PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1033 

Public Law 114–255 

114th Congress 

An Act 

To accelerate the discovery, development, and delivery of 21st century cures, and 

for other purposes. 

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 Reduction 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 populations in clinical trials. 

Subtitle E—Advancement of the National Institutes of Health Research and Data 

Access 

Sec. 2051. Technical updates to clinical trials database. 

Sec. 2052. Compliance activities reports. 

Sec. 2053. Updates to policies to improve data. 

Sec. 2054. Consultation. 

Subtitle F—Facilitating Collaborative Research 

Sec. 2061. National neurological conditions surveillance system. 

Sec. 2062. Tick-borne diseases. 

Sec. 2063. Accessing, sharing, and using health data for research purposes. 

Subtitle G—Promoting Pediatric Research 

Sec. 2071. National pediatric research network. 

Sec. 2072. Global pediatric clinical study network. 

TITLE III—DEVELOPMENT 

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 therapies. 

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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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 Assessment Service. 

Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 

Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes. 

Sec. 3074. Scientific engagement. 

Sec. 3075. Drug surveillance. 

Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration. 

Subtitle H—Medical Countermeasures Innovation 

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 Immunization 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 prevention, and substance abuse treatment. 

Sec. 6008. Advisory councils. 

Sec. 6009. Peer review. 

Subtitle B—Oversight and Accountability 

Sec. 6021. Improving oversight of mental and substance use disorders programs 

through the Assistant Secretary for Planning and Evaluation. 

Sec. 6022. Reporting for protection and advocacy organizations. 

Sec. 6023. GAO study. 

Subtitle C—Interdepartmental Serious Mental Illness Coordinating Committee 

Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee. 

TITLE VII—ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH 

SCIENCE AND TECHNOLOGY 

Sec. 7001. Encouraging innovation and evidence-based programs. 

Sec. 7002. Promoting access to information on evidence-based programs and practices. 

Sec. 7003. Priority mental health needs of regional and national significance. 

Sec. 7004. Priority substance use disorder treatment needs of regional and national 

significance. 

Sec. 7005. Priority substance use disorder prevention needs of regional and national significance. 

TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND 

RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS 

Sec. 8001. Community mental health services block grant. 

Sec. 8002. Substance abuse prevention and treatment block grant. 

Sec. 8003. Additional provisions related to the block grants. 

Sec. 8004. Study of distribution of funds under the substance abuse prevention and 

treatment block grant and the community mental health services block 

grant. 

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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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 information. 

Sec. 11004. Development and dissemination of model training programs. 

TITLE XII—MEDICAID MENTAL HEALTH COVERAGE 

Sec. 12001. Rule of construction related to Medicaid coverage of mental health 

services and primary care services furnished on the same day. 

Sec. 12002. Study and report related to Medicaid managed care regulation. 

Sec. 12003. Guidance on opportunities for innovation. 

Sec. 12004. Study and report on Medicaid emergency psychiatric demonstration 

project. 

Sec. 12005. Providing EPSDT services to children in IMDs. 

Sec. 12006. Electronic visit verification system required for personal care services 

and home health care services under Medicaid. 

TITLE XIII—MENTAL HEALTH PARITY 

Sec. 13001. Enhanced compliance with mental health and substance use disorder 

coverage requirements. 

Sec. 13002. Action plan for enhanced enforcement of mental health and substance 

use disorder coverage. 

Sec. 13003. Report on investigations regarding parity in mental health and substance use disorder benefits. 

Sec. 13004. GAO study on parity in mental health and substance use disorder benefits. 

Sec. 13005. Information and awareness on eating disorders. 

Sec. 13006. Education and training on eating disorders. 

Sec. 13007. Clarification of existing parity rules. 

TITLE XIV—MENTAL HEALTH AND SAFE COMMUNITIES 

Subtitle A—Mental Health and Safe Communities 

Sec. 14001. Law enforcement grants for crisis intervention teams, mental health 

purposes. 

Sec. 14002. Assisted outpatient treatment programs. 

Sec. 14003. Federal drug and mental health courts. 

Sec. 14004. Mental health in the judicial system. 

Sec. 14005. Forensic assertive community treatment initiatives. 

Sec. 14006. Assistance for individuals transitioning out of systems. 

Sec. 14007. Co-occurring substance abuse and mental health challenges in drug 

courts. 

Sec. 14008. Mental health training for Federal uniformed services. 

Sec. 14009. Advancing mental health as part of offender reentry. 

Sec. 14010. School mental health crisis intervention teams. 

Sec. 14011. Active-shooter training for law enforcement. 


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Sec. 14012. Co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs. 

Sec. 14013. Mental health and drug treatment alternatives to incarceration programs. 

Sec. 14014. National criminal justice and mental health training and technical assistance. 

Sec. 14015. Improving Department of Justice data collection on mental illness involved in crime. 

Sec. 14016. Reports on the number of mentally ill offenders in prison. 

Sec. 14017. Codification of due process for determinations by secretary of veterans 

affairs of mental capacity of beneficiaries. 

Sec. 14018. Reauthorization of appropriations. 

Subtitle B—Comprehensive Justice and Mental Health 

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 authority. 

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 program. 

Sec. 15004. Regulatory relief for LTCHs. 

Sec. 15005. Savings from IPPS MACRA pay-for through not applying documentation and coding adjustments. 

Sec. 15006. Extension of certain LTCH Medicare payment rules. 

Sec. 15007. Application of rules on the calculation of hospital length of stay to all 

LTCHs. 

Sec. 15008. Change in Medicare classification for certain hospitals. 

Sec. 15009. Temporary exception to the application of the Medicare LTCH site neutral provisions for certain spinal cord specialty hospitals. 

Sec. 15010. Temporary extension to the application of the Medicare LTCH site neutral provisions for certain discharges with severe wounds. 

TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B 

Sec. 16001. Continuing Medicare payment under HOPD prospective payment system for services furnished by mid-build off-campus outpatient departments of providers. 

Sec. 16002. Treatment of cancer hospitals in off-campus outpatient department of 

a provider policy. 

Sec. 16003. Treatment of eligible professionals in ambulatory surgical centers for 

meaningful use and MIPS. 

Sec. 16004. Continuing Access to Hospitals Act of 2016. 

Sec. 16005. Delay of implementation of Medicare fee schedule adjustments for 

wheelchair accessories and seating systems when used in conjunction 

with complex rehabilitation technology (CRT) wheelchairs. 

Sec. 16006. Allowing physical therapists to utilize locum tenens arrangements 

under Medicare. 

Sec. 16007. Extension of the transition to new payment rates for durable medical 

equipment under the Medicare program. 

Sec. 16008. Requirements in determining adjustments using information from competitive bidding programs. 

TITLE XVII—OTHER MEDICARE PROVISIONS 

Sec. 17001. Delay in authority to terminate contracts for Medicare Advantage plans 

failing to achieve minimum quality ratings. 


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Sec. 17002. Requirement for enrollment data reporting for Medicare. 

Sec. 17003. Updating the Welcome to Medicare package. 

Sec. 17004. No payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area. 

Sec. 17005. Preservation of Medicare beneficiary choice under Medicare Advantage. 

Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a Medicare Advantage plan. 

Sec. 17007. Improvements to the assignment of beneficiaries under the Medicare 

Shared Savings Program. 

TITLE XVIII—OTHER PROVISIONS 

Sec. 18001. Exception from group health plan requirements for qualified small employer health reimbursement arrangements. 

DIVISION A—21ST CENTURY CURES 

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 appropriations in subsection (b)(3) to carry out the National Institutes 

of Health innovation projects described in subsection (b)(4) (referred 

to in this section as the ‘‘NIH Innovation Projects’’). 

(b) NATIONAL INSTITUTES OF HEALTH INNOVATION ACCOUNT.— 

(1) ESTABLISHMENT OF NIH INNOVATION ACCOUNT.—There 

is established in the Treasury an account, to be known as 

the ‘‘NIH Innovation Account’’ (referred to in this subsection 

as the ‘‘Account’’), for purposes of carrying out the NIH Innovation Projects described in paragraph (4). 

(2) TRANSFER OF DIRECT SPENDING SAVINGS.— 

(A) IN GENERAL.—The following amounts shall be 

transferred to the Account from the general fund of the 

Treasury: 

(i) For fiscal year 2017, $352,000,000. 

(ii) For fiscal year 2018, $496,000,000. 

(iii) For fiscal year 2019, $711,000,000. 

(iv) For fiscal year 2020, $492,000,000. 

(v) For fiscal year 2021, $404,000,000. 

(vi) For fiscal year 2022, $496,000,000. 

(vii) For fiscal year 2023, $1,085,000,000. 

(viii) For fiscal year 2024, $407,000,000. 

(ix) For fiscal year 2025, $127,000,000. 

(x) For fiscal year 2026, $226,000,000. 

(B) AMOUNTS DEPOSITED.—Any amounts transferred 

under subparagraph (A) shall remain unavailable in the 

Account until such amounts are appropriated pursuant 

to paragraph (3). 

(3) APPROPRIATIONS.— 

(A) AUTHORIZATION OF APPROPRIATIONS.—For each of 

the fiscal years 2017 through 2026, there is authorized 

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 transferred to the Account under paragraph (2)(A), to remain 

available until expended. 

(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of 

fiscal years 2017 through 2026, for any discretionary appropriation under the heading ‘‘NIH Innovation Account’’ provided to the Director of NIH pursuant to the authorization 

of appropriations under subparagraph (A) for the purpose 

of carrying out the NIH Innovation Projects, the total 

amount of such appropriations for the applicable fiscal 

year (not to exceed the total amount remaining in the 

Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any 

estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and 

Emergency Deficit Control Act of 1985, and the amount 

transferred to the Account shall be reduced by the same 

amount. 

(4) NIH INNOVATION PROJECTS.—NIH Innovation Projects 

authorized to be funded under this section shall consist of 

the following and, of the total amounts authorized to be appropriated under paragraph (3), there are authorized to be appropriated to each such project a total amount not to exceed 

the following, over the period of fiscal years 2017 through 

2026: 

(A) For the Precision Medicine Initiative, including 

for the advancement of a cohort of individuals to support 

the goals of the Precision Medicine Initiative, not to exceed 

a total of $1,455,000,000, as follows: 

(i) For fiscal year 2017, $40,000,000. 

(ii) For fiscal year 2018, $100,000,000. 

(iii) For fiscal year 2019, $186,000,000. 

(iv) For fiscal year 2020, $149,000,000. 

(v) For fiscal year 2021, $109,000,000. 

(vi) For fiscal year 2022, $150,000,000. 

(vii) For fiscal year 2023, $419,000,000. 

(viii) For fiscal year 2024, $235,000,000. 

(ix) For fiscal year 2025, $36,000,000. 

(x) For fiscal year 2026, $31,000,000. 

(B) For the Brain Research through Advancing Innovative Neurotechnologies Initiative (known as the ‘‘BRAIN 

Initiative’’), not to exceed a total of $1,511,000,000, as 

follows: 

(i) For fiscal year 2017, $10,000,000. 

(ii) For fiscal year 2018, $86,000,000. 

(iii) For fiscal year 2019, $115,000,000. 

(iv) For fiscal year 2020, $140,000,000. 

(v) For fiscal year 2021, $100,000,000. 

(vi) For fiscal year 2022, $152,000,000. 

(vii) For fiscal year 2023, $450,000,000. 

(viii) For fiscal year 2024, $172,000,000. 

(ix) For fiscal year 2025, $91,000,000. 

(x) For fiscal year 2026, $195,000,000. 

(C) To support cancer research, such as the development of cancer vaccines, the development of more sensitive 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1041 

diagnostic tests for cancer, immunotherapy and the 

development of combination therapies, and research that 

has the potential to transform the scientific field, that 

has inherently higher risk, and that seeks to address major 

challenges related to cancer, not to exceed a total of 

$1,800,000,000, as follows: 

(i) For fiscal year 2017, $300,000,000. 

(ii) For fiscal year 2018, $300,000,000. 

(iii) For fiscal year 2019, $400,000,000. 

(iv) For fiscal year 2020, $195,000,000. 

(v) For fiscal year 2021, $195,000,000. 

(vi) For fiscal year 2022, $194,000,000. 

(vii) For fiscal year 2023, $216,000,000. 

(D) For the National Institutes of Health, in coordination with the Food and Drug Administration, to award 

grants and contracts for clinical research to further the 

field of regenerative medicine using adult stem cells, 

including autologous stem cells, for which grants and contracts shall be contingent upon the recipient making available non-Federal contributions toward the costs of such 

research in an amount not less than $1 for each $1 of 

Federal funds provided in the award, not to exceed a total 

of $30,000,000, as follows: 

(i) For fiscal year 2017, $2,000,000. 

(ii) For each of fiscal years 2018 and 2019, 

$10,000,000. 

(iii) For fiscal year 2020, $8,000,000. 

(iv) For each of fiscal years 2021 through 2026, 

$0. 

(c) ACCOUNTABILITY AND OVERSIGHT.— 

(1) WORK PLAN.— 

(A) IN GENERAL.—Not later than 180 days after the 

date of enactment of this Act, the Director of NIH shall 

submit to the Committee on Health, Education, Labor, 

and Pensions and the Committee on Appropriations of the 

Senate and the Committee on Energy and Commerce and 

the Committee on Appropriations of the House of Representatives, a work plan including the proposed allocation 

of funds authorized to be appropriated pursuant to subsection (b)(3) for each of fiscal years 2017 through 2026 

for the NIH Innovation Projects and the contents described 

in subparagraph (B). 

(B) CONTENTS.—The work plan submitted under 

subparagraph (A) shall include— 

(i) recommendations from the Advisory Committee 

described in subparagraph (C); 

(ii) the amount of money to be obligated or 

expended in each fiscal year for each NIH Innovation 

Project; 

(iii) a description and justification of each such 

project; and 

(iv) a description of how each such project supports 

the strategic research priorities identified in the NIH 

Strategic Plan under subsection (m) of section 402 

of the Public Health Service Act (42 U.S.C. 282), as 

added by section 2031. 


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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 Representatives, a report including— 

(i) the amount of money obligated or expended 

in the prior fiscal year for each NIH Innovation Project; 

(ii) a description of any such project using funds 

provided pursuant to the authorization of appropriations under subsection (b)(3); and 

(iii) whether such projects are advancing the strategic research priorities identified in the NIH Strategic 

Plan under subsection (m) of section 402 of the Public 

Health Service Act (42 U.S.C. 282), as added by section 

2031. 

(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the 

Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on 

Appropriations of the House of Representatives, the 

Director of NIH shall provide an update in the form of 

testimony and any additional reports to the respective 

congressional committee regarding the allocation of funding 

under this section or the description of the NIH Innovation 

Projects. 

(d) LIMITATIONS.—Notwithstanding any transfer authority 

authorized by this Act or any appropriations Act, any funds made 

available pursuant to the authorization of appropriations under 

subsection (b)(3) may not be used for any purpose other than 

a NIH Innovation Project. 

(e) SUNSET.—This section shall expire on September 30, 2026. 

SEC. 1002. FDA INNOVATION PROJECTS. 

(a) IN GENERAL.—The Commissioner of Food and Drugs 

(referred to in this section as the ‘‘Commissioner’’) shall use any 

funds appropriated pursuant to the authorization of appropriations 

under subsection (b)(3) to carry out the activities described in 

subsection (b)(4). 

(b) FDA INNOVATION ACCOUNT.— (1) ESTABLISHMENT OF FDA INNOVATION ACCOUNT.—There 

is established in the Treasury an account, to be known as 

the ‘‘FDA Innovation Account’’ (referred to in this subsection 

as the ‘‘Account’’), for purposes of carrying out the activities 

described in paragraph (4). 

(2) TRANSFER OF DIRECT SPENDING SAVINGS.— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1043 

(A) IN GENERAL.—For each of fiscal years 2017 through 

2025, the following amounts shall be transferred to the 

Account from the general fund of the Treasury: (i) For fiscal year 2017, $20,000,000. 

(ii) For fiscal year 2018, $60,000,000. 

(iii) For fiscal year 2019, $70,000,000. 

(iv) For fiscal year 2020, $75,000,000. 

(v) For fiscal year 2021, $70,000,000. 

(vi) For fiscal year 2022, $50,000,000. 

(vii) For fiscal year 2023, $50,000,000. 

(viii) For fiscal year 2024, $50,000,000. 

(ix) For fiscal year 2025, $55,000,000. 

(B) AMOUNTS DEPOSITED.—Any amounts transferred 

under subparagraph (A) shall remain unavailable in the 

Account until such amounts are appropriated pursuant 

to paragraph (3). 

(3) APPROPRIATIONS.— 

(A) AUTHORIZATION OF APPROPRIATIONS.—For each of 

the fiscal years 2017 through 2025, there is authorized 

to be appropriated from the Account to the Commissioner, 

for the purpose of carrying out the activities described 

in paragraph (5), an amount not to exceed the total amount 

transferred to the Account under paragraph (2)(A), to 

remain available until expended. 

(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of 

fiscal years 2017 through 2025, for any discretionary appropriation under the heading ‘‘FDA Innovation Account’’ provided to the Commissioner pursuant to the authorization 

of appropriations under subparagraph (A) for the purpose 

of carrying out the projects activities described in paragraph (4), the total amount of such appropriations in the 

applicable fiscal year (not to exceed the total amount 

remaining in the Account) shall be subtracted from the 

estimate of discretionary budget authority and the resulting 

outlays for any estimate under the Congressional Budget 

and Impoundment Control Act of 1974 or the Balanced 

Budget and Emergency Deficit Control Act of 1985, and 

the amount transferred to the Account shall be reduced 

by the same amount. 

(4) FDA ACTIVITIES.—The activities authorized to be funded 

under this section are the activities under subtitles A through 

F (including the amendments made by such subtitles) of title 

III of this Act and section 1014 of the Federal Food, Drug, 

and Cosmetic Act, as added by section 3073 of this Act. 

(c) ACCOUNTABILITY AND OVERSIGHT.— 

(1) WORK PLAN.— 

(A) IN GENERAL.—Not later than 180 days after the 

date of enactment of this Act, the Commissioner shall 

submit to the Committee on Health, Education, Labor, 

and Pensions and the Committee on Appropriations of the 

Senate and the Committee on Energy and Commerce and 

the Committee on Appropriations of the House of Representatives, a work plan including the proposed allocation 

of funds appropriated pursuant to the authorization of 

appropriations under subsection (b)(3) for each of fiscal 

years 2017 through 2025 and the contents described in 

subparagraph (B). 


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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 appropriations under subsection (b)(3) for each of fiscal years 2017 

through 2025 and on the contents of the proposed work 

plan. 

(2) REPORTS.— 

(A) ANNUAL REPORTS.—Not later than October 1 of 

each of fiscal years 2018 through 2026, the Commissioner 

shall submit to the Committee on Health, Education, Labor, 

and Pensions and the Committee on Appropriations of the 

Senate and the Committee on Energy and Commerce and 

the Committee on Appropriations of the House of Representatives, a report including— 

(i) the amount of money obligated or expended 

in the prior fiscal year for each activity described in 

subsection (b)(4); 

(ii) a description of all such activities using funds 

provided pursuant to the authorization of appropriations under subsection (b)(3); and 

(iii) how the activities are advancing public health. 

(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the 

Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on 

Appropriations of the House of Representatives, the 

Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under 

this section or the description of the activities undertaken 

with such funding. 

(d) LIMITATIONS.—Notwithstanding any transfer authority 

authorized by this Act or any appropriations Act, any funds made 

available pursuant to the authorization of appropriations in subsection (b)(3) shall not be used for any purpose other than an 

activity described in subsection (b)(4). 

(e) SUNSET.—This section shall expire on September 30, 2025. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1045 

(b) ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE

CRISIS.— 

(1) ESTABLISHMENT.—There is established in the Treasury 

an account, to be known as the ‘‘Account For the State Response 

to the Opioid Abuse Crisis’’ (referred to in this subsection 

as the ‘‘Account’’), to carry out the opioid grant program 

described in subsection (c). 

(2) TRANSFER OF DIRECT SPENDING SAVINGS.— 

(A) IN GENERAL.—The following amounts shall be 

transferred to the Account from the general fund of the 

Treasury: 

(i) For fiscal year 2017, $500,000,000. 

(ii) For fiscal year 2018, $500,000,000. 

(B) AMOUNTS DEPOSITED.—Any amounts transferred 

under subparagraph (A) shall remain unavailable in the 

Account until such amounts are appropriated pursuant 

to paragraph (3). 

(3) APPROPRIATIONS.— 

(A) AUTHORIZATION OF APPROPRIATIONS.—In each of 

the fiscal years 2017 and 2018, there is authorized to 

be appropriated from the Account to the Secretary, for 

the grant program described in subsection (c), an amount 

not to exceed the total amount transferred to the Account 

under paragraph (2)(A), to remain available until expended. 

(B) OFFSETTING FUTURE APPROPRIATIONS.—In each of 

fiscal years 2017 and 2018, for any discretionary appropriation under the heading ‘‘Account For the State Response 

to the Opioid Abuse Crisis’’ for the grant program described 

in subsection (c), the total amount of such appropriations 

in the applicable fiscal year (not to exceed the total amount 

remaining in the Account) shall be subtracted from the 

estimate of discretionary budget authority and the resulting 

outlays for any estimate under the Congressional Budget 

and Impoundment Control Act of 1974 or the Balanced 

Budget and Emergency Deficit Control Act of 1985, and 

the amount transferred to the Account shall be reduced 

by the same amount. 

(c) OPIOID GRANT PROGRAM.— 

(1) STATE RESPONSE TO THE OPIOID ABUSE CRISIS.—Subject 

to the availability of appropriations, the Secretary shall award 

grants to States for the purpose of addressing the opioid abuse 

crisis within such States, in accordance with subparagraph 

(B). In awarding such grants, the Secretary shall give preference to States with an incidence or prevalence of opioid 

use disorders that is substantially higher relative to other 

States. 

(2) OPIOID GRANTS.—Grants awarded to a State under this 

subsection shall be used for carrying out activities that supplement activities pertaining to opioids undertaken by the State 

agency responsible for administering the substance abuse 

prevention and treatment block grant under subpart II of part 

B of title XIX of the Public Health Service Act (42 U.S.C. 

300x–21 et seq.), which may include public health-related activities such as the following: 

(A) Improving State prescription drug monitoring programs. 


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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, recognizing potential cases of substance abuse, referral of 

patients to treatment programs, and overdose prevention. 

(D) Supporting access to health care services, including 

those services provided by Federally certified opioid treatment programs or other appropriate health care providers 

to treat substance use disorders. 

(E) Other public health-related activities, as the State 

determines appropriate, related to addressing the opioid 

abuse crisis within the State. 

(d) ACCOUNTABILITY AND OVERSIGHT.—A State receiving a grant 

under subsection (c) shall include in a report related to substance 

abuse submitted to the Secretary pursuant to section 1942 of the 

Public Health Service Act (42 U.S.C. 300x–52), a description of— 

(1) the purposes for which the grant funds received by 

the State under such subsection for the preceding fiscal year 

were expended and a description of the activities of the State 

under the program; and 

(2) the ultimate recipients of amounts provided to the State 

in the grant. 

(e) LIMITATIONS.—Any funds made available pursuant to the 

authorization of appropriations under subsection (b)— 

(1) notwithstanding any transfer authority in any appropriations Act, shall not be used for any purpose other than 

the grant program in subsection (c); and 

(2) shall be subject to the same requirements as substance 

abuse prevention and treatment programs under titles V and 

XIX of the Public Health Service Act (42 U.S.C. 290aa et 

seq., 300w et seq.). 

(f) SUNSET.—This section shall expire on September 30, 2026. 

SEC. 1004. BUDGETARY TREATMENT. 

(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects of 

division A of this Act shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory PayAs-You-Go Act of 2010. 

(b) SENATE PAYGO SCORECARDS.—The budgetary effects of division A of this Act shall not be entered on any PAYGO scorecard 

maintained for purposes of section 201 of S. Con. Res. 21 (110th 

Congress). 

(c) RESERVATION OF SAVINGS.—None of the funds in the NIH 

Innovation Account, the FDA Innovation Account, or the Account 

For the State Response to the Opioid Abuse Crisis established 

by this title shall be made available except to the extent provided 

in advance in appropriations Acts, and legislation or an Act that 

rescinds or reduces amounts in such accounts shall not be estimated 

as a reduction in direct spending under the Congressional Budget 

and Impoundment Control Act of 1974 or the Balanced Budget 

and Emergency Deficit Control Act of 1985. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1047 

TITLE II—DISCOVERY 

Subtitle A—National Institutes of Health 

Reauthorization 

SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION. 

Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 

282a(a)(1)) is amended— 

(1) in subparagraph (B), by striking ‘‘and’’ at the end; 

(2) in subparagraph (C), by striking the period at the 

end and inserting a semicolon; and 

(3) by adding at the end the following new subparagraphs: ‘‘(D) $34,851,000,000 for fiscal year 2018; 

‘‘(E) $35,585,871,000 for fiscal year 2019; and 

‘‘(F) $36,472,442,775 for fiscal year 2020.’’. 

SEC. 2002. EUREKA PRIZE COMPETITIONS. 

(a) IN GENERAL.—Pursuant to the authorities and processes 

established under section 24 of the Stevenson-Wydler Technology 

Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National 

Institutes of Health shall support prize competitions for one or 

both of the following goals: 

(1) Identifying and funding areas of biomedical science 

that could realize significant advancements through a prize 

competition. 

(2) Improving health outcomes, particularly with respect 

to human diseases and conditions— 

(A) for which public and private investment in research 

is disproportionately small relative to Federal Government 

expenditures on prevention and treatment activities with 

respect to such diseases and conditions, such that Federal 

expenditures on health programs would be reduced; 

(B) that are serious and represent a significant disease 

burden in the United States; or 

(C) for which there is potential for significant return 

on investment to the United States. 

(b) TRACKING; REPORTING.—The Director of the National 

Institutes of Health shall— 

(1) collect information on— 

(A) the effect of innovations funded through the prize 

competitions under this section in advancing biomedical 

science or improving health outcomes pursuant to subsection (a); and 

(B) the effect of the innovations on Federal expenditures; and 

(2) include the information collected under paragraph (1) 

in the triennial report under section 403 of the Public Health 

Service Act (42 U.S.C. 283) (as amended by section 2032). 

Subtitle B—Advancing Precision Medicine 

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 section, the Secretary may— 

‘‘(1) coordinate with the Secretary of Energy, private 

industry, and others, as the Secretary determines appropriate, 

to identify and address the advanced supercomputing and other 

advanced technology needs for the Initiative; 

‘‘(2) develop and utilize public-private partnerships; and 

‘‘(3) leverage existing data sources. 

‘‘(d) REQUIREMENTS.—In the implementation of the Initiative 

under subsection (a), the Secretary shall— 

‘‘(1) ensure the collaboration of the National Institutes 

of Health, the Food and Drug Administration, the Office of 

the National Coordinator for Health Information Technology, 

and the Office for Civil Rights of the Department of Health 

and Human Services; 

‘‘(2) comply with existing laws and regulations for the 

protection of human subjects involved in research, including 

the protection of participant privacy; 

‘‘(3) implement policies and mechanisms for appropriate 

secure data sharing across systems that include protections 

for privacy and security of data; 

‘‘(4) consider the diversity of the cohort to ensure inclusion 

of a broad range of participants, including consideration of 

biological, social, and other determinants of health that contribute to health disparities; 

‘‘(5) ensure that only authorized individuals may access 

controlled or sensitive, identifiable biological material and associated information collected or stored in connection with the 

Initiative; and 

‘‘(6) on the appropriate Internet website of the Department 

of Health and Human Services, identify any entities with access 

to such information and provide information with respect to 

the purpose of such access, a summary of the research project 

for which such access is granted, as applicable, and a description of the biological material and associated information to 

which the entity has access. 

‘‘(e) REPORT.—Not later than 1 year after the date of enactment 

of the 21st Century Cures Act, the Secretary shall submit a report 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1049 

on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate 

and the Committee on Energy and Commerce of the House of 

Representatives. Such report shall include steps the Secretary has 

taken to consult with experts or other heads of departments or 

agencies of the Federal Government in the development of such 

policies.’’. 

SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS. 

(a) IN GENERAL.—Subsection (d) of section 301 of the Public 

Health Service Act (42 U.S.C. 241) is amended to read as follows: 

‘‘(d)(1)(A) If a person is engaged in biomedical, behavioral, 

clinical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research 

on the use and effect of alcohol and other psychoactive drugs), 

the Secretary, in coordination with other agencies, as applicable— 

‘‘(i) shall issue to such person a certificate of confidentiality 

to protect the privacy of individuals who are the subjects of 

such research if the research is funded wholly or in part by 

the Federal Government; and 

‘‘(ii) may, upon application by a person engaged in research, 

issue to such person a certificate of confidentiality to protect 

the privacy of such individuals if the research is not so funded. 

‘‘(B) Except as provided in subparagraph (C), any person to 

whom a certificate is issued under subparagraph (A) to protect 

the privacy of individuals described in such subparagraph shall 

not disclose or provide to any other person not connected with 

the research the name of such an individual or any information, 

document, or biospecimen that contains identifiable, sensitive 

information about such an individual and that was created or 

compiled for purposes of the research. 

‘‘(C) The disclosure prohibition in subparagraph (B) shall not 

apply to disclosure or use that is— 

‘‘(i) required by Federal, State, or local laws, excluding 

instances described in subparagraph (D); 

‘‘(ii) necessary for the medical treatment of the individual 

to whom the information, document, or biospecimen pertains 

and made with the consent of such individual; 

‘‘(iii) made with the consent of the individual to whom 

the information, document, or biospecimen pertains; or 

‘‘(iv) made for the purposes of other scientific research 

that is in compliance with applicable Federal regulations governing the protection of human subjects in research. 

‘‘(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such 

subparagraph shall not, in any Federal, State, or local civil, 

criminal, administrative, legislative, or other proceeding, disclose 

or provide the name of such individual or any such information, 

document, or biospecimen that contains identifiable, sensitive 

information about the individual and that was created or compiled 

for purposes of the research, except in the circumstance described 

in subparagraph (C)(iii). 

‘‘(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal 

process, and shall not, without the consent of the individual to 

whom the information pertains, be admissible as evidence or used 


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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 information about himself or herself collected during such individual’s 

participation in the research. 

‘‘(4) For purposes of this subsection, the term ‘identifiable, 

sensitive information’ means information that is about an individual 

and that is gathered or used during the course of research described 

in paragraph (1)(A) and— 

‘‘(A) through which an individual is identified; or 

‘‘(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, 

that some combination of the information, a request for the 

information, and other available data sources could be used 

to deduce the identity of an individual.’’. 

(b) APPLICABILITY.—Beginning 180 days after the date of enactment of this Act, all persons engaged in research and authorized 

by the Secretary of Health and Human Services to protect information under section 301(d) of the Public Health Service Act (42 

U.S.C. 241(d)) prior to the date of enactment of this Act shall 

be subject to the requirements of such section (as amended by 

this Act). 

SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION. 

Section 301 of the Public Health Service Act (42 U.S.C. 241) 

is amended by adding at the end the following: 

‘‘(f)(1) The Secretary may exempt from disclosure under section 

552(b)(3) of title 5, United States Code, biomedical information 

that is about an individual and that is gathered or used during 

the course of biomedical research if— 

‘‘(A) an individual is identified; or 

‘‘(B) there is at least a very small risk, as determined 

by current scientific practices or statistical methods, that some 

combination of the information, the request, and other available 

data sources could be used to deduce the identity of an individual. 

‘‘(2)(A) Each determination of the Secretary under paragraph 

(1) to exempt information from disclosure shall be made in writing 

and accompanied by a statement of the basis for the determination. 

‘‘(B) Each such determination and statement of basis shall 

be available to the public, upon request, through the Office of 

the Chief FOIA Officer of the Department of Health and Human 

Services. 

42 USC 241 note. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1051 

‘‘(3) Nothing in this subsection shall be construed to limit 

a research participant’s access to information about such participant 

collected during the participant’s participation in the research.’’. 

SEC. 2014. DATA SHARING. 

(a) IN GENERAL.—Section 402(b) of the Public Health Service 

Act (42 U.S.C. 282(b)) is amended— 

(1) in paragraph (23), by striking ‘‘and’’ at the end; 

(2) in paragraph (24), by striking the period and inserting 

‘‘; and’’; and 

(3) by inserting after paragraph (24) the following: 

‘‘(25) may require recipients of National Institutes of Health 

awards to share scientific data, to the extent feasible, generated 

from such National Institutes of Health awards in a manner 

that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection 

of— 

‘‘(A) human research participants, including with 

respect to privacy, security, informed consent, and protected 

health information; and 

‘‘(B) proprietary interests, confidential commercial 

information, and the intellectual property rights of the 

funding recipient.’’. 

(b) CONFIDENTIALITY.—Nothing in the amendments made by 

subsection (a) authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other 

privileged or confidential information, described in section 552(b)(4) 

of title 5, United States Code, or section 1905 of title 18, United 

States Code, or be construed to require recipients of grants or 

cooperative agreements through the National Institutes of Health 

to share such information. 

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 independence, including existing policies and programs, as appropriate; 

42 USC 283o. 

42 USC 282 note. 


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130 STAT. 1052 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 Academies of Sciences, Engineering, and Medicine as part of the comprehensive study on policies affecting the next generation of 

researchers under the Department of Health and Human Services 

Appropriations Act, 2016 (Public Law 114–113), and submit a report 

to the Committee on Health, Education, Labor, and Pensions and 

the Committee on Appropriations of the Senate, and the Committee 

on Energy and Commerce and the Committee on Appropriations 

of the House of Representatives, with respect to any actions taken 

by the National Institutes of Health based on the recommendations 

not later than 2 years after the completion of the study required 

pursuant to the Department of Health and Human Services Appropriations Act, 2016. 

SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM. 

(a) INTRAMURAL LOAN REPAYMENT PROGRAM.—Section 487A 

of the Public Health Service Act (42 U.S.C. 288–1) is amended— 

(1) by amending the section heading to read as follows: 

‘‘INTRAMURAL LOAN REPAYMENT PROGRAM’’; 

(2) in subsection (a)— 

(A) by striking ‘‘The Secretary shall carry out a program’’ and inserting ‘‘The Director of the National 

Institutes of Health shall, as appropriate and based on 

workforce and scientific priorities, carry out a program 

through the subcategories listed in subsection (b)(1) (or 

modified subcategories as provided for in subsection (b)(2))’’; 

(B) by striking ‘‘conduct’’ and inserting ‘‘conduct 

research’’; 

(C) by striking ‘‘research with respect to acquired 

immune deficiency syndrome’’; and 

(D) by striking ‘‘$35,000’’ and inserting ‘‘$50,000’’; 

(3) by redesignating subsection (b) as subsection (d); 

(4) by inserting after subsection (a), the following: 

‘‘(b) SUBCATEGORIES OF RESEARCH.— 

‘‘(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health— 

‘‘(A) shall continue to focus on— 

‘‘(i) general research; 


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‘‘(ii) research on acquired immune deficiency syndrome; and 

‘‘(iii) clinical research conducted by appropriately 

qualified health professional who are from disadvantaged backgrounds; and 

‘‘(B) may focus on an area of emerging scientific or 

workforce need. 

‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— 

The Director of the National Institutes of Health may eliminate 

one or more subcategories provided for in paragraph (1) due 

to changes in workforce or scientific needs related to biomedical 

research. The Director may establish other subcategory areas 

based on workforce and scientific priorities if the total number 

of subcategories does not exceed the number of subcategories 

listed in paragraph (1). 

‘‘(c) LIMITATION.—The Director of the National Institutes of 

Health may not enter into a contract with a health professional 

pursuant to subsection (a) unless such professional has a substantial 

amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).’’; and 

(5) by adding at the end the following: 

‘‘(e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for 

carrying out this section shall remain available until the expiration 

of the second fiscal year beginning after the fiscal year for which 

such amounts are made available.’’. 

(b) EXTRAMURAL LOAN REPAYMENT PROGRAM.—Section 487B 

of the Public Health Service Act (42 U.S.C. 288–2) is amended— 

(1) by amending the section heading to read as follows: 

‘‘EXTRAMURAL LOAN REPAYMENT PROGRAM’’; 

(2) in subsection (a)— 

(A) by striking ‘‘The Secretary, in consultation with 

the Director of the Eunice Kennedy Shriver National 

Institute of Child Health and Human Development, shall 

establish a program’’ and inserting ‘‘IN GENERAL.—The 

Director of the National Institutes of Health shall, as appropriate and based on workforce and scientific priorities, 

carry out a program through the subcategories listed in 

subsection (b)(1) (or modified subcategories as provided 

for in subsection (b)(2)),’’; 

(B) by striking ‘‘(including graduate students)’’; 

(C) by striking ‘‘with respect to contraception, or with 

respect to infertility,’’; and 

(D) by striking ‘‘service, not more than $35,000’’ and 

inserting ‘‘research, not more than $50,000’’; 

(3) by redesignating subsections (b) and (c) as subsections 

(d) and (e), respectively; 

(4) by inserting after subsection (a), the following: 

‘‘(b) SUBCATEGORIES OF RESEARCH.— 

‘‘(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health— 

‘‘(A) shall continue to focus on— 

‘‘(i) contraception or infertility research; 

‘‘(ii) pediatric research, including pediatric 

pharmacological research; 

‘‘(iii) minority health disparities research; 

‘‘(iv) clinical research; and 


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‘‘(v) clinical research conducted by appropriately 

qualified health professional who are from disadvantaged backgrounds; and 

‘‘(B) may focus on an area of emerging scientific or 

workforce need. 

‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may eliminate 

one or more subcategories provided for in paragraph (1) due 

to changes in workforce or scientific needs related to biomedical 

research. The Director may establish other subcategory areas 

based on workforce and scientific priorities if the total number 

of subcategories does not exceed the number of subcategories 

listed in paragraph (1). 

‘‘(c) LIMITATION.—The Director of the National Institutes of 

Health may not enter into a contract with a health professional 

pursuant to subsection (a) unless such professional has a substantial 

amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).’’; 

(5) in subsection (d) (as so redesignated), by striking ‘‘The 

provisions’’ and inserting ‘‘APPLICABILITY OF CERTAIN 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 repayment for clinical researchers; and 

(5) by striking section 487F (42 U.S.C. 288–6), as added 

by section 1002(b) of Public Law 106–310 relating to pediatric 

research loan repayment. 

(d) GAO REPORT.—Not later than 18 months after the date 

of enactment of this Act, the Comptroller General of the United 

States shall submit to Congress a report on the efforts of the 

National Institutes of Health to attract, retain, and develop 

emerging scientists, including underrepresented individuals in the 

sciences, such as women, racial and ethnic minorities, and other 

groups. Such report shall include an analysis of the impact of 

the additional authority provided to the Secretary of Health and 

Human Services under this Act to address workforce shortages 

and gaps in priority research areas, including which centers and 

research areas offered loan repayment program participants the 

increased award amount. 

Subtitle D—National Institutes of Health 

Planning and Administration 

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 committees of Congress and post on the Internet website of the 

National Institutes of Health, a coordinated strategy (to be 

known as the ‘National Institutes of Health Strategic Plan’) 

to provide direction to the biomedical research investments 

made by the National Institutes of Health, to facilitate 

collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine. 

‘‘(2) REQUIREMENTS.—The strategy under paragraph (1) 

shall— 

‘‘(A) identify strategic research priorities and objectives 

across biomedical research, including— 

‘‘(i) an assessment of the state of biomedical and 

behavioral research, including areas of opportunity 

with respect to basic, clinical, and translational 

research; 

‘‘(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions; 

‘‘(iii) emerging scientific opportunities, rising 

public health challenges, and scientific knowledge gaps; 

and 

‘‘(iv) the identification of near-, mid-, and longterm scientific needs; 

‘‘(B) consider, in carrying out subparagraph (A)— 

‘‘(i) disease burden in the United States and the 

potential for return on investment to the United States; 

‘‘(ii) rare diseases and conditions; 

‘‘(iii) biological, social, and other determinants of 

health that contribute to health disparities; and 

‘‘(iv) other factors the Director of National 

Institutes of Health determines appropriate; 

‘‘(C) include multi-institute priorities, including 

coordination of research among institutes and centers; 

‘‘(D) include strategic priorities for funding research 

through the Common Fund, in accordance with section 

402A(c)(1)(C); 

‘‘(E) address the National Institutes of Health’s proposed and ongoing activities related to training and the 

biomedical workforce; and 

‘‘(F) describe opportunities for collaboration with other 

agencies and departments, as appropriate. 

‘‘(3) USE OF PLANS.—Strategic plans developed and updated 

by the national research institutes and national centers of 

the National Institutes of Health shall be prepared regularly 

and in such a manner that such plans will be informed by 

the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national 

research institutes and national centers shall have a common 

template. 


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‘‘(4) CONSULTATION.—The Director of National Institutes 

of Health shall develop the strategic plan under paragraph 

(1) in consultation with the directors of the national research 

institutes and national centers, researchers, patient advocacy 

groups, and industry leaders.’’. 

(b) CONFORMING AMENDMENT.—Section 402A(c)(1)(C) of the 

Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended 

by striking ‘‘Not later than June 1, 2007, and every 2 years thereafter,’’ and inserting ‘‘As part of the National Institutes of Health 

Strategic Plan required under section 402(m),’’. 

(c) STRATEGIC PLAN.—Section 492B(a) of the Public Health 

Service Act (42 U.S.C. 289a–2(a)) is amended by adding at the 

end the following: 

‘‘(3) STRATEGIC PLANNING.— ‘‘(A) IN GENERAL.—The directors of the national 

institutes and national centers shall consult at least once 

annually with the Director of the National Institute on 

Minority Health and Health Disparities and the Director 

of the Office of Research on Women’s Health regarding 

objectives of the national institutes and national centers 

to ensure that future activities by such institutes and centers take into account women and minorities and are 

focused on reducing health disparities. 

‘‘(B) STRATEGIC PLANS.—Any strategic plan issued by 

a national institute or national center shall include details 

on the objectives described in subparagraph (A).’’. 

SEC. 2032. TRIENNIAL REPORTS. 

Section 403 of the Public Health Service Act (42 U.S.C. 283) 

is amended— 

(1) in the section heading, by striking ‘‘BIENNIAL’’ and 

inserting ‘‘TRIENNIAL’’ ; and 

(2) in subsection (a)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘biennial’’ and inserting ‘‘triennial’’; 

(B) by amending paragraph (3) to read as follows: 

‘‘(3) A description of intra-National Institutes of Health 

activities, including— 

‘‘(A) identification of the percentage of funds made 

available by each national research institute and national 

center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration 

between the institute or center and 1 or more other national 

research institutes or national centers; and 

‘‘(B) recommendations for promoting coordination of 

information among the centers of excellence.’’; 

(C) in paragraph (4)— 

(i) in subparagraph (B), by striking ‘‘demographic 

variables and other variables’’ and inserting ‘‘demographic variables, including biological and social variables and relevant age categories (such as pediatric 

subgroups), and determinants of health,’’; and 

(ii) in subparagraph (C)(v)— 

(I) by striking ‘‘demographic variables and 

such’’ and inserting ‘‘demographic variables, 

including relevant age categories (such as pediatric 

subgroups), information submitted by each 


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national research institute and national center to 

the Director of National Institutes of Health under 

section 492B(f), and such’’; and 

(II) by striking ‘‘(regarding inclusion of women 

and minorities in clinical research)’’ and inserting 

‘‘and other applicable requirements regarding 

inclusion of demographic groups’’; and 

(D) in paragraph (6)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘the following:’’ and inserting ‘‘the following— 

’’; 

(ii) in subparagraph (A)— 

(I) by striking ‘‘An evaluation’’ and inserting 

‘‘an evaluation’’; and 

(II) by striking the period and inserting ‘‘; 

and’’; 

(iii) by striking subparagraphs (B) and (D); 

(iv) by redesignating subparagraph (C) as subparagraph (B); and 

(v) in subparagraph (B), as redesignated by clause 

(iv), by striking ‘‘Recommendations’’ and inserting ‘‘recommendations’’. 

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 standards applicable to the relevant appointment mechanism. 

There shall be no limit on the number of terms that a 

Director may serve. 

‘‘(C) VACANCIES.—If the office of a Director of a national 

research institute or national center becomes vacant before 

the end of such Director’s term, the Director appointed 

to fill the vacancy shall be appointed for a 5-year term 

starting on the date of such appointment. 

‘‘(D) CURRENT DIRECTORS.—Each Director of a national 

research institute or national center who is serving on 

the date of enactment of the 21st Century Cures Act shall 


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be deemed to be appointed for a 5-year term under this 

subsection beginning on such date of enactment. 

‘‘(E) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to limit the authority of the 

Secretary or the Director of National Institutes of Health 

to terminate the appointment of a director referred to in 

subparagraph (A) before the expiration of such director’s 

5-year term. 

‘‘(F) NATURE OF APPOINTMENT.—Appointments and reappointments under this subsection shall be made on the 

basis of ability and experience as it relates to the mission 

of the National Institutes of Health and its components, 

including compliance with any legal requirement that the 

Secretary or Director of National Institutes of Health determines relevant. 

‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.—The restrictions contained in section 202 of the Departments of Labor, 

Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 

238f note) related to consultants and individual scientists 

appointed for limited periods of time shall not apply to Directors 

appointed under this subsection.’’. 

(b) REVIEW OF CERTAIN AWARDS BY DIRECTORS.—Section 405(b) 

of the Public Health Service Act (42 U.S.C. 284(b)) is amended 

by adding at the end the following: 

‘‘(3) Before an award is made by a national research institute 

or by a national center for a grant for a research program or 

project (commonly referred to as an ‘R-series grant’), other than 

an award constituting a noncompetitive renewal of such a grant, 

or a noncompetitive administrative supplement to such a grant, 

the Director of such national research institute or national center 

shall, consistent with the peer review process— 

‘‘(A) review and make the final decision with respect to 

making the award; and 

‘‘(B) take into consideration, as appropriate— 

‘‘(i) the mission of the national research institute or 

national center and the scientific priorities identified in 

the strategic plan under section 402(m); 

‘‘(ii) programs or projects funded by other agencies 

on similar research topics; and 

‘‘(iii) advice by staff and the advisory council or board 

of such national research institute or national center.’’. 

(c) REPORT ON DUPLICATION IN FEDERAL BIOMEDICAL

RESEARCH.—The Secretary of Health and Human Services (referred 

to in this subsection as the ‘‘Secretary’’), shall, not later than 

2 years after the date of enactment of this Act, submit a report 

to Congress on efforts to prevent and eliminate duplicative biomedical research that is not necessary for scientific purposes. Such 

report shall— 

(1) describe the procedures in place to identify such duplicative research, including procedures for monitoring research 

applications and funded research awards to prevent unnecessary duplication; 

(2) describe the steps taken to improve the procedures 

described in paragraph (1), in response to relevant recommendations made by the Comptroller General of the United States; 


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(3) describe how the Secretary operationally distinguishes 

necessary and appropriate scientific replication from unnecessary duplication; and 

(4) provide examples of instances where the Secretary has 

identified unnecessarily duplicative research and the steps 

taken to eliminate the unnecessary duplication. 

SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS. 

(a) PLAN PREPARATION AND IMPLEMENTATION OF MEASURES TO

REDUCE ADMINISTRATIVE BURDENS.— (1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) shall— 

(A) lead a review by research funding agencies of all 

regulations and policies related to the disclosure of financial 

conflicts of interest, including the minimum threshold for 

reporting financial conflicts of interest; 

(B) make revisions, as appropriate, to harmonize 

existing policies and reduce administrative burden on 

researchers while maintaining the integrity and credibility 

of research findings and protections of human participants; 

and 

(C) confer with the Office of the Inspector General 

about the activities of such office related to financial conflicts of interest involving research funding agencies. 

(2) CONSIDERATIONS.—In updating policies under paragraph (1)(B), the Secretary shall consider— 

(A) modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by 

institutions receiving grant or cooperative agreement 

funding from the National Institutes of Health; 

(B) ensuring that financial interest disclosure reporting 

requirements are appropriate for, and relevant to, awards 

that will directly fund research, which may include modification of the definition of the term ‘‘investigator’’ for purposes of the regulations and policies described in subparagraphs (A) and (B) of paragraph (1); and 

(C) updating any applicable training modules of the 

National Institutes of Health related to Federal financial 

interest disclosure. 

(b) MONITORING OF SUBRECIPIENTS OF FUNDING FROM THE

NATIONAL INSTITUTES OF HEALTH.—The Director of the National 

Institutes of Health (referred to in this section as the ‘‘Director 

of National Institutes of Health’’) shall implement measures to 

reduce the administrative burdens related to monitoring of subrecipients of grants by primary awardees of funding from the 

National Institutes of Health, which may incorporate findings and 

recommendations from existing and ongoing activities. Such measures may include, as appropriate— 

(1) an exemption from subrecipient monitoring requirements, upon request from the primary awardees, provided 

that— 

(A) the subrecipient is subject to Federal audit requirements pursuant to the Uniform Guidance of the Office 

of Management and Budget; 

(B) the primary awardee conducts, pursuant to guidance of the National Institutes of Health, a pre-award 

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 appropriate, to reduce administrative burden on investigators while 

maintaining the integrity and credibility of research findings and 

protection of research animals. In carrying out this effort, the 

Director of the National Institutes of Health shall seek the input 

of experts, as appropriate. The Director of the National Institutes 

of Health shall— 

(1) identify ways to ensure such regulations and policies 

are not inconsistent, overlapping, or unnecessarily duplicative, 

including with respect to inspection and review requirements 

by Federal agencies and accrediting associations; 

(2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and 

(3) take other actions, as appropriate, to improve the 

coordination of regulations and policies with respect to research 

with laboratory animals. 

(e) DOCUMENTATION OF PERSONNEL EXPENSES.—The Secretary 

shall clarify the applicability of the requirements under the Office 

of Management and Budget Uniform Guidance for management 

and certification systems adopted by entities receiving Federal 

research grants through the Department of Health and Human 

Services regarding documentation of personnel expenses, including 

clarification of the extent to which any flexibility to such requirements specified in such Uniform Guidance applies to entities 

receiving grants through the Department of Health and Human 

Services. 

(f) RESEARCH POLICY BOARD.— 

(1) ESTABLISHMENT.—Not later than 1 year after the date 

of enactment of this Act, the Director of the Office of Management and Budget shall establish an advisory committee, to 

be known as the ‘‘Research Policy Board’’ (referred to in this 

subsection as the ‘‘Board’’), to provide Federal Government 

officials with information on the effects of regulations related 

to Federal research requirements. 

(2) MEMBERSHIP.— 


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(A) IN GENERAL.—The Board shall include not more 

than 10 Federal members, including each of the following 

Federal members or their designees: 

(i) The Administrator of the Office of Information 

and Regulatory Affairs of the Office of Management 

and Budget. 

(ii) The Director of the Office of Science and Technology Policy. 

(iii) The Secretary of Health and Human Services. 

(iv) The Director of the National Science Foundation. 

(v) The secretaries and directors of other departments and agencies that support or regulate scientific 

research, as determined by the Director of the Office 

of Management and Budget. 

(B) NON-FEDERAL MEMBERS.—The Board shall be comprised of not less than 9 and not more than 12 representatives of academic research institutions, other private, nonprofit research institutions, or other nonprofit organizations 

with relevant expertise. Such members shall be appointed 

by a formal process, to be established by the Director 

of the Office of Management and Budget, in consultation 

with the Federal membership, and that incorporates— 

(i) nomination by members of the nonprofit scientific research community, including academic 

research institutions; and 

(ii) procedures to fill membership positions vacated 

before the end of a member’s term. 

(3) PURPOSE AND RESPONSIBILITIES.—The Board shall make 

recommendations regarding the modification and harmonization of regulations and policies having similar purposes across 

research funding agencies to ensure that the administrative 

burden of such research policy and regulation is minimized 

to the greatest extent possible and consistent with maintaining 

responsible oversight of federally funded research. Activities 

of the Board may include— 

(A) providing thorough and informed analysis of regulations and policies; 

(B) identifying negative or adverse consequences of 

existing policies and making actionable recommendations 

regarding possible improvement of such policies; 

(C) making recommendations with respect to efforts 

within the Federal Government to improve coordination 

of regulation and policy related to research; 

(D) creating a forum for the discussion of research 

policy or regulatory gaps, challenges, clarification, or 

harmonization of such policies or regulation, and best practices; and 

(E) conducting ongoing assessment and evaluation of 

regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes. 

(4) EXPERT SUBCOMMITTEES.—The Board may form temporary expert subcommittees, as appropriate, to develop timely 

analysis on pressing issues and assist the Board in anticipating 

future regulatory challenges, including challenges emerging 

from new scientific advances. 


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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 Management and Budget, the Director of the Office of Science and 

Technology Policy, the heads of relevant Federal departments 

and agencies, the Committee on Health, Education, Labor, and 

Pensions of the Senate, and the Committee on Energy and 

Commerce of the House of Representatives containing formal 

recommendations on the conceptualization, development, 

harmonization, and reconsideration of scientific research policy, 

including the regulatory benefits and burdens. 

(6) SUNSET.—The Board shall terminate on September 30, 

2021. 

(7) GAO REPORT.—Not later than 4 years after the date 

of enactment of this Act, the Comptroller General of the United 

States shall conduct an independent evaluation of the activities 

carried out by the Board pursuant to this subsection and submit 

to the appropriate committees of Congress a report regarding 

the results of the independent evaluation. Such report shall 

review and assess the Board’s activities with respect to the 

responsibilities described in paragraph (3). 

SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH 

FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS. 

Section 301 of the Public Health Service Act (42 U.S.C. 241), 

as amended by section 2013, is further amended by adding at 

the end the following: 

‘‘(g) Subchapter I of chapter 35 of title 44, United States Code, 

shall not apply to the voluntary collection of information during 

the conduct of research by the National Institutes of Health.’’. 

SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH. 

(a) IN GENERAL.—Section 402 of the Public Health Service 

Act (42 U.S.C. 282), as amended by section 2031, is further amended 

by adding at the end the following: 

‘‘(n) UNIQUE RESEARCH INITIATIVES.— 

‘‘(1) IN GENERAL.—The Director of NIH may approve, after 

consideration of a proposal under paragraph (2)(A), requests 

by the national research institutes and centers, or program 

officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement 

with respect to projects that carry out— 

‘‘(A) the Precision Medicine Initiative under section 

498E; or 

‘‘(B) section 402(b)(7), except that not more than 50 

percent of the funds available for a fiscal year through 

the Common Fund under section 402A(c)(1) for purposes 

of carrying out such section 402(b)(7) may be used to engage 

in such other transactions. 

‘‘(2) REQUIREMENTS.—The authority provided under this 

subsection may be used to conduct or support high impact 

cutting-edge research described in paragraph (1) using the other 

transactions authority described in such paragraph if the 

institute, center, or office— 


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‘‘(A) submits a proposal to the Director of NIH for 

the use of such authority before conducting or supporting 

the research, including why the use of such authority is 

essential to promoting the success of the project; 

‘‘(B) receives approval for the use of such authority 

from the Director of NIH; and 

‘‘(C) for each year in which the institute, center, or 

office has used such authority in accordance with this 

subsection, submits a report to the Director of NIH on 

the activities of the institute, center, or office relating to 

such research.’’. 

(b) REPORT TO CONGRESS.—Not later than September 30, 2020, 

the Secretary of Health and Human Services, acting through the 

Director of the National Institutes of Health, shall conduct an 

evaluation of the activities under subsection (n) of section 402 

of the Public Health Service Act (42 U.S.C. 282), as added by 

subsection (a), and submit a report to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives on the 

results of such evaluation. 

(c) DUTIES OF DIRECTORS OF INSTITUTES.—Section 405(b)(1) 

of the Public Health Service Act (42 U.S.C. 284(b)(1)) is amended— 

(1) by redesignating subparagraphs (C) through (L) as subparagraphs (D) through (M), respectively; and 

(2) by inserting after subparagraph (B), the following: 

‘‘(C) shall, as appropriate, conduct and support research 

that has the potential to transform the scientific field, has 

inherently higher risk, and that seeks to address major current 

challenges;’’. 

SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL 

SCIENCES. 

(a) IN GENERAL.—Section 479(b) of the Public Health Service 

Act (42 U.S.C. 287(b)) is amended— 

(1) in paragraph (1), by striking ‘‘phase IIA’’ and inserting 

‘‘phase IIB’’; and 

(2) in paragraph (2)— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘phase IIB’’ and inserting ‘‘phase III’’; 

(B) in subparagraph (A), by striking ‘‘phase IIB’’ and 

inserting ‘‘phase III’’; 

(C) in subparagraph (B), by striking ‘‘phase IIA’’ and 

inserting ‘‘phase IIB’’; and 

(D) in subparagraph (C), by striking ‘‘phase IIB’’ and 

inserting ‘‘phase III’’. 

(b) INCREASED TRANSPARENCY.—Section 479 of the Public 

Health Service Act (42 U.S.C. 287) is amended— 

(1) in subsection (c)— 

(A) in paragraph (4)(D), by striking ‘‘and’’ at the end; 

(B) in paragraph (5), by striking the period and 

inserting a semicolon; and 

(C) by adding at the end the following: 

‘‘(6) the methods and tools, if any, that have been developed 

since the last biennial report was prepared; and 

‘‘(7) the methods and tools, if any, that have been developed 

and are being utilized by the Food and Drug Administration 

to support medical product reviews.’’; and 


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(2) by adding at the end the following: 

‘‘(d) INCLUSION OF LIST.—The first biennial report submitted 

under this section after the date of enactment of the 21st Century 

Cures Act shall include a complete list of all of the methods and 

tools, if any, which have been developed by research supported 

by the Center. 

‘‘(e) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed as authorizing the Secretary to disclose any information that is a trade secret, or other privileged or confidential 

information subject to section 552(b)(4) of title 5, United States 

Code, or section 1905 of title 18, United States Code.’’. 

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 opportunity, public health burdens, and progress in reducing 

health disparities; and 

‘‘(B) data on study populations of clinical research, 

funded by or conducted at each national research institute 

and national center, which— 

‘‘(i) specifies the inclusion of— 

‘‘(I) women; 

‘‘(II) members of minority groups; 

‘‘(III) relevant age categories, including pediatric subgroups; and 

‘‘(IV) other demographic variables as the 

Director of the National Institutes of Health determines appropriate; 

‘‘(ii) is disaggregated by research area, condition, 

and disease categories; and 

‘‘(iii) is to be made publicly available on the Internet website of the National Institutes of Health;’’; and 

(2) in paragraph (8)— 

(A) in subparagraph (A), by striking ‘‘and’’ at the end; 

and 

(B) by adding at the end the following: 

‘‘(C) foster collaboration between clinical research 

projects funded by the respective national research 

institutes and national centers that— 

‘‘(i) conduct research involving human subjects; 

and 

‘‘(ii) collect similar data; and 

‘‘(D) encourage the collaboration described in subparagraph (C) to— 

‘‘(i) allow for an increase in the number of subjects 

studied; and 

‘‘(ii) utilize diverse study populations, with special 

consideration to biological, social, and other determinants of health that contribute to health disparities;’’. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1065 

(b) REPORTING.—Section 492B(f) of the Public Health Service 

Act (42 U.S.C. 289a–2(f)) is amended— 

(1) by striking ‘‘biennial’’ each place such term appears 

and inserting ‘‘triennial’’; 

(2) by striking ‘‘The advisory council’’ and inserting the 

following: 

‘‘(1) IN GENERAL.—The advisory council’’; and 

(3) by adding at the end the following: 

‘‘(2) CONTENTS.—Each triennial report prepared by an 

advisory council of each national research institute as described 

in paragraph (1) shall include each of the following: 

‘‘(A) The number of women included as subjects, and 

the proportion of subjects that are women, in any project 

of clinical research conducted during the applicable 

reporting period, disaggregated by categories of research 

area, condition, or disease, and accounting for single-sex 

studies. 

‘‘(B) The number of members of minority groups 

included as subjects, and the proportion of subjects that 

are members of minority groups, in any project of clinical 

research conducted during the applicable reporting period, 

disaggregated by categories of research area, condition, 

or disease and accounting for single-race and single-ethnicity studies. 

‘‘(C) For the applicable reporting period, the number 

of projects of clinical research that include women and 

members of minority groups and that— 

‘‘(i) have been completed during such reporting 

period; and 

‘‘(ii) are being carried out during such reporting 

period and have not been completed. 

‘‘(D) The number of studies completed during the 

applicable reporting period for which reporting has been 

submitted in accordance with subsection (c)(2)(A).’’. 

(c) COORDINATION.—Section 486(c)(2) of the Public Health 

Service Act (42 U.S.C. 287d(c)(2)) is amended by striking ‘‘designees’’ 

and inserting ‘‘senior-level staff designees’’. 

(d) IN GENERAL.—Part A of title IV of the Public Health Service 

Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further 

amended by adding at the end the following: 

‘‘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 participation, as applicable; 

‘‘(2) facilitating the development of valid and reliable 

methods for research relevant to sexual and gender minority 

populations; and 

‘‘(3) addressing methodological challenges.’’. 

(e) REPORTING.— 

(1) IN GENERAL.—The Secretary, in collaboration with the 

Director of the National Institutes of Health, shall as appropriate— 

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 ‘‘INTERAGENCY’’ and inserting ‘‘INTRA-NATIONAL INSTITUTES OF

HEALTH’’; 

(B) by striking ‘‘as the primary Federal officials’’ and 

inserting ‘‘as the primary Federal official’’; 

(C) by inserting a comma after ‘‘review’’; 

(D) by striking ‘‘Institutes and Centers of the National 

Institutes of Health’’ and inserting ‘‘national research 

institutes and national centers’’; and 

(E) by adding at the end the following: ‘‘The Director 

of the Institute may foster partnerships between the 

national research institutes and national centers and may 

encourage the funding of collaborative research projects 

to achieve the goals of the National Institutes of Health 

that are related to minority health and health disparities.’’. 

(g) BASIC RESEARCH.— 

(1) DEVELOPING POLICIES.—Not later than 2 years after 

the date of enactment of this Act, the Director of the National 

Institutes of Health (referred to in this section as the ‘‘Director 

of the National Institutes of Health’’), taking into consideration 

the recommendations developed under section 2039, shall 

develop policies for projects of basic research funded by National 

Institutes of Health to assess— 

(A) relevant biological variables including sex, as 

appropriate; and 

(B) how differences between male and female cells, 

tissues, or animals may be examined and analyzed. 

(2) REVISING POLICIES.—The Director of the National 

Institutes of Health may update or revise the policies developed 

under paragraph (1) as appropriate. 

(3) CONSULTATION AND OUTREACH.—In developing, 

updating, or revising the policies under this section, the 

Director of the National Institutes of Health shall— 

(A) consult with— 

(i) the Office of Research on Women’s Health; 

(ii) the Office of Laboratory Animal Welfare; and 

(iii) appropriate members of the scientific and academic communities; and 

(B) conduct outreach to solicit feedback from members 

of the scientific and academic communities on the influence 

of sex as a variable in basic research, including feedback 

42 USC 284r. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1067 

on when it is appropriate for projects of basic research 

involving cells, tissues, or animals to include both male 

and female cells, tissues, or animals. 

(4) ADDITIONAL REQUIREMENTS.—The Director of the 

National Institutes of Health shall— 

(A) ensure that projects of basic research funded by 

the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under 

this section, as applicable; and 

(B) encourage that the results of such research, when 

published or reported, be disaggregated as appropriate with 

respect to the analysis of any sex differences. 

(h) CLINICAL RESEARCH.— 

(1) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Director of the National Institutes 

of Health, in consultation with the Director of the Office of 

Research on Women’s Health and the Director of the National 

Institute on Minority Health and Health Disparities, shall 

update the guidelines established under section 492B(d) of 

Public Health Service Act (42 U.S.C. 289a–2(d)) in accordance 

with paragraph (2). 

(2) REQUIREMENTS.—The updated guidelines described in 

paragraph (1) shall— 

(A) reflect the science regarding sex differences; 

(B) improve adherence to the requirements under section 492B of the Public Health Service Act (42 U.S.C. 

289a–2), including the reporting requirements under subsection (f) of such section; and 

(C) clarify the circumstances under which studies 

should be designed to support the conduct of analyses 

to detect significant differences in the intervention effect 

due to demographic factors related to section 492B of the 

Public Health Service Act, including in the absence of 

prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the 

effects of the absence of such analyses on the availability 

of data related to demographic differences. 

(i) APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.— 

(1) INPUT FROM EXPERTS.—Not later than 180 days after 

the date of enactment of this Act, the Director of the National 

Institutes of Health shall convene a workshop of experts on 

pediatric and older populations to provide input on— 

(A) appropriate age groups to be included in research 

studies involving human subjects; and 

(B) acceptable justifications for excluding participants 

from a range of age groups from human subjects research 

studies. 

(2) POLICY UPDATES.—Not later than 180 days after the 

conclusion of the workshop under paragraph (1), the Director 

of the National Institutes of Health shall make a determination 

with respect to whether the policies of the National Institutes 

of Health on the inclusion of relevant age groups in clinical 

studies need to be updated, and shall update such policies 

as appropriate. In making the determination, the Director of 

the National Institutes of Health shall take into consideration 

whether such policies— 

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 agerelated exclusions in such research. 

(3) PUBLIC AVAILABILITY OF FINDINGS AND CONCLUSIONS.— The Director of the National Institutes of Health shall— 

(A) make the findings and conclusions resulting from 

the workshop under paragraph (1) and updates to policies 

in accordance with paragraph (2), as applicable, available 

to the public on the Internet website of the National 

Institutes of Health; and 

(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service 

Act (42 U.S.C. 283) (as amended by section 2032) are 

made available to the public on the Internet website of 

the National Institutes of Health. 

SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH. 

(a) ESTABLISHMENT.—Not later than 1 year after the date of 

enactment of this Act, the Secretary of Health and Human Services, 

acting through the Director of the National Institutes of Health, 

shall convene a working group under the Advisory Committee to 

the Director of the National Institutes of Health (referred to in 

this section as the ‘‘Advisory Committee’’), appointed under section 

222 of the Public Health Service Act (42 U.S.C. 217a), to develop 

and issue recommendations through the Advisory Committee for 

a formal policy, which may incorporate or be informed by relevant 

existing and ongoing activities, to enhance rigor and reproducibility 

of scientific research funded by the National Institutes of Health. 

(b) CONSIDERATIONS.—In developing and issuing recommendations through the Advisory Committee under subsection (a), the 

working group established under such subsection shall consider, 

as appropriate— 

(1) preclinical experiment design, including analysis of sex 

as a biological variable; 

(2) clinical experiment design, including— 

(A) the diversity of populations studied for clinical 

research, with respect to biological, social, and other determinants of health that contribute to health disparities; 

(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and 

(C) the circumstances under which clinical studies, 

including clinical trials, should conduct an analysis of the 

data collected during the study on the basis of biological, 

social, and other factors that contribute to health disparities; 

(3) applicable levels of rigor in statistical methods, methodology, and analysis; 

(4) data and information sharing in accordance with 

applicable privacy laws and regulations; and 

(5) any other matter the working group determines relevant. 

(c) POLICIES.—Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health 

shall consider the recommendations developed by the working group 

42 USC 282 note. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1069 

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 following: 

‘‘(4) The Director of the Center, in consultation with the Director 

of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection 

(f), shall revise and update the Research Plan periodically, as appropriate, or not less than every 5 years. Not later than 30 days 

after the Research Plan is so revised and updated, the Director 

of the Center shall transmit the revised and updated Research 

Plan to the President, the Committee on Health, Education, Labor, 

and Pensions of the Senate, and the Committee on Energy and 

Commerce of the House of Representatives.’’; and 

(D) by adding at the end the following: 


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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 rehabilitation research and’’ after ‘‘The Coordinating Committee 

shall’’; and 

(B) in paragraph (3), by inserting ‘‘the Director of the 

Division of Program Coordination, Planning, and Strategic 

Initiatives within the Office of the Director of the National 

Institutes of Health,’’ after ‘‘shall be composed of’’; 

(5) in subsection (f)(3)(B)— 

(A) by redesignating clauses (ix) through (xi) as clauses 

(x) through (xii), respectively; and 

(B) by inserting after clause (viii) the following: 

‘‘(ix) The Director of the Division of Program Coordination, 

Planning, and Strategic Initiatives.’’; and 

(6) by adding at the end the following: 

‘‘(g)(1) The Secretary and the heads of other Federal agencies 

shall jointly review the programs carried out (or proposed to be 

carried out) by each such official with respect to medical rehabilitation research and, as appropriate, enter into agreements preventing 

duplication among such programs. 

‘‘(2) The Secretary shall, as appropriate, enter into interagency 

agreements relating to the coordination of medical rehabilitation 

research conducted by agencies of the National Institutes of Health 

and other agencies of the Federal Government. 

‘‘(h) For purposes of this section, the term ‘medical rehabilitation research’ means the science of mechanisms and interventions 

that prevent, improve, restore, or replace lost, underdeveloped, or 

deteriorating function.’’. 

(b) CONFORMING AMENDMENT.—Section 3 of the National 

Institutes of Health Amendments of 1990 (42 U.S.C. 285g–4 note) 

is amended— 

(1) in subsection (a), by striking ‘‘IN GENERAL.—’’; and 

(2) by striking subsection (b). 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1071 

Force on Research Specific to Pregnant Women and Lactating 

Women’’ (in this section referred to as the ‘‘Task Force’’). 

(2) DUTIES.—The Task Force shall provide advice and guidance to the Secretary regarding Federal activities related to 

identifying and addressing gaps in knowledge and research 

regarding safe and effective therapies for pregnant women and 

lactating women, including the development of such therapies 

and the collaboration on and coordination of such activities. 

(3) MEMBERSHIP.— (A) FEDERAL MEMBERS.—The Task Force shall be composed of each of the following Federal members, or the 

designees of such members: 

(i) The Director of the Centers for Disease Control 

and Prevention. 

(ii) The Director of the National Institutes of 

Health, the Director of the Eunice Kennedy Shriver 

National Institute of Child Health and Human 

Development, and the directors of such other appropriate national research institutes. 

(iii) The Commissioner of Food and Drugs. 

(iv) The Director of the Office on Women’s Health. 

(v) The Director of the National Vaccine Program 

Office. 

(vi) The head of any other research-related agency 

or department not described in clauses (i) through 

(v) that the Secretary determines appropriate, which 

may include the Department of Veterans Affairs and 

the Department of Defense. 

(B) NON-FEDERAL MEMBERS.—The Task Force shall be 

composed of each of the following non-Federal members, 

including— 

(i) representatives from relevant medical societies 

with subject matter expertise on pregnant women, lactating women, or children; 

(ii) nonprofit organizations with expertise related 

to the health of women and children; 

(iii) relevant industry representatives; and 

(iv) other representatives, as appropriate. 

(C) LIMITATIONS.—The non-Federal members described 

in subparagraph (B) shall— 

(i) compose not more than one-half, and not less 

than one-third, of the total membership of the Task 

Force; and 

(ii) be appointed by the Secretary. 

(4) TERMINATION.— 

(A) IN GENERAL.—Subject to subparagraph (B), the 

Task Force shall terminate on the date that is 2 years 

after the date on which the Task Force is established 

under paragraph (1). 

(B) EXTENSION.—The Secretary may extend the operation of the Task Force for one additional 2-year period 

following the 2-year period described in subparagraph (A), 

if the Secretary determines that the extension is appropriate for carrying out the purpose of this section. 

(5) MEETINGS.—The Task Force shall meet not less than 

2 times each year and shall convene public meetings, as appropriate, to fulfill its duties under paragraph (2). 


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130 STAT. 1072 PUBLIC LAW 114–255—DEC. 13, 2016 

(6) TASK FORCE REPORT TO CONGRESS.—Not later than 18 

months after the date on which the Task Force is established 

under paragraph (1), the Task Force shall prepare and submit 

to the Secretary, the Committee on Health, Education, Labor, 

and Pensions of the Senate, and the Committee on Energy 

and Commerce of the House of Representatives a report that 

includes each of the following: 

(A) A plan to identify and address gaps in knowledge 

and research regarding safe and effective therapies for 

pregnant women and lactating women, including the 

development of such therapies. 

(B) Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research. 

(C) Effective communication strategies with health care 

providers and the public on information relevant to pregnant women and lactating women. 

(D) Identification of Federal activities, including— 

(i) the state of research on pregnancy and lactation; 

(ii) recommendations for the coordination of, and 

collaboration on research related to pregnant women 

and lactating women; 

(iii) dissemination of research findings and 

information relevant to pregnant women and lactating 

women to providers and the public; and 

(iv) existing Federal efforts and programs to 

improve the scientific understanding of the health 

impacts on pregnant women, lactating women, and 

related birth and pediatric outcomes, including with 

respect to pharmacokinetics, pharmacodynamics, and 

toxicities. 

(E) Recommendations to improve the development of 

safe and effective therapies for pregnant women and lactating women. 

(b) CONFIDENTIALITY.—Nothing in this section shall authorize 

the Secretary of Health and Human Services to disclose any 

information that is a trade secret, or other privileged or confidential 

information, described in section 552(b)(4) of title 5, United States 

Code, or section 1905 of title 18, United States Code. 

(c) UPDATING PROTECTIONS FOR PREGNANT WOMEN AND LACTATING WOMEN IN RESEARCH.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act, the Secretary, considering any recommendations of the Task Force available at such time and 

in consultation with the heads of relevant agencies of the 

Department of Health and Human Services, shall, as appropriate, update regulations and guidance, as applicable, 

regarding the inclusion of pregnant women and lactating 

women in clinical research. 

(2) CRITERIA FOR EXCLUDING PREGNANT OR LACTATING

WOMEN.—In updating any regulations or guidance described 

in paragraph (1), the Secretary shall consider any appropriate 

criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women 

or lactating women as a study population requiring additional 

protections from participating in human subject research. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1073 

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 ‘‘subsections (a) and (b)’’ and inserting ‘‘subsection (a)’’. 

(c) DOCTORAL DEGREES REPORTING.—Section 403C(a)(2) of the 

Public Health Service Act (42 U.S.C. 283a–2(a)(2)) is amended 

by striking ‘‘(not including any leaves of absence)’’. 

(d) VACCINE REPORTING.—Section 404B of the Public Health 

Service Act (42 U.S.C. 283d) is amended— 

(1) by striking subsection (b); and 

(2) by striking ‘‘(a) DEVELOPMENT OF NEW VACCINES.— 

The Secretary’’ and inserting ‘‘The Secretary’’. 

(e) NATIONAL CENTER FOR ADVANCING TRANSLATIONAL

SCIENCES.—Section 479(c) of the Public Health Service Act (42 

U.S.C. 287(c)) is amended— 

(1) in the subsection heading, by striking ‘‘ANNUAL’’ and 

inserting ‘‘BIENNIAL’’; and 

(2) in the matter preceding paragraph (1), by striking ‘‘an 

annual report’’ and inserting ‘‘a report on a biennial basis’’. 

(f) REVIEW OF CENTERS OF EXCELLENCE.— 

(1) REPEAL.—Section 404H of the Public Health Service 

Act (42 U.S.C. 283j) is repealed. 

(2) CONFORMING AMENDMENT.—Section 399EE(c) of the 

Public Health Service Act (42 U.S.C. 280–4(c)) is amended 

by striking ‘‘399CC, 404H,’’ and inserting ‘‘399CC’’. 

(g) RAPID HIV TEST REPORT.—Section 502(a) of the Ryan White 

CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is amended— 

(1) by striking paragraph (2); and 

(2) by redesignating paragraph (3) as paragraph (2). 

(h) NATIONAL INSTITUTE OF NURSING RESEARCH.— 

(1) REPEAL.—Section 464Y of the Public Health Service 

Act (42 U.S.C. 285q–3) is repealed. 

(2) CONFORMING AMENDMENT.—Section 464X(g) of the 

Public Health Service Act (42 U.S.C. 285q–2(g)) is amended 

by striking ‘‘biennial report made under section 464Y,’’ and 

inserting ‘‘triennial report made under section 403’’. 


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130 STAT. 1074 PUBLIC LAW 114–255—DEC. 13, 2016 

SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING 

ORGANISMS. 

Section 301 of the Public Health Service Act (42 U.S.C. 241), 

as amended by section 2035, is further amended— 

(1) in the flush matter at the end of subsection (a)— 

(A) by redesignating such matter as subsection (h)(1); 

and 

(B) by moving such matter so as to appear at the 

end of such section; and 

(2) in subsection (h) (as so redesignated), by adding at 

the end the following: 

‘‘(2) Where research substances and living organisms are made 

available under paragraph (1) through contractors, the Secretary 

may direct such contractors to collect payments on behalf of the 

Secretary for the costs incurred to make available such substances 

and organisms and to forward amounts so collected to the Secretary, 

in the time and manner specified by the Secretary. 

‘‘(3) Amounts collected under paragraph (2) shall be credited 

to the appropriations accounts that incurred the costs to make 

available the research substances and living organisms involved, 

and shall remain available until expended for carrying out activities 

under such accounts.’’. 

SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDERREPRESENTED POPULATIONS IN CLINICAL TRIALS. 

It is the sense of Congress that the National Institute on 

Minority Health and Health Disparities should include within its 

strategic plan under section 402(m) of the Public Health Service 

Act (42 U.S.C. 282(m)) ways to increase representation of underrepresented populations in clinical trials. 

Subtitle E—Advancement of the National 

Institutes of Health Research and Data 

Access 

SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE. 

Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 

282(j)(2)(D)) is amended— 

(1) in clause (ii)(I), by inserting before the semicolon ‘‘, 

unless the responsible party affirmatively requests that the 

Director of the National Institutes of Health publicly post such 

clinical trial information for an applicable device clinical trial 

prior to such date of clearance or approval’’; and 

(2) by adding at the end the following: 

‘‘(iii) OPTION TO MAKE CERTAIN CLINICAL TRIAL

INFORMATION AVAILABLE EARLIER.—The Director of the 

National Institutes of Health shall inform responsible 

parties of the option to request that clinical trial 

information for an applicable device clinical trial be 

publicly posted prior to the date of clearance or 

approval, in accordance with clause (ii)(I). 

‘‘(iv) COMBINATION PRODUCTS.—An applicable clinical trial for a product that is a combination of drug, 

device, or biological product shall be considered— 


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‘‘(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 clinical trial’’ has the meaning given the term in section 402(j) 

of the Public Health Service Act (42 U.S.C. 282(j)). 

(2) SECRETARY.—The term ‘‘Secretary’’ means the Secretary 

of Health and Human Services. 

(b) REPORT ON ACTIVITIES TO ENCOURAGE COMPLIANCE.—Not 

later than 2 years after the date of enactment of this Act, the 

Secretary, acting through the Director of the National Institutes 

of Health and in collaboration with the Commissioner of Food 

and Drugs, shall submit to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, a report that 

describes education and outreach, guidance, enforcement, and other 

activities undertaken to encourage compliance with section 402(j) 

of the Public Health Service Act (42 U.S.C. 282(j)). 

(c) REPORTS ON CLINICAL TRIALS.— 

(1) IN GENERAL.—Not later than 2 years after the final 

compliance date under the final rule implementing section 

402(j) of the Public Health Service Act, and every 2 years 

thereafter for the next 4 years, the Secretary, acting through 

the Director of the National Institutes of Health and in 

collaboration with the Commissioner of Food and Drugs, shall 

submit to the Committee on Health, Education, Labor, and 

Pensions of the Senate and the Committee on Energy and 

Commerce of the House of Representatives, a report 

describing— 

(A) the total number of applicable clinical trials with 

complete data bank registration information registered 

during the period for which the report is being prepared 

(broken down by each year of such reporting period); 

(B) the total number of applicable clinical trials registered during the period for which the report is being 

prepared for which results have been submitted to the 

data bank (broken down by each year of such reporting 

period); 

(C) the activities undertaken by the Secretary to educate responsible persons about data bank registration and 

results submission requirements, including through 

issuance of guidance documents, informational meetings, 

and training sessions; and 

(D) the activities described in the report submitted 

under subsection (b). 

(2) ACTIONS TO ENFORCE COMPLIANCE.—After the Secretary 

has undertaken the educational activities described in paragraph (1)(C), the Secretary shall include in subsequent reports 


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submitted under paragraph (1) the number of actions taken 

by the Secretary during the period for which the report is 

being prepared to enforce compliance with data bank registration and results submission requirements. 

SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA. 

Section 492B(c) of the Public Health Service Act (42 U.S.C. 

289a–2(c)) is amended— 

(1) by striking ‘‘In the case’’ and inserting the following: 

‘‘(1) IN GENERAL.—In the case’’; and 

(2) by adding at the end the following: 

‘‘(2) REPORTING REQUIREMENTS.—For any new and competing project of clinical research subject to the requirements 

under this section that receives a grant award 1 year after 

the date of enactment of the 21st Century Cures Act, or any 

date thereafter, for which a valid analysis is provided under 

paragraph (1)— 

‘‘(A) and which is an applicable clinical trial as defined 

in section 402(j), the entity conducting such clinical 

research shall submit the results of such valid analysis 

to the clinical trial registry data bank expanded under 

section 402(j)(3), and the Director of the National Institutes 

of Health shall, as appropriate, consider whether such 

entity has complied with the reporting requirement 

described in this subparagraph in awarding any future 

grant to such entity, including pursuant to section 

402(j)(5)(A)(ii) when applicable; and 

‘‘(B) the Director of the National Institutes of Health 

shall encourage the reporting of the results of such valid 

analysis described in paragraph (1) through any additional 

means determined appropriate by the Director.’’. 

SEC. 2054. CONSULTATION. 

Not later than 90 days after the date of enactment of this 

Act, the Secretary of Health and Human Services shall consult 

with relevant Federal agencies, including the Food and Drug 

Administration, the Office of the National Coordinator for Health 

Information Technology, and the National Institutes of Health, 

as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to 

enhancements to the clinical trial registry data bank under section 

402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including 

with respect to usability, functionality, and search capability. 

Subtitle F—Facilitating Collaborative 

Research 

SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE 

SYSTEM. 

Part P of title III of the Public Health Service Act (42 U.S.C. 

280g et seq.) is amended by inserting after section 399S the following: 


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‘‘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 coordination with other agencies as the Secretary determines, shall, as 

appropriate— 

‘‘(1) enhance and expand infrastructure and activities to 

track the epidemiology of neurological diseases; and 

‘‘(2) incorporate information obtained through such activities into an integrated surveillance system, which may consist 

of or include a registry, to be known as the National Neurological Conditions Surveillance System. 

‘‘(b) RESEARCH.—The Secretary shall ensure that the National 

Neurological Conditions Surveillance System is designed in a 

manner that facilitates further research on neurological diseases. 

‘‘(c) CONTENT.—In carrying out subsection (a), the Secretary— 

‘‘(1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases 

in the United States; 

‘‘(2) to the extent practicable, shall provide for the collection 

and storage of other available information on neurological diseases, including information related to persons living with 

neurological diseases who choose to participate, such as— 

‘‘(A) demographics, such as age, race, ethnicity, sex, 

geographic location, family history, and other information, 

as appropriate; 

‘‘(B) risk factors that may be associated with neurological diseases, such as genetic and environmental risk 

factors and other information, as appropriate; and 

‘‘(C) diagnosis and progression markers; 

‘‘(3) may provide for the collection and storage of information relevant to analysis on neurological diseases, such as 

information concerning— 

‘‘(A) the natural history of the diseases; 

‘‘(B) the prevention of the diseases; 

‘‘(C) the detection, management, and treatment 

approaches for the diseases; and 

‘‘(D) the development of outcomes measures; 

‘‘(4) may address issues identified during the consultation 

process under subsection (d); and 

‘‘(5) initially may address a limited number of neurological 

diseases. 

‘‘(d) CONSULTATION.—In carrying out this section, the Secretary 

shall consult with individuals with appropriate expertise, which 

may include— 

‘‘(1) epidemiologists with experience in disease surveillance 

or registries; 

‘‘(2) representatives of national voluntary health associations that— 

‘‘(A) focus on neurological diseases; and 

‘‘(B) have demonstrated experience in research, care, 

or patient services; 

‘‘(3) health information technology experts or other information management specialists; 

‘‘(4) clinicians with expertise in neurological diseases; and 

‘‘(5) research scientists with experience conducting 

translational research or utilizing surveillance systems for scientific research purposes. 

42 USC 280g–7a. 


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‘‘(e) GRANTS.—The Secretary may award grants to, or enter 

into contracts or cooperative agreements with, public or private 

nonprofit entities to carry out activities under this section. 

‘‘(f) COORDINATION WITH OTHER FEDERAL, STATE, AND LOCAL

AGENCIES.—Subject to subsection (h), the Secretary shall— 

‘‘(1) make information and analysis in the National Neurological Conditions Surveillance System available, as appropriate— 

‘‘(A) to Federal departments and agencies, such as 

the National Institutes of Health and the Department of 

Veterans Affairs; and 

‘‘(B) to State and local agencies; and 

‘‘(2) identify, build upon, leverage, and coordinate among 

existing data and surveillance systems, surveys, registries, and 

other Federal public health infrastructure, wherever practicable. 

‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary 

shall ensure that information and analysis in the National Neurological Conditions Surveillance System are available, as appropriate, 

to the public, including researchers. 

‘‘(h) PRIVACY.—The Secretary shall ensure that information 

and analysis in the National Neurological Conditions Surveillance 

System are made available only to the extent permitted by 

applicable Federal and State law, and in a manner that protects 

personal privacy, to the extent required by applicable Federal and 

State privacy law, at a minimum. 

‘‘(i) REPORTS.— 

‘‘(1) REPORT ON INFORMATION AND ANALYSES.—Not later 

than 1 year after the date on which any system is established 

under this section, the Secretary shall submit an interim report 

to the Committee on Health, Education, Labor, and Pensions 

of the Senate and the Committee on Energy and Commerce 

of the House of Representatives regarding aggregate information collected pursuant to this section and epidemiological analyses, as appropriate. Such report shall be posted on the Internet 

website of the Department of Health and Human Services 

and shall be updated biennially. 

‘‘(2) IMPLEMENTATION REPORT.—Not later than 4 years after 

the date of the enactment of this section, the Secretary shall 

submit a report to the Congress concerning the implementation 

of this section. Such report shall include information on— 

‘‘(A) the development and maintenance of the National 

Neurological Conditions Surveillance System; 

‘‘(B) the type of information collected and stored in 

the surveillance system; 

‘‘(C) the use and availability of such information, 

including guidelines for such use; and 

‘‘(D) the use and coordination of databases that collect 

or maintain information on neurological diseases. 

‘‘(j) DEFINITION.—In this section, the term ‘national voluntary 

health association’ means a national nonprofit organization with 

chapters, other affiliated organizations, or networks in States 

throughout the United States with experience serving the population of individuals with neurological disease and have demonstrated experience in neurological disease research, care, and 

patient services. 


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‘‘(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 diseases. 

(b) REPORTS.—The Secretary shall ensure that each triennial 

report under section 403 of the Public Health Service Act (42 

U.S.C. 283) (as amended by section 2032) includes information 

on actions undertaken by the National Institutes of Health to 

carry out subsection (a) with respect to tick-borne diseases. 

(c) TICK-BORNE DISEASES WORKING GROUP.— 

(1) ESTABLISHMENT.—The Secretary shall establish a 

working group, to be known as the Tick-Borne Disease Working 

Group (referred to in this section as the ‘‘Working Group’’), 

comprised of representatives of appropriate Federal agencies 

and other non-Federal entities, to provide expertise and to 

review all efforts within the Department of Health and Human 

Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine 

research priorities. 

(2) RESPONSIBILITIES.—The working group shall— 

(A) not later than 2 years after the date of enactment 

of this Act, develop or update a summary of— 

(i) ongoing tick-borne disease research, including 

research related to causes, prevention, treatment, 

surveillance, diagnosis, diagnostics, duration of illness, 

and intervention for individuals with tick-borne diseases; 

(ii) advances made pursuant to such research; 

(iii) Federal activities related to tick-borne diseases, including— 

(I) epidemiological activities related to tickborne diseases; and 

(II) basic, clinical, and translational tick-borne 

disease research related to the pathogenesis, 

prevention, diagnosis, and treatment of tick-borne 

diseases; 

(iv) gaps in tick-borne disease research described 

in clause (iii)(II); 

(v) the Working Group’s meetings required under 

paragraph (4); and 

(vi) the comments received by the Working Group; 

(B) make recommendations to the Secretary regarding 

any appropriate changes or improvements to such activities 

and research; and 

(C) solicit input from States, localities, and nongovernmental entities, including organizations representing 

patients, health care providers, researchers, and industry 

regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms. 

42 USC 284s. 


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(3) MEMBERSHIP.—The members of the working group shall 

represent a diversity of scientific disciplines and views and 

shall be composed of the following members: 

(A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representatives of each of the following: 

(i) The Office of the Assistant Secretary for Health. 

(ii) The Food and Drug Administration. 

(iii) The Centers for Disease Control and Prevention. 

(iv) The National Institutes of Health. 

(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary 

determines appropriate. 

(B) NON–FEDERAL PUBLIC MEMBERS.—Seven non–Federal public members, consisting of representatives of the 

following categories: 

(i) Physicians and other medical providers with 

experience in diagnosing and treating tick-borne diseases. 

(ii) Scientists or researchers with expertise. 

(iii) Patients and their family members. 

(iv) Nonprofit organizations that advocate for 

patients with respect to tick-borne diseases. 

(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. 

(4) MEETINGS.—The Working Group shall meet not less 

than twice each year. 

(5) REPORTING.—Not later than 2 years after the date 

of enactment of this Act, and every 2 years thereafter until 

termination of the Working Group pursuant to paragraph (7), 

the Working Group shall— 

(A) submit a report on its activities under paragraph 

(2)(A) and any recommendations under paragraph (2)(B) 

to the Secretary, the Committee on Energy and Commerce 

of the House of Representatives, and the Committee on 

Health, Education, Labor, and Pensions of the Senate; and 

(B) make such report publicly available on the Internet 

website of the Department of Health and Human Services. 

(6) APPLICABILITY OF FACA.—The Working Group shall be 

treated as an advisory committee subject to the Federal 

Advisory Committee Act (5 U.S.C. App.). 

(7) SUNSET.—The Working Group under this section shall 

terminate 6 years after the date of enactment of this Act. 

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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(1) at a minimum, security and privacy safeguards, consistent with the requirements of the Rule, are maintained by 

the covered entity and the researcher; and 

(2) the protected health information is not copied or otherwise retained by the researcher. 

(b) GUIDANCE RELATED TO STREAMLINING AUTHORIZATION.— Not later than 1 year after the date of enactment of this Act, 

the Secretary shall issue guidance on the following: 

(1) AUTHORIZATION FOR USE AND DISCLOSURE OF HEALTH

INFORMATION.—Clarification of the circumstances under which 

the authorization for the use or disclosure of protected health 

information, with respect to an individual, for future research 

purposes contains a sufficient description of the purpose of 

the use or disclosure, such as if the authorization— 

(A) sufficiently describes the purposes such that it 

would be reasonable for the individual to expect that the 

protected health information could be used or disclosed 

for such future research; 

(B) either— 

(i) states that the authorization will expire on a 

particular date or on the occurrence of a particular 

event; or 

(ii) states that the authorization will remain valid 

unless and until it is revoked by the individual; and 

(C) provides instruction to the individual on how to 

revoke such authorization at any time. 

(2) REMINDER OF THE RIGHT TO REVOKE.—Clarification of 

the circumstances under which it is appropriate to provide 

an individual with an annual notice or reminder that the individual has the right to revoke such authorization. 

(3) REVOCATION OF AUTHORIZATION.—Clarification of appropriate mechanisms by which an individual may revoke an 

authorization for future research purposes, such as described 

in paragraph (1)(C). 

(c) WORKING GROUP ON PROTECTED HEALTH INFORMATION FOR

RESEARCH.— 

(1) ESTABLISHMENT.—Not later than 1 year after the date 

of enactment of this Act, the Secretary shall convene a working 

group to study and report on the uses and disclosures of protected health information for research purposes, under the 

Health Insurance Portability and Accountability Act of 1996 

(Public Law 104–191). 

(2) MEMBERS.—The working group shall include representatives of— 

(A) relevant Federal agencies, including the National 

Institutes of Health, the Centers for Disease Control and 

Prevention, the Food and Drug Administration, and the 

Office for Civil Rights; 

(B) the research community; 

(C) patients; 

(D) experts in civil rights, such as privacy rights; 

(E) developers of health information technology; 

(F) experts in data privacy and security; 

(G) health care providers; 

(H) bioethicists; and 

(I) other experts and entities, as the Secretary determines appropriate. 


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(3) REPORT.—Not later than 1 year after the date on which 

the working group is convened under paragraph (1), the 

working group shall conduct a review and submit a report 

to the Secretary containing recommendations on whether the 

uses and disclosures of protected health information for 

research purposes should be modified to allow protected health 

information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge, 

while protecting individuals’ privacy rights. In conducting the 

review and making recommendations, the working group 

shall— 

(A) address, at a minimum— 

(i) the appropriate manner and timing of 

authorization, including whether additional notification 

to the individual should be required when the individual’s protected health information will be used or disclosed for such research; 

(ii) opportunities for individuals to set preferences 

on the manner in which their protected health information is used in research; 

(iii) opportunities for patients to revoke authorization; 

(iv) notification to individuals of a breach in privacy; 

(v) existing gaps in statute, regulation, or policy 

related to protecting the privacy of individuals, and 

(vi) existing barriers to research related to the 

current restrictions on the uses and disclosures of protected health information; and 

(B) consider, at a minimum— 

(i) expectations and preferences on how an individual’s protected health information is shared and used; 

(ii) issues related to specific subgroups of people, 

such as children, incarcerated individuals, and individuals with a cognitive or intellectual disability 

impacting capacity to consent; 

(iii) relevant Federal and State laws; 

(iv) models of facilitating data access and levels 

of data access, including data segmentation, where 

applicable; 

(v) potential impacts of disclosure and non-disclosure of protected health information on access to health 

care services; and 

(vi) the potential uses of such data. 

(4) REPORT SUBMISSION.—The Secretary shall submit the 

report under paragraph (3) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives, 

and shall post such report on the appropriate Internet website 

of the Department of Health and Human Services. 

(5) TERMINATION.—The working group convened under 

paragraph (1) shall terminate the day after the report under 

paragraph (3) is submitted to Congress and made public in 

accordance with paragraph (4). 

(d) DEFINITIONS.—In this section: 


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(1) THE RULE.—References to ‘‘the Rule’’ refer to part 160 

or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation). 

(2) PART 164.—References to a specified section of ‘‘part 

164’’, refer to such specified section of part 164 of title 45, 

Code of Federal Regulations (or any successor section). 

Subtitle G—Promoting Pediatric Research 

SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK. 

Section 409D(d) of the Public Health Service Act (42 U.S.C. 

284h(d)) is amended— 

(1) in paragraph (1), by striking ‘‘in consultation with the 

Director of the Eunice Kennedy Shriver National Institute of 

Child Health and Human Development and in collaboration 

with other appropriate national research institutes and national 

centers that carry out activities involving pediatric research, 

may provide for the establishment of’’ and inserting ‘‘in 

collaboration with the national research institutes and national 

centers that carry out activities involving pediatric research, 

shall support’’; and 

(2) in paragraph (2)(A) and the first sentence of paragraph 

(2)(E), by striking ‘‘may’’ each place such term appears and 

inserting ‘‘shall’’. 

SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK. 

It is the sense of Congress that— 

(1) the National Institutes of Health should encourage a 

global pediatric clinical study network by providing grants, 

contracts, or cooperative agreements to support new and early 

stage investigators who participate in the global pediatric clinical study network; 

(2) the Secretary of Health and Human Services (referred 

to in this section as the ‘‘Secretary’’) should engage with clinical 

investigators and appropriate authorities outside of the United 

States, including authorities in the European Union, during 

the formation of the global pediatric clinical study network 

to encourage the participation of such investigator and authorities; and 

(3) once a global pediatric clinical study network is established and becomes operational, the Secretary should continue 

to encourage and facilitate the participation of clinical investigators and appropriate authorities outside of the United 

States, including in the European Union, to participate in the 

network with the goal of enhancing the global reach of the 

network. 

TITLE III—DEVELOPMENT 

Subtitle A—Patient-Focused Drug 

Development 

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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(1) in subsection (a)— 

(A) in the subsection heading, by striking ‘‘IN GENERAL’’ 

and inserting ‘‘PATIENT ENGAGEMENT IN DRUGS AND

DEVICES’’; 

(B) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving such subparagraphs 2 ems to the right; and 

(C) by striking ‘‘The Secretary’’ and inserting the following: 

‘‘(1) IN GENERAL.—The Secretary’’; 

(2) by redesignating subsections (b) through (e) as paragraphs (2) through (5), respectively, and moving such paragraphs 2 ems to the right; and 

(3) by adding at the end the following: 

‘‘(b) STATEMENT OF PATIENT EXPERIENCE.— 

‘‘(1) IN GENERAL.—Following the approval of an application 

that was submitted under section 505(b) of this Act or section 

351(a) of the Public Health Service Act at least 180 days 

after the date of enactment of the 21st Century Cures Act, 

the Secretary shall make public a brief statement regarding 

the patient experience data and related information, if any, 

submitted and reviewed as part of such application. 

‘‘(2) DATA AND INFORMATION.—The data and information 

referred to in paragraph (1) are— 

‘‘(A) patient experience data; 

‘‘(B) information on patient-focused drug development 

tools; and 

‘‘(C) other relevant information, as determined by the 

Secretary. 

‘‘(c) PATIENT EXPERIENCE DATA.—For purposes of this section, 

the term ‘patient experience data’ includes data that— 

‘‘(1) are collected by any persons (including patients, family 

members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug 

manufacturers); and 

‘‘(2) are intended to provide information about patients’ 

experiences with a disease or condition, including— 

‘‘(A) the impact of such disease or condition, or a related 

therapy, on patients’ lives; and 

‘‘(B) patient preferences with respect to treatment of 

such disease or condition.’’. 

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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(b) PATIENT EXPERIENCE DATA.—For purposes of this section, 

the term ‘‘patient experience data’’ has the meaning given such 

term in section 569C of the Federal Food, Drug, and Cosmetic 

Act (as added by section 3001). 

(c) CONTENTS.—The guidance documents described in subsection (a) shall address— 

(1) methodological approaches that a person seeking to 

collect patient experience data for submission to, and proposed 

use by, the Secretary in regulatory decisionmaking may use, 

that are relevant and objective and ensure that such data 

are accurate and representative of the intended population, 

including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis; 

(2) methodological approaches that may be used to develop 

and identify what is most important to patients with respect 

to burden of disease, burden of treatment, and the benefits 

and risks in the management of the patient’s disease; 

(3) approaches to identifying and developing methods to 

measure impacts to patients that will help facilitate collection 

of patient experience data in clinical trials; 

(4) methodologies, standards, and technologies to collect 

and analyze clinical outcome assessments for purposes of regulatory decisionmaking; 

(5) how a person seeking to develop and submit proposed 

draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance 

to the Secretary; 

(6) the format and content required for submissions under 

this section to the Secretary, including with respect to the 

information described in paragraph (1); 

(7) how the Secretary intends to respond to submissions 

of information described in paragraph (1), if applicable, 

including any timeframe for response when such submission 

is not part of a regulatory application or other submission 

that has an associated timeframe for response; and 

(8) how the Secretary, if appropriate, anticipates using 

relevant patient experience data and related information, 

including with respect to the structured risk-benefit assessment 

framework described in section 505(d) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory 

decisionmaking. 

SEC. 3003. STREAMLINING PATIENT INPUT. 

Chapter 35 of title 44, United States Code, shall not apply 

to the collection of information to which a response is voluntary, 

that is initiated by the Secretary under section 569C of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended 

by section 3001) or section 3002. 

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 accordance with this section. 

‘‘(2) ACCEPTANCE AND REVIEW OF SUBMISSIONS.— 

‘‘(A) IN GENERAL.—Subparagraphs (B), (C), and (D) 

shall apply with respect to the treatment of a letter of 

intent, a qualification plan, or a full qualification package 

submitted under paragraph (1) (referred to in this paragraph as ‘qualification submissions’). 

‘‘(B) ACCEPTANCE FACTORS; NONACCEPTANCE.—The Secretary shall determine whether to accept a qualification 

submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall 

not be construed as a final determination by the Secretary 

under this section regarding the qualification of a drug 

development tool for its proposed context of use. 

‘‘(C) PRIORITIZATION OF QUALIFICATION REVIEW.—The 

Secretary may prioritize the review of a full qualification 

package submitted under paragraph (1) with respect to 

a drug development tool, based on factors determined 

appropriate by the Secretary, including— 

‘‘(i) as applicable, the severity, rarity, or prevalence 

of the disease or condition targeted by the drug 

21 USC 357. 


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development tool and the availability or lack of alternative treatments for such disease or condition; and 

‘‘(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority. 

‘‘(D) ENGAGEMENT OF EXTERNAL EXPERTS.—The Secretary may, for purposes of the review of qualification 

submissions, through the use of cooperative agreements, 

grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review 

of any qualification plan submitted under paragraph (1) 

or the review of any full qualification package under paragraph (3). 

‘‘(3) REVIEW OF FULL QUALIFICATION PACKAGE.—The Secretary shall— 

‘‘(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and 

‘‘(B) determine whether the drug development tool at 

issue is qualified for its proposed context of use. 

‘‘(4) QUALIFICATION.—The Secretary shall determine 

whether a drug development tool is qualified for a proposed 

context of use based on the scientific merit of a full qualification 

package reviewed under paragraph (3). 

‘‘(b) EFFECT OF QUALIFICATION.— 

‘‘(1) IN GENERAL.—A drug development tool determined 

to be qualified under subsection (a)(4) for a proposed context 

of use specified by the requestor may be used by any person 

in such context of use for the purposes described in paragraph 

(2). 

‘‘(2) USE OF A DRUG DEVELOPMENT TOOL.—Subject to paragraph (3), a drug development tool qualified under this section 

may be used for— 

‘‘(A) supporting or obtaining approval or licensure (as 

applicable) of a drug or biological product (including in 

accordance with section 506(c)) under section 505 of this 

Act or section 351 of the Public Health Service Act; or 

‘‘(B) supporting the investigational use of a drug or 

biological product under section 505(i) of this Act or section 

351(a)(3) of the Public Health Service Act. 

‘‘(3) RESCISSION OR MODIFICATION.— 

‘‘(A) IN GENERAL.—The Secretary may rescind or 

modify a determination under this section to qualify a 

drug development tool if the Secretary determines that 

the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a 

determination may be based on new information that calls 

into question the basis for such qualification. 

‘‘(B) MEETING FOR REVIEW.—If the Secretary rescinds 

or modifies under subparagraph (A) a determination to 

qualify a drug development tool, the requestor involved 

shall, on request, be granted a meeting with the Secretary 

to discuss the basis of the Secretary’s decision to rescind 

or modify the determination before the effective date of 

the rescission or modification. 

‘‘(c) TRANSPARENCY.— 


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130 STAT. 1088 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(1) IN GENERAL.—Subject to paragraph (3), the Secretary 

shall make publicly available, and update on at least a biannual 

basis, on the Internet website of the Food and Drug Administration the following: 

‘‘(A) Information with respect to each qualification 

submission under the qualification process under subsection (a), including— 

‘‘(i) the stage of the review process applicable to 

the submission; 

‘‘(ii) the date of the most recent change in stage 

status; 

‘‘(iii) whether external scientific experts were utilized in the development of a qualification plan or 

the review of a full qualification package; and 

‘‘(iv) submissions from requestors under the qualification process under subsection (a), including any 

data and evidence contained in such submissions, and 

any updates to such submissions. 

‘‘(B) The Secretary’s formal written determinations in 

response to such qualification submissions. 

‘‘(C) Any rescissions or modifications under subsection 

(b)(3) of a determination to qualify a drug development 

tool. 

‘‘(D) Summary reviews that document conclusions and 

recommendations for determinations to qualify drug 

development tools under subsection (a). 

‘‘(E) A comprehensive list of— 

‘‘(i) all drug development tools qualified under subsection (a); and 

‘‘(ii) all surrogate endpoints which were the basis 

of approval or licensure (as applicable) of a drug or 

biological product (including in accordance with section 

506(c)) under section 505 of this Act or section 351 

of the Public Health Service Act. 

‘‘(2) RELATION TO TRADE SECRETS ACT.—Information made 

publicly available by the Secretary under paragraph (1) shall 

be considered a disclosure authorized by law for purposes of 

section 1905 of title 18, United States Code. 

‘‘(3) APPLICABILITY.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information 

contained in an application submitted under section 505 of 

this Act or section 351 of the Public Health Service Act that 

is confidential commercial or trade secret information subject 

to section 552(b)(4) of title 5, United States Code, or section 

1905 of title 18, United States Code. 

‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed— 

‘‘(1) to alter the standards of evidence under subsection 

(c) or (d) of section 505, including the substantial evidence 

standard in such subsection (d), or under section 351 of the 

Public Health Service Act (as applicable); or 

‘‘(2) to limit the authority of the Secretary to approve 

or license products under this Act or the Public Health Service 

Act, as applicable (as in effect before the date of the enactment 

of the 21st Century Cures Act). 

‘‘(e) DEFINITIONS.—In this section: 

‘‘(1) BIOMARKER.—The term ‘biomarker’— 


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‘‘(A) means a characteristic (such as a physiologic, 

pathologic, or anatomic characteristic or measurement) that 

is objectively measured and evaluated as an indicator of 

normal biologic processes, pathologic processes, or biological 

responses to a therapeutic intervention; and 

‘‘(B) includes a surrogate endpoint. 

‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The term ‘biomedical research consortia’ means collaborative groups that 

may take the form of public-private partnerships and may 

include government agencies, institutions of higher education 

(as defined in section 101(a) of the Higher Education Act of 

1965), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and 

individuals. 

‘‘(3) CLINICAL OUTCOME ASSESSMENT.—The term ‘clinical 

outcome assessment’ means— 

‘‘(A) a measurement of a patient’s symptoms, overall 

mental state, or the effects of a disease or condition on 

how the patient functions; and 

‘‘(B) includes a patient-reported outcome. 

‘‘(4) CONTEXT OF USE.—The term ‘context of use’ means, 

with respect to a drug development tool, the circumstances 

under which the drug development tool is to be used in drug 

development and regulatory review. 

‘‘(5) DRUG DEVELOPMENT TOOL.—The term ‘drug development tool’ includes— 

‘‘(A) a biomarker; 

‘‘(B) a clinical outcome assessment; and 

‘‘(C) any other method, material, or measure that the 

Secretary determines aids drug development and regulatory review for purposes of this section. 

‘‘(6) PATIENT-REPORTED OUTCOME.—The term ‘patientreported outcome’ means a measurement based on a report 

from a patient regarding the status of the patient’s health 

condition without amendment or interpretation of the patient’s 

report by a clinician or any other person. 

‘‘(7) QUALIFICATION.—The terms ‘qualification’ and ‘qualified’ mean a determination by the Secretary that a drug 

development tool and its proposed context of use can be relied 

upon to have a specific interpretation and application in drug 

development and regulatory review under this Act. 

‘‘(8) REQUESTOR.—The term ‘requestor’ means an entity 

or entities, including a drug sponsor or a biomedical research 

consortia, seeking to qualify a drug development tool for a 

proposed context of use under this section. 

‘‘(9) SURROGATE ENDPOINT.—The term ‘surrogate endpoint’ 

means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not 

itself a direct measurement of clinical benefit, and— 

‘‘(A) is known to predict clinical benefit and could be 

used to support traditional approval of a drug or biological 

product; or 

‘‘(B) is reasonably likely to predict clinical benefit and 

could be used to support the accelerated approval of a 

drug or biological product in accordance with section 

506(c).’’. 

(b) GUIDANCE.— 21 USC 357 note. 


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130 STAT. 1090 PUBLIC LAW 114–255—DEC. 13, 2016 

(1) IN GENERAL.—The Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) shall, 

in consultation with biomedical research consortia (as defined 

in subsection (e) of section 507 of the Federal Food, Drug, 

and Cosmetic Act (as added by subsection (a)) and other 

interested parties through a collaborative public process, issue 

guidance to implement such section 507 that— 

(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the 

development of biomarkers delineated under the taxonomy 

established under paragraph (3); 

(B) with respect to the qualification process under such 

section 507— 

(i) describes the requirements that entities seeking 

to qualify a drug development tool under such section 

shall observe when engaging in such process; 

(ii) outlines reasonable timeframes for the Secretary’s review of letters, qualification plans, or full 

qualification packages submitted under such process; 

and 

(iii) establishes a process by which such entities 

or the Secretary may consult with biomedical research 

consortia and other individuals and entities with expert 

knowledge and insights that may assist the Secretary 

in the review of qualification plans and full qualification submissions under such section; and 

(C) includes such other information as the Secretary 

determines appropriate. 

(2) TIMING.—Not later than 3 years after the date of the 

enactment of this Act, the Secretary shall issue draft guidance 

under paragraph (1) on the implementation of section 507 of 

the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). The Secretary shall issue final guidance on the 

implementation of such section not later than 6 months after 

the date on which the comment period for the draft guidance 

closes. 

(3) TAXONOMY.— 

(A) IN GENERAL.—For purposes of informing guidance 

under this subsection, the Secretary shall, in consultation 

with biomedical research consortia and other interested 

parties through a collaborative public process, establish 

a taxonomy for the classification of biomarkers (and related 

scientific concepts) for use in drug development. 

(B) PUBLIC AVAILABILITY.—Not later than 2 years after 

the date of the enactment of this Act, the Secretary shall 

make such taxonomy publicly available in draft form for 

public comment. The Secretary shall finalize the taxonomy 

not later than 1 year after the close of the public comment 

period. 

(c) MEETING AND REPORT.— 

(1) MEETING.—Not later than 2 years after the date of 

the enactment of this Act, the Secretary shall convene a public 

meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug, 

and Cosmetic Act, as added by subsection (a). 


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(2) REPORT.—Not later than 5 years after the date of the 

enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the 

qualification process under section 507 of the Federal Food, 

Drug, and Cosmetic Act, as added by subsection (a), information 

on— 

(A) the number of requests submitted, as a letter of 

intent, for qualification of a drug development tool (as 

defined in subsection (e) of such section 507); 

(B) the number of such requests accepted and determined to be eligible for submission of a qualification plan 

or full qualification package (as such terms are defined 

in subsection (e) of such section 507), respectively; 

(C) the number of such requests for which external 

scientific experts were utilized in the development of a 

qualification plan or review of a full qualification package; 

(D) the number of qualification plans and full qualification packages, respectively, submitted to the Secretary; 

and 

(E) the drug development tools qualified through such 

qualification process, specified by type of tool, such as 

a biomarker or clinical outcome assessment (as such terms 

are defined in subsection (e) of such section 507). 

SEC. 3012. TARGETED DRUGS FOR RARE DISEASES. 

Subchapter B of chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by inserting 

after section 529 the following: 

‘‘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 genetically targeted technology as the drug or drugs that are the subject 

21 USC 360ff–1. 


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of an application or applications described in paragraph (2) or 

for a variant protein targeted drug that is the same or incorporates 

or utilizes the same variant protein targeted drug, as the drug 

or drugs that are the subject of an application or applications 

described in paragraph (2). 

‘‘(c) DEFINITIONS.—For purposes of this section— 

‘‘(1) the term ‘genetically targeted drug’ means a drug 

that— 

‘‘(A) is the subject of an application under section 

505(b)(1) of this Act or section 351(a) of the Public Health 

Service Act for the treatment of a rare disease or condition 

(as such term is defined in section 526) that is serious 

or life-threatening; 

‘‘(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene 

or its associated gene product; and 

‘‘(C) incorporates or utilizes a genetically targeted technology; 

‘‘(2) the term ‘genetically targeted technology’ means a 

technology comprising non-replicating nucleic acid or analogous 

compounds with a common or similar chemistry that is intended 

to treat one or more patient subgroups, including subgroups 

of patients with different mutations of a gene, with the same 

disease or condition, including a disease or condition due to 

other variants in the same gene; and 

‘‘(3) the term ‘variant protein targeted drug’ means a drug 

that— 

‘‘(A) is the subject of an application under section 

505(b)(1) of this Act or section 351(a) of the Public Health 

Service Act for the treatment of a rare disease or condition 

(as such term is defined in section 526) that is serious 

or life-threatening; 

‘‘(B) modulates the function of a product of a mutated 

gene where such mutation is responsible in whole or in 

part for a given disease or condition; and 

‘‘(C) is intended to treat one or more patient subgroups, 

including subgroups of patients with different mutations 

of a gene, with the same disease or condition. 

‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to— 

‘‘(1) alter the authority of the Secretary to approve drugs 

pursuant to this Act or section 351 of the Public Health Service 

Act (as authorized prior to the date of enactment of the 21st 

Century Cures Act), including the standards of evidence, and 

applicable conditions, for approval under such applicable Act; 

or 

‘‘(2) confer any new rights, beyond those authorized under 

this Act or the Public Health Service Act prior to enactment 

of this section, with respect to the permissibility of a sponsor 

referencing information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) 

of the Public Health Service Act.’’. 


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SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES. 

(a) IN GENERAL.—Section 529(b) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) and inserting the following: 

‘‘(5) TERMINATION OF AUTHORITY.—The Secretary may not 

award any priority review vouchers under paragraph (1) after 

September 30, 2020, unless the rare pediatric disease product 

application— 

‘‘(A) is for a drug that, not later than September 30, 

2020, is designated under subsection (d) as a drug for 

a rare pediatric disease; and 

‘‘(B) is, not later than September 30, 2022, approved 

under section 505(b)(1) of this Act or section 351(a) of 

the Public Health Service Act.’’. 

(b) REPORT.—The Advancing Hope Act of 2016 (Public Law 

114–229) is amended by striking section 3. 

SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS. 

(a) STUDY.—The Comptroller General of the United States 

(referred to in this section as the ‘‘Comptroller General’’) shall 

conduct a study addressing the effectiveness and overall impact 

of the following priority review voucher programs, including any 

such programs amended or established by this Act: 

(1) The neglected tropical disease priority review voucher 

program under section 524 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360n). 

(2) The rare pediatric disease priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff). 

(3) The medical countermeasure priority review voucher 

program under section 565A of the Federal Food, Drug, and 

Cosmetic Act, as added by section 3086. 

(b) ISSUANCE OF REPORT.—Not later than January 31, 2020, 

the Comptroller General shall submit to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives a report 

containing the results of the study under subsection (a). 

(c) CONTENTS OF REPORTS.—The report submitted under subsection (b) shall address— 

(1) for each drug for which a priority review voucher has 

been awarded as of initiation of the study— 

(A) the indications for which the drug is approved 

under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application 

under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 

262(a)); 

(B) whether, and to what extent, the voucher impacted 

the sponsor’s decision to develop the drug; and 

(C) whether, and to what extent, the approval or licensure of the drug, as applicable and appropriate— 

(i) addressed a global unmet need related to the 

treatment or prevention of a neglected tropical disease, 

including whether the sponsor of a drug coordinated 

with international development organizations; 


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(ii) addressed an unmet need related to the treatment of a rare pediatric disease; or 

(iii) affected the Nation’s preparedness against a 

chemical, biological, radiological, or nuclear threat, 

including naturally occurring threats; 

(2) for each drug for which a priority review voucher has 

been used— 

(A) the indications for which such drug is approved 

under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application 

under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 

262); 

(B) the value of the voucher, if transferred; and 

(C) the length of time between the date on which 

the voucher was awarded and the date on which the 

voucher was used; and 

(3) an analysis of the priority review voucher programs 

described in subsection (a), including— 

(A) the resources used by the Food and Drug Administration in reviewing drugs for which vouchers were used, 

including the effect of the programs on the Food and Drug 

Administration’s review of drugs for which priority review 

vouchers were not awarded or used; 

(B) whether any improvements to such programs are 

necessary to appropriately target incentives for the development of drugs that would likely not otherwise be developed, 

or developed in as timely a manner, and, as applicable 

and appropriate— 

(i) address global unmet needs related to the treatment or prevention of neglected tropical diseases, 

including in countries in which neglected tropical diseases are endemic; or 

(ii) address unmet needs related to the treatment 

of rare pediatric diseases; and 

(C) whether the sunset of the rare pediatric disease 

program and medical countermeasure program has had 

an impact on the program, including any potential unintended consequences. 

(d) PROTECTION OF NATIONAL SECURITY.—The Comptroller General shall conduct the study and issue reports under this section 

in a manner that does not compromise national security. 

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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‘‘(C) prospectively planned and designed observational 

studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition 

and in the development of a therapy, including studies 

and analyses to— 

‘‘(i) develop or validate a drug development tool 

related to a rare disease or condition; or 

‘‘(ii) understand the full spectrum of the disease 

manifestations, including describing genotypic and 

phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition.’’. 

SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING. 

(a) IN GENERAL.—The Secretary of Health and Human Services 

may award grants to institutions of higher education and nonprofit 

organizations for the purpose of studying and recommending 

improvements to the process of continuous manufacturing of drugs 

and biological products and similar innovative monitoring and control techniques. 

(b) DEFINITIONS.—In this section— 

(1) the term ‘‘drug’’ has the meaning given such term 

in section 201 of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 321); 

(2) the term ‘‘biological product’’ has the meaning given 

such term in section 351(i) of the Public Health Service Act 

(42 U.S.C. 262(i)); and 

(3) the term ‘‘institution of higher education’’ has the 

meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)). 

Subtitle C—Modern Trial Design and 

Evidence Development 

SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS. 

(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 guidance addressing the use of complex adaptive and other novel 

trial design in the development and regulatory review and 

approval or licensure for drugs and biological products. 

(2) CONTENTS.—The guidance under paragraph (1) shall 

address— 

21 USC 355 note. 

21 USC 399h. 


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(A) the use of complex adaptive and other novel trial 

designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard 

under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)); 

(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to— 

(i) completion of such modeling or simulations; 

or 

(ii) the submission of resulting information to the 

Secretary; 

(C) the types of quantitative and qualitative information that should be submitted for review; and 

(D) recommended analysis methodologies. 

(3) PUBLIC MEETING.—Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult 

with stakeholders, including representatives of regulated 

industry, academia, patient advocacy organizations, consumer 

groups, and disease research foundations, through a public 

meeting to be held not later than 18 months after the date 

of enactment of this Act. 

(4) TIMING.—The Secretary shall update or issue a draft 

version of the guidance required by paragraph (1) not later 

than 18 months after the date of the public meeting required 

by paragraph (3) and finalize such guidance not later than 

1 year after the date on which the public comment period 

for the draft guidance closes. 

SEC. 3022. REAL WORLD EVIDENCE. 

Chapter V of the Federal Food, Drug, and Cosmetic Act is 

amended by inserting after section 505E (21 U.S.C. 355f) the following: 

‘‘SEC. 505F. UTILIZING REAL WORLD EVIDENCE. 

‘‘(a) IN GENERAL.—The Secretary shall establish a program 

to evaluate the potential use of real world evidence— 

‘‘(1) to help to support the approval of a new indication 

for a drug approved under section 505(c); and 

‘‘(2) to help to support or satisfy postapproval study requirements. 

‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this section, the term 

‘real world evidence’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than 

randomized clinical trials. 

‘‘(c) PROGRAM FRAMEWORK.— 

‘‘(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of the 21st Century Cures Act, the Secretary 

shall establish a draft framework for implementation of the 

program under this section. 

‘‘(2) CONTENTS OF FRAMEWORK.—The framework shall 

include information describing— 

‘‘(A) the sources of real world evidence, including 

ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research 

activities; 

‘‘(B) the gaps in data collection activities; 

21 USC 355g. 


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‘‘(C) the standards and methodologies for collection 

and analysis of real world evidence; and 

‘‘(D) the priority areas, remaining challenges, and 

potential pilot opportunities that the program established 

under this section will address. 

‘‘(3) CONSULTATION.— ‘‘(A) IN GENERAL.—In developing the program framework under this subsection, the Secretary shall consult 

with regulated industry, academia, medical professional 

organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties. 

‘‘(B) PROCESS.—The consultation under subparagraph 

(A) may be carried out through approaches such as— 

‘‘(i) a public-private partnership with the entities 

described in such subparagraph in which the Secretary 

may participate; 

‘‘(ii) a contract, grant, or other arrangement, as 

the Secretary determines appropriate, with such a 

partnership or an independent research organization; 

or 

‘‘(iii) public workshops with the entities described 

in such subparagraph. 

‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary shall, not later 

than 2 years after the date of enactment of the 21st Century 

Cures Act and in accordance with the framework established under 

subsection (c), implement the program to evaluate the potential 

use of real world evidence. 

‘‘(e) GUIDANCE FOR INDUSTRY.—The Secretary shall— 

‘‘(1) utilize the program established under subsection (a), 

its activities, and any subsequent pilots or written reports, 

to inform a guidance for industry on— 

‘‘(A) the circumstances under which sponsors of drugs 

and the Secretary may rely on real world evidence for 

the purposes described in paragraphs (1) and (2) of subsection (a); and 

‘‘(B) the appropriate standards and methodologies for 

collection and analysis of real world evidence submitted 

for such purposes; 

‘‘(2) not later than 5 years after the date of enactment 

of the 21st Century Cures Act, issue draft guidance for industry 

as described in paragraph (1); and 

‘‘(3) not later than 18 months after the close of the public 

comment period for the draft guidance described in paragraph 

(2), issue revised draft guidance or final guidance. 

‘‘(f) RULE OF CONSTRUCTION.— 

‘‘(1) IN GENERAL.—Subject to paragraph (2), nothing in 

this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the 

Secretary determines that sufficient basis exists for any such 

nonspecified use. 

‘‘(2) STANDARDS OF EVIDENCE AND SECRETARY’S

AUTHORITY.—This section shall not be construed to alter— 

‘‘(A) the standards of evidence under— 

‘‘(i) subsection (c) or (d) of section 505, including 

the substantial evidence standard in such subsection 

(d); or 


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‘‘(ii) section 351(a) of the Public Health Service 

Act; or 

‘‘(B) the Secretary’s authority to require postapproval 

studies or clinical trials, or the standards of evidence under 

which studies or trials are evaluated.’’. 

SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS. 

(a) IN GENERAL.—In order to simplify and facilitate compliance 

by researchers with applicable regulations for the protection of 

human subjects in research, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) shall, to 

the extent practicable and consistent with other statutory provisions, harmonize differences between the HHS Human Subject 

Regulations and the FDA Human Subject Regulations in accordance 

with subsection (b). 

(b) AVOIDING REGULATORY DUPLICATION AND UNNECESSARY

DELAYS.—The Secretary shall, as appropriate— 

(1) make such modifications to the provisions of the HHS 

Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary— 

(A) to reduce regulatory duplication and unnecessary 

delays; 

(B) to modernize such provisions in the context of 

multisite and cooperative research projects; and 

(C) to protect vulnerable populations, incorporate local 

considerations, and support community engagement 

through mechanisms such as consultation with local 

researchers and human research protection programs, in 

a manner consistent with subparagraph (B); and 

(2) ensure that human subject research that is subject 

to the HHS Human Subject Regulations and to the FDA Human 

Subject Regulations may— 

(A) use joint or shared review; 

(B) rely upon the review of— 

(i) an independent institutional review board; or 

(ii) an institutional review board of an entity other 

than the sponsor of the research; or 

(C) use similar arrangements to avoid duplication of 

effort. 

(c) CONSULTATION.—In harmonizing or modifying regulations 

or guidance under this section, the Secretary shall consult with 

stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology, 

and medical device developers, clinical research organizations, 

patient groups, and others). 

(d) TIMING.—The Secretary shall complete the harmonization 

described in subsection (a) not later than 3 years after the date 

of enactment of this Act. 

(e) PROGRESS REPORT.—Not later than 2 years after the date 

of enactment of this Act, the Secretary shall submit to Congress 

a report on the progress made toward completing such harmonization. 

(f) DEFINITIONS.— 

(1) HUMAN SUBJECT REGULATIONS.—In this section: 

(A) FDA HUMAN SUBJECT REGULATIONS.—The term 

‘‘FDA Human Subject Regulations’’ means the provisions 

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 Regulations (or any successor regulations). 

(C) VULNERABLE POPULATION RULES.—The term 

‘‘vulnerable population rules’’ means— 

(i) except in the case of research described in clause 

(ii), the provisions of subparts B through D of part 

46, Code of Federal Regulations (or any successor regulations); and 

(ii) in the case of research that is subject to FDA 

Human Subject Regulations, the provisions applicable 

to vulnerable populations under part 56 of title 21, 

Code of Federal Regulations (or any successor regulations) and subpart D of part 50 of such title 21 (or 

any successor regulations). 

(2) INSTITUTIONAL REVIEW BOARD DEFINED.—In this section, 

the term ‘‘institutional review board’’ has the meaning that 

applies to the term ‘‘institutional review board’’ under the HHS 

Human Subject Regulations. 

SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS. 

(a) DEVICES.—Section 520(g)(3) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended— 

(1) in subparagraph (D), by striking ‘‘except where subject 

to such conditions as the Secretary may prescribe, the investigator’’ and inserting the following: ‘‘except where, subject to 

such conditions as the Secretary may prescribe— 

‘‘(i) the proposed clinical testing poses no more than 

minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare 

of the human subject; or 

‘‘(ii) the investigator’’; and 

(2) in the matter following subparagraph (D), by striking 

‘‘subparagraph (D)’’ and inserting ‘‘subparagraph (D)(ii)’’. 

(b) DRUGS.—Section 505(i)(4) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ‘‘except 

where it is not feasible or it is contrary to the best interests 

of such human beings’’ and inserting ‘‘except where it is not feasible, 

it is contrary to the best interests of such human beings, or the 

proposed clinical testing poses no more than minimal risk to such 

human beings and includes appropriate safeguards as prescribed 

to protect the rights, safety, and welfare of such human beings’’. 

Subtitle D—Patient Access to Therapies 

and Information 

SEC. 3031. SUMMARY LEVEL REVIEW. 

(a) FFDCA.—Section 505(c) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the end 

the following: 

‘‘(5)(A) The Secretary may rely upon qualified data summaries 

to support the approval of a supplemental application, with respect 


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to a qualified indication for a drug, submitted under subsection 

(b), if such supplemental application complies with subparagraph 

(B). 

‘‘(B) A supplemental application is eligible for review as 

described in subparagraph (A) only if— 

‘‘(i) there is existing data available and acceptable to the 

Secretary demonstrating the safety of the drug; and 

‘‘(ii) all data used to develop the qualified data summaries 

are submitted to the Secretary as part of the supplemental 

application. 

‘‘(C) The Secretary shall post on the Internet website of the 

Food and Drug Administration and update annually— 

‘‘(i) the number of applications reviewed solely under 

subparagraph (A) or section 351(a)(2)(E) of the Public Health 

Service Act; 

‘‘(ii) the average time for completion of review under 

subparagraph (A) or section 351(a)(2)(E) of the Public Health 

Service Act; 

‘‘(iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under 

subparagraph (A) or section 351(a)(2)(E) of the Public Health 

Service Act; and 

‘‘(iv) the number of applications reviewed under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service 

Act for which the Secretary made use of full data sets in 

addition to the qualified data summary. 

‘‘(D) In this paragraph— 

‘‘(i) the term ‘qualified indication’ means an indication for 

a drug that the Secretary determines to be appropriate for 

summary level review under this paragraph; and 

‘‘(ii) the term ‘qualified data summary’ means a summary 

of clinical data that demonstrates the safety and effectiveness 

of a drug with respect to a qualified indication.’’. 

(b) PHSA.—Section 351(a)(2) of the Public Health Service Act 

(42 U.S.C. 262(a)(2)) is amended by adding at the end the following: 

‘‘(E)(i) The Secretary may rely upon qualified data summaries 

to support the approval of a supplemental application, with respect 

to a qualified indication for a drug, submitted under this subsection, 

if such supplemental application complies with the requirements 

of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, 

and Cosmetic Act. 

‘‘(ii) In this subparagraph, the terms ‘qualified indication’ and 

‘qualified data summary’ have the meanings given such terms in 

section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.’’. 

SEC. 3032. EXPANDED ACCESS POLICY. 

Chapter V of the Federal Food, Drug, and Cosmetic Act is 

amended by inserting after section 561 (21 U.S.C. 360bbb) the 

following: 

‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS. 

‘‘(a) IN GENERAL.—The manufacturer or distributor of one or 

more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make 

available the policy of the manufacturer or distributor on evaluating 

and responding to requests submitted under section 561(b) for provision of such a drug. 

21 USC 

360bbb–0. 


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‘‘(b) PUBLIC AVAILABILITY OF EXPANDED ACCESS POLICY.—The 

policies under subsection (a) shall be made public and readily 

available, such as by posting such policies on a publicly available 

Internet website. Such policies may be generally applicable to all 

investigational drugs of such manufacturer or distributor. 

‘‘(c) CONTENT OF POLICY.—A policy described in subsection (a) 

shall include— 

‘‘(1) contact information for the manufacturer or distributor 

to facilitate communication about requests described in subsection (a); 

‘‘(2) procedures for making such requests; 

‘‘(3) the general criteria the manufacturer or distributor 

will use to evaluate such requests for individual patients, and 

for responses to such requests; 

‘‘(4) the length of time the manufacturer or distributor 

anticipates will be necessary to acknowledge receipt of such 

requests; and 

‘‘(5) a hyperlink or other reference to the clinical trial 

record containing information about the expanded access for 

such drug that is required under section 402(j)(2)(A)(ii)(II)(gg) 

of the Public Health Service Act. 

‘‘(d) NO GUARANTEE OF ACCESS.—The posting of policies by 

manufacturers and distributors under subsection (a) shall not serve 

as a guarantee of access to any specific investigational drug by 

any individual patient. 

‘‘(e) REVISED POLICY.—Nothing in this section shall prevent 

a manufacturer or distributor from revising a policy required under 

this section at any time. 

‘‘(f) APPLICATION.—This section shall apply to a manufacturer 

or distributor with respect to an investigational drug beginning 

on the later of— 

‘‘(1) the date that is 60 calendar days after the date of 

enactment of the 21st Century Cures Act; or 

‘‘(2) the first initiation of a phase 2 or phase 3 study 

(as such terms are defined in section 312.21(b) and (c) of title 

21, Code of Federal Regulations (or any successor regulations)) 

with respect to such investigational drug.’’. 

SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED 

THERAPIES. 

(a) IN GENERAL.—Section 506 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 356) is amended— 

(1) by transferring subsection (e) (relating to construction) 

so that it appears before subsection (f) (relating to awareness 

efforts); and 

(2) by adding at the end the following: 

‘‘(g) REGENERATIVE ADVANCED THERAPY.— 

‘‘(1) IN GENERAL.—The Secretary, at the request of the 

sponsor of a drug, shall facilitate an efficient development 

program for, and expedite review of, such drug if the drug 

qualifies as a regenerative advanced therapy under the criteria 

described in paragraph (2). 

‘‘(2) CRITERIA.—A drug is eligible for designation as a regenerative advanced therapy under this subsection if— 

‘‘(A) the drug is a regenerative medicine therapy (as 

defined in paragraph (8)); 


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‘‘(B) the drug is intended to treat, modify, reverse, 

or cure a serious or life-threatening disease or condition; 

and 

‘‘(C) preliminary clinical evidence indicates that the 

drug has the potential to address unmet medical needs 

for such a disease or condition. 

‘‘(3) REQUEST FOR DESIGNATION.—The sponsor of a drug 

may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, 

submission of an application for the investigation of the drug 

under section 505(i) of this Act or section 351(a)(3) of the 

Public Health Service Act. 

‘‘(4) DESIGNATION.—Not later than 60 calendar days after 

the receipt of a request under paragraph (3), the Secretary 

shall determine whether the drug that is the subject of the 

request meets the criteria described in paragraph (2). If the 

Secretary determines that the drug meets the criteria, the 

Secretary shall designate the drug as a regenerative advanced 

therapy and shall take such actions as are appropriate under 

paragraph (1). If the Secretary determines that a drug does 

not meet the criteria for such designation, the Secretary shall 

include with the determination a written description of the 

rationale for such determination. 

‘‘(5) ACTIONS.—The sponsor of a regenerative advanced 

therapy shall be eligible for the actions to expedite development 

and review of such therapy under subsection (a)(3)(B), including 

early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval 

of an application for the product under subsection (c). 

‘‘(6) ACCESS TO EXPEDITED APPROVAL PATHWAYS.—An 

application for a regenerative advanced therapy under section 

505(b)(1) of this Act or section 351(a) of the Public Health 

Service Act may be— 

‘‘(A) eligible for priority review, as described in the 

Manual of Policies and Procedures of the Food and Drug 

Administration and goals identified in the letters described 

in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and 

‘‘(B) eligible for accelerated approval under subsection 

(c), as agreed upon pursuant to subsection (a)(3)(B), 

through, as appropriate— 

‘‘(i) surrogate or intermediate endpoints reasonably 

likely to predict long-term clinical benefit; or 

‘‘(ii) reliance upon data obtained from a meaningful 

number of sites, including through expansion to additional sites, as appropriate. 

‘‘(7) POSTAPPROVAL REQUIREMENTS.—The sponsor of a 

regenerative advanced therapy that is granted accelerated 

approval and is subject to the postapproval requirements under 

subsection (c) may, as appropriate, fulfill such requirements, 

as the Secretary may require, through— 

‘‘(A) the submission of clinical evidence, clinical studies, 

patient registries, or other sources of real world evidence, 

such as electronic health records; 

‘‘(B) the collection of larger confirmatory data sets, 

as agreed upon pursuant to subsection (a)(3)(B); or 


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‘‘(C) postapproval monitoring of all patients treated 

with such therapy prior to approval of the therapy. 

‘‘(8) DEFINITION.—For purposes of this section, the term 

‘regenerative medicine therapy’ includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or 

products, except for those regulated solely under section 361 

of the Public Health Service Act and part 1271 of title 21, 

Code of Federal Regulations.’’. 

(b) RULE OF CONSTRUCTION.—Nothing in this section and the 

amendments made by this section shall be construed to alter the 

authority of the Secretary of Health and Human Services— 

(1) to approve drugs pursuant to the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 

of the Public Health Service Act (42 U.S.C. 262) as authorized 

prior to the date of enactment of the 21st Century Cures 

Act, including the standards of evidence, and applicable conditions, for approval under such Acts; or 

(2) to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior 

to the date of enactment of the 21st Century Cures Act. 

(c) CONFORMING AMENDMENT.—Section 506(e)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended 

by inserting ‘‘and the 21st Century Cures Act’’ after ‘‘Food and 

Drug Administration Safety and Innovation Act’’. 

SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY, 

ISOLATION, OR DELIVERY OF REGENERATIVE ADVANCED 

THERAPIES. 

(a) DRAFT GUIDANCE.—Not later than 1 year after the date 

of enactment of the 21st Century Cures Act, the Secretary of Health 

and Human Services, acting through the Commissioner of Food 

and Drugs, shall issue draft guidance clarifying how, in the context 

of regenerative advanced therapies, the Secretary will evaluate 

devices used in the recovery, isolation, or delivery of regenerative 

advanced therapies. In doing so, the Secretary shall specifically 

address— 

(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination 

device and cell or tissue products; 

(2) what, if any, intended uses or specific attributes would 

result in a device used with a regenerative therapy product 

to be classified as a class III device; 

(3) when the Food and Drug Administration considers it 

is necessary, if ever, for the intended use of a device to be 

limited to a specific intended use with only one particular 

type of cell; and 

(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell 

type. 

(b) FINAL GUIDANCE.—Not later than 12 months after the close 

of the period for public comment on the draft guidance under 

subsection (a), the Secretary of Health and Human Services shall 

finalize such guidance. 

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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respect to the previous calendar year, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate 

and the Committee on Energy and Commerce of the House of 

Representatives on— 

(1) the number and type of applications for approval of 

regenerative advanced therapies filed, approved or licensed as 

applicable, withdrawn, or denied; and 

(2) how many of such applications or therapies, as 

applicable, were granted accelerated approval or priority 

review. 

(b) REGENERATIVE ADVANCED THERAPY.—In this section, the 

term ‘‘regenerative advanced therapy’’ has the meaning given such 

term in section 506(g) of the Federal Food, Drug, and Cosmetic 

Act, as added by section 3033 of this Act. 

SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES. 

Subchapter A of chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 

section 506F the following: 

‘‘SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES. 

‘‘(a) IN GENERAL.—Not later than 2 years after the date of 

enactment of the 21st Century Cures Act, the Secretary, in consultation with the National Institute of Standards and Technology and 

stakeholders (including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine and advanced therapies industry organizations, and standard 

setting organizations), shall facilitate an effort to coordinate and 

prioritize the development of standards and consensus definition 

of terms, through a public process, to support, through regulatory 

predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, 

including with respect to the manufacturing processes and controls 

of such products. 

‘‘(b) ACTIVITIES.— 

‘‘(1) IN GENERAL.—In carrying out this section, the Secretary shall continue to— 

‘‘(A) identity opportunities to help advance the development of regenerative medicine therapies and regenerative 

advanced therapies; 

‘‘(B) identify opportunities for the development of laboratory regulatory science research and documentary 

standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and 

‘‘(C) work with stakeholders, such as those described 

in subsection (a), as appropriate, in the development of 

such standards. 

‘‘(2) REGULATIONS AND GUIDANCE.—Not later than 1 year 

after the development of standards as described in subsection 

(a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations 

and guidance as the Secretary determines appropriate. 

21 USC 356g. 


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‘‘(c) DEFINITIONS.—For purposes of this section, the terms 

‘regenerative medicine therapy’ and ‘regenerative advanced therapy’ 

have the meanings given such terms in section 506(g).’’. 

SEC. 3037. HEALTH CARE ECONOMIC INFORMATION. 

Section 502(a) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 352(a)) is amended— 

(1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) If its’’; 

(2) by striking ‘‘a formulary committee, or other similar 

entity, in the course of the committee or the entity carrying 

out its responsibilities for the selection of drugs for managed 

care or other similar organizations’’ and inserting ‘‘a payor, 

formulary committee, or other similar entity with knowledge 

and expertise in the area of health care economic analysis, 

carrying out its responsibilities for the selection of drugs for 

coverage or reimbursement’’; 

(3) by striking ‘‘directly relates’’ and inserting ‘‘relates’’; 

(4) by striking ‘‘and is based on competent and reliable 

scientific evidence. The requirements set forth in section 505(a) 

or in section 351(a) of the Public Health Service Act shall 

not apply to health care economic information provided to such 

a committee or entity in accordance with this paragraph’’ and 

inserting ‘‘, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between 

the health care economic information and the labeling approved 

for the drug under section 505 or under section 351 of the 

Public Health Service Act. The requirements set forth in section 

505(a) or in subsections (a) and (k) of section 351 of the Public 

Health Service Act shall not apply to health care economic 

information provided to such a payor, committee, or entity 

in accordance with this paragraph’’; and 

(5) by striking ‘‘In this paragraph, the term’’ and all that 

follows and inserting the following: 

‘‘(2)(A) For purposes of this paragraph, the term ‘health care 

economic information’ means any analysis (including the clinical 

data, inputs, clinical or other assumptions, methods, results, and 

other components underlying or comprising the analysis) that 

identifies, measures, or describes the economic consequences, which 

may be based on the separate or aggregated clinical consequences 

of the represented health outcomes, of the use of a drug. Such 

analysis may be comparative to the use of another drug, to another 

health care intervention, or to no intervention. 

‘‘(B) Such term does not include any analysis that relates only 

to an indication that is not approved under section 505 or under 

section 351 of the Public Health Service Act for such drug.’’. 

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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‘‘(g)(1)(A) The Secretary shall, in accordance with this subsection, assign a primary agency center to regulate products that 

constitute a combination of a drug, device, or biological product. 

‘‘(B) The Secretary shall conduct the premarket review of any 

combination product under a single application, whenever appropriate. 

‘‘(C) For purposes of this subsection, the term ‘primary mode 

of action’ means the single mode of action of a combination product 

expected to make the greatest contribution to the overall intended 

therapeutic effects of the combination product. 

‘‘(D) The Secretary shall determine the primary mode of action 

of the combination product. If the Secretary determines that the 

primary mode of action is that of— 

‘‘(i) a drug (other than a biological product), the agency 

center charged with premarket review of drugs shall have 

primary jurisdiction; 

‘‘(ii) a device, the agency center charged with premarket 

review of devices shall have primary jurisdiction; or 

‘‘(iii) a biological product, the agency center charged with 

premarket review of biological products shall have primary 

jurisdiction. 

‘‘(E) In determining the primary mode of action of a combination 

product, the Secretary shall not determine that the primary mode 

of action is that of a drug or biological product solely because 

the combination product has any chemical action within or on 

the human body. 

‘‘(F) If a sponsor of a combination product disagrees with the 

determination under subparagraph (D)— 

‘‘(i) such sponsor may request, and the Secretary shall 

provide, a substantive rationale to such sponsor that references 

scientific evidence provided by the sponsor and any other scientific evidence relied upon by the Secretary to support such 

determination; and 

‘‘(ii)(I) the sponsor of the combination product may propose 

one or more studies (which may be nonclinical, clinical, or 

both) to establish the relevance, if any, of the chemical action 

in achieving the primary mode of action of such product; 

‘‘(II) if the sponsor proposes any such studies, the Secretary 

and the sponsor of such product shall collaborate and seek 

to reach agreement, within a reasonable time of such proposal, 

not to exceed 90 calendar days, on the design of such studies; 

and 

‘‘(III) if an agreement is reached under subclause (II) and 

the sponsor conducts one or more of such studies, the Secretary 

shall consider the data resulting from any such study when 

reevaluating the determination of the primary mode of action 

of such product, and unless and until such reevaluation has 

occurred and the Secretary issues a new determination, the 

determination of the Secretary under subparagraph (D) shall 

remain in effect. 

‘‘(2)(A)(i) To establish clarity and certainty for the sponsor, 

the sponsor of a combination product may request a meeting on 

such combination product. If the Secretary concludes that a determination of the primary mode of action pursuant to paragraph 

(1)(D) is necessary, the sponsor may request such meeting only 

after the Secretary makes such determination. If the sponsor submits a written meeting request, the Secretary shall, not later than 


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75 calendar days after receiving such request, meet with the sponsor 

of such combination product. 

‘‘(ii) A meeting under clause (i) may— 

‘‘(I) address the standards and requirements for market 

approval or clearance of the combination product; 

‘‘(II) address other issues relevant to such combination 

product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and 

‘‘(III) identify elements under subclauses (I) and (II) that 

may be more appropriate for discussion and agreement with 

the Secretary at a later date given that scientific or other 

information is not available, or agreement is otherwise not 

feasible regarding such elements, at the time a request for 

such meeting is made. 

‘‘(iii) Any agreement under this subparagraph shall be in 

writing and made part of the administrative record by the Secretary. 

‘‘(iv) Any such agreement shall remain in effect, except— 

‘‘(I) upon the written agreement of the Secretary and the 

sponsor or applicant; or 

‘‘(II) pursuant to a decision by the director of the reviewing 

division of the primary agency center, or a person more senior 

than such director, in consultation with consulting centers and 

the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other 

applicable standard under this Act or the Public Health Service 

Act applicable to the combination product has been identified 

since the agreement was reached, or that deviating from the 

agreement is otherwise justifiable based on scientific evidence, 

for public health reasons. 

‘‘(3) For purposes of conducting the premarket review of a 

combination product that contains an approved constituent part 

described in paragraph (4), the Secretary may require that the 

sponsor of such combination product submit to the Secretary only 

data or information that the Secretary determines is necessary 

to meet the standard for clearance or approval, as applicable, under 

this Act or the Public Health Service Act, including any incremental 

risks and benefits posed by such combination product, using a 

risk-based approach and taking into account any prior finding of 

safety and effectiveness or substantial equivalence for the approved 

constituent part relied upon by the applicant in accordance with 

paragraph (5). 

‘‘(4) For purposes of paragraph (3), an approved constituent 

part is— 

‘‘(A) a drug constituent part of a combination product being 

reviewed in a single application or request under section 515, 

510(k), or 513(f)(2) (submitted in accordance with paragraph 

(5)), that is an approved drug, provided such application or 

request complies with paragraph (5); 

‘‘(B) a device constituent part approved under section 515 

that is referenced by the sponsor and that is available for 

use by the Secretary under section 520(h)(4); or 

‘‘(C) any constituent part that was previously approved, 

cleared, or classified under section 505, 510(k), 513(f)(2), or 

515 of this Act for which the sponsor has a right of reference 

or any constituent part that is a nonprescription drug, as 

defined in section 760(a)(2). 


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‘‘(5)(A) If an application is submitted under section 515 or 

510(k) or a request is submitted under section 513(f)(2), consistent 

with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved 

drug— 

‘‘(i) the application or request shall include the certification 

or statement described in section 505(b)(2); and 

‘‘(ii) the applicant or requester shall provide notice as 

described in section 505(b)(3). 

‘‘(B) For purposes of this paragraph and paragraph (4), the 

term ‘approved drug’ means an active ingredient— 

‘‘(i) that was in an application previously approved under 

section 505(c); 

‘‘(ii) where such application is relied upon by the applicant 

submitting the application or request described in subparagraph (A); 

‘‘(iii) for which full reports of investigations that have been 

made to show whether such drug is safe for use and whether 

such drug is effective in use were not conducted by or for 

the applicant submitting the application or request described 

in subparagraph (A); and 

‘‘(iv) for which the applicant submitting the application 

or request described in subparagraph (A) has not obtained 

a right of reference or use from the person by or for whom 

the investigations described in clause (iii) were conducted. 

‘‘(C) The following provisions shall apply with respect to an 

application or request described in subparagraph (A) to the same 

extent and in the same manner as if such application or request 

were an application described in section 505(b)(2) that referenced 

the approved drug: 

‘‘(i) Subparagraphs (A), (B), (C), and (D) of section 505(c)(3). 

‘‘(ii) Clauses (ii), (iii), and (iv) of section 505(c)(3)(E). 

‘‘(iii) Subsections (b) and (c) of section 505A. 

‘‘(iv) Section 505E(a). 

‘‘(v) Section 527(a). 

‘‘(D) Notwithstanding any other provision of this subsection, 

an application or request for classification for a combination product 

described in subparagraph (A) shall be considered an application 

submitted under section 505(b)(2) for purposes of section 

271(e)(2)(A) of title 35, United States Code. 

‘‘(6) Nothing in this subsection shall be construed as prohibiting 

a sponsor from submitting separate applications for the constituent 

parts of a combination product, unless the Secretary determines 

that a single application is necessary.’’; 

(5) in paragraph (8) (as redesignated by paragraph (3))— 

(A) in subparagraph (C)— 

(i) by amending clause (i) to read as follows: 

‘‘(i) In carrying out this subsection, the Office shall help to 

ensure timely and effective premarket review that involves more 

than one agency center by coordinating such reviews, overseeing 

the timeliness of such reviews, and overseeing the alignment of 

feedback regarding such reviews.’’; 

(ii) in clause (ii), by inserting ‘‘and alignment’’ 

after ‘‘the timeliness’’ each place it appears; and 

(iii) by adding at the end the following new clauses: 

‘‘(iii) The Office shall ensure that, with respect to a combination 

product, a designated person or persons in the primary agency 


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center is the primary point or points of contact for the sponsor 

of such combination product. The Office shall also coordinate 

communications to and from any consulting center involved in 

such premarket review, if requested by such primary agency center 

or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and 

the requirements of all affected agency centers, from the primary 

agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review. 

‘‘(iv) The Office shall, with respect to the premarket review 

of a combination product— 

‘‘(I) ensure that any meeting between the Secretary and 

the sponsor of such product is attended by each agency center 

involved in the review, as appropriate; 

‘‘(II) ensure that each consulting agency center has completed its premarket review and provided the results of such 

review to the primary agency center in a timely manner; and 

‘‘(III) ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on 

other relevant regulations, guidances, and policies. 

‘‘(v) In seeking agency action with respect to a combination 

product, the sponsor of such product— 

‘‘(I) shall identify the product as a combination product; 

and 

‘‘(II) may request in writing the participation of representatives of the Office in meetings related to such combination 

product, or to have the Office otherwise engage on such regulatory matters concerning the combination product. 

‘‘(vi) Not later than 4 years after the date of enactment of 

the 21st Century Cures Act, and after a public comment period 

of not less than 60 calendar days, the Secretary shall issue a 

final guidance that describes— 

‘‘(I) the structured process for managing pre-submission 

interactions with sponsors developing combination products; 

‘‘(II) the best practices for ensuring that the feedback in 

such pre-submission interactions represents the Agency’s best 

advice based on the information provided during such presubmission interactions; 

‘‘(III) the information that is required to be submitted 

with a meeting request under paragraph (2), how such meetings 

relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached 

through a meeting under such paragraph (2);’’; and 

(B) in subparagraph (G)— 

(i) in the matter preceding clause (i), by inserting 

‘‘(except with respect to clause (iv), beginning not later 

than one year after the date of the enactment of the 

21st Century Cures Act)’’ after ‘‘enactment of this paragraph’’; 

(ii) in clause (ii), by striking ‘‘and’’ at the end; 

(iii) in clause (iii), by striking the period at the 

end and inserting ‘‘; and’’; and 

(iv) by adding at the end the following new clause: 

‘‘(iv) identifying the percentage of combination products 

for which a dispute resolution, with respect to premarket 

review, was requested by the combination product’s sponsor.’’; 

and 


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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 investigational use of the product.’’. 

(b) INFORMATION FOR APPROVAL OF COMBINATION PRODUCTS.— 

Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360j(h)(4)) is amended— 

(1) in subparagraph (A), by striking ‘‘Any information’’ 

and inserting ‘‘Subject to subparagraph (C), any information’’; 

and 

(2) by adding at the end the following new subparagraph: 

‘‘(C) No information contained in an application for premarket 

approval filed with the Secretary pursuant to section 515(c) may 

be used to approve or clear any application submitted under section 

515 or 510(k) or to classify a product under section 513(f)(2) for 

a combination product containing as a constituent part an approved 

drug (as defined in section 503(g)(5)(B)) unless— 

‘‘(i) the application includes the certification or statement 

referenced in section 503(g)(5)(A); 

‘‘(ii) the applicant provides notice as described in section 

503(g)(5)(A); and 

‘‘(iii) the Secretary’s approval of such application is subject 

to the provisions in section 503(g)(5)(C).’’. 

(c) VARIATIONS FROM CGMP STREAMLINED APPROACH.—Not 

later than 18 months after the date of enactment of this Act, 

the Secretary of Health and Human Services (referred to in this 

subsection as the ‘‘Secretary’’) shall identify types of combination 

products and manufacturing processes with respect to which the 

Secretary proposes that good manufacturing processes may be 

adopted that vary from the requirements set forth in section 4.4 

of title 21, Code of Federal Regulations (or any successor regulations) or that the Secretary proposes can satisfy the requirements 

in section 4.4 through alternative or streamlined mechanisms. The 

Secretary shall identify such types, variations from such requirements, and such mechanisms, in a proposed list published in the 

Federal Register. After a public comment period regarding the 

appropriate good manufacturing practices for such types, the Secretary shall publish a final list in the Federal Register, notwithstanding section 553 of title 5, United States Code. The Secretary 

shall evaluate such types, variations, and mechanisms using a 

risk-based approach. The Secretary shall periodically review such 

final list. 

21 USC 355 note. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1111 

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 summaries of State efforts to address antimicrobial resistance in 

humans to antimicrobial drugs and antimicrobial stewardship; 

and 

‘‘(3) coordination between the Director of the Centers for 

Disease Control and Prevention and the Commissioner of Food 

and Drugs with respect to the monitoring of— 

‘‘(A) any applicable resistance under paragraph (1); 

and 

‘‘(B) drugs approved under section 506(h) of the Federal 

Food, Drug, and Cosmetic Act. 

‘‘(h) INFORMATION RELATED TO ANTIMICROBIAL STEWARDSHIP

PROGRAMS.—The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related 

to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, 

such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals. 

‘‘(i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTIMICROBIAL RESISTANCE.—The Secretary shall continue to work with 

State and local public health departments on statewide or regional 

programs related to antimicrobial resistance. Such efforts may 

include activities to related to— 

‘‘(1) identifying patterns of bacterial and fungal resistance 

in humans to antimicrobial drugs; 

‘‘(2) preventing the spread of bacterial and fungal infections 

that are resistant to antimicrobial drugs; and 

‘‘(3) promoting antimicrobial stewardship. 


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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 stewardship activities, examining changes in antimicrobial resistance, 

and evaluating the effectiveness of section 506(h) of the Federal 

Food, Drug, and Cosmetic Act, the Secretary shall— 

‘‘(A) provide a mechanism for facilities to report data 

related to their antimicrobial stewardship activities 

(including analyzing the outcomes of such activities); and 

‘‘(B) evaluate— 

‘‘(i) antimicrobial resistance data using a standardized approach; and 

‘‘(ii) trends in the utilization of drugs approved 

under such section 506(h) with respect to patient populations. 

‘‘(2) USE OF SYSTEMS.—The Secretary shall use available 

systems, including the National Healthcare Safety Network 

or other systems identified by the Secretary, to fulfill the 

requirements or conduct activities under this section. 

‘‘(k) ANTIMICROBIAL.—For purposes of subsections (f) through 

(j), the term ‘antimicrobial’ includes any antibacterial or antifungal 

drugs, and may include drugs that eliminate or inhibit the growth 

of other microorganisms, as appropriate.’’. 

(b) AVAILABILITY OF DATA.—The Secretary shall make the data 

collected pursuant to this subsection public. Nothing in this subsection shall be construed as authorizing the Secretary to disclose 

any information that is a trade secret or confidential information 

subject to section 552(b)(4) of title 5, United States Code, or section 

1905 of title 18, United States Code. 

SEC. 3042. LIMITED POPULATION PATHWAY. 

Section 506 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 356), as amended by section 3033, is further amended by 

adding at the end the following: 

‘‘(h) LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL AND

ANTIFUNGAL DRUGS.— 

‘‘(1) IN GENERAL.—The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one 

or more other drugs, as a limited population drug pursuant 

to this subsection only if— 

‘‘(A) the drug is intended to treat a serious or lifethreatening infection in a limited population of patients 

with unmet needs; 

‘‘(B) the standards for approval under section 505(c) 

and (d), or the standards for licensure under section 351 

of the Public Health Service Act, as applicable, are met; 

and 

‘‘(C) the Secretary receives a written request from the 

sponsor to approve the drug as a limited population drug 

pursuant to this subsection. 

‘‘(2) BENEFIT-RISK CONSIDERATION.—The Secretary’s determination of safety and effectiveness of an antibacterial or 

antifungal drug shall reflect the benefit-risk profile of such 

drug in the intended limited population, taking into account 

the severity, rarity, or prevalence of the infection the drug 

is intended to treat and the availability or lack of alternative 

treatment in such limited population. Such drug may be 

42 USC 247d–5 

note. 


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approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a 

population that is broader than the intended limited population. 

‘‘(3) ADDITIONAL REQUIREMENTS.—A drug approved under 

this subsection shall be subject to the following requirements, 

in addition to any other applicable requirements of this Act: 

‘‘(A) LABELING.—To indicate that the safety and 

effectiveness of a drug approved under this subsection has 

been demonstrated only with respect to a limited population— 

‘‘(i) all labeling and advertising of an antibacterial 

or antifungal drug approved under this subsection shall 

contain the statement ‘Limited Population’ in a prominent manner and adjacent to, and not more prominent 

than— 

‘‘(I) the proprietary name of such drug, if any; 

or 

‘‘(II) if there is no proprietary name, the established name of the drug, if any, as defined in 

section 503(e)(3), or, in the case of a drug that 

is a biological product, the proper name, as defined 

by regulation; and 

‘‘(ii) the prescribing information for the drug 

required by section 201.57 of title 21, Code of Federal 

Regulations (or any successor regulation) shall also 

include the following statement: ‘This drug is indicated 

for use in a limited and specific population of patients.’. 

‘‘(B) PROMOTIONAL MATERIAL.—The sponsor of an antibacterial or antifungal drug subject to this subsection shall 

submit to the Secretary copies of all promotional materials 

related to such drug at least 30 calendar days prior to 

dissemination of the materials. 

‘‘(4) OTHER PROGRAMS.—A sponsor of a drug that seeks 

approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other 

applicable sections or subsections of this Act or the Public 

Health Service Act. 

‘‘(5) GUIDANCE.—Not later than 18 months after the date 

of enactment of the 21st Century Cures Act, the Secretary 

shall issue draft guidance describing criteria, processes, and 

other general considerations for demonstrating the safety and 

effectiveness of limited population antibacterial and antifungal 

drugs. The Secretary shall publish final guidance within 18 

months of the close of the public comment period on such 

draft guidance. The Secretary may approve antibacterial and 

antifungal drugs under this subsection prior to issuing guidance 

under this paragraph. 

‘‘(6) ADVICE.—The Secretary shall provide prompt advice 

to the sponsor of a drug for which the sponsor seeks approval 

under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval, 

and to conduct any additional studies that would be required 

to gain approval of such drug for use in a broader population. 

‘‘(7) TERMINATION OF LIMITATIONS.—If, after approval of 

a drug under this subsection, the Secretary approves a broader 

indication for such drug under section 505(b) or section 351(a) 

of the Public Health Service Act, the Secretary may remove 


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any postmarketing conditions, including requirements with 

respect to labeling and review of promotional materials under 

paragraph (3), applicable to the approval of the drug under 

this subsection. 

‘‘(8) RULES OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to alter the authority of the Secretary to 

approve drugs pursuant to this Act or section 351 of the Public 

Health Service Act, including the standards of evidence and 

applicable conditions for approval under such Acts, the standards of approval of a drug under such Acts, or to alter the 

authority of the Secretary to monitor drugs pursuant to such 

Acts. 

‘‘(9) REPORTING AND ACCOUNTABILITY.— ‘‘(A) BIENNIAL REPORTING.—The Secretary shall report 

to Congress not less often than once every 2 years on 

the number of requests for approval, and the number of 

approvals, of an antibacterial or antifungal drug under 

this subsection. 

‘‘(B) GAO REPORT.—Not later than December 2021, 

the Comptroller General of the United States shall submit 

to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the 

coordination of activities required under section 319E of 

the Public Health Service Act. Such report shall include 

a review of such activities, and the extent to which the 

use of the pathway established under this subsection has 

streamlined premarket approval for antibacterial or 

antifungal drugs for limited populations, if such pathway 

has functioned as intended, if such pathway has helped 

provide for safe and effective treatment for patients, if 

such premarket approval would be appropriate for other 

categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.’’. 

SEC. 3043. PRESCRIBING AUTHORITY. 

Nothing in this subtitle, or an amendment made by this subtitle, shall be construed to restrict the prescribing of antimicrobial 

drugs or other products, including drugs approved under subsection 

(h) of section 506 of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 356) (as added by section 3042), by health care professionals, or to limit the practice of health care. 

SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 

MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY 

TESTING DEVICES. 

(a) IN GENERAL.—Subchapter A of chapter V of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

by inserting after section 511 the following: 

‘‘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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health, due to, among other things, the constant evolution 

of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique 

management of antimicrobial drugs that is inappropriate 

for most other drugs in order to delay or prevent the 

development of further resistance to existing therapies; 

‘‘(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and 

‘‘(C) clear under section 510(k), classify under section 

513(f)(2), or approve under section 515, antimicrobial 

susceptibility testing devices utilizing updated, recognized 

susceptibility test interpretive criteria to characterize the 

in vitro susceptibility of particular bacteria, fungi, or other 

microorganisms, as applicable, to antimicrobial drugs. 

‘‘(2) IDENTIFICATION OF CRITERIA.—The Secretary shall 

identify appropriate susceptibility test interpretive criteria with 

respect to antimicrobial drugs— 

‘‘(A) if such criteria are available on the date of 

approval of the drug under section 505 of this Act or 

licensure of the drug under section 351 of the Public Health 

Service Act (as applicable), upon such approval or licensure; 

or 

‘‘(B) if such criteria are unavailable on such date, on 

the date on which such criteria are available for such 

drug. 

‘‘(3) BASES FOR INITIAL IDENTIFICATION.—The Secretary 

shall identify appropriate susceptibility test interpretive criteria 

under paragraph (2), based on the Secretary’s review of, to 

the extent available and relevant— 

‘‘(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data; 

‘‘(B) the relationship of susceptibility test interpretive 

criteria to morbidity and mortality associated with the 

disease or condition for which such drug is used; and 

‘‘(C) such other evidence and information as the Secretary considers appropriate. 

‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA WEBSITE.— 

‘‘(1) IN GENERAL.—Not later than 1 year after the date 

of the enactment of the 21st Century Cures Act, the Secretary 

shall establish, and maintain thereafter, on the website of 

the Food and Drug Administration, a dedicated website that 

contains a list of any appropriate new or updated susceptibility 

test interpretive criteria standards and interpretive criteria 

in accordance with paragraph (2) (referred to in this section 

as the ‘Interpretive Criteria Website’). 

‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA

STANDARDS AND INTERPRETIVE CRITERIA.— 

‘‘(A) IN GENERAL.—The list described in paragraph (1) 

shall consist of any new or updated susceptibility test 

interpretive criteria standards that are— 

‘‘(i) established by a nationally or internationally 

recognized standard development organization that— 

‘‘(I) establishes and maintains procedures to 

address potential conflicts of interest and ensure 

transparent decisionmaking; 


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‘‘(II) holds open meetings to ensure that there 

is an opportunity for public input by interested 

parties, and establishes and maintains processes 

to ensure that such input is considered in decisionmaking; and 

‘‘(III) permits its standards to be made publicly 

available, through the National Library of Medicine or another similar source acceptable to the 

Secretary; and 

‘‘(ii) recognized in whole, or in part, by the Secretary under subsection (c). 

‘‘(B) OTHER LIST.—The Interpretive Criteria Website 

shall, in addition to the list described in subparagraph 

(A), include a list of interpretive criteria, if any, that the 

Secretary has determined to be appropriate with respect 

to legally marketed antimicrobial drugs, where— 

‘‘(i) the Secretary does not recognize, in whole or 

in part, an interpretive criteria standard described 

under subparagraph (A) otherwise applicable to such 

a drug; 

‘‘(ii) the Secretary withdraws under subsection 

(c)(1)(A) recognition of a standard, in whole or in part, 

otherwise applicable to such a drug; 

‘‘(iii) the Secretary approves an application under 

section 505 of this Act or section 351 of the Public 

Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant 

interpretive criteria included in a standard recognized 

by the Secretary under subsection (c); or 

‘‘(iv) because the characteristics of such a drug 

differ from other drugs with the same active ingredient, 

the interpretive criteria with respect to such drug— 

‘‘(I) differ from otherwise applicable interpretive criteria included in a standard listed under 

subparagraph (A) or interpretive criteria otherwise 

listed under this subparagraph; and 

‘‘(II) are determined by the Secretary to be 

appropriate for the drug. 

‘‘(C) REQUIRED STATEMENTS.—The Interpretive Criteria 

Website shall include statements conveying— 

‘‘(i) that the website provides information about 

the in vitro susceptibility of bacteria, fungi, or other 

microorganisms, as applicable to a certain drug (or 

drugs); 

‘‘(ii) that— 

‘‘(I) the safety and efficacy of such drugs in 

treating clinical infections due to such bacteria, 

fungi, or other microorganisms, as applicable, may 

or may not have been established in adequate 

and well-controlled clinical trials in order for the 

susceptibility information described in clause (i) 

to be included on the website; and 

‘‘(II) the clinical significance of such susceptibility information in such instances is unknown; 

‘‘(iii) that the approved product labeling for specific 

drugs provides the uses for which the Secretary has 

approved the product; and 


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‘‘(iv) any other information that the Secretary 

determines appropriate to adequately convey the 

meaning of the data supporting the recognition or 

listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included 

on the website. 

‘‘(3) NOTICE.—Not later than the date on which the 

Interpretive Criteria Website is established, the Secretary shall 

publish a notice of that establishment in the Federal Register. 

‘‘(4) INAPPLICABILITY OF MISBRANDING PROVISION.—The 

inclusion in the approved labeling of an antimicrobial drug 

of a reference or hyperlink to the Interpretive Criteria Website, 

in and of itself, shall not cause the drug to be misbranded 

in violation of section 502. 

‘‘(5) TRADE SECRETS AND CONFIDENTIAL INFORMATION.— Nothing in this section shall be construed as authorizing the 

Secretary to disclose any information that is a trade secret 

or confidential information subject to section 552(b)(4) of title 

5, United States Code. 

‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA.— 

‘‘(1) EVALUATION AND PUBLICATION.— 

‘‘(A) IN GENERAL.—Beginning on the date of the 

establishment of the Interpretive Criteria Website, and 

at least every 6 months thereafter, the Secretary shall— 

‘‘(i) evaluate any appropriate new or updated 

susceptibility test interpretive criteria standards established by a nationally or internationally recognized 

standard development organization described in subsection (b)(2)(A)(i); and 

‘‘(ii) publish on the public website of the Food 

and Drug Administration a notice— 

‘‘(I) withdrawing recognition of any different 

susceptibility test interpretive criteria standard, 

in whole or in part; 

‘‘(II) recognizing the new or updated standards; 

‘‘(III) recognizing one or more parts of the 

new or updated interpretive criteria specified in 

such a standard and declining to recognize the 

remainder of such standard; and 

‘‘(IV) making any necessary updates to the 

lists under subsection (b)(2). 

‘‘(B) UPON APPROVAL OF A DRUG.—Upon the approval 

of an initial or supplemental application for an antimicrobial drug under section 505 of this Act or section 

351 of the Public Health Service Act, as applicable, where 

such approval is based on susceptibility test interpretive 

criteria which differ from those contained in a standard 

recognized, or from those otherwise listed, by the Secretary 

pursuant to this subsection, or for which there are no 

relevant interpretive criteria standards recognized, or 

interpretive criteria otherwise listed, by the Secretary 

pursuant to this subsection, the Secretary shall update 

the lists under subparagraphs (A) and (B) of subsection 

(b)(2) to include the susceptibility test interpretive criteria 

upon which such approval was based. 


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130 STAT. 1118 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STANDARDS.—In evaluating new or updated susceptibility test 

interpretive criteria standards under paragraph (1)(A), the Secretary may consider— 

‘‘(A) the Secretary’s determination that such a standard 

is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same 

active ingredient; 

‘‘(B) information provided by interested third parties, 

including public comment on the annual compilation of 

notices published under paragraph (3); 

‘‘(C) any bases used to identify susceptibility test 

interpretive criteria under subsection (a)(2); and 

‘‘(D) such other information or factors as the Secretary 

determines appropriate. 

‘‘(3) ANNUAL COMPILATION OF NOTICES.—Each year, the 

Secretary shall compile the notices published under paragraph 

(1)(A) and publish such compilation in the Federal Register 

and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the 

Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria— 

‘‘(A) recognized by the Secretary under this subsection; 

or 

‘‘(B) otherwise listed on the Interpretive Criteria 

Website under subsection (b)(2). 

‘‘(4) RELATION TO SECTION 514(c).—Any susceptibility test 

interpretive standard recognized under this subsection or any 

criteria otherwise listed under subsection (b)(2)(B) shall be 

deemed to be recognized as a standard by the Secretary under 

section 514(c)(1). 

‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRITERIA.—Nothing 

in this section prohibits a person from seeking approval or 

clearance of a drug or device, or changes to the drug or the 

device, on the basis of susceptibility test interpretive criteria 

which differ from those contained in a standard recognized, 

or from those otherwise listed, by the Secretary pursuant to 

subsection (b)(2). 

‘‘(d) ANTIMICROBIAL DRUG LABELING.— 

‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISHMENT OF

INTERPRETIVE CRITERIA WEBSITE.— 

‘‘(A) IN GENERAL.—With respect to an antimicrobial 

drug lawfully introduced or delivered for introduction into 

interstate commerce for commercial distribution before the 

establishment of the Interpretive Criteria Website, a holder 

of an approved application under section 505 of this Act 

or section 351 of the Public Health Service Act, as 

applicable, for each such drug, not later than 1 year after 

establishment of the Interpretive Criteria Website 

described in subsection (b)(1), shall remove susceptibility 

test interpretive criteria, if any, and related information 

from the approved drug labeling and replace it with a 

reference to the Interpretive Criteria Website. 

‘‘(B) LABELING CHANGES.—The labeling changes 

required by this section shall be considered a minor change 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1119 

under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable 

annual report. 

‘‘(2) DRUGS MARKETED SUBSEQUENT TO ESTABLISHMENT OF

INTERPRETIVE CRITERIA WEBSITE.—With respect to antimicrobial 

drugs approved on or after the date of the establishment of 

the Interpretive Criteria Website described in subsection (b)(1), 

the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website. 

‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTIMICROBIAL

SUSCEPTIBILITY TESTING DEVICES.— ‘‘(1) IN GENERAL.—Notwithstanding sections 501, 502, 505, 

510, 513, and 515, if the conditions specified in paragraph 

(2) are met (in addition to other applicable provisions under 

this chapter) with respect to an antimicrobial susceptibility 

testing device described in subsection (f)(1), the Secretary may 

authorize the marketing of such device for a use described 

in such subsection. 

‘‘(2) CONDITIONS APPLICABLE TO ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES.—The conditions specified in this paragraph are the following: 

‘‘(A) The device is used to make a determination of 

susceptibility using susceptibility test interpretive criteria 

that are— 

‘‘(i) included in a standard recognized by the Secretary under subsection (c); or 

‘‘(ii) otherwise listed on the Interpretive Criteria 

Website under subsection (b)(2). 

‘‘(B) The labeling of such device includes statements 

conveying— 

‘‘(i) that the device provides information about the 

in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs; 

‘‘(ii) that— 

‘‘(I) the safety and efficacy of such drugs in 

treating clinical infections due to such bacteria, 

fungi, or other microorganisms, as applicable, may 

or may not have been established in adequate 

and well-controlled clinical trials in order for the 

device to report the susceptibility of such bacteria, 

fungi, or other microorganisms, as applicable, to 

such drugs; and 

‘‘(II) the clinical significance of such susceptibility information in those instances is unknown; 

‘‘(iii) that the approved labeling for drugs tested 

using such a device provides the uses for which the 

Secretary has approved such drugs; and 

‘‘(iv) any other information the Secretary determines appropriate to adequately convey the meaning 

of the data supporting the recognition or listing of 

susceptibility test interpretive criteria standards or 

susceptibility test interpretive criteria described in 

subparagraph (A). 

‘‘(C) The antimicrobial susceptibility testing device 

meets all other requirements to be cleared under section 


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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 microorganisms to the drug tested; and 

‘‘(B) related categorizations of such susceptibility, 

including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary 

determines appropriate. 

‘‘(4)(A) The term ‘antimicrobial drug’ means, subject to 

subparagraph (B), a systemic antibacterial or antifungal drug 

that— 

‘‘(i) is intended for human use in the treatment of 

a disease or condition caused by a bacterium or fungus; 

‘‘(ii) may include a qualified infectious disease product 

designated under section 505E(d); and 

‘‘(iii) is subject to section 503(b)(1). 

‘‘(B) If provided by the Secretary through regulations, such 

term may include— 

‘‘(i) drugs other than systemic antibacterial and 

antifungal drugs; and 

‘‘(ii) biological products (as such term is defined in 

section 351 of the Public Health Service Act) to the extent 

such products exhibit antimicrobial activity. 

‘‘(5) The term ‘interpretive criteria standard’ means a compilation of susceptibility test interpretive criteria developed by 

a standard development organization that meets the criteria 

set forth in subsection (b)(2)(A)(i). 

‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to— 

‘‘(1) alter the standards of evidence under subsection (c) 

or (d) of section 505 (including the substantial evidence 

standard under section 505(d)) or under section 351 of the 

Public Health Service Act (as applicable); or 

‘‘(2) with respect to clearing devices under section 510(k), 

classifying devices under section 513(f)(2), or approving devices 

under section 515— 

‘‘(A) apply with respect to any drug, device, or biological 

product, in any context other than an antimicrobial drug 

and an antimicrobial susceptibility testing device that uses 

susceptibility test interpretive criteria to characterize and 

report the susceptibility of certain bacteria, fungi, or other 

microorganisms, as applicable, to such drug to reflect 

patient morbidity and mortality in accordance with this 

section; or 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1121 

‘‘(B) unless specifically stated, have any effect on 

authorities provided under other sections of this Act, 

including any regulations issued under such sections.’’. 

(b) CONFORMING AMENDMENTS.— 

(1) REPEAL OF PRIOR RELATED AUTHORITY.—Section 1111 

of the Food and Drug Administration Amendments Act of 2007 

(42 U.S.C. 247d–5a), relating to identification of clinically 

susceptible concentrations of antimicrobials, is repealed. 

(2) ADDITION TO CATEGORIES OF MISBRANDED DRUGS.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 352) is amended by adding at the end the following: 

‘‘(dd) If it is an antimicrobial drug, as defined in section 511A(f), 

and its labeling fails to conform with the requirements under section 

511A(d).’’. 

(3) RECOGNITION OF INTERPRETIVE CRITERIA STANDARD AS

DEVICE STANDARD.—Section 514(c)(1)(A) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended 

by inserting after ‘‘the Secretary shall, by publication in the 

Federal Register’’ the following: ‘‘(or, with respect to a susceptibility test interpretive criteria standard under section 511A, 

by posting on the Interpretive Criteria Website in accordance 

with such section)’’. 

(c) REPORT TO CONGRESS.—Not later than 2 years after the 

date of enactment of this Act, the Secretary of Health and Human 

Services shall submit to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives a report on the 

progress made in implementing section 511A of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360a), as added by subsection 

(a). 

(d) REQUESTS FOR UPDATES TO INTERPRETIVE CRITERIA

WEBSITE.—Chapter 35 of title 44, United States Code, shall not 

apply to the collection of information from interested parties 

regarding updating the lists established under section 511A(b) of 

the Federal Food, Drug, and Cosmetic Act and posted on the 

Interpretive Criteria Website established under section 511A(c) of 

such Act. 

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 development of, and prioritize the Food and Drug Administration’s review 

of, devices that represent breakthrough technologies. 

‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary shall establish a program to expedite the development of, and provide for 

the priority review for, devices, as determined by the Secretary— 

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, compared to existing approved alternatives, to reduce or eliminate 

the need for hospitalization, improve patient quality of life, 

facilitate patients’ ability to manage their own care (such as 

through self-directed personal assistance), or establish longterm clinical efficiencies; or 

‘‘(D) the availability of which is in the best interest of 

patients. 

‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a device may 

request that the Secretary designate such device for expedited 

development and priority review under this section. Any such 

request for designation may be made at any time prior to the 

submission of an application under section 515(c), a notification 

under section 510(k), or a petition for classification under section 

513(f)(2). 

‘‘(d) DESIGNATION PROCESS.— 

‘‘(1) IN GENERAL.—Not later than 60 calendar days after 

the receipt of a request under subsection (c), the Secretary 

shall determine whether the device that is the subject of the 

request meets the criteria described in subsection (b). If the 

Secretary determines that the device meets the criteria, the 

Secretary shall designate the device for expedited development 

and priority review. 

‘‘(2) REVIEW.—Review of a request under subsection (c) 

shall be undertaken by a team that is composed of experienced 

staff and senior managers of the Food and Drug Administration. 

‘‘(3) WITHDRAWAL.—The Secretary may not withdraw a designation granted under this section on the basis of the criteria 

under subsection (b) no longer applying because of the subsequent clearance or approval of another device that— 

‘‘(A) was designated under this section; or 

‘‘(B) was given priority review under section 515(d)(5), 

as in effect prior to the date of enactment of the 21st 

Century Cures Act. 

‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY REVIEW.— 

‘‘(1) ACTIONS.—For purposes of expediting the development 

and review of devices designated under subsection (d) the Secretary shall— 

‘‘(A) assign a team of staff, including a team leader 

with appropriate subject matter expertise and experience, 

for each device for which a request is submitted under 

subsection (c); 

‘‘(B) provide for oversight of the team by senior agency 

personnel to facilitate the efficient development of the 

device and the efficient review of any submission described 

in subsection (c) for the device; 

‘‘(C) adopt an efficient process for timely dispute resolution; 

‘‘(D) provide for interactive and timely communication 

with the sponsor of the device during the development 

program and review process; 


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‘‘(E) expedite the Secretary’s review of manufacturing 

and quality systems compliance, as applicable; 

‘‘(F) disclose to the sponsor, not less than 5 business 

days in advance, the topics of any consultation the Secretary intends to undertake with external experts or an 

advisory committee concerning the sponsor’s device and 

provide the sponsor the opportunity to recommend such 

external experts; 

‘‘(G) provide for advisory committee input, as the Secretary determines appropriate (including in response to 

the request of the sponsor) for applications submitted under 

section 515(c); and 

‘‘(H) assign staff to be available within a reasonable 

time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device 

pursuant to an exemption under section 520(g). 

‘‘(2) ADDITIONAL ACTIONS.—In addition to the actions 

described in paragraph (1), for purposes of expediting the 

development and review of devices designated under subsection 

(d), the Secretary, in collaboration with the device sponsor, 

may, as appropriate— 

‘‘(A) coordinate with the sponsor regarding early agreement on a data development plan; 

‘‘(B) take steps to ensure that the design of clinical 

trials is as efficient and flexible as practicable, when scientifically appropriate; 

‘‘(C) facilitate, when scientifically appropriate, expedited and efficient development and review of the device 

through utilization of timely postmarket data collection 

with regard to application for approval under section 515(c); 

and 

‘‘(D) agree in writing to clinical protocols that the Secretary will consider binding on the Secretary and the 

sponsor, subject to— 

‘‘(i) changes to such protocols agreed to in writing 

by the sponsor and the Secretary; or 

‘‘(ii) a decision, made by the director of the office 

responsible for reviewing the device submission, that 

a substantial scientific issue essential to determining 

the safety or effectiveness of such device exists, provided that such decision is in writing, and is made 

only after the Secretary provides to the device sponsor 

or applicant an opportunity for a meeting at which 

the director and the sponsor or applicant are present 

and at which the director documents the substantial 

scientific issue. 

‘‘(f) PRIORITY REVIEW GUIDANCE.— 

‘‘(1) CONTENT.—Not later than 1 year after the date of 

enactment of the 21st Century Cures Act, the Secretary shall 

issue guidance on the implementation of this section. Such 

guidance shall— 

‘‘(A) set forth the process by which a person may seek 

a designation under subsection (d); 

‘‘(B) provide a template for requests under subsection 

(c); 


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130 STAT. 1124 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and 

‘‘(D) identify the criteria and processes the Secretary 

will use to assign a team of staff, including team leaders, 

to review devices designated for expedited development 

and priority review, including any training required for 

such personnel to ensure effective and efficient review. 

‘‘(2) PROCESS.—Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a proposed guidance. 

‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to affect— 

‘‘(1) the criteria and standards for evaluating an application 

pursuant to section 515(c), a report and request for classification 

under section 513(f)(2), or a report under section 510(k), 

including the recognition of valid scientific evidence as 

described in section 513(a)(3)(B) and consideration and application of the least burdensome means of evaluating device 

effectiveness or demonstrating substantial equivalence between 

devices with differing technological characteristics, as 

applicable; 

‘‘(2) the authority of the Secretary with respect to clinical 

holds under section 520(g)(8)(A); 

‘‘(3) the authority of the Secretary to act on an application 

pursuant to section 515(d) before completion of an establishment inspection, as the Secretary determines appropriate; or 

‘‘(4) the authority of the Secretary with respect to 

postmarket surveillance under sections 519(h) and 522.’’. 

(b) DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.— 

Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360g–1(a)(1)) is amended by inserting ‘‘a request for 

designation under section 515C,’’ after ‘‘application under section 

515,’’. 

(c) TERMINATION OF PREVIOUS PROGRAM.— 

(1) IN GENERAL.—Section 515(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360e(d)) is amended— 

(A) by striking paragraph (5); and 

(B) by redesignating paragraph (6) as paragraph (5). 

(2) CONFORMING AMENDMENT.—Section 737(5) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is 

amended by striking ‘‘515(d)(6)’’ and inserting ‘‘515(d)(5)’’. 

(d) REPORT.—On January 1, 2019, the Secretary of Health 

and Human Services shall issue a report to the Committee on 

Health, Education, Labor, and Pensions of the Senate and the 

Committee on Energy and Commerce of the House of Representatives— 

(1) on the program under section 515C of the Federal 

Food, Drug, and Cosmetic Act, as added by subsection (a), 

in bringing safe and effective devices included in such program 

to patients as soon as possible; and 

(2) that includes recommendations, if any, to strengthen 

the program to better meet patient device needs in a manner 

as timely as possible. 

SEC. 3052. HUMANITARIAN DEVICE EXEMPTION. 

(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360j) is amended— 


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(1) in paragraph (1) by striking ‘‘fewer than 4,000’’ and 

inserting ‘‘not more than 8,000’’; 

(2) in paragraph (2)(A) by striking ‘‘fewer than 4,000’’ and 

inserting ‘‘not more than 8,000’’; and 

(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ and inserting 

‘‘8,000’’. 

(b) GUIDANCE DOCUMENT ON PROBABLE BENEFIT.—Not later 

than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that 

defines the criteria for establishing ‘‘probable benefit’’ as that term 

is used in section 520(m)(2)(C) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). 

SEC. 3053. RECOGNITION OF STANDARDS. 

(a) IN GENERAL.—Section 514(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360d(c)) is amended— 

(1) in paragraph (1), by inserting after subparagraph (B) 

the following new subparagraphs: 

‘‘(C)(i) Any person may submit a request for recognition under 

subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard 

organization. 

‘‘(ii) Not later than 60 calendar days after the Secretary receives 

such a request, the Secretary shall— 

‘‘(I) make a determination to recognize all, part, or none 

of the standard that is the subject of the request; and 

‘‘(II) issue to the person who submitted such request a 

response in writing that states the Secretary’s rationale for 

that determination, including the scientific, technical, regulatory, or other basis for such determination. 

‘‘(iii) The Secretary shall make a response issued under clause 

(ii)(II) publicly available, in such a manner as the Secretary determines appropriate. 

‘‘(iv) The Secretary shall take such actions as may be necessary 

to implement all or part of a standard recognized under clause 

(ii)(I), in accordance with subparagraph (A). 

‘‘(D) The Secretary shall make publicly available, in such 

manner as the Secretary determines appropriate, the rationale for 

recognition under subparagraph (A) of all, part, or none of a 

standard, including the scientific, technical, regulatory, or other 

basis for the decision regarding such recognition.’’; and 

(2) by adding at the end the following: 

‘‘(4) The Secretary shall provide to all employees of the Food 

and Drug Administration who review premarket submissions for 

devices periodic training on the concept and use of recognized 

standards for purposes of meeting a premarket submission requirement or other applicable requirement under this Act, including 

standards relevant to an employee’s area of device review.’’. 

(b) GUIDANCE.—The Secretary of Health and Human Services, 

acting through the Commissioner of Food and Drugs, shall review 

and update, if necessary, previously published guidance and 

standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards, 

under section 514(c) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360d(c)), taking into account the experience with and 

reliance on a standard by foreign regulatory authorities and the 

21 USC 360d 

note. 

21 USC 360j 

note. 


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130 STAT. 1126 PUBLIC LAW 114–255—DEC. 13, 2016 

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 enactment of the 21st Century Cures Act and at least once every 5 

years thereafter, as the Secretary determines appropriate, the Secretary shall identify, through publication in the Federal Register, 

any type of class I device that the Secretary determines no longer 

requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication— 

‘‘(A) each type of class I device so identified shall be exempt 

from the requirement for a report under subsection (k); and 

‘‘(B) the classification regulation applicable to each such 

type of device shall be deemed amended to incorporate such 

exemption.’’. 

(b) CLASS II DEVICES.—Section 510(m) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended— 

(1) by striking ‘‘(m)(1)’’ and all that follows through ‘‘by 

the Secretary.’’ and inserting the following: 

‘‘(m)(1) The Secretary shall— 

‘‘(A) not later than 90 days after the date of enactment 

of the 21st Century Cures Act and at least once every 5 years 

thereafter, as the Secretary determines appropriate— 

‘‘(i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary 

determines no longer requires a report under subsection 

(k) to provide reasonable assurance of safety and effectiveness; and 

‘‘(ii) provide for a period of not less than 60 calendar 

days for public comment beginning on the date of the 

publication of such notice; and 

‘‘(B) not later than 210 calendar days after the date of 

enactment of the 21st Century Cures Act, publish in the Federal 

Register a list representing the Secretary’s final determination 

with respect to the devices contained in the list published 

under subparagraph (A).’’; and 

(2) in paragraph (2)— 

(A) by striking ‘‘1 day after the date of publication 

of a list under this subsection,’’ and inserting ‘‘1 calendar 

day after the date of publication of the final list under 

paragraph (1)(B),’’; and 

(B) by striking ‘‘30-day period’’ and inserting ‘‘60-calendar-day period’’; and 

(C) by adding at the end the following new paragraph: 

‘‘(3) Upon the publication of the final list under paragraph 

(1)(B)— 

‘‘(A) each type of class II device so listed shall be exempt 

from the requirement for a report under subsection (k); and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1127 

‘‘(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 recommendations on the expertise needed among the voting members of the panel. 

‘‘(C) For purposes of subparagraph (B)(i), the term ‘adequate 

expertise’ means that the membership of the classification panel 

includes— 

‘‘(i) two or more voting members, with a specialty or other 

expertise clinically relevant to the device under review; and 

‘‘(ii) at least one voting member who is knowledgeable 

about the technology of the device. 

‘‘(D) The Secretary shall provide an annual opportunity for 

patients, representatives of patients, and sponsors of medical device 

submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification 

panels.’’. 

(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended— 

(1) in subparagraph (A)(iii), by inserting before the period 

at the end ‘‘, including, subject to the discretion of the panel 

chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel 

for the purpose of correcting misstatements of fact or providing 

clarifying information, and permitting the person or representative to call on experts within the person’s organization to 

address such specific issues in the time provided’’; and 

(2) by striking subparagraph (B) and inserting the following 

new subparagraph: 

‘‘(B)(i) Any meeting of a classification panel with respect to 

the review of a device shall— 

‘‘(I) provide adequate time for initial presentations by the 

person whose device is specifically the subject of such review 

and by the Secretary; and 

‘‘(II) encourage free and open participation by all interested 

persons. 

‘‘(ii) Following the initial presentations described in clause (i), 

the panel may— 

‘‘(I) pose questions to a designated representative described 

in subparagraph (A)(iii); and 


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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 institutional’’ and inserting ‘‘an institutional’’; and 

(2) in subsection (m)(4)— 

(A) by striking subparagraph (A) and inserting the 

following: 

‘‘(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in 

accordance with the regulations of the Secretary; and’’; 

(B) in subparagraph (B), by striking ‘‘a local institutional’’ and inserting ‘‘an institutional’’; and 

(C) in the matter following subparagraph (B), by 

striking ‘‘local’’. 

SEC. 3057. CLIA WAIVER IMPROVEMENTS. 

(a) DRAFT REVISED GUIDANCE.—Not later than 1 year after 

the date of the enactment of this Act, the Secretary of Health 

and Human Services, acting through the Commissioner of Food 

and Drugs, shall publish a draft guidance that— 

(1) revises ‘‘Section V. Demonstrating Insignificant Risk 

of an Erroneous Result – Accuracy’’ of the guidance entitled 

‘‘Recommendations for Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’ and dated January 30, 

2008; and 

(2) includes the appropriate use of comparable performance 

between a waived user and a moderately complex laboratory 

user to demonstrate accuracy. 

(b) FINAL REVISED GUIDANCE.—The Secretary of Health and 

Human Services, acting through the Commissioner of Food and 

Drugs, shall finalize the draft guidance published under subsection 

(a) not later than 1 year after the comment period for such draft 

guidance closes. 

SEC. 3058. LEAST BURDENSOME DEVICE REVIEW. 

(a) IN GENERAL.—Section 513 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 

the following: 

‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDENSOME REQUIREMENTS.— 

‘‘(1) The Secretary shall— 

‘‘(A) ensure that each employee of the Food and Drug 

Administration who is involved in the review of premarket 

submissions, including supervisors, receives training 

regarding the meaning and implementation of the least 

burdensome requirements under subsections (a)(3)(D) and 

(i)(1)(D) of this section and section 515(c)(5); and 

‘‘(B) periodically assess the implementation of the least 

burdensome requirements, including the employee training 

42 USC 263a 

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under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied. 

‘‘(2) Not later than 18 months after the date of enactment 

of the 21st Century Cures Act, the ombudsman for any 

organizational unit of the Food and Drug Administration 

responsible for the premarket review of devices shall— 

‘‘(A) conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training 

in implementing the least burdensome requirements; 

‘‘(B) include in such audit interviews of persons who 

are representatives of the device industry regarding their 

experiences in the device premarket review process, 

including with respect to the application of least burdensome concepts to premarket review and decisionmaking; 

‘‘(C) include in such audit a list of the measurement 

tools the Secretary uses to assess the implementation of 

the least burdensome requirements, including under paragraph (1)(B) and section 517A(a)(3), and may also provide 

feedback on the effectiveness of such tools in the 

implementation of the least burdensome requirements; 

‘‘(D) summarize the findings of such audit in a final 

audit report; and 

‘‘(E) within 30 calendar days of completion of such 

final audit report, make such final audit report available— 

‘‘(i) to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives; 

and 

‘‘(ii) on the Internet website of the Food and Drug 

Administration.’’. 

(b) PREMARKET APPLICATIONS.—Section 515(c) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by 

adding at the end the following: 

‘‘(5)(A) In requesting additional information with respect to 

an application under this section, the Secretary shall consider the 

least burdensome appropriate means necessary to demonstrate a 

reasonable assurance of device safety and effectiveness. 

‘‘(B) For purposes of subparagraph (A), the term ‘necessary’ 

means the minimum required information that would support a 

determination by the Secretary that an application provides a 

reasonable assurance of the safety and effectiveness of the device. 

‘‘(C) For purposes of this paragraph, the Secretary shall consider 

the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device 

safety and effectiveness. 

‘‘(D) Nothing in this paragraph alters the standards for premarket approval of a device.’’. 

(c) RATIONALE FOR SIGNIFICANT DECISIONS REGARDING

DEVICES.—Section 517A(a) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360g–1(a)) is amended by adding at the end the 

following: 

‘‘(3) APPLICATION OF LEAST BURDENSOME REQUIREMENTS.— 

The substantive summary required under this subsection shall 

include a brief statement regarding how the least burdensome 

requirements were considered and applied consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as 

applicable.’’. 


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SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIREMENT. 

(a) IN GENERAL.—Section 510 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360) is amended by adding at the end 

the following: 

‘‘(q) REUSABLE MEDICAL DEVICES.— 

‘‘(1) IN GENERAL.—Not later than 180 days after the date 

of enactment of the 21st Century Cures Act, the Secretary 

shall identify and publish a list of reusable device types for 

which reports under subsection (k) are required to include— 

‘‘(A) instructions for use, which have been validated 

in a manner specified by the Secretary; and 

‘‘(B) validation data, the types of which shall be specified by the Secretary; 

regarding cleaning, disinfection, and sterilization, and for which 

a substantial equivalence determination may be based. 

‘‘(2) REVISION OF LIST.—The Secretary shall revise the list 

under paragraph (2), as the Secretary determines appropriate, 

with notice in the Federal Register. 

‘‘(3) CONTENT OF REPORTS.—Reports under subsection (k) 

that are submitted after the publication of the list described 

in paragraph (1), for devices or types of devices included on 

such list, shall include such instructions for use and validation 

data.’’. 

(b) DEVICE MODIFICATIONS.—The Secretary of Health and 

Human Services, acting through the Commissioner of Food and 

Drugs, shall issue final guidance regarding when a premarket 

notification under section 510(k) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for 

a modification or change to a legally marketed device. Such final 

guidance shall be issued not later than 1 year after the date 

on which the comment period closes for the draft guidance on 

such subject. 

SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION. 

(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end 

the following: 

‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECISIONS SUPPORT

SOFTWARE.— 

‘‘(1) The term device, as defined in section 201(h), shall 

not include a software function that is intended— 

‘‘(A) for administrative support of a health care facility, 

including the processing and maintenance of financial 

records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, 

analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit 

eligibility, population health management, and laboratory 

workflow; 

‘‘(B) for maintaining or encouraging a healthy lifestyle 

and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; 

‘‘(C) to serve as electronic patient records, including 

patient-provided information, to the extent that such 

records are intended to transfer, store, convert formats, 

21 USC 360 note. 


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or display the equivalent of a paper medical chart, so 

long as— 

‘‘(i) such records were created, stored, transferred, 

or reviewed by health care professionals, or by individuals working under supervision of such professionals; 

‘‘(ii) such records are part of health information 

technology that is certified under section 3001(c)(5) 

of the Public Health Service Act; and 

‘‘(iii) such function is not intended to interpret 

or analyze patient records, including medical image 

data, for the purpose of the diagnosis, cure, mitigation, 

prevention, or treatment of a disease or condition; 

‘‘(D) for transferring, storing, converting formats, or 

displaying clinical laboratory test or other device data and 

results, findings by a health care professional with respect 

to such data and results, general information about such 

findings, and general background information about such 

laboratory test or other device, unless such function is 

intended to interpret or analyze clinical laboratory test 

or other device data, results, and findings; or 

‘‘(E) unless the function is intended to acquire, process, 

or analyze a medical image or a signal from an in vitro 

diagnostic device or a pattern or signal from a signal 

acquisition system, for the purpose of— 

‘‘(i) displaying, analyzing, or printing medical 

information about a patient or other medical information (such as peer-reviewed clinical studies and clinical 

practice guidelines); 

‘‘(ii) supporting or providing recommendations to 

a health care professional about prevention, diagnosis, 

or treatment of a disease or condition; and 

‘‘(iii) enabling such health care professional to 

independently review the basis for such recommendations that such software presents so that it is not 

the intent that such health care professional rely primarily on any of such recommendations to make a 

clinical diagnosis or treatment decision regarding an 

individual patient. 

‘‘(2) In the case of a product with multiple functions that 

contains— 

‘‘(A) at least one software function that meets the 

criteria under paragraph (1) or that otherwise does not 

meet the definition of device under section 201(h); and 

‘‘(B) at least one function that does not meet the criteria 

under paragraph (1) and that otherwise meets the definition of a device under section 201(h), 

the Secretary shall not regulate the software function of such 

product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety 

and effectiveness of the device function or functions of such 

product described in subparagraph (B), the Secretary may 

assess the impact that the software function or functions 

described in subparagraph (A) have on such device function 

or functions. 

‘‘(3)(A) Notwithstanding paragraph (1), a software function 

described in subparagraph (C), (D), or (E) of paragraph (1) 


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shall not be excluded from the definition of device under section 

201(h) if— 

‘‘(i) the Secretary makes a finding that use of such 

software function would be reasonably likely to have 

serious adverse health consequences; and 

‘‘(ii) the software function has been identified in a 

final order issued by the Secretary under subparagraph 

(B). 

‘‘(B) Subparagraph (A) shall apply only if the Secretary— 

‘‘(i) publishes a notification and proposed order in the 

Federal Register; 

‘‘(ii) includes in such notification the Secretary’s 

finding, including the rationale and identification of the 

evidence on which such finding was based, as described 

in subparagraph (A)(i); and 

‘‘(iii) provides for a period of not less than 30 calendar 

days for public comment before issuing a final order or 

withdrawing such proposed order. 

‘‘(C) In making a finding under subparagraph (A)(i) with 

respect to a software function, the Secretary shall consider— 

‘‘(i) the likelihood and severity of patient harm if the 

software function were to not perform as intended; 

‘‘(ii) the extent to which the software function is 

intended to support the clinical judgment of a health care 

professional; 

‘‘(iii) whether there is a reasonable opportunity for 

a health care professional to review the basis of the 

information or treatment recommendation provided by the 

software function; and 

‘‘(iv) the intended user and user environment, such 

as whether a health care professional will use a software 

function of a type described in subparagraph (E) of paragraph (1). 

‘‘(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to— 

‘‘(A) exercise enforcement discretion as to any device 

subject to regulation under this Act; 

‘‘(B) regulate software used in the manufacture and 

transfusion of blood and blood components to assist in 

the prevention of disease in humans; or 

‘‘(C) regulate software as a device under this Act if 

such software meets the criteria under section 

513(a)(1)(C).’’. 

(b) REPORTS.—The Secretary of Health and Human Services 

(referred to in this subsection as the ‘‘Secretary’’), after consultation 

with agencies and offices of the Department of Health and Human 

Services involved in health information technology, shall publish 

a report, not later than 2 years after the date of enactment of 

this Act and every 2 years thereafter, that— 

(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup 

companies, health plans or other third-party payers, venture 

capital investors, information technology vendors, health 

information technology vendors, small businesses, purchasers, 

employers, and other stakeholders with relevant expertise, as 

determined by the Secretary; 

21 USC 360j 

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(2) examines information available to the Secretary on 

any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360j) (as amended by subsection 

(a)); and 

(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to 

promote safety, education, and competency related to such functions. 

(c) CLASSIFICATION OF ACCESSORIES.—Section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended 

by adding at the end the following: 

‘‘(9) The Secretary shall classify an accessory under this section 

based on the intended use of the accessory, notwithstanding the 

classification of any other device with which such accessory is 

intended to be used.’’. 

(d) CONFORMING AMENDMENT.—Section 201(h) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by 

adding at the end the following: ‘‘The term ‘device’ does not include 

software functions excluded pursuant to section 520(o).’’. 

Subtitle G—Improving Scientific Expertise 

and Outreach at FDA 

SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE. 

(a) HIRING AND RETENTION AUTHORITY.—Section 228 of the 

Public Health Service Act (42 U.S.C. 237) is amended— 

(1) in the section heading, by inserting ‘‘AND BIOMEDICAL

PRODUCT ASSESSMENT’’ after ‘‘RESEARCH’’; 

(2) in subsection (a)— 

(A) in paragraph (1), by striking ‘‘Silvio O. Conte Senior 

Biomedical Research Service, not to exceed 500 members’’ 

and inserting ‘‘Silvio O. Conte Senior Biomedical Research 

and Biomedical Product Assessment Service (in this section 

referred to as the ‘Service’), not to exceed 2,000 members, 

the purpose of which is to recruit and retain outstanding 

and qualified scientific and technical experts in the fields 

of biomedical research, clinical research evaluation, and 

biomedical product assessment’’; 

(B) by amending paragraph (2) to read as follows: 

‘‘(2) The authority established in paragraph (1) may not be 

construed to require the Secretary to reduce the number of 

employees serving under any other employment system in order 

to offset the number of members serving in the Service.’’; and 

(C) by adding at the end the following: 

‘‘(3) The Secretary shall assign experts under this section to 

agencies within the Department of Health and Human Services 

taking into account the need for the expertise of such expert.’’; 

(3) in subsection (b)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘or clinical research evaluation’’ and inserting ‘‘, clinical 

research evaluation, or biomedical product assessment’’; 

and 


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(B) in paragraph (1), by inserting ‘‘or a doctoral or 

master’s level degree in engineering, bioinformatics, or a 

related or emerging field,’’ after the comma; 

(4) in subsection (d)(2), by striking ‘‘and shall not exceed 

the rate payable for level I of the Executive Schedule unless 

approved by the President under section 5377(d)(2) of title 

5, United States Code’’ and inserting ‘‘and shall not exceed 

the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code’’; 

(5) by striking subsection (e); and 

(6) by redesignating subsections (f) and (g) as subsections 

(e) and (f), respectively. 

(b) GAO STUDY.— 

(1) IN GENERAL.—The Comptroller General of the United 

States shall conduct a study of the effectiveness of the amendments to section 228 of the Public Health Service Act (42 

U.S.C. 237) made by subsection (a) and the impact of such 

amendments, if any, on all agencies or departments of the 

Department of Health and Human Services, and, not later 

than 4 years after the date of enactment of this Act, shall 

submit a report based on such study to the Committee on 

Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of Representatives. 

(2) CONTENT OF STUDY AND REPORT.—The study and report 

under paragraph (1) shall include an examination of the extent 

to which recruitment and retention of outstanding and qualified 

scientific, medical, or technical experts in the fields of biomedical research, clinical research evaluation, and biomedical 

product assessment have improved or otherwise have been 

affected by the amendments to section 228 of the Public Health 

Service Act (42 U.S.C. 237) made by subsection (a), including 

by determining, during the period between the date of enactment of this Act and the completion of the study— 

(A) the total number of members recruited and retained 

under the Senior Biomedical Research and Biomedical 

Product Assessment Service under such section 228, and 

the effect of increasing the number of members eligible 

for such Service; 

(B) the number of members of such Senior Biomedical 

Research and Biomedical Product Assessment Service hired 

with a doctoral level degree in biomedicine or a related 

field, and the number of such members hired with a doctoral or master’s level degree in engineering, bioinformatics, 

or a related or emerging field; and 

(C) the number of Senior Biomedical Research and 

Biomedical Product Assessment Service members that have 

been hired by each agency or department of the Department 

of Health and Human Services, and how such Department 

assigns such members to each agency or department. 

SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 

PROFESSIONAL PERSONNEL. 

(a) IN GENERAL.—The Federal Food, Drug, and Cosmetic Act 

is amended by inserting after section 714 (21 U.S.C. 379d–3) the 

following: 


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‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 

PROFESSIONAL PERSONNEL. 

‘‘(a) IN GENERAL.—The Secretary may, notwithstanding title 

5, United States Code, governing appointments in the competitive 

service, appoint outstanding and qualified candidates to scientific, 

technical, or professional positions that support the development, 

review, and regulation of medical products. Such positions shall 

be within the competitive service. 

‘‘(b) COMPENSATION.— ‘‘(1) IN GENERAL.—Notwithstanding any other provision of 

law, including any requirement with respect to General 

Schedule pay rates under subchapter III of chapter 53 of title 

5, United States Code, and consistent with the requirements 

of paragraph (2), the Commissioner of Food and Drugs may 

determine and set— 

‘‘(A) the annual rate of pay of any individual appointed 

under subsection (a); and 

‘‘(B) for purposes of retaining qualified employees, the 

annual rate of pay for any qualified scientific, technical, 

or professional personnel appointed to a position described 

in subsection (a) before the date of enactment of the 21st 

Century Cures Act. 

‘‘(2) LIMITATION.—The annual rate of pay established 

pursuant to paragraph (1) may not exceed the amount of annual 

compensation (excluding expenses) specified in section 102 of 

title 3, United States Code. 

‘‘(3) PUBLIC AVAILABILITY.—The annual rate of pay provided 

to an individual in accordance with this section shall be publicly 

available information. 

‘‘(c) RULE OF CONSTRUCTION.—The authorities under this section shall not be construed to affect the authority provided under 

section 714. 

‘‘(d) REPORT ON WORKFORCE PLANNING.— 

‘‘(1) IN GENERAL.—Not later than 18 months after the date 

of enactment of the 21st Century Cures Act, the Secretary 

shall submit a report on workforce planning to the Committee 

on Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of Representatives that examines the extent to which the Food and 

Drug Administration has a critical need for qualified individuals 

for scientific, technical, or professional positions, including— 

‘‘(A) an analysis of the workforce needs at the Food 

and Drug Administration and the Secretary’s strategic plan 

for addressing such needs, including through use of the 

authority under this section; and 

‘‘(B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which 

may include the use of— 

‘‘(i) recruitment through nongovernmental recruitment or placement agencies; 

‘‘(ii) recruitment through academic institutions; 

‘‘(iii) recruitment or hiring bonuses, if applicable; 

‘‘(iv) recruitment using targeted direct hiring 

authorities; and 

‘‘(v) retention of qualified scientific, technical, and 

professional employees using the authority under this 

section, or other applicable authorities of the Secretary. 

21 USC 379d–3a. 


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‘‘(2) RECOMMENDATIONS.—The report under paragraph (1) 

may include the recommendations of the Commissioner of Food 

and Drugs that would help the Food and Drug Administration 

to better recruit and retain qualified individuals for scientific, 

technical, or professional positions at the agency.’’. 

(b) GAO STUDY AND REPORT.— (1) IN GENERAL.—The Comptroller General of the United 

States shall conduct a study of the ability of the Food and 

Drug Administration to hire, train, and retain qualified scientific, technical, and professional staff, not including contractors, necessary to fulfill the mission of the Food and Drug 

Administration to protect and promote public health. Not later 

than January 1, 2022, the Comptroller General shall submit 

a report on such study to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives. 

(2) CONTENTS OF STUDY.—The Comptroller General shall 

include in the study and report under paragraph (1)— 

(A) information about the progress of the Food and 

Drug Administration in recruiting and retaining qualified 

scientific, technical, and professional staff outstanding in 

the field of biomedical research, clinical research evaluation, and biomedical product assessment; 

(B) the extent to which critical staffing needs exist 

at the Food and Drug Administration, and barriers to 

hiring, training, and retaining qualified staff, if any; 

(C) an examination of the recruitment and retention 

strategies of the Food and Drug Administration, including 

examining any strategic workforce plan, focused on 

improving scientific, technical, and professional staff 

recruitment and retention; and 

(D) recommendations for potential improvements that 

would address staffing needs of the Food and Drug 

Administration. 

SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION 

INTERCENTER INSTITUTES. 

(a) IN GENERAL.—Chapter X of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at 

the end the following: 

‘‘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 processes for coordination of activities, as applicable to such major 

disease area or areas, among the Center for Drug Evaluation and 

Research, the Center for Biologics Evaluation and Research, and 

the Center for Devices and Radiological Health (for the purposes 

of this section, referred to as the ‘Centers’). Such activities may 

include— 

‘‘(1) coordination of staff from the Centers with diverse 

product expertise in the diagnosis, cure, mitigation, treatment, 

or prevention of the specific diseases relevant to the major 

disease area of focus of the Institute; 

21 USC 399g. 


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‘‘(2) streamlining, where appropriate, the review of medical 

products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of 

the Institute, applying relevant standards under sections 505, 

510(k), 513(f)(2), and 515 of this Act and section 351 of the 

Public Health Service Act, and other applicable authorities; 

‘‘(3) promotion of scientific programs within the Centers 

related to the major disease area of focus of the Institute; 

‘‘(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education 

opportunities for the personnel of the Centers with expertise 

related to the major disease area of focus of the Institute; 

‘‘(5) enhancement of the interactions of the Centers with 

patients, sponsors, and the external biomedical community 

regarding the major disease area of focus of the Institute; 

and 

‘‘(6) facilitation of the collaborative relationships of the 

Centers with other agencies within the Department of Health 

and Human Services regarding the major disease area of focus 

of the Institute. 

‘‘(b) PUBLIC PROCESS.—The Secretary shall provide a period 

for public comment during the time that each Institute is being 

implemented. 

‘‘(c) TIMING.—The Secretary shall establish at least one 

Institute under subsection (a) before the date that is 1 year after 

the date of enactment of the 21st Century Cures Act. 

‘‘(d) TERMINATION OF INSTITUTES.—The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public 

health. Not less than 60 days prior to so terminating an Institute, 

the Secretary shall provide public notice, including the rationale 

for such termination.’’. 

(b) TECHNICAL AMENDMENTS.—Chapter X of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended— 

(1) by redesignating section 1012 as section 1013; and 

(2) by redesignating the second section 1011 (with respect 

to improving the training of State, local, territorial, and tribal 

food safety officials), as added by section 209(a) of the FDA 

Food Safety Modernization Act (Public Law 111–353), as section 

1012. 

SEC. 3074. SCIENTIFIC ENGAGEMENT. 

(a) IN GENERAL.—Scientific meetings that are attended by scientific or medical personnel, or other professionals, of the Department of Health and Human Services for whom attendance at such 

meeting is directly related to their professional duties and the 

mission of the Department— 

(1) shall not be considered conferences for the purposes 

of complying with Federal reporting requirements contained 

in annual appropriations Acts or in this section; and 

(2) shall not be considered conferences for purposes of 

a restriction contained in an annual appropriations Act, based 

on Office of Management and Budget Memorandum M-12-12 

or any other regulation restricting travel to such meeting. 

(b) LIMITATION.—Nothing in this section shall be construed 

to exempt travel for scientific meetings from Federal regulations 

relating to travel. 

42 USC 3506a. 


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(c) REPORTS.—Not later than 90 days after the end of the 

fiscal year, each operating division of the Department of Health 

and Human Services shall prepare, and post on an Internet website 

of the operating division, an annual report on scientific meeting 

attendance and related travel spending for each fiscal year. Such 

report shall include— 

(1) general information concerning the scientific meeting 

activities involved; 

(2) information concerning the total amount expended for 

such meetings; 

(3) a description of all such meetings that were attended 

by scientific or medical personnel, or other professionals, of 

each such operating division where the total amount expended 

by the operating division associated with each such meeting 

were in excess of $30,000, including— 

(A) the total amount of meeting expenses incurred 

by the operating division for such meeting; 

(B) the location of such meeting; 

(C) the date of such meeting; 

(D) a brief explanation on how such meeting advanced 

the mission of the operating division; and 

(E) the total number of individuals whose travel 

expenses or other scientific meeting expenses were paid 

by the operating division; and 

(4) with respect to any such meeting where the total 

expenses to the operating division exceeded $150,000, a description of the exceptional circumstances that necessitated the 

expenditure of such amounts. 

SEC. 3075. DRUG SURVEILLANCE. 

(a) NEW DRUGS.—Section 505(k)(5) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 

2074, is further amended— 

(1) in subparagraph (A), by striking ‘‘, bi-weekly screening’’ 

and inserting ‘‘screenings’’; 

(2) in subparagraph (B), as redesignated by section 

2074(1)(C), by striking the period at the end and inserting 

‘‘; and’’; and 

(3) by adding at the end the following: 

‘‘(C) make available on the Internet website of the Food 

and Drug Administration— 

‘‘(i) guidelines, developed with input from experts qualified by scientific training and experience to evaluate the 

safety and effectiveness of drugs, that detail best practices 

for drug safety surveillance using the Adverse Event 

Reporting System; and 

‘‘(ii) criteria for public posting of adverse event signals.’’. 

(b) FAERS REVISION.—Section 505(r)(2)(D) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by 

striking ‘‘, by 18 months’’ and all that follows through the semicolon 

at the end of the subparagraph and inserting ‘‘and making publicly 

available on the Internet website established under paragraph (1) 

best practices for drug safety surveillance activities for drugs 

approved under this section or section 351 of the Public Health 

Service Act;’’. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1139 

(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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) 

is amended— 

(A) by redesignating clause (ii) as clause (iii); 

(B) by inserting after clause (i) the following: 

‘‘(ii) ADDITIONAL MEMBERS.—The Board, through 

amendments to the bylaws of the Foundation, may 

provide that the number of voting members of the 

Board shall be a number (to be specified in such 

amendment) greater than 14. Any Board positions that 

are established by any such amendment shall be 

appointed (by majority vote) by the individuals who, 

as of the date of such amendment, are voting members 

of the Board and persons so appointed may represent 

any of the categories specified in subclauses (I) through 

(V) of clause (i), so long as no more than 30 percent 

of the total voting members of the Board (including 

members whose positions are established by such 

amendment) are representatives of the general 

pharmaceutical, device, food, cosmetic, and biotechnology industries.’’; and 

(C) in clause (iii)(I), as redesignated by subparagraph 

(A), by striking ‘‘The ex officio members shall ensure’’ and 

inserting ‘‘The ex officio members, acting pursuant to clause 

(i), and the Board, acting pursuant to clause (ii), shall 

ensure’’. 

(2) FEDERAL EMPLOYEES ALLOWED TO SERVE ON BOARD.— 

Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated 

by paragraph (1)(A), is amended by adding at the end the 

following: ‘‘For purposes of this section, the term ‘employee 

of the Federal Government’ does not include a special Government employee, as that term is defined in section 202(a) of 

title 18, United States Code.’’. 

(3) STAGGERED TERMS.—Subparagraph (A) of section 

770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379dd(d)(3)) is amended to read as follows: 

‘‘(A) TERM.—The term of office of each member of the 

Board appointed under paragraph (1)(C)(i), and the term 

of office of any member of the Board whose position is 

established pursuant to paragraph (1)(C)(ii), shall be 4 

years, except that— 

‘‘(i) the terms of offices for the members of the 

Board initially appointed under paragraph (1)(C)(i) 


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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 paragraph (1)(C)(ii) may be made to expire on a staggered 

basis, as determined by the individuals who, as of 

the date of the amendment establishing such positions, 

are members of the Board.’’. 

(b) EXECUTIVE DIRECTOR COMPENSATION.—Section 770(g)(2) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) 

is amended by striking ‘‘but shall not be greater than the compensation of the Commissioner’’. 

(c) SEPARATION OF FUNDS.—Section 770(m) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking 

‘‘are held in separate accounts from funds received from entities 

under subsection (i)’’ and inserting ‘‘are managed as individual 

programmatic funds under subsection (i), according to best 

accounting practices’’. 

Subtitle H—Medical Countermeasures 

Innovation 

SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES. 

Section 319F–2 of the Public Health Service Act (42 U.S.C. 

247d–6b) is amended— 

(1) in subsection (a), by adding at the end the following: 

‘‘(3) UTILIZATION GUIDELINES.—The Secretary shall ensure 

timely and accurate recommended utilization guidelines for 

qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products (as defined in section 

319F–3), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.’’; and 

(2) in subsection (g)— 

(A) by amending paragraph (4) to read as follows: 

‘‘(4) REPORT ON SECURITY COUNTERMEASURE PROCUREMENT.—Not later than March 1 of each year in which the 

Secretary determines that the amount of funds available for 

procurement of security countermeasures is less than 

$1,500,000,000, the Secretary shall submit to the Committee 

on Appropriations and the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the 

House of Representatives a report detailing the amount of 

such funds available for procurement and the impact such 

amount of funding will have— 

‘‘(A) in meeting the security countermeasure needs 

identified under this section; and 

‘‘(B) on the annual Public Health Emergency Medical 

Countermeasures Enterprise and Strategy Implementation 

Plan (pursuant to section 2811(d)).’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1141 

‘‘(5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Secretary, acting through the Director of the Biomedical Advanced 

Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement 

of security countermeasures under subsection (c) and for carrying out section 319L), including the execution of procurement 

contracts, grants, and cooperative agreements pursuant to this 

section and section 319L.’’. 

(b) BARDA CONTRACTING AUTHORITY.—Section 319L(c)(3) of 

the Public Health Service Act (42 U.S.C. 247d–7c) is amended 

by inserting ‘‘, including the execution of procurement contracts, 

grants, and cooperative agreements pursuant to this section’’ before 

the period. 

SEC. 3083. COUNTERMEASURE BUDGET PLAN. 

Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 

300hh–10(b)(7)) is amended— 

(1) in the matter preceding subparagraph (A), by striking 

the first sentence and inserting ‘‘Develop, and update not later 

than March 1 of each year, a coordinated 5-year budget plan 

based on the medical countermeasure priorities described in 

subsection (d), including with respect to chemical, biological, 

radiological, and nuclear agent or agents that may present 

a threat to the Nation, including such agents that are novel 

or emerging infectious diseases, and the corresponding efforts 

to develop qualified countermeasures (as defined in section 

319F–1), security countermeasures (as defined in section 319F– 

2), and qualified pandemic or epidemic products (as defined 

in section 319F–3) for each such threat.’’; 

(2) in subparagraph (C), by striking ‘‘; and’’ and inserting 

a semicolon; 

(3) in subparagraph (D), by striking ‘‘to the appropriate 

committees of Congress upon request.’’ and inserting ‘‘, not 

later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and 

Pensions of the Senate and the Committee on Appropriations 

and the Committee on Energy and Commerce of the House 

of Representatives; and’’; and 

(4) by adding at the end the following: 

‘‘(E) not later than March 15 of each year, be made 

publicly available in a manner that does not compromise 

national security.’’. 

SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION. 

Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 

247d–7e(c)(4)) is amended by adding at the end the following: 

‘‘(E) MEDICAL COUNTERMEASURES INNOVATION

PARTNER.— 

‘‘(i) IN GENERAL.—To support the purposes 

described in paragraph (2), the Secretary, acting 

through the Director of BARDA, may enter into an 

agreement (including through the use of grants, contracts, cooperative agreements, or other transactions 

as described in paragraph (5)) with an independent, 

nonprofit entity to— 

‘‘(I) foster and accelerate the development and 

innovation of medical countermeasures and technologies that may assist advanced research and 


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130 STAT. 1142 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 practices and methods; 

‘‘(II) promote the development of new and 

promising technologies that address urgent medical countermeasure needs, as identified by the 

Secretary; 

‘‘(III) address unmet public health needs that 

are directly related to medical countermeasure 

requirements, such as novel antimicrobials for 

multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and 

‘‘(IV) provide expert consultation and advice 

to foster viable medical countermeasure 

innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, 

biological, radiological, and nuclear countermeasure products. 

‘‘(ii) ELIGIBILITY.— 

‘‘(I) IN GENERAL.—To be eligible to enter into 

an agreement under clause (i) an entity shall— 

‘‘(aa) be an independent, nonprofit entity; 

‘‘(bb) have a demonstrated record of being 

able to create linkages between innovators and 

investors and leverage such partnerships and 

resources for the purpose of addressing identified strategic needs of the Federal Government; 

‘‘(cc) have experience in promoting novel 

technology innovation; 

‘‘(dd) be problem-driven and solutionfocused based on the needs, requirements, and 

problems identified by the Secretary under 

clause (iv); 

‘‘(ee) demonstrate the ability, or the potential ability, to promote the development of 

medical countermeasure products; 

‘‘(ff) demonstrate expertise, or the capacity 

to develop or acquire expertise, related to technical and regulatory considerations with 

respect to medical countermeasures; and 

‘‘(gg) not be within the Department of 

Health and Human Services. 

‘‘(II) PARTNERING EXPERIENCE.—In selecting 

an entity with which to enter into an agreement 

under clause (i), the Secretary shall place a high 

value on the demonstrated experience of the entity 

in partnering with the Federal Government to 

meet identified strategic needs. 

‘‘(iii) NOT AGENCY.—An entity that enters into an 

agreement under clause (i) shall not be deemed to 

be a Federal agency for any purpose, including for 

any purpose under title 5, United States Code. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1143 

‘‘(iv) DIRECTION.—Pursuant to an agreement 

entered into under this subparagraph, the Secretary, 

acting through the Director of BARDA, shall provide 

direction to the entity that enters into an agreement 

under clause (i). As part of this agreement the Director 

of BARDA shall— 

‘‘(I) communicate the medical countermeasure 

needs, requirements, and problems to be addressed 

by the entity under the agreement; 

‘‘(II) develop a description of work to be performed by the entity under the agreement; 

‘‘(III) provide technical feedback and appropriate oversight over work carried out by the entity 

under the agreement, including subsequent 

development and partnerships consistent with the 

needs and requirements set forth in this subparagraph; 

‘‘(IV) ensure fair consideration of products 

developed under the agreement in order to maintain competition to the maximum practical extent, 

as applicable and appropriate under applicable 

provisions of this section; and 

‘‘(V) ensure, as a condition of the agreement 

that the entity— 

‘‘(aa) has in place a comprehensive set 

of policies that demonstrate a commitment to 

transparency and accountability; 

‘‘(bb) protects against conflicts of interest 

through a comprehensive set of policies that 

address potential conflicts of interest, ethics, 

disclosure, and reporting requirements; 

‘‘(cc) provides monthly accounting on the 

use of funds provided under such agreement; 

and 

‘‘(dd) provides on a quarterly basis, reports 

regarding the progress made toward meeting 

the identified needs set forth in the agreement. 

‘‘(v) SUPPLEMENT NOT SUPPLANT.—Activities carried out under this subparagraph shall supplement, 

and not supplant, other activities carried out under 

this section. 

‘‘(vi) NO ESTABLISHMENT OF ENTITY.—To prevent 

unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed 

to authorize the Secretary to establish within the 

Department of Health and Human Services an entity 

for the purposes of carrying out this subparagraph. 

‘‘(vii) TRANSPARENCY AND OVERSIGHT.—Upon 

request, the Secretary shall provide to Congress the 

information provided to the Secretary under clause 

(iv)(V)(dd). 

‘‘(viii) INDEPENDENT EVALUATION.—Not later than 

4 years after the date of enactment of the 21st Century 

Cures Act, the Comptroller General of the United 

States shall conduct an independent evaluation, and 

submit to the Secretary and the appropriate committees of Congress a report, concerning the activities 


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130 STAT. 1144 PUBLIC LAW 114–255—DEC. 13, 2016 

conducted under this subparagraph. Such report shall 

include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph. 

‘‘(ix) SUNSET.—This subparagraph shall have no 

force or effect after September 30, 2022.’’. 

SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT. 

Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 

247d–6b(c)) is amended— 

(1) in paragraph (4)(A)(ii), by striking ‘‘make a recommendation under paragraph (6) that the special reserve fund 

as defined in subsection (h) be made available for the procurement of such countermeasure’’ and inserting ‘‘and subject to 

the availability of appropriations, make available the special 

reserve fund as defined in subsection (h) for procurement of 

such countermeasure, as applicable’’; 

(2) in paragraph (6)— 

(A) by striking subparagraphs (A), (B), and (E); 

(B) by redesignating subparagraphs (C) and (D) as 

subparagraphs (A) and (B), respectively; 

(C) by amending subparagraph (A), as so redesignated, 

to read as follows: 

‘‘(A) NOTICE TO APPROPRIATE CONGRESSIONAL COMMITTEES.—The Secretary shall notify the Committee on Appropriations and the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce 

of the House of Representatives of each decision to make 

available the special reserve fund as defined in subsection 

(h) for procurement of a security countermeasure, 

including, where available, the number of, the nature of, 

and other information concerning potential suppliers of 

such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and 

the reasons for each such rejection.’’; and 

(D) in the heading, by striking ‘‘RECOMMENDATION FOR

PRESIDENT’S APPROVAL’’ and inserting ‘‘RECOMMENDATIONS

FOR PROCUREMENT’’; and 

(3) in paragraph (7)— 

(A) by striking subparagraphs (A) and (B) and inserting 

the following: 

‘‘(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The special reserve fund as defined in subsection (h) shall be 

available for payments made by the Secretary to a vendor 

for procurement of a security countermeasure in accordance 

with the provisions of this paragraph.’’; and 

(B) by redesignating subparagraph (C) as subparagraph (B). 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1145 

‘‘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 APPLICATION.—The term ‘material threat medical countermeasure 

application’ means an application that— 

‘‘(A) is a human drug application for a drug intended 

for use— 

‘‘(i) to prevent, or treat harm from a biological, 

chemical, radiological, or nuclear agent identified as 

a material threat under section 319F–2(c)(2)(A)(ii) of 

the Public Health Service Act; or 

‘‘(ii) to mitigate, prevent, or treat harm from a 

condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such 

agent; and 

‘‘(B) the Secretary determines eligible for priority 

review; 

‘‘(C) is approved after the date of enactment of the 

21st Century Cures Act; and 

‘‘(D) is for a human drug, no active ingredient 

(including any ester or salt of the active ingredient) of 

which has been approved in any other application under 

section 505(b)(1) or section 351(a) of the Public Health 

Service Act. 

‘‘(b) PRIORITY REVIEW VOUCHER.— 

‘‘(1) IN GENERAL.—The Secretary shall award a priority 

review voucher to the sponsor of a material threat medical 

countermeasure application upon approval by the Secretary 

of such material threat medical countermeasure application. 

‘‘(2) TRANSFERABILITY.—The sponsor of a material threat 

medical countermeasure application that receives a priority 

review voucher under this section may transfer (including by 

sale) the entitlement to such voucher to a sponsor of a human 

drug for which an application under section 505(b)(1) or section 

351(a) of the Public Health Service Act will be submitted after 

the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times 

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 September 30, 2016, for that fiscal year, the amount of the priority 

review user fee. 

‘‘(4) PAYMENT.— 

‘‘(A) IN GENERAL.—The priority review user fee 

required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) 

or section 351(a) of the Public Health Service Act for which 

the priority review voucher is used. 

‘‘(B) COMPLETE APPLICATION.—An application described 

under subparagraph (A) for which the sponsor requests 

the use of a priority review voucher shall be considered 

incomplete if the fee required by this subsection and all 

other applicable user fees are not paid in accordance with 

the Secretary’s procedures for paying such fees. 

‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR

REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable 

under this section. 

‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 

this subsection for any fiscal year— 

‘‘(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food 

and Drug Administration; and 


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‘‘(6) shall not be collected for any fiscal year except to 

the extent provided in advance in appropriation Acts. 

‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary shall publish a notice in 

the Federal Register and on the Internet website of the Food and 

Drug Administration not later than 30 calendar days after the 

occurrence of each of the following: 

‘‘(1) The Secretary issues a priority review voucher under 

this section. 

‘‘(2) The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 351(a) 

of the Public Health Service Act for which the sponsor of 

the application used a priority review voucher issued under 

this section. 

‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section 

precludes a sponsor who seeks a priority review voucher under 

this section from participating in any other incentive program, 

including under this Act, except that no sponsor of a material 

threat medical countermeasure application may receive more than 

one priority review voucher issued under any section of this Act 

with respect to such drug. 

‘‘(f) RELATION TO OTHER PROVISIONS.—The provisions of this 

section shall supplement, not supplant, any other provisions of 

this Act or the Public Health Service Act that encourage the 

development of medical countermeasures. 

‘‘(g) SUNSET.—The Secretary may not award any priority review 

vouchers under subsection (b) after October 1, 2023.’’. 

SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC 

HEALTH EMERGENCY. 

Section 319 of the Public Health Service Act (42 U.S.C. 247d) 

is amended by adding at the end the following: 

‘‘(f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION

ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.— 

‘‘(1) DETERMINATION.—If the Secretary determines, after 

consultation with such public health officials as may be necessary, that— 

‘‘(A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has 

been met; or 

‘‘(ii) a disease or disorder, including a novel and 

emerging public health threat, is significantly likely to 

become a public health emergency; and 

‘‘(B) the circumstances of such public health emergency, 

or potential for such significantly likely public health emergency, including the specific preparation for and response 

to such public health emergency or threat, necessitate a 

waiver from the requirements of subchapter I of chapter 

35 of title 44, United States Code (commonly referred to 

as the Paperwork Reduction Act), 

then the requirements of such subchapter I with respect to 

voluntary collection of information shall not be applicable 

during the immediate investigation of, and response to, such 

public health emergency during the period of such public health 

emergency or the period of time necessary to determine if 

a disease or disorder, including a novel and emerging public 


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130 STAT. 1148 PUBLIC LAW 114–255—DEC. 13, 2016 

health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information 

shall not be applicable during the immediate postresponse 

review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length 

of time. 

‘‘(2) TRANSPARENCY.—If the Secretary determines that a 

waiver is necessary under paragraph (1), the Secretary shall 

promptly post on the Internet website of the Department of 

Health and Human Services a brief justification for such waiver, 

the anticipated period of time such waiver will be in effect, 

and the agencies and offices within the Department of Health 

and Human Services to which such waiver shall apply, and 

update such information posted on the Internet website of 

the Department of Health and Human Services, as applicable. 

‘‘(3) EFFECTIVENESS OF WAIVER.—Any waiver under this 

subsection shall take effect on the date on which the Secretary 

posts information on the Internet website as provided for in 

this subsection. 

‘‘(4) TERMINATION OF WAIVER.—Upon determining that the 

circumstances necessitating a waiver under paragraph (1) no 

longer exist, the Secretary shall promptly update the Internet 

website of the Department of Health and Human Services 

to reflect the termination of such waiver. 

‘‘(5) LIMITATIONS.— 

‘‘(A) PERIOD OF WAIVER.—The period of a waiver under 

paragraph (1) shall not exceed the period of time for the 

related public health emergency, including a public health 

emergency declared pursuant to subsection (a), and any 

immediate postresponse review regarding the public health 

emergency consistent with the requirements of this subsection. 

‘‘(B) SUBSEQUENT COMPLIANCE.—An initiative subject 

to a waiver under paragraph (1) that is ongoing after 

the date on which the waiver expires, shall be subject 

to the requirements of subchapter I of chapter 35 of title 

44, United States Code, and the Secretary shall ensure 

that compliance with such requirements occurs in as timely 

a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the 

expiration of the applicable waiver.’’. 

SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION. 

(a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.—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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(B) in subparagraph (B), by inserting ‘‘conditionally 

approved under section 571,’’ after ‘‘approved,’’ each place 

the term appears; 

(2) in subsection (b)(4), by striking the second comma after 

‘‘determination’’; 

(3) in subsection (e)(3)(B), by striking ‘‘section 503(b)’’ and 

inserting ‘‘subsection (b) or (f) of section 503 or under section 

504’’; 

(4) in subsection (f)(2)— 

(A) by inserting ‘‘, or an animal to which,’’ after ‘‘to 

a patient to whom’’; and 

(B) by inserting ‘‘or by the veterinarian caring for 

such animal, as applicable’’ after ‘‘attending physician’’; 

(5) in subsection (g)(1), by inserting ‘‘conditional approval 

under section 571,’’ after ‘‘approval,’’; 

(6) in subsection (h)(1), by striking ‘‘or section 520(g)’’and 

inserting ‘‘512(j), or 520(g)’’; and 

(7) in subsection (k), by striking ‘‘section 520(g),’’and 

inserting ‘‘512(j), or 520(g)’’. 

(b) NEW ANIMAL DRUGS.—Section 512(a)(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended— 

(1) in subparagraph (B), by striking ‘‘or’’ at the end; 

(2) in subparagraph (C), by striking the period and 

inserting ‘‘; or’’; and 

(3) by inserting after subparagraph (C) the following: 

‘‘(D) there is in effect an authorization pursuant to section 

564 with respect to such use or intended use of such drug, 

and such drug, its labeling, and such use conform to any 

conditions of such authorization.’’. 

(c) EMERGENCY USE OF MEDICAL PRODUCTS.—Section 564A of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

3a) is amended— 

(1) in subsection (a)(1)(A), by inserting ‘‘, conditionally 

approved under section 571,’’ after ‘‘chapter’’; and 

(2) in subsection (d), by striking ‘‘sections 503(b) and 520(e)’’ 

and inserting ‘‘subsections (b) and (f) of section 503, section 

504, and section 520(e)’’. 

(d) PRODUCTS HELD FOR EMERGENCY USE.—Section 564B(2) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

3b(2)) is amended— 

(1) in subparagraph (A)— 

(A) by inserting ‘‘or conditionally approved under section 571 of this Act’’ after ‘‘Public Health Service Act’’; 

and 

(B) by striking ‘‘or 515’’ and inserting ‘‘512, or 515’’; 

and 

(2) in subparagraph (B), by striking ‘‘or 520’’ and inserting 

‘‘512, or 520’’. 

Subtitle I—Vaccine Access, Certainty, and 

Innovation 

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 Committee on Immunization Practices’’ and ‘‘Advisory Committee’’ mean 

the Advisory Committee on Immunization Practices established by 

the Secretary pursuant to section 222 of the Public Health Service 

Act (42 U.S.C. 217a), acting through the Director of the Centers 

for Disease Control and Prevention.’’. 

SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY 

COMMITTEE ON IMMUNIZATION PRACTICES RECOMMENDATIONS. 

(a) REVIEW.—The Director of the Centers for Disease Control 

and Prevention shall conduct a review of the processes used by 

the Advisory Committee on Immunization Practices in formulating 

and issuing recommendations pertaining to vaccines, including with 

respect to consistency. 

(b) CONSIDERATIONS.—The review under subsection (a) shall 

include an assessment of— 

(1) the criteria used to evaluate new and existing vaccines, 

including the identification of any areas for which flexibility 

in evaluating such criteria is necessary and the reason for 

such flexibility; 

(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and 

analysis of scientific and economic data, including the scientific 

basis for such approach; and 

(3) the extent to which the processes used by the work 

groups of the Advisory Committee on Immunization Practices 

are consistent among such groups, including the identification 

of reasons for any variation. 

(c) STAKEHOLDERS.—In carrying out the review under subsection (a), the Director of the Centers for Disease Control and 

Prevention shall solicit input from vaccine stakeholders. 

(d) REPORT.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control 

and Prevention shall submit to the appropriate committees of the 

Congress, and make publicly available, a report on the results 

of the review under subsection (a), including any recommendations 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1151 

on improving the consistency of the processes described in such 

subsection. 

(e) DEFINITION.—In this section, the term ‘‘Advisory Committee 

on Immunization Practices’’ means the Advisory Committee on 

Immunization Practices established by the Secretary of Health and 

Human Services pursuant to section 222 of the Public Health 

Service Act (42 U.S.C. 217a), acting through the Director of the 

Centers for Disease Control and Prevention. 

SEC. 3093. ENCOURAGING VACCINE INNOVATION. 

(a) VACCINE MEETINGS.—The Director of the Centers for Disease Control and Prevention shall ensure that appropriate staff 

within the relevant centers and divisions of the Office of Infectious 

Diseases, and others, as appropriate, coordinate with respect to 

the public health needs, epidemiology, and program planning and 

implementation considerations related to immunization, including 

with regard to meetings with stakeholders related to such topics. 

(b) REPORT ON VACCINE INNOVATION.— 

(1) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’), in 

collaboration with appropriate agencies or offices within the 

Department of Health and Human Services, including the 

National Institutes of Health, the Centers for Disease Control 

and Prevention, the Food and Drug Administration, and the 

Biomedical Advanced Research and Development Authority, 

shall submit to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, and post publicly on the Internet website of the Department of Health 

and Human Services, a report on ways to promote innovation 

in the development of vaccines that minimize the burden of 

infectious disease. 

(2) CONTENTS.—The report described in paragraph (1) shall 

review the current status of vaccine development and, as appropriate— 

(A) consider the optimal process to determine which 

vaccines would be beneficial to public health and how 

information on such vaccines is disseminated to key stakeholders; 

(B) examine and identify whether obstacles exist that 

inhibit the development of beneficial vaccines; and 

(C) make recommendations about how best to remove 

any obstacles identified under subparagraph (B) in order 

to promote and incentivize vaccine innovation and development. 

(3) CONSULTATION.—In preparing the report under this 

subsection, the Secretary may consult with— 

(A) representatives of relevant Federal agencies and 

departments, including the Department of Defense and 

the Department of Veterans Affairs; 

(B) academic researchers; 

(C) developers and manufacturers of vaccines; 

(D) medical and public health practitioners; 

(E) representatives of patient, policy, and advocacy 

organizations; and 

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 subparagraphs (B) and (C) of paragraph (2) with respect to such vaccines.’’. 

(2) PETITION CONTENT.—Section 2111 of the Public Health 

Service Act (42 U.S.C. 300aa–11) is amended by adding at 

the end the following: 

‘‘(f) MATERNAL IMMUNIZATION.— 

‘‘(1) IN GENERAL.—Notwithstanding any other provision of 

law, for purposes of this subtitle, both a woman who received 

a covered vaccine while pregnant and any child who was in 

utero at the time such woman received the vaccine shall be 

considered persons to whom the covered vaccine was administered and persons who received the covered vaccine. 

‘‘(2) DEFINITION.—As used in this subsection, the term 

‘child’ shall have the meaning given that term by subsections 

(a) and (b) of section 8 of title 1, United States Code, except 

that, for purposes of this subsection, such section 8 shall be 

applied as if the term ‘include’ in subsection (a) of such section 

were replaced with the term ‘mean’.’’. 

(3) PETITIONERS.—Section 2111(b)(2) of the Public Health 

Service Act (42 U.S.C. 300aa–11(b)(2)) is amended by adding 

‘‘A covered vaccine administered to a pregnant woman shall 

constitute more than one administration, one to the mother 

and one to each child (as such term is defined in subsection 

(f)(2)) who was in utero at the time such woman was administered the vaccine.’’ at the end. 

Subtitle J—Technical Corrections 

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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(i) in subsection (d), in the last sentence, by 

striking ‘‘premarket approval’’ and inserting ‘‘marketing approval’’; and 

(ii) in subsection (q)(5)(A), by striking ‘‘subsection 

(b)(2) or (j) of the Act or 351(k)’’ and inserting ‘‘subsection (b)(2) or (j) of this section or section 351(k)’’. 

(C) RISK EVALUATION AND MITIGATION STRATEGIES.— 

Section 505–1(h)(21 U.S.C. 355–1(h)) is amended— 

(i) in paragraph (2)(A)(iii)— 

(I) in the clause heading, by striking ‘‘LABEL’’ 

and inserting ‘‘LABELING’’; 

(II) by striking ‘‘label’’ each place the term 

appears and inserting ‘‘labeling’’; and 

(III) by striking ‘‘sponsor’’ and inserting 

‘‘responsible person’’; and 

(ii) in paragraph (8), by striking ‘‘and (7).’’ and 

inserting ‘‘and (7)’’. 

(D) PEDIATRIC STUDY PLANS.—Section 505B (21 U.S.C. 

355c) is amended— 

(i) in subsection (e)— 

(I) in paragraph (2)— 

(aa) in subparagraph (A), by inserting 

‘‘study’’ after ‘‘initial pediatric’’ each place the 

term appears; and 

(bb) in subparagraph (B), in the subparagraph heading, by striking ‘‘INITIAL PLAN’’ and 

inserting ‘‘INITIAL PEDIATRIC STUDY PLAN’’; 

(II) in paragraph (5), in the paragraph 

heading, by inserting ‘‘AGREED INITIAL PEDIATRIC

STUDY’’ before ‘‘PLAN’’; and 

(III) in paragraph (6), by striking ‘‘agreed initial pediatric plan’’ and inserting ‘‘agreed initial 

pediatric study plan’’; and 

(ii) in subsection (f)(1), by inserting ‘‘and any 

significant amendments to such plans,’’ after ‘‘agreed 

initial pediatric study plans,’’. 

(E) DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIVE-SAVING DRUGS.—Section 506C (21 U.S.C. 356c) 

is amended— 

(i) in subsection (c), by striking ‘‘discontinuation’’ 

and inserting ‘‘discontinuance’’; and 

(ii) in subsection (g)(1), by striking ‘‘section 505(j) 

that could help’’ and inserting ‘‘section 505(j), that 

could help’’. 

(F) ANNUAL REPORTING ON DRUG SHORTAGES.—Section 

506C–1(a) (21 U.S.C. 331(a)) is amended, in the matter 

before paragraph (1)— 

(i) by striking ‘‘Not later than the end of calendar 

year 2013, and not later than the end of each calendar 

year thereafter,’’ and inserting ‘‘Not later than March 

31 of each calendar year,’’; and 

(ii) by inserting ‘‘, with respect to the preceding 

calendar year,’’ after ‘‘a report’’. 

(G) DRUG SHORTAGE LIST.—Section 506E(b)(3)(E) (21 

U.S.C. 356e(b)(3)(E)) is amended by striking ‘‘discontinuation’’ and inserting ‘‘discontinuance’’. 


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130 STAT. 1154 PUBLIC LAW 114–255—DEC. 13, 2016 

(H) INSPECTIONS OF ESTABLISHMENTS.—Section 510(h) 

(21 U.S.C. 360(h)) is amended— 

(i) in paragraph (4), in the matter preceding 

subparagraph (A), by striking ‘‘establishing the riskbased scheduled’’ and inserting ‘‘establishing a riskbased schedule’’; and 

(ii) in paragraph (6)— 

(I) in subparagraph (A), by striking ‘‘fiscal’’ 

and inserting ‘‘calendar’’ each place the term 

appears; and 

(II) in subparagraph (B), by striking ‘‘an active 

ingredient of a drug, a finished drug product, or 

an excipient of a drug’’ and inserting ‘‘an active 

ingredient of a drug or a finished drug product’’. 

(I) CLASSIFICATION OF DEVICES INTENDED FOR HUMAN

USE.—Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is 

amended— 

(i) in clause (i), by striking ‘‘within 30 days’’; and 

(ii) in clause (iv), by striking ‘‘low-moderate’’ and 

inserting ‘‘low to moderate’’. 

(J) PREMARKET APPROVAL.—Section 515(a)(1) (21 

U.S.C. 360e(a)(1)) is amended by striking ‘‘subject to a 

an order’’ and inserting ‘‘subject to an order’’. 

(K) PROGRAM TO IMPROVE THE DEVICE RECALL

SYSTEM.—Section 518A (21 U.S.C. 360h–1) is amended— 

(i) by striking subsection (c); and 

(ii) by redesignating subsection (d) as subsection 

(c). 

(L) UNIQUE DEVICE IDENTIFIER.—Section 519(f) (21 

U.S.C. 360i(f)) is amended by striking ‘‘and life sustaining’’ 

and inserting ‘‘or life sustaining’’. 

(M) PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR

TROPICAL DISEASES.—Section 524(c)(4)(A) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) 

is amended by striking ‘‘Services Act’’ and inserting 

‘‘Service Act’’. 

(N) PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.—Section 524A (21 U.S.C. 360n–1) is 

amended— 

(i) by striking ‘‘If the Secretary’’ and inserting the 

following: 

‘‘(a) IN GENERAL.—If the Secretary’’; 

(ii) by striking ‘‘any’’ and inserting ‘‘the first’’; and 

(iii) by adding at the end the following: 

‘‘(b) CONSTRUCTION.—Nothing in this section shall prohibit the 

Secretary from giving priority review to a human drug application 

or efficacy supplement submitted for approval under section 505(b) 

that otherwise meets the criteria for the Secretary to grant priority 

review.’’. 

(O) CONSULTATION WITH EXTERNAL EXPERTS ON RARE

DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING

OF TREATMENTS.—Section 569(a)(2)(A) (21 U.S.C. 360bbb– 

8(a)(2)(A)) is amended, in the first sentence, by striking 

‘‘subsection (c)’’ and inserting ‘‘subsection (b)’’. 

(P) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 

569A(c) (21 U.S.C. 360bbb–8a(c)) is amended by inserting 

‘‘or under the Public Health Service Act’’ after ‘‘this Act’’. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1155 

(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 introduce or deliver for introduction a designated medical 

gas into interstate commerce’’ after ‘‘any person’’; and 

(ii) in paragraph (3)— 

(I) in subparagraph (A)— 

(aa) in clause (i)(VIII), by inserting ‘‘for 

a new drug’’ after ‘‘any period of exclusivity’’; 

and 

(bb) in clause (ii), in the matter preceding 

subclause (I), by inserting ‘‘the’’ before ‘‘final 

use’’; and 

(II) in subparagraph (B)— 

(aa) in clause (i), by inserting ‘‘for a new 

drug’’ after ‘‘any period of exclusivity’’; and 

(bb) in clause (ii), by inserting a comma 

after ‘‘drug product’’. 

(T) INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL GASES.—Section 577 (21 U.S.C. 360ddd–2) is amended 

by inserting ‘‘or 740(a)’’ after ‘‘section 736(a)’’. 

(U) CONFLICTS OF INTEREST.—Section 712(e)(1)(B) (21 

U.S.C. 379d–1(e)(1)(B)) is amended by striking ‘‘services’’ 

and inserting ‘‘service’’. 

(V) AUTHORITY TO ASSESS AND USE BIOSIMILAR

BIOLOGICAL PRODUCT FEES.—Section 744H(a) (21 U.S.C. 

379j–52(a)) is amended— 

(i) in paragraph (1)(A)(v), by striking ‘‘Biosimilars 

User Fee Act of 2012’’ and inserting ‘‘Biosimilar User 

Fee Act of 2012’’; and 

(ii) in paragraph (2)(B), by striking ‘‘Biosimilars 

User Fee Act of 2012’’ and inserting ‘‘Biosimilar User 

Fee Act of 2012’’. 

(W) REGISTRATION OF COMMERCIAL IMPORTERS.— 

(i) AMENDMENT.—Section 801(s)(2) (21 U.S.C. 

381(s)(2)) is amended by adding at the end the following: 

‘‘(D) EFFECTIVE DATE.—In establishing the effective 

date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border 

Protection, as determined appropriate by the Secretary of 

Health and Human Services, provide a reasonable period 

of time for an importer of a drug to comply with good 


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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 INSPECTIONS.—Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended 

by striking ‘‘conduction’’ and inserting ‘‘conducting’’. 

(b) FDASIA.— 

(1) FINDINGS RELATING TO DRUG APPROVAL.—Section 

901(a)(1)(A) of the Food and Drug Administration Safety and 

Innovation Act (Public Law 112–144; 21 U.S.C. 356 note) is 

amended by striking ‘‘serious and life-threatening diseases’’ 

and inserting ‘‘serious or life-threatening diseases’’. 

(2) REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS.—Section 907 of the Food and Drug Administration 

Safety and Innovation Act (Public Law 112–144; 126 Stat. 

1092, 1093) is amended— 

(A) in the section heading, by striking ‘‘BIOLOGICS’’ 

in the heading and inserting ‘‘BIOLOGICAL PRODUCTS’’; 

and 

(B) in subsection (a)(2)(B), by striking ‘‘applications 

for new drug applications’’ and inserting ‘‘new drug applications’’. 

(3) COMBATING PRESCRIPTION DRUG ABUSE.—Section 1122 

of the Food and Drug Administration Safety and Innovation 

Act (Public Law 112–144; 126 Stat. 1112, 1113) is amended— 

(A) in subsection (a)(2), by striking ‘‘dependance’’ and 

inserting ‘‘dependence’’; and 

(B) in subsection (c), by striking ‘‘promulgate’’ and 

inserting ‘‘issue’’. 

SEC. 3102. COMPLETED STUDIES. 

The Federal Food, Drug, and Cosmetic Act is amended— 

(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))— 

(A) in subparagraph (A), by inserting ‘‘and’’ after the 

semicolon; 

(B) by striking subparagraph (B); and 

(C) by redesignating subparagraph (C) as subparagraph (B); 

(2) in section 505A (21 U.S.C. 355a), by striking subsection 

(p); 

(3) in section 505B (21 U.S.C. 355c)— 

(A) by striking subsection (l); and 

(B) by redesignating subsection (m) as subsection (l); 

and 

(4) in section 523 (21 U.S.C. 360m), by striking subsection 

(d). 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1157 

TITLE IV—DELIVERY 

SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 

QUALITY OF CARE FOR PATIENTS. 

(a) IN GENERAL.—The Health Information Technology for Economic and Clinical Health Act (title XIII of division A of Public 

Law 111–5) is amended— 

(1) by adding at the end of part 1 of subtitle A the following: 

‘‘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 suppliers of services, health care payers, health professional societies, 

health information technology developers, health care quality 

organizations, health care accreditation organizations, public health 

entities, States, and other appropriate entities, shall, in accordance 

with subsection (b)— 

‘‘(1) establish a goal with respect to the reduction of regulatory or administrative burdens (such as documentation 

requirements) relating to the use of electronic health records; 

‘‘(2) develop a strategy for meeting the goal established 

under paragraph (1); and 

‘‘(3) develop recommendations for meeting the goal established under paragraph (1). 

‘‘(b) STRATEGY AND RECOMMENDATIONS.— 

‘‘(1) IN GENERAL.—To achieve the goal established under 

subsection (a)(1), the Secretary, in consultation with the entities 

described in such subsection, shall, not later than 1 year after 

the date of enactment of the 21st Century Cures Act, develop 

a strategy and recommendations to meet the goal in accordance 

with this subsection. 

‘‘(2) STRATEGY.—The strategy developed under paragraph 

(1) shall address the regulatory and administrative burdens 

(such as documentation requirements) relating to the use of 

electronic health records. Such strategy shall include broad 

public comment and shall prioritize— 

‘‘(A)(i) incentives for meaningful use of certified EHR 

technology for eligible professionals and hospitals under 

sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of 

the Social Security Act (42 U.S.C. 1395w–4(a)(7), 

1395ww(b)(3)(B)(ix)); 

‘‘(ii) the program for making payments under section 

1903(a)(3)(F) of the Social Security Act (42 U.S.C. 

1396b(a)(3)(F)) to encourage the adoption and use of certified EHR technology by Medicaid providers; 

‘‘(iii) the Merit-based Incentive Payment System under 

section 1848(q) of the Social Security Act (42 U.S.C. 1395w– 

4(q)); 

‘‘(iv) alternative payment models (as defined in section 

1833(z)(3)(C) of the Social Security Act (42 U.S.C. 

1395l(z)(3)(C)); 

‘‘(v) the Hospital Value-Based Purchasing Program 

under section 1886(o) of the Social Security Act (42 U.S.C. 

1395ww(o)); and 

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 Secretary determines appropriate; 

‘‘(B) health information technology certification; 

‘‘(C) standards and implementation specifications, as 

appropriate; 

‘‘(D) activities that provide individuals access to their 

electronic health information; 

‘‘(E) activities related to protecting the privacy of electronic health information; 

‘‘(F) activities related to protecting the security of electronic health information; 

‘‘(G) activities related to facilitating health and clinical 

research; 

‘‘(H) activities related to public health; 

‘‘(I) activities related to aligning and simplifying 

quality measures across Federal programs and other 

payers; 

‘‘(J) activities related to reporting clinical data for 

administrative purposes; and 

‘‘(K) other areas, as the Secretary determines appropriate. 

‘‘(3) RECOMMENDATIONS.—The recommendations developed 

under paragraph (1) shall address— 

‘‘(A) actions that improve the clinical documentation 

experience; 

‘‘(B) actions that improve patient care; 

‘‘(C) actions to be taken by the Secretary and by other 

entities; and 

‘‘(D) other areas, as the Secretary determines appropriate, to reduce the reporting burden required of health 

care providers. 

‘‘(4) FACA.—The Federal Advisory Committee Act (5 U.S.C. 

App.) shall not apply to the development of the goal, strategies, 

or recommendations described in this section. 

‘‘(c) APPLICATION OF CERTAIN REGULATORY REQUIREMENTS.— A physician (as defined in section 1861(r)(1) of the Social Security 

Act), to the extent consistent with applicable State law, may delegate electronic medical record documentation requirements specified 

in regulations promulgated by the Centers for Medicare & Medicaid 

Services to a person performing a scribe function who is not such 

physician if such physician has signed and verified the documentation.’’; and 

(2) in the table of contents in section 13001(b), by inserting 

after the item relating to section 13102 the following: 

‘‘13103. Assisting doctors and hospitals in improving the quality and care for patients.’’. 

(b) CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY FOR

MEDICAL SPECIALTIES AND SITES OF SERVICE.—Section 3001(c)(5) 

of the Public Health Service Act (42 U.S.C. 300jj–11(c)(5)) is 

amended by adding at the end the following: 

‘‘(C) HEALTH INFORMATION TECHNOLOGY FOR MEDICAL

SPECIALTIES AND SITES OF SERVICE.— 

‘‘(i) IN GENERAL.—The National Coordinator shall 

encourage, keep, or recognize, through existing authorities, the voluntary certification of health information 

technology under the program developed under 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1159 

subparagraph (A) for use in medical specialties and 

sites of service for which no such technology is available or where more technological advancement or 

integration is needed. 

‘‘(ii) SPECIFIC MEDICAL SPECIALTIES.—The Secretary shall accept public comment on specific medical 

specialties and sites of service, in addition to those 

described in clause (i), for the purpose of selecting 

additional specialties and sites of service as necessary. 

‘‘(iii) HEALTH INFORMATION TECHNOLOGY FOR

PEDIATRICS.—Not later than 18 months after the date 

of enactment of the 21st Century Cures Act, the Secretary, in consultation with relevant stakeholders, 

shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of 

children. Not later than 2 years after the date of enactment of the 21st Century Cures Act, the Secretary 

shall adopt certification criteria under section 3004 

to support the voluntary certification of health information technology for use by pediatric health providers 

to support the health care of children.’’. 

(c) MEANINGFUL USE STATISTICS.— 

(1) IN GENERAL.—Not later than 6 months after the date 

of enactment of this Act, the Secretary of Health and Human 

Services shall submit to the HIT Advisory Committee of the 

Office of the National Coordinator for Health Information Technology, a report concerning attestation statistics for the Medicare and Medicaid EHR Meaningful Use Incentive programs 

to assist in informing standards adoption and related practices. 

Such statistics shall include attestation information delineated 

by State, including, to the extent practicable, the number of 

providers who did not meet the minimum criteria necessary 

to attest for the Medicare and Medicaid EHR Meaningful Use 

Incentive programs for a calendar year, and shall be made 

publicly available on the Internet website of the Secretary 

on at least a quarterly basis. 

(2) AUTHORITY TO ALTER FORMAT.—The Secretary of Health 

and Human Services may alter the format of the reports on 

the attestation of eligible health care professionals following 

the first performance year of the Merit-based Incentive Payment System to account for changes arising from the 

implementation of such payment system. 

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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conditions and requirements under this title, that the 

health information technology developer or entity— 

‘‘(i) does not take any action that constitutes 

information blocking as defined in section 3022(a); 

‘‘(ii) provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take 

any action described in clause (i) or any other action 

that may inhibit the appropriate exchange, access, and 

use of electronic health information; 

‘‘(iii) does not prohibit or restrict communication 

regarding— 

‘‘(I) the usability of the health information 

technology; 

‘‘(II) the interoperability of the health information technology; 

‘‘(III) the security of the health information 

technology; 

‘‘(IV) relevant information regarding users’ 

experiences when using the health information 

technology; 

‘‘(V) the business practices of developers of 

health information technology related to 

exchanging electronic health information; and 

‘‘(VI) the manner in which a user of the health 

information technology has used such technology; 

‘‘(iv) has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without 

special effort through the use of application programming interfaces or successor technology or standards, 

as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under 

applicable privacy laws; 

‘‘(v) has successfully tested the real world use of 

the technology for interoperability (as defined in section 3000) in the type of setting in which such technology would be marketed; 

‘‘(vi) provides to the Secretary an attestation that 

the developer or entity— 

‘‘(I) has not engaged in any of the conduct 

described in clause (i); 

‘‘(II) has provided assurances satisfactory to 

the Secretary in accordance with clause (ii); 

‘‘(III) does not prohibit or restrict communication as described in clause (iii); 

‘‘(IV) has published information in accordance 

with clause (iv); 

‘‘(V) ensures that its technology allows for 

health information to be exchanged, accessed, and 

used, in the manner described in clause (iv); and 

‘‘(VI) has undertaken real world testing as 

described in clause (v); and 

‘‘(vii) submits reporting criteria in accordance with 

section 3009A(b).’’. 


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‘‘(E) COMPLIANCE WITH CONDITIONS OF CERTIFICATION.—The Secretary may encourage compliance with 

the conditions of certification described in subparagraph 

(D) and take action to discourage noncompliance, as appropriate.’’. 

(b) EHR SIGNIFICANT HARDSHIP EXCEPTION.— 

(1) APPLICATION TO ELIGIBLE PROFESSIONALS.— 

(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 technology used by such professional has been decertified under 

a program kept or recognized pursuant to section 3001(c)(5) 

of the Public Health Service Act.’’. 

(B) CONTINUED APPLICATION UNDER MIPS.—Section 

1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w– 

4(o)(2)(D)) is amended by adding at the end the following 

new sentence: ‘‘The provisions of subparagraphs (B) and 

(D) of subsection (a)(7), shall apply to assessments of MIPS 

eligible professionals under subsection (q) with respect to 

the performance category described in subsection 

(q)(2)(A)(iv) in an appropriate manner which may be similar 

to the manner in which such provisions apply with respect 

to payment adjustments made under subsection (a)(7)(A).’’. 

(2) APPLICATION TO ELIGIBLE HOSPITALS.—Section 

1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 

1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first 

sentence the following new sentence: ‘‘The Secretary shall 

exempt an eligible hospital from the application of the payment 

adjustment under subclause (I) with respect to a fiscal year, 

subject to annual renewal, if the Secretary determines that 

compliance with the requirement for being a meaningful EHR 

user is not possible because the certified EHR technology used 

by such hospital is decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service 

Act.’’. 

(c) ELECTRONIC HEALTH RECORD REPORTING PROGRAM.—Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 

300jj–11 et seq.) is amended by adding at the end the following: 

‘‘SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM. 

‘‘(a) REPORTING CRITERIA.— 

‘‘(1) CONVENING OF STAKEHOLDERS.—Not later than 1 year 

after the date of enactment of the 21st Century Cures Act, 

the Secretary shall convene stakeholders, as described in paragraph (2), for the purpose of developing the reporting criteria 

in accordance with paragraph (3). 

‘‘(2) DEVELOPMENT OF REPORTING CRITERIA.—The reporting 

criteria under this subsection shall be developed through a 

public, transparent process that reflects input from relevant 

stakeholders, including— 

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 laboratories; 

‘‘(G) security experts; 

‘‘(H) relevant manufacturers of medical devices; 

‘‘(I) experts in health information technology market 

economics; 

‘‘(J) public and private entities engaged in the evaluation of health information technology performance; 

‘‘(K) quality organizations, including the consensus 

based entity described in section 1890 of the Social Security 

Act; 

‘‘(L) experts in human factors engineering and the 

measurement of user-centered design; and 

‘‘(M) other entities or individuals, as the Secretary 

determines appropriate. 

‘‘(3) CONSIDERATIONS FOR REPORTING CRITERIA.—The 

reporting criteria developed under this subsection— 

‘‘(A) shall include measures that reflect categories 

including— 

‘‘(i) security; 

‘‘(ii) usability and user-centered design; 

‘‘(iii) interoperability; 

‘‘(iv) conformance to certification testing; and 

‘‘(v) other categories, as appropriate to measure 

the performance of electronic health record technology; 

‘‘(B) may include categories such as— 

‘‘(i) enabling the user to order and view the results 

of laboratory tests, imaging tests, and other diagnostic 

tests; 

‘‘(ii) submitting, editing, and retrieving data from 

registries such as clinician-led clinical data registries; 

‘‘(iii) accessing and exchanging information and 

data from and through health information exchanges; 

‘‘(iv) accessing and exchanging information and 

data from medical devices; 

‘‘(v) accessing and exchanging information and 

data held by Federal, State, and local agencies and 

other applicable entities useful to a health care provider or other applicable user in the furtherance of 

patient care; 

‘‘(vi) accessing and exchanging information from 

other health care providers or applicable users; 

‘‘(vii) accessing and exchanging patient generated 

information; 

‘‘(viii) providing the patient or an authorized designee with a complete copy of their health information 

from an electronic record in a computable format; 

‘‘(ix) providing accurate patient information for the 

correct patient, including exchanging such information, 

and avoiding the duplication of patients records; and 


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‘‘(x) other categories regarding performance, accessibility, as the Secretary determines appropriate; and 

‘‘(C) shall be designed to ensure that small and startup 

health information technology developers are not unduly 

disadvantaged by the reporting criteria. 

‘‘(4) MODIFICATIONS.—After the reporting criteria have been 

developed under paragraph (3), the Secretary may convene 

stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such 

paragraph. 

‘‘(b) PARTICIPATION.—As a condition of maintaining certification 

under section 3001(c)(5)(D), a developer of certified electronic health 

records shall submit to an appropriate recipient of a grant, contract, 

or agreement under subsection (c)(1) responses to the criteria developed under subsection (a), with respect to all certified technology 

offered by such developer. 

‘‘(c) REPORTING PROGRAM.— 

‘‘(1) IN GENERAL.—Not later than 1 year after the date 

of enactment of the 21st Century Cures Act, the Secretary 

shall award grants, contracts, or agreements to independent 

entities on a competitive basis to support the convening of 

stakeholders as described in subsection (a)(2), collect the 

information required to be reported in accordance with the 

criteria established as described subsection (a)(3), and develop 

and implement a process in accordance with paragraph (5) 

and report such information to the Secretary. 

‘‘(2) APPLICATIONS.—An independent entity that seeks a 

grant, contract, or agreement under this subsection shall submit 

an application to the Secretary at such time, in such manner, 

and containing such information as the Secretary may reasonably require, including a description of— 

‘‘(A) the proposed method for reviewing and summarizing information gathered based on reporting criteria 

established under subsection (a); 

‘‘(B) if applicable, the intended focus on a specific 

subset of certified electronic health record technology users, 

such as health care providers, including primary care, specialty care, and care provided in rural settings; hospitals 

and hospital systems; and patients, consumers, and 

patients and consumer advocates; 

‘‘(C) the plan for widely distributing reports described 

in paragraph (6); 

‘‘(D) the period for which the grant, contract, or agreement is requested, which may be up to 2 years; and 

‘‘(E) the budget for reporting program participation, 

and whether the eligible independent entity intends to 

continue participation after the period of the grant, contract, or agreement. 

‘‘(3) CONSIDERATIONS FOR INDEPENDENT ENTITIES.—In 

awarding grants, contracts, and agreements under paragraph 

(1), the Secretary shall give priority to independent entities 

with appropriate expertise in health information technology 

usability, interoperability, and security (especially entities with 

such expertise in electronic health records) with respect to— 

‘‘(A) health care providers, including primary care, specialty care, and care provided in rural settings; 

‘‘(B) hospitals and hospital systems; and 


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130 STAT. 1164 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(C) patients, consumers, and patient and consumer 

advocates. 

‘‘(4) LIMITATIONS.— 

‘‘(A) ASSESSMENT AND REDETERMINATION.—Not later 

than 4 years after the date of enactment of the 21st Century Cures Act and every 2 years thereafter, the Secretary, 

in consultation with stakeholders, shall— 

‘‘(i) assess performance of the recipients of the 

grants, contracts, and agreements under paragraph 

(1) based on quality and usability of reports described 

in paragraph (6); and 

‘‘(ii) re-determine grants, contracts, and agreements as necessary. 

‘‘(B) PROHIBITIONS ON PARTICIPATION.—The Secretary 

may not award a grant, contract, or cooperative agreement 

under paragraph (1) to— 

‘‘(i) a proprietor of certified health information 

technology or a business affiliate of such a proprietor; 

‘‘(ii) a developer of certified health information 

technology; or 

‘‘(iii) a State or local government agency. 

‘‘(5) FEEDBACK.—Based on reporting criteria established 

under subsection (a), the recipients of grants, contracts, and 

agreements under paragraph (1) shall develop and implement 

a process to collect and verify confidential feedback on such 

criteria from— 

‘‘(A) health care providers, patients, and other users 

of certified electronic health record technology; and 

‘‘(B) developers of certified electronic health record 

technology. 

‘‘(6) REPORTS.— 

‘‘(A) DEVELOPMENT OF REPORTS.—Each recipient of a 

grant, contract, or agreement under paragraph (1) shall 

report on the information reported to such recipient pursuant to subsection (a) and the user feedback collected under 

paragraph (5) by preparing summary reports and detailed 

reports of such information. 

‘‘(B) DISTRIBUTION OF REPORTS.—Each recipient of a 

grant, contract, or agreement under paragraph (1) shall 

submit the reports prepared under subparagraph (A) to 

the Secretary for public distribution in accordance with 

subsection (d). 

‘‘(d) PUBLICATION.—The Secretary shall distribute widely, as 

appropriate, and publish, on the Internet website of the Office 

of the National Coordinator— 

‘‘(1) the reporting criteria developed under subsection (a); 

and 

‘‘(2) the summary and detailed reports under subsection 

(c)(6). 

‘‘(e) REVIEW.—Each recipient of a grant, contract, or agreement 

under paragraph (1) shall develop and implement a process through 

which participating electronic health record technology developers 

may review and recommend changes to the reports created under 

subsection (c)(6) for products developed by such developer prior 

to the publication of such report under subsection (d). 

‘‘(f) ADDITIONAL RESOURCES.—The Secretary may provide additional resources on the Internet website of the Office of the National 


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Coordinator to better inform consumers of health information technology. Such reports may be carried out through partnerships with 

private organizations with appropriate expertise.’’. 

(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 

to be appropriated $15,000,000 for purposes of carrying out subparagraph (D) of section 3001(c)(5) of the Public Health Service Act 

(42 U.S.C. 300jj–11) (as added by subsection (a)) and section 3009A 

of the Public Health Service Act (as added by subsection (b)), 

including for purposes of administering any contracts, grants, or 

agreements, to remain available until expended. 

SEC. 4003. INTEROPERABILITY. 

(a) DEFINITION.—Section 3000 of the Public Health Service 

Act (42 U.S.C. 300jj) is amended— 

(1) by redesignating paragraphs (10) through (14), as paragraphs (11) through (15), respectively; and 

(2) by inserting after paragraph (9) the following: 

‘‘(10) INTEROPERABILITY.—The term ‘interoperability’, with 

respect to health information technology, means such health 

information technology that— 

‘‘(A) enables the secure exchange of electronic health 

information with, and use of electronic health information 

from, other health information technology without special 

effort on the part of the user; 

‘‘(B) allows for complete access, exchange, and use of 

all electronically accessible health information for authorized use under applicable State or Federal law; and 

‘‘(C) does not constitute information blocking as defined 

in section 3022(a).’’. 

(b) SUPPORT FOR INTEROPERABLE NETWORK EXCHANGE.—Section 3001(c) of the Public Health Service Act (42 U.S.C. 300jj– 

11(c)) is amended by adding at the end the following: 

‘‘(9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.— 

‘‘(A) IN GENERAL.—The National Coordinator shall, in 

collaboration with the National Institute of Standards and 

Technology and other relevant agencies within the Department of Health and Human Services, for the purpose of 

ensuring full network-to-network exchange of health 

information, convene public-private and public-public partnerships to build consensus and develop or support a 

trusted exchange framework, including a common agreement among health information networks nationally. Such 

convention may occur at a frequency determined appropriate by the Secretary. 

‘‘(B) ESTABLISHING A TRUSTED EXCHANGE FRAMEWORK.— 

‘‘(i) IN GENERAL.—Not later than 6 months after 

the date of enactment of the 21st Century Cures Act, 

the National Coordinator shall convene appropriate 

public and private stakeholders to develop or support 

a trusted exchange framework for trust policies and 

practices and for a common agreement for exchange 

between health information networks. The common 

agreement may include— 

‘‘(I) a common method for authenticating 

trusted health information network participants; 


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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 noncompliance with the terms of the common agreement. 

‘‘(ii) TECHNICAL ASSISTANCE.—The National Coordinator, in collaboration with the National Institute of 

Standards and Technology, shall provide technical 

assistance on how to implement the trusted exchange 

framework and common agreement under this paragraph. 

‘‘(iii) PILOT TESTING.—The National Coordinator, 

in consultation with the National Institute of Standards and Technology, shall provide for the pilot testing 

of the trusted exchange framework and common agreement established or supported under this subsection 

(as authorized under section 13201 of the Health 

Information Technology for Economic and Clinical 

Health Act). The National Coordinator, in consultation 

with the National Institute of Standards and Technology, may delegate pilot testing activities under this 

clause to independent entities with appropriate expertise. 

‘‘(C) PUBLICATION OF A TRUSTED EXCHANGE FRAMEWORK

AND COMMON AGREEMENT.—Not later than 1 year after 

convening stakeholders under subparagraph (A), the 

National Coordinator shall publish on its public Internet 

website, and in the Federal register, the trusted exchange 

framework and common agreement developed or supported 

under subparagraph (B). Such trusted exchange framework 

and common agreement shall be published in a manner 

that protects proprietary and security information, 

including trade secrets and any other protected intellectual 

property. 

‘‘(D) DIRECTORY OF PARTICIPATING HEALTH INFORMATION NETWORKS.— 

‘‘(i) IN GENERAL.—Not later than 2 years after 

convening stakeholders under subparagraph (A), and 

annually thereafter, the National Coordinator shall 

publish on its public Internet website a list of the 

health information networks that have adopted the 

common agreement and are capable of trusted 

exchange pursuant to the common agreement developed or supported under paragraph (B). 

‘‘(ii) PROCESS.—The Secretary shall, through notice 

and comment rulemaking, establish a process for 

health information networks that voluntarily elect to 

adopt the trusted exchange framework and common 

agreement to attest to such adoption of the framework 

and agreement. 

‘‘(E) APPLICATION OF THE TRUSTED EXCHANGE FRAME- WORK AND COMMON AGREEMENT.—As appropriate, Federal 

agencies contracting or entering into agreements with 


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health information exchange networks may require that 

as each such network upgrades health information technology or trust and operational practices, such network 

may adopt, where available, the trusted exchange framework and common agreement published under subparagraph (C). 

‘‘(F) RULE OF CONSTRUCTION.— ‘‘(i) GENERAL ADOPTION.—Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework 

or common agreement. 

‘‘(ii) ADOPTION WHEN EXCHANGE OF INFORMATION

IS WITHIN NETWORK.—Nothing in this paragraph shall 

be construed to require a health information network 

to adopt the trusted exchange framework or common 

agreement for the exchange of electronic health 

information between participants of the same network. 

‘‘(iii) EXISTING FRAMEWORKS AND AGREEMENTS.— 

The trusted exchange framework and common agreement published under subparagraph (C) shall take into 

account existing trusted exchange frameworks and 

agreements used by health information networks to 

avoid the disruption of existing exchanges between 

participants of health information networks. 

‘‘(iv) APPLICATION BY FEDERAL AGENCIES.—Notwithstanding clauses (i), (ii), and (iii), Federal agencies 

may require the adoption of the trusted exchange 

framework and common agreement published under 

subparagraph (C) for health information exchanges 

contracting with or entering into agreements pursuant 

to subparagraph (E). 

‘‘(v) CONSIDERATION OF ONGOING WORK.—In carrying out this paragraph, the Secretary shall ensure 

the consideration of activities carried out by public 

and private organizations related to exchange between 

health information exchanges to avoid duplication of 

efforts.’’. 

(c) PROVIDER DIGITAL CONTACT INFORMATION INDEX.— 

(1) IN GENERAL.—Not later than 3 years after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this subsection as the ‘‘Secretary’’) shall, 

directly or through a partnership with a private entity, establish a provider digital contact information index to provide 

digital contact information for health professionals and health 

facilities. 

(2) USE OF EXISTING INDEX.—In establishing the initial 

index under paragraph (1), the Secretary may utilize an existing 

provider directory to make such digital contact information 

available. 

(3) CONTACT INFORMATION.—An index established under 

this subsection shall ensure that contact information is available at the individual health care provider level and at the 

health facility or practice level. 

(4) RULE OF CONSTRUCTION.— 

(A) IN GENERAL.—The purpose of this subsection is 

to encourage the exchange of electronic health information 

by providing the most useful, reliable, and comprehensive 

42 USC 300jj–11 

note. 


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index of providers possible. In furthering such purpose, 

the Secretary shall include all health professionals and 

health facilities applicable to provide a useful, reliable, 

and comprehensive index for use in the exchange of health 

information. 

(B) LIMITATION.—In no case shall exclusion from the 

index of providers be used as a measure to achieve objectives other the objectives described in subparagraph (A). 

(d) STANDARDS DEVELOPMENT ORGANIZATIONS.—Section 3004 

of the Public Health Service Act (42 U.S.C. 300jj–14) is amended 

by adding at the end the following: 

‘‘(c) DEFERENCE TO STANDARDS DEVELOPMENT ORGANIZA- TIONS.—In adopting and implementing standards under this section, 

the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based 

standards bodies.’’. 

(e) HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.— 

(1) IN GENERAL.—Title XXX of the Public Health Service 

Act (42 U.S.C. 300jj et seq.) is amended by striking sections 

3002 (42 U.S.C. 300jj–12) and 3003 (42 U.S.C. 300jj–13) and 

inserting the following: 

‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE. 

‘‘(a) ESTABLISHMENT.—There is established a Health Information Technology Advisory Committee (referred to in this section 

as the ‘HIT Advisory Committee’) to recommend to the National 

Coordinator, consistent with the implementation of the strategic 

plan described in section 3001(c)(3), policies, and, for purposes 

of adoption under section 3004, standards, implementation specifications, and certification criteria, relating to the implementation of 

a health information technology infrastructure, nationally and 

locally, that advances the electronic access, exchange, and use of 

health information. Such Committee shall serve to unify the roles 

of, and replace, the HIT Policy Committee and the HIT Standards 

Committee, as in existence before the date of the enactment of 

the 21st Century Cures Act. 

‘‘(b) DUTIES.— 

‘‘(1) RECOMMENDATIONS ON POLICY FRAMEWORK TO ADVANCE

AN INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRASTRUCTURE.— 

‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 

recommend to the National Coordinator a policy framework 

for adoption by the Secretary consistent with the strategic 

plan under section 3001(c)(3) for advancing the target areas 

described in this subsection. Such policy framework shall 

seek to prioritize achieving advancements in the target 

areas specified in subparagraph (B) of paragraph (2) and 

may, to the extent consistent with this section, incorporate 

policy recommendations made by the HIT Policy Committee, as in existence before the date of the enactment 

of the 21st Century Cures Act. 

‘‘(B) UPDATES.—The HIT Advisory Committee shall 

propose updates to such recommendations to the policy 

framework and make new recommendations, as appropriate. 

42 USC 300jj–12. 


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‘‘(2) GENERAL DUTIES AND TARGET AREAS.— ‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 

recommend to the National Coordinator for purposes of 

adoption under section 3004, standards, implementation 

specifications, and certification criteria and an order of 

priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria. Such recommendations shall include recommended 

standards, architectures, and software schemes for access 

to electronic individually identifiable health information 

across disparate systems including user vetting, authentication, privilege management, and access control. 

‘‘(B) PRIORITY TARGET AREAS.—For purposes of this 

section, the HIT Advisory Committee shall make recommendations under subparagraph (A) with respect to at 

least each of the following target areas: 

‘‘(i) Achieving a health information technology 

infrastructure, nationally and locally, that allows for 

the electronic access, exchange, and use of health 

information, including through technology that provides accurate patient information for the correct 

patient, including exchanging such information, and 

avoids the duplication of patient records. 

‘‘(ii) The promotion and protection of privacy and 

security of health information in health information 

technology, including technologies that allow for an 

accounting of disclosures and protections against 

disclosures of individually identifiable health information made by a covered entity for purposes of treatment, payment, and health care operations (as such 

terms are defined for purposes of the regulation 

promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996), 

including for the segmentation and protection from 

disclosure of specific and sensitive individually identifiable health information with the goal of minimizing 

the reluctance of patients to seek care. 

‘‘(iii) The facilitation of secure access by an individual to such individual’s protected health information 

and access to such information by a family member, 

caregiver, or guardian acting on behalf of a patient, 

including due to age-related and other disability, cognitive impairment, or dementia. 

‘‘(iv) Subject to subparagraph (D), any other target 

area that the HIT Advisory Committee identifies as 

an appropriate target area to be considered under this 

subparagraph. 

‘‘(C) ADDITIONAL TARGET AREAS.—For purposes of this 

section, the HIT Advisory Committee may make recommendations under subparagraph (A), in addition to areas 

described in subparagraph (B), with respect to any of the 

following areas: 

‘‘(i) The use of health information technology to 

improve the quality of health care, such as by promoting the coordination of health care and improving 

continuity of health care among health care providers, 

reducing medical errors, improving population health, 


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reducing chronic disease, and advancing research and 

education. 

‘‘(ii) The use of technologies that address the needs 

of children and other vulnerable populations. 

‘‘(iii) The use of electronic systems to ensure the 

comprehensive collection of patient demographic data, 

including at a minimum, race, ethnicity, primary language, and gender information. 

‘‘(iv) The use of self-service, telemedicine, home 

health care, and remote monitoring technologies. 

‘‘(v) The use of technologies that meet the needs 

of diverse populations. 

‘‘(vi) The use of technologies that support— 

‘‘(I) data for use in quality and public reporting 

programs; 

‘‘(II) public health; or 

‘‘(III) drug safety. 

‘‘(vii) The use of technologies that allow individually identifiable health information to be rendered 

unusable, unreadable, or indecipherable to unauthorized individuals when such information is transmitted 

in a health information network or transported outside 

of the secure facilities or systems where the disclosing 

covered entity is responsible for security conditions. 

‘‘(viii) The use of a certified health information 

technology for each individual in the United States. 

‘‘(D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY

TARGET AREAS.—For purposes of subparagraph (B)(iv), the 

HIT Advisory Committee may identify an area to be considered for purposes of recommendations under this subsection 

as a target area described in subparagraph (B) if— 

‘‘(i) the area is so identified for purposes of 

responding to new circumstances that have arisen in 

the health information technology community that 

affect the interoperability, privacy, or security of health 

information, or affect patient safety; and 

‘‘(ii) at least 30 days prior to treating such area 

as if it were a target area described in subparagraph 

(B), the National Coordinator provides adequate notice 

to Congress of the intent to treat such area as so 

described. 

‘‘(E) FOCUS OF COMMITTEE WORK.—It is the sense of 

Congress that the HIT Advisory Committee shall focus 

its work on the priority areas described in subparagraph 

(B) before proceeding to other work under subparagraph 

(C). 

‘‘(3) RULES RELATING TO RECOMMENDATIONS FOR STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA.— 

‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 

recommend to the National Coordinator standards, 

implementation specifications, and certification criteria 

described in subsection (a), which may include standards, 

implementation specifications, and certification criteria 

that have been developed, harmonized, or recognized by 

the HIT Advisory Committee or predecessor committee. 


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The HIT Advisory Committee shall update such recommendations and make new recommendations as appropriate, including in response to a notification sent under 

section 3004(a)(2)(B). Such recommendations shall be consistent with the latest recommendations made by the Committee. 

‘‘(B) HARMONIZATION.—The HIT Advisory Committee 

may recognize harmonized or updated standards from an 

entity or entities for the purpose of harmonizing or 

updating standards and implementation specifications in 

order to achieve uniform and consistent implementation 

of the standards and implementation specification. 

‘‘(C) PILOT TESTING OF STANDARDS AND IMPLEMENTA- TION SPECIFICATIONS.—In the development, harmonization, 

or recognition of standards and implementation specifications, the HIT Advisory Committee for purposes of recommendations under paragraph (2)(B), shall, as appropriate, provide for the testing of such standards and specifications by the National Institute for Standards and Technology under section 13201(a) of the Health Information 

Technology for Economic and Clinical Health Act. 

‘‘(D) CONSISTENCY.—The standards, implementation 

specifications, and certification criteria recommended under 

paragraph (2)(B) shall be consistent with the standards 

for information transactions and data elements adopted 

pursuant to section 1173 of the Social Security Act. 

‘‘(E) SPECIAL RULE RELATED TO INTEROPERABILITY.— 

Any recommendation made by the HIT Advisory Committee 

after the date of the enactment of this subparagraph with 

respect to interoperability of health information technology 

shall be consistent with interoperability as described in 

section 3000. 

‘‘(4) FORUM.—The HIT Advisory Committee shall serve as 

a forum for the participation of a broad range of stakeholders 

with specific expertise in policies, including technical expertise, 

relating to the matters described in paragraphs (1), (2), and 

(3) to provide input on the development, harmonization, and 

recognition of standards, implementation specifications, and 

certification criteria necessary for the development and adoption of health information technology infrastructure nationally 

and locally that allows for the electronic access, exchange, 

and use of health information. 

‘‘(5) SCHEDULE.—Not later than 30 days after the date 

on which the HIT Advisory Committee first meets, such HIT 

Advisory Committee shall develop a schedule for the assessment 

of policy recommendations developed under paragraph (1). The 

HIT Advisory Committee shall update such schedule annually. 

The Secretary shall publish such schedule in the Federal Register. 

‘‘(6) PUBLIC INPUT.—The HIT Advisory Committee shall 

conduct open public meetings and develop a process to allow 

for public comment on the schedule described in paragraph 

(5) and recommendations described in this subsection. Under 

such process comments shall be submitted in a timely manner 

after the date of publication of a recommendation under this 

subsection. 

‘‘(c) MEASURED PROGRESS IN ADVANCING PRIORITY AREAS.— 


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‘‘(1) IN GENERAL.—For purposes of this section, the National 

Coordinator, in collaboration with the Secretary, shall establish, 

and update as appropriate, objectives and benchmarks for 

advancing and measuring the advancement of the priority target areas described in subsection (b)(2)(B). 

‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING INTEROPERABILITY.— 

‘‘(A) IN GENERAL.—The HIT Advisory Committee, in 

consultation with the National Coordinator, shall annually 

submit to the Secretary and Congress a report on the 

progress made during the preceding fiscal year in— 

‘‘(i) achieving a health information technology 

infrastructure, nationally and locally, that allows for 

the electronic access, exchange, and use of health 

information; and 

‘‘(ii) meeting the objectives and benchmarks 

described in paragraph (1). 

‘‘(B) CONTENT.—Each such report shall include, for 

a fiscal year— 

‘‘(i) a description of the work conducted by the 

HIT Advisory Committee during the preceding fiscal 

year with respect to the areas described in subsection 

(b)(2)(B); 

‘‘(ii) an assessment of the status of the infrastructure described in subparagraph (A), including the 

extent to which electronic health information is appropriately and readily available to enhance the access, 

exchange, and the use of electronic health information 

between users and across technology offered by different developers; 

‘‘(iii) the extent to which advancements have been 

achieved with respect to areas described in subsection 

(b)(2)(B); 

‘‘(iv) an analysis identifying existing gaps in policies and resources for— 

‘‘(I) achieving the objectives and benchmarks 

established under paragraph (1); and 

‘‘(II) furthering interoperability throughout the 

health information technology infrastructure; 

‘‘(v) recommendations for addressing the gaps 

identified in clause (iii); and 

‘‘(vi) a description of additional initiatives as the 

HIT Advisory Committee and National Coordinator 

determine appropriate. 

‘‘(3) SIGNIFICANT ADVANCEMENT DETERMINATION.—The Secretary shall periodically, based on the reports submitted under 

this subsection, review the target areas described in subsection 

(b)(2)(B), and, based on the objectives and benchmarks established under paragraph (1), the Secretary shall determine if 

significant advancement has been achieved with respect to 

such an area. Such determination shall be taken into consideration by the HIT Advisory Committee when determining to 

what extent the Committee makes recommendations for an 

area other than an area described in subsection (b)(2)(B). 

‘‘(d) MEMBERSHIP AND OPERATIONS.— 


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‘‘(1) IN GENERAL.—The National Coordinator shall take a 

leading position in the establishment and operations of the 

HIT Advisory Committee. 

‘‘(2) MEMBERSHIP.—The membership of the HIT Advisory 

Committee shall— 

‘‘(A) include at least 25 members, of which— 

‘‘(i) no fewer than 2 members are advocates for 

patients or consumers of health information technology; 

‘‘(ii) 3 members are appointed by the Secretary, 

1 of whom shall be appointed to represent the Department of Health and Human Services and 1 of whom 

shall be a public health official; 

‘‘(iii) 2 members are appointed by the majority 

leader of the Senate; 

‘‘(iv) 2 members are appointed by the minority 

leader of the Senate; 

‘‘(v) 2 members are appointed by the Speaker of 

the House of Representatives; 

‘‘(vi) 2 members are appointed by the minority 

leader of the House of Representatives; and 

‘‘(vii) such other members are appointed by the 

Comptroller General of the United States; and 

‘‘(B) at least reflect providers, ancillary health care 

workers, consumers, purchasers, health plans, health 

information technology developers, researchers, patients, 

relevant Federal agencies, and individuals with technical 

expertise on health care quality, system functions, privacy, 

security, and on the electronic exchange and use of health 

information, including the use standards for such activity. 

‘‘(3) PARTICIPATION.—The members of the HIT Advisory 

Committee shall represent a balance among various sectors 

of the health care system so that no single sector unduly 

influences the recommendations of the Committee. 

‘‘(4) TERMS.— 

‘‘(A) IN GENERAL.—The terms of the members of the 

HIT Advisory Committee shall be for 3 years, except that 

the Secretary shall designate staggered terms of the members first appointed. 

‘‘(B) VACANCIES.—Any member appointed to fill a 

vacancy in the membership of the HIT Advisory Committee 

that occurs prior to the expiration of the term for which 

the member’s predecessor was appointed shall be appointed 

only for the remainder of that term. A member may serve 

after the expiration of that member’s term until a successor 

has been appointed. A vacancy in the HIT Advisory Committee shall be filled in the manner in which the original 

appointment was made. 

‘‘(C) LIMITS.—Members of the HIT Advisory Committee 

shall be limited to two 3-year terms, for a total of not 

to exceed 6 years of service on the Committee. 

‘‘(5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee 

shall ensure an opportunity for the participation in activities 

of the Committee of outside advisors, including individuals 

with expertise in the development of policies and standards 

for the electronic exchange and use of health information, 


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including in the areas of health information privacy and security. 

‘‘(6) QUORUM.—A majority of the members of the HIT 

Advisory Committee shall constitute a quorum for purposes 

of voting, but a lesser number of members may meet and 

hold hearings. 

‘‘(7) CONSIDERATION.—The National Coordinator shall 

ensure that the relevant and available recommendations and 

comments from the National Committee on Vital and Health 

Statistics are considered in the development of policies. 

‘‘(8) ASSISTANCE.—For the purposes of carrying out this 

section, the Secretary may provide or ensure that financial 

assistance is provided by the HIT Advisory Committee to defray 

in whole or in part any membership fees or dues charged 

by such Committee to those consumer advocacy groups and 

not-for-profit entities that work in the public interest as a 

party of their mission. 

‘‘(e) APPLICATION OF FACA.—The Federal Advisory Committee 

Act (5 U.S.C. App.), other than section 14 of such Act, shall apply 

to the HIT Advisory Committee. 

‘‘(f) PUBLICATION.—The Secretary shall provide for publication 

in the Federal Register and the posting on the Internet website 

of the Office of the National Coordinator for Health Information 

Technology of all policy recommendations made by the HIT Advisory 

Committee under this section.’’. 

(2) TECHNICAL AND CONFORMING AMENDMENTS.—Title XXX 

of the Public Health Service Act (42 U.S.C. 300jj et seq.) is 

amended— 

(A) by striking— 

(i) ‘‘HIT Policy Committee’’ and ‘‘HIT Standards 

Committee’’ each place that such terms appear (other 

than within the term ‘‘HIT Policy Committee and the 

HIT Standards Committee’’ or within the term ‘‘HIT 

Policy Committee or the HIT Standards Committee’’) 

and inserting ‘‘HIT Advisory Committee’’; 

(ii) ‘‘HIT Policy Committee and the HIT Standards 

Committee’’ each place that such term appears and 

inserting ‘‘HIT Advisory Committee’’; and 

(iii) ‘‘HIT Policy Committee or the HIT Standards 

Committee’’ each place that such term appears and 

inserting ‘‘HIT Advisory Committee’’; 

(B) in section 3000 (42 U.S.C. 300jj)— 

(i) by striking paragraphs (7) and (8) and redesignating paragraphs (9) through (14) as paragraphs (8) 

through (13), respectively; and 

(ii) by inserting after paragraph (6) the following 

paragraph: 

‘‘(7) HIT ADVISORY COMMITTEE.—The term ‘HIT Advisory 

Committee’ means such Committee established under section 

3002(a).’’; 

(C) in section 3001(c) (42 U.S.C. 300jj–11(c))— 

(i) in paragraph (1)(A), by striking ‘‘under section 

3003’’ and inserting ‘‘under section 3002’’; 

(ii) in paragraph (2), by striking subparagraph (B) 

and inserting the following: 

‘‘(B) HIT ADVISORY COMMITTEE.—The National Coordinator shall be a leading member in the establishment 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1175 

and operations of the HIT Advisory Committee and shall 

serve as a liaison between that Committee and the Federal 

Government.’’; 

(D) in section 3004(b)(3) (42 U.S.C. 300jj–14(b)(3)), by 

striking ‘‘3003(b)(2)’’ and inserting ‘‘3002(b)(4)’’; 

(E) in section 3007(b) (42 U.S.C. 300jj–17(b)), by 

striking ‘‘3003(a)’’ and inserting ‘‘3002(a)(2)’’; and 

(F) in section 3008 (42 U.S.C. 300jj–18)— 

(i) in subsection (b), by striking ‘‘or 3003’’; and 

(ii) in subsection (c), by striking ‘‘3003(b)(1)(A)’’ 

and inserting ‘‘3002(b)(2)’’. 

(3) TRANSITION TO THE HIT ADVISORY COMMITTEE.—The Secretary of Health and Human Services shall provide for an 

orderly and timely transition to the HIT Advisory Committee 

established under amendments made by this section. 

(f) PRIORITIES FOR ADOPTION OF STANDARDS, IMPLEMENTATION

SPECIFICATIONS, AND CERTIFICATION CRITERIA.—Title XXX of the 

Public Health Service Act (42 U.S.C. 300jj et seq.), as amended 

by subsection (e), is further amended by inserting after section 

3002 the following: 

‘‘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 Committee to— 

‘‘(A) identify priority uses of health information technology, focusing on priorities— 

‘‘(i) arising from the implementation of the incentive programs for the meaningful use of certified EHR 

technology, the Merit-based Incentive Payment 

System, Alternative Payment Models, the Hospital 

Value-Based Purchasing Program, and any other 

value-based payment program determined appropriate 

by the Secretary; 

‘‘(ii) related to the quality of patient care; 

‘‘(iii) related to public health; 

‘‘(iv) related to clinical research; 

‘‘(v) related to the privacy and security of electronic 

health information; 

‘‘(vi) related to innovation in the field of health 

information technology; 

‘‘(vii) related to patient safety; 

‘‘(viii) related to the usability of health information 

technology; 

‘‘(ix) related to individuals’ access to electronic 

health information; and 

‘‘(x) other priorities determined appropriate by the 

Secretary; 

‘‘(B) identify existing standards and implementation 

specifications that support the use and exchange of electronic health information needed to meet the priorities 

identified in subparagraph (A); and 

‘‘(C) publish a report summarizing the findings of the 

analysis conducted under subparagraphs (A) and (B) and 

make appropriate recommendations. 

42 USC 300jj–13. 

42 USC 300jj–12 

note. 


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‘‘(2) PRIORITIZATION.—In identifying such standards and 

implementation specifications under paragraph (1)(B), the HIT 

Advisory Committee shall prioritize standards and implementation specifications developed by consensus-based standards 

development organizations. 

‘‘(3) GUIDELINES FOR REVIEW OF EXISTING STANDARDS AND

SPECIFICATIONS.—In consultation with the consensus-based 

entity described in section 1890 of the Social Security Act 

and other appropriate Federal agencies, the analysis of existing 

standards under paragraph (1)(B) shall include an evaluation 

of the need for a core set of common data elements and associated value sets to enhance the ability of certified health 

information technology to capture, use, and exchange structured 

electronic health information. 

‘‘(b) REVIEW OF ADOPTED STANDARDS.— ‘‘(1) IN GENERAL.—Beginning 5 years after the date of enactment of the 21st Century Cures Act and every 3 years thereafter, the National Coordinator shall convene stakeholders to 

review the existing set of adopted standards and implementation specifications and make recommendations with respect 

to whether to— 

‘‘(A) maintain the use of such standards and 

implementation specifications; or 

‘‘(B) phase out such standards and implementation 

specifications. 

‘‘(2) PRIORITIES.—The HIT Advisory Committee, in 

collaboration with the National Institute for Standards and 

Technology, shall annually and through the use of public input, 

review and publish priorities for the use of health information 

technology, standards, and implementation specifications to 

support those priorities. 

‘‘(c) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to prevent the use or adoption of novel standards 

that improve upon the existing health information technology infrastructure and facilitate the secure exchange of health information.’’. 

SEC. 4004. INFORMATION BLOCKING. 

Subtitle C of title XXX of the Public Health Service Act (42 

U.S.C. 300jj–51 et seq.) is amended by adding at the end the 

following: 

‘‘SEC. 3022. INFORMATION BLOCKING. 

‘‘(a) DEFINITION.— ‘‘(1) IN GENERAL.—In this section, the term ‘information 

blocking’ means a practice that— 

‘‘(A) except as required by law or specified by the 

Secretary pursuant to rulemaking under paragraph (3), 

is likely to interfere with, prevent, or materially discourage 

access, exchange, or use of electronic health information; 

and 

‘‘(B)(i) if conducted by a health information technology 

developer, exchange, or network, such developer, exchange, 

or network knows, or should know, that such practice is 

likely to interfere with, prevent, or materially discourage 

the access, exchange, or use of electronic health information; or 

‘‘(ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is 

42 USC 300jj–52. 


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likely to interfere with, prevent, or materially discourage 

access, exchange, or use of electronic health information. 

‘‘(2) PRACTICES DESCRIBED.—The information blocking practices described in paragraph (1) may include— 

‘‘(A) practices that restrict authorized access, exchange, 

or use under applicable State or Federal law of such 

information for treatment and other permitted purposes 

under such applicable law, including transitions between 

certified health information technologies; 

‘‘(B) implementing health information technology in 

nonstandard ways that are likely to substantially increase 

the complexity or burden of accessing, exchanging, or using 

electronic health information; and 

‘‘(C) implementing health information technology in 

ways that are likely to— 

‘‘(i) restrict the access, exchange, or use of electronic health information with respect to exporting 

complete information sets or in transitioning between 

health information technology systems; or 

‘‘(ii) lead to fraud, waste, or abuse, or impede 

innovations and advancements in health information 

access, exchange, and use, including care delivery 

enabled by health information technology. 

‘‘(3) RULEMAKING.—The Secretary, through rulemaking, 

shall identify reasonable and necessary activities that do not 

constitute information blocking for purposes of paragraph (1). 

‘‘(4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.— 

The term ‘information blocking’ does not include any practice 

or conduct occurring prior to the date that is 30 days after 

the date of enactment of the 21st Century Cures Act. 

‘‘(5) CONSULTATION.—The Secretary may consult with the 

Federal Trade Commission in promulgating regulations under 

this subsection, to the extent that such regulations define practices that are necessary to promote competition and consumer 

welfare. 

‘‘(6) APPLICATION.—The term ‘information blocking’, with 

respect to an individual or entity, shall not include an act 

or practice other than an act or practice committed by such 

individual or entity. 

‘‘(7) CLARIFICATION.—In carrying out this section, the Secretary shall ensure that health care providers are not penalized 

for the failure of developers of health information technology 

or other entities offering health information technology to such 

providers to ensure that such technology meets the requirements to be certified under this title. 

‘‘(b) INSPECTOR GENERAL AUTHORITY.— 

‘‘(1) IN GENERAL.—The inspector general of the Department 

of Health and Human Services (referred to in this section 

as the ‘Inspector General’) may investigate any claim that— 

‘‘(A) a health information technology developer of certified health information technology or other entity offering 

certified health information technology— 

‘‘(i) submitted a false attestation under section 

3001(c)(5)(D)(vii); or 

‘‘(ii) engaged in information blocking; 

‘‘(B) a health care provider engaged in information 

blocking; or 


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‘‘(C) a health information exchange or network engaged 

in information blocking. 

‘‘(2) PENALTIES.— 

‘‘(A) DEVELOPERS, NETWORKS, AND EXCHANGES.—Any 

individual or entity described in subparagraph (A) or (C) 

of paragraph (1) that the Inspector General, following an 

investigation conducted under this subsection, determines 

to have committed information blocking shall be subject 

to a civil monetary penalty determined by the Secretary 

for all such violations identified through such investigation, 

which may not exceed $1,000,000 per violation. Such determination shall take into account factors such as the nature 

and extent of the information blocking and harm resulting 

from such information blocking, including, where 

applicable, the number of patients affected, the number 

of providers affected, and the number of days the information blocking persisted. 

‘‘(B) PROVIDERS.—Any individual or entity described 

in subparagraph (B) of paragraph (1) determined by the 

Inspector General to have committed information blocking 

shall be referred to the appropriate agency to be subject 

to appropriate disincentives using authorities under 

applicable Federal law, as the Secretary sets forth through 

notice and comment rulemaking. 

‘‘(C) PROCEDURE.—The provisions of section 1128A of 

the Social Security Act (other than subsections (a) and 

(b) of such section) shall apply to a civil money penalty 

applied under this paragraph in the same manner as such 

provisions apply to a civil money penalty or proceeding 

under such section 1128A(a). 

‘‘(D) RECOVERED PENALTY FUNDS.—The amounts recovered under this paragraph shall be allocated as follows: 

‘‘(i) ANNUAL OPERATING EXPENSES.—Each year following the establishment of the authority under this 

subsection, the Office of the Inspector General shall 

provide to the Secretary an estimate of the costs to 

carry out investigations under this section. Such estimate may include reasonable reserves to account for 

variance in annual amounts recovered under this paragraph. There is authorized to be appropriated for purposes of carrying out this section an amount equal 

to the amount specified in such estimate for the fiscal 

year. 

‘‘(ii) APPLICATION TO OTHER PROGRAMS.—The 

amounts recovered under this paragraph and 

remaining after amounts are made available under 

clause (i) shall be transferred to the Federal Hospital 

Insurance Trust Fund under section 1817 of the Social 

Security Act and the Federal Supplementary Medical 

Insurance Trust Fund under section 1841 of such Act, 

in such proportion as the Secretary determines appropriate. 

‘‘(E) AUTHORIZATION OF APPROPRIATIONS.—There is 

authorized to be appropriated to the Office of the Inspector 

General to carry out this section $10,000,000, to remain 

available until expended. 

‘‘(3) RESOLUTION OF CLAIMS.— 


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‘‘(A) IN GENERAL.—The Office of the Inspector General, 

if such Office determines that a consultation regarding 

the health privacy and security rules promulgated under 

section 264(c) of the Health Insurance Portability and 

Accountability Act of 1996 (42 U.S.C. 1320d–2 note) will 

resolve an information blocking claim, may refer such 

instances of information blocking to the Office for Civil 

Rights of the Department of Health and Human Services 

for resolution. 

‘‘(B) LIMITATION ON LIABILITY.—If a health care provider or health information technology developer makes 

information available based on a good faith reliance on 

consultations with the Office for Civil Rights of the Department of Health and Human Services pursuant to a referral 

under subparagraph (A), with respect to such information, 

the health care provider or developer shall not be liable 

for such disclosure or disclosures made pursuant to 

subparagraph (A). 

‘‘(c) IDENTIFYING BARRIERS TO EXCHANGE OF CERTIFIED HEALTH

INFORMATION TECHNOLOGY.— 

‘‘(1) TRUSTED EXCHANGE DEFINED.—In this section, the term 

‘trusted exchange’ with respect to certified electronic health 

records means that the certified electronic health record technology has the technical capability to enable secure health 

information exchange between users and multiple certified electronic health record technology systems. 

‘‘(2) GUIDANCE.—The National Coordinator, in consultation 

with the Office for Civil Rights of the Department of Health 

and Human Services, shall issue guidance on common legal, 

governance, and security barriers that prevent the trusted 

exchange of electronic health information. 

‘‘(3) REFERRAL.—The National Coordinator and the Office 

for Civil Rights of the Department of Health and Human Services may refer to the Inspector General instances or patterns 

of refusal to exchange health information with an individual 

or entity using certified electronic health record technology 

that is technically capable of trusted exchange and under conditions when exchange is legally permissible. 

‘‘(d) ADDITIONAL PROVISIONS.— 

‘‘(1) INFORMATION SHARING PROVISIONS.—The National 

Coordinator may serve as a technical consultant to the 

Inspector General and the Federal Trade Commission for purposes of carrying out this section. The National Coordinator 

may, notwithstanding any other provision of law, share 

information related to claims or investigations under subsection 

(b) with the Federal Trade Commission for purposes of such 

investigations and shall share information with the Inspector 

General, as required by law. 

‘‘(2) PROTECTION FROM DISCLOSURE OF INFORMATION.—Any 

information that is received by the National Coordinator in 

connection with a claim or suggestion of possible information 

blocking and that could reasonably be expected to facilitate 

identification of the source of the information— 

‘‘(A) shall not be disclosed by the National Coordinator 

except as may be necessary to carry out the purpose of 

this section; 


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‘‘(B) shall be exempt from mandatory disclosure under 

section 552 of title 5, United States Code, as provided 

by subsection (b)(3) of such section; and 

‘‘(C) may be used by the Inspector General or Federal 

Trade Commission for reporting purposes to the extent 

that such information could not reasonably be expected 

to facilitate identification of the source of such information. 

‘‘(3) STANDARDIZED PROCESS.— ‘‘(A) IN GENERAL.—The National Coordinator shall 

implement a standardized process for the public to submit 

reports on claims of— 

‘‘(i) health information technology products or 

developers of such products (or other entities offering 

such products to health care providers) not being interoperable or resulting in information blocking; 

‘‘(ii) actions described in subsection (b)(1) that 

result in information blocking as described in subsection (a); and 

‘‘(iii) any other act described in subsection (a). 

‘‘(B) COLLECTION OF INFORMATION.—The standardized 

process implemented under subparagraph (A) shall provide 

for the collection of such information as the originating 

institution, location, type of transaction, system and 

version, timestamp, terminating institution, locations, 

system and version, failure notice, and other related 

information. 

‘‘(4) NONDUPLICATION OF PENALTY STRUCTURES.—In carrying out this subsection, the Secretary shall, to the extent 

possible, ensure that penalties do not duplicate penalty structures that would otherwise apply with respect to information 

blocking and the type of individual or entity involved as of 

the day before the date of the enactment of this section.’’. 

SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE 

PATIENT CARE. 

(a) REQUIREMENT RELATING TO REGISTRIES.— 

(1) IN GENERAL.—To be certified in accordance with title 

XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.), 

electronic health records shall be capable of transmitting to, 

and where applicable, receiving and accepting data from, registries in accordance with standards recognized by the Office 

of the National Coordinator for Health Information Technology, 

including clinician-led clinical data registries, that are also 

certified to be technically capable of receiving and accepting 

from, and where applicable, transmitting data to certified electronic health record technology in accordance with such standards. 

(2) RULE OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to require the certification of registries 

beyond the technical capability to exchange data in accordance 

with applicable recognized standards. 

(b) DEFINITION.—For purposes of this Act, the term ‘‘clinicianled clinical data registry’’ means a clinical data repository— 

(1) that is established and operated by a clinician-led or 

controlled, tax-exempt (pursuant to section 501(c) of the 

Internal Revenue Code of 1986), professional society or other 

similar clinician-led or -controlled organization, or such 

42 USC 300jj–14 

note. 


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organization’s controlled affiliate, devoted to the care of a population defined by a particular disease, condition, exposure or 

therapy; 

(2) that is designed to collect detailed, standardized data 

on an ongoing basis for medical procedures, services, or therapies for particular diseases, conditions, or exposures; 

(3) that provides feedback to participants who submit 

reports to the repository; 

(4) that meets standards for data quality including— 

(A) systematically collecting clinical and other health 

care data, using standardized data elements and having 

procedures in place to verify the completeness and validity 

of those data; and 

(B) being subject to regular data checks or audits to 

verify completeness and validity; and 

(5) that provides ongoing participant training and support. 

(c) TREATMENT OF HEALTH INFORMATION TECHNOLOGY DEVELOPERS WITH RESPECT TO PATIENT SAFETY ORGANIZATIONS.— 

(1) IN GENERAL.—In applying part C of title IX of the 

Public Health Service Act (42 U.S.C. 299b–21 et seq.), a health 

information technology developer shall be treated as a provider 

(as defined in section 921 of such Act) for purposes of reporting 

and conducting patient safety activities concerning improving 

clinical care through the use of health information technology 

that could result in improved patient safety, health care quality, 

or health care outcomes. 

(2) REPORT.—Not later than 4 years after the date of enactment of this Act, the Secretary of Health and Human Services 

shall submit to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, a report concerning best practices and current trends voluntarily provided, 

without identifying individual providers or disclosing or using 

protected health information or individually identifiable 

information, by patient safety organizations to improve the 

integration of health information technology into clinical practice. 

SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS 

TO THEIR ELECTRONIC HEALTH INFORMATION. 

(a) USE OF HEALTH INFORMATION EXCHANGES FOR PATIENT

ACCESS.—Section 3009 of the Public Health Service Act (42 U.S.C. 

300jj–19) is amended by adding at the end the following: 

‘‘(c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH

INFORMATION THROUGH HEALTH INFORMATION EXCHANGES .— 

‘‘(1) IN GENERAL.—The Secretary shall use existing authorities to encourage partnerships between health information 

exchange organizations and networks and health care providers, health plans, and other appropriate entities with the 

goal of offering patients access to their electronic health 

information in a single, longitudinal format that is easy to 

understand, secure, and may be updated automatically. 

‘‘(2) EDUCATION OF PROVIDERS.—The Secretary, in coordination with the Office for Civil Rights of the Department of 

Health and Human Services, shall— 

‘‘(A) educate health care providers on ways of 

leveraging the capabilities of health information exchanges 


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(or other relevant platforms) to provide patients with access 

to their electronic health information; 

‘‘(B) clarify misunderstandings by health care providers 

about using health information exchanges (or other relevant platforms) for patient access to electronic health 

information; and 

‘‘(C) to the extent practicable, educate providers about 

health information exchanges (or other relevant platforms) 

that employ some or all of the capabilities described in 

paragraph (1). 

‘‘(3) REQUIREMENTS.—In carrying out paragraph (1), the 

Secretary, in coordination with the Office for Civil Rights, shall 

issue guidance to health information exchanges related to best 

practices to ensure that the electronic health information provided to patients is— 

‘‘(A) private and secure; 

‘‘(B) accurate; 

‘‘(C) verifiable; and 

‘‘(D) where a patient’s authorization to exchange 

information is required by law, easily exchanged pursuant 

to such authorization. 

‘‘(4) RULE OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to preempt State laws applicable to patient 

consent for the access of information through a health information exchange (or other relevant platform) that provide protections to patients that are greater than the protections otherwise 

provided for under applicable Federal law. 

‘‘(d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.— 

The National Coordinator and the Office for Civil Rights of the 

Department of Health and Human Services shall jointly promote 

patient access to health information in a manner that would ensure 

that such information is available in a form convenient for the 

patient, in a reasonable manner, without burdening the health 

care provider involved. 

‘‘(e) ACCESSIBILITY OF PATIENT RECORDS.— ‘‘(1) ACCESSIBILITY AND UPDATING OF INFORMATION.— 

‘‘(A) IN GENERAL.—The Secretary, in consultation with 

the National Coordinator, shall promote policies that 

ensure that a patient’s electronic health information is 

accessible to that patient and the patient’s designees, in 

a manner that facilitates communication with the patient’s 

health care providers and other individuals, including 

researchers, consistent with such patient’s consent. 

‘‘(B) UPDATING EDUCATION ON ACCESSING AND

EXCHANGING PERSONAL HEALTH INFORMATION.—To promote 

awareness that an individual has a right of access to 

inspect, obtain a copy of, and transmit to a third party 

a copy of such individual’s protected health information 

pursuant to the Health Information Portability and 

Accountability Act, Privacy Rule (subpart E of part 164 

of title 45, Code of Federal Regulations), the Director of 

the Office for Civil Rights, in consultation with the National 

Coordinator, shall assist individuals and health care providers in understanding a patient’s rights to access and 

protect personal health information under the Health 

Insurance Portability and Accountability Act of 1996 

(Public Law 104–191), including providing best practices 


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for requesting personal health information in a computable 

format, including using patient portals or third-party 

applications and common cases when a provider is permitted to exchange and provide access to health information.’’. 

‘‘(2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out 

certification programs under section 3001(c)(5), the National 

Coordinator may require that— 

‘‘(A) the certification criteria support— 

‘‘(i) patient access to their electronic health 

information, including in a single longitudinal format 

that is easy to understand, secure, and may be updated 

automatically; 

‘‘(ii) the patient’s ability to electronically communicate patient-reported information (such as family history and medical history); and 

‘‘(iii) patient access to their personal electronic 

health information for research at the option of the 

patient; and 

‘‘(B) the HIT Advisory Committee develop and 

prioritize standards, implementation specifications, and 

certification criteria required to help support patient access 

to electronic health information, patient usability, and support for technologies that offer patients access to their 

electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated 

automatically.’’. 

(b) ACCESS TO INFORMATION IN AN ELECTRONIC FORMAT.—Section 13405(e) of the Health Information Technology for Economic 

and Clinical Health Act (42 U.S.C. 17935) is amended— 

(1) in paragraph (1), by striking ‘‘and’’ at the end; 

(2) by redesignating paragraph (2) as paragraph (3); and 

(3) by inserting after paragraph (1), the following: 

‘‘(2) if the individual makes a request to a business associate for access to, or a copy of, protected health information 

about the individual, or if an individual makes a request to 

a business associate to grant such access to, or transmit such 

copy directly to, a person or entity designated by the individual, 

a business associate may provide the individual with such 

access or copy, which may be in an electronic form, or grant 

or transmit such access or copy to such person or entity designated by the individual; and’’. 

SEC. 4007. GAO STUDY ON PATIENT MATCHING. 

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States 

shall conduct a study to— 

(1) review the policies and activities of the Office of the 

National Coordinator for Health Information Technology and 

other relevant stakeholders, which may include standards 

development organizations, experts in the technical aspects 

of health information technology, health information technology 

developers, providers of health services, health care suppliers, 

health care payers, health care quality organizations, States, 

health information technology policy experts, and other appropriate entities, to ensure appropriate patient matching to protect patient privacy and security with respect to electronic 


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health records and the exchange of electronic health information; and 

(2) survey ongoing efforts related to the policies and activities described in paragraph (1) and the effectiveness of such 

efforts occurring in the private sector. 

(b) AREAS OF CONCENTRATION.—In conducting the study under 

subsection (a), the Comptroller General shall— 

(1) evaluate current methods used in certified electronic 

health records for patient matching based on performance 

related to factors such as— 

(A) the privacy of patient information; 

(B) the security of patient information; 

(C) improving matching rates; 

(D) reducing matching errors; and 

(E) reducing duplicate records; and 

(2) determine whether the Office of the National Coordinator for Health Information Technology could improve patient 

matching by taking steps including— 

(A) defining additional data elements to assist in 

patient data matching; 

(B) agreeing on a required minimum set of elements 

that need to be collected and exchanged; 

(C) requiring electronic health records to have the 

ability to make certain fields required and use specific 

standards; and 

(D) other options recommended by the relevant stakeholders consulted pursuant to subsection (a). 

(c) REPORT.—Not later than 2 years after the date of enactment 

of this Act, the Comptroller General shall submit to the appropriate 

committees of Congress a report concerning the findings of the 

study conducted under subsection (a). 

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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and format requested by the individual, including examples 

of such instances; 

(D) instances in which third parties may request protected health information through patients’ individual right 

of access, including instances where such requests may 

be used to circumvent appropriate fees that may be charged 

to third parties; 

(E) opportunities that permit covered entities to charge 

appropriate fees to third parties for patient records while 

providing patients with access to their protected health 

information at low or no cost; 

(F) the ability of providers to distinguish between 

requests originating from an individual that require limitation to a cost-based fee and requests originating from third 

parties that may not be limited to cost-based fees; and 

(G) other circumstances that may inhibit the ability 

of providers to provide patients with access to their records, 

and the ability of patients to gain access to their records. 

(b) REPORT.—Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit a report 

to Congress on the findings of the study conducted under subsection 

(a). 

SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS. 

(a) IN GENERAL.—Section 1862(l)(5) of the Social Security Act 

(42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph: 

‘‘(D) LOCAL COVERAGE DETERMINATIONS.—The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to 

make available on the Internet website of such contractor 

and on the Medicare Internet website, at least 45 days 

before the effective date of such determination, the following information: 

‘‘(i) Such determination in its entirety. 

‘‘(ii) Where and when the proposed determination 

was first made public. 

‘‘(iii) Hyperlinks to the proposed determination and 

a response to comments submitted to the contractor 

with respect to such proposed determination. 

‘‘(iv) A summary of evidence that was considered 

by the contractor during the development of such determination and a list of the sources of such evidence. 

‘‘(v) An explanation of the rationale that supports 

such determination.’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall apply with respect to local coverage determinations that are 

proposed or revised on or after the date that is 180 days after 

the date of enactment of this Act. 

SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN. 

Section 1808 of the Social Security Act (42 U.S.C. 1395b– 

9) is amended by adding at the end the following new subsection: 

‘‘(d) PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.— 

‘‘(1) IN GENERAL.—Not later than 12 months after the date 

of enactment of this paragraph, the Secretary shall provide 

42 USC 1395y 

note. 


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for a pharmaceutical and technology ombudsman within the 

Centers for Medicare & Medicaid Services who shall receive 

and respond to complaints, grievances, and requests that— 

‘‘(A) are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought 

under this title; and 

‘‘(B) are with respect to coverage, coding, or payment 

under this title for such products. 

‘‘(2) APPLICATION.—The second sentence of subsection (c)(2) 

shall apply to the ombudsman under subparagraph (A) in the 

same manner as such sentence applies to the Medicare Beneficiary Ombudsman under subsection (c).’’. 

SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY. 

Section 1834 of the Social Security Act (42 U.S.C. 1395m) 

is amended by adding at the end the following new subsection: 

‘‘(t) SITE-OF-SERVICE PRICE TRANSPARENCY.— 

‘‘(1) IN GENERAL.—In order to facilitate price transparency 

with respect to items and services for which payment may 

be made either to a hospital outpatient department or to an 

ambulatory surgical center under this title, the Secretary shall, 

for 2018 and each year thereafter, make available to the public 

via a searchable Internet website, with respect to an appropriate number of such items and services— 

‘‘(A) the estimated payment amount for the item or 

service under the outpatient department fee schedule under 

subsection (t) of section 1833 and the ambulatory surgical 

center payment system under subsection (i) of such section; 

and 

‘‘(B) the estimated amount of beneficiary liability 

applicable to the item or service. 

‘‘(2) CALCULATION OF ESTIMATED BENEFICIARY LIABILITY.— 

For purposes of paragraph (1)(B), the estimated amount of 

beneficiary liability, with respect to an item or service, is the 

amount for such item or service for which an individual who 

does not have coverage under a Medicare supplemental policy 

certified under section 1882 or any other supplemental insurance coverage is responsible. 

‘‘(3) IMPLEMENTATION.—In carrying out this subsection, the 

Secretary— 

‘‘(A) shall include in the notice described in section 

1804(a) a notification of the availability of the estimated 

amounts made available under paragraph (1); and 

‘‘(B) may utilize mechanisms in existence on the date 

of enactment of this subsection, such as the portion of 

the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician 

performance is posted (commonly referred to as the Physician Compare Internet website), to make available such 

estimated amounts under such paragraph. 

‘‘(4) FUNDING.—For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the 

Federal Supplementary Medical Insurance Trust Fund under 

section 1841 to the Centers for Medicare & Medicaid Services 

Program Management Account, of $6,000,000 for fiscal year 

2017, to remain available until expended.’’. 


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SEC. 4012. TELEHEALTH SERVICES IN MEDICARE. 

(a) PROVISION OF INFORMATION BY CENTERS FOR MEDICARE

& MEDICAID SERVICES.—Not later than 1 year after the date of 

enactment of this Act, the Administrator of the Centers for Medicare 

& Medicaid Services shall provide to the committees of jurisdiction 

of the House of Representatives and the Senate information on 

the following: 

(1) The populations of Medicare beneficiaries, such as those 

who are dually eligible for the Medicare program under title 

XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and 

the Medicaid program under title XIX of such Act (42 U.S.C. 

1396 et seq.) and those with chronic conditions, whose care 

may be improved most in terms of quality and efficiency by 

the expansion, in a manner that meets or exceeds the existing 

in-person standard of care under the Medicare program under 

such title XVIII, of telehealth services under section 1834(m)(4) 

of such Act (42 U.S.C. 1395m(m)(4)). 

(2) Activities by the Center for Medicare and Medicaid 

Innovation which examine the use of telehealth services in 

models, projects, or initiatives funded through section 1115A 

of such Act (42 U.S.C. 1315a). 

(3) The types of high-volume services (and related 

diagnoses) under such title XVIII which might be suitable 

to be furnished using telehealth. 

(4) Barriers that might prevent the expansion of telehealth 

services under section 1834(m)(4) of the Social Security Act 

(42 U.S.C. 1395m(m)(4)) beyond such services that are in effect 

as of the date of enactment of this Act. 

(b) PROVISION OF INFORMATION BY MEDPAC.—Not later than 

March 15, 2018, the Medicare Payment Advisory Commission established under section 1805 of the Social Security Act (42 U.S.C. 

1395b–6) shall, using quantitative and qualitative research 

methods, provide information to the committees of jurisdiction of 

the House of Representatives and the Senate that identifies— 

(1) the telehealth services for which payment can be made, 

as of the date of enactment of this Act, under the fee-forservice program under parts A and B of title XVIII of such 

Act; 

(2) the telehealth services for which payment can be made, 

as of such date, under private health insurance plans; and 

(3) with respect to services identified under paragraph 

(2) but not under paragraph (1), ways in which payment for 

such services might be incorporated into such fee-for-service 

program (including any recommendations for ways to accomplish this incorporation). 

(c) SENSE OF CONGRESS.—It is the sense of Congress that— 

(1) eligible originating sites should be expanded beyond 

those originating sites described in section 1834(m)(4)(C) of 

the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and 

(2) any expansion of telehealth services under the Medicare 

program under title XVIII of such Act should— 

(A) recognize that telemedicine is the delivery of safe, 

effective, quality health care services, by a health care 

provider, using technology as the mode of care delivery; 

(B) meet or exceed the conditions of coverage and payment with respect to the Medicare program if the service 


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was furnished in person, including standards of care, unless 

specifically addressed in subsequent legislation; and 

(C) involve clinically appropriate means to furnish such 

services. 

TITLE V—SAVINGS 

SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND. 

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 

1395iii(b)(1)), as amended by section 704(h) of the Comprehensive 

Addiction and Recovery Act of 2016, is amended by striking 

‘‘$140,000,000’’ and inserting ‘‘$270,000,000’’. 

SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE 

MEDICAL EQUIPMENT. 

Section 1903(i)(27) of the Social Security Act (42 U.S.C. 

1396b(i)(27)) is amended by striking ‘‘January 1, 2019’’ and inserting 

‘‘January 1, 2018’’. 

SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND 

OTHER AGREEMENTS. 

(a) IN GENERAL.—Section 1128A of the Social Security Act 

(42 U.S.C. 1320a–7a) is amended by adding at the end the following 

new subsections: 

‘‘(o) Any person (including an organization, agency, or other 

entity, but excluding a program beneficiary, as defined in subsection 

(q)(4)) that, with respect to a grant, contract, or other agreement 

for which the Secretary provides funding— 

‘‘(1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant, 

contract, or other agreement that the person knows or should 

know is false or fraudulent; 

‘‘(2) knowingly makes, uses, or causes to be made or used 

any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or 

other document that is required to be submitted in order to 

directly or indirectly receive or retain funds provided in whole 

or in part by such Secretary pursuant to such grant, contract, 

or other agreement; 

‘‘(3) knowingly makes, uses, or causes to be made or used, 

a false record or statement material to a false or fraudulent 

specified claim under such grant, contract, or other agreement; 

‘‘(4) knowingly makes, uses, or causes to be made or used, 

a false record or statement material to an obligation (as defined 

in subsection (s)) to pay or transmit funds or property to such 

Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly 

avoids or decreases an obligation to pay or transmit funds 

or property to such Secretary with respect to such grant, contract, or other agreement; or 

‘‘(5) fails to grant timely access, upon reasonable request 

(as defined by such Secretary in regulations), to the Inspector 

General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector 

General in matters involving such grants, contracts, or other 

agreements; 


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shall be subject, in addition to any other penalties that may be 

prescribed by law, to a civil money penalty in cases under paragraph 

(1), of not more than $10,000 for each specified claim; in cases 

under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases 

under paragraph (3), not more than $50,000 for each false record 

or statement; in cases under paragraph (4), not more than $50,000 

for each false record or statement or $10,000 for each day that 

the person knowingly conceals or knowingly and improperly avoids 

or decreases an obligation to pay; or in cases under paragraph 

(5), not more than $15,000 for each day of the failure described 

in such paragraph. In addition, in cases under paragraphs (1) 

and (3), such a person shall be subject to an assessment of not 

more than 3 times the amount claimed in the specified claim 

described in such paragraph in lieu of damages sustained by the 

United States or a specified State agency because of such specified 

claim, and in cases under paragraphs (2) and (4), such a person 

shall be subject to an assessment of not more than 3 times the 

total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to 

the Secretary described in paragraph (4), of the value of the property 

described in such paragraph) in lieu of damages sustained by the 

United States or a specified State agency because of such case. 

In addition, the Secretary may make a determination in the same 

proceeding to exclude the person from participation in the Federal 

health care programs (as defined in section 1128B(f)(1)) and to 

direct the appropriate State agency to exclude the person from 

participation in any State health care program. 

‘‘(p) The provisions of subsections (c), (d), (g), and (h) shall 

apply to a civil money penalty or assessment under subsection 

(o) in the same manner as such provisions apply to a penalty, 

assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall 

be treated as including a reference to a specified claim (as defined 

in subsection (r)). 

‘‘(q) For purposes of this subsection and subsections (o) and 

(p): 

‘‘(1) The term ‘Department’ means the Department of 

Health and Human Services. 

‘‘(2) The term ‘material’ means having a natural tendency 

to influence, or be capable of influencing, the payment or receipt 

of money or property. 

‘‘(3) The term ‘other agreement’ includes a cooperative 

agreement, scholarship, fellowship, loan, subsidy, payment for 

a specified use, donation agreement, award, or subaward 

(regardless of whether one or more of the persons entering 

into the agreement is a contractor or subcontractor). 

‘‘(4) The term ‘program beneficiary’ means, in the case 

of a grant, contract, or other agreement designed to accomplish 

the objective of awarding or otherwise furnishing benefits or 

assistance to individuals and for which the Secretary provides 

funding, an individual who applies for, or who receives, such 

benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, 

contract, or other agreement, an officer, employee, or agent 

of a person or entity that receives such grant or that enters 

into such contract or other agreement. 


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‘‘(5) The term ‘recipient’ includes a subrecipient or subcontractor. 

‘‘(6) The term ‘specified State agency’ means an agency 

of a State government established or designated to administer 

or supervise the administration of a grant, contract, or other 

agreement funded in whole or in part by the Secretary. 

‘‘(r) For purposes of this section, the term ‘specified claim’ 

means any application, request, or demand under a grant, contract, 

or other agreement for money or property, whether or not the 

United States or a specified State agency has title to the money 

or property, that is not a claim (as defined in subsection (i)(2)) 

and that— 

‘‘(1) is presented or caused to be presented to an officer, 

employee, or agent of the Department or agency thereof, or 

of any specified State agency; or 

‘‘(2) is made to a contractor, grantee, or any other recipient 

if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, 

and if the Department— 

‘‘(A) provides or has provided any portion of the money 

or property requested or demanded; or 

‘‘(B) will reimburse such contractor, grantee, or other 

recipient for any portion of the money or property which 

is requested or demanded. 

‘‘(s) For purposes of subsection (o), the term ‘obligation’ means 

an established duty, whether or not fixed, arising from an express 

or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.’’. 

(b) CONFORMING AMENDMENTS.—Section 1128A of the Social 

Security Act (42 U.S.C. 1320a–7a) is amended— 

(1) in subsection (e), by inserting ‘‘or specified claim’’ after 

‘‘claim’’ in the first sentence; and 

(2) in subsection (f)— 

(A) in the matter preceding paragraph (1)— 

(i) by inserting ‘‘or specified claim (as defined in 

subsection (r))’’ after ‘‘district where the claim’’; and 

(ii) by inserting ‘‘(or, with respect to a person 

described in subsection (o), the person)’’ after ‘‘claimant’’; and 

(B) in the matter following paragraph (4), by inserting 

‘‘(or, in the case of a penalty or assessment under subsection 

(o), by a specified State agency (as defined in subsection 

(q)(6)),’’ after ‘‘or a State agency’’. 

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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(i) by striking ‘‘2004’’ and inserting ‘‘2004, and 

before January 1, 2017’’; and 

(ii) by striking ‘‘for such drug’’. 

(b) NONINCLUSION OF DME INFUSION DRUGS UNDER DME 

COMPETITIVE ACQUISITION PROGRAMS.— 

(1) IN GENERAL.—Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)(A)) is amended— 

(A) by striking ‘‘and excluding’’ and inserting ‘‘, 

excluding’’; and 

(B) by inserting before the period at the end the following: ‘‘, and excluding drugs and biologicals described 

in section 1842(o)(1)(D)’’. 

(2) CONFORMING AMENDMENT.—Section 1842(o)(1)(D)(ii) of 

the Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended 

by striking ‘‘2007’’ and inserting ‘‘2007, and before the date 

of the enactment of the 21st Century Cures Act.’’. 

SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID 

PROVIDERS. 

(a) INCREASED OVERSIGHT AND REPORTING.— 

(1) STATE REPORTING REQUIREMENTS.—Section 1902(kk) of 

the Social Security Act (42 U.S.C. 1396a(kk)) is amended— 

(A) by redesignating paragraph (8) as paragraph (9); 

and 

(B) by inserting after paragraph (7) the following new 

paragraph: 

‘‘(8) PROVIDER TERMINATIONS.— 

‘‘(A) IN GENERAL.—Beginning on July 1, 2018, in the 

case of a notification under subsection (a)(41) with respect 

to a termination for a reason specified in section 455.101 

of title 42, Code of Federal Regulations (as in effect on 

November 1, 2015) or for any other reason specified by 

the Secretary, of the participation of a provider of services 

or any other person under the State plan (or under a 

waiver of the plan), the State, not later than 30 days 

after the effective date of such termination, submits to 

the Secretary with respect to any such provider or person, 

as appropriate— 

‘‘(i) the name of such provider or person; 

‘‘(ii) the provider type of such provider or person; 

‘‘(iii) the specialty of such provider’s or person’s 

practice; 

‘‘(iv) the date of birth, Social Security number, 

national provider identifier (if applicable), Federal taxpayer identification number, and the State license or 

certification number of such provider or person (if 

applicable); 

‘‘(v) the reason for the termination; 

‘‘(vi) a copy of the notice of termination sent to 

the provider or person; 

‘‘(vii) the date on which such termination is effective, as specified in the notice; and 

‘‘(viii) any other information required by the Secretary. 

‘‘(B) EFFECTIVE DATE DEFINED.—For purposes of this 

paragraph, the term ‘effective date’ means, with respect 


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130 STAT. 1192 PUBLIC LAW 114–255—DEC. 13, 2016 

to a termination described in subparagraph (A), the later 

of— 

‘‘(i) the date on which such termination is effective, 

as specified in the notice of such termination; or 

‘‘(ii) the date on which all appeal rights applicable 

to such termination have been exhausted or the 

timeline for any such appeal has expired.’’. 

(2) CONTRACT REQUIREMENT FOR MANAGED CARE 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 subsection (a)(41) (as applicable), review such termination and, if the 

Secretary determines appropriate, include such termination in any 

database or similar system developed pursuant to section 6401(b)(2) 

of the Patient Protection and Affordable Care Act (42 U.S.C. 1395cc 

note; Public Law 111–148).’’. 

(4) NO FEDERAL FUNDS FOR ITEMS AND SERVICES FURNISHED

BY TERMINATED PROVIDERS.—Section 1903 of the Social Security 

Act (42 U.S.C. 1396b) is amended— 

(A) in subsection (i)(2)— 

(i) in subparagraph (A), by striking the comma 

at the end and inserting a semicolon; 

(ii) in subparagraph (B), by striking ‘‘or’’ at the 

end; and 

(iii) by adding at the end the following new 

subparagraph: 

‘‘(D) beginning on July 1, 2018, under the plan by 

any provider of services or person whose participation in 

the State plan is terminated (as described in section 

1902(kk)(8)) after the date that is 60 days after the date 

on which such termination is included in the database 

or other system under section 1902(ll); or’’; and 

(B) in subsection (m), by inserting after paragraph 

(2) the following new paragraph: 

‘‘(3) No payment shall be made under this title to a State 

with respect to expenditures incurred by the State for payment 

for services provided by a managed care entity (as defined under 

section 1932(a)(1)) under the State plan under this title (or under 

a waiver of the plan) unless the State— 


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‘‘(A) beginning on July 1, 2018, has a contract with such 

entity that complies with the requirement specified in section 

1932(d)(5); and 

‘‘(B) beginning on January 1, 2018, complies with the 

requirement specified in section 1932(d)(6)(A).’’. 

(5) DEVELOPMENT OF UNIFORM TERMINOLOGY FOR REASONS

FOR PROVIDER TERMINATION.—Not later than July 1, 2017, the 

Secretary of Health and Human Services shall, in consultation 

with the heads of State agencies administering State Medicaid 

plans (or waivers of such plans), issue regulations establishing 

uniform terminology to be used with respect to specifying reasons under subparagraph (A)(v) of paragraph (8) of section 

1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)), as 

added by paragraph (1), for the termination (as described in 

such paragraph (8)) of the participation of certain providers 

in the Medicaid program under title XIX of such Act or the 

Children’s Health Insurance Program under title XXI of such 

Act. 

(6) CONFORMING AMENDMENT.—Section 1902(a)(41) of the 

Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by 

striking ‘‘provide that whenever’’ and inserting ‘‘provide, in 

accordance with subsection (kk)(8) (as applicable), that whenever’’. 

(b) INCREASING AVAILABILITY OF MEDICAID PROVIDER INFORMATION.— 

(1) FFS PROVIDER ENROLLMENT.—Section 1902(a) of the 

Social Security Act (42 U.S.C. 1396a(a)) is amended by inserting 

after paragraph (77) the following new paragraph: 

‘‘(78) provide that, not later than January 1, 2017, in the 

case of a State that pursuant to its State plan or waiver 

of the plan for medical assistance pays for medical assistance 

on a fee-for-service basis, the State shall require each provider 

furnishing items and services to, or ordering, prescribing, referring, or certifying eligibility for, services for individuals eligible 

to receive medical assistance under such plan to enroll with 

the State agency and provide to the State agency the provider’s 

identifying information, including the name, specialty, date of 

birth, Social Security number, national provider identifier (if 

applicable), Federal taxpayer identification number, and the 

State license or certification number of the provider (if 

applicable);’’. 

(2) MANAGED CARE PROVIDER ENROLLMENT.—Section 

1932(d) of the Social Security Act (42 U.S.C. 1396u–2(d)), as 

amended by subsection (a)(2), is amended by adding at the 

end the following new paragraph: 

‘‘(6) ENROLLMENT OF PARTICIPATING PROVIDERS.— 

‘‘(A) IN GENERAL.—Beginning not later than January 

1, 2018, a State shall require that, in order to participate 

as a provider in the network of a managed care entity 

that provides services to, or orders, prescribes, refers, or 

certifies eligibility for services for, individuals who are 

eligible for medical assistance under the State plan under 

this title (or under a waiver of the plan) and who are 

enrolled with the entity, the provider is enrolled consistent 

with section 1902(kk) with the State agency administering 

the State plan under this title. Such enrollment shall 

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 identifying information, including the name, specialty, date of 

birth, Social Security number, national provider identifier, 

Federal taxpayer identification number, and the State 

license or certification number of the provider. 

‘‘(B) RULE OF CONSTRUCTION.—Nothing in subparagraph (A) shall be construed as requiring a provider 

described in such subparagraph to provide services to 

individuals who are not enrolled with a managed care 

entity under this title.’’. 

(c) COORDINATION WITH CHIP.— 

(1) IN GENERAL.—Section 2107(e)(1) of the Social Security 

Act (42 U.S.C. 1397gg(e)(1)) is amended— 

(A) by redesignating subparagraphs (B), (C), (D), (E), 

(F), (G), (H), (I), (J), (K), (L), (M), (N), and (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), (O), 

(P), (Q), and (R), respectively; 

(B) by inserting after subparagraph (A) the following 

new subparagraphs: 

‘‘(B) Section 1902(a)(39) (relating to termination of 

participation of certain providers). 

‘‘(C) Section 1902(a)(78) (relating to enrollment of providers participating in State plans providing medical assistance on a fee-for-service basis).’’; 

(C) by inserting after subparagraph (K) (as redesignated by subparagraph (A)) the following new subparagraph: 

‘‘(L) Section 1903(m)(3) (relating to limitation on payment with respect to managed care).’’; and 

(D) in subparagraph (P) (as redesignated by subparagraph (A)), by striking ‘‘(a)(2)(C) and (h)’’ and inserting 

‘‘(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating 

to contract requirement for managed care entities), (d)(6) 

(relating to enrollment of providers participating with a 

managed care entity), and (h) (relating to special rules 

with respect to Indian enrollees, Indian health care providers, and Indian managed care entities)’’. 

(2) EXCLUDING FROM MEDICAID PROVIDERS EXCLUDED FROM

CHIP.—Section 1902(a)(39) of the Social Security Act (42 U.S.C. 

1396a(a)(39)) is amended by striking ‘‘title XVIII or any other 

State plan under this title’’ and inserting ‘‘title XVIII, any 

other State plan under this title (or waiver of the plan), or 

any State child health plan under title XXI (or waiver of the 

plan) and such termination is included by the Secretary in 

any database or similar system developed pursuant to section 

6401(b)(2) of the Patient Protection and Affordable Care Act’’. 

(d) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed as changing or limiting the appeal rights of providers 

or the process for appeals of States under the Social Security 

Act. 

(e) OIG REPORT.—Not later than March 31, 2020, the Inspector 

General of the Department of Health and Human Services shall 

submit to Congress a report on the implementation of the amendments made by this section. Such report shall include the following: 

(1) An assessment of the extent to which providers who 

are included under subsection (ll) of section 1902 of the Social 

Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3)) 

42 USC 1396a 

note. 


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in the database or similar system referred to in such subsection 

are terminated (as described in paragraph (8) of subsection 

(kk) of such section, as added by subsection (a)(1)) from participation in all State plans under title XIX of such Act (or waivers 

of such plans). 

(2) Information on the amount of Federal financial participation paid to States under section 1903 of such Act in violation 

of the limitation on such payment specified in subparagraph 

(D) of subsection (i)(2) of such section and paragraph (3) of 

subsection (m) of such section, as added by subsection (a)(4). 

(3) An assessment of the extent to which contracts with 

managed care entities under title XIX of such Act comply 

with the requirement specified in paragraph (5) of section 

1932(d) of such Act, as added by subsection (a)(2). 

(4) An assessment of the extent to which providers have 

been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such 

Act (42 U.S.C. 1396a(a)(78), 1396u–2(d)(6)(A)) with State agencies administering State plans under title XIX of such Act 

(or waivers of such plans). 

SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER 

DIRECTORY. 

(a) IN GENERAL.—Section 1902(a) of the Social Security Act 

(42 U.S.C. 1396a(a)) is amended— 

(1) in paragraph (81), by striking ‘‘and’’ at the end; 

(2) in paragraph (82), by striking the period at the end 

and inserting ‘‘; and’’; and 

(3) by inserting after paragraph (82) the following new 

paragraph: 

‘‘(83) provide that, not later than January 1, 2017, in the 

case of a State plan (or waiver of the plan) that provides 

medical assistance on a fee-for-service basis or through a primary care case-management system described in section 

1915(b)(1) (other than a primary care case management entity 

(as defined by the Secretary)), the State shall publish (and 

update on at least an annual basis) on the public website 

of the State agency administering the State plan, a directory 

of the physicians described in subsection (mm) and, at State 

option, other providers described in such subsection that— 

‘‘(A) includes— 

‘‘(i) with respect to each such physician or provider— 

‘‘(I) the name of the physician or provider; 

‘‘(II) the specialty of the physician or provider; 

‘‘(III) the address at which the physician or 

provider provides services; and 

‘‘(IV) the telephone number of the physician 

or provider; and 

‘‘(ii) with respect to any such physician or provider 

participating in such a primary care case-management 

system, information regarding— 

‘‘(I) whether the physician or provider is 

accepting as new patients individuals who receive 

medical assistance under this title; and 

‘‘(II) the physician’s or provider’s cultural and 

linguistic capabilities, including the languages 

spoken by the physician or provider or by the 


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skilled medical interpreter providing interpretation services at the physician’s or provider’s office; 

and 

‘‘(B) may include, at State option, with respect to each 

such physician or provider— 

‘‘(i) the Internet website of such physician or provider; or 

‘‘(ii) whether the physician or provider is accepting 

as new patients individuals who receive medical assistance under this title.’’. 

(b) DIRECTORY PHYSICIAN OR PROVIDER DESCRIBED.—Section 

1902 of the Social Security Act (42 U.S.C. 1396a), as amended 

by section 5005(a)(3), is further amended by adding at the end 

the following new subsection: 

‘‘(mm) DIRECTORY PHYSICIAN OR PROVIDER DESCRIBED.—A 

physician or provider described in this subsection is— 

‘‘(1) in the case of a physician or provider of a provider 

type for which the State agency, as a condition on receiving 

payment for items and services furnished by the physician 

or provider to individuals eligible to receive medical assistance 

under the State plan, requires the enrollment of the physician 

or provider with the State agency, a physician or a provider 

that— 

‘‘(A) is enrolled with the agency as of the date on 

which the directory is published or updated (as applicable) 

under subsection (a)(83); and 

‘‘(B) received payment under the State plan in the 

12-month period preceding such date; and 

‘‘(2) in the case of a physician or provider of a provider 

type for which the State agency does not require such enrollment, a physician or provider that received payment under 

the State plan (or a waiver of the plan) in the 12-month 

period preceding the date on which the directory is published 

or updated (as applicable) under subsection (a)(83).’’. 

(c) RULE OF CONSTRUCTION.— 

(1) IN GENERAL.—The amendment made by subsection (a) 

shall not be construed to apply in the case of a State (as 

defined for purposes of title XIX of the Social Security Act) 

in which all the individuals enrolled in the State plan under 

such title (or under a waiver of such plan), other than individuals described in paragraph (2), are enrolled with a medicaid 

managed care organization (as defined in section 1903(m)(1)(A) 

of such Act (42 U.S.C. 1396b(m)(1)(A))), including prepaid 

inpatient health plans and prepaid ambulatory health plans 

(as defined by the Secretary of Health and Human Services). 

(2) INDIVIDUALS DESCRIBED.—An individual described in 

this paragraph is an individual who is an Indian (as defined 

in section 4 of the Indian Health Care Improvement Act (25 

U.S.C. 1603)) or an Alaska Native. 

(d) EXCEPTION FOR STATE LEGISLATION.—In the case of a State 

plan under title XIX of the Social Security Act (42 U.S.C. 1396 

et seq.), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan 

to meet one or more additional requirements imposed by amendments made by this section, the respective plan shall not be 

regarded as failing to comply with the requirements of such title 

42 USC 1396a 

note. 

42 USC 1396a 

note. 


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solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning 

after the close of the first regular session of the State legislature 

that begins after the date of enactment of this Act. For purposes 

of the previous sentence, in the case of a State that has a 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 individual,’’ after ‘‘for the benefit of such individual by’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall apply to trusts established on or after the date of the enactment of this Act. 

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.—Subparagraphs (C) and (D) of section 161(h)(2) of the Energy Policy and 

Conservation Act (42 U.S.C. 6241(h)(2)(C) and (D)) are both 

amended by striking ‘‘500,000,000’’ and inserting ‘‘450,000,000’’. 

SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING. 

Of the unobligated amounts available under section 1323(c)(1) 

of the Patient Protection and Affordable Care Act (42 U.S.C. 

18043(c)(1)), $464,000,000 is rescinded immediately upon the date 

of the enactment of this Act. 

SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY. 

(a) IN GENERAL.—Section 1861 of the Social Security Act (42 

U.S.C. 1395x) is amended— 

(1) in subsection (s)(2)— 

(A) by striking ‘‘and’’ at the end of subparagraph (EE); 

(B) by inserting ‘‘and’’ at the end of subparagraph 

(FF); and 

(C) by inserting at the end the following new subparagraph: 

‘‘(GG) home infusion therapy (as defined in subsection 

(iii)(1));’’; and 

(2) by adding at the end the following new subsection: 

‘‘(iii) HOME INFUSION THERAPY.—(1) The term ‘home infusion 

therapy’ means the items and services described in paragraph (2) 

furnished by a qualified home infusion therapy supplier (as defined 

in paragraph (3)(D)) which are furnished in the individual’s home 

(as defined in paragraph (3)(B)) to an individual— 

‘‘(A) who is under the care of an applicable provider (as 

defined in paragraph (3)(A)); and 

‘‘(B) with respect to whom a plan prescribing the type, 

amount, and duration of infusion therapy services that are 

to be furnished such individual has been established by a 

physician (as defined in subsection (r)(1)) and is periodically 

reviewed by a physician (as so defined) in coordination with 

the furnishing of home infusion drugs (as defined in paragraph 

(3)(C)) under part B. 

‘‘(2) The items and services described in this paragraph are 

the following: 

‘‘(A) Professional services, including nursing services, furnished in accordance with the plan. 

‘‘(B) Training and education (not otherwise paid for as 

durable medical equipment (as defined in subsection (n)), 

remote monitoring, and monitoring services for the provision 

of home infusion therapy and home infusion drugs furnished 

by a qualified home infusion therapy supplier. 

‘‘(3) For purposes of this subsection: 

‘‘(A) The term ‘applicable provider’ means— 

‘‘(i) a physician; 

42 USC 6241 

note. 


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‘‘(ii) a nurse practitioner; and 

‘‘(iii) a physician assistant. 

‘‘(B) The term ‘home’ means a place of residence used 

as the home of an individual (as defined for purposes of subsection (n)). 

‘‘(C) The term ‘home infusion drug’ means a parenteral 

drug or biological administered intravenously, or 

subcutaneously for an administration period of 15 minutes or 

more, in the home of an individual through a pump that is 

an item of durable medical equipment (as defined in subsection 

(n)). Such term does not include the following: 

‘‘(i) Insulin pump systems. 

‘‘(ii) A self-administered drug or biological on a selfadministered drug exclusion list. 

‘‘(D)(i) The term ‘qualified home infusion therapy supplier’ 

means a pharmacy, physician, or other provider of services 

or supplier licensed by the State in which the pharmacy, physician, or provider or services or supplier furnishes items or 

services and that— 

‘‘(I) furnishes infusion therapy to individuals with acute 

or chronic conditions requiring administration of home infusion drugs; 

‘‘(II) ensures the safe and effective provision and 

administration of home infusion therapy on a 7-day-a-week, 

24-hour-a-day basis; 

‘‘(III) is accredited by an organization designated by 

the Secretary pursuant to section 1834(u)(5); and 

‘‘(IV) meets such other requirements as the Secretary 

determines appropriate, taking into account the standards 

of care for home infusion therapy established by Medicare 

Advantage plans under part C and in the private sector. 

‘‘(ii) A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or 

supplier to meet the requirements of this subparagraph.’’. 

(b) PAYMENT AND RELATED REQUIREMENTS FOR HOME INFUSION

THERAPY.—Section 1834 of the Social Security Act (42 U.S.C. 

1395m), as amended by section 4011, is further amended by adding 

at the end the following new subsection: 

‘‘(u) PAYMENT AND RELATED REQUIREMENTS FOR HOME INFUSION THERAPY.— 

‘‘(1) PAYMENT.— 

‘‘(A) SINGLE PAYMENT.— 

‘‘(i) IN GENERAL.—Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement 

a payment system under which a single payment is 

made under this title to a qualified home infusion 

therapy supplier for items and services described in 

subparagraphs (A) and (B) of section 1861(iii)(2)) furnished by a qualified home infusion therapy supplier 

(as defined in section 1861(iii)(3)(D)) in coordination 

with the furnishing of home infusion drugs (as defined 

in section 1861(iii)(3)(C)) under this part. 

‘‘(ii) UNIT OF SINGLE PAYMENT.—A unit of single 

payment under the payment system implemented 

under this subparagraph is for each infusion drug 

administration calendar day in the individual’s home. 

The Secretary shall, as appropriate, establish single 


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payment amounts for types of infusion therapy, 

including to take into account variation in utilization 

of nursing services by therapy type. 

‘‘(iii) LIMITATION.—The single payment amount 

determined under this subparagraph after application 

of subparagraph (B) and paragraph (3) shall not exceed 

the amount determined under the fee schedule under 

section 1848 for infusion therapy services furnished 

in a calendar day if furnished in a physician office 

setting, except such single payment shall not reflect 

more than 5 hours of infusion for a particular therapy 

in a calendar day. 

‘‘(B) REQUIRED ADJUSTMENTS.—The Secretary shall 

adjust the single payment amount determined under 

subparagraph (A) for home infusion therapy services under 

section 1861(iii)(1) to reflect other factors such as— 

‘‘(i) a geographic wage index and other costs that 

may vary by region; and 

‘‘(ii) patient acuity and complexity of drug administration. 

‘‘(C) DISCRETIONARY ADJUSTMENTS.— 

‘‘(i) IN GENERAL.—Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of 

subparagraph (B)) to reflect outlier situations and 

other factors as the Secretary determines appropriate. 

‘‘(ii) REQUIREMENT OF BUDGET NEUTRALITY.—Any 

adjustment under this subparagraph shall be made 

in a budget neutral manner. 

‘‘(2) CONSIDERATIONS.—In developing the payment system 

under this subsection, the Secretary may consider the costs 

of furnishing infusion therapy in the home, consult with home 

infusion therapy suppliers, consider payment amounts for 

similar items and services under this part and part A, and 

consider payment amounts established by Medicare Advantage 

plans under part C and in the private insurance market for 

home infusion therapy (including average per treatment day 

payment amounts by type of home infusion therapy). 

‘‘(3) ANNUAL UPDATES.— 

‘‘(A) IN GENERAL.—Subject to subparagraph (B), the 

Secretary shall update the single payment amount under 

this subsection from year to year beginning in 2022 by 

increasing the single payment amount from the prior year 

by the percentage increase in the Consumer Price Index 

for all urban consumers (United States city average) for 

the 12-month period ending with June of the preceding 

year. 

‘‘(B) ADJUSTMENT.—For each year, the Secretary shall 

reduce the percentage increase described in subparagraph 

(A) by the productivity adjustment described in section 

1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in a percentage being less than 0.0 for 

a year, and may result in payment being less than such 

payment rates for the preceding year. 

‘‘(4) AUTHORITY TO APPLY PRIOR AUTHORIZATION.—The Secretary may, as determined appropriate by the Secretary, apply 


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prior authorization for home infusion therapy services under 

section 1861(iii)(1). 

‘‘(5) ACCREDITATION OF QUALIFIED HOME INFUSION THERAPY

SUPPLIERS.— 

‘‘(A) FACTORS FOR DESIGNATION OF ACCREDITATION

ORGANIZATIONS.—The Secretary shall consider the following 

factors in designating accreditation organizations under 

subparagraph (B) and in reviewing and modifying the list 

of accreditation organizations designated pursuant to 

subparagraph (C): 

‘‘(i) The ability of the organization to conduct 

timely reviews of accreditation applications. 

‘‘(ii) The ability of the organization to take into 

account the capacities of suppliers located in a rural 

area (as defined in section 1886(d)(2)(D)). 

‘‘(iii) Whether the organization has established 

reasonable fees to be charged to suppliers applying 

for accreditation. 

‘‘(iv) Such other factors as the Secretary determines appropriate. 

‘‘(B) DESIGNATION.—Not later than January 1, 2021, 

the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C). 

‘‘(C) REVIEW AND MODIFICATION OF LIST OF ACCREDITATION ORGANIZATIONS.— 

‘‘(i) IN GENERAL.—The Secretary shall review the 

list of accreditation organizations designated under 

subparagraph (B) taking into account the factors under 

subparagraph (A). Taking into account the results of 

such review, the Secretary may, by regulation, modify 

the list of accreditation organizations designated under 

subparagraph (B). 

‘‘(ii) SPECIAL RULE FOR ACCREDITATIONS DONE

PRIOR TO REMOVAL FROM LIST OF DESIGNATED ACCREDITATION ORGANIZATIONS.—In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph 

(B), any supplier that is accredited by the organization 

during the period beginning on the date on which 

the organization is designated as an accreditation 

organization under subparagraph (B) and ending on 

the date on which the organization is removed from 

such list shall be considered to have been accredited 

by an organization designated by the Secretary under 

subparagraph (B) for the remaining period such 

accreditation is in effect. 

‘‘(D) RULE FOR ACCREDITATIONS MADE PRIOR TO DESIGNATION.—In the case of a supplier that is accredited 

before January 1, 2021, by an accreditation organization 

designated by the Secretary under subparagraph (B) as 

of January 1, 2019, such supplier shall be considered to 

have been accredited by an organization designated by 

the Secretary under such paragraph as of January 1, 2023, 

for the remaining period such accreditation is in effect. 


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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 following: ‘‘, and (I) in the case of home infusion therapy, 

payment shall be made to the qualified home infusion 

therapy supplier’’. 

(3) EXCLUSION FROM HOME HEALTH SERVICES.—Section 

1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is 

amended, in the first sentence, by inserting the following before 

the period at the end: ‘‘and home infusion therapy (as defined 

in subsection (iii)(i))’’. 

(d) EFFECTIVE DATE.—The amendments made by this section 

shall apply to items and services furnished on or after January 

1, 2021. 

DIVISION B—HELPING FAMILIES IN 

MENTAL HEALTH CRISIS 

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 SUBSTANCE USE. 

(a) ASSISTANT SECRETARY.—Section 501(c) of the Public Health 

Service Act (42 U.S.C. 290aa(c)) is amended to read as follows: 

‘‘(c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SECRETARY.— 

42 USC 201 note. 

Helping Families 

in Mental Health 

Crisis Reform Act 

of 2016. 

42 USC 13951 

note. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1203 

‘‘(1) ASSISTANT SECRETARY.—The Administration shall be 

headed by an official to be known as the Assistant Secretary 

for Mental Health and Substance Use (hereinafter in this title 

referred to as the ‘Assistant Secretary’) who shall be appointed 

by the President, by and with the advice and consent of the 

Senate. 

‘‘(2) DEPUTY ASSISTANT SECRETARY.—The Assistant Secretary, with the approval of the Secretary, may appoint a 

Deputy Assistant Secretary and may employ and prescribe 

the functions of such officers and employees, including attorneys, as are necessary to administer the activities to be carried 

out through the Administration.’’. 

(b) TRANSFER OF AUTHORITIES.—The Secretary of Health and 

Human Services shall delegate to the Assistant Secretary for Mental 

Health and Substance Use all duties and authorities that— 

(1) as of the day before the date of enactment of this 

Act, were vested in the Administrator of the Substance Abuse 

and Mental Health Services Administration; and 

(2) are not terminated by this Act. 

(c) CONFORMING AMENDMENTS.—Title V of the Public Health 

Service Act (42 U.S.C. 290aa et seq.), as amended by the previous 

provisions of this section, is further amended— 

(1) by striking ‘‘Administrator of the Substance Abuse and 

Mental Health Services Administration’’ each place it appears 

and inserting ‘‘Assistant Secretary for Mental Health and Substance Use’’; and 

(2) by striking ‘‘Administrator’’ or ‘‘ADMINISTRATOR’’ each 

place it appears (including in any headings) and inserting 

‘‘Assistant Secretary’’ or ‘‘ASSISTANT SECRETARY’’, respectively, 

except where the term ‘‘Administrator’’ appears— 

(A) in each of subsections (e) and (f) of section 501 

of such Act (42 U.S.C. 290aa), including the headings of 

such subsections, within the term ‘‘Associate Administrator’’; 

(B) in section 507(b)(6) of such Act (42 U.S.C. 

290bb(b)(6)), within the term ‘‘Administrator of the Health 

Resources and Services Administration’’; 

(C) in section 507(b)(6) of such Act (42 U.S.C. 

290bb(b)(6)), within the term ‘‘Administrator of the Centers 

for Medicare & Medicaid Services’’; 

(D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 

290bb–25b(c)(1)(B)), within the term ‘‘Administrator of the 

National Highway Traffic Safety Administration’’; or 

(E) in each of sections 519B(c)(1)(B), 520C(a), and 

520D(a) of such Act (42 U.S.C. 290bb–25b(c)(1)(B), 290bb– 

34(a), 290bb–35(a)), within the term ‘‘Administrator of the 

Office of Juvenile Justice and Delinquency Prevention’’. 

(d) REFERENCES.—After executing subsections (a), (b), and (c), 

any reference in statute, regulation, or guidance to the Administrator of the Substance Abuse and Mental Health Services Administration shall be construed to be a reference to the Assistant Secretary for Mental Health and Substance Use. 

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 ADMINISTRATION. 

Section 501 of the Public Health Service Act (42 U.S.C. 290aa), 

as amended by section 6001, is further amended— 

(1) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘AGENCIES’’ 

and inserting ‘‘CENTERS’’; and 

(B) in the matter preceding paragraph (1), by striking 

‘‘entities’’ and inserting ‘‘Centers’’; 

(2) in subsection (d)— 

(A) in paragraph (1)— 

(i) by striking ‘‘agencies’’ each place the term 

appears and inserting ‘‘Centers’’; and 

(ii) by striking ‘‘such agency’’ and inserting ‘‘such 

Center’’; 

(B) in paragraph (2)— 

(i) by striking ‘‘agencies’’ and inserting ‘‘Centers’’; 

(ii) by striking ‘‘with respect to substance abuse’’ 

and inserting ‘‘with respect to substance use disorders’’; 

and 

(iii) by striking ‘‘and individuals who are substance 

abusers’’ and inserting ‘‘and individuals with substance 

use disorders’’; 

(C) in paragraph (5), by striking ‘‘substance abuse’’ 

and inserting ‘‘substance use disorder’’; 

(D) in paragraph (6)— 

(i) by striking ‘‘the Centers for Disease Control’’ 

and inserting ‘‘the Centers for Disease Control and 

Prevention,’’; 

(ii) by striking ‘‘Administration develop’’ and 

inserting ‘‘Administration, develop’’; 

(iii) by striking ‘‘HIV or tuberculosis among substance abusers and individuals with mental illness’’ 

and inserting ‘‘HIV, hepatitis, tuberculosis, and other 

communicable diseases among individuals with mental 

or substance use disorders,’’; and 

(iv) by striking ‘‘illnesses’’ at the end and inserting 

‘‘diseases or disorders’’; 

(E) in paragraph (7), by striking ‘‘abuse utilizing antiaddiction medications, including methadone’’ and inserting 

‘‘use disorders, including services that utilize drugs or 

devices approved or cleared by the Food and Drug Administration for the treatment of substance use disorders’’; 

(F) in paragraph (8)— 

(i) by striking ‘‘Agency for Health Care Policy 

Research’’ and inserting ‘‘Agency for Healthcare 

Research and Quality’’; and 

(ii) by striking ‘‘treatment and prevention’’ and 

inserting ‘‘prevention and treatment’’; 

(G) in paragraph (9)— 

(i) by inserting ‘‘and maintenance’’ after ‘‘development’’; 

(ii) by striking ‘‘Agency for Health Care Policy 

Research’’ and inserting ‘‘Agency for Healthcare 

Research and Quality’’; and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1205 

(iii) by striking ‘‘treatment and prevention services’’ and inserting ‘‘prevention, treatment, and 

recovery support services and are appropriately incorporated into programs carried out by the Administration’’; 

(H) in paragraph (10), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; 

(I) by striking paragraph (11) and inserting the following: 

‘‘(11) work with relevant agencies of the Department of 

Health and Human Services on integrating mental health promotion and substance use disorder prevention with general 

health promotion and disease prevention and integrating 

mental and substance use disorders treatment services with 

physical health treatment services;’’; 

(J) in paragraph (13)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘this title, assure that’’ and inserting ‘‘this 

title or part B of title XIX, or grant programs otherwise 

funded by the Administration’’; 

(ii) in subparagraph (A)— 

(I) by inserting ‘‘require that’’ before ‘‘all 

grants’’; and 

(II) by striking ‘‘and’’ at the end; 

(iii) by redesignating subparagraph (B) as subparagraph (C); 

(iv) by inserting after subparagraph (A) the following: 

‘‘(B) ensure that the director of each Center of the 

Administration consistently documents the application of 

criteria when awarding grants and the ongoing oversight 

of grantees after such grants are awarded;’’; 

(v) in subparagraph (C), as so redesignated— 

(I) by inserting ‘‘require that’’ before ‘‘all 

grants’’; and 

(II) in clause (ii), by inserting ‘‘and’’ after the 

semicolon at the end; and 

(vi) by adding at the end the following: 

‘‘(D) inform a State when any funds are awarded 

through such a grant to any entity within such State;’’; 

(K) in paragraph (16), by striking ‘‘abuse and mental 

health information’’ and inserting ‘‘use disorder information, including evidence-based and promising best practices 

for prevention, treatment, and recovery support services 

for individuals with mental and substance use disorders,’’; 

(L) in paragraph (17)— 

(i) by striking ‘‘substance abuse’’ and inserting 

‘‘substance use disorder’’; and 

(ii) by striking ‘‘and’’ at the end; 

(M) in paragraph (18), by striking the period and 

inserting a semicolon; and 

(N) by adding at the end the following: 

‘‘(19) consult with State, local, and tribal governments, 

nongovernmental entities, and individuals with mental illness, 

particularly adults with a serious mental illness, children with 

a serious emotional disturbance, and the family members of 


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130 STAT. 1206 PUBLIC LAW 114–255—DEC. 13, 2016 

such adults and children, with respect to improving communitybased and other mental health services; 

‘‘(20) collaborate with the Secretary of Defense and the 

Secretary of Veterans Affairs to improve the provision of mental 

and substance use disorder services provided by the Department of Defense and the Department of Veterans Affairs to 

members of the Armed Forces, veterans, and the family members of such members and veterans, including through the 

provision of services using the telehealth capabilities of the 

Department of Defense and the Department of Veterans Affairs; 

‘‘(21) collaborate with the heads of relevant Federal agencies and departments, States, communities, and nongovernmental experts to improve mental and substance use disorders 

services for chronically homeless individuals, including by 

designing strategies to provide such services in supportive 

housing; 

‘‘(22) work with States and other stakeholders to develop 

and support activities to recruit and retain a workforce 

addressing mental and substance use disorders; 

‘‘(23) collaborate with the Attorney General and representatives of the criminal justice system to improve mental and 

substance use disorders services for individuals who have been 

arrested or incarcerated; 

‘‘(24) after providing an opportunity for public input, set 

standards for grant programs under this title for mental and 

substance use disorders services and prevention programs, 

which standards may address— 

‘‘(A) the capacity of the grantee to implement the 

award; 

‘‘(B) requirements for the description of the program 

implementation approach; 

‘‘(C) the extent to which the grant plan submitted 

by the grantee as part of its application must explain 

how the grantee will reach the population of focus and 

provide a statement of need, which may include information 

on how the grantee will increase access to services and 

a description of measurable objectives for improving outcomes; 

‘‘(D) the extent to which the grantee must collect and 

report on required performance measures; and 

‘‘(E) the extent to which the grantee is proposing to 

use evidence-based practices; and 

‘‘(25) advance, through existing programs, the use of 

performance metrics, including those based on the recommendations on performance metrics from the Assistant Secretary for 

Planning and Evaluation under section 6021(d) of the Helping 

Families in Mental Health Crisis Reform Act of 2016.’’; and 

(3) in subsection (m), by adding at the end the following: 

‘‘(4) EMERGENCY RESPONSE.—Amounts made available for 

carrying out this subsection shall remain available through 

the end of the fiscal year following the fiscal year for which 

such amounts are appropriated.’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1207 

(1) by redesignating subsections (g) through (j) and subsections (k) through (o) as subsections (h) through (k) and 

subsections (m) through (q), respectively; 

(2) in subsection (e)(3)(C), by striking ‘‘subsection (k)’’ and 

inserting ‘‘subsection (m)’’; 

(3) in subsection (f)(2)(C)(iii), by striking ‘‘subsection (k)’’ 

and inserting ‘‘subsection (m)’’; and 

(4) by inserting after subsection (f) the following: 

‘‘(g) CHIEF MEDICAL OFFICER.— 

‘‘(1) IN GENERAL.—The Assistant Secretary, with the 

approval of the Secretary, shall appoint a Chief Medical Officer 

to serve within the Administration. 

‘‘(2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall 

select the Chief Medical Officer from among individuals who— 

‘‘(A) have a doctoral degree in medicine or osteopathic 

medicine; 

‘‘(B) have experience in the provision of mental or 

substance use disorder services; 

‘‘(C) have experience working with mental or substance 

use disorder programs; 

‘‘(D) have an understanding of biological, psychosocial, 

and pharmaceutical treatments of mental or substance use 

disorders; and 

‘‘(E) are licensed to practice medicine in one or more 

States. 

‘‘(3) DUTIES.—The Chief Medical Officer shall— 

‘‘(A) serve as a liaison between the Administration 

and providers of mental and substance use disorders 

prevention, treatment, and recovery services; 

‘‘(B) assist the Assistant Secretary in the evaluation, 

organization, integration, and coordination of programs 

operated by the Administration; 

‘‘(C) promote evidence-based and promising best practices, including culturally and linguistically appropriate 

practices, as appropriate, for the prevention and treatment 

of, and recovery from, mental and substance use disorders, 

including serious mental illness and serious emotional 

disturbances; 

‘‘(D) participate in regular strategic planning with the 

Administration; 

‘‘(E) coordinate with the Assistant Secretary for Planning and Evaluation to assess the use of performance 

metrics to evaluate activities within the Administration 

related to mental and substance use disorders; and 

‘‘(F) coordinate with the Assistant Secretary to ensure 

mental and substance use disorders grant programs within 

the Administration consistently utilize appropriate 

performance metrics and evaluation designs.’’. 

SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH PROGRAMS. 

Section 505 of the Public Health Service Act (42 U.S.C. 290aa– 

4), as amended by section 6001(c), is amended— 

(1) by striking the section designation and heading and 

inserting the following: 


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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 subsections (b) through (e), respectively; 

(3) before subsection (b), as redesignated by paragraph 

(2), by inserting the following: 

‘‘(a) IN GENERAL.—The Assistant Secretary shall maintain 

within the Administration a Center for Behavioral Health Statistics 

and Quality (in this section referred to as the ‘Center’). The Center 

shall be headed by a Director (in this section referred to as the 

‘Director’) appointed by the Secretary from among individuals with 

extensive experience and academic qualifications in research and 

analysis in behavioral health care or related fields.’’; 

(4) in subsection (b), as redesignated by paragraph (2)— 

(A) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively; 

(B) by striking ‘‘The Secretary, acting’’ and all that 

follows through ‘‘year on—’’ and inserting ‘‘The Director 

shall— 

‘‘(1) coordinate the Administration’s integrated data 

strategy, including by collecting data each year on—’’; 

(C) in the subparagraph (B), as redesignated by 

subparagraph (A), by striking ‘‘Assistant Secretary’’ and 

inserting ‘‘Director’’; and 

(D) by adding at the end the following new paragraphs: 

‘‘(2) provide statistical and analytical support for activities 

of the Administration; 

‘‘(3) recommend a core set of performance metrics to 

evaluate activities supported by the Administration; and 

‘‘(4) coordinate with the Assistant Secretary, the Assistant 

Secretary for Planning and Evaluation, and the Chief Medical 

Officer appointed under section 501(g), as appropriate, to 

improve the quality of services provided by programs of the 

Administration and the evaluation of activities carried out by 

the Administration.’’. 

(5) in subsection (c), as so redesignated— 

(A) by striking ‘‘With respect to the activities’’ and 

inserting ‘‘MENTAL HEALTH.—With respect to the activities’’; 

(B) by striking ‘‘Assistant Secretary’’ each place it 

appears and inserting ‘‘Director’’; and 

(C) by striking ‘‘subsection (a)’’ and inserting ‘‘subsection (b)(1)’’; 

(6) in subsection (d), as so redesignated— 

(A) by striking the subsection designation and all that 

follows through ‘‘With respect to the activities’’ and 

inserting the following: 

‘‘(d) SUBSTANCE ABUSE.— 

‘‘(1) IN GENERAL.—With respect to the activities’’; 

(B) in paragraph (1)— 

(i) in the matter before subparagraph (A)— 

(I) by striking ‘‘subsection (a)’’ and inserting 

‘‘subsection (b)(1)’’; and 

(II) by striking ‘‘Assistant Secretary’’ each 

place it appears and inserting ‘‘Director’’; and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1209 

(ii) in subparagraph (B), by inserting ‘‘in coordination with the Centers for Disease Control and Prevention’’ before the semicolon at the end; and 

(C) in paragraph (2), by striking ‘‘ANNUAL SURVEYS’’ 

and inserting ‘‘ANNUAL SURVEYS; PUBLIC AVAILABILITY OF

DATA.—Annual surveys’’; and 

(7) in subsection (e), as so redesignated— 

(A) by striking ‘‘After consultation’’ and inserting ‘‘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 paragraph (1) to the Committee on Energy and Commerce and 

the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, 

Labor, and Pensions and the Committee on Appropriations 

of the Senate; and 

‘‘(B) post such plan on the Internet website of the 

Administration. 

‘‘(4) CONTENTS.—The strategic plan developed under paragraph (1) shall— 

‘‘(A) identify strategic priorities, goals, and measurable 

objectives for mental and substance use disorders activities 

and programs operated and supported by the Administration, including priorities to prevent or eliminate the burden 

of mental and substance use disorders; 

‘‘(B) identify ways to improve the quality of services 

for individuals with mental and substance use disorders, 

and to reduce homelessness, arrest, incarceration, violence, 

including self-directed violence, and unnecessary hospitalization of individuals with a mental or substance use 

disorder, including adults with a serious mental illness 

or children with a serious emotional disturbance; 


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130 STAT. 1210 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(C) ensure that programs provide, as appropriate, 

access to effective and evidence-based prevention, diagnosis, intervention, treatment, and recovery services, 

including culturally and linguistically appropriate services, 

as appropriate, for individuals with a mental or substance 

use disorder; 

‘‘(D) identify opportunities to collaborate with the 

Health Resources and Services Administration to develop 

or improve— 

‘‘(i) initiatives to encourage individuals to pursue 

careers (especially in rural and underserved areas and 

with rural and underserved populations) as psychiatrists, including child and adolescent psychiatrists, 

psychologists, psychiatric nurse practitioners, physician assistants, clinical social workers, certified peer 

support specialists, licensed professional counselors, or 

other licensed or certified mental health or substance 

use disorder professionals, including such professionals 

specializing in the diagnosis, evaluation, or treatment 

of adults with a serious mental illness or children 

with a serious emotional disturbance; and 

‘‘(ii) a strategy to improve the recruitment, 

training, and retention of a workforce for the treatment 

of individuals with mental or substance use disorders, 

or co-occurring disorders; 

‘‘(E) identify opportunities to improve collaboration 

with States, local governments, communities, and Indian 

tribes and tribal organizations (as such terms are defined 

in section 4 of the Indian Self-Determination and Education 

Assistance Act); and 

‘‘(F) specify a strategy to disseminate evidence-based 

and promising best practices related to prevention, diagnosis, early intervention, treatment, and recovery services 

related to mental illness, particularly for adults with a 

serious mental illness and children with a serious emotional disturbance, and for individuals with a substance 

use disorder.’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1211 

‘‘(2) an assessment of programs and activities carried out 

by the Assistant Secretary, including the extent to which programs and activities under this title and part B of title XIX 

meet identified goals and performance measures developed for 

the respective programs and activities; 

‘‘(3) a description of the progress made in addressing gaps 

in mental and substance use disorders prevention, treatment, 

and recovery services and improving outcomes by the Administration, including with respect to serious mental illnesses, 

serious emotional disturbances, and co-occurring disorders; 

‘‘(4) a description of the manner in which the Administration coordinates and partners with other Federal agencies and 

departments related to mental and substance use disorders, 

including activities related to— 

‘‘(A) the implementation and dissemination of research 

findings into improved programs, including with respect 

to how advances in serious mental illness and serious emotional disturbance research have been incorporated into 

programs; 

‘‘(B) the recruitment, training, and retention of a 

mental and substance use disorders workforce; 

‘‘(C) the integration of mental disorder services, substance use disorder services, and physical health services; 

‘‘(D) homelessness; and 

‘‘(E) veterans; 

‘‘(5) a description of the manner in which the Administration promotes coordination by grantees under this title, and 

part B of title XIX, with State or local agencies; and 

‘‘(6) a description of the activities carried out under section 

501A(e), with respect to mental and substance use disorders, 

including— 

‘‘(A) the number and a description of grants awarded; 

‘‘(B) the total amount of funding for grants awarded; 

‘‘(C) a description of the activities supported through 

such grants, including outcomes of programs supported; 

and 

‘‘(D) information on how the National Mental Health 

and Substance Use Policy Laboratory is consulting with 

the Assistant Secretary for Planning and Evaluation and 

collaborating with the Center for Substance Abuse Treatment, the Center for Substance Abuse Prevention, the 

Center for Behavioral Health Statistics and Quality, and 

the Center for Mental Health Services to carry out such 

activities; and 

‘‘(7) recommendations made by the Assistant Secretary for 

Planning and Evaluation under section 6021 of the Helping 

Families in Mental Health Crisis Reform Act of 2016 to improve 

programs within the Administration, and actions taken in 

response to such recommendations to improve programs within 

the Administration. 

The Assistant Secretary may meet reporting requirements established under this title by providing the contents of such reports 

as an addendum to the biennial report established under this subsection, notwithstanding the timeline of other reporting requirements in this title. Nothing in this subsection shall be construed 

to alter the content requirements of such reports or authorize 

the Assistant Secretary to alter the timeline of any such reports 


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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 SERVICES, SUBSTANCE ABUSE PREVENTION, AND SUBSTANCE 

ABUSE TREATMENT. 

(a) CENTER FOR MENTAL HEALTH SERVICES.—Section 520(b) 

of the Public Health Service Act (42 U.S.C. 290bb–31(b)) is 

amended— 

(1) by redesignating paragraphs (3) through (15) as paragraphs (4) through (16), respectively; 

(2) by inserting after paragraph (2) the following: 

‘‘(3) collaborate with the Director of the National Institute 

of Mental Health and the Chief Medical Officer, appointed 

under section 501(g), to ensure that, as appropriate, programs 

related to the prevention and treatment of mental illness and 

the promotion of mental health and recovery support are carried 

out in a manner that reflects the best available science and 

evidence-based practices, including culturally and linguistically 

appropriate services, as appropriate;’’; 

(3) in paragraph (5), as so redesignated, by inserting ‘‘, 

including through programs that reduce risk and promote resiliency’’ before the semicolon; 

(4) in paragraph (6), as so redesignated, by inserting ‘‘in 

collaboration with the Director of the National Institute of 

Mental Health,’’ before ‘‘develop’’; 

(5) in paragraph (8), as so redesignated, by inserting ‘‘, 

increase meaningful participation of individuals with mental 

illness in programs and activities of the Administration,’’ before 

‘‘and protect the legal’’; 

(6) in paragraph (10), as so redesignated, by striking 

‘‘professional and paraprofessional personnel pursuant to section 303’’ and inserting ‘‘health paraprofessional personnel and 

health professionals’’; 

(7) in paragraph (11), as so redesignated, by inserting 

‘‘and tele-mental health’’ after ‘‘rural mental health’’; 

(8) in paragraph (12), as so redesignated, by striking ‘‘establish a clearinghouse for mental health information to assure 

the widespread dissemination of such information’’ and 

inserting ‘‘disseminate mental health information, including 

evidence-based practices,’’; 

(9) in paragraph (15), as so redesignated, by striking ‘‘and’’ 

at the end; 

(10) in paragraph (16), as so redesignated, by striking 

the period and inserting ‘‘; and’’; and 

(11) by adding at the end the following: 

‘‘(17) ensure the consistent documentation of the application 

of criteria when awarding grants and the ongoing oversight 

of grantees after such grants are awarded.’’. 

(b) DIRECTOR OF THE CENTER FOR SUBSTANCE ABUSE PREVENTION.—Section 515 of the Public Health Service Act (42 U.S.C. 

290bb–21) is amended— 

(1) in the section heading, by striking ‘‘OFFICE’’ and 

inserting ‘‘CENTER’’; 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1213 

(2) in subsection (a)— 

(A) by striking ‘‘an Office’’ and inserting ‘‘a Center’’; 

and 

(B) by striking ‘‘The Office’’ and inserting ‘‘The Prevention Center’’; and 

(3) in subsection (b)— 

(A) in paragraph (1), by inserting ‘‘through the reduction of risk and the promotion of resiliency’’ before the 

semicolon; 

(B) by redesignating paragraphs (3) through (11) as 

paragraphs (4) through (12), respectively; 

(C) by inserting after paragraph (2) the following: 

‘‘(3) collaborate with the Director of the National Institute 

on Drug Abuse, the Director of the National Institute on Alcohol 

Abuse and Alcoholism, and States to promote the study of 

substance abuse prevention and the dissemination and 

implementation of research findings that will improve the 

delivery and effectiveness of substance abuse prevention activities;’’; 

(D) in paragraph (4), as so redesignated, by striking 

‘‘literature on the adverse effects of cocaine free base 

(known as crack)’’ and inserting ‘‘educational information 

on the effects of drugs abused by individuals, including 

drugs that are emerging as abused drugs’’; 

(E) in paragraph (6), as so redesignated— 

(i) by striking ‘‘substance abuse counselors’’ and 

inserting ‘‘health professionals who provide substance 

use and misuse prevention and treatment services’’; 

and 

(ii) by striking ‘‘drug abuse education, prevention,’’ 

and inserting ‘‘illicit drug use education and prevention’’; 

(F) by amending paragraph (7), as so redesignated, 

to read as follows: 

‘‘(7) in cooperation with the Director of the Centers for 

Disease Control and Prevention, develop and disseminate educational materials to increase awareness for individuals at 

greatest risk for substance use disorders to prevent the transmission of communicable diseases, such as HIV, hepatitis, 

tuberculosis, and other communicable diseases;’’; 

(G) in paragraph (9), as so redesignated— 

(i) by striking ‘‘to discourage’’ and inserting ‘‘that 

reduce the risk of’’; and 

(ii) by inserting before the semicolon ‘‘and promote 

resiliency’’; 

(H) in paragraph (11), as so redesignated, by striking 

‘‘and’’ after the semicolon; 

(I) in paragraph (12), as so redesignated, by striking 

the period and inserting a semicolon; and 

(J) by adding at the end the following: 

‘‘(13) ensure the consistent documentation of the application 

of criteria when awarding grants and the ongoing oversight 

of grantees after such grants are awarded; and 

‘‘(14) assist and support States in preventing illicit drug 

use, including emerging illicit drug use issues.’’. 


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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 subsections (a)(1)(A) and (a)(1)(D); 

‘‘(H) the Director of the National Institute on Drug 

Abuse for the advisory councils appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); 

‘‘(I) the Director of the National Institute on Alcohol 

Abuse and Alcoholism for the advisory councils appointed 

under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and’’; 

and 

(2) in paragraph (3), by adding at the end the following: 

‘‘(C) Not less than half of the members of the advisory 

council appointed under subsection (a)(1)(D)— 

‘‘(i) shall— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1215 

‘‘(I) have a medical degree; 

‘‘(II) have a doctoral degree in psychology; or 

‘‘(III) have an advanced degree in nursing or 

social work from an accredited graduate school 

or be a certified physician assistant; and 

‘‘(ii) shall specialize in the mental health field. 

‘‘(D) Not less than half of the members of the advisory 

councils appointed under subsections (a)(1)(B) and 

(a)(1)(C)— 

‘‘(i) shall— 

‘‘(I) have a medical degree; 

‘‘(II) have a doctoral degree; or 

‘‘(III) have an advanced degree in nursing, 

public health, behavioral or social sciences, or 

social work from an accredited graduate school 

or be a certified physician assistant; and 

‘‘(ii) shall have experience in the provision of substance use disorder services or the development and 

implementation of programs to prevent substance 

misuse.’’. 

SEC. 6009. PEER REVIEW. 

Section 504(b) of the Public Health Service Act (42 U.S.C. 

290aa–3(b)) is amended by adding at the end the following: ‘‘In 

the case of any such peer review group that is reviewing a grant, 

cooperative agreement, or contract related to mental illness treatment, not less than half of the members of such peer review group 

shall be licensed and experienced professionals in the prevention, 

diagnosis, or treatment of, or recovery from, mental illness or cooccurring mental illness and substance use disorders and have 

a medical degree, a doctoral degree in psychology, or an advanced 

degree in nursing or social work from an accredited program, and 

the Secretary, in consultation with the Assistant Secretary, shall, 

to the extent possible, ensure such peer review groups include 

broad geographic representation, including both urban and rural 

representatives.’’. 

Subtitle B—Oversight and Accountability 

SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE 

DISORDERS PROGRAMS THROUGH THE ASSISTANT SECRETARY 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 programs and related activities. 

(b) EVALUATION STRATEGY.—In carrying out subsection (a), the 

Assistant Secretary for Planning and Evaluation shall, not later 

than 180 days after the date of enactment of this Act, develop 

a strategy for conducting ongoing evaluations that identifies priority 

programs to be evaluated by the Assistant Secretary for Planning 

and Evaluation and priority programs to be evaluated by other 

relevant offices and agencies within the Department of Health 

and Human Services. The strategy shall— 

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 emotional disturbance; 

(B) the reduction of homelessness and incarceration 

among individuals with a mental or substance use disorder; 

and 

(C) public health and health services; and 

(2) include a plan for assessing the use of performance 

metrics to evaluate activities carried out by entities receiving 

grants, contracts, or cooperative agreements related to mental 

and substance use disorders prevention and treatment services 

under title V or title XIX of the Public Health Service Act 

(42 U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.). 

(c) CONSULTATION.—In carrying out this section, the Assistant 

Secretary for Planning and Evaluation shall consult, as appropriate, 

with the Assistant Secretary for Mental Health and Substance 

Use, the Chief Medical Officer of the Substance Abuse and Mental 

Health Services Administration appointed under section 501(g) of 

the Public Health Service Act (42 U.S.C. 290aa(g)), as amended 

by section 6003, the Behavioral Health Coordinating Council of 

the Department of Health and Human Services, other agencies 

within the Department of Health and Human Services, and other 

relevant Federal departments and agencies. 

(d) RECOMMENDATIONS.—In carrying out this section, the 

Assistant Secretary for Planning and Evaluation shall provide recommendations to the Secretary of Health and Human Services, 

the Assistant Secretary for Mental Health and Substance Use, 

and the Congress on improving the quality of prevention and treatment programs and activities related to mental and substance use 

disorders, including recommendations for the use of performance 

metrics. The Assistant Secretary for Mental Health and Substance 

Use shall include such recommendations in the biennial report 

required by subsection 501(m) of the Public Health Service Act, 

as redesignated by section 6003 of this Act. 

SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY ORGANIZATIONS. 

(a) PUBLIC AVAILABILITY OF REPORTS.—Section 105(a)(7) of the 

Protection and Advocacy for Individuals with Mental Illness Act 

(42 U.S.C. 10805(a)(7)) is amended by striking ‘‘is located a report’’ 

and inserting ‘‘is located, and make publicly available, a report’’. 

(b) DETAILED ACCOUNTING.—Section 114(a) of the Protection 

and Advocacy for Individuals with Mental Illness Act (42 U.S.C. 

10824(a)) is amended— 

(1) in paragraph (3), by striking ‘‘and’’ at the end; 

(2) in paragraph (4), by striking the period at the end 

and inserting ‘‘; and’’; and 

(3) by adding at the end the following: 

‘‘(5) using data from the existing required annual program 

progress reports submitted by each system funded under this 

title, a detailed accounting for each such system of how funds 

are spent, disaggregated according to whether the funds were 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1217 

received from the Federal Government, the State government, 

a local government, or a private entity.’’. 

SEC. 6023. GAO STUDY. 

(a) IN GENERAL.—Not later than 18 months after the date 

of enactment of this Act, the Comptroller General of the United 

States, in consultation with the Secretary of Health and Human 

Services and the Assistant Secretary for Mental Health and Substance Use, shall conduct an independent evaluation, and submit 

a report, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce 

of the House of Representatives, on programs funded by allotments 

made under title I of the Protection and Advocacy for Individuals 

with Mental Illness Act (42 U.S.C. 10801 et seq.). 

(b) CONTENTS.—The report and evaluation required under subsection (a) shall include— 

(1) a review of the programs described in such subsection 

that are carried out by State agencies and such programs 

that are carried out by private, nonprofit organizations; and 

(2) a review of the compliance of the programs described 

in subsection (a) with statutory and regulatory responsibilities, 

such as— 

(A) responsibilities relating to family engagement; 

(B) responsibilities relating to the grievance procedure 

for clients or prospective clients of the system to assure 

that individuals with mental illness have full access to 

the services of the system, for individuals who have 

received or are receiving mental health services, and for 

family members of such individuals with mental illness, 

or representatives of such individuals or family members, 

to assure that the eligible system is operating in compliance 

with the provisions of the Protection and Advocacy for 

Individuals with Mental Illness Act, as required to be established by section 105(a)(9) of such Act (42 U.S.C. 

10805(a)(9)); 

(C) investigation of alleged abuse and neglect of persons with mental illness; 

(D) availability of adequate medical and behavioral 

health treatment; 

(E) denial of rights for persons with mental illness; 

and 

(F) compliance with the Federal prohibition on lobbying. 

Subtitle C—Interdepartmental Serious 

Mental Illness Coordinating Committee 

SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING COMMITTEE. 

(a) ESTABLISHMENT.— (1) IN GENERAL.—Not later than 3 months after the date 

of enactment of this Act, the Secretary of Health and Human 

Services, or the designee of the Secretary, shall establish a 

committee to be known as the Interdepartmental Serious 

Mental Illness Coordinating Committee (in this section referred 

to as the ‘‘Committee’’). 


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130 STAT. 1218 PUBLIC LAW 114–255—DEC. 13, 2016 

(2) FEDERAL ADVISORY COMMITTEE ACT.—Except as provided 

in this section, the provisions of the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee. 

(b) MEETINGS.—The Committee shall meet not fewer than 2 

times each year. 

(c) RESPONSIBILITIES.—Not later than 1 year after the date 

of enactment of this Act, and 5 years after such date of enactment, 

the Committee shall submit to Congress and any other relevant 

Federal department or agency a report including— 

(1) a summary of advances in serious mental illness and 

serious emotional disturbance research related to the prevention of, diagnosis of, intervention in, and treatment and 

recovery of serious mental illnesses, serious emotional disturbances, and advances in access to services and support for adults 

with a serious mental illness or children with a serious emotional disturbance; 

(2) an evaluation of the effect Federal programs related 

to serious mental illness have on public health, including public 

health outcomes such as— 

(A) rates of suicide, suicide attempts, incidence and 

prevalence of serious mental illnesses, serious emotional 

disturbances, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room 

boarding, preventable emergency room visits, interaction 

with the criminal justice system, homelessness, and 

unemployment; 

(B) increased rates of employment and enrollment in 

educational and vocational programs; 

(C) quality of mental and substance use disorders treatment services; or 

(D) any other criteria as may be determined by the 

Secretary; and 

(3) specific recommendations for actions that agencies can 

take to better coordinate the administration of mental health 

services for adults with a serious mental illness or children 

with a serious emotional disturbance. 

(d) COMMITTEE EXTENSION.—Upon the submission of the second 

report under subsection (c), the Secretary shall submit a recommendation to Congress on whether to extend the operation of 

the Committee. 

(e) MEMBERSHIP.— 

(1) FEDERAL MEMBERS.—The Committee shall be composed 

of the following Federal representatives, or the designees of 

such representatives— 

(A) the Secretary of Health and Human Services, who 

shall serve as the Chair of the Committee; 

(B) the Assistant Secretary for Mental Health and 

Substance Use; 

(C) the Attorney General; 

(D) the Secretary of Veterans Affairs; 

(E) the Secretary of Defense; 

(F) the Secretary of Housing and Urban Development; 

(G) the Secretary of Education; 

(H) the Secretary of Labor; 

(I) the Administrator of the Centers for Medicare & 

Medicaid Services; and 

(J) the Commissioner of Social Security. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1219 

(2) NON-FEDERAL MEMBERS.—The Committee shall also 

include not less than 14 non-Federal public members appointed 

by the Secretary of Health and Human Services, of which— 

(A) at least 2 members shall be an individual who 

has received treatment for a diagnosis of a serious mental 

illness; 

(B) at least 1 member shall be a parent or legal 

guardian of an adult with a history of a serious mental 

illness or a child with a history of a serious emotional 

disturbance; 

(C) at least 1 member shall be a representative of 

a leading research, advocacy, or service organization for 

adults with a serious mental illness; 

(D) at least 2 members shall be— 

(i) a licensed psychiatrist with experience in 

treating serious mental illnesses; 

(ii) a licensed psychologist with experience in 

treating serious mental illnesses or serious emotional 

disturbances; 

(iii) a licensed clinical social worker with experience treating serious mental illnesses or serious emotional disturbances; or 

(iv) a licensed psychiatric nurse, nurse practitioner, or physician assistant with experience in 

treating serious mental illnesses or serious emotional 

disturbances; 

(E) at least 1 member shall be a licensed mental health 

professional with a specialty in treating children and 

adolescents with a serious emotional disturbance; 

(F) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with minorities; 

(G) at least 1 member shall be a mental health professional who has research or clinical mental health experience in working with medically underserved populations; 

(H) at least 1 member shall be a State certified mental 

health peer support specialist; 

(I) at least 1 member shall be a judge with experience 

in adjudicating cases related to criminal justice or serious 

mental illness; 

(J) at least 1 member shall be a law enforcement 

officer or corrections officer with extensive experience in 

interfacing with adults with a serious mental illness, children with a serious emotional disturbance, or individuals 

in a mental health crisis; and 

(K) at least 1 member shall have experience providing 

services for homeless individuals and working with adults 

with a serious mental illness, children with a serious emotional disturbance, or individuals in a mental health crisis. 

(3) TERMS.—A member of the Committee appointed under 

subsection (e)(2) shall serve for a term of 3 years, and may 

be reappointed for 1 or more additional 3-year terms. Any 

member appointed to fill a vacancy for an unexpired term 

shall be appointed for the remainder of such term. A member 

may serve after the expiration of the member’s term until 

a successor has been appointed. 


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130 STAT. 1220 PUBLIC LAW 114–255—DEC. 13, 2016 

(f) WORKING GROUPS.—In carrying out its functions, the Committee may establish working groups. Such working groups shall 

be composed of Committee members, or their designees, and may 

hold such meetings as are necessary. 

(g) SUNSET.—The Committee shall terminate on the date that 

is 6 years after the date on which the Committee is established 

under subsection (a)(1). 

TITLE VII—ENSURING MENTAL AND 

SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH 

SCIENCE AND TECHNOLOGY 

SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED PROGRAMS. 

Title V of the Public Health Service Act (42 U.S.C. 290aa 

et seq.) is amended by inserting after section 501 (42 U.S.C. 290aa) 

the following: 

‘‘SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY 

LABORATORY. 

‘‘(a) IN GENERAL.—There shall be established within the 

Administration a National Mental Health and Substance Use Policy 

Laboratory (referred to in this section as the ‘Laboratory’). 

‘‘(b) RESPONSIBILITIES.—The Laboratory shall— 

‘‘(1) continue to carry out the authorities and activities 

that were in effect for the Office of Policy, Planning, and Innovation as such Office existed prior to the date of enactment 

of the Helping Families in Mental Health Crisis Reform Act 

of 2016; 

‘‘(2) identify, coordinate, and facilitate the implementation 

of policy changes likely to have a significant effect on mental 

health, mental illness, recovery supports, and the prevention 

and treatment of substance use disorder services; 

‘‘(3) work with the Center for Behavioral Health Statistics 

and Quality to collect, as appropriate, information from 

grantees under programs operated by the Administration in 

order to evaluate and disseminate information on evidencebased practices, including culturally and linguistically appropriate services, as appropriate, and service delivery models; 

‘‘(4) provide leadership in identifying and coordinating policies and programs, including evidence-based programs, related 

to mental and substance use disorders; 

‘‘(5) periodically review programs and activities operated 

by the Administration relating to the diagnosis or prevention 

of, treatment for, and recovery from, mental and substance 

use disorders to— 

‘‘(A) identify any such programs or activities that are 

duplicative; 

‘‘(B) identify any such programs or activities that are 

not evidence-based, effective, or efficient; and 

‘‘(C) formulate recommendations for coordinating, 

eliminating, or improving programs or activities identified 

42 USC 290aa–0. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1221 

under subparagraph (A) or (B) and merging such programs 

or activities into other successful programs or activities; 

and 

‘‘(6) carry out other activities as deemed necessary to continue to encourage innovation and disseminate evidence-based 

programs and practices. 

‘‘(c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY

MODELS.— 

‘‘(1) IN GENERAL.—In carrying out subsection (b)(3), the 

Laboratory— 

‘‘(A) may give preference to models that improve— 

‘‘(i) the coordination between mental health and 

physical health providers; 

‘‘(ii) the coordination among such providers and 

the justice and corrections system; and 

‘‘(iii) the cost effectiveness, quality, effectiveness, 

and efficiency of health care services furnished to 

adults with a serious mental illness, children with 

a serious emotional disturbance, or individuals in a 

mental health crisis; and 

‘‘(B) may include clinical protocols and practices that 

address the needs of individuals with early serious mental 

illness. 

‘‘(2) CONSULTATION.—In carrying out this section, the Laboratory shall consult with— 

‘‘(A) the Chief Medical Officer appointed under section 

501(g); 

‘‘(B) representatives of the National Institute of Mental 

Health, the National Institute on Drug Abuse, and the 

National Institute on Alcohol Abuse and Alcoholism, on 

an ongoing basis; 

‘‘(C) other appropriate Federal agencies; 

‘‘(D) clinical and analytical experts with expertise in 

psychiatric medical care and clinical psychological care, 

health care management, education, corrections health 

care, and mental health court systems, as appropriate; 

and 

‘‘(E) other individuals and agencies as determined 

appropriate by the Assistant Secretary. 

‘‘(d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Laboratory shall begin implementation of this section not later than 

January 1, 2018. 

‘‘(e) PROMOTING INNOVATION.— 

‘‘(1) IN GENERAL.—The Assistant Secretary, in coordination 

with the Laboratory, may award grants to States, local governments, Indian tribes or tribal organizations (as such terms 

are defined in section 4 of the Indian Self-Determination and 

Education Assistance Act), educational institutions, and nonprofit organizations to develop evidence-based interventions, 

including culturally and linguistically appropriate services, as 

appropriate, for— 

‘‘(A) evaluating a model that has been scientifically 

demonstrated to show promise, but would benefit from 

further applied development, for— 


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130 STAT. 1222 PUBLIC LAW 114–255—DEC. 13, 2016 

‘‘(i) enhancing the prevention, diagnosis, intervention, and treatment of, and recovery from, mental illness, serious emotional disturbances, substance use 

disorders, and co-occurring illness or disorders; or 

‘‘(ii) integrating or coordinating physical health 

services and mental and substance use disorders services; and 

‘‘(B) expanding, replicating, or scaling evidence-based 

programs across a wider area to enhance effective 

screening, early diagnosis, intervention, and treatment 

with respect to mental illness, serious mental illness, 

serious emotional disturbances, and substance use disorders, primarily by— 

‘‘(i) applying such evidence-based programs to the 

delivery of care, including by training staff in effective 

evidence-based treatments; or 

‘‘(ii) integrating such evidence-based programs into 

models of care across specialties and jurisdictions. 

‘‘(2) CONSULTATION.—In awarding grants under this subsection, the Assistant Secretary shall, as appropriate, consult 

with the Chief Medical Officer, appointed under section 501(g), 

the advisory councils described in section 502, the National 

Institute of Mental Health, the National Institute on Drug 

Abuse, and the National Institute on Alcohol Abuse and Alcoholism, as appropriate. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—There are 

authorized to be appropriated— 

‘‘(A) to carry out paragraph (1)(A), $7,000,000 for the 

period of fiscal years 2018 through 2020; and 

‘‘(B) to carry out paragraph (1)(B), $7,000,000 for the 

period of fiscal years 2018 through 2020.’’. 

SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCEBASED PROGRAMS AND PRACTICES. 

Part D of title V of the Public Health Service Act (42 U.S.C. 

290dd et seq.) is amended by inserting after section 543 of such 

Act (42 U.S.C. 290dd–2) the following: 

‘‘SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCEBASED PROGRAMS AND PRACTICES. 

‘‘(a) IN GENERAL.—The Assistant Secretary shall, as appropriate, improve access to reliable and valid information on evidencebased programs and practices, including information on the strength 

of evidence associated with such programs and practices, related 

to mental and substance use disorders for States, local communities, 

nonprofit entities, and other stakeholders, by posting on the Internet website of the Administration information on evidence-based 

programs and practices that have been reviewed by the Assistant 

Secretary in accordance with the requirements of this section. 

‘‘(b) APPLICATIONS.— 

‘‘(1) APPLICATION PERIOD.—In carrying out subsection (a), 

the Assistant Secretary may establish a period for the submission of applications for evidence-based programs and practices 

to be posted publicly in accordance with subsection (a). 

‘‘(2) NOTICE.—In establishing the application period under 

paragraph (1), the Assistant Secretary shall provide for the 

public notice of such application period in the Federal Register. 

42 USC 

290dd–2a. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1223 

Such notice may solicit applications for evidence-based programs and practices to address gaps in information identified 

by the Assistant Secretary, the National Mental Health and 

Substance Use Policy Laboratory established under section 

501A, or the Assistant Secretary for Planning and Evaluation, 

including pursuant to the evaluation and recommendations 

under section 6021 of the Helping Families in Mental Health 

Crisis Reform Act of 2016 or priorities identified in the strategic 

plan under section 501(l). 

‘‘(c) REQUIREMENTS.—The Assistant Secretary may establish 

minimum requirements for the applications submitted under subsection (b), including applications related to the submission of 

research and evaluation. 

‘‘(d) REVIEW AND RATING.— ‘‘(1) IN GENERAL.—The Assistant Secretary shall review 

applications prior to public posting in accordance with subsection (a), and may prioritize the review of applications for 

evidence-based programs and practices that are related to topics 

included in the notice provided under subsection (b)(2). 

‘‘(2) SYSTEM.—In carrying out paragraph (1), the Assistant 

Secretary may utilize a rating and review system, which may 

include information on the strength of evidence associated with 

the evidence-based programs and practices and a rating of 

the methodological rigor of the research supporting the applications. 

‘‘(3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant 

Secretary shall make the metrics used to evaluate applications 

under this section, and any resulting ratings of such applications, publicly available.’’. 

SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND 

NATIONAL SIGNIFICANCE. 

Section 520A of the Public Health Service Act (42 U.S.C. 290bb– 

32) is amended— 

(1) in subsection (a)— 

(A) in paragraph (4), by inserting before the period 

‘‘, which may include technical assistance centers’’; and 

(B) in the flush sentence following paragraph (4)— 

(i) by inserting ‘‘, contracts,’’ before ‘‘or cooperative 

agreements’’; and 

(ii) by striking ‘‘Indian tribes and tribal organizations’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the 

Indian Self-Determination and Education Assistance 

Act), health facilities, or programs operated by or in 

accordance with a contract or grant with the Indian 

Health Service, or’’; and 

(2) by amending subsection (f) to read as follows: 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section $394,550,000 for each 

of fiscal years 2018 through 2022.’’. 

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 organizations,’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the 

Indian Self-Determination and Education Assistance 

Act), health facilities, or programs operated by or in 

accordance with a contract or grant with the Indian 

Health Service, or’’; 

(2) in subsection (b)— 

(A) in paragraph (1), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; and 

(B) in paragraph (2), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; 

(3) in subsection (e), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; and 

(4) in subsection (f), by striking ‘‘$300,000,000’’ and all 

that follows through the period and inserting ‘‘$333,806,000 

for each of fiscal years 2018 through 2022.’’. 

SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS 

OF REGIONAL AND NATIONAL SIGNIFICANCE. 

Section 516 of the Public Health Service Act (42 U.S.C. 290bb– 

22) is amended— 

(1) in the section heading, by striking ‘‘ABUSE’’ and 

inserting ‘‘USE DISORDER’’; 

(2) in subsection (a)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘abuse’’ and inserting ‘‘use disorder’’; 

(B) in paragraph (3), by inserting before the period 

‘‘, including such programs that focus on emerging drug 

abuse issues’’; and 

(C) in the flush sentence following paragraph (3)— 

(i) by inserting ‘‘, contracts,’’ before ‘‘or cooperative 

agreements’’; and 

(ii) by striking ‘‘Indian tribes and tribal organizations,’’ and inserting ‘‘Indian tribes or tribal organizations (as such terms are defined in section 4 of the 

Indian Self-Determination and Education Assistance 

Act), health facilities, or programs operated by or in 

accordance with a contract or grant with the Indian 

Health Service,’’; 

(3) in subsection (b)— 

(A) in paragraph (1), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; and 

(B) in paragraph (2)— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1225 

(i) in subparagraph (A), by striking ‘‘; and’’ at 

the end and inserting ‘‘;’’; 

(ii) in subparagraph (B)— 

(I) by striking ‘‘abuse’’ and inserting ‘‘use disorder’’; and 

(II) by striking the period and inserting ‘‘; 

and’’; and 

(iii) by adding at the end the following: 

‘‘(C) substance use disorder prevention among highrisk groups.’’; 

(4) in subsection (e), by striking ‘‘abuse’’ and inserting 

‘‘use disorder’’; and 

(5) in subsection (f), by striking ‘‘$300,000,000’’ and all 

that follows through the period and inserting ‘‘$211,148,000 

for each of fiscal years 2018 through 2022.’’. 

TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO MENTAL HEALTH AND 

SUBSTANCE USE DISORDER NEEDS 

SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT. 

(a) FORMULA GRANTS.—Section 1911(b) of the Public Health 

Service Act (42 U.S.C. 300x(b)) is amended— 

(1) by redesignating paragraphs (1) through (3) as paragraphs (2) through (4), respectively; and 

(2) by inserting before paragraph (2) (as so redesignated) 

the following: 

‘‘(1) providing community mental health services for adults 

with a serious mental illness and children with a serious emotional disturbance as defined in accordance with section 

1912(c);’’. 

(b) STATE PLAN.—Section 1912(b) of the Public Health Service 

Act (42 U.S.C. 300x–1(b)) is amended— 

(1) in paragraph (3), by redesignating subparagraphs (A) 

through (C) as clauses (i) through (iii), respectively, and 

realigning the margins accordingly; 

(2) by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively, and realigning the margins 

accordingly; 

(3) in the matter preceding subparagraph (A) (as so redesignated), by striking ‘‘With respect to’’ and all that follows 

through ‘‘are as follows:’’ and inserting ‘‘In accordance with 

subsection (a), a State shall submit to the Secretary a plan 

every two years that, at a minimum, includes each of the 

following:’’; 

(4) by inserting before subparagraph (A) (as so redesignated) the following: 

‘‘(1) SYSTEM OF CARE.—A description of the State’s system 

of care that contains the following:’’; 

(5) by striking subparagraph (A) (as so redesignated) and 

inserting the following: 

‘‘(A) COMPREHENSIVE COMMUNITY-BASED HEALTH 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 responsible for the administration of the program under the 

grant, including any third party who administers 

mental health services and is responsible for complying 

with the requirements of this part with respect to 

the grant; 

‘‘(ii) provide for an organized community-based 

system of care for individuals with mental illness, and 

describe available services and resources in a comprehensive system of care, including services for 

individuals with co-occurring disorders; 

‘‘(iii) include a description of the manner in which 

the State and local entities will coordinate services 

to maximize the efficiency, effectiveness, quality, and 

cost-effectiveness of services and programs to produce 

the best possible outcomes (including health services, 

rehabilitation services, employment services, housing 

services, educational services, substance use disorder 

services, legal services, law enforcement services, social 

services, child welfare services, medical and dental 

care services, and other support services to be provided 

with Federal, State, and local public and private 

resources) with other agencies to enable individuals 

receiving services to function outside of inpatient or 

residential institutions, to the maximum extent of their 

capabilities, including services to be provided by local 

school systems under the Individuals with Disabilities 

Education Act; 

‘‘(iv) include a description of how the State promotes evidence-based practices, including those evidence-based programs that address the needs of 

individuals with early serious mental illness regardless 

of the age of the individual at onset, provide comprehensive individualized treatment, or integrate 

mental and physical health services; 

‘‘(v) include a description of case management services; 

‘‘(vi) include a description of activities that seek 

to engage adults with a serious mental illness or children with a serious emotional disturbance and their 

caregivers where appropriate in making health care 

decisions, including activities that enhance communication among individuals, families, caregivers, and treatment providers; and 

‘‘(vii) as appropriate to, and reflective of, the uses 

the State proposes for the block grant funds, include— 

‘‘(I) a description of the activities intended to 

reduce hospitalizations and hospital stays using 

the block grant funds; 

‘‘(II) a description of the activities intended 

to reduce incidents of suicide using the block grant 

funds; 

‘‘(III) a description of how the State integrates 

mental health and primary care using the block 

grant funds, which may include providing, in the 

case of individuals with co-occurring mental and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1227 

substance use disorders, both mental and substance use disorders services in primary care settings or arrangements to provide primary and specialty care services in community-based mental 

and substance use disorders settings; and 

‘‘(IV) a description of recovery and recovery 

support services for adults with a serious mental 

illness and children with a serious emotional 

disturbance.’’; 

(6) in subparagraph (B) (as so redesignated)— 

(A) by striking ‘‘The plan contains’’ and inserting ‘‘The 

plan shall contain’’; and 

(B) by striking ‘‘presents quantitative targets to be 

achieved in the implementation of the system described 

in paragraph (1)’’ and inserting ‘‘present quantitative targets and outcome measures for programs and services provided under this subpart’’; 

(7) in subparagraph (C) (as so redesignated)— 

(A) by striking ‘‘serious emotional disturbance’’ in the 

matter preceding clause (i) (as so redesignated) and all 

that follows through ‘‘substance abuse services’’ in clause 

(i) (as so redesignated) and inserting the following: ‘‘a 

serious emotional disturbance (as defined pursuant to subsection (c)), the plan shall provide for a system of integrated 

social services, educational services, child welfare services, 

juvenile justice services, law enforcement services, and substance use disorder services’’; 

(B) by striking ‘‘Education Act);’’ and inserting ‘‘Education Act).’’; and 

(C) by striking clauses (ii) and (iii) (as so redesignated); 

(8) in subparagraph (D) (as so redesignated), by striking 

‘‘plan describes’’ and inserting ‘‘plan shall describe’’; 

(9) in subparagraph (E) (as so redesignated)— 

(A) in the subparagraph heading by striking ‘‘SYSTEMS’’ 

and inserting ‘‘SERVICES’’; 

(B) in the first sentence, by striking ‘‘plan describes’’ 

and all that follows through ‘‘and provides for’’ and 

inserting ‘‘plan shall describe the financial resources available, the existing mental health workforce, and the 

workforce trained in treating individuals with co-occurring 

mental and substance use disorders, and shall provide for’’; 

and 

(C) in the second sentence— 

(i) by striking ‘‘further describes’’ and inserting 

‘‘shall further describe’’; and 

(ii) by striking ‘‘involved.’’ and inserting ‘‘involved, 

and the manner in which the State intends to comply 

with each of the funding agreements in this subpart 

and subpart III.’’; 

(10) by striking the flush matter at the end; and 

(11) by adding at the end the following: 

‘‘(2) GOALS AND OBJECTIVES.—The establishment of goals 

and objectives for the period of the plan, including targets 

and milestones that are intended to be met, and the activities 

that will be undertaken to achieve those targets.’’. 


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130 STAT. 1228 PUBLIC LAW 114–255—DEC. 13, 2016 

(c) EARLY SERIOUS MENTAL ILLNESS.—Section 1920 of the 

Public Health Service Act (42 U.S.C. 300x–9) is amended by adding 

at the end the following: 

‘‘(c) EARLY SERIOUS MENTAL ILLNESS.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 

a State shall expend not less than 10 percent of the amount 

the State receives for carrying out this section for each fiscal 

year to support evidence-based programs that address the needs 

of individuals with early serious mental illness, including psychotic disorders, regardless of the age of the individual at 

onset. 

‘‘(2) STATE FLEXIBILITY.—In lieu of expending 10 percent 

of the amount the State receives under this section for a fiscal 

year as required under paragraph (1), a State may elect to 

expend not less than 20 percent of such amount by the end 

of such succeeding fiscal year.’’. 

(d) ADDITIONAL PROVISIONS.—Section 1915(b) of the Public 

Health Service Act (42 U.S.C. 300x–4(b)) is amended— 

(1) in paragraph (3)— 

(A) by striking ‘‘The Secretary’’ and inserting the following: 

‘‘(A) IN GENERAL.—The Secretary’’; 

(B) by striking ‘‘paragraph (1) if’’ and inserting ‘‘paragraph (1) in whole or in part if’’; 

(C) by striking ‘‘State justify the waiver.’’ and inserting 

‘‘State in the fiscal year involved or in the previous fiscal 

year justify the waiver’’; and 

(D) by adding at the end the following: 

‘‘(B) DATE CERTAIN FOR ACTION UPON REQUEST.—The 

Secretary shall approve or deny a request for a waiver 

under this paragraph not later than 120 days after the 

date on which the request is made. 

‘‘(C) APPLICABILITY OF WAIVER.—A waiver provided by 

the Secretary under this paragraph shall be applicable 

only to the fiscal year involved.’’; and 

(2) in paragraph (4)— 

(A) in subparagraph (A)— 

(i) by inserting after the subparagraph designation 

the following: ‘‘IN GENERAL.—’’; 

(ii) by striking ‘‘In making a grant’’ and inserting 

the following: 

‘‘(i) DETERMINATION.—In making a grant’’; and 

(iii) by inserting at the end the following: 

‘‘(ii) ALTERNATIVE.—A State that has failed to 

comply with paragraph (1) and would otherwise be 

subject to a reduction in the State’s allotment under 

section 1911 may, upon request by the State, in lieu 

of having the amount of the allotment under section 

1911 for the State reduced for the fiscal year of the 

grant, agree to comply with a negotiated agreement 

that is approved by the Secretary and carried out 

in accordance with guidelines issued by the Secretary. 

If a State fails to enter into or comply with a negotiated 

agreement, the Secretary may take action under this 

paragraph or the terms of the negotiated agreement.’’; 

and 

(B) in subparagraph (B)— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1229 

(i) by inserting after the subparagraph designation 

the following: ‘‘SUBMISSION OF INFORMATION TO THE

SECRETARY.—’’; and 

(ii) by striking ‘‘subparagraph (A)’’ and inserting 

‘‘subparagraph (A)(i)’’. 

(e) APPLICATION FOR GRANT.—Section 1917(a) of the Public 

Health Service Act (42 U.S.C. 300x–6(a)) is amended— 

(1) in paragraph (1), by striking ‘‘1941’’ and inserting 

‘‘1942(a)’’; and 

(2) in paragraph (5), by striking ‘‘1915(b)(3)(B)’’ and 

inserting ‘‘1915(b)’’. 

(f) FUNDING.—Section 1920 of the Public Health Service Act 

(42 U.S.C. 300x–9) is amended— 

(1) in subsection (a)— 

(A) by striking ‘‘section 505’’ and inserting ‘‘section 

505(c)’’; and 

(B) by striking ‘‘$450,000,000’’ and all that follows through the period and inserting ‘‘$532,571,000 for each 

of fiscal years 2018 through 2022.’’; and 

(2) in subsection (b)(2) by striking ‘‘sections 505 and’’ and 

inserting ‘‘sections 505(c) and’’. 

SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK 

GRANT. 

(a) FORMULA GRANTS.—Section 1921(b) of the Public Health 

Service Act (42 U.S.C. 300x–21(b)) is amended— 

(1) by inserting ‘‘carrying out the plan developed in accordance with section 1932(b) and for’’ after ‘‘for the purpose of’’; 

and 

(2) by striking ‘‘abuse’’ and inserting ‘‘use disorders’’. 

(b) OUTREACH TO PERSONS WHO INJECT DRUGS.—Section 

1923(b) of the Public Health Service Act (42 U.S.C. 300x–23(b)) 

is amended— 

(1) in the subsection heading, by striking ‘‘REGARDING

INTRAVENOUS SUBSTANCE ABUSE’’ and inserting ‘‘TO PERSONS

WHO INJECT DRUGS’’; and 

(2) by striking ‘‘for intravenous drug abuse’’ and inserting 

‘‘for persons who inject drugs’’. 

(c) REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN

IMMUNODEFICIENCY VIRUS.—Section 1924 of the Public Health 

Service Act (42 U.S.C. 300x–24) is amended— 

(1) in subsection (a)(1)— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘substance abuse’’ and inserting ‘‘substance use 

disorders’’; and 

(B) in subparagraph (A), by striking ‘‘such abuse’’ and 

inserting ‘‘such disorders’’; 

(2) in subsection (b)— 

(A) in paragraph (1)(A), by striking ‘‘substance abuse’’ 

and inserting ‘‘substance use disorders’’; 

(B) in paragraph (2), by inserting ‘‘and Prevention’’ 

after ‘‘Disease Control’’; 

(C) in paragraph (3)— 

(i) in the paragraph heading, by striking ‘‘ABUSE’’ 

and inserting ‘‘USE DISORDERS’’; and 

(ii) by striking ‘‘substance abuse’’ and inserting 

‘‘substance use disorders’’; and 


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130 STAT. 1230 PUBLIC LAW 114–255—DEC. 13, 2016 

(D) in paragraph (6)(B), by striking ‘‘substance abuse’’ 

and inserting ‘‘substance use disorders’’; 

(3) by striking subsection (d); and 

(4) by redesignating subsection (e) as subsection (d). 

(d) GROUP HOMES.—Section 1925 of the Public Health Service 

Act (42 U.S.C. 300x–25) is amended— 

(1) in the section heading, by striking ‘‘RECOVERING SUBSTANCE ABUSERS’’ and inserting ‘‘PERSONS IN RECOVERY FROM

SUBSTANCE USE DISORDERS’’; and 

(2) in subsection (a), in the matter preceding paragraph 

(1), by striking ‘‘recovering substance abusers’’ and inserting 

‘‘persons in recovery from substance use disorders’’. 

(e) ADDITIONAL AGREEMENTS.—Section 1928 of the Public 

Health Service Act (42 U.S.C. 300x–28) is amended— 

(1) in subsection (a), by striking ‘‘(relative to fiscal year 

1992)’’; 

(2) by striking subsection (b) and inserting the following: 

‘‘(b) PROFESSIONAL DEVELOPMENT.—A funding agreement for 

a grant under section 1921 is that the State involved will ensure 

that prevention, treatment, and recovery personnel operating in 

the State’s substance use disorder prevention, treatment, and 

recovery systems have an opportunity to receive training, on an 

ongoing basis, concerning— 

‘‘(1) recent trends in substance use disorders in the State; 

‘‘(2) improved methods and evidence-based practices for 

providing substance use disorder prevention and treatment 

services; 

‘‘(3) performance-based accountability; 

‘‘(4) data collection and reporting requirements; and 

‘‘(5) any other matters that would serve to further improve 

the delivery of substance use disorder prevention and treatment 

services within the State.’’; and 

(3) in subsection (d)(1), by striking ‘‘substance abuse’’ and 

inserting ‘‘substance use disorders’’. 

(f) REPEAL.—Section 1929 of the Public Health Service Act 

(42 U.S.C. 300x–29) is repealed. 

(g) MAINTENANCE OF EFFORT.—Section 1930 of the Public 

Health Service Act (42 U.S.C. 300x–30) is amended— 

(1) in subsection (c)(1), by striking ‘‘in the State justify 

the waiver’’ and inserting ‘‘exist in the State, or any part 

of the State, to justify the waiver’’; and 

(2) in subsection (d), by inserting at the end the following: 

‘‘(3) ALTERNATIVE.—A State that has failed to comply with 

this section and would otherwise be subject to a reduction 

in the State’s allotment under section 1921, may, upon request 

by the State, in lieu of having the State’s allotment under 

section 1921 reduced, agree to comply with a negotiated agreement that is approved by the Secretary and carried out in 

accordance with guidelines issued by the Secretary. If a State 

fails to enter into or comply with a negotiated agreement, 

the Secretary may take action under this paragraph or the 

terms of the negotiated agreement.’’. 

(h) RESTRICTIONS ON EXPENDITURES.—Section 1931(b)(1) of the 

Public Health Service Act (42 U.S.C. 300x–31(b)(1)) is amended 

by striking ‘‘substance abuse’’ and inserting ‘‘substance use disorders’’. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1231 

(i) APPLICATION.—Section 1932 of the Public Health Service 

Act (42 U.S.C. 300x–32) is amended— 

(1) in subsection (a)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘subsections (c) and (d)(2)’’ and inserting ‘‘subsection (c)’’; 

and 

(B) in paragraph (5), by striking ‘‘the information 

required in section 1929, the information required in section 1930(c)(2), and’’; 

(2) in subsection (b)— 

(A) by striking paragraph (1) and inserting the following: 

‘‘(1) IN GENERAL.—In order for a State to be in compliance 

with subsection (a)(6), the State shall submit to the Secretary 

a plan that, at a minimum, includes the following: 

‘‘(A) A description of the State’s system of care that— 

‘‘(i) identifies the single State agency responsible 

for the administration of the program, including any 

third party who administers substance use disorder 

services and is responsible for complying with the 

requirements of the grant; 

‘‘(ii) provides information on the need for substance 

use disorder prevention and treatment services in the 

State, including estimates on the number of individuals 

who need treatment, who are pregnant women, women 

with dependent children, individuals with a co-occurring mental health and substance use disorder, persons 

who inject drugs, and persons who are experiencing 

homelessness; 

‘‘(iii) provides aggregate information on the 

number of individuals in treatment within the State, 

including the number of such individuals who are pregnant women, women with dependent children, individuals with a co-occurring mental health and substance 

use disorder, persons who inject drugs, and persons 

who are experiencing homelessness; 

‘‘(iv) provides a description of the system that is 

available to provide services by modality, including 

the provision of recovery support services; 

‘‘(v) provides a description of the State’s comprehensive statewide prevention efforts, including the 

number of individuals being served in the system, target populations, and priority needs, and provides a 

description of the amount of funds from the prevention 

set-aside expended on primary prevention; 

‘‘(vi) provides a description of the financial 

resources available; 

‘‘(vii) describes the existing substance use disorders 

workforce and workforce trained in treating co-occurring substance use and mental disorders; 

‘‘(viii) includes a description of how the State promotes evidence-based practices; and 

‘‘(ix) describes how the State integrates substance 

use disorder services and primary health care, which 

in the case of those individuals with co-occurring 

mental health and substance use disorders may include 


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130 STAT. 1232 PUBLIC LAW 114–255—DEC. 13, 2016 

providing both mental health and substance use disorder services in primary care settings or providing 

primary and specialty care services in communitybased mental health and substance use disorder service 

settings. 

‘‘(B) The establishment of goals and objectives for the 

period of the plan, including targets and milestones that 

are intended to be met, and the activities that will be 

undertaken to achieve those targets. 

‘‘(C) A description of how the State will comply with 

each funding agreement for a grant under section 1921 

that is applicable to the State, including a description 

of the manner in which the State intends to expend grant 

funds.’’; and 

(B) in paragraph (2)— 

(i) in the paragraph heading, by striking 

‘‘AUTHORITY OF SECRETARY REGARDING MODIFICATIONS’’ 

and inserting ‘‘MODIFICATIONS’’; 

(ii) by striking ‘‘As a condition’’ and inserting the 

following: 

‘‘(A) AUTHORITY OF SECRETARY.—As a condition;’’; and 

(iii) by adding at the end the following: 

‘‘(B) STATE REQUEST FOR MODIFICATION.—If the State 

determines that a modification to such plan is necessary, 

the State may request the Secretary to approve the modification. Any such modification shall be in accordance with 

paragraph (1) and section 1941.’’; and 

(C) in paragraph (3), by inserting, ‘‘, including any 

modification under paragraph (2)’’ after ‘‘subsection (a)(6)’’; 

and 

(3) in subsection (e)(2), by striking ‘‘section 1922(c)’’ and 

inserting ‘‘section 1922(b)’’. 

(j) DEFINITIONS.—Section 1934 of the Public Health Service 

Act (42 U.S.C. 300x–34) is amended— 

(1) in paragraph (3), by striking ‘‘substance abuse’’ and 

inserting ‘‘substance use disorders’’; and 

(2) in paragraph (7), by striking ‘‘substance abuse’’ and 

inserting ‘‘substance use disorders’’. 

(k) FUNDING.—Section 1935 of the Public Health Service Act 

(42 U.S.C. 300x–35) is amended— 

(1) in subsection (a)— 

(A) by striking ‘‘section 505’’ and inserting ‘‘section 

505(d)’’; and 

(B) by striking ‘‘$2,000,000,000 for fiscal year 2001, 

and such sums as may be necessary for each of the fiscal 

years 2002 and 2003’’ and inserting ‘‘$1,858,079,000 for 

each of fiscal years 2018 through 2022.’’; and 

(2) in subsection (b)(1)(B) by striking ‘‘sections 505 and’’ 

and inserting ‘‘sections 505(d) and’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1233 

(2) in section 1953(b) (42 U.S.C. 300x–63(b)), by striking 

‘‘substance abuse’’ and inserting ‘‘substance use disorder’’; and 

(3) by adding at the end the following: 

‘‘SEC. 1957. PUBLIC HEALTH EMERGENCIES. 

‘‘In the case of a public health emergency (as determined under 

section 319), the Secretary, on a State by State basis, may, as 

the circumstances of the emergency reasonably require and for 

the period of the emergency, grant an extension, or waive application deadlines or compliance with any other requirement, of a 

grant authorized under section 521, 1911, or 1921 or an allotment 

authorized under Public Law 99–319 (42 U.S.C. 10801 et seq.). 

‘‘SEC. 1958. JOINT APPLICATIONS. 

‘‘The Secretary, acting through the Assistant Secretary for 

Mental Health and Substance Use, shall permit a joint application 

to be submitted for grants under subpart I and subpart II upon 

the request of a State. Such application may be jointly reviewed 

and approved by the Secretary with respect to such subparts, consistent with the purposes and authorized activities of each such 

grant program. A State submitting such a joint application shall 

otherwise meet the requirements with respect to each such subpart.’’. 

SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK 

GRANT AND THE COMMUNITY MENTAL HEALTH SERVICES 

BLOCK GRANT. 

(a) IN GENERAL.—The Secretary of Health and Human Services, 

acting through the Assistant Secretary for Mental Health and Substance Use, shall through a grant or contract, or through an agreement with a third party, conduct a study on the formulas for 

distribution of funds under the substance abuse prevention and 

treatment block grant, and the community mental health services 

block grant, under part B of title XIX of the Public Health Service 

Act (42 U.S.C. 300x et seq.) and recommend changes if necessary. 

Such study shall include— 

(1) an analysis of whether the distributions under such 

block grants accurately reflect the need for the services under 

the grants in the States; 

(2) an examination of whether the indices used under the 

formulas for distribution of funds under such block grants 

are appropriate, and if not, alternatives recommended by the 

Secretary; 

(3) where recommendations are included under paragraph 

(2) for the use of different indices, a description of the variables 

and data sources that should be used to determine the indices; 

(4) an evaluation of the variables and data sources that 

are being used for each of the indices involved, and whether 

such variables and data sources accurately represent the need 

for services, the cost of providing services, and the ability 

of the States to pay for such services; 

(5) the effect that the minimum allotment requirements 

for each such block grant have on each State’s final allotment 

and the effect of such requirements, if any, on each State’s 

formula-based allotment; 

42 USC 300x–68. 

42 USC 300x–67. 


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(6) recommendations for modifications to the minimum 

allotment provisions to ensure an appropriate distribution of 

funds; and 

(7) any other information that the Secretary determines 

appropriate. 

(b) REPORT.—Not later than 2 years after the date of enactment 

of this Act, the Secretary of Health and Human Services shall 

submit to the Committee on Health, Education, Labor, and Pensions 

of the Senate and the Committee on Energy and Commerce of 

the House of Representatives, a report containing the findings 

and recommendations of the study conducted under subsection (a) 

and the study conducted under section 9004(g). 

TITLE IX—PROMOTING ACCESS TO 

MENTAL HEALTH AND SUBSTANCE 

USE DISORDER CARE 

Subtitle A—Helping Individuals and 

Families 

SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS 

INDIVIDUALS. 

Section 506 of the Public Health Service Act (42 U.S.C. 290aa– 

5) is amended— 

(1) in subsection (a), by striking ‘‘substance abuse’’ and 

inserting ‘‘substance use disorder’’; 

(2) in subsection (b)— 

(A) in paragraphs (1) and (3), by striking ‘‘substance 

abuse’’ each place the term appears and inserting ‘‘substance use disorder’’; and 

(B) in paragraph (4), by striking ‘‘substance abuse’’ 

and inserting ‘‘a substance use disorder’’; 

(3) in subsection (c)— 

(A) in paragraph (1), by striking ‘‘substance abuse disorder’’ and inserting ‘‘substance use disorder’’; and 

(B) in paragraph (2)— 

(i) in subparagraph (A), by striking ‘‘substance 

abuse’’ and inserting ‘‘a substance use disorder’’; and 

(ii) in subparagraph (B), by striking ‘‘substance 

abuse’’ and inserting ‘‘substance use disorder’’; and 

(4) in subsection (e), by striking ‘‘, $50,000,000 for fiscal 

year 2001, and such sums as may be necessary for each of 

the fiscal years 2002 and 2003’’ and inserting ‘‘$41,304,000 

for each of fiscal years 2018 through 2022’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1235 

defined in section 4 of the Indian Self-Determination and 

Education Assistance Act)’’; and 

(B) by inserting ‘‘or a health facility or program operated by or in accordance with a contract or grant with 

the Indian Health Service,’’ after ‘‘entities,’’; 

(3) in subsection (c)(2)(A)(i), by striking ‘‘the best known’’ 

and inserting ‘‘evidence-based’’; 

(4) by redesignating subsections (d) through (i) as subsections (e) through (j), respectively; 

(5) by inserting after subsection (c) the following: 

‘‘(d) SPECIAL CONSIDERATION REGARDING VETERANS.—In 

awarding grants under subsection (a), the Secretary shall, as appropriate, give special consideration to entities proposing to use grant 

funding to support jail diversion services for veterans.’’; 

(6) in subsection (e), as so redesignated— 

(A) in paragraph (3), by striking ‘‘; and’’ and inserting 

a semicolon; 

(B) in paragraph (4), by striking the period and 

inserting ‘‘; and’’; and 

(C) by adding at the end the following: 

‘‘(5) develop programs to divert individuals prior to booking 

or arrest.’’; and 

(7) in subsection (j), as so redesignated, by striking ‘‘$10,000,000 for fiscal year 2001, and such sums as may be 

necessary for fiscal years 2002 through 2003’’ and inserting 

‘‘$4,269,000 for each of fiscal years 2018 through 2022’’. 

SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL 

HEALTH CARE. 

Section 520K of the Public Health Service Act (42 U.S.C. 290bb– 

42) is amended to read as follows: 

‘‘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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improvement of integrated care for primary care and behavioral 

health care in accordance with paragraph (2). 

‘‘(2) PURPOSES.—A grant or cooperative agreement awarded 

under this section shall be designed to— 

‘‘(A) promote full integration and collaboration in clinical practices between primary and behavioral health care; 

‘‘(B) support the improvement of integrated care models 

for primary care and behavioral health care to improve 

the overall wellness and physical health status of adults 

with a serious mental illness or children with a serious 

emotional disturbance; and 

‘‘(C) promote integrated care services related to 

screening, diagnosis, prevention, and treatment of mental 

and substance use disorders, and co-occurring physical 

health conditions and chronic diseases. 

‘‘(c) APPLICATIONS.— 

‘‘(1) IN GENERAL.—An eligible entity seeking a grant or 

cooperative agreement under this section shall submit an 

application to the Secretary at such time, in such manner, 

and accompanied by such information as the Secretary may 

require, including the contents described in paragraph (2). 

‘‘(2) CONTENTS.—The contents described in this paragraph 

are— 

‘‘(A) a description of a plan to achieve fully collaborative 

agreements to provide services to special populations; 

‘‘(B) a document that summarizes the policies, if any, 

that serve as barriers to the provision of integrated care, 

and the specific steps, if applicable, that will be taken 

to address such barriers; 

‘‘(C) a description of partnerships or other arrangements with local health care providers to provide services 

to special populations; 

‘‘(D) an agreement and plan to report to the Secretary 

performance measures necessary to evaluate patient outcomes and facilitate evaluations across participating 

projects; and 

‘‘(E) a plan for sustainability beyond the grant or 

cooperative agreement period under subsection (e). 

‘‘(d) GRANT AND COOPERATIVE AGREEMENT AMOUNTS.— 

‘‘(1) TARGET AMOUNT.—The target amount that an eligible 

entity may receive for a year through a grant or cooperative 

agreement under this section shall be $2,000,000. 

‘‘(2) ADJUSTMENT PERMITTED.—The Secretary, taking into 

consideration the quality of the application and the number 

of eligible entities that received grants under this section prior 

to the date of enactment of the Helping Families in Mental 

Health Crisis Reform Act of 2016, may adjust the target amount 

that an eligible entity may receive for a year through a grant 

or cooperative agreement under this section. 

‘‘(3) LIMITATION.—An eligible entity receiving funding 

under this section may not allocate more than 10 percent 

of funds awarded under this section to administrative functions, 

and the remaining amounts shall be allocated to health facilities 

that provide integrated care. 

‘‘(e) DURATION.—A grant or cooperative agreement under this 

section shall be for a period not to exceed 5 years. 


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‘‘(f) REPORT ON PROGRAM OUTCOMES.—An eligible entity 

receiving a grant or cooperative agreement under this section shall 

submit an annual report to the Secretary that includes— 

‘‘(1) the progress made to reduce barriers to integrated 

care as described in the entity’s application under subsection 

(c); and 

‘‘(2) a description of functional outcomes of special populations, including— 

‘‘(A) with respect to adults with a serious mental illness, participation in supportive housing or independent 

living programs, attendance in social and rehabilitative 

programs, participation in job training opportunities, satisfactory performance in work settings, attendance at scheduled medical and mental health appointments, and compliance with prescribed medication regimes; 

‘‘(B) with respect to individuals with co-occurring 

mental illness and physical health conditions and chronic 

diseases, attendance at scheduled medical and mental 

health appointments, compliance with prescribed medication regimes, and participation in learning opportunities 

related to improved health and lifestyle practices; and 

‘‘(C) with respect to children and adolescents with a 

serious emotional disturbance who have co-occurring physical health conditions and chronic diseases, attendance at 

scheduled medical and mental health appointments, 

compliance with prescribed medication regimes, and 

participation in learning opportunities at school and extracurricular activities. 

‘‘(g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH

CARE INTEGRATION.— 

‘‘(1) IN GENERAL.—The Secretary may provide appropriate 

information, training, and technical assistance to eligible entities that receive a grant or cooperative agreement under this 

section, in order to help such entities meet the requirements 

of this section, including assistance with— 

‘‘(A) development and selection of integrated care 

models; 

‘‘(B) dissemination of evidence-based interventions in 

integrated care; 

‘‘(C) establishment of organizational practices to support operational and administrative success; and 

‘‘(D) other activities, as the Secretary determines 

appropriate. 

‘‘(2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMATION.—The information and resources provided by the Secretary 

under paragraph (1) shall, as appropriate, be made available 

to States, political subdivisions of States, Indian tribes or tribal 

organizations (as defined in section 4 of the Indian Self-Determination and Education Assistance Act), outpatient mental 

health and addiction treatment centers, community mental 

health centers that meet the criteria under section 1913(c), 

certified community behavioral health clinics described in section 223 of the Protecting Access to Medicare Act of 2014, 

primary care organizations such as Federally qualified health 

centers or rural health clinics as defined in section 1861(aa) 


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130 STAT. 1238 PUBLIC LAW 114–255—DEC. 13, 2016 

of the Social Security Act, other community-based organizations, or other entities engaging in integrated care activities, 

as the Secretary determines appropriate. 

‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $51,878,000 for 

each of fiscal years 2018 through 2022.’’. 

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.—Section 527 of the Public Health Service Act (42 U.S.C. 290cc–27) 

is amended by striking ‘‘substance abuse’’ each place such term 

appears and inserting ‘‘substance use disorder’’. 

(d) TECHNICAL ASSISTANCE.—Section 530 of the Public Health 

Service Act (42 U.S.C. 290cc–30) is amended by striking ‘‘through 

the National Institute of Mental Health, the National Institute 

of Alcohol Abuse and Alcoholism, and the National Institute on 

Drug Abuse’’ and inserting ‘‘acting through the Assistant Secretary’’. 

(e) DEFINITIONS.—Section 534(4) of the Public Health Service 

Act (42 U.S.C. 290cc–34(4)) is amended to read as follows: 

‘‘(4) SUBSTANCE USE DISORDER SERVICES.—The term ‘substance use disorder services’ has the meaning given the term 

‘substance abuse services’ in section 330(h)(5)(C).’’. 

(f) FUNDING.—Section 535(a) of the Public Health Service Act 

(42 U.S.C. 290cc–35(a)) is amended by striking ‘‘$75,000,000 for 

each of the fiscal years 2001 through 2003’’ and inserting 

‘‘$64,635,000 for each of fiscal years 2018 through 2022’’. 

(g) STUDY CONCERNING FORMULA.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act, the Assistant Secretary for Mental 

Health and Substance Use (referred to in this section as the 

‘‘Assistant Secretary’’) shall conduct a study concerning the 

formula used under section 524 of the Public Health Service 

Act (42 U.S.C. 290cc–24) for making allotments to States under 

section 521 of such Act (42 U.S.C. 290cc–21). Such study shall 

include an evaluation of quality indicators of need for purposes 


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of revising the formula for determining the amount of each 

allotment for the fiscal years following the submission of the 

study. 

(2) REPORT.—In accordance with section 8004(b), the Assistant Secretary shall submit to the committees of Congress 

described in such section a report concerning the results of 

the study conducted under paragraph (1). 

SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM. 

Subpart 3 of part B of title V of the Public Health Service 

Act (42 U.S.C. 290bb–31 et seq.) is amended by inserting after 

section 520E–2 (42 U.S.C. 290bb–36b) the following: 

‘‘SEC. 520E–3. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM. 

‘‘(a) IN GENERAL.—The Secretary, acting through the Assistant 

Secretary, shall maintain the National Suicide Prevention Lifeline 

program (referred to in this section as the ‘program’), authorized 

under section 520A and in effect prior to the date of enactment 

of the Helping Families in Mental Health Crisis Reform Act of 

2016. 

‘‘(b) ACTIVITIES.—In maintaining the program, the activities 

of the Secretary shall include— 

‘‘(1) coordinating a network of crisis centers across the 

United States for providing suicide prevention and crisis intervention services to individuals seeking help at any time, day 

or night; 

‘‘(2) maintaining a suicide prevention hotline to link callers 

to local emergency, mental health, and social services resources; 

and 

‘‘(3) consulting with the Secretary of Veterans Affairs to 

ensure that veterans calling the suicide prevention hotline have 

access to a specialized veterans’ suicide prevention hotline. 

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $7,198,000 for each 

of fiscal years 2018 through 2022.’’. 

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 communitybased organizations in a manner that is confidential, without 

requiring individuals to identify themselves, is in languages 

that include at least English and Spanish, and is at no cost 

to the individual using the Routing Service; and 

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 providers and community-based organizations, which shall include 

information on the name, location, contact information, and 

basic services provided by such providers and organizations. 

‘‘(c) REMOVING PRACTITIONER CONTACT INFORMATION.—In the 

event that the Internet website described in subsection (b)(2) contains information on any qualified practitioner that is certified 

to prescribe medication for opioid dependency under section 

303(g)(2)(B) of the Controlled Substances Act, the Assistant Secretary— 

‘‘(1) shall provide an opportunity to such practitioner to 

have the contact information of the practitioner removed from 

the website at the request of the practitioner; and 

‘‘(2) may evaluate other methods to periodically update 

the information displayed on such website. 

‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to prevent the Assistant Secretary from using any 

unobligated amounts otherwise made available to the Administration to maintain the Routing Service.’’. 

SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS. 

Section 520F of the Public Health Service Act (42 U.S.C. 290bb– 

37) is amended to read as follows: 

‘‘SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS. 

‘‘(a) IN GENERAL.—The Secretary shall award competitive 

grants to— 

‘‘(1) State and local governments and Indian tribes and 

tribal organizations, to enhance community-based crisis 

response systems; or 

‘‘(2) States to develop, maintain, or enhance a database 

of beds at inpatient psychiatric facilities, crisis stabilization 

units, and residential community mental health and residential 

substance use disorder treatment facilities, for adults with a 

serious mental illness, children with a serious emotional 

disturbance, or individuals with a substance use disorder. 

‘‘(b) APPLICATIONS.— 

‘‘(1) IN GENERAL.—To receive a grant under subsection (a), 

an entity shall submit to the Secretary an application, at such 

time, in such manner, and containing such information as 

the Secretary may require. 

‘‘(2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An application for a grant under subsection (a)(1) shall include a plan 

for— 

‘‘(A) promoting integration and coordination between 

local public and private entities engaged in crisis response, 

including first responders, emergency health care providers, 

primary care providers, law enforcement, court systems, 

health care payers, social service providers, and behavioral 

health providers; 

‘‘(B) developing memoranda of understanding with 

public and private entities to implement crisis response 

services; 

‘‘(C) addressing gaps in community resources for crisis 

intervention and prevention; and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1241 

‘‘(D) developing models for minimizing hospital readmissions, including through appropriate discharge planning. 

‘‘(3) BEDS DATABASE PLAN.—An application for a grant 

under subsection (a)(2) shall include a plan for developing, 

maintaining, or enhancing a real-time, Internet-based bed database to collect, aggregate, and display information about beds 

in inpatient psychiatric facilities and crisis stabilization units, 

and residential community mental health and residential substance use disorder treatment facilities to facilitate the identification and designation of facilities for the temporary treatment of individuals in mental or substance use disorder crisis. 

‘‘(c) DATABASE REQUIREMENTS.—A bed database described in 

this section is a database that— 

‘‘(1) includes information on inpatient psychiatric facilities, 

crisis stabilization units, and residential community mental 

health and residential substance use disorder facilities in the 

State involved, including contact information for the facility 

or unit; 

‘‘(2) provides real-time information about the number of 

beds available at each facility or unit and, for each available 

bed, the type of patient that may be admitted, the level of 

security provided, and any other information that may be necessary to allow for the proper identification of appropriate 

facilities for treatment of individuals in mental or substance 

use disorder crisis; and 

‘‘(3) enables searches of the database to identify available 

beds that are appropriate for the treatment of individuals in 

mental or substance use disorder crisis. 

‘‘(d) EVALUATION.—An entity receiving a grant under subsection 

(a)(1) shall submit to the Secretary, at such time, in such manner, 

and containing such information as the Secretary may reasonably 

require, a report, including an evaluation of the effect of such 

grant on— 

‘‘(1) local crisis response services and measures for individuals receiving crisis planning and early intervention supports; 

‘‘(2) individuals reporting improved functional outcomes; 

and 

‘‘(3) individuals receiving regular followup care following 

a crisis. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section, $12,500,000 for the 

period of fiscal years 2018 through 2022.’’. 

SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION. 

(a) SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.—Section 520C of the Public Health Service Act (42 U.S.C. 290bb– 

34), as amended by section 6001, is further amended— 

(1) in the section heading, by striking ‘‘YOUTH INTERAGENCY RESEARCH, TRAINING, AND TECHNICAL ASSISTANCE

CENTERS’’ and inserting ‘‘SUICIDE PREVENTION TECHNICAL

ASSISTANCE CENTER’’; 

(2) in subsection (a), by striking ‘‘acting through the Assistant Secretary for Mental Health and Substance Use’’ and all 

that follows through the period at the end of paragraph (2) 

and inserting ‘‘acting through the Assistant Secretary, shall 

establish a research, training, and technical assistance resource 


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center to provide appropriate information, training, and technical assistance to States, political subdivisions of States, federally recognized Indian tribes, tribal organizations, institutions 

of higher education, public organizations, or private nonprofit 

organizations regarding the prevention of suicide among all 

ages, particularly among groups that are at a high risk for 

suicide.’’; 

(3) by striking subsections (b) and (c); 

(4) by redesignating subsection (d) as subsection (b); 

(5) in subsection (b), as so redesignated— 

(A) in the subsection heading, by striking ‘‘ADDITIONAL

CENTER’’ and inserting ‘‘RESPONSIBILITIES OF THE CENTER’’; 

(B) in the matter preceding paragraph (1), by striking 

‘‘The additional research’’ and all that follows through ‘‘nonprofit organizations for’’ and inserting ‘‘The center established under subsection (a) shall conduct activities for the 

purpose of’’; 

(C) by striking ‘‘youth suicide’’ each place such term 

appears and inserting ‘‘suicide’’; 

(D) in paragraph (1)— 

(i) by striking ‘‘the development or continuation 

of’’ and inserting ‘‘developing and continuing’’; and 

(ii) by inserting ‘‘for all ages, particularly among 

groups that are at a high risk for suicide’’ before the 

semicolon at the end; 

(E) in paragraph (2), by inserting ‘‘for all ages, particularly among groups that are at a high risk for suicide’’ 

before the semicolon at the end; 

(F) in paragraph (3), by inserting ‘‘and tribal’’ after 

‘‘statewide’’; 

(G) in paragraph (5), by inserting ‘‘and prevention’’ 

after ‘‘intervention’’; 

(H) in paragraph (8), by striking ‘‘in youth’’; 

(I) in paragraph (9), by striking ‘‘and behavioral health’’ 

and inserting ‘‘health and substance use disorder’’; and 

(J) in paragraph (10), by inserting ‘‘conducting’’ before 

‘‘other’’; and 

(6) by striking subsection (e) and inserting the following: 

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 

carrying out this section, there are authorized to be appropriated 

$5,988,000 for each of fiscal years 2018 through 2022. 

‘‘(d) ANNUAL REPORT.—Not later than 2 years after the date 

of enactment of this subsection, the Secretary shall submit to Congress a report on the activities carried out by the center established 

under subsection (a) during the year involved, including the potential effects of such activities, and the States, organizations, and 

institutions that have worked with the center.’’. 

(b) YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION

STRATEGIES.—Section 520E of the Public Health Service Act (42 

U.S.C. 290bb–36) is amended— 

(1) in paragraph (1) of subsection (a) and in subsection 

(c), by striking ‘‘substance abuse’’ each place such term appears 

and inserting ‘‘substance use disorder’’; 

(2) in subsection (b)— 

(A) in paragraph (2)— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1243 

(i) by striking ‘‘ensure that each State is awarded 

only 1 grant or cooperative agreement under this section’’ and inserting ‘‘ensure that a State does not 

receive more than 1 grant or cooperative agreement 

under this section at any 1 time’’; and 

(ii) by striking ‘‘been awarded’’ and inserting 

‘‘received’’; and 

(B) by adding after paragraph (2) the following: 

‘‘(3) CONSIDERATION.—In awarding grants under this section, the Secretary shall take into consideration the extent 

of the need of the applicant, including the incidence and prevalence of suicide in the State and among the populations of 

focus, including rates of suicide determined by the Centers 

for Disease Control and Prevention for the State or population 

of focus.’’; 

(3) in subsection (g)(2), by striking ‘‘2 years after the date 

of enactment of this section,’’ and insert ‘‘2 years after the 

date of enactment of Helping Families in Mental Health Crisis 

Reform Act of 2016,’’; and 

(4) by striking subsection (m) and inserting the following: 

‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 

carrying out this section, there are authorized to be appropriated 

$30,000,000 for each of fiscal years 2018 through 2022.’’. 

SEC. 9009. ADULT SUICIDE PREVENTION. 

Subpart 3 of part B of title V of the Public Health Service 

Act (42 U.S.C. 290bb–31 et seq.) is amended by adding at the 

end the following: 

‘‘SEC. 520L. ADULT SUICIDE PREVENTION. 

‘‘(a) GRANTS.— ‘‘(1) IN GENERAL.—The Assistant Secretary shall award 

grants to eligible entities described in paragraph (2) to implement suicide prevention and intervention programs, for individuals who are 25 years of age or older, that are designed to 

raise awareness of suicide, establish referral processes, and 

improve care and outcomes for such individuals who are at 

risk of suicide. 

‘‘(2) ELIGIBLE ENTITIES.—To be eligible to receive a grant 

under this section, an entity shall be a community-based primary care or behavioral health care setting, an emergency 

department, a State mental health agency (or State health 

agency with mental or behavioral health functions), public 

health agency, a territory of the United States, or an Indian 

tribe or tribal organization (as the terms ‘Indian tribe’ and 

‘tribal organization’ are defined in section 4 of the Indian SelfDetermination and Education Assistance Act). 

‘‘(3) USE OF FUNDS.—The grants awarded under paragraph 

(1) shall be used to implement programs, in accordance with 

such paragraph, that include one or more of the following 

components: 

‘‘(A) Screening for suicide risk, suicide intervention 

services, and services for referral for treatment for individuals at risk for suicide. 

‘‘(B) Implementing evidence-based practices to provide 

treatment for individuals at risk for suicide, including 

appropriate followup services. 

‘‘(C) Raising awareness and reducing stigma of suicide. 

42 USC 

290bb–43. 


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‘‘(b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant 

Secretary shall— 

‘‘(1) evaluate the activities supported by grants awarded 

under subsection (a), and disseminate, as appropriate, the 

findings from the evaluation; and 

‘‘(2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities that receive 

a grant under this section, in order to help such entities to 

meet the requirements of this section, including assistance 

with selection and implementation of evidence-based interventions and frameworks to prevent suicide. 

‘‘(c) DURATION.—A grant under this section shall be for a period 

of not more than 5 years. 

‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section $30,000,000 for the 

period of fiscal years 2018 through 2022.’’. 

SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS. 

Section 520J of the Public Health Service Act (42 U.S.C. 290bb– 

41) is amended— 

(1) in the section heading, by inserting ‘‘MENTAL HEALTH

AWARENESS’’ before ‘‘TRAINING’’; and 

(2) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘ILLNESS’’ 

and inserting ‘‘HEALTH’’; 

(B) in paragraph (1), by inserting ‘‘veterans, law 

enforcement, and other categories of individuals, as determined by the Secretary,’’ after ‘‘emergency services personnel’’; 

(C) in paragraph (5)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘to’’ and inserting ‘‘for evidence-based programs that provide training and education in accordance with paragraph (1) on matters including’’; and 

(ii) by striking subparagraphs (A) through (C) and 

inserting the following: 

‘‘(A) recognizing the signs and symptoms of mental 

illness; and 

‘‘(B)(i) resources available in the community for individuals with a mental illness and other relevant resources; 

or 

‘‘(ii) safely de-escalating crisis situations involving 

individuals with a mental illness.’’; and (D) in paragraph (7), by striking ‘‘, $25,000,000’’ and 

all that follows through the period at the end and inserting 

‘‘$14,693,000 for each of fiscal years 2018 through 2022.’’. 

SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS 

AND ALASKA NATIVE YOUTH WITHIN SUICIDE PREVENTION PROGRAMS. 

(a) FINDINGS.—The Congress finds as follows: 

(1) Suicide is the eighth leading cause of death among 

American Indians and Alaska Natives across all ages. 

(2) Among American Indians and Alaska Natives who are 

10 to 34 years of age, suicide is the second leading cause 

of death. 

(3) The suicide rate among American Indian and Alaska 

Native adolescents and young adults ages 15 to 34 (17.9 per 


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100,000) is approximately 1.3 times higher than the national 

average for that age group (13.3 per 100,000). 

(b) SENSE OF CONGRESS.—It is the sense of Congress that 

the Secretary of Health and Human Services, in carrying out suicide 

prevention and intervention programs, should prioritize programs 

and activities for populations with disproportionately high rates 

of suicide, such as American Indians and Alaska Natives. 

SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS. 

Section 520A(e) of the Public Health Service Act (42 U.S.C. 

290bb–32(e)) is amended by adding at the end the following: 

‘‘(3) GERIATRIC MENTAL DISORDERS.—The Secretary shall, 

as appropriate, provide technical assistance to grantees 

regarding evidence-based practices for the prevention and treatment of geriatric mental disorders and co-occurring mental 

health and substance use disorders among geriatric populations, as well as disseminate information about such evidencebased practices to States and nongrantees throughout the 

United States.’’. 

SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM. 

The Secretary of Health and Human Services, acting through 

the Director of the Centers for Disease Control and Prevention, 

is encouraged to improve, particularly through the inclusion of 

additional States, the National Violent Death Reporting System 

as authorized by title III of the Public Health Service Act (42 

U.S.C. 241 et seq.). Participation in the system by the States 

shall be voluntary. 

SEC. 9014. ASSISTED OUTPATIENT TREATMENT. 

Section 224 of the Protecting Access to Medicare Act of 2014 

(42 U.S.C. 290aa note) is amended— 

(1) in subsection (e), by striking ‘‘and 2018,’’ and inserting 

‘‘2018, 2019, 2020, 2021, and 2022,’’; and 

(2) in subsection (g)— 

(A) in paragraph (1), by striking ‘‘2018’’ and inserting 

‘‘2022’’; and 

(B) in paragraph (2), by striking ‘‘is authorized to be 

appropriated to carry out this section $15,000,000 for each 

of fiscal years 2015 through 2018’’ and inserting ‘‘are 

authorized to be appropriated to carry out this section 

$15,000,000 for each of fiscal years 2015 through 2017, 

$20,000,000 for fiscal year 2018, $19,000,000 for each of 

fiscal years 2019 and 2020, and $18,000,000 for each of 

fiscal years 2021 and 2022’’. 

SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM. 

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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‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under 

this section, an entity shall be a State, political subdivision of 

a State, Indian tribe or tribal organization (as such terms are 

defined in section 4 of the Indian Self-Determination and Education 

Assistance Act), mental health system, health care facility, or any 

other entity the Assistant Secretary deems appropriate. 

‘‘(c) SPECIAL CONSIDERATION.—In selecting among applicants 

for a grant under this section, the Assistant Secretary may give 

special consideration to the potential of the applicant’s program 

to reduce hospitalization, homelessness, and involvement with the 

criminal justice system while improving the health and social outcomes of the patient. 

‘‘(d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall— 

‘‘(1) not later than the end of fiscal year 2021, submit 

a report to the appropriate congressional committees on the 

grant program under this section, including an evaluation of— 

‘‘(A) any cost savings and public health outcomes such 

as mortality, suicide, substance use disorders, hospitalization, and use of services; 

‘‘(B) rates of involvement with the criminal justice 

system of patients; 

‘‘(C) rates of homelessness among patients; and 

‘‘(D) patient and family satisfaction with program 

participation; and 

‘‘(2) provide appropriate information, training, and technical assistance to grant recipients under this section to help 

such recipients to establish, maintain, or expand their assertive 

community treatment programs. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

‘‘(1) IN GENERAL.—To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years 

2018 through 2022. 

‘‘(2) USE OF CERTAIN FUNDS.—Of the funds appropriated 

to carry out this section in any fiscal year, not more than 

5 percent shall be available to the Assistant Secretary for 

carrying out subsection (d).’’. 

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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‘‘(1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO

REDUCE UNDERAGE DRINKING.—The Assistant Secretary may 

make grants to eligible entities to increase implementation 

of practices for reducing the prevalence of alcohol use among 

individuals under the age of 21, including college students. 

‘‘(2) PURPOSES.—Grants under this subsection shall be 

made to improve— 

‘‘(A) screening children and adolescents for alcohol use; 

‘‘(B) offering brief interventions to children and adolescents to discourage such use; 

‘‘(C) educating parents about the dangers of, and 

methods of discouraging, such use; 

‘‘(D) diagnosing and treating alcohol use disorders; and 

‘‘(E) referring patients, when necessary, to other appropriate care. 

‘‘(3) USE OF FUNDS.—An entity receiving a grant under 

this subsection may use such funding for the purposes identified 

in paragraph (2) by— 

‘‘(A) providing training to health care providers; 

‘‘(B) disseminating best practices, including culturally 

and linguistically appropriate best practices, as appropriate, and developing and distributing materials; and 

‘‘(C) supporting other activities, as determined appropriate by the Assistant Secretary. 

‘‘(4) APPLICATION.—To be eligible to receive a grant under 

this subsection, an entity shall submit an application to the 

Assistant Secretary at such time, and in such manner, and 

accompanied by such information as the Assistant Secretary 

may require. Each application shall include— 

‘‘(A) a description of the entity; 

‘‘(B) a description of activities to be completed; 

‘‘(C) a description of how the services specified in paragraphs (2) and (3) will be carried out and the qualifications 

for providing such services; and 

‘‘(D) a timeline for the completion of such activities. 

‘‘(5) DEFINITIONS.—For the purpose of this subsection: 

‘‘(A) BRIEF INTERVENTION.—The term ‘brief intervention’ means, after screening a patient, providing the patient 

with brief advice and other brief motivational enhancement 

techniques designed to increase the insight of the patient 

regarding the patient’s alcohol use, and any realized or 

potential consequences of such use, to effect the desired 

related behavioral change. 

‘‘(B) CHILDREN AND ADOLESCENTS.—The term ‘children 

and adolescents’ means any person under 21 years of age. 

‘‘(C) ELIGIBLE ENTITY.—The term ‘eligible entity’ means 

an entity consisting of pediatric health care providers and 

that is qualified to support or provide the activities identified in paragraph (2). 

‘‘(D) PEDIATRIC HEALTH CARE PROVIDER.—The term 

‘pediatric health care provider’ means a provider of primary 

health care to individuals under the age of 21 years. 

‘‘(E) SCREENING.—The term ‘screening’ means using 

validated patient interview techniques to identify and 

assess the existence and extent of alcohol use in a patient.’’. 


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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, marriage and family therapy, occupational therapy, school counseling, or professional counseling, including such programs with 

a focus on child and adolescent mental health and transitionalage youth; 

‘‘(2) accredited doctoral, internship, and post-doctoral residency programs of health service psychology (including clinical 

psychology, counseling, and school psychology) for the development and implementation of interdisciplinary training of psychology graduate students for providing behavioral health services, including substance use disorder prevention and treatment 

services, as well as the development of faculty in health service 

psychology; 

‘‘(3) accredited master’s and doctoral degree programs of 

social work for the development and implementation of interdisciplinary training of social work graduate students for providing behavioral health services, including substance use disorder prevention and treatment services, and the development 

of faculty in social work; and 

‘‘(4) State-licensed mental health nonprofit and for-profit 

organizations to enable such organizations to pay for programs 

for preservice or in-service training in a behavioral healthrelated paraprofessional field with preference for preservice 

or in-service training of paraprofessional child and adolescent 

mental health workers.’’; 

(2) in subsection (b)— 

(A) by striking paragraph (5); 


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(B) by redesignating paragraphs (1) through (4) as 

paragraphs (2) through (5), respectively; 

(C) by inserting before paragraph (2), as so redesignated, the following: 

‘‘(1) an ability to recruit and place the students described 

in subsection (a) in areas with a high need and high demand 

population;’’; 

(D) in paragraph (3), as so redesignated, by striking 

‘‘subsection (a)’’ and inserting ‘‘paragraph (2), especially 

individuals with mental disorder symptoms or diagnoses, 

particularly children and adolescents, and transitional-age 

youth’’; 

(E) in paragraph (4), as so redesignated, by striking 

‘‘;’’ and inserting ‘‘; and’’; and 

(F) in paragraph (5), as so redesignated, by striking 

‘‘; and’’ and inserting a period; 

(3) in subsection (c), by striking ‘‘authorized under subsection (a)(1)’’ and inserting ‘‘awarded under paragraphs (2) 

and (3) of subsection (a)’’; 

(4) by amending subsection (d) to read as follows: 

‘‘(d) PRIORITY.—In selecting grant recipients under this section, 

the Secretary shall give priority to— 

‘‘(1) programs that have demonstrated the ability to train 

psychology, psychiatry, and social work professionals to work 

in integrated care settings for purposes of recipients under 

paragraphs (1), (2), and (3) of subsection (a); and 

‘‘(2) programs for paraprofessionals that emphasize the role 

of the family and the lived experience of the consumer and 

family-paraprofessional partnerships for purposes of recipients 

under subsection (a)(4).’’; and 

(5) by striking subsection (e) and inserting the following: 

‘‘(e) REPORT TO CONGRESS.—Not later than 4 years after the 

date of enactment of the Helping Families in Mental Health Crisis 

Reform Act of 2016, the Secretary shall include in the biennial 

report submitted to Congress under section 501(m) an assessment 

on the effectiveness of the grants under this section in— 

‘‘(1) providing graduate students support for experiential 

training (internship or field placement); 

‘‘(2) recruiting students interested in behavioral health 

practice; 

‘‘(3) recruiting students in accordance with subsection 

(b)(1); 

‘‘(4) developing and implementing interprofessional training 

and integration within primary care; 

‘‘(5) developing and implementing accredited field placements and internships; and 

‘‘(6) collecting data on the number of students trained in 

behavioral health care and the number of available accredited 

internships and field placements. 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal 

years 2018 through 2022, there are authorized to be appropriated 

to carry out this section $50,000,000, to be allocated as follows: 

‘‘(1) For grants described in subsection (a)(1), $15,000,000. 

‘‘(2) For grants described in subsection (a)(2), $15,000,000. 

‘‘(3) For grants described in subsection (a)(3), $10,000,000. 

‘‘(4) For grants described in subsection (a)(4), $10,000,000.’’. 


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130 STAT. 1250 PUBLIC LAW 114–255—DEC. 13, 2016 

SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE DISORDERS WORKFORCE. 

Part D of title VII of the Public Health Service Act (42 U.S.C. 

294 et seq.) is amended by adding at the end the following: 

‘‘SEC. 760. TRAINING DEMONSTRATION PROGRAM. 

‘‘(a) IN GENERAL.—The Secretary shall establish a training 

demonstration program to award grants to eligible entities to support— 

‘‘(1) training for medical residents and fellows to practice 

psychiatry and addiction medicine in underserved, communitybased settings that integrate primary care with mental and 

substance use disorders prevention and treatment services; 

‘‘(2) training for nurse practitioners, physician assistants, 

health service psychologists, and social workers to provide 

mental and substance use disorders services in underserved 

community-based settings that integrate primary care and 

mental and substance use disorders services; and 

‘‘(3) establishing, maintaining, or improving academic units 

or programs that— 

‘‘(A) provide training for students or faculty, including 

through clinical experiences and research, to improve the 

ability to be able to recognize, diagnose, and treat mental 

and substance use disorders, with a special focus on addiction; or 

‘‘(B) develop evidence-based practices or recommendations for the design of the units or programs described 

in subparagraph (A), including curriculum content standards. 

‘‘(b) ACTIVITIES.— 

‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.—A recipient 

of a grant under subsection (a)(1)— 

‘‘(A) shall use the grant funds— 

‘‘(i)(I) to plan, develop, and operate a training program for medical psychiatry residents and fellows in 

addiction medicine practicing in eligible entities 

described in subsection (c)(1); or 

‘‘(II) to train new psychiatric residents and fellows 

in addiction medicine to provide and expand access 

to integrated mental and substance use disorders services; and 

‘‘(ii) to provide at least 1 training track that is— 

‘‘(I) a virtual training track that includes an 

in-person rotation at a teaching health center or 

in a community-based setting, followed by a virtual 

rotation in which the resident or fellow continues 

to support the care of patients at the teaching 

health center or in the community-based setting 

through the use of health information technology 

and, as appropriate, telehealth services; 

‘‘(II) an in-person training track that includes 

a rotation, during which the resident or fellow 

practices at a teaching health center or in a 

community-based setting; or 

‘‘(III) an in-person training track that includes 

a rotation during which the resident practices in 

a community-based setting that specializes in the 

42 USC 294k. 


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treatment of infants, children, adolescents, or pregnant or postpartum women; and 

‘‘(B) may use the grant funds to provide additional 

support for the administration of the program or to meet 

the costs of projects to establish, maintain, or improve 

faculty development, or departments, divisions, or other 

units necessary to implement such training. 

‘‘(2) TRAINING FOR OTHER PROVIDERS.—A recipient of a 

grant under subsection (a)(2)— 

‘‘(A) shall use the grant funds to plan, develop, or 

operate a training program to provide mental and substance use disorders services in underserved, communitybased settings, as appropriate, that integrate primary care 

and mental and substance use disorders prevention and 

treatment services; and 

‘‘(B) may use the grant funds to provide additional 

support for the administration of the program or to meet 

the costs of projects to establish, maintain, or improve 

faculty development, or departments, divisions, or other 

units necessary to implement such program. 

‘‘(3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant 

under subsection (a)(3) shall enter into a partnership with 

organizations such as an education accrediting organization 

(such as the Liaison Committee on Medical Education, the 

Accreditation Council for Graduate Medical Education, the 

Commission on Osteopathic College Accreditation, the Accreditation Commission for Education in Nursing, the Commission 

on Collegiate Nursing Education, the Accreditation Council for 

Pharmacy Education, the Council on Social Work Education, 

American Psychological Association Commission on Accreditation, or the Accreditation Review Commission on Education 

for the Physician Assistant) to carry out activities under subsection (a)(3). 

‘‘(c) ELIGIBLE ENTITIES.— 

‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.—To be eligible 

to receive a grant under subsection (a)(1), an entity shall— 

‘‘(A) be a consortium consisting of— 

‘‘(i) at least one teaching health center; and 

‘‘(ii) the sponsoring institution (or parent institution of the sponsoring institution) of— 

‘‘(I) a psychiatry residency program that is 

accredited by the Accreditation Council of Graduate Medical Education (or the parent institution 

of such a program); or 

‘‘(II) a fellowship in addiction medicine, as 

determined appropriate by the Secretary; or 

‘‘(B) be an entity described in subparagraph (A)(ii) 

that provides opportunities for residents or fellows to train 

in community-based settings that integrate primary care 

with mental and substance use disorders prevention and 

treatment services. 

‘‘(2) TRAINING FOR OTHER PROVIDERS.—To be eligible to 

receive a grant under subsection (a)(2), an entity shall be— 

‘‘(A) a teaching health center (as defined in section 

749A(f)); 

‘‘(B) a Federally qualified health center (as defined 

in section 1905(l)(2)(B) of the Social Security Act); 


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‘‘(C) a community mental health center (as defined 

in section 1861(ff)(3)(B) of the Social Security Act); 

‘‘(D) a rural health clinic (as defined in section 1861(aa) 

of the Social Security Act); 

‘‘(E) a health center operated by the Indian Health 

Service, an Indian tribe, a tribal organization, or an urban 

Indian organization (as defined in section 4 of the Indian 

Health Care Improvement Act); or 

‘‘(F) an entity with a demonstrated record of success 

in providing training for nurse practitioners, physician 

assistants, health service psychologists, and social workers. 

‘‘(3) ACADEMIC UNITS OR PROGRAMS.—To be eligible to 

receive a grant under subsection (a)(3), an entity shall be 

a school of medicine or osteopathic medicine, a nursing school, 

a physician assistant training program, a school of pharmacy, 

a school of social work, an accredited public or nonprofit private 

hospital, an accredited medical residency program, or a public 

or private nonprofit entity which the Secretary has determined 

is capable of carrying out such grant. 

‘‘(d) PRIORITY.— 

‘‘(1) IN GENERAL.—In awarding grants under subsection 

(a)(1) or (a)(2), the Secretary shall give priority to eligible 

entities that— 

‘‘(A) demonstrate sufficient size, scope, and capacity 

to undertake the requisite training of an appropriate 

number of psychiatric residents, fellows, nurse practitioners, physician assistants, or social workers in addiction 

medicine per year to meet the needs of the area served; 

‘‘(B) demonstrate experience in training providers to 

practice team-based care that integrates mental and substance use disorder prevention and treatment services with 

primary care in community-based settings; 

‘‘(C) demonstrate experience in using health information technology and, as appropriate, telehealth to support— 

‘‘(i) the delivery of mental and substance use disorders services at the eligible entities described in subsections (c)(1) and (c)(2); and 

‘‘(ii) community health centers in integrating primary care and mental and substance use disorders 

treatment; or 

‘‘(D) have the capacity to expand access to mental 

and substance use disorders services in areas with demonstrated need, as determined by the Secretary, such as 

tribal, rural, or other underserved communities. 

‘‘(2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants 

under subsection (a)(3), the Secretary shall give priority to 

eligible entities that— 

‘‘(A) have a record of training the greatest percentage 

of mental and substance use disorders providers who enter 

and remain in these fields or who enter and remain in 

settings with integrated primary care and mental and substance use disorder prevention and treatment services; 

‘‘(B) have a record of training individuals who are 

from underrepresented minority groups, including native 

populations, or from a rural or disadvantaged background; 

‘‘(C) provide training in the care of vulnerable populations such as infants, children, adolescents, pregnant and 


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postpartum women, older adults, homeless individuals, victims of abuse or trauma, individuals with disabilities, and 

other groups as defined by the Secretary; 

‘‘(D) teach trainees the skills to provide interprofessional, integrated care through collaboration among health 

professionals; or 

‘‘(E) provide training in cultural competency and health 

literacy. 

‘‘(e) DURATION.—Grants awarded under this section shall be 

for a minimum of 5 years. 

‘‘(f) STUDY AND REPORT.— ‘‘(1) STUDY.— ‘‘(A) IN GENERAL.—The Secretary, acting through the 

Administrator of the Health Resources and Services 

Administration, shall conduct a study on the results of 

the demonstration program under this section. 

‘‘(B) DATA SUBMISSION.—Not later than 90 days after 

the completion of the first year of the training program 

and each subsequent year that the program is in effect, 

each recipient of a grant under subsection (a) shall submit 

to the Secretary such data as the Secretary may require 

for analysis for the report described in paragraph (2). 

‘‘(2) REPORT TO CONGRESS.—Not later than 1 year after 

receipt of the data described in paragraph (1)(B), the Secretary 

shall submit to Congress a report that includes— 

‘‘(A) an analysis of the effect of the demonstration 

program under this section on the quality, quantity, and 

distribution of mental and substance use disorders services; 

‘‘(B) an analysis of the effect of the demonstration 

program on the prevalence of untreated mental and substance use disorders in the surrounding communities of 

health centers participating in the demonstration; and 

‘‘(C) recommendations on whether the demonstration 

program should be expanded. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section $10,000,000 for each 

of fiscal years 2018 through 2022.’’. 

SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR LOAN 

REPAYMENT PROGRAMS. 

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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‘‘(1) increasing the knowledge of mental and substance 

use disorders practitioners on issues related to prevention, 

treatment, and recovery support for individuals who are from 

racial and ethnic minority populations and who have a mental 

or substance use disorder; 

‘‘(2) improving the quality of mental and substance use 

disorder prevention and treatment services delivered to racial 

and ethnic minority populations; and 

‘‘(3) increasing the number of culturally competent mental 

and substance use disorders professionals who teach, administer services, conduct research, and provide direct mental or 

substance use disorder services to racial and ethnic minority 

populations. 

‘‘(b) TRAINING COVERED.—The fellowships awarded under subsection (a) shall be for postbaccalaureate training (including for 

master’s and doctoral degrees) for mental and substance use disorder treatment professionals, including in the fields of psychiatry, 

nursing, social work, psychology, marriage and family therapy, 

mental health counseling, and substance use disorder and addiction 

counseling. 

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $12,669,000 for each 

of fiscal years 2018 through 2022.’’. 

SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL VOLUNTEERS AT COMMUNITY HEALTH CENTERS. 

Section 224 of the Public Health Service Act (42 U.S.C. 233) 

is amended by adding at the end the following: 

‘‘(q)(1) For purposes of this section, a health professional volunteer at a deemed entity described in subsection (g)(4) shall, in 

providing a health professional service eligible for funding under 

section 330 to an individual, be deemed to be an employee of 

the Public Health Service for a calendar year that begins during 

a fiscal year for which a transfer was made under paragraph 

(4)(C). The preceding sentence is subject to the provisions of this 

subsection. 

‘‘(2) In providing a health service to an individual, a health 

care practitioner shall for purposes of this subsection be considered 

to be a health professional volunteer at an entity described in 

subsection (g)(4) if the following conditions are met: 

‘‘(A) The service is provided to the individual at the facilities of an entity described in subsection (g)(4), or through 

offsite programs or events carried out by the entity. 

‘‘(B) The entity is sponsoring the health care practitioner 

pursuant to paragraph (3)(B). 

‘‘(C) The health care practitioner does not receive any compensation for the service from the individual, the entity 

described in subsection (g)(4), or any third-party payer 

(including reimbursement under any insurance policy or health 

plan, or under any Federal or State health benefits program), 

except that the health care practitioner may receive repayment 

from the entity described in subsection (g)(4) for reasonable 

expenses incurred by the health care practitioner in the provision of the service to the individual, which may include travel 

expenses to or from the site of services. 

‘‘(D) Before the service is provided, the health care practitioner or the entity described in subsection (g)(4) posts a clear 


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and conspicuous notice at the site where the service is provided 

of the extent to which the legal liability of the health care 

practitioner is limited pursuant to this subsection. 

‘‘(E) At the time the service is provided, the health care 

practitioner is licensed or certified in accordance with applicable 

Federal and State laws regarding the provision of the service. 

‘‘(F) At the time the service is provided, the entity described 

in subsection (g)(4) maintains relevant documentation certifying 

that the health care practitioner meets the requirements of 

this subsection. 

‘‘(3) Subsection (g) (other than paragraphs (3) and (5)) and 

subsections (h), (i), and (l) apply to a health care practitioner 

for purposes of this subsection to the same extent and in the 

same manner as such subsections apply to an officer, governing 

board member, employee, or contractor of an entity described in 

subsection (g)(4), subject to paragraph (4), and subject to the following: 

‘‘(A) The first sentence of paragraph (1) applies in lieu 

of the first sentence of subsection (g)(1)(A). 

‘‘(B) With respect to an entity described in subsection (g)(4), 

a health care practitioner is not a health professional volunteer 

at such entity unless the entity sponsors the health care practitioner. For purposes of this subsection, the entity shall be 

considered to be sponsoring the health care practitioner if— 

‘‘(i) with respect to the health care practitioner, the 

entity submits to the Secretary an application meeting 

the requirements of subsection (g)(1)(D); and 

‘‘(ii) the Secretary, pursuant to subsection (g)(1)(E), 

determines that the health care practitioner is deemed 

to be an employee of the Public Health Service. 

‘‘(C) In the case of a health care practitioner who is determined by the Secretary pursuant to subsection (g)(1)(E) to 

be a health professional volunteer at such entity, this subsection 

applies to the health care practitioner (with respect to services 

performed on behalf of the entity sponsoring the health care 

practitioner pursuant to subparagraph (B)) for any cause of 

action arising from an act or omission of the health care practitioner occurring on or after the date on which the Secretary 

makes such determination. 

‘‘(D) Subsection (g)(1)(F) applies to a health care practitioner for purposes of this subsection only to the extent that, 

in providing health services to an individual, each of the conditions specified in paragraph (2) is met. 

‘‘(4)(A) Amounts in the fund established under subsection (k)(2) 

shall be available for transfer under subparagraph (C) for purposes 

of carrying out this subsection. 

‘‘(B)(i) Not later than May 1 of each fiscal year, the Attorney 

General, in consultation with the Secretary, shall submit to the 

Congress a report providing an estimate of the amount of claims 

(together with related fees and expenses of witnesses) that, by 

reason of the acts or omissions of health professional volunteers, 

will be paid pursuant to this section during the calendar year 

that begins in the following fiscal year. 

‘‘(ii) Subsection (k)(1)(B) applies to the estimate under clause 

(i) regarding health professional volunteers to the same extent 

and in the same manner as such subsection applies to the estimate 


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130 STAT. 1256 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 Secretary shall transfer from the fund under subsection (k)(2) to the 

appropriate accounts in the Treasury an amount equal to the estimate made under subparagraph (B) for the calendar year beginning 

in such fiscal year, subject to the extent of amounts in the fund. 

‘‘(5)(A) This subsection shall take effect on October 1, 2017, 

except as provided in subparagraph (B) and paragraph (6). 

‘‘(B) Effective on the date of the enactment of this subsection— 

‘‘(i) the Secretary may issue regulations for carrying out 

this subsection, and the Secretary may accept and consider 

applications submitted pursuant to paragraph (3)(B); and 

‘‘(ii) reports under paragraph (4)(B) may be submitted to 

Congress. 

‘‘(6) Beginning on October 1, 2022, this subsection shall cease 

to have any force or effect.’’. 

SEC. 9026. REPORTS. 

(a) WORKFORCE DEVELOPMENT REPORT.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act, the Administrator of the Health 

Resources and Services Administration, in consultation with 

the Assistant Secretary for Mental Health and Substance Use, 

shall conduct a study and publicly post on the appropriate 

Internet website of the Department of Health and Human 

Services a report on the adult and pediatric mental health 

and substance use disorder workforce in order to inform Federal, State, and local efforts related to workforce enhancement. 

(2) CONTENTS.—The report under this subsection shall contain— 

(A) national and State-level projections of the supply 

and demand of the mental health and substance use disorder health workforce, disaggregated by profession; 

(B) an assessment of the mental health and substance 

use disorder workforce capacity, strengths, and weaknesses 

as of the date of the report, including the extent to which 

primary care providers are preventing, screening, or referring for mental and substance use disorder services; 

(C) information on trends within the mental health 

and substance use disorder provider workforce, including 

the number of individuals expected to enter the mental 

health workforce over the next 5 years; and 

(D) any additional information determined by the 

Administrator of the Health Resources and Services 

Administration, in consultation with the Assistant Secretary for Mental Health and Substance Use, to be relevant 

to the mental health and substance use disorder provider 

workforce. 

(b) PEER-SUPPORT SPECIALIST PROGRAMS.— 

(1) IN GENERAL.—The Comptroller General of the United 

States shall conduct a study on peer-support specialist programs in up to 10 States that receive funding from the Substance Abuse and Mental Health Services Administration. 


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(2) CONTENTS OF STUDY.—In conducting the study under 

paragraph (1), the Comptroller General of the United States 

shall examine and identify best practices, in the States selected 

pursuant to such paragraph, related to training and credential 

requirements for peer-support specialist programs, such as— 

(A) hours of formal work or volunteer experience 

related to mental and substance use disorders conducted 

through such programs; 

(B) types of peer-support specialist exams required for 

such programs in the selected States; 

(C) codes of ethics used by such programs in the 

selected States; 

(D) required or recommended skill sets for such programs in the selected States; and 

(E) requirements for continuing education. 

(3) REPORT.—Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States 

shall submit to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives a report on 

the study conducted under paragraph (1). 

Subtitle C—Mental Health on Campus 

Improvement 

SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES ON CAMPUS. 

Section 520E–2 of the Public Health Service Act (42 U.S.C. 

290bb–36b) is amended— 

(1) in the section heading, by striking ‘‘AND BEHAVIORAL

HEALTH’’ and inserting ‘‘HEALTH AND SUBSTANCE USE 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 ‘‘substance use disorders’’; and 

(D) by adding after, ‘‘suicide attempts,’’ the following: 

‘‘prevent mental and substance use disorders, reduce 

stigma, and improve the identification and treatment for 

students at risk,’’; 

(3) in subsection (b)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘for—’’ and inserting ‘‘for one or more of the following:’’; 

and 

(B) by striking paragraphs (1) through (6) and inserting 

the following: 

‘‘(1) Educating students, families, faculty, and staff to 

increase awareness of mental and substance use disorders. 

‘‘(2) The operation of hotlines. 

‘‘(3) Preparing informational material. 

‘‘(4) Providing outreach services to notify students about 

available mental and substance use disorder services. 

‘‘(5) Administering voluntary mental and substance use 

disorder screenings and assessments. 


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‘‘(6) Supporting the training of students, faculty, and staff 

to respond effectively to students with mental and substance 

use disorders. 

‘‘(7) Creating a network infrastructure to link institutions 

of higher education with health care providers who treat mental 

and substance use disorders. 

‘‘(8) Providing mental and substance use disorders prevention and treatment services to students, which may include 

recovery support services and programming and early intervention, treatment, and management, including through the use 

of telehealth services. 

‘‘(9) Conducting research through a counseling or health 

center at the institution of higher education involved regarding 

improving the behavioral health of students through clinical 

services, outreach, prevention, or academic success, in a manner 

that is in compliance with all applicable personal privacy laws. 

‘‘(10) Supporting student groups on campus, including athletic teams, that engage in activities to educate students, 

including activities to reduce stigma surrounding mental and 

behavioral disorders, and promote mental health. 

‘‘(11) Employing appropriately trained staff. 

‘‘(12) Developing and supporting evidence-based and 

emerging best practices, including a focus on culturally and 

linguistically appropriate best practices.’’; 

(4) in subsection (c)(5), by striking ‘‘substance abuse’’ and 

inserting ‘‘substance use disorder’’; 

(5) in subsection (d)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘An institution of higher education desiring a grant under 

this section’’ and inserting ‘‘To be eligible to receive a 

grant under this section, an institution of higher education’’; 

(B) by striking paragraph (1) and inserting— 

‘‘(1) A description of the population to be targeted by the 

program carried out under the grant, including veterans whenever possible and appropriate, and of identified mental and 

substance use disorder needs of students at the institution 

of higher education.’’; 

(C) in paragraph (2), by inserting ‘‘, which may include, 

as appropriate and in accordance with subsection (b)(7), 

a plan to seek input from relevant stakeholders in the 

community, including appropriate public and private entities, in order to carry out the program under the grant’’ 

before the period at the end; and 

(D) by adding after paragraph (5) the following new 

paragraphs: 

‘‘(6) An outline of the objectives of the program carried 

out under the grant. 

‘‘(7) For an institution of higher education proposing to 

use the grant for an activity described in paragraph (8) or 

(9) of subsection (b), a description of the policies and procedures 

of the institution of higher education that are related to 

applicable laws regarding access to, and sharing of, treatment 

records of students at any campus-based mental health center 

or partner organization, including the policies and State laws 

governing when such records can be accessed and shared for 

non-treatment purposes and a description of the process used 


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by the institution of higher education to notify students of 

these policies and procedures, including the extent to which 

written consent is required. 

‘‘(8) An assurance that grant funds will be used to supplement and not supplant any other Federal, State, or local funds 

available to carry out activities of the type carried out under 

the grant.’’; 

(6) in subsection (e)(1), by striking ‘‘and behavioral health 

problems’’ and inserting ‘‘health and substance use disorders’’; 

(7) in subsection (f)(2)— 

(A) by striking ‘‘and behavioral health’’ and inserting 

‘‘health and substance use disorder’’; and 

(B) by striking ‘‘suicide and substance abuse’’ and 

inserting ‘‘suicide and substance use disorders’’; 

(8) by redesignating subsection (h) as subsection (i); 

(9) by inserting after subsection (g) the following new subsection: 

‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to grantees in carrying out this section.’’; and 

(10) in subsection (i), as redesignated by paragraph (8), 

by striking ‘‘$5,000,000 for fiscal year 2005’’ and all that follows 

through the period at the end and inserting ‘‘$7,000,000 for 

each of fiscal years 2018 through 2022.’’. 

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 establish a College Campus Task Force (referred to in this section as 

the ‘‘Task Force’’) to discuss mental and behavioral health concerns 

on campuses of institutions of higher education. 

(c) MEMBERSHIP.—The Task Force shall be composed of a representative from each Federal agency (as appointed by the head 

of the agency) that has jurisdiction over, or is affected by, mental 

health and education policies and projects, including— 

(1) the Department of Education; 

(2) the Department of Health and Human Services; 

(3) the Department of Veterans Affairs; and 

(4) such other Federal agencies as the Assistant Secretary 

for Mental Health and Substance Use, in consultation with 

the Secretary, determines to be appropriate. 

(d) DUTIES.—The Task Force shall— 

(1) serve as a centralized mechanism to coordinate a 

national effort to— 

(A) discuss and evaluate evidence and knowledge on 

mental and behavioral health services available to, and 

the prevalence of mental illness among, the age population 

of students attending institutions of higher education in 

the United States; 

(B) determine the range of effective, feasible, and comprehensive actions to improve mental and behavioral health 

on campuses of institutions of higher education; 

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 education dealing with mental illness; 

(D) survey Federal agencies to determine which policies 

are effective in encouraging, and how best to facilitate 

outreach without duplicating, efforts relating to mental 

and behavioral health promotion; 

(E) establish specific goals within and across Federal 

agencies for mental health promotion, including determinations of accountability for reaching those goals; 

(F) develop a strategy for allocating responsibilities 

and ensuring participation in mental and behavioral health 

promotion, particularly in the case of competing agency 

priorities; 

(G) coordinate plans to communicate research results 

relating to mental and behavioral health amongst the age 

population of students attending institutions of higher education to enable reporting and outreach activities to produce 

more useful and timely information; 

(H) provide a description of evidence-based practices, 

model programs, effective guidelines, and other strategies 

for promoting mental and behavioral health on campuses 

of institutions of higher education; 

(I) make recommendations to improve Federal efforts 

relating to mental and behavioral health promotion on 

campuses of institutions of higher education and to ensure 

Federal efforts are consistent with available standards, 

evidence, and other programs in existence as of the date 

of enactment of this Act; 

(J) monitor Federal progress in meeting specific mental 

and behavioral health promotion goals as they relate to 

settings of institutions of higher education; and 

(K) examine and disseminate best practices related 

to intracampus sharing of treatment records; 

(2) consult with national organizations with expertise in 

mental and behavioral health, especially those organizations 

working with the age population of students attending institutions of higher education; and 

(3) consult with and seek input from mental health professionals working on campuses of institutions of higher education 

as appropriate. 

(e) MEETINGS.— 

(1) IN GENERAL.—The Task Force shall meet not fewer 

than three times each year. 

(2) ANNUAL CONFERENCE.—The Secretary shall sponsor an 

annual conference on mental and behavioral health in settings 

of institutions of higher education to enhance coordination, 

build partnerships, and share best practices in mental and 

behavioral health promotion, data collection, analysis, and services. 

(f) DEFINITION.—In this section, the term ‘‘institution of higher 

education’’ has the meaning given such term in section 101 of 

the Higher Education Act of 1965 (20 U.S.C. 1001). 

(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $1,000,000 for the 

period of fiscal years 2018 through 2022. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1261 

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 EDUCATION ON COLLEGE CAMPUSES. 

‘‘(a) PURPOSE.—It is the purpose of this section to increase 

access to, and reduce the stigma associated with, mental health 

services to ensure that students at institutions of higher education 

have the support necessary to successfully complete their studies. 

‘‘(b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary, 

acting through the Assistant Secretary and in collaboration with 

the Director of the Centers for Disease Control and Prevention, 

shall convene an interagency, public-private sector working group 

to plan, establish, and begin coordinating and evaluating a targeted 

public education campaign that is designed to focus on mental 

and behavioral health on the campuses of institutions of higher 

education. Such campaign shall be designed to— 

‘‘(1) improve the general understanding of mental health 

and mental disorders; 

‘‘(2) encourage help-seeking behaviors relating to the promotion of mental health, prevention of mental disorders, and 

treatment of such disorders; 

‘‘(3) make the connection between mental and behavioral 

health and academic success; and 

‘‘(4) assist the general public in identifying the early 

warning signs and reducing the stigma of mental illness. 

‘‘(c) COMPOSITION.—The working group convened under subsection (b) shall include— 

‘‘(1) mental health consumers, including students and 

family members; 

‘‘(2) representatives of institutions of higher education; 

‘‘(3) representatives of national mental and behavioral 

health associations and associations of institutions of higher 

education; 

‘‘(4) representatives of health promotion and prevention 

organizations at institutions of higher education; 

‘‘(5) representatives of mental health providers, including 

community mental health centers; and 

‘‘(6) representatives of private-sector and public-sector 

groups with experience in the development of effective public 

health education campaigns. 

‘‘(d) PLAN.—The working group under subsection (b) shall 

develop a plan that— 

‘‘(1) targets promotional and educational efforts to the age 

population of students at institutions of higher education and 

individuals who are employed in settings of institutions of 

higher education, including through the use of roundtables; 

‘‘(2) develops and proposes the implementation of researchbased public health messages and activities; 

‘‘(3) provides support for local efforts to reduce stigma 

by using the National Health Information Center as a primary 

point of contact for information, publications, and service program referrals; and 

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 students attending institutions of higher education and individuals 

who are employed in settings of institutions of higher education. 

‘‘(e) DEFINITION.—In this section, the term ‘institution of higher 

education’ has the meaning given such term in section 101 of 

the Higher Education Act of 1965 (20 U.S.C. 1001). 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this 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 ADOLESCENTS 

SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL 

DISTURBANCE. 

(a) COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR

CHILDREN WITH A SERIOUS EMOTIONAL DISTURBANCE.—Section 

561(a)(1) of the Public Health Service Act (42 U.S.C. 290ff(a)(1)) 

is amended by inserting ‘‘, which may include efforts to identify 

and serve children at risk’’ before the period. 

(b) REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE

OF GRANTS.—Section 562(b) of the Public Health Service Act (42 

U.S.C. 290ff–1(b)) is amended by striking ‘‘will not provide an 

individual with access to the system if the individual is more 

than 21 years of age’’ and inserting ‘‘will provide an individual 

with access to the system through the age of 21 years’’. 

(c) ADDITIONAL PROVISIONS.—Section 564(f) of the Public Health 

Service Act (42 U.S.C. 290ff–3(f)) is amended by inserting ‘‘(and 

provide a copy to the State involved)’’ after ‘‘to the Secretary’’. 

(d) GENERAL PROVISIONS.—Section 565 of the Public Health 

Service Act (42 U.S.C. 290ff–4) is amended— 

(1) in subsection (b)(1)— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘receiving a grant under section 561(a)’’ and 

inserting ‘‘, regardless of whether such public entity is 

receiving a grant under section 561(a)’’; and 

(B) in subparagraph (B), by striking ‘‘pursuant to’’ 

and inserting ‘‘described in’’; 

(2) in subsection (d)(1), by striking ‘‘not more than 21 

years of age’’ and inserting ‘‘through the age of 21 years’’; 

and 

(3) in subsection (f)(1), by striking ‘‘$100,000,000 for fiscal 

year 2001, and such sums as may be necessary for each of 

the fiscal years 2002 and 2003’’ and inserting ‘‘$119,026,000 

for each of fiscal years 2018 through 2022’’. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1263 

‘‘SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS. 

‘‘(a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Administration and 

in coordination with other relevant Federal agencies, shall award 

grants to States, political subdivisions of States, and Indian tribes 

and tribal organizations (for purposes of this section, as such terms 

are defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b)) to promote behavioral health 

integration in pediatric primary care by— 

‘‘(1) supporting the development of statewide or regional 

pediatric mental health care telehealth access programs; and 

‘‘(2) supporting the improvement of existing statewide or 

regional pediatric mental health care telehealth access programs. 

‘‘(b) PROGRAM REQUIREMENTS.— ‘‘(1) IN GENERAL.—A pediatric mental health care telehealth 

access program referred to in subsection (a), with respect to 

which a grant under such subsection may be used, shall— 

‘‘(A) be a statewide or regional network of pediatric 

mental health teams that provide support to pediatric primary care sites as an integrated team; 

‘‘(B) support and further develop organized State or 

regional networks of pediatric mental health teams to provide consultative support to pediatric primary care sites; 

‘‘(C) conduct an assessment of critical behavioral consultation needs among pediatric providers and such providers’ preferred mechanisms for receiving consultation, 

training, and technical assistance; 

‘‘(D) develop an online database and communication 

mechanisms, including telehealth, to facilitate consultation 

support to pediatric practices; 

‘‘(E) provide rapid statewide or regional clinical telephone or telehealth consultations when requested between 

the pediatric mental health teams and pediatric primary 

care providers; 

‘‘(F) conduct training and provide technical assistance 

to pediatric primary care providers to support the early 

identification, diagnosis, treatment, and referral of children 

with behavioral health conditions; 

‘‘(G) provide information to pediatric providers about, 

and assist pediatric providers in accessing, pediatric mental 

health care providers, including child and adolescent 

psychiatrists, and licensed mental health professionals, 

such as psychologists, social workers, or mental health 

counselors and in scheduling and conducting technical 

assistance; 

‘‘(H) assist with referrals to specialty care and community or behavioral health resources; and 

‘‘(I) establish mechanisms for measuring and monitoring increased access to pediatric mental health care 

services by pediatric primary care providers and expanded 

capacity of pediatric primary care providers to identify, 

treat, and refer children with mental health problems. 

‘‘(2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, 

the term ‘pediatric mental health team’ means a team consisting of at least one case coordinator, at least one child 

and adolescent psychiatrist, and at least one licensed clinical 

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 regionally based. 

‘‘(c) APPLICATION.—A State, political subdivision of a State, 

Indian tribe, or tribal organization seeking a grant under this 

section shall submit an application to the Secretary at such time, 

in such manner, and containing such information as the Secretary 

may require, including a plan for the comprehensive evaluation 

of activities that are carried out with funds received under such 

grant. 

‘‘(d) EVALUATION.—A State, political subdivision of a State, 

Indian tribe, or tribal organization that receives a grant under 

this section shall prepare and submit an evaluation of activities 

that are carried out with funds received under such grant to the 

Secretary at such time, in such manner, and containing such 

information as the Secretary may reasonably require, including 

a process and outcome evaluation. 

‘‘(e) ACCESS TO BROADBAND.—In administering grants under 

this section, the Secretary may coordinate with other agencies to 

ensure that funding opportunities are available to support access 

to reliable, high-speed Internet for providers. 

‘‘(f) MATCHING REQUIREMENT.—The Secretary may not award 

a grant under this section unless the State, political subdivision 

of a State, Indian tribe, or tribal organization involved agrees, 

with respect to the costs to be incurred by the State, political 

subdivision of a State, Indian tribe, or tribal organization in carrying out the purpose described in this section, to make available 

non-Federal contributions (in cash or in kind) toward such costs 

in an amount that is not less than 20 percent of Federal funds 

provided in the grant. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this 

section, there are authorized to be appropriated, $9,000,000 for 

the period of fiscal years 2018 through 2022.’’. 

SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY 

INTERVENTION SERVICES FOR CHILDREN AND ADOLESCENTS. 

The first section 514 of the Public Health Service Act (42 

U.S.C. 290bb–7), relating to substance abuse treatment services 

for children and adolescents, is amended— 

(1) in the section heading, by striking ‘‘ABUSE TREATMENT’’ 

and inserting ‘‘USE DISORDER TREATMENT AND EARLY INTERVENTION’’; 

(2) by striking subsection (a) and inserting the following: 

‘‘(a) IN GENERAL.—The Secretary shall award grants, contracts, 

or cooperative agreements to public and private nonprofit entities, 

including Indian tribes or tribal organizations (as such terms are 

defined in section 4 of the Indian Self-Determination and Education 

Assistance Act), or health facilities or programs operated by or 

in accordance with a contract or grant with the Indian Health 

Service, for the purpose of— 

‘‘(1) providing early identification and services to meet the 

needs of children and adolescents who are at risk of substance 

use disorders; 

‘‘(2) providing substance use disorder treatment services 

for children, including children and adolescents with co-occurring mental illness and substance use disorders; and 


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‘‘(3) providing assistance to pregnant women, and parenting 

women, with substance use disorders, in obtaining treatment 

services, linking mothers to community resources to support 

independent family lives, and staying in recovery so that children are in safe, stable home environments and receive appropriate health care services.’’; 

(3) in subsection (b)— 

(A) by striking paragraph (1) and inserting the following: 

‘‘(1) apply evidence-based and cost-effective methods;’’; 

(B) in paragraph (2)— 

(i) by striking ‘‘treatment’’; and 

(ii) by inserting ‘‘substance abuse,’’ after ‘‘child welfare,’’; 

(C) in paragraph (3), by striking ‘‘substance abuse disorders’’ and inserting ‘‘substance use disorders, including 

children and adolescents with co-occurring mental illness 

and substance use disorders,’’; 

(D) in paragraph (5), by striking ‘‘treatment;’’ and 

inserting ‘‘services; and’’; 

(E) in paragraph (6), by striking ‘‘substance abuse 

treatment; and’’ and inserting ‘‘treatment.’’; and 

(F) by striking paragraph (7); and 

(4) in subsection (f), by striking ‘‘$40,000,000’’ and all that 

follows through the period and inserting ‘‘$29,605,000 for each 

of fiscal years 2018 through 2022.’’. 

SEC. 10004. CHILDREN’S RECOVERY FROM TRAUMA. 

The first section 582 of the Public Health Service Act (42 

U.S.C. 290hh–1; relating to grants to address the problems of 

persons who experience violence related stress) is amended— 

(1) in subsection (a), by striking ‘‘developing programs’’ 

and all that follows through the period at the end and inserting 

the following: ‘‘developing and maintaining programs that provide for— 

‘‘(1) the continued operation of the National Child Traumatic Stress Initiative (referred to in this section as the 

‘NCTSI’), which includes a cooperative agreement with a coordinating center, that focuses on the mental, behavioral, and 

biological aspects of psychological trauma response, prevention 

of the long-term consequences of child trauma, and early intervention services and treatment to address the long-term consequences of child trauma; and 

‘‘(2) the development of knowledge with regard to evidencebased practices for identifying and treating mental, behavioral, 

and biological disorders of children and youth resulting from 

witnessing or experiencing a traumatic event.’’; 

(2) in subsection (b)— 

(A) by striking ‘‘subsection (a) related’’ and inserting 

‘‘subsection (a)(2) (related’’; 

(B) by striking ‘‘treating disorders associated with 

psychological trauma’’ and inserting ‘‘treating mental, 

behavioral, and biological disorders associated with psychological trauma)’’; and 

(C) by striking ‘‘mental health agencies and programs 

that have established clinical and basic research’’ and 

inserting ‘‘universities, hospitals, mental health agencies, 


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and other programs that have established clinical expertise 

and research’’; 

(3) by redesignating subsections (c) through (g) as subsections (g) through (k), respectively; 

(4) by inserting after subsection (b), the following: 

‘‘(c) CHILD OUTCOME DATA.—The NCTSI coordinating center 

described in subsection (a)(1) shall collect, analyze, report, and 

make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding the early identification 

and delivery of evidence-based treatment and services for children 

and families served by the NCTSI grantees. 

‘‘(d) TRAINING.—The NCTSI coordinating center shall facilitate 

the coordination of training initiatives in evidence-based and 

trauma-informed treatments, interventions, and practices offered 

to NCTSI grantees, providers, and partners. 

‘‘(e) DISSEMINATION AND COLLABORATION.—The NCTSI coordinating center shall, as appropriate, collaborate with— 

‘‘(1) the Secretary, in the dissemination of evidence-based 

and trauma-informed interventions, treatments, products, and 

other resources to appropriate stakeholders; and 

‘‘(2) appropriate agencies that conduct or fund research 

within the Department of Health and Human Services, for 

purposes of sharing NCTSI expertise, evaluation data, and 

other activities, as appropriate. 

‘‘(f) REVIEW.—The Secretary shall, consistent with the peerreview process, ensure that NCTSI applications are reviewed by 

appropriate experts in the field as part of a consensus-review 

process. The Secretary shall include review criteria related to expertise and experience in child trauma and evidence-based practices.’’; 

(5) in subsection (g) (as so redesignated), by striking ‘‘with 

respect to centers of excellence are distributed equitably among 

the regions of the country’’ and inserting ‘‘are distributed equitably among the regions of the United States’’; 

(6) in subsection (i) (as so redesignated), by striking 

‘‘recipient may not exceed 5 years’’ and inserting ‘‘recipient 

shall not be less than 4 years, but shall not exceed 5 years’’; 

and 

(7) in subsection (j) (as so redesignated), by striking ‘‘$50,000,000’’ and all that follows through ‘‘2006’’ and inserting 

‘‘$46,887,000 for each of fiscal years 2018 through 2022’’. 

SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION. 

Part B of title III of the Public Health Service Act (42 U.S.C. 

243 et seq.) is amended by inserting after section 317L (42 U.S.C. 

247b–13) the following: 

‘‘SEC. 317L–1. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION. 

‘‘(a) GRANTS.—The Secretary shall make grants to States to 

establish, improve, or maintain programs for screening, assessment, 

and treatment services, including culturally and linguistically 

appropriate services, as appropriate, for women who are pregnant, 

or who have given birth within the preceding 12 months, for 

maternal depression. 

‘‘(b) APPLICATION.—To seek a grant under this section, a State 

shall submit an application to the Secretary at such time, in such 

manner, and containing such information as the Secretary may 

42 USC 

247b–13a. 


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require. At a minimum, any such application shall include explanations of— 

‘‘(1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for 

maternal depression in 1 or more communities; and 

‘‘(2) how a program, or programs, if expanded, would 

increase access to screening and treatment services for 

maternal depression. 

‘‘(c) PRIORITY.—In awarding grants under this section, the Secretary may give priority to States proposing to improve or enhance 

access to screening services for maternal depression in primary 

care settings. 

‘‘(d) USE OF FUNDS.—The activities eligible for funding through 

a grant under subsection (a)— 

‘‘(1) shall include— 

‘‘(A) providing appropriate training to health care providers; and 

‘‘(B) providing information to health care providers, 

including information on maternal depression screening, 

treatment, and followup support services, and linkages to 

community-based resources; and 

‘‘(2) may include— 

‘‘(A) enabling health care providers (including obstetrician-gynecologists, pediatricians, psychiatrists, mental 

health care providers, and adult primary care clinicians) 

to provide or receive real-time psychiatric consultation (inperson or remotely) to aid in the treatment of pregnant 

and parenting women; 

‘‘(B) establishing linkages with and among communitybased resources, including mental health resources, primary care resources, and support groups; and 

‘‘(C) utilizing telehealth services for rural areas and 

medically underserved areas (as defined in section 330I(a)). 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $5,000,000 for each 

of fiscal years 2018 through 2022.’’. 

SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT. 

Part Q of title III of the Public Health Service Act (42 U.S.C. 

280h et seq.) is amended by adding at the end the following: 

‘‘SEC. 399Z–2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, 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 emotional disturbance; and 

‘‘(B) multigenerational therapy and other services that 

support the caregiving relationship; and 

‘‘(2) ensure that programs funded through grants under 

this section are evidence-informed or evidence-based models, 

practices, and methods that are, as appropriate, culturally and 

42 USC 280h–6. 


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linguistically appropriate, and can be replicated in other appropriate settings. 

‘‘(b) ELIGIBLE CHILDREN AND ENTITIES.—In this section: 

‘‘(1) ELIGIBLE CHILD.—The term ‘eligible child’ means a 

child from birth to not more than 12 years of age who— 

‘‘(A) is at risk for, shows early signs of, or has been 

diagnosed with a mental illness, including a serious emotional disturbance; and 

‘‘(B) may benefit from infant and early childhood intervention or treatment programs or specialized preschool or 

elementary school programs that are evidence-based or that 

have been scientifically demonstrated to show promise but 

would benefit from further applied development. 

‘‘(2) ELIGIBLE ENTITY.—The term ‘eligible entity’ means a 

human services agency or nonprofit institution that— 

‘‘(A) employs licensed mental health professionals who 

have specialized training and experience in infant and early 

childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the appropriate State 

agency, as applicable, to provide for children from infancy 

to 12 years of age mental health promotion, intervention, 

or treatment services; and 

‘‘(B) provides services or programs described in subsection (a) that are evidence-based or that have been scientifically demonstrated to show promise but would benefit 

from further applied development. 

‘‘(c) APPLICATION.—An eligible entity seeking a grant under 

subsection (a) shall submit to the Secretary an application at such 

time, in such manner, and containing such information as the 

Secretary may require. 

‘‘(d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT

PROGRAMS.—An eligible entity may use amounts awarded under 

a grant under subsection (a)(1) to carry out the following: 

‘‘(1) Provide age-appropriate mental health promotion and 

early intervention services or mental illness treatment services, 

which may include specialized programs, for eligible children 

at significant risk of developing, showing early signs of, or 

having been diagnosed with a mental illness, including a serious 

emotional disturbance. Such services may include social and 

behavioral services as well as multigenerational therapy and 

other services that support the caregiving relationship. 

‘‘(2) Provide training for health care professionals with 

expertise in infant and early childhood mental health care 

with respect to appropriate and relevant integration with other 

disciplines such as primary care clinicians, early intervention 

specialists, child welfare staff, home visitors, early care and 

education providers, and others who work with young children 

and families. 

‘‘(3) Provide mental health consultation to personnel of 

early care and education programs (including licensed or regulated center-based and home-based child care, home visiting, 

preschool special education, and early intervention programs) 

who work with children and families. 

‘‘(4) Provide training for mental health clinicians in infant 

and early childhood in promising and evidence-based practices 

and models for infant and early childhood mental health treatment and early intervention, including with regard to practices 


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for identifying and treating mental illness and behavioral disorders of infants and children resulting from exposure or 

repeated exposure to adverse childhood experiences or childhood 

trauma. 

‘‘(5) Provide age-appropriate assessment, diagnostic, and 

intervention services for eligible children, including early 

mental health promotion, intervention, and treatment services. 

‘‘(e) MATCHING FUNDS.—The Secretary may not award a grant 

under this section to an eligible entity unless the eligible entity 

agrees, with respect to the costs to be incurred by the eligible 

entity in carrying out the activities described in subsection (d), 

to make available non-Federal contributions (in cash or in kind) 

toward such costs in an amount that is not less than 10 percent 

of the total amount of Federal funds provided in the grant. 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this 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 functional impairment and substantially interferes with or limits 

one or more major life activities. 

(3) In reporting on the incidence of serious mental illness, 

the Substance Abuse and Mental Health Services Administration includes major depression, schizophrenia, bipolar disorder, 

and other mental disorders that cause serious impairment. 

(4) Adults with a serious mental illness are at a higher 

risk for chronic physical illnesses and premature death. 

(5) According to the World Health Organization, adults 

with a serious mental illness have lifespans that are 10 to 

25 years shorter than those without serious mental illness. 

The vast majority of these deaths are due to chronic physical 

medical conditions, such as cardiovascular, respiratory, and 

infectious diseases, as well as diabetes and hypertension. 

(6) According to the World Health Organization, the 

majority of deaths of adults with a serious mental illness that 

are due to physical medical conditions are preventable. 

(7) Supported decision making can facilitate care decisions 

in areas where serious mental illness may impact the capacity 

of an individual to determine a course of treatment while 

still allowing the individual to make decisions independently. 

(8) Help should be provided to adults with a serious mental 

illness to address their acute or chronic physical illnesses, 

make informed choices about treatment, and understand and 

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(9) There is confusion in the health care community 

regarding permissible practices under the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (commonly known as ‘‘HIPAA’’). This confusion may hinder appropriate communication of health care 

information or treatment preferences with appropriate caregivers. 

(b) SENSE OF CONGRESS.—It is the sense of Congress that 

clarification is needed regarding the privacy rule promulgated under 

section 264(c) of the Health Insurance Portability and Accountability 

Act of 1996 (42 U.S.C. 1320d–2 note) regarding existing permitted 

uses and disclosures of health information by health care professionals to communicate with caregivers of adults with a serious 

mental illness to facilitate treatment. 

SEC. 11002. CONFIDENTIALITY OF RECORDS. 

Not later than 1 year after the date on which the Secretary 

of Health and Human Services (in this title referred to as the 

‘‘Secretary’’) first finalizes regulations updating part 2 of title 42, 

Code of Federal Regulations, relating to confidentiality of alcohol 

and drug abuse patient records, after the date of enactment of 

this Act, the Secretary shall convene relevant stakeholders to determine the effect of such regulations on patient care, health outcomes, 

and patient privacy. 

SEC. 11003. CLARIFICATION ON PERMITTED USES AND DISCLOSURES 

OF PROTECTED HEALTH INFORMATION. 

(a) IN GENERAL.—The Secretary, acting through the Director 

of the Office for Civil Rights, shall ensure that health care providers, 

professionals, patients and their families, and others involved in 

mental or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate 

uses and disclosures of protected health information under the 

regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d– 

2 note). 

(b) GUIDANCE.— (1) ISSUANCE.—In carrying out subsection (a), not later 

than 1 year after the date of enactment of this section, the 

Secretary shall issue guidance clarifying the circumstances 

under which, consistent with regulations promulgated under 

section 264(c) of the Health Insurance Portability and Accountability Act of 1996, a health care provider or covered entity 

may use or disclose protected health information. 

(2) CIRCUMSTANCES ADDRESSED.—The guidance issued 

under this section shall address circumstances including those 

that— 

(A) require the consent of the patient; 

(B) require providing the patient with an opportunity 

to object; 

(C) are based on the exercise of professional judgment 

regarding whether the patient would object when the opportunity to object cannot practicably be provided because 

of the incapacity of the patient or an emergency treatment 

circumstance; and 

(D) are determined, based on the exercise of professional judgment, to be in the best interest of the patient 

when the patient is not present or otherwise incapacitated. 

42 USC 1320d–2 

note. 


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(3) COMMUNICATION WITH FAMILY MEMBERS AND CARE- GIVERS.—In addressing the circumstances described in paragraph (2), the guidance issued under this section shall clarify 

permitted uses or disclosures of protected health information 

for purposes of— 

(A) communicating with a family member of the 

patient, caregiver of the patient, or other individual, to 

the extent that such family member, caregiver, or individual is involved in the care of the patient; 

(B) in the case that the patient is an adult, communicating with a family member of the patient, caregiver 

of the patient, or other individual involved in the care 

of the patient; 

(C) in the case that the patient is a minor, communicating with the parent or caregiver of the patient; 

(D) involving the family members or caregivers of the 

patient, or others involved in the patient’s care or care 

plan, including facilitating treatment and medication 

adherence; 

(E) listening to the patient, or receiving information 

with respect to the patient from the family or caregiver 

of the patient; 

(F) communicating with family members of the patient, 

caregivers of the patient, law enforcement, or others when 

the patient presents a serious and imminent threat of 

harm to self or others; and 

(G) communicating to law enforcement and family 

members or caregivers of the patient about the admission 

of the patient to receive care at, or the release of a patient 

from, a facility for an emergency psychiatric hold or involuntary treatment. 

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 programs or materials exist) recognize private or public entities to 

develop and disseminate each of the following: 

(1) Model programs and materials for training health care 

providers (including physicians, emergency medical personnel, 

psychiatrists, including child and adolescent psychiatrists, 

psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care 

managers, and hospitals, including individuals such as general 

counsels or regulatory compliance staff who are responsible 

for establishing provider privacy policies) regarding the permitted uses and disclosures, consistent with the standards governing the privacy and security of individually identifiable 

health information promulgated by the Secretary under part 

C of title XI of the Social Security Act (42 U.S.C. 1320d et 

seq.) and regulations promulgated under section 264(c) of the 

Health Insurance Portability and Accountability Act of 1996 

(42 U.S.C. 1320d–2 note) and such part C, of the protected 

health information of patients seeking or undergoing mental 

or substance use disorder treatment. 

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 Assistant Secretary for Mental Health and Substance Use, the Administrator of the Health Resources and Services Administration, and 

the heads of other relevant agencies within the Department of 

Health and Human Services. 

(d) INPUT OF CERTAIN ENTITIES.—In identifying, reviewing, or 

updating the model programs and materials under subsections (a) 

and (b), the Secretary shall solicit the input of relevant national, 

State, and local associations; medical societies; licensing boards; 

providers of mental and substance use disorder treatment; organizations with expertise on domestic violence, sexual assault, elder 

abuse, and child abuse; and organizations representing patients 

and consumers and the families of patients and consumers. 

(e) FUNDING.—There are authorized to be appropriated to carry 

out this section— 

(1) $4,000,000 for fiscal year 2018; 

(2) $2,000,000 for each of fiscal years 2019 and 2020; and 

(3) $1,000,000 for each of fiscal years 2021 and 2022. 

TITLE XII—MEDICAID MENTAL HEALTH 

COVERAGE 

SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COVERAGE OF MENTAL HEALTH SERVICES AND PRIMARY 

CARE SERVICES FURNISHED ON THE SAME DAY. 

Nothing in title XIX of the Social Security Act (42 U.S.C. 

1396 et seq.) shall be construed as prohibiting separate payment 

under the State plan under such title (or under a waiver of the 

plan) for the provision of a mental health service or primary care 

service under such plan, with respect to an individual, because 

such service is— 

(1) a primary care service furnished to the individual by 

a provider at a facility on the same day a mental health 

service is furnished to such individual by such provider (or 

another provider) at the facility; or 

(2) a mental health service furnished to the individual 

by a provider at a facility on the same day a primary care 

service is furnished to such individual by such provider (or 

another provider) at the facility. 

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 

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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 managed care organization (as defined in section 1903(m) of such Act 

(42 U.S.C. 1396b(m)) or a prepaid inpatient health plan (as defined 

in section 438.2 of title 42, Code of Federal Regulations (or any 

successor regulation)) with respect to individuals over the age of 

21 and under the age of 65 for the treatment of a mental health 

disorder in institutions for mental diseases (as defined in section 

1905(i) of such Act (42 U.S.C. 1396d(i))). Such study shall include 

information on the following: 

(1) The extent to which States, including the District of 

Columbia and each territory or possession of the United States, 

are providing capitated payments to such organizations or plans 

for enrollees who are receiving services in institutions for 

mental diseases. 

(2) The number of individuals receiving medical assistance 

under a State plan under such title XIX, or a waiver of such 

plan, who receive services in institutions for mental diseases 

through such organizations and plans. 

(3) The range of and average number of months, and the 

length of stay during such months, that such individuals are 

receiving such services in such institutions. 

(4) How such organizations or plans determine when to 

provide for the furnishing of such services through an institution for mental diseases in lieu of other benefits (including 

the full range of community-based services) under their contract 

with the State agency administering the State plan under such 

title XIX, or a waiver of such plan, to address psychiatric 

or substance use disorder treatment. 

(5) The extent to which the provision of services within 

such institutions has affected the capitated payments for such 

organizations or plans. 

(b) REPORT.—Not later than 3 years after the date of the 

enactment of this Act, the Secretary shall submit to Congress 

a report on the study conducted under subsection (a). 

SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVATION. 

Not later than 1 year after the date of the enactment of this 

Act, the Administrator of the Centers for Medicare & Medicaid 

Services shall issue a State Medicaid Director letter regarding 

opportunities to design innovative service delivery systems, 

including systems for providing community-based services, for 

adults with a serious mental illness or children with a serious 

emotional disturbance who are receiving medical assistance under 

title XIX of the Social Security Act (42 U.S.C. 1396 et seq.). The 

letter shall include opportunities for demonstration projects under 

section 1115 of such Act (42 U.S.C. 1315) to improve care for 

such adults and children. 

SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY PSYCHIATRIC DEMONSTRATION PROJECT. 

(a) COLLECTION OF INFORMATION.—The Secretary of Health 

and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall, to the extent practical 

and data is available, with respect to each State that has participated in the demonstration project established under section 2707 

42 USC 1315 

note. 


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of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a 

note), collect from each such State information on the following: 

(1) The number of institutions for mental diseases (as 

defined in section 1905(i) of the Social Security Act (42 U.S.C. 

1396d(i))) and beds in such institutions that received payment 

for the provision of services to individuals who receive medical 

assistance under a State plan under the Medicaid program 

under title XIX of the Social Security Act (42 U.S.C. 1396 

et seq.) (or under a waiver of such plan) through the demonstration project in each such State as compared to the total number 

of institutions for mental diseases and beds in the State. 

(2) The extent to which there is a reduction in expenditures 

under the Medicaid program under title XIX of the Social 

Security Act (42 U.S.C. 1396 et seq.) or other spending on 

the full continuum of physical or mental health care for individuals who receive treatment in an institution for mental diseases 

under the demonstration project, including outpatient, 

inpatient, emergency, and ambulatory care, that is attributable 

to such individuals receiving treatment in institutions for 

mental diseases under the demonstration project. 

(3) The number of forensic psychiatric hospitals, the 

number of beds in such hospitals, and the number of forensic 

psychiatric beds in other hospitals in such State, based on 

the most recent data available, to the extent practical, as determined by such Administrator. 

(4) The amount of any disproportionate share hospital payments under section 1923 of the Social Security Act (42 U.S.C. 

1396r–4) that institutions for mental diseases in the State 

received during the period beginning on July 1, 2012, and 

ending on June 30, 2015, and the extent to which the demonstration project reduced the amount of such payments. 

(5) The most recent data regarding all facilities or sites 

in the State in which any adults with a serious mental illness 

who are receiving medical assistance under a State plan under 

the Medicaid program under title XIX of the Social Security 

Act (42 U.S.C. 1396 et seq.) (or under a waiver of such plan) 

are treated during the period referred to in paragraph (4), 

to the extent practical, as determined by the Administrator, 

including— 

(A) the types of such facilities or sites (such as an 

institution for mental diseases, a hospital emergency 

department, or other inpatient hospital); 

(B) the average length of stay in such a facility or 

site by such an individual, disaggregated by facility type; 

and 

(C) the payment rate under the State plan (or a waivers 

of such plan) for services furnished to such an individual 

for that treatment, disaggregated by facility type, during 

the period in which the demonstration project is in operation. 

(6) The extent to which the utilization of hospital emergency departments during the period in which the demonstration project was is in operation differed, with respect to individuals who are receiving medical assistance under a State plan 

under the Medicaid program under title XIX of the Social 

Security Act (42 U.S.C. 1396 et seq.) (or under a waiver of 

such plan), between— 


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(A) those individuals who received treatment in an 

institution for mental diseases under the demonstration 

project; 

(B) those individuals who met the eligibility requirements for the demonstration project but who did not receive 

treatment in an institution for mental diseases under the 

demonstration project; and 

(C) those adults with a serious mental illness who 

did not meet such eligibility requirements and did not 

receive treatment for such illness in an institution for 

mental diseases. 

(b) REPORT.—Not later than 2 years after the date of the 

enactment of this Act, the Secretary of Health and Human Services 

shall submit to Congress a report that summarizes and analyzes 

the information collected under subsection (a). Such report may 

be submitted as part of the report required under section 2707(f) 

of the Patient Protection and Affordable Care Act (42 U.S.C. 1396a 

note) or separately. 

SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS. 

(a) IN GENERAL.—Section 1905(a)(16) of the Social Security 

Act (42 U.S.C. 1396d(a)(16)) is amended— 

(1) by striking ‘‘effective January 1, 1973’’ and inserting 

‘‘(A) effective January 1, 1973’’; and 

(2) by inserting before the semicolon at the end the following: ‘‘, and, (B) for individuals receiving services described 

in subparagraph (A), early and periodic screening, diagnostic, 

and treatment services (as defined in subsection (r)), whether 

or not such screening, diagnostic, and treatment services are 

furnished by the provider of the services described in such 

subparagraph’’. 

(b) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall apply with respect to items and services furnished in 

calendar quarters beginning on or after January 1, 2019. 

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 thereafter, by 1 percentage point; and 

‘‘(B) in the case of home health care services— 

‘‘(i) for calendar quarters in 2023 and 2024, by .25 

percentage points; 

‘‘(ii) for calendar quarters in 2025, by .5 percentage 

points; 

‘‘(iii) for calendar quarters in 2026, by .75 percentage 

points; and 

‘‘(iv) for calendar quarters in 2027 and each year thereafter, by 1 percentage point. 

‘‘(2) Subject to paragraphs (3) and (4), in implementing the 

requirement for the use of an electronic visit verification system 

under paragraph (1), a State shall— 

‘‘(A) consult with agencies and entities that provide personal care services, home health care services, or both under 

the State plan (or under a waiver of the plan) to ensure that 

such system— 

‘‘(i) is minimally burdensome; 

‘‘(ii) takes into account existing best practices and electronic visit verification systems in use in the State; and 

‘‘(iii) is conducted in accordance with the requirements 

of HIPAA privacy and security law (as defined in section 

3009 of the Public Health Service Act); 

‘‘(B) take into account a stakeholder process that includes 

input from beneficiaries, family caregivers, individuals who furnish personal care services or home health care services, and 

other stakeholders, as determined by the State in accordance 

with guidance from the Secretary; and 

‘‘(C) ensure that individuals who furnish personal care 

services, home health care services, or both under the State 

plan (or under a waiver of the plan) are provided the opportunity for training on the use of such system. 

‘‘(3) Paragraphs (1) and (2) shall not apply in the case of 

a State that, as of the date of the enactment of this subsection, 

requires the use of any system for the electronic verification of 

visits conducted as part of both personal care services and home 

health care services, so long as the State continues to require 

the use of such system with respect to the electronic verification 

of such visits. 

‘‘(4)(A) In the case of a State described in subparagraph (B), 

the reduction under paragraph (1) shall not apply— 

‘‘(i) in the case of personal care services, for calendar quarters in 2019; and 

‘‘(ii) in the case of home health care services, for calendar 

quarters in 2023. 

‘‘(B) For purposes of subparagraph (A), a State described in 

this subparagraph is a State that demonstrates to the Secretary 

that the State— 

‘‘(i) has made a good faith effort to comply with the requirements of paragraphs (1) and (2) (including by taking steps 

to adopt the technology used for an electronic visit verification 

system); and 

‘‘(ii) in implementing such a system, has encountered 

unavoidable system delays. 

‘‘(5) In this subsection: 


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‘‘(A) The term ‘electronic visit verification system’ means, 

with respect to personal care services or home health care 

services, a system under which visits conducted as part of 

such services are electronically verified with respect to— 

‘‘(i) the type of service performed; 

‘‘(ii) the individual receiving the service; 

‘‘(iii) the date of the service; 

‘‘(iv) the location of service delivery; 

‘‘(v) the individual providing the service; and 

‘‘(vi) the time the service begins and ends. 

‘‘(B) The term ‘home health care services’ means services 

described in section 1905(a)(7) provided under a State plan 

under this title (or under a waiver of the plan). 

‘‘(C) The term ‘personal care services’ means personal care 

services provided under a State plan under this title (or under 

a waiver of the plan), including services provided under section 

1905(a)(24), 1915(c), 1915(i), 1915(j), or 1915(k) or under a 

wavier under section 1115. 

‘‘(6)(A) In the case in which a State requires personal care 

service and home health care service providers to utilize an electronic visit verification system operated by the State or a contractor 

on behalf of the State, the Secretary shall pay to the State, for 

each quarter, an amount equal to 90 per centum of so much of 

the sums expended during such quarter as are attributable to 

the design, development, or installation of such system, and 75 

per centum of so much of the sums for the operation and maintenance of such system. 

‘‘(B) Subparagraph (A) shall not apply in the case in which 

a State requires personal care service and home health care service 

providers to utilize an electronic visit verification system that is 

not operated by the State or a contractor on behalf of the State.’’. 

(b) COLLECTION AND DISSEMINATION OF BEST PRACTICES.—Not 

later than January 1, 2018, the Secretary of Health and Human 

Services shall, with respect to electronic visit verification systems 

(as defined in subsection (l)(5) of section 1903 of the Social Security 

Act (42 U.S.C. 1396b), as inserted by subsection (a)), collect and 

disseminate best practices to State Medicaid Directors with respect 

to— 

(1) training individuals who furnish personal care services, 

home health care services, or both under the State plan under 

title XIX of such Act (or under a waiver of the plan) on such 

systems and the operation of such systems and the prevention 

of fraud with respect to the provision of personal care services 

or home health care services (as defined in such subsection 

(l)(5)); and 

(2) the provision of notice and educational materials to 

family caregivers and beneficiaries with respect to the use 

of such electronic visit verification systems and other means 

to prevent such fraud. 

(c) RULES OF CONSTRUCTION.— 

(1) NO EMPLOYER-EMPLOYEE RELATIONSHIP ESTABLISHED.— 

Nothing in the amendment made by this section may be construed as establishing an employer-employee relationship 

between the agency or entity that provides for personal care 

services or home health care services and the individuals who, 

under a contract with such an agency or entity, furnish such 

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’ selection of a caregiver, or impede the manner in which care is 

delivered. 

(4) NO PROHIBITION ON STATE QUALITY MEASURES REQUIREMENTS.—Nothing in the amendment made by this section shall 

be construed as prohibiting a State, in implementing an electronic visit verification system (as defined in subsection (l)(5) 

of section 1903 of the Social Security Act (42 U.S.C. 1396b), 

as inserted by subsection (a)), from establishing requirements 

related to quality measures for such system. 

TITLE XIII—MENTAL HEALTH PARITY 

SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND SUBSTANCE USE DISORDER COVERAGE REQUIREMENTS. 

(a) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—Section 

2726(a) of the Public Health Service Act (42 U.S.C. 300gg–26(a)) 

is amended by adding at the end the following: 

‘‘(6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.— 

‘‘(A) IN GENERAL.—Not later than 12 months after the 

date of enactment of the Helping Families in Mental Health 

Crisis Reform Act of 2016, the Secretary, the Secretary 

of Labor, and the Secretary of the Treasury, in consultation 

with the Inspector General of the Department of Health 

and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury, shall issue a compliance program 

guidance document to help improve compliance with this 

section, section 712 of the Employee Retirement Income 

Security Act of 1974, and section 9812 of the Internal 

Revenue Code of 1986, as applicable. In carrying out this 

paragraph, the Secretaries may take into consideration 

the 2016 publication of the Department of Health and 

Human Services and the Department of Labor, entitled 

‘Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance’. 

‘‘(B) EXAMPLES ILLUSTRATING COMPLIANCE AND NON- COMPLIANCE.— 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1279 

‘‘(i) IN GENERAL.—The compliance program guidance document required under this paragraph shall 

provide illustrative, de-identified examples (that do not 

disclose any protected health information or individually identifiable information) of previous findings of 

compliance and noncompliance with this section, section 712 of the Employee Retirement Income Security 

Act of 1974, or section 9812 of the Internal Revenue 

Code of 1986, as applicable, based on investigations 

of violations of such sections, including— 

‘‘(I) examples illustrating requirements for 

information disclosures and nonquantitative treatment limitations; and 

‘‘(II) descriptions of the violations uncovered 

during the course of such investigations. 

‘‘(ii) NONQUANTITATIVE TREATMENT LIMITATIONS.— To the extent that any example described in clause 

(i) involves a finding of compliance or noncompliance 

with regard to any requirement for nonquantitative 

treatment limitations, the example shall provide sufficient detail to fully explain such finding, including 

a full description of the criteria involved for approving 

medical and surgical benefits and the criteria involved 

for approving mental health and substance use disorder benefits. 

‘‘(iii) ACCESS TO ADDITIONAL INFORMATION

REGARDING COMPLIANCE.—In developing and issuing 

the compliance program guidance document required 

under this paragraph, the Secretaries specified in 

subparagraph (A)— 

‘‘(I) shall enter into interagency agreements 

with the Inspector General of the Department of 

Health and Human Services, the Inspector General 

of the Department of Labor, and the Inspector 

General of the Department of the Treasury to 

share findings of compliance and noncompliance 

with this section, section 712 of the Employee 

Retirement Income Security Act of 1974, or section 

9812 of the Internal Revenue Code of 1986, as 

applicable; and 

‘‘(II) shall seek to enter into an agreement 

with a State to share information on findings of 

compliance and noncompliance with this section, 

section 712 of the Employee Retirement Income 

Security Act of 1974, or section 9812 of the Internal 

Revenue Code of 1986, as applicable. 

‘‘(C) RECOMMENDATIONS.—The compliance program 

guidance document shall include recommendations to 

advance compliance with this section, section 712 of the 

Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as 

applicable, and encourage the development and use of 

internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal 

controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance 

use disorder benefits, which may fail to comply with this 


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130 STAT. 1280 PUBLIC LAW 114–255—DEC. 13, 2016 

section, section 712 of the Employee Retirement Income 

Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. 

‘‘(D) UPDATING THE COMPLIANCE PROGRAM GUIDANCE

DOCUMENT.—The Secretary, the Secretary of Labor, and 

the Secretary of the Treasury, in consultation with the 

Inspector General of the Department of Health and Human 

Services, the Inspector General of the Department of Labor, 

and the Inspector General of the Department of the 

Treasury, shall update the compliance program guidance 

document every 2 years to include illustrative, de-identified 

examples (that do not disclose any protected health 

information or individually identifiable information) of previous findings of compliance and noncompliance with this 

section, section 712 of the Employee Retirement Income 

Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable.’’. 

(b) ADDITIONAL GUIDANCE.—Section 2726(a) of the Public 

Health Service Act (42 U.S.C. 300gg–26(a)), as amended by subsection (a), is further amended by adding at the end the following: 

‘‘(7) ADDITIONAL GUIDANCE.— 

‘‘(A) IN GENERAL.—Not later than 12 months after the 

date of enactment of the Helping Families in Mental Health 

Crisis Reform Act of 2016, the Secretary, the Secretary 

of Labor, and the Secretary of the Treasury shall issue 

guidance to group health plans and health insurance 

issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the 

requirements of this section, section 712 of the Employee 

Retirement Income Security Act of 1974, or section 9812 

of the Internal Revenue Code of 1986, as applicable. 

‘‘(B) DISCLOSURE.— 

‘‘(i) GUIDANCE FOR PLANS AND ISSUERS.—The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods 

that group health plans and health insurance issuers 

offering group or individual health insurance coverage 

may use for disclosing information to ensure compliance with the requirements under this section, section 

712 of the Employee Retirement Income Security Act 

of 1974, or section 9812 of the Internal Revenue Code 

of 1986, as applicable, (and any regulations promulgated pursuant to such sections, as applicable). 

‘‘(ii) DOCUMENTS FOR PARTICIPANTS, BENEFICIARIES, 

CONTRACTING PROVIDERS, OR AUTHORIZED REPRESENTATIVES.—The guidance issued under this paragraph 

shall include clarifying information and illustrative 

examples of methods that group health plans and 

health insurance issuers offering group or individual 

health insurance coverage may use to provide any 

participant, beneficiary, contracting provider, or 

authorized representative, as applicable, with documents containing information that the health plans 

or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1281 

section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, compliance with any 

regulation issued pursuant to such respective section, 

or compliance with any other applicable law or regulation. Such guidance shall include information that is 

comparative in nature with respect to— 

‘‘(I) nonquantitative treatment limitations for 

both medical and surgical benefits and mental 

health and substance use disorder benefits; 

‘‘(II) the processes, strategies, evidentiary 

standards, and other factors used to apply the 

limitations described in subclause (I); and 

‘‘(III) the application of the limitations 

described in subclause (I) to ensure that such 

limitations are applied in parity with respect to 

both medical and surgical benefits and mental 

health and substance use disorder benefits. 

‘‘(C) NONQUANTITATIVE TREATMENT LIMITATIONS.—The 

guidance issued under this paragraph shall include clarifying information and illustrative examples of methods, 

processes, strategies, evidentiary standards, and other factors that group health plans and health insurance issuers 

offering group or individual health insurance coverage may 

use regarding the development and application of nonquantitative treatment limitations to ensure compliance 

with this section, section 712 of the Employee Retirement 

Income Security Act of 1974, or section 9812 of the Internal 

Revenue Code of 1986, as applicable, (and any regulations 

promulgated pursuant to such respective section), 

including— 

‘‘(i) examples of methods of determining appropriate types of nonquantitative treatment limitations 

with respect to both medical and surgical benefits and 

mental health and substance use disorder benefits, 

including nonquantitative treatment limitations pertaining to— 

‘‘(I) medical management standards based on 

medical necessity or appropriateness, or whether 

a treatment is experimental or investigative; 

‘‘(II) limitations with respect to prescription 

drug formulary design; and 

‘‘(III) use of fail-first or step therapy protocols; 

‘‘(ii) examples of methods of determining— 

‘‘(I) network admission standards (such as 

credentialing); and 

‘‘(II) factors used in provider reimbursement 

methodologies (such as service type, geographic 

market, demand for services, and provider supply, 

practice size, training, experience, and licensure) 

as such factors apply to network adequacy; 

‘‘(iii) examples of sources of information that may 

serve as evidentiary standards for the purposes of 

making determinations regarding the development and 

application of nonquantitative treatment limitations; 

‘‘(iv) examples of specific factors, and the evidentiary standards used to evaluate such factors, used 


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130 STAT. 1282 PUBLIC LAW 114–255—DEC. 13, 2016 

by such plans or issuers in performing a nonquantitative treatment limitation analysis; 

‘‘(v) examples of how specific evidentiary standards 

may be used to determine whether treatments are 

considered experimental or investigative; 

‘‘(vi) examples of how specific evidentiary standards may be applied to each service category or classification of benefits; 

‘‘(vii) examples of methods of reaching appropriate 

coverage determinations for new mental health or substance use disorder treatments, such as evidence-based 

early intervention programs for individuals with a 

serious mental illness and types of medical management techniques; 

‘‘(viii) examples of methods of reaching appropriate 

coverage determinations for which there is an indirect 

relationship between the covered mental health or substance use disorder benefit and a traditional covered 

medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or involuntary commitment; and 

‘‘(ix) additional illustrative examples of methods, 

processes, strategies, evidentiary standards, and other 

factors for which the Secretary determines that additional guidance is necessary to improve compliance 

with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 

of the Internal Revenue Code of 1986, as applicable. 

‘‘(D) PUBLIC COMMENT.—Prior to issuing any final guidance under this paragraph, the Secretary shall provide 

a public comment period of not less than 60 days during 

which any member of the public may provide comments 

on a draft of the guidance.’’. 

(c) AVAILABILITY OF PLAN INFORMATION.— 

(1) SOLICITATION OF PUBLIC FEEDBACK.—Not later than 

6 months after the date of enactment of this Act, the Secretary 

of Health and Human Services, the Secretary of Labor, and 

the Secretary of the Treasury shall solicit feedback from the 

public on how the disclosure request process for documents 

containing information that health plans or health insurance 

issuers are required under Federal or State law to disclose 

to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with existing mental 

health parity and addiction equity requirements can be 

improved while continuing to ensure consumers’ rights to access 

all information required by Federal or State law to be disclosed. 

(2) PUBLIC AVAILABILITY.—Not later than 12 months after 

the date of the enactment of this Act, the Secretary of Health 

and Human Services, the Secretary of Labor, and the Secretary 

of the Treasury shall make such feedback publicly available. 

(3) NAIC.—The Secretary of Health and Human Services, 

the Secretary of Labor, and the Secretary of the Treasury 

shall share feedback obtained pursuant to paragraph (1) 

directly with the National Association of Insurance Commissioners to the extent such feedback includes recommendations 

for the development of simplified information disclosure tools 

to provide consistent information for consumers. Such feedback 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1283 

may be taken into consideration by the National Association 

of Insurance Commissioners and other appropriate entities for 

the voluntary development and voluntary use of common templates and other sample standardized forms to improve consumer access to plan information. 

(d) IMPROVING COMPLIANCE.— 

(1) IN GENERAL.—In the case that the Secretary of Health 

and Human Services, the Secretary of Labor, or the Secretary 

of the Treasury determines that a group health plan or health 

insurance issuer offering group or individual health insurance 

coverage has violated, at least 5 times, section 2726 of the 

Public Health Service Act (42 U.S.C. 300gg–26), section 712 

of the Employee Retirement Income Security Act of 1974 (29 

U.S.C. 1185a), or section 9812 of the Internal Revenue Code 

of 1986, respectively, the appropriate Secretary shall audit 

plan documents for such health plan or issuer in the plan 

year following the Secretary’s determination in order to help 

improve compliance with such section. 

(2) RULE OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to limit the authority, as in effect on the 

day before the date of enactment of this Act, of the Secretary 

of Health and Human Services, the Secretary of Labor, or 

the Secretary of the Treasury to audit documents of health 

plans or health insurance issuers. 

SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL 

HEALTH AND SUBSTANCE USE DISORDER COVERAGE. 

(a) PUBLIC MEETING.— 

(1) IN GENERAL.—Not later than 6 months after the date 

of enactment of this Act, the Secretary of Health and Human 

Services shall convene a public meeting of stakeholders 

described in paragraph (2) to produce an action plan for 

improved Federal and State coordination related to the enforcement of section 2726 of the Public Health Service Act (42 

U.S.C. 300gg–26), section 712 of the Employee Retirement 

Income Security Act of 1974 (29 U.S.C. 1185a), and section 

9812 of the Internal Revenue Code of 1986, and any comparable 

provisions of State law (in this section such sections and provisions are collectively referred to as ‘‘mental health parity and 

addiction equity requirements’’). 

(2) STAKEHOLDERS.—The stakeholders described in this 

paragraph shall include each of the following: 

(A) The Federal Government, including representatives 

from— 

(i) the Department of Health and Human Services; 

(ii) the Department of the Treasury; 

(iii) the Department of Labor; and 

(iv) the Department of Justice. 

(B) State governments, including— 

(i) State health insurance commissioners; 

(ii) appropriate State agencies, including agencies 

on public health or mental health; and 

(iii) State attorneys general or other representatives of State entities involved in the enforcement of 

mental health parity and addiction equity requirements. 

42 USC 

300gg–26 note. 


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130 STAT. 1284 PUBLIC LAW 114–255—DEC. 13, 2016 

(C) Representatives from key stakeholder groups, 

including— 

(i) the National Association of Insurance Commissioners; 

(ii) health insurance issuers; 

(iii) providers of mental health and substance use 

disorder treatment; 

(iv) employers; and 

(v) patients or their advocates. 

(b) ACTION PLAN.—Not later than 6 months after the conclusion 

of the public meeting under subsection (a), the Secretary of Health 

and Human Services shall finalize the action plan described in 

such subsection and make it plainly available on the Internet 

website of the Department of Health and Human Services. 

(c) CONTENT.—The action plan under this section shall— 

(1) take into consideration the recommendations of the 

Mental Health and Substance Use Disorder Parity Task Force 

in its final report issued in October of 2016, and any subsequent 

Federal and State actions in relation to such recommendations; 

(2) reflect the input of the stakeholders participating in 

the public meeting under subsection (a); 

(3) identify specific strategic objectives regarding how the 

various Federal and State agencies charged with enforcement 

of mental health parity and addiction equity requirements will 

collaborate to improve enforcement of such requirements; 

(4) provide a timeline for implementing the action plan; 

and 

(5) provide specific examples of how such objectives may 

be met, which may include— 

(A) providing common educational information and 

documents, such as the Consumer Guide to Disclosure 

Rights, to patients about their rights under mental health 

parity and addiction equity requirements; 

(B) facilitating the centralized collection of, monitoring 

of, and response to patient complaints or inquiries relating 

to mental health parity and addiction equity requirements, 

which may be through the development and administration 

of— 

(i) a single, toll-free telephone number; and 

(ii) a new parity website— 

(I) to help consumers find the appropriate Federal or State agency to assist with their parity 

complaints, appeals, and other actions; and 

(II) that takes into consideration, but is not 

duplicative of, the parity beta site being tested, 

and released for public comment, by the Department of Health and Human Services as of the 

date of the enactment of this Act; 

(C) Federal and State law enforcement agencies 

entering into memoranda of understanding to better coordinate enforcement responsibilities and information 

sharing— 

(i) including whether such agencies should make 

the results of enforcement actions related to mental 

health parity and addiction equity requirements publicly available; and 


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(ii) which may include State Policy Academies on 

Parity Implementation for State Officials and other 

forums to bring together national experts to provide 

technical assistance to teams of State officials on 

strategies to advance compliance with mental health 

parity and addiction equity requirements in both the 

commercial market, and in the Medicaid program 

under title XIX of the Social Security Act and the 

State Children’s Health Insurance Program under title 

XXI of such Act; and 

(D) recommendations to the Congress regarding the 

need for additional legal authority to improve enforcement 

of mental health parity and addiction equity requirements, 

including the need for additional legal authority to ensure 

that nonquantitative treatment limitations are applied, and 

the extent and frequency of the applications of such limitations, both to medical and surgical benefits and to mental 

health and substance use disorder benefits in a comparable 

manner. 

SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN 

MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS. 

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, and annually thereafter for the subsequent 5 

years, the Assistant Secretary of Labor of the Employee Benefits 

Security Administration, in collaboration with the Administrator 

of the Centers for Medicare & Medicaid Services and the Secretary 

of the Treasury, shall submit to the Committee on Energy and 

Commerce of the House of Representatives and the Committee 

on Health, Education, Labor, and Pensions of the Senate a report 

summarizing the results of all closed Federal investigations completed during the preceding 12-month period with findings of any 

serious violation regarding compliance with mental health and substance use disorder coverage requirements under section 2726 of 

the Public Health Service Act (42 U.S.C. 300gg–26), section 712 

of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 

1185a), and section 9812 of the Internal Revenue Code of 1986. 

(b) CONTENTS.—Subject to subsection (c), a report under subsection (a) shall, with respect to investigations described in such 

subsection, include each of the following: 

(1) The number of closed Federal investigations conducted 

during the covered reporting period. 

(2) Each benefit classification examined by any such investigation conducted during the covered reporting period. 

(3) Each subject matter, including compliance with requirements for quantitative and nonquantitative treatment limitations, of any such investigation conducted during the covered 

reporting period. 

(4) A summary of the basis of the final decision rendered 

for each closed investigation conducted during the covered 

reporting period that resulted in a finding of a serious violation. 

(c) LIMITATION.—Any individually identifiable information shall 

be excluded from reports under subsection (a) consistent with 

protections under the health privacy and security rules promulgated 

under section 264(c) of the Health Insurance Portability and 

Accountability Act of 1996 (42 U.S.C. 1320d–2 note). 


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SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS. 

Not later than 3 years after the date of enactment of this 

Act, the Comptroller General of the United States, in consultation 

with the Secretary of Health and Human Services, the Secretary 

of Labor, and the Secretary of the Treasury, shall submit to the 

Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions 

of the Senate a report detailing the extent to which group health 

plans or health insurance issuers offering group or individual health 

insurance coverage that provides both medical and surgical benefits 

and mental health or substance use disorder benefits, medicaid 

managed care organizations with a contract under section 1903(m) 

of the Social Security Act (42 U.S.C. 1396b(m)), and health plans 

provided under the State Children’s Health Insurance Program 

under title XXI of the Social Security Act (42 U.S.C. 1397aa et 

seq.) comply with section 2726 of the Public Health Service Act 

(42 U.S.C. 300gg–26), section 712 of the Employee Retirement 

Income Security Act of 1974 (29 U.S.C. 1185a), and section 9812 

of the Internal Revenue Code of 1986, including— 

(1) how nonquantitative treatment limitations, including 

medical necessity criteria, of such plans or issuers comply with 

such sections; 

(2) how the responsible Federal departments and agencies 

ensure that such plans or issuers comply with such sections, 

including an assessment of how the Secretary of Health and 

Human Services has used its authority to conduct audits of 

such plans to ensure compliance; 

(3) a review of how the various Federal and State agencies 

responsible for enforcing mental health parity requirements 

have improved enforcement of such requirements in accordance 

with the objectives and timeline described in the action plan 

under section 13002; and 

(4) recommendations for how additional enforcement, education, and coordination activities by responsible Federal and 

State departments and agencies could better ensure compliance 

with such sections, including recommendations regarding the 

need for additional legal authority. 

SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS. 

(a) INFORMATION.—The Secretary of Health and Human Services, acting through the Director of the Office on Women’s Health, 

may— 

(1) update information, related fact sheets, and resource 

lists related to eating disorders that are available on the public 

Internet website of the National Women’s Health Information 

Center sponsored by the Office on Women’s Health, to include— 

(A) updated findings and current research related to 

eating disorders, as appropriate; and 

(B) information about eating disorders, including 

information related to males and females; 

(2) incorporate, as appropriate, and in coordination with 

the Secretary of Education, information from publicly available 

resources into appropriate obesity prevention programs developed by the Office on Women’s Health; and 

(3) make publicly available (through a public Internet 

website or other method) information, related fact sheets, and 

42 USC 237a 

note. 


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resource lists, as updated under paragraph (1), and the information incorporated into appropriate obesity prevention programs 

under paragraph (2). 

(b) AWARENESS.—The Secretary of Health and Human Services 

may advance public awareness on— 

(1) the types of eating disorders; 

(2) the seriousness of eating disorders, including prevalence, comorbidities, and physical and mental health consequences; 

(3) methods to identify, intervene, refer for treatment, and 

prevent behaviors that may lead to the development of eating 

disorders; 

(4) discrimination and bullying based on body size; 

(5) the effects of media on self-esteem and body image; 

and 

(6) the signs and symptoms of eating disorders. 

SEC. 13006. EDUCATION AND TRAINING ON EATING DISORDERS. 

The Secretary of Health and Human Services may facilitate 

the identification of model programs and materials for educating 

and training health professionals in effective strategies to— 

(1) identify individuals with eating disorders; 

(2) provide early intervention services for individuals with 

eating disorders; 

(3) refer patients with eating disorders for appropriate 

treatment; 

(4) prevent the development of eating disorders; and 

(5) provide appropriate treatment services for individuals 

with eating disorders. 

SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES. 

If a group health plan or a health insurance issuer offering 

group or individual health insurance coverage provides coverage 

for eating disorder benefits, including residential treatment, such 

group health plan or health insurance issuer shall provide such 

benefits consistent with the requirements of section 2726 of the 

Public Health Service Act (42 U.S.C. 300gg–26), section 712 of 

the Employee Retirement Income Security Act of 1974 (29 U.S.C. 

1185a), and section 9812 of the Internal Revenue Code of 1986. 

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 enforcement and corrections programs, including behavioral programs and crisis intervention teams.’’. 

42 USC 

300gg–26 note. 

42 USC 237a 

note. 


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(b) COMMUNITY ORIENTED POLICING SERVICES PROGRAM.—Section 1701(b) of title I of the Omnibus Crime Control and Safe 

Streets Act of 1968 (42 U.S.C. 3796dd(b)) is amended— 

(1) in paragraph (17), by striking ‘‘and’’ at the end; 

(2) by redesignating paragraph (18) as paragraph (22); 

(3) by inserting after paragraph (17) the following: 

‘‘(18) to provide specialized training to law enforcement 

officers to— 

‘‘(A) recognize individuals who have a mental illness; 

and 

‘‘(B) properly interact with individuals who have a 

mental illness, including strategies for verbal de-escalation 

of crises; 

‘‘(19) to establish collaborative programs that enhance the 

ability of law enforcement agencies to address the mental 

health, behavioral, and substance abuse problems of individuals 

encountered by law enforcement officers in the line of duty; 

‘‘(20) to provide specialized training to corrections officers 

to recognize individuals who have a mental illness; 

‘‘(21) to enhance the ability of corrections officers to address 

the mental health of individuals under the care and custody 

of jails and prisons, including specialized training and strategies 

for verbal de-escalation of crises; and’’; and 

(4) in paragraph (22), as redesignated, by striking ‘‘through 

(17)’’ and inserting ‘‘through (21)’’. 

(c) MODIFICATIONS TO THE STAFFING FOR ADEQUATE FIRE AND

EMERGENCY RESPONSE GRANTS.—Section 34(a)(1)(B) of the Federal 

Fire Prevention and Control Act of 1974 (15 U.S.C. 2229a(a)(1)(B)) 

is amended by inserting before the period at the end the following: 

‘‘and to provide specialized training to paramedics, emergency medical services workers, and other first responders to recognize individuals who have mental illness and how to properly intervene with 

individuals with mental illness, including strategies for verbal deescalation of crises’’. 

SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS. 

(a) IN GENERAL.—Section 2201 of title I of the Omnibus Crime 

Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) is amended 

in paragraph (2)(B), by inserting before the semicolon the following: 

‘‘, or court-ordered assisted outpatient treatment when the court 

has determined such treatment to be necessary’’. 

(b) DEFINITIONS.—Section 2202 of title I of the Omnibus Crime 

Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii—1) is 

amended— 

(1) in paragraph (1), by striking ‘‘and’’ at the end; 

(2) in paragraph (2), by striking the period at the end 

and inserting a semicolon; and 

(3) by adding at the end the following: 

‘‘(3) the term ‘court-ordered assisted outpatient treatment’ 

means a program through which a court may order a treatment 

plan for an eligible patient that— 

‘‘(A) requires such patient to obtain outpatient mental 

health treatment while the patient is not currently residing 

in a correctional facility or inpatient treatment facility; 

and 


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‘‘(B) is designed to improve access and adherence by 

such patient to intensive behavioral health services in order 

to— 

‘‘(i) avert relapse, repeated hospitalizations, arrest, 

incarceration, suicide, property destruction, and violent 

behavior; and 

‘‘(ii) provide such patient with the opportunity to 

live in a less restrictive alternative to incarceration 

or involuntary hospitalization; and 

‘‘(4) the term ‘eligible patient’ means an adult, mentally 

ill person who, as determined by a court— 

‘‘(A) has a history of violence, incarceration, or medically unnecessary hospitalizations; 

‘‘(B) without supervision and treatment, may be a 

danger to self or others in the community; 

‘‘(C) is substantially unlikely to voluntarily participate 

in treatment; 

‘‘(D) may be unable, for reasons other than indigence, 

to provide for any of his or her basic needs, such as food, 

clothing, shelter, health, or safety; 

‘‘(E) has a history of mental illness or a condition 

that is likely to substantially deteriorate if the person 

is not provided with timely treatment; or 

‘‘(F) due to mental illness, lacks capacity to fully understand or lacks judgment to make informed decisions 

regarding his or her need for treatment, care, or supervision.’’. 

SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS. 

(a) DEFINITIONS.—In this section— 

(1) the term ‘‘eligible offender’’ means a person who— 

(A)(i) previously or currently has been diagnosed by 

a qualified mental health professional as having a mental 

illness, mental retardation, or co-occurring mental illness 

and substance abuse disorders; or 

(ii) manifests obvious signs of mental illness, mental 

retardation, or co-occurring mental illness and substance 

abuse disorders during arrest or confinement or before 

any court; 

(B) comes into contact with the criminal justice system 

or is arrested or charged with an offense that is not— 

(i) a crime of violence, as defined under applicable 

State law or in section 3156 of title 18, United States 

Code; or 

(ii) a serious drug offense, as defined in section 

924(e)(2)(A) of title 18, United States Code; and 

(C) is determined by a judge to be eligible; and 

(2) the term ‘‘mental illness’’ means a diagnosable mental, 

behavioral, or emotional disorder— 

(A) of sufficient duration to meet diagnostic criteria 

within the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association; and 

(B) that has resulted in functional impairment that 

substantially interferes with or limits 1 or more major 

life activities. 

42 USC 3796ii 

note. 


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(b) ESTABLISHMENT OF PROGRAM.—Not later than 1 year after 

the date of enactment of this Act, the Attorney General shall 

establish a pilot program to determine the effectiveness of diverting 

eligible offenders from Federal prosecution, Federal probation, or 

a Bureau of Prisons facility, and placing such eligible offenders 

in drug or mental health courts. 

(c) PROGRAM SPECIFICATIONS.—The pilot program established 

under subsection (b) shall involve— 

(1) continuing judicial supervision, including periodic 

review, of program participants who have a substance abuse 

problem or mental illness; and 

(2) the integrated administration of services and sanctions, 

which shall include— 

(A) mandatory periodic testing, as appropriate, for the 

use of controlled substances or other addictive substances 

during any period of supervised release or probation for 

each program participant; 

(B) substance abuse treatment for each program 

participant who requires such services; 

(C) diversion, probation, or other supervised release 

with the possibility of prosecution, confinement, or incarceration based on noncompliance with program requirements 

or failure to show satisfactory progress toward completing 

program requirements; 

(D) programmatic offender management, including case 

management, and aftercare services, such as relapse 

prevention, health care, education, vocational training, job 

placement, housing placement, and child care or other 

family support services for each program participant who 

requires such services; 

(E) outpatient or inpatient mental health treatment, 

as ordered by the court, that carries with it the possibility 

of dismissal of charges or reduced sentencing upon successful completion of such treatment; 

(F) centralized case management, including— 

(i) the consolidation of all cases, including violations of probations, of the program participant; and 

(ii) coordination of all mental health treatment 

plans and social services, including life skills and vocational training, housing and job placement, education, 

health care, and relapse prevention for each program 

participant who requires such services; and 

(G) continuing supervision of treatment plan compliance by the program participant for a term not to exceed 

the maximum allowable sentence or probation period for 

the charged or relevant offense and, to the extent practicable, continuity of psychiatric care at the end of the 

supervised period. 

(d) IMPLEMENTATION; DURATION.—The pilot program established under subsection (b) shall be conducted— 

(1) in not less than 1 United States judicial district, designated by the Attorney General in consultation with the 

Director of the Administrative Office of the United States 

Courts, as appropriate for the pilot program; and 

(2) during fiscal year 2017 through fiscal year 2021. 

(e) CRITERIA FOR DESIGNATION.—Before making a designation 

under subsection (d)(1), the Attorney General shall— 


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(1) obtain the approval, in writing, of the United States 

Attorney for the United States judicial district being designated; 

(2) obtain the approval, in writing, of the chief judge for 

the United States judicial district being designated; and 

(3) determine that the United States judicial district being 

designated has adequate behavioral health systems for treatment, including substance abuse and mental health treatment. 

(f) ASSISTANCE FROM OTHER FEDERAL ENTITIES.—The Administrative Office of the United States Courts and the United States 

Probation Offices shall provide such assistance and carry out such 

functions as the Attorney General may request in monitoring, supervising, providing services to, and evaluating eligible offenders placed 

in a drug or mental health court under this section. 

(g) REPORTS.—The Attorney General, in consultation with the 

Director of the Administrative Office of the United States Courts, 

shall monitor the drug and mental health courts under this section, 

and shall submit a report to Congress on the outcomes of the 

program at the end of the period described in subsection (d)(2). 

SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM. 

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 illness. 

‘‘(2) ALLOWABLE USES.—Grants awarded under this subsection may be may be used for— 

‘‘(A) behavioral health needs and risk screening of 

defendants, including verification of interview information, 

mental health evaluation, and criminal history screening; 

‘‘(B) assessment of risk of pretrial misconduct through 

objective, statistically validated means, and presentation 

to the court of recommendations based on such assessment, 

including services that will reduce the risk of pre-trial 

misconduct; 

‘‘(C) followup review of defendants unable to meet the 

conditions of pretrial release; 

‘‘(D) evaluation of process and results of pre-trial 

service programs; 

‘‘(E) supervision of defendants who are on pretrial 

release, including reminders to defendants of scheduled 

court dates; 

‘‘(F) reporting on process and results of pretrial services 

programs to relevant public and private mental health 

stakeholders; and 

‘‘(G) data collection and analysis necessary to make 

available information required for assessment of risk. 

‘‘(b) BEHAVIORAL HEALTH ASSESSMENTS AND INTERVENTION.— 

‘‘(1) IN GENERAL.—The Attorney General may award grants 

to States, units of local government, territories, Indian Tribes, 

nonprofit agencies, or any combination thereof, to develop, 

42 USC 3796ii–8. 


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implement, or expand a behavioral health screening and assessment program framework for State or local criminal justice 

systems. 

‘‘(2) ALLOWABLE USES.—Grants awarded under this subsection may be used for— 

‘‘(A) promotion of the use of validated assessment tools 

to gauge the criminogenic risk, substance abuse needs, 

and mental health needs of individuals; 

‘‘(B) initiatives to match the risk factors and needs 

of individuals to programs and practices associated with 

research-based, positive outcomes; 

‘‘(C) implementing methods for identifying and treating 

individuals who are most likely to benefit from coordinated 

supervision and treatment strategies, and identifying 

individuals who can do well with fewer interventions; and 

‘‘(D) collaborative decision-making among the heads 

of criminal justice agencies, mental health systems, judicial 

systems, substance abuse systems, and other relevant systems or agencies for determining how treatment and intensive supervision services should be allocated in order to 

maximize benefits, and developing and utilizing capacity 

accordingly. 

‘‘(c) USE OF GRANT FUNDS.—A State, unit of local government, 

territory, Indian Tribe, or nonprofit agency that receives a grant 

under this section shall, in accordance with subsection (b)(2), use 

grant funds for the expenses of a treatment program, including— 

‘‘(1) salaries, personnel costs, equipment costs, and other 

costs directly related to the operation of the program, including 

costs relating to enforcement; 

‘‘(2) payments for treatment providers that are approved 

by the State or Indian Tribe and licensed, if necessary, to 

provide needed treatment to program participants, including 

aftercare supervision, vocational training, education, and job 

placement; and 

‘‘(3) payments to public and nonprofit private entities that 

are approved by the State or Indian Tribe and licensed, if 

necessary, to provide alcohol and drug addiction treatment 

to offenders participating in the program. 

‘‘(d) SUPPLEMENT OF NON-FEDERAL FUNDS.— 

‘‘(1) IN GENERAL.—Grants awarded under this section shall 

be used to supplement, and not supplant, non-Federal funds 

that would otherwise be available for programs described in 

this section. 

‘‘(2) FEDERAL SHARE.—The Federal share of a grant made 

under this section may not exceed 50 percent of the total 

costs of the program described in an application under subsection (e). 

‘‘(e) APPLICATIONS.—To request a grant under this section, a 

State, unit of local government, territory, Indian Tribe, or nonprofit 

agency shall submit an application to the Attorney General in 

such form and containing such information as the Attorney General 

may reasonably require. 

‘‘(f) GEOGRAPHIC DISTRIBUTION.—The Attorney General shall 

ensure that, to the extent practicable, the distribution of grants 

under this section is equitable and includes— 

‘‘(1) each State; and 


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‘‘(2) a unit of local government, territory, Indian Tribe, 

or nonprofit agency— 

‘‘(A) in each State; and 

‘‘(B) in rural, suburban, Tribal, and urban jurisdictions. 

‘‘(g) REPORTS AND EVALUATIONS.—For each fiscal year, each 

grantee under this section during that fiscal year shall submit 

to the Attorney General a report on the effectiveness of activities 

carried out using such grant. Each report shall include an evaluation in such form and containing such information as the Attorney 

General may reasonably require. The Attorney General shall specify 

the dates on which such reports shall be submitted. 

‘‘(h) ACCOUNTABILITY.—Grants awarded under this section shall 

be subject to the following accountability provisions: 

‘‘(1) AUDIT REQUIREMENT.— ‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit 

report of the Inspector General of the Department of Justice 

under subparagraph (C) that the audited grantee has used 

grant funds for an unauthorized expenditure or otherwise 

unallowable cost that is not closed or resolved within 1 

year after the date on which final audit report is issued. 

‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this section, and in 

each fiscal year thereafter, the Inspector General of the 

Department of Justice shall conduct audits of grantees 

under this section to prevent waste, fraud, and abuse of 

funds by grantees. The Inspector General shall determine 

the appropriate number of grantees to be audited each 

year. 

‘‘(C) FINAL AUDIT REPORT.—The Inspector General of 

the Department of Justice shall submit to the Attorney 

General a final report on each audit conducted under 

subparagraph (B). 

‘‘(D) MANDATORY EXCLUSION.—Grantees under this section about which there is an unresolved audit finding shall 

not be eligible to receive a grant under this section during 

the 2 fiscal years beginning after the end of the 1-year 

period described in subparagraph (A). 

‘‘(E) PRIORITY.—In making grants under this section, 

the Attorney General shall give priority to applicants that 

did not have an unresolved audit finding during the 3 

fiscal years before submitting an application for a grant 

under this section. 

‘‘(F) REIMBURSEMENT.—If an entity receives a grant 

under this section during the 2-fiscal-year period during 

which the entity is prohibited from receiving grants under 

subparagraph (D), the Attorney General shall— 

‘‘(i) deposit an amount equal to the amount of 

the grant that was improperly awarded to the grantee 

into the General Fund of the Treasury; and 

‘‘(ii) seek to recoup the costs of the repayment 

under clause (i) from the grantee that was erroneously 

awarded grant funds. 

‘‘(2) NONPROFIT AGENCY REQUIREMENTS.— 

‘‘(A) DEFINITION.—For purposes of this paragraph and 

the grant program under this section, the term ‘nonprofit 

agency’ means an organization that is described in section 


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501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 

501(c)(3)) and is exempt from taxation under section 501(a) 

of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)). 

‘‘(B) PROHIBITION.—The Attorney General may not 

award a grant under this section to a nonprofit agency 

that holds money in an offshore account for the purpose 

of avoiding paying the tax described in section 511(a) of 

the Internal Revenue Code of 1986 (26 U.S.C. 511(a)). 

‘‘(C) DISCLOSURE.—Each nonprofit agency that is 

awarded a grant under this section and uses the procedures 

prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, 

directors, trustees, and key employees, shall disclose to 

the Attorney General, in the application for the grant, 

the process for determining such compensation, including 

the independent persons involved in reviewing and 

approving such compensation, the comparability data used, 

and contemporaneous substantiation of the deliberation 

and decision. Upon request, the Attorney General shall 

make the information disclosed under this subparagraph 

available for public inspection. 

‘‘(3) CONFERENCE EXPENDITURES.— 

‘‘(A) LIMITATION.—Not more than $20,000 of the 

amounts made available to the Department of Justice to 

carry out this section may be used by the Attorney General, 

or by any individual or entity awarded a grant under 

this section to host, or make any expenditures relating 

to, a conference unless the Deputy Attorney General provides prior written authorization that the funds may be 

expended to host the conference or make such expenditure. 

‘‘(B) WRITTEN APPROVAL.—Written approval under 

subparagraph (A) shall include a written estimate of all 

costs associated with the conference, including the cost 

of all food, beverages, audio-visual equipment, honoraria 

for speakers, and entertainment. 

‘‘(C) REPORT.—The Deputy Attorney General shall 

submit an annual report to the Committee on the Judiciary 

of the Senate and the Committee on the Judiciary of the 

House of Representatives on all conference expenditures 

approved under this paragraph. 

‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal 

year beginning after the date of enactment of this subsection, 

the Attorney General shall submit to the Committee on the 

Judiciary and the Committee on Appropriations of the Senate 

and the Committee on the Judiciary and the Committee on 

Appropriations of the House of Representatives an annual certification— 

‘‘(A) indicating whether— 

‘‘(i) all final audit reports issued by the Office 

of the Inspector General under paragraph (1) have 

been completed and reviewed by the appropriate 

Assistant Attorney General or Director; 

‘‘(ii) all mandatory exclusions required under paragraph (1)(D) have been issued; and 

‘‘(iii) any reimbursements required under paragraph (1)(F) have been made; and 


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‘‘(B) that includes a list of any grantees excluded under 

paragraph (1)(D) from the previous year. 

‘‘(i) PREVENTING DUPLICATIVE GRANTS.— 

‘‘(1) IN GENERAL.—Before the Attorney General awards a 

grant to an applicant under this section, the Attorney General 

shall compare the possible grant with any other grants awarded 

to the applicant under this Act to determine whether the grants 

are for the same purpose. 

‘‘(2) REPORT.—If the Attorney General awards multiple 

grants to the same applicant for the same purpose, the Attorney 

General shall submit to the Committee on the Judiciary of 

the Senate and the Committee on the Judiciary of the House 

of Representatives a report that includes— 

‘‘(A) a list of all duplicate grants awarded, including 

the total dollar amount of any such grants awarded; and 

‘‘(B) the reason the Attorney General awarded the 

duplicate grants.’’. 

SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT INITIATIVES. 

Section 2991 of the Omnibus Crime Control and Safe Streets 

Act of 1968 (42 U.S.C. 3797aa) is amended by— 

(1) redesignating subsection (j) as subsection (o); and 

(2) inserting after subsection (i) the following: 

‘‘(j) FORENSIC ASSERTIVE COMMUNITY TREATMENT (FACT) INITIATIVE PROGRAM.— 

‘‘(1) IN GENERAL.—The Attorney General may make grants 

to States, units of local government, territories, Indian Tribes, 

nonprofit agencies, or any combination thereof, to develop, 

implement, or expand Assertive Community Treatment initiatives to develop forensic assertive community treatment 

(referred to in this subsection as ‘FACT’) programs that provide 

high intensity services in the community for individuals with 

mental illness with involvement in the criminal justice system 

to prevent future incarcerations. 

‘‘(2) ALLOWABLE USES.—Grant funds awarded under this 

subsection may be used for— 

‘‘(A) multidisciplinary team initiatives for individuals 

with mental illnesses with criminal justice involvement 

that address criminal justice involvement as part of treatment protocols; 

‘‘(B) FACT programs that involve mental health professionals, criminal justice agencies, chemical dependency 

specialists, nurses, psychiatrists, vocational specialists, 

forensic peer specialists, forensic specialists, and dedicated 

administrative support staff who work together to provide 

recovery oriented, 24/7 wraparound services; 

‘‘(C) services such as integrated evidence-based practices for the treatment of co-occurring mental health and 

substance-related disorders, assertive outreach and engagement, community-based service provision at participants’ 

residence or in the community, psychiatric rehabilitation, 

recovery oriented services, services to address criminogenic 

risk factors, and community tenure; 

‘‘(D) payments for treatment providers that are 

approved by the State or Indian Tribe and licensed, if 

necessary, to provide needed treatment to eligible offenders 


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participating in the program, including behavioral health 

services and aftercare supervision; and 

‘‘(E) training for all FACT teams to promote highfidelity practice principles and technical assistance to support effective and continuing integration with criminal justice agency partners. 

‘‘(3) SUPPLEMENT AND NOT SUPPLANT.—Grants made under 

this subsection shall be used to supplement, and not supplant, 

non-Federal funds that would otherwise be available for programs described in this subsection. 

‘‘(4) APPLICATIONS.—To request a grant under this subsection, a State, unit of local government, territory, Indian 

Tribe, or nonprofit agency shall submit an application to the 

Attorney General in such form and containing such information 

as the Attorney General may reasonably require.’’. 

SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING OUT OF 

SYSTEMS. 

Section 2976(f) of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797w(f)) is amended— 

(1) in paragraph (5), by striking ‘‘and’’ at the end; 

(2) in paragraph (6), by striking the period at the end 

and inserting a semicolon; and 

(3) by adding at the end the following: 

‘‘(7) provide mental health treatment and transitional services for those with mental illnesses or with co-occurring disorders, including housing placement or assistance; and’’. 

SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MENTAL HEALTH 

CHALLENGES IN DRUG COURTS. 

Part EE of title I of the Omnibus Crime Control and Safe 

Streets Act of 1968 (42 U.S.C. 3797u et seq.) is amended— 

(1) in section 2951(a)(1) (42 U.S.C. 3797u(a)(1)), by 

inserting ‘‘, including co-occurring substance abuse and mental 

health problems,’’ after ‘‘problems’’; and 

(2) in section 2959(a) (42 U.S.C. 3797u–8(a)), by inserting 

‘‘, including training for drug court personnel and officials on 

identifying and addressing co-occurring substance abuse and 

mental health problems’’ after ‘‘part’’. 

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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(3) COOPERATIVE PROGRAMS.—The establishment and 

expansion of cooperative efforts to promote public safety 

through the use of effective intervention with respect to mentally ill individuals encountered by members of the uniformed 

services. 

SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OFFENDER 

REENTRY. 

(a) REENTRY DEMONSTRATION PROJECTS.—Section 2976(f) of 

title I of the Omnibus Crime Control and Safe Streets Act of 

1968 (42 U.S.C. 3797w(f)), as amended by section 14006, is 

amended— 

(1) in paragraph (3)(C), by inserting ‘‘mental health services,’’ before ‘‘drug treatment’’; and 

(2) by adding at the end the following: 

‘‘(8) target offenders with histories of homelessness, substance abuse, or mental illness, including a prerelease assessment of the housing status of the offender and behavioral 

health needs of the offender with clear coordination with mental 

health, substance abuse, and homelessness services systems 

to achieve stable and permanent housing outcomes with appropriate support service.’’. 

(b) MENTORING GRANTS.—Section 211(b)(2) of the Second 

Chance Act of 2007 (42 U.S.C. 17531(b)(2)) is amended by inserting 

‘‘, including mental health care’’ after ‘‘community’’. 

SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVENTION TEAMS. 

Section 2701(b) of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797a(b)) is amended— 

(1) by redesignating paragraphs (4) and (5) as paragraphs 

(5) and (6), respectively; and 

(2) by inserting after paragraph (3) the following: 

‘‘(4) The development and operation of crisis intervention 

teams that may include coordination with law enforcement 

agencies and specialized training for school officials in 

responding to mental health crises.’’. 

SEC. 14011. ACTIVE-SHOOTER TRAINING FOR LAW ENFORCEMENT. 

The Attorney General, as part of the Preventing Violence 

Against Law Enforcement and Ensuring Officer Resilience and 

Survivability Initiative (VALOR) of the Department of Justice, may 

provide safety training and technical assistance to local law enforcement agencies, including active-shooter response training. 

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 INCARCERATION 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 treatment alternative to incarceration program for eligible participants, 

including— 

‘‘(1) pre-booking treatment alternative to incarceration programs, including— 

‘‘(A) law enforcement training on substance use disorders, mental illness, and co-occurring mental illness and 

substance use disorders; 

‘‘(B) receiving centers as alternatives to incarceration 

of eligible participants; 

‘‘(C) specialized response units for calls related to substance use disorders, mental illness, or co-occurring mental 

illness and substance use disorders; and 

‘‘(D) other arrest and pre-booking treatment alternatives to incarceration models; or 

‘‘(2) post-booking treatment alternative to incarceration programs, including— 

‘‘(A) specialized clinical case management; 

42 USC 3797q. 


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‘‘(B) pre-trial services related to substances use disorders, mental illness, and co-occurring mental illness and 

substance use disorders; 

‘‘(C) prosecutor and defender based programs; 

‘‘(D) specialized probation; 

‘‘(E) treatment and rehabilitation programs; and 

‘‘(F) problem-solving courts, including mental health 

courts, drug courts, co-occurring mental health and substance abuse courts, DWI courts, and veterans treatment 

courts. 

‘‘(c) APPLICATION.— ‘‘(1) IN GENERAL.—An eligible entity desiring a grant under 

this section shall submit an application to the Attorney General— 

‘‘(A) that meets the criteria under paragraph (2); and 

‘‘(B) at such time, in such manner, and accompanied 

by such information as the Attorney General may require. 

‘‘(2) CRITERIA.—An eligible entity, in submitting an application under paragraph (1), shall— 

‘‘(A) provide extensive evidence of collaboration with 

State and local government agencies overseeing health, 

community corrections, courts, prosecution, substance 

abuse, mental health, victims services, and employment 

services, and with local law enforcement agencies; 

‘‘(B) demonstrate consultation with the Single State 

Authority for Substance Abuse of the State (as that term 

is defined in section 201(e) of the Second Chance Act of 

2007); 

‘‘(C) demonstrate that evidence-based treatment practices will be utilized; and 

‘‘(D) demonstrate that evidence-based screening and 

assessment tools will be used to place participants in the 

treatment alternative to incarceration program. 

‘‘(d) REQUIREMENTS.—Each eligible entity awarded a grant for 

a treatment alternative to incarceration program under this section 

shall— 

‘‘(1) determine the terms and conditions of participation 

in the program by eligible participants, taking into consideration the collateral consequences of an arrest, prosecution or 

criminal conviction; 

‘‘(2) ensure that each substance abuse and mental health 

treatment component is licensed and qualified by the relevant 

jurisdiction; 

‘‘(3) for programs described in subsection (b)(2), organize 

an enforcement unit comprised of appropriately trained law 

enforcement professionals under the supervision of the State, 

Tribal, or local criminal justice agency involved, the duties 

of which shall include— 

‘‘(A) the verification of addresses and other contact 

information of each eligible participant who participates 

or desires to participate in the program; and 

‘‘(B) if necessary, the location, apprehension, arrest, 

and return to custody of an eligible participant in the 

program who has absconded from the facility of a treatment 

provider or has otherwise significantly violated the terms 

and conditions of the program, consistent with Federal 

and State confidentiality requirements; 


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‘‘(4) notify the relevant criminal justice entity if any eligible 

participant in the program absconds from the facility of the 

treatment provider or otherwise violates the terms and conditions of the program, consistent with Federal and State confidentiality requirements; 

‘‘(5) submit periodic reports on the progress of treatment 

or other measured outcomes from participation in the program 

of each eligible participant in the program to the relevant 

State, Tribal, or local criminal justice agency, including mental 

health courts, drug courts, co-occurring mental health and substance abuse courts, DWI courts, and veterans treatment courts; 

‘‘(6) describe the evidence-based methodology and outcome 

measurements that will be used to evaluate the program, and 

specifically explain how such measurements will provide valid 

measures of the impact of the program; and 

‘‘(7) describe how the program could be broadly replicated 

if demonstrated to be effective. 

‘‘(e) USE OF FUNDS.—An eligible entity shall use a grant 

received under this section for expenses of a treatment alternative 

to incarceration program, including— 

‘‘(1) salaries, personnel costs, equipment costs, and other 

costs directly related to the operation of the program, including 

the enforcement unit; 

‘‘(2) payments for treatment providers that are approved 

by the relevant State or Tribal jurisdiction and licensed, if 

necessary, to provide needed treatment to eligible offenders 

participating in the program, including aftercare supervision, 

vocational training, education, and job placement; and 

‘‘(3) payments to public and nonprofit private entities that 

are approved by the State or Tribal jurisdiction and licensed, 

if necessary, to provide alcohol and drug addiction treatment 

to eligible offenders participating in the program. 

‘‘(f) SUPPLEMENT NOT SUPPLANT.—An eligible entity shall use 

Federal funds received under this section only to supplement the 

funds that would, in the absence of those Federal funds, be made 

available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds. 

The Federal share of a grant made under this section may not 

exceed 50 percent of the total costs of the program described in 

an application under subsection (d). 

‘‘(g) GEOGRAPHIC DISTRIBUTION.—The Attorney General shall 

ensure that, to the extent practicable, the geographical distribution 

of grants under this section is equitable and includes a grant 

to an eligible entity in— 

‘‘(1) each State; 

‘‘(2) rural, suburban, and urban areas; and 

‘‘(3) Tribal jurisdictions. 

‘‘(h) REPORTS AND EVALUATIONS.—Each fiscal year, each 

recipient of a grant under this section during that fiscal year 

shall submit to the Attorney General a report on the outcomes 

of activities carried out using that grant in such form, containing 

such information, and on such dates as the Attorney General shall 

specify. 

‘‘(i) ACCOUNTABILITY.—All grants awarded by the Attorney General under this section shall be subject to the following accountability provisions: 

‘‘(1) AUDIT REQUIREMENT.— 


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‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit 

report of the Inspector General of the Department of Justice 

that the audited grantee has utilized grant funds for an 

unauthorized expenditure or otherwise unallowable cost 

that is not closed or resolved within 12 months from the 

date on which the final audit report is issued. 

‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this subsection, and 

in each fiscal year thereafter, the Inspector General of 

the Department of Justice shall conduct audits of recipients 

of grants under this section to prevent waste, fraud, and 

abuse of funds by grantees. The Inspector General shall 

determine the appropriate number of grantees to be audited 

each year. 

‘‘(C) MANDATORY EXCLUSION.—A recipient of grant 

funds under this section that is found to have an unresolved 

audit finding shall not be eligible to receive grant funds 

under this section during the first 2 fiscal years beginning 

after the end of the 12-month period described in subparagraph (A). 

‘‘(D) PRIORITY.—In awarding grants under this section, 

the Attorney General shall give priority to eligible 

applicants that did not have an unresolved audit finding 

during the 3 fiscal years before submitting an application 

for a grant under this section. 

‘‘(E) REIMBURSEMENT.—If an entity is awarded grant 

funds under this section during the 2-fiscal-year period 

during which the entity is barred from receiving grants 

under subparagraph (C), the Attorney General shall— 

‘‘(i) deposit an amount equal to the amount of 

the grant funds that were improperly awarded to the 

grantee into the General Fund of the Treasury; and 

‘‘(ii) seek to recoup the costs of the repayment 

to the fund from the grant recipient that was erroneously awarded grant funds. 

‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.— 

‘‘(A) DEFINITION.—For purposes of this paragraph and 

the grant programs under this part, the term ‘nonprofit 

organization’ means an organization that is described in 

section 501(c)(3) of the Internal Revenue Code of 1986 

and is exempt from taxation under section 501(a) of such 

Code. 

‘‘(B) PROHIBITION.—The Attorney General may not 

award a grant under this part to a nonprofit organization 

that holds money in offshore accounts for the purpose of 

avoiding paying the tax described in section 511(a) of the 

Internal Revenue Code of 1986. 

‘‘(C) DISCLOSURE.—Each nonprofit organization that is 

awarded a grant under this section and uses the procedures 

prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, 

directors, trustees, and key employees, shall disclose to 

the Attorney General, in the application for the grant, 

the process for determining such compensation, including 

the independent persons involved in reviewing and 

approving such compensation, the comparability data used, 


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and contemporaneous substantiation of the deliberation 

and decision. Upon request, the Attorney General shall 

make the information disclosed under this subparagraph 

available for public inspection. 

‘‘(3) CONFERENCE EXPENDITURES.— 

‘‘(A) LIMITATION.—No amounts made available to the 

Department of Justice under this section may be used 

by the Attorney General, or by any individual or entity 

awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure 

for conferences that uses more than $20,000 in funds made 

available by the Department of Justice, unless the head 

of the relevant agency or department, provides prior written authorization that the funds may be expended to host 

the conference. 

‘‘(B) WRITTEN APPROVAL.—Written approval under 

subparagraph (A) shall include a written estimate of all 

costs associated with the conference, including the cost 

of all food, beverages, audio-visual equipment, honoraria 

for speakers, and entertainment. 

‘‘(C) REPORT.—The Deputy Attorney General shall 

submit an annual report to the Committee on the Judiciary 

of the Senate and the Committee on the Judiciary of the 

House of Representatives on all conference expenditures 

approved under this paragraph. 

‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal 

year beginning after the date of enactment of this subsection, 

the Attorney General shall submit, to the Committee on the 

Judiciary and the Committee on Appropriations of the Senate 

and the Committee on the Judiciary and the Committee on 

Appropriations of the House of Representatives, an annual 

certification— 

‘‘(A) indicating whether— 

‘‘(i) all audits issued by the Office of the Inspector 

General under paragraph (1) have been completed and 

reviewed by the appropriate Assistant Attorney General or Director; 

‘‘(ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and 

‘‘(iii) all reimbursements required under paragraph 

(1)(E) have been made; and 

‘‘(B) that includes a list of any grant recipients excluded 

under paragraph (1) from the previous year. 

‘‘(5) PREVENTING DUPLICATIVE GRANTS.— 

‘‘(A) IN GENERAL.—Before the Attorney General awards 

a grant to an applicant under this section, the Attorney 

General shall compare potential grant awards with other 

grants awarded under this Act to determine if duplicate 

grant awards are awarded for the same purpose. 

‘‘(B) REPORT.—If the Attorney General awards duplicate grants to the same applicant for the same purpose 

the Attorney General shall submit to the Committee on 

the Judiciary of the Senate and the Committee on the 

Judiciary of the House of Representatives a report that 

includes— 


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‘‘(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 Assistance Center. 

‘‘(b) ELIGIBLE ORGANIZATION.—For purposes of subsection (a), 

the term ‘eligible organization’ means a national nonprofit organization that provides technical assistance and training to, and has 

special expertise and broad, national-level experience in, mental 

health, crisis intervention, criminal justice systems, law enforcement, translating evidence into practice, training, and research, 

and education and support of people with mental illness and the 

families of such individuals. 

‘‘(c) USE OF FUNDS.—Any organization that receives a grant 

under subsection (a) shall collaborate with other grant recipients 

to establish and operate a National Criminal Justice and Mental 

Health Training and Technical Assistance Center to— 

‘‘(1) provide law enforcement officer training regarding 

mental health and working with individuals with mental illnesses, with an emphasis on de-escalation of encounters 

between law enforcement officers and those with mental disorders or in crisis, which shall include support the development 

of in-person and technical information exchanges between systems and the individuals working in those systems in support 

of the concepts identified in the training; 

‘‘(2) provide education, training, and technical assistance 

for States, Indian tribes, territories, units of local government, 

service providers, nonprofit organizations, probation or parole 

officers, prosecutors, defense attorneys, emergency response 

providers, and corrections institutions to advance practice and 

knowledge relating to mental health crisis and approaches to 

mental health and criminal justice across systems; 

‘‘(3) provide training and best practices to mental health 

providers and criminal justice agencies relating to diversion 

initiatives, jail and prison strategies, reentry of individuals 

with mental illnesses into the community, and dispatch protocols and triage capabilities, including the establishment of 

learning sites; 

‘‘(4) develop suicide prevention and crisis intervention 

training and technical assistance for criminal justice agencies; 

‘‘(5) develop a receiving center system and pilot strategy 

that provides, for a jurisdiction, a single point of entry into 

the mental health and substance abuse system for assessments 

and appropriate placement of individuals experiencing a crisis; 

42 USC 

3797aa–1. 


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‘‘(6) collect data and best practices in mental health and 

criminal health and criminal justice initiatives and policies 

from grantees under this part, other recipients of grants under 

this section, Federal, State, and local agencies involved in the 

provision of mental health services, and nongovernmental 

organizations involved in the provision of mental health services; 

‘‘(7) develop and disseminate to mental health providers 

and criminal justice agencies evaluation tools, mechanisms, 

and measures to better assess and document performance measures and outcomes relating to the provision of mental health 

services; 

‘‘(8) disseminate information to States, units of local government, criminal justice agencies, law enforcement agencies, and 

other relevant entities about best practices, policy standards, 

and research findings relating to the provision of mental health 

services; and 

‘‘(9) provide education and support to individuals with 

mental illness involved with, or at risk of involvement with, 

the criminal justice system, including the families of such 

individuals. 

‘‘(d) ACCOUNTABILITY.—Grants awarded under this section shall 

be subject to the following accountability provisions: 

‘‘(1) AUDIT REQUIREMENT.— 

‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit 

report of the Inspector General of the Department of Justice 

under subparagraph (C) that the audited grantee has used 

grant funds for an unauthorized expenditure or otherwise 

unallowable cost that is not closed or resolved within 1 

year after the date on which the final audit report is 

issued. 

‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this section, and in 

each fiscal year thereafter, the Inspector General of the 

Department of Justice shall conduct audits of grantees 

under this section to prevent waste, fraud, and abuse of 

funds by grantees. The Inspector General shall determine 

the appropriate number of grantees to be audited each 

year. 

‘‘(C) FINAL AUDIT REPORT.—The Inspector General of 

the Department of Justice shall submit to the Attorney 

General a final report on each audit conducted under 

subparagraph (B). 

‘‘(D) MANDATORY EXCLUSION.—Grantees under this section about which there is an unresolved audit finding shall 

not be eligible to receive a grant under this section during 

the 2 fiscal years beginning after the end of the 1-year 

period described in subparagraph (A). 

‘‘(E) PRIORITY.—In making grants under this section, 

the Attorney General shall give priority to applicants that 

did not have an unresolved audit finding during the 3 

fiscal years before submitting an application for a grant 

under this section. 

‘‘(F) REIMBURSEMENT.—If an entity receives a grant 

under this section during the 2-fiscal-year period during 


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which the entity is prohibited from receiving grants under 

subparagraph (D), the Attorney General shall— 

‘‘(i) deposit an amount equal to the amount of 

the grant that was improperly awarded to the grantee 

into the General Fund of the Treasury; and 

‘‘(ii) seek to recoup the costs of the repayment 

under clause (i) from the grantee that was erroneously 

awarded grant funds. 

‘‘(2) NONPROFIT AGENCY REQUIREMENTS.— ‘‘(A) DEFINITION.—For purposes of this paragraph and 

the grant program under this section, the term ‘nonprofit 

agency’ means an organization that is described in section 

501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 

501(c)(3)) and is exempt from taxation under section 501(a) 

of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)). 

‘‘(B) PROHIBITION.—The Attorney General may not 

award a grant under this section to a nonprofit agency 

that holds money in an offshore account for the purpose 

of avoiding paying the tax described in section 511(a) of 

the Internal Revenue Code of 1986 (26 U.S.C. 511(a)). 

‘‘(C) DISCLOSURE.—Each nonprofit agency that is 

awarded a grant under this section and uses the procedures 

prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, 

directors, trustees, and key employees, shall disclose to 

the Attorney General, in the application for the grant, 

the process for determining such compensation, including 

the independent persons involved in reviewing and 

approving such compensation, the comparability data used, 

and contemporaneous substantiation of the deliberation 

and decision. Upon request, the Attorney General shall 

make the information disclosed under this subparagraph 

available for public inspection. 

‘‘(3) CONFERENCE EXPENDITURES.— 

‘‘(A) LIMITATION.—No amounts made available to the 

Department of Justice under this section may be used 

by the Attorney General, or by any individual or entity 

awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure 

for conferences that uses more than $20,000 in funds made 

available by the Department of Justice, unless the head 

of the relevant agency or department, provides prior written authorization that the funds may be expended to host 

the conference. 

‘‘(B) WRITTEN APPROVAL.—Written approval under 

subparagraph (A) shall include a written estimate of all 

costs associated with the conference, including the cost 

of all food, beverages, audio-visual equipment, honoraria 

for speakers, and entertainment. 

‘‘(C) REPORT.—The Deputy Attorney General shall 

submit an annual report to the Committee on the Judiciary 

of the Senate and the Committee on the Judiciary of the 

House of Representatives on all conference expenditures 

approved under this paragraph. 

‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal 

year beginning after the date of enactment of this subsection, 

the Attorney General shall submit to the Committee on the 


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Judiciary and the Committee on Appropriations of the Senate 

and the Committee on the Judiciary and the Committee on 

Appropriations of the House of Representatives an annual certification— 

‘‘(A) indicating whether— 

‘‘(i) all final audit reports issued by the Office 

of the Inspector General under paragraph (1) have 

been completed and reviewed by the appropriate 

Assistant Attorney General or Director; 

‘‘(ii) all mandatory exclusions required under paragraph (1)(D) have been issued; and 

‘‘(iii) any reimbursements required under paragraph (1)(F) have been made; and 

‘‘(B) that includes a list of any grantees excluded under 

paragraph (1)(D) from the previous year. 

‘‘(5) PREVENTING DUPLICATIVE GRANTS.— ‘‘(A) IN GENERAL.—Before the Attorney General awards 

a grant to an applicant under this section, the Attorney 

General shall compare potential grant awards with other 

grants awarded under this Act to determine if duplicate 

grant awards are awarded for the same purpose. 

‘‘(B) REPORT.—If the Attorney General awards duplicate grants to the same applicant for the same purpose 

the Attorney General shall submit to the Committee on 

the Judiciary of the Senate and the Committee on the 

Judiciary of the House of Representatives a report that 

includes— 

‘‘(i) a list of all duplicate grants awarded, including 

the total dollar amount of any duplicate grants 

awarded; and 

‘‘(ii) the reason the Attorney General awarded the 

duplicate grants.’’. 

SEC. 14015. IMPROVING DEPARTMENT OF JUSTICE DATA COLLECTION 

ON MENTAL ILLNESS INVOLVED IN CRIME. 

(a) IN GENERAL.—Notwithstanding any other provision of law, 

on or after the date that is 90 days after the date on which 

the Attorney General promulgates regulations under subsection 

(b), any data prepared by, or submitted to, the Attorney General 

or the Director of the Federal Bureau of Investigation with respect 

to the incidences of homicides, law enforcement officers killed, seriously injured, and assaulted, or individuals killed or seriously 

injured by law enforcement officers shall include data with respect 

to the involvement of mental illness in such incidences, if any. 

(b) REGULATIONS.—Not later than 90 days after the date of 

the enactment of this Act, the Attorney General shall promulgate 

or revise regulations as necessary to carry out subsection (a). 

SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL OFFENDERS 

IN PRISON. 

(a) REPORT ON THE COST OF TREATING THE MENTALLY ILL

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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(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 determinations 

‘‘The Secretary may not make an adverse determination concerning the mental capacity of a beneficiary to manage monetary 

benefits paid to or for the beneficiary by the Secretary under this 

title unless such beneficiary has been provided all of the following, 

subject to the procedures and timelines prescribed by the Secretary 

for determinations of incompetency: 

‘‘(1) Notice of the proposed adverse determination and the 

supporting evidence. 

‘‘(2) An opportunity to request a hearing. 

‘‘(3) An opportunity to present evidence, including an 

opinion from a medical professional or other person, on the 

capacity of the beneficiary to manage monetary benefits paid 

to or for the beneficiary by the Secretary under this title. 

‘‘(4) An opportunity to be represented at no expense to 

the Government (including by counsel) at any such hearing 

and to bring a medical professional or other person to provide 

relevant testimony at any such hearing.’’. 

(b) CLERICAL AMENDMENT.—The table of sections at the beginning of such chapter 55 is amended by inserting after the item 

relating to section 5501 the following new item: 

‘‘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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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 paragraph (3). 

‘‘(3) SEQUENTIAL INTERCEPT MAPPING; IMPLEMENTATION.— An eligible entity that receives a grant under this subsection 

may use funds for— 

‘‘(A) sequential intercept mapping, which— 

‘‘(i) shall consist of— 

‘‘(I) convening mental health and criminal justice stakeholders to— 

‘‘(aa) develop a shared understanding of 

the flow of justice-involved individuals with 

mental illnesses through the criminal justice 

system; and 

‘‘(bb) identify opportunities for improved 

collaborative responses to the risks and needs 

of individuals described in item (aa); and 

‘‘(II) developing strategies to address gaps in 

services and bring innovative and effective programs to scale along multiple intercepts, 

including— 

‘‘(aa) emergency and crisis services; 

‘‘(bb) specialized police-based responses; 

‘‘(cc) court hearings and disposition alternatives; 

‘‘(dd) reentry from jails and prisons; and 

‘‘(ee) community supervision, treatment 

and support services; and 

‘‘(ii) may serve as a starting point for the development of strategic plans to achieve positive public health 

and safety outcomes; and 

‘‘(B) implementation, which shall— 

‘‘(i) be derived from the strategic plans described 

in subparagraph (A)(ii); and 

‘‘(ii) consist of— 

‘‘(I) hiring and training personnel; 

‘‘(II) identifying the eligible entity’s target 

population; 

‘‘(III) providing services and supports to reduce 

unnecessary penetration into the criminal justice 

system; 

‘‘(IV) reducing recidivism; 

‘‘(V) evaluating the impact of the eligible 

entity’s approach; and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1309 

‘‘(VI) planning for the sustainability of effective interventions.’’. 

SEC. 14022. PRISON AND JAILS. 

Section 2991 of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting 

after subsection (k), as added by section 14021, the following: 

‘‘(l) CORRECTIONAL FACILITIES.— ‘‘(1) DEFINITIONS.— ‘‘(A) CORRECTIONAL FACILITY.—The term ‘correctional 

facility’ means a jail, prison, or other detention facility 

used to house people who have been arrested, detained, 

held, or convicted by a criminal justice agency or a court. 

‘‘(B) ELIGIBLE INMATE.—The term ‘eligible inmate’ 

means an individual who— 

‘‘(i) is being held, detained, or incarcerated in a 

correctional facility; and 

‘‘(ii) manifests obvious signs of a mental illness 

or has been diagnosed by a qualified mental health 

professional as having a mental illness. 

‘‘(2) CORRECTIONAL FACILITY GRANTS.—The Attorney General may award grants to applicants to enhance the capabilities 

of a correctional facility— 

‘‘(A) to identify and screen for eligible inmates; 

‘‘(B) to plan and provide— 

‘‘(i) initial and periodic assessments of the clinical, 

medical, and social needs of inmates; and 

‘‘(ii) appropriate treatment and services that 

address the mental health and substance abuse needs 

of inmates; 

‘‘(C) to develop, implement, and enhance— 

‘‘(i) post-release transition plans for eligible 

inmates that, in a comprehensive manner, coordinate 

health, housing, medical, employment, and other 

appropriate services and public benefits; 

‘‘(ii) the availability of mental health care services 

and substance abuse treatment services; and 

‘‘(iii) alternatives to solitary confinement and segregated housing and mental health screening and 

treatment for inmates placed in solitary confinement 

or segregated housing; and 

‘‘(D) to train each employee of the correctional facility 

to identify and appropriately respond to incidents involving 

inmates with mental health or co-occurring mental health 

and substance abuse disorders.’’. 

SEC. 14023. ALLOWABLE USES. 

Section 2991(b)(5)(I) of title I of the Omnibus Crime Control 

and Safe Streets Act of 1968 (42 U.S.C. 3797aa(b)(5)(I)) is amended 

by adding at the end the following: 

‘‘(v) TEAMS ADDRESSING FREQUENT USERS OF CRISIS

SERVICES.—Multidisciplinary teams that— 

‘‘(I) coordinate, implement, and administer 

community-based crisis responses and long-term 

plans for frequent users of crisis services; 

‘‘(II) provide training on how to respond appropriately to the unique issues involving frequent 

users of crisis services for public service personnel, 


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130 STAT. 1310 PUBLIC LAW 114–255—DEC. 13, 2016 

including criminal justice, mental health, substance abuse, emergency room, healthcare, law 

enforcement, corrections, and housing personnel; 

‘‘(III) develop or support alternatives to hospital and jail admissions for frequent users of crisis 

services that provide treatment, stabilization, and 

other appropriate supports in the least restrictive, 

yet appropriate, environment; and 

‘‘(IV) develop protocols and systems among law 

enforcement, mental health, substance abuse, 

housing, corrections, and emergency medical 

service operations to provide coordinated assistance to frequent users of crisis services.’’. 

SEC. 14024. LAW ENFORCEMENT TRAINING. 

Section 2991(h) of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797aa(h)) is amended— 

(1) in paragraph (1), by adding at the end the following: 

‘‘(F) ACADEMY TRAINING.—To provide support for 

academy curricula, law enforcement officer orientation programs, continuing education training, and other programs 

that teach law enforcement personnel how to identify and 

respond to incidents involving persons with mental health 

disorders or co-occurring mental health and substance 

abuse disorders.’’; and 

(2) by adding at the end the following: 

‘‘(4) PRIORITY CONSIDERATION.—The Attorney General, in 

awarding grants under this subsection, shall give priority to 

programs that law enforcement personnel and members of the 

mental health and substance abuse professions develop and 

administer cooperatively.’’. 

SEC. 14025. FEDERAL LAW ENFORCEMENT TRAINING. 

Not later than 1 year after the date of enactment of this 

Act, the Attorney General shall provide direction and guidance 

for the following: 

(1) TRAINING PROGRAMS.—Programs that offer specialized 

and comprehensive training, in procedures to identify and 

appropriately respond to incidents in which the unique needs 

of individuals who have a mental illness are involved, to first 

responders and tactical units of— 

(A) Federal law enforcement agencies; and 

(B) other Federal criminal justice agencies such as 

the Bureau of Prisons, the Administrative Office of the 

United States Courts, and other agencies that the Attorney 

General determines appropriate. 

(2) IMPROVED TECHNOLOGY.—The establishment of, or 

improvement of existing, computerized information systems to 

provide timely information to employees of Federal law enforcement agencies, and Federal criminal justice agencies to improve 

the response of such employees to situations involving individuals who have a mental illness. 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1311 

(1) the practices that Federal first responders, tactical 

units, and corrections officers are trained to use in responding 

to individuals with mental illness; 

(2) procedures to identify and appropriately respond to 

incidents in which the unique needs of individuals who have 

a mental illness are involved, to Federal first responders and 

tactical units; 

(3) the application of evidence-based practices in criminal 

justice settings to better address individuals with mental illnesses; and 

(4) recommendations on how the Department of Justice 

can expand and improve information sharing and dissemination 

of best practices. 

SEC. 14027. EVIDENCE BASED PRACTICES. 

Section 2991(c) of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797aa(c)) is amended— 

(1) in paragraph (3), by striking ‘‘or’’ at the end; 

(2) by redesignating paragraph (4) as paragraph (6); and 

(3) by inserting after paragraph (3), the following: 

‘‘(4) propose interventions that have been shown by empirical evidence to reduce recidivism; 

‘‘(5) when appropriate, use validated assessment tools to 

target preliminarily qualified offenders with a moderate or 

high risk of recidivism and a need for treatment and services; 

or’’. 

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 disorder’ mean’’; and 

(2) by striking paragraph (9) and inserting the following: 

‘‘(9) PRELIMINARILY QUALIFIED OFFENDER.— 

‘‘(A) IN GENERAL.—The term ‘preliminarily qualified 

offender’ means an adult or juvenile accused of an offense 

who— 

‘‘(i)(I) previously or currently has been diagnosed 

by a qualified mental health professional as having 

a mental illness or co-occurring mental illness and 

substance abuse disorders; 

‘‘(II) manifests obvious signs of mental illness or 

co-occurring mental illness and substance abuse disorders during arrest or confinement or before any court; 

or 

‘‘(III) in the case of a veterans treatment court 

provided under subsection (i), has been diagnosed with, 

or manifests obvious signs of, mental illness or a substance abuse disorder or co-occurring mental illness 

and substance abuse disorder; 


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‘‘(ii) has been unanimously approved for participation in a program funded under this section by, when 

appropriate— 

‘‘(I) the relevant— 

‘‘(aa) prosecuting attorney; 

‘‘(bb) defense attorney; 

‘‘(cc) probation or corrections official; and 

‘‘(dd) judge; and 

‘‘(II) a representative from the relevant mental 

health agency described in subsection (b)(5)(B)(i); 

‘‘(iii) has been determined, by each person 

described in clause (ii) who is involved in approving 

the adult or juvenile for participation in a program 

funded under this section, to not pose a risk of violence 

to any person in the program, or the public, if selected 

to participate in the program; and 

‘‘(iv) has not been charged with or convicted of— 

‘‘(I) any sex offense (as defined in section 111 

of the Sex Offender Registration and Notification 

Act (42 U.S.C. 16911)) or any offense relating to 

the sexual exploitation of children; or 

‘‘(II) murder or assault with intent to commit 

murder. 

‘‘(B) DETERMINATION.—In determining whether to designate a defendant as a preliminarily qualified offender, 

the relevant prosecuting attorney, defense attorney, probation or corrections official, judge, and mental health or 

substance abuse agency representative shall take into 

account— 

‘‘(i) whether the participation of the defendant in 

the program would pose a substantial risk of violence 

to the community; 

‘‘(ii) the criminal history of the defendant and the 

nature and severity of the offense for which the defendant is charged; 

‘‘(iii) the views of any relevant victims to the 

offense; 

‘‘(iv) the extent to which the defendant would benefit from participation in the program; 

‘‘(v) the extent to which the community would 

realize cost savings because of the defendant’s participation in the program; and 

‘‘(vi) whether the defendant satisfies the eligibility 

criteria for program participation unanimously established by the relevant prosecuting attorney, defense 

attorney, probation or corrections official, judge and 

mental health or substance abuse agency representative.’’. 

(b) TECHNICAL AND CONFORMING AMENDMENT.—Section 2927(2) 

of title I of the Omnibus Crime Control and Safe Streets Act 

of 1968 (42 U.S.C. 3797s–6(2)) is amended by striking ‘‘has the 

meaning given that term in section 2991(a).’’ and inserting ‘‘means 

an offense that— 

‘‘(A) does not have as an element the use, attempted 

use, or threatened use of physical force against the person 

or property of another; or 


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‘‘(B) is not a felony that by its nature involves a 

substantial risk that physical force against the person or 

property of another may be used in the course of committing the offense.’’. 

SEC. 14029. GRANT ACCOUNTABILITY. 

Section 2991 of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amended by inserting 

after subsection (l), as added by section 14022, the following: 

‘‘(m) ACCOUNTABILITY.—All grants awarded by the Attorney 

General under this section shall be subject to the following accountability provisions: 

‘‘(1) AUDIT REQUIREMENT.— 

‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit 

report of the Inspector General of the Department of Justice 

that the audited grantee has utilized grant funds for an 

unauthorized expenditure or otherwise unallowable cost 

that is not closed or resolved within 12 months from the 

date when the final audit report is issued. 

‘‘(B) AUDITS.—Beginning in the first fiscal year beginning after the date of enactment of this subsection, and 

in each fiscal year thereafter, the Inspector General of 

the Department of Justice shall conduct audits of recipients 

of grants under this section to prevent waste, fraud, and 

abuse of funds by grantees. The Inspector General shall 

determine the appropriate number of grantees to be audited 

each year. 

‘‘(C) MANDATORY EXCLUSION.—A recipient of grant 

funds under this section that is found to have an unresolved 

audit finding shall not be eligible to receive grant funds 

under this section during the first 2 fiscal years beginning 

after the end of the 12-month period described in subparagraph (A). 

‘‘(D) PRIORITY.—In awarding grants under this section, 

the Attorney General shall give priority to eligible 

applicants that did not have an unresolved audit finding 

during the 3 fiscal years before submitting an application 

for a grant under this section. 

‘‘(E) REIMBURSEMENT.—If an entity is awarded grant 

funds under this section during the 2-fiscal-year period 

during which the entity is barred from receiving grants 

under subparagraph (C), the Attorney General shall— 

‘‘(i) deposit an amount equal to the amount of 

the grant funds that were improperly awarded to the 

grantee into the General Fund of the Treasury; and 

‘‘(ii) seek to recoup the costs of the repayment 

to the fund from the grant recipient that was erroneously awarded grant funds. 

‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.— 

‘‘(A) DEFINITION.—For purposes of this paragraph and 

the grant programs under this part, the term ‘nonprofit 

organization’ means an organization that is described in 

section 501(c)(3) of the Internal Revenue Code of 1986 

and is exempt from taxation under section 501(a) of such 

Code. 


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‘‘(B) PROHIBITION.—The Attorney General may not 

award a grant under this part to a nonprofit organization 

that holds money in offshore accounts for the purpose of 

avoiding paying the tax described in section 511(a) of the 

Internal Revenue Code of 1986. 

‘‘(C) DISCLOSURE.—Each nonprofit organization that is 

awarded a grant under this section and uses the procedures 

prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, 

directors, trustees, and key employees, shall disclose to 

the Attorney General, in the application for the grant, 

the process for determining such compensation, including 

the independent persons involved in reviewing and 

approving such compensation, the comparability data used, 

and contemporaneous substantiation of the deliberation 

and decision. Upon request, the Attorney General shall 

make the information disclosed under this subparagraph 

available for public inspection. 

‘‘(3) CONFERENCE EXPENDITURES.— 

‘‘(A) LIMITATION.—No amounts made available to the 

Department of Justice under this section may be used 

by the Attorney General, or by any individual or entity 

awarded discretionary funds through a cooperative agreement under this section, to host or support any expenditure 

for conferences that uses more than $20,000 in funds made 

available by the Department of Justice, unless the head 

of the relevant agency or department, provides prior written authorization that the funds may be expended to host 

the conference. 

‘‘(B) WRITTEN APPROVAL.—Written approval under 

subparagraph (A) shall include a written estimate of all 

costs associated with the conference, including the cost 

of all food, beverages, audio-visual equipment, honoraria 

for speakers, and entertainment. 

‘‘(C) REPORT.—The Deputy Attorney General shall 

submit an annual report to the Committee on the Judiciary 

of the Senate and the Committee on the Judiciary of the 

House of Representatives on all conference expenditures 

approved under this paragraph. 

‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal 

year beginning after the date of enactment of this subsection, 

the Attorney General shall submit, to the Committee on the 

Judiciary and the Committee on Appropriations of the Senate 

and the Committee on the Judiciary and the Committee on 

Appropriations of the House of Representatives, an annual 

certification— 

‘‘(A) indicating whether— 

‘‘(i) all audits issued by the Office of the Inspector 

General under paragraph (1) have been completed and 

reviewed by the appropriate Assistant Attorney General or Director; 

‘‘(ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and 

‘‘(iii) all reimbursements required under paragraph 

(1)(E) have been made; and 

‘‘(B) that includes a list of any grant recipients excluded 

under paragraph (1) from the previous year. 


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‘‘(n) PREVENTING DUPLICATIVE GRANTS.— ‘‘(1) IN GENERAL.—Before the Attorney General awards a 

grant to an applicant under this section, the Attorney General 

shall compare potential grant awards with other grants 

awarded under this Act to determine if duplicate grant awards 

are awarded for the same purpose. 

‘‘(2) REPORT.—If the Attorney General awards duplicate 

grants to the same applicant for the same purpose the Attorney 

General shall submit to the Committee on the Judiciary of 

the Senate and the Committee on the Judiciary of the House 

of Representatives a report that includes— 

‘‘(A) a list of all duplicate grants awarded, including 

the total dollar amount of any duplicate grants awarded; 

and 

‘‘(B) the reason the Attorney General awarded the 

duplicate grants.’’. 

DIVISION C—INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE 

FOR AMERICANS 

SEC. 15000. SHORT TITLE. 

This division may be cited as the ‘‘Increasing Choice, Access, 

and Quality in Health Care for Americans Act’’. 

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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manual and software shall be in the public domain and 

available for use and redistribution without charge. 

‘‘(B) USE OF PREVIOUS ANALYSIS DONE BY MEDPAC.— 

In developing the HCPCS MS–DRG definitions manual 

and software under subparagraph (A), the Secretary shall 

consult with the Medicare Payment Advisory Commission 

and shall consider the analysis done by such Commission 

in translating outpatient surgical claims into inpatient surgical MS–DRGs in preparing chapter 7 (relating to hospital 

short-stay policy issues) of its ‘Medicare and the Health 

Care Delivery System’ report submitted to Congress in 

June 2015. 

‘‘(4) DEFINITION AND REFERENCE.—In this subsection: 

‘‘(A) HCPCS.—The term ‘HCPCS’ means, with respect 

to hospital items and services, the code under the 

Healthcare Common Procedure Coding System (HCPCS) 

(or a successor code) for such items and services. 

‘‘(B) ICD–10–PCS.—The term ‘ICD–10–PCS’ means the 

International Classification of Diseases, 10th Revision, 

Procedure Coding System, and includes any subsequent 

revision of such International Classification of Diseases, 

Procedure Coding System.’’. 

SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE MEDICARE 

HOSPITAL READMISSION PROGRAM. 

(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 subparagraph (D),’’ after ‘‘purposes of paragraph (1),’’; and 

(2) by adding at the end the following new subparagraph: 

‘‘(D) TRANSITIONAL ADJUSTMENT FOR DUAL ELIGIBLES.— 

‘‘(i) IN GENERAL.—In determining a hospital’s 

adjustment factor under this paragraph for purposes 

of making payments for discharges occurring during 

and after fiscal year 2019, and before the application 

of clause (i) of subparagraph (E), the Secretary shall 

assign hospitals to groups (as defined by the Secretary 

under clause (ii)) and apply the applicable provisions 

of this subsection using a methodology in a manner 

that allows for separate comparison of hospitals within 

each such group, as determined by the Secretary. 

‘‘(ii) DEFINING GROUPS.—For purposes of this 

subparagraph, the Secretary shall define groups of hospitals, based on their overall proportion, of the 

inpatients who are entitled to, or enrolled for, benefits 

under part A, and who are full-benefit dual eligible 

individuals (as defined in section 1935(c)(6)). In 

defining groups, the Secretary shall consult the Medicare Payment Advisory Commission and may consider 

the analysis done by such Commission in preparing 

the portion of its report submitted to Congress in June 

2013 relating to readmissions. 

‘‘(iii) MINIMIZING REPORTING BURDEN ON HOSPITALS.—In carrying out this subparagraph, the Secretary shall not impose any additional reporting 

requirements on hospitals. 


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‘‘(iv) BUDGET NEUTRAL DESIGN METHODOLOGY.— 

The Secretary shall design the methodology to implement this subparagraph so that the estimated total 

amount of reductions in payments under this subsection equals the estimated total amount of reductions 

in payments that would otherwise occur under this 

subsection if this subparagraph did not apply.’’. 

(b) CHANGES IN RISK ADJUSTMENT.—Section 1886(q)(3) of the 

Social Security Act (42 U.S.C. 1395ww(q)(3)), as amended by subsection (a), is further amended by adding at the end the following 

new subparagraph: 

‘‘(E) CHANGES IN RISK ADJUSTMENT.— 

‘‘(i) CONSIDERATION OF RECOMMENDATIONS IN

IMPACT REPORTS.—The Secretary may take into account 

the studies conducted and the recommendations made 

by the Secretary under section 2(d)(1) of the IMPACT 

Act of 2014 (Public Law 113–185; 42 U.S.C. 1395lll 

note) with respect to the application under this subsection of risk adjustment methodologies. Nothing in 

this clause shall be construed as precluding consideration of the use of groupings of hospitals. 

‘‘(ii) CONSIDERATION OF EXCLUSION OF PATIENT

CASES BASED ON V OR OTHER APPROPRIATE CODES.— 

In promulgating regulations to carry out this subsection with respect to discharges occurring after fiscal 

year 2018, the Secretary may consider the use of V 

or other ICD-related codes for removal of a readmission. The Secretary may consider modifying measures 

under this subsection to incorporate V or other ICDrelated codes at the same time as other changes are 

being made under this subparagraph. 

‘‘(iii) REMOVAL OF CERTAIN READMISSIONS.—In 

promulgating regulations to carry out this subsection, 

with respect to discharges occurring after fiscal year 

2018, the Secretary may consider removal as a 

readmission of an admission that is classified within 

one or more of the following: transplants, end-stage 

renal disease, burns, trauma, psychosis, or substance 

abuse. The Secretary may consider modifying measures 

under this subsection to remove readmissions at the 

same time as other changes are being made under 

this subparagraph.’’. 

(c) MEDPAC STUDY ON READMISSIONS PROGRAM.—The Medicare 

Payment Advisory Commission shall conduct a study to review 

overall hospital readmissions described in section 1886(q)(5)(E) of 

the Social Security Act (42 U.S.C. 1395ww(q)(5)(E)) and whether 

such readmissions are related to any changes in outpatient and 

emergency services furnished. The Commission shall submit to 

Congress a report on such study in its report to Congress in June 

2018. 

SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMUNITY HOSPITAL DEMONSTRATION PROGRAM. 

(a) EXTENSION.—Section 410A of the Medicare Prescription 

Drug, Improvement, and Modernization Act of 2003 (Public Law 

108–173; 42 U.S.C. 1395ww note) is amended— 


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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, notwithstanding subsection (a)(2) or paragraph (2) of this subsection, not later than 120 days after the date of the 

enactment of this paragraph, issue a solicitation for applications to select up to the maximum number of additional 

rural community hospitals located in any State to participate in the demonstration program under this section for 

the second 5 years of the 10-year extension period without 

exceeding the limitation under paragraph (3) of this subsection. 

‘‘(B) PRIORITY.—In determining which rural community 

hospitals that submitted an application pursuant to the 

solicitation under subparagraph (A) to select for participation in the demonstration program, the Secretary— 

‘‘(i) shall give priority to rural community hospitals 

located in one of the 20 States with the lowest population densities (as determined by the Secretary using 

the 2015 Statistical Abstract of the United States); 

and 

‘‘(ii) may consider— 

‘‘(I) closures of hospitals located in rural areas 

in the State in which the rural community hospital 

is located during the 5-year period immediately 

preceding the date of the enactment of this paragraph; and 

‘‘(II) the population density of the State in 

which the rural community hospital is located.’’. 

(b) CHANGE IN TIMING FOR REPORT.—Subsection (e) of such 

section 410A is amended— 

(1) by striking ‘‘Not later than 6 months after the completion of the demonstration program under this section’’ and 

inserting ‘‘Not later than August 1, 2018’’; and 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1319 

(2) by striking ‘‘such program’’ and inserting ‘‘the demonstration program under this section’’. 

SEC. 15004. REGULATORY RELIEF FOR LTCHS. 

(a) TECHNICAL CHANGE TO THE MEDICARE LONG-TERM CARE

HOSPITAL MORATORIUM EXCEPTION.— (1) IN GENERAL.—Section 114(d)(7) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww 

note), as amended by sections 3106(b) and 10312(b) of Public 

Law 111–148, section 1206(b)(2) of the Pathway for SGR Reform 

Act of 2013 (division B of Public Law 113–67), and section 

112 of the Protecting Access to Medicare Act of 2014 (Public 

Law 113–93), is amended by striking ‘‘The moratorium under 

paragraph (1)(A)’’ and inserting ‘‘Any moratorium under paragraph (1)’’. 

(2) EFFECTIVE DATE.—The amendment made by paragraph 

(1) shall take effect as if included in the enactment of section 

112 of the Protecting Access to Medicare Act of 2014. 

(b) MODIFICATION TO MEDICARE LONG-TERM CARE HOSPITAL

HIGH COST OUTLIER PAYMENTS.—Section 1886(m) of the Social 

Security Act (42 U.S.C. 1395ww(m)) is amended by adding at the 

end the following new paragraph: 

‘‘(7) TREATMENT OF HIGH COST OUTLIER PAYMENTS.— ‘‘(A) ADJUSTMENT TO THE STANDARD FEDERAL PAYMENT

RATE FOR ESTIMATED HIGH COST OUTLIER PAYMENTS.— Under the system described in paragraph (1), for fiscal 

years beginning on or after October 1, 2017, the Secretary 

shall reduce the standard Federal payment rate as if the 

estimated aggregate amount of high cost outlier payments 

for standard Federal payment rate discharges for each 

such fiscal year would be equal to 8 percent of estimated 

aggregate payments for standard Federal payment rate 

discharges for each such fiscal year. 

‘‘(B) LIMITATION ON HIGH COST OUTLIER PAYMENT

AMOUNTS.—Notwithstanding subparagraph (A), the Secretary shall set the fixed loss amount for high cost outlier 

payments such that the estimated aggregate amount of 

high cost outlier payments made for standard Federal payment rate discharges for fiscal years beginning on or after 

October 1, 2017, shall be equal to 99.6875 percent of 8 

percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year. 

‘‘(C) WAIVER OF BUDGET NEUTRALITY.—Any reduction 

in payments resulting from the application of subparagraph 

(B) shall not be taken into account in applying any budget 

neutrality provision under such system. 

‘‘(D) NO EFFECT ON SITE NEUTRAL HIGH COST OUTLIER

PAYMENT RATE.—This paragraph shall not apply with 

respect to the computation of the applicable site neutral 

payment rate under paragraph (6).’’. 

SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH NOT 

APPLYING DOCUMENTATION AND CODING ADJUSTMENTS. 

Section 7(b)(1)(B) of the TMA, Abstinence Education, and QI 

Programs Extension Act of 2007 (Public Law 110–90), as amended 

by section 631(b) of the American Taxpayer Relief Act of 2012 

(Public Law 112–240) and section 414(1)(B)(iii) of the Medicare 

42 USC 1395ww 

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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 percentage points for discharges occurring during each of fiscal years 

2018 through 2023’’ and inserting ‘‘an increase of 0.4588 percentage 

points for discharges occurring during fiscal year 2018 and 0.5 

percentage points for discharges occurring during each of fiscal 

years 2019 through 2023’’. 

SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAYMENT 

RULES. 

(a) 25–PERCENT PATIENT THRESHOLD PAYMENT ADJUSTMENT.— 

Section 114(c)(1)(A) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (42 U.S.C. 1395ww note), as amended by section 

4302(a) of division B of the American Recovery and Reinvestment 

Act (Public Law 111–5), sections 3106(a) and 10312(a) of Public 

Law 111–148, and section 1206(b)(1)(B) of the Pathway for SGR 

Reform Act of 2013 (division B of Public Law 113–67), is amended 

by striking ‘‘for a 9-year period’’ and inserting ‘‘through June 30, 

2016, and for discharges occurring on or after October 1, 2016, 

and before October 1, 2017’’. 

(b) PAYMENT FOR HOSPITALS-WITHIN-HOSPITALS.—Section 

114(c)(2) of the Medicare, Medicaid, and SCHIP Extension Act 

of 2007 (42 U.S.C. 1395ww note), as amended by section 4302(a) 

of division B of the American Recovery and Reinvestment Act 

(Public Law 111–5), sections 3106(a) and 10312(a) of Public Law 

111–148, and section 1206(b)(1)(A) of the Pathway for SGR Reform 

Act of 2013 (division B of Public Law 113–67), is amended— 

(1) in subparagraph (A), by inserting ‘‘or any similar provision,’’ after ‘‘Regulations,’’; 

(2) in subparagraph (B)— 

(A) in clause (i), by inserting ‘‘or any similar provision,’’ 

after ‘‘Regulations,’’; and 

(B) in clause (ii), by inserting ‘‘, or any similar provision,’’ after ‘‘Regulations’’; and 

(3) in subparagraph (C), by striking ‘‘for a 9-year period’’ 

and inserting ‘‘through June 30, 2016, and for discharges occurring on or after October 1, 2016, and before October 1, 2017’’. 

SEC. 15007. APPLICATION OF RULES ON THE CALCULATION OF HOSPITAL LENGTH OF STAY TO ALL LTCHS. 

(a) IN GENERAL.—Section 1206(a)(3) of the Pathway for SGR 

Reform Act of 2013 (division B of Public Law 113–67; 42 U.S.C. 

1395ww note) is amended— 

(1) by striking subparagraph (B); 

(2) by striking ‘‘SITE NEUTRAL BASIS.—’’ and all that follows 

through ‘‘For discharges occurring’’ and inserting ‘‘SITE NEUTRAL

BASIS.—For discharges occurring’’; 

(3) by striking ‘‘subject to subparagraph (B),’’; and 

(4) by redesignating clauses (i) and (ii) as subparagraphs 

(A) and (B), respectively, and moving each of such subparagraphs (as so redesignated) 2 ems to the left. 

(b) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall be effective as if included in the enactment of section 

1206(a)(3) of the Pathway for SGR Reform Act of 2013 (division 

B of Public Law 113–67; 42 U.S.C. 1395ww note). 

42 USC 1395ww 

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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1321 

SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR CERTAIN 

HOSPITALS. 

(a) IN GENERAL.—Subsection (d)(1)(B)(iv) of section 1886 of 

the Social Security Act (42 U.S.C. 1395ww) is amended— 

(1) in subclause (I), by striking ‘‘or’’ at the end; 

(2) in subclause (II)— 

(A) by striking ‘‘, or’’ at the end and inserting a semicolon; 

(B) by redesignating such subclause as clause (vi) and 

by moving it to immediately follow clause (v); and 

(C) in clause (v), by striking the semicolon at the 

end and inserting ‘‘, or’’; and 

(3) by striking ‘‘(iv)(I) a hospital’’ and inserting ‘‘(iv) a 

hospital’’. 

(b) CONFORMING PAYMENT REFERENCES.—The second sentence 

of subsection (d)(1)(B) of such section is amended— 

(1) by inserting ‘‘(as in effect as of such date)’’ after ‘‘clause 

(iv)’’; and 

(2) by inserting ‘‘(or, in the case of a hospital described 

in clause (iv)(II), as so in effect, shall be classified under clause 

(vi) on and after the effective date of such clause (vi) and 

for cost reporting periods beginning on or after January 1, 

2015, shall not be subject to subsection (m) as of the date 

of such classification)’’ after ‘‘so classified’’. 

(c) APPLICATION.— 

(1) IN GENERAL.—For cost reporting periods beginning on 

or after January 1, 2015, in the case of an applicable hospital 

(as defined in paragraph (3)), the following shall apply: 

(A) Payment for inpatient operating costs shall be made 

on a reasonable cost basis in the manner provided in section 

412.526(c)(3) of title 42, Code of Federal Regulations (as 

in effect on January 1, 2015) and in any subsequent modifications. 

(B) Payment for capital costs shall be made in the 

manner provided by section 412.526(c)(4) of title 42, Code 

of Federal Regulations (as in effect on such date). 

(C) Claims for payment for Medicare beneficiaries who 

are discharged on or after January 1, 2017, shall be processed as claims which are paid on a reasonable cost basis 

as described in section 412.526(c) of title 42, Code of Federal Regulations (as in effect on such date). 

(2) APPLICABLE HOSPITAL DEFINED.—In this subsection, the 

term ‘‘applicable hospital’’ means a hospital that is classified 

under clause (iv)(II) of section 1886(d)(1)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(1)(B)) on the day before the 

date of the enactment of this Act and which is classified under 

clause (vi) of such section, as redesignated and moved by subsection (a), on or after such date of enactment. 

(d) CONFORMING TECHNICAL AMENDMENTS.— 

(1) Section 1899B(a)(2)(A)(iv) of the Social Security Act 

(42 U.S.C. 1395lll(a)(2)(A)(iv)) is amended by striking 

‘‘1886(d)(1)(B)(iv)(II)’’ and inserting ‘‘1886(d)(1)(B)(vi)’’. 

(2) Section 1886(m)(5)(F) of such Act (42 U.S.C. 

1395ww(m)(5)(F)) is amended in each of clauses (i) and (ii) 

by striking ‘‘(d)(1)(B)(iv)(II)’’ and inserting ‘‘(d)(1)(B)(vi)’’. 

42 USC 1395ww 

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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 CERTAIN SPINAL CORD SPECIALTY HOSPITALS. 

(a) EXCEPTION.—Section 1886(m)(6) of the Social Security Act 

(42 U.S.C. 1395ww(m)(6)) is amended— 

(1) in subparagraph (A)(i), by striking ‘‘and (E)’’ and 

inserting ‘‘, (E), and (F)’’; and 

(2) by adding at the end the following new subparagraph: 

‘‘(F) TEMPORARY EXCEPTION FOR CERTAIN SPINAL CORD

SPECIALTY HOSPITALS.—For discharges in cost reporting 

periods beginning during fiscal years 2018 and 2019, 

subparagraph (A)(i) shall not apply (and payment shall 

be made to a long-term care hospital without regard to 

this paragraph) if such discharge is from a long-term care 

hospital that meets each of the following requirements: 

‘‘(i) NOT-FOR-PROFIT.—The long-term care hospital 

was a not-for-profit long-term care hospital on June 

1, 2014, as determined by cost report data. 

‘‘(ii) PRIMARILY PROVIDING TREATMENT FOR CATA- STROPHIC SPINAL CORD OR ACQUIRED BRAIN INJURIES

OR OTHER PARALYZING NEUROMUSCULAR CONDITIONS.— 

Of the discharges in calendar year 2013 from the longterm care hospital for which payment was made under 

this section, at least 50 percent were classified under 

MS–LTCH–DRGs 28, 29, 52, 57, 551, 573, and 963. 

‘‘(iii) SIGNIFICANT OUT-OF-STATE ADMISSIONS.— 

‘‘(I) IN GENERAL.—The long-term care hospital 

discharged inpatients (including both individuals 

entitled to, or enrolled for, benefits under this 

title and individuals not so entitled or enrolled) 

during fiscal year 2014 who had been admitted 

from at least 20 of the 50 States, determined by 

the States of residency of such inpatients and 

based on such data submitted by the hospital to 

the Secretary as the Secretary may require. 

‘‘(II) IMPLEMENTATION.—Notwithstanding any 

other provision of law, the Secretary may implement subclause (I) by program instruction or otherwise. 

‘‘(III) NON-APPLICATION OF PAPERWORK REDUCTION ACT.—Chapter 35 of title 44, United States 

Code, shall not apply to data collected under this 

clause.’’. 

(b) STUDY AND REPORT ON THE STATUS AND VIABILITY OF CERTAIN SPINAL CORD SPECIALTY LONG-TERM CARE HOSPITALS.— 

(1) STUDY.—The Comptroller General of the United States 

shall conduct a study on long-term care hospitals described 

in section 1886(m)(6)(F) of the Social Security Act, as added 

by subsection (a). Such report shall include an analysis of 

the following: 

(A) The impact on such hospitals of the classification 

and facility licensure by State agencies of such hospitals. 

(B) The Medicare payment rates for such hospitals. 

(C) Data on the number and health care needs of 

Medicare beneficiaries who have been diagnosed with catastrophic spinal cord or acquired brain injuries or other 

paralyzing neuromuscular conditions (as described within 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1323 

the discharge classifications specified in clause (ii) of such 

section) who are receiving services from such hospitals. 

(2) REPORT.—Not later than October 1, 2018, the Comptroller General shall submit to Congress a report on the study 

conducted under paragraph (1), including recommendations for 

such legislation and administrative action as the Comptroller 

General determines appropriate. 

SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION OF THE 

MEDICARE LTCH SITE NEUTRAL PROVISIONS FOR CERTAIN DISCHARGES WITH SEVERE WOUNDS. 

(a) IN GENERAL.—Section 1886(m)(6) of the Social Security 

Act (42 U.S.C. 1395ww(m)(6)), as amended by section 15009, is 

further amended— 

(1) in subparagraph (A)(i) by striking ‘‘and (F)’’ and 

inserting ‘‘(F), and (G)’’; 

(2) in subparagraph (E)(i)(I)(aa), by striking ‘‘the amendment made’’ and all that follows before the semicolon and 

inserting ‘‘the last sentence of subsection (d)(1)(B)’’; and 

(3) by adding at the end the following new subparagraph: 

‘‘(G) ADDITIONAL TEMPORARY EXCEPTION FOR CERTAIN

SEVERE WOUND DISCHARGES FROM CERTAIN LONG-TERM CARE

HOSPITALS.— 

‘‘(i) IN GENERAL.—For a discharge occurring in a 

cost reporting period beginning during fiscal year 2018, 

subparagraph (A)(i) shall not apply (and payment shall 

be made to a long-term care hospital without regard 

to this paragraph) if such discharge— 

‘‘(I) is from a long-term care hospital identified 

by the last sentence of subsection (d)(1)(B); 

‘‘(II) is classified under MS–LTCH–DRG 602, 

603, 539, or 540; and 

‘‘(III) is with respect to an individual treated 

by a long-term care hospital for a severe wound. 

‘‘(ii) SEVERE WOUND DEFINED.—In this subparagraph, the term ‘severe wound’ means a wound which 

is a stage 3 wound, stage 4 wound, unstageable wound, 

non-healing surgical wound, or fistula as identified 

in the claim from the long-term care hospital. 

‘‘(iii) WOUND DEFINED.—In this subparagraph, the 

term ‘wound’ means an injury involving division of 

tissue or rupture of the integument or mucous membrane with exposure to the external environment.’’. 

(c) STUDY AND REPORT TO CONGRESS.— 

(1) STUDY.—The Comptroller General of the United States 

shall, in consultation with relevant stakeholders, conduct a 

study on the treatment needs of individuals entitled to benefits 

under part A of title XVIII of the Social Security Act or enrolled 

under part B of such title who require specialized wound care, 

and the cost, for such individuals and the Medicare program 

under such title, of treating severe wounds in rural and urban 

areas. Such study shall include an assessment of— 

(A) access of such individuals to appropriate levels 

of care for such cases; 

(B) the potential impact that section 1886(m)(6)(A)(i) 

of such Act (42 U.S.C. 1395ww(m)(6)(A)(i)) will have on 


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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 Comptroller General shall submit to Congress a report on the study 

conducted under paragraph (1), including recommendations for 

such legislation and administrative action as the Comptroller 

General determines appropriate. 

TITLE XVI—PROVISIONS RELATING TO 

MEDICARE PART B 

SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER HOPD PROSPECTIVE PAYMENT SYSTEM FOR SERVICES FURNISHED BY 

MID-BUILD OFF-CAMPUS OUTPATIENT DEPARTMENTS 

OF PROVIDERS. 

(a) IN GENERAL.—Section 1833(t)(21) of the Social Security 

Act (42 U.S.C. 1395l(t)(21)) is amended— 

(1) in subparagraph (B)— 

(A) in clause (i), by striking ‘‘clause (ii)’’ and inserting 

‘‘the subsequent provisions of this subparagraph’’; and 

(B) by adding at the end the following new clauses: 

‘‘(iii) DEEMED TREATMENT FOR 2017.—For purposes 

of applying clause (ii) with respect to applicable items 

and services furnished during 2017, a department of 

a provider (as so defined) not described in such clause 

is deemed to be billing under this subsection with 

respect to covered OPD services furnished prior to 

November 2, 2015, if the Secretary received from the 

provider prior to December 2, 2015, an attestation 

(pursuant to section 413.65(b)(3) of title 42 of the Code 

of Federal Regulations) that such department was a 

department of a provider (as so defined). 

‘‘(iv) ALTERNATIVE EXCEPTION BEGINNING WITH

2018.—For purposes of paragraph (1)(B)(v) and this 

paragraph with respect to applicable items and services 

furnished during 2018 or a subsequent year, the term 

‘off-campus outpatient department of a provider’ also 

shall not include a department of a provider (as so 

defined) that is not described in clause (ii) if— 

‘‘(I) the Secretary receives from the provider 

an attestation (pursuant to such section 

413.65(b)(3)) not later than December 31, 2016 

(or, if later, 60 days after the date of the enactment 

of this clause), that such department met the 

requirements of a department of a provider specified in section 413.65 of title 42 of the Code of 

Federal Regulations; 

‘‘(II) the provider includes such department 

as part of the provider on its enrollment form 

in accordance with the enrollment process under 

section 1866(j); and 

‘‘(III) the department met the mid-build 

requirement of clause (v) and the Secretary 

receives, not later than 60 days after the date 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1325 

of the enactment of this clause, from the chief 

executive officer or chief operating officer of the 

provider a written certification that the department met such requirement. 

‘‘(v) MID-BUILD REQUIREMENT DESCRIBED.—The 

mid-build requirement of this clause is, with respect 

to a department of a provider, that before November 

2, 2015, the provider had a binding written agreement 

with an outside unrelated party for the actual construction of such department. 

‘‘(vii) AUDIT.—Not later than December 31, 2018, 

the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department 

of a provider to which such clause applies. If the Secretary finds as a result of an audit under this clause 

that the applicable requirements were not met with 

respect to such department, the department shall not 

be excluded from the term ‘off-campus outpatient 

department of a provider’ under such clause. 

‘‘(viii) IMPLEMENTATION.—For purposes of implementing clauses (iii) through (vii): 

‘‘(I) Notwithstanding any other provision of 

law, the Secretary may implement such clauses 

by program instruction or otherwise. 

‘‘(II) Subchapter I of chapter 35 of title 44, 

United States Code, shall not apply. 

‘‘(III) For purposes of carrying out this 

subparagraph with respect to clauses (iii) and (iv) 

(and clause (vii) insofar as it relates to clause 

(iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund 

under section 1841, to remain available until 

December 31, 2018.’’; and 

(2) in subparagraph (E), by adding at the end the following 

new clause: 

‘‘(iv) The determination of an audit under subparagraph (B)(vii).’’. 

(b) EFFECTIVE DATE.—The amendments made by this section 

shall be effective as if included in the enactment of section 603 

of the Bipartisan Budget Act of 2015 (Public Law 114–74). 

SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER POLICY. 

(a) IN GENERAL.—Section 1833(t)(21)(B) of the Social Security 

Act (42 U.S.C. 1395l(t)(21)(B)), as amended by section 16001(a), 

is amended— 

(1) by inserting after clause (v) the following new clause: 

‘‘(vi) EXCLUSION FOR CERTAIN CANCER HOSPITALS.— 

For purposes of paragraph (1)(B)(v) and this paragraph 

with respect to applicable items and services furnished 

during 2017 or a subsequent year, the term ‘off-campus 

outpatient department of a provider’ also shall not 

include a department of a provider (as so defined) 

that is not described in clause (ii) if the provider is 

a hospital described in section 1886(d)(1)(B)(v) and— 

‘‘(I) in the case of a department that met the 

requirements of section 413.65 of title 42 of the 

42 USC 1395l 

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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 provider an attestation that such department met 

such requirements not later than 60 days after 

such date of enactment; or 

‘‘(II) in the case of a department that meets 

such requirements after such date of enactment, 

the Secretary receives from the provider an 

attestation that such department meets such 

requirements not later than 60 days after the date 

such requirements are first met with respect to 

such department.’’; 

(2) in clause (vii), by inserting after the first sentence 

the following: ‘‘Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to 

compliance of a department of a provider with requirements 

referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department.’’; 

and 

(3) in clause (viii)(III), by adding at the end the following: 

‘‘For purposes of carrying out this subparagraph with respect 

to clause (vi) (and clause (vii) insofar as it relates to such 

clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841, 

to remain available until expended.’’. 

(b) OFFSETTING SAVINGS.—Section 1833(t)(18) of the Social 

Security Act (42 U.S.C. 1395l(t)(18)) is amended— 

(1) in subparagraph (B), by inserting ‘‘, subject to subparagraph (C),’’ after ‘‘shall’’; and 

(2) by adding at the end the following new subparagraph: 

‘‘(C) TARGET PCR ADJUSTMENT.—In applying section 

419.43(i) of title 42 of the Code of Federal Regulations 

to implement the appropriate adjustment under this paragraph for services furnished on or after January 1, 2018, 

the Secretary shall use a target PCR that is 1.0 percentage 

points less than the target PCR that would otherwise apply. 

In addition to the percentage point reduction under the 

previous sentence, the Secretary may consider making an 

additional percentage point reduction to such target PCR 

that takes into account payment rates for applicable items 

and services described in paragraph (21)(C) other than 

for services furnished by hospitals described in section 

1886(d)(1)(B)(v). In making any budget neutrality adjustments under this subsection for 2018 or a subsequent year, 

the Secretary shall not take into account the reduced 

expenditures that result from the application of this 

subparagraph.’’. 

(c) EFFECTIVE DATE.—The amendments made by this section 

shall be effective as if included in the enactment of section 603 

of the Bipartisan Budget Act of 2015 (Public Law 114–74). 

SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN AMBULATORY SURGICAL CENTERS FOR MEANINGFUL USE AND 

MIPS. 

Section 1848(a)(7)(D) of the Social Security Act (42 U.S.C. 

1395w–4(a)(7)(D)) is amended— 

42 USC 1395l 

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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1327 

(1) by striking ‘‘HOSPITAL-BASED ELIGIBLE PROFESSIONALS’’ 

and all that follows through ‘‘No payment’’ and inserting the 

following: ‘‘HOSPITAL-BASED AND AMBULATORY SURGICAL CENTERBASED ELIGIBLE PROFESSIONALS.— 

‘‘(i) HOSPITAL-BASED.—No payment’’; and 

(2) by adding at the end the following new clauses: 

‘‘(ii) AMBULATORY SURGICAL CENTER-BASED.—Subject to clause (iv), no payment adjustment may be 

made under subparagraph (A) for 2017 and 2018 in 

the case of an eligible professional with respect to 

whom substantially all of the covered professional services furnished by such professional are furnished in 

an ambulatory surgical center. 

‘‘(iii) DETERMINATION.—The determination of 

whether an eligible professional is an eligible professional described in clause (ii) may be made on the 

basis of— 

‘‘(I) the site of service (as defined by the Secretary); or 

‘‘(II) an attestation submitted by the eligible 

professional. 

Determinations made under subclauses (I) and (II) 

shall be made without regard to any employment or 

billing arrangement between the eligible professional 

and any other supplier or provider of services. 

‘‘(iv) SUNSET.—Clause (ii) shall no longer apply 

as of the first year that begins more than 3 years 

after the date on which the Secretary determines, 

through notice and comment rulemaking, that certified 

EHR technology applicable to the ambulatory surgical 

center setting is available.’’. 

SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 2016. 

(a) EXTENSION OF ENFORCEMENT INSTRUCTION ON SUPERVISION

REQUIREMENTS FOR OUTPATIENT THERAPEUTIC SERVICES IN CRITICAL ACCESS AND SMALL RURAL HOSPITALS THROUGH 2016.—Section 

1 of Public Law 113–198, as amended by section 1 of Public Law 

114–112, is amended— 

(1) in the heading, by striking ‘‘2014 AND 2015’’ and inserting 

‘‘2016’’; and 

(2) by striking ‘‘and 2015’’ and inserting ‘‘, 2015, and 2016’’. 

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Medicare Payment Advisory Commission 

(established under section 1805 of the Social Security Act (42 U.S.C. 

1395b–6)) shall submit to Congress a report analyzing the effect 

of the extension of the enforcement instruction under section 1 

of Public Law 113–198, as amended by section 1 of Public Law 

114–112 and subsection (a) of this section, on the access to health 

care by Medicare beneficiaries, on the economic impact and the 

impact upon hospital staffing needs, and on the quality of health 

care furnished to such beneficiaries. 


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130 STAT. 1328 PUBLIC LAW 114–255—DEC. 13, 2016 

SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE 

SCHEDULE ADJUSTMENTS FOR WHEELCHAIR ACCESSORIES AND SEATING SYSTEMS WHEN USED IN 

CONJUNCTION WITH COMPLEX REHABILITATION TECHNOLOGY (CRT) WHEELCHAIRS. 

Section 2(a) of the Patient Access and Medicare Protection 

Act (42 U.S.C. 1305 note) is amended by striking ‘‘January 1, 

2017’’ and inserting ‘‘July 1, 2017’’. 

SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE LOCUM 

TENENS ARRANGEMENTS UNDER MEDICARE. 

(a) IN GENERAL.—The first sentence of section 1842(b)(6) of 

the Social Security Act (42 U.S.C. 1395u(b)(6)), as amended by 

section 5012, is further amended— 

(1) by striking ‘‘and’’ before ‘‘(I)’’; and 

(2) by inserting before the period at the end the following: 

‘‘, and (J) in the case of outpatient physical therapy services 

furnished by physical therapists in a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health 

Service Act), a medically underserved area (as designated 

pursuant to section 330(b)(3)(A) of such Act), or a rural area 

(as defined in section 1886(d)(2)(D)), subparagraph (D) of this 

sentence shall apply to such services and therapists in the 

same manner as such subparagraph applies to physicians’ services furnished by physicians’’. 

(b) EFFECTIVE DATE; IMPLEMENTATION.— 

(1) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall apply to services furnished beginning not later than 

six months after the date of the enactment of this Act. 

(2) IMPLEMENTATION.—The Secretary of Health and Human 

Services may implement subparagraph (J) of section 1842(b)(6) 

of the Social Security Act (42 U.S.C. 1395u(b)(6)), as added 

by subsection (a)(2), by program instruction or otherwise. 

SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAYMENT RATES 

FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM. 

(a) IN GENERAL.—The Secretary of Health and Human Services 

shall extend the transition period described in clause (i) of section 

414.210(g)(9) of title 42, Code of Federal Regulations, from June 

30, 2016, to December 31, 2016 (with the full implementation 

described in clause (ii) of such section applying to items and services 

furnished with dates of service on or after January 1, 2017). 

(b) STUDY AND REPORT.— 

(1) STUDY.— 

(A) IN GENERAL.—The Secretary of Health and Human 

Services shall conduct a study that examines the impact 

of applicable payment adjustments upon— 

(i) the number of suppliers of durable medical 

equipment that, on a date that is not before January 

1, 2016, and not later than December 31, 2016, ceased 

to conduct business as such suppliers; and 

(ii) the availability of durable medical equipment, 

during the period beginning on January 1, 2016, and 

ending on December 31, 2016, to individuals entitled 

to benefits under part A of title XVIII of the Social 

42 USC 1395u 

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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1329 

Security Act (42 U.S.C. 1395 et seq.) or enrolled under 

part B of such title. 

(B) DEFINITIONS.—For purposes of this subsection, the 

following definitions apply: 

(i) SUPPLIER; DURABLE MEDICAL EQUIPMENT.—The 

terms ‘‘supplier’’ and ‘‘durable medical equipment’’ have 

the meanings given such terms by section 1861 of 

the Social Security Act (42 U.S.C. 1395x). 

(ii) APPLICABLE PAYMENT ADJUSTMENT.—The term 

‘‘applicable payment adjustment’’ means a payment 

adjustment described in section 414.210(g) of title 42, 

Code of Federal Regulations, that is phased in by paragraph (9)(i) of such section. For purposes of the preceding sentence, a payment adjustment that is phased 

in pursuant to the extension under subsection (a) shall 

be considered a payment adjustment that is phased 

in by such paragraph (9)(i). 

(2) REPORT.—The Secretary of Health and Human Services 

shall, not later than January 12, 2017, submit to the Committees on Ways and Means and on Energy and Commerce of 

the House of Representatives, and to the Committee on Finance 

of the Senate, a report on the findings of the study conducted 

under paragraph (1). 

SEC. 16008. REQUIREMENTS IN DETERMINING ADJUSTMENTS USING 

INFORMATION FROM COMPETITIVE BIDDING PROGRAMS. 

(a) IN GENERAL.—Section 1834(a)(1)(G) of the Social Security 

Act (42 U.S.C. 1395m(a)(1)(G)) is amended by adding at the end 

the following new sentence: ‘‘In the case of items and services 

furnished on or after January 1, 2019, in making any adjustments 

under clause (ii) or (iii) of subparagraph (F), under subsection 

(h)(1)(H)(ii), or under section 1842(s)(3)(B), the Secretary shall— 

‘‘(i) solicit and take into account stakeholder input; 

and 

‘‘(ii) take into account the highest amount bid by 

a winning supplier in a competitive acquisition area 

and a comparison of each of the following with respect 

to non-competitive acquisition areas and competitive 

acquisition areas: 

‘‘(I) The average travel distance and cost associated with furnishing items and services in the 

area. 

‘‘(II) The average volume of items and services 

furnished by suppliers in the area. 

‘‘(III) The number of suppliers in the area.’’. 

(b) CONFORMING AMENDMENTS.—(1) Section 1834(h)(1)(H)(ii) of 

the Social Security Act (42 U.S.C. 1395m(h)(1)(H)(ii)) is amended 

by striking ‘‘the Secretary’’ and inserting ‘‘subject to subsection 

(a)(1)(G), the Secretary’’. 

(2) Section 1842(s)(3)(B) of the Social Security Act (42 U.S.C. 

1395m(s)(3)(B)) is amended by striking ‘‘the Secretary’’ and inserting 

‘‘subject to section 1834(a)(1)(G), the Secretary’’. 


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130 STAT. 1330 PUBLIC LAW 114–255—DEC. 13, 2016 

TITLE XVII—OTHER MEDICARE 

PROVISIONS 

SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CONTRACTS FOR 

MEDICARE ADVANTAGE PLANS FAILING TO ACHIEVE 

MINIMUM QUALITY RATINGS. 

(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 Medicare enrollment data (and, in the case of part A, on data 

on individuals receiving benefits under such part) as of a date 

in such year specified by the Secretary. Such data shall be 

presented— 

‘‘(A) by Congressional district and State; and 

‘‘(B) in a manner that provides for such data based 

on— 

‘‘(i) fee-for-service enrollment (as defined in paragraph (2)); 

‘‘(ii) enrollment under part C (including separate 

for aggregate enrollment in MA–PD plans and aggregate enrollment in MA plans that are not MA–PD 

plans); and 

‘‘(iii) enrollment under part D. 

42 USC 

1395w–27 note. 


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‘‘(2) FEE-FOR-SERVICE ENROLLMENT DEFINED.—For purpose 

of paragraph (1)(B)(i), the term ‘fee-for-service enrollment’ 

means aggregate enrollment (including receipt of benefits other 

than through enrollment) under— 

‘‘(A) part A only; 

‘‘(B) part B only; and 

‘‘(C) both part A and part B.’’. 

SEC. 17003. UPDATING THE WELCOME TO MEDICARE PACKAGE. 

(a) IN GENERAL.—Not later than 12 months after the last 

day of the period for the request of information described in subsection (b), the Secretary of Health and Human Services shall, 

taking into consideration information collected pursuant to subsection (b), update the information included in the Welcome to 

Medicare package to include information, presented in a clear and 

simple manner, about options for receiving benefits under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 

1395 et seq.), including through the original medicare fee-for-service 

program under parts A and B of such title (42 U.S.C. 1395c et 

seq., 42 U.S.C. 1395j et seq.), Medicare Advantage plans under 

part C of such title (42 U.S.C. 1395w–21 et seq.), and prescription 

drug plans under part D of such title (42 U.S.C. 1395w–101 et 

seq.)). The Secretary shall make subsequent updates to the information included in the Welcome to Medicare package as appropriate. 

(b) REQUEST FOR INFORMATION.—Not later than 6 months after 

the date of the enactment of this Act, the Secretary of Health 

and Human Services shall request information, including recommendations, from stakeholders (including patient advocates, 

issuers, and employers) on information included in the Welcome 

to Medicare package, including pertinent data and information 

regarding enrollment and coverage for Medicare eligible individuals. 

SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FURNISHED BY 

NEWLY ENROLLED PROVIDERS OR SUPPLIERS WITHIN 

A TEMPORARY MORATORIUM AREA. 

(a) MEDICARE.—Section 1866(j)(7) of the Social Security Act 

(42 U.S.C. 1395cc(j)(7)) is amended— 

(1) in the paragraph heading, by inserting ‘‘; NONPAYMENT’’ 

before the period; and 

(2) by adding at the end the following new subparagraph: 

‘‘(C) NONPAYMENT.— ‘‘(i) IN GENERAL.—No payment may be made under 

this title or under a program described in subparagraph (A) with respect to an item or service described 

in clause (ii) furnished on or after October 1, 2017. 

‘‘(ii) ITEM OR SERVICE DESCRIBED.—An item or 

service described in this clause is an item or service 

furnished— 

‘‘(I) within a geographic area with respect to 

which a temporary moratorium imposed under 

subparagraph (A) is in effect; and 

‘‘(II) by a provider of services or supplier that 

meets the requirements of clause (iii). 

‘‘(iii) REQUIREMENTS.—For purposes of clause (ii), 

the requirements of this clause are that a provider 

of services or supplier— 

‘‘(I) enrolls under this title on or after the 

effective date of such temporary moratorium; and 

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 services and suppliers (as described in subparagraph 

(A)) subject to such temporary moratorium. 

‘‘(iv) PROHIBITION ON CHARGES FOR SPECIFIED

ITEMS OR SERVICES.—In no case shall a provider of 

services or supplier described in clause (ii)(II) charge 

an individual or other person for an item or service 

described in clause (ii) furnished on or after October 

1, 2017, to an individual entitled to benefits under 

part A or enrolled under part B or an individual under 

a program specified in subparagraph (A).’’. 

(b) CONFORMING AMENDMENTS.— (1) MEDICAID.— (A) IN GENERAL.—Section 1903(i)(2) of the Social Security Act (42 U.S.C. 1396b(i)(2)), as amended by section 

5005(a)(4), is further amended— 

(i) in subparagraph (C), by striking ‘‘or’’ at the 

end; and 

(ii) by adding at the end the following new 

subparagraph: 

‘‘(E) with respect to any amount expended for such 

an item or service furnished during calendar quarters 

beginning on or after October 1, 2017, subject to section 

1902(kk)(4)(A)(ii)(II), within a geographic area that is subject to a moratorium imposed under section 1866(j)(7) by 

a provider or supplier that meets the requirements specified 

in subparagraph (C)(iii) of such section, during the period 

of such moratorium; or’’. 

(B) EXCEPTION WITH RESPECT TO ACCESS.—Section 

1902(kk)(4)(A)(ii) of the Social Security Act (42 U.S.C. 

1396a(kk)(4)(A)(ii)) is amended to read as follows: 

‘‘(ii) EXCEPTIONS.— 

‘‘(I) COMPLIANCE WITH MORATORIUM.—A State 

shall not be required to comply with a temporary 

moratorium described in clause (i) if the State 

determines that the imposition of such temporary 

moratorium would adversely impact beneficiaries’ 

access to medical assistance. 

‘‘(II) FFP AVAILABLE.—Notwithstanding section 1903(i)(2)(E), payment may be made to a State 

under this title with respect to amounts expended 

for items and services described in such section 

if the Secretary, in consultation with the State 

agency administering the State plan under this 

title (or a waiver of the plan), determines that 

denying payment to the State pursuant to such 

section would adversely impact beneficiaries’ 

access to medical assistance. ’’. 

(C) STATE PLAN REQUIREMENT WITH RESPECT TO LIMITATION ON CHARGES TO BENEFICIARIES.—Section 

1902(kk)(4)(A) of the Social Security Act (42 U.S.C. 

1396a(kk)(4)(A)) is amended by adding at the end the following new clause: 

‘‘(iii) LIMITATION ON CHARGES TO BENEFICIARIES.— 

With respect to any amount expended for items or 

services furnished during calendar quarters beginning 

on or after October 1, 2017, the State prohibits, during 


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the period of a temporary moratorium described in 

clause (i), a provider meeting the requirements specified in subparagraph (C)(iii) of section 1866(j)(7) from 

charging an individual or other person eligible to 

receive medical assistance under the State plan under 

this title (or a waiver of the plan) for an item or 

service described in section 1903(i)(2)(E) furnished to 

such an individual.’’. 

(2) CORRECTING AMENDMENTS TO RELATED PROVISIONS.— (A) SECTION 1866(J).—Section 1866(j) of the Social Security Act (42 U.S.C. 1395cc(j)) is amended— 

(i) in paragraph (1)(A)— 

(I) by striking ‘‘paragraph (4)’’ and inserting 

‘‘paragraph (5)’’; 

(II) by striking ‘‘moratoria in accordance with 

paragraph (5)’’ and inserting ‘‘moratoria in accordance with paragraph (7)’’; and 

(III) by striking ‘‘paragraph (6)’’ and inserting 

‘‘paragraph (9)’’; and 

(ii) by redesignating the second paragraph (8) 

(redesignated by section 1304(1) of Public Law 111– 

152) as paragraph (9). 

(B) SECTION 1902(KK).—Section 1902(kk) of such Act 

(42 U.S.C. 1396a(kk)) is amended— 

(i) in paragraph (1), by striking ‘‘section 1886(j)(2)’’ 

and inserting ‘‘section 1866(j)(2)’’; 

(ii) in paragraph (2), by striking ‘‘section 1886(j)(3)’’ 

and inserting ‘‘section 1866(j)(3)’’; 

(iii) in paragraph (3), by striking ‘‘section 

1886(j)(4)’’ and inserting ‘‘section 1866(j)(5)’’; and 

(iv) in paragraph (4)(A), by striking ‘‘section 

1886(j)(6)’’ and inserting ‘‘section 1866(j)(7)’’. 

SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY CHOICE 

UNDER MEDICARE ADVANTAGE. 

Section 1851(e)(2) of the Social Security Act (42 U.S.C. 1395w– 

21(e)(2)) is amended— 

(1) in subparagraph (C)— 

(A) in the heading, by inserting ‘‘FROM 2011 THROUGH

2018’’ after ‘‘45-DAY PERIOD’’; and 

(B) by inserting ‘‘and ending with 2018’’ after ‘‘beginning with 2011’’; and 

(2) by adding at the end the following new subparagraph: 

‘‘(G) CONTINUOUS OPEN ENROLLMENT AND

DISENROLLMENT FOR FIRST 3 MONTHS IN 2016 AND SUBSEQUENT YEARS.— 

‘‘(i) IN GENERAL.—Subject to clause (ii) and 

subparagraph (D)— 

‘‘(I) in the case of an MA eligible individual 

who is enrolled in an MA plan, at any time during 

the first 3 months of a year (beginning with 2019); 

or 

‘‘(II) in the case of an individual who first 

becomes an MA eligible individual during a year 

(beginning with 2019) and enrolls in an MA plan, 

during the first 3 months during such year in 

which the individual is an MA eligible individual; 


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such MA eligible individual may change the election 

under subsection (a)(1). 

‘‘(ii) LIMITATION OF ONE CHANGE DURING OPEN

ENROLLMENT PERIOD EACH YEAR.—An individual may 

change the election pursuant to clause (i) only once 

during the applicable 3-month period described in such 

clause in each year. The limitation under this clause 

shall not apply to changes in elections effected during 

an annual, coordinated election period under paragraph (3) or during a special enrollment period under 

paragraph (4). 

‘‘(iii) LIMITED APPLICATION TO PART D.—Clauses 

(i) and (ii) of this subparagraph shall only apply with 

respect to changes in enrollment in a prescription drug 

plan under part D in the case of an individual who, 

previous to such change in enrollment, is enrolled in 

a Medicare Advantage plan. 

‘‘(iv) LIMITATIONS ON MARKETING.— Pursuant to 

subsection (j), no unsolicited marketing or marketing 

materials may be sent to an individual described in 

clause (i) during the continuous open enrollment and 

disenrollment period established for the individual 

under such clause, notwithstanding marketing guidelines established by the Centers for Medicare & Medicaid Services.’’. 

SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENEFICIARIES 

TO CHOOSE A MEDICARE ADVANTAGE PLAN. 

(a) REMOVING PROHIBITION.— 

(1) IN GENERAL.—Section 1851(a)(3) of the Social Security 

Act (42 U.S.C. 1395w–21(a)(3)) is amended— 

(A) by striking subparagraph (B); and 

(B) by striking ‘‘ELIGIBLE INDIVIDUAL’’ and all that follows through ‘‘In this title, subject to subparagraph (B),’’ 

and inserting ‘‘ELIGIBLE INDIVIDUAL.—In this title,’’. 

(2) CONFORMING AMENDMENTS.— 

(A) Section 1852(b)(1) of the Social Security Act (42 

U.S.C. 1395w–22(b)(1)) is amended— 

(i) by striking subparagraph (B); and 

(ii) by striking ‘‘BENEFICIARIES’’ and all that follows 

through ‘‘A Medicare+Choice organization’’ and 

inserting ‘‘BENEFICIARIES.—A Medicare Advantage 

organization’’. 

(B) Section 1859(b)(6) of the Social Security Act (42 

U.S.C. 1395w–28(b)(6)) is amended, in the last sentence, 

by striking ‘‘may waive’’ and all that follows through 

‘‘subparagraph and’’. 

(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply with respect to plan years beginning on 

or after January 1, 2021. 

(b) EXCLUDING COSTS FOR KIDNEY ACQUISITIONS FROM MA 

BENCHMARK.—Section 1853 of the Social Security Act (42 U.S.C. 

1395w–23) is amended— 

(1) in subsection (k)— 

(A) in paragraph (1)— 

42 USC 

1395w–21 note. 


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(i) in the matter preceding subparagraph (A), by 

striking ‘‘paragraphs (2) and (4)’’ and inserting ‘‘paragraphs (2), (4), and (5)’’; and 

(ii) in subparagraph (B)(i), by striking ‘‘paragraphs 

(2) and (4)’’ and inserting ‘‘paragraphs (2), (4), and 

(5)’’; and 

(B) by adding at the end the following new paragraph: 

‘‘(5) EXCLUSION OF COSTS FOR KIDNEY ACQUISITIONS FROM

CAPITATION RATES.—After determining the applicable amount 

for an area for a year under paragraph (1) (beginning with 

2021), the Secretary shall adjust such applicable amount to 

exclude from such applicable amount the Secretary’s estimate 

of the standardized costs for payments for organ acquisitions 

for kidney transplants covered under this title (including 

expenses covered under section 1881(d)) in the area for the 

year.’’; and 

(2) in subsection (n)(2)— 

(A) in subparagraph (A)(i), by inserting ‘‘and, for 2021 

and subsequent years, the exclusion of payments for organ 

acquisitions for kidney transplants from the capitation rate 

as described in subsection (k)(5)’’ before the semicolon at 

the end; 

(B) in subparagraph (E), in the matter preceding clause 

(i), by striking ‘‘subparagraph (F)’’ and inserting ‘‘subparagraphs (F) and (G)’’; and 

(C) by adding at the end the following new subparagraph: 

‘‘(G) APPLICATION OF KIDNEY ACQUISITIONS ADJUSTMENT.—The base payment amount specified in subparagraph (E) for a year (beginning with 2021) shall be adjusted 

in the same manner under paragraph (5) of subsection 

(k) as the applicable amount is adjusted under such subsection.’’. 

(c) FFS COVERAGE OF KIDNEY ACQUISITIONS.— 

(1) IN GENERAL.—Section 1852(a)(1)(B)(i) of the Social Security Act (42 U.S.C. 1395w–22(a)(1)(B)(i)) is amended by 

inserting ‘‘or coverage for organ acquisitions for kidney transplants, including as covered under section 1881(d)’’ after ‘‘hospice care’’. 

(2) CONFORMING AMENDMENT.—Section 1851(i) of the Social 

Security Act (42 U.S.C. 1395w–21(i)) is amended by adding 

at the end the following new paragraph: 

‘‘(3) FFS PAYMENT FOR EXPENSES FOR KIDNEY ACQUISITIONS.—Paragraphs (1) and (2) shall not apply with respect 

to expenses for organ acquisitions for kidney transplants 

described in section 1852(a)(1)(B)(i).’’. 

(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply with respect to plan years beginning on 

or after January 1, 2021. 

(d) EVALUATION OF QUALITY.— 

(1) IN GENERAL.—The Secretary of Health and Human 

Services (in this subsection referred to as the ‘‘Secretary’’) shall 

conduct an evaluation of whether the 5-star rating system 

based on the data collected under section 1852(e) of the Social 

Security Act (42 U.S.C. 1395w–22(e)) should include a quality 

measure specifically related to care for enrollees in Medicare 

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 determined to have end-stage renal disease. 

(2) PUBLIC AVAILABILITY.—Not later than April 1, 2020, 

the Secretary shall post on the Internet website of the Centers 

for Medicare & Medicaid Services the results of the evaluation 

under paragraph (1). 

(e) REPORT.—Not later than December 31, 2023, the Secretary 

of Health and Human Services (in this subsection referred to as 

the ‘‘Secretary’’) shall submit to Congress a report on the impact 

of the provisions of, and amendments made by, this section with 

respect to the following: 

(1) Spending under— 

(A) the original Medicare fee-for-service program under 

parts A and B of title XVIII of the Social Security Act; 

and 

(B) the Medicare Advantage program under part C 

of such title. 

(2) The number of enrollees determined to have end-stage 

renal disease— 

(A) in the original Medicare fee-for-service program; 

and 

(B) in the Medicare Advantage program. 

(3) The sufficiency of the amount of data under the original 

Medicare fee-for-service program for individuals determined to 

have end-stage renal disease for purposes of determining payment rates for end-stage renal disease under the Medicare 

Advantage program. 

(f) IMPROVEMENTS TO RISK ADJUSTMENT UNDER MEDICARE

ADVANTAGE.— 

(1) IN GENERAL.—Section 1853(a)(1) of the Social Security 

Act (42 U.S.C. 1395w–23(a)(1)) is amended— 

(A) in subparagraph (C)(i), by striking ‘‘The Secretary’’ 

and inserting ‘‘Subject to subparagraph (I), the Secretary’’; 

and 

(B) by adding at the end the following new subparagraph: 

‘‘(I) IMPROVEMENTS TO RISK ADJUSTMENT FOR 2019 AND

SUBSEQUENT YEARS.— 

‘‘(i) IN GENERAL.—In order to determine the appropriate adjustment for health status under subparagraph (C)(i), the following shall apply: 

‘‘(I) TAKING INTO ACCOUNT TOTAL NUMBER OF

DISEASES OR CONDITIONS.—The Secretary shall 

take into account the total number of diseases 

or conditions of an individual enrolled in an MA 

plan. The Secretary shall make an additional 

adjustment under such subparagraph as the 

number of diseases or conditions of an individual 

increases. 

‘‘(II) USING AT LEAST 2 YEARS OF DIAGNOSTIC

DATA.—The Secretary may use at least 2 years 

of diagnosis data. 

‘‘(III) PROVIDING SEPARATE ADJUSTMENTS FOR

DUAL ELIGIBLE INDIVIDUALS.—With respect to 

individuals who are dually eligible for benefits 

under this title and title XIX, the Secretary shall 


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make separate adjustments for each of the following: 

‘‘(aa) Full-benefit dual eligible individuals 

(as defined in section 1935(c)(6)). 

‘‘(bb) Such individuals not described in 

item (aa). 

‘‘(IV) EVALUATION OF MENTAL HEALTH AND

SUBSTANCE USE DISORDERS.—The Secretary shall 

evaluate the impact of including additional diagnosis codes related to mental health and substance 

use disorders in the risk adjustment model. 

‘‘(V) EVALUATION OF CHRONIC KIDNEY 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 ENDSTAGE RENAL DISEASE.—The Secretary shall 

evaluate whether other factors (in addition to those 

described in subparagraph (H)) should be taken 

into consideration when computing payment rates 

under such subparagraph. 

‘‘(ii) PHASED-IN IMPLEMENTATION.—The Secretary 

shall phase-in any changes to risk adjustment payment 

amounts under subparagraph (C)(i) under this 

subparagraph over a 3-year period, beginning with 

2019, with such changes being fully implemented for 

2022 and subsequent years. 

‘‘(iii) OPPORTUNITY FOR REVIEW AND PUBLIC COMMENT.—The Secretary shall provide an opportunity for 

review of the proposed changes to such risk adjustment 

payment amounts under this subparagraph and a 

public comment period of not less than 60 days before 

implementing such changes.’’. 

(2) STUDIES AND REPORTS.— 

(A) REPORTS ON THE RISK ADJUSTMENT SYSTEM.— (i) MEDPAC EVALUATION AND REPORT.— 

(I) EVALUATION.—The Medicare Payment 

Advisory Commission shall conduct an evaluation 

of the impact of the provisions of, and amendments 

made by, this section on risk scores for enrollees 

in Medicare Advantage plans under part C of title 

XVIII of the Social Security Act and payments 

to Medicare Advantage plans under such part, 

including the impact of such provisions and amendments on the overall accuracy of risk scores under 

the Medicare Advantage program. 

(II) REPORT.—Not later than July 1, 2020, the 

Medicare Payment Advisory Commission shall 

submit to Congress a report on the evaluation 

under subclause (I), together with recommendations for such legislation and administrative action 

as the Commission determines appropriate. 

(ii) REPORTS BY SECRETARY OF HEALTH AND HUMAN

SERVICES.—Not later than December 31, 2018, and 

every 3 years thereafter, the Secretary of Health and 

Human Services shall submit to Congress a report 

on the risk adjustment model and the ESRD risk 

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 program under part C of title XVIII of the Social Security 

Act, including any revisions to either such model since 

the previous report. Such report shall include information on how such revisions impact the predictive ratios 

under either such model for groups of enrollees in 

Medicare Advantage plans, including very high and 

very low cost enrollees, and groups defined by the 

number of chronic conditions of enrollees. 

(B) STUDY AND REPORT ON FUNCTIONAL STATUS.— (i) STUDY.—The Comptroller General of the United 

States (in this subparagraph referred to as the ‘‘Comptroller General’’) shall conduct a study on how to most 

accurately measure the functional status of enrollees 

in Medicare Advantage plans and whether the use 

of such functional status would improve the accuracy 

of risk adjustment payments under the Medicare 

Advantage program under part C of title XVIII of 

the Social Security Act. Such study shall include an 

analysis of the challenges in collecting and reporting 

functional status information for Medicare Advantage 

plans under such part, providers of services and suppliers under the Medicare program, and the Centers 

for Medicare & Medicaid Services. 

(ii) REPORT.—Not later than June 30, 2018, the 

Comptroller General shall submit to Congress a report 

containing the results of the study under clause (i), 

together with recommendations for such legislation and 

administrative action as the Comptroller General 

determines appropriate. 

SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENEFICIARIES 

UNDER THE MEDICARE SHARED SAVINGS PROGRAM. 

Section 1899(c) of the Social Security Act (42 U.S.C. 1395jjj(c)) 

is amended— 

(1) by striking ‘‘utilization of primary’’ and inserting ‘‘utilization of— 

‘‘(1) in the case of performance years beginning on or after 

April 1, 2012, primary’’; 

(2) in paragraph (1), as added by paragraph (1) of this 

section, by striking the period at the end and inserting ‘‘; 

and’’; 

(3) by adding at the end the following new paragraph: 

‘‘(2) in the case of performance years beginning on or after 

January 1, 2019, services provided under this title by a Federally qualified health center or rural health clinic (as those 

terms are defined in section 1861(aa)), as may be determined 

by the Secretary.’’. 

TITLE XVIII—OTHER PROVISIONS 

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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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1339 

(1) IN GENERAL.—Section 9831 of the Internal Revenue 

Code of 1986 is amended by adding at the end the following 

new subsection: 

‘‘(d) EXCEPTION FOR QUALIFIED SMALL EMPLOYER HEALTH

REIMBURSEMENT ARRANGEMENTS.— 

‘‘(1) IN GENERAL.—For purposes of this title (except as 

provided in section 4980I(f)(4) and notwithstanding any other 

provision of this title), the term ‘group health plan’ shall not 

include any qualified small employer health reimbursement 

arrangement. 

‘‘(2) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT

ARRANGEMENT.—For purposes of this subsection— 

‘‘(A) IN GENERAL.—The term ‘qualified small employer 

health reimbursement arrangement’ means an arrangement which— 

‘‘(i) is described in subparagraph (B), and 

‘‘(ii) is provided on the same terms to all eligible 

employees of the eligible employer. 

‘‘(B) ARRANGEMENT DESCRIBED.—An arrangement is 

described in this subparagraph if— 

‘‘(i) such arrangement is funded solely by an 

eligible employer and no salary reduction contributions 

may be made under such arrangement, 

‘‘(ii) such arrangement provides, after the employee 

provides proof of coverage, for the payment of, or 

reimbursement of, an eligible employee for expenses 

for medical care (as defined in section 213(d)) incurred 

by the eligible employee or the eligible employee’s 

family members (as determined under the terms of 

the arrangement), and 

‘‘(iii) the amount of payments and reimbursements 

described in clause (ii) for any year do not exceed 

$4,950 ($10,000 in the case of an arrangement that 

also provides for payments or reimbursements for 

family members of the employee). 

‘‘(C) CERTAIN VARIATION PERMITTED.—For purposes of 

subparagraph (A)(ii), an arrangement shall not fail to be 

treated as provided on the same terms to each eligible 

employee merely because the employee’s permitted benefit 

under such arrangement varies in accordance with the 

variation in the price of an insurance policy in the relevant 

individual health insurance market based on— 

‘‘(i) the age of the eligible employee (and, in the 

case of an arrangement which covers medical expenses 

of the eligible employee’s family members, the age 

of such family members), or 

‘‘(ii) the number of family members of the eligible 

employee the medical expenses of which are covered 

under such arrangement. 

The variation permitted under the preceding sentence shall 

be determined by reference to the same insurance policy 

with respect to all eligible employees. 

‘‘(D) RULES RELATING TO MAXIMUM DOLLAR LIMITATION.— 


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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 arrangement for the entire year, the limitation under subparagraph (B)(iii) for such year shall be an amount which 

bears the same ratio to the amount which would (but 

for this clause) be in effect for such individual for 

such year under subparagraph (B)(iii) as the number 

of months for which such individual is covered by 

the arrangement for such year bears to 12. 

‘‘(ii) INFLATION ADJUSTMENT.—In the case of any 

year beginning after 2016, each of the dollar amounts 

in subparagraph (B)(iii) shall be increased by an 

amount equal to— 

‘‘(I) such dollar amount, multiplied by 

‘‘(II) the cost-of-living adjustment determined 

under section 1(f)(3) for the calendar year in which 

the taxable year begins, determined by substituting ‘calendar year 2015’ for ‘calendar year 

1992’ in subparagraph (B) thereof. 

If any dollar amount increased under the preceding 

sentence is not a multiple of $50, such dollar amount 

shall be rounded to the next lowest multiple of $50. 

‘‘(3) OTHER DEFINITIONS.—For purposes of this subsection— 

‘‘(A) ELIGIBLE EMPLOYEE.—The term ‘eligible employee’ 

means any employee of an eligible employer, except that 

the terms of the arrangement may exclude from consideration employees described in any clause of section 

105(h)(3)(B) (applied by substituting ‘90 days’ for ‘3 years’ 

in clause (i) thereof). 

‘‘(B) ELIGIBLE EMPLOYER.—The term ‘eligible employer’ 

means an employer that— 

‘‘(i) is not an applicable large employer as defined 

in section 4980H(c)(2), and 

‘‘(ii) does not offer a group health plan to any 

of its employees. 

‘‘(C) PERMITTED BENEFIT.—The term ‘permitted benefit’ 

means, with respect to any eligible employee, the maximum 

dollar amount of payments and reimbursements which may 

be made under the terms of the qualified small employer 

health reimbursement arrangement for the year with 

respect to such employee. 

‘‘(4) NOTICE.— 

‘‘(A) IN GENERAL.—An employer funding a qualified 

small employer health reimbursement arrangement for any 

year shall, not later than 90 days before the beginning 

of such year (or, in the case of an employee who is not 

eligible to participate in the arrangement as of the beginning of such year, the date on which such employee is 

first so eligible), provide a written notice to each eligible 

employee which includes the information described in 

subparagraph (B). 

‘‘(B) CONTENTS OF NOTICE.—The notice required under 

subparagraph (A) shall include each of the following: 

‘‘(i) A statement of the amount which would be 

such eligible employee’s permitted benefit under the 

arrangement for the year. 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1341 

‘‘(ii) A statement that the eligible employee should 

provide the information described in clause (i) to any 

health insurance exchange to which the employee 

applies for advance payment of the premium assistance 

tax credit. 

‘‘(iii) A statement that if the employee is not covered under minimum essential coverage for any month 

the employee may be subject to tax under section 

5000A for such month and reimbursements under the 

arrangement may be includible in gross income.’’. 

(2) LIMITATION ON EXCLUSION FROM GROSS INCOME.—Section 106 of such Code is amended by adding at the end the 

following: 

‘‘(g) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT

ARRANGEMENT.—For purposes of this section and section 105, payments or reimbursements from a qualified small employer health 

reimbursement arrangement (as defined in section 9831(d)) of an 

individual for medical care (as defined in section 213(d)) shall 

not be treated as paid or reimbursed under employer-provided 

coverage for medical expenses under an accident or health plan 

if for the month in which such medical care is provided the individual does not have minimum essential coverage (within the 

meaning of section 5000A(f)).’’. 

(3) COORDINATION WITH HEALTH INSURANCE PREMIUM

CREDIT.—Section 36B(c) of such Code is amended by adding 

at the end the following new paragraph: 

‘‘(4) SPECIAL RULES FOR QUALIFIED SMALL EMPLOYER

HEALTH REIMBURSEMENT ARRANGEMENTS.— 

‘‘(A) IN GENERAL.—The term ‘coverage month’ shall 

not include any month with respect to an employee (or 

any spouse or dependent of such employee) if for such 

month the employee is provided a qualified small employer 

health reimbursement arrangement which constitutes 

affordable coverage. 

‘‘(B) DENIAL OF DOUBLE BENEFIT.—In the case of any 

employee who is provided a qualified small employer health 

reimbursement arrangement for any coverage month 

(determined without regard to subparagraph (A)), the credit 

otherwise allowable under subsection (a) to the taxpayer 

for such month shall be reduced (but not below zero) by 

the amount described in subparagraph (C)(i)(II) for such 

month. 

‘‘(C) AFFORDABLE COVERAGE.—For purposes of subparagraph (A), a qualified small employer health reimbursement arrangement shall be treated as constituting affordable coverage for a month if— 

‘‘(i) the excess of— 

‘‘(I) the amount that would be paid by the 

employee as the premium for such month for selfonly coverage under the second lowest cost silver 

plan offered in the relevant individual health 

insurance market, over 

‘‘(II) 1⁄12 of the employee’s permitted benefit 

(as defined in section 9831(d)(3)(C)) under such 

arrangement, does not exceed— 

‘‘(ii) 1⁄12 of 9.5 percent of the employee’s household 

income. 


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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 subsection (b)(3)(A)(ii).’’. 

(4) APPLICATION OF EXCISE TAX ON HIGH COST EMPLOYERSPONSORED HEALTH COVERAGE.— 

(A) IN GENERAL.—Section 4980I(f)(4) of such Code is 

amended by adding at the end the following: ‘‘Section 

9831(d)(1) shall not apply for purposes of this section.’’. 

(B) DETERMINATION OF COST OF COVERAGE.—Section 

4980I(d)(2) of such Code is amended by redesignating 

subparagraph (D) as subparagraph (E) and by inserting 

after subparagraph (C) the following new subparagraph: 

‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.—In the case of applicable employersponsored coverage consisting of coverage under any qualified small employer health reimbursement arrangement 

(as defined in section 9831(d)(2)), the cost of coverage shall 

be equal to the amount described in section 6051(a)(15).’’. 

(5) ENFORCEMENT OF NOTICE REQUIREMENT.—Section 6652 

of such Code is amended by adding at the end the following 

new subsection: 

‘‘(o) FAILURE TO PROVIDE NOTICES WITH RESPECT TO QUALIFIED

SMALL EMPLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.—In 

the case of each failure to provide a written notice as required 

by section 9831(d)(4), unless it is shown that such failure is due 

to reasonable cause and not willful neglect, there shall be paid, 

on notice and demand of the Secretary and in the same manner 

as tax, by the person failing to provide such written notice, an 

amount equal to $50 per employee per incident of failure to provide 

such notice, but the total amount imposed on such person for 

all such failures during any calendar year shall not exceed $2,500.’’. 

(6) REPORTING.— 

(A) W–2 REPORTING.—Section 6051(a) of such Code 

is amended by striking ‘‘and’’ at the end of paragraph 

(13), by striking the period at the end of paragraph (14) 

and inserting ‘‘, and’’, and by inserting after paragraph 

(14) the following new paragraph: 

‘‘(15) the total amount of permitted benefit (as defined 

in section 9831(d)(3)(C)) for the year under a qualified small 

employer health reimbursement arrangement (as defined in 

section 9831(d)(2)) with respect to the employee.’’. 

(B) INFORMATION REQUIRED TO BE PROVIDED BY

EXCHANGE SUBSIDY APPLICANTS.—Section 1411(b)(3) of the 

Patient Protection and Affordable Care Act is amended 


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PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1343 

by redesignating subparagraph (B) as subparagraph (C) 

and by inserting after subparagraph (A) the following new 

subparagraph: 

‘‘(B) CERTAIN INDIVIDUAL HEALTH INSURANCE POLICIES

OBTAINED THROUGH SMALL EMPLOYERS.—The amount of the 

enrollee’s permitted benefit (as defined in section 

9831(d)(3)(C) of the Internal Revenue Code of 1986) under 

a qualified small employer health reimbursement arrangement (as defined in section 9831(d)(2) of such Code).’’. 

(7) EFFECTIVE DATES.— (A) IN GENERAL.—Except as otherwise provided in this 

paragraph, the amendments made by this subsection shall 

apply to years beginning after December 31, 2016. 

(B) TRANSITION RELIEF.—The relief under Treasury 

Notice 2015–17 shall be treated as applying to any plan 

year beginning on or before December 31, 2016. 

(C) COORDINATION WITH HEALTH INSURANCE PREMIUM

CREDIT.—The amendments made by paragraph (3) shall 

apply to taxable years beginning after December 31, 2016. 

(D) EMPLOYEE NOTICE.— 

(i) IN GENERAL.—The amendments made by paragraph (5) shall apply to notices with respect to years 

beginning after December 31, 2016. 

(ii) TRANSITION RELIEF.—For purposes of section 

6652(o) of the Internal Revenue Code of 1986 (as added 

by this Act), a person shall not be treated as failing 

to provide a written notice as required by section 

9831(d)(4) of such Code if such notice is so provided 

not later than 90 days after the date of the enactment 

of this Act. 

(E) W–2 REPORTING.—The amendments made by paragraph (6)(A) shall apply to calendar years beginning after 

December 31, 2016. 

(F) INFORMATION PROVIDED BY EXCHANGE SUBSIDY

APPLICANTS.— (i) IN GENERAL.—The amendments made by paragraph (6)(B) shall apply to applications for enrollment 

made after December 31, 2016. 

(ii) VERIFICATION.—Verification under section 1411 

of the Patient Protection and Affordable Care Act of 

information provided under section 1411(b)(3)(B) of 

such Act shall apply with respect to months beginning 

after October 2016. 

(iii) TRANSITIONAL RELIEF.—In the case of an 

application for enrollment under section 1411(b) of the 

Patient Protection and Affordable Care Act made before 

April 1, 2017, the requirement of section 1411(b)(3)(B) 

of such Act shall be treated as met if the information 

described therein is provided not later than 30 days 

after the date on which the applicant receives the 

notice described in section 9831(d)(4) of the Internal 

Revenue Code of 1986. 

(8) SUBSTANTIATION REQUIREMENTS.—The Secretary of the 

Treasury (or his designee) may issue substantiation requirements as necessary to carry out this subsection. 

(b) AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME 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 Transportation). 

CONGRESSIONAL RECORD: 

Vol. 161 (2015): Jan. 7, considered and passed House. 

Oct. 6, considered and passed Senate, amended. 

Vol. 162 (2016): Nov. 30, House concurred in Senate amendment with an 

amendment. 

Dec. 1, 5–7, Senate considered and concurred in House 

amendment. 

DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016): 

Dec. 13, Presidential remarks. 

Æ 

(1) IN GENERAL.—Section 733(a)(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191b(a)(1)) is 

amended by adding at the end the following: ‘‘Such term shall 

not include any qualified small employer health reimbursement 

arrangement (as defined in section 9831(d)(2) of the Internal 

Revenue Code of 1986).’’. 

(2) EXCEPTION FROM CONTINUATION COVERAGE 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 subsection shall apply to plan years beginning after December 

31, 2016. 

(c) AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.— (1) IN GENERAL.—Section 2791(a)(1) of the Public Health 

Service Act (42 U.S.C. 300gg–91(a)(1)) is amended by adding 

at the end the following: ‘‘Except for purposes of part C of 

title XI of the Social Security Act (42 U.S.C. 1320d et seq.), 

such term shall not include any qualified small employer health 

reimbursement arrangement (as defined in section 9831(d)(2) 

of the Internal Revenue Code of 1986).’’. 

(2) EXCEPTION FROM CONTINUATION COVERAGE REQUIREMENTS.—Section 2208(1) of the Public Health Service Act (42 

U.S.C. 300bb–8(1)) is amended by adding at the end the following: ‘‘Such term shall not include any qualified small 

employer health reimbursement arrangement (as defined in 

section 9831(d)(2) of the Internal Revenue Code of 1986).’’. 

(3) EFFECTIVE DATE.—The amendments made by this subsection shall apply to plan years beginning after December 

31, 2016. 

Approved December 13, 2016. 

42 USC 300bb–8 

note. 

29 USC 1167 

note. 


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