesignating the second paragraph (8)
(redesignated by section 1304(1) of Public Law 111–
152) as paragraph (9).
(B) SECTION 1902(KK).—Section 1902(kk) of such Act
(42 U.S.C. 1396a(kk)) is amended—
(i) in paragraph (1), by striking ‘‘section 1886(j)(2)’’
and inserting ‘‘section 1866(j)(2)’’;
(ii) in paragraph (2), by striking ‘‘section 1886(j)(3)’’
and inserting ‘‘section 1866(j)(3)’’;
(iii) in paragraph (3), by striking ‘‘section
1886(j)(4)’’ and inserting ‘‘section 1866(j)(5)’’; and
(iv) in paragraph (4)(A), by striking ‘‘section
1886(j)(6)’’ and inserting ‘‘section 1866(j)(7)’’.
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SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE
UNDER MEDICARE ADVANTAGE.
Section 1851(e)(2) of the Social Security Act (42 U.S.C. 1395w–
21(e)(2)) is amended—
(1) in subparagraph (C)—
(A) in the heading, by inserting ‘‘FROM 2011 THROUGH
2018’’ after ‘‘45-DAY PERIOD’’; and
(B) by inserting ‘‘and ending with 2018’’ after ‘‘beginning with 2011’’; and
(2) by adding at the end the following new subparagraph:
‘‘(G)
CONTINUOUS
OPEN
ENROLLMENT
AND
DISENROLLMENT FOR FIRST 3 MONTHS IN 2016 AND SUBSEQUENT YEARS.—
‘‘(i) IN GENERAL.—Subject to clause (ii) and
subparagraph (D)—
‘‘(I) in the case of an MA eligible individual
who is enrolled in an MA plan, at any time during
the first 3 months of a year (beginning with 2019);
or
‘‘(II) in the case of an individual who first
becomes an MA eligible individual during a year
(beginning with 2019) and enrolls in an MA plan,
during the first 3 months during such year in
which the individual is an MA eligible individual;
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PUBLIC LAW 114–255—DEC. 13, 2016
such MA eligible individual may change the election
under subsection (a)(1).
‘‘(ii) LIMITATION OF ONE CHANGE DURING OPEN
ENROLLMENT PERIOD EACH YEAR.—An individual may
change the election pursuant to clause (i) only once
during the applicable 3-month period described in such
clause in each year. The limitation under this clause
shall not apply to changes in elections effected during
an annual, coordinated election period under paragraph (3) or during a special enrollment period under
paragraph (4).
‘‘(iii) LIMITED APPLICATION TO PART D.—Clauses
(i) and (ii) of this subparagraph shall only apply with
respect to changes in enrollment in a prescription drug
plan under part D in the case of an individual who,
previous to such change in enrollment, is enrolled in
a Medicare Advantage plan.
‘‘(iv) LIMITATIONS ON MARKETING.— Pursuant to
subsection (j), no unsolicited marketing or marketing
materials may be sent to an individual described in
clause (i) during the continuous open enrollment and
disenrollment period established for the individual
under such clause, notwithstanding marketing guidelines established by the Centers for Medicare & Medicaid Services.’’.
SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES
TO CHOOSE A MEDICARE ADVANTAGE PLAN.
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(a) REMOVING PROHIBITION.—
(1) IN GENERAL.—Section 1851(a)(3) of the Social Security
Act (42 U.S.C. 1395w–21(a)(3)) is amended—
(A) by striking subparagraph (B); and
(B) by striking ‘‘ELIGIBLE INDIVIDUAL’’ and all that follows through ‘‘In this title, subject to subparagraph (B),’’
and inserting ‘‘ELIGIBLE INDIVIDUAL.—In this title,’’.
(2) CONFORMING AMENDMENTS.—
(A) Section 1852(b)(1) of the Social Security Act (42
U.S.C. 1395w–22(b)(1)) is amended—
(i) by striking subparagraph (B); and
(ii) by striking ‘‘BENEFICIARIES’’ and all that follows
through ‘‘A Medicare+Choice organization’’ and
inserting ‘‘BENEFICIARIES.—A Medicare Advantage
organization’’.
(B) Section 1859(b)(6) of the Social Security Act (42
U.S.C. 1395w–28(b)(6)) is amended, in the last sentence,
by striking ‘‘may waive’’ and all that follows through
‘‘subparagraph and’’.
(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply with respect to plan years beginning on
or after January 1, 2021.
(b) EXCLUDING COSTS FOR KIDNEY ACQUISITIONS FROM MA
BENCHMARK.—Section 1853 of the Social Security Act (42 U.S.C.
1395w–23) is amended—
(1) in subsection (k)—
(A) in paragraph (1)—
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130 STAT. 1335
(i) in the matter preceding subparagraph (A), by
striking ‘‘paragraphs (2) and (4)’’ and inserting ‘‘paragraphs (2), (4), and (5)’’; and
(ii) in subparagraph (B)(i), by striking ‘‘paragraphs
(2) and (4)’’ and inserting ‘‘paragraphs (2), (4), and
(5)’’; and
(B) by adding at the end the following new paragraph:
‘‘(5) EXCLUSION OF COSTS FOR KIDNEY ACQUISITIONS FROM
CAPITATION RATES.—After determining the applicable amount
for an area for a year under paragraph (1) (beginning with
2021), the Secretary shall adjust such applicable amount to
exclude from such applicable amount the Secretary’s estimate
of the standardized costs for payments for organ acquisitions
for kidney transplants covered under this title (including
expenses covered under section 1881(d)) in the area for the
year.’’; and
(2) in subsection (n)(2)—
(A) in subparagraph (A)(i), by inserting ‘‘and, for 2021
and subsequent years, the exclusion of payments for organ
acquisitions for kidney transplants from the capitation rate
as described in subsection (k)(5)’’ before the semicolon at
the end;
(B) in subparagraph (E), in the matter preceding clause
(i), by striking ‘‘subparagraph (F)’’ and inserting ‘‘subparagraphs (F) and (G)’’; and
(C) by adding at the end the following new subparagraph:
‘‘(G) APPLICATION OF KIDNEY ACQUISITIONS ADJUSTMENT.—The base payment amount specified in subparagraph (E) for a year (beginning with 2021) shall be adjusted
in the same manner under paragraph (5) of subsection
(k) as the applicable amount is adjusted under such subsection.’’.
(c) FFS COVERAGE OF KIDNEY ACQUISITIONS.—
(1) IN GENERAL.—Section 1852(a)(1)(B)(i) of the Social Security Act (42 U.S.C. 1395w–22(a)(1)(B)(i)) is amended by
inserting ‘‘or coverage for organ acquisitions for kidney transplants, including as covered under section 1881(d)’’ after ‘‘hospice care’’.
(2) CONFORMING AMENDMENT.—Section 1851(i) of the Social
Security Act (42 U.S.C. 1395w–21(i)) is amended by adding
at the end the following new paragraph:
‘‘(3) FFS PAYMENT FOR EXPENSES FOR KIDNEY ACQUISITIONS.—Paragraphs (1) and (2) shall not apply with respect
to expenses for organ acquisitions for kidney transplants
described in section 1852(a)(1)(B)(i).’’.
(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply with respect to plan years beginning on
or after January 1, 2021.
(d) EVALUATION OF QUALITY.—
(1) IN GENERAL.—The Secretary of Health and Human
Services (in this subsection referred to as the ‘‘Secretary’’) shall
conduct an evaluation of whether the 5-star rating system
based on the data collected under section 1852(e) of the Social
Security Act (42 U.S.C. 1395w–22(e)) should include a quality
measure specifically related to care for enrollees in Medicare
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Advantage plans under part C of title XVIII of such Act determined to have end-stage renal disease.
(2) PUBLIC AVAILABILITY.—Not later than April 1, 2020,
the Secretary shall post on the Internet website of the Centers
for Medicare & Medicaid Services the results of the evaluation
under paragraph (1).
(e) REPORT.—Not later than December 31, 2023, the Secretary
of Health and Human Services (in this subsection referred to as
the ‘‘Secretary’’) shall submit to Congress a report on the impact
of the provisions of, and amendments made by, this section with
respect to the following:
(1) Spending under—
(A) the original Medicare fee-for-service program under
parts A and B of title XVIII of the Social Security Act;
and
(B) the Medicare Advantage program under part C
of such title.
(2) The number of enrollees determined to have end-stage
renal disease—
(A) in the original Medicare fee-for-service program;
and
(B) in the Medicare Advantage program.
(3) The sufficiency of the amount of data under the original
Medicare fee-for-service program for individuals determined to
have end-stage renal disease for purposes of determining payment rates for end-stage renal disease under the Medicare
Advantage program.
(f) IMPROVEMENTS TO RISK ADJUSTMENT UNDER MEDICARE
ADVANTAGE.—
(1) IN GENERAL.—Section 1853(a)(1) of the Social Security
Act (42 U.S.C. 1395w–23(a)(1)) is amended—
(A) in subparagraph (C)(i), by striking ‘‘The Secretary’’
and inserting ‘‘Subject to subparagraph (I), the Secretary’’;
and
(B) by adding at the end the following new subparagraph:
‘‘(I) IMPROVEMENTS TO RISK ADJUSTMENT FOR 2019 AND
SUBSEQUENT YEARS.—
‘‘(i) IN GENERAL.—In order to determine the appropriate adjustment for health status under subparagraph (C)(i), the following shall apply:
‘‘(I) TAKING INTO ACCOUNT TOTAL NUMBER OF
DISEASES OR CONDITIONS.—The Secretary shall
take into account the total number of diseases
or conditions of an individual enrolled in an MA
plan. The Secretary shall make an additional
adjustment under such subparagraph as the
number of diseases or conditions of an individual
increases.
‘‘(II) USING AT LEAST 2 YEARS OF DIAGNOSTIC
DATA.—The Secretary may use at least 2 years
of diagnosis data.
‘‘(III) PROVIDING SEPARATE ADJUSTMENTS FOR
DUAL ELIGIBLE INDIVIDUALS.—With respect to
individuals who are dually eligible for benefits
under this title and title XIX, the Secretary shall
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130 STAT. 1337
make separate adjustments for each of the following:
‘‘(aa) Full-benefit dual eligible individuals
(as defined in section 1935(c)(6)).
‘‘(bb) Such individuals not described in
item (aa).
‘‘(IV) EVALUATION OF MENTAL HEALTH AND
SUBSTANCE USE DISORDERS.—The Secretary shall
evaluate the impact of including additional diagnosis codes related to mental health and substance
use disorders in the risk adjustment model.
‘‘(V) EVALUATION OF CHRONIC KIDNEY DISEASE.—The Secretary shall evaluate the impact
of including the severity of chronic kidney disease
in the risk adjustment model.
‘‘(VI) EVALUATION OF PAYMENT RATES FOR ENDSTAGE
RENAL
DISEASE.—The
Secretary shall
evaluate whether other factors (in addition to those
described in subparagraph (H)) should be taken
into consideration when computing payment rates
under such subparagraph.
‘‘(ii) PHASED-IN IMPLEMENTATION.—The Secretary
shall phase-in any changes to risk adjustment payment
amounts under subparagraph (C)(i) under this
subparagraph over a 3-year period, beginning with
2019, with such changes being fully implemented for
2022 and subsequent years.
‘‘(iii) OPPORTUNITY FOR REVIEW AND PUBLIC COMMENT.—The Secretary shall provide an opportunity for
review of the proposed changes to such risk adjustment
payment amounts under this subparagraph and a
public comment period of not less than 60 days before
implementing such changes.’’.
(2) STUDIES AND REPORTS.—
(A) REPORTS ON THE RISK ADJUSTMENT SYSTEM.—
(i) MEDPAC EVALUATION AND REPORT.—
(I) EVALUATION.—The Medicare Payment
Advisory Commission shall conduct an evaluation
of the impact of the provisions of, and amendments
made by, this section on risk scores for enrollees
in Medicare Advantage plans under part C of title
XVIII of the Social Security Act and payments
to Medicare Advantage plans under such part,
including the impact of such provisions and amendments on the overall accuracy of risk scores under
the Medicare Advantage program.
(II) REPORT.—Not later than July 1, 2020, the
Medicare Payment Advisory Commission shall
submit to Congress a report on the evaluation
under subclause (I), together with recommendations for such legislation and administrative action
as the Commission determines appropriate.
(ii) REPORTS BY SECRETARY OF HEALTH AND HUMAN
SERVICES.—Not later than December 31, 2018, and
every 3 years thereafter, the Secretary of Health and
Human Services shall submit to Congress a report
on the risk adjustment model and the ESRD risk
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adjustment model under the Medicare Advantage program under part C of title XVIII of the Social Security
Act, including any revisions to either such model since
the previous report. Such report shall include information on how such revisions impact the predictive ratios
under either such model for groups of enrollees in
Medicare Advantage plans, including very high and
very low cost enrollees, and groups defined by the
number of chronic conditions of enrollees.
(B) STUDY AND REPORT ON FUNCTIONAL STATUS.—
(i) STUDY.—The Comptroller General of the United
States (in this subparagraph referred to as the ‘‘Comptroller General’’) shall conduct a study on how to most
accurately measure the functional status of enrollees
in Medicare Advantage plans and whether the use
of such functional status would improve the accuracy
of risk adjustment payments under the Medicare
Advantage program under part C of title XVIII of
the Social Security Act. Such study shall include an
analysis of the challenges in collecting and reporting
functional status information for Medicare Advantage
plans under such part, providers of services and suppliers under the Medicare program, and the Centers
for Medicare & Medicaid Services.
(ii) REPORT.—Not later than June 30, 2018, the
Comptroller General shall submit to Congress a report
containing the results of the study under clause (i),
together with recommendations for such legislation and
administrative action as the Comptroller General
determines appropriate.
SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES
UNDER THE MEDICARE SHARED SAVINGS PROGRAM.
Section 1899(c) of the Social Security Act (42 U.S.C. 1395jjj(c))
is amended—
(1) by striking ‘‘utilization of primary’’ and inserting ‘‘utilization of—
‘‘(1) in the case of performance years beginning on or after
April 1, 2012, primary’’;
(2) in paragraph (1), as added by paragraph (1) of this
section, by striking the period at the end and inserting ‘‘;
and’’;
(3) by adding at the end the following new paragraph:
‘‘(2) in the case of performance years beginning on or after
January 1, 2019, services provided under this title by a Federally qualified health center or rural health clinic (as those
terms are defined in section 1861(aa)), as may be determined
by the Secretary.’’.
TITLE XVIII—OTHER PROVISIONS
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SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN REQUIREMENTS
FOR
QUALIFIED
SMALL
EMPLOYER
HEALTH
REIMBURSEMENT ARRANGEMENTS.
(a) AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986
PATIENT PROTECTION AND AFFORDABLE CARE ACT.—
AND THE
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(1) IN GENERAL.—Section 9831 of the Internal Revenue
Code of 1986 is amended by adding at the end the following
new subsection:
‘‘(d) EXCEPTION FOR QUALIFIED SMALL EMPLOYER HEALTH
REIMBURSEMENT ARRANGEMENTS.—
‘‘(1) IN GENERAL.—For purposes of this title (except as
provided in section 4980I(f)(4) and notwithstanding any other
provision of this title), the term ‘group health plan’ shall not
include any qualified small employer health reimbursement
arrangement.
‘‘(2) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT
ARRANGEMENT.—For purposes of this subsection—
‘‘(A) IN GENERAL.—The term ‘qualified small employer
health reimbursement arrangement’ means an arrangement which—
‘‘(i) is described in subparagraph (B), and
‘‘(ii) is provided on the same terms to all eligible
employees of the eligible employer.
‘‘(B) ARRANGEMENT DESCRIBED.—An arrangement is
described in this subparagraph if—
‘‘(i) such arrangement is funded solely by an
eligible employer and no salary reduction contributions
may be made under such arrangement,
‘‘(ii) such arrangement provides, after the employee
provides proof of coverage, for the payment of, or
reimbursement of, an eligible employee for expenses
for medical care (as defined in section 213(d)) incurred
by the eligible employee or the eligible employee’s
family members (as determined under the terms of
the arrangement), and
‘‘(iii) the amount of payments and reimbursements
described in clause (ii) for any year do not exceed
$4,950 ($10,000 in the case of an arrangement that
also provides for payments or reimbursements for
family members of the employee).
‘‘(C) CERTAIN VARIATION PERMITTED.—For purposes of
subparagraph (A)(ii), an arrangement shall not fail to be
treated as provided on the same terms to each eligible
employee merely because the employee’s permitted benefit
under such arrangement varies in accordance with the
variation in the price of an insurance policy in the relevant
individual health insurance market based on—
‘‘(i) the age of the eligible employee (and, in the
case of an arrangement which covers medical expenses
of the eligible employee’s family members, the age
of such family members), or
‘‘(ii) the number of family members of the eligible
employee the medical expenses of which are covered
under such arrangement.
The variation permitted under the preceding sentence shall
be determined by reference to the same insurance policy
with respect to all eligible employees.
‘‘(D) RULES RELATING TO MAXIMUM DOLLAR LIMITATION.—
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‘‘(i) AMOUNT PRORATED IN CERTAIN CASES.—In the
case of an individual who is not covered by an arrangement for the entire year, the limitation under subparagraph (B)(iii) for such year shall be an amount which
bears the same ratio to the amount which would (but
for this clause) be in effect for such individual for
such year under subparagraph (B)(iii) as the number
of months for which such individual is covered by
the arrangement for such year bears to 12.
‘‘(ii) INFLATION ADJUSTMENT.—In the case of any
year beginning after 2016, each of the dollar amounts
in subparagraph (B)(iii) shall be increased by an
amount equal to—
‘‘(I) such dollar amount, multiplied by
‘‘(II) the cost-of-living adjustment determined
under section 1(f)(3) for the calendar year in which
the taxable year begins, determined by substituting ‘calendar year 2015’ for ‘calendar year
1992’ in subparagraph (B) thereof.
If any dollar amount increased under the preceding
sentence is not a multiple of $50, such dollar amount
shall be rounded to the next lowest multiple of $50.
‘‘(3) OTHER DEFINITIONS.—For purposes of this subsection—
‘‘(A) ELIGIBLE EMPLOYEE.—The term ‘eligible employee’
means any employee of an eligible employer, except that
the terms of the arrangement may exclude from consideration employees described in any clause of section
105(h)(3)(B) (applied by substituting ‘90 days’ for ‘3 years’
in clause (i) thereof).
‘‘(B) ELIGIBLE EMPLOYER.—The term ‘eligible employer’
means an employer that—
‘‘(i) is not an applicable large employer as defined
in section 4980H(c)(2), and
‘‘(ii) does not offer a group health plan to any
of its employees.
‘‘(C) PERMITTED BENEFIT.—The term ‘permitted benefit’
means, with respect to any eligible employee, the maximum
dollar amount of payments and reimbursements which may
be made under the terms of the qualified small employer
health reimbursement arrangement for the year with
respect to such employee.
‘‘(4) NOTICE.—
‘‘(A) IN GENERAL.—An employer funding a qualified
small employer health reimbursement arrangement for any
year shall, not later than 90 days before the beginning
of such year (or, in the case of an employee who is not
eligible to participate in the arrangement as of the beginning of such year, the date on which such employee is
first so eligible), provide a written notice to each eligible
employee which includes the information described in
subparagraph (B).
‘‘(B) CONTENTS OF NOTICE.—The notice required under
subparagraph (A) shall include each of the following:
‘‘(i) A statement of the amount which would be
such eligible employee’s permitted benefit under the
arrangement for the year.
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‘‘(ii) A statement that the eligible employee should
provide the information described in clause (i) to any
health insurance exchange to which the employee
applies for advance payment of the premium assistance
tax credit.
‘‘(iii) A statement that if the employee is not covered under minimum essential coverage for any month
the employee may be subject to tax under section
5000A for such month and reimbursements under the
arrangement may be includible in gross income.’’.
(2) LIMITATION ON EXCLUSION FROM GROSS INCOME.—Section 106 of such Code is amended by adding at the end the
following:
‘‘(g) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT
ARRANGEMENT.—For purposes of this section and section 105, payments or reimbursements from a qualified small employer health
reimbursement arrangement (as defined in section 9831(d)) of an
individual for medical care (as defined in section 213(d)) shall
not be treated as paid or reimbursed under employer-provided
coverage for medical expenses under an accident or health plan
if for the month in which such medical care is provided the individual does not have minimum essential coverage (within the
meaning of section 5000A(f)).’’.
(3) COORDINATION WITH HEALTH INSURANCE PREMIUM
CREDIT.—Section 36B(c) of such Code is amended by adding
at the end the following new paragraph:
‘‘(4) SPECIAL RULES FOR QUALIFIED SMALL EMPLOYER
HEALTH REIMBURSEMENT ARRANGEMENTS.—
‘‘(A) IN GENERAL.—The term ‘coverage month’ shall
not include any month with respect to an employee (or
any spouse or dependent of such employee) if for such
month the employee is provided a qualified small employer
health reimbursement arrangement which constitutes
affordable coverage.
‘‘(B) DENIAL OF DOUBLE BENEFIT.—In the case of any
employee who is provided a qualified small employer health
reimbursement arrangement for any coverage month
(determined without regard to subparagraph (A)), the credit
otherwise allowable under subsection (a) to the taxpayer
for such month shall be reduced (but not below zero) by
the amount described in subparagraph (C)(i)(II) for such
month.
‘‘(C) AFFORDABLE COVERAGE.—For purposes of subparagraph (A), a qualified small employer health reimbursement arrangement shall be treated as constituting affordable coverage for a month if—
‘‘(i) the excess of—
‘‘(I) the amount that would be paid by the
employee as the premium for such month for selfonly coverage under the second lowest cost silver
plan offered in the relevant individual health
insurance market, over
‘‘(II) 1⁄12 of the employee’s permitted benefit
(as defined in section 9831(d)(3)(C)) under such
arrangement, does not exceed—
‘‘(ii) 1⁄12 of 9.5 percent of the employee’s household
income.
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‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENT.—For purposes of this paragraph, the
term ‘qualified small employer health reimbursement
arrangement’ has the meaning given such term by section
9831(d)(2).
‘‘(E) COVERAGE FOR LESS THAN ENTIRE YEAR.—In the
case of an employee who is provided a qualified small
employer health reimbursement arrangement for less than
an entire year, subparagraph (C)(i)(II) shall be applied
by substituting ‘the number of months during the year
for which such arrangement was provided’ for ‘12’.
‘‘(F) INDEXING.—In the case of plan years beginning
in any calendar year after 2014, the Secretary shall adjust
the 9.5 percent amount under subparagraph (C)(ii) in the
same manner as the percentages are adjusted under subsection (b)(3)(A)(ii).’’.
(4) APPLICATION OF EXCISE TAX ON HIGH COST EMPLOYERSPONSORED HEALTH COVERAGE.—
(A) IN GENERAL.—Section 4980I(f)(4) of such Code is
amended by adding at the end the following: ‘‘Section
9831(d)(1) shall not apply for purposes of this section.’’.
(B) DETERMINATION OF COST OF COVERAGE.—Section
4980I(d)(2) of such Code is amended by redesignating
subparagraph (D) as subparagraph (E) and by inserting
after subparagraph (C) the following new subparagraph:
‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.—In the case of applicable employersponsored coverage consisting of coverage under any qualified small employer health reimbursement arrangement
(as defined in section 9831(d)(2)), the cost of coverage shall
be equal to the amount described in section 6051(a)(15).’’.
(5) ENFORCEMENT OF NOTICE REQUIREMENT.—Section 6652
of such Code is amended by adding at the end the following
new subsection:
‘‘(o) FAILURE TO PROVIDE NOTICES WITH RESPECT TO QUALIFIED
SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.—In
the case of each failure to provide a written notice as required
by section 9831(d)(4), unless it is shown that such failure is due
to reasonable cause and not willful neglect, there shall be paid,
on notice and demand of the Secretary and in the same manner
as tax, by the person failing to provide such written notice, an
amount equal to $50 per employee per incident of failure to provide
such notice, but the total amount imposed on such person for
all such failures during any calendar year shall not exceed $2,500.’’.
(6) REPORTING.—
(A) W–2 REPORTING.—Section 6051(a) of such Code
is amended by striking ‘‘and’’ at the end of paragraph
(13), by striking the period at the end of paragraph (14)
and inserting ‘‘, and’’, and by inserting after paragraph
(14) the following new paragraph:
‘‘(15) the total amount of permitted benefit (as defined
in section 9831(d)(3)(C)) for the year under a qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2)) with respect to the employee.’’.
(B) INFORMATION REQUIRED TO BE PROVIDED BY
EXCHANGE SUBSIDY APPLICANTS.—Section 1411(b)(3) of the
Patient Protection and Affordable Care Act is amended
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by redesignating subparagraph (B) as subparagraph (C)
and by inserting after subparagraph (A) the following new
subparagraph:
‘‘(B) CERTAIN INDIVIDUAL HEALTH INSURANCE POLICIES
OBTAINED THROUGH SMALL EMPLOYERS.—The amount of the
enrollee’s permitted benefit (as defined in section
9831(d)(3)(C) of the Internal Revenue Code of 1986) under
a qualified small employer health reimbursement arrangement (as defined in section 9831(d)(2) of such Code).’’.
(7) EFFECTIVE DATES.—
(A) IN GENERAL.—Except as otherwise provided in this
paragraph, the amendments made by this subsection shall
apply to years beginning after December 31, 2016.
(B) TRANSITION RELIEF.—The relief under Treasury
Notice 2015–17 shall be treated as applying to any plan
year beginning on or before December 31, 2016.
(C) COORDINATION WITH HEALTH INSURANCE PREMIUM
CREDIT.—The amendments made by paragraph (3) shall
apply to taxable years beginning after December 31, 2016.
(D) EMPLOYEE NOTICE.—
(i) IN GENERAL.—The amendments made by paragraph (5) shall apply to notices with respect to years
beginning after December 31, 2016.
(ii) TRANSITION RELIEF.—For purposes of section
6652(o) of the Internal Revenue Code of 1986 (as added
by this Act), a person shall not be treated as failing
to provide a written notice as required by section
9831(d)(4) of such Code if such notice is so provided
not later than 90 days after the date of the enactment
of this Act.
(E) W–2 REPORTING.—The amendments made by paragraph (6)(A) shall apply to calendar years beginning after
December 31, 2016.
(F) INFORMATION PROVIDED BY EXCHANGE SUBSIDY
APPLICANTS.—
(i) IN GENERAL.—The amendments made by paragraph (6)(B) shall apply to applications for enrollment
made after December 31, 2016.
(ii) VERIFICATION.—Verification under section 1411
of the Patient Protection and Affordable Care Act of
information provided under section 1411(b)(3)(B) of
such Act shall apply with respect to months beginning
after October 2016.
(iii) TRANSITIONAL RELIEF.—In the case of an
application for enrollment under section 1411(b) of the
Patient Protection and Affordable Care Act made before
April 1, 2017, the requirement of section 1411(b)(3)(B)
of such Act shall be treated as met if the information
described therein is provided not later than 30 days
after the date on which the applicant receives the
notice described in section 9831(d)(4) of the Internal
Revenue Code of 1986.
(8) SUBSTANTIATION REQUIREMENTS.—The Secretary of the
Treasury (or his designee) may issue substantiation requirements as necessary to carry out this subsection.
(b) AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.—
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26 USC 36B note.
26 USC 36B note.
PUBL255
130 STAT. 1344
PUBLIC LAW 114–255—DEC. 13, 2016
(1) IN GENERAL.—Section 733(a)(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b(a)(1)) is
amended by adding at the end the following: ‘‘Such term shall
not include any qualified small employer health reimbursement
arrangement (as defined in section 9831(d)(2) of the Internal
Revenue Code of 1986).’’.
(2) EXCEPTION FROM CONTINUATION COVERAGE REQUIREMENTS, ETC.—Section 607(1) of such Act (29 U.S.C. 1167(1))
is amended by adding at the end the following: ‘‘Such term
shall not include any qualified small employer health
reimbursement arrangement (as defined in section 9831(d)(2)
of the Internal Revenue Code of 1986).’’.
(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply to plan years beginning after December
31, 2016.
(c) AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.—
(1) IN GENERAL.—Section 2791(a)(1) of the Public Health
Service Act (42 U.S.C. 300gg–91(a)(1)) is amended by adding
at the end the following: ‘‘Except for purposes of part C of
title XI of the Social Security Act (42 U.S.C. 1320d et seq.),
such term shall not include any qualified small employer health
reimbursement arrangement (as defined in section 9831(d)(2)
of the Internal Revenue Code of 1986).’’.
(2) EXCEPTION FROM CONTINUATION COVERAGE REQUIREMENTS.—Section 2208(1) of the Public Health Service Act (42
U.S.C. 300bb–8(1)) is amended by adding at the end the following: ‘‘Such term shall not include any qualified small
employer health reimbursement arrangement (as defined in
section 9831(d)(2) of the Internal Revenue Code of 1986).’’.
(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply to plan years beginning after December
31, 2016.
29 USC 1167
note.
42 USC 300bb–8
note.
dkrause on DSKHT7XVN1PROD with PUBLAWS
Approved December 13, 2016.
LEGISLATIVE HISTORY—H.R. 34:
SENATE REPORTS: No. 114–146 (Comm. on Commerce, Science, and Transportation).
CONGRESSIONAL RECORD:
Vol. 161 (2015): Jan. 7, considered and passed House.
Oct. 6, considered and passed Senate, amended.
Vol. 162 (2016): Nov. 30, House concurred in Senate amendment with an
amendment.
Dec. 1, 5–7, Senate considered and concurred in House
amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):
Dec. 13, Presidential remarks.
Æ
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PUBL255
| File Type | application/pdf |
| File Title | PUBL255.PS |
| File Modified | 2020-12-29 |
| File Created | 2017-05-10 |