21st Century Cures Act
PL 114-255 (H.R.34), enacted 12/13/2016

130 STAT. 1033 
PUBLIC LAW 114–255—DEC. 13, 2016 
Public Law 114–255 
114th Congress 
An Act 
To accelerate the discovery, development, and delivery of 21st century cures, and 
for other purposes. 
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. 
(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. 
Subtitle B—Advancing Precision Medicine 
Sec. 2011. Precision Medicine Initiative. 
Sec. 2012. Privacy protection for human research subjects. 
Sec. 2013. Protection of identifiable and sensitive information. 
Sec. 2014. Data sharing. 
Subtitle C—Supporting Young Emerging Scientists 
Sec. 2021. Investing in the next generation of researchers. 
Sec. 2022. Improvement of loan repayment program. 
Subtitle D—National Institutes of Health Planning and Administration 
Sec. 2031. National Institutes of Health strategic plan. 
Sec. 2032. Triennial reports. 
Sec. 2033. Increasing accountability at the National Institutes of Health. 
Sec. 2034. Reducing administrative burden for researchers. 
Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Re-
duction Act requirements. 
Sec. 2036. High-risk, high-reward research. 
Sec. 2037. National Center for Advancing Translational Sciences. 
Sec. 2038. Collaboration and coordination to enhance research. 
Sec. 2039. Enhancing the rigor and reproducibility of scientific research. 
Sec. 2040. Improving medical rehabilitation research at the National Institutes of 
Health. 
21st Century 
Cures Act. 
42 USC 201 note. 
Dec. 13, 2016 
[H.R. 34] 
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130 STAT. 1034 
PUBLIC LAW 114–255—DEC. 13, 2016 
Sec. 2041. Task force on research specific to pregnant women and lactating women. 
Sec. 2042. Streamlining National Institutes of Health reporting requirements. 
Sec. 2043. Reimbursement for research substances and living organisms. 
Sec. 2044. Sense of Congress on increased inclusion of underrepresented popu-
lations 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 
Subtitle A—Patient-Focused Drug Development 
Sec. 3001. Patient experience data. 
Sec. 3002. Patient-focused drug development guidance. 
Sec. 3003. Streamlining patient input. 
Sec. 3004. 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. 
Subtitle C—Modern Trial Design and Evidence Development 
Sec. 3021. Novel clinical trial designs. 
Sec. 3022. Real world evidence. 
Sec. 3023. Protection of human research subjects. 
Sec. 3024. Informed consent waiver or alteration for clinical investigations. 
Subtitle D—Patient Access to Therapies and Information 
Sec. 3031. Summary level review. 
Sec. 3032. Expanded access policy. 
Sec. 3033. Accelerated approval for regenerative advanced therapies. 
Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery 
of regenerative advanced therapies. 
Sec. 3035. Report on regenerative advanced therapies. 
Sec. 3036. Standards for regenerative medicine and regenerative advanced thera-
pies. 
Sec. 3037. Health care economic information. 
Sec. 3038. Combination product innovation. 
Subtitle E—Antimicrobial Innovation and Stewardship 
Sec. 3041. Antimicrobial resistance monitoring. 
Sec. 3042. Limited population pathway. 
Sec. 3043. Prescribing authority. 
Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial 
susceptibility testing devices. 
Subtitle F—Medical Device Innovations 
Sec. 3051. Breakthrough devices. 
Sec. 3052. Humanitarian device exemption. 
Sec. 3053. Recognition of standards. 
Sec. 3054. Certain class I and class II devices. 
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130 STAT. 1035 
PUBLIC LAW 114–255—DEC. 13, 2016 
Sec. 3055. Classification panels. 
Sec. 3056. Institutional review board flexibility. 
Sec. 3057. CLIA waiver improvements. 
Sec. 3058. Least burdensome device review. 
Sec. 3059. Cleaning instructions and validation data requirement. 
Sec. 3060. Clarifying medical software regulation. 
Subtitle G—Improving Scientific Expertise and Outreach at FDA 
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product As-
sessment 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 
Sec. 3081. Medical countermeasure guidelines. 
Sec. 3082. Clarifying BARDA contracting authority. 
Sec. 3083. Countermeasure budget plan. 
Sec. 3084. Medical countermeasures innovation. 
Sec. 3085. Streamlining Project BioShield procurement. 
Sec. 3086. 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. 
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 Immuni-
zation Practices recommendations. 
Sec. 3093. Encouraging vaccine innovation. 
Subtitle J—Technical Corrections 
Sec. 3101. Technical corrections. 
Sec. 3102. Completed studies. 
TITLE IV—DELIVERY 
Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients. 
Sec. 4002. Transparent reporting on usability, security, and functionality. 
Sec. 4003. Interoperability. 
Sec. 4004. Information blocking. 
Sec. 4005. Leveraging electronic health records to improve patient care. 
Sec. 4006. Empowering patients and improving patient access to their electronic 
health information. 
Sec. 4007. GAO study on patient matching. 
Sec. 4008. GAO study on patient access to health information. 
Sec. 4009. Improving Medicare local coverage determinations. 
Sec. 4010. Medicare pharmaceutical and technology ombudsman. 
Sec. 4011. Medicare site-of-service price transparency. 
Sec. 4012. Telehealth services in Medicare. 
TITLE V—SAVINGS 
Sec. 5001. Savings in the Medicare Improvement Fund. 
Sec. 5002. Medicaid reimbursement to States for durable medical equipment. 
Sec. 5003. Penalties for violations of grants, contracts, and other agreements. 
Sec. 5004. Reducing overpayments of infusion drugs. 
Sec. 5005. Increasing oversight of termination of Medicaid providers. 
Sec. 5006. Requiring publication of fee-for-service provider directory. 
Sec. 5007. Fairness in Medicaid supplemental needs trusts. 
Sec. 5008. Eliminating Federal financial participation with respect to expenditures 
under Medicaid for agents used for cosmetic purposes or hair growth. 
Sec. 5009. Amendment to the Prevention and Public Health Fund. 
Sec. 5010. Strategic Petroleum Reserve drawdown. 
Sec. 5011. Rescission of portion of ACA territory funding. 
Sec. 5012. Medicare coverage of home infusion therapy. 
DIVISION B—HELPING FAMILIES IN MENTAL HEALTH CRISIS 
Sec. 6000. Short title. 
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130 STAT. 1036 
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 pre-
vention, 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 PRE-
VENTION, 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 prac-
tices. 
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 na-
tional 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. 
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. 
Sec. 9002. Grants for jail diversion programs. 
Sec. 9003. Promoting integration of primary and behavioral health care. 
Sec. 9004. Projects for assistance in transition from homelessness. 
Sec. 9005. National Suicide Prevention Lifeline Program. 
Sec. 9006. Connecting individuals and families with care. 
Sec. 9007. Strengthening community crisis response systems. 
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization. 
Sec. 9009. Adult suicide prevention. 
Sec. 9010. Mental health awareness training grants. 
Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska Native 
youth within suicide prevention programs. 
Sec. 9012. Evidence-based practices for older adults. 
Sec. 9013. National violent death reporting system. 
Sec. 9014. Assisted outpatient treatment. 
Sec. 9015. Assertive community treatment grant program. 
Sec. 9016. Sober truth on preventing underage drinking reauthorization. 
Sec. 9017. 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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130 STAT. 1037 
PUBLIC LAW 114–255—DEC. 13, 2016 
Sec. 9022. Strengthening the mental and substance use disorders workforce. 
Sec. 9023. Clarification on current eligibility for loan repayment programs. 
Sec. 9024. Minority fellowship program. 
Sec. 9025. 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 in-
formation. 
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 sub-
stance use disorder benefits. 
Sec. 13004. GAO study on parity in mental health and substance use disorder ben-
efits. 
Sec. 13005. Information and awareness on eating disorders. 
Sec. 13006. Education and training on eating disorders. 
Sec. 13007. Clarification of existing parity rules. 
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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130 STAT. 1038 
PUBLIC LAW 114–255—DEC. 13, 2016 
Sec. 14012. Co-occurring substance abuse and mental health challenges in residen-
tial substance abuse treatment programs. 
Sec. 14013. Mental health and drug treatment alternatives to incarceration pro-
grams. 
Sec. 14014. National criminal justice and mental health training and technical as-
sistance. 
Sec. 14015. Improving Department of Justice data collection on mental illness in-
volved 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 
Sec. 14021. Sequential intercept model. 
Sec. 14022. Prison and jails. 
Sec. 14023. Allowable uses. 
Sec. 14024. Law enforcement training. 
Sec. 14025. Federal law enforcement training. 
Sec. 14026. GAO report. 
Sec. 14027. Evidence based practices. 
Sec. 14028. Transparency, program accountability, and enhancement of local au-
thority. 
Sec. 14029. Grant accountability. 
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 pro-
gram. 
Sec. 15004. Regulatory relief for LTCHs. 
Sec. 15005. Savings from IPPS MACRA pay-for through not applying documenta-
tion 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 neu-
tral provisions for certain spinal cord specialty hospitals. 
Sec. 15010. Temporary extension to the application of the Medicare LTCH site neu-
tral provisions for certain discharges with severe wounds. 
TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B 
Sec. 16001. Continuing Medicare payment under HOPD prospective payment sys-
tem for services furnished by mid-build off-campus outpatient depart-
ments 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 com-
petitive 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 pro-
viders 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 Ad-
vantage 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 em-
ployer health reimbursement arrangements. 
DIVISION A—21ST CENTURY CURES 
SEC. 1000. SHORT TITLE. 
This Division may be cited as the ‘‘21st Century Cures Act’’. 
TITLE I—INNOVATION PROJECTS AND 
STATE RESPONSES TO OPIOID ABUSE 
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 appro-
priations 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 Innova-
tion 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 
42 USC 201 note. 
21st Century 
Cures Act. 
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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 trans-
ferred 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 appro-
priation under the heading ‘‘NIH Innovation Account’’ pro-
vided 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 discre-
tionary budget authority and the resulting outlays for any 
estimate under the Congressional Budget and Impound-
ment 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 appro-
priated under paragraph (3), there are authorized to be appro-
priated 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 Innova-
tive 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 develop-
ment of cancer vaccines, the development of more sensitive 
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130 STAT. 1041 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 coordina-
tion 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 con-
tracts shall be contingent upon the recipient making avail-
able 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 Rep-
resentatives, a work plan including the proposed allocation 
of funds authorized to be appropriated pursuant to sub-
section (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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130 STAT. 1042 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 Rep-
resentatives, 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 appropria-
tions under subsection (b)(3); and 
(iii) whether such projects are advancing the stra-
tegic 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 Com-
mittee on Health, Education, Labor, and Pensions or the 
Committee on Appropriations of the Senate, or the Com-
mittee 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. 
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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130 STAT. 1043 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 appro-
priation under the heading ‘‘FDA Innovation Account’’ pro-
vided to the Commissioner pursuant to the authorization 
of appropriations under subparagraph (A) for the purpose 
of carrying out the projects activities described in para-
graph (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 Rep-
resentatives, 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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130 STAT. 1044 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 appropria-
tions 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 Rep-
resentatives, 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 appropria-
tions under subsection (b)(3); and 
(iii) how the activities are advancing public health. 
(B) ADDITIONAL REPORTS.—At the request of the Com-
mittee on Health, Education, Labor, and Pensions or the 
Committee on Appropriations of the Senate, or the Com-
mittee on Energy and Commerce or the Committee on 
Appropriations of the House of Representatives, the 
Commissioner shall provide an update in the form of testi-
mony and any additional reports to the respective congres-
sional 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 sub-
section (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. 
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. 
42 USC 290ee–3 
note. 
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130 STAT. 1045 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 appropria-
tion 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 pref-
erence 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 supple-
ment 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 activi-
ties such as the following: 
(A) Improving State prescription drug monitoring pro-
grams. 
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130 STAT. 1046 
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, recog-
nizing 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 treat-
ment 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 appro-
priations 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. 
SEC. 1004. BUDGETARY TREATMENT. 
(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects of 
division A of this Act shall not be entered on either PAYGO score-
card maintained pursuant to section 4(d) of the Statutory Pay- 
As-You-Go Act of 2010. 
(b) SENATE PAYGO SCORECARDS.—The budgetary effects of divi-
sion 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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130 STAT. 1047 
PUBLIC LAW 114–255—DEC. 13, 2016 
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. 
(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 sub-
section (a); and 
(B) the effect of the innovations on Federal expendi-
tures; 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 
SEC. 2011. PRECISION MEDICINE INITIATIVE. 
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: 
42 USC 289g–5. 
42 USC 283q. 
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130 STAT. 1048 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘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 sec-
tion, 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 con-
tribute to health disparities; 
‘‘(5) ensure that only authorized individuals may access 
controlled or sensitive, identifiable biological material and asso-
ciated 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 descrip-
tion 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
on the relevant data access policies and procedures to the Com-
mittee 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.’’. 
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 informa-
tion 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 gov-
erning the protection of human subjects in research. 
‘‘(D) Any person to whom a certificate is issued under subpara-
graph (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 subpara-
graph (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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130 STAT. 1050 
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 informa-
tion 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 deter-
mined 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 enact-
ment of this Act, all persons engaged in research and authorized 
by the Secretary of Health and Human Services to protect informa-
tion 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). 
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMA-
TION. 
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 indi-
vidual. 
‘‘(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. 
42 USC 241 note. 
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130 STAT. 1051 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 regula-
tions, 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 Serv-
ices 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. 
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: 
‘‘SEC. 404M. NEXT GENERATION OF RESEARCHERS. 
‘‘(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 independ-
ence, including existing policies and programs, as appropriate; 
42 USC 283o. 
42 USC 282 note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 Acad-
emies of Sciences, Engineering, and Medicine as part of the com-
prehensive 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 Appro-
priations Act, 2016. 
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 pro-
gram’’ 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 sub-
section (a), the Director of the National Institutes of Health— 
‘‘(A) shall continue to focus on— 
‘‘(i) general research; 
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‘‘(ii) research on acquired immune deficiency syn-
drome; and 
‘‘(iii) clinical research conducted by appropriately 
qualified health professional who are from disadvan-
taged 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 pursu-
ant 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 appro-
priate 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 sub-
section (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 disadvan-
taged 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 pursu-
ant to guidelines issued by the Director).’’; 
(5) in subsection (d) (as so redesignated), by striking ‘‘The 
provisions’’ and inserting ‘‘APPLICABILITY OF CERTAIN PROVI-
SIONS 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 repay-
ment 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 
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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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 commit-
tees 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 sci-
entific 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 treat-
ment, 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 long- 
term 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 pro-
posed 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 sub-
section. Such plans developed by and updated by the national 
research institutes and national centers shall have a common 
template. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 there-
after,’’ 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 cen-
ters 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).’’. 
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 con-
ducting 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 ‘‘demo-
graphic variables, including biological and social vari-
ables 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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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 subpara-
graph (B); and 
(v) in subparagraph (B), as redesignated by clause 
(iv), by striking ‘‘Recommendations’’ and inserting ‘‘rec-
ommendations’’. 
SEC. 
2033. 
INCREASING 
ACCOUNTABILITY 
AT 
THE 
NATIONAL 
INSTITUTES OF HEALTH. 
(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 stand-
ards 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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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 sub-
section 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 re-
appointments 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 deter-
mines relevant. 
‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.—The restric-
tions contained in section 202 of the Departments of Labor, 
Health and Human Services, and Education, and Related Agen-
cies 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 bio-
medical research that is not necessary for scientific purposes. Such 
report shall— 
(1) describe the procedures in place to identify such duplica-
tive research, including procedures for monitoring research 
applications and funded research awards to prevent unneces-
sary duplication; 
(2) describe the steps taken to improve the procedures 
described in paragraph (1), in response to relevant recommenda-
tions 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 unneces-
sary duplication; and 
(4) provide examples of instances where the Secretary has 
identified unnecessarily duplicative research and the steps 
taken to eliminate the unnecessary duplication. 
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 con-
flicts of interest involving research funding agencies. 
(2) CONSIDERATIONS.—In updating policies under para-
graph (1)(B), the Secretary shall consider— 
(A) modifying the timelines for the reporting of finan-
cial 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 modi-
fication of the definition of the term ‘‘investigator’’ for pur-
poses of the regulations and policies described in subpara-
graphs (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 sub-
recipients 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 meas-
ures may include, as appropriate— 
(1) an exemption from subrecipient monitoring require-
ments, upon request from the primary awardees, provided 
that— 
(A) the subrecipient is subject to Federal audit require-
ments pursuant to the Uniform Guidance of the Office 
of Management and Budget; 
(B) the primary awardee conducts, pursuant to guid-
ance of the National Institutes of Health, a pre-award 
42 USC 3501 
note. 
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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 appro-
priate, 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 inconsist-
encies, overlap, or duplication among such regulations and poli-
cies; 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 require-
ments 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 Manage-
ment 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 Tech-
nology Policy. 
(iii) The Secretary of Health and Human Services. 
(iv) The Director of the National Science Founda-
tion. 
(v) The secretaries and directors of other depart-
ments 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 com-
prised of not less than 9 and not more than 12 representa-
tives of academic research institutions, other private, non-
profit 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 sci-
entific 
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 harmoni-
zation 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 regula-
tions 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 prac-
tices; and 
(E) conducting ongoing assessment and evaluation of 
regulatory burden, including development of metrics, peri-
odic measurement, and identification of process improve-
ments and policy changes. 
(4) EXPERT SUBCOMMITTEES.—The Board may form tem-
porary 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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130 STAT. 1062 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 Manage-
ment 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 REQUIRE-
MENTS. 
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.’’. 
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 trans-
actions 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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130 STAT. 1063 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 sub-
paragraphs (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;’’. 
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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130 STAT. 1064 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 informa-
tion 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.’’. 
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE 
RESEARCH. 
(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 oppor-
tunity, 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 pedi-
atric subgroups; and 
‘‘(IV) other demographic variables as the 
Director of the National Institutes of Health deter-
mines appropriate; 
‘‘(ii) is disaggregated by research area, condition, 
and disease categories; and 
‘‘(iii) is to be made publicly available on the Inter-
net 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 subpara-
graph (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 deter-
minants of health that contribute to health dispari-
ties;’’. 
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130 STAT. 1065 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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-eth-
nicity 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: 
‘‘SEC. 404N. POPULATION FOCUSED RESEARCH. 
‘‘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 participa-
tion, 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 appro-
priate— 
42 USC 283p 
note. 
42 USC 283p. 
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130 STAT. 1066 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 ‘‘INTER-
AGENCY’’ 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 aca-
demic 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 
42 USC 284r. 
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130 STAT. 1067 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 accord-
ance 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 sec-
tion 492B of the Public Health Service Act (42 U.S.C. 
289a–2), including the reporting requirements under sub-
section (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 out-
comes 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— 
42 USC 282 note. 
42 USC 289a–2 
note. 
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130 STAT. 1068 
PUBLIC LAW 114–255—DEC. 13, 2016 
(A) address the consideration of age as an inclusion 
variable in research involving human subjects; and 
(B) identify the criteria for justification for any age- 
related 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 tri-
ennial 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. 
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCI-
ENTIFIC 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 recommenda-
tions 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 deter-
minants of health that contribute to health disparities; 
(B) the circumstances under which summary informa-
tion regarding biological, social, and other factors that con-
tribute 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 dispari-
ties; 
(3) applicable levels of rigor in statistical methods, method-
ology, and analysis; 
(4) data and information sharing in accordance with 
applicable privacy laws and regulations; and 
(5) any other matter the working group determines rel-
evant. 
(c) POLICIES.—Not later than 18 months after the date of enact-
ment of this Act, the Director of the National Institutes of Health 
shall consider the recommendations developed by the working group 
42 USC 282 note. 
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130 STAT. 1069 
PUBLIC LAW 114–255—DEC. 13, 2016 
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. 
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 fol-
lowing: 
‘‘(4) The Director of the Center, in consultation with the Director 
of the Institute, the coordinating committee established under sub-
section (e), and the advisory board established under subsection 
(f), shall revise and update the Research Plan periodically, as appro-
priate, 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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130 STAT. 1070 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 rehabilita-
tion 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 rehabilita-
tion 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 rehabilita-
tion 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). 
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT 
WOMEN AND LACTATING WOMEN. 
(a) TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN 
AND 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 
42 USC 289a–2 
note. 
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130 STAT. 1071 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 guid-
ance 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 com-
posed 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 appro-
priate 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, lac-
tating 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 oper-
ation 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 appro-
priate 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 appro-
priate, 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 preg-
nant women and lactating women in clinical research. 
(C) Effective communication strategies with health care 
providers and the public on information relevant to preg-
nant 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 lac-
tating 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 LAC-
TATING WOMEN IN RESEARCH.— 
(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of this Act, the Secretary, considering any rec-
ommendations 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 appro-
priate, 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 individ-
uals 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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130 STAT. 1073 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 
2042. 
STREAMLINING 
NATIONAL 
INSTITUTES 
OF 
HEALTH 
REPORTING REQUIREMENTS. 
(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 ‘‘sub-
sections (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 UNDER-
REPRESENTED 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 underrep-
resented 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. 
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 clin-
ical trial for a product that is a combination of drug, 
device, or biological product shall be considered— 
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130 STAT. 1075 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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.’’. 
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS. 
(a) DEFINITIONS.—In this section: 
(1) APPLICABLE CLINICAL TRIAL.—The term ‘‘applicable clin-
ical 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 reg-
istered 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 edu-
cate 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 para-
graph (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 registra-
tion 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 com-
peting 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, physi-
cians, industry representatives, and developers of health informa-
tion 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 
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 fol-
lowing: 
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130 STAT. 1077 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘SEC. 399S–1. SURVEILLANCE OF NEUROLOGICAL DISEASES. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in coordina-
tion 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 activi-
ties into an integrated surveillance system, which may consist 
of or include a registry, to be known as the National Neuro-
logical 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 informa-
tion 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 dis-
eases, 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 neuro-
logical 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 informa-
tion 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 associa-
tions that— 
‘‘(A) focus on neurological diseases; and 
‘‘(B) have demonstrated experience in research, care, 
or patient services; 
‘‘(3) health information technology experts or other informa-
tion management specialists; 
‘‘(4) clinicians with expertise in neurological diseases; and 
‘‘(5) 
research 
scientists 
with 
experience 
conducting 
translational research or utilizing surveillance systems for sci-
entific research purposes. 
42 USC 280g–7a. 
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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 Neuro-
logical Conditions Surveillance System available, as appro-
priate— 
‘‘(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 prac-
ticable. 
‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary 
shall ensure that information and analysis in the National Neuro-
logical 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 informa-
tion collected pursuant to this section and epidemiological anal-
yses, 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 popu-
lation of individuals with neurological disease and have dem-
onstrated experience in neurological disease research, care, and 
patient services. 
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130 STAT. 1079 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(k) AUTHORIZATION
OF APPROPRIATIONS.—To carry out this 
section, there is authorized to be appropriated $5,000,000 for each 
of fiscal years 2018 through 2022.’’. 
SEC. 2062. TICK-BORNE DISEASES. 
(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 dis-
eases. 
(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 inter-
agency 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 dis-
eases; 
(ii) advances made pursuant to such research; 
(iii) Federal activities related to tick-borne dis-
eases, including— 
(I) epidemiological activities related to tick- 
borne 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 nongovern-
mental entities, including organizations representing 
patients, health care providers, researchers, and industry 
regarding scientific advances, research questions, surveil-
lance activities, and emerging strains in species of patho-
genic organisms. 
42 USC 284s. 
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130 STAT. 1080 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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, con-
sisting of one or more representatives of each of the fol-
lowing: 
(i) The Office of the Assistant Secretary for Health. 
(ii) The Food and Drug Administration. 
(iii) The Centers for Disease Control and Preven-
tion. 
(iv) The National Institutes of Health. 
(v) Such other agencies and offices of the Depart-
ment of Health and Human Services as the Secretary 
determines appropriate. 
(B) NON–FEDERAL PUBLIC MEMBERS.—Seven non–Fed-
eral public members, consisting of representatives of the 
following categories: 
(i) Physicians and other medical providers with 
experience in diagnosing and treating tick-borne dis-
eases. 
(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 deter-
mined by the Secretary to be beneficial to the func-
tioning 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. 
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— 
42 USC 1320d–2 
note. 
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130 STAT. 1081 
PUBLIC LAW 114–255—DEC. 13, 2016 
(1) at a minimum, security and privacy safeguards, con-
sistent 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 other-
wise 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 indi-
vidual has the right to revoke such authorization. 
(3) REVOCATION OF AUTHORIZATION.—Clarification of appro-
priate 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 pro-
tected 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 represent-
atives 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 deter-
mines 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 pur-
poses, 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 individ-
ual’s protected health information will be used or dis-
closed for such research; 
(ii) opportunities for individuals to set preferences 
on the manner in which their protected health informa-
tion is used in research; 
(iii) opportunities for patients to revoke authoriza-
tion; 
(iv) notification to individuals of a breach in pri-
vacy; 
(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 pro-
tected health information; and 
(B) consider, at a minimum— 
(i) expectations and preferences on how an individ-
ual’s protected health information is shared and used; 
(ii) issues related to specific subgroups of people, 
such as children, incarcerated individuals, and individ-
uals 
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-disclo-
sure 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, Edu-
cation, 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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130 STAT. 1083 
PUBLIC LAW 114–255—DEC. 13, 2016 
(1) THE RULE.—References to ‘‘the Rule’’ refer to part 160 
or part 164, as appropriate, of title 45, Code of Federal Regula-
tions (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 clin-
ical 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 authori-
ties; and 
(3) once a global pediatric clinical study network is estab-
lished and becomes operational, the Secretary should continue 
to encourage and facilitate the participation of clinical inves-
tigators 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 
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 subpara-
graphs (A) and (B), respectively, and moving such subpara-
graphs 2 ems to the right; and 
(C) by striking ‘‘The Secretary’’ and inserting the fol-
lowing: 
‘‘(1) IN GENERAL.—The Secretary’’; 
(2) by redesignating subsections (b) through (e) as para-
graphs (2) through (5), respectively, and moving such para-
graphs 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 organiza-
tions, 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.’’. 
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. 
21 USC 
360bbb–8c note. 
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130 STAT. 1085 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 sub-
section (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 through-
out the drug development process and methodological consider-
ations 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 regu-
latory decisionmaking; 
(5) how a person seeking to develop and submit proposed 
draft guidance relating to patient experience data for consider-
ation 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. 
SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT. 
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 
21 USC 355 note. 
21 USC 
360bbb–8c note. 
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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: 
‘‘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 accord-
ance 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 para-
graph as ‘qualification submissions’). 
‘‘(B) ACCEPTANCE FACTORS; NONACCEPTANCE.—The Sec-
retary shall determine whether to accept a qualification 
submission based on factors which may include the sci-
entific merit of the qualification submission. A determina-
tion 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 
21 USC 357. 
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130 STAT. 1087 
PUBLIC LAW 114–255—DEC. 13, 2016 
development tool and the availability or lack of alter-
native treatments for such disease or condition; and 
‘‘(ii) the identification, by the Secretary or by bio-
medical research consortia and other expert stake-
holders, of such a drug development tool and its pro-
posed context of use as a public health priority. 
‘‘(D) ENGAGEMENT OF EXTERNAL EXPERTS.—The Sec-
retary may, for purposes of the review of qualification 
submissions, through the use of cooperative agreements, 
grants, or other appropriate mechanisms, consult with bio-
medical research consortia and may consider the rec-
ommendations 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 para-
graph (3). 
‘‘(3) REVIEW OF FULL QUALIFICATION PACKAGE.—The Sec-
retary shall— 
‘‘(A) conduct a comprehensive review of a full qualifica-
tion 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 para-
graph (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 pro-
posed 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 Administra-
tion the following: 
‘‘(A) Information with respect to each qualification 
submission under the qualification process under sub-
section (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 uti-
lized in the development of a qualification plan or 
the review of a full qualification package; and 
‘‘(iv) submissions from requestors under the quali-
fication 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 sub-
section (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 con-
strued 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 ‘bio-
medical 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, clin-
ical 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 develop-
ment 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 regu-
latory review for purposes of this section. 
‘‘(6) PATIENT-REPORTED
OUTCOME.—The term ‘patient- 
reported 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 ‘quali-
fied’ 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, radio-
graphic 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.— 
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 appro-
priate 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 Sec-
retary’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 qualifica-
tion 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 sub-
section (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 quali-
fication process under section 507 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a). 
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PUBLIC LAW 114–255—DEC. 13, 2016 
(2) REPORT.—Not later than 5 years after the date of the 
enactment of this Act, the Secretary shall make publicly avail-
able on the Internet website of the Food and Drug Administra-
tion 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 deter-
mined 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 qualifica-
tion 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: 
‘‘SEC. 529A. TARGETED DRUGS FOR RARE DISEASES. 
‘‘(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 geneti-
cally targeted technology as the drug or drugs that are the subject 
21 USC 360ff–1. 
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130 STAT. 1092 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 suppres-
sion, up-regulation, or activation) of the function of a gene 
or its associated gene product; and 
‘‘(C) incorporates or utilizes a genetically targeted tech-
nology; 
‘‘(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 sub-
mitted 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREAT-
MENTS 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 para-
graph (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. 
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 pro-
gram under section 529 of the Federal Food, Drug, and Cos-
metic 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 sub-
section (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 Cos-
metic Act (21 U.S.C. 355(c)), pursuant to an application 
under section 505(b)(1) of such Act, or licensed under sec-
tion 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 licen-
sure 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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130 STAT. 1094 
PUBLIC LAW 114–255—DEC. 13, 2016 
(ii) addressed an unmet need related to the treat-
ment 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 Cos-
metic Act (21 U.S.C. 355(c)), pursuant to an application 
under section 505(b)(1) of such Act, or licensed under sec-
tion 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 Adminis-
tration 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 develop-
ment 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 treat-
ment or prevention of neglected tropical diseases, 
including in countries in which neglected tropical dis-
eases 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 unin-
tended consequences. 
(d) PROTECTION OF NATIONAL SECURITY.—The Comptroller Gen-
eral shall conduct the study and issue reports under this section 
in a manner that does not compromise national security. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(C) prospectively planned and designed observational 
studies and other analyses conducted to assist in the under-
standing 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 dis-
tinct subpopulations affected by a rare disease or condi-
tion.’’. 
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFAC-
TURING. 
(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 con-
trol 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 Edu-
cation Act of 1965 (20 U.S.C. 1001(a)). 
Subtitle C—Modern Trial Design and 
Evidence Development 
SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS. 
(a) PROPOSALS FOR USE OF NOVEL CLINICAL TRIAL DESIGNS 
FOR 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 guid-
ance 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— 
21 USC 355 note. 
21 USC 399h. 
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130 STAT. 1096 
PUBLIC LAW 114–255—DEC. 13, 2016 
(A) the use of complex adaptive and other novel trial 
designs, including how such clinical trials proposed or sub-
mitted help to satisfy the substantial evidence standard 
under section 505(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(d)); 
(B) how sponsors may obtain feedback from the Sec-
retary on technical issues related to modeling and simula-
tions 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 informa-
tion that should be submitted for review; and 
(D) recommended analysis methodologies. 
(3) PUBLIC MEETING.—Prior to updating or issuing the guid-
ance 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 fol-
lowing: 
‘‘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 require-
ments. 
‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this section, the term 
‘real world evidence’ means data regarding the usage, or the poten-
tial 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, reg-
istries, claims, and patient-centered outcomes research 
activities; 
‘‘(B) the gaps in data collection activities; 
21 USC 355g. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 frame-
work under this subsection, the Secretary shall consult 
with regulated industry, academia, medical professional 
organizations, representatives of patient advocacy organiza-
tions, consumer organizations, disease research founda-
tions, 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 sub-
section (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 evi-
dence 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.’’. 
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 provi-
sions, 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 Regula-
tions, and the vulnerable populations rules as may be nec-
essary— 
(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, hos-
pitals, 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 harmoni-
zation. 
(f) DEFINITIONS.— 
(1) HUMAN SUBJECT REGULATIONS.—In this section: 
(A) FDA HUMAN
SUBJECT
REGULATIONS.—The term 
‘‘FDA Human Subject Regulations’’ means the provisions 
42 USC 289 note. 
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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 Regula-
tions (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 regu-
lations); 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 regula-
tions) 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 CLIN-
ICAL 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 investi-
gator’’ 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 appro-
priate 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 
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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130 STAT. 1100 
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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 applica-
tions 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 subpara-
graph (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: 
‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGA-
TIONAL DRUGS. 
‘‘(a) IN GENERAL.—The manufacturer or distributor of one or 
more investigational drugs for the diagnosis, monitoring, or treat-
ment 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 provi-
sion of such a drug. 
21 USC 
360bbb–0. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 sub-
section (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.’’. 
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 regen-
erative advanced therapy under this subsection if— 
‘‘(A) the drug is a regenerative medicine therapy (as 
defined in paragraph (8)); 
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130 STAT. 1102 
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 regenera-
tive 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 inter-
mediate 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 Amend-
ments 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 addi-
tional 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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‘‘(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, thera-
peutic tissue engineering products, human cell and tissue prod-
ucts, 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 condi-
tions, for approval under such Acts; or 
(2) to alter the authority of the Secretary to require post-
approval 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. 
(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 sim-
plify 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 dem-
onstrate 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. 
SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES. 
(a) REPORT TO CONGRESS.—Before March 1 of each calendar 
year, the Secretary of Health and Human Services shall, with 
21 USC 356 note. 
21 USC 356g 
note. 
21 USC 356 note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
respect to the previous calendar year, submit a report to the Com-
mittee 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 REGEN-
ERATIVE 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: 
‘‘SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGEN-
ERATIVE ADVANCED THERAPIES. 
‘‘(a) IN GENERAL.—Not later than 2 years after the date of 
enactment of the 21st Century Cures Act, the Secretary, in consulta-
tion with the National Institute of Standards and Technology and 
stakeholders (including regenerative medicine and advanced thera-
pies manufacturers and clinical trial sponsors, contract manufactur-
ers, academic institutions, practicing clinicians, regenerative medi-
cine 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 regenera-
tive 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 Sec-
retary shall continue to— 
‘‘(A) identity opportunities to help advance the develop-
ment of regenerative medicine therapies and regenerative 
advanced therapies; 
‘‘(B) identify opportunities for the development of lab-
oratory regulatory science research and documentary 
standards that the Secretary determines would help sup-
port the development, evaluation, and review of regenera-
tive medicine therapies and regenerative advanced thera-
pies 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 guid-
ance and, through a public process, update such regulations 
and guidance as the Secretary determines appropriate. 
21 USC 356g. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 evi-
dence, and includes, where applicable, a conspicuous and promi-
nent 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.’’. 
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 sub-
section, 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 appro-
priate. 
‘‘(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 sci-
entific 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 deter-
mination 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 sub-
mits a written meeting request, the Secretary shall, not later than 
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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 modifica-
tion of such combination product and good manufacturing prac-
tices 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 deter-
mining 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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130 STAT. 1108 
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 com-
bination 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 subpara-
graph (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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 commit-
ments, 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 Sec-
retary 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 com-
pleted 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 guid-
ance 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 representa-
tives of the Office in meetings related to such combination 
product, or to have the Office otherwise engage on such regu-
latory 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 pre- 
submission 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 Adminis-
tration, 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 para-
graph’’; 
(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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130 STAT. 1110 
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 investiga-
tional 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 regula-
tions) 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 require-
ments, 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 Sec-
retary shall publish a final list in the Federal Register, notwith-
standing 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. 
21 USC 355 note. 
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130 STAT. 1111 
PUBLIC LAW 114–255—DEC. 13, 2016 
Subtitle E—Antimicrobial Innovation and 
Stewardship 
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 sum-
maries 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 guid-
ance, educational materials, or other appropriate materials related 
to the development and implementation of evidence-based anti-
microbial stewardship programs or practices at health care facilities, 
such as nursing homes and other long-term care facilities, ambula-
tory surgical centers, dialysis centers, outpatient clinics, and hos-
pitals, including community and rural hospitals. 
‘‘(i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTI-
MICROBIAL 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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130 STAT. 1112 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(j) ANTIMICROBIAL
RESISTANCE
AND
STEWARDSHIP
ACTIVI-
TIES.— 
‘‘(1) IN GENERAL.—For the purposes of supporting steward-
ship 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 standard-
ized approach; and 
‘‘(ii) trends in the utilization of drugs approved 
under such section 506(h) with respect to patient popu-
lations. 
‘‘(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 sub-
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, or section 
1905 of title 18, United States Code. 
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 anti-
bacterial 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 life- 
threatening 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 deter-
mination 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 
42 USC 247d–5 
note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
approved under this subsection notwithstanding a lack of evi-
dence 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 popu-
lation— 
‘‘(i) all labeling and advertising of an antibacterial 
or antifungal drug approved under this subsection shall 
contain the statement ‘Limited Population’ in a promi-
nent 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 estab-
lished 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 anti-
bacterial 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 designa-
tion 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 develop-
ment 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 stand-
ards 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, Edu-
cation, 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 sub-
section have affected antibacterial or antifungal resist-
ance.’’. 
SEC. 3043. PRESCRIBING AUTHORITY. 
Nothing in this subtitle, or an amendment made by this sub-
title, 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 profes-
sionals, 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: 
‘‘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 
21 USC 360a–2. 
21 USC 356 note. 
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130 STAT. 1115 
PUBLIC LAW 114–255—DEC. 13, 2016 
health, due to, among other things, the constant evolution 
of microorganisms that leads to the development of resist-
ance to drugs that have been effective in decreasing mor-
bidity 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 recog-
nized interpretive criteria and interpretive criteria stand-
ards; 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 pharmaco-
kinetic, 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 Sec-
retary 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 decision-
making; and 
‘‘(III) permits its standards to be made publicly 
available, through the National Library of Medi-
cine or another similar source acceptable to the 
Secretary; and 
‘‘(ii) recognized in whole, or in part, by the Sec-
retary 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 mar-
keting 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 interpre-
tive 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 suscepti-
bility 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 stand-
ards 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 CRI-
TERIA.— 
‘‘(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 estab-
lished by a nationally or internationally recognized 
standard development organization described in sub-
section (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 stand-
ards; 
‘‘(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 anti-
microbial 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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130 STAT. 1118 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STAND-
ARDS.—In evaluating new or updated susceptibility test 
interpretive criteria standards under paragraph (1)(A), the Sec-
retary may consider— 
‘‘(A) the Secretary’s determination that such a standard 
is not applicable to a particular drug because the character-
istics 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 com-
ments, the Secretary shall review such comments and, if the 
Secretary determines appropriate, update pursuant to this sub-
section susceptibility test interpretive criteria standards or cri-
teria— 
‘‘(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
under section 314.70 of title 21, Code of Federal Regula-
tions (or any successor regulations) that may be imple-
mented 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 suscepti-
bility test interpretive criteria and related information, a ref-
erence 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 SUSCEPTI-
BILITY TESTING DEVICES.—The conditions specified in this para-
graph 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 Sec-
retary 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 micro-
organisms, 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 suscepti-
bility 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 deter-
mines 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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130 STAT. 1120 
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 micro-
organisms to the drug tested; and 
‘‘(B) related categorizations of such susceptibility, 
including categorization of the drug as susceptible, inter-
mediate, 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 com-
pilation 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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.—Sec-
tion 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 suscepti-
bility 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. 
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: 
‘‘SEC. 515C. BREAKTHROUGH DEVICES. 
‘‘(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 develop-
ment of, and prioritize the Food and Drug Administration’s review 
of, devices that represent breakthrough technologies. 
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary shall estab-
lish a program to expedite the development of, and provide for 
the priority review for, devices, as determined by the Secretary— 
21 USC 360e–3. 
21 USC 360a–2 
note. 
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130 STAT. 1122 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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, com-
pared 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 long- 
term 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 des-
ignation granted under this section on the basis of the criteria 
under subsection (b) no longer applying because of the subse-
quent 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 Sec-
retary 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 resolu-
tion; 
‘‘(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 Sec-
retary 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 Sec-
retary 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 commit-
tees concerning the conditions and clinical testing require-
ments 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 agree-
ment on a data development plan; 
‘‘(B) take steps to ensure that the design of clinical 
trials is as efficient and flexible as practicable, when sci-
entifically appropriate; 
‘‘(C) facilitate, when scientifically appropriate, expe-
dited 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 Sec-
retary 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, pro-
vided 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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130 STAT. 1124 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(C) identify the criteria the Secretary will use in evalu-
ating 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 para-
graph (1), the Secretary shall seek public comment on a pro-
posed 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 applica-
tion 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 establish-
ment 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 Fed-
eral 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 Representa-
tives— 
(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. 
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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PUBLIC LAW 114–255—DEC. 13, 2016 
(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 Sec-
retary of Health and Human Services, acting through the Commis-
sioner 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)). 
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 estab-
lished 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, regu-
latory, 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 deter-
mines 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 require-
ment 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 recog-
nizing 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 
21 USC 360d 
note. 
21 USC 360j 
note. 
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device industry, and whether recognition of a standard will promote 
harmonization among regulatory authorities in the regulation of 
devices. 
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 enact-
ment of the 21st Century Cures Act and at least once every 5 
years thereafter, as the Secretary determines appropriate, the Sec-
retary 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 assur-
ance 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 con-
tains 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 effective-
ness; 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-cal-
endar-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.’’. 
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 rec-
ommendations on the expertise needed among the voting mem-
bers 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 appro-
priate 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 pro-
vided 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 representa-
tive 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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130 STAT. 1128 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 institu-
tional’’ 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 super-
vised by an institutional review committee established in 
accordance with the regulations of the Secretary; and’’; 
(B) in subparagraph (B), by striking ‘‘a local institu-
tional’’ and inserting ‘‘an institutional’’; and 
(C) in the matter following subparagraph (B), by 
striking ‘‘local’’. 
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 Manufac-
turers 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. 
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 REQUIRE-
MENTS.— 
‘‘(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 
42 USC 263a 
note. 
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130 STAT. 1129 
PUBLIC LAW 114–255—DEC. 13, 2016 
under subparagraph (A), to ensure that the least burden-
some 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 para-
graph (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 burden-
some 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 para-
graph (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 burden-
some means of demonstrating a reasonable assurance of device 
safety and effectiveness. 
‘‘(D) Nothing in this paragraph alters the standards for pre-
market 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 sec-
tion 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as 
applicable.’’. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIRE-
MENT. 
(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 speci-
fied 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. 
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 sched-
ules, business analytics, information about patient popu-
lations, admissions, practice and inventory management, 
analysis of historical claims data to predict future utiliza-
tion 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, preven-
tion, 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, 
21 USC 360 note. 
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130 STAT. 1131 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 individ-
uals 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 informa-
tion (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 recommenda-
tions that such software presents so that it is not 
the intent that such health care professional rely pri-
marily 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 defini-
tion 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. Notwith-
standing 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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130 STAT. 1132 
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 para-
graph (1). 
‘‘(4) Nothing in this subsection shall be construed as lim-
iting 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 representa-
tives 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; 
21 USC 360j 
note. 
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130 STAT. 1133 
PUBLIC LAW 114–255—DEC. 13, 2016 
(2) examines information available to the Secretary on 
any risks and benefits to health associated with software func-
tions 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 soft-
ware functions on patient safety, including best practices to 
promote safety, education, and competency related to such func-
tions. 
(c) CLASSIFICATION OF ACCESSORIES.—Section 513(b) of the Fed-
eral 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 
SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIO-
MEDICAL 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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130 STAT. 1134 
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) speci-
fied 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 amend-
ments 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 Rep-
resentatives. 
(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 bio-
medical 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 enact-
ment 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 doc-
toral 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. 
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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130 STAT. 1135 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
PROFESSIONAL PERSONNEL. 
‘‘(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 sec-
tion 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 Rep-
resentatives 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 quali-
fied scientific, technical, and professional candidates, which 
may include the use of— 
‘‘(i) recruitment through nongovernmental recruit-
ment 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. 
21 USC 379d–3a. 
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130 STAT. 1136 
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 sci-
entific, technical, and professional staff, not including contrac-
tors, 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 evalua-
tion, 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: 
‘‘SEC. 
1014. 
FOOD 
AND 
DRUG 
ADMINISTRATION 
INTERCENTER 
INSTITUTES. 
‘‘(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 proc-
esses 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; 
21 USC 399g. 
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130 STAT. 1137 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(2) streamlining, where appropriate, the review of medical 
products to diagnose, cure, mitigate, treat, or prevent the spe-
cific 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 strate-
gies 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 termi-
nate any Institute established pursuant to this section if the Sec-
retary 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. 
SEC. 3074. SCIENTIFIC ENGAGEMENT. 
(a) IN GENERAL.—Scientific meetings that are attended by sci-
entific or medical personnel, or other professionals, of the Depart-
ment 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. 
42 USC 3506a. 
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130 STAT. 1138 
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 descrip-
tion of the exceptional circumstances that necessitated the 
expenditure of such amounts. 
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 quali-
fied 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 sig-
nals.’’. 
(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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130 STAT. 1139 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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’’. 
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 Fed-
eral 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 bio-
technology 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 Govern-
ment 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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130 STAT. 1140 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 para-
graph (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 compensa-
tion 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), quali-
fied pandemic and epidemic products (as defined in section 
319F–3), and security countermeasures (as defined in sub-
section (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
PROCURE-
MENT.—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 Appro-
priations 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)).’’. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Sec-
retary, acting through the Director of the Biomedical Advanced 
Research and Development Authority, shall carry out the pro-
grams funded by the special reserve fund (for the procurement 
of security countermeasures under subsection (c) and for car-
rying 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 Appro-
priations 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.’’. 
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, con-
tracts, 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 tech-
nologies that may assist advanced research and 
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130 STAT. 1142 
PUBLIC LAW 114–255—DEC. 13, 2016 
the development of qualified countermeasures and 
qualified pandemic or epidemic products, including 
through the use of strategic venture capital prac-
tices and methods; 
‘‘(II) promote the development of new and 
promising technologies that address urgent med-
ical 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 plat-
form technologies for diagnostics, prophylaxis, vac-
cines, and therapeutics; and 
‘‘(IV) provide expert consultation and advice 
to 
foster 
viable 
medical 
countermeasure 
innovators, including helping qualified counter-
measure innovators navigate unique industry chal-
lenges with respect to developing chemical, 
biological, 
radiological, 
and 
nuclear 
counter-
measure 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 identi-
fied strategic needs of the Federal Govern-
ment; 
‘‘(cc) have experience in promoting novel 
technology innovation; 
‘‘(dd) be problem-driven and solution- 
focused based on the needs, requirements, and 
problems identified by the Secretary under 
clause (iv); 
‘‘(ee) demonstrate the ability, or the poten-
tial ability, to promote the development of 
medical countermeasure products; 
‘‘(ff) demonstrate expertise, or the capacity 
to develop or acquire expertise, related to tech-
nical 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 per-
formed by the entity under the agreement; 
‘‘(III) provide technical feedback and appro-
priate 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 subpara-
graph; 
‘‘(IV) ensure fair consideration of products 
developed under the agreement in order to main-
tain 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 car-
ried 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 effec-
tively, 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 commit-
tees of Congress a report, concerning the activities 
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130 STAT. 1144 
PUBLIC LAW 114–255—DEC. 13, 2016 
conducted under this subparagraph. Such report shall 
include recommendations with respect to any agree-
ment or activities carried out pursuant to this subpara-
graph. 
‘‘(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 rec-
ommendation under paragraph (6) that the special reserve fund 
as defined in subsection (h) be made available for the procure-
ment 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 COMMIT-
TEES.—The Secretary shall notify the Committee on Appro-
priations and the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Appro-
priations 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 sup-
pliers of the same or similar countermeasures were consid-
ered 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 spe-
cial 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 subpara-
graph (B). 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
AGENTS THAT PRESENT NATIONAL SECURITY THREATS. 
‘‘(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 APPLICA-
TION.—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 con-
sequences or death and may be caused by admin-
istering 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 counter-
measure application. There is no limit on the number of times 
21 USC 
360bbb–4a. 
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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 Sep-
tember 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 submis-
sion 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, exemp-
tion, 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 collec-
tions to the account providing appropriations to the Food 
and Drug Administration; and 
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130 STAT. 1147 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 PROD-
UCTS 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 applica-
tion 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.’’. 
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 nec-
essary, that— 
‘‘(A)(i) the criteria set forth for a public health emer-
gency 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 emer-
gency, 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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130 STAT. 1148 
PUBLIC LAW 114–255—DEC. 13, 2016 
health threat, will become a public health emergency as pro-
vided for in this paragraph. The requirements of such sub-
chapter I with respect to voluntary collection of information 
shall not be applicable during the immediate postresponse 
review regarding such public health emergency if such imme-
diate postresponse review does not exceed a reasonable length 
of time. 
‘‘(2) TRANSPARENCY.—If the Secretary determines that a 
waiver is necessary under paragraph (1), the Secretary shall 
promptly post on the Internet website of the Department of 
Health and Human Services a brief justification for such waiver, 
the anticipated period of time such waiver will be in effect, 
and the agencies and offices within the Department of Health 
and Human Services to which such waiver shall apply, and 
update such information posted on the Internet website of 
the Department of Health and Human Services, as applicable. 
‘‘(3) EFFECTIVENESS OF WAIVER.—Any waiver under this 
subsection shall take effect on the date on which the Secretary 
posts information on the Internet website as provided for in 
this subsection. 
‘‘(4) TERMINATION OF WAIVER.—Upon determining that the 
circumstances necessitating a waiver under paragraph (1) no 
longer exist, the Secretary shall promptly update the Internet 
website of the Department of Health and Human Services 
to reflect the termination of such waiver. 
‘‘(5) LIMITATIONS.— 
‘‘(A) PERIOD OF WAIVER.—The period of a waiver under 
paragraph (1) shall not exceed the period of time for the 
related public health emergency, including a public health 
emergency declared pursuant to subsection (a), and any 
immediate postresponse review regarding the public health 
emergency consistent with the requirements of this sub-
section. 
‘‘(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 cir-
cumstances, but not to exceed 30 calendar days after the 
expiration of the applicable waiver.’’. 
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMER-
GENCY USE AUTHORIZATION. 
(a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMER-
GENCIES.—Section 564 of the Federal Food, Drug, and 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 sec-
tion 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 
SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE 
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES. 
(a) CONSIDERATION
OF NEW VACCINES.—Upon the licensure 
of any vaccine or any new indication for a vaccine, the Advisory 
21 USC 
360bbb–4 note. 
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130 STAT. 1150 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 Com-
mittee 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.’’. 
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY 
COMMITTEE 
ON 
IMMUNIZATION 
PRACTICES 
REC-
OMMENDATIONS. 
(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, Develop-
ment, 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 sub-
section (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 enact-
ment 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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. 
SEC. 3093. ENCOURAGING VACCINE INNOVATION. 
(a) VACCINE MEETINGS.—The Director of the Centers for Dis-
ease 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 pub-
licly 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 appro-
priate— 
(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 stake-
holders; 
(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 develop-
ment. 
(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 
42 USC 300aa–2 
note. 
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130 STAT. 1152 
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 subpara-
graphs (B) and (C) of paragraph (2) with respect to such vac-
cines.’’. 
(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 adminis-
tered 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 adminis-
tered the vaccine.’’ at the end. 
Subtitle J—Technical Corrections 
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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130 STAT. 1153 
PUBLIC LAW 114–255—DEC. 13, 2016 
(i) in subsection (d), in the last sentence, by 
striking ‘‘premarket approval’’ and inserting ‘‘mar-
keting approval’’; and 
(ii) in subsection (q)(5)(A), by striking ‘‘subsection 
(b)(2) or (j) of the Act or 351(k)’’ and inserting ‘‘sub-
section (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 subpara-
graph 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 ini-
tial 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 PRODUC-
TION 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 ‘‘discontinu-
ation’’ and inserting ‘‘discontinuance’’. 
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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 risk- 
based scheduled’’ and inserting ‘‘establishing a risk- 
based 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 DIS-
EASE
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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130 STAT. 1155 
PUBLIC LAW 114–255—DEC. 13, 2016 
(Q) USE OF CLINICAL INVESTIGATION DATA FROM OUT-
SIDE 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 intro-
duce 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 MED-
ICAL 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 fol-
lowing: 
‘‘(D) EFFECTIVE
DATE.—In establishing the effective 
date of the regulations under subparagraph (A), the Sec-
retary shall, in consultation with the Secretary of Home-
land 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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130 STAT. 1156 
PUBLIC LAW 114–255—DEC. 13, 2016 
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
INSPEC-
TIONS.—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
SUB-
GROUPS.—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 applica-
tions’’. 
(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. 
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 subpara-
graph (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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PUBLIC LAW 114–255—DEC. 13, 2016 
TITLE IV—DELIVERY 
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
QUALITY OF CARE FOR PATIENTS. 
(a) IN GENERAL.—The Health Information Technology for Eco-
nomic 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: 
‘‘SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
QUALITY OF CARE FOR PATIENTS. 
‘‘(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 sup-
pliers 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 regu-
latory 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 estab-
lished 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 cer-
tified 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 
42 USC 300jj–11 
note. 
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130 STAT. 1158 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(vi) other value-based payment programs, as the Sec-
retary 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 elec-
tronic health information; 
‘‘(F) activities related to protecting the security of elec-
tronic 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 appro-
priate. 
‘‘(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 appro-
priate, 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 dele-
gate 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 documenta-
tion.’’; and 
(2) in the table of contents in section 13001(b), by inserting 
after the item relating to section 13102 the following: 
‘‘13103. Assisting doctors and hospitals in improving the quality and care for pa-
tients.’’. 
(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 authori-
ties, the voluntary certification of health information 
technology under the program developed under 
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130 STAT. 1159 
PUBLIC LAW 114–255—DEC. 13, 2016 
subparagraph (A) for use in medical specialties and 
sites of service for which no such technology is avail-
able or where more technological advancement or 
integration is needed. 
‘‘(ii) SPECIFIC
MEDICAL
SPECIALTIES.—The Sec-
retary 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 Sec-
retary, in consultation with relevant stakeholders, 
shall make recommendations for the voluntary certifi-
cation of health information technology for use by pedi-
atric health providers to support the health care of 
children. Not later than 2 years after the date of enact-
ment of the 21st Century Cures Act, the Secretary 
shall adopt certification criteria under section 3004 
to support the voluntary certification of health informa-
tion 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 Tech-
nology, a report concerning attestation statistics for the Medi-
care 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 Pay-
ment System to account for changes arising from the 
implementation of such payment system. 
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 Sec-
retary that such developer or entity, unless for legiti-
mate 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 informa-
tion 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 inter-
faces and allows health information from such tech-
nology to be accessed, exchanged, and used without 
special effort through the use of application program-
ming interfaces or successor technology or standards, 
as provided for under applicable law, including pro-
viding access to all data elements of a patient’s elec-
tronic 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 sec-
tion 3000) in the type of setting in which such tech-
nology 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 communica-
tion 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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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(E) 
COMPLIANCE
WITH
CONDITIONS
OF
CERTIFI-
CATION.—The Secretary may encourage compliance with 
the conditions of certification described in subparagraph 
(D) and take action to discourage noncompliance, as appro-
priate.’’. 
(b) EHR SIGNIFICANT HARDSHIP EXCEPTION.— 
(1) APPLICATION TO ELIGIBLE PROFESSIONALS.— 
(A) 
IN
CASE
OF
DECERTIFICATION.—Section 
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 tech-
nology 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 recog-
nized pursuant to section 3001(c)(5) of the Public Health Service 
Act.’’. 
(c) ELECTRONIC HEALTH RECORD REPORTING PROGRAM.—Sub-
title 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: 
‘‘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 para-
graph (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— 
42 USC 
300jj–19a. 
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‘‘(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 labora-
tories; 
‘‘(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 evalua-
tion 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 pro-
vider 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 des-
ignee 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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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(x) other categories regarding performance, acces-
sibility, 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 pur-
pose 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 devel-
oped 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 reason-
ably require, including a description of— 
‘‘(A) the proposed method for reviewing and summa-
rizing 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, spe-
cialty 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 agree-
ment 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, con-
tract, 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, spe-
cialty 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 Cen-
tury 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 agree-
ments 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 pursu-
ant 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 addi-
tional resources on the Internet website of the Office of the National 
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130 STAT. 1165 
PUBLIC LAW 114–255—DEC. 13, 2016 
Coordinator to better inform consumers of health information tech-
nology. 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 subpara-
graph (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. 
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 para-
graphs (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 author-
ized 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.—Sec-
tion 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 Depart-
ment of Health and Human Services, for the purpose of 
ensuring full network-to-network exchange of health 
information, convene public-private and public-public part-
nerships to build consensus and develop or support a 
trusted exchange framework, including a common agree-
ment among health information networks nationally. Such 
convention may occur at a frequency determined appro-
priate by the Secretary. 
‘‘(B) ESTABLISHING
A
TRUSTED
EXCHANGE
FRAME-
WORK.— 
‘‘(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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130 STAT. 1166 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 non-
compliance with the terms of the common agree-
ment. 
‘‘(ii) TECHNICAL ASSISTANCE.—The National Coordi-
nator, 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 para-
graph. 
‘‘(iii) PILOT TESTING.—The National Coordinator, 
in consultation with the National Institute of Stand-
ards and Technology, shall provide for the pilot testing 
of the trusted exchange framework and common agree-
ment 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 Tech-
nology, may delegate pilot testing activities under this 
clause to independent entities with appropriate exper-
tise. 
‘‘(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 INFORMA-
TION 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 devel-
oped 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 FRAME-
WORK AND COMMON AGREEMENT.—As appropriate, Federal 
agencies contracting or entering into agreements with 
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130 STAT. 1167 
PUBLIC LAW 114–255—DEC. 13, 2016 
health information exchange networks may require that 
as each such network upgrades health information tech-
nology or trust and operational practices, such network 
may adopt, where available, the trusted exchange frame-
work and common agreement published under subpara-
graph (C). 
‘‘(F) RULE OF CONSTRUCTION.— 
‘‘(i) GENERAL
ADOPTION.—Nothing in this para-
graph shall be construed to require a health informa-
tion 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 agree-
ment 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.—Not-
withstanding 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 car-
rying 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, estab-
lish 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 avail-
able 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 
42 USC 300jj–11 
note. 
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130 STAT. 1168 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 objec-
tives 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
ORGANIZA-
TIONS.—In adopting and implementing standards under this section, 
the Secretary shall give deference to standards published by stand-
ards development organizations and voluntary consensus-based 
standards bodies.’’. 
(e) 
HEALTH
INFORMATION
TECHNOLOGY
ADVISORY
COM-
MITTEE.— 
(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: 
‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY COM-
MITTEE. 
‘‘(a) ESTABLISHMENT.—There is established a Health Informa-
tion 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 specifica-
tions, 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 INFRA-
STRUCTURE.— 
‘‘(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 Com-
mittee, 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 appro-
priate. 
42 USC 300jj–12. 
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130 STAT. 1169 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 recogni-
tion of such standards, specifications, and certification cri-
teria. Such recommendations shall include recommended 
standards, architectures, and software schemes for access 
to electronic individually identifiable health information 
across disparate systems including user vetting, authen-
tication, privilege management, and access control. 
‘‘(B) PRIORITY
TARGET
AREAS.—For purposes of this 
section, the HIT Advisory Committee shall make rec-
ommendations 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 pro-
vides 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 informa-
tion made by a covered entity for purposes of treat-
ment, payment, and health care operations (as such 
terms are defined for purposes of the regulation 
promulgated under section 264(c) of the Health Insur-
ance Portability and Accountability Act of 1996), 
including for the segmentation and protection from 
disclosure of specific and sensitive individually identifi-
able health information with the goal of minimizing 
the reluctance of patients to seek care. 
‘‘(iii) The facilitation of secure access by an indi-
vidual 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, cog-
nitive 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 rec-
ommendations 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 pro-
moting 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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130 STAT. 1170 
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 lan-
guage, 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 individ-
ually identifiable health information to be rendered 
unusable, unreadable, or indecipherable to unauthor-
ized 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 consid-
ered 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 STAND-
ARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRI-
TERIA.— 
‘‘(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
The HIT Advisory Committee shall update such rec-
ommendations and make new recommendations as appro-
priate, including in response to a notification sent under 
section 3004(a)(2)(B). Such recommendations shall be con-
sistent with the latest recommendations made by the Com-
mittee. 
‘‘(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 IMPLEMENTA-
TION SPECIFICATIONS.—In the development, harmonization, 
or recognition of standards and implementation specifica-
tions, the HIT Advisory Committee for purposes of rec-
ommendations under paragraph (2)(B), shall, as appro-
priate, provide for the testing of such standards and speci-
fications by the National Institute for Standards and Tech-
nology 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 adop-
tion 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 Reg-
ister. 
‘‘(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 tar-
get areas described in subsection (b)(2)(B). 
‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING INTEROPER-
ABILITY.— 
‘‘(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 infrastruc-
ture described in subparagraph (A), including the 
extent to which electronic health information is appro-
priately and readily available to enhance the access, 
exchange, and the use of electronic health information 
between users and across technology offered by dif-
ferent 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 poli-
cies 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 Sec-
retary 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 estab-
lished 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 consider-
ation 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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130 STAT. 1173 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 tech-
nology; 
‘‘(ii) 3 members are appointed by the Secretary, 
1 of whom shall be appointed to represent the Depart-
ment 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 mem-
bers 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 Com-
mittee 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 secu-
rity. 
‘‘(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 redesig-
nating 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 Coordi-
nator shall be a leading member in the establishment 
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130 STAT. 1175 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 Sec-
retary 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: 
‘‘SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION. 
‘‘(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 Com-
mittee to— 
‘‘(A) identify priority uses of health information tech-
nology, focusing on priorities— 
‘‘(i) arising from the implementation of the incen-
tive 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 elec-
tronic 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. 
42 USC 300jj–13. 
42 USC 300jj–12 
note. 
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130 STAT. 1176 
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 implementa-
tion 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 associ-
ated 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 enact-
ment of the 21st Century Cures Act and every 3 years there-
after, the National Coordinator shall convene stakeholders to 
review the existing set of adopted standards and implementa-
tion 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 infra-
structure 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: 
‘‘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 informa-
tion; or 
‘‘(ii) if conducted by a health care provider, such pro-
vider knows that such practice is unreasonable and is 
42 USC 300jj–52. 
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130 STAT. 1177 
PUBLIC LAW 114–255—DEC. 13, 2016 
likely to interfere with, prevent, or materially discourage 
access, exchange, or use of electronic health information. 
‘‘(2) PRACTICES DESCRIBED.—The information blocking prac-
tices 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 elec-
tronic 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 prac-
tices 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 Sec-
retary 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 require-
ments 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 cer-
tified 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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130 STAT. 1178 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 deter-
mination 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 informa-
tion 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 recov-
ered under this paragraph shall be allocated as follows: 
‘‘(i) ANNUAL OPERATING EXPENSES.—Each year fol-
lowing 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 esti-
mate may include reasonable reserves to account for 
variance in annual amounts recovered under this para-
graph. There is authorized to be appropriated for pur-
poses 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 appro-
priate. 
‘‘(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 pro-
vider or health information technology developer makes 
information available based on a good faith reliance on 
consultations with the Office for Civil Rights of the Depart-
ment 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 tech-
nology has the technical capability to enable secure health 
information exchange between users and multiple certified elec-
tronic 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 Serv-
ices 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 condi-
tions 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 pur-
poses 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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130 STAT. 1180 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 inter-
operable or resulting in information blocking; 
‘‘(ii) actions described in subsection (b)(1) that 
result in information blocking as described in sub-
section (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 car-
rying out this subsection, the Secretary shall, to the extent 
possible, ensure that penalties do not duplicate penalty struc-
tures 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.’’. 
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, reg-
istries 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 elec-
tronic health record technology in accordance with such stand-
ards. 
(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 ‘‘clinician- 
led 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 
42 USC 300jj–14 
note. 
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130 STAT. 1181 
PUBLIC LAW 114–255—DEC. 13, 2016 
organization’s controlled affiliate, devoted to the care of a popu-
lation 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 thera-
pies 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 DEVEL-
OPERS 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 enact-
ment 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 con-
cerning 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 prac-
tice. 
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 authori-
ties to encourage partnerships between health information 
exchange organizations and networks and health care pro-
viders, 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 coordina-
tion 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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130 STAT. 1182 
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 rel-
evant 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 pro-
vided 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 informa-
tion exchange (or other relevant platform) that provide protec-
tions 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 pro-
viders 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
for requesting personal health information in a computable 
format, including using patient portals or third-party 
applications and common cases when a provider is per-
mitted to exchange and provide access to health informa-
tion.’’. 
‘‘(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 commu-
nicate patient-reported information (such as family his-
tory 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 sup-
port for technologies that offer patients access to their 
electronic health information in a single, longitudinal for-
mat that is easy to understand, secure, and may be updated 
automatically.’’. 
(b) ACCESS TO INFORMATION IN AN ELECTRONIC FORMAT.—Sec-
tion 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 asso-
ciate 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 des-
ignated by the individual; and’’. 
SEC. 4007. GAO STUDY ON PATIENT MATCHING. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment 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 appro-
priate entities, to ensure appropriate patient matching to pro-
tect patient privacy and security with respect to electronic 
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130 STAT. 1184 
PUBLIC LAW 114–255—DEC. 13, 2016 
health records and the exchange of electronic health informa-
tion; and 
(2) survey ongoing efforts related to the policies and activi-
ties 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 Coordi-
nator 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 stake-
holders 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). 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
and format requested by the individual, including examples 
of such instances; 
(D) instances in which third parties may request pro-
tected 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 limita-
tion 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 enact-
ment 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 DETERMINA-
TIONS. 
(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 fol-
lowing new subparagraph: 
‘‘(D) LOCAL
COVERAGE
DETERMINATIONS.—The Sec-
retary shall require each Medicare administrative con-
tractor 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 fol-
lowing 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 deter-
mination 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. 
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDS-
MAN. 
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 
42 USC 1395y 
note. 
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130 STAT. 1186 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 pharma-
ceutical, biotechnology, medical device, or diagnostic prod-
ucts 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 Bene-
ficiary Ombudsman under subsection (c).’’. 
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 appro-
priate 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 insur-
ance 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 & Med-
icaid Services on which information comparing physician 
performance is posted (commonly referred to as the Physi-
cian Compare Internet website), to make available such 
estimated amounts under such paragraph. 
‘‘(4) FUNDING.—For purposes of implementing this sub-
section, 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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130 STAT. 1187 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 estab-
lished 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-for- 
service 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 accom-
plish 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 pay-
ment with respect to the Medicare program if the service 
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130 STAT. 1188 
PUBLIC LAW 114–255—DEC. 13, 2016 
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’’. 
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 speci-
fied 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 mate-
rial 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 agree-
ment, 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, con-
tract, 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, investiga-
tions, evaluations, or other statutory functions of such Inspector 
General in matters involving such grants, contracts, or other 
agreements; 
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130 STAT. 1189 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 state-
ment, 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), respec-
tively (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 sub-
section (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 agree-
ment. 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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130 STAT. 1190 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(5) The term ‘recipient’ includes a subrecipient or subcon-
tractor. 
‘‘(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 Depart-
ment’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 relation-
ship, for a fee-based or similar relationship, from statute or regula-
tion, 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 ‘‘claim-
ant’’; 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’’. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 Secu-
rity 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 fol-
lowing: ‘‘, 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.’’. 
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 tax-
payer 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 effec-
tive, as specified in the notice; and 
‘‘(viii) any other information required by the Sec-
retary. 
‘‘(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
ENTI-
TIES.—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
ENTI-
TIES.—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 sub-
section (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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130 STAT. 1193 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 rea-
sons 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 when-
ever’’. 
(b) INCREASING AVAILABILITY OF MEDICAID PROVIDER INFORMA-
TION.— 
(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, refer-
ring, 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 
42 USC 1396a 
note. 
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130 STAT. 1194 
PUBLIC LAW 114–255—DEC. 13, 2016 
include providing to the State agency the provider’s identi-
fying 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 subpara-
graph (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 subpara-
graphs (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 pro-
viders participating in State plans providing medical assist-
ance on a fee-for-service basis).’’; 
(C) by inserting after subparagraph (K) (as redesig-
nated by subparagraph (A)) the following new subpara-
graph: 
‘‘(L) Section 1903(m)(3) (relating to limitation on pay-
ment with respect to managed care).’’; and 
(D) in subparagraph (P) (as redesignated by subpara-
graph (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 pro-
viders, 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 amend-
ments 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)) 
42 USC 1396a 
note. 
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130 STAT. 1195 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 partici-
pation in all State plans under title XIX of such Act (or waivers 
of such plans). 
(2) Information on the amount of Federal financial partici-
pation 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 agen-
cies administering State plans under title XIX of such Act 
(or waivers of such plans). 
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 pri-
mary 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 pro-
vider— 
‘‘(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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130 STAT. 1196 
PUBLIC LAW 114–255—DEC. 13, 2016 
skilled medical interpreter providing interpreta-
tion 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 pro-
vider; or 
‘‘(ii) whether the physician or provider is accepting 
as new patients individuals who receive medical assist-
ance 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 enroll-
ment, 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 individ-
uals 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 deter-
mines requires State legislation in order for the respective plan 
to meet one or more additional requirements imposed by amend-
ments made by this section, the respective plan shall not be 
regarded as failing to comply with the requirements of such title 
42 USC 1396a 
note. 
42 USC 1396a 
note. 
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130 STAT. 1197 
PUBLIC LAW 114–255—DEC. 13, 2016 
solely on the basis of its failure to meet such an additional require-
ment 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 2- 
year 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 indi-
vidual,’’ 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 enact-
ment of this Act. 
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. 
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.’’. 
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. 
42 USC 6241 
note. 
42 USC 1396b 
note. 
42 USC 1396p 
note. 
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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.—Subpara-
graphs (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. 
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 subpara-
graph: 
‘‘(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, fur-
nished 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; 
42 USC 6241 
note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 sub-
section (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 self- 
administered 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, physi-
cian, 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 infu-
sion 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 sub-
contract 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 INFU-
SION THERAPY.— 
‘‘(1) PAYMENT.— 
‘‘(A) SINGLE PAYMENT.— 
‘‘(i) IN GENERAL.—Subject to clause (iii) and sub-
paragraphs (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)) fur-
nished 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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130 STAT. 1200 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 adminis-
tration. 
‘‘(C) DISCRETIONARY ADJUSTMENTS.— 
‘‘(i) IN GENERAL.—Subject to clause (ii), the Sec-
retary may adjust the single payment amount deter-
mined 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 sen-
tence 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 Sec-
retary may, as determined appropriate by the Secretary, apply 
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130 STAT. 1201 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 deter-
mines appropriate. 
‘‘(B) DESIGNATION.—Not later than January 1, 2021, 
the Secretary shall designate organizations to accredit sup-
pliers furnishing home infusion therapy. The list of accredi-
tation organizations so designated may be modified pursu-
ant to subparagraph (C). 
‘‘(C) REVIEW AND MODIFICATION OF LIST OF ACCREDITA-
TION 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 ACCREDI-
TATION ORGANIZATIONS.—In the case where the Sec-
retary removes an organization from the list of accredi-
tation 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 DES-
IGNATION.—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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130 STAT. 1202 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(6) NOTIFICATION OF INFUSION THERAPY OPTIONS AVAIL-
ABLE PRIOR TO FURNISHING HOME INFUSION THERAPY.—Prior 
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 fol-
lowing: ‘‘, 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 
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 
SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUB-
STANCE 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
SEC-
RETARY.— 
42 USC 201 note. 
Helping Families 
in Mental Health 
Crisis Reform Act 
of 2016. 
42 USC 13951 
note. 
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130 STAT. 1203 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 Sec-
retary, 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 attor-
neys, 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 Sub-
stance 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 Adminis-
trator’’; 
(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 Adminis-
trator of the Substance Abuse and Mental Health Services Adminis-
tration shall be construed to be a reference to the Assistant Sec-
retary for Mental Health and Substance Use. 
42 USC 290aa 
note. 
42 USC 290aa 
note. 
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130 STAT. 1204 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE 
ABUSE AND MENTAL HEALTH SERVICES ADMINISTRA-
TION. 
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 sub-
stance 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 anti- 
addiction medications, including methadone’’ and inserting 
‘‘use disorders, including services that utilize drugs or 
devices approved or cleared by the Food and Drug Adminis-
tration 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 ‘‘develop-
ment’’; 
(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(iii) by striking ‘‘treatment and prevention serv-
ices’’ 
and 
inserting 
‘‘prevention, 
treatment, 
and 
recovery support services and are appropriately incor-
porated into programs carried out by the Administra-
tion’’; 
(H) in paragraph (10), by striking ‘‘abuse’’ and inserting 
‘‘use disorder’’; 
(I) by striking paragraph (11) and inserting the fol-
lowing: 
‘‘(11) work with relevant agencies of the Department of 
Health and Human Services on integrating mental health pro-
motion 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 subpara-
graph (C); 
(iv) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(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 informa-
tion, 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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130 STAT. 1206 
PUBLIC LAW 114–255—DEC. 13, 2016 
such adults and children, with respect to improving community- 
based 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 Depart-
ment of Defense and the Department of Veterans Affairs to 
members of the Armed Forces, veterans, and the family mem-
bers 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 agen-
cies and departments, States, communities, and nongovern-
mental 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 representa-
tives 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 out-
comes; 
‘‘(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 recommenda-
tions 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.’’. 
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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130 STAT. 1207 
PUBLIC LAW 114–255—DEC. 13, 2016 
(1) by redesignating subsections (g) through (j) and sub-
sections (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 prac-
tices, 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 Plan-
ning 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.’’. 
SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PRO-
GRAMS. 
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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130 STAT. 1208 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND 
QUALITY.’’; 
(2) by redesignating subsections (a) through (d) as sub-
sections (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 subpara-
graphs (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 activi-
ties’’; 
(B) by striking ‘‘Assistant Secretary’’ each place it 
appears and inserting ‘‘Director’’; and 
(C) by striking ‘‘subsection (a)’’ and inserting ‘‘sub-
section (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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(ii) in subparagraph (B), by inserting ‘‘in coordina-
tion with the Centers for Disease Control and Preven-
tion’’ 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 ‘‘CON-
SULTATION.—After consultation’’; and 
(B) by striking ‘‘Assistant Secretary shall develop’’ and 
inserting ‘‘Assistant Secretary shall use existing standards 
and best practices to develop’’. 
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 para-
graph (1) to the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives 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 para-
graph (1) shall— 
‘‘(A) identify strategic priorities, goals, and measurable 
objectives for mental and substance use disorders activities 
and programs operated and supported by the Administra-
tion, 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 hos-
pitalization 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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130 STAT. 1210 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(C) ensure that programs provide, as appropriate, 
access to effective and evidence-based prevention, diag-
nosis, 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 psychia-
trists, including child and adolescent psychiatrists, 
psychologists, psychiatric nurse practitioners, physi-
cian 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, diag-
nosis, early intervention, treatment, and recovery services 
related to mental illness, particularly for adults with a 
serious mental illness and children with a serious emo-
tional disturbance, and for individuals with a substance 
use disorder.’’. 
SEC. 
6006. 
BIENNIAL 
REPORT 
CONCERNING 
ACTIVITIES 
AND 
PROGRESS. 
(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(2) an assessment of programs and activities carried out 
by the Assistant Secretary, including the extent to which pro-
grams 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 Adminis-
tration, including with respect to serious mental illnesses, 
serious emotional disturbances, and co-occurring disorders; 
‘‘(4) a description of the manner in which the Administra-
tion 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 emo-
tional 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, sub-
stance use disorder services, and physical health services; 
‘‘(D) homelessness; and 
‘‘(E) veterans; 
‘‘(5) a description of the manner in which the Administra-
tion 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 Treat-
ment, 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 estab-
lished under this title by providing the contents of such reports 
as an addendum to the biennial report established under this sub-
section, notwithstanding the timeline of other reporting require-
ments 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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130 STAT. 1212 
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)’’. 
SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERV-
ICES, 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 para-
graphs (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 resil-
iency’’ 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 sec-
tion 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 ‘‘estab-
lish 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 PREVEN-
TION.—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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130 STAT. 1213 
PUBLIC LAW 114–255—DEC. 13, 2016 
(2) in subsection (a)— 
(A) by striking ‘‘an Office’’ and inserting ‘‘a Center’’; 
and 
(B) by striking ‘‘The Office’’ and inserting ‘‘The Preven-
tion Center’’; and 
(3) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘through the reduc-
tion 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 activi-
ties;’’; 
(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 preven-
tion’’; 
(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 edu-
cational materials to increase awareness for individuals at 
greatest risk for substance use disorders to prevent the trans-
mission 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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130 STAT. 1214 
PUBLIC LAW 114–255—DEC. 13, 2016 
(c) DIRECTOR OF THE CENTER FOR SUBSTANCE ABUSE TREAT-
MENT.—Section 507 of the Public Health Service Act (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.’’. 
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 sub-
sections (a)(1)(A) and (a)(1)(D); 
‘‘(H) the Director of the National Institute on Drug 
Abuse for the advisory councils appointed under sub-
sections (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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130 STAT. 1215 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 sub-
stance 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 treat-
ment, 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 co- 
occurring 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 
SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE 
DISORDERS PROGRAMS THROUGH THE ASSISTANT SEC-
RETARY FOR PLANNING AND EVALUATION. 
(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 pro-
grams 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— 
42 USC 290aa 
note. 
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130 STAT. 1216 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 emo-
tional 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 rec-
ommendations 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 treat-
ment 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. 
SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZA-
TIONS. 
(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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 Sub-
stance Use, shall conduct an independent evaluation, and submit 
a report, to the Committee on Health, Education, Labor, and Pen-
sions 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 sub-
section (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 estab-
lished by section 105(a)(9) of such Act (42 U.S.C. 
10805(a)(9)); 
(C) investigation of alleged abuse and neglect of per-
sons 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 lob-
bying. 
Subtitle C—Interdepartmental Serious 
Mental Illness Coordinating Committee 
SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDI-
NATING 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 Com-
mittee 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 preven-
tion of, diagnosis of, intervention in, and treatment and 
recovery of serious mental illnesses, serious emotional disturb-
ances, and advances in access to services and support for adults 
with a serious mental illness or children with a serious emo-
tional 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, over-
dose 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 treat-
ment 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 rec-
ommendation 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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130 STAT. 1219 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 experi-
ence treating serious mental illnesses or serious emo-
tional disturbances; or 
(iv) a licensed psychiatric nurse, nurse practi-
tioner, 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 profes-
sional who has research or clinical mental health experi-
ence in working with minorities; 
(G) at least 1 member shall be a mental health profes-
sional who has research or clinical mental health experi-
ence 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, chil-
dren 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 emo-
tional 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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130 STAT. 1220 
PUBLIC LAW 114–255—DEC. 13, 2016 
(f) WORKING GROUPS.—In carrying out its functions, the Com-
mittee 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 
PRE-
VENTION, TREATMENT, AND RECOV-
ERY PROGRAMS KEEP PACE WITH 
SCIENCE AND TECHNOLOGY 
SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PRO-
GRAMS. 
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: 
‘‘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 Innova-
tion 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 evidence- 
based practices, including culturally and linguistically appro-
priate services, as appropriate, and service delivery models; 
‘‘(4) provide leadership in identifying and coordinating poli-
cies 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 
42 USC 290aa–0. 
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130 STAT. 1221 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 con-
tinue 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 Lab-
oratory 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 Labora-
tory 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 govern-
ments, 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 non-
profit 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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130 STAT. 1222 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(i) enhancing the prevention, diagnosis, interven-
tion, and treatment of, and recovery from, mental ill-
ness, 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 serv-
ices; 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 dis-
orders, 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 sub-
section, 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 Alco-
holism, 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 EVIDENCE- 
BASED 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: 
‘‘SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCE- 
BASED PROGRAMS AND PRACTICES. 
‘‘(a) IN GENERAL.—The Assistant Secretary shall, as appro-
priate, improve access to reliable and valid information on evidence- 
based 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 Inter-
net 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 submis-
sion 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. 
42 USC 
290dd–2a. 
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130 STAT. 1223 
PUBLIC LAW 114–255—DEC. 13, 2016 
Such notice may solicit applications for evidence-based pro-
grams 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 sub-
section (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 sub-
section (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 applica-
tions. 
‘‘(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 applica-
tions, 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 organiza-
tions’’ and inserting ‘‘Indian tribes or tribal organiza-
tions (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.’’. 
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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130 STAT. 1224 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 organiza-
tions,’’ and inserting ‘‘Indian tribes or tribal organiza-
tions (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.’’. 
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 organiza-
tions,’’ and inserting ‘‘Indian tribes or tribal organiza-
tions (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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(i) in subparagraph (A), by striking ‘‘; and’’ at 
the end and inserting ‘‘;’’; 
(ii) in subparagraph (B)— 
(I) by striking ‘‘abuse’’ and inserting ‘‘use dis-
order’’; and 
(II) by striking the period and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the following: 
‘‘(C) substance use disorder prevention among high- 
risk 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 PRE-
VENTION 
ACTIVITIES 
AND 
RE-
SPONSES TO MENTAL HEALTH AND 
SUBSTANCE USE DISORDER NEEDS 
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 para-
graphs (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 emo-
tional 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 subpara-
graphs (A) through (E), respectively, and realigning the margins 
accordingly; 
(3) in the matter preceding subparagraph (A) (as so redesig-
nated), 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 redesig-
nated) 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 SYS-
TEMS.—The plan shall— 
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130 STAT. 1226 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(i) identify the single State agency to be respon-
sible 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 com-
prehensive 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 pro-
motes evidence-based practices, including those evi-
dence-based programs that address the needs of 
individuals with early serious mental illness regardless 
of the age of the individual at onset, provide com-
prehensive individualized treatment, or integrate 
mental and physical health services; 
‘‘(v) include a description of case management serv-
ices; 
‘‘(vi) include a description of activities that seek 
to engage adults with a serious mental illness or chil-
dren with a serious emotional disturbance and their 
caregivers where appropriate in making health care 
decisions, including activities that enhance communica-
tion among individuals, families, caregivers, and treat-
ment 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
substance use disorders, both mental and sub-
stance use disorders services in primary care set-
tings or arrangements to provide primary and spe-
cialty 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 tar-
gets and outcome measures for programs and services pro-
vided 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 sub-
section (c)), the plan shall provide for a system of integrated 
social services, educational services, child welfare services, 
juvenile justice services, law enforcement services, and sub-
stance use disorder services’’; 
(B) by striking ‘‘Education Act);’’ and inserting ‘‘Edu-
cation 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 avail-
able, 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 psy-
chotic 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 fol-
lowing: 
‘‘(A) IN GENERAL.—The Secretary’’; 
(B) by striking ‘‘paragraph (1) if’’ and inserting ‘‘para-
graph (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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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’’. 
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 accord-
ance 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 SUB-
STANCE 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 agree-
ment 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 dis-
orders’’. 
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130 STAT. 1231 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 sec-
tion 1930(c)(2), and’’; 
(2) in subsection (b)— 
(A) by striking paragraph (1) and inserting the fol-
lowing: 
‘‘(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-occur-
ring 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 preg-
nant women, women with dependent children, individ-
uals 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 com-
prehensive statewide prevention efforts, including the 
number of individuals being served in the system, tar-
get 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-occur-
ring substance use and mental disorders; 
‘‘(viii) includes a description of how the State pro-
motes 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 dis-
order services in primary care settings or providing 
primary and specialty care services in community- 
based 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 modi-
fication. 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’’. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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. 
‘‘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 applica-
tion 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. 
‘‘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, con-
sistent 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 sub-
part.’’. 
SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUB-
STANCE 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 Sub-
stance Use, shall through a grant or contract, or through an agree-
ment 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; 
42 USC 300x–68. 
42 USC 300x–67. 
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130 STAT. 1234 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 ‘‘sub-
stance 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 dis-
order’’ 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’’. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
defined in section 4 of the Indian Self-Determination and 
Education Assistance Act)’’; and 
(B) by inserting ‘‘or a health facility or program oper-
ated 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 sub-
sections (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 appro-
priate, 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: 
‘‘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 clin-
ical 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 arrange-
ments 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 out-
comes 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 popu-
lations, including— 
‘‘(A) with respect to adults with a serious mental ill-
ness, participation in supportive housing or independent 
living programs, attendance in social and rehabilitative 
programs, participation in job training opportunities, satis-
factory performance in work settings, attendance at sched-
uled medical and mental health appointments, and compli-
ance 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 medica-
tion 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 phys-
ical 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 extra-
curricular 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 enti-
ties 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 sup-
port operational and administrative success; and 
‘‘(D) other activities, as the Secretary determines 
appropriate. 
‘‘(2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA-
TION.—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-Deter-
mination 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 sec-
tion 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 organiza-
tions, 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.’’. 
SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM 
HOMELESSNESS. 
(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.—Sec-
tion 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 ‘sub-
stance 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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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 Assist-
ant 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 inter-
vention 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 sec-
tion, there are authorized to be appropriated $7,198,000 for each 
of fiscal years 2018 through 2022.’’. 
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: 
‘‘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 community- 
based 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 
42 USC 
290bb–36d. 
42 USC 
290bb–36c. 
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‘‘(2) an Internet website to provide a searchable, online 
treatment services locator of behavioral health treatment pro-
viders 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) con-
tains 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 Sec-
retary— 
‘‘(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 Administra-
tion 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: 
‘‘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 applica-
tion 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 re-
admissions, including through appropriate discharge plan-
ning. 
‘‘(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 data-
base to collect, aggregate, and display information about beds 
in inpatient psychiatric facilities and crisis stabilization units, 
and residential community mental health and residential sub-
stance use disorder treatment facilities to facilitate the identi-
fication and designation of facilities for the temporary treat-
ment 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 nec-
essary 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 individ-
uals 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.’’. 
SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION. 
(a) SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.—Sec-
tion 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
INTER-
AGENCY RESEARCH, TRAINING, AND TECHNICAL ASSISTANCE 
CENTERS’’ and inserting ‘‘SUICIDE
PREVENTION
TECHNICAL 
ASSISTANCE CENTER’’; 
(2) in subsection (a), by striking ‘‘acting through the Assist-
ant 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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center to provide appropriate information, training, and tech-
nical assistance to States, political subdivisions of States, feder-
ally 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 ‘‘non-
profit organizations for’’ and inserting ‘‘The center estab-
lished 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, particu-
larly 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 Con-
gress a report on the activities carried out by the center established 
under subsection (a) during the year involved, including the poten-
tial 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 sec-
tion’’ 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 sec-
tion, the Secretary shall take into consideration the extent 
of the need of the applicant, including the incidence and preva-
lence 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: 
‘‘SEC. 520L. ADULT SUICIDE PREVENTION. 
‘‘(a) GRANTS.— 
‘‘(1) IN
GENERAL.—The Assistant Secretary shall award 
grants to eligible entities described in paragraph (2) to imple-
ment suicide prevention and intervention programs, for individ-
uals 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 pri-
mary 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 Self- 
Determination 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 individ-
uals 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. 
42 USC 
290bb–43. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 tech-
nical 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 interven-
tions 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 deter-
mined by the Secretary,’’ after ‘‘emergency services per-
sonnel’’; 
(C) in paragraph (5)— 
(i) in the matter preceding subparagraph (A), by 
striking ‘‘to’’ and inserting ‘‘for evidence-based pro-
grams that provide training and education in accord-
ance 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 individ-
uals 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.’’. 
SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS 
AND ALASKA NATIVE YOUTH WITHIN SUICIDE PREVEN-
TION 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 treat-
ment of geriatric mental disorders and co-occurring mental 
health and substance use disorders among geriatric popu-
lations, as well as disseminate information about such evidence- 
based 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. 
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: 
‘‘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. 
42 USC 
290bb–44. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 out-
comes 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, hospitaliza-
tion, 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 tech-
nical 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 author-
ized 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).’’. 
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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 adoles-
cents 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 appro-
priate 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 appro-
priate, and developing and distributing materials; and 
‘‘(C) supporting other activities, as determined appro-
priate 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 para-
graphs (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 interven-
tion’ 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 identi-
fied 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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130 STAT. 1248 
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 
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, mar-
riage and family therapy, occupational therapy, school coun-
seling, or professional counseling, including such programs with 
a focus on child and adolescent mental health and transitional- 
age youth; 
‘‘(2) accredited doctoral, internship, and post-doctoral resi-
dency programs of health service psychology (including clinical 
psychology, counseling, and school psychology) for the develop-
ment and implementation of interdisciplinary training of psy-
chology graduate students for providing behavioral health serv-
ices, 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 inter-
disciplinary training of social work graduate students for pro-
viding behavioral health services, including substance use dis-
order 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 health- 
related 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(B) by redesignating paragraphs (1) through (4) as 
paragraphs (2) through (5), respectively; 
(C) by inserting before paragraph (2), as so redesig-
nated, 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 sub-
section (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 place-
ments 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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130 STAT. 1250 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE DIS-
ORDERS 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: 
‘‘SEC. 760. TRAINING DEMONSTRATION PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish a training 
demonstration program to award grants to eligible entities to sup-
port— 
‘‘(1) training for medical residents and fellows to practice 
psychiatry and addiction medicine in underserved, community- 
based 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 addic-
tion; or 
‘‘(B) develop evidence-based practices or recommenda-
tions for the design of the units or programs described 
in subparagraph (A), including curriculum content stand-
ards. 
‘‘(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 pro-
gram 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 serv-
ices; 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 
42 USC 294k. 
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130 STAT. 1251 
PUBLIC LAW 114–255—DEC. 13, 2016 
treatment of infants, children, adolescents, or preg-
nant 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 sub-
stance use disorders services in underserved, community- 
based 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 Accredi-
tation 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 Accredita-
tion, or the Accreditation Review Commission on Education 
for the Physician Assistant) to carry out activities under sub-
section (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 institu-
tion of the sponsoring institution) of— 
‘‘(I) a psychiatry residency program that is 
accredited by the Accreditation Council of Grad-
uate 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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130 STAT. 1252 
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 practi-
tioners, 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 sub-
stance use disorder prevention and treatment services with 
primary care in community-based settings; 
‘‘(C) demonstrate experience in using health informa-
tion technology and, as appropriate, telehealth to support— 
‘‘(i) the delivery of mental and substance use dis-
orders services at the eligible entities described in sub-
sections (c)(1) and (c)(2); and 
‘‘(ii) community health centers in integrating pri-
mary 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 dem-
onstrated 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 sub-
stance 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 popu-
lations such as infants, children, adolescents, pregnant and 
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130 STAT. 1253 
PUBLIC LAW 114–255—DEC. 13, 2016 
postpartum women, older adults, homeless individuals, vic-
tims of abuse or trauma, individuals with disabilities, and 
other groups as defined by the Secretary; 
‘‘(D) teach trainees the skills to provide interprofes-
sional, 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 sub-
stance 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. 
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 
‘‘SEC. 597. FELLOWSHIPS. 
‘‘(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— 
42 USC 290ll. 
42 USC 294l–1 
note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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, admin-
ister 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 sub-
section (a) shall be for postbaccalaureate training (including for 
master’s and doctoral degrees) for mental and substance use dis-
order 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 sec-
tion, there are authorized to be appropriated $12,669,000 for each 
of fiscal years 2018 through 2022.’’. 
SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL VOL-
UNTEERS 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 volun-
teer 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 facili-
ties 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 com-
pensation 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 provi-
sion 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 practi-
tioner or the entity described in subsection (g)(4) posts a clear 
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130 STAT. 1255 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 fol-
lowing: 
‘‘(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 practi-
tioner. 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 deter-
mined 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 practi-
tioner occurring on or after the date on which the Secretary 
makes such determination. 
‘‘(D) Subsection (g)(1)(F) applies to a health care practi-
tioner for purposes of this subsection only to the extent that, 
in providing health services to an individual, each of the condi-
tions 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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PUBLIC LAW 114–255—DEC. 13, 2016 
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 Sec-
retary shall transfer from the fund under subsection (k)(2) to the 
appropriate accounts in the Treasury an amount equal to the esti-
mate 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.’’. 
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 Fed-
eral, State, and local efforts related to workforce enhancement. 
(2) CONTENTS.—The report under this subsection shall con-
tain— 
(A) national and State-level projections of the supply 
and demand of the mental health and substance use dis-
order 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 refer-
ring 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 Sec-
retary 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 pro-
grams in up to 10 States that receive funding from the Sub-
stance Abuse and Mental Health Services Administration. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
(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 pro-
grams in the selected States; and 
(E) requirements for continuing education. 
(3) REPORT.—Not later than 2 years after the date of enact-
ment 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 
SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERV-
ICES 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
DIS-
ORDER’’; 
(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 ‘‘sub-
stance 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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130 STAT. 1258 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 preven-
tion and treatment services to students, which may include 
recovery support services and programming and early interven-
tion, 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 ath-
letic 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 edu-
cation’’; 
(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 when-
ever 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 enti-
ties, 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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130 STAT. 1259 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 supple-
ment 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 sub-
section: 
‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may provide tech-
nical 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.’’. 
SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE MENTAL 
HEALTH. 
(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 estab-
lish 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 rep-
resentative 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 com-
prehensive actions to improve mental and behavioral health 
on campuses of institutions of higher education; 
42 USC 
290bb–36b note. 
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130 STAT. 1260 
PUBLIC LAW 114–255—DEC. 13, 2016 
(C) examine and better address the needs of the age 
population of students attending institutions of higher edu-
cation 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 determina-
tions 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 edu-
cation 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 institu-
tions of higher education; and 
(3) consult with and seek input from mental health profes-
sionals 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 serv-
ices. 
(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 sec-
tion, there are authorized to be appropriated $1,000,000 for the 
period of fiscal years 2018 through 2022. 
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130 STAT. 1261 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAMPUSES. 
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: 
‘‘SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDU-
CATION 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 pro-
motion 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 sub-
section (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 research- 
based 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 pro-
gram referrals; and 
42 USC 290ee–4. 
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130 STAT. 1262 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(4) develops and proposes the implementation of a social 
marketing campaign that is targeted at the population of stu-
dents 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 sec-
tion, 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 ADOLES-
CENTS 
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’’. 
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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130 STAT. 1263 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Adminis-
trator of the Health Resources and Services Administration and 
in coordination with other relevant Federal agencies, shall award 
grants 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 Edu-
cation 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 pro-
grams. 
‘‘(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 pri-
mary care sites as an integrated team; 
‘‘(B) support and further develop organized State or 
regional networks of pediatric mental health teams to pro-
vide consultative support to pediatric primary care sites; 
‘‘(C) conduct an assessment of critical behavioral con-
sultation needs among pediatric providers and such pro-
viders’ 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 tele-
phone 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 commu-
nity or behavioral health resources; and 
‘‘(I) establish mechanisms for measuring and moni-
toring 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 con-
sisting of at least one case coordinator, at least one child 
and adolescent psychiatrist, and at least one licensed clinical 
42 USC 254c–19. 
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130 STAT. 1264 
PUBLIC LAW 114–255—DEC. 13, 2016 
mental health professional, such as a psychologist, social 
worker, or mental health counselor. Such a team may be region-
ally 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 car-
rying 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.’’. 
SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY 
INTERVENTION SERVICES FOR CHILDREN AND ADOLES-
CENTS. 
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 INTER-
VENTION’’; 
(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-occur-
ring 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 chil-
dren are in safe, stable home environments and receive appro-
priate health care services.’’; 
(3) in subsection (b)— 
(A) by striking paragraph (1) and inserting the fol-
lowing: 
‘‘(1) apply evidence-based and cost-effective methods;’’; 
(B) in paragraph (2)— 
(i) by striking ‘‘treatment’’; and 
(ii) by inserting ‘‘substance abuse,’’ after ‘‘child wel-
fare,’’; 
(C) in paragraph (3), by striking ‘‘substance abuse dis-
orders’’ 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.’’. 
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 pro-
vide for— 
‘‘(1) the continued operation of the National Child Trau-
matic Stress Initiative (referred to in this section as the 
‘NCTSI’), which includes a cooperative agreement with a coordi-
nating 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 inter-
vention services and treatment to address the long-term con-
sequences of child trauma; and 
‘‘(2) the development of knowledge with regard to evidence- 
based 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 psycho-
logical 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 sub-
sections (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 treat-
ment 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 coordi-
nating 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 peer- 
review 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 exper-
tise 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 equi-
tably 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 DEPRES-
SION. 
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: 
‘‘SEC. 317L–1. SCREENING AND TREATMENT FOR MATERNAL DEPRES-
SION. 
‘‘(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 
42 USC 
247b–13a. 
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require. At a minimum, any such application shall include expla-
nations of— 
‘‘(1) how a program, or programs, will increase the percent-
age 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 Sec-
retary 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 pro-
viders; 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 obstetri-
cian-gynecologists, 
pediatricians, 
psychiatrists, 
mental 
health care providers, and adult primary care clinicians) 
to provide or receive real-time psychiatric consultation (in- 
person or remotely) to aid in the treatment of pregnant 
and parenting women; 
‘‘(B) establishing linkages with and among community- 
based resources, including mental health resources, pri-
mary 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 sec-
tion, 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 PRO-
MOTION, 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: 
‘‘SEC. 399Z–2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PRO-
MOTION, INTERVENTION, AND TREATMENT. 
‘‘(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 emo-
tional 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 
42 USC 280h–6. 
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130 STAT. 1268 
PUBLIC LAW 114–255—DEC. 13, 2016 
linguistically appropriate, and can be replicated in other appro-
priate 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 emo-
tional disturbance; and 
‘‘(B) may benefit from infant and early childhood inter-
vention 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 treat-
ment, 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 sub-
section (a) that are evidence-based or that have been sci-
entifically 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 regu-
lated 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 treat-
ment and early intervention, including with regard to practices 
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130 STAT. 1269 
PUBLIC LAW 114–255—DEC. 13, 2016 
for identifying and treating mental illness and behavioral dis-
orders 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 sec-
tion, there are authorized to be appropriated $20,000,000 for the 
period of fiscal years 2018 through 2022.’’. 
TITLE XI—COMPASSIONATE 
COMMUNICATION ON HIPAA 
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 func-
tional 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 Administra-
tion 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 promul-
gated under the Health Insurance Portability and Account-
ability Act of 1996 (commonly known as ‘‘HIPAA’’). This confu-
sion may hinder appropriate communication of health care 
information or treatment preferences with appropriate care-
givers. 
(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 profes-
sionals 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 deter-
mine the effect of such regulations on patient care, health outcomes, 
and patient privacy. 
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, acces-
sible, 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 Insur-
ance 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 Account-
ability 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 oppor-
tunity 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 profes-
sional judgment, to be in the best interest of the patient 
when the patient is not present or otherwise incapacitated. 
42 USC 1320d–2 
note. 
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130 STAT. 1271 
PUBLIC LAW 114–255—DEC. 13, 2016 
(3) COMMUNICATION
WITH
FAMILY
MEMBERS
AND
CARE-
GIVERS.—In addressing the circumstances described in para-
graph (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 indi-
vidual is involved in the care of the patient; 
(B) in the case that the patient is an adult, commu-
nicating 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, commu-
nicating 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 invol-
untary treatment. 
SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING 
PROGRAMS. 
(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 pro-
grams 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, physi-
cian 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 per-
mitted uses and disclosures, consistent with the standards gov-
erning 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. 
42 USC 1320d–2 
note. 
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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 Assist-
ant Secretary for Mental Health and Substance Use, the Adminis-
trator 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; organiza-
tions 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 
SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COV-
ERAGE 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. 
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 & 
42 USC 1396 
note. 
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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 man-
aged 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 institu-
tion 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. 
SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSY-
CHIATRIC DEMONSTRATION PROJECT. 
(a) COLLECTION
OF INFORMATION.—The Secretary of Health 
and Human Services, acting through the Administrator of the Cen-
ters for Medicare & Medicaid Services, shall, to the extent practical 
and data is available, with respect to each State that has partici-
pated in the demonstration project established under section 2707 
42 USC 1315 
note. 
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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 demonstra-
tion 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 individ-
uals 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 deter-
mined by such Administrator. 
(4) The amount of any disproportionate share hospital pay-
ments 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 dem-
onstration 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 oper-
ation. 
(6) The extent to which the utilization of hospital emer-
gency departments during the period in which the demonstra-
tion project was is in operation differed, with respect to individ-
uals 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
(A) those individuals who received treatment in an 
institution for mental diseases under the demonstration 
project; 
(B) those individuals who met the eligibility require-
ments 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 fol-
lowing: ‘‘, 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. 
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 
42 USC 1396d 
note. 
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130 STAT. 1276 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(iv) for calendar quarters in 2023 and each year there-
after, 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 there-
after, 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 per-
sonal 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 elec-
tronic 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 fur-
nish 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 oppor-
tunity 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 quar-
ters 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 require-
ments 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 elec-
tronic 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 mainte-
nance 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 con-
strued 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 
42 USC 1396b 
note. 
42 USC 1396b 
note. 
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130 STAT. 1278 
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’ selec-
tion of a caregiver, or impede the manner in which care is 
delivered. 
(4) NO PROHIBITION ON STATE QUALITY MEASURES REQUIRE-
MENTS.—Nothing in the amendment made by this section shall 
be construed as prohibiting a State, in implementing an elec-
tronic 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 
SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUB-
STANCE 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 Depart-
ment of Labor, and the Inspector General of the Depart-
ment 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 Treat-
ment Limitations (NQTLs) that Require Additional Anal-
ysis to Determine Mental Health Parity Compliance’. 
‘‘(B) EXAMPLES ILLUSTRATING COMPLIANCE AND NON-
COMPLIANCE.— 
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130 STAT. 1279 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(i) IN GENERAL.—The compliance program guid-
ance document required under this paragraph shall 
provide illustrative, de-identified examples (that do not 
disclose any protected health information or individ-
ually identifiable information) of previous findings of 
compliance and noncompliance with this section, sec-
tion 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 treat-
ment 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 suffi-
cient 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 dis-
order 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 sec-
tion 9812 of the Internal Revenue Code of 1986, as 
applicable, and encourage the development and use of 
internal controls to monitor adherence to applicable stat-
utes, regulations, and program requirements. Such internal 
controls may include illustrative examples of nonquantita-
tive 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 Rev-
enue Code of 1986, as applicable, in relation to nonquantita-
tive 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 pre-
vious 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 Rev-
enue 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 sub-
section (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 cov-
erage 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 guid-
ance issued under this paragraph shall include clari-
fying 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 compli-
ance 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 promul-
gated pursuant to such sections, as applicable). 
‘‘(ii) DOCUMENTS FOR PARTICIPANTS, BENEFICIARIES, 
CONTRACTING PROVIDERS, OR AUTHORIZED REPRESENTA-
TIVES.—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 docu-
ments containing information that the health plans 
or issuers are required to disclose to participants, bene-
ficiaries, contracting providers, or authorized rep-
resentatives to ensure compliance with this section, 
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130 STAT. 1281 
PUBLIC LAW 114–255—DEC. 13, 2016 
section 712 of the Employee Retirement Income Secu-
rity Act of 1974, or section 9812 of the Internal Rev-
enue Code of 1986, as applicable, compliance with any 
regulation issued pursuant to such respective section, 
or compliance with any other applicable law or regula-
tion. 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 clari-
fying information and illustrative examples of methods, 
processes, strategies, evidentiary standards, and other fac-
tors that group health plans and health insurance issuers 
offering group or individual health insurance coverage may 
use regarding the development and application of non-
quantitative 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 appro-
priate 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 per-
taining 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 evi-
dentiary 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 nonquantita-
tive 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 stand-
ards may be applied to each service category or classi-
fication of benefits; 
‘‘(vii) examples of methods of reaching appropriate 
coverage determinations for new mental health or sub-
stance use disorder treatments, such as evidence-based 
early intervention programs for individuals with a 
serious mental illness and types of medical manage-
ment techniques; 
‘‘(viii) examples of methods of reaching appropriate 
coverage determinations for which there is an indirect 
relationship between the covered mental health or sub-
stance use disorder benefit and a traditional covered 
medical and surgical benefit, such as residential treat-
ment or hospitalizations involving voluntary or invol-
untary commitment; and 
‘‘(ix) additional illustrative examples of methods, 
processes, strategies, evidentiary standards, and other 
factors for which the Secretary determines that addi-
tional guidance is necessary to improve compliance 
with this section, section 712 of the Employee Retire-
ment 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 guid-
ance 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 author-
ized 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 Commis-
sioners 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 tem-
plates and other sample standardized forms to improve con-
sumer 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. 
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 enforce-
ment 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 provi-
sions 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 representa-
tives of State entities involved in the enforcement of 
mental health parity and addiction equity require-
ments. 
42 USC 
300gg–26 note. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
(C) Representatives from key stakeholder groups, 
including— 
(i) the National Association of Insurance Commis-
sioners; 
(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 Fed-
eral 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 Depart-
ment 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 coordi-
nate 
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 pub-
licly available; and 
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130 STAT. 1285 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 limita-
tions, both to medical and surgical benefits and to mental 
health and substance use disorder benefits in a comparable 
manner. 
SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN 
MENTAL HEALTH AND SUBSTANCE USE DISORDER BENE-
FITS. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment 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 com-
pleted during the preceding 12-month period with findings of any 
serious violation regarding compliance with mental health and sub-
stance 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 sub-
section (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 inves-
tigation conducted during the covered reporting period. 
(3) Each subject matter, including compliance with require-
ments for quantitative and nonquantitative treatment limita-
tions, 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 SUB-
STANCE 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 Representa-
tives 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, edu-
cation, 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. 
SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS. 
(a) INFORMATION.—The Secretary of Health and Human Serv-
ices, 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 devel-
oped 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 
42 USC 237a 
note. 
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130 STAT. 1287 
PUBLIC LAW 114–255—DEC. 13, 2016 
resource lists, as updated under paragraph (1), and the informa-
tion 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 preva-
lence, comorbidities, and physical and mental health con-
sequences; 
(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. 
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. 
(a) EDWARD BYRNE MEMORIAL JUSTICE ASSISTANCE GRANT PRO-
GRAM.—Section 501(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 enforce-
ment and corrections programs, including behavioral pro-
grams and crisis intervention teams.’’. 
42 USC 
300gg–26 note. 
42 USC 237a 
note. 
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130 STAT. 1288 
PUBLIC LAW 114–255—DEC. 13, 2016 
(b) COMMUNITY ORIENTED POLICING SERVICES PROGRAM.—Sec-
tion 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 med-
ical services workers, and other first responders to recognize individ-
uals who have mental illness and how to properly intervene with 
individuals with mental illness, including strategies for verbal de- 
escalation of crises’’. 
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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130 STAT. 1289 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 medi-
cally 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 under-
stand or lacks judgment to make informed decisions 
regarding his or her need for treatment, care, or super-
vision.’’. 
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 Statis-
tical Manual of Mental Disorders published by the Amer-
ican Psychiatric Association; and 
(B) that has resulted in functional impairment that 
substantially interferes with or limits 1 or more major 
life activities. 
42 USC 3796ii 
note. 
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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 incarcer-
ation 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 success-
ful completion of such treatment; 
(F) centralized case management, including— 
(i) the consolidation of all cases, including viola-
tions of probations, of the program participant; and 
(ii) coordination of all mental health treatment 
plans and social services, including life skills and voca-
tional 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 compli-
ance 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 prac-
ticable, continuity of psychiatric care at the end of the 
supervised period. 
(d) IMPLEMENTATION; DURATION.—The pilot program estab-
lished under subsection (b) shall be conducted— 
(1) in not less than 1 United States judicial district, des-
ignated 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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PUBLIC LAW 114–255—DEC. 13, 2016 
(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 treat-
ment, including substance abuse and mental health treatment. 
(f) ASSISTANCE FROM OTHER FEDERAL ENTITIES.—The Adminis-
trative 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, super-
vising, 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. 
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: 
‘‘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 ill-
ness. 
‘‘(2) ALLOWABLE USES.—Grants awarded under this sub-
section 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, 
42 USC 3796ii–8. 
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PUBLIC LAW 114–255—DEC. 13, 2016 
implement, or expand a behavioral health screening and assess-
ment program framework for State or local criminal justice 
systems. 
‘‘(2) ALLOWABLE USES.—Grants awarded under this sub-
section 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 sys-
tems or agencies for determining how treatment and inten-
sive 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 sub-
section (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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130 STAT. 1293 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 evalua-
tion 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 ‘unre-
solved 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 begin-
ning 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 sec-
tion 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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130 STAT. 1294 
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 presump-
tion 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 pro-
vides 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 cer-
tification— 
‘‘(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 para-
graph (1)(D) have been issued; and 
‘‘(iii) any reimbursements required under para-
graph (1)(F) have been made; and 
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130 STAT. 1295 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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.’’. 
SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIA-
TIVES. 
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) INI-
TIATIVE 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 initia-
tives 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 treat-
ment protocols; 
‘‘(B) FACT programs that involve mental health profes-
sionals, 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 prac-
tices for the treatment of co-occurring mental health and 
substance-related disorders, assertive outreach and engage-
ment, 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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130 STAT. 1296 
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 high- 
fidelity practice principles and technical assistance to sup-
port effective and continuing integration with criminal jus-
tice 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 pro-
grams described in this subsection. 
‘‘(4) APPLICATIONS.—To request a grant under this sub-
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.’’. 
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 serv-
ices for those with mental illnesses or with co-occurring dis-
orders, 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’’. 
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. 
42 USC 
3797aa–1 note. 
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130 STAT. 1297 
PUBLIC LAW 114–255—DEC. 13, 2016 
(3) COOPERATIVE
PROGRAMS.—The establishment and 
expansion of cooperative efforts to promote public safety 
through the use of effective intervention with respect to men-
tally 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 serv-
ices,’’ before ‘‘drug treatment’’; and 
(2) by adding at the end the following: 
‘‘(8) target offenders with histories of homelessness, sub-
stance abuse, or mental illness, including a prerelease assess-
ment 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 appro-
priate 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 enforce-
ment agencies, including active-shooter response training. 
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.’’. 
42 USC 3752 
note. 
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130 STAT. 1298 
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 INCARCER-
ATION PROGRAMS 
‘‘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 treat-
ment alternative to incarceration program for eligible participants, 
including— 
‘‘(1) pre-booking treatment alternative to incarceration pro-
grams, including— 
‘‘(A) law enforcement training on substance use dis-
orders, 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 sub-
stance use disorders, mental illness, or co-occurring mental 
illness and substance use disorders; and 
‘‘(D) other arrest and pre-booking treatment alter-
natives to incarceration models; or 
‘‘(2) post-booking treatment alternative to incarceration pro-
grams, including— 
‘‘(A) specialized clinical case management; 
42 USC 3797q. 
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130 STAT. 1299 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(B) pre-trial services related to substances use dis-
orders, 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 sub-
stance 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 Gen-
eral— 
‘‘(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 applica-
tion 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 prac-
tices 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 consider-
ation 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 condi-
tions of the program, consistent with Federal and State con-
fidentiality 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 sub-
stance 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 activi-
ties 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 Gen-
eral under this section shall be subject to the following account-
ability provisions: 
‘‘(1) AUDIT REQUIREMENT.— 
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130 STAT. 1301 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(A) DEFINITION.—In this paragraph, the term ‘unre-
solved 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 begin-
ning 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 subpara-
graph (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 erro-
neously 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 presump-
tion 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 agree-
ment 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 writ-
ten 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 Gen-
eral or Director; 
‘‘(ii) all mandatory exclusions required under para-
graph (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 dupli-
cate 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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. 
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: 
‘‘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 Assist-
ance Center. 
‘‘(b) ELIGIBLE ORGANIZATION.—For purposes of subsection (a), 
the term ‘eligible organization’ means a national nonprofit organiza-
tion 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 enforce-
ment, 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 ill-
nesses, with an emphasis on de-escalation of encounters 
between law enforcement officers and those with mental dis-
orders or in crisis, which shall include support the development 
of in-person and technical information exchanges between sys-
tems 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 proto-
cols 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; 
42 USC 
3797aa–1. 
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130 STAT. 1304 
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 serv-
ices; 
‘‘(7) develop and disseminate to mental health providers 
and criminal justice agencies evaluation tools, mechanisms, 
and measures to better assess and document performance meas-
ures and outcomes relating to the provision of mental health 
services; 
‘‘(8) disseminate information to States, units of local govern-
ment, 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 ‘unre-
solved 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 begin-
ning 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 sec-
tion 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 presump-
tion 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 agree-
ment 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 writ-
ten 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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130 STAT. 1306 
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 cer-
tification— 
‘‘(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 para-
graph (1)(D) have been issued; and 
‘‘(iii) any reimbursements required under para-
graph (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 dupli-
cate 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.’’. 
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, seri-
ously 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 
IN THE 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— 
28 USC 534 note. 
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130 STAT. 1307 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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. 
(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 deter-
minations 
‘‘The Secretary may not make an adverse determination con-
cerning 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 begin-
ning of such chapter 55 is amended by inserting after the item 
relating to section 5501 the following new item: 
‘‘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. 
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).’’. 
38 USC 5501A 
note. 
38 USC 
5501 prec. 
38 USC 5501A. 
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130 STAT. 1308 
PUBLIC LAW 114–255—DEC. 13, 2016 
Subtitle B—Comprehensive Justice and 
Mental Health 
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 para-
graph (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 jus-
tice 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 pro-
grams 
to 
scale 
along 
multiple 
intercepts, 
including— 
‘‘(aa) emergency and crisis services; 
‘‘(bb) specialized police-based responses; 
‘‘(cc) court hearings and disposition alter-
natives; 
‘‘(dd) reentry from jails and prisons; and 
‘‘(ee) community supervision, treatment 
and support services; and 
‘‘(ii) may serve as a starting point for the develop-
ment 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(VI) planning for the sustainability of effec-
tive 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 Gen-
eral 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 seg-
regated 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.’’. 
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 appro-
priately to the unique issues involving frequent 
users of crisis services for public service personnel, 
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130 STAT. 1310 
PUBLIC LAW 114–255—DEC. 13, 2016 
including criminal justice, mental health, sub-
stance abuse, emergency room, healthcare, law 
enforcement, corrections, and housing personnel; 
‘‘(III) develop or support alternatives to hos-
pital 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 assist-
ance 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 pro-
grams, 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.’’. 
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 enforce-
ment agencies, and Federal criminal justice agencies to improve 
the response of such employees to situations involving individ-
uals who have a mental illness. 
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— 
42 USC 
3797aa–1 note. 
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130 STAT. 1311 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 ill-
nesses; 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 empir-
ical 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’’. 
SEC. 
14028. 
TRANSPARENCY, 
PROGRAM 
ACCOUNTABILITY, 
AND 
ENHANCEMENT OF LOCAL AUTHORITY. 
(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 dis-
order’ 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 dis-
orders 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 sub-
stance 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 participa-
tion 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 des-
ignate a defendant as a preliminarily qualified offender, 
the relevant prosecuting attorney, defense attorney, proba-
tion 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 defend-
ant is charged; 
‘‘(iii) the views of any relevant victims to the 
offense; 
‘‘(iv) the extent to which the defendant would ben-
efit from participation in the program; 
‘‘(v) the extent to which the community would 
realize cost savings because of the defendant’s partici-
pation in the program; and 
‘‘(vi) whether the defendant satisfies the eligibility 
criteria for program participation unanimously estab-
lished by the relevant prosecuting attorney, defense 
attorney, probation or corrections official, judge and 
mental health or substance abuse agency representa-
tive.’’. 
(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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130 STAT. 1313 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 commit-
ting the offense.’’. 
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 account-
ability provisions: 
‘‘(1) AUDIT REQUIREMENT.— 
‘‘(A) DEFINITION.—In this paragraph, the term ‘unre-
solved 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 begin-
ning 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 subpara-
graph (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 erro-
neously 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 presump-
tion 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 agree-
ment 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 writ-
ten 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 Gen-
eral or Director; 
‘‘(ii) all mandatory exclusions required under para-
graph (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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130 STAT. 1315 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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, AC-
CESS, 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’’. 
TITLE XV—PROVISIONS RELATING TO 
MEDICARE PART A 
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 
42 USC 1305 
note. 
Increasing 
Choice, Access, 
and Quality in 
Health Care for 
Americans Act. 
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130 STAT. 1316 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 sur-
gical 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. 
(a) TRANSITIONAL ADJUSTMENT
FOR DUAL ELIGIBLE POPU-
LATION.—Section 1886(q)(3) of the Social Security Act (42 U.S.C. 
1395ww(q)(3)) is amended— 
(1) in subparagraph (A), by inserting ‘‘subject to subpara-
graph (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 hos-
pitals, 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 Medi-
care 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
HOS-
PITALS.—In carrying out this subparagraph, the Sec-
retary shall not impose any additional reporting 
requirements on hospitals. 
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130 STAT. 1317 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(iv) BUDGET
NEUTRAL
DESIGN
METHODOLOGY.— 
The Secretary shall design the methodology to imple-
ment this subparagraph so that the estimated total 
amount of reductions in payments under this sub-
section 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 sub-
section (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 sub-
section of risk adjustment methodologies. Nothing in 
this clause shall be construed as precluding consider-
ation 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 sub-
section 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 readmis-
sion. The Secretary may consider modifying measures 
under this subsection to incorporate V or other ICD- 
related 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. 
SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOS-
PITAL 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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130 STAT. 1318 
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 5- 
year 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, notwith-
standing subsection (a)(2) or paragraph (2) of this sub-
section, not later than 120 days after the date of the 
enactment of this paragraph, issue a solicitation for applica-
tions to select up to the maximum number of additional 
rural community hospitals located in any State to partici-
pate 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 sub-
section. 
‘‘(B) PRIORITY.—In determining which rural community 
hospitals that submitted an application pursuant to the 
solicitation under subparagraph (A) to select for participa-
tion in the demonstration program, the Secretary— 
‘‘(i) shall give priority to rural community hospitals 
located in one of the 20 States with the lowest popu-
lation 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 para-
graph; 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 comple-
tion of the demonstration program under this section’’ and 
inserting ‘‘Not later than August 1, 2018’’; and 
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130 STAT. 1319 
PUBLIC LAW 114–255—DEC. 13, 2016 
(2) by striking ‘‘such program’’ and inserting ‘‘the dem-
onstration 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, Med-
icaid, 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 para-
graph (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 Sec-
retary 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 pay-
ment 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 Fed-
eral 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).’’. 
SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT 
APPLYING 
DOCUMENTATION 
AND 
CODING 
ADJUST-
MENTS. 
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 
42 USC 1395ww 
note. 
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130 STAT. 1320 
PUBLIC LAW 114–255—DEC. 13, 2016 
Access and CHIP Reauthorization Act of 2015 (Public Law 114– 
10), is amended in clause (iii) by striking ‘‘an increase of 0.5 percent-
age 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 Exten-
sion 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 provi-
sion,’’ 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 provi-
sion,’’ after ‘‘Regulations’’; and 
(3) in subparagraph (C), by striking ‘‘for a 9-year period’’ 
and inserting ‘‘through June 30, 2016, and for discharges occur-
ring on or after October 1, 2016, and before October 1, 2017’’. 
SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF HOS-
PITAL LENGTH OF STAY TO ALL LTCHS. 
(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 subpara-
graphs (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). 
42 USC 1395ww 
note. 
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130 STAT. 1321 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 semi-
colon; 
(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 modi-
fications. 
(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 proc-
essed as claims which are paid on a reasonable cost basis 
as described in section 412.526(c) of title 42, Code of Fed-
eral 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 Secu-
rity 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 sub-
section (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)’’. 
42 USC 1395ww 
note. 
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130 STAT. 1322 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION OF THE 
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CER-
TAIN 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-
STROPHIC SPINAL CORD OR ACQUIRED BRAIN INJURIES 
OR OTHER PARALYZING NEUROMUSCULAR CONDITIONS.— 
Of the discharges in calendar year 2013 from the long- 
term 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 imple-
ment subclause (I) by program instruction or other-
wise. 
‘‘(III) NON-APPLICATION OF PAPERWORK REDUC-
TION 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 CER-
TAIN 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 cata-
strophic spinal cord or acquired brain injuries or other 
paralyzing neuromuscular conditions (as described within 
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130 STAT. 1323 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 Comp-
troller 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. 
SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE 
MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CER-
TAIN 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 amend-
ment 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 subpara-
graph, 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 mem-
brane 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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130 STAT. 1324 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 Comp-
troller 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 
SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPEC-
TIVE 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 speci-
fied 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
of the enactment of this clause, from the chief 
executive officer or chief operating officer of the 
provider a written certification that the depart-
ment 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 construc-
tion of such department. 
‘‘(vii) AUDIT.—Not later than December 31, 2018, 
the Secretary shall audit the compliance with require-
ments of clause (iv) with respect to each department 
of a provider to which such clause applies. If the Sec-
retary 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 imple-
menting 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 Fed-
eral 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 subpara-
graph (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). 
SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUT-
PATIENT 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 
42 USC 1395l 
note. 
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130 STAT. 1326 
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 pro-
vider 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 Sec-
retary 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 compli-
ance 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 Supple-
mentary 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 subpara-
graph (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 para-
graph 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 adjust-
ments 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). 
SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULA-
TORY 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— 
42 USC 1395l 
note. 
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130 STAT. 1327 
PUBLIC LAW 114–255—DEC. 13, 2016 
(1) by striking ‘‘HOSPITAL-BASED ELIGIBLE PROFESSIONALS’’ 
and all that follows through ‘‘No payment’’ and inserting the 
following: ‘‘HOSPITAL-BASED AND AMBULATORY SURGICAL CENTER- 
BASED ELIGIBLE PROFESSIONALS.— 
‘‘(i) HOSPITAL-BASED.—No payment’’; and 
(2) by adding at the end the following new clauses: 
‘‘(ii) AMBULATORY SURGICAL CENTER-BASED.—Sub-
ject 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 serv-
ices furnished by such professional are furnished in 
an ambulatory surgical center. 
‘‘(iii) 
DETERMINATION.—The 
determination 
of 
whether an eligible professional is an eligible profes-
sional described in clause (ii) may be made on the 
basis of— 
‘‘(I) the site of service (as defined by the Sec-
retary); 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. 
(a) EXTENSION OF ENFORCEMENT INSTRUCTION ON SUPERVISION 
REQUIREMENTS FOR OUTPATIENT THERAPEUTIC SERVICES IN CRIT-
ICAL 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 enact-
ment 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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130 STAT. 1328 
PUBLIC LAW 114–255—DEC. 13, 2016 
SEC. 
16005. 
DELAY 
OF 
IMPLEMENTATION 
OF 
MEDICARE 
FEE 
SCHEDULE ADJUSTMENTS FOR WHEELCHAIR ACCES-
SORIES 
AND 
SEATING 
SYSTEMS 
WHEN 
USED 
IN 
CONJUNCTION WITH COMPLEX REHABILITATION TECH-
NOLOGY (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. 
(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 short-
age 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’ serv-
ices 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. 
SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES 
FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDI-
CARE 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 
42 USC 1395u 
note. 
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130 STAT. 1329 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 para-
graph (9)(i) of such section. For purposes of the pre-
ceding 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 Commit-
tees 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). 
SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING 
INFORMATION 
FROM 
COMPETITIVE 
BIDDING 
PRO-
GRAMS. 
(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 asso-
ciated 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. 
(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).’’. 
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 Medi-
care 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 para-
graph (2)); 
‘‘(ii) enrollment under part C (including separate 
for aggregate enrollment in MA–PD plans and aggre-
gate enrollment in MA plans that are not MA–PD 
plans); and 
‘‘(iii) enrollment under part D. 
42 USC 
1395w–27 note. 
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130 STAT. 1331 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 sub-
section (b), the Secretary of Health and Human Services shall, 
taking into consideration information collected pursuant to sub-
section (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 Medi-
care 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 informa-
tion 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 rec-
ommendations, 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. 
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 subpara-
graph (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 
42 USC 1395a 
note. 
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130 STAT. 1332 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(II) is within a category of providers of serv-
ices 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 Secu-
rity 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 sub-
ject 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 sec-
tion 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 LIMITA-
TION
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 fol-
lowing 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 
PUBLIC LAW 114–255—DEC. 13, 2016 
the period of a temporary moratorium described in 
clause (i), a provider meeting the requirements speci-
fied 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 Secu-
rity 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 accord-
ance 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)’’. 
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 ‘‘begin-
ning 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 SUBSE-
QUENT 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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130 STAT. 1334 
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 para-
graph (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 guide-
lines established by the Centers for Medicare & Med-
icaid Services.’’. 
SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES 
TO CHOOSE A MEDICARE ADVANTAGE PLAN. 
(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 fol-
lows 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 sub-
section 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)— 
42 USC 
1395w–21 note. 
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130 STAT. 1335 
PUBLIC LAW 114–255—DEC. 13, 2016 
(i) in the matter preceding subparagraph (A), by 
striking ‘‘paragraphs (2) and (4)’’ and inserting ‘‘para-
graphs (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 ‘‘subpara-
graphs (F) and (G)’’; and 
(C) by adding at the end the following new subpara-
graph: 
‘‘(G) APPLICATION
OF
KIDNEY
ACQUISITIONS
ADJUST-
MENT.—The base payment amount specified in subpara-
graph (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 sub-
section.’’. 
(c) FFS COVERAGE OF KIDNEY ACQUISITIONS.— 
(1) IN GENERAL.—Section 1852(a)(1)(B)(i) of the Social Secu-
rity Act (42 U.S.C. 1395w–22(a)(1)(B)(i)) is amended by 
inserting ‘‘or coverage for organ acquisitions for kidney trans-
plants, including as covered under section 1881(d)’’ after ‘‘hos-
pice 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
ACQUISI-
TIONS.—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 sub-
section 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 
42 USC 
1395w–21 note. 
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130 STAT. 1336 
PUBLIC LAW 114–255—DEC. 13, 2016 
Advantage plans under part C of title XVIII of such Act deter-
mined 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 pay-
ment 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 subpara-
graph: 
‘‘(I) IMPROVEMENTS TO RISK ADJUSTMENT FOR 2019 AND 
SUBSEQUENT YEARS.— 
‘‘(i) IN GENERAL.—In order to determine the appro-
priate adjustment for health status under subpara-
graph (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 
PUBLIC LAW 114–255—DEC. 13, 2016 
make separate adjustments for each of the fol-
lowing: 
‘‘(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 diag-
nosis codes related to mental health and substance 
use disorders in the risk adjustment model. 
‘‘(V) EVALUATION
OF
CHRONIC
KIDNEY
DIS-
EASE.—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 END- 
STAGE
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 COM-
MENT.—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 amend-
ments 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 recommenda-
tions 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 
42 USC 
1395w–23 note. 
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130 STAT. 1338 
PUBLIC LAW 114–255—DEC. 13, 2016 
adjustment model under the Medicare Advantage pro-
gram 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 informa-
tion 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 ‘‘Comp-
troller 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 sup-
pliers 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 ‘‘utili-
zation 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 Feder-
ally 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 
SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN REQUIREMENTS 
FOR 
QUALIFIED 
SMALL 
EMPLOYER 
HEALTH 
REIMBURSEMENT ARRANGEMENTS. 
(a) AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986 
AND THE PATIENT PROTECTION AND AFFORDABLE CARE ACT.— 
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130 STAT. 1339 
PUBLIC LAW 114–255—DEC. 13, 2016 
(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 arrange-
ment 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
LIMITA-
TION.— 
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130 STAT. 1340 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(i) AMOUNT PRORATED IN CERTAIN CASES.—In the 
case of an individual who is not covered by an arrange-
ment for the entire year, the limitation under subpara-
graph (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 sub-
stituting ‘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 consider-
ation 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 begin-
ning 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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130 STAT. 1341 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(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 cov-
ered 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.—Sec-
tion 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, pay-
ments 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 indi-
vidual 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 subpara-
graph (A), a qualified small employer health reimburse-
ment arrangement shall be treated as constituting afford-
able 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 self- 
only 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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130 STAT. 1342 
PUBLIC LAW 114–255—DEC. 13, 2016 
‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSE-
MENT 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 sub-
section (b)(3)(A)(ii).’’. 
(4) APPLICATION OF EXCISE TAX ON HIGH COST EMPLOYER- 
SPONSORED 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 REIMBURSE-
MENT ARRANGEMENTS.—In the case of applicable employer- 
sponsored coverage consisting of coverage under any quali-
fied 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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130 STAT. 1343 
PUBLIC LAW 114–255—DEC. 13, 2016 
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 arrange-
ment (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 para-
graph (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 para-
graph (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 para-
graph (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 require-
ments as necessary to carry out this subsection. 
(b) AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECU-
RITY ACT OF 1974.— 
26 USC 36B note. 
26 USC 36B note. 
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130 STAT. 1344 
PUBLIC LAW 114–255—DEC. 13, 2016 
LEGISLATIVE HISTORY—H.R. 34: 
SENATE REPORTS: No. 114–146 (Comm. on Commerce, Science, and Transporta-
tion). 
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. 
(1) IN GENERAL.—Section 733(a)(1) of the Employee Retire-
ment 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
REQUIRE-
MENTS, 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 sub-
section 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
REQUIRE-
MENTS.—Section 2208(1) of the Public Health Service Act (42 
U.S.C. 300bb–8(1)) is amended by adding at the end the fol-
lowing: ‘‘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 sub-
section shall apply to plan years beginning after December 
31, 2016. 
Approved December 13, 2016. 
42 USC 300bb–8 
note. 
29 USC 1167 
note. 
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