In the House of Representatives, U. S., 

November 30, 2016. 

Resolved, That the House agree to the amendment of the 

Senate to the bill (H.R. 34) entitled ‘‘An Act to authorize 

and strengthen the tsunami detection, forecast, warning, research, and mitigation program of the National Oceanic and 

Atmospheric Administration, and for other purposes.’’, with 

the following 

HOUSE AMENDMENT TO SENATE AMENDMENT: 

In lieu of the matter proposed to be added after the 

enacting clause, insert the following: 

1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the ‘‘21st 

3 Century Cures Act’’. 

4 (b) TABLE OF CONTENTS.—The table of contents for 

5 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. 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. 
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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. 

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. 
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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. 

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. 
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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. 
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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. 

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. 
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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. 

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. 
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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. 
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Sec. 14010. School mental health crisis intervention teams. 

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

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. 
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TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B 

Sec. 16001. Continuing Medicare payment under HOPD prospective payment 

system for services furnished by mid-build off-campus outpatient 

departments of providers. 

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

a provider policy. 

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

meaningful use and MIPS. 

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

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

wheelchair accessories and seating systems when used in conjunction with complex rehabilitation technology (CRT) wheelchairs. 

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

under Medicare. 

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

equipment under the Medicare program. 

Sec. 16008. Requirements in determining adjustments using information from 

competitive bidding programs. 

TITLE XVII—OTHER MEDICARE PROVISIONS 

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

plans failing to achieve minimum quality ratings. 

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. 

1 DIVISION A—21ST CENTURY 

2 CURES 

3 SEC. 1000. SHORT TITLE. 

4 This Division may be cited as the ‘‘21st Century Cures 

5 Act’’. 
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1 TITLE I—INNOVATION 

2 PROJECTS AND STATE RE3 SPONSES TO OPIOID ABUSE 

4 SEC. 1001. NIH INNOVATION PROJECTS. 

5 (a) IN GENERAL.—The Director of the National Insti6 tutes of Health (referred to in this section as the ‘‘Director 

7 of NIH’’) shall use any funds appropriated pursuant to the 

8 authorization of appropriations in subsection (b)(3) to 

9 carry out the National Institutes of Health innovation 

10 projects described in subsection (b)(4) (referred to in this 

11 section as the ‘‘NIH Innovation Projects’’). 

12 (b) NATIONAL INSTITUTES OF HEALTH INNOVATION

13 ACCOUNT.— 

14 (1) ESTABLISHMENT OF NIH INNOVATION AC15 COUNT.—There is established in the Treasury an ac16 count, to be known as the ‘‘NIH Innovation Account’’ 

17 (referred to in this subsection as the ‘‘Account’’), for 

18 purposes of carrying out the NIH Innovation Projects 

19 described in paragraph (4). 

20 (2) TRANSFER OF DIRECT SPENDING SAVINGS.— 

21 (A) IN GENERAL.—The following amounts 

22 shall be transferred to the Account from the gen23 eral fund of the Treasury: 

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

25 (ii) For fiscal year 2018, $496,000,000. 
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1 (iii) For fiscal year 2019, 

2 $711,000,000. 

3 (iv) For fiscal year 2020, 

4 $492,000,000. 

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

6 (vi) For fiscal year 2022, 

7 $496,000,000. 

8 (vii) For fiscal year 2023, 

9 $1,085,000,000. 

10 (viii) For fiscal year 2024, 

11 $407,000,000. 

12 (ix) For fiscal year 2025, 

13 $127,000,000. 

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

15 (B) AMOUNTS DEPOSITED.—Any amounts 

16 transferred under subparagraph (A) shall re17 main unavailable in the Account until such 

18 amounts are appropriated pursuant to para19 graph (3). 

20 (3) APPROPRIATIONS.— 

21 (A) AUTHORIZATION OF APPROPRIA22 TIONS.—For each of the fiscal years 2017 

23 through 2026, there is authorized to be appro24 priated from the Account to the Director of NIH, 

25 for the purpose of carrying out the NIH Innova-
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1 tion Projects, an amount not to exceed the total 

2 amount transferred to the Account under para3 graph (2)(A), to remain available until ex4 pended. 

5 (B) OFFSETTING FUTURE APPROPRIA6 TIONS.—For any of fiscal years 2017 through 

7 2026, for any discretionary appropriation under 

8 the heading ‘‘NIH Innovation Account’’ provided 

9 to the Director of NIH pursuant to the author10 ization of appropriations under subparagraph 

11 (A) for the purpose of carrying out the NIH In12 novation Projects, the total amount of such ap13 propriations for the applicable fiscal year (not to 

14 exceed the total amount remaining in the Ac15 count) shall be subtracted from the estimate of 

16 discretionary budget authority and the resulting 

17 outlays for any estimate under the Congressional 

18 Budget and Impoundment Control Act of 1974 

19 or the Balanced Budget and Emergency Deficit 

20 Control Act of 1985, and the amount transferred 

21 to the Account shall be reduced by the same 

22 amount. 

23 (4) NIH INNOVATION PROJECTS.—NIH Innova24 tion Projects authorized to be funded under this sec25 tion shall consist of the following and, of the total 
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1 amounts authorized to be appropriated under para2 graph (3), there are authorized to be appropriated to 

3 each such project a total amount not to exceed the fol4 lowing, over the period of fiscal years 2017 through 

5 2026: 

6 (A) For the Precision Medicine Initiative, 

7 including for the advancement of a cohort of in8 dividuals to support the goals of the Precision 

9 Medicine Initiative, not to exceed a total of 

10 $1,455,000,000, as follows: 

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

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

13 (iii) For fiscal year 2019, 

14 $186,000,000. 

15 (iv) For fiscal year 2020, 

16 $149,000,000. 

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

18 (vi) For fiscal year 2022, 

19 $150,000,000. 

20 (vii) For fiscal year 2023, 

21 $419,000,000. 

22 (viii) For fiscal year 2024, 

23 $235,000,000. 

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

25 (x) For fiscal year 2026, $31,000,000. 
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1 (B) For the Brain Research through Ad2 vancing Innovative Neurotechnologies Initiative 

3 (known as the ‘‘BRAIN Initiative’’), not to ex4 ceed a total of $1,511,000,000, as follows: 

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

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

7 (iii) For fiscal year 2019, 

8 $115,000,000. 

9 (iv) For fiscal year 2020, 

10 $140,000,000. 

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

12 (vi) For fiscal year 2022, 

13 $152,000,000. 

14 (vii) For fiscal year 2023, 

15 $450,000,000. 

16 (viii) For fiscal year 2024, 

17 $172,000,000. 

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

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

20 (C) To support cancer research, such as the 

21 development of cancer vaccines, the development 

22 of more sensitive diagnostic tests for cancer, 

23 immunotherapy and the development of com24 bination therapies, and research that has the po25 tential to transform the scientific field, that has 
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1 inherently higher risk, and that seeks to address 

2 major challenges related to cancer, not to exceed 

3 a total of $1,800,000,000, as follows: 

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

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

6 (iii) For fiscal year 2019, 

7 $400,000,000. 

8 (iv) For fiscal year 2020, 

9 $195,000,000. 

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

11 (vi) For fiscal year 2022, 

12 $194,000,000. 

13 (vii) For fiscal year 2023, 

14 $216,000,000. 

15 (D) For the National Institutes of Health, 

16 in coordination with the Food and Drug Admin17 istration, to award grants and contracts for clin18 ical research to further the field of regenerative 

19 medicine using adult stem cells, including 

20 autologous stem cells, for which grants and con21 tracts shall be contingent upon the recipient 

22 making available non-Federal contributions to23 ward the costs of such research in an amount not 

24 less than $1 for each $1 of Federal funds pro-
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1 vided in the award, not to exceed a total of 

2 $30,000,000, as follows: 

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

4 (ii) For each of fiscal years 2018 and 

5 2019, $10,000,000. 

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

7 (iv) For each of fiscal years 2021 

8 through 2026, $0. 

9 (c) ACCOUNTABILITY AND OVERSIGHT.— 

10 (1) WORK PLAN.— 

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

12 after the date of enactment of this Act, the Direc13 tor of NIH shall submit to the Committee on 

14 Health, Education, Labor, and Pensions and the 

15 Committee on Appropriations of the Senate and 

16 the Committee on Energy and Commerce and the 

17 Committee on Appropriations of the House of 

18 Representatives, a work plan including the pro19 posed allocation of funds authorized to be appro20 priated pursuant to subsection (b)(3) for each of 

21 fiscal years 2017 through 2026 for the NIH In22 novation Projects and the contents described in 

23 subparagraph (B). 

24 (B) CONTENTS.—The work plan submitted 

25 under subparagraph (A) shall include— 
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1 (i) recommendations from the Advisory 

2 Committee described in subparagraph (C); 

3 (ii) the amount of money to be obli4 gated or expended in each fiscal year for 

5 each NIH Innovation Project; 

6 (iii) a description and justification of 

7 each such project; and 

8 (iv) a description of how each such 

9 project supports the strategic research prior10 ities identified in the NIH Strategic Plan 

11 under subsection (m) of section 402 of the 

12 Public Health Service Act (42 U.S.C. 282), 

13 as added by section 2031. 

14 (C) RECOMMENDATIONS.—Prior to submit15 ting the work plan under this paragraph, the Di16 rector of NIH shall seek recommendations from 

17 the Advisory Committee to the Director of NIH 

18 appointed under section 222 of the Public Health 

19 Service Act (42 U.S.C. 217a) on— 

20 (i) the allocations of funds appro21 priated pursuant to the authorization of ap22 propriations under subsection (b)(3) for 

23 each of fiscal years 2017 through 2026; and 

24 (ii) on the contents of the proposed 

25 work plan. 
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1 (2) REPORTS.— 

2 (A) ANNUAL REPORTS.—Not later than Oc3 tober 1 of each of fiscal years 2018 through 2027, 

4 the Director of NIH shall submit to the Com5 mittee on Health, Education, Labor, and Pen6 sions and the Committee on Appropriations of 

7 the Senate and the Committee on Energy and 

8 Commerce and the Committee on Appropriations 

9 of the House of Representatives, a report includ10 ing— 

11 (i) the amount of money obligated or 

12 expended in the prior fiscal year for each 

13 NIH Innovation Project; 

14 (ii) a description of any such project 

15 using funds provided pursuant to the au16 thorization of appropriations under sub17 section (b)(3); and 

18 (iii) whether such projects are advanc19 ing the strategic research priorities identi20 fied in the NIH Strategic Plan under sub21 section (m) of section 402 of the Public 

22 Health Service Act (42 U.S.C. 282), as 

23 added by section 2031. 

24 (B) ADDITIONAL REPORTS.—At the request 

25 of the Committee on Health, Education, Labor, 
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1 and Pensions or the Committee on Appropria2 tions of the Senate, or the Committee on Energy 

3 and Commerce or the Committee on Appropria4 tions of the House of Representatives, the Direc5 tor of NIH shall provide an update in the form 

6 of testimony and any additional reports to the 

7 respective congressional committee regarding the 

8 allocation of funding under this section or the 

9 description of the NIH Innovation Projects. 

10 (d) LIMITATIONS.—Notwithstanding any transfer au11 thority authorized by this Act or any appropriations Act, 

12 any funds made available pursuant to the authorization of 

13 appropriations under subsection (b)(3) may not be used for 

14 any purpose other than a NIH Innovation Project. 

15 (e) SUNSET.—This section shall expire on September 

16 30, 2026. 

17 SEC. 1002. FDA INNOVATION PROJECTS. 

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

19 Drugs (referred to in this section as the ‘‘Commissioner’’) 

20 shall use any funds appropriated pursuant to the author21 ization of appropriations under subsection (b)(3) to carry 

22 out the activities described in subsection (b)(4). 

23 (b) FDA INNOVATION ACCOUNT.— 

24 (1) ESTABLISHMENT OF FDA INNOVATION AC25 COUNT.—There is established in the Treasury an ac-
20 

•HR 34 EAH 

1 count, to be known as the ‘‘FDA Innovation Account’’ 

2 (referred to in this subsection as the ‘‘Account’’), for 

3 purposes of carrying out the activities described in 

4 paragraph (4). 

5 (2) TRANSFER OF DIRECT SPENDING SAVINGS.— 

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

7 2017 through 2025, the following amounts shall 

8 be transferred to the Account from the general 

9 fund of the Treasury: 

10 (i) For fiscal year 2017, $20,000,000. 

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

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

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

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

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

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

17 (viii) For fiscal year 2024, 

18 $50,000,000. 

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

20 (B) AMOUNTS DEPOSITED.—Any amounts 

21 transferred under subparagraph (A) shall re22 main unavailable in the Account until such 

23 amounts are appropriated pursuant to para24 graph (3). 

25 (3) APPROPRIATIONS.— 
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•HR 34 EAH 

1 (A) AUTHORIZATION OF APPROPRIA2 TIONS.—For each of the fiscal years 2017 

3 through 2025, there is authorized to be appro4 priated from the Account to the Commissioner, 

5 for the purpose of carrying out the activities de6 scribed in paragraph (5), an amount not to ex7 ceed the total amount transferred to the Account 

8 under paragraph (2)(A), to remain available 

9 until expended. 

10 (B) OFFSETTING FUTURE APPROPRIA11 TIONS.—For any of fiscal years 2017 through 

12 2025, for any discretionary appropriation under 

13 the heading ‘‘FDA Innovation Account’’ provided 

14 to the Commissioner pursuant to the authoriza15 tion of appropriations under subparagraph (A) 

16 for the purpose of carrying out the projects ac17 tivities described in paragraph (4), the total 

18 amount of such appropriations in the applicable 

19 fiscal year (not to exceed the total amount re20 maining in the Account) shall be subtracted from 

21 the estimate of discretionary budget authority 

22 and the resulting outlays for any estimate under 

23 the Congressional Budget and Impoundment 

24 Control Act of 1974 or the Balanced Budget and 

25 Emergency Deficit Control Act of 1985, and the 
22 

•HR 34 EAH 

1 amount transferred to the Account shall be re2 duced by the same amount. 

3 (4) FDA ACTIVITIES.—The activities authorized 

4 to be funded under this section are the activities 

5 under subtitles A through F (including the amend6 ments made by such subtitles) of title III of this Act 

7 and section 1014 of the Federal Food, Drug, and Cos8 metic Act, as added by section 3073 of this Act. 

9 (c) ACCOUNTABILITY AND OVERSIGHT.— 

10 (1) WORK PLAN.— 

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

12 after the date of enactment of this Act, the Com13 missioner shall submit to the Committee on 

14 Health, Education, Labor, and Pensions and the 

15 Committee on Appropriations of the Senate and 

16 the Committee on Energy and Commerce and the 

17 Committee on Appropriations of the House of 

18 Representatives, a work plan including the pro19 posed allocation of funds appropriated pursuant 

20 to the authorization of appropriations under 

21 subsection (b)(3) for each of fiscal years 2017 

22 through 2025 and the contents described in sub23 paragraph (B). 

24 (B) CONTENTS.—The work plan submitted 

25 under subparagraph (A) shall include— 
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•HR 34 EAH 

1 (i) recommendations from the Advisory 

2 Committee described in subparagraph (C); 

3 (ii) the amount of money to be obli4 gated or expended in each fiscal year for 

5 each activity described in subsection (b)(4); 

6 and 

7 (iii) a description and justification of 

8 each such project activity. 

9 (C) RECOMMENDATIONS.—Prior to submit10 ting the work plan under this paragraph, the 

11 Commissioner shall seek recommendations from 

12 the Science Board to the Food and Drug Admin13 istration, on the proposed allocation of funds ap14 propriated pursuant to the authorization of ap15 propriations under subsection (b)(3) for each of 

16 fiscal years 2017 through 2025 and on the con17 tents of the proposed work plan. 

18 (2) REPORTS.— 

19 (A) ANNUAL REPORTS.—Not later than Oc20 tober 1 of each of fiscal years 2018 through 2026, 

21 the Commissioner shall submit to the Committee 

22 on Health, Education, Labor, and Pensions and 

23 the Committee on Appropriations of the Senate 

24 and the Committee on Energy and Commerce 
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•HR 34 EAH 

1 and the Committee on Appropriations of the 

2 House of Representatives, a report including— 

3 (i) the amount of money obligated or 

4 expended in the prior fiscal year for each 

5 activity described in subsection (b)(4); 

6 (ii) a description of all such activities 

7 using funds provided pursuant to the au8 thorization of appropriations under sub9 section (b)(3); and 

10 (iii) how the activities are advancing 

11 public health. 

12 (B) ADDITIONAL REPORTS.—At the request 

13 of the Committee on Health, Education, Labor, 

14 and Pensions or the Committee on Appropria15 tions of the Senate, or the Committee on Energy 

16 and Commerce or the Committee on Appropria17 tions of the House of Representatives, the Com18 missioner shall provide an update in the form of 

19 testimony and any additional reports to the re20 spective congressional committee regarding the 

21 allocation of funding under this section or the 

22 description of the activities undertaken with such 

23 funding. 

24 (d) LIMITATIONS.—Notwithstanding any transfer au25 thority authorized by this Act or any appropriations Act, 
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•HR 34 EAH 

1 any funds made available pursuant to the authorization of 

2 appropriations in subsection (b)(3) shall not be used for 

3 any purpose other than an activity described in subsection 

4 (b)(4). 

5 (e) SUNSET.—This section shall expire on September 

6 30, 2025. 

7 SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE 

8 OPIOID ABUSE CRISIS. 

9 (a) IN GENERAL.—The Secretary of Health and 

10 Human Services (referred to in this section as the ‘‘Sec11 retary’’) shall use any funds appropriated pursuant to the 

12 authorization of appropriations under subsection (b) to 

13 carry out the grant program described in subsection (c) for 

14 purposes of addressing the opioid abuse crisis within the 

15 States. 

16 (b) ACCOUNT FOR THE STATE RESPONSE TO THE

17 OPIOID ABUSE CRISIS.— 

18 (1) ESTABLISHMENT.—There is established in 

19 the Treasury an account, to be known as the ‘‘Account 

20 For the State Response to the Opioid Abuse Crisis’’ 

21 (referred to in this subsection as the ‘‘Account’’), to 

22 carry out the opioid grant program described in sub23 section (c). 

24 (2) TRANSFER OF DIRECT SPENDING SAVINGS.— 
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•HR 34 EAH 

1 (A) IN GENERAL.—The following amounts 

2 shall be transferred to the Account from the gen3 eral fund of the Treasury: 

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

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

6 (B) AMOUNTS DEPOSITED.—Any amounts 

7 transferred under subparagraph (A) shall re8 main unavailable in the Account until such 

9 amounts are appropriated pursuant to para10 graph (3). 

11 (3) APPROPRIATIONS.— 

12 (A) AUTHORIZATION OF APPROPRIA13 TIONS.—In each of the fiscal years 2017 and 

14 2018, there is authorized to be appropriated from 

15 the Account to the Secretary, for the grant pro16 gram described in subsection (c), an amount not 

17 to exceed the total amount transferred to the Ac18 count under paragraph (2)(A), to remain avail19 able until expended. 

20 (B) OFFSETTING FUTURE APPROPRIA21 TIONS.—In each of fiscal years 2017 and 2018, 

22 for any discretionary appropriation under the 

23 heading ‘‘Account For the State Response to the 

24 Opioid Abuse Crisis’’ for the grant program de25 scribed in subsection (c), the total amount of 
27 

•HR 34 EAH 

1 such appropriations in the applicable fiscal year 

2 (not to exceed the total amount remaining in the 

3 Account) shall be subtracted from the estimate of 

4 discretionary budget authority and the resulting 

5 outlays for any estimate under the Congressional 

6 Budget and Impoundment Control Act of 1974 

7 or the Balanced Budget and Emergency Deficit 

8 Control Act of 1985, and the amount transferred 

9 to the Account shall be reduced by the same 

10 amount. 

11 (c) OPIOID GRANT PROGRAM.— 

12 (1) STATE RESPONSE TO THE OPIOID ABUSE

13 CRISIS.—Subject to the availability of appropriations, 

14 the Secretary shall award grants to States for the 

15 purpose of addressing the opioid abuse crisis within 

16 such States, in accordance with subparagraph (B). In 

17 awarding such grants, the Secretary shall give pref18 erence to States with an incidence or prevalence of 

19 opioid use disorders that is substantially higher rel20 ative to other States. 

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

22 under this subsection shall be used for carrying out 

23 activities that supplement activities pertaining to 

24 opioids undertaken by the State agency responsible 

25 for administering the substance abuse prevention and 
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•HR 34 EAH 

1 treatment block grant under subpart II of part B of 

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

3 300x–21 et seq.), which may include public health-re4 lated activities such as the following: 

5 (A) Improving State prescription drug 

6 monitoring programs. 

7 (B) Implementing prevention activities, and 

8 evaluating such activities to identify effective 

9 strategies to prevent opioid abuse. 

10 (C) Training for health care practitioners, 

11 such as best practices for prescribing opioids, 

12 pain management, recognizing potential cases of 

13 substance abuse, referral of patients to treatment 

14 programs, and overdose prevention. 

15 (D) Supporting access to health care serv16 ices, including those services provided by Feder17 ally certified opioid treatment programs or other 

18 appropriate health care providers to treat sub19 stance use disorders. 

20 (E) Other public health-related activities, as 

21 the State determines appropriate, related to ad22 dressing the opioid abuse crisis within the State. 

23 (d) ACCOUNTABILITY AND OVERSIGHT.—A State re24 ceiving a grant under subsection (c) shall include in a re25 port related to substance abuse submitted to the Secretary 
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•HR 34 EAH 

1 pursuant to section 1942 of the Public Health Service Act 

2 (42 U.S.C. 300x–52), a description of— 

3 (1) the purposes for which the grant funds re4 ceived by the State under such subsection for the pre5 ceding fiscal year were expended and a description of 

6 the activities of the State under the program; and 

7 (2) the ultimate recipients of amounts provided 

8 to the State in the grant. 

9 (e) LIMITATIONS.—Any funds made available pursu10 ant to the authorization of appropriations under subsection 

11 (b)— 

12 (1) notwithstanding any transfer authority in 

13 any appropriations Act, shall not be used for any 

14 purpose other than the grant program in subsection 

15 (c); and 

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

17 substance abuse prevention and treatment programs 

18 under titles V and XIX of the Public Health Service 

19 Act (42 U.S.C. 290aa et seq., 300w et seq.). 

20 (f) SUNSET.—This section shall expire on September 

21 30, 2026. 

22 SEC. 1004. BUDGETARY TREATMENT. 

23 (a) STATUTORY PAYGO SCORECARDS.—The budgetary 

24 effects of division A of this Act shall not be entered on either 
30 

•HR 34 EAH 

1 PAYGO scorecard maintained pursuant to section 4(d) of 

2 the Statutory Pay-As-You-Go Act of 2010. 

3 (b) SENATE PAYGO SCORECARDS.—The budgetary ef4 fects of division A of this Act shall not be entered on any 

5 PAYGO scorecard maintained for purposes of section 201 

6 of S. Con. Res. 21 (110th Congress). 

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

8 the NIH Innovation Account, the FDA Innovation Account, 

9 or the Account For the State Response to the Opioid Abuse 

10 Crisis established by this title shall be made available except 

11 to the extent provided in advance in appropriations Acts, 

12 and legislation or an Act that rescinds or reduces amounts 

13 in such accounts shall not be estimated as a reduction in 

14 direct spending under the Congressional Budget and Im15 poundment Control Act of 1974 or the Balanced Budget and 

16 Emergency Deficit Control Act of 1985. 

17 TITLE II—DISCOVERY 

18 Subtitle A—National Institutes of 

19 Health Reauthorization 

20 SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHOR21 IZATION. 

22 Section 402A(a)(1) of the Public Health Service Act 

23 (42 U.S.C. 282a(a)(1)) is amended— 

24 (1) in subparagraph (B), by striking ‘‘and’’ at 

25 the end; 
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•HR 34 EAH 

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

2 at the end and inserting a semicolon; and 

3 (3) by adding at the end the following new sub4 paragraphs: 

5 ‘‘(D) $34,851,000,000 for fiscal year 2018; 

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

7 and 

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

9 SEC. 2002. EUREKA PRIZE COMPETITIONS. 

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

11 processes established under section 24 of the Stevenson12 Wydler Technology Innovation Act of 1980 (15 U.S.C. 

13 3719), the Director of the National Institutes of Health shall 

14 support prize competitions for one or both of the following 

15 goals: 

16 (1) Identifying and funding areas of biomedical 

17 science that could realize significant advancements 

18 through a prize competition. 

19 (2) Improving health outcomes, particularly with 

20 respect to human diseases and conditions— 

21 (A) for which public and private investment 

22 in research is disproportionately small relative 

23 to Federal Government expenditures on preven24 tion and treatment activities with respect to such 
32 

•HR 34 EAH 

1 diseases and conditions, such that Federal ex2 penditures on health programs would be reduced; 

3 (B) that are serious and represent a signifi4 cant disease burden in the United States; or 

5 (C) for which there is potential for signifi6 cant return on investment to the United States. 

7 (b) TRACKING; REPORTING.—The Director of the Na8 tional Institutes of Health shall— 

9 (1) collect information on— 

10 (A) the effect of innovations funded through 

11 the prize competitions under this section in ad12 vancing biomedical science or improving health 

13 outcomes pursuant to subsection (a); and 

14 (B) the effect of the innovations on Federal 

15 expenditures; and 

16 (2) include the information collected under para17 graph (1) in the triennial report under section 403 of 

18 the Public Health Service Act (42 U.S.C. 283) (as 

19 amended by section 2032). 

20 Subtitle B—Advancing Precision 

21 Medicine 

22 SEC. 2011. PRECISION MEDICINE INITIATIVE. 

23 Part H of title IV of the Public Health Service Act 

24 (42 U.S.C. 289 et seq.) is amended by adding at the end 

25 the following: 
33 

•HR 34 EAH 

1 ‘‘SEC. 498E. PRECISION MEDICINE INITIATIVE. 

2 ‘‘(a) IN GENERAL.—The Secretary is encouraged to es3 tablish and carry out an initiative, to be known as the ‘Pre4 cision Medicine Initiative’ (in this section referred to as 

5 the ‘Initiative’), to augment efforts to address disease pre6 vention, diagnosis, and treatment. 

7 ‘‘(b) COMPONENTS.—The Initiative described under 

8 subsection (a) may include— 

9 ‘‘(1) developing a network of scientists to assist 

10 in carrying out the purposes of the Initiative; 

11 ‘‘(2) developing new approaches for addressing 

12 scientific, medical, public health, and regulatory 

13 science issues; 

14 ‘‘(3) applying genomic technologies, such as 

15 whole genomic sequencing, to provide data on the mo16 lecular basis of disease; 

17 ‘‘(4) collecting information voluntarily provided 

18 by a diverse cohort of individuals that can be used to 

19 better understand health and disease; and 

20 ‘‘(5) other activities to advance the goals of the 

21 Initiative, as the Secretary determines appropriate. 

22 ‘‘(c) AUTHORITY OF THE SECRETARY.—In carrying 

23 out this section, the Secretary may— 

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

25 private industry, and others, as the Secretary deter26 mines appropriate, to identify and address the ad-
34 

•HR 34 EAH 

1 vanced supercomputing and other advanced tech2 nology needs for the Initiative; 

3 ‘‘(2) develop and utilize public-private partner4 ships; and 

5 ‘‘(3) leverage existing data sources. 

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

7 Initiative under subsection (a), the Secretary shall— 

8 ‘‘(1) ensure the collaboration of the National In9 stitutes of Health, the Food and Drug Administra10 tion, the Office of the National Coordinator for 

11 Health Information Technology, and the Office for 

12 Civil Rights of the Department of Health and Human 

13 Services; 

14 ‘‘(2) comply with existing laws and regulations 

15 for the protection of human subjects involved in re16 search, including the protection of participant pri17 vacy; 

18 ‘‘(3) implement policies and mechanisms for ap19 propriate secure data sharing across systems that in20 clude protections for privacy and security of data; 

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

22 inclusion of a broad range of participants, including 

23 consideration of biological, social, and other deter24 minants of health that contribute to health dispari25 ties; 
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•HR 34 EAH 

1 ‘‘(5) ensure that only authorized individuals 

2 may access controlled or sensitive, identifiable biologi3 cal material and associated information collected or 

4 stored in connection with the Initiative; and 

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

6 Department of Health and Human Services, identify 

7 any entities with access to such information and pro8 vide information with respect to the purpose of such 

9 access, a summary of the research project for which 

10 such access is granted, as applicable, and a descrip11 tion of the biological material and associated infor12 mation to which the entity has access. 

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

14 of enactment of the 21st Century Cures Act, the Secretary 

15 shall submit a report on the relevant data access policies 

16 and procedures to the Committee on Health, Education, 

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

18 Energy and Commerce of the House of Representatives. 

19 Such report shall include steps the Secretary has taken to 

20 consult with experts or other heads of departments or agen21 cies of the Federal Government in the development of such 

22 policies.’’. 
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1 SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH 

2 SUBJECTS. 

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

4 Public Health Service Act (42 U.S.C. 241) is amended to 

5 read as follows: 

6 ‘‘(d)(1)(A) If a person is engaged in biomedical, behav7 ioral, clinical, or other research, in which identifiable, sen8 sitive information is collected (including research on mental 

9 health and research on the use and effect of alcohol and 

10 other psychoactive drugs), the Secretary, in coordination 

11 with other agencies, as applicable— 

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

13 confidentiality to protect the privacy of individuals 

14 who are the subjects of such research if the research 

15 is funded wholly or in part by the Federal Govern16 ment; and 

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

18 in research, issue to such person a certificate of con19 fidentiality to protect the privacy of such individuals 

20 if the research is not so funded. 

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

22 person to whom a certificate is issued under subparagraph 

23 (A) to protect the privacy of individuals described in such 

24 subparagraph shall not disclose or provide to any other per25 son not connected with the research the name of such an 

26 individual or any information, document, or biospecimen 
37 

•HR 34 EAH 

1 that contains identifiable, sensitive information about such 

2 an individual and that was created or compiled for pur3 poses of the research. 

4 ‘‘(C) The disclosure prohibition in subparagraph (B) 

5 shall not apply to disclosure or use that is— 

6 ‘‘(i) required by Federal, State, or local laws, ex7 cluding instances described in subparagraph (D); 

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

9 individual to whom the information, document, or 

10 biospecimen pertains and made with the consent of 

11 such individual; 

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

13 whom the information, document, or biospecimen per14 tains; or 

15 ‘‘(iv) made for the purposes of other scientific re16 search that is in compliance with applicable Federal 

17 regulations governing the protection of human sub18 jects in research. 

19 ‘‘(D) Any person to whom a certificate is issued under 

20 subparagraph (A) to protect the privacy of an individual 

21 described in such subparagraph shall not, in any Federal, 

22 State, or local civil, criminal, administrative, legislative, 

23 or other proceeding, disclose or provide the name of such 

24 individual or any such information, document, or biospeci25 men that contains identifiable, sensitive information about 
38 

•HR 34 EAH 

1 the individual and that was created or compiled for pur2 poses of the research, except in the circumstance described 

3 in subparagraph (C)(iii). 

4 ‘‘(E) Identifiable, sensitive information protected 

5 under subparagraph (A), and all copies thereof, shall be im6 mune from the legal process, and shall not, without the con7 sent of the individual to whom the information pertains, 

8 be admissible as evidence or used for any purpose in any 

9 action, suit, or other judicial, legislative, or administrative 

10 proceeding. 

11 ‘‘(F) Identifiable, sensitive information collected by a 

12 person to whom a certificate has been issued under subpara13 graph (A), and all copies thereof, shall be subject to the pro14 tections afforded by this section for perpetuity. 

15 ‘‘(G) The Secretary shall take steps to minimize the 

16 burden to researchers, streamline the process, and reduce 

17 the time it takes to comply with the requirements of this 

18 subsection. 

19 ‘‘(2) The Secretary shall coordinate with the heads of 

20 other applicable Federal agencies to ensure that such de21 partments have policies in place with respect to the issuance 

22 of a certificate of confidentiality pursuant to paragraph (1) 

23 and other requirements of this subsection. 

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

25 limit the access of an individual who is a subject of research 
39 

•HR 34 EAH 

1 to information about himself or herself collected during such 

2 individual’s participation in the research. 

3 ‘‘(4) For purposes of this subsection, the term ‘identifi4 able, sensitive information’ means information that is 

5 about an individual and that is gathered or used during 

6 the course of research described in paragraph (1)(A) and— 

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

8 or 

9 ‘‘(B) for which there is at least a very small risk, 

10 as determined by current scientific practices or statis11 tical methods, that some combination of the informa12 tion, a request for the information, and other avail13 able data sources could be used to deduce the identity 

14 of an individual.’’. 

15 (b) APPLICABILITY.—Beginning 180 days after the 

16 date of enactment of this Act, all persons engaged in re17 search and authorized by the Secretary of Health and 

18 Human Services to protect information under section 

19 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) 

20 prior to the date of enactment of this Act shall be subject 

21 to the requirements of such section (as amended by this 

22 Act). 
40 

•HR 34 EAH 

1 SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE 

2 INFORMATION. 

3 Section 301 of the Public Health Service Act (42 

4 U.S.C. 241) is amended by adding at the end the following: 

5 ‘‘(f)(1) The Secretary may exempt from disclosure 

6 under section 552(b)(3) of title 5, United States Code, bio7 medical information that is about an individual and that 

8 is gathered or used during the course of biomedical research 

9 if— 

10 ‘‘(A) an individual is identified; or 

11 ‘‘(B) there is at least a very small risk, as deter12 mined by current scientific practices or statistical 

13 methods, that some combination of the information, 

14 the request, and other available data sources could be 

15 used to deduce the identity of an individual. 

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

17 paragraph (1) to exempt information from disclosure shall 

18 be made in writing and accompanied by a statement of the 

19 basis for the determination. 

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

21 shall be available to the public, upon request, through the 

22 Office of the Chief FOIA Officer of the Department of 

23 Health and Human Services. 

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

25 limit a research participant’s access to information about 
41 

•HR 34 EAH 

1 such participant collected during the participant’s partici2 pation in the research.’’. 

3 SEC. 2014. DATA SHARING. 

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

5 Service Act (42 U.S.C. 282(b)) is amended— 

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

7 end; 

8 (2) in paragraph (24), by striking the period 

9 and inserting ‘‘; and’’; and 

10 (3) by inserting after paragraph (24) the fol11 lowing: 

12 ‘‘(25) may require recipients of National Insti13 tutes of Health awards to share scientific data, to the 

14 extent feasible, generated from such National Insti15 tutes of Health awards in a manner that is consistent 

16 with all applicable Federal laws and regulations, in17 cluding such laws and regulations for the protection 

18 of— 

19 ‘‘(A) human research participants, includ20 ing with respect to privacy, security, informed 

21 consent, and protected health information; and 

22 ‘‘(B) proprietary interests, confidential 

23 commercial information, and the intellectual 

24 property rights of the funding recipient.’’. 
42 

•HR 34 EAH 

1 (b) CONFIDENTIALITY.—Nothing in the amendments 

2 made by subsection (a) authorizes the Secretary of Health 

3 and Human Services to disclose any information that is 

4 a trade secret, or other privileged or confidential informa5 tion, described in section 552(b)(4) of title 5, United States 

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

7 be construed to require recipients of grants or cooperative 

8 agreements through the National Institutes of Health to 

9 share such information. 

10 Subtitle C—Supporting Young 

11 Emerging Scientists 

12 SEC. 2021. INVESTING IN THE NEXT GENERATION OF RE13 SEARCHERS. 

14 (a) IN GENERAL.—Part A of title IV of the Public 

15 Health Service Act (42 U.S.C. 281 et seq.) is amended by 

16 adding at the end the following: 

17 ‘‘SEC. 404M. NEXT GENERATION OF RESEARCHERS. 

18 ‘‘(a) NEXT GENERATION OF RESEARCHERS INITIA19 TIVE.—There shall be established within the Office of the 

20 Director of the National Institutes of Health, the Next Gen21 eration of Researchers Initiative (referred to in this section 

22 as the ‘Initiative’), through which the Director shall coordi23 nate all policies and programs within the National Insti24 tutes of Health that are focused on promoting and pro-
43 

•HR 34 EAH 

1 viding opportunities for new researchers and earlier re2 search independence. 

3 ‘‘(b) ACTIVITIES.—The Director of the National Insti4 tutes of Health, through the Initiative shall— 

5 ‘‘(1) promote policies and programs within the 

6 National Institutes of Health that are focused on im7 proving opportunities for new researchers and pro8 moting earlier research independence, including exist9 ing policies and programs, as appropriate; 

10 ‘‘(2) develop, modify, or prioritize policies, as 

11 needed, within the National Institutes of Health to 

12 promote opportunities for new researchers and earlier 

13 research independence, such as policies to increase op14 portunities for new researchers to receive funding, en15 hance training and mentorship programs for re16 searchers, and enhance workforce diversity; 

17 ‘‘(3) coordinate, as appropriate, with relevant 

18 agencies, professional and academic associations, aca19 demic institutions, and others, to improve and update 

20 existing information on the biomedical research work21 force in order to inform programs related to the 

22 training, recruitment, and retention of biomedical re23 searchers; and 

24 ‘‘(4) carry out other activities, including evalua25 tion and oversight of existing programs, as appro-
44 

•HR 34 EAH 

1 priate, to promote the development of the next genera2 tion of researchers and earlier research independ3 ence.’’. 

4 (b) CONSIDERATION OF RECOMMENDATIONS.—In car5 rying out activities under section 404M(b) of the Public 

6 Health Service Act, the Director of the National Institutes 

7 of Health shall take into consideration the recommendations 

8 made by the National Academies of Sciences, Engineering, 

9 and Medicine as part of the comprehensive study on policies 

10 affecting the next generation of researchers under the De11 partment of Health and Human Services Appropriations 

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

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

14 and the Committee on Appropriations of the Senate, and 

15 the Committee on Energy and Commerce and the Com16 mittee on Appropriations of the House of Representatives, 

17 with respect to any actions taken by the National Institutes 

18 of Health based on the recommendations not later than 2 

19 years after the completion of the study required pursuant 

20 to the Department of Health and Human Services Appro21 priations Act, 2016. 

22 SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM. 

23 (a) INTRAMURAL LOAN REPAYMENT PROGRAM.—Sec24 tion 487A of the Public Health Service Act (42 U.S.C. 288– 

25 1) is amended— 
45 

•HR 34 EAH 

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

2 follows: ‘‘INTRAMURAL LOAN REPAYMENT PRO3 GRAM’’; 

4 (2) in subsection (a)— 

5 (A) by striking ‘‘The Secretary shall carry 

6 out a program’’ and inserting ‘‘The Director of 

7 the National Institutes of Health shall, as appro8 priate and based on workforce and scientific pri9 orities, carry out a program through the subcat10 egories listed in subsection (b)(1) (or modified 

11 subcategories as provided for in subsection 

12 (b)(2))’’; 

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

14 ‘‘conduct research’’; 

15 (C) by striking ‘‘research with respect to ac16 quired immune deficiency syndrome’’; and 

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

18 ‘‘$50,000’’; 

19 (3) by redesignating subsection (b) as subsection 

20 (d); 

21 (4) by inserting after subsection (a), the fol22 lowing: 

23 ‘‘(b) SUBCATEGORIES OF RESEARCH.— 
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•HR 34 EAH 

1 ‘‘(1) IN GENERAL.—In carrying out the program 

2 under subsection (a), the Director of the National In3 stitutes of Health— 

4 ‘‘(A) shall continue to focus on— 

5 ‘‘(i) general research; 

6 ‘‘(ii) research on acquired immune de7 ficiency syndrome; and 

8 ‘‘(iii) clinical research conducted by 

9 appropriately qualified health professional 

10 who are from disadvantaged backgrounds; 

11 and 

12 ‘‘(B) may focus on an area of emerging sci13 entific or workforce need. 

14 ‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUB15 CATEGORIES.—The Director of the National Institutes 

16 of Health may eliminate one or more subcategories 

17 provided for in paragraph (1) due to changes in 

18 workforce or scientific needs related to biomedical re19 search. The Director may establish other subcategory 

20 areas based on workforce and scientific priorities if 

21 the total number of subcategories does not exceed the 

22 number of subcategories listed in paragraph (1). 

23 ‘‘(c) LIMITATION.—The Director of the National Insti24 tutes of Health may not enter into a contract with a health 

25 professional pursuant to subsection (a) unless such profes-
47 

•HR 34 EAH 

1 sional has a substantial amount of education loans relative 

2 to income (as determined pursuant to guidelines issued by 

3 the Director).’’; and 

4 (5) by adding at the end the following: 

5 ‘‘(e) AVAILABILITY OF APPROPRIATIONS.—Amounts 

6 available for carrying out this section shall remain avail7 able until the expiration of the second fiscal year beginning 

8 after the fiscal year for which such amounts are made avail9 able.’’. 

10 (b) EXTRAMURAL LOAN REPAYMENT PROGRAM.—Sec11 tion 487B of the Public Health Service Act (42 U.S.C. 288– 

12 2) is amended— 

13 (1) by amending the section heading to read as 

14 follows: ‘‘EXTRAMURAL LOAN REPAYMENT PRO15 GRAM’’; 

16 (2) in subsection (a)— 

17 (A) by striking ‘‘The Secretary, in consulta18 tion with the Director of the Eunice Kennedy 

19 Shriver National Institute of Child Health and 

20 Human Development, shall establish a program’’ 

21 and inserting ‘‘IN GENERAL.—The Director of 

22 the National Institutes of Health shall, as appro23 priate and based on workforce and scientific pri24 orities, carry out a program through the subcat25 egories listed in subsection (b)(1) (or modified 
48 

•HR 34 EAH 

1 subcategories as provided for in subsection 

2 (b)(2)),’’; 

3 (B) by striking ‘‘(including graduate stu4 dents)’’; 

5 (C) by striking ‘‘with respect to contracep6 tion, or with respect to infertility,’’; and 

7 (D) by striking ‘‘service, not more than 

8 $35,000’’ and inserting ‘‘research, not more than 

9 $50,000’’; 

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

11 subsections (d) and (e), respectively; 

12 (4) by inserting after subsection (a), the fol13 lowing: 

14 ‘‘(b) SUBCATEGORIES OF RESEARCH.— 

15 ‘‘(1) IN GENERAL.—In carrying out the program 

16 under subsection (a), the Director of the National In17 stitutes of Health— 

18 ‘‘(A) shall continue to focus on— 

19 ‘‘(i) contraception or infertility re20 search; 

21 ‘‘(ii) pediatric research, including pe22 diatric pharmacological research; 

23 ‘‘(iii) minority health disparities re24 search; 

25 ‘‘(iv) clinical research; and 
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•HR 34 EAH 

1 ‘‘(v) clinical research conducted by ap2 propriately qualified health professional 

3 who are from disadvantaged backgrounds; 

4 and 

5 ‘‘(B) may focus on an area of emerging sci6 entific or workforce need. 

7 ‘‘(2) ELIMINATION OR ESTABLISHMENT OF SUB8 CATEGORIES.—The Director of the National Institutes 

9 of Health may eliminate one or more subcategories 

10 provided for in paragraph (1) due to changes in 

11 workforce or scientific needs related to biomedical re12 search. The Director may establish other subcategory 

13 areas based on workforce and scientific priorities if 

14 the total number of subcategories does not exceed the 

15 number of subcategories listed in paragraph (1). 

16 ‘‘(c) LIMITATION.—The Director of the National Insti17 tutes of Health may not enter into a contract with a health 

18 professional pursuant to subsection (a) unless such profes19 sional has a substantial amount of education loans relative 

20 to income (as determined pursuant to guidelines issued by 

21 the Director).’’; 

22 (5) in subsection (d) (as so redesignated), by 

23 striking ‘‘The provisions’’ and inserting ‘‘APPLICA24 BILITY OF CERTAIN PROVISIONS REGARDING OBLI25 GATED SERVICE.—The provisions’’; and 
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•HR 34 EAH 

1 (6) in subsection (e) (as so redesignated), by 

2 striking ‘‘Amounts’’ and inserting ‘‘AVAILABILITY OF

3 APPROPRIATIONS.—Amounts’’. 

4 (c) TECHNICAL AND CONFORMING AMENDMENTS.— 

5 Title IV of the Public Health Service Act is amended— 

6 (1) by striking section 464z–5 (42 U.S.C. 285t– 

7 2); 

8 (2) by striking section 487C (42 U.S.C. 288–3); 

9 (3) by striking section 487E (42 U.S.C. 288–5); 

10 (4) by striking section 487F (42 U.S.C. 288–5a), 

11 as added by section 205 of Public Law 106–505, re12 lating to loan repayment for clinical researchers; and 

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

14 as added by section 1002(b) of Public Law 106–310 

15 relating to pediatric research loan repayment. 

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

17 date of enactment of this Act, the Comptroller General of 

18 the United States shall submit to Congress a report on the 

19 efforts of the National Institutes of Health to attract, retain, 

20 and develop emerging scientists, including underrepresented 

21 individuals in the sciences, such as women, racial and eth22 nic minorities, and other groups. Such report shall include 

23 an analysis of the impact of the additional authority pro24 vided to the Secretary of Health and Human Services under 

25 this Act to address workforce shortages and gaps in priority 
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1 research areas, including which centers and research areas 

2 offered loan repayment program participants the increased 

3 award amount. 

4 Subtitle D—National Institutes of 

5 Health Planning and Adminis6 tration 

7 SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC 

8 PLAN. 

9 (a) STRATEGIC PLAN.—Section 402 of the Public 

10 Health Service Act (42 U.S.C. 282) is amended— 

11 (1) in subsection (b)(5), by inserting before the 

12 semicolon the following: ‘‘, and through the develop13 ment, implementation, and updating of the strategic 

14 plan developed under subsection (m)’’; and 

15 (2) by adding at the end the following: 

16 ‘‘(m) NATIONAL INSTITUTES OF HEALTH STRATEGIC

17 PLAN.— 

18 ‘‘(1) IN GENERAL.—Not later than 2 years after 

19 the date of enactment of the 21st Century Cures Act, 

20 and at least every 6 years thereafter, the Director of 

21 the National Institutes of Health shall develop and 

22 submit to the appropriate committees of Congress and 

23 post on the Internet website of the National Institutes 

24 of Health, a coordinated strategy (to be known as the 

25 ‘National Institutes of Health Strategic Plan’) to pro-
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•HR 34 EAH 

1 vide direction to the biomedical research investments 

2 made by the National Institutes of Health, to facili3 tate collaboration across the institutes and centers, to 

4 leverage scientific opportunity, and to advance bio5 medicine. 

6 ‘‘(2) REQUIREMENTS.—The strategy under para7 graph (1) shall— 

8 ‘‘(A) identify strategic research priorities 

9 and objectives across biomedical research, includ10 ing— 

11 ‘‘(i) an assessment of the state of bio12 medical and behavioral research, including 

13 areas of opportunity with respect to basic, 

14 clinical, and translational research; 

15 ‘‘(ii) priorities and objectives to ad16 vance the treatment, cure, and prevention of 

17 health conditions; 

18 ‘‘(iii) emerging scientific opportunities, 

19 rising public health challenges, and sci20 entific knowledge gaps; and 

21 ‘‘(iv) the identification of near-, mid-, 

22 and long-term scientific needs; 

23 ‘‘(B) consider, in carrying out subpara24 graph (A)— 
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1 ‘‘(i) disease burden in the United 

2 States and the potential for return on in3 vestment to the United States; 

4 ‘‘(ii) rare diseases and conditions; 

5 ‘‘(iii) biological, social, and other de6 terminants of health that contribute to 

7 health disparities; and 

8 ‘‘(iv) other factors the Director of Na9 tional Institutes of Health determines ap10 propriate; 

11 ‘‘(C) include multi-institute priorities, in12 cluding coordination of research among insti13 tutes and centers; 

14 ‘‘(D) include strategic priorities for funding 

15 research through the Common Fund, in accord16 ance with section 402A(c)(1)(C); 

17 ‘‘(E) address the National Institutes of 

18 Health’s proposed and ongoing activities related 

19 to training and the biomedical workforce; and 

20 ‘‘(F) describe opportunities for collaboration 

21 with other agencies and departments, as appro22 priate. 

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

24 and updated by the national research institutes and 

25 national centers of the National Institutes of Health 
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•HR 34 EAH 

1 shall be prepared regularly and in such a manner 

2 that such plans will be informed by the strategic 

3 plans developed and updated under this subsection. 

4 Such plans developed by and updated by the national 

5 research institutes and national centers shall have a 

6 common template. 

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

8 Institutes of Health shall develop the strategic plan 

9 under paragraph (1) in consultation with the direc10 tors of the national research institutes and national 

11 centers, researchers, patient advocacy groups, and in12 dustry leaders.’’. 

13 (b) CONFORMING AMENDMENT.—Section 

14 402A(c)(1)(C) of the Public Health Service Act (42 U.S.C. 

15 282a(c)(1)(C)) is amended by striking ‘‘Not later than June 

16 1, 2007, and every 2 years thereafter,’’ and inserting ‘‘As 

17 part of the National Institutes of Health Strategic Plan re18 quired under section 402(m),’’. 

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

20 Health Service Act (42 U.S.C. 289a–2(a)) is amended by 

21 adding at the end the following: 

22 ‘‘(3) STRATEGIC PLANNING.— 

23 ‘‘(A) IN GENERAL.—The directors of the na24 tional institutes and national centers shall con25 sult at least once annually with the Director of 
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1 the National Institute on Minority Health and 

2 Health Disparities and the Director of the Office 

3 of Research on Women’s Health regarding objec4 tives of the national institutes and national cen5 ters to ensure that future activities by such insti6 tutes and centers take into account women and 

7 minorities and are focused on reducing health 

8 disparities. 

9 ‘‘(B) STRATEGIC PLANS.—Any strategic 

10 plan issued by a national institute or national 

11 center shall include details on the objectives de12 scribed in subparagraph (A).’’. 

13 SEC. 2032. TRIENNIAL REPORTS. 

14 Section 403 of the Public Health Service Act (42 

15 U.S.C. 283) is amended— 

16 (1) in the section heading, by striking ‘‘BIEN17 NIAL’’ and inserting ‘‘TRIENNIAL’’ ; and 

18 (2) in subsection (a)— 

19 (A) in the matter preceding paragraph (1), 

20 by striking ‘‘biennial’’ and inserting ‘‘triennial’’; 

21 (B) by amending paragraph (3) to read as 

22 follows: 

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

24 Health activities, including— 
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1 ‘‘(A) identification of the percentage of 

2 funds made available by each national research 

3 institute and national center with respect to each 

4 applicable fiscal year for conducting or sup5 porting research that involves collaboration be6 tween the institute or center and 1 or more other 

7 national research institutes or national centers; 

8 and 

9 ‘‘(B) recommendations for promoting co10 ordination of information among the centers of 

11 excellence.’’; 

12 (C) in paragraph (4)— 

13 (i) in subparagraph (B), by striking 

14 ‘‘demographic variables and other vari15 ables’’ and inserting ‘‘demographic vari16 ables, including biological and social vari17 ables and relevant age categories (such as 

18 pediatric subgroups), and determinants of 

19 health,’’; and 

20 (ii) in subparagraph (C)(v)— 

21 (I) by striking ‘‘demographic 

22 variables and such’’ and inserting ‘‘de23 mographic variables, including rel24 evant age categories (such as pediatric 

25 subgroups), information submitted by 
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•HR 34 EAH 

1 each national research institute and 

2 national center to the Director of Na3 tional Institutes of Health under sec4 tion 492B(f), and such’’; and 

5 (II) by striking ‘‘(regarding inclu6 sion of women and minorities in clin7 ical research)’’ and inserting ‘‘and 

8 other applicable requirements regard9 ing inclusion of demographic groups’’; 

10 and 

11 (D) in paragraph (6)— 

12 (i) in the matter preceding subpara13 graph (A), by striking ‘‘the following:’’ and 

14 inserting ‘‘the following—’’; 

15 (ii) in subparagraph (A)— 

16 (I) by striking ‘‘An evaluation’’ 

17 and inserting ‘‘an evaluation’’; and 

18 (II) by striking the period and in19 serting ‘‘; and’’; 

20 (iii) by striking subparagraphs (B) 

21 and (D); 

22 (iv) by redesignating subparagraph (C) 

23 as subparagraph (B); and 

24 (v) in subparagraph (B), as redesig25 nated by clause (iv), by striking ‘‘Rec-
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1 ommendations’’ and inserting ‘‘rec2 ommendations’’. 

3 SEC. 2033. INCREASING ACCOUNTABILITY AT THE NA4 TIONAL INSTITUTES OF HEALTH. 

5 (a) APPOINTMENT AND TERMS OF DIRECTORS OF NA6 TIONAL RESEARCH INSTITUTES AND NATIONAL CEN7 TERS.—Subsection (a) of section 405 of the Public Health 

8 Service Act (42 U.S.C. 284) is amended to read as follows: 

9 ‘‘(a) APPOINTMENT.— 

10 ‘‘(1) IN GENERAL.—The Director of the National 

11 Cancer Institute shall be appointed by the President, 

12 and the Directors of the other national research insti13 tutes and national centers shall be appointed by the 

14 Secretary, acting through the Director of National In15 stitutes of Health. Each Director of a national re16 search institute or national center shall report di17 rectly to the Director of National Institutes of Health. 

18 ‘‘(2) APPOINTMENT.— 

19 ‘‘(A) TERM.—A Director of a national re20 search institute or national center who is ap21 pointed by the Secretary, acting through the Di22 rector of National Institutes of Health, shall be 

23 appointed for 5 years. 

24 ‘‘(B) REAPPOINTMENT.—At the end of the 

25 term of a Director of a national research insti-
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1 tute or national center, the Director may be re2 appointed in accordance with standards applica3 ble to the relevant appointment mechanism. 

4 There shall be no limit on the number of terms 

5 that a Director may serve. 

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

7 of a national research institute or national cen8 ter becomes vacant before the end of such Direc9 tor’s term, the Director appointed to fill the va10 cancy shall be appointed for a 5-year term start11 ing on the date of such appointment. 

12 ‘‘(D) CURRENT DIRECTORS.—Each Director 

13 of a national research institute or national cen14 ter who is serving on the date of enactment of the 

15 21st Century Cures Act shall be deemed to be ap16 pointed for a 5-year term under this subsection 

17 beginning on such date of enactment. 

18 ‘‘(E) RULE OF CONSTRUCTION.—Nothing in 

19 this subsection shall be construed to limit the au20 thority of the Secretary or the Director of Na21 tional Institutes of Health to terminate the ap22 pointment of a director referred to in subpara23 graph (A) before the expiration of such director’s 

24 5-year term. 
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1 ‘‘(F) NATURE OF APPOINTMENT.—Appoint2 ments and reappointments under this subsection 

3 shall be made on the basis of ability and experi4 ence as it relates to the mission of the National 

5 Institutes of Health and its components, includ6 ing compliance with any legal requirement that 

7 the Secretary or Director of National Institutes 

8 of Health determines relevant. 

9 ‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.— 

10 The restrictions contained in section 202 of the De11 partments of Labor, Health and Human Services, 

12 and Education, and Related Agencies Appropriations 

13 Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) 

14 related to consultants and individual scientists ap15 pointed for limited periods of time shall not apply to 

16 Directors appointed under this subsection.’’. 

17 (b) REVIEW OF CERTAIN AWARDS BY DIRECTORS.— 

18 Section 405(b) of the Public Health Service Act (42 U.S.C. 

19 284(b)) is amended by adding at the end the following: 

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

21 institute or by a national center for a grant for a research 

22 program or project (commonly referred to as an ‘R-series 

23 grant’), other than an award constituting a noncompetitive 

24 renewal of such a grant, or a noncompetitive administrative 

25 supplement to such a grant, the Director of such national 
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•HR 34 EAH 

1 research institute or national center shall, consistent with 

2 the peer review process— 

3 ‘‘(A) review and make the final decision with re4 spect to making the award; and 

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

6 ‘‘(i) the mission of the national research in7 stitute or national center and the scientific pri8 orities identified in the strategic plan under sec9 tion 402(m); 

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

11 agencies on similar research topics; and 

12 ‘‘(iii) advice by staff and the advisory coun13 cil or board of such national research institute or 

14 national center.’’. 

15 (c) REPORT ON DUPLICATION IN FEDERAL BIO16 MEDICAL RESEARCH.—The Secretary of Health and 

17 Human Services (referred to in this subsection as the ‘‘Sec18 retary’’), shall, not later than 2 years after the date of en19 actment of this Act, submit a report to Congress on efforts 

20 to prevent and eliminate duplicative biomedical research 

21 that is not necessary for scientific purposes. Such report 

22 shall— 

23 (1) describe the procedures in place to identify 

24 such duplicative research, including procedures for 
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1 monitoring research applications and funded research 

2 awards to prevent unnecessary duplication; 

3 (2) describe the steps taken to improve the proce4 dures described in paragraph (1), in response to rel5 evant recommendations made by the Comptroller Gen6 eral of the United States; 

7 (3) describe how the Secretary operationally dis8 tinguishes necessary and appropriate scientific rep9 lication from unnecessary duplication; and 

10 (4) provide examples of instances where the Sec11 retary has identified unnecessarily duplicative re12 search and the steps taken to eliminate the unneces13 sary duplication. 

14 SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RE15 SEARCHERS. 

16 (a) PLAN PREPARATION AND IMPLEMENTATION OF

17 MEASURES TO REDUCE ADMINISTRATIVE BURDENS.— 

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

19 the date of enactment of this Act, the Secretary of 

20 Health and Human Services (referred to in this sec21 tion as the ‘‘Secretary’’) shall— 

22 (A) lead a review by research funding agen23 cies of all regulations and policies related to the 

24 disclosure of financial conflicts of interest, in-
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•HR 34 EAH 

1 cluding the minimum threshold for reporting fi2 nancial conflicts of interest; 

3 (B) make revisions, as appropriate, to har4 monize existing policies and reduce administra5 tive burden on researchers while maintaining the 

6 integrity and credibility of research findings and 

7 protections of human participants; and 

8 (C) confer with the Office of the Inspector 

9 General about the activities of such office related 

10 to financial conflicts of interest involving re11 search funding agencies. 

12 (2) CONSIDERATIONS.—In updating policies 

13 under paragraph (1)(B), the Secretary shall con14 sider— 

15 (A) modifying the timelines for the report16 ing of financial conflicts of interest to just-in17 time information by institutions receiving grant 

18 or cooperative agreement funding from the Na19 tional Institutes of Health; 

20 (B) ensuring that financial interest disclo21 sure reporting requirements are appropriate for, 

22 and relevant to, awards that will directly fund 

23 research, which may include modification of the 

24 definition of the term ‘‘investigator’’ for purposes 
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•HR 34 EAH 

1 of the regulations and policies described in sub2 paragraphs (A) and (B) of paragraph (1); and 

3 (C) updating any applicable training mod4 ules of the National Institutes of Health related 

5 to Federal financial interest disclosure. 

6 (b) MONITORING OF SUBRECIPIENTS OF FUNDING

7 FROM THE NATIONAL INSTITUTES OF HEALTH.—The Di8 rector of the National Institutes of Health (referred to in 

9 this section as the ‘‘Director of National Institutes of 

10 Health’’) shall implement measures to reduce the adminis11 trative burdens related to monitoring of subrecipients of 

12 grants by primary awardees of funding from the National 

13 Institutes of Health, which may incorporate findings and 

14 recommendations from existing and ongoing activities. 

15 Such measures may include, as appropriate— 

16 (1) an exemption from subrecipient monitoring 

17 requirements, upon request from the primary award18 ees, provided that— 

19 (A) the subrecipient is subject to Federal 

20 audit requirements pursuant to the Uniform 

21 Guidance of the Office of Management and 

22 Budget; 

23 (B) the primary awardee conducts, pursu24 ant to guidance of the National Institutes of 

25 Health, a pre-award evaluation of each sub-
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•HR 34 EAH 

1 recipient’s risk of noncompliance with Federal 

2 statutes and regulations, the conditions of the 

3 subaward, and any recurring audit findings; 

4 and 

5 (C) such exemption does not absolve the pri6 mary awardee of liability for misconduct by sub7 recipients; and 

8 (2) the implementation of alternative grant 

9 structures that obviate the need for subrecipient moni10 toring, which may include collaborative grant models 

11 allowing for multiple primary awardees. 

12 (c) REPORTING OF FINANCIAL EXPENDITURES.—The 

13 Secretary, in consultation with the Director of National In14 stitutes of Health, shall evaluate financial expenditure re15 porting procedures and requirements for recipients of fund16 ing from the National Institutes of Health and take action, 

17 as appropriate, to avoid duplication between department 

18 and agency procedures and requirements and minimize 

19 burden to funding recipients. 

20 (d) ANIMAL CARE AND USE IN RESEARCH.—Not later 

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

22 Director of National Institutes of Health, in collaboration 

23 with the Secretary of Agriculture and the Commissioner of 

24 Food and Drugs, shall complete a review of applicable regu25 lations and policies for the care and use of laboratory ani-
66 

•HR 34 EAH 

1 mals and make revisions, as appropriate, to reduce admin2 istrative burden on investigators while maintaining the in3 tegrity and credibility of research findings and protection 

4 of research animals. In carrying out this effort, the Director 

5 of the National Institutes of Health shall seek the input of 

6 experts, as appropriate. The Director of the National Insti7 tutes of Health shall— 

8 (1) identify ways to ensure such regulations and 

9 policies are not inconsistent, overlapping, or unneces10 sarily duplicative, including with respect to inspec11 tion and review requirements by Federal agencies and 

12 accrediting associations; 

13 (2) take steps to eliminate or reduce identified 

14 inconsistencies, overlap, or duplication among such 

15 regulations and policies; and 

16 (3) take other actions, as appropriate, to im17 prove the coordination of regulations and policies 

18 with respect to research with laboratory animals. 

19 (e) DOCUMENTATION OF PERSONNEL EXPENSES.—The 

20 Secretary shall clarify the applicability of the requirements 

21 under the Office of Management and Budget Uniform Guid22 ance for management and certification systems adopted by 

23 entities receiving Federal research grants through the De24 partment of Health and Human Services regarding docu25 mentation of personnel expenses, including clarification of 
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•HR 34 EAH 

1 the extent to which any flexibility to such requirements 

2 specified in such Uniform Guidance applies to entities re3 ceiving grants through the Department of Health and 

4 Human Services. 

5 (f) RESEARCH POLICY BOARD.— 

6 (1) ESTABLISHMENT.—Not later than 1 year 

7 after the date of enactment of this Act, the Director 

8 of the Office of Management and Budget shall estab9 lish an advisory committee, to be known as the ‘‘Re10 search Policy Board’’ (referred to in this subsection as 

11 the ‘‘Board’’), to provide Federal Government officials 

12 with information on the effects of regulations related 

13 to Federal research requirements. 

14 (2) MEMBERSHIP.— 

15 (A) IN GENERAL.—The Board shall include 

16 not more than 10 Federal members, including 

17 each of the following Federal members or their 

18 designees: 

19 (i) The Administrator of the Office of 

20 Information and Regulatory Affairs of the 

21 Office of Management and Budget. 

22 (ii) The Director of the Office of 

23 Science and Technology Policy. 

24 (iii) The Secretary of Health and 

25 Human Services. 
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•HR 34 EAH 

1 (iv) The Director of the National 

2 Science Foundation. 

3 (v) The secretaries and directors of 

4 other departments and agencies that sup5 port or regulate scientific research, as deter6 mined by the Director of the Office of Man7 agement and Budget. 

8 (B) NON-FEDERAL MEMBERS.—The Board 

9 shall be comprised of not less than 9 and not 

10 more than 12 representatives of academic re11 search institutions, other private, nonprofit re12 search institutions, or other nonprofit organiza13 tions with relevant expertise. Such members shall 

14 be appointed by a formal process, to be estab15 lished by the Director of the Office of Manage16 ment and Budget, in consultation with the Fed17 eral membership, and that incorporates— 

18 (i) nomination by members of the non19 profit scientific research community, in20 cluding academic research institutions; and 

21 (ii) procedures to fill membership posi22 tions vacated before the end of a member’s 

23 term. 

24 (3) PURPOSE AND RESPONSIBILITIES.—The 

25 Board shall make recommendations regarding the 
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•HR 34 EAH 

1 modification and harmonization of regulations and 

2 policies having similar purposes across research fund3 ing agencies to ensure that the administrative burden 

4 of such research policy and regulation is minimized 

5 to the greatest extent possible and consistent with 

6 maintaining responsible oversight of federally funded 

7 research. Activities of the Board may include— 

8 (A) providing thorough and informed anal9 ysis of regulations and policies; 

10 (B) identifying negative or adverse con11 sequences of existing policies and making action12 able recommendations regarding possible im13 provement of such policies; 

14 (C) making recommendations with respect 

15 to efforts within the Federal Government to im16 prove coordination of regulation and policy re17 lated to research; 

18 (D) creating a forum for the discussion of 

19 research policy or regulatory gaps, challenges, 

20 clarification, or harmonization of such policies 

21 or regulation, and best practices; and 

22 (E) conducting ongoing assessment and 

23 evaluation of regulatory burden, including devel24 opment of metrics, periodic measurement, and 
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•HR 34 EAH 

1 identification of process improvements and pol2 icy changes. 

3 (4) EXPERT SUBCOMMITTEES.—The Board may 

4 form temporary expert subcommittees, as appropriate, 

5 to develop timely analysis on pressing issues and as6 sist the Board in anticipating future regulatory chal7 lenges, including challenges emerging from new sci8 entific advances. 

9 (5) REPORTING REQUIREMENTS.—Not later than 

10 2 years after the date of enactment of this Act, and 

11 once thereafter, the Board shall submit a report to the 

12 Director of the Office of Management and Budget, the 

13 Administrator of the Office of Information and Regu14 latory Affairs of the Office of Management and Budg15 et, the Director of the Office of Science and Tech16 nology Policy, the heads of relevant Federal depart17 ments and agencies, the Committee on Health, Edu18 cation, Labor, and Pensions of the Senate, and the 

19 Committee on Energy and Commerce of the House of 

20 Representatives containing formal recommendations 

21 on the conceptualization, development, harmonization, 

22 and reconsideration of scientific research policy, in23 cluding the regulatory benefits and burdens. 

24 (6) SUNSET.—The Board shall terminate on 

25 September 30, 2021. 
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•HR 34 EAH 

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

2 the date of enactment of this Act, the Comptroller 

3 General of the United States shall conduct an inde4 pendent evaluation of the activities carried out by the 

5 Board pursuant to this subsection and submit to the 

6 appropriate committees of Congress a report regard7 ing the results of the independent evaluation. Such re8 port shall review and assess the Board’s activities 

9 with respect to the responsibilities described in para10 graph (3). 

11 SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF 

12 HEALTH FROM THE PAPERWORK REDUCTION 

13 ACT REQUIREMENTS. 

14 Section 301 of the Public Health Service Act (42 

15 U.S.C. 241), as amended by section 2013, is further amend16 ed by adding at the end the following: 

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

18 States Code, shall not apply to the voluntary collection of 

19 information during the conduct of research by the National 

20 Institutes of Health.’’. 

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

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

23 Service Act (42 U.S.C. 282), as amended by section 2031, 

24 is further amended by adding at the end the following: 

25 ‘‘(n) UNIQUE RESEARCH INITIATIVES.— 
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1 ‘‘(1) IN GENERAL.—The Director of NIH may 

2 approve, after consideration of a proposal under 

3 paragraph (2)(A), requests by the national research 

4 institutes and centers, or program officers within the 

5 Office of the Director to engage in transactions other 

6 than a contract, grant, or cooperative agreement with 

7 respect to projects that carry out— 

8 ‘‘(A) the Precision Medicine Initiative 

9 under section 498E; or 

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

11 than 50 percent of the funds available for a fiscal 

12 year through the Common Fund under section 

13 402A(c)(1) for purposes of carrying out such sec14 tion 402(b)(7) may be used to engage in such 

15 other transactions. 

16 ‘‘(2) REQUIREMENTS.—The authority provided 

17 under this subsection may be used to conduct or sup18 port high impact cutting-edge research described in 

19 paragraph (1) using the other transactions authority 

20 described in such paragraph if the institute, center, or 

21 office— 

22 ‘‘(A) submits a proposal to the Director of 

23 NIH for the use of such authority before con24 ducting or supporting the research, including 
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1 why the use of such authority is essential to pro2 moting the success of the project; 

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

4 authority from the Director of NIH; and 

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

6 center, or office has used such authority in ac7 cordance with this subsection, submits a report 

8 to the Director of NIH on the activities of the in9 stitute, center, or office relating to such re10 search.’’. 

11 (b) REPORT TO CONGRESS.—Not later than September 

12 30, 2020, the Secretary of Health and Human Services, act13 ing through the Director of the National Institutes of 

14 Health, shall conduct an evaluation of the activities under 

15 subsection (n) of section 402 of the Public Health Service 

16 Act (42 U.S.C. 282), as added by subsection (a), and submit 

17 a report to the Committee on Health, Education, Labor, 

18 and Pensions of the Senate and the Committee on Energy 

19 and Commerce of the House of Representatives on the re20 sults of such evaluation. 

21 (c) DUTIES OF DIRECTORS OF INSTITUTES.—Section 

22 405(b)(1) of the Public Health Service Act (42 U.S.C. 

23 284(b)(1)) is amended— 
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1 (1) by redesignating subparagraphs (C) through 

2 (L) as subparagraphs (D) through (M), respectively; 

3 and 

4 (2) by inserting after subparagraph (B), the fol5 lowing: 

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

7 research that has the potential to transform the sci8 entific field, has inherently higher risk, and that seeks 

9 to address major current challenges;’’. 

10 SEC. 2037. NATIONAL CENTER FOR ADVANCING 

11 TRANSLATIONAL SCIENCES. 

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

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

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

15 and inserting ‘‘phase IIB’’; and 

16 (2) in paragraph (2)— 

17 (A) in the matter preceding subparagraph 

18 (A), by striking ‘‘phase IIB’’ and inserting 

19 ‘‘phase III’’; 

20 (B) in subparagraph (A), by striking 

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

22 (C) in subparagraph (B), by striking 

23 ‘‘phase IIA’’ and inserting ‘‘phase IIB’’; and 

24 (D) in subparagraph (C), by striking 

25 ‘‘phase IIB’’ and inserting ‘‘phase III’’. 
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1 (b) INCREASED TRANSPARENCY.—Section 479 of the 

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

3 (1) in subsection (c)— 

4 (A) in paragraph (4)(D), by striking ‘‘and’’ 

5 at the end; 

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

7 and inserting a semicolon; and 

8 (C) by adding at the end the following: 

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

10 been developed since the last biennial report was pre11 pared; and 

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

13 been developed and are being utilized by the Food and 

14 Drug Administration to support medical product re15 views.’’; and 

16 (2) by adding at the end the following: 

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

18 submitted under this section after the date of enactment of 

19 the 21st Century Cures Act shall include a complete list 

20 of all of the methods and tools, if any, which have been 

21 developed by research supported by the Center. 

22 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed as authorizing the Secretary to dis24 close any information that is a trade secret, or other privi25 leged or confidential information subject to section 
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1 552(b)(4) of title 5, United States Code, or section 1905 

2 of title 18, United States Code.’’. 

3 SEC. 2038. COLLABORATION AND COORDINATION TO EN4 HANCE RESEARCH. 

5 (a) RESEARCH PRIORITIES; COLLABORATIVE RE6 SEARCH PROJECTS.—Section 402(b) of the Public Health 

7 Service Act (42 U.S.C. 282(b)) is amended— 

8 (1) by amending paragraph (4) to read as fol9 lows: 

10 ‘‘(4) shall assemble accurate data to be used to 

11 assess research priorities, including— 

12 ‘‘(A) information to better evaluate sci13 entific opportunity, public health burdens, and 

14 progress in reducing health disparities; and 

15 ‘‘(B) data on study populations of clinical 

16 research, funded by or conducted at each na17 tional research institute and national center, 

18 which— 

19 ‘‘(i) specifies the inclusion of— 

20 ‘‘(I) women; 

21 ‘‘(II) members of minority groups; 

22 ‘‘(III) relevant age categories, in23 cluding pediatric subgroups; and 
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1 ‘‘(IV) other demographic variables 

2 as the Director of the National Insti3 tutes of Health determines appropriate; 

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

5 condition, and disease categories; and 

6 ‘‘(iii) is to be made publicly available 

7 on the Internet website of the National In8 stitutes of Health;’’; and 

9 (2) in paragraph (8)— 

10 (A) in subparagraph (A), by striking ‘‘and’’ 

11 at the end; and 

12 (B) by adding at the end the following: 

13 ‘‘(C) foster collaboration between clinical re14 search projects funded by the respective national 

15 research institutes and national centers that— 

16 ‘‘(i) conduct research involving human 

17 subjects; and 

18 ‘‘(ii) collect similar data; and 

19 ‘‘(D) encourage the collaboration described 

20 in subparagraph (C) to— 

21 ‘‘(i) allow for an increase in the num22 ber of subjects studied; and 

23 ‘‘(ii) utilize diverse study populations, 

24 with special consideration to biological, so-
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1 cial, and other determinants of health that 

2 contribute to health disparities;’’. 

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

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

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

6 appears and inserting ‘‘triennial’’; 

7 (2) by striking ‘‘The advisory council’’ and in8 serting the following: 

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

10 (3) by adding at the end the following: 

11 ‘‘(2) CONTENTS.—Each triennial report pre12 pared by an advisory council of each national re13 search institute as described in paragraph (1) shall 

14 include each of the following: 

15 ‘‘(A) The number of women included as sub16 jects, and the proportion of subjects that are 

17 women, in any project of clinical research con18 ducted during the applicable reporting period, 

19 disaggregated by categories of research area, con20 dition, or disease, and accounting for single-sex 

21 studies. 

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

23 groups included as subjects, and the proportion 

24 of subjects that are members of minority groups, 

25 in any project of clinical research conducted dur-
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1 ing the applicable reporting period, 

2 disaggregated by categories of research area, con3 dition, or disease and accounting for single-race 

4 and single-ethnicity studies. 

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

6 the number of projects of clinical research that 

7 include women and members of minority groups 

8 and that— 

9 ‘‘(i) have been completed during such 

10 reporting period; and 

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

12 reporting period and have not been com13 pleted. 

14 ‘‘(D) The number of studies completed dur15 ing the applicable reporting period for which re16 porting has been submitted in accordance with 

17 subsection (c)(2)(A).’’. 

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

19 Health Service Act (42 U.S.C. 287d(c)(2)) is amended by 

20 striking ‘‘designees’’ and inserting ‘‘senior-level staff des21 ignees’’. 

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

23 Health Service Act (42 U.S.C. 281 et seq.), as amended by 

24 section 2021, is further amended by adding at the end the 

25 following: 
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1 ‘‘SEC. 404N. POPULATION FOCUSED RESEARCH. 

2 ‘‘The Director of the National Institutes of Health 

3 shall, as appropriate, encourage efforts to improve research 

4 related to the health of sexual and gender minority popu5 lations, including by— 

6 ‘‘(1) facilitating increased participation of sex7 ual and gender minority populations in clinical re8 search supported by the National Institutes of Health, 

9 and reporting on such participation, as applicable; 

10 ‘‘(2) facilitating the development of valid and re11 liable methods for research relevant to sexual and gen12 der minority populations; and 

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

14 (e) REPORTING.— 

15 (1) IN GENERAL.—The Secretary, in collabora16 tion with the Director of the National Institutes of 

17 Health, shall as appropriate— 

18 (A) continue to support research for the de19 velopment of appropriate measures related to re20 porting health information about sexual and 

21 gender minority populations; and 

22 (B) not later than 2 years after the date of 

23 enactment of this Act, disseminate and make 

24 public such measures. 

25 (2) NATIONAL ACADEMY OF MEDICINE REC26 OMMENDATIONS.—In developing the measures de-
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1 scribed in paragraph (1)(A), the Secretary shall take 

2 into account recommendations made by the National 

3 Academy of Medicine. 

4 (f) IMPROVING COORDINATION RELATED TO MINORITY

5 HEALTH AND HEALTH DISPARITIES.—Section 464z–3 of 

6 the Public Health Service Act (42 U.S.C. 285t) is amend7 ed— 

8 (1) by redesignating subsection (h), relating to 

9 interagency coordination, that follows subsection (j) 

10 as subsection (k); and 

11 (2) in subsection (k) (as so redesignated)— 

12 (A) in the subsection heading, by striking 

13 ‘‘INTERAGENCY’’ and inserting ‘‘INTRA-NATIONAL

14 INSTITUTES OF HEALTH’’; 

15 (B) by striking ‘‘as the primary Federal of16 ficials’’ and inserting ‘‘as the primary Federal 

17 official’’; 

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

19 (D) by striking ‘‘Institutes and Centers of 

20 the National Institutes of Health’’ and inserting 

21 ‘‘national research institutes and national cen22 ters’’; and 

23 (E) by adding at the end the following: 

24 ‘‘The Director of the Institute may foster part25 nerships between the national research institutes 
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1 and national centers and may encourage the 

2 funding of collaborative research projects to 

3 achieve the goals of the National Institutes of 

4 Health that are related to minority health and 

5 health disparities.’’. 

6 (g) BASIC RESEARCH.— 

7 (1) DEVELOPING POLICIES.—Not later than 2 

8 years after the date of enactment of this Act, the Di9 rector of the National Institutes of Health (referred to 

10 in this section as the ‘‘Director of the National Insti11 tutes of Health’’), taking into consideration the rec12 ommendations developed under section 2039, shall de13 velop policies for projects of basic research funded by 

14 National Institutes of Health to assess— 

15 (A) relevant biological variables including 

16 sex, as appropriate; and 

17 (B) how differences between male and fe18 male cells, tissues, or animals may be examined 

19 and analyzed. 

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

21 National Institutes of Health may update or revise 

22 the policies developed under paragraph (1) as appro23 priate. 

24 (3) CONSULTATION AND OUTREACH.—In devel25 oping, updating, or revising the policies under this 
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1 section, the Director of the National Institutes of 

2 Health shall— 

3 (A) consult with— 

4 (i) the Office of Research on Women’s 

5 Health; 

6 (ii) the Office of Laboratory Animal 

7 Welfare; and 

8 (iii) appropriate members of the sci9 entific and academic communities; and 

10 (B) conduct outreach to solicit feedback 

11 from members of the scientific and academic 

12 communities on the influence of sex as a variable 

13 in basic research, including feedback on when it 

14 is appropriate for projects of basic research in15 volving cells, tissues, or animals to include both 

16 male and female cells, tissues, or animals. 

17 (4) ADDITIONAL REQUIREMENTS.—The Director 

18 of the National Institutes of Health shall— 

19 (A) ensure that projects of basic research 

20 funded by the National Institutes of Health are 

21 conducted in accordance with the policies devel22 oped, updated, or revised under this section, as 

23 applicable; and 

24 (B) encourage that the results of such re25 search, when published or reported, be 
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1 disaggregated as appropriate with respect to the 

2 analysis of any sex differences. 

3 (h) CLINICAL RESEARCH.— 

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

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

6 National Institutes of Health, in consultation with 

7 the Director of the Office of Research on Women’s 

8 Health and the Director of the National Institute on 

9 Minority Health and Health Disparities, shall update 

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

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

12 accordance with paragraph (2). 

13 (2) REQUIREMENTS.—The updated guidelines 

14 described in paragraph (1) shall— 

15 (A) reflect the science regarding sex dif16 ferences; 

17 (B) improve adherence to the requirements 

18 under section 492B of the Public Health Service 

19 Act (42 U.S.C. 289a–2), including the reporting 

20 requirements under subsection (f) of such section; 

21 and 

22 (C) clarify the circumstances under which 

23 studies should be designed to support the conduct 

24 of analyses to detect significant differences in the 

25 intervention effect due to demographic factors re-
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1 lated to section 492B of the Public Health Serv2 ice Act, including in the absence of prior studies 

3 that demonstrate a difference in study outcomes 

4 on the basis of such factors and considering the 

5 effects of the absence of such analyses on the 

6 availability of data related to demographic dif7 ferences. 

8 (i) APPROPRIATE AGE GROUPINGS IN CLINICAL RE9 SEARCH.— 

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

11 days after the date of enactment of this Act, the Di12 rector of the National Institutes of Health shall con13 vene a workshop of experts on pediatric and older 

14 populations to provide input on— 

15 (A) appropriate age groups to be included 

16 in research studies involving human subjects; 

17 and 

18 (B) acceptable justifications for excluding 

19 participants from a range of age groups from 

20 human subjects research studies. 

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

22 after the conclusion of the workshop under paragraph 

23 (1), the Director of the National Institutes of Health 

24 shall make a determination with respect to whether 

25 the policies of the National Institutes of Health on the 
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1 inclusion of relevant age groups in clinical studies 

2 need to be updated, and shall update such policies as 

3 appropriate. In making the determination, the Direc4 tor of the National Institutes of Health shall take into 

5 consideration whether such policies— 

6 (A) address the consideration of age as an 

7 inclusion variable in research involving human 

8 subjects; and 

9 (B) identify the criteria for justification for 

10 any age-related exclusions in such research. 

11 (3) PUBLIC AVAILABILITY OF FINDINGS AND CON12 CLUSIONS.—The Director of the National Institutes of 

13 Health shall— 

14 (A) make the findings and conclusions re15 sulting from the workshop under paragraph (1) 

16 and updates to policies in accordance with para17 graph (2), as applicable, available to the public 

18 on the Internet website of the National Institutes 

19 of Health; and 

20 (B) ensure that age-related data reported in 

21 the triennial report under section 403 of the 

22 Public Health Service Act (42 U.S.C. 283) (as 

23 amended by section 2032) are made available to 

24 the public on the Internet website of the National 

25 Institutes of Health. 
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1 SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY 

2 OF SCIENTIFIC RESEARCH. 

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

4 date of enactment of this Act, the Secretary of Health and 

5 Human Services, acting through the Director of the Na6 tional Institutes of Health, shall convene a working group 

7 under the Advisory Committee to the Director of the Na8 tional Institutes of Health (referred to in this section as 

9 the ‘‘Advisory Committee’’), appointed under section 222 of 

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

11 and issue recommendations through the Advisory Com12 mittee for a formal policy, which may incorporate or be 

13 informed by relevant existing and ongoing activities, to en14 hance rigor and reproducibility of scientific research funded 

15 by the National Institutes of Health. 

16 (b) CONSIDERATIONS.—In developing and issuing rec17 ommendations through the Advisory Committee under sub18 section (a), the working group established under such sub19 section shall consider, as appropriate— 

20 (1) preclinical experiment design, including 

21 analysis of sex as a biological variable; 

22 (2) clinical experiment design, including— 

23 (A) the diversity of populations studied for 

24 clinical research, with respect to biological, so25 cial, and other determinants of health that con26 tribute to health disparities; 
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1 (B) the circumstances under which sum2 mary information regarding biological, social, 

3 and other factors that contribute to health dis4 parities should be reported; and 

5 (C) the circumstances under which clinical 

6 studies, including clinical trials, should conduct 

7 an analysis of the data collected during the 

8 study on the basis of biological, social, and other 

9 factors that contribute to health disparities; 

10 (3) applicable levels of rigor in statistical meth11 ods, methodology, and analysis; 

12 (4) data and information sharing in accordance 

13 with applicable privacy laws and regulations; and 

14 (5) any other matter the working group deter15 mines relevant. 

16 (c) POLICIES.—Not later than 18 months after the date 

17 of enactment of this Act, the Director of the National Insti18 tutes of Health shall consider the recommendations devel19 oped by the working group and issued by the Advisory Com20 mittee under subsection (a) and develop or update policies 

21 as appropriate. 

22 (d) REPORT.—Not later than 2 years after the date 

23 of enactment of this Act, the Director of the National Insti24 tutes of Health shall issue a report to the Secretary of 

25 Health and Human Services, the Committee on Health, 
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1 Education, Labor, and Pensions of the Senate, and the 

2 Committee on Energy and Commerce of the House of Rep3 resentatives regarding recommendations developed under 

4 subsection (a) and any subsequent policy changes imple5 mented, to enhance rigor and reproducibility in scientific 

6 research funded by the National Institutes of Health. 

7 (e) CONFIDENTIALITY.—Nothing in this section au8 thorizes the Secretary of Health and Human Services to 

9 disclose any information that is a trade secret, or other 

10 privileged or confidential information, described in section 

11 552(b)(4) of title 5, United States Code, or section 1905 

12 of title 18, United States Code. 

13 SEC. 2040. IMPROVING MEDICAL REHABILITATION RE14 SEARCH AT THE NATIONAL INSTITUTES OF 

15 HEALTH. 

16 (a) IN GENERAL.—Section 452 of the Public Health 

17 Service Act (42 U.S.C. 285g–4) is amended— 

18 (1) in subsection (b), by striking ‘‘conduct and 

19 support’’ and inserting ‘‘conduct, support, and co20 ordination’’; 

21 (2) in subsection (c)(1)(C), by striking ‘‘of the 

22 Center’’ and inserting ‘‘within the Center’’; 

23 (3) in subsection (d)— 
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1 (A) by striking ‘‘(d)(1) In consultation’’ 

2 and all that follows through the end of para3 graph (1) and inserting the following: 

4 ‘‘(d)(1) The Director of the Center, in consultation 

5 with the Director of the Institute, the coordinating com6 mittee established under subsection (e), and the advisory 

7 board established under subsection (f), shall develop a com8 prehensive plan (referred to in this section as the ‘Research 

9 Plan’) for the conduct, support, and coordination of medical 

10 rehabilitation research.’’; 

11 (B) in paragraph (2)— 

12 (i) in subparagraph (A), by striking ‘‘; 

13 and’’ and inserting a semicolon; 

14 (ii) in subparagraph (B), by striking 

15 the period and inserting ‘‘; and’’; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(C) include goals and objectives for conducting, 

19 supporting, and coordinating medical rehabilitation 

20 research, consistent with the purpose described in sub21 section (b).’’; 

22 (C) by striking paragraph (4) and inserting 

23 the following: 

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

25 the Director of the Institute, the coordinating committee es-
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1 tablished under subsection (e), and the advisory board es2 tablished under subsection (f), shall revise and update the 

3 Research Plan periodically, as appropriate, or not less than 

4 every 5 years. Not later than 30 days after the Research 

5 Plan is so revised and updated, the Director of the Center 

6 shall transmit the revised and updated Research Plan to 

7 the President, the Committee on Health, Education, Labor, 

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

9 and Commerce of the House of Representatives.’’; and 

10 (D) by adding at the end the following: 

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

12 the Director of the Institute, shall, prior to revising and 

13 updating the Research Plan, prepare a report for the co14 ordinating committee established under subsection (e) and 

15 the advisory board established under subsection (f) that de16 scribes and analyzes the progress during the preceding fiscal 

17 year in achieving the goals and objectives described in para18 graph (2)(C) and includes expenditures for rehabilitation 

19 research at the National Institutes of Health. The report 

20 shall include recommendations for revising and updating 

21 the Research Plan, and such initiatives as the Director of 

22 the Center and the Director of the Institute determine ap23 propriate. In preparing the report, the Director of the Cen24 ter and the Director of the Institute shall consult with the 

25 Director of the National Institutes of Health.’’; 
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1 (4) in subsection (e)— 

2 (A) in paragraph (2), by inserting ‘‘peri3 odically host a scientific conference or workshop 

4 on medical rehabilitation research and’’ after 

5 ‘‘The Coordinating Committee shall’’; and 

6 (B) in paragraph (3), by inserting ‘‘the Di7 rector of the Division of Program Coordination, 

8 Planning, and Strategic Initiatives within the 

9 Office of the Director of the National Institutes 

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

11 (5) in subsection (f)(3)(B)— 

12 (A) by redesignating clauses (ix) through 

13 (xi) as clauses (x) through (xii), respectively; and 

14 (B) by inserting after clause (viii) the fol15 lowing: 

16 ‘‘(ix) The Director of the Division of Program 

17 Coordination, Planning, and Strategic Initiatives.’’; 

18 and 

19 (6) by adding at the end the following: 

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

21 agencies shall jointly review the programs carried out (or 

22 proposed to be carried out) by each such official with respect 

23 to medical rehabilitation research and, as appropriate, 

24 enter into agreements preventing duplication among such 

25 programs. 
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1 ‘‘(2) The Secretary shall, as appropriate, enter into 

2 interagency agreements relating to the coordination of med3 ical rehabilitation research conducted by agencies of the Na4 tional Institutes of Health and other agencies of the Federal 

5 Government. 

6 ‘‘(h) For purposes of this section, the term ‘medical re7 habilitation research’ means the science of mechanisms and 

8 interventions that prevent, improve, restore, or replace lost, 

9 underdeveloped, or deteriorating function.’’. 

10 (b) CONFORMING AMENDMENT.—Section 3 of the Na11 tional Institutes of Health Amendments of 1990 (42 U.S.C. 

12 285g–4 note) is amended— 

13 (1) in subsection (a), by striking ‘‘IN GEN14 ERAL.—’’; and 

15 (2) by striking subsection (b). 

16 SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREG17 NANT WOMEN AND LACTATING WOMEN. 

18 (a) TASK FORCE ON RESEARCH SPECIFIC TO PREG19 NANT WOMEN AND LACTATING WOMEN.— 

20 (1) ESTABLISHMENT.—Not later than 90 days 

21 after the date of enactment of this Act, the Secretary 

22 of Health and Human Services (referred to in this 

23 section as the ‘‘Secretary’’) shall establish a task force, 

24 in accordance with the Federal Advisory Committee 

25 Act (5 U.S.C. App.), to be known as the ‘‘Task Force 
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•HR 34 EAH 

1 on Research Specific to Pregnant Women and Lac2 tating Women’’ (in this section referred to as the 

3 ‘‘Task Force’’). 

4 (2) DUTIES.—The Task Force shall provide ad5 vice and guidance to the Secretary regarding Federal 

6 activities related to identifying and addressing gaps 

7 in knowledge and research regarding safe and effective 

8 therapies for pregnant women and lactating women, 

9 including the development of such therapies and the 

10 collaboration on and coordination of such activities. 

11 (3) MEMBERSHIP.— 

12 (A) FEDERAL MEMBERS.—The Task Force 

13 shall be composed of each of the following Federal 

14 members, or the designees of such members: 

15 (i) The Director of the Centers for Dis16 ease Control and Prevention. 

17 (ii) The Director of the National Insti18 tutes of Health, the Director of the Eunice 

19 Kennedy Shriver National Institute of 

20 Child Health and Human Development, 

21 and the directors of such other appropriate 

22 national research institutes. 

23 (iii) The Commissioner of Food and 

24 Drugs. 
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1 (iv) The Director of the Office on 

2 Women’s Health. 

3 (v) The Director of the National Vac4 cine Program Office. 

5 (vi) The head of any other research-re6 lated agency or department not described in 

7 clauses (i) through (v) that the Secretary 

8 determines appropriate, which may include 

9 the Department of Veterans Affairs and the 

10 Department of Defense. 

11 (B) NON-FEDERAL MEMBERS.—The Task 

12 Force shall be composed of each of the following 

13 non-Federal members, including— 

14 (i) representatives from relevant med15 ical societies with subject matter expertise 

16 on pregnant women, lactating women, or 

17 children; 

18 (ii) nonprofit organizations with ex19 pertise related to the health of women and 

20 children; 

21 (iii) relevant industry representatives; 

22 and 

23 (iv) other representatives, as appro24 priate. 
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1 (C) LIMITATIONS.—The non-Federal mem2 bers described in subparagraph (B) shall— 

3 (i) compose not more than one-half, 

4 and not less than one-third, of the total 

5 membership of the Task Force; and 

6 (ii) be appointed by the Secretary. 

7 (4) TERMINATION.— 

8 (A) IN GENERAL.—Subject to subparagraph 

9 (B), the Task Force shall terminate on the date 

10 that is 2 years after the date on which the Task 

11 Force is established under paragraph (1). 

12 (B) EXTENSION.—The Secretary may ex13 tend the operation of the Task Force for one ad14 ditional 2-year period following the 2-year pe15 riod described in subparagraph (A), if the Sec16 retary determines that the extension is appro17 priate for carrying out the purpose of this sec18 tion. 

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

20 less than 2 times each year and shall convene public 

21 meetings, as appropriate, to fulfill its duties under 

22 paragraph (2). 

23 (6) TASK FORCE REPORT TO CONGRESS.—Not 

24 later than 18 months after the date on which the Task 

25 Force is established under paragraph (1), the Task 
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1 Force shall prepare and submit to the Secretary, the 

2 Committee on Health, Education, Labor, and Pen3 sions of the Senate, and the Committee on Energy 

4 and Commerce of the House of Representatives a re5 port that includes each of the following: 

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

7 knowledge and research regarding safe and effec8 tive therapies for pregnant women and lactating 

9 women, including the development of such thera10 pies. 

11 (B) Ethical issues surrounding the inclu12 sion of pregnant women and lactating women in 

13 clinical research. 

14 (C) Effective communication strategies with 

15 health care providers and the public on informa16 tion relevant to pregnant women and lactating 

17 women. 

18 (D) Identification of Federal activities, in19 cluding— 

20 (i) the state of research on pregnancy 

21 and lactation; 

22 (ii) recommendations for the coordina23 tion of, and collaboration on research re24 lated to pregnant women and lactating 

25 women; 
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1 (iii) dissemination of research findings 

2 and information relevant to pregnant 

3 women and lactating women to providers 

4 and the public; and 

5 (iv) existing Federal efforts and pro6 grams to improve the scientific under7 standing of the health impacts on pregnant 

8 women, lactating women, and related birth 

9 and pediatric outcomes, including with re10 spect to pharmacokinetics, 

11 pharmacodynamics, and toxicities. 

12 (E) Recommendations to improve the devel13 opment of safe and effective therapies for preg14 nant women and lactating women. 

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

16 authorize the Secretary of Health and Human Services to 

17 disclose any information that is a trade secret, or other 

18 privileged or confidential information, described in section 

19 552(b)(4) of title 5, United States Code, or section 1905 

20 of title 18, United States Code. 

21 (c) UPDATING PROTECTIONS FOR PREGNANT WOMEN

22 AND LACTATING WOMEN IN RESEARCH.— 

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

24 the date of enactment of this Act, the Secretary, con25 sidering any recommendations of the Task Force 
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1 available at such time and in consultation with the 

2 heads of relevant agencies of the Department of 

3 Health and Human Services, shall, as appropriate, 

4 update regulations and guidance, as applicable, re5 garding the inclusion of pregnant women and lac6 tating women in clinical research. 

7 (2) CRITERIA FOR EXCLUDING PREGNANT OR

8 LACTATING WOMEN.—In updating any regulations or 

9 guidance described in paragraph (1), the Secretary 

10 shall consider any appropriate criteria to be used by 

11 institutional review boards and individuals reviewing 

12 grant proposals for excluding pregnant women or lac13 tating women as a study population requiring addi14 tional protections from participating in human sub15 ject research. 

16 SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF 

17 HEALTH REPORTING REQUIREMENTS. 

18 (a) TRANS-NATIONAL INSTITUTES OF HEALTH RE19 SEARCH REPORTING.—Section 402A(c)(2) of the Public 

20 Health Service Act (42 U.S.C. 282a(c)(2)) is amended— 

21 (1) by amending subparagraph (B) to read as 

22 follows: 

23 ‘‘(B) REPORTING.—Not later than 2 years 

24 after the date of enactment of 21st Century Cures 

25 Act, the head of each national research institute 
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1 or national center shall submit to the Director of 

2 the National Institutes of Health a report, to be 

3 included in the triennial report under section 

4 403, on the amount made available by the insti5 tute or center for conducting or supporting re6 search that involves collaboration between the in7 stitute or center and 1 or more other national re8 search institutes or national centers.’’; and 

9 (2) in subparagraphs (D) and (E) by striking 

10 ‘‘(B)(i)’’ each place it appears and inserting ‘‘(B)’’. 

11 (b) FRAUD AND ABUSE REPORTING.—Section 403B of 

12 the Public Health Service Act (42 U.S.C. 283a–1) is amend13 ed— 

14 (1) by striking subsection (b); 

15 (2) by redesignating subsection (c) as subsection 

16 (b); and 

17 (3) in subsection (b) (as so redesignated), by 

18 striking ‘‘subsections (a) and (b)’’ and inserting ‘‘sub19 section (a)’’. 

20 (c) DOCTORAL DEGREES REPORTING.—Section 

21 403C(a)(2) of the Public Health Service Act (42 U.S.C. 

22 283a–2(a)(2)) is amended by striking ‘‘(not including any 

23 leaves of absence)’’. 

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

25 Health Service Act (42 U.S.C. 283d) is amended— 
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1 (1) by striking subsection (b); and 

2 (2) by striking ‘‘(a) DEVELOPMENT OF NEW

3 VACCINES.—The Secretary’’ and inserting ‘‘The Sec4 retary’’. 

5 (e) NATIONAL CENTER FOR ADVANCING

6 TRANSLATIONAL SCIENCES.—Section 479(c) of the Public 

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

8 (1) in the subsection heading, by striking ‘‘AN9 NUAL’’ and inserting ‘‘BIENNIAL’’; and 

10 (2) in the matter preceding paragraph (1), by 

11 striking ‘‘an annual report’’ and inserting ‘‘a report 

12 on a biennial basis’’. 

13 (f) REVIEW OF CENTERS OF EXCELLENCE.— 

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

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

16 (2) CONFORMING AMENDMENT.—Section 

17 399EE(c) of the Public Health Service Act (42 U.S.C. 

18 280–4(c)) is amended by striking ‘‘399CC, 404H,’’ 

19 and inserting ‘‘399CC’’. 

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

21 Ryan White CARE Act Amendments of 2000 (42 U.S.C. 

22 300cc note) is amended— 

23 (1) by striking paragraph (2); and 

24 (2) by redesignating paragraph (3) as para25 graph (2). 
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1 (h) NATIONAL INSTITUTE OF NURSING RESEARCH.— 

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

3 Service Act (42 U.S.C. 285q–3) is repealed. 

4 (2) CONFORMING AMENDMENT.—Section 464X(g) 

5 of the Public Health Service Act (42 U.S.C. 285q– 

6 2(g)) is amended by striking ‘‘biennial report made 

7 under section 464Y,’’ and inserting ‘‘triennial report 

8 made under section 403’’. 

9 SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES 

10 AND LIVING ORGANISMS. 

11 Section 301 of the Public Health Service Act (42 

12 U.S.C. 241), as amended by section 2035, is further amend13 ed— 

14 (1) in the flush matter at the end of subsection 

15 (a)— 

16 (A) by redesignating such matter as sub17 section (h)(1); and 

18 (B) by moving such matter so as to appear 

19 at the end of such section; and 

20 (2) in subsection (h) (as so redesignated), by 

21 adding at the end the following: 

22 ‘‘(2) Where research substances and living organisms 

23 are made available under paragraph (1) through contrac24 tors, the Secretary may direct such contractors to collect 

25 payments on behalf of the Secretary for the costs incurred 
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1 to make available such substances and organisms and to 

2 forward amounts so collected to the Secretary, in the time 

3 and manner specified by the Secretary. 

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

5 credited to the appropriations accounts that incurred the 

6 costs to make available the research substances and living 

7 organisms involved, and shall remain available until ex8 pended for carrying out activities under such accounts.’’. 

9 SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION 

10 OF UNDERREPRESENTED POPULATIONS IN 

11 CLINICAL TRIALS. 

12 It is the sense of Congress that the National Institute 

13 on Minority Health and Health Disparities should include 

14 within its strategic plan under section 402(m) of the Public 

15 Health Service Act (42 U.S.C. 282(m)) ways to increase 

16 representation of underrepresented populations in clinical 

17 trials. 

18 Subtitle E—Advancement of the Na19 tional Institutes of Health Re20 search and Data Access 

21 SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS 

22 DATABASE. 

23 Section 402(j)(2)(D) of the Public Health Service Act 

24 (42 U.S.C. 282(j)(2)(D)) is amended— 
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1 (1) in clause (ii)(I), by inserting before the semi2 colon ‘‘, unless the responsible party affirmatively re3 quests that the Director of the National Institutes of 

4 Health publicly post such clinical trial information 

5 for an applicable device clinical trial prior to such 

6 date of clearance or approval’’; and 

7 (2) by adding at the end the following: 

8 ‘‘(iii) OPTION TO MAKE CERTAIN CLIN9 ICAL TRIAL INFORMATION AVAILABLE EAR10 LIER.—The Director of the National Insti11 tutes of Health shall inform responsible par12 ties of the option to request that clinical 

13 trial information for an applicable device 

14 clinical trial be publicly posted prior to the 

15 date of clearance or approval, in accordance 

16 with clause (ii)(I). 

17 ‘‘(iv) COMBINATION PRODUCTS.—An 

18 applicable clinical trial for a product that 

19 is a combination of drug, device, or biologi20 cal product shall be considered— 

21 ‘‘(I) an applicable drug clinical 

22 trial, if the Secretary determines under 

23 section 503(g) of the Federal Food, 

24 Drug, and Cosmetic Act that the pri-
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1 mary mode of action of such product is 

2 that of a drug or biological product; or 

3 ‘‘(II) an applicable device clinical 

4 trial, if the Secretary determines under 

5 such section that the primary mode of 

6 action of such product is that of a de7 vice.’’. 

8 SEC. 2052. COMPLIANCE ACTIVITIES REPORTS. 

9 (a) DEFINITIONS.—In this section: 

10 (1) APPLICABLE CLINICAL TRIAL.—The term 

11 ‘‘applicable clinical trial’’ has the meaning given the 

12 term in section 402(j) of the Public Health Service 

13 Act (42 U.S.C. 282(j)). 

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

15 the Secretary of Health and Human Services. 

16 (b) REPORT ON ACTIVITIES TO ENCOURAGE COMPLI17 ANCE.—Not later than 2 years after the date of enactment 

18 of this Act, the Secretary, acting through the Director of 

19 the National Institutes of Health and in collaboration with 

20 the Commissioner of Food and Drugs, shall submit to the 

21 Committee on Health, Education, Labor, and Pensions of 

22 the Senate and the Committee on Energy and Commerce 

23 of the House of Representatives, a report that describes edu24 cation and outreach, guidance, enforcement, and other ac-
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1 tivities undertaken to encourage compliance with section 

2 402(j) of the Public Health Service Act (42 U.S.C. 282(j)). 

3 (c) REPORTS ON CLINICAL TRIALS.— 

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

5 the final compliance date under the final rule imple6 menting section 402(j) of the Public Health Service 

7 Act, and every 2 years thereafter for the next 4 years, 

8 the Secretary, acting through the Director of the Na9 tional Institutes of Health and in collaboration with 

10 the Commissioner of Food and Drugs, shall submit to 

11 the Committee on Health, Education, Labor, and 

12 Pensions of the Senate and the Committee on Energy 

13 and Commerce of the House of Representatives, a re14 port describing— 

15 (A) the total number of applicable clinical 

16 trials with complete data bank registration in17 formation registered during the period for which 

18 the report is being prepared (broken down by 

19 each year of such reporting period); 

20 (B) the total number of applicable clinical 

21 trials registered during the period for which the 

22 report is being prepared for which results have 

23 been submitted to the data bank (broken down by 

24 each year of such reporting period); 
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1 (C) the activities undertaken by the Sec2 retary to educate responsible persons about data 

3 bank registration and results submission require4 ments, including through issuance of guidance 

5 documents, informational meetings, and training 

6 sessions; and 

7 (D) the activities described in the report 

8 submitted under subsection (b). 

9 (2) ACTIONS TO ENFORCE COMPLIANCE.—After 

10 the Secretary has undertaken the educational activi11 ties described in paragraph (1)(C), the Secretary shall 

12 include in subsequent reports submitted under para13 graph (1) the number of actions taken by the Sec14 retary during the period for which the report is being 

15 prepared to enforce compliance with data bank reg16 istration and results submission requirements. 

17 SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA. 

18 Section 492B(c) of the Public Health Service Act (42 

19 U.S.C. 289a–2(c)) is amended— 

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

21 following: 

22 ‘‘(1) IN GENERAL.—In the case’’; and 

23 (2) by adding at the end the following: 

24 ‘‘(2) REPORTING REQUIREMENTS.—For any new 

25 and competing project of clinical research subject to 
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1 the requirements under this section that receives a 

2 grant award 1 year after the date of enactment of the 

3 21st Century Cures Act, or any date thereafter, for 

4 which a valid analysis is provided under paragraph 

5 (1)— 

6 ‘‘(A) and which is an applicable clinical 

7 trial as defined in section 402(j), the entity con8 ducting such clinical research shall submit the 

9 results of such valid analysis to the clinical trial 

10 registry data bank expanded under section 

11 402(j)(3), and the Director of the National Insti12 tutes of Health shall, as appropriate, consider 

13 whether such entity has complied with the re14 porting requirement described in this subpara15 graph in awarding any future grant to such en16 tity, including pursuant to section 

17 402(j)(5)(A)(ii) when applicable; and 

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

19 of Health shall encourage the reporting of the re20 sults of such valid analysis described in para21 graph (1) through any additional means deter22 mined appropriate by the Director.’’. 

23 SEC. 2054. CONSULTATION. 

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

25 this Act, the Secretary of Health and Human Services shall 
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1 consult with relevant Federal agencies, including the Food 

2 and Drug Administration, the Office of the National Coor3 dinator for Health Information Technology, and the Na4 tional Institutes of Health, as well as other stakeholders (in5 cluding patients, researchers, physicians, industry rep6 resentatives, and developers of health information tech7 nology) to receive recommendations with respect to enhance8 ments to the clinical trial registry data bank under section 

9 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), 

10 including with respect to usability, functionality, and 

11 search capability. 

12 Subtitle F—Facilitating 

13 Collaborative Research 

14 SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SUR15 VEILLANCE SYSTEM. 

16 Part P of title III of the Public Health Service Act 

17 (42 U.S.C. 280g et seq.) is amended by inserting after sec18 tion 399S the following: 

19 ‘‘SEC. 399S–1. SURVEILLANCE OF NEUROLOGICAL DISEASES. 

20 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

21 Director of the Centers for Disease Control and Prevention 

22 and in coordination with other agencies as the Secretary 

23 determines, shall, as appropriate— 
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1 ‘‘(1) enhance and expand infrastructure and ac2 tivities to track the epidemiology of neurological dis3 eases; and 

4 ‘‘(2) incorporate information obtained through 

5 such activities into an integrated surveillance system, 

6 which may consist of or include a registry, to be 

7 known as the National Neurological Conditions Sur8 veillance System. 

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

10 National Neurological Conditions Surveillance System is 

11 designed in a manner that facilitates further research on 

12 neurological diseases. 

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

14 Secretary— 

15 ‘‘(1) shall provide for the collection and storage 

16 of information on the incidence and prevalence of 

17 neurological diseases in the United States; 

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

19 the collection and storage of other available informa20 tion on neurological diseases, including information 

21 related to persons living with neurological diseases 

22 who choose to participate, such as— 

23 ‘‘(A) demographics, such as age, race, eth24 nicity, sex, geographic location, family history, 

25 and other information, as appropriate; 
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1 ‘‘(B) risk factors that may be associated 

2 with neurological diseases, such as genetic and 

3 environmental risk factors and other informa4 tion, as appropriate; and 

5 ‘‘(C) diagnosis and progression markers; 

6 ‘‘(3) may provide for the collection and storage 

7 of information relevant to analysis on neurological 

8 diseases, such as information concerning— 

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

10 ‘‘(B) the prevention of the diseases; 

11 ‘‘(C) the detection, management, and treat12 ment approaches for the diseases; and 

13 ‘‘(D) the development of outcomes measures; 

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

15 consultation process under subsection (d); and 

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

17 neurological diseases. 

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

19 Secretary shall consult with individuals with appropriate 

20 expertise, which may include— 

21 ‘‘(1) epidemiologists with experience in disease 

22 surveillance or registries; 

23 ‘‘(2) representatives of national voluntary health 

24 associations that— 

25 ‘‘(A) focus on neurological diseases; and 
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1 ‘‘(B) have demonstrated experience in re2 search, care, or patient services; 

3 ‘‘(3) health information technology experts or 

4 other information management specialists; 

5 ‘‘(4) clinicians with expertise in neurological 

6 diseases; and 

7 ‘‘(5) research scientists with experience con8 ducting translational research or utilizing surveil9 lance systems for scientific research purposes. 

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

11 or enter into contracts or cooperative agreements with, pub12 lic or private nonprofit entities to carry out activities under 

13 this section. 

14 ‘‘(f) COORDINATION WITH OTHER FEDERAL, STATE, 

15 AND LOCAL AGENCIES.—Subject to subsection (h), the Sec16 retary shall— 

17 ‘‘(1) make information and analysis in the Na18 tional Neurological Conditions Surveillance System 

19 available, as appropriate— 

20 ‘‘(A) to Federal departments and agencies, 

21 such as the National Institutes of Health and the 

22 Department of Veterans Affairs; and 

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

24 ‘‘(2) identify, build upon, leverage, and coordi25 nate among existing data and surveillance systems, 
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1 surveys, registries, and other Federal public health in2 frastructure, wherever practicable. 

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

4 Secretary shall ensure that information and analysis in the 

5 National Neurological Conditions Surveillance System are 

6 available, as appropriate, to the public, including research7 ers. 

8 ‘‘(h) PRIVACY.—The Secretary shall ensure that infor9 mation and analysis in the National Neurological Condi10 tions Surveillance System are made available only to the 

11 extent permitted by applicable Federal and State law, and 

12 in a manner that protects personal privacy, to the extent 

13 required by applicable Federal and State privacy law, at 

14 a minimum. 

15 ‘‘(i) REPORTS.— 

16 ‘‘(1) REPORT ON INFORMATION AND ANALYSES.— 

17 Not later than 1 year after the date on which any sys18 tem is established under this section, the Secretary 

19 shall submit an interim report to the Committee on 

20 Health, Education, Labor, and Pensions of the Senate 

21 and the Committee on Energy and Commerce of the 

22 House of Representatives regarding aggregate infor23 mation collected pursuant to this section and epide24 miological analyses, as appropriate. Such report shall 

25 be posted on the Internet website of the Department 
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1 of Health and Human Services and shall be updated 

2 biennially. 

3 ‘‘(2) IMPLEMENTATION REPORT.—Not later than 

4 4 years after the date of the enactment of this section, 

5 the Secretary shall submit a report to the Congress 

6 concerning the implementation of this section. Such 

7 report shall include information on— 

8 ‘‘(A) the development and maintenance of 

9 the National Neurological Conditions Surveil10 lance System; 

11 ‘‘(B) the type of information collected and 

12 stored in the surveillance system; 

13 ‘‘(C) the use and availability of such infor14 mation, including guidelines for such use; and 

15 ‘‘(D) the use and coordination of databases 

16 that collect or maintain information on neuro17 logical diseases. 

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

19 voluntary health association’ means a national nonprofit 

20 organization with chapters, other affiliated organizations, 

21 or networks in States throughout the United States with 

22 experience serving the population of individuals with neu23 rological disease and have demonstrated experience in neu24 rological disease research, care, and patient services. 
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1 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—To carry 

2 out this section, there is authorized to be appropriated 

3 $5,000,000 for each of fiscal years 2018 through 2022.’’. 

4 SEC. 2062. TICK-BORNE DISEASES. 

5 (a) IN GENERAL.—The Secretary of Health and 

6 Human Services (referred to in this section as ‘‘the Sec7 retary’’) shall continue to conduct or support epidemiolog8 ical, basic, translational, and clinical research related to 

9 vector-borne diseases, including tick-borne diseases. 

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

11 triennial report under section 403 of the Public Health 

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

13 includes information on actions undertaken by the National 

14 Institutes of Health to carry out subsection (a) with respect 

15 to tick-borne diseases. 

16 (c) TICK-BORNE DISEASES WORKING GROUP.— 

17 (1) ESTABLISHMENT.—The Secretary shall estab18 lish a working group, to be known as the Tick-Borne 

19 Disease Working Group (referred to in this section as 

20 the ‘‘Working Group’’), comprised of representatives of 

21 appropriate Federal agencies and other non-Federal 

22 entities, to provide expertise and to review all efforts 

23 within the Department of Health and Human Serv24 ices related to all tick-borne diseases, to help ensure 
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1 interagency coordination and minimize overlap, and 

2 to examine research priorities. 

3 (2) RESPONSIBILITIES.—The working group 

4 shall— 

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

6 enactment of this Act, develop or update a sum7 mary of— 

8 (i) ongoing tick-borne disease research, 

9 including research related to causes, preven10 tion, treatment, surveillance, diagnosis, 

11 diagnostics, duration of illness, and inter12 vention for individuals with tick-borne dis13 eases; 

14 (ii) advances made pursuant to such 

15 research; 

16 (iii) Federal activities related to tick17 borne diseases, including— 

18 (I) epidemiological activities re19 lated to tick-borne diseases; and 

20 (II) basic, clinical, and 

21 translational tick-borne disease re22 search related to the pathogenesis, pre23 vention, diagnosis, and treatment of 

24 tick-borne diseases; 
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1 (iv) gaps in tick-borne disease research 

2 described in clause (iii)(II); 

3 (v) the Working Group’s meetings re4 quired under paragraph (4); and 

5 (vi) the comments received by the 

6 Working Group; 

7 (B) make recommendations to the Secretary 

8 regarding any appropriate changes or improve9 ments to such activities and research; and 

10 (C) solicit input from States, localities, and 

11 nongovernmental entities, including organiza12 tions representing patients, health care pro13 viders, researchers, and industry regarding sci14 entific advances, research questions, surveillance 

15 activities, and emerging strains in species of 

16 pathogenic organisms. 

17 (3) MEMBERSHIP.—The members of the working 

18 group shall represent a diversity of scientific dis19 ciplines and views and shall be composed of the fol20 lowing members: 

21 (A) FEDERAL MEMBERS.—Seven Federal 

22 members, consisting of one or more representa23 tives of each of the following: 

24 (i) The Office of the Assistant Sec25 retary for Health. 
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1 (ii) The Food and Drug Administra2 tion. 

3 (iii) The Centers for Disease Control 

4 and Prevention. 

5 (iv) The National Institutes of Health. 

6 (v) Such other agencies and offices of 

7 the Department of Health and Human 

8 Services as the Secretary determines appro9 priate. 

10 (B) NON–FEDERAL PUBLIC MEMBERS.— 

11 Seven non–Federal public members, consisting of 

12 representatives of the following categories: 

13 (i) Physicians and other medical pro14 viders with experience in diagnosing and 

15 treating tick-borne diseases. 

16 (ii) Scientists or researchers with ex17 pertise. 

18 (iii) Patients and their family mem19 bers. 

20 (iv) Nonprofit organizations that advo21 cate for patients with respect to tick-borne 

22 diseases. 

23 (v) Other individuals whose expertise 

24 is determined by the Secretary to be bene-
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1 ficial to the functioning of the Working 

2 Group. 

3 (4) MEETINGS.—The Working Group shall meet 

4 not less than twice each year. 

5 (5) REPORTING.—Not later than 2 years after 

6 the date of enactment of this Act, and every 2 years 

7 thereafter until termination of the Working Group 

8 pursuant to paragraph (7), the Working Group 

9 shall— 

10 (A) submit a report on its activities under 

11 paragraph (2)(A) and any recommendations 

12 under paragraph (2)(B) to the Secretary, the 

13 Committee on Energy and Commerce of the 

14 House of Representatives, and the Committee on 

15 Health, Education, Labor, and Pensions of the 

16 Senate; and 

17 (B) make such report publicly available on 

18 the Internet website of the Department of Health 

19 and Human Services. 

20 (6) APPLICABILITY OF FACA.—The Working 

21 Group shall be treated as an advisory committee sub22 ject to the Federal Advisory Committee Act (5 U.S.C. 

23 App.). 
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1 (7) SUNSET.—The Working Group under this 

2 section shall terminate 6 years after the date of enact3 ment of this Act. 

4 SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA 

5 FOR RESEARCH PURPOSES. 

6 (a) GUIDANCE RELATED TO REMOTE ACCESS.—Not 

7 later than 1 year after the date of enactment of this Act, 

8 the Secretary of Health and Human Services (referred to 

9 in this section as the ‘‘Secretary’’) shall issue guidance 

10 clarifying that subparagraph (B) of section 

11 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the 

12 removal of protected health information by a researcher) 

13 does not prohibit remote access to health information by a 

14 researcher for such purposes as described in section 

15 164.512(i)(1)(ii) of part 164 of the Rule so long as— 

16 (1) at a minimum, security and privacy safe17 guards, consistent with the requirements of the Rule, 

18 are maintained by the covered entity and the re19 searcher; and 

20 (2) the protected health information is not copied 

21 or otherwise retained by the researcher. 

22 (b) GUIDANCE RELATED TO STREAMLINING AUTHOR23 IZATION.—Not later than 1 year after the date of enactment 

24 of this Act, the Secretary shall issue guidance on the fol25 lowing: 
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1 (1) AUTHORIZATION FOR USE AND DISCLOSURE

2 OF HEALTH INFORMATION.—Clarification of the cir3 cumstances under which the authorization for the use 

4 or disclosure of protected health information, with re5 spect to an individual, for future research purposes 

6 contains a sufficient description of the purpose of the 

7 use or disclosure, such as if the authorization— 

8 (A) sufficiently describes the purposes such 

9 that it would be reasonable for the individual to 

10 expect that the protected health information 

11 could be used or disclosed for such future re12 search; 

13 (B) either— 

14 (i) states that the authorization will 

15 expire on a particular date or on the occur16 rence of a particular event; or 

17 (ii) states that the authorization will 

18 remain valid unless and until it is revoked 

19 by the individual; and 

20 (C) provides instruction to the individual 

21 on how to revoke such authorization at any time. 

22 (2) REMINDER OF THE RIGHT TO REVOKE.— 

23 Clarification of the circumstances under which it is 

24 appropriate to provide an individual with an annual 
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1 notice or reminder that the individual has the right 

2 to revoke such authorization. 

3 (3) REVOCATION OF AUTHORIZATION.—Clarifica4 tion of appropriate mechanisms by which an indi5 vidual may revoke an authorization for future re6 search purposes, such as described in paragraph 

7 (1)(C). 

8 (c) WORKING GROUP ON PROTECTED HEALTH INFOR9 MATION FOR RESEARCH.— 

10 (1) ESTABLISHMENT.—Not later than 1 year 

11 after the date of enactment of this Act, the Secretary 

12 shall convene a working group to study and report on 

13 the uses and disclosures of protected health informa14 tion for research purposes, under the Health Insur15 ance Portability and Accountability Act of 1996 

16 (Public Law 104–191). 

17 (2) MEMBERS.—The working group shall include 

18 representatives of— 

19 (A) relevant Federal agencies, including the 

20 National Institutes of Health, the Centers for 

21 Disease Control and Prevention, the Food and 

22 Drug Administration, and the Office for Civil 

23 Rights; 

24 (B) the research community; 

25 (C) patients; 
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1 (D) experts in civil rights, such as privacy 

2 rights; 

3 (E) developers of health information tech4 nology; 

5 (F) experts in data privacy and security; 

6 (G) health care providers; 

7 (H) bioethicists; and 

8 (I) other experts and entities, as the Sec9 retary determines appropriate. 

10 (3) REPORT.—Not later than 1 year after the 

11 date on which the working group is convened under 

12 paragraph (1), the working group shall conduct a re13 view and submit a report to the Secretary containing 

14 recommendations on whether the uses and disclosures 

15 of protected health information for research purposes 

16 should be modified to allow protected health informa17 tion to be available, as appropriate, for research pur18 poses, including studies to obtain generalizable knowl19 edge, while protecting individuals’ privacy rights. In 

20 conducting the review and making recommendations, 

21 the working group shall— 

22 (A) address, at a minimum— 

23 (i) the appropriate manner and timing 

24 of authorization, including whether addi25 tional notification to the individual should 
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1 be required when the individual’s protected 

2 health information will be used or disclosed 

3 for such research; 

4 (ii) opportunities for individuals to set 

5 preferences on the manner in which their 

6 protected health information is used in re7 search; 

8 (iii) opportunities for patients to re9 voke authorization; 

10 (iv) notification to individuals of a 

11 breach in privacy; 

12 (v) existing gaps in statute, regulation, 

13 or policy related to protecting the privacy of 

14 individuals, and 

15 (vi) existing barriers to research re16 lated to the current restrictions on the uses 

17 and disclosures of protected health informa18 tion; and 

19 (B) consider, at a minimum— 

20 (i) expectations and preferences on how 

21 an individual’s protected health informa22 tion is shared and used; 

23 (ii) issues related to specific subgroups 

24 of people, such as children, incarcerated in25 dividuals, and individuals with a cognitive 
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1 or intellectual disability impacting capacity 

2 to consent; 

3 (iii) relevant Federal and State laws; 

4 (iv) models of facilitating data access 

5 and levels of data access, including data 

6 segmentation, where applicable; 

7 (v) potential impacts of disclosure and 

8 non-disclosure of protected health informa9 tion on access to health care services; and 

10 (vi) the potential uses of such data. 

11 (4) REPORT SUBMISSION.—The Secretary shall 

12 submit the report under paragraph (3) to the Com13 mittee on Health, Education, Labor, and Pensions of 

14 the Senate and the Committee on Energy and Com15 merce of the House of Representatives, and shall post 

16 such report on the appropriate Internet website of the 

17 Department of Health and Human Services. 

18 (5) TERMINATION.—The working group convened 

19 under paragraph (1) shall terminate the day after the 

20 report under paragraph (3) is submitted to Congress 

21 and made public in accordance with paragraph (4). 

22 (d) DEFINITIONS.—In this section: 

23 (1) THE RULE.—References to ‘‘the Rule’’ refer 

24 to part 160 or part 164, as appropriate, of title 45, 
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1 Code of Federal Regulations (or any successor regula2 tion). 

3 (2) PART 164.—References to a specified section 

4 of ‘‘part 164’’, refer to such specified section of part 

5 164 of title 45, Code of Federal Regulations (or any 

6 successor section). 

7 Subtitle G—Promoting Pediatric 

8 Research 

9 SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK. 

10 Section 409D(d) of the Public Health Service Act (42 

11 U.S.C. 284h(d)) is amended— 

12 (1) in paragraph (1), by striking ‘‘in consulta13 tion with the Director of the Eunice Kennedy Shriver 

14 National Institute of Child Health and Human De15 velopment and in collaboration with other appro16 priate national research institutes and national cen17 ters that carry out activities involving pediatric re18 search, may provide for the establishment of’’ and in19 serting ‘‘in collaboration with the national research 

20 institutes and national centers that carry out activi21 ties involving pediatric research, shall support’’; and 

22 (2) in paragraph (2)(A) and the first sentence of 

23 paragraph (2)(E), by striking ‘‘may’’ each place such 

24 term appears and inserting ‘‘shall’’. 
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1 SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK. 

2 It is the sense of Congress that— 

3 (1) the National Institutes of Health should en4 courage a global pediatric clinical study network by 

5 providing grants, contracts, or cooperative agreements 

6 to support new and early stage investigators who par7 ticipate in the global pediatric clinical study network; 

8 (2) the Secretary of Health and Human Services 

9 (referred to in this section as the ‘‘Secretary’’) should 

10 engage with clinical investigators and appropriate 

11 authorities outside of the United States, including au12 thorities in the European Union, during the forma13 tion of the global pediatric clinical study network to 

14 encourage the participation of such investigator and 

15 authorities; and 

16 (3) once a global pediatric clinical study network 

17 is established and becomes operational, the Secretary 

18 should continue to encourage and facilitate the par19 ticipation of clinical investigators and appropriate 

20 authorities outside of the United States, including in 

21 the European Union, to participate in the network 

22 with the goal of enhancing the global reach of the net23 work. 
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1 TITLE III—DEVELOPMENT 

2 Subtitle A—Patient-Focused Drug 

3 Development 

4 SEC. 3001. PATIENT EXPERIENCE DATA. 

5 Section 569C of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360bbb–8c) is amended— 

7 (1) in subsection (a)— 

8 (A) in the subsection heading, by striking 

9 ‘‘IN GENERAL’’ and inserting ‘‘PATIENT EN10 GAGEMENT IN DRUGS AND DEVICES’’; 

11 (B) by redesignating paragraphs (1) and 

12 (2) as subparagraphs (A) and (B), respectively, 

13 and moving such subparagraphs 2 ems to the 

14 right; and 

15 (C) by striking ‘‘The Secretary’’ and insert16 ing the following: 

17 ‘‘(1) IN GENERAL.—The Secretary’’; 

18 (2) by redesignating subsections (b) through (e) 

19 as paragraphs (2) through (5), respectively, and mov20 ing such paragraphs 2 ems to the right; and 

21 (3) by adding at the end the following: 

22 ‘‘(b) STATEMENT OF PATIENT EXPERIENCE.— 

23 ‘‘(1) IN GENERAL.—Following the approval of an 

24 application that was submitted under section 505(b) 

25 of this Act or section 351(a) of the Public Health 
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1 Service Act at least 180 days after the date of enact2 ment of the 21st Century Cures Act, the Secretary 

3 shall make public a brief statement regarding the pa4 tient experience data and related information, if any, 

5 submitted and reviewed as part of such application. 

6 ‘‘(2) DATA AND INFORMATION.—The data and 

7 information referred to in paragraph (1) are— 

8 ‘‘(A) patient experience data; 

9 ‘‘(B) information on patient-focused drug 

10 development tools; and 

11 ‘‘(C) other relevant information, as deter12 mined by the Secretary. 

13 ‘‘(c) PATIENT EXPERIENCE DATA.—For purposes of 

14 this section, the term ‘patient experience data’ includes data 

15 that— 

16 ‘‘(1) are collected by any persons (including pa17 tients, family members and caregivers of patients, pa18 tient advocacy organizations, disease research founda19 tions, researchers, and drug manufacturers); and 

20 ‘‘(2) are intended to provide information about 

21 patients’ experiences with a disease or condition, in22 cluding— 

23 ‘‘(A) the impact of such disease or condi24 tion, or a related therapy, on patients’ lives; and 
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1 ‘‘(B) patient preferences with respect to 

2 treatment of such disease or condition.’’. 

3 SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUID4 ANCE. 

5 (a) PUBLICATION OF GUIDANCE DOCUMENTS.—Not 

6 later than 180 days after the date of enactment of this Act, 

7 the Secretary of Health and Human Services (referred to 

8 in this section as the ‘‘Secretary’’), acting through the Com9 missioner of Food and Drugs, shall develop a plan to issue 

10 draft and final versions of one or more guidance documents, 

11 over a period of 5 years, regarding the collection of patient 

12 experience data, and the use of such data and related infor13 mation in drug development. Not later than 18 months after 

14 the date of enactment of this Act, the Secretary shall issue 

15 a draft version of at least one such guidance document. Not 

16 later than 18 months after the public comment period on 

17 the draft guidance ends, the Secretary shall issue a revised 

18 draft guidance or final guidance. 

19 (b) PATIENT EXPERIENCE DATA.—For purposes of 

20 this section, the term ‘‘patient experience data’’ has the 

21 meaning given such term in section 569C of the Federal 

22 Food, Drug, and Cosmetic Act (as added by section 3001). 

23 (c) CONTENTS.—The guidance documents described in 

24 subsection (a) shall address— 
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1 (1) methodological approaches that a person 

2 seeking to collect patient experience data for submis3 sion to, and proposed use by, the Secretary in regu4 latory decisionmaking may use, that are relevant and 

5 objective and ensure that such data are accurate and 

6 representative of the intended population, including 

7 methods to collect meaningful patient input through8 out the drug development process and methodological 

9 considerations for data collection, reporting, manage10 ment, and analysis; 

11 (2) methodological approaches that may be used 

12 to develop and identify what is most important to pa13 tients with respect to burden of disease, burden of 

14 treatment, and the benefits and risks in the manage15 ment of the patient’s disease; 

16 (3) approaches to identifying and developing 

17 methods to measure impacts to patients that will help 

18 facilitate collection of patient experience data in clin19 ical trials; 

20 (4) methodologies, standards, and technologies to 

21 collect and analyze clinical outcome assessments for 

22 purposes of regulatory decisionmaking; 

23 (5) how a person seeking to develop and submit 

24 proposed draft guidance relating to patient experience 
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1 data for consideration by the Secretary may submit 

2 such proposed draft guidance to the Secretary; 

3 (6) the format and content required for submis4 sions under this section to the Secretary, including 

5 with respect to the information described in para6 graph (1); 

7 (7) how the Secretary intends to respond to sub8 missions of information described in paragraph (1), 

9 if applicable, including any timeframe for response 

10 when such submission is not part of a regulatory ap11 plication or other submission that has an associated 

12 timeframe for response; and 

13 (8) how the Secretary, if appropriate, antici14 pates using relevant patient experience data and re15 lated information, including with respect to the struc16 tured risk-benefit assessment framework described in 

17 section 505(d) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(d)), to inform regulatory 

19 decisionmaking. 

20 SEC. 3003. STREAMLINING PATIENT INPUT. 

21 Chapter 35 of title 44, United States Code, shall not 

22 apply to the collection of information to which a response 

23 is voluntary, that is initiated by the Secretary under sec24 tion 569C of the Federal Food, Drug, and Cosmetic Act (21 
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1 U.S.C. 360bbb–8c) (as amended by section 3001) or section 

2 3002. 

3 SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVEL4 OPMENT. 

5 Not later than June 1 of 2021, 2026, and 2031, the 

6 Secretary of Health and Human Services, acting through 

7 the Commissioner of Food and Drugs, shall prepare and 

8 publish on the Internet website of the Food and Drug Ad9 ministration a report assessing the use of patient experience 

10 data in regulatory decisionmaking, in particular with re11 spect to the review of patient experience data and informa12 tion on patient-focused drug development tools as part of 

13 applications approved under section 505(c) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 

15 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). 

16 Subtitle B—Advancing New Drug 

17 Therapies 

18 SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 

19 (a) IN GENERAL.—Chapter V of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

21 by inserting after section 506F the following new section: 

22 ‘‘SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 

23 ‘‘(a) PROCESS FOR QUALIFICATION.— 
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1 ‘‘(1) IN GENERAL.—The Secretary shall establish 

2 a process for the qualification of drug development 

3 tools for a proposed context of use under which— 

4 ‘‘(A)(i) a requestor initiates such process by 

5 submitting a letter of intent to the Secretary; 

6 and 

7 ‘‘(ii) the Secretary accepts or declines to ac8 cept such letter of intent; 

9 ‘‘(B)(i) if the Secretary accepts the letter of 

10 intent, a requestor submits a qualification plan 

11 to the Secretary; and 

12 ‘‘(ii) the Secretary accepts or declines to ac13 cept the qualification plan; and 

14 ‘‘(C)(i) if the Secretary accepts the quali15 fication plan, the requestor submits to the Sec16 retary a full qualification package; 

17 ‘‘(ii) the Secretary determines whether to 

18 accept such qualification package for review; and 

19 ‘‘(iii) if the Secretary accepts such quali20 fication package for review, the Secretary con21 ducts such review in accordance with this sec22 tion. 

23 ‘‘(2) ACCEPTANCE AND REVIEW OF SUBMIS24 SIONS.— 
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1 ‘‘(A) IN GENERAL.—Subparagraphs (B), 

2 (C), and (D) shall apply with respect to the 

3 treatment of a letter of intent, a qualification 

4 plan, or a full qualification package submitted 

5 under paragraph (1) (referred to in this para6 graph as ‘qualification submissions’). 

7 ‘‘(B) ACCEPTANCE FACTORS; NONACCEPT8 ANCE.—The Secretary shall determine whether to 

9 accept a qualification submission based on fac10 tors which may include the scientific merit of the 

11 qualification submission. A determination not to 

12 accept a submission under paragraph (1) shall 

13 not be construed as a final determination by the 

14 Secretary under this section regarding the quali15 fication of a drug development tool for its pro16 posed context of use. 

17 ‘‘(C) PRIORITIZATION OF QUALIFICATION

18 REVIEW.—The Secretary may prioritize the re19 view of a full qualification package submitted 

20 under paragraph (1) with respect to a drug de21 velopment tool, based on factors determined ap22 propriate by the Secretary, including— 

23 ‘‘(i) as applicable, the severity, rarity, 

24 or prevalence of the disease or condition 

25 targeted by the drug development tool and 
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•HR 34 EAH 

1 the availability or lack of alternative treat2 ments for such disease or condition; and 

3 ‘‘(ii) the identification, by the Sec4 retary or by biomedical research consortia 

5 and other expert stakeholders, of such a 

6 drug development tool and its proposed con7 text of use as a public health priority. 

8 ‘‘(D) ENGAGEMENT OF EXTERNAL EX9 PERTS.—The Secretary may, for purposes of the 

10 review of qualification submissions, through the 

11 use of cooperative agreements, grants, or other 

12 appropriate mechanisms, consult with bio13 medical research consortia and may consider the 

14 recommendations of such consortia with respect 

15 to the review of any qualification plan submitted 

16 under paragraph (1) or the review of any full 

17 qualification package under paragraph (3). 

18 ‘‘(3) REVIEW OF FULL QUALIFICATION PACK19 AGE.—The Secretary shall— 

20 ‘‘(A) conduct a comprehensive review of a 

21 full qualification package accepted under para22 graph (1)(C); and 

23 ‘‘(B) determine whether the drug develop24 ment tool at issue is qualified for its proposed 

25 context of use. 
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1 ‘‘(4) QUALIFICATION.—The Secretary shall deter2 mine whether a drug development tool is qualified for 

3 a proposed context of use based on the scientific merit 

4 of a full qualification package reviewed under para5 graph (3). 

6 ‘‘(b) EFFECT OF QUALIFICATION.— 

7 ‘‘(1) IN GENERAL.—A drug development tool de8 termined to be qualified under subsection (a)(4) for a 

9 proposed context of use specified by the requestor may 

10 be used by any person in such context of use for the 

11 purposes described in paragraph (2). 

12 ‘‘(2) USE OF A DRUG DEVELOPMENT TOOL.— 

13 Subject to paragraph (3), a drug development tool 

14 qualified under this section may be used for— 

15 ‘‘(A) supporting or obtaining approval or 

16 licensure (as applicable) of a drug or biological 

17 product (including in accordance with section 

18 506(c)) under section 505 of this Act or section 

19 351 of the Public Health Service Act; or 

20 ‘‘(B) supporting the investigational use of a 

21 drug or biological product under section 505(i) 

22 of this Act or section 351(a)(3) of the Public 

23 Health Service Act. 

24 ‘‘(3) RESCISSION OR MODIFICATION.— 
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1 ‘‘(A) IN GENERAL.—The Secretary may re2 scind or modify a determination under this sec3 tion to qualify a drug development tool if the 

4 Secretary determines that the drug development 

5 tool is not appropriate for the proposed context 

6 of use specified by the requestor. Such a deter7 mination may be based on new information that 

8 calls into question the basis for such qualifica9 tion. 

10 ‘‘(B) MEETING FOR REVIEW.—If the Sec11 retary rescinds or modifies under subparagraph 

12 (A) a determination to qualify a drug develop13 ment tool, the requestor involved shall, on re14 quest, be granted a meeting with the Secretary to 

15 discuss the basis of the Secretary’s decision to re16 scind or modify the determination before the ef17 fective date of the rescission or modification. 

18 ‘‘(c) TRANSPARENCY.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraph (3), the 

20 Secretary shall make publicly available, and update 

21 on at least a biannual basis, on the Internet website 

22 of the Food and Drug Administration the following: 

23 ‘‘(A) Information with respect to each qual24 ification submission under the qualification 

25 process under subsection (a), including— 
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•HR 34 EAH 

1 ‘‘(i) the stage of the review process ap2 plicable to the submission; 

3 ‘‘(ii) the date of the most recent change 

4 in stage status; 

5 ‘‘(iii) whether external scientific ex6 perts were utilized in the development of a 

7 qualification plan or the review of a full 

8 qualification package; and 

9 ‘‘(iv) submissions from requestors 

10 under the qualification process under sub11 section (a), including any data and evi12 dence contained in such submissions, and 

13 any updates to such submissions. 

14 ‘‘(B) The Secretary’s formal written deter15 minations in response to such qualification sub16 missions. 

17 ‘‘(C) Any rescissions or modifications under 

18 subsection (b)(3) of a determination to qualify a 

19 drug development tool. 

20 ‘‘(D) Summary reviews that document con21 clusions and recommendations for determina22 tions to qualify drug development tools under 

23 subsection (a). 

24 ‘‘(E) A comprehensive list of— 
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•HR 34 EAH 

1 ‘‘(i) all drug development tools quali2 fied under subsection (a); and 

3 ‘‘(ii) all surrogate endpoints which 

4 were the basis of approval or licensure (as 

5 applicable) of a drug or biological product 

6 (including in accordance with section 

7 506(c)) under section 505 of this Act or sec8 tion 351 of the Public Health Service Act. 

9 ‘‘(2) RELATION TO TRADE SECRETS ACT.—Infor10 mation made publicly available by the Secretary 

11 under paragraph (1) shall be considered a disclosure 

12 authorized by law for purposes of section 1905 of title 

13 18, United States Code. 

14 ‘‘(3) APPLICABILITY.—Nothing in this section 

15 shall be construed as authorizing the Secretary to dis16 close any information contained in an application 

17 submitted under section 505 of this Act or section 351 

18 of the Public Health Service Act that is confidential 

19 commercial or trade secret information subject to sec20 tion 552(b)(4) of title 5, United States Code, or sec21 tion 1905 of title 18, United States Code. 

22 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed— 

24 ‘‘(1) to alter the standards of evidence under sub25 section (c) or (d) of section 505, including the sub-
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•HR 34 EAH 

1 stantial evidence standard in such subsection (d), or 

2 under section 351 of the Public Health Service Act (as 

3 applicable); or 

4 ‘‘(2) to limit the authority of the Secretary to 

5 approve or license products under this Act or the Pub6 lic Health Service Act, as applicable (as in effect be7 fore the date of the enactment of the 21st Century 

8 Cures Act). 

9 ‘‘(e) DEFINITIONS.—In this section: 

10 ‘‘(1) BIOMARKER.—The term ‘biomarker’— 

11 ‘‘(A) means a characteristic (such as a 

12 physiologic, pathologic, or anatomic char13 acteristic or measurement) that is objectively 

14 measured and evaluated as an indicator of nor15 mal biologic processes, pathologic processes, or 

16 biological responses to a therapeutic intervention; 

17 and 

18 ‘‘(B) includes a surrogate endpoint. 

19 ‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The 

20 term ‘biomedical research consortia’ means collabo21 rative groups that may take the form of public-pri22 vate partnerships and may include government agen23 cies, institutions of higher education (as defined in 

24 section 101(a) of the Higher Education Act of 1965), 

25 patient advocacy groups, industry representatives, 
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•HR 34 EAH 

1 clinical and scientific experts, and other relevant enti2 ties and individuals. 

3 ‘‘(3) CLINICAL OUTCOME ASSESSMENT.—The 

4 term ‘clinical outcome assessment’ means— 

5 ‘‘(A) a measurement of a patient’s symp6 toms, overall mental state, or the effects of a dis7 ease or condition on how the patient functions; 

8 and 

9 ‘‘(B) includes a patient-reported outcome. 

10 ‘‘(4) CONTEXT OF USE.—The term ‘context of 

11 use’ means, with respect to a drug development tool, 

12 the circumstances under which the drug development 

13 tool is to be used in drug development and regulatory 

14 review. 

15 ‘‘(5) DRUG DEVELOPMENT TOOL.—The term 

16 ‘drug development tool’ includes— 

17 ‘‘(A) a biomarker; 

18 ‘‘(B) a clinical outcome assessment; and 

19 ‘‘(C) any other method, material, or meas20 ure that the Secretary determines aids drug de21 velopment and regulatory review for purposes of 

22 this section. 

23 ‘‘(6) PATIENT-REPORTED OUTCOME.—The term 

24 ‘patient-reported outcome’ means a measurement 

25 based on a report from a patient regarding the status 
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1 of the patient’s health condition without amendment 

2 or interpretation of the patient’s report by a clinician 

3 or any other person. 

4 ‘‘(7) QUALIFICATION.—The terms ‘qualification’ 

5 and ‘qualified’ mean a determination by the Sec6 retary that a drug development tool and its proposed 

7 context of use can be relied upon to have a specific 

8 interpretation and application in drug development 

9 and regulatory review under this Act. 

10 ‘‘(8) REQUESTOR.—The term ‘requestor’ means 

11 an entity or entities, including a drug sponsor or a 

12 biomedical research consortia, seeking to qualify a 

13 drug development tool for a proposed context of use 

14 under this section. 

15 ‘‘(9) SURROGATE ENDPOINT.—The term ‘surro16 gate endpoint’ means a marker, such as a laboratory 

17 measurement, radiographic image, physical sign, or 

18 other measure, that is not itself a direct measurement 

19 of clinical benefit, and— 

20 ‘‘(A) is known to predict clinical benefit 

21 and could be used to support traditional ap22 proval of a drug or biological product; or 

23 ‘‘(B) is reasonably likely to predict clinical 

24 benefit and could be used to support the acceler-
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1 ated approval of a drug or biological product in 

2 accordance with section 506(c).’’. 

3 (b) GUIDANCE.— 

4 (1) IN GENERAL.—The Secretary of Health and 

5 Human Services (referred to in this section as the 

6 ‘‘Secretary’’) shall, in consultation with biomedical 

7 research consortia (as defined in subsection (e) of sec8 tion 507 of the Federal Food, Drug, and Cosmetic Act 

9 (as added by subsection (a)) and other interested par10 ties through a collaborative public process, issue guid11 ance to implement such section 507 that— 

12 (A) provides a conceptual framework de13 scribing appropriate standards and scientific 

14 approaches to support the development of bio15 markers delineated under the taxonomy estab16 lished under paragraph (3); 

17 (B) with respect to the qualification process 

18 under such section 507— 

19 (i) describes the requirements that enti20 ties seeking to qualify a drug development 

21 tool under such section shall observe when 

22 engaging in such process; 

23 (ii) outlines reasonable timeframes for 

24 the Secretary’s review of letters, qualifica-
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•HR 34 EAH 

1 tion plans, or full qualification packages 

2 submitted under such process; and 

3 (iii) establishes a process by which 

4 such entities or the Secretary may consult 

5 with biomedical research consortia and 

6 other individuals and entities with expert 

7 knowledge and insights that may assist the 

8 Secretary in the review of qualification 

9 plans and full qualification submissions 

10 under such section; and 

11 (C) includes such other information as the 

12 Secretary determines appropriate. 

13 (2) TIMING.—Not later than 3 years after the 

14 date of the enactment of this Act, the Secretary shall 

15 issue draft guidance under paragraph (1) on the im16 plementation of section 507 of the Federal Food, 

17 Drug, and Cosmetic Act (as added by subsection (a)). 

18 The Secretary shall issue final guidance on the imple19 mentation of such section not later than 6 months 

20 after the date on which the comment period for the 

21 draft guidance closes. 

22 (3) TAXONOMY.— 

23 (A) IN GENERAL.—For purposes of inform24 ing guidance under this subsection, the Secretary 

25 shall, in consultation with biomedical research 
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1 consortia and other interested parties through a 

2 collaborative public process, establish a tax3 onomy for the classification of biomarkers (and 

4 related scientific concepts) for use in drug devel5 opment. 

6 (B) PUBLIC AVAILABILITY.—Not later than 

7 2 years after the date of the enactment of this 

8 Act, the Secretary shall make such taxonomy 

9 publicly available in draft form for public com10 ment. The Secretary shall finalize the taxonomy 

11 not later than 1 year after the close of the public 

12 comment period. 

13 (c) MEETING AND REPORT.— 

14 (1) MEETING.—Not later than 2 years after the 

15 date of the enactment of this Act, the Secretary shall 

16 convene a public meeting to describe and solicit pub17 lic input regarding the qualification process under 

18 section 507 of the Federal Food, Drug, and Cosmetic 

19 Act, as added by subsection (a). 

20 (2) REPORT.—Not later than 5 years after the 

21 date of the enactment of this Act, the Secretary shall 

22 make publicly available on the Internet website of the 

23 Food and Drug Administration a report. Such report 

24 shall include, with respect to the qualification process 

25 under section 507 of the Federal Food, Drug, and 
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•HR 34 EAH 

1 Cosmetic Act, as added by subsection (a), information 

2 on— 

3 (A) the number of requests submitted, as a 

4 letter of intent, for qualification of a drug devel5 opment tool (as defined in subsection (e) of such 

6 section 507); 

7 (B) the number of such requests accepted 

8 and determined to be eligible for submission of a 

9 qualification plan or full qualification package 

10 (as such terms are defined in subsection (e) of 

11 such section 507), respectively; 

12 (C) the number of such requests for which 

13 external scientific experts were utilized in the de14 velopment of a qualification plan or review of a 

15 full qualification package; 

16 (D) the number of qualification plans and 

17 full qualification packages, respectively, sub18 mitted to the Secretary; and 

19 (E) the drug development tools qualified 

20 through such qualification process, specified by 

21 type of tool, such as a biomarker or clinical out22 come assessment (as such terms are defined in 

23 subsection (e) of such section 507). 
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1 SEC. 3012. TARGETED DRUGS FOR RARE DISEASES. 

2 Subchapter B of chapter V of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by 

4 inserting after section 529 the following: 

5 ‘‘SEC. 529A. TARGETED DRUGS FOR RARE DISEASES. 

6 ‘‘(a) PURPOSE.—The purpose of this section, through 

7 the approach provided for in subsection (b), is to— 

8 ‘‘(1) facilitate the development, review, and ap9 proval of genetically targeted drugs and variant pro10 tein targeted drugs to address an unmet medical need 

11 in one or more patient subgroups, including sub12 groups of patients with different mutations of a gene, 

13 with respect to rare diseases or conditions that are se14 rious or life-threatening; and 

15 ‘‘(2) maximize the use of scientific tools or meth16 ods, including surrogate endpoints and other bio17 markers, for such purposes. 

18 ‘‘(b) LEVERAGING OF DATA FROM PREVIOUSLY AP19 PROVED DRUG APPLICATION OR APPLICATIONS.—The Sec20 retary may, consistent with applicable standards for ap21 proval under this Act or section 351(a) of the Public Health 

22 Service Act, allow the sponsor of an application under sec23 tion 505(b)(1) of this Act or section 351(a) of the Public 

24 Health Service Act for a genetically targeted drug or a vari25 ant protein targeted drug to rely upon data and informa26 tion— 
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1 ‘‘(1) previously developed by the same sponsor 

2 (or another sponsor that has provided the sponsor 

3 with a contractual right of reference to such data and 

4 information); and 

5 ‘‘(2) submitted by a sponsor described in para6 graph (1) in support of one or more previously ap7 proved applications that were submitted under section 

8 505(b)(1) of this Act or section 351(a) of the Public 

9 Health Service Act, 

10 for a drug that incorporates or utilizes the same or similar 

11 genetically targeted technology as the drug or drugs that 

12 are the subject of an application or applications described 

13 in paragraph (2) or for a variant protein targeted drug 

14 that is the same or incorporates or utilizes the same variant 

15 protein targeted drug, as the drug or drugs that are the 

16 subject of an application or applications described in para17 graph (2). 

18 ‘‘(c) DEFINITIONS.—For purposes of this section— 

19 ‘‘(1) the term ‘genetically targeted drug’ means a 

20 drug that— 

21 ‘‘(A) is the subject of an application under 

22 section 505(b)(1) of this Act or section 351(a) of 

23 the Public Health Service Act for the treatment 

24 of a rare disease or condition (as such term is 
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1 defined in section 526) that is serious or life2 threatening; 

3 ‘‘(B) may result in the modulation (includ4 ing suppression, up-regulation, or activation) of 

5 the function of a gene or its associated gene 

6 product; and 

7 ‘‘(C) incorporates or utilizes a genetically 

8 targeted technology; 

9 ‘‘(2) the term ‘genetically targeted technology’ 

10 means a technology comprising non-replicating nu11 cleic acid or analogous compounds with a common or 

12 similar chemistry that is intended to treat one or 

13 more patient subgroups, including subgroups of pa14 tients with different mutations of a gene, with the 

15 same disease or condition, including a disease or con16 dition due to other variants in the same gene; and 

17 ‘‘(3) the term ‘variant protein targeted drug’ 

18 means a drug that— 

19 ‘‘(A) is the subject of an application under 

20 section 505(b)(1) of this Act or section 351(a) of 

21 the Public Health Service Act for the treatment 

22 of a rare disease or condition (as such term is 

23 defined in section 526) that is serious or life24 threatening; 
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1 ‘‘(B) modulates the function of a product of 

2 a mutated gene where such mutation is respon3 sible in whole or in part for a given disease or 

4 condition; and 

5 ‘‘(C) is intended to treat one or more pa6 tient subgroups, including subgroups of patients 

7 with different mutations of a gene, with the same 

8 disease or condition. 

9 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec10 tion shall be construed to— 

11 ‘‘(1) alter the authority of the Secretary to ap12 prove drugs pursuant to this Act or section 351 of the 

13 Public Health Service Act (as authorized prior to the 

14 date of enactment of the 21st Century Cures Act), in15 cluding the standards of evidence, and applicable con16 ditions, for approval under such applicable Act; or 

17 ‘‘(2) confer any new rights, beyond those author18 ized under this Act or the Public Health Service Act 

19 prior to enactment of this section, with respect to the 

20 permissibility of a sponsor referencing information 

21 contained in another application submitted under sec22 tion 505(b)(1) of this Act or section 351(a) of the 

23 Public Health Service Act.’’. 
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1 SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOUR2 AGE TREATMENTS FOR RARE PEDIATRIC DIS3 EASES. 

4 (a) IN GENERAL.—Section 529(b) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended 

6 by striking paragraph (5) and inserting the following: 

7 ‘‘(5) TERMINATION OF AUTHORITY.—The Sec8 retary may not award any priority review vouchers 

9 under paragraph (1) after September 30, 2020, unless 

10 the rare pediatric disease product application— 

11 ‘‘(A) is for a drug that, not later than Sep12 tember 30, 2020, is designated under subsection 

13 (d) as a drug for a rare pediatric disease; and 

14 ‘‘(B) is, not later than September 30, 2022, 

15 approved under section 505(b)(1) of this Act or 

16 section 351(a) of the Public Health Service Act.’’. 

17 (b) REPORT.—The Advancing Hope Act of 2016 (Pub18 lic Law 114–229) is amended by striking section 3. 

19 SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PRO20 GRAMS. 

21 (a) STUDY.—The Comptroller General of the United 

22 States (referred to in this section as the ‘‘Comptroller Gen23 eral’’) shall conduct a study addressing the effectiveness and 

24 overall impact of the following priority review voucher pro25 grams, including any such programs amended or estab26 lished by this Act: 
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1 (1) The neglected tropical disease priority review 

2 voucher program under section 524 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 360n). 

4 (2) The rare pediatric disease priority review 

5 voucher program under section 529 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 360ff). 

7 (3) The medical countermeasure priority review 

8 voucher program under section 565A of the Federal 

9 Food, Drug, and Cosmetic Act, as added by section 

10 3086. 

11 (b) ISSUANCE OF REPORT.—Not later than January 

12 31, 2020, the Comptroller General shall submit to the Com13 mittee on Health, Education, Labor, and Pensions of the 

14 Senate and the Committee on Energy and Commerce of the 

15 House of Representatives a report containing the results of 

16 the study under subsection (a). 

17 (c) CONTENTS OF REPORTS.—The report submitted 

18 under subsection (b) shall address— 

19 (1) for each drug for which a priority review 

20 voucher has been awarded as of initiation of the 

21 study— 

22 (A) the indications for which the drug is 

23 approved under section 505(c) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 

25 355(c)), pursuant to an application under sec-
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1 tion 505(b)(1) of such Act, or licensed under sec2 tion 351(a) of the Public Health Service Act (42 

3 U.S.C. 262(a)); 

4 (B) whether, and to what extent, the vouch5 er impacted the sponsor’s decision to develop the 

6 drug; and 

7 (C) whether, and to what extent, the ap8 proval or licensure of the drug, as applicable and 

9 appropriate— 

10 (i) addressed a global unmet need re11 lated to the treatment or prevention of a ne12 glected tropical disease, including whether 

13 the sponsor of a drug coordinated with 

14 international development organizations; 

15 (ii) addressed an unmet need related to 

16 the treatment of a rare pediatric disease; or 

17 (iii) affected the Nation’s preparedness 

18 against a chemical, biological, radiological, 

19 or nuclear threat, including naturally oc20 curring threats; 

21 (2) for each drug for which a priority review 

22 voucher has been used— 

23 (A) the indications for which such drug is 

24 approved under section 505(c) of the Federal 

25 Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 355(c)), pursuant to an application under sec2 tion 505(b)(1) of such Act, or licensed under sec3 tion 351(a) of the Public Health Service Act (42 

4 U.S.C. 262); 

5 (B) the value of the voucher, if transferred; 

6 and 

7 (C) the length of time between the date on 

8 which the voucher was awarded and the date on 

9 which the voucher was used; and 

10 (3) an analysis of the priority review voucher 

11 programs described in subsection (a), including— 

12 (A) the resources used by the Food and 

13 Drug Administration in reviewing drugs for 

14 which vouchers were used, including the effect of 

15 the programs on the Food and Drug Administra16 tion’s review of drugs for which priority review 

17 vouchers were not awarded or used; 

18 (B) whether any improvements to such pro19 grams are necessary to appropriately target in20 centives for the development of drugs that would 

21 likely not otherwise be developed, or developed in 

22 as timely a manner, and, as applicable and ap23 propriate— 

24 (i) address global unmet needs related 

25 to the treatment or prevention of neglected 
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1 tropical diseases, including in countries in 

2 which neglected tropical diseases are en3 demic; or 

4 (ii) address unmet needs related to the 

5 treatment of rare pediatric diseases; and 

6 (C) whether the sunset of the rare pediatric 

7 disease program and medical countermeasure 

8 program has had an impact on the program, in9 cluding any potential unintended consequences. 

10 (d) PROTECTION OF NATIONAL SECURITY.—The 

11 Comptroller General shall conduct the study and issue re12 ports under this section in a manner that does not com13 promise national security. 

14 SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS. 

15 Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) 

16 is amended— 

17 (1) in subsection (a), by striking paragraph (1) 

18 and inserting the following: ‘‘(1) defraying the costs 

19 of developing drugs for rare diseases or conditions, in20 cluding qualified testing expenses,’’; and 

21 (2) in subsection (b)(1)— 

22 (A) in subparagraph (A)(ii), by striking 

23 ‘‘and’’ after the semicolon; 

24 (B) in subparagraph (B), by striking the 

25 period and inserting ‘‘; and’’; and 
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1 (C) by adding at the end the following: 

2 ‘‘(C) prospectively planned and designed ob3 servational studies and other analyses conducted 

4 to assist in the understanding of the natural his5 tory of a rare disease or condition and in the de6 velopment of a therapy, including studies and 

7 analyses to— 

8 ‘‘(i) develop or validate a drug develop9 ment tool related to a rare disease or condi10 tion; or 

11 ‘‘(ii) understand the full spectrum of 

12 the disease manifestations, including de13 scribing genotypic and phenotypic varia14 bility and identifying and defining distinct 

15 subpopulations affected by a rare disease or 

16 condition.’’. 

17 SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG 

18 MANUFACTURING. 

19 (a) IN GENERAL.—The Secretary of Health and 

20 Human Services may award grants to institutions of higher 

21 education and nonprofit organizations for the purpose of 

22 studying and recommending improvements to the process 

23 of continuous manufacturing of drugs and biological prod24 ucts and similar innovative monitoring and control tech25 niques. 
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1 (b) DEFINITIONS.—In this section— 

2 (1) the term ‘‘drug’’ has the meaning given such 

3 term in section 201 of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 321); 

5 (2) the term ‘‘biological product’’ has the mean6 ing given such term in section 351(i) of the Public 

7 Health Service Act (42 U.S.C. 262(i)); and 

8 (3) the term ‘‘institution of higher education’’ 

9 has the meaning given such term in section 101(a) of 

10 the Higher Education Act of 1965 (20 U.S.C. 

11 1001(a)). 

12 Subtitle C—Modern Trial Design 

13 and Evidence Development 

14 SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS. 

15 (a) PROPOSALS FOR USE OF NOVEL CLINICAL TRIAL

16 DESIGNS FOR DRUGS AND BIOLOGICAL PRODUCTS.—For 

17 purposes of assisting sponsors in incorporating complex 

18 adaptive and other novel trial designs into proposed clinical 

19 protocols and applications for new drugs under section 505 

20 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 355) and biological products under section 351 of the Public 

22 Health Service Act (42 U.S.C. 262), the Secretary of Health 

23 and Human Services (referred to in this section as the ‘‘Sec24 retary’’) shall conduct a public meeting and issue guidance 

25 in accordance with subsection (b). 
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1 (b) GUIDANCE ADDRESSING USE OF NOVEL CLINICAL

2 TRIAL DESIGNS.— 

3 (1) IN GENERAL.—The Secretary, acting through 

4 the Commissioner of Food and Drugs, shall update or 

5 issue guidance addressing the use of complex adaptive 

6 and other novel trial design in the development and 

7 regulatory review and approval or licensure for drugs 

8 and biological products. 

9 (2) CONTENTS.—The guidance under paragraph 

10 (1) shall address— 

11 (A) the use of complex adaptive and other 

12 novel trial designs, including how such clinical 

13 trials proposed or submitted help to satisfy the 

14 substantial evidence standard under section 

15 505(d) of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 355(d)); 

17 (B) how sponsors may obtain feedback from 

18 the Secretary on technical issues related to mod19 eling and simulations prior to— 

20 (i) completion of such modeling or sim21 ulations; or 

22 (ii) the submission of resulting infor23 mation to the Secretary; 
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1 (C) the types of quantitative and qualitative 

2 information that should be submitted for review; 

3 and 

4 (D) recommended analysis methodologies. 

5 (3) PUBLIC MEETING.—Prior to updating or 

6 issuing the guidance required by paragraph (1), the 

7 Secretary shall consult with stakeholders, including 

8 representatives of regulated industry, academia, pa9 tient advocacy organizations, consumer groups, and 

10 disease research foundations, through a public meet11 ing to be held not later than 18 months after the date 

12 of enactment of this Act. 

13 (4) TIMING.—The Secretary shall update or issue 

14 a draft version of the guidance required by paragraph 

15 (1) not later than 18 months after the date of the pub16 lic meeting required by paragraph (3) and finalize 

17 such guidance not later than 1 year after the date on 

18 which the public comment period for the draft guid19 ance closes. 

20 SEC. 3022. REAL WORLD EVIDENCE. 

21 Chapter V of the Federal Food, Drug, and Cosmetic 

22 Act is amended by inserting after section 505E (21 U.S.C. 

23 355f) the following: 
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1 ‘‘SEC. 505F. UTILIZING REAL WORLD EVIDENCE. 

2 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

3 program to evaluate the potential use of real world evi4 dence— 

5 ‘‘(1) to help to support the approval of a new in6 dication for a drug approved under section 505(c); 

7 and 

8 ‘‘(2) to help to support or satisfy postapproval 

9 study requirements. 

10 ‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this sec11 tion, the term ‘real world evidence’ means data regarding 

12 the usage, or the potential benefits or risks, of a drug de13 rived from sources other than randomized clinical trials. 

14 ‘‘(c) PROGRAM FRAMEWORK.— 

15 ‘‘(1) IN GENERAL.—Not later than 2 years after 

16 the date of enactment of the 21st Century Cures Act, 

17 the Secretary shall establish a draft framework for 

18 implementation of the program under this section. 

19 ‘‘(2) CONTENTS OF FRAMEWORK.—The frame20 work shall include information describing— 

21 ‘‘(A) the sources of real world evidence, in22 cluding ongoing safety surveillance, observational 

23 studies, registries, claims, and patient-centered 

24 outcomes research activities; 

25 ‘‘(B) the gaps in data collection activities; 
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1 ‘‘(C) the standards and methodologies for 

2 collection and analysis of real world evidence; 

3 and 

4 ‘‘(D) the priority areas, remaining chal5 lenges, and potential pilot opportunities that the 

6 program established under this section will ad7 dress. 

8 ‘‘(3) CONSULTATION.— 

9 ‘‘(A) IN GENERAL.—In developing the pro10 gram framework under this subsection, the Sec11 retary shall consult with regulated industry, aca12 demia, medical professional organizations, rep13 resentatives of patient advocacy organizations, 

14 consumer organizations, disease research founda15 tions, and other interested parties. 

16 ‘‘(B) PROCESS.—The consultation under 

17 subparagraph (A) may be carried out through 

18 approaches such as— 

19 ‘‘(i) a public-private partnership with 

20 the entities described in such subparagraph 

21 in which the Secretary may participate; 

22 ‘‘(ii) a contract, grant, or other ar23 rangement, as the Secretary determines ap24 propriate, with such a partnership or an 

25 independent research organization; or 
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1 ‘‘(iii) public workshops with the enti2 ties described in such subparagraph. 

3 ‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary 

4 shall, not later than 2 years after the date of enactment 

5 of the 21st Century Cures Act and in accordance with the 

6 framework established under subsection (c), implement the 

7 program to evaluate the potential use of real world evidence. 

8 ‘‘(e) GUIDANCE FOR INDUSTRY.—The Secretary 

9 shall— 

10 ‘‘(1) utilize the program established under sub11 section (a), its activities, and any subsequent pilots or 

12 written reports, to inform a guidance for industry 

13 on— 

14 ‘‘(A) the circumstances under which spon15 sors of drugs and the Secretary may rely on real 

16 world evidence for the purposes described in 

17 paragraphs (1) and (2) of subsection (a); and 

18 ‘‘(B) the appropriate standards and meth19 odologies for collection and analysis of real world 

20 evidence submitted for such purposes; 

21 ‘‘(2) not later than 5 years after the date of en22 actment of the 21st Century Cures Act, issue draft 

23 guidance for industry as described in paragraph (1); 

24 and 
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1 ‘‘(3) not later than 18 months after the close of 

2 the public comment period for the draft guidance de3 scribed in paragraph (2), issue revised draft guidance 

4 or final guidance. 

5 ‘‘(f) RULE OF CONSTRUCTION.— 

6 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

7 nothing in this section prohibits the Secretary from 

8 using real world evidence for purposes not specified in 

9 this section, provided the Secretary determines that 

10 sufficient basis exists for any such nonspecified use. 

11 ‘‘(2) STANDARDS OF EVIDENCE AND SEC12 RETARY’S AUTHORITY.—This section shall not be con13 strued to alter— 

14 ‘‘(A) the standards of evidence under— 

15 ‘‘(i) subsection (c) or (d) of section 505, 

16 including the substantial evidence standard 

17 in such subsection (d); or 

18 ‘‘(ii) section 351(a) of the Public 

19 Health Service Act; or 

20 ‘‘(B) the Secretary’s authority to require 

21 postapproval studies or clinical trials, or the 

22 standards of evidence under which studies or 

23 trials are evaluated.’’. 
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1 SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS. 

2 (a) IN GENERAL.—In order to simplify and facilitate 

3 compliance by researchers with applicable regulations for 

4 the protection of human subjects in research, the Secretary 

5 of Health and Human Services (referred to in this section 

6 as the ‘‘Secretary’’) shall, to the extent practicable and con7 sistent with other statutory provisions, harmonize dif8 ferences between the HHS Human Subject Regulations and 

9 the FDA Human Subject Regulations in accordance with 

10 subsection (b). 

11 (b) AVOIDING REGULATORY DUPLICATION AND UN12 NECESSARY DELAYS.—The Secretary shall, as appro13 priate— 

14 (1) make such modifications to the provisions of 

15 the HHS Human Subject Regulations, the FDA 

16 Human Subject Regulations, and the vulnerable pop17 ulations rules as may be necessary— 

18 (A) to reduce regulatory duplication and 

19 unnecessary delays; 

20 (B) to modernize such provisions in the con21 text of multisite and cooperative research 

22 projects; and 

23 (C) to protect vulnerable populations, incor24 porate local considerations, and support commu25 nity engagement through mechanisms such as 

26 consultation with local researchers and human 
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1 research protection programs, in a manner con2 sistent with subparagraph (B); and 

3 (2) ensure that human subject research that is 

4 subject to the HHS Human Subject Regulations and 

5 to the FDA Human Subject Regulations may— 

6 (A) use joint or shared review; 

7 (B) rely upon the review of— 

8 (i) an independent institutional review 

9 board; or 

10 (ii) an institutional review board of an 

11 entity other than the sponsor of the re12 search; or 

13 (C) use similar arrangements to avoid du14 plication of effort. 

15 (c) CONSULTATION.—In harmonizing or modifying 

16 regulations or guidance under this section, the Secretary 

17 shall consult with stakeholders (including researchers, aca18 demic organizations, hospitals, institutional research 

19 boards, pharmaceutical, biotechnology, and medical device 

20 developers, clinical research organizations, patient groups, 

21 and others). 

22 (d) TIMING.—The Secretary shall complete the harmo23 nization described in subsection (a) not later than 3 years 

24 after the date of enactment of this Act. 
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1 (e) PROGRESS REPORT.—Not later than 2 years after 

2 the date of enactment of this Act, the Secretary shall submit 

3 to Congress a report on the progress made toward com4 pleting such harmonization. 

5 (f) DEFINITIONS.— 

6 (1) HUMAN SUBJECT REGULATIONS.—In this 

7 section: 

8 (A) FDA HUMAN SUBJECT REGULATIONS.— 

9 The term ‘‘FDA Human Subject Regulations’’ 

10 means the provisions of parts 50, 56, 312, and 

11 812 of title 21, Code of Federal Regulations (or 

12 any successor regulations). 

13 (B) HHS HUMAN SUBJECT REGULA14 TIONS.—The term ‘‘HHS Human Subject Regu15 lations’’ means the provisions of subpart A of 

16 part 46 of title 45, Code of Federal Regulations 

17 (or any successor regulations). 

18 (C) VULNERABLE POPULATION RULES.—The 

19 term ‘‘vulnerable population rules’’ means— 

20 (i) except in the case of research de21 scribed in clause (ii), the provisions of sub22 parts B through D of part 46, Code of Fed23 eral Regulations (or any successor regula24 tions); and 
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1 (ii) in the case of research that is sub2 ject to FDA Human Subject Regulations, 

3 the provisions applicable to vulnerable pop4 ulations under part 56 of title 21, Code of 

5 Federal Regulations (or any successor regu6 lations) and subpart D of part 50 of such 

7 title 21 (or any successor regulations). 

8 (2) INSTITUTIONAL REVIEW BOARD DEFINED.— 

9 In this section, the term ‘‘institutional review board’’ 

10 has the meaning that applies to the term ‘‘institu11 tional review board’’ under the HHS Human Subject 

12 Regulations. 

13 SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION 

14 FOR CLINICAL INVESTIGATIONS. 

15 (a) DEVICES.—Section 520(g)(3) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amend17 ed— 

18 (1) in subparagraph (D), by striking ‘‘except 

19 where subject to such conditions as the Secretary may 

20 prescribe, the investigator’’ and inserting the fol21 lowing: ‘‘except where, subject to such conditions as 

22 the Secretary may prescribe— 

23 ‘‘(i) the proposed clinical testing poses no 

24 more than minimal risk to the human subject 

25 and includes appropriate safeguards to protect 
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1 the rights, safety, and welfare of the human sub2 ject; or 

3 ‘‘(ii) the investigator’’; and 

4 (2) in the matter following subparagraph (D), by 

5 striking ‘‘subparagraph (D)’’ and inserting ‘‘subpara6 graph (D)(ii)’’. 

7 (b) DRUGS.—Section 505(i)(4) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended 

9 by striking ‘‘except where it is not feasible or it is contrary 

10 to the best interests of such human beings’’ and inserting 

11 ‘‘except where it is not feasible, it is contrary to the best 

12 interests of such human beings, or the proposed clinical test13 ing poses no more than minimal risk to such human beings 

14 and includes appropriate safeguards as prescribed to pro15 tect the rights, safety, and welfare of such human beings’’. 

16 Subtitle D—Patient Access to 

17 Therapies and Information 

18 SEC. 3031. SUMMARY LEVEL REVIEW. 

19 (a) FFDCA.—Section 505(c) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 355(c)) is amended by 

21 adding at the end the following: 

22 ‘‘(5)(A) The Secretary may rely upon qualified data 

23 summaries to support the approval of a supplemental ap24 plication, with respect to a qualified indication for a drug, 
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1 submitted under subsection (b), if such supplemental appli2 cation complies with subparagraph (B). 

3 ‘‘(B) A supplemental application is eligible for review 

4 as described in subparagraph (A) only if— 

5 ‘‘(i) there is existing data available and accept6 able to the Secretary demonstrating the safety of the 

7 drug; and 

8 ‘‘(ii) all data used to develop the qualified data 

9 summaries are submitted to the Secretary as part of 

10 the supplemental application. 

11 ‘‘(C) The Secretary shall post on the Internet website 

12 of the Food and Drug Administration and update annu13 ally— 

14 ‘‘(i) the number of applications reviewed solely 

15 under subparagraph (A) or section 351(a)(2)(E) of 

16 the Public Health Service Act; 

17 ‘‘(ii) the average time for completion of review 

18 under subparagraph (A) or section 351(a)(2)(E) of 

19 the Public Health Service Act; 

20 ‘‘(iii) the average time for review of supple21 mental applications where the Secretary did not use 

22 review flexibility under subparagraph (A) or section 

23 351(a)(2)(E) of the Public Health Service Act; and 

24 ‘‘(iv) the number of applications reviewed under 

25 subparagraph (A) or section 351(a)(2)(E) of the Pub-
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1 lic Health Service Act for which the Secretary made 

2 use of full data sets in addition to the qualified data 

3 summary. 

4 ‘‘(D) In this paragraph— 

5 ‘‘(i) the term ‘qualified indication’ means an in6 dication for a drug that the Secretary determines to 

7 be appropriate for summary level review under this 

8 paragraph; and 

9 ‘‘(ii) the term ‘qualified data summary’ means a 

10 summary of clinical data that demonstrates the safety 

11 and effectiveness of a drug with respect to a qualified 

12 indication.’’. 

13 (b) PHSA.—Section 351(a)(2) of the Public Health 

14 Service Act (42 U.S.C. 262(a)(2)) is amended by adding 

15 at the end the following: 

16 ‘‘(E)(i) The Secretary may rely upon qualified data 

17 summaries to support the approval of a supplemental ap18 plication, with respect to a qualified indication for a drug, 

19 submitted under this subsection, if such supplemental appli20 cation complies with the requirements of subparagraph (B) 

21 of section 505(c)(5) of the Federal Food, Drug, and Cos22 metic Act. 

23 ‘‘(ii) In this subparagraph, the terms ‘qualified indica24 tion’ and ‘qualified data summary’ have the meanings 
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1 given such terms in section 505(c)(5) of the Federal Food, 

2 Drug, and Cosmetic Act.’’. 

3 SEC. 3032. EXPANDED ACCESS POLICY. 

4 Chapter V of the Federal Food, Drug, and Cosmetic 

5 Act is amended by inserting after section 561 (21 U.S.C. 

6 360bbb) the following: 

7 ‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR IN8 VESTIGATIONAL DRUGS. 

9 ‘‘(a) IN GENERAL.—The manufacturer or distributor 

10 of one or more investigational drugs for the diagnosis, mon11 itoring, or treatment of one or more serious diseases or con12 ditions shall make available the policy of the manufacturer 

13 or distributor on evaluating and responding to requests sub14 mitted under section 561(b) for provision of such a drug. 

15 ‘‘(b) PUBLIC AVAILABILITY OF EXPANDED ACCESS

16 POLICY.—The policies under subsection (a) shall be made 

17 public and readily available, such as by posting such poli18 cies on a publicly available Internet website. Such policies 

19 may be generally applicable to all investigational drugs of 

20 such manufacturer or distributor. 

21 ‘‘(c) CONTENT OF POLICY.—A policy described in sub22 section (a) shall include— 

23 ‘‘(1) contact information for the manufacturer or 

24 distributor to facilitate communication about requests 

25 described in subsection (a); 
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1 ‘‘(2) procedures for making such requests; 

2 ‘‘(3) the general criteria the manufacturer or dis3 tributor will use to evaluate such requests for indi4 vidual patients, and for responses to such requests; 

5 ‘‘(4) the length of time the manufacturer or dis6 tributor anticipates will be necessary to acknowledge 

7 receipt of such requests; and 

8 ‘‘(5) a hyperlink or other reference to the clinical 

9 trial record containing information about the ex10 panded access for such drug that is required under 

11 section 402(j)(2)(A)(ii)(II)(gg) of the Public Health 

12 Service Act. 

13 ‘‘(d) NO GUARANTEE OF ACCESS.—The posting of 

14 policies by manufacturers and distributors under subsection 

15 (a) shall not serve as a guarantee of access to any specific 

16 investigational drug by any individual patient. 

17 ‘‘(e) REVISED POLICY.—Nothing in this section shall 

18 prevent a manufacturer or distributor from revising a pol19 icy required under this section at any time. 

20 ‘‘(f) APPLICATION.—This section shall apply to a man21 ufacturer or distributor with respect to an investigational 

22 drug beginning on the later of— 

23 ‘‘(1) the date that is 60 calendar days after the 

24 date of enactment of the 21st Century Cures Act; or 
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1 ‘‘(2) the first initiation of a phase 2 or phase 3 

2 study (as such terms are defined in section 312.21(b) 

3 and (c) of title 21, Code of Federal Regulations (or 

4 any successor regulations)) with respect to such inves5 tigational drug.’’. 

6 SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE 

7 ADVANCED THERAPIES. 

8 (a) IN GENERAL.—Section 506 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 356) is amended— 

10 (1) by transferring subsection (e) (relating to 

11 construction) so that it appears before subsection (f) 

12 (relating to awareness efforts); and 

13 (2) by adding at the end the following: 

14 ‘‘(g) REGENERATIVE ADVANCED THERAPY.— 

15 ‘‘(1) IN GENERAL.—The Secretary, at the request 

16 of the sponsor of a drug, shall facilitate an efficient 

17 development program for, and expedite review of, such 

18 drug if the drug qualifies as a regenerative advanced 

19 therapy under the criteria described in paragraph 

20 (2). 

21 ‘‘(2) CRITERIA.—A drug is eligible for designa22 tion as a regenerative advanced therapy under this 

23 subsection if— 

24 ‘‘(A) the drug is a regenerative medicine 

25 therapy (as defined in paragraph (8)); 
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1 ‘‘(B) the drug is intended to treat, modify, 

2 reverse, or cure a serious or life-threatening dis3 ease or condition; and 

4 ‘‘(C) preliminary clinical evidence indicates 

5 that the drug has the potential to address unmet 

6 medical needs for such a disease or condition. 

7 ‘‘(3) REQUEST FOR DESIGNATION.—The sponsor 

8 of a drug may request the Secretary to designate the 

9 drug as a regenerative advanced therapy concurrently 

10 with, or at any time after, submission of an applica11 tion for the investigation of the drug under section 

12 505(i) of this Act or section 351(a)(3) of the Public 

13 Health Service Act. 

14 ‘‘(4) DESIGNATION.—Not later than 60 calendar 

15 days after the receipt of a request under paragraph 

16 (3), the Secretary shall determine whether the drug 

17 that is the subject of the request meets the criteria de18 scribed in paragraph (2). If the Secretary determines 

19 that the drug meets the criteria, the Secretary shall 

20 designate the drug as a regenerative advanced therapy 

21 and shall take such actions as are appropriate under 

22 paragraph (1). If the Secretary determines that a 

23 drug does not meet the criteria for such designation, 

24 the Secretary shall include with the determination a 
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1 written description of the rationale for such deter2 mination. 

3 ‘‘(5) ACTIONS.—The sponsor of a regenerative 

4 advanced therapy shall be eligible for the actions to 

5 expedite development and review of such therapy 

6 under subsection (a)(3)(B), including early inter7 actions to discuss any potential surrogate or inter8 mediate endpoint to be used to support the accelerated 

9 approval of an application for the product under sub10 section (c). 

11 ‘‘(6) ACCESS TO EXPEDITED APPROVAL PATH12 WAYS.—An application for a regenerative advanced 

13 therapy under section 505(b)(1) of this Act or section 

14 351(a) of the Public Health Service Act may be— 

15 ‘‘(A) eligible for priority review, as de16 scribed in the Manual of Policies and Procedures 

17 of the Food and Drug Administration and goals 

18 identified in the letters described in section 

19 101(b) of the Prescription Drug User Fee 

20 Amendments of 2012; and 

21 ‘‘(B) eligible for accelerated approval under 

22 subsection (c), as agreed upon pursuant to sub23 section (a)(3)(B), through, as appropriate— 
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1 ‘‘(i) surrogate or intermediate 

2 endpoints reasonably likely to predict long3 term clinical benefit; or 

4 ‘‘(ii) reliance upon data obtained from 

5 a meaningful number of sites, including 

6 through expansion to additional sites, as 

7 appropriate. 

8 ‘‘(7) POSTAPPROVAL REQUIREMENTS.—The spon9 sor of a regenerative advanced therapy that is granted 

10 accelerated approval and is subject to the post11 approval requirements under subsection (c) may, as 

12 appropriate, fulfill such requirements, as the Sec13 retary may require, through— 

14 ‘‘(A) the submission of clinical evidence, 

15 clinical studies, patient registries, or other 

16 sources of real world evidence, such as electronic 

17 health records; 

18 ‘‘(B) the collection of larger confirmatory 

19 data sets, as agreed upon pursuant to subsection 

20 (a)(3)(B); or 

21 ‘‘(C) postapproval monitoring of all pa22 tients treated with such therapy prior to ap23 proval of the therapy. 

24 ‘‘(8) DEFINITION.—For purposes of this section, 

25 the term ‘regenerative medicine therapy’ includes cell 
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1 therapy, therapeutic tissue engineering products, 

2 human cell and tissue products, and combination 

3 products using any such therapies or products, except 

4 for those regulated solely under section 361 of the 

5 Public Health Service Act and part 1271 of title 21, 

6 Code of Federal Regulations.’’. 

7 (b) RULE OF CONSTRUCTION.—Nothing in this section 

8 and the amendments made by this section shall be construed 

9 to alter the authority of the Secretary of Health and 

10 Human Services— 

11 (1) to approve drugs pursuant to the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 

13 and section 351 of the Public Health Service Act (42 

14 U.S.C. 262) as authorized prior to the date of enact15 ment of the 21st Century Cures Act, including the 

16 standards of evidence, and applicable conditions, for 

17 approval under such Acts; or 

18 (2) to alter the authority of the Secretary to re19 quire postapproval studies pursuant to such Acts, as 

20 authorized prior to the date of enactment of the 21st 

21 Century Cures Act. 

22 (c) CONFORMING AMENDMENT.—Section 506(e)(1) of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 356(e)(1)) is amended by inserting ‘‘and the 21st Century 
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1 Cures Act’’ after ‘‘Food and Drug Administration Safety 

2 and Innovation Act’’. 

3 SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE 

4 RECOVERY, ISOLATION, OR DELIVERY OF RE5 GENERATIVE ADVANCED THERAPIES. 

6 (a) DRAFT GUIDANCE.—Not later than 1 year after 

7 the date of enactment of the 21st Century Cures Act, the 

8 Secretary of Health and Human Services, acting through 

9 the Commissioner of Food and Drugs, shall issue draft guid10 ance clarifying how, in the context of regenerative advanced 

11 therapies, the Secretary will evaluate devices used in the 

12 recovery, isolation, or delivery of regenerative advanced 

13 therapies. In doing so, the Secretary shall specifically ad14 dress— 

15 (1) how the Food and Drug Administration in16 tends to simplify and streamline regulatory require17 ments for combination device and cell or tissue prod18 ucts; 

19 (2) what, if any, intended uses or specific at20 tributes would result in a device used with a regen21 erative therapy product to be classified as a class III 

22 device; 

23 (3) when the Food and Drug Administration 

24 considers it is necessary, if ever, for the intended use 
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1 of a device to be limited to a specific intended use 

2 with only one particular type of cell; and 

3 (4) application of the least burdensome approach 

4 to demonstrate how a device may be used with more 

5 than one cell type. 

6 (b) FINAL GUIDANCE.—Not later than 12 months after 

7 the close of the period for public comment on the draft guid8 ance under subsection (a), the Secretary of Health and 

9 Human Services shall finalize such guidance. 

10 SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERA11 PIES. 

12 (a) REPORT TO CONGRESS.—Before March 1 of each 

13 calendar year, the Secretary of Health and Human Services 

14 shall, with respect to the previous calendar year, submit a 

15 report to the Committee on Health, Education, Labor, and 

16 Pensions of the Senate and the Committee on Energy and 

17 Commerce of the House of Representatives on— 

18 (1) the number and type of applications for ap19 proval of regenerative advanced therapies filed, ap20 proved or licensed as applicable, withdrawn, or de21 nied; and 

22 (2) how many of such applications or therapies, 

23 as applicable, were granted accelerated approval or 

24 priority review. 
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1 (b) REGENERATIVE ADVANCED THERAPY.—In this sec2 tion, the term ‘‘regenerative advanced therapy’’ has the 

3 meaning given such term in section 506(g) of the Federal 

4 Food, Drug, and Cosmetic Act, as added by section 3033 

5 of this Act. 

6 SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND 

7 REGENERATIVE ADVANCED THERAPIES. 

8 Subchapter A of chapter V of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 

10 inserting after section 506F the following: 

11 ‘‘SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE 

12 AND REGENERATIVE ADVANCED THERAPIES. 

13 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

14 date of enactment of the 21st Century Cures Act, the Sec15 retary, in consultation with the National Institute of 

16 Standards and Technology and stakeholders (including re17 generative medicine and advanced therapies manufacturers 

18 and clinical trial sponsors, contract manufacturers, aca19 demic institutions, practicing clinicians, regenerative medi20 cine and advanced therapies industry organizations, and 

21 standard setting organizations), shall facilitate an effort to 

22 coordinate and prioritize the development of standards and 

23 consensus definition of terms, through a public process, to 

24 support, through regulatory predictability, the development, 

25 evaluation, and review of regenerative medicine therapies 
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•HR 34 EAH 

1 and regenerative advanced therapies, including with respect 

2 to the manufacturing processes and controls of such prod3 ucts. 

4 ‘‘(b) ACTIVITIES.— 

5 ‘‘(1) IN GENERAL.—In carrying out this section, 

6 the Secretary shall continue to— 

7 ‘‘(A) identity opportunities to help advance 

8 the development of regenerative medicine thera9 pies and regenerative advanced therapies; 

10 ‘‘(B) identify opportunities for the develop11 ment of laboratory regulatory science research 

12 and documentary standards that the Secretary 

13 determines would help support the development, 

14 evaluation, and review of regenerative medicine 

15 therapies and regenerative advanced therapies 

16 through regulatory predictability; and 

17 ‘‘(C) work with stakeholders, such as those 

18 described in subsection (a), as appropriate, in 

19 the development of such standards. 

20 ‘‘(2) REGULATIONS AND GUIDANCE.—Not later 

21 than 1 year after the development of standards as de22 scribed in subsection (a), the Secretary shall review 

23 relevant regulations and guidance and, through a 

24 public process, update such regulations and guidance 

25 as the Secretary determines appropriate. 
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1 ‘‘(c) DEFINITIONS.—For purposes of this section, the 

2 terms ‘regenerative medicine therapy’ and ‘regenerative ad3 vanced therapy’ have the meanings given such terms in sec4 tion 506(g).’’. 

5 SEC. 3037. HEALTH CARE ECONOMIC INFORMATION. 

6 Section 502(a) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 352(a)) is amended— 

8 (1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) 

9 If its’’; 

10 (2) by striking ‘‘a formulary committee, or other 

11 similar entity, in the course of the committee or the 

12 entity carrying out its responsibilities for the selec13 tion of drugs for managed care or other similar orga14 nizations’’ and inserting ‘‘a payor, formulary com15 mittee, or other similar entity with knowledge and ex16 pertise in the area of health care economic analysis, 

17 carrying out its responsibilities for the selection of 

18 drugs for coverage or reimbursement’’; 

19 (3) by striking ‘‘directly relates’’ and inserting 

20 ‘‘relates’’; 

21 (4) by striking ‘‘and is based on competent and 

22 reliable scientific evidence. The requirements set forth 

23 in section 505(a) or in section 351(a) of the Public 

24 Health Service Act shall not apply to health care eco25 nomic information provided to such a committee or 
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•HR 34 EAH 

1 entity in accordance with this paragraph’’ and in2 serting ‘‘, is based on competent and reliable scientific 

3 evidence, and includes, where applicable, a con4 spicuous and prominent statement describing any 

5 material differences between the health care economic 

6 information and the labeling approved for the drug 

7 under section 505 or under section 351 of the Public 

8 Health Service Act. The requirements set forth in sec9 tion 505(a) or in subsections (a) and (k) of section 

10 351 of the Public Health Service Act shall not apply 

11 to health care economic information provided to such 

12 a payor, committee, or entity in accordance with this 

13 paragraph’’; and 

14 (5) by striking ‘‘In this paragraph, the term’’ 

15 and all that follows and inserting the following: 

16 ‘‘(2)(A) For purposes of this paragraph, the term 

17 ‘health care economic information’ means any analysis (in18 cluding the clinical data, inputs, clinical or other assump19 tions, methods, results, and other components underlying or 

20 comprising the analysis) that identifies, measures, or de21 scribes the economic consequences, which may be based on 

22 the separate or aggregated clinical consequences of the rep23 resented health outcomes, of the use of a drug. Such analysis 

24 may be comparative to the use of another drug, to another 

25 health care intervention, or to no intervention. 
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1 ‘‘(B) Such term does not include any analysis that re2 lates only to an indication that is not approved under sec3 tion 505 or under section 351 of the Public Health Service 

4 Act for such drug.’’. 

5 SEC. 3038. COMBINATION PRODUCT INNOVATION. 

6 (a) IN GENERAL.—Section 503(g) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended— 

8 (1) by striking paragraph (3); 

9 (2) by redesignating paragraph (2) as para10 graph (7); 

11 (3) by redesignating paragraphs (4) and (5) as 

12 paragraphs (8) and (9), respectively; 

13 (4) by striking ‘‘(g)(1)’’ and all that follows 

14 through the end of paragraph (1) and inserting the 

15 following: 

16 ‘‘(g)(1)(A) The Secretary shall, in accordance with this 

17 subsection, assign a primary agency center to regulate 

18 products that constitute a combination of a drug, device, 

19 or biological product. 

20 ‘‘(B) The Secretary shall conduct the premarket review 

21 of any combination product under a single application, 

22 whenever appropriate. 

23 ‘‘(C) For purposes of this subsection, the term ‘primary 

24 mode of action’ means the single mode of action of a com25 bination product expected to make the greatest contribution 
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•HR 34 EAH 

1 to the overall intended therapeutic effects of the combination 

2 product. 

3 ‘‘(D) The Secretary shall determine the primary mode 

4 of action of the combination product. If the Secretary deter5 mines that the primary mode of action is that of— 

6 ‘‘(i) a drug (other than a biological product), the 

7 agency center charged with premarket review of drugs 

8 shall have primary jurisdiction; 

9 ‘‘(ii) a device, the agency center charged with 

10 premarket review of devices shall have primary juris11 diction; or 

12 ‘‘(iii) a biological product, the agency center 

13 charged with premarket review of biological products 

14 shall have primary jurisdiction. 

15 ‘‘(E) In determining the primary mode of action of 

16 a combination product, the Secretary shall not determine 

17 that the primary mode of action is that of a drug or biologi18 cal product solely because the combination product has any 

19 chemical action within or on the human body. 

20 ‘‘(F) If a sponsor of a combination product disagrees 

21 with the determination under subparagraph (D)— 

22 ‘‘(i) such sponsor may request, and the Secretary 

23 shall provide, a substantive rationale to such sponsor 

24 that references scientific evidence provided by the 
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•HR 34 EAH 

1 sponsor and any other scientific evidence relied upon 

2 by the Secretary to support such determination; and 

3 ‘‘(ii)(I) the sponsor of the combination product 

4 may propose one or more studies (which may be non5 clinical, clinical, or both) to establish the relevance, if 

6 any, of the chemical action in achieving the primary 

7 mode of action of such product; 

8 ‘‘(II) if the sponsor proposes any such studies, 

9 the Secretary and the sponsor of such product shall 

10 collaborate and seek to reach agreement, within a rea11 sonable time of such proposal, not to exceed 90 cal12 endar days, on the design of such studies; and 

13 ‘‘(III) if an agreement is reached under sub14 clause (II) and the sponsor conducts one or more of 

15 such studies, the Secretary shall consider the data re16 sulting from any such study when reevaluating the 

17 determination of the primary mode of action of such 

18 product, and unless and until such reevaluation has 

19 occurred and the Secretary issues a new determina20 tion, the determination of the Secretary under sub21 paragraph (D) shall remain in effect. 

22 ‘‘(2)(A)(i) To establish clarity and certainty for the 

23 sponsor, the sponsor of a combination product may request 

24 a meeting on such combination product. If the Secretary 

25 concludes that a determination of the primary mode of ac-
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•HR 34 EAH 

1 tion pursuant to paragraph (1)(D) is necessary, the sponsor 

2 may request such meeting only after the Secretary makes 

3 such determination. If the sponsor submits a written meet4 ing request, the Secretary shall, not later than 75 calendar 

5 days after receiving such request, meet with the sponsor of 

6 such combination product. 

7 ‘‘(ii) A meeting under clause (i) may— 

8 ‘‘(I) address the standards and requirements for 

9 market approval or clearance of the combination 

10 product; 

11 ‘‘(II) address other issues relevant to such com12 bination product, such as requirements related to 

13 postmarket modification of such combination product 

14 and good manufacturing practices applicable to such 

15 combination product; and 

16 ‘‘(III) identify elements under subclauses (I) and 

17 (II) that may be more appropriate for discussion and 

18 agreement with the Secretary at a later date given 

19 that scientific or other information is not available, 

20 or agreement is otherwise not feasible regarding such 

21 elements, at the time a request for such meeting is 

22 made. 

23 ‘‘(iii) Any agreement under this subparagraph shall 

24 be in writing and made part of the administrative record 

25 by the Secretary. 
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•HR 34 EAH 

1 ‘‘(iv) Any such agreement shall remain in effect, ex2 cept— 

3 ‘‘(I) upon the written agreement of the Secretary 

4 and the sponsor or applicant; or 

5 ‘‘(II) pursuant to a decision by the director of 

6 the reviewing division of the primary agency center, 

7 or a person more senior than such director, in con8 sultation with consulting centers and the Office, as 

9 appropriate, that an issue essential to determining 

10 whether the standard for market clearance or other 

11 applicable standard under this Act or the Public 

12 Health Service Act applicable to the combination 

13 product has been identified since the agreement was 

14 reached, or that deviating from the agreement is oth15 erwise justifiable based on scientific evidence, for pub16 lic health reasons. 

17 ‘‘(3) For purposes of conducting the premarket review 

18 of a combination product that contains an approved con19 stituent part described in paragraph (4), the Secretary may 

20 require that the sponsor of such combination product sub21 mit to the Secretary only data or information that the Sec22 retary determines is necessary to meet the standard for 

23 clearance or approval, as applicable, under this Act or the 

24 Public Health Service Act, including any incremental risks 

25 and benefits posed by such combination product, using a 
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•HR 34 EAH 

1 risk-based approach and taking into account any prior 

2 finding of safety and effectiveness or substantial equivalence 

3 for the approved constituent part relied upon by the appli4 cant in accordance with paragraph (5). 

5 ‘‘(4) For purposes of paragraph (3), an approved con6 stituent part is— 

7 ‘‘(A) a drug constituent part of a combination 

8 product being reviewed in a single application or re9 quest under section 515, 510(k), or 513(f)(2) (sub10 mitted in accordance with paragraph (5)), that is an 

11 approved drug, provided such application or request 

12 complies with paragraph (5); 

13 ‘‘(B) a device constituent part approved under 

14 section 515 that is referenced by the sponsor and that 

15 is available for use by the Secretary under section 

16 520(h)(4); or 

17 ‘‘(C) any constituent part that was previously 

18 approved, cleared, or classified under section 505, 

19 510(k), 513(f)(2), or 515 of this Act for which the 

20 sponsor has a right of reference or any constituent 

21 part that is a nonprescription drug, as defined in sec22 tion 760(a)(2). 

23 ‘‘(5)(A) If an application is submitted under section 

24 515 or 510(k) or a request is submitted under section 

25 513(f)(2), consistent with any determination made under 
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1 paragraph (1)(D), for a combination product containing as 

2 a constituent part an approved drug— 

3 ‘‘(i) the application or request shall include the 

4 certification or statement described in section 

5 505(b)(2); and 

6 ‘‘(ii) the applicant or requester shall provide no7 tice as described in section 505(b)(3). 

8 ‘‘(B) For purposes of this paragraph and paragraph 

9 (4), the term ‘approved drug’ means an active ingredient— 

10 ‘‘(i) that was in an application previously ap11 proved under section 505(c); 

12 ‘‘(ii) where such application is relied upon by 

13 the applicant submitting the application or request 

14 described in subparagraph (A); 

15 ‘‘(iii) for which full reports of investigations that 

16 have been made to show whether such drug is safe for 

17 use and whether such drug is effective in use were not 

18 conducted by or for the applicant submitting the ap19 plication or request described in subparagraph (A); 

20 and 

21 ‘‘(iv) for which the applicant submitting the ap22 plication or request described in subparagraph (A) 

23 has not obtained a right of reference or use from the 

24 person by or for whom the investigations described in 

25 clause (iii) were conducted. 
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1 ‘‘(C) The following provisions shall apply with respect 

2 to an application or request described in subparagraph (A) 

3 to the same extent and in the same manner as if such appli4 cation or request were an application described in section 

5 505(b)(2) that referenced the approved drug: 

6 ‘‘(i) Subparagraphs (A), (B), (C), and (D) of 

7 section 505(c)(3). 

8 ‘‘(ii) Clauses (ii), (iii), and (iv) of section 

9 505(c)(3)(E). 

10 ‘‘(iii) Subsections (b) and (c) of section 505A. 

11 ‘‘(iv) Section 505E(a). 

12 ‘‘(v) Section 527(a). 

13 ‘‘(D) Notwithstanding any other provision of this sub14 section, an application or request for classification for a 

15 combination product described in subparagraph (A) shall 

16 be considered an application submitted under section 

17 505(b)(2) for purposes of section 271(e)(2)(A) of title 35, 

18 United States Code. 

19 ‘‘(6) Nothing in this subsection shall be construed as 

20 prohibiting a sponsor from submitting separate applica21 tions for the constituent parts of a combination product, 

22 unless the Secretary determines that a single application 

23 is necessary.’’; 

24 (5) in paragraph (8) (as redesignated by para25 graph (3))— 
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•HR 34 EAH 

1 (A) in subparagraph (C)— 

2 (i) by amending clause (i) to read as 

3 follows: 

4 ‘‘(i) In carrying out this subsection, the Office shall 

5 help to ensure timely and effective premarket review that 

6 involves more than one agency center by coordinating such 

7 reviews, overseeing the timeliness of such reviews, and over8 seeing the alignment of feedback regarding such reviews.’’; 

9 (ii) in clause (ii), by inserting ‘‘and 

10 alignment’’ after ‘‘the timeliness’’ each place 

11 it appears; and 

12 (iii) by adding at the end the following 

13 new clauses: 

14 ‘‘(iii) The Office shall ensure that, with respect to a 

15 combination product, a designated person or persons in the 

16 primary agency center is the primary point or points of 

17 contact for the sponsor of such combination product. The 

18 Office shall also coordinate communications to and from 

19 any consulting center involved in such premarket review, 

20 if requested by such primary agency center or any such con21 sulting center. Agency communications and commitments, 

22 to the extent consistent with other provisions of law and 

23 the requirements of all affected agency centers, from the pri24 mary agency center shall be considered as communication 
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•HR 34 EAH 

1 from the Secretary on behalf of all agency centers involved 

2 in the review. 

3 ‘‘(iv) The Office shall, with respect to the premarket 

4 review of a combination product— 

5 ‘‘(I) ensure that any meeting between the Sec6 retary and the sponsor of such product is attended by 

7 each agency center involved in the review, as appro8 priate; 

9 ‘‘(II) ensure that each consulting agency center 

10 has completed its premarket review and provided the 

11 results of such review to the primary agency center in 

12 a timely manner; and 

13 ‘‘(III) ensure that each consulting center follows 

14 the guidance described in clause (vi) and advises, as 

15 appropriate, on other relevant regulations, guidances, 

16 and policies. 

17 ‘‘(v) In seeking agency action with respect to a com18 bination product, the sponsor of such product— 

19 ‘‘(I) shall identify the product as a combination 

20 product; and 

21 ‘‘(II) may request in writing the participation of 

22 representatives of the Office in meetings related to 

23 such combination product, or to have the Office other24 wise engage on such regulatory matters concerning 

25 the combination product. 
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•HR 34 EAH 

1 ‘‘(vi) Not later than 4 years after the date of enactment 

2 of the 21st Century Cures Act, and after a public comment 

3 period of not less than 60 calendar days, the Secretary shall 

4 issue a final guidance that describes— 

5 ‘‘(I) the structured process for managing pre-sub6 mission interactions with sponsors developing com7 bination products; 

8 ‘‘(II) the best practices for ensuring that the feed9 back in such pre-submission interactions represents 

10 the Agency’s best advice based on the information pro11 vided during such pre-submission interactions; 

12 ‘‘(III) the information that is required to be sub13 mitted with a meeting request under paragraph (2), 

14 how such meetings relate to other types of meetings in 

15 the Food and Drug Administration, and the form and 

16 content of any agreement reached through a meeting 

17 under such paragraph (2);’’; and 

18 (B) in subparagraph (G)— 

19 (i) in the matter preceding clause (i), 

20 by inserting ‘‘(except with respect to clause 

21 (iv), beginning not later than one year after 

22 the date of the enactment of the 21st Cen23 tury Cures Act)’’ after ‘‘enactment of this 

24 paragraph’’; 
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•HR 34 EAH 

1 (ii) in clause (ii), by striking ‘‘and’’ at 

2 the end; 

3 (iii) in clause (iii), by striking the pe4 riod at the end and inserting ‘‘; and’’; and 

5 (iv) by adding at the end the following 

6 new clause: 

7 ‘‘(iv) identifying the percentage of combination 

8 products for which a dispute resolution, with respect 

9 to premarket review, was requested by the combina10 tion product’s sponsor.’’; and 

11 (6) in paragraph (9) (as redesignated by para12 graph (3))— 

13 (A) in subparagraph (C)— 

14 (i) in clause (i), by striking the comma 

15 at the end and inserting a semicolon; 

16 (ii) in clause (ii), by striking ‘‘, and’’ 

17 at the end and inserting a semicolon; 

18 (iii) in clause (iii), by striking the pe19 riod at the end and inserting ‘‘; and’’; and 

20 (iv) by adding at the end the following: 

21 ‘‘(iv) de novo classification under sec22 tion 513(a)(1).’’; and 

23 (B) by adding at the end the following: 

24 ‘‘(D) The terms ‘premarket review’ and ‘reviews’ 

25 include all activities of the Food and Drug Adminis-
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•HR 34 EAH 

1 tration conducted prior to approval or clearance of 

2 an application, notification, or request for classifica3 tion submitted under section 505, 510(k), 513(f)(2), 

4 515, or 520 of this Act or under section 351 of the 

5 Public Health Service Act, including with respect to 

6 investigational use of the product.’’. 

7 (b) INFORMATION FOR APPROVAL OF COMBINATION

8 PRODUCTS.—Section 520(h)(4) of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 360j(h)(4)) is amended— 

10 (1) in subparagraph (A), by striking ‘‘Any infor11 mation’’ and inserting ‘‘Subject to subparagraph (C), 

12 any information’’; and 

13 (2) by adding at the end the following new sub14 paragraph: 

15 ‘‘(C) No information contained in an application for 

16 premarket approval filed with the Secretary pursuant to 

17 section 515(c) may be used to approve or clear any applica18 tion submitted under section 515 or 510(k) or to classify 

19 a product under section 513(f)(2) for a combination product 

20 containing as a constituent part an approved drug (as de21 fined in section 503(g)(5)(B)) unless— 

22 ‘‘(i) the application includes the certification or 

23 statement referenced in section 503(g)(5)(A); 

24 ‘‘(ii) the applicant provides notice as described 

25 in section 503(g)(5)(A); and 
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1 ‘‘(iii) the Secretary’s approval of such applica2 tion is subject to the provisions in section 

3 503(g)(5)(C).’’. 

4 (c) VARIATIONS FROM CGMP STREAMLINED AP5 PROACH.—Not later than 18 months after the date of enact6 ment of this Act, the Secretary of Health and Human Serv7 ices (referred to in this subsection as the ‘‘Secretary’’) shall 

8 identify types of combination products and manufacturing 

9 processes with respect to which the Secretary proposes that 

10 good manufacturing processes may be adopted that vary 

11 from the requirements set forth in section 4.4 of title 21, 

12 Code of Federal Regulations (or any successor regulations) 

13 or that the Secretary proposes can satisfy the requirements 

14 in section 4.4 through alternative or streamlined mecha15 nisms. The Secretary shall identify such types, variations 

16 from such requirements, and such mechanisms, in a pro17 posed list published in the Federal Register. After a public 

18 comment period regarding the appropriate good manufac19 turing practices for such types, the Secretary shall publish 

20 a final list in the Federal Register, notwithstanding section 

21 553 of title 5, United States Code. The Secretary shall 

22 evaluate such types, variations, and mechanisms using a 

23 risk-based approach. The Secretary shall periodically re24 view such final list. 
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•HR 34 EAH 

1 Subtitle E—Antimicrobial 

2 Innovation and Stewardship 

3 SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING. 

4 (a) IN GENERAL.—Section 319E of the Public Health 

5 Service Act (42 U.S.C. 247d–5) is amended— 

6 (1) by redesignating subsections (f) and (g) as 

7 subsections (l) and (m), respectively; and 

8 (2) by inserting after subsection (e), the fol9 lowing: 

10 ‘‘(f) MONITORING AT FEDERAL HEALTH CARE FACILI11 TIES.—The Secretary shall encourage reporting on aggre12 gate antimicrobial drug use and antimicrobial resistance 

13 to antimicrobial drugs and the implementation of anti14 microbial stewardship programs by health care facilities of 

15 the Department of Defense, the Department of Veterans Af16 fairs, and the Indian Health Service and shall provide tech17 nical assistance to the Secretary of Defense and the Sec18 retary of Veterans Affairs, as appropriate and upon request. 

19 ‘‘(g) REPORT ON ANTIMICROBIAL RESISTANCE IN HU20 MANS AND USE OF ANTIMICROBIAL DRUGS.—Not later than 

21 1 year after the date of enactment of the 21st Century Cures 

22 Act, and annually thereafter, the Secretary shall prepare 

23 and make publicly available data and information con24 cerning— 
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1 ‘‘(1) aggregate national and regional trends of 

2 antimicrobial resistance in humans to antimicrobial 

3 drugs, including such drugs approved under section 

4 506(h) of the Federal Food, Drug, and Cosmetic Act; 

5 ‘‘(2) antimicrobial stewardship, which may in6 clude summaries of State efforts to address anti7 microbial resistance in humans to antimicrobial 

8 drugs and antimicrobial stewardship; and 

9 ‘‘(3) coordination between the Director of the 

10 Centers for Disease Control and Prevention and the 

11 Commissioner of Food and Drugs with respect to the 

12 monitoring of— 

13 ‘‘(A) any applicable resistance under para14 graph (1); and 

15 ‘‘(B) drugs approved under section 506(h) 

16 of the Federal Food, Drug, and Cosmetic Act. 

17 ‘‘(h) INFORMATION RELATED TO ANTIMICROBIAL

18 STEWARDSHIP PROGRAMS.—The Secretary shall, as appro19 priate, disseminate guidance, educational materials, or 

20 other appropriate materials related to the development and 

21 implementation of evidence-based antimicrobial steward22 ship programs or practices at health care facilities, such 

23 as nursing homes and other long-term care facilities, ambu24 latory surgical centers, dialysis centers, outpatient clinics, 

25 and hospitals, including community and rural hospitals. 
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1 ‘‘(i) SUPPORTING STATE-BASED ACTIVITIES TO COM2 BAT ANTIMICROBIAL RESISTANCE.—The Secretary shall 

3 continue to work with State and local public health depart4 ments on statewide or regional programs related to anti5 microbial resistance. Such efforts may include activities to 

6 related to— 

7 ‘‘(1) identifying patterns of bacterial and fungal 

8 resistance in humans to antimicrobial drugs; 

9 ‘‘(2) preventing the spread of bacterial and 

10 fungal infections that are resistant to antimicrobial 

11 drugs; and 

12 ‘‘(3) promoting antimicrobial stewardship. 

13 ‘‘(j) ANTIMICROBIAL RESISTANCE AND STEWARDSHIP

14 ACTIVITIES.— 

15 ‘‘(1) IN GENERAL.—For the purposes of sup16 porting stewardship activities, examining changes in 

17 antimicrobial resistance, and evaluating the effective18 ness of section 506(h) of the Federal Food, Drug, and 

19 Cosmetic Act, the Secretary shall— 

20 ‘‘(A) provide a mechanism for facilities to 

21 report data related to their antimicrobial stew22 ardship activities (including analyzing the out23 comes of such activities); and 

24 ‘‘(B) evaluate— 
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1 ‘‘(i) antimicrobial resistance data 

2 using a standardized approach; and 

3 ‘‘(ii) trends in the utilization of drugs 

4 approved under such section 506(h) with re5 spect to patient populations. 

6 ‘‘(2) USE OF SYSTEMS.—The Secretary shall use 

7 available systems, including the National Healthcare 

8 Safety Network or other systems identified by the Sec9 retary, to fulfill the requirements or conduct activities 

10 under this section. 

11 ‘‘(k) ANTIMICROBIAL.—For purposes of subsections (f) 

12 through (j), the term ‘antimicrobial’ includes any anti13 bacterial or antifungal drugs, and may include drugs that 

14 eliminate or inhibit the growth of other microorganisms, 

15 as appropriate.’’. 

16 (b) AVAILABILITY OF DATA.—The Secretary shall 

17 make the data collected pursuant to this subsection public. 

18 Nothing in this subsection shall be construed as authorizing 

19 the Secretary to disclose any information that is a trade 

20 secret or confidential information subject to section 

21 552(b)(4) of title 5, United States Code, or section 1905 

22 of title 18, United States Code. 
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1 SEC. 3042. LIMITED POPULATION PATHWAY. 

2 Section 506 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 356), as amended by section 3033, is further 

4 amended by adding at the end the following: 

5 ‘‘(h) LIMITED POPULATION PATHWAY FOR ANTI6 BACTERIAL AND ANTIFUNGAL DRUGS.— 

7 ‘‘(1) IN GENERAL.—The Secretary may approve 

8 an antibacterial or antifungal drug, alone or in com9 bination with one or more other drugs, as a limited 

10 population drug pursuant to this subsection only if— 

11 ‘‘(A) the drug is intended to treat a serious 

12 or life-threatening infection in a limited popu13 lation of patients with unmet needs; 

14 ‘‘(B) the standards for approval under sec15 tion 505(c) and (d), or the standards for licen16 sure under section 351 of the Public Health 

17 Service Act, as applicable, are met; and 

18 ‘‘(C) the Secretary receives a written request 

19 from the sponsor to approve the drug as a lim20 ited population drug pursuant to this subsection. 

21 ‘‘(2) BENEFIT-RISK CONSIDERATION.—The Sec22 retary’s determination of safety and effectiveness of 

23 an antibacterial or antifungal drug shall reflect the 

24 benefit-risk profile of such drug in the intended lim25 ited population, taking into account the severity, rar26 ity, or prevalence of the infection the drug is intended 
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1 to treat and the availability or lack of alternative 

2 treatment in such limited population. Such drug may 

3 be approved under this subsection notwithstanding a 

4 lack of evidence to fully establish a favorable benefit5 risk profile in a population that is broader than the 

6 intended limited population. 

7 ‘‘(3) ADDITIONAL REQUIREMENTS.—A drug ap8 proved under this subsection shall be subject to the fol9 lowing requirements, in addition to any other appli10 cable requirements of this Act: 

11 ‘‘(A) LABELING.—To indicate that the safe12 ty and effectiveness of a drug approved under 

13 this subsection has been demonstrated only with 

14 respect to a limited population— 

15 ‘‘(i) all labeling and advertising of an 

16 antibacterial or antifungal drug approved 

17 under this subsection shall contain the 

18 statement ‘Limited Population’ in a promi19 nent manner and adjacent to, and not more 

20 prominent than— 

21 ‘‘(I) the proprietary name of such 

22 drug, if any; or 

23 ‘‘(II) if there is no proprietary 

24 name, the established name of the drug, 

25 if any, as defined in section 503(e)(3), 
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1 or, in the case of a drug that is a bio2 logical product, the proper name, as 

3 defined by regulation; and 

4 ‘‘(ii) the prescribing information for 

5 the drug required by section 201.57 of title 

6 21, Code of Federal Regulations (or any 

7 successor regulation) shall also include the 

8 following statement: ‘This drug is indicated 

9 for use in a limited and specific population 

10 of patients.’. 

11 ‘‘(B) PROMOTIONAL MATERIAL.—The spon12 sor of an antibacterial or antifungal drug subject 

13 to this subsection shall submit to the Secretary 

14 copies of all promotional materials related to 

15 such drug at least 30 calendar days prior to dis16 semination of the materials. 

17 ‘‘(4) OTHER PROGRAMS.—A sponsor of a drug 

18 that seeks approval of a drug under this subsection 

19 may also seek designation or approval, as applicable, 

20 of such drug under other applicable sections or sub21 sections of this Act or the Public Health Service Act. 

22 ‘‘(5) GUIDANCE.—Not later than 18 months after 

23 the date of enactment of the 21st Century Cures Act, 

24 the Secretary shall issue draft guidance describing 

25 criteria, processes, and other general considerations 
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1 for demonstrating the safety and effectiveness of lim2 ited population antibacterial and antifungal drugs. 

3 The Secretary shall publish final guidance within 18 

4 months of the close of the public comment period on 

5 such draft guidance. The Secretary may approve 

6 antibacterial and antifungal drugs under this sub7 section prior to issuing guidance under this para8 graph. 

9 ‘‘(6) ADVICE.—The Secretary shall provide 

10 prompt advice to the sponsor of a drug for which the 

11 sponsor seeks approval under this subsection to enable 

12 the sponsor to plan a development program to obtain 

13 the necessary data for such approval, and to conduct 

14 any additional studies that would be required to gain 

15 approval of such drug for use in a broader popu16 lation. 

17 ‘‘(7) TERMINATION OF LIMITATIONS.—If, after 

18 approval of a drug under this subsection, the Sec19 retary approves a broader indication for such drug 

20 under section 505(b) or section 351(a) of the Public 

21 Health Service Act, the Secretary may remove any 

22 postmarketing conditions, including requirements 

23 with respect to labeling and review of promotional 

24 materials under paragraph (3), applicable to the ap25 proval of the drug under this subsection. 
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1 ‘‘(8) RULES OF CONSTRUCTION.—Nothing in this 

2 subsection shall be construed to alter the authority of 

3 the Secretary to approve drugs pursuant to this Act 

4 or section 351 of the Public Health Service Act, in5 cluding the standards of evidence and applicable con6 ditions for approval under such Acts, the standards of 

7 approval of a drug under such Acts, or to alter the 

8 authority of the Secretary to monitor drugs pursuant 

9 to such Acts. 

10 ‘‘(9) REPORTING AND ACCOUNTABILITY.— 

11 ‘‘(A) BIENNIAL REPORTING.—The Secretary 

12 shall report to Congress not less often than once 

13 every 2 years on the number of requests for ap14 proval, and the number of approvals, of an anti15 bacterial or antifungal drug under this sub16 section. 

17 ‘‘(B) GAO REPORT.—Not later than Decem18 ber 2021, the Comptroller General of the United 

19 States shall submit to the Committee on Energy 

20 and Commerce of the House of Representatives 

21 and the Committee on Health, Education, Labor 

22 and Pensions of the Senate a report on the co23 ordination of activities required under section 

24 319E of the Public Health Service Act. Such re25 port shall include a review of such activities, and 
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1 the extent to which the use of the pathway estab2 lished under this subsection has streamlined pre3 market approval for antibacterial or antifungal 

4 drugs for limited populations, if such pathway 

5 has functioned as intended, if such pathway has 

6 helped provide for safe and effective treatment 

7 for patients, if such premarket approval would 

8 be appropriate for other categories of drugs, and 

9 if the authorities under this subsection have af10 fected antibacterial or antifungal resistance.’’. 

11 SEC. 3043. PRESCRIBING AUTHORITY. 

12 Nothing in this subtitle, or an amendment made by 

13 this subtitle, shall be construed to restrict the prescribing 

14 of antimicrobial drugs or other products, including drugs 

15 approved under subsection (h) of section 506 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as added 

17 by section 3042), by health care professionals, or to limit 

18 the practice of health care. 

19 SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

20 FOR MICROORGANISMS; ANTIMICROBIAL SUS21 CEPTIBILITY TESTING DEVICES. 

22 (a) IN GENERAL.—Subchapter A of chapter V of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 

24 seq.) is amended by inserting after section 511 the following: 
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1 ‘‘SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

2 FOR MICROORGANISMS. 

3 ‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.— 

4 ‘‘(1) PURPOSE.—The purpose of this section is to 

5 clarify the Secretary’s authority to— 

6 ‘‘(A) efficiently update susceptibility test in7 terpretive criteria for antimicrobial drugs when 

8 necessary for public health, due to, among other 

9 things, the constant evolution of microorganisms 

10 that leads to the development of resistance to 

11 drugs that have been effective in decreasing mor12 bidity and mortality for patients, which war13 rants unique management of antimicrobial drugs 

14 that is inappropriate for most other drugs in 

15 order to delay or prevent the development of fur16 ther resistance to existing therapies; 

17 ‘‘(B) provide for public notice of the avail18 ability of recognized interpretive criteria and in19 terpretive criteria standards; and 

20 ‘‘(C) clear under section 510(k), classify 

21 under section 513(f)(2), or approve under section 

22 515, antimicrobial susceptibility testing devices 

23 utilizing updated, recognized susceptibility test 

24 interpretive criteria to characterize the in vitro 

25 susceptibility of particular bacteria, fungi, or 
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1 other microorganisms, as applicable, to anti2 microbial drugs. 

3 ‘‘(2) IDENTIFICATION OF CRITERIA.—The Sec4 retary shall identify appropriate susceptibility test 

5 interpretive criteria with respect to antimicrobial 

6 drugs— 

7 ‘‘(A) if such criteria are available on the 

8 date of approval of the drug under section 505 

9 of this Act or licensure of the drug under section 

10 351 of the Public Health Service Act (as applica11 ble), upon such approval or licensure; or 

12 ‘‘(B) if such criteria are unavailable on 

13 such date, on the date on which such criteria are 

14 available for such drug. 

15 ‘‘(3) BASES FOR INITIAL IDENTIFICATION.—The 

16 Secretary shall identify appropriate susceptibility test 

17 interpretive criteria under paragraph (2), based on 

18 the Secretary’s review of, to the extent available and 

19 relevant— 

20 ‘‘(A) preclinical and clinical data, includ21 ing pharmacokinetic, pharmacodynamic, and ep22 idemiological data; 

23 ‘‘(B) the relationship of susceptibility test 

24 interpretive criteria to morbidity and mortality 
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1 associated with the disease or condition for 

2 which such drug is used; and 

3 ‘‘(C) such other evidence and information as 

4 the Secretary considers appropriate. 

5 ‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA

6 WEBSITE.— 

7 ‘‘(1) IN GENERAL.—Not later than 1 year after 

8 the date of the enactment of the 21st Century Cures 

9 Act, the Secretary shall establish, and maintain there10 after, on the website of the Food and Drug Adminis11 tration, a dedicated website that contains a list of 

12 any appropriate new or updated susceptibility test 

13 interpretive criteria standards and interpretive cri14 teria in accordance with paragraph (2) (referred to in 

15 this section as the ‘Interpretive Criteria Website’). 

16 ‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER17 PRETIVE CRITERIA STANDARDS AND INTERPRETIVE

18 CRITERIA.— 

19 ‘‘(A) IN GENERAL.—The list described in 

20 paragraph (1) shall consist of any new or up21 dated susceptibility test interpretive criteria 

22 standards that are— 

23 ‘‘(i) established by a nationally or 

24 internationally recognized standard devel25 opment organization that— 
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1 ‘‘(I) establishes and maintains 

2 procedures to address potential con3 flicts of interest and ensure trans4 parent decisionmaking; 

5 ‘‘(II) holds open meetings to en6 sure that there is an opportunity for 

7 public input by interested parties, and 

8 establishes and maintains processes to 

9 ensure that such input is considered in 

10 decisionmaking; and 

11 ‘‘(III) permits its standards to be 

12 made publicly available, through the 

13 National Library of Medicine or an14 other similar source acceptable to the 

15 Secretary; and 

16 ‘‘(ii) recognized in whole, or in part, 

17 by the Secretary under subsection (c). 

18 ‘‘(B) OTHER LIST.—The Interpretive Cri19 teria Website shall, in addition to the list de20 scribed in subparagraph (A), include a list of in21 terpretive criteria, if any, that the Secretary has 

22 determined to be appropriate with respect to le23 gally marketed antimicrobial drugs, where— 

24 ‘‘(i) the Secretary does not recognize, 

25 in whole or in part, an interpretive criteria 
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•HR 34 EAH 

1 standard described under subparagraph (A) 

2 otherwise applicable to such a drug; 

3 ‘‘(ii) the Secretary withdraws under 

4 subsection (c)(1)(A) recognition of a stand5 ard, in whole or in part, otherwise applica6 ble to such a drug; 

7 ‘‘(iii) the Secretary approves an appli8 cation under section 505 of this Act or sec9 tion 351 of the Public Health Service Act, 

10 as applicable, with respect to marketing of 

11 such a drug for which there are no relevant 

12 interpretive criteria included in a standard 

13 recognized by the Secretary under sub14 section (c); or 

15 ‘‘(iv) because the characteristics of such 

16 a drug differ from other drugs with the 

17 same active ingredient, the interpretive cri18 teria with respect to such drug— 

19 ‘‘(I) differ from otherwise applica20 ble interpretive criteria included in a 

21 standard listed under subparagraph 

22 (A) or interpretive criteria otherwise 

23 listed under this subparagraph; and 

24 ‘‘(II) are determined by the Sec25 retary to be appropriate for the drug. 
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1 ‘‘(C) REQUIRED STATEMENTS.—The Inter2 pretive Criteria Website shall include statements 

3 conveying— 

4 ‘‘(i) that the website provides informa5 tion about the in vitro susceptibility of bac6 teria, fungi, or other microorganisms, as 

7 applicable to a certain drug (or drugs); 

8 ‘‘(ii) that— 

9 ‘‘(I) the safety and efficacy of such 

10 drugs in treating clinical infections 

11 due to such bacteria, fungi, or other 

12 microorganisms, as applicable, may or 

13 may not have been established in ade14 quate and well-controlled clinical trials 

15 in order for the susceptibility informa16 tion described in clause (i) to be in17 cluded on the website; and 

18 ‘‘(II) the clinical significance of 

19 such susceptibility information in such 

20 instances is unknown; 

21 ‘‘(iii) that the approved product label22 ing for specific drugs provides the uses for 

23 which the Secretary has approved the prod24 uct; and 
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1 ‘‘(iv) any other information that the 

2 Secretary determines appropriate to ade3 quately convey the meaning of the data sup4 porting the recognition or listing of suscep5 tibility test interpretive criteria standards 

6 or susceptibility test interpretive criteria 

7 included on the website. 

8 ‘‘(3) NOTICE.—Not later than the date on which 

9 the Interpretive Criteria Website is established, the 

10 Secretary shall publish a notice of that establishment 

11 in the Federal Register. 

12 ‘‘(4) INAPPLICABILITY OF MISBRANDING PROVI13 SION.—The inclusion in the approved labeling of an 

14 antimicrobial drug of a reference or hyperlink to the 

15 Interpretive Criteria Website, in and of itself, shall 

16 not cause the drug to be misbranded in violation of 

17 section 502. 

18 ‘‘(5) TRADE SECRETS AND CONFIDENTIAL INFOR19 MATION.—Nothing in this section shall be construed 

20 as authorizing the Secretary to disclose any informa21 tion that is a trade secret or confidential information 

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

23 Code. 

24 ‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER25 PRETIVE CRITERIA.— 
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1 ‘‘(1) EVALUATION AND PUBLICATION.— 

2 ‘‘(A) IN GENERAL.—Beginning on the date 

3 of the establishment of the Interpretive Criteria 

4 Website, and at least every 6 months thereafter, 

5 the Secretary shall— 

6 ‘‘(i) evaluate any appropriate new or 

7 updated susceptibility test interpretive cri8 teria standards established by a nationally 

9 or internationally recognized standard de10 velopment organization described in sub11 section (b)(2)(A)(i); and 

12 ‘‘(ii) publish on the public website of 

13 the Food and Drug Administration a no14 tice— 

15 ‘‘(I) withdrawing recognition of 

16 any different susceptibility test inter17 pretive criteria standard, in whole or 

18 in part; 

19 ‘‘(II) recognizing the new or up20 dated standards; 

21 ‘‘(III) recognizing one or more 

22 parts of the new or updated interpre23 tive criteria specified in such a stand24 ard and declining to recognize the re25 mainder of such standard; and 
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•HR 34 EAH 

1 ‘‘(IV) making any necessary up2 dates to the lists under subsection 

3 (b)(2). 

4 ‘‘(B) UPON APPROVAL OF A DRUG.—Upon 

5 the approval of an initial or supplemental appli6 cation for an antimicrobial drug under section 

7 505 of this Act or section 351 of the Public 

8 Health Service Act, as applicable, where such 

9 approval is based on susceptibility test interpre10 tive criteria which differ from those contained in 

11 a standard recognized, or from those otherwise 

12 listed, by the Secretary pursuant to this sub13 section, or for which there are no relevant inter14 pretive criteria standards recognized, or inter15 pretive criteria otherwise listed, by the Secretary 

16 pursuant to this subsection, the Secretary shall 

17 update the lists under subparagraphs (A) and 

18 (B) of subsection (b)(2) to include the suscepti19 bility test interpretive criteria upon which such 

20 approval was based. 

21 ‘‘(2) BASES FOR UPDATING INTERPRETIVE CRI22 TERIA STANDARDS.—In evaluating new or updated 

23 susceptibility test interpretive criteria standards 

24 under paragraph (1)(A), the Secretary may con25 sider— 
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1 ‘‘(A) the Secretary’s determination that 

2 such a standard is not applicable to a particular 

3 drug because the characteristics of the drug differ 

4 from other drugs with the same active ingredient; 

5 ‘‘(B) information provided by interested 

6 third parties, including public comment on the 

7 annual compilation of notices published under 

8 paragraph (3); 

9 ‘‘(C) any bases used to identify suscepti10 bility test interpretive criteria under subsection 

11 (a)(2); and 

12 ‘‘(D) such other information or factors as 

13 the Secretary determines appropriate. 

14 ‘‘(3) ANNUAL COMPILATION OF NOTICES.—Each 

15 year, the Secretary shall compile the notices published 

16 under paragraph (1)(A) and publish such compila17 tion in the Federal Register and provide for public 

18 comment. If the Secretary receives comments, the Sec19 retary shall review such comments and, if the Sec20 retary determines appropriate, update pursuant to 

21 this subsection susceptibility test interpretive criteria 

22 standards or criteria— 

23 ‘‘(A) recognized by the Secretary under this 

24 subsection; or 
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•HR 34 EAH 

1 ‘‘(B) otherwise listed on the Interpretive 

2 Criteria Website under subsection (b)(2). 

3 ‘‘(4) RELATION TO SECTION 514(c).—Any suscep4 tibility test interpretive standard recognized under 

5 this subsection or any criteria otherwise listed under 

6 subsection (b)(2)(B) shall be deemed to be recognized 

7 as a standard by the Secretary under section 

8 514(c)(1). 

9 ‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRI10 TERIA.—Nothing in this section prohibits a person 

11 from seeking approval or clearance of a drug or de12 vice, or changes to the drug or the device, on the basis 

13 of susceptibility test interpretive criteria which differ 

14 from those contained in a standard recognized, or 

15 from those otherwise listed, by the Secretary pursuant 

16 to subsection (b)(2). 

17 ‘‘(d) ANTIMICROBIAL DRUG LABELING.— 

18 ‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH19 MENT OF INTERPRETIVE CRITERIA WEBSITE.— 

20 ‘‘(A) IN GENERAL.—With respect to an 

21 antimicrobial drug lawfully introduced or deliv22 ered for introduction into interstate commerce 

23 for commercial distribution before the establish24 ment of the Interpretive Criteria Website, a hold25 er of an approved application under section 505 
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1 of this Act or section 351 of the Public Health 

2 Service Act, as applicable, for each such drug, 

3 not later than 1 year after establishment of the 

4 Interpretive Criteria Website described in sub5 section (b)(1), shall remove susceptibility test in6 terpretive criteria, if any, and related informa7 tion from the approved drug labeling and replace 

8 it with a reference to the Interpretive Criteria 

9 Website. 

10 ‘‘(B) LABELING CHANGES.—The labeling 

11 changes required by this section shall be consid12 ered a minor change under section 314.70 of title 

13 21, Code of Federal Regulations (or any suc14 cessor regulations) that may be implemented 

15 through documentation in the next applicable 

16 annual report. 

17 ‘‘(2) DRUGS MARKETED SUBSEQUENT TO ESTAB18 LISHMENT OF INTERPRETIVE CRITERIA WEBSITE.— 

19 With respect to antimicrobial drugs approved on or 

20 after the date of the establishment of the Interpretive 

21 Criteria Website described in subsection (b)(1), the la22 beling for such a drug shall include, in lieu of suscep23 tibility test interpretive criteria and related informa24 tion, a reference to such Website. 
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•HR 34 EAH 

1 ‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI2 MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 

3 ‘‘(1) IN GENERAL.—Notwithstanding sections 

4 501, 502, 505, 510, 513, and 515, if the conditions 

5 specified in paragraph (2) are met (in addition to 

6 other applicable provisions under this chapter) with 

7 respect to an antimicrobial susceptibility testing de8 vice described in subsection (f)(1), the Secretary may 

9 authorize the marketing of such device for a use de10 scribed in such subsection. 

11 ‘‘(2) CONDITIONS APPLICABLE TO ANTI12 MICROBIAL SUSCEPTIBILITY TESTING DEVICES.—The 

13 conditions specified in this paragraph are the fol14 lowing: 

15 ‘‘(A) The device is used to make a deter16 mination of susceptibility using susceptibility 

17 test interpretive criteria that are— 

18 ‘‘(i) included in a standard recognized 

19 by the Secretary under subsection (c); or 

20 ‘‘(ii) otherwise listed on the Interpre21 tive Criteria Website under subsection 

22 (b)(2). 

23 ‘‘(B) The labeling of such device includes 

24 statements conveying— 
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•HR 34 EAH 

1 ‘‘(i) that the device provides informa2 tion about the in vitro susceptibility of bac3 teria, fungi, or other microorganisms, as 

4 applicable to antimicrobial drugs; 

5 ‘‘(ii) that— 

6 ‘‘(I) the safety and efficacy of such 

7 drugs in treating clinical infections 

8 due to such bacteria, fungi, or other 

9 microorganisms, as applicable, may or 

10 may not have been established in ade11 quate and well-controlled clinical trials 

12 in order for the device to report the 

13 susceptibility of such bacteria, fungi, 

14 or other microorganisms, as applicable, 

15 to such drugs; and 

16 ‘‘(II) the clinical significance of 

17 such susceptibility information in 

18 those instances is unknown; 

19 ‘‘(iii) that the approved labeling for 

20 drugs tested using such a device provides 

21 the uses for which the Secretary has ap22 proved such drugs; and 

23 ‘‘(iv) any other information the Sec24 retary determines appropriate to adequately 

25 convey the meaning of the data supporting 
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•HR 34 EAH 

1 the recognition or listing of susceptibility 

2 test interpretive criteria standards or sus3 ceptibility test interpretive criteria de4 scribed in subparagraph (A). 

5 ‘‘(C) The antimicrobial susceptibility test6 ing device meets all other requirements to be 

7 cleared under section 510(k), classified under sec8 tion 513(f)(2), or approved under section 515. 

9 ‘‘(f) DEFINITIONS.—In this section: 

10 ‘‘(1) The term ‘antimicrobial susceptibility test11 ing device’ means a device that utilizes susceptibility 

12 test interpretive criteria to determine and report the 

13 in vitro susceptibility of certain microorganisms to a 

14 drug (or drugs). 

15 ‘‘(2) The term ‘qualified infectious disease prod16 uct’ means a qualified infectious disease product des17 ignated under section 505E(d). 

18 ‘‘(3) The term ‘susceptibility test interpretive cri19 teria’ means— 

20 ‘‘(A) one or more specific numerical values 

21 which characterize the susceptibility of bacteria 

22 or other microorganisms to the drug tested; and 

23 ‘‘(B) related categorizations of such suscep24 tibility, including categorization of the drug as 
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1 susceptible, intermediate, resistant, or such other 

2 term as the Secretary determines appropriate. 

3 ‘‘(4)(A) The term ‘antimicrobial drug’ means, 

4 subject to subparagraph (B), a systemic antibacterial 

5 or antifungal drug that— 

6 ‘‘(i) is intended for human use in the treat7 ment of a disease or condition caused by a bac8 terium or fungus; 

9 ‘‘(ii) may include a qualified infectious dis10 ease product designated under section 505E(d); 

11 and 

12 ‘‘(iii) is subject to section 503(b)(1). 

13 ‘‘(B) If provided by the Secretary through regu14 lations, such term may include— 

15 ‘‘(i) drugs other than systemic antibacterial 

16 and antifungal drugs; and 

17 ‘‘(ii) biological products (as such term is de18 fined in section 351 of the Public Health Service 

19 Act) to the extent such products exhibit anti20 microbial activity. 

21 ‘‘(5) The term ‘interpretive criteria standard’ 

22 means a compilation of susceptibility test interpretive 

23 criteria developed by a standard development organi24 zation that meets the criteria set forth in subsection 

25 (b)(2)(A)(i). 
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1 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed to— 

3 ‘‘(1) alter the standards of evidence under sub4 section (c) or (d) of section 505 (including the sub5 stantial evidence standard under section 505(d)) or 

6 under section 351 of the Public Health Service Act (as 

7 applicable); or 

8 ‘‘(2) with respect to clearing devices under sec9 tion 510(k), classifying devices under section 

10 513(f)(2), or approving devices under section 515— 

11 ‘‘(A) apply with respect to any drug, device, 

12 or biological product, in any context other than 

13 an antimicrobial drug and an antimicrobial sus14 ceptibility testing device that uses susceptibility 

15 test interpretive criteria to characterize and re16 port the susceptibility of certain bacteria, fungi, 

17 or other microorganisms, as applicable, to such 

18 drug to reflect patient morbidity and mortality 

19 in accordance with this section; or 

20 ‘‘(B) unless specifically stated, have any ef21 fect on authorities provided under other sections 

22 of this Act, including any regulations issued 

23 under such sections.’’. 

24 (b) CONFORMING AMENDMENTS.— 
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1 (1) REPEAL OF PRIOR RELATED AUTHORITY.— 

2 Section 1111 of the Food and Drug Administration 

3 Amendments Act of 2007 (42 U.S.C. 247d–5a), relat4 ing to identification of clinically susceptible con5 centrations of antimicrobials, is repealed. 

6 (2) ADDITION TO CATEGORIES OF MISBRANDED

7 DRUGS.—Section 502 of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 352) is amended by adding 

9 at the end the following: 

10 ‘‘(dd) If it is an antimicrobial drug, as defined in sec11 tion 511A(f), and its labeling fails to conform with the re12 quirements under section 511A(d).’’. 

13 (3) RECOGNITION OF INTERPRETIVE CRITERIA

14 STANDARD AS DEVICE STANDARD.—Section 

15 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 360d(c)(1)(A)) is amended by insert17 ing after ‘‘the Secretary shall, by publication in the 

18 Federal Register’’ the following: ‘‘(or, with respect to 

19 a susceptibility test interpretive criteria standard 

20 under section 511A, by posting on the Interpretive 

21 Criteria Website in accordance with such section)’’. 

22 (c) REPORT TO CONGRESS.—Not later than 2 years 

23 after the date of enactment of this Act, the Secretary of 

24 Health and Human Services shall submit to the Committee 

25 on Health, Education, Labor, and Pensions of the Senate 
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1 and the Committee on Energy and Commerce of the House 

2 of Representatives a report on the progress made in imple3 menting section 511A of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360a), as added by subsection (a). 

5 (d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI6 TERIA WEBSITE.—Chapter 35 of title 44, United States 

7 Code, shall not apply to the collection of information from 

8 interested parties regarding updating the lists established 

9 under section 511A(b) of the Federal Food, Drug, and Cos10 metic Act and posted on the Interpretive Criteria Website 

11 established under section 511A(c) of such Act. 

12 Subtitle F—Medical Device 

13 Innovations 

14 SEC. 3051. BREAKTHROUGH DEVICES. 

15 (a) IN GENERAL.—Chapter V of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

17 by inserting after section 515B, as added by section 

18 3034(b), the following: 

19 ‘‘SEC. 515C. BREAKTHROUGH DEVICES. 

20 ‘‘(a) PURPOSE.—The purpose of this section is to en21 courage the Secretary, and provide the Secretary with suffi22 cient authority, to apply efficient and flexible approaches 

23 to expedite the development of, and prioritize the Food and 

24 Drug Administration’s review of, devices that represent 

25 breakthrough technologies. 
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1 ‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 

2 shall establish a program to expedite the development of, 

3 and provide for the priority review for, devices, as deter4 mined by the Secretary— 

5 ‘‘(1) that provide for more effective treatment or 

6 diagnosis of life-threatening or irreversibly debili7 tating human disease or conditions; and 

8 ‘‘(2)(A) that represent breakthrough technologies; 

9 ‘‘(B) for which no approved or cleared alter10 natives exist; 

11 ‘‘(C) that offer significant advantages over exist12 ing approved or cleared alternatives, including the 

13 potential, compared to existing approved alternatives, 

14 to reduce or eliminate the need for hospitalization, 

15 improve patient quality of life, facilitate patients’ 

16 ability to manage their own care (such as through 

17 self-directed personal assistance), or establish long18 term clinical efficiencies; or 

19 ‘‘(D) the availability of which is in the best in20 terest of patients. 

21 ‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a de22 vice may request that the Secretary designate such device 

23 for expedited development and priority review under this 

24 section. Any such request for designation may be made at 

25 any time prior to the submission of an application under 
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1 section 515(c), a notification under section 510(k), or a pe2 tition for classification under section 513(f)(2). 

3 ‘‘(d) DESIGNATION PROCESS.— 

4 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

5 days after the receipt of a request under subsection 

6 (c), the Secretary shall determine whether the device 

7 that is the subject of the request meets the criteria de8 scribed in subsection (b). If the Secretary determines 

9 that the device meets the criteria, the Secretary shall 

10 designate the device for expedited development and 

11 priority review. 

12 ‘‘(2) REVIEW.—Review of a request under sub13 section (c) shall be undertaken by a team that is com14 posed of experienced staff and senior managers of the 

15 Food and Drug Administration. 

16 ‘‘(3) WITHDRAWAL.—The Secretary may not 

17 withdraw a designation granted under this section on 

18 the basis of the criteria under subsection (b) no longer 

19 applying because of the subsequent clearance or ap20 proval of another device that— 

21 ‘‘(A) was designated under this section; or 

22 ‘‘(B) was given priority review under sec23 tion 515(d)(5), as in effect prior to the date of 

24 enactment of the 21st Century Cures Act. 
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1 ‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY RE2 VIEW.— 

3 ‘‘(1) ACTIONS.—For purposes of expediting the 

4 development and review of devices designated under 

5 subsection (d) the Secretary shall— 

6 ‘‘(A) assign a team of staff, including a 

7 team leader with appropriate subject matter ex8 pertise and experience, for each device for which 

9 a request is submitted under subsection (c); 

10 ‘‘(B) provide for oversight of the team by 

11 senior agency personnel to facilitate the efficient 

12 development of the device and the efficient review 

13 of any submission described in subsection (c) for 

14 the device; 

15 ‘‘(C) adopt an efficient process for timely 

16 dispute resolution; 

17 ‘‘(D) provide for interactive and timely 

18 communication with the sponsor of the device 

19 during the development program and review 

20 process; 

21 ‘‘(E) expedite the Secretary’s review of 

22 manufacturing and quality systems compliance, 

23 as applicable; 

24 ‘‘(F) disclose to the sponsor, not less than 5 

25 business days in advance, the topics of any con-
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1 sultation the Secretary intends to undertake with 

2 external experts or an advisory committee con3 cerning the sponsor’s device and provide the 

4 sponsor the opportunity to recommend such ex5 ternal experts; 

6 ‘‘(G) provide for advisory committee input, 

7 as the Secretary determines appropriate (includ8 ing in response to the request of the sponsor) for 

9 applications submitted under section 515(c); and 

10 ‘‘(H) assign staff to be available within a 

11 reasonable time to address questions by institu12 tional review committees concerning the condi13 tions and clinical testing requirements applica14 ble to the investigational use of the device pursu15 ant to an exemption under section 520(g). 

16 ‘‘(2) ADDITIONAL ACTIONS.—In addition to the 

17 actions described in paragraph (1), for purposes of 

18 expediting the development and review of devices des19 ignated under subsection (d), the Secretary, in col20 laboration with the device sponsor, may, as appro21 priate— 

22 ‘‘(A) coordinate with the sponsor regarding 

23 early agreement on a data development plan; 
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•HR 34 EAH 

1 ‘‘(B) take steps to ensure that the design of 

2 clinical trials is as efficient and flexible as prac3 ticable, when scientifically appropriate; 

4 ‘‘(C) facilitate, when scientifically appro5 priate, expedited and efficient development and 

6 review of the device through utilization of timely 

7 postmarket data collection with regard to appli8 cation for approval under section 515(c); and 

9 ‘‘(D) agree in writing to clinical protocols 

10 that the Secretary will consider binding on the 

11 Secretary and the sponsor, subject to— 

12 ‘‘(i) changes to such protocols agreed to 

13 in writing by the sponsor and the Sec14 retary; or 

15 ‘‘(ii) a decision, made by the director 

16 of the office responsible for reviewing the de17 vice submission, that a substantial scientific 

18 issue essential to determining the safety or 

19 effectiveness of such device exists, provided 

20 that such decision is in writing, and is 

21 made only after the Secretary provides to 

22 the device sponsor or applicant an oppor23 tunity for a meeting at which the director 

24 and the sponsor or applicant are present 
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•HR 34 EAH 

1 and at which the director documents the 

2 substantial scientific issue. 

3 ‘‘(f) PRIORITY REVIEW GUIDANCE.— 

4 ‘‘(1) CONTENT.—Not later than 1 year after the 

5 date of enactment of the 21st Century Cures Act, the 

6 Secretary shall issue guidance on the implementation 

7 of this section. Such guidance shall— 

8 ‘‘(A) set forth the process by which a person 

9 may seek a designation under subsection (d); 

10 ‘‘(B) provide a template for requests under 

11 subsection (c); 

12 ‘‘(C) identify the criteria the Secretary will 

13 use in evaluating a request for designation under 

14 this section; and 

15 ‘‘(D) identify the criteria and processes the 

16 Secretary will use to assign a team of staff, in17 cluding team leaders, to review devices des18 ignated for expedited development and priority 

19 review, including any training required for such 

20 personnel to ensure effective and efficient review. 

21 ‘‘(2) PROCESS.—Prior to finalizing the guidance 

22 under paragraph (1), the Secretary shall seek public 

23 comment on a proposed guidance. 

24 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec25 tion shall be construed to affect— 
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1 ‘‘(1) the criteria and standards for evaluating an 

2 application pursuant to section 515(c), a report and 

3 request for classification under section 513(f)(2), or a 

4 report under section 510(k), including the recognition 

5 of valid scientific evidence as described in section 

6 513(a)(3)(B) and consideration and application of 

7 the least burdensome means of evaluating device effec8 tiveness or demonstrating substantial equivalence be9 tween devices with differing technological characteris10 tics, as applicable; 

11 ‘‘(2) the authority of the Secretary with respect 

12 to clinical holds under section 520(g)(8)(A); 

13 ‘‘(3) the authority of the Secretary to act on an 

14 application pursuant to section 515(d) before comple15 tion of an establishment inspection, as the Secretary 

16 determines appropriate; or 

17 ‘‘(4) the authority of the Secretary with respect 

18 to postmarket surveillance under sections 519(h) and 

19 522.’’. 

20 (b) DOCUMENTATION AND REVIEW OF SIGNIFICANT

21 DECISIONS.—Section 517A(a)(1) of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 

23 amended by inserting ‘‘a request for designation under sec24 tion 515C,’’ after ‘‘application under section 515,’’. 

25 (c) TERMINATION OF PREVIOUS PROGRAM.— 
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•HR 34 EAH 

1 (1) IN GENERAL.—Section 515(d) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is 

3 amended— 

4 (A) by striking paragraph (5); and 

5 (B) by redesignating paragraph (6) as 

6 paragraph (5). 

7 (2) CONFORMING AMENDMENT.—Section 737(5) 

8 of the Federal Food, Drug, and Cosmetics Act (21 

9 U.S.C. 379i(5)) is amended by striking ‘‘515(d)(6)’’ 

10 and inserting ‘‘515(d)(5)’’. 

11 (d) REPORT.—On January 1, 2019, the Secretary of 

12 Health and Human Services shall issue a report to the 

13 Committee on Health, Education, Labor, and Pensions of 

14 the Senate and the Committee on Energy and Commerce 

15 of the House of Representatives— 

16 (1) on the program under section 515C of the 

17 Federal Food, Drug, and Cosmetic Act, as added by 

18 subsection (a), in bringing safe and effective devices 

19 included in such program to patients as soon as pos20 sible; and 

21 (2) that includes recommendations, if any, to 

22 strengthen the program to better meet patient device 

23 needs in a manner as timely as possible. 
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1 SEC. 3052. HUMANITARIAN DEVICE EXEMPTION. 

2 (a) IN GENERAL.—Section 520(m) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amend4 ed— 

5 (1) in paragraph (1) by striking ‘‘fewer than 

6 4,000’’ and inserting ‘‘not more than 8,000’’; 

7 (2) in paragraph (2)(A) by striking ‘‘fewer than 

8 4,000’’ and inserting ‘‘not more than 8,000’’; and 

9 (3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ 

10 and inserting ‘‘8,000’’. 

11 (b) GUIDANCE DOCUMENT ON PROBABLE BENEFIT.— 

12 Not later than 18 months after the date of enactment of 

13 this Act, the Secretary of Health and Human Services, act14 ing through the Commissioner of Food and Drugs, shall 

15 publish a draft guidance that defines the criteria for estab16 lishing ‘‘probable benefit’’ as that term is used in section 

17 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 360j(m)(2)(C)). 

19 SEC. 3053. RECOGNITION OF STANDARDS. 

20 (a) IN GENERAL.—Section 514(c) of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended— 

22 (1) in paragraph (1), by inserting after subpara23 graph (B) the following new subparagraphs: 

24 ‘‘(C)(i) Any person may submit a request for recogni25 tion under subparagraph (A) of all or part of an appro-
237 

•HR 34 EAH 

1 priate standard established by a nationally or internation2 ally recognized standard organization. 

3 ‘‘(ii) Not later than 60 calendar days after the Sec4 retary receives such a request, the Secretary shall— 

5 ‘‘(I) make a determination to recognize all, part, 

6 or none of the standard that is the subject of the re7 quest; and 

8 ‘‘(II) issue to the person who submitted such re9 quest a response in writing that states the Secretary’s 

10 rationale for that determination, including the sci11 entific, technical, regulatory, or other basis for such 

12 determination. 

13 ‘‘(iii) The Secretary shall make a response issued 

14 under clause (ii)(II) publicly available, in such a manner 

15 as the Secretary determines appropriate. 

16 ‘‘(iv) The Secretary shall take such actions as may be 

17 necessary to implement all or part of a standard recognized 

18 under clause (ii)(I), in accordance with subparagraph (A). 

19 ‘‘(D) The Secretary shall make publicly available, in 

20 such manner as the Secretary determines appropriate, the 

21 rationale for recognition under subparagraph (A) of all, 

22 part, or none of a standard, including the scientific, tech23 nical, regulatory, or other basis for the decision regarding 

24 such recognition.’’; and 

25 (2) by adding at the end the following: 
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•HR 34 EAH 

1 ‘‘(4) The Secretary shall provide to all employees of 

2 the Food and Drug Administration who review premarket 

3 submissions for devices periodic training on the concept and 

4 use of recognized standards for purposes of meeting a pre5 market submission requirement or other applicable require6 ment under this Act, including standards relevant to an 

7 employee’s area of device review.’’. 

8 (b) GUIDANCE.—The Secretary of Health and Human 

9 Services, acting through the Commissioner of Food and 

10 Drugs, shall review and update, if necessary, previously 

11 published guidance and standard operating procedures 

12 identifying the principles for recognizing standards, and for 

13 withdrawing the recognition of standards, under section 

14 514(c) of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 360d(c)), taking into account the experience with 

16 and reliance on a standard by foreign regulatory authori17 ties and the device industry, and whether recognition of a 

18 standard will promote harmonization among regulatory 

19 authorities in the regulation of devices. 

20 SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES. 

21 (a) CLASS I DEVICES.—Section 510(l) of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amend23 ed— 
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•HR 34 EAH 

1 (1) by striking ‘‘A report under subsection (k)’’ 

2 and inserting ‘‘(1) A report under subsection (k)’’; 

3 and 

4 (2) by adding at the end the following new para5 graph: 

6 ‘‘(2) Not later than 120 calendar days after the date 

7 of enactment of the 21st Century Cures Act and at least 

8 once every 5 years thereafter, as the Secretary determines 

9 appropriate, the Secretary shall identify, through publica10 tion in the Federal Register, any type of class I device that 

11 the Secretary determines no longer requires a report under 

12 subsection (k) to provide reasonable assurance of safety and 

13 effectiveness. Upon such publication— 

14 ‘‘(A) each type of class I device so identified shall 

15 be exempt from the requirement for a report under 

16 subsection (k); and 

17 ‘‘(B) the classification regulation applicable to 

18 each such type of device shall be deemed amended to 

19 incorporate such exemption.’’. 

20 (b) CLASS II DEVICES.—Section 510(m) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is 

22 amended— 

23 (1) by striking ‘‘(m)(1)’’ and all that follows 

24 through ‘‘by the Secretary.’’ and inserting the fol25 lowing: 
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•HR 34 EAH 

1 ‘‘(m)(1) The Secretary shall— 

2 ‘‘(A) not later than 90 days after the date of en3 actment of the 21st Century Cures Act and at least 

4 once every 5 years thereafter, as the Secretary deter5 mines appropriate— 

6 ‘‘(i) publish in the Federal Register a notice 

7 that contains a list of each type of class II device 

8 that the Secretary determines no longer requires 

9 a report under subsection (k) to provide reason10 able assurance of safety and effectiveness; and 

11 ‘‘(ii) provide for a period of not less than 

12 60 calendar days for public comment beginning 

13 on the date of the publication of such notice; and 

14 ‘‘(B) not later than 210 calendar days after the 

15 date of enactment of the 21st Century Cures Act, pub16 lish in the Federal Register a list representing the 

17 Secretary’s final determination with respect to the de18 vices contained in the list published under subpara19 graph (A).’’; and 

20 (2) in paragraph (2)— 

21 (A) by striking ‘‘1 day after the date of 

22 publication of a list under this subsection,’’ and 

23 inserting ‘‘1 calendar day after the date of publi24 cation of the final list under paragraph (1)(B),’’; 

25 and 
241 

•HR 34 EAH 

1 (B) by striking ‘‘30-day period’’ and insert2 ing ‘‘60-calendar-day period’’; and 

3 (C) by adding at the end the following new 

4 paragraph: 

5 ‘‘(3) Upon the publication of the final list under para6 graph (1)(B)— 

7 ‘‘(A) each type of class II device so listed shall 

8 be exempt from the requirement for a report under 

9 subsection (k); and 

10 ‘‘(B) the classification regulation applicable to 

11 each such type of device shall be deemed amended to 

12 incorporate such exemption.’’. 

13 SEC. 3055. CLASSIFICATION PANELS. 

14 (a) CLASSIFICATION PANELS.—Paragraph (5) of sec15 tion 513(b) of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 360c(b)) is amended— 

17 (1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 

18 and 

19 (2) by adding at the end the following: 

20 ‘‘(B) When a device is specifically the subject of review 

21 by a classification panel, the Secretary shall— 

22 ‘‘(i) ensure that adequate expertise is represented 

23 on the classification panel to assess— 
242 

•HR 34 EAH 

1 ‘‘(I) the disease or condition which the de2 vice is intended to cure, treat, mitigate, prevent, 

3 or diagnose; and 

4 ‘‘(II) the technology of the device; and 

5 ‘‘(ii) provide an opportunity for the person 

6 whose device is specifically the subject of panel review 

7 to provide recommendations on the expertise needed 

8 among the voting members of the panel. 

9 ‘‘(C) For purposes of subparagraph (B)(i), the term 

10 ‘adequate expertise’ means that the membership of the clas11 sification panel includes— 

12 ‘‘(i) two or more voting members, with a spe13 cialty or other expertise clinically relevant to the de14 vice under review; and 

15 ‘‘(ii) at least one voting member who is knowl16 edgeable about the technology of the device. 

17 ‘‘(D) The Secretary shall provide an annual oppor18 tunity for patients, representatives of patients, and spon19 sors of medical device submissions to provide recommenda20 tions for individuals with appropriate expertise to fill vot21 ing member positions on classification panels.’’. 

22 (b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 360c(b)(6)) is amended— 
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•HR 34 EAH 

1 (1) in subparagraph (A)(iii), by inserting before 

2 the period at the end ‘‘, including, subject to the dis3 cretion of the panel chairperson, by designating a 

4 representative who will be provided a time during the 

5 panel meeting to address the panel for the purpose of 

6 correcting misstatements of fact or providing clari7 fying information, and permitting the person or rep8 resentative to call on experts within the person’s orga9 nization to address such specific issues in the time 

10 provided’’; and 

11 (2) by striking subparagraph (B) and inserting 

12 the following new subparagraph: 

13 ‘‘(B)(i) Any meeting of a classification panel with re14 spect to the review of a device shall— 

15 ‘‘(I) provide adequate time for initial presen16 tations by the person whose device is specifically the 

17 subject of such review and by the Secretary; and 

18 ‘‘(II) encourage free and open participation by 

19 all interested persons. 

20 ‘‘(ii) Following the initial presentations described in 

21 clause (i), the panel may— 

22 ‘‘(I) pose questions to a designated representative 

23 described in subparagraph (A)(iii); and 

24 ‘‘(II) consider the responses to such questions in 

25 the panel’s review of the device.’’. 
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1 SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY. 

2 Section 520 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360j) is amended— 

4 (1) in subsection (g)(3)— 

5 (A) in subparagraph (A)(i)— 

6 (i) by striking ‘‘local’’; and 

7 (ii) by striking ‘‘which has been’’; and 

8 (B) in subparagraph (B), by striking ‘‘a 

9 local institutional’’ and inserting ‘‘an institu10 tional’’; and 

11 (2) in subsection (m)(4)— 

12 (A) by striking subparagraph (A) and in13 serting the following: 

14 ‘‘(A) in facilities in which clinical testing of de15 vices is supervised by an institutional review com16 mittee established in accordance with the regulations 

17 of the Secretary; and’’; 

18 (B) in subparagraph (B), by striking ‘‘a 

19 local institutional’’ and inserting ‘‘an institu20 tional’’; and 

21 (C) in the matter following subparagraph 

22 (B), by striking ‘‘local’’. 

23 SEC. 3057. CLIA WAIVER IMPROVEMENTS. 

24 (a) DRAFT REVISED GUIDANCE.—Not later than 1 

25 year after the date of the enactment of this Act, the Sec26 retary of Health and Human Services, acting through the 
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•HR 34 EAH 

1 Commissioner of Food and Drugs, shall publish a draft 

2 guidance that— 

3 (1) revises ‘‘Section V. Demonstrating Insignifi4 cant Risk of an Erroneous Result – Accuracy’’ of the 

5 guidance entitled ‘‘Recommendations for Clinical 

6 Laboratory Improvement Amendments of 1988 

7 (CLIA) Waiver Applications for Manufacturers of In 

8 Vitro Diagnostic Devices’’ and dated January 30, 

9 2008; and 

10 (2) includes the appropriate use of comparable 

11 performance between a waived user and a moderately 

12 complex laboratory user to demonstrate accuracy. 

13 (b) FINAL REVISED GUIDANCE.—The Secretary of 

14 Health and Human Services, acting through the Commis15 sioner of Food and Drugs, shall finalize the draft guidance 

16 published under subsection (a) not later than 1 year after 

17 the comment period for such draft guidance closes. 

18 SEC. 3058. LEAST BURDENSOME DEVICE REVIEW. 

19 (a) IN GENERAL.—Section 513 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 

21 adding at the end the following: 

22 ‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDEN23 SOME REQUIREMENTS.— 

24 ‘‘(1) The Secretary shall— 
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•HR 34 EAH 

1 ‘‘(A) ensure that each employee of the Food 

2 and Drug Administration who is involved in the 

3 review of premarket submissions, including su4 pervisors, receives training regarding the mean5 ing and implementation of the least burdensome 

6 requirements under subsections (a)(3)(D) and 

7 (i)(1)(D) of this section and section 515(c)(5); 

8 and 

9 ‘‘(B) periodically assess the implementation 

10 of the least burdensome requirements, including 

11 the employee training under subparagraph (A), 

12 to ensure that the least burdensome requirements 

13 are fully and consistently applied. 

14 ‘‘(2) Not later than 18 months after the date of 

15 enactment of the 21st Century Cures Act, the ombuds16 man for any organizational unit of the Food and 

17 Drug Administration responsible for the premarket 

18 review of devices shall— 

19 ‘‘(A) conduct an audit of the training de20 scribed in paragraph (1)(A), including the effec21 tiveness of such training in implementing the 

22 least burdensome requirements; 

23 ‘‘(B) include in such audit interviews of 

24 persons who are representatives of the device in25 dustry regarding their experiences in the device 
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•HR 34 EAH 

1 premarket review process, including with respect 

2 to the application of least burdensome concepts 

3 to premarket review and decisionmaking; 

4 ‘‘(C) include in such audit a list of the 

5 measurement tools the Secretary uses to assess 

6 the implementation of the least burdensome re7 quirements, including under paragraph (1)(B) 

8 and section 517A(a)(3), and may also provide 

9 feedback on the effectiveness of such tools in the 

10 implementation of the least burdensome require11 ments; 

12 ‘‘(D) summarize the findings of such audit 

13 in a final audit report; and 

14 ‘‘(E) within 30 calendar days of completion 

15 of such final audit report, make such final audit 

16 report available— 

17 ‘‘(i) to the Committee on Health, Edu18 cation, Labor, and Pensions of the Senate 

19 and the Committee on Energy and Com20 merce of the House of Representatives; and 

21 ‘‘(ii) on the Internet website of the 

22 Food and Drug Administration.’’. 

23 (b) PREMARKET APPLICATIONS.—Section 515(c) of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 

25 is amended by adding at the end the following: 
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•HR 34 EAH 

1 ‘‘(5)(A) In requesting additional information with re2 spect to an application under this section, the Secretary 

3 shall consider the least burdensome appropriate means nec4 essary to demonstrate a reasonable assurance of device safe5 ty and effectiveness. 

6 ‘‘(B) For purposes of subparagraph (A), the term ‘nec7 essary’ means the minimum required information that 

8 would support a determination by the Secretary that an 

9 application provides a reasonable assurance of the safety 

10 and effectiveness of the device. 

11 ‘‘(C) For purposes of this paragraph, the Secretary 

12 shall consider the role of postmarket information in deter13 mining the least burdensome means of demonstrating a rea14 sonable assurance of device safety and effectiveness. 

15 ‘‘(D) Nothing in this paragraph alters the standards 

16 for premarket approval of a device.’’. 

17 (c) RATIONALE FOR SIGNIFICANT DECISIONS REGARD18 ING DEVICES.—Section 517A(a) of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 360g–1(a)) is amended by 

20 adding at the end the following: 

21 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE22 QUIREMENTS.—The substantive summary required 

23 under this subsection shall include a brief statement 

24 regarding how the least burdensome requirements 

25 were considered and applied consistent with section 
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1 513(i)(1)(D), section 513(a)(3)(D), and section 

2 515(c)(5), as applicable.’’. 

3 SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION 

4 DATA REQUIREMENT. 

5 (a) IN GENERAL.—Section 510 of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 360) is amended by 

7 adding at the end the following: 

8 ‘‘(q) REUSABLE MEDICAL DEVICES.— 

9 ‘‘(1) IN GENERAL.—Not later than 180 days 

10 after the date of enactment of the 21st Century Cures 

11 Act, the Secretary shall identify and publish a list of 

12 reusable device types for which reports under sub13 section (k) are required to include— 

14 ‘‘(A) instructions for use, which have been 

15 validated in a manner specified by the Sec16 retary; and 

17 ‘‘(B) validation data, the types of which 

18 shall be specified by the Secretary; 

19 regarding cleaning, disinfection, and sterilization, 

20 and for which a substantial equivalence determina21 tion may be based. 

22 ‘‘(2) REVISION OF LIST.—The Secretary shall re23 vise the list under paragraph (2), as the Secretary de24 termines appropriate, with notice in the Federal Reg25 ister. 
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1 ‘‘(3) CONTENT OF REPORTS.—Reports under sub2 section (k) that are submitted after the publication of 

3 the list described in paragraph (1), for devices or 

4 types of devices included on such list, shall include 

5 such instructions for use and validation data.’’. 

6 (b) DEVICE MODIFICATIONS.—The Secretary of Health 

7 and Human Services, acting through the Commissioner of 

8 Food and Drugs, shall issue final guidance regarding when 

9 a premarket notification under section 510(k) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is re11 quired to be submitted for a modification or change to a 

12 legally marketed device. Such final guidance shall be issued 

13 not later than 1 year after the date on which the comment 

14 period closes for the draft guidance on such subject. 

15 SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION. 

16 (a) IN GENERAL.—Section 520 of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 

18 adding at the end the following: 

19 ‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECI20 SIONS SUPPORT SOFTWARE.— 

21 ‘‘(1) The term device, as defined in section 

22 201(h), shall not include a software function that is 

23 intended— 

24 ‘‘(A) for administrative support of a health 

25 care facility, including the processing and main-
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1 tenance of financial records, claims or billing in2 formation, appointment schedules, business ana3 lytics, information about patient populations, 

4 admissions, practice and inventory management, 

5 analysis of historical claims data to predict fu6 ture utilization or cost-effectiveness, determina7 tion of health benefit eligibility, population 

8 health management, and laboratory workflow; 

9 ‘‘(B) for maintaining or encouraging a 

10 healthy lifestyle and is unrelated to the diag11 nosis, cure, mitigation, prevention, or treatment 

12 of a disease or condition; 

13 ‘‘(C) to serve as electronic patient records, 

14 including patient-provided information, to the 

15 extent that such records are intended to transfer, 

16 store, convert formats, or display the equivalent 

17 of a paper medical chart, so long as— 

18 ‘‘(i) such records were created, stored, 

19 transferred, or reviewed by health care pro20 fessionals, or by individuals working under 

21 supervision of such professionals; 

22 ‘‘(ii) such records are part of health in23 formation technology that is certified under 

24 section 3001(c)(5) of the Public Health 

25 Service Act; and 
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1 ‘‘(iii) such function is not intended to 

2 interpret or analyze patient records, includ3 ing medical image data, for the purpose of 

4 the diagnosis, cure, mitigation, prevention, 

5 or treatment of a disease or condition; 

6 ‘‘(D) for transferring, storing, converting 

7 formats, or displaying clinical laboratory test or 

8 other device data and results, findings by a 

9 health care professional with respect to such data 

10 and results, general information about such find11 ings, and general background information about 

12 such laboratory test or other device, unless such 

13 function is intended to interpret or analyze clin14 ical laboratory test or other device data, results, 

15 and findings; or 

16 ‘‘(E) unless the function is intended to ac17 quire, process, or analyze a medical image or a 

18 signal from an in vitro diagnostic device or a 

19 pattern or signal from a signal acquisition sys20 tem, for the purpose of— 

21 ‘‘(i) displaying, analyzing, or printing 

22 medical information about a patient or 

23 other medical information (such as peer-re24 viewed clinical studies and clinical practice 

25 guidelines); 
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1 ‘‘(ii) supporting or providing rec2 ommendations to a health care professional 

3 about prevention, diagnosis, or treatment of 

4 a disease or condition; and 

5 ‘‘(iii) enabling such health care profes6 sional to independently review the basis for 

7 such recommendations that such software 

8 presents so that it is not the intent that 

9 such health care professional rely primarily 

10 on any of such recommendations to make a 

11 clinical diagnosis or treatment decision re12 garding an individual patient. 

13 ‘‘(2) In the case of a product with multiple func14 tions that contains— 

15 ‘‘(A) at least one software function that 

16 meets the criteria under paragraph (1) or that 

17 otherwise does not meet the definition of device 

18 under section 201(h); and 

19 ‘‘(B) at least one function that does not 

20 meet the criteria under paragraph (1) and that 

21 otherwise meets the definition of a device under 

22 section 201(h), 

23 the Secretary shall not regulate the software function 

24 of such product described in subparagraph (A) as a 

25 device. Notwithstanding the preceding sentence, when 
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1 assessing the safety and effectiveness of the device 

2 function or functions of such product described in 

3 subparagraph (B), the Secretary may assess the im4 pact that the software function or functions described 

5 in subparagraph (A) have on such device function or 

6 functions. 

7 ‘‘(3)(A) Notwithstanding paragraph (1), a soft8 ware function described in subparagraph (C), (D), or 

9 (E) of paragraph (1) shall not be excluded from the 

10 definition of device under section 201(h) if— 

11 ‘‘(i) the Secretary makes a finding that use 

12 of such software function would be reasonably 

13 likely to have serious adverse health con14 sequences; and 

15 ‘‘(ii) the software function has been identi16 fied in a final order issued by the Secretary 

17 under subparagraph (B). 

18 ‘‘(B) Subparagraph (A) shall apply only if the 

19 Secretary— 

20 ‘‘(i) publishes a notification and proposed 

21 order in the Federal Register; 

22 ‘‘(ii) includes in such notification the Sec23 retary’s finding, including the rationale and 

24 identification of the evidence on which such find-
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1 ing was based, as described in subparagraph 

2 (A)(i); and 

3 ‘‘(iii) provides for a period of not less than 

4 30 calendar days for public comment before 

5 issuing a final order or withdrawing such pro6 posed order. 

7 ‘‘(C) In making a finding under subparagraph 

8 (A)(i) with respect to a software function, the Sec9 retary shall consider— 

10 ‘‘(i) the likelihood and severity of patient 

11 harm if the software function were to not per12 form as intended; 

13 ‘‘(ii) the extent to which the software func14 tion is intended to support the clinical judgment 

15 of a health care professional; 

16 ‘‘(iii) whether there is a reasonable oppor17 tunity for a health care professional to review 

18 the basis of the information or treatment rec19 ommendation provided by the software function; 

20 and 

21 ‘‘(iv) the intended user and user environ22 ment, such as whether a health care professional 

23 will use a software function of a type described 

24 in subparagraph (E) of paragraph (1). 
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1 ‘‘(4) Nothing in this subsection shall be construed 

2 as limiting the authority of the Secretary to— 

3 ‘‘(A) exercise enforcement discretion as to 

4 any device subject to regulation under this Act; 

5 ‘‘(B) regulate software used in the manufac6 ture and transfusion of blood and blood compo7 nents to assist in the prevention of disease in hu8 mans; or 

9 ‘‘(C) regulate software as a device under 

10 this Act if such software meets the criteria under 

11 section 513(a)(1)(C).’’. 

12 (b) REPORTS.—The Secretary of Health and Human 

13 Services (referred to in this subsection as the ‘‘Secretary’’), 

14 after consultation with agencies and offices of the Depart15 ment of Health and Human Services involved in health in16 formation technology, shall publish a report, not later than 

17 2 years after the date of enactment of this Act and every 

18 2 years thereafter, that— 

19 (1) includes input from outside experts, such as 

20 representatives of patients, consumers, health care 

21 providers, startup companies, health plans or other 

22 third-party payers, venture capital investors, infor23 mation technology vendors, health information tech24 nology vendors, small businesses, purchasers, employ-
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1 ers, and other stakeholders with relevant expertise, as 

2 determined by the Secretary; 

3 (2) examines information available to the Sec4 retary on any risks and benefits to health associated 

5 with software functions described in section 520(o)(1) 

6 of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360j) (as amended by subsection (a)); and 

8 (3) summarizes findings regarding the impact of 

9 such software functions on patient safety, including 

10 best practices to promote safety, education, and com11 petency related to such functions. 

12 (c) CLASSIFICATION OF ACCESSORIES.—Section 

13 513(b) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 360c(b)) is amended by adding at the end the fol15 lowing: 

16 ‘‘(9) The Secretary shall classify an accessory under 

17 this section based on the intended use of the accessory, not18 withstanding the classification of any other device with 

19 which such accessory is intended to be used.’’. 

20 (d) CONFORMING AMENDMENT.—Section 201(h) of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) 

22 is amended by adding at the end the following: ‘‘The term 

23 ‘device’ does not include software functions excluded pursu24 ant to section 520(o).’’. 
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1 Subtitle G—Improving Scientific 

2 Expertise and Outreach at FDA 

3 SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RE4 SEARCH AND BIOMEDICAL PRODUCT ASSESS5 MENT SERVICE. 

6 (a) HIRING AND RETENTION AUTHORITY.—Section 

7 228 of the Public Health Service Act (42 U.S.C. 237) is 

8 amended— 

9 (1) in the section heading, by inserting ‘‘AND

10 BIOMEDICAL PRODUCT ASSESSMENT’’ after ‘‘RE11 SEARCH’’; 

12 (2) in subsection (a)— 

13 (A) in paragraph (1), by striking ‘‘Silvio O. 

14 Conte Senior Biomedical Research Service, not 

15 to exceed 500 members’’ and inserting ‘‘Silvio O. 

16 Conte Senior Biomedical Research and Bio17 medical Product Assessment Service (in this sec18 tion referred to as the ‘Service’), not to exceed 

19 2,000 members, the purpose of which is to recruit 

20 and retain outstanding and qualified scientific 

21 and technical experts in the fields of biomedical 

22 research, clinical research evaluation, and bio23 medical product assessment’’; 

24 (B) by amending paragraph (2) to read as 

25 follows: 
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1 ‘‘(2) The authority established in paragraph (1) may 

2 not be construed to require the Secretary to reduce the num3 ber of employees serving under any other employment sys4 tem in order to offset the number of members serving in 

5 the Service.’’; and 

6 (C) by adding at the end the following: 

7 ‘‘(3) The Secretary shall assign experts under this sec8 tion to agencies within the Department of Health and 

9 Human Services taking into account the need for the exper10 tise of such expert.’’; 

11 (3) in subsection (b)— 

12 (A) in the matter preceding paragraph (1), 

13 by striking ‘‘or clinical research evaluation’’ and 

14 inserting ‘‘, clinical research evaluation, or bio15 medical product assessment’’; and 

16 (B) in paragraph (1), by inserting ‘‘or a 

17 doctoral or master’s level degree in engineering, 

18 bioinformatics, or a related or emerging field,’’ 

19 after the comma; 

20 (4) in subsection (d)(2), by striking ‘‘and shall 

21 not exceed the rate payable for level I of the Executive 

22 Schedule unless approved by the President under sec23 tion 5377(d)(2) of title 5, United States Code’’ and 

24 inserting ‘‘and shall not exceed the amount of annual 
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1 compensation (excluding expenses) specified in section 

2 102 of title 3, United States Code’’; 

3 (5) by striking subsection (e); and 

4 (6) by redesignating subsections (f) and (g) as 

5 subsections (e) and (f), respectively. 

6 (b) GAO STUDY.— 

7 (1) IN GENERAL.—The Comptroller General of 

8 the United States shall conduct a study of the effec9 tiveness of the amendments to section 228 of the Pub10 lic Health Service Act (42 U.S.C. 237) made by sub11 section (a) and the impact of such amendments, if 

12 any, on all agencies or departments of the Depart13 ment of Health and Human Services, and, not later 

14 than 4 years after the date of enactment of this Act, 

15 shall submit a report based on such study to the Com16 mittee on Health, Education, Labor, and Pensions of 

17 the Senate and the Committee on Energy and Com18 merce of the House of Representatives. 

19 (2) CONTENT OF STUDY AND REPORT.—The 

20 study and report under paragraph (1) shall include 

21 an examination of the extent to which recruitment 

22 and retention of outstanding and qualified scientific, 

23 medical, or technical experts in the fields of bio24 medical research, clinical research evaluation, and 

25 biomedical product assessment have improved or oth-
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1 erwise have been affected by the amendments to sec2 tion 228 of the Public Health Service Act (42 U.S.C. 

3 237) made by subsection (a), including by deter4 mining, during the period between the date of enact5 ment of this Act and the completion of the study— 

6 (A) the total number of members recruited 

7 and retained under the Senior Biomedical Re8 search and Biomedical Product Assessment Serv9 ice under such section 228, and the effect of in10 creasing the number of members eligible for such 

11 Service; 

12 (B) the number of members of such Senior 

13 Biomedical Research and Biomedical Product 

14 Assessment Service hired with a doctoral level 

15 degree in biomedicine or a related field, and the 

16 number of such members hired with a doctoral or 

17 master’s level degree in engineering, 

18 bioinformatics, or a related or emerging field; 

19 and 

20 (C) the number of Senior Biomedical Re21 search and Biomedical Product Assessment Serv22 ice members that have been hired by each agency 

23 or department of the Department of Health and 

24 Human Services, and how such Department as-
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1 signs such members to each agency or depart2 ment. 

3 SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECH4 NICAL, AND PROFESSIONAL PERSONNEL. 

5 (a) IN GENERAL.—The Federal Food, Drug, and Cos6 metic Act is amended by inserting after section 714 (21 

7 U.S.C. 379d–3) the following: 

8 ‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECH9 NICAL, AND PROFESSIONAL PERSONNEL. 

10 ‘‘(a) IN GENERAL.—The Secretary may, notwith11 standing title 5, United States Code, governing appoint12 ments in the competitive service, appoint outstanding and 

13 qualified candidates to scientific, technical, or professional 

14 positions that support the development, review, and regula15 tion of medical products. Such positions shall be within the 

16 competitive service. 

17 ‘‘(b) COMPENSATION.— 

18 ‘‘(1) IN GENERAL.—Notwithstanding any other 

19 provision of law, including any requirement with re20 spect to General Schedule pay rates under subchapter 

21 III of chapter 53 of title 5, United States Code, and 

22 consistent with the requirements of paragraph (2), the 

23 Commissioner of Food and Drugs may determine and 

24 set— 
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1 ‘‘(A) the annual rate of pay of any indi2 vidual appointed under subsection (a); and 

3 ‘‘(B) for purposes of retaining qualified em4 ployees, the annual rate of pay for any qualified 

5 scientific, technical, or professional personnel ap6 pointed to a position described in subsection (a) 

7 before the date of enactment of the 21st Century 

8 Cures Act. 

9 ‘‘(2) LIMITATION.—The annual rate of pay es10 tablished pursuant to paragraph (1) may not exceed 

11 the amount of annual compensation (excluding ex12 penses) specified in section 102 of title 3, United 

13 States Code. 

14 ‘‘(3) PUBLIC AVAILABILITY.—The annual rate of 

15 pay provided to an individual in accordance with 

16 this section shall be publicly available information. 

17 ‘‘(c) RULE OF CONSTRUCTION.—The authorities under 

18 this section shall not be construed to affect the authority 

19 provided under section 714. 

20 ‘‘(d) REPORT ON WORKFORCE PLANNING.— 

21 ‘‘(1) IN GENERAL.—Not later than 18 months 

22 after the date of enactment of the 21st Century Cures 

23 Act, the Secretary shall submit a report on workforce 

24 planning to the Committee on Health, Education, 

25 Labor, and Pensions of the Senate and the Committee 
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1 on Energy and Commerce of the House of Representa2 tives that examines the extent to which the Food and 

3 Drug Administration has a critical need for qualified 

4 individuals for scientific, technical, or professional 

5 positions, including— 

6 ‘‘(A) an analysis of the workforce needs at 

7 the Food and Drug Administration and the Sec8 retary’s strategic plan for addressing such needs, 

9 including through use of the authority under this 

10 section; and 

11 ‘‘(B) a recruitment and retention plan for 

12 hiring qualified scientific, technical, and profes13 sional candidates, which may include the use 

14 of— 

15 ‘‘(i) recruitment through nongovern16 mental recruitment or placement agencies; 

17 ‘‘(ii) recruitment through academic in18 stitutions; 

19 ‘‘(iii) recruitment or hiring bonuses, if 

20 applicable; 

21 ‘‘(iv) recruitment using targeted direct 

22 hiring authorities; and 

23 ‘‘(v) retention of qualified scientific, 

24 technical, and professional employees using 
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1 the authority under this section, or other 

2 applicable authorities of the Secretary. 

3 ‘‘(2) RECOMMENDATIONS.—The report under 

4 paragraph (1) may include the recommendations of 

5 the Commissioner of Food and Drugs that would help 

6 the Food and Drug Administration to better recruit 

7 and retain qualified individuals for scientific, tech8 nical, or professional positions at the agency.’’. 

9 (b) GAO STUDY AND REPORT.— 

10 (1) IN GENERAL.—The Comptroller General of 

11 the United States shall conduct a study of the ability 

12 of the Food and Drug Administration to hire, train, 

13 and retain qualified scientific, technical, and profes14 sional staff, not including contractors, necessary to 

15 fulfill the mission of the Food and Drug Administra16 tion to protect and promote public health. Not later 

17 than January 1, 2022, the Comptroller General shall 

18 submit a report on such study to the Committee on 

19 Health, Education, Labor, and Pensions of the Senate 

20 and the Committee on Energy and Commerce of the 

21 House of Representatives. 

22 (2) CONTENTS OF STUDY.—The Comptroller 

23 General shall include in the study and report under 

24 paragraph (1)— 
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1 (A) information about the progress of the 

2 Food and Drug Administration in recruiting 

3 and retaining qualified scientific, technical, and 

4 professional staff outstanding in the field of bio5 medical research, clinical research evaluation, 

6 and biomedical product assessment; 

7 (B) the extent to which critical staffing 

8 needs exist at the Food and Drug Administra9 tion, and barriers to hiring, training, and re10 taining qualified staff, if any; 

11 (C) an examination of the recruitment and 

12 retention strategies of the Food and Drug Ad13 ministration, including examining any strategic 

14 workforce plan, focused on improving scientific, 

15 technical, and professional staff recruitment and 

16 retention; and 

17 (D) recommendations for potential improve18 ments that would address staffing needs of the 

19 Food and Drug Administration. 

20 SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINIS21 TRATION INTERCENTER INSTITUTES. 

22 (a) IN GENERAL.—Chapter X of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended 

24 by adding at the end the following: 
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1 ‘‘SEC. 1014. FOOD AND DRUG ADMINISTRATION INTER2 CENTER INSTITUTES. 

3 ‘‘(a) IN GENERAL.—The Secretary shall establish one 

4 or more Intercenter Institutes within the Food and Drug 

5 Administration (referred to in this section as an ‘Institute’) 

6 for a major disease area or areas. With respect to the major 

7 disease area of focus of an Institute, such Institute shall 

8 develop and implement processes for coordination of activi9 ties, as applicable to such major disease area or areas, 

10 among the Center for Drug Evaluation and Research, the 

11 Center for Biologics Evaluation and Research, and the Cen12 ter for Devices and Radiological Health (for the purposes 

13 of this section, referred to as the ‘Centers’). Such activities 

14 may include— 

15 ‘‘(1) coordination of staff from the Centers with 

16 diverse product expertise in the diagnosis, cure, miti17 gation, treatment, or prevention of the specific dis18 eases relevant to the major disease area of focus of the 

19 Institute; 

20 ‘‘(2) streamlining, where appropriate, the review 

21 of medical products to diagnose, cure, mitigate, treat, 

22 or prevent the specific diseases relevant to the major 

23 disease area of focus of the Institute, applying rel24 evant standards under sections 505, 510(k), 513(f)(2), 

25 and 515 of this Act and section 351 of the Public 

26 Health Service Act, and other applicable authorities; 
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1 ‘‘(3) promotion of scientific programs within the 

2 Centers related to the major disease area of focus of 

3 the Institute; 

4 ‘‘(4) development of programs and enhancement 

5 of strategies to recruit, train, and provide continuing 

6 education opportunities for the personnel of the Cen7 ters with expertise related to the major disease area 

8 of focus of the Institute; 

9 ‘‘(5) enhancement of the interactions of the Cen10 ters with patients, sponsors, and the external bio11 medical community regarding the major disease area 

12 of focus of the Institute; and 

13 ‘‘(6) facilitation of the collaborative relationships 

14 of the Centers with other agencies within the Depart15 ment of Health and Human Services regarding the 

16 major disease area of focus of the Institute. 

17 ‘‘(b) PUBLIC PROCESS.—The Secretary shall provide 

18 a period for public comment during the time that each In19 stitute is being implemented. 

20 ‘‘(c) TIMING.—The Secretary shall establish at least 

21 one Institute under subsection (a) before the date that is 

22 1 year after the date of enactment of the 21st Century Cures 

23 Act. 

24 ‘‘(d) TERMINATION OF INSTITUTES.—The Secretary 

25 may terminate any Institute established pursuant to this 
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1 section if the Secretary determines such Institute is no 

2 longer benefitting the public health. Not less than 60 days 

3 prior to so terminating an Institute, the Secretary shall 

4 provide public notice, including the rationale for such ter5 mination.’’. 

6 (b) TECHNICAL AMENDMENTS.—Chapter X of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) 

8 is amended— 

9 (1) by redesignating section 1012 as section 

10 1013; and 

11 (2) by redesignating the second section 1011 

12 (with respect to improving the training of State, 

13 local, territorial, and tribal food safety officials), as 

14 added by section 209(a) of the FDA Food Safety Mod15 ernization Act (Public Law 111–353), as section 

16 1012. 

17 SEC. 3074. SCIENTIFIC ENGAGEMENT. 

18 (a) IN GENERAL.—Scientific meetings that are at19 tended by scientific or medical personnel, or other profes20 sionals, of the Department of Health and Human Services 

21 for whom attendance at such meeting is directly related to 

22 their professional duties and the mission of the Depart23 ment— 

24 (1) shall not be considered conferences for the 

25 purposes of complying with Federal reporting require-
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1 ments contained in annual appropriations Acts or in 

2 this section; and 

3 (2) shall not be considered conferences for pur4 poses of a restriction contained in an annual appro5 priations Act, based on Office of Management and 

6 Budget Memorandum M-12-12 or any other regula7 tion restricting travel to such meeting. 

8 (b) LIMITATION.—Nothing in this section shall be con9 strued to exempt travel for scientific meetings from Federal 

10 regulations relating to travel. 

11 (c) REPORTS.—Not later than 90 days after the end 

12 of the fiscal year, each operating division of the Department 

13 of Health and Human Services shall prepare, and post on 

14 an Internet website of the operating division, an annual 

15 report on scientific meeting attendance and related travel 

16 spending for each fiscal year. Such report shall include— 

17 (1) general information concerning the scientific 

18 meeting activities involved; 

19 (2) information concerning the total amount ex20 pended for such meetings; 

21 (3) a description of all such meetings that were 

22 attended by scientific or medical personnel, or other 

23 professionals, of each such operating division where 

24 the total amount expended by the operating division 
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1 associated with each such meeting were in excess of 

2 $30,000, including— 

3 (A) the total amount of meeting expenses 

4 incurred by the operating division for such meet5 ing; 

6 (B) the location of such meeting; 

7 (C) the date of such meeting; 

8 (D) a brief explanation on how such meet9 ing advanced the mission of the operating divi10 sion; and 

11 (E) the total number of individuals whose 

12 travel expenses or other scientific meeting ex13 penses were paid by the operating division; and 

14 (4) with respect to any such meeting where the 

15 total expenses to the operating division exceeded 

16 $150,000, a description of the exceptional cir17 cumstances that necessitated the expenditure of such 

18 amounts. 

19 SEC. 3075. DRUG SURVEILLANCE. 

20 (a) NEW DRUGS.—Section 505(k)(5) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as 

22 amended by section 2074, is further amended— 

23 (1) in subparagraph (A), by striking ‘‘, bi-weekly 

24 screening’’ and inserting ‘‘screenings’’; 
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1 (2) in subparagraph (B), as redesignated by sec2 tion 2074(1)(C), by striking the period at the end and 

3 inserting ‘‘; and’’; and 

4 (3) by adding at the end the following: 

5 ‘‘(C) make available on the Internet website of 

6 the Food and Drug Administration— 

7 ‘‘(i) guidelines, developed with input from 

8 experts qualified by scientific training and expe9 rience to evaluate the safety and effectiveness of 

10 drugs, that detail best practices for drug safety 

11 surveillance using the Adverse Event Reporting 

12 System; and 

13 ‘‘(ii) criteria for public posting of adverse 

14 event signals.’’. 

15 (b) FAERS REVISION.—Section 505(r)(2)(D) of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 355(r)(2)(D)) is amended by striking ‘‘, by 18 months’’ and 

18 all that follows through the semicolon at the end of the sub19 paragraph and inserting ‘‘and making publicly available 

20 on the Internet website established under paragraph (1) best 

21 practices for drug safety surveillance activities for drugs 

22 approved under this section or section 351 of the Public 

23 Health Service Act;’’. 
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1 (c) RISK EVALUATION AND MITIGATION STRATE2 GIES.—Section 505–1(f)(5) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355–1(f)(5)) is amended— 

4 (1) in the matter preceding subparagraph (A), 

5 by inserting ‘‘or other advisory committee’’ after ‘‘(or 

6 successor committee)’’; and 

7 (2) in subparagraph (B), by striking ‘‘at least 

8 annually,’’ and inserting ‘‘periodically’’. 

9 SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD 

10 AND DRUG ADMINISTRATION. 

11 (a) BOARD OF DIRECTORS.— 

12 (1) COMPOSITION AND SIZE.—Section 

13 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 379dd(d)(1)(C)) is amended— 

15 (A) by redesignating clause (ii) as clause 

16 (iii); 

17 (B) by inserting after clause (i) the fol18 lowing: 

19 ‘‘(ii) ADDITIONAL MEMBERS.—The 

20 Board, through amendments to the bylaws 

21 of the Foundation, may provide that the 

22 number of voting members of the Board 

23 shall be a number (to be specified in such 

24 amendment) greater than 14. Any Board 

25 positions that are established by any such 
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1 amendment shall be appointed (by majority 

2 vote) by the individuals who, as of the date 

3 of such amendment, are voting members of 

4 the Board and persons so appointed may 

5 represent any of the categories specified in 

6 subclauses (I) through (V) of clause (i), so 

7 long as no more than 30 percent of the total 

8 voting members of the Board (including 

9 members whose positions are established by 

10 such amendment) are representatives of the 

11 general pharmaceutical, device, food, cos12 metic, and biotechnology industries.’’; and 

13 (C) in clause (iii)(I), as redesignated by 

14 subparagraph (A), by striking ‘‘The ex officio 

15 members shall ensure’’ and inserting ‘‘The ex 

16 officio members, acting pursuant to clause (i), 

17 and the Board, acting pursuant to clause (ii), 

18 shall ensure’’. 

19 (2) FEDERAL EMPLOYEES ALLOWED TO SERVE

20 ON BOARD.—Clause (iii)(II) of section 770(d)(1)(C) of 

21 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 379dd(d)(1)(C)), as redesignated by paragraph 

23 (1)(A), is amended by adding at the end the fol24 lowing: ‘‘For purposes of this section, the term ‘em25 ployee of the Federal Government’ does not include a 
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1 special Government employee, as that term is defined 

2 in section 202(a) of title 18, United States Code.’’. 

3 (3) STAGGERED TERMS.—Subparagraph (A) of 

4 section 770(d)(3) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379dd(d)(3)) is amended to read 

6 as follows: 

7 ‘‘(A) TERM.—The term of office of each 

8 member of the Board appointed under para9 graph (1)(C)(i), and the term of office of any 

10 member of the Board whose position is estab11 lished pursuant to paragraph (1)(C)(ii), shall be 

12 4 years, except that— 

13 ‘‘(i) the terms of offices for the members 

14 of the Board initially appointed under 

15 paragraph (1)(C)(i) shall expire on a stag16 gered basis as determined by the ex officio 

17 members; and 

18 ‘‘(ii) the terms of office for the persons 

19 initially appointed to positions established 

20 pursuant to paragraph (1)(C)(ii) may be 

21 made to expire on a staggered basis, as de22 termined by the individuals who, as of the 

23 date of the amendment establishing such po24 sitions, are members of the Board.’’. 
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1 (b) EXECUTIVE DIRECTOR COMPENSATION.—Section 

2 770(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379dd(g)(2)) is amended by striking ‘‘but shall not 

4 be greater than the compensation of the Commissioner’’. 

5 (c) SEPARATION OF FUNDS.—Section 770(m) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 379dd(m)) is amended by striking ‘‘are held in separate 

8 accounts from funds received from entities under subsection 

9 (i)’’ and inserting ‘‘are managed as individual pro10 grammatic funds under subsection (i), according to best ac11 counting practices’’. 

12 Subtitle H—Medical 

13 Countermeasures Innovation 

14 SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES. 

15 Section 319F–2 of the Public Health Service Act (42 

16 U.S.C. 247d–6b) is amended— 

17 (1) in subsection (a), by adding at the end the 

18 following: 

19 ‘‘(3) UTILIZATION GUIDELINES.—The Secretary 

20 shall ensure timely and accurate recommended utili21 zation guidelines for qualified countermeasures (as 

22 defined in section 319F–1), qualified pandemic and 

23 epidemic products (as defined in section 319F–3), 

24 and security countermeasures (as defined in sub-
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1 section (c)), including for such products in the stock2 pile.’’; and 

3 (2) in subsection (g)— 

4 (A) by amending paragraph (4) to read as 

5 follows: 

6 ‘‘(4) REPORT ON SECURITY COUNTERMEASURE

7 PROCUREMENT.—Not later than March 1 of each year 

8 in which the Secretary determines that the amount of 

9 funds available for procurement of security counter10 measures is less than $1,500,000,000, the Secretary 

11 shall submit to the Committee on Appropriations and 

12 the Committee on Health, Education, Labor, and 

13 Pensions of the Senate and the Committee on Appro14 priations and the Committee on Energy and Com15 merce of the House of Representatives a report detail16 ing the amount of such funds available for procure17 ment and the impact such amount of funding will 

18 have— 

19 ‘‘(A) in meeting the security countermeasure 

20 needs identified under this section; and 

21 ‘‘(B) on the annual Public Health Emer22 gency Medical Countermeasures Enterprise and 

23 Strategy Implementation Plan (pursuant to sec24 tion 2811(d)).’’. 
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1 SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY. 

2 (a) IN GENERAL.—Section 319F–2(g) of the Public 

3 Health Service Act (42 U.S.C. 247d–6b(g)) is amended by 

4 adding at the end the following: 

5 ‘‘(5) CLARIFICATION ON CONTRACTING AUTHOR6 ITY.—The Secretary, acting through the Director of 

7 the Biomedical Advanced Research and Development 

8 Authority, shall carry out the programs funded by the 

9 special reserve fund (for the procurement of security 

10 countermeasures under subsection (c) and for car11 rying out section 319L), including the execution of 

12 procurement contracts, grants, and cooperative agree13 ments pursuant to this section and section 319L.’’. 

14 (b) BARDA CONTRACTING AUTHORITY.—Section 

15 319L(c)(3) of the Public Health Service Act (42 U.S.C. 

16 247d–7c) is amended by inserting ‘‘, including the execution 

17 of procurement contracts, grants, and cooperative agree18 ments pursuant to this section’’ before the period. 

19 SEC. 3083. COUNTERMEASURE BUDGET PLAN. 

20 Section 2811(b)(7) of the Public Health Service Act 

21 (42 U.S.C. 300hh–10(b)(7)) is amended— 

22 (1) in the matter preceding subparagraph (A), 

23 by striking the first sentence and inserting ‘‘Develop, 

24 and update not later than March 1 of each year, a 

25 coordinated 5-year budget plan based on the medical 

26 countermeasure priorities described in subsection (d), 
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1 including with respect to chemical, biological, radio2 logical, and nuclear agent or agents that may present 

3 a threat to the Nation, including such agents that are 

4 novel or emerging infectious diseases, and the cor5 responding efforts to develop qualified counter6 measures (as defined in section 319F–1), security 

7 countermeasures (as defined in section 319F–2), and 

8 qualified pandemic or epidemic products (as defined 

9 in section 319F–3) for each such threat.’’; 

10 (2) in subparagraph (C), by striking ‘‘; and’’ 

11 and inserting a semicolon; 

12 (3) in subparagraph (D), by striking ‘‘to the ap13 propriate committees of Congress upon request.’’ and 

14 inserting ‘‘, not later than March 15 of each year, to 

15 the Committee on Appropriations and the Committee 

16 on Health, Education, Labor, and Pensions of the 

17 Senate and the Committee on Appropriations and the 

18 Committee on Energy and Commerce of the House of 

19 Representatives; and’’; and 

20 (4) by adding at the end the following: 

21 ‘‘(E) not later than March 15 of each year, 

22 be made publicly available in a manner that 

23 does not compromise national security.’’. 
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1 SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION. 

2 Section 319L(c)(4) of the Public Health Service Act 

3 (42 U.S.C. 247d–7e(c)(4)) is amended by adding at the end 

4 the following: 

5 ‘‘(E) MEDICAL COUNTERMEASURES INNOVA6 TION PARTNER.— 

7 ‘‘(i) IN GENERAL.—To support the 

8 purposes described in paragraph (2), the 

9 Secretary, acting through the Director of 

10 BARDA, may enter into an agreement (in11 cluding through the use of grants, contracts, 

12 cooperative agreements, or other trans13 actions as described in paragraph (5)) with 

14 an independent, nonprofit entity to— 

15 ‘‘(I) foster and accelerate the de16 velopment and innovation of medical 

17 countermeasures and technologies that 

18 may assist advanced research and the 

19 development of qualified counter20 measures and qualified pandemic or 

21 epidemic products, including through 

22 the use of strategic venture capital 

23 practices and methods; 

24 ‘‘(II) promote the development of 

25 new and promising technologies that 
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1 address urgent medical countermeasure 

2 needs, as identified by the Secretary; 

3 ‘‘(III) address unmet public 

4 health needs that are directly related to 

5 medical countermeasure requirements, 

6 such as novel antimicrobials for 

7 multidrug resistant organisms and 

8 multiuse platform technologies for 

9 diagnostics, prophylaxis, vaccines, and 

10 therapeutics; and 

11 ‘‘(IV) provide expert consultation 

12 and advice to foster viable medical 

13 countermeasure innovators, including 

14 helping qualified countermeasure 

15 innovators navigate unique industry 

16 challenges with respect to developing 

17 chemical, biological, radiological, and 

18 nuclear countermeasure products. 

19 ‘‘(ii) ELIGIBILITY.— 

20 ‘‘(I) IN GENERAL.—To be eligible 

21 to enter into an agreement under 

22 clause (i) an entity shall— 

23 ‘‘(aa) be an independent, 

24 nonprofit entity; 
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1 ‘‘(bb) have a demonstrated 

2 record of being able to create link3 ages between innovators and in4 vestors and leverage such partner5 ships and resources for the pur6 pose of addressing identified stra7 tegic needs of the Federal Govern8 ment; 

9 ‘‘(cc) have experience in pro10 moting novel technology innova11 tion; 

12 ‘‘(dd) be problem-driven and 

13 solution-focused based on the 

14 needs, requirements, and problems 

15 identified by the Secretary under 

16 clause (iv); 

17 ‘‘(ee) demonstrate the ability, 

18 or the potential ability, to pro19 mote the development of medical 

20 countermeasure products; 

21 ‘‘(ff) demonstrate expertise, 

22 or the capacity to develop or ac23 quire expertise, related to tech24 nical and regulatory consider-
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1 ations with respect to medical 

2 countermeasures; and 

3 ‘‘(gg) not be within the De4 partment of Health and Human 

5 Services. 

6 ‘‘(II) PARTNERING EXPERI7 ENCE.—In selecting an entity with 

8 which to enter into an agreement 

9 under clause (i), the Secretary shall 

10 place a high value on the demonstrated 

11 experience of the entity in partnering 

12 with the Federal Government to meet 

13 identified strategic needs. 

14 ‘‘(iii) NOT AGENCY.—An entity that 

15 enters into an agreement under clause (i) 

16 shall not be deemed to be a Federal agency 

17 for any purpose, including for any purpose 

18 under title 5, United States Code. 

19 ‘‘(iv) DIRECTION.—Pursuant to an 

20 agreement entered into under this subpara21 graph, the Secretary, acting through the Di22 rector of BARDA, shall provide direction to 

23 the entity that enters into an agreement 

24 under clause (i). As part of this agreement 

25 the Director of BARDA shall— 
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1 ‘‘(I) communicate the medical 

2 countermeasure needs, requirements, 

3 and problems to be addressed by the 

4 entity under the agreement; 

5 ‘‘(II) develop a description of 

6 work to be performed by the entity 

7 under the agreement; 

8 ‘‘(III) provide technical feedback 

9 and appropriate oversight over work 

10 carried out by the entity under the 

11 agreement, including subsequent devel12 opment and partnerships consistent 

13 with the needs and requirements set 

14 forth in this subparagraph; 

15 ‘‘(IV) ensure fair consideration of 

16 products developed under the agree17 ment in order to maintain competition 

18 to the maximum practical extent, as 

19 applicable and appropriate under ap20 plicable provisions of this section; and 

21 ‘‘(V) ensure, as a condition of the 

22 agreement that the entity— 

23 ‘‘(aa) has in place a com24 prehensive set of policies that 
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1 demonstrate a commitment to 

2 transparency and accountability; 

3 ‘‘(bb) protects against con4 flicts of interest through a com5 prehensive set of policies that ad6 dress potential conflicts of inter7 est, ethics, disclosure, and report8 ing requirements; 

9 ‘‘(cc) provides monthly ac10 counting on the use of funds pro11 vided under such agreement; and 

12 ‘‘(dd) provides on a quarterly 

13 basis, reports regarding the 

14 progress made toward meeting the 

15 identified needs set forth in the 

16 agreement. 

17 ‘‘(v) SUPPLEMENT NOT SUPPLANT.— 

18 Activities carried out under this subpara19 graph shall supplement, and not supplant, 

20 other activities carried out under this sec21 tion. 

22 ‘‘(vi) NO ESTABLISHMENT OF ENTI23 TY.—To prevent unnecessary duplication 

24 and target resources effectively, nothing in 

25 this subparagraph shall be construed to au-
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1 thorize the Secretary to establish within the 

2 Department of Health and Human Services 

3 an entity for the purposes of carrying out 

4 this subparagraph. 

5 ‘‘(vii) TRANSPARENCY AND OVER6 SIGHT.—Upon request, the Secretary shall 

7 provide to Congress the information pro8 vided to the Secretary under clause 

9 (iv)(V)(dd). 

10 ‘‘(viii) INDEPENDENT EVALUATION.— 

11 Not later than 4 years after the date of en12 actment of the 21st Century Cures Act, the 

13 Comptroller General of the United States 

14 shall conduct an independent evaluation, 

15 and submit to the Secretary and the appro16 priate committees of Congress a report, con17 cerning the activities conducted under this 

18 subparagraph. Such report shall include 

19 recommendations with respect to any agree20 ment or activities carried out pursuant to 

21 this subparagraph. 

22 ‘‘(ix) SUNSET.—This subparagraph 

23 shall have no force or effect after September 

24 30, 2022.’’. 
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1 SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCURE2 MENT. 

3 Section 319F–2(c) of the Public Health Service Act (42 

4 U.S.C. 247d–6b(c)) is amended— 

5 (1) in paragraph (4)(A)(ii), by striking ‘‘make a 

6 recommendation under paragraph (6) that the special 

7 reserve fund as defined in subsection (h) be made 

8 available for the procurement of such countermeasure’’ 

9 and inserting ‘‘and subject to the availability of ap10 propriations, make available the special reserve fund 

11 as defined in subsection (h) for procurement of such 

12 countermeasure, as applicable’’; 

13 (2) in paragraph (6)— 

14 (A) by striking subparagraphs (A), (B), and 

15 (E); 

16 (B) by redesignating subparagraphs (C) 

17 and (D) as subparagraphs (A) and (B), respec18 tively; 

19 (C) by amending subparagraph (A), as so 

20 redesignated, to read as follows: 

21 ‘‘(A) NOTICE TO APPROPRIATE CONGRES22 SIONAL COMMITTEES.—The Secretary shall no23 tify the Committee on Appropriations and the 

24 Committee on Health, Education, Labor, and 

25 Pensions of the Senate and the Committee on 

26 Appropriations and the Committee on Energy 
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1 and Commerce of the House of Representatives of 

2 each decision to make available the special re3 serve fund as defined in subsection (h) for pro4 curement of a security countermeasure, includ5 ing, where available, the number of, the nature 

6 of, and other information concerning potential 

7 suppliers of such countermeasure, and whether 

8 other potential suppliers of the same or similar 

9 countermeasures were considered and rejected for 

10 procurement under this section and the reasons 

11 for each such rejection.’’; and 

12 (D) in the heading, by striking ‘‘REC13 OMMENDATION FOR PRESIDENT’S APPROVAL’’ 

14 and inserting ‘‘RECOMMENDATIONS FOR PRO15 CUREMENT’’; and 

16 (3) in paragraph (7)— 

17 (A) by striking subparagraphs (A) and (B) 

18 and inserting the following: 

19 ‘‘(A) PAYMENTS FROM SPECIAL RESERVE

20 FUND.—The special reserve fund as defined in 

21 subsection (h) shall be available for payments 

22 made by the Secretary to a vendor for procure23 ment of a security countermeasure in accordance 

24 with the provisions of this paragraph.’’; and 
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1 (B) by redesignating subparagraph (C) as 

2 subparagraph (B). 

3 SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT 

4 PRESENT A NATIONAL SECURITY THREAT. 

5 Subchapter E of chapter V of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

7 by inserting after section 565 the following: 

8 ‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT9 MENTS FOR AGENTS THAT PRESENT NA10 TIONAL SECURITY THREATS. 

11 ‘‘(a) DEFINITIONS.—In this section: 

12 ‘‘(1) HUMAN DRUG APPLICATION.—The term 

13 ‘human drug application’ has the meaning given such 

14 term in section 735(1). 

15 ‘‘(2) PRIORITY REVIEW.—The term ‘priority re16 view’, with respect to a human drug application, 

17 means review and action by the Secretary on such 

18 application not later than 6 months after receipt by 

19 the Secretary of such application, as described in the 

20 Manual of Policies and Procedures in the Food and 

21 Drug Administration and goals identified in the let22 ters described in section 101(b) of the Food and Drug 

23 Administration Safety and Innovation Act. 

24 ‘‘(3) PRIORITY REVIEW VOUCHER.—The term 

25 ‘priority review voucher’ means a voucher issued by 
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•HR 34 EAH 

1 the Secretary to the sponsor of a material threat med2 ical countermeasure application that entitles the hold3 er of such voucher to priority review of a single 

4 human drug application submitted under section 

5 505(b)(1) or section 351(a) of the Public Health Serv6 ice Act after the date of approval of the material 

7 threat medical countermeasure application. 

8 ‘‘(4) MATERIAL THREAT MEDICAL COUNTER9 MEASURE APPLICATION.—The term ‘material threat 

10 medical countermeasure application’ means an appli11 cation that— 

12 ‘‘(A) is a human drug application for a 

13 drug intended for use— 

14 ‘‘(i) to prevent, or treat harm from a 

15 biological, chemical, radiological, or nuclear 

16 agent identified as a material threat under 

17 section 319F–2(c)(2)(A)(ii) of the Public 

18 Health Service Act; or 

19 ‘‘(ii) to mitigate, prevent, or treat 

20 harm from a condition that may result in 

21 adverse health consequences or death and 

22 may be caused by administering a drug, or 

23 biological product against such agent; and 

24 ‘‘(B) the Secretary determines eligible for 

25 priority review; 
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1 ‘‘(C) is approved after the date of enactment 

2 of the 21st Century Cures Act; and 

3 ‘‘(D) is for a human drug, no active ingre4 dient (including any ester or salt of the active 

5 ingredient) of which has been approved in any 

6 other application under section 505(b)(1) or sec7 tion 351(a) of the Public Health Service Act. 

8 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall award a 

10 priority review voucher to the sponsor of a material 

11 threat medical countermeasure application upon ap12 proval by the Secretary of such material threat med13 ical countermeasure application. 

14 ‘‘(2) TRANSFERABILITY.—The sponsor of a mate15 rial threat medical countermeasure application that 

16 receives a priority review voucher under this section 

17 may transfer (including by sale) the entitlement to 

18 such voucher to a sponsor of a human drug for which 

19 an application under section 505(b)(1) or section 

20 351(a) of the Public Health Service Act will be sub21 mitted after the date of the approval of the material 

22 threat medical countermeasure application. There is 

23 no limit on the number of times a priority review 

24 voucher may be transferred before such voucher is 

25 used. 
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1 ‘‘(3) NOTIFICATION.— 

2 ‘‘(A) IN GENERAL.—The sponsor of a 

3 human drug application shall notify the Sec4 retary not later than 90 calendar days prior to 

5 submission of the human drug application that 

6 is the subject of a priority review voucher of an 

7 intent to submit the human drug application, 

8 including the date on which the sponsor intends 

9 to submit the application. Such notification 

10 shall be a legally binding commitment to pay for 

11 the user fee to be assessed in accordance with this 

12 section. 

13 ‘‘(B) TRANSFER AFTER NOTICE.—The spon14 sor of a human drug application that provides 

15 notification of the intent of such sponsor to use 

16 the voucher for the human drug application 

17 under subparagraph (A) may transfer the vouch18 er after such notification is provided, if such 

19 sponsor has not yet submitted the human drug 

20 application described in the notification. 

21 ‘‘(c) PRIORITY REVIEW USER FEE.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall establish 

23 a user fee program under which a sponsor of a 

24 human drug application that is the subject of a pri25 ority review voucher shall pay to the Secretary a fee 
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•HR 34 EAH 

1 determined under paragraph (2). Such fee shall be in 

2 addition to any fee required to be submitted by the 

3 sponsor under chapter VII. 

4 ‘‘(2) FEE AMOUNT.—The amount of the priority 

5 review user fee shall be determined each fiscal year by 

6 the Secretary and based on the average cost incurred 

7 by the agency in the review of a human drug applica8 tion subject to priority review in the previous fiscal 

9 year. 

10 ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall 

11 establish, before the beginning of each fiscal year be12 ginning after September 30, 2016, for that fiscal year, 

13 the amount of the priority review user fee. 

14 ‘‘(4) PAYMENT.— 

15 ‘‘(A) IN GENERAL.—The priority review 

16 user fee required by this subsection shall be due 

17 upon the submission of a human drug applica18 tion under section 505(b)(1) or section 351(a) of 

19 the Public Health Service Act for which the pri20 ority review voucher is used. 

21 ‘‘(B) COMPLETE APPLICATION.—An appli22 cation described under subparagraph (A) for 

23 which the sponsor requests the use of a priority 

24 review voucher shall be considered incomplete if 

25 the fee required by this subsection and all other 
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1 applicable user fees are not paid in accordance 

2 with the Secretary’s procedures for paying such 

3 fees. 

4 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC5 TIONS, OR REFUNDS.—The Secretary may not 

6 grant a waiver, exemption, reduction, or refund 

7 of any fees due and payable under this section. 

8 ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected 

9 pursuant to this subsection for any fiscal year— 

10 ‘‘(A) shall be deposited and credited as off11 setting collections to the account providing ap12 propriations to the Food and Drug Administra13 tion; and 

14 ‘‘(6) shall not be collected for any fiscal year ex15 cept to the extent provided in advance in appropria16 tion Acts. 

17 ‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP18 PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 

19 shall publish a notice in the Federal Register and on the 

20 Internet website of the Food and Drug Administration not 

21 later than 30 calendar days after the occurrence of each of 

22 the following: 

23 ‘‘(1) The Secretary issues a priority review 

24 voucher under this section. 
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1 ‘‘(2) The Secretary approves a drug pursuant to 

2 an application submitted under section 505(b) of this 

3 Act or section 351(a) of the Public Health Service Act 

4 for which the sponsor of the application used a pri5 ority review voucher issued under this section. 

6 ‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 

7 in this section precludes a sponsor who seeks a priority re8 view voucher under this section from participating in any 

9 other incentive program, including under this Act, except 

10 that no sponsor of a material threat medical counter11 measure application may receive more than one priority 

12 review voucher issued under any section of this Act with 

13 respect to such drug. 

14 ‘‘(f) RELATION TO OTHER PROVISIONS.—The provi15 sions of this section shall supplement, not supplant, any 

16 other provisions of this Act or the Public Health Service 

17 Act that encourage the development of medical counter18 measures. 

19 ‘‘(g) SUNSET.—The Secretary may not award any pri20 ority review vouchers under subsection (b) after October 1, 

21 2023.’’. 
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1 SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A 

2 PUBLIC HEALTH EMERGENCY. 

3 Section 319 of the Public Health Service Act (42 

4 U.S.C. 247d) is amended by adding at the end the fol5 lowing: 

6 ‘‘(f) DETERMINATION WITH RESPECT TO PAPERWORK

7 REDUCTION ACT WAIVER DURING A PUBLIC HEALTH

8 EMERGENCY.— 

9 ‘‘(1) DETERMINATION.—If the Secretary deter10 mines, after consultation with such public health offi11 cials as may be necessary, that— 

12 ‘‘(A)(i) the criteria set forth for a public 

13 health emergency under paragraph (1) or (2) of 

14 subsection (a) has been met; or 

15 ‘‘(ii) a disease or disorder, including a 

16 novel and emerging public health threat, is sig17 nificantly likely to become a public health emer18 gency; and 

19 ‘‘(B) the circumstances of such public health 

20 emergency, or potential for such significantly 

21 likely public health emergency, including the spe22 cific preparation for and response to such public 

23 health emergency or threat, necessitate a waiver 

24 from the requirements of subchapter I of chapter 

25 35 of title 44, United States Code (commonly re26 ferred to as the Paperwork Reduction Act), 
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1 then the requirements of such subchapter I with re2 spect to voluntary collection of information shall not 

3 be applicable during the immediate investigation of, 

4 and response to, such public health emergency during 

5 the period of such public health emergency or the pe6 riod of time necessary to determine if a disease or dis7 order, including a novel and emerging public health 

8 threat, will become a public health emergency as pro9 vided for in this paragraph. The requirements of such 

10 subchapter I with respect to voluntary collection of 

11 information shall not be applicable during the imme12 diate postresponse review regarding such public health 

13 emergency if such immediate postresponse review does 

14 not exceed a reasonable length of time. 

15 ‘‘(2) TRANSPARENCY.—If the Secretary deter16 mines that a waiver is necessary under paragraph 

17 (1), the Secretary shall promptly post on the Internet 

18 website of the Department of Health and Human 

19 Services a brief justification for such waiver, the an20 ticipated period of time such waiver will be in effect, 

21 and the agencies and offices within the Department of 

22 Health and Human Services to which such waiver 

23 shall apply, and update such information posted on 

24 the Internet website of the Department of Health and 

25 Human Services, as applicable. 
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1 ‘‘(3) EFFECTIVENESS OF WAIVER.—Any waiver 

2 under this subsection shall take effect on the date on 

3 which the Secretary posts information on the Internet 

4 website as provided for in this subsection. 

5 ‘‘(4) TERMINATION OF WAIVER.—Upon deter6 mining that the circumstances necessitating a waiver 

7 under paragraph (1) no longer exist, the Secretary 

8 shall promptly update the Internet website of the De9 partment of Health and Human Services to reflect the 

10 termination of such waiver. 

11 ‘‘(5) LIMITATIONS.— 

12 ‘‘(A) PERIOD OF WAIVER.—The period of a 

13 waiver under paragraph (1) shall not exceed the 

14 period of time for the related public health emer15 gency, including a public health emergency de16 clared pursuant to subsection (a), and any im17 mediate postresponse review regarding the public 

18 health emergency consistent with the require19 ments of this subsection. 

20 ‘‘(B) SUBSEQUENT COMPLIANCE.—An ini21 tiative subject to a waiver under paragraph (1) 

22 that is ongoing after the date on which the waiv23 er expires, shall be subject to the requirements of 

24 subchapter I of chapter 35 of title 44, United 

25 States Code, and the Secretary shall ensure that 
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1 compliance with such requirements occurs in as 

2 timely a manner as possible based on the appli3 cable circumstances, but not to exceed 30 cal4 endar days after the expiration of the applicable 

5 waiver.’’. 

6 SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION 

7 EMERGENCY USE AUTHORIZATION. 

8 (a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR

9 USE IN EMERGENCIES.—Section 564 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend11 ed— 

12 (1) in subsection (a)(2)— 

13 (A) in subparagraph (A)— 

14 (i) by striking ‘‘or 515’’ and inserting 

15 ‘‘512, or 515’’; and 

16 (ii) by inserting ‘‘or conditionally ap17 proved under section 571 of this Act’’ after 

18 ‘‘Public Health Service Act’’; and 

19 (B) in subparagraph (B), by inserting 

20 ‘‘conditionally approved under section 571,’’ 

21 after ‘‘approved,’’ each place the term appears; 

22 (2) in subsection (b)(4), by striking the second 

23 comma after ‘‘determination’’; 
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1 (3) in subsection (e)(3)(B), by striking ‘‘section 

2 503(b)’’ and inserting ‘‘subsection (b) or (f) of section 

3 503 or under section 504’’; 

4 (4) in subsection (f)(2)— 

5 (A) by inserting ‘‘, or an animal to which,’’ 

6 after ‘‘to a patient to whom’’; and 

7 (B) by inserting ‘‘or by the veterinarian 

8 caring for such animal, as applicable’’ after ‘‘at9 tending physician’’; 

10 (5) in subsection (g)(1), by inserting ‘‘condi11 tional approval under section 571,’’ after ‘‘approval,’’; 

12 (6) in subsection (h)(1), by striking ‘‘or section 

13 520(g)’’and inserting ‘‘512(j), or 520(g)’’; and 

14 (7) in subsection (k), by striking ‘‘section 

15 520(g),’’and inserting ‘‘512(j), or 520(g)’’. 

16 (b) NEW ANIMAL DRUGS.—Section 512(a)(1) of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 360b(a)(1)) is amended— 

19 (1) in subparagraph (B), by striking ‘‘or’’ at the 

20 end; 

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

22 and inserting ‘‘; or’’; and 

23 (3) by inserting after subparagraph (C) the fol24 lowing: 
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1 ‘‘(D) there is in effect an authorization pursuant 

2 to section 564 with respect to such use or intended use 

3 of such drug, and such drug, its labeling, and such 

4 use conform to any conditions of such authorization.’’. 

5 (c) EMERGENCY USE OF MEDICAL PRODUCTS.—Sec6 tion 564A of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360bbb–3a) is amended— 

8 (1) in subsection (a)(1)(A), by inserting ‘‘, con9 ditionally approved under section 571,’’ after ‘‘chap10 ter’’; and 

11 (2) in subsection (d), by striking ‘‘sections 503(b) 

12 and 520(e)’’ and inserting ‘‘subsections (b) and (f) of 

13 section 503, section 504, and section 520(e)’’. 

14 (d) PRODUCTS HELD FOR EMERGENCY USE.—Section 

15 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 360bbb–3b(2)) is amended— 

17 (1) in subparagraph (A)— 

18 (A) by inserting ‘‘or conditionally approved 

19 under section 571 of this Act’’ after ‘‘Public 

20 Health Service Act’’; and 

21 (B) by striking ‘‘or 515’’ and inserting 

22 ‘‘512, or 515’’; and 

23 (2) in subparagraph (B), by striking ‘‘or 520’’ 

24 and inserting ‘‘512, or 520’’. 
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1 Subtitle I—Vaccine Access, 

2 Certainty, and Innovation 

3 SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES 

4 BY THE ADVISORY COMMITTEE ON IMMUNIZA5 TION PRACTICES. 

6 (a) CONSIDERATION OF NEW VACCINES.—Upon the li7 censure of any vaccine or any new indication for a vaccine, 

8 the Advisory Committee on Immunization Practices (in this 

9 section referred to as the ‘‘Advisory Committee’’) shall, as 

10 appropriate, consider the use of the vaccine at its next regu11 larly scheduled meeting. 

12 (b) ADDITIONAL INFORMATION.—If the Advisory Com13 mittee does not make a recommendation with respect to the 

14 use of a vaccine at the Advisory Committee’s first regularly 

15 scheduled meeting after the licensure of the vaccine or any 

16 new indication for the vaccine, the Advisory Committee 

17 shall provide an update on the status of such committee’s 

18 review. 

19 (c) CONSIDERATION FOR BREAKTHROUGH THERAPIES

20 AND FOR POTENTIAL USE DURING PUBLIC HEALTH EMER21 GENCY.—The Advisory Committee shall make recommenda22 tions with respect to the use of certain vaccines in a timely 

23 manner, as appropriate, including vaccines that— 

24 (1) are designated as a breakthrough therapy 

25 under section 506 of the Federal Food, Drug, and 
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1 Cosmetic Act (21 U.S.C. 356) and licensed under sec2 tion 351 of the Public Health Service Act (42 U.S.C. 

3 262); or 

4 (2) could be used in a public health emergency. 

5 (d) DEFINITION.—In this section, the terms ‘‘Advisory 

6 Committee on Immunization Practices’’ and ‘‘Advisory 

7 Committee’’ mean the Advisory Committee on Immuniza8 tion Practices established by the Secretary pursuant to sec9 tion 222 of the Public Health Service Act (42 U.S.C. 217a), 

10 acting through the Director of the Centers for Disease Con11 trol and Prevention.’’. 

12 SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF 

13 ADVISORY COMMITTEE ON IMMUNIZATION 

14 PRACTICES RECOMMENDATIONS. 

15 (a) REVIEW.—The Director of the Centers for Disease 

16 Control and Prevention shall conduct a review of the proc17 esses used by the Advisory Committee on Immunization 

18 Practices in formulating and issuing recommendations per19 taining to vaccines, including with respect to consistency. 

20 (b) CONSIDERATIONS.—The review under subsection 

21 (a) shall include an assessment of— 

22 (1) the criteria used to evaluate new and existing 

23 vaccines, including the identification of any areas for 

24 which flexibility in evaluating such criteria is nec25 essary and the reason for such flexibility; 
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1 (2) the Grading of Recommendations, Assess2 ment, Development, and Evaluation (GRADE) ap3 proach to the review and analysis of scientific and 

4 economic data, including the scientific basis for such 

5 approach; and 

6 (3) the extent to which the processes used by the 

7 work groups of the Advisory Committee on Immuni8 zation Practices are consistent among such groups, 

9 including the identification of reasons for any vari10 ation. 

11 (c) STAKEHOLDERS.—In carrying out the review 

12 under subsection (a), the Director of the Centers for Disease 

13 Control and Prevention shall solicit input from vaccine 

14 stakeholders. 

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

16 of enactment of this Act, the Director of the Centers for Dis17 ease Control and Prevention shall submit to the appropriate 

18 committees of the Congress, and make publicly available, 

19 a report on the results of the review under subsection (a), 

20 including any recommendations on improving the consist21 ency of the processes described in such subsection. 

22 (e) DEFINITION.—In this section, the term ‘‘Advisory 

23 Committee on Immunization Practices’’ means the Advi24 sory Committee on Immunization Practices established by 

25 the Secretary of Health and Human Services pursuant to 
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1 section 222 of the Public Health Service Act (42 U.S.C. 

2 217a), acting through the Director of the Centers for Disease 

3 Control and Prevention. 

4 SEC. 3093. ENCOURAGING VACCINE INNOVATION. 

5 (a) VACCINE MEETINGS.—The Director of the Centers 

6 for Disease Control and Prevention shall ensure that appro7 priate staff within the relevant centers and divisions of the 

8 Office of Infectious Diseases, and others, as appropriate, co9 ordinate with respect to the public health needs, epidemi10 ology, and program planning and implementation consid11 erations related to immunization, including with regard to 

12 meetings with stakeholders related to such topics. 

13 (b) REPORT ON VACCINE INNOVATION.— 

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

15 the date of enactment of this Act, the Secretary of 

16 Health and Human Services (referred to in this sec17 tion as the ‘‘Secretary’’), in collaboration with appro18 priate agencies or offices within the Department of 

19 Health and Human Services, including the National 

20 Institutes of Health, the Centers for Disease Control 

21 and Prevention, the Food and Drug Administration, 

22 and the Biomedical Advanced Research and Develop23 ment Authority, shall submit to the Committee on 

24 Health, Education, Labor, and Pensions of the Senate 

25 and the Committee on Energy and Commerce of the 
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1 House of Representatives, and post publicly on the 

2 Internet website of the Department of Health and 

3 Human Services, a report on ways to promote inno4 vation in the development of vaccines that minimize 

5 the burden of infectious disease. 

6 (2) CONTENTS.—The report described in para7 graph (1) shall review the current status of vaccine 

8 development and, as appropriate— 

9 (A) consider the optimal process to deter10 mine which vaccines would be beneficial to pub11 lic health and how information on such vaccines 

12 is disseminated to key stakeholders; 

13 (B) examine and identify whether obstacles 

14 exist that inhibit the development of beneficial 

15 vaccines; and 

16 (C) make recommendations about how best 

17 to remove any obstacles identified under sub18 paragraph (B) in order to promote and 

19 incentivize vaccine innovation and development. 

20 (3) CONSULTATION.—In preparing the report 

21 under this subsection, the Secretary may consult 

22 with— 

23 (A) representatives of relevant Federal agen24 cies and departments, including the Department 
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1 of Defense and the Department of Veterans Af2 fairs; 

3 (B) academic researchers; 

4 (C) developers and manufacturers of vac5 cines; 

6 (D) medical and public health practitioners; 

7 (E) representatives of patient, policy, and 

8 advocacy organizations; and 

9 (F) representatives of other entities, as the 

10 Secretary determines appropriate. 

11 (c) UPDATES RELATED TO MATERNAL IMMUNIZA12 TION.— 

13 (1) ADDITIONAL VACCINES.—Section 2114(e) of 

14 the Public Health Service Act (42 U.S.C. 300aa– 

15 14(e)) is amended by adding at the end the following: 

16 ‘‘(3) VACCINES RECOMMENDED FOR USE IN

17 PREGNANT WOMEN.—The Secretary shall revise the 

18 Vaccine Injury Table included in subsection (a), 

19 through the process described in subsection (c), to in20 clude vaccines recommended by the Centers for Dis21 ease Control and Prevention for routine administra22 tion in pregnant women and the information de23 scribed in subparagraphs (B) and (C) of paragraph 

24 (2) with respect to such vaccines.’’. 
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1 (2) PETITION CONTENT.—Section 2111 of the 

2 Public Health Service Act (42 U.S.C. 300aa–11) is 

3 amended by adding at the end the following: 

4 ‘‘(f) MATERNAL IMMUNIZATION.— 

5 ‘‘(1) IN GENERAL.—Notwithstanding any other 

6 provision of law, for purposes of this subtitle, both a 

7 woman who received a covered vaccine while pregnant 

8 and any child who was in utero at the time such 

9 woman received the vaccine shall be considered per10 sons to whom the covered vaccine was administered 

11 and persons who received the covered vaccine. 

12 ‘‘(2) DEFINITION.—As used in this subsection, 

13 the term ‘child’ shall have the meaning given that 

14 term by subsections (a) and (b) of section 8 of title 

15 1, United States Code, except that, for purposes of 

16 this subsection, such section 8 shall be applied as if 

17 the term ‘include’ in subsection (a) of such section 

18 were replaced with the term ‘mean’.’’. 

19 (3) PETITIONERS.—Section 2111(b)(2) of the 

20 Public Health Service Act (42 U.S.C. 300aa–11(b)(2)) 

21 is amended by adding ‘‘A covered vaccine adminis22 tered to a pregnant woman shall constitute more than 

23 one administration, one to the mother and one to each 

24 child (as such term is defined in subsection (f)(2)) 
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1 who was in utero at the time such woman was ad2 ministered the vaccine.’’ at the end. 

3 Subtitle J—Technical Corrections 

4 SEC. 3101. TECHNICAL CORRECTIONS. 

5 (a) FFDCA.— 

6 (1) REFERENCES.—Except as otherwise expressly 

7 provided, whenever in this subsection an amendment 

8 is expressed in terms of an amendment to a section 

9 or other provision, the reference shall be considered to 

10 be made to that section or other provision of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

12 seq.). 

13 (2) AMENDMENTS.— 

14 (A) PROHIBITED ACTS.—Section 301(r) (21 

15 U.S.C. 331(r)) is amended by inserting ‘‘, drug,’’ 

16 after ‘‘device’’ each place the term appears. 

17 (B) NEW DRUGS.—Section 505 (21 U.S.C. 

18 355) is amended— 

19 (i) in subsection (d), in the last sen20 tence, by striking ‘‘premarket approval’’ 

21 and inserting ‘‘marketing approval’’; and 

22 (ii) in subsection (q)(5)(A), by striking 

23 ‘‘subsection (b)(2) or (j) of the Act or 

24 351(k)’’ and inserting ‘‘subsection (b)(2) or 

25 (j) of this section or section 351(k)’’. 
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1 (C) RISK EVALUATION AND MITIGATION

2 STRATEGIES.—Section 505–1(h)(21 U.S.C. 355– 

3 1(h)) is amended— 

4 (i) in paragraph (2)(A)(iii)— 

5 (I) in the clause heading, by strik6 ing ‘‘LABEL’’ and inserting ‘‘LABEL7 ING’’; 

8 (II) by striking ‘‘label’’ each place 

9 the term appears and inserting ‘‘label10 ing’’; and 

11 (III) by striking ‘‘sponsor’’ and 

12 inserting ‘‘responsible person’’; and 

13 (ii) in paragraph (8), by striking ‘‘and 

14 (7).’’ and inserting ‘‘and (7)’’. 

15 (D) PEDIATRIC STUDY PLANS.—Section 

16 505B (21 U.S.C. 355c) is amended— 

17 (i) in subsection (e)— 

18 (I) in paragraph (2)— 

19 (aa) in subparagraph (A), by 

20 inserting ‘‘study’’ after ‘‘initial 

21 pediatric’’ each place the term ap22 pears; and 

23 (bb) in subparagraph (B), in 

24 the subparagraph heading, by 

25 striking ‘‘INITIAL PLAN’’ and in-
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1 serting ‘‘INITIAL PEDIATRIC

2 STUDY PLAN’’; 

3 (II) in paragraph (5), in the 

4 paragraph heading, by inserting 

5 ‘‘AGREED INITIAL PEDIATRIC STUDY’’ 

6 before ‘‘PLAN’’; and 

7 (III) in paragraph (6), by strik8 ing ‘‘agreed initial pediatric plan’’ 

9 and inserting ‘‘agreed initial pediatric 

10 study plan’’; and 

11 (ii) in subsection (f)(1), by inserting 

12 ‘‘and any significant amendments to such 

13 plans,’’ after ‘‘agreed initial pediatric study 

14 plans,’’. 

15 (E) DISCONTINUANCE OR INTERRUPTION IN

16 THE PRODUCTION OF LIVE-SAVING DRUGS.—Sec17 tion 506C (21 U.S.C. 356c) is amended— 

18 (i) in subsection (c), by striking ‘‘dis19 continuation’’ and inserting ‘‘discontinu20 ance’’; and 

21 (ii) in subsection (g)(1), by striking 

22 ‘‘section 505(j) that could help’’ and insert23 ing ‘‘section 505(j), that could help’’. 
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1 (F) ANNUAL REPORTING ON DRUG SHORT2 AGES.—Section 506C–1(a) (21 U.S.C. 331(a)) is 

3 amended, in the matter before paragraph (1)— 

4 (i) by striking ‘‘Not later than the end 

5 of calendar year 2013, and not later than 

6 the end of each calendar year thereafter,’’ 

7 and inserting ‘‘Not later than March 31 of 

8 each calendar year,’’; and 

9 (ii) by inserting ‘‘, with respect to the 

10 preceding calendar year,’’ after ‘‘a report’’. 

11 (G) DRUG SHORTAGE LIST.—Section 

12 506E(b)(3)(E) (21 U.S.C. 356e(b)(3)(E)) is 

13 amended by striking ‘‘discontinuation’’ and in14 serting ‘‘discontinuance’’. 

15 (H) INSPECTIONS OF ESTABLISHMENTS.— 

16 Section 510(h) (21 U.S.C. 360(h)) is amended— 

17 (i) in paragraph (4), in the matter 

18 preceding subparagraph (A), by striking 

19 ‘‘establishing the risk-based scheduled’’ and 

20 inserting ‘‘establishing a risk-based sched21 ule’’; and 

22 (ii) in paragraph (6)— 

23 (I) in subparagraph (A), by strik24 ing ‘‘fiscal’’ and inserting ‘‘calendar’’ 

25 each place the term appears; and 
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1 (II) in subparagraph (B), by 

2 striking ‘‘an active ingredient of a 

3 drug, a finished drug product, or an 

4 excipient of a drug’’ and inserting ‘‘an 

5 active ingredient of a drug or a fin6 ished drug product’’. 

7 (I) CLASSIFICATION OF DEVICES INTENDED

8 FOR HUMAN USE.—Section 513(f)(2)(A) (21 

9 U.S.C. 360c(f)(2)(A)) is amended— 

10 (i) in clause (i), by striking ‘‘within 

11 30 days’’; and 

12 (ii) in clause (iv), by striking ‘‘low13 moderate’’ and inserting ‘‘low to moderate’’. 

14 (J) PREMARKET APPROVAL.—Section 

15 515(a)(1) (21 U.S.C. 360e(a)(1)) is amended by 

16 striking ‘‘subject to a an order’’ and inserting 

17 ‘‘subject to an order’’. 

18 (K) PROGRAM TO IMPROVE THE DEVICE RE19 CALL SYSTEM.—Section 518A (21 U.S.C. 360h– 

20 1) is amended— 

21 (i) by striking subsection (c); and 

22 (ii) by redesignating subsection (d) as 

23 subsection (c). 

24 (L) UNIQUE DEVICE IDENTIFIER.—Section 

25 519(f) (21 U.S.C. 360i(f)) is amended by strik-
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1 ing ‘‘and life sustaining’’ and inserting ‘‘or life 

2 sustaining’’. 

3 (M) PRIORITY REVIEW TO ENCOURAGE

4 TREATMENTS FOR TROPICAL DISEASES.—Section 

5 524(c)(4)(A) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 360n(c)(4)(A)) is amended 

7 by striking ‘‘Services Act’’ and inserting ‘‘Serv8 ice Act’’. 

9 (N) PRIORITY REVIEW FOR QUALIFIED IN10 FECTIOUS DISEASE PRODUCTS.—Section 524A 

11 (21 U.S.C. 360n–1) is amended— 

12 (i) by striking ‘‘If the Secretary’’ and 

13 inserting the following: 

14 ‘‘(a) IN GENERAL.—If the Secretary’’; 

15 (ii) by striking ‘‘any’’ and inserting 

16 ‘‘the first’’; and 

17 (iii) by adding at the end the fol18 lowing: 

19 ‘‘(b) CONSTRUCTION.—Nothing in this section shall 

20 prohibit the Secretary from giving priority review to a 

21 human drug application or efficacy supplement submitted 

22 for approval under section 505(b) that otherwise meets the 

23 criteria for the Secretary to grant priority review.’’. 

24 (O) CONSULTATION WITH EXTERNAL EX25 PERTS ON RARE DISEASES, TARGETED THERA-
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1 PIES, AND GENETIC TARGETING OF TREAT2 MENTS.—Section 569(a)(2)(A) (21 U.S.C. 

3 360bbb–8(a)(2)(A)) is amended, in the first sen4 tence, by striking ‘‘subsection (c)’’ and inserting 

5 ‘‘subsection (b)’’. 

6 (P) OPTIMIZING GLOBAL CLINICAL

7 TRIALS.—Section 569A(c) (21 U.S.C. 360bbb– 

8 8a(c)) is amended by inserting ‘‘or under the 

9 Public Health Service Act’’ after ‘‘this Act’’. 

10 (Q) USE OF CLINICAL INVESTIGATION DATA

11 FROM OUTSIDE THE UNITED STATES.—Section 

12 569B (21 U.S.C. 360bbb–8b) is amended by 

13 striking ‘‘drug or device’’ and inserting ‘‘drug, 

14 biological product, or device’’ each place the term 

15 appears. 

16 (R) MEDICAL GASES DEFINITIONS.—Section 

17 575(1)(H) (21 U.S.C. 360ddd(1)(H)) is amend18 ed— 

19 (i) by inserting ‘‘for a new drug’’ after 

20 ‘‘any period of exclusivity’’; and 

21 (ii) by inserting ‘‘or any period of ex22 clusivity for a new animal drug under sec23 tion 512(c)(2)(F),’’ after ‘‘section 505A,’’. 
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1 (S) REGULATION OF MEDICAL GASES.—Sec2 tion 576(a) (21 U.S.C. 360ddd–1(a)) is amend3 ed— 

4 (i) in the matter preceding subpara5 graph (A) of paragraph (1), by inserting 

6 ‘‘who seeks to initially introduce or deliver 

7 for introduction a designated medical gas 

8 into interstate commerce’’ after ‘‘any per9 son’’; and 

10 (ii) in paragraph (3)— 

11 (I) in subparagraph (A)— 

12 (aa) in clause (i)(VIII), by 

13 inserting ‘‘for a new drug’’ after 

14 ‘‘any period of exclusivity’’; and 

15 (bb) in clause (ii), in the 

16 matter preceding subclause (I), by 

17 inserting ‘‘the’’ before ‘‘final use’’; 

18 and 

19 (II) in subparagraph (B)— 

20 (aa) in clause (i), by insert21 ing ‘‘for a new drug’’ after ‘‘any 

22 period of exclusivity’’; and 

23 (bb) in clause (ii), by insert24 ing a comma after ‘‘drug prod25 uct’’. 
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1 (T) INAPPLICABILITY OF DRUG FEES TO

2 DESIGNATED MEDICAL GASES.—Section 577 (21 

3 U.S.C. 360ddd–2) is amended by inserting ‘‘or 

4 740(a)’’ after ‘‘section 736(a)’’. 

5 (U) CONFLICTS OF INTEREST.—Section 

6 712(e)(1)(B) (21 U.S.C. 379d–1(e)(1)(B)) is 

7 amended by striking ‘‘services’’ and inserting 

8 ‘‘service’’. 

9 (V) AUTHORITY TO ASSESS AND USE BIO10 SIMILAR BIOLOGICAL PRODUCT FEES.—Section 

11 744H(a) (21 U.S.C. 379j–52(a)) is amended— 

12 (i) in paragraph (1)(A)(v), by striking 

13 ‘‘Biosimilars User Fee Act of 2012’’ and in14 serting ‘‘Biosimilar User Fee Act of 2012’’; 

15 and 

16 (ii) in paragraph (2)(B), by striking 

17 ‘‘Biosimilars User Fee Act of 2012’’ and in18 serting ‘‘Biosimilar User Fee Act of 2012’’. 

19 (W) REGISTRATION OF COMMERCIAL IM20 PORTERS.— 

21 (i) AMENDMENT.—Section 801(s)(2) 

22 (21 U.S.C. 381(s)(2)) is amended by adding 

23 at the end the following: 

24 ‘‘(D) EFFECTIVE DATE.—In establishing the 

25 effective date of the regulations under subpara-
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1 graph (A), the Secretary shall, in consultation 

2 with the Secretary of Homeland Security acting 

3 through U.S. Customs and Border Protection, as 

4 determined appropriate by the Secretary of 

5 Health and Human Services, provide a reason6 able period of time for an importer of a drug to 

7 comply with good importer practices, taking into 

8 account differences among importers and types 

9 of imports, including based on the level of risk 

10 posed by the imported product.’’. 

11 (ii) CONFORMING AMENDMENT.—Sec12 tion 714 of the Food and Drug Administra13 tion Safety and Innovation Act (Public 

14 Law 112–144; 126 Stat. 1074) is amended 

15 by striking subsection (d). 

16 (X) RECOGNITION OF FOREIGN GOVERN17 MENT INSPECTIONS.—Section 809(a)(2) (21 

18 U.S.C. 384e(a)(2)) is amended by striking ‘‘con19 duction’’ and inserting ‘‘conducting’’. 

20 (b) FDASIA.— 

21 (1) FINDINGS RELATING TO DRUG APPROVAL.— 

22 Section 901(a)(1)(A) of the Food and Drug Adminis23 tration Safety and Innovation Act (Public Law 112– 

24 144; 21 U.S.C. 356 note) is amended by striking ‘‘se-
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1 rious and life-threatening diseases’’ and inserting ‘‘se2 rious or life-threatening diseases’’. 

3 (2) REPORTING OF INCLUSION OF DEMOGRAPHIC

4 SUBGROUPS.—Section 907 of the Food and Drug Ad5 ministration Safety and Innovation Act (Public Law 

6 112–144; 126 Stat. 1092, 1093) is amended— 

7 (A) in the section heading, by striking 

8 ‘‘BIOLOGICS’’ in the heading and inserting 

9 ‘‘BIOLOGICAL PRODUCTS’’; and 

10 (B) in subsection (a)(2)(B), by striking 

11 ‘‘applications for new drug applications’’ and 

12 inserting ‘‘new drug applications’’. 

13 (3) COMBATING PRESCRIPTION DRUG ABUSE.— 

14 Section 1122 of the Food and Drug Administration 

15 Safety and Innovation Act (Public Law 112–144; 126 

16 Stat. 1112, 1113) is amended— 

17 (A) in subsection (a)(2), by striking 

18 ‘‘dependance’’ and inserting ‘‘dependence’’; and 

19 (B) in subsection (c), by striking ‘‘promul20 gate’’ and inserting ‘‘issue’’. 

21 SEC. 3102. COMPLETED STUDIES. 

22 The Federal Food, Drug, and Cosmetic Act is amend23 ed— 

24 (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))— 
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1 (A) in subparagraph (A), by inserting 

2 ‘‘and’’ after the semicolon; 

3 (B) by striking subparagraph (B); and 

4 (C) by redesignating subparagraph (C) as 

5 subparagraph (B); 

6 (2) in section 505A (21 U.S.C. 355a), by striking 

7 subsection (p); 

8 (3) in section 505B (21 U.S.C. 355c)— 

9 (A) by striking subsection (l); and 

10 (B) by redesignating subsection (m) as sub11 section (l); and 

12 (4) in section 523 (21 U.S.C. 360m), by striking 

13 subsection (d). 

14 TITLE IV—DELIVERY 

15 SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IM16 PROVING QUALITY OF CARE FOR PATIENTS. 

17 (a) IN GENERAL.—The Health Information Tech18 nology for Economic and Clinical Health Act (title XIII 

19 of division A of Public Law 111–5) is amended— 

20 (1) by adding at the end of part 1 of subtitle A 

21 the following: 

22 ‘‘SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IM23 PROVING QUALITY OF CARE FOR PATIENTS. 

24 ‘‘(a) REDUCTION IN BURDENS GOAL.—The Secretary 

25 of Health and Human Services (referred to in this section 
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1 as the ‘Secretary’), in consultation with providers of health 

2 services, health care suppliers of services, health care payers, 

3 health professional societies, health information technology 

4 developers, health care quality organizations, health care 

5 accreditation organizations, public health entities, States, 

6 and other appropriate entities, shall, in accordance with 

7 subsection (b)— 

8 ‘‘(1) establish a goal with respect to the reduction 

9 of regulatory or administrative burdens (such as doc10 umentation requirements) relating to the use of elec11 tronic health records; 

12 ‘‘(2) develop a strategy for meeting the goal es13 tablished under paragraph (1); and 

14 ‘‘(3) develop recommendations for meeting the 

15 goal established under paragraph (1). 

16 ‘‘(b) STRATEGY AND RECOMMENDATIONS.— 

17 ‘‘(1) IN GENERAL.—To achieve the goal estab18 lished under subsection (a)(1), the Secretary, in con19 sultation with the entities described in such sub20 section, shall, not later than 1 year after the date of 

21 enactment of the 21st Century Cures Act, develop a 

22 strategy and recommendations to meet the goal in ac23 cordance with this subsection. 

24 ‘‘(2) STRATEGY.—The strategy developed under 

25 paragraph (1) shall address the regulatory and ad-
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1 ministrative burdens (such as documentation require2 ments) relating to the use of electronic health records. 

3 Such strategy shall include broad public comment 

4 and shall prioritize— 

5 ‘‘(A)(i) incentives for meaningful use of cer6 tified EHR technology for eligible professionals 

7 and hospitals under sections 1848(a)(7) and 

8 1886(b)(3)(B)(ix), respectively, of the Social Se9 curity Act (42 U.S.C. 1395w–4(a)(7), 

10 1395ww(b)(3)(B)(ix)); 

11 ‘‘(ii) the program for making payments 

12 under section 1903(a)(3)(F) of the Social Secu13 rity Act (42 U.S.C. 1396b(a)(3)(F)) to encourage 

14 the adoption and use of certified EHR tech15 nology by Medicaid providers; 

16 ‘‘(iii) the Merit-based Incentive Payment 

17 System under section 1848(q) of the Social Secu18 rity Act (42 U.S.C. 1395w–4(q)); 

19 ‘‘(iv) alternative payment models (as de20 fined in section 1833(z)(3)(C) of the Social Secu21 rity Act (42 U.S.C. 1395l(z)(3)(C)); 

22 ‘‘(v) the Hospital Value-Based Purchasing 

23 Program under section 1886(o) of the Social Se24 curity Act (42 U.S.C. 1395ww(o)); and 
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1 ‘‘(vi) other value-based payment programs, 

2 as the Secretary determines appropriate; 

3 ‘‘(B) health information technology certifi4 cation; 

5 ‘‘(C) standards and implementation speci6 fications, as appropriate; 

7 ‘‘(D) activities that provide individuals ac8 cess to their electronic health information; 

9 ‘‘(E) activities related to protecting the pri10 vacy of electronic health information; 

11 ‘‘(F) activities related to protecting the se12 curity of electronic health information; 

13 ‘‘(G) activities related to facilitating health 

14 and clinical research; 

15 ‘‘(H) activities related to public health; 

16 ‘‘(I) activities related to aligning and sim17 plifying quality measures across Federal pro18 grams and other payers; 

19 ‘‘(J) activities related to reporting clinical 

20 data for administrative purposes; and 

21 ‘‘(K) other areas, as the Secretary deter22 mines appropriate. 

23 ‘‘(3) RECOMMENDATIONS.—The recommenda24 tions developed under paragraph (1) shall address— 
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1 ‘‘(A) actions that improve the clinical docu2 mentation experience; 

3 ‘‘(B) actions that improve patient care; 

4 ‘‘(C) actions to be taken by the Secretary 

5 and by other entities; and 

6 ‘‘(D) other areas, as the Secretary deter7 mines appropriate, to reduce the reporting bur8 den required of health care providers. 

9 ‘‘(4) FACA.—The Federal Advisory Committee 

10 Act (5 U.S.C. App.) shall not apply to the develop11 ment of the goal, strategies, or recommendations de12 scribed in this section. 

13 ‘‘(c) APPLICATION OF CERTAIN REGULATORY RE14 QUIREMENTS.—A physician (as defined in section 

15 1861(r)(1) of the Social Security Act), to the extent con16 sistent with applicable State law, may delegate electronic 

17 medical record documentation requirements specified in 

18 regulations promulgated by the Centers for Medicare & 

19 Medicaid Services to a person performing a scribe function 

20 who is not such physician if such physician has signed and 

21 verified the documentation.’’; and 

22 (2) in the table of contents in section 13001(b), 

23 by inserting after the item relating to section 13102 

24 the following: 

‘‘13103. Assisting doctors and hospitals in improving the quality and care for patients.’’. 
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1 (b) CERTIFICATION OF HEALTH INFORMATION TECH2 NOLOGY FOR MEDICAL SPECIALTIES AND SITES OF SERV3 ICE.—Section 3001(c)(5) of the Public Health Service Act 

4 (42 U.S.C. 300jj–11(c)(5)) is amended by adding at the end 

5 the following: 

6 ‘‘(C) HEALTH INFORMATION TECHNOLOGY

7 FOR MEDICAL SPECIALTIES AND SITES OF SERV8 ICE.— 

9 ‘‘(i) IN GENERAL.—The National Coor10 dinator shall encourage, keep, or recognize, 

11 through existing authorities, the voluntary 

12 certification of health information tech13 nology under the program developed under 

14 subparagraph (A) for use in medical spe15 cialties and sites of service for which no 

16 such technology is available or where more 

17 technological advancement or integration is 

18 needed. 

19 ‘‘(ii) SPECIFIC MEDICAL SPECIAL20 TIES.—The Secretary shall accept public 

21 comment on specific medical specialties and 

22 sites of service, in addition to those de23 scribed in clause (i), for the purpose of se24 lecting additional specialties and sites of 

25 service as necessary. 
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1 ‘‘(iii) HEALTH INFORMATION TECH2 NOLOGY FOR PEDIATRICS.—Not later than 

3 18 months after the date of enactment of the 

4 21st Century Cures Act, the Secretary, in 

5 consultation with relevant stakeholders, 

6 shall make recommendations for the vol7 untary certification of health information 

8 technology for use by pediatric health pro9 viders to support the health care of children. 

10 Not later than 2 years after the date of en11 actment of the 21st Century Cures Act, the 

12 Secretary shall adopt certification criteria 

13 under section 3004 to support the voluntary 

14 certification of health information tech15 nology for use by pediatric health providers 

16 to support the health care of children.’’. 

17 (c) MEANINGFUL USE STATISTICS.— 

18 (1) IN GENERAL.—Not later than 6 months after 

19 the date of enactment of this Act, the Secretary of 

20 Health and Human Services shall submit to the HIT 

21 Advisory Committee of the Office of the National Co22 ordinator for Health Information Technology, a re23 port concerning attestation statistics for the Medicare 

24 and Medicaid EHR Meaningful Use Incentive pro25 grams to assist in informing standards adoption and 
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1 related practices. Such statistics shall include attesta2 tion information delineated by State, including, to 

3 the extent practicable, the number of providers who 

4 did not meet the minimum criteria necessary to attest 

5 for the Medicare and Medicaid EHR Meaningful Use 

6 Incentive programs for a calendar year, and shall be 

7 made publicly available on the Internet website of the 

8 Secretary on at least a quarterly basis. 

9 (2) AUTHORITY TO ALTER FORMAT.—The Sec10 retary of Health and Human Services may alter the 

11 format of the reports on the attestation of eligible 

12 health care professionals following the first perform13 ance year of the Merit-based Incentive Payment Sys14 tem to account for changes arising from the imple15 mentation of such payment system. 

16 SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECU17 RITY, AND FUNCTIONALITY. 

18 (a) ENHANCEMENTS TO CERTIFICATION.—Section 

19 3001(c)(5) of the Public Health Service Act (42 U.S.C. 

20 300jj–11), as amended by section 4001(b), is further amend21 ed by adding at the end the following: 

22 ‘‘(D) CONDITIONS OF CERTIFICATION.—Not 

23 later than 1 year after the date of enactment of 

24 the 21st Century Cures Act, the Secretary, 

25 through notice and comment rulemaking, shall 
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1 require, as a condition of certification and 

2 maintenance of certification for programs main3 tained or recognized under this paragraph, con4 sistent with other conditions and requirements 

5 under this title, that the health information tech6 nology developer or entity— 

7 ‘‘(i) does not take any action that con8 stitutes information blocking as defined in 

9 section 3022(a); 

10 ‘‘(ii) provides assurances satisfactory 

11 to the Secretary that such developer or enti12 ty, unless for legitimate purposes specified 

13 by the Secretary, will not take any action 

14 described in clause (i) or any other action 

15 that may inhibit the appropriate exchange, 

16 access, and use of electronic health informa17 tion; 

18 ‘‘(iii) does not prohibit or restrict com19 munication regarding— 

20 ‘‘(I) the usability of the health in21 formation technology; 

22 ‘‘(II) the interoperability of the 

23 health information technology; 

24 ‘‘(III) the security of the health 

25 information technology; 
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1 ‘‘(IV) relevant information re2 garding users’ experiences when using 

3 the health information technology; 

4 ‘‘(V) the business practices of de5 velopers of health information tech6 nology related to exchanging electronic 

7 health information; and 

8 ‘‘(VI) the manner in which a user 

9 of the health information technology 

10 has used such technology; 

11 ‘‘(iv) has published application pro12 gramming interfaces and allows health in13 formation from such technology to be 

14 accessed, exchanged, and used without spe15 cial effort through the use of application 

16 programming interfaces or successor tech17 nology or standards, as provided for under 

18 applicable law, including providing access 

19 to all data elements of a patient’s electronic 

20 health record to the extent permissible under 

21 applicable privacy laws; 

22 ‘‘(v) has successfully tested the real 

23 world use of the technology for interoper24 ability (as defined in section 3000) in the 
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1 type of setting in which such technology 

2 would be marketed; 

3 ‘‘(vi) provides to the Secretary an at4 testation that the developer or entity— 

5 ‘‘(I) has not engaged in any of the 

6 conduct described in clause (i); 

7 ‘‘(II) has provided assurances sat8 isfactory to the Secretary in accord9 ance with clause (ii); 

10 ‘‘(III) does not prohibit or restrict 

11 communication as described in clause 

12 (iii); 

13 ‘‘(IV) has published information 

14 in accordance with clause (iv); 

15 ‘‘(V) ensures that its technology 

16 allows for health information to be ex17 changed, accessed, and used, in the 

18 manner described in clause (iv); and 

19 ‘‘(VI) has undertaken real world 

20 testing as described in clause (v); and 

21 ‘‘(vii) submits reporting criteria in ac22 cordance with section 3009A(b).’’. 

23 ‘‘(E) COMPLIANCE WITH CONDITIONS OF

24 CERTIFICATION.—The Secretary may encourage 

25 compliance with the conditions of certification 
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1 described in subparagraph (D) and take action 

2 to discourage noncompliance, as appropriate.’’. 

3 (b) EHR SIGNIFICANT HARDSHIP EXCEPTION.— 

4 (1) APPLICATION TO ELIGIBLE PROFES5 SIONALS.— 

6 (A) IN CASE OF DECERTIFICATION.—Section 

7 1848(a)(7)(B) of the Social Security Act (42 

8 U.S.C. 1395w–4(a)(7)(B)) is amended by insert9 ing after the first sentence the following new sen10 tence: ‘‘The Secretary shall exempt an eligible 

11 professional from the application of the payment 

12 adjustment under subparagraph (A) with respect 

13 to a year, subject to annual renewal, if the Sec14 retary determines that compliance with the re15 quirement for being a meaningful EHR user is 

16 not possible because the certified EHR technology 

17 used by such professional has been decertified 

18 under a program kept or recognized pursuant to 

19 section 3001(c)(5) of the Public Health Service 

20 Act.’’. 

21 (B) CONTINUED APPLICATION UNDER

22 MIPS.—Section 1848(o)(2)(D) of the Social Secu23 rity Act (42 U.S.C. 1395w–4(o)(2)(D)) is 

24 amended by adding at the end the following new 

25 sentence: ‘‘The provisions of subparagraphs (B) 
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1 and (D) of subsection (a)(7), shall apply to as2 sessments of MIPS eligible professionals under 

3 subsection (q) with respect to the performance 

4 category described in subsection (q)(2)(A)(iv) in 

5 an appropriate manner which may be similar to 

6 the manner in which such provisions apply with 

7 respect to payment adjustments made under sub8 section (a)(7)(A).’’. 

9 (2) APPLICATION TO ELIGIBLE HOSPITALS.—Sec10 tion 1886(b)(3)(B)(ix)(II) of the Social Security Act 

11 (42 U.S.C. 1395ww(b)(3)(B)(ix)(II)) is amended by 

12 inserting after the first sentence the following new 

13 sentence: ‘‘The Secretary shall exempt an eligible hos14 pital from the application of the payment adjustment 

15 under subclause (I) with respect to a fiscal year, sub16 ject to annual renewal, if the Secretary determines 

17 that compliance with the requirement for being a 

18 meaningful EHR user is not possible because the cer19 tified EHR technology used by such hospital is decer20 tified under a program kept or recognized pursuant 

21 to section 3001(c)(5) of the Public Health Service 

22 Act.’’. 

23 (c) ELECTRONIC HEALTH RECORD REPORTING PRO24 GRAM.—Subtitle A of title XXX of the Public Health Service 
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1 Act (42 U.S.C. 300jj–11 et seq.) is amended by adding at 

2 the end the following: 

3 ‘‘SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING 

4 PROGRAM. 

5 ‘‘(a) REPORTING CRITERIA.— 

6 ‘‘(1) CONVENING OF STAKEHOLDERS.—Not later 

7 than 1 year after the date of enactment of the 21st 

8 Century Cures Act, the Secretary shall convene stake9 holders, as described in paragraph (2), for the pur10 pose of developing the reporting criteria in accordance 

11 with paragraph (3). 

12 ‘‘(2) DEVELOPMENT OF REPORTING CRITERIA.— 

13 The reporting criteria under this subsection shall be 

14 developed through a public, transparent process that 

15 reflects input from relevant stakeholders, including— 

16 ‘‘(A) health care providers, including pri17 mary care and specialty care health care profes18 sionals; 

19 ‘‘(B) hospitals and hospital systems; 

20 ‘‘(C) health information technology devel21 opers; 

22 ‘‘(D) patients, consumers, and their advo23 cates; 

24 ‘‘(E) data sharing networks, such as health 

25 information exchanges; 
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1 ‘‘(F) authorized certification bodies and 

2 testing laboratories; 

3 ‘‘(G) security experts; 

4 ‘‘(H) relevant manufacturers of medical de5 vices; 

6 ‘‘(I) experts in health information tech7 nology market economics; 

8 ‘‘(J) public and private entities engaged in 

9 the evaluation of health information technology 

10 performance; 

11 ‘‘(K) quality organizations, including the 

12 consensus based entity described in section 1890 

13 of the Social Security Act; 

14 ‘‘(L) experts in human factors engineering 

15 and the measurement of user-centered design; 

16 and 

17 ‘‘(M) other entities or individuals, as the 

18 Secretary determines appropriate. 

19 ‘‘(3) CONSIDERATIONS FOR REPORTING CRI20 TERIA.—The reporting criteria developed under this 

21 subsection— 

22 ‘‘(A) shall include measures that reflect cat23 egories including— 

24 ‘‘(i) security; 
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1 ‘‘(ii) usability and user-centered de2 sign; 

3 ‘‘(iii) interoperability; 

4 ‘‘(iv) conformance to certification test5 ing; and 

6 ‘‘(v) other categories, as appropriate to 

7 measure the performance of electronic health 

8 record technology; 

9 ‘‘(B) may include categories such as— 

10 ‘‘(i) enabling the user to order and 

11 view the results of laboratory tests, imaging 

12 tests, and other diagnostic tests; 

13 ‘‘(ii) submitting, editing, and retriev14 ing data from registries such as clinician15 led clinical data registries; 

16 ‘‘(iii) accessing and exchanging infor17 mation and data from and through health 

18 information exchanges; 

19 ‘‘(iv) accessing and exchanging infor20 mation and data from medical devices; 

21 ‘‘(v) accessing and exchanging infor22 mation and data held by Federal, State, 

23 and local agencies and other applicable en24 tities useful to a health care provider or 
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1 other applicable user in the furtherance of 

2 patient care; 

3 ‘‘(vi) accessing and exchanging infor4 mation from other health care providers or 

5 applicable users; 

6 ‘‘(vii) accessing and exchanging pa7 tient generated information; 

8 ‘‘(viii) providing the patient or an au9 thorized designee with a complete copy of 

10 their health information from an electronic 

11 record in a computable format; 

12 ‘‘(ix) providing accurate patient infor13 mation for the correct patient, including ex14 changing such information, and avoiding 

15 the duplication of patients records; and 

16 ‘‘(x) other categories regarding per17 formance, accessibility, as the Secretary de18 termines appropriate; and 

19 ‘‘(C) shall be designed to ensure that small 

20 and startup health information technology devel21 opers are not unduly disadvantaged by the re22 porting criteria. 

23 ‘‘(4) MODIFICATIONS.—After the reporting cri24 teria have been developed under paragraph (3), the 

25 Secretary may convene stakeholders and conduct a 
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1 public comment period for the purpose of modifying 

2 the reporting criteria developed under such para3 graph. 

4 ‘‘(b) PARTICIPATION.—As a condition of maintaining 

5 certification under section 3001(c)(5)(D), a developer of cer6 tified electronic health records shall submit to an appro7 priate recipient of a grant, contract, or agreement under 

8 subsection (c)(1) responses to the criteria developed under 

9 subsection (a), with respect to all certified technology offered 

10 by such developer. 

11 ‘‘(c) REPORTING PROGRAM.— 

12 ‘‘(1) IN GENERAL.—Not later than 1 year after 

13 the date of enactment of the 21st Century Cures Act, 

14 the Secretary shall award grants, contracts, or agree15 ments to independent entities on a competitive basis 

16 to support the convening of stakeholders as described 

17 in subsection (a)(2), collect the information required 

18 to be reported in accordance with the criteria estab19 lished as described subsection (a)(3), and develop and 

20 implement a process in accordance with paragraph 

21 (5) and report such information to the Secretary. 

22 ‘‘(2) APPLICATIONS.—An independent entity 

23 that seeks a grant, contract, or agreement under this 

24 subsection shall submit an application to the Sec25 retary at such time, in such manner, and containing 
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1 such information as the Secretary may reasonably re2 quire, including a description of— 

3 ‘‘(A) the proposed method for reviewing and 

4 summarizing information gathered based on re5 porting criteria established under subsection (a); 

6 ‘‘(B) if applicable, the intended focus on a 

7 specific subset of certified electronic health record 

8 technology users, such as health care providers, 

9 including primary care, specialty care, and care 

10 provided in rural settings; hospitals and hospital 

11 systems; and patients, consumers, and patients 

12 and consumer advocates; 

13 ‘‘(C) the plan for widely distributing re14 ports described in paragraph (6); 

15 ‘‘(D) the period for which the grant, con16 tract, or agreement is requested, which may be 

17 up to 2 years; and 

18 ‘‘(E) the budget for reporting program par19 ticipation, and whether the eligible independent 

20 entity intends to continue participation after the 

21 period of the grant, contract, or agreement. 

22 ‘‘(3) CONSIDERATIONS FOR INDEPENDENT ENTI23 TIES.—In awarding grants, contracts, and agree24 ments under paragraph (1), the Secretary shall give 

25 priority to independent entities with appropriate ex-
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1 pertise in health information technology usability, 

2 interoperability, and security (especially entities with 

3 such expertise in electronic health records) with re4 spect to— 

5 ‘‘(A) health care providers, including pri6 mary care, specialty care, and care provided in 

7 rural settings; 

8 ‘‘(B) hospitals and hospital systems; and 

9 ‘‘(C) patients, consumers, and patient and 

10 consumer advocates. 

11 ‘‘(4) LIMITATIONS.— 

12 ‘‘(A) ASSESSMENT AND REDETERMINA13 TION.—Not later than 4 years after the date of 

14 enactment of the 21st Century Cures Act and 

15 every 2 years thereafter, the Secretary, in con16 sultation with stakeholders, shall— 

17 ‘‘(i) assess performance of the recipi18 ents of the grants, contracts, and agreements 

19 under paragraph (1) based on quality and 

20 usability of reports described in paragraph 

21 (6); and 

22 ‘‘(ii) re-determine grants, contracts, 

23 and agreements as necessary. 

24 ‘‘(B) PROHIBITIONS ON PARTICIPATION.— 

25 The Secretary may not award a grant, contract, 
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•HR 34 EAH 

1 or cooperative agreement under paragraph (1) 

2 to— 

3 ‘‘(i) a proprietor of certified health in4 formation technology or a business affiliate 

5 of such a proprietor; 

6 ‘‘(ii) a developer of certified health in7 formation technology; or 

8 ‘‘(iii) a State or local government 

9 agency. 

10 ‘‘(5) FEEDBACK.—Based on reporting criteria 

11 established under subsection (a), the recipients of 

12 grants, contracts, and agreements under paragraph 

13 (1) shall develop and implement a process to collect 

14 and verify confidential feedback on such criteria 

15 from— 

16 ‘‘(A) health care providers, patients, and 

17 other users of certified electronic health record 

18 technology; and 

19 ‘‘(B) developers of certified electronic health 

20 record technology. 

21 ‘‘(6) REPORTS.— 

22 ‘‘(A) DEVELOPMENT OF REPORTS.—Each 

23 recipient of a grant, contract, or agreement 

24 under paragraph (1) shall report on the infor25 mation reported to such recipient pursuant to 
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1 subsection (a) and the user feedback collected 

2 under paragraph (5) by preparing summary re3 ports and detailed reports of such information. 

4 ‘‘(B) DISTRIBUTION OF REPORTS.—Each 

5 recipient of a grant, contract, or agreement 

6 under paragraph (1) shall submit the reports 

7 prepared under subparagraph (A) to the Sec8 retary for public distribution in accordance with 

9 subsection (d). 

10 ‘‘(d) PUBLICATION.—The Secretary shall distribute 

11 widely, as appropriate, and publish, on the Internet website 

12 of the Office of the National Coordinator— 

13 ‘‘(1) the reporting criteria developed under sub14 section (a); and 

15 ‘‘(2) the summary and detailed reports under 

16 subsection (c)(6). 

17 ‘‘(e) REVIEW.—Each recipient of a grant, contract, or 

18 agreement under paragraph (1) shall develop and imple19 ment a process through which participating electronic 

20 health record technology developers may review and rec21 ommend changes to the reports created under subsection 

22 (c)(6) for products developed by such developer prior to the 

23 publication of such report under subsection (d). 

24 ‘‘(f) ADDITIONAL RESOURCES.—The Secretary may 

25 provide additional resources on the Internet website of the 
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1 Office of the National Coordinator to better inform con2 sumers of health information technology. Such reports may 

3 be carried out through partnerships with private organiza4 tions with appropriate expertise.’’. 

5 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 

6 authorized to be appropriated $15,000,000 for purposes of 

7 carrying out subparagraph (D) of section 3001(c)(5) of the 

8 Public Health Service Act (42 U.S.C. 300jj–11) (as added 

9 by subsection (a)) and section 3009A of the Public Health 

10 Service Act (as added by subsection (b)), including for pur11 poses of administering any contracts, grants, or agreements, 

12 to remain available until expended. 

13 SEC. 4003. INTEROPERABILITY. 

14 (a) DEFINITION.—Section 3000 of the Public Health 

15 Service Act (42 U.S.C. 300jj) is amended— 

16 (1) by redesignating paragraphs (10) through 

17 (14), as paragraphs (11) through (15), respectively; 

18 and 

19 (2) by inserting after paragraph (9) the fol20 lowing: 

21 ‘‘(10) INTEROPERABILITY.—The term ‘interoper22 ability’, with respect to health information technology, 

23 means such health information technology that— 

24 ‘‘(A) enables the secure exchange of elec25 tronic health information with, and use of elec-
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1 tronic health information from, other health in2 formation technology without special effort on 

3 the part of the user; 

4 ‘‘(B) allows for complete access, exchange, 

5 and use of all electronically accessible health in6 formation for authorized use under applicable 

7 State or Federal law; and 

8 ‘‘(C) does not constitute information block9 ing as defined in section 3022(a).’’. 

10 (b) SUPPORT FOR INTEROPERABLE NETWORK EX11 CHANGE.—Section 3001(c) of the Public Health Service Act 

12 (42 U.S.C. 300jj–11(c)) is amended by adding at the end 

13 the following: 

14 ‘‘(9) SUPPORT FOR INTEROPERABLE NETWORKS

15 EXCHANGE.— 

16 ‘‘(A) IN GENERAL.—The National Coordi17 nator shall, in collaboration with the National 

18 Institute of Standards and Technology and other 

19 relevant agencies within the Department of 

20 Health and Human Services, for the purpose of 

21 ensuring full network-to-network exchange of 

22 health information, convene public-private and 

23 public-public partnerships to build consensus 

24 and develop or support a trusted exchange 

25 framework, including a common agreement 
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1 among health information networks nationally. 

2 Such convention may occur at a frequency deter3 mined appropriate by the Secretary. 

4 ‘‘(B) ESTABLISHING A TRUSTED EXCHANGE

5 FRAMEWORK.— 

6 ‘‘(i) IN GENERAL.—Not later than 6 

7 months after the date of enactment of the 

8 21st Century Cures Act, the National Coor9 dinator shall convene appropriate public 

10 and private stakeholders to develop or sup11 port a trusted exchange framework for trust 

12 policies and practices and for a common 

13 agreement for exchange between health in14 formation networks. The common agreement 

15 may include— 

16 ‘‘(I) a common method for au17 thenticating trusted health information 

18 network participants; 

19 ‘‘(II) a common set of rules for 

20 trusted exchange; 

21 ‘‘(III) organizational and oper22 ational policies to enable the exchange 

23 of health information among networks, 

24 including minimum conditions for 

25 such exchange to occur; and 
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1 ‘‘(IV) a process for filing and ad2 judicating noncompliance with the 

3 terms of the common agreement. 

4 ‘‘(ii) TECHNICAL ASSISTANCE.—The 

5 National Coordinator, in collaboration with 

6 the National Institute of Standards and 

7 Technology, shall provide technical assist8 ance on how to implement the trusted ex9 change framework and common agreement 

10 under this paragraph. 

11 ‘‘(iii) PILOT TESTING.—The National 

12 Coordinator, in consultation with the Na13 tional Institute of Standards and Tech14 nology, shall provide for the pilot testing of 

15 the trusted exchange framework and com16 mon agreement established or supported 

17 under this subsection (as authorized under 

18 section 13201 of the Health Information 

19 Technology for Economic and Clinical 

20 Health Act). The National Coordinator, in 

21 consultation with the National Institute of 

22 Standards and Technology, may delegate 

23 pilot testing activities under this clause to 

24 independent entities with appropriate ex25 pertise. 
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1 ‘‘(C) PUBLICATION OF A TRUSTED EX2 CHANGE FRAMEWORK AND COMMON AGREE3 MENT.—Not later than 1 year after convening 

4 stakeholders under subparagraph (A), the Na5 tional Coordinator shall publish on its public 

6 Internet website, and in the Federal register, the 

7 trusted exchange framework and common agree8 ment developed or supported under subpara9 graph (B). Such trusted exchange framework and 

10 common agreement shall be published in a man11 ner that protects proprietary and security infor12 mation, including trade secrets and any other 

13 protected intellectual property. 

14 ‘‘(D) DIRECTORY OF PARTICIPATING

15 HEALTH INFORMATION NETWORKS.— 

16 ‘‘(i) IN GENERAL.—Not later than 2 

17 years after convening stakeholders under 

18 subparagraph (A), and annually thereafter, 

19 the National Coordinator shall publish on 

20 its public Internet website a list of the 

21 health information networks that have 

22 adopted the common agreement and are ca23 pable of trusted exchange pursuant to the 

24 common agreement developed or supported 

25 under paragraph (B). 
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1 ‘‘(ii) PROCESS.—The Secretary shall, 

2 through notice and comment rulemaking, es3 tablish a process for health information net4 works that voluntarily elect to adopt the 

5 trusted exchange framework and common 

6 agreement to attest to such adoption of the 

7 framework and agreement. 

8 ‘‘(E) APPLICATION OF THE TRUSTED EX9 CHANGE FRAMEWORK AND COMMON AGREE10 MENT.—As appropriate, Federal agencies con11 tracting or entering into agreements with health 

12 information exchange networks may require that 

13 as each such network upgrades health informa14 tion technology or trust and operational prac15 tices, such network may adopt, where available, 

16 the trusted exchange framework and common 

17 agreement published under subparagraph (C). 

18 ‘‘(F) RULE OF CONSTRUCTION.— 

19 ‘‘(i) GENERAL ADOPTION.—Nothing in 

20 this paragraph shall be construed to require 

21 a health information network to adopt the 

22 trusted exchange framework or common 

23 agreement. 

24 ‘‘(ii) ADOPTION WHEN EXCHANGE OF

25 INFORMATION IS WITHIN NETWORK.—Noth-
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1 ing in this paragraph shall be construed to 

2 require a health information network to 

3 adopt the trusted exchange framework or 

4 common agreement for the exchange of elec5 tronic health information between partici6 pants of the same network. 

7 ‘‘(iii) EXISTING FRAMEWORKS AND

8 AGREEMENTS.—The trusted exchange frame9 work and common agreement published 

10 under subparagraph (C) shall take into ac11 count existing trusted exchange frameworks 

12 and agreements used by health information 

13 networks to avoid the disruption of existing 

14 exchanges between participants of health in15 formation networks. 

16 ‘‘(iv) APPLICATION BY FEDERAL AGEN17 CIES.—Notwithstanding clauses (i), (ii), 

18 and (iii), Federal agencies may require the 

19 adoption of the trusted exchange framework 

20 and common agreement published under 

21 subparagraph (C) for health information ex22 changes contracting with or entering into 

23 agreements pursuant to subparagraph (E). 

24 ‘‘(v) CONSIDERATION OF ONGOING

25 WORK.—In carrying out this paragraph, the 
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1 Secretary shall ensure the consideration of 

2 activities carried out by public and private 

3 organizations related to exchange between 

4 health information exchanges to avoid du5 plication of efforts.’’. 

6 (c) PROVIDER DIGITAL CONTACT INFORMATION

7 INDEX.— 

8 (1) IN GENERAL.—Not later than 3 years after 

9 the date of enactment of this Act, the Secretary of 

10 Health and Human Services (referred to in this sub11 section as the ‘‘Secretary’’) shall, directly or through 

12 a partnership with a private entity, establish a pro13 vider digital contact information index to provide 

14 digital contact information for health professionals 

15 and health facilities. 

16 (2) USE OF EXISTING INDEX.—In establishing 

17 the initial index under paragraph (1), the Secretary 

18 may utilize an existing provider directory to make 

19 such digital contact information available. 

20 (3) CONTACT INFORMATION.—An index estab21 lished under this subsection shall ensure that contact 

22 information is available at the individual health care 

23 provider level and at the health facility or practice 

24 level. 

25 (4) RULE OF CONSTRUCTION.— 
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1 (A) IN GENERAL.—The purpose of this sub2 section is to encourage the exchange of electronic 

3 health information by providing the most useful, 

4 reliable, and comprehensive index of providers 

5 possible. In furthering such purpose, the Sec6 retary shall include all health professionals and 

7 health facilities applicable to provide a useful, 

8 reliable, and comprehensive index for use in the 

9 exchange of health information. 

10 (B) LIMITATION.—In no case shall exclusion 

11 from the index of providers be used as a measure 

12 to achieve objectives other the objectives described 

13 in subparagraph (A). 

14 (d) STANDARDS DEVELOPMENT ORGANIZATIONS.— 

15 Section 3004 of the Public Health Service Act (42 U.S.C. 

16 300jj–14) is amended by adding at the end the following: 

17 ‘‘(c) DEFERENCE TO STANDARDS DEVELOPMENT OR18 GANIZATIONS.—In adopting and implementing standards 

19 under this section, the Secretary shall give deference to 

20 standards published by standards development organiza21 tions and voluntary consensus-based standards bodies.’’. 

22 (e) HEALTH INFORMATION TECHNOLOGY ADVISORY

23 COMMITTEE.— 

24 (1) IN GENERAL.—Title XXX of the Public 

25 Health Service Act (42 U.S.C. 300jj et seq.) is amend-
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1 ed by striking sections 3002 (42 U.S.C. 300jj–12) and 

2 3003 (42 U.S.C. 300jj–13) and inserting the fol3 lowing: 

4 ‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVI5 SORY COMMITTEE. 

6 ‘‘(a) ESTABLISHMENT.—There is established a Health 

7 Information Technology Advisory Committee (referred to in 

8 this section as the ‘HIT Advisory Committee’) to rec9 ommend to the National Coordinator, consistent with the 

10 implementation of the strategic plan described in section 

11 3001(c)(3), policies, and, for purposes of adoption under 

12 section 3004, standards, implementation specifications, and 

13 certification criteria, relating to the implementation of a 

14 health information technology infrastructure, nationally 

15 and locally, that advances the electronic access, exchange, 

16 and use of health information. Such Committee shall serve 

17 to unify the roles of, and replace, the HIT Policy Committee 

18 and the HIT Standards Committee, as in existence before 

19 the date of the enactment of the 21st Century Cures Act. 

20 ‘‘(b) DUTIES.— 

21 ‘‘(1) RECOMMENDATIONS ON POLICY FRAMEWORK

22 TO ADVANCE AN INTEROPERABLE HEALTH INFORMA23 TION TECHNOLOGY INFRASTRUCTURE.— 

24 ‘‘(A) IN GENERAL.—The HIT Advisory 

25 Committee shall recommend to the National Co-
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•HR 34 EAH 

1 ordinator a policy framework for adoption by 

2 the Secretary consistent with the strategic plan 

3 under section 3001(c)(3) for advancing the target 

4 areas described in this subsection. Such policy 

5 framework shall seek to prioritize achieving ad6 vancements in the target areas specified in sub7 paragraph (B) of paragraph (2) and may, to the 

8 extent consistent with this section, incorporate 

9 policy recommendations made by the HIT Policy 

10 Committee, as in existence before the date of the 

11 enactment of the 21st Century Cures Act. 

12 ‘‘(B) UPDATES.—The HIT Advisory Com13 mittee shall propose updates to such rec14 ommendations to the policy framework and make 

15 new recommendations, as appropriate. 

16 ‘‘(2) GENERAL DUTIES AND TARGET AREAS.— 

17 ‘‘(A) IN GENERAL.—The HIT Advisory 

18 Committee shall recommend to the National Co19 ordinator for purposes of adoption under section 

20 3004, standards, implementation specifications, 

21 and certification criteria and an order of pri22 ority for the development, harmonization, and 

23 recognition of such standards, specifications, and 

24 certification criteria. Such recommendations 

25 shall include recommended standards, architec-
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•HR 34 EAH 

1 tures, and software schemes for access to elec2 tronic individually identifiable health informa3 tion across disparate systems including user vet4 ting, authentication, privilege management, and 

5 access control. 

6 ‘‘(B) PRIORITY TARGET AREAS.—For pur7 poses of this section, the HIT Advisory Com8 mittee shall make recommendations under sub9 paragraph (A) with respect to at least each of the 

10 following target areas: 

11 ‘‘(i) Achieving a health information 

12 technology infrastructure, nationally and 

13 locally, that allows for the electronic access, 

14 exchange, and use of health information, in15 cluding through technology that provides ac16 curate patient information for the correct 

17 patient, including exchanging such infor18 mation, and avoids the duplication of pa19 tient records. 

20 ‘‘(ii) The promotion and protection of 

21 privacy and security of health information 

22 in health information technology, including 

23 technologies that allow for an accounting of 

24 disclosures and protections against disclo25 sures of individually identifiable health in-
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1 formation made by a covered entity for pur2 poses of treatment, payment, and health 

3 care operations (as such terms are defined 

4 for purposes of the regulation promulgated 

5 under section 264(c) of the Health Insur6 ance Portability and Accountability Act of 

7 1996), including for the segmentation and 

8 protection from disclosure of specific and 

9 sensitive individually identifiable health in10 formation with the goal of minimizing the 

11 reluctance of patients to seek care. 

12 ‘‘(iii) The facilitation of secure access 

13 by an individual to such individual’s pro14 tected health information and access to such 

15 information by a family member, caregiver, 

16 or guardian acting on behalf of a patient, 

17 including due to age-related and other dis18 ability, cognitive impairment, or dementia. 

19 ‘‘(iv) Subject to subparagraph (D), any 

20 other target area that the HIT Advisory 

21 Committee identifies as an appropriate tar22 get area to be considered under this sub23 paragraph. 

24 ‘‘(C) ADDITIONAL TARGET AREAS.—For 

25 purposes of this section, the HIT Advisory Com-
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1 mittee may make recommendations under sub2 paragraph (A), in addition to areas described in 

3 subparagraph (B), with respect to any of the fol4 lowing areas: 

5 ‘‘(i) The use of health information tech6 nology to improve the quality of health care, 

7 such as by promoting the coordination of 

8 health care and improving continuity of 

9 health care among health care providers, re10 ducing medical errors, improving popu11 lation health, reducing chronic disease, and 

12 advancing research and education. 

13 ‘‘(ii) The use of technologies that ad14 dress the needs of children and other vulner15 able populations. 

16 ‘‘(iii) The use of electronic systems to 

17 ensure the comprehensive collection of pa18 tient demographic data, including at a 

19 minimum, race, ethnicity, primary lan20 guage, and gender information. 

21 ‘‘(iv) The use of self-service, telemedi22 cine, home health care, and remote moni23 toring technologies. 

24 ‘‘(v) The use of technologies that meet 

25 the needs of diverse populations. 
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1 ‘‘(vi) The use of technologies that sup2 port— 

3 ‘‘(I) data for use in quality and 

4 public reporting programs; 

5 ‘‘(II) public health; or 

6 ‘‘(III) drug safety. 

7 ‘‘(vii) The use of technologies that 

8 allow individually identifiable health infor9 mation to be rendered unusable, unreadable, 

10 or indecipherable to unauthorized individ11 uals when such information is transmitted 

12 in a health information network or trans13 ported outside of the secure facilities or sys14 tems where the disclosing covered entity is 

15 responsible for security conditions. 

16 ‘‘(viii) The use of a certified health in17 formation technology for each individual in 

18 the United States. 

19 ‘‘(D) AUTHORITY FOR TEMPORARY ADDI20 TIONAL PRIORITY TARGET AREAS.—For purposes 

21 of subparagraph (B)(iv), the HIT Advisory Com22 mittee may identify an area to be considered for 

23 purposes of recommendations under this sub24 section as a target area described in subpara25 graph (B) if— 
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1 ‘‘(i) the area is so identified for pur2 poses of responding to new circumstances 

3 that have arisen in the health information 

4 technology community that affect the inter5 operability, privacy, or security of health 

6 information, or affect patient safety; and 

7 ‘‘(ii) at least 30 days prior to treating 

8 such area as if it were a target area de9 scribed in subparagraph (B), the National 

10 Coordinator provides adequate notice to 

11 Congress of the intent to treat such area as 

12 so described. 

13 ‘‘(E) FOCUS OF COMMITTEE WORK.—It is 

14 the sense of Congress that the HIT Advisory 

15 Committee shall focus its work on the priority 

16 areas described in subparagraph (B) before pro17 ceeding to other work under subparagraph (C). 

18 ‘‘(3) RULES RELATING TO RECOMMENDATIONS

19 FOR STANDARDS, IMPLEMENTATION SPECIFICATIONS, 

20 AND CERTIFICATION CRITERIA.— 

21 ‘‘(A) IN GENERAL.—The HIT Advisory 

22 Committee shall recommend to the National Co23 ordinator standards, implementation specifica24 tions, and certification criteria described in sub25 section (a), which may include standards, imple-
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1 mentation specifications, and certification cri2 teria that have been developed, harmonized, or 

3 recognized by the HIT Advisory Committee or 

4 predecessor committee. The HIT Advisory Com5 mittee shall update such recommendations and 

6 make new recommendations as appropriate, in7 cluding in response to a notification sent under 

8 section 3004(a)(2)(B). Such recommendations 

9 shall be consistent with the latest recommenda10 tions made by the Committee. 

11 ‘‘(B) HARMONIZATION.—The HIT Advisory 

12 Committee may recognize harmonized or up13 dated standards from an entity or entities for the 

14 purpose of harmonizing or updating standards 

15 and implementation specifications in order to 

16 achieve uniform and consistent implementation 

17 of the standards and implementation specifica18 tion. 

19 ‘‘(C) PILOT TESTING OF STANDARDS AND

20 IMPLEMENTATION SPECIFICATIONS.—In the de21 velopment, harmonization, or recognition of 

22 standards and implementation specifications, the 

23 HIT Advisory Committee for purposes of rec24 ommendations under paragraph (2)(B), shall, as 

25 appropriate, provide for the testing of such 
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1 standards and specifications by the National In2 stitute for Standards and Technology under sec3 tion 13201(a) of the Health Information Tech4 nology for Economic and Clinical Health Act. 

5 ‘‘(D) CONSISTENCY.—The standards, imple6 mentation specifications, and certification cri7 teria recommended under paragraph (2)(B) shall 

8 be consistent with the standards for information 

9 transactions and data elements adopted pursu10 ant to section 1173 of the Social Security Act. 

11 ‘‘(E) SPECIAL RULE RELATED TO INTER12 OPERABILITY.—Any recommendation made by 

13 the HIT Advisory Committee after the date of 

14 the enactment of this subparagraph with respect 

15 to interoperability of health information tech16 nology shall be consistent with interoperability 

17 as described in section 3000. 

18 ‘‘(4) FORUM.—The HIT Advisory Committee 

19 shall serve as a forum for the participation of a broad 

20 range of stakeholders with specific expertise in poli21 cies, including technical expertise, relating to the 

22 matters described in paragraphs (1), (2), and (3) to 

23 provide input on the development, harmonization, 

24 and recognition of standards, implementation speci25 fications, and certification criteria necessary for the 
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1 development and adoption of health information tech2 nology infrastructure nationally and locally that al3 lows for the electronic access, exchange, and use of 

4 health information. 

5 ‘‘(5) SCHEDULE.—Not later than 30 days after 

6 the date on which the HIT Advisory Committee first 

7 meets, such HIT Advisory Committee shall develop a 

8 schedule for the assessment of policy recommendations 

9 developed under paragraph (1). The HIT Advisory 

10 Committee shall update such schedule annually. The 

11 Secretary shall publish such schedule in the Federal 

12 Register. 

13 ‘‘(6) PUBLIC INPUT.—The HIT Advisory Com14 mittee shall conduct open public meetings and develop 

15 a process to allow for public comment on the schedule 

16 described in paragraph (5) and recommendations de17 scribed in this subsection. Under such process com18 ments shall be submitted in a timely manner after the 

19 date of publication of a recommendation under this 

20 subsection. 

21 ‘‘(c) MEASURED PROGRESS IN ADVANCING PRIORITY

22 AREAS.— 

23 ‘‘(1) IN GENERAL.—For purposes of this section, 

24 the National Coordinator, in collaboration with the 

25 Secretary, shall establish, and update as appropriate, 
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1 objectives and benchmarks for advancing and meas2 uring the advancement of the priority target areas de3 scribed in subsection (b)(2)(B). 

4 ‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING

5 INTEROPERABILITY.— 

6 ‘‘(A) IN GENERAL.—The HIT Advisory 

7 Committee, in consultation with the National 

8 Coordinator, shall annually submit to the Sec9 retary and Congress a report on the progress 

10 made during the preceding fiscal year in— 

11 ‘‘(i) achieving a health information 

12 technology infrastructure, nationally and 

13 locally, that allows for the electronic access, 

14 exchange, and use of health information; 

15 and 

16 ‘‘(ii) meeting the objectives and bench17 marks described in paragraph (1). 

18 ‘‘(B) CONTENT.—Each such report shall in19 clude, for a fiscal year— 

20 ‘‘(i) a description of the work con21 ducted by the HIT Advisory Committee 

22 during the preceding fiscal year with re23 spect to the areas described in subsection 

24 (b)(2)(B); 
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1 ‘‘(ii) an assessment of the status of the 

2 infrastructure described in subparagraph 

3 (A), including the extent to which electronic 

4 health information is appropriately and 

5 readily available to enhance the access, ex6 change, and the use of electronic health in7 formation between users and across tech8 nology offered by different developers; 

9 ‘‘(iii) the extent to which advancements 

10 have been achieved with respect to areas de11 scribed in subsection (b)(2)(B); 

12 ‘‘(iv) an analysis identifying existing 

13 gaps in policies and resources for— 

14 ‘‘(I) achieving the objectives and 

15 benchmarks established under para16 graph (1); and 

17 ‘‘(II) furthering interoperability 

18 throughout the health information tech19 nology infrastructure; 

20 ‘‘(v) recommendations for addressing 

21 the gaps identified in clause (iii); and 

22 ‘‘(vi) a description of additional ini23 tiatives as the HIT Advisory Committee 

24 and National Coordinator determine appro25 priate. 
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1 ‘‘(3) SIGNIFICANT ADVANCEMENT DETERMINA2 TION.—The Secretary shall periodically, based on the 

3 reports submitted under this subsection, review the 

4 target areas described in subsection (b)(2)(B), and, 

5 based on the objectives and benchmarks established 

6 under paragraph (1), the Secretary shall determine if 

7 significant advancement has been achieved with re8 spect to such an area. Such determination shall be 

9 taken into consideration by the HIT Advisory Com10 mittee when determining to what extent the Com11 mittee makes recommendations for an area other than 

12 an area described in subsection (b)(2)(B). 

13 ‘‘(d) MEMBERSHIP AND OPERATIONS.— 

14 ‘‘(1) IN GENERAL.—The National Coordinator 

15 shall take a leading position in the establishment and 

16 operations of the HIT Advisory Committee. 

17 ‘‘(2) MEMBERSHIP.—The membership of the HIT 

18 Advisory Committee shall— 

19 ‘‘(A) include at least 25 members, of 

20 which— 

21 ‘‘(i) no fewer than 2 members are ad22 vocates for patients or consumers of health 

23 information technology; 

24 ‘‘(ii) 3 members are appointed by the 

25 Secretary, 1 of whom shall be appointed to 
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1 represent the Department of Health and 

2 Human Services and 1 of whom shall be a 

3 public health official; 

4 ‘‘(iii) 2 members are appointed by the 

5 majority leader of the Senate; 

6 ‘‘(iv) 2 members are appointed by the 

7 minority leader of the Senate; 

8 ‘‘(v) 2 members are appointed by the 

9 Speaker of the House of Representatives; 

10 ‘‘(vi) 2 members are appointed by the 

11 minority leader of the House of Representa12 tives; and 

13 ‘‘(vii) such other members are ap14 pointed by the Comptroller General of the 

15 United States; and 

16 ‘‘(B) at least reflect providers, ancillary 

17 health care workers, consumers, purchasers, 

18 health plans, health information technology de19 velopers, researchers, patients, relevant Federal 

20 agencies, and individuals with technical exper21 tise on health care quality, system functions, pri22 vacy, security, and on the electronic exchange 

23 and use of health information, including the use 

24 standards for such activity. 
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1 ‘‘(3) PARTICIPATION.—The members of the HIT 

2 Advisory Committee shall represent a balance among 

3 various sectors of the health care system so that no 

4 single sector unduly influences the recommendations 

5 of the Committee. 

6 ‘‘(4) TERMS.— 

7 ‘‘(A) IN GENERAL.—The terms of the mem8 bers of the HIT Advisory Committee shall be for 

9 3 years, except that the Secretary shall designate 

10 staggered terms of the members first appointed. 

11 ‘‘(B) VACANCIES.—Any member appointed 

12 to fill a vacancy in the membership of the HIT 

13 Advisory Committee that occurs prior to the ex14 piration of the term for which the member’s 

15 predecessor was appointed shall be appointed 

16 only for the remainder of that term. A member 

17 may serve after the expiration of that member’s 

18 term until a successor has been appointed. A va19 cancy in the HIT Advisory Committee shall be 

20 filled in the manner in which the original ap21 pointment was made. 

22 ‘‘(C) LIMITS.—Members of the HIT Advi23 sory Committee shall be limited to two 3-year 

24 terms, for a total of not to exceed 6 years of serv25 ice on the Committee. 
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•HR 34 EAH 

1 ‘‘(5) OUTSIDE INVOLVEMENT.—The HIT Advi2 sory Committee shall ensure an opportunity for the 

3 participation in activities of the Committee of outside 

4 advisors, including individuals with expertise in the 

5 development of policies and standards for the elec6 tronic exchange and use of health information, in7 cluding in the areas of health information privacy 

8 and security. 

9 ‘‘(6) QUORUM.—A majority of the members of 

10 the HIT Advisory Committee shall constitute a 

11 quorum for purposes of voting, but a lesser number of 

12 members may meet and hold hearings. 

13 ‘‘(7) CONSIDERATION.—The National Coordi14 nator shall ensure that the relevant and available rec15 ommendations and comments from the National Com16 mittee on Vital and Health Statistics are considered 

17 in the development of policies. 

18 ‘‘(8) ASSISTANCE.—For the purposes of carrying 

19 out this section, the Secretary may provide or ensure 

20 that financial assistance is provided by the HIT Ad21 visory Committee to defray in whole or in part any 

22 membership fees or dues charged by such Committee 

23 to those consumer advocacy groups and not-for-profit 

24 entities that work in the public interest as a party of 

25 their mission. 
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1 ‘‘(e) APPLICATION OF FACA.—The Federal Advisory 

2 Committee Act (5 U.S.C. App.), other than section 14 of 

3 such Act, shall apply to the HIT Advisory Committee. 

4 ‘‘(f) PUBLICATION.—The Secretary shall provide for 

5 publication in the Federal Register and the posting on the 

6 Internet website of the Office of the National Coordinator 

7 for Health Information Technology of all policy rec8 ommendations made by the HIT Advisory Committee under 

9 this section.’’. 

10 (2) TECHNICAL AND CONFORMING AMEND11 MENTS.—Title XXX of the Public Health Service Act 

12 (42 U.S.C. 300jj et seq.) is amended— 

13 (A) by striking— 

14 (i) ‘‘HIT Policy Committee’’ and 

15 ‘‘HIT Standards Committee’’ each place 

16 that such terms appear (other than within 

17 the term ‘‘HIT Policy Committee and the 

18 HIT Standards Committee’’ or within the 

19 term ‘‘HIT Policy Committee or the HIT 

20 Standards Committee’’) and inserting 

21 ‘‘HIT Advisory Committee’’; 

22 (ii) ‘‘HIT Policy Committee and the 

23 HIT Standards Committee’’ each place that 

24 such term appears and inserting ‘‘HIT Ad25 visory Committee’’; and 
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•HR 34 EAH 

1 (iii) ‘‘HIT Policy Committee or the 

2 HIT Standards Committee’’ each place that 

3 such term appears and inserting ‘‘HIT Ad4 visory Committee’’; 

5 (B) in section 3000 (42 U.S.C. 300jj)— 

6 (i) by striking paragraphs (7) and (8) 

7 and redesignating paragraphs (9) through 

8 (14) as paragraphs (8) through (13), respec9 tively; and 

10 (ii) by inserting after paragraph (6) 

11 the following paragraph: 

12 ‘‘(7) HIT ADVISORY COMMITTEE.—The term 

13 ‘HIT Advisory Committee’ means such Committee es14 tablished under section 3002(a).’’; 

15 (C) in section 3001(c) (42 U.S.C. 300jj– 

16 11(c))— 

17 (i) in paragraph (1)(A), by striking 

18 ‘‘under section 3003’’ and inserting ‘‘under 

19 section 3002’’; 

20 (ii) in paragraph (2), by striking sub21 paragraph (B) and inserting the following: 

22 ‘‘(B) HIT ADVISORY COMMITTEE.—The Na23 tional Coordinator shall be a leading member in 

24 the establishment and operations of the HIT Ad25 visory Committee and shall serve as a liaison be-
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1 tween that Committee and the Federal Govern2 ment.’’; 

3 (D) in section 3004(b)(3) (42 U.S.C. 300jj– 

4 14(b)(3)), by striking ‘‘3003(b)(2)’’ and inserting 

5 ‘‘3002(b)(4)’’; 

6 (E) in section 3007(b) (42 U.S.C. 300jj– 

7 17(b)), by striking ‘‘3003(a)’’ and inserting 

8 ‘‘3002(a)(2)’’; and 

9 (F) in section 3008 (42 U.S.C. 300jj–18)— 

10 (i) in subsection (b), by striking ‘‘or 

11 3003’’; and 

12 (ii) in subsection (c), by striking 

13 ‘‘3003(b)(1)(A)’’ and inserting 

14 ‘‘3002(b)(2)’’. 

15 (3) TRANSITION TO THE HIT ADVISORY COM16 MITTEE.—The Secretary of Health and Human Serv17 ices shall provide for an orderly and timely transition 

18 to the HIT Advisory Committee established under 

19 amendments made by this section. 

20 (f) PRIORITIES FOR ADOPTION OF STANDARDS, IMPLE21 MENTATION SPECIFICATIONS, AND CERTIFICATION CRI22 TERIA.—Title XXX of the Public Health Service Act (42 

23 U.S.C. 300jj et seq.), as amended by subsection (e), is fur24 ther amended by inserting after section 3002 the following: 
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•HR 34 EAH 

1 ‘‘SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOP2 TION. 

3 ‘‘(a) IDENTIFYING PRIORITIES.— 

4 ‘‘(1) IN GENERAL.—Not later than 6 months 

5 after the date on which the HIT Advisory Committee 

6 first meets, the National Coordinator shall periodi7 cally convene the HIT Advisory Committee to— 

8 ‘‘(A) identify priority uses of health infor9 mation technology, focusing on priorities— 

10 ‘‘(i) arising from the implementation 

11 of the incentive programs for the meaning12 ful use of certified EHR technology, the 

13 Merit-based Incentive Payment System, Al14 ternative Payment Models, the Hospital 

15 Value-Based Purchasing Program, and any 

16 other value-based payment program deter17 mined appropriate by the Secretary; 

18 ‘‘(ii) related to the quality of patient 

19 care; 

20 ‘‘(iii) related to public health; 

21 ‘‘(iv) related to clinical research; 

22 ‘‘(v) related to the privacy and security 

23 of electronic health information; 

24 ‘‘(vi) related to innovation in the field 

25 of health information technology; 

26 ‘‘(vii) related to patient safety; 
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1 ‘‘(viii) related to the usability of health 

2 information technology; 

3 ‘‘(ix) related to individuals’ access to 

4 electronic health information; and 

5 ‘‘(x) other priorities determined appro6 priate by the Secretary; 

7 ‘‘(B) identify existing standards and imple8 mentation specifications that support the use 

9 and exchange of electronic health information 

10 needed to meet the priorities identified in sub11 paragraph (A); and 

12 ‘‘(C) publish a report summarizing the 

13 findings of the analysis conducted under sub14 paragraphs (A) and (B) and make appropriate 

15 recommendations. 

16 ‘‘(2) PRIORITIZATION.—In identifying such 

17 standards and implementation specifications under 

18 paragraph (1)(B), the HIT Advisory Committee shall 

19 prioritize standards and implementation specifica20 tions developed by consensus-based standards develop21 ment organizations. 

22 ‘‘(3) GUIDELINES FOR REVIEW OF EXISTING

23 STANDARDS AND SPECIFICATIONS.—In consultation 

24 with the consensus-based entity described in section 

25 1890 of the Social Security Act and other appropriate 
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1 Federal agencies, the analysis of existing standards 

2 under paragraph (1)(B) shall include an evaluation 

3 of the need for a core set of common data elements 

4 and associated value sets to enhance the ability of cer5 tified health information technology to capture, use, 

6 and exchange structured electronic health informa7 tion. 

8 ‘‘(b) REVIEW OF ADOPTED STANDARDS.— 

9 ‘‘(1) IN GENERAL.—Beginning 5 years after the 

10 date of enactment of the 21st Century Cures Act and 

11 every 3 years thereafter, the National Coordinator 

12 shall convene stakeholders to review the existing set of 

13 adopted standards and implementation specifications 

14 and make recommendations with respect to whether 

15 to— 

16 ‘‘(A) maintain the use of such standards 

17 and implementation specifications; or 

18 ‘‘(B) phase out such standards and imple19 mentation specifications. 

20 ‘‘(2) PRIORITIES.—The HIT Advisory Com21 mittee, in collaboration with the National Institute 

22 for Standards and Technology, shall annually and 

23 through the use of public input, review and publish 

24 priorities for the use of health information technology, 
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1 standards, and implementation specifications to sup2 port those priorities. 

3 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to prevent the use or adoption of 

5 novel standards that improve upon the existing health in6 formation technology infrastructure and facilitate the se7 cure exchange of health information.’’. 

8 SEC. 4004. INFORMATION BLOCKING. 

9 Subtitle C of title XXX of the Public Health Service 

10 Act (42 U.S.C. 300jj–51 et seq.) is amended by adding at 

11 the end the following: 

12 ‘‘SEC. 3022. INFORMATION BLOCKING. 

13 ‘‘(a) DEFINITION.— 

14 ‘‘(1) IN GENERAL.—In this section, the term ‘in15 formation blocking’ means a practice that— 

16 ‘‘(A) except as required by law or specified 

17 by the Secretary pursuant to rulemaking under 

18 paragraph (3), is likely to interfere with, pre19 vent, or materially discourage access, exchange, 

20 or use of electronic health information; and 

21 ‘‘(B)(i) if conducted by a health informa22 tion technology developer, exchange, or network, 

23 such developer, exchange, or network knows, or 

24 should know, that such practice is likely to inter25 fere with, prevent, or materially discourage the 
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1 access, exchange, or use of electronic health infor2 mation; or 

3 ‘‘(ii) if conducted by a health care provider, 

4 such provider knows that such practice is unrea5 sonable and is likely to interfere with, prevent, 

6 or materially discourage access, exchange, or use 

7 of electronic health information. 

8 ‘‘(2) PRACTICES DESCRIBED.—The information 

9 blocking practices described in paragraph (1) may in10 clude— 

11 ‘‘(A) practices that restrict authorized ac12 cess, exchange, or use under applicable State or 

13 Federal law of such information for treatment 

14 and other permitted purposes under such appli15 cable law, including transitions between certified 

16 health information technologies; 

17 ‘‘(B) implementing health information tech18 nology in nonstandard ways that are likely to 

19 substantially increase the complexity or burden 

20 of accessing, exchanging, or using electronic 

21 health information; and 

22 ‘‘(C) implementing health information tech23 nology in ways that are likely to— 

24 ‘‘(i) restrict the access, exchange, or use 

25 of electronic health information with respect 
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1 to exporting complete information sets or in 

2 transitioning between health information 

3 technology systems; or 

4 ‘‘(ii) lead to fraud, waste, or abuse, or 

5 impede innovations and advancements in 

6 health information access, exchange, and 

7 use, including care delivery enabled by 

8 health information technology. 

9 ‘‘(3) RULEMAKING.—The Secretary, through 

10 rulemaking, shall identify reasonable and necessary 

11 activities that do not constitute information blocking 

12 for purposes of paragraph (1). 

13 ‘‘(4) NO ENFORCEMENT BEFORE EXCEPTION

14 IDENTIFIED.—The term ‘information blocking’ does 

15 not include any practice or conduct occurring prior 

16 to the date that is 30 days after the date of enactment 

17 of the 21st Century Cures Act. 

18 ‘‘(5) CONSULTATION.—The Secretary may con19 sult with the Federal Trade Commission in promul20 gating regulations under this subsection, to the extent 

21 that such regulations define practices that are nec22 essary to promote competition and consumer welfare. 

23 ‘‘(6) APPLICATION.—The term ‘information 

24 blocking’, with respect to an individual or entity, 
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1 shall not include an act or practice other than an act 

2 or practice committed by such individual or entity. 

3 ‘‘(7) CLARIFICATION.—In carrying out this sec4 tion, the Secretary shall ensure that health care pro5 viders are not penalized for the failure of developers 

6 of health information technology or other entities of7 fering health information technology to such providers 

8 to ensure that such technology meets the requirements 

9 to be certified under this title. 

10 ‘‘(b) INSPECTOR GENERAL AUTHORITY.— 

11 ‘‘(1) IN GENERAL.—The inspector general of the 

12 Department of Health and Human Services (referred 

13 to in this section as the ‘Inspector General’) may in14 vestigate any claim that— 

15 ‘‘(A) a health information technology devel16 oper of certified health information technology or 

17 other entity offering certified health information 

18 technology— 

19 ‘‘(i) submitted a false attestation under 

20 section 3001(c)(5)(D)(vii); or 

21 ‘‘(ii) engaged in information blocking; 

22 ‘‘(B) a health care provider engaged in in23 formation blocking; or 

24 ‘‘(C) a health information exchange or net25 work engaged in information blocking. 
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1 ‘‘(2) PENALTIES.— 

2 ‘‘(A) DEVELOPERS, NETWORKS, AND EX3 CHANGES.—Any individual or entity described 

4 in subparagraph (A) or (C) of paragraph (1) 

5 that the Inspector General, following an inves6 tigation conducted under this subsection, deter7 mines to have committed information blocking 

8 shall be subject to a civil monetary penalty de9 termined by the Secretary for all such violations 

10 identified through such investigation, which may 

11 not exceed $1,000,000 per violation. Such deter12 mination shall take into account factors such as 

13 the nature and extent of the information blocking 

14 and harm resulting from such information block15 ing, including, where applicable, the number of 

16 patients affected, the number of providers af17 fected, and the number of days the information 

18 blocking persisted. 

19 ‘‘(B) PROVIDERS.—Any individual or enti20 ty described in subparagraph (B) of paragraph 

21 (1) determined by the Inspector General to have 

22 committed information blocking shall be referred 

23 to the appropriate agency to be subject to appro24 priate disincentives using authorities under ap-
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1 plicable Federal law, as the Secretary sets forth 

2 through notice and comment rulemaking. 

3 ‘‘(C) PROCEDURE.—The provisions of sec4 tion 1128A of the Social Security Act (other 

5 than subsections (a) and (b) of such section) 

6 shall apply to a civil money penalty applied 

7 under this paragraph in the same manner as 

8 such provisions apply to a civil money penalty 

9 or proceeding under such section 1128A(a). 

10 ‘‘(D) RECOVERED PENALTY FUNDS.—The 

11 amounts recovered under this paragraph shall be 

12 allocated as follows: 

13 ‘‘(i) ANNUAL OPERATING EXPENSES.— 

14 Each year following the establishment of the 

15 authority under this subsection, the Office of 

16 the Inspector General shall provide to the 

17 Secretary an estimate of the costs to carry 

18 out investigations under this section. Such 

19 estimate may include reasonable reserves to 

20 account for variance in annual amounts re21 covered under this paragraph. There is au22 thorized to be appropriated for purposes of 

23 carrying out this section an amount equal 

24 to the amount specified in such estimate for 

25 the fiscal year. 
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1 ‘‘(ii) APPLICATION TO OTHER PRO2 GRAMS.—The amounts recovered under this 

3 paragraph and remaining after amounts 

4 are made available under clause (i) shall be 

5 transferred to the Federal Hospital Insur6 ance Trust Fund under section 1817 of the 

7 Social Security Act and the Federal Sup8 plementary Medical Insurance Trust Fund 

9 under section 1841 of such Act, in such pro10 portion as the Secretary determines appro11 priate. 

12 ‘‘(E) AUTHORIZATION OF APPROPRIA13 TIONS.—There is authorized to be appropriated 

14 to the Office of the Inspector General to carry 

15 out this section $10,000,000, to remain available 

16 until expended. 

17 ‘‘(3) RESOLUTION OF CLAIMS.— 

18 ‘‘(A) IN GENERAL.—The Office of the In19 spector General, if such Office determines that a 

20 consultation regarding the health privacy and se21 curity rules promulgated under section 264(c) of 

22 the Health Insurance Portability and Account23 ability Act of 1996 (42 U.S.C. 1320d–2 note) 

24 will resolve an information blocking claim, may 

25 refer such instances of information blocking to 
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1 the Office for Civil Rights of the Department of 

2 Health and Human Services for resolution. 

3 ‘‘(B) LIMITATION ON LIABILITY.—If a 

4 health care provider or health information tech5 nology developer makes information available 

6 based on a good faith reliance on consultations 

7 with the Office for Civil Rights of the Depart8 ment of Health and Human Services pursuant 

9 to a referral under subparagraph (A), with re10 spect to such information, the health care pro11 vider or developer shall not be liable for such dis12 closure or disclosures made pursuant to subpara13 graph (A). 

14 ‘‘(c) IDENTIFYING BARRIERS TO EXCHANGE OF CER15 TIFIED HEALTH INFORMATION TECHNOLOGY.— 

16 ‘‘(1) TRUSTED EXCHANGE DEFINED.—In this 

17 section, the term ‘trusted exchange’ with respect to 

18 certified electronic health records means that the cer19 tified electronic health record technology has the tech20 nical capability to enable secure health information 

21 exchange between users and multiple certified elec22 tronic health record technology systems. 

23 ‘‘(2) GUIDANCE.—The National Coordinator, in 

24 consultation with the Office for Civil Rights of the 

25 Department of Health and Human Services, shall 
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1 issue guidance on common legal, governance, and se2 curity barriers that prevent the trusted exchange of 

3 electronic health information. 

4 ‘‘(3) REFERRAL.—The National Coordinator and 

5 the Office for Civil Rights of the Department of 

6 Health and Human Services may refer to the Inspec7 tor General instances or patterns of refusal to ex8 change health information with an individual or enti9 ty using certified electronic health record technology 

10 that is technically capable of trusted exchange and 

11 under conditions when exchange is legally permis12 sible. 

13 ‘‘(d) ADDITIONAL PROVISIONS.— 

14 ‘‘(1) INFORMATION SHARING PROVISIONS.—The 

15 National Coordinator may serve as a technical con16 sultant to the Inspector General and the Federal 

17 Trade Commission for purposes of carrying out this 

18 section. The National Coordinator may, notwith19 standing any other provision of law, share informa20 tion related to claims or investigations under sub21 section (b) with the Federal Trade Commission for 

22 purposes of such investigations and shall share infor23 mation with the Inspector General, as required by 

24 law. 
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1 ‘‘(2) PROTECTION FROM DISCLOSURE OF INFOR2 MATION.—Any information that is received by the 

3 National Coordinator in connection with a claim or 

4 suggestion of possible information blocking and that 

5 could reasonably be expected to facilitate identifica6 tion of the source of the information— 

7 ‘‘(A) shall not be disclosed by the National 

8 Coordinator except as may be necessary to carry 

9 out the purpose of this section; 

10 ‘‘(B) shall be exempt from mandatory dis11 closure under section 552 of title 5, United 

12 States Code, as provided by subsection (b)(3) of 

13 such section; and 

14 ‘‘(C) may be used by the Inspector General 

15 or Federal Trade Commission for reporting pur16 poses to the extent that such information could 

17 not reasonably be expected to facilitate identi18 fication of the source of such information. 

19 ‘‘(3) STANDARDIZED PROCESS.— 

20 ‘‘(A) IN GENERAL.—The National Coordi21 nator shall implement a standardized process for 

22 the public to submit reports on claims of— 

23 ‘‘(i) health information technology 

24 products or developers of such products (or 

25 other entities offering such products to 
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1 health care providers) not being interoper2 able or resulting in information blocking; 

3 ‘‘(ii) actions described in subsection 

4 (b)(1) that result in information blocking as 

5 described in subsection (a); and 

6 ‘‘(iii) any other act described in sub7 section (a). 

8 ‘‘(B) COLLECTION OF INFORMATION.—The 

9 standardized process implemented under sub10 paragraph (A) shall provide for the collection of 

11 such information as the originating institution, 

12 location, type of transaction, system and version, 

13 timestamp, terminating institution, locations, 

14 system and version, failure notice, and other re15 lated information. 

16 ‘‘(4) NONDUPLICATION OF PENALTY STRUC17 TURES.—In carrying out this subsection, the Sec18 retary shall, to the extent possible, ensure that pen19 alties do not duplicate penalty structures that would 

20 otherwise apply with respect to information blocking 

21 and the type of individual or entity involved as of the 

22 day before the date of the enactment of this section.’’. 

23 SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO 

24 IMPROVE PATIENT CARE. 

25 (a) REQUIREMENT RELATING TO REGISTRIES.— 
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1 (1) IN GENERAL.—To be certified in accordance 

2 with title XXX of the Public Health Service Act (42 

3 U.S.C. 300jj et seq.), electronic health records shall be 

4 capable of transmitting to, and where applicable, re5 ceiving and accepting data from, registries in accord6 ance with standards recognized by the Office of the 

7 National Coordinator for Health Information Tech8 nology, including clinician-led clinical data reg9 istries, that are also certified to be technically capable 

10 of receiving and accepting from, and where applica11 ble, transmitting data to certified electronic health 

12 record technology in accordance with such standards. 

13 (2) RULE OF CONSTRUCTION.—Nothing in this 

14 subsection shall be construed to require the certifi15 cation of registries beyond the technical capability to 

16 exchange data in accordance with applicable recog17 nized standards. 

18 (b) DEFINITION.—For purposes of this Act, the term 

19 ‘‘clinician-led clinical data registry’’ means a clinical data 

20 repository— 

21 (1) that is established and operated by a clini22 cian-led or controlled, tax-exempt (pursuant to section 

23 501(c) of the Internal Revenue Code of 1986), profes24 sional society or other similar clinician-led or -con25 trolled organization, or such organization’s controlled 
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1 affiliate, devoted to the care of a population defined 

2 by a particular disease, condition, exposure or ther3 apy; 

4 (2) that is designed to collect detailed, standard5 ized data on an ongoing basis for medical procedures, 

6 services, or therapies for particular diseases, condi7 tions, or exposures; 

8 (3) that provides feedback to participants who 

9 submit reports to the repository; 

10 (4) that meets standards for data quality includ11 ing— 

12 (A) systematically collecting clinical and 

13 other health care data, using standardized data 

14 elements and having procedures in place to 

15 verify the completeness and validity of those 

16 data; and 

17 (B) being subject to regular data checks or 

18 audits to verify completeness and validity; and 

19 (5) that provides ongoing participant training 

20 and support. 

21 (c) TREATMENT OF HEALTH INFORMATION TECH22 NOLOGY DEVELOPERS WITH RESPECT TO PATIENT SAFETY

23 ORGANIZATIONS.— 

24 (1) IN GENERAL.—In applying part C of title IX 

25 of the Public Health Service Act (42 U.S.C. 299b–21 
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1 et seq.), a health information technology developer 

2 shall be treated as a provider (as defined in section 

3 921 of such Act) for purposes of reporting and con4 ducting patient safety activities concerning improv5 ing clinical care through the use of health information 

6 technology that could result in improved patient safe7 ty, health care quality, or health care outcomes. 

8 (2) REPORT.—Not later than 4 years after the 

9 date of enactment of this Act, the Secretary of Health 

10 and Human Services shall submit to the Committee 

11 on Health, Education, Labor, and Pensions of the 

12 Senate and the Committee on Energy and Commerce 

13 of the House of Representatives, a report concerning 

14 best practices and current trends voluntarily pro15 vided, without identifying individual providers or 

16 disclosing or using protected health information or 

17 individually identifiable information, by patient safe18 ty organizations to improve the integration of health 

19 information technology into clinical practice. 

20 SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PA21 TIENT ACCESS TO THEIR ELECTRONIC 

22 HEALTH INFORMATION. 

23 (a) USE OF HEALTH INFORMATION EXCHANGES FOR

24 PATIENT ACCESS.—Section 3009 of the Public Health Serv-
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1 ice Act (42 U.S.C. 300jj–19) is amended by adding at the 

2 end the following: 

3 ‘‘(c) PROMOTING PATIENT ACCESS TO ELECTRONIC

4 HEALTH INFORMATION THROUGH HEALTH INFORMATION

5 EXCHANGES .— 

6 ‘‘(1) IN GENERAL.—The Secretary shall use ex7 isting authorities to encourage partnerships between 

8 health information exchange organizations and net9 works and health care providers, health plans, and 

10 other appropriate entities with the goal of offering pa11 tients access to their electronic health information in 

12 a single, longitudinal format that is easy to under13 stand, secure, and may be updated automatically. 

14 ‘‘(2) EDUCATION OF PROVIDERS.—The Secretary, 

15 in coordination with the Office for Civil Rights of the 

16 Department of Health and Human Services, shall— 

17 ‘‘(A) educate health care providers on ways 

18 of leveraging the capabilities of health informa19 tion exchanges (or other relevant platforms) to 

20 provide patients with access to their electronic 

21 health information; 

22 ‘‘(B) clarify misunderstandings by health 

23 care providers about using health information 

24 exchanges (or other relevant platforms) for pa25 tient access to electronic health information; and 
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1 ‘‘(C) to the extent practicable, educate pro2 viders about health information exchanges (or 

3 other relevant platforms) that employ some or all 

4 of the capabilities described in paragraph (1). 

5 ‘‘(3) REQUIREMENTS.—In carrying out para6 graph (1), the Secretary, in coordination with the Of7 fice for Civil Rights, shall issue guidance to health in8 formation exchanges related to best practices to ensure 

9 that the electronic health information provided to pa10 tients is— 

11 ‘‘(A) private and secure; 

12 ‘‘(B) accurate; 

13 ‘‘(C) verifiable; and 

14 ‘‘(D) where a patient’s authorization to ex15 change information is required by law, easily ex16 changed pursuant to such authorization. 

17 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

18 subsection shall be construed to preempt State laws 

19 applicable to patient consent for the access of infor20 mation through a health information exchange (or 

21 other relevant platform) that provide protections to 

22 patients that are greater than the protections other23 wise provided for under applicable Federal law. 

24 ‘‘(d) EFFORTS TO PROMOTE ACCESS TO HEALTH IN25 FORMATION.—The National Coordinator and the Office for 
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1 Civil Rights of the Department of Health and Human Serv2 ices shall jointly promote patient access to health informa3 tion in a manner that would ensure that such information 

4 is available in a form convenient for the patient, in a rea5 sonable manner, without burdening the health care provider 

6 involved. 

7 ‘‘(e) ACCESSIBILITY OF PATIENT RECORDS.— 

8 ‘‘(1) ACCESSIBILITY AND UPDATING OF INFORMA9 TION.— 

10 ‘‘(A) IN GENERAL.—The Secretary, in con11 sultation with the National Coordinator, shall 

12 promote policies that ensure that a patient’s elec13 tronic health information is accessible to that 

14 patient and the patient’s designees, in a manner 

15 that facilitates communication with the patient’s 

16 health care providers and other individuals, in17 cluding researchers, consistent with such pa18 tient’s consent. 

19 ‘‘(B) UPDATING EDUCATION ON ACCESSING

20 AND EXCHANGING PERSONAL HEALTH INFORMA21 TION.—To promote awareness that an individual 

22 has a right of access to inspect, obtain a copy of, 

23 and transmit to a third party a copy of such in24 dividual’s protected health information pursuant 

25 to the Health Information Portability and Ac-
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1 countability Act, Privacy Rule (subpart E of 

2 part 164 of title 45, Code of Federal Regula3 tions), the Director of the Office for Civil Rights, 

4 in consultation with the National Coordinator, 

5 shall assist individuals and health care providers 

6 in understanding a patient’s rights to access and 

7 protect personal health information under the 

8 Health Insurance Portability and Accountability 

9 Act of 1996 (Public Law 104–191), including 

10 providing best practices for requesting personal 

11 health information in a computable format, in12 cluding using patient portals or third-party ap13 plications and common cases when a provider is 

14 permitted to exchange and provide access to 

15 health information.’’. 

16 ‘‘(2) CERTIFYING USABILITY FOR PATIENTS.—In 

17 carrying out certification programs under section 

18 3001(c)(5), the National Coordinator may require 

19 that— 

20 ‘‘(A) the certification criteria support— 

21 ‘‘(i) patient access to their electronic 

22 health information, including in a single 

23 longitudinal format that is easy to under24 stand, secure, and may be updated auto25 matically; 
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1 ‘‘(ii) the patient’s ability to electroni2 cally communicate patient-reported infor3 mation (such as family history and medical 

4 history); and 

5 ‘‘(iii) patient access to their personal 

6 electronic health information for research at 

7 the option of the patient; and 

8 ‘‘(B) the HIT Advisory Committee develop 

9 and prioritize standards, implementation speci10 fications, and certification criteria required to 

11 help support patient access to electronic health 

12 information, patient usability, and support for 

13 technologies that offer patients access to their 

14 electronic health information in a single, longi15 tudinal format that is easy to understand, se16 cure, and may be updated automatically.’’. 

17 (b) ACCESS TO INFORMATION IN AN ELECTRONIC FOR18 MAT.—Section 13405(e) of the Health Information Tech19 nology for Economic and Clinical Health Act (42 U.S.C. 

20 17935) is amended— 

21 (1) in paragraph (1), by striking ‘‘and’’ at the 

22 end; 

23 (2) by redesignating paragraph (2) as para24 graph (3); and 
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1 (3) by inserting after paragraph (1), the fol2 lowing: 

3 ‘‘(2) if the individual makes a request to a busi4 ness associate for access to, or a copy of, protected 

5 health information about the individual, or if an in6 dividual makes a request to a business associate to 

7 grant such access to, or transmit such copy directly 

8 to, a person or entity designated by the individual, a 

9 business associate may provide the individual with 

10 such access or copy, which may be in an electronic 

11 form, or grant or transmit such access or copy to such 

12 person or entity designated by the individual; and’’. 

13 SEC. 4007. GAO STUDY ON PATIENT MATCHING. 

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

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

16 United States shall conduct a study to— 

17 (1) review the policies and activities of the Office 

18 of the National Coordinator for Health Information 

19 Technology and other relevant stakeholders, which 

20 may include standards development organizations, ex21 perts in the technical aspects of health information 

22 technology, health information technology developers, 

23 providers of health services, health care suppliers, 

24 health care payers, health care quality organizations, 

25 States, health information technology policy experts, 
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•HR 34 EAH 

1 and other appropriate entities, to ensure appropriate 

2 patient matching to protect patient privacy and secu3 rity with respect to electronic health records and the 

4 exchange of electronic health information; and 

5 (2) survey ongoing efforts related to the policies 

6 and activities described in paragraph (1) and the ef7 fectiveness of such efforts occurring in the private sec8 tor. 

9 (b) AREAS OF CONCENTRATION.—In conducting the 

10 study under subsection (a), the Comptroller General shall— 

11 (1) evaluate current methods used in certified 

12 electronic health records for patient matching based 

13 on performance related to factors such as— 

14 (A) the privacy of patient information; 

15 (B) the security of patient information; 

16 (C) improving matching rates; 

17 (D) reducing matching errors; and 

18 (E) reducing duplicate records; and 

19 (2) determine whether the Office of the National 

20 Coordinator for Health Information Technology could 

21 improve patient matching by taking steps includ22 ing— 

23 (A) defining additional data elements to as24 sist in patient data matching; 
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1 (B) agreeing on a required minimum set of 

2 elements that need to be collected and exchanged; 

3 (C) requiring electronic health records to 

4 have the ability to make certain fields required 

5 and use specific standards; and 

6 (D) other options recommended by the rel7 evant stakeholders consulted pursuant to sub8 section (a). 

9 (c) REPORT.—Not later than 2 years after the date of 

10 enactment of this Act, the Comptroller General shall submit 

11 to the appropriate committees of Congress a report con12 cerning the findings of the study conducted under subsection 

13 (a). 

14 SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH IN15 FORMATION. 

16 (a) STUDY.— 

17 (1) IN GENERAL.—The Comptroller General of 

18 the United States (referred to in this section as the 

19 ‘‘Comptroller General’’) shall build on prior Govern20 ment Accountability Office studies and other lit21 erature review and conduct a study to review patient 

22 access to their own protected health information, in23 cluding barriers to such patient access and complica24 tions or difficulties providers experience in providing 

25 access to patients. In conducting such study, the 
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1 Comptroller General shall consider the increase in 

2 adoption of health information technology and the in3 creasing prevalence of protected health information 

4 that is maintained electronically. 

5 (2) AREAS OF CONCENTRATION.—In conducting 

6 the review under paragraph (1), the Comptroller Gen7 eral shall consider— 

8 (A) instances when covered entities charge 

9 individuals, including patients, third parties, 

10 and health care providers, for record requests, in11 cluding records that are requested in an elec12 tronic format; 

13 (B) examples of the amounts and types of 

14 fees charged to individuals for record requests, 

15 including instances when the record is requested 

16 to be transmitted to a third party; 

17 (C) the extent to which covered entities are 

18 unable to provide the access requested by individ19 uals in the form and format requested by the in20 dividual, including examples of such instances; 

21 (D) instances in which third parties may 

22 request protected health information through pa23 tients’ individual right of access, including in24 stances where such requests may be used to cir-
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1 cumvent appropriate fees that may be charged to 

2 third parties; 

3 (E) opportunities that permit covered enti4 ties to charge appropriate fees to third parties 

5 for patient records while providing patients with 

6 access to their protected health information at 

7 low or no cost; 

8 (F) the ability of providers to distinguish 

9 between requests originating from an individual 

10 that require limitation to a cost-based fee and re11 quests originating from third parties that may 

12 not be limited to cost-based fees; and 

13 (G) other circumstances that may inhibit 

14 the ability of providers to provide patients with 

15 access to their records, and the ability of patients 

16 to gain access to their records. 

17 (b) REPORT.—Not later than 18 months after the date 

18 of enactment of this Act, the Comptroller General shall sub19 mit a report to Congress on the findings of the study con20 ducted under subsection (a). 

21 SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DE22 TERMINATIONS. 

23 (a) IN GENERAL.—Section 1862(l)(5) of the Social Se24 curity Act (42 U.S.C. 1395y(l)(5)) is amended by adding 

25 at the end the following new subparagraph: 
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1 ‘‘(D) LOCAL COVERAGE DETERMINATIONS.— 

2 The Secretary shall require each Medicare ad3 ministrative contractor that develops a local cov4 erage determination to make available on the 

5 Internet website of such contractor and on the 

6 Medicare Internet website, at least 45 days before 

7 the effective date of such determination, the fol8 lowing information: 

9 ‘‘(i) Such determination in its en10 tirety. 

11 ‘‘(ii) Where and when the proposed de12 termination was first made public. 

13 ‘‘(iii) Hyperlinks to the proposed deter14 mination and a response to comments sub15 mitted to the contractor with respect to such 

16 proposed determination. 

17 ‘‘(iv) A summary of evidence that was 

18 considered by the contractor during the de19 velopment of such determination and a list 

20 of the sources of such evidence. 

21 ‘‘(v) An explanation of the rationale 

22 that supports such determination.’’. 

23 (b) EFFECTIVE DATE.—The amendment made by sub24 section (a) shall apply with respect to local coverage deter-
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1 minations that are proposed or revised on or after the date 

2 that is 180 days after the date of enactment of this Act. 

3 SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY 

4 OMBUDSMAN. 

5 Section 1808 of the Social Security Act (42 U.S.C. 

6 1395b–9) is amended by adding at the end the following 

7 new subsection: 

8 ‘‘(d) PHARMACEUTICAL AND TECHNOLOGY OMBUDS9 MAN.— 

10 ‘‘(1) IN GENERAL.—Not later than 12 months 

11 after the date of enactment of this paragraph, the Sec12 retary shall provide for a pharmaceutical and tech13 nology ombudsman within the Centers for Medicare & 

14 Medicaid Services who shall receive and respond to 

15 complaints, grievances, and requests that— 

16 ‘‘(A) are from entities that manufacture 

17 pharmaceutical, biotechnology, medical device, or 

18 diagnostic products that are covered or for which 

19 coverage is being sought under this title; and 

20 ‘‘(B) are with respect to coverage, coding, or 

21 payment under this title for such products. 

22 ‘‘(2) APPLICATION.—The second sentence of sub23 section (c)(2) shall apply to the ombudsman under 

24 subparagraph (A) in the same manner as such sen-
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1 tence applies to the Medicare Beneficiary Ombuds2 man under subsection (c).’’. 

3 SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANS4 PARENCY. 

5 Section 1834 of the Social Security Act (42 U.S.C. 

6 1395m) is amended by adding at the end the following new 

7 subsection: 

8 ‘‘(t) SITE-OF-SERVICE PRICE TRANSPARENCY.— 

9 ‘‘(1) IN GENERAL.—In order to facilitate price 

10 transparency with respect to items and services for 

11 which payment may be made either to a hospital out12 patient department or to an ambulatory surgical cen13 ter under this title, the Secretary shall, for 2018 and 

14 each year thereafter, make available to the public via 

15 a searchable Internet website, with respect to an ap16 propriate number of such items and services— 

17 ‘‘(A) the estimated payment amount for the 

18 item or service under the outpatient department 

19 fee schedule under subsection (t) of section 1833 

20 and the ambulatory surgical center payment sys21 tem under subsection (i) of such section; and 

22 ‘‘(B) the estimated amount of beneficiary li23 ability applicable to the item or service. 

24 ‘‘(2) CALCULATION OF ESTIMATED BENEFICIARY

25 LIABILITY.—For purposes of paragraph (1)(B), the es-
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1 timated amount of beneficiary liability, with respect 

2 to an item or service, is the amount for such item or 

3 service for which an individual who does not have 

4 coverage under a Medicare supplemental policy cer5 tified under section 1882 or any other supplemental 

6 insurance coverage is responsible. 

7 ‘‘(3) IMPLEMENTATION.—In carrying out this 

8 subsection, the Secretary— 

9 ‘‘(A) shall include in the notice described in 

10 section 1804(a) a notification of the availability 

11 of the estimated amounts made available under 

12 paragraph (1); and 

13 ‘‘(B) may utilize mechanisms in existence 

14 on the date of enactment of this subsection, such 

15 as the portion of the Internet website of the Cen16 ters for Medicare & Medicaid Services on which 

17 information comparing physician performance is 

18 posted (commonly referred to as the Physician 

19 Compare Internet website), to make available 

20 such estimated amounts under such paragraph. 

21 ‘‘(4) FUNDING.—For purposes of implementing 

22 this subsection, the Secretary shall provide for the 

23 transfer, from the Federal Supplementary Medical In24 surance Trust Fund under section 1841 to the Centers 

25 for Medicare & Medicaid Services Program Manage-
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1 ment Account, of $6,000,000 for fiscal year 2017, to 

2 remain available until expended.’’. 

3 SEC. 4012. TELEHEALTH SERVICES IN MEDICARE. 

4 (a) PROVISION OF INFORMATION BY CENTERS FOR

5 MEDICARE & MEDICAID SERVICES.—Not later than 1 year 

6 after the date of enactment of this Act, the Administrator 

7 of the Centers for Medicare & Medicaid Services shall pro8 vide to the committees of jurisdiction of the House of Rep9 resentatives and the Senate information on the following: 

10 (1) The populations of Medicare beneficiaries, 

11 such as those who are dually eligible for the Medicare 

12 program under title XVIII of the Social Security Act 

13 (42 U.S.C. 1395 et seq.) and the Medicaid program 

14 under title XIX of such Act (42 U.S.C. 1396 et seq.) 

15 and those with chronic conditions, whose care may be 

16 improved most in terms of quality and efficiency by 

17 the expansion, in a manner that meets or exceeds the 

18 existing in-person standard of care under the Medi19 care program under such title XVIII, of telehealth 

20 services under section 1834(m)(4) of such Act (42 

21 U.S.C. 1395m(m)(4)). 

22 (2) Activities by the Center for Medicare and 

23 Medicaid Innovation which examine the use of tele24 health services in models, projects, or initiatives fund-
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1 ed through section 1115A of such Act (42 U.S.C. 

2 1315a). 

3 (3) The types of high-volume services (and re4 lated diagnoses) under such title XVIII which might 

5 be suitable to be furnished using telehealth. 

6 (4) Barriers that might prevent the expansion of 

7 telehealth services under section 1834(m)(4) of the So8 cial Security Act (42 U.S.C. 1395m(m)(4)) beyond 

9 such services that are in effect as of the date of enact10 ment of this Act. 

11 (b) PROVISION OF INFORMATION BY MEDPAC.—Not 

12 later than March 15, 2018, the Medicare Payment Advisory 

13 Commission established under section 1805 of the Social Se14 curity Act (42 U.S.C. 1395b–6) shall, using quantitative 

15 and qualitative research methods, provide information to 

16 the committees of jurisdiction of the House of Representa17 tives and the Senate that identifies— 

18 (1) the telehealth services for which payment can 

19 be made, as of the date of enactment of this Act, 

20 under the fee-for-service program under parts A and 

21 B of title XVIII of such Act; 

22 (2) the telehealth services for which payment can 

23 be made, as of such date, under private health insur24 ance plans; and 
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1 (3) with respect to services identified under 

2 paragraph (2) but not under paragraph (1), ways in 

3 which payment for such services might be incor4 porated into such fee-for-service program (including 

5 any recommendations for ways to accomplish this in6 corporation). 

7 (c) SENSE OF CONGRESS.—It is the sense of Congress 

8 that— 

9 (1) eligible originating sites should be expanded 

10 beyond those originating sites described in section 

11 1834(m)(4)(C) of the Social Security Act (42 U.S.C. 

12 1395m(m)(4)(C)); and 

13 (2) any expansion of telehealth services under the 

14 Medicare program under title XVIII of such Act 

15 should— 

16 (A) recognize that telemedicine is the deliv17 ery of safe, effective, quality health care services, 

18 by a health care provider, using technology as 

19 the mode of care delivery; 

20 (B) meet or exceed the conditions of cov21 erage and payment with respect to the Medicare 

22 program if the service was furnished in person, 

23 including standards of care, unless specifically 

24 addressed in subsequent legislation; and 
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1 (C) involve clinically appropriate means to 

2 furnish such services. 

3 TITLE V—SAVINGS 

4 SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT 

5 FUND. 

6 Section 1898(b)(1) of the Social Security Act (42 

7 U.S.C. 1395iii(b)(1)), as amended by section 704(h) of the 

8 Comprehensive Addiction and Recovery Act of 2016, is 

9 amended by striking ‘‘$140,000,000’’ and inserting 

10 ‘‘$270,000,000’’. 

11 SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DU12 RABLE MEDICAL EQUIPMENT. 

13 Section 1903(i)(27) of the Social Security Act (42 

14 U.S.C. 1396b(i)(27)) is amended by striking ‘‘January 1, 

15 2019’’ and inserting ‘‘January 1, 2018’’. 

16 SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CON17 TRACTS, AND OTHER AGREEMENTS. 

18 (a) IN GENERAL.—Section 1128A of the Social Secu19 rity Act (42 U.S.C. 1320a–7a) is amended by adding at 

20 the end the following new subsections: 

21 ‘‘(o) Any person (including an organization, agency, 

22 or other entity, but excluding a program beneficiary, as de23 fined in subsection (q)(4)) that, with respect to a grant, 

24 contract, or other agreement for which the Secretary pro25 vides funding— 
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1 ‘‘(1) knowingly presents or causes to be presented 

2 a specified claim (as defined in subsection (r)) under 

3 such grant, contract, or other agreement that the per4 son knows or should know is false or fraudulent; 

5 ‘‘(2) knowingly makes, uses, or causes to be made 

6 or used any false statement, omission, or misrepresen7 tation of a material fact in any application, pro8 posal, bid, progress report, or other document that is 

9 required to be submitted in order to directly or indi10 rectly receive or retain funds provided in whole or in 

11 part by such Secretary pursuant to such grant, con12 tract, or other agreement; 

13 ‘‘(3) knowingly makes, uses, or causes to be made 

14 or used, a false record or statement material to a false 

15 or fraudulent specified claim under such grant, con16 tract, or other agreement; 

17 ‘‘(4) knowingly makes, uses, or causes to be made 

18 or used, a false record or statement material to an ob19 ligation (as defined in subsection (s)) to pay or trans20 mit funds or property to such Secretary with respect 

21 to such grant, contract, or other agreement, or know22 ingly conceals or knowingly and improperly avoids or 

23 decreases an obligation to pay or transmit funds or 

24 property to such Secretary with respect to such grant, 

25 contract, or other agreement; or 
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1 ‘‘(5) fails to grant timely access, upon reasonable 

2 request (as defined by such Secretary in regulations), 

3 to the Inspector General of the Department, for the 

4 purpose of audits, investigations, evaluations, or other 

5 statutory functions of such Inspector General in mat6 ters involving such grants, contracts, or other agree7 ments; 

8 shall be subject, in addition to any other penalties that may 

9 be prescribed by law, to a civil money penalty in cases 

10 under paragraph (1), of not more than $10,000 for each 

11 specified claim; in cases under paragraph (2), not more 

12 than $50,000 for each false statement, omission, or mis13 representation of a material fact; in cases under paragraph 

14 (3), not more than $50,000 for each false record or state15 ment; in cases under paragraph (4), not more than $50,000 

16 for each false record or statement or $10,000 for each day 

17 that the person knowingly conceals or knowingly and im18 properly avoids or decreases an obligation to pay; or in 

19 cases under paragraph (5), not more than $15,000 for each 

20 day of the failure described in such paragraph. In addition, 

21 in cases under paragraphs (1) and (3), such a person shall 

22 be subject to an assessment of not more than 3 times the 

23 amount claimed in the specified claim described in such 

24 paragraph in lieu of damages sustained by the United 

25 States or a specified State agency because of such specified 
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1 claim, and in cases under paragraphs (2) and (4), such 

2 a person shall be subject to an assessment of not more than 

3 3 times the total amount of the funds described in para4 graph (2) or (4), respectively (or, in the case of an obliga5 tion to transmit property to the Secretary described in 

6 paragraph (4), of the value of the property described in such 

7 paragraph) in lieu of damages sustained by the United 

8 States or a specified State agency because of such case. In 

9 addition, the Secretary may make a determination in the 

10 same proceeding to exclude the person from participation 

11 in the Federal health care programs (as defined in section 

12 1128B(f)(1)) and to direct the appropriate State agency to 

13 exclude the person from participation in any State health 

14 care program. 

15 ‘‘(p) The provisions of subsections (c), (d), (g), and (h) 

16 shall apply to a civil money penalty or assessment under 

17 subsection (o) in the same manner as such provisions apply 

18 to a penalty, assessment, or proceeding under subsection 

19 (a). In applying subsection (d), each reference to a claim 

20 under such subsection shall be treated as including a ref21 erence to a specified claim (as defined in subsection (r)). 

22 ‘‘(q) For purposes of this subsection and subsections 

23 (o) and (p): 

24 ‘‘(1) The term ‘Department’ means the Depart25 ment of Health and Human Services. 
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1 ‘‘(2) The term ‘material’ means having a natural 

2 tendency to influence, or be capable of influencing, the 

3 payment or receipt of money or property. 

4 ‘‘(3) The term ‘other agreement’ includes a coop5 erative agreement, scholarship, fellowship, loan, sub6 sidy, payment for a specified use, donation agree7 ment, award, or subaward (regardless of whether one 

8 or more of the persons entering into the agreement is 

9 a contractor or subcontractor). 

10 ‘‘(4) The term ‘program beneficiary’ means, in 

11 the case of a grant, contract, or other agreement de12 signed to accomplish the objective of awarding or oth13 erwise furnishing benefits or assistance to individuals 

14 and for which the Secretary provides funding, an in15 dividual who applies for, or who receives, such bene16 fits or assistance from such grant, contract, or other 

17 agreement. Such term does not include, with respect 

18 to such grant, contract, or other agreement, an officer, 

19 employee, or agent of a person or entity that receives 

20 such grant or that enters into such contract or other 

21 agreement. 

22 ‘‘(5) The term ‘recipient’ includes a subrecipient 

23 or subcontractor. 

24 ‘‘(6) The term ‘specified State agency’ means an 

25 agency of a State government established or des-
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1 ignated to administer or supervise the administration 

2 of a grant, contract, or other agreement funded in 

3 whole or in part by the Secretary. 

4 ‘‘(r) For purposes of this section, the term ‘specified 

5 claim’ means any application, request, or demand under 

6 a grant, contract, or other agreement for money or property, 

7 whether or not the United States or a specified State agency 

8 has title to the money or property, that is not a claim (as 

9 defined in subsection (i)(2)) and that— 

10 ‘‘(1) is presented or caused to be presented to an 

11 officer, employee, or agent of the Department or agen12 cy thereof, or of any specified State agency; or 

13 ‘‘(2) is made to a contractor, grantee, or any 

14 other recipient if the money or property is to be spent 

15 or used on the Department’s behalf or to advance a 

16 Department program or interest, and if the Depart17 ment— 

18 ‘‘(A) provides or has provided any portion 

19 of the money or property requested or demanded; 

20 or 

21 ‘‘(B) will reimburse such contractor, grant22 ee, or other recipient for any portion of the 

23 money or property which is requested or de24 manded. 
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1 ‘‘(s) For purposes of subsection (o), the term ‘obliga2 tion’ means an established duty, whether or not fixed, aris3 ing from an express or implied contractual, grantor-grant4 ee, or licensor-licensee relationship, for a fee-based or simi5 lar relationship, from statute or regulation, or from the re6 tention of any overpayment.’’. 

7 (b) CONFORMING AMENDMENTS.—Section 1128A of the 

8 Social Security Act (42 U.S.C. 1320a–7a) is amended— 

9 (1) in subsection (e), by inserting ‘‘or specified 

10 claim’’ after ‘‘claim’’ in the first sentence; and 

11 (2) in subsection (f)— 

12 (A) in the matter preceding paragraph 

13 (1)— 

14 (i) by inserting ‘‘or specified claim (as 

15 defined in subsection (r))’’ after ‘‘district 

16 where the claim’’; and 

17 (ii) by inserting ‘‘(or, with respect to a 

18 person described in subsection (o), the per19 son)’’ after ‘‘claimant’’; and 

20 (B) in the matter following paragraph (4), 

21 by inserting ‘‘(or, in the case of a penalty or as22 sessment under subsection (o), by a specified 

23 State agency (as defined in subsection (q)(6)),’’ 

24 after ‘‘or a State agency’’. 
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1 SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION 

2 DRUGS. 

3 (a) TREATMENT OF INFUSION DRUGS FURNISHED

4 THROUGH DURABLE MEDICAL EQUIPMENT.—Section 

5 1842(o)(1) of the Social Security Act (42 U.S.C. 

6 1395u(o)(1)) is amended— 

7 (1) in subparagraph (C), by inserting ‘‘(and in8 cluding a drug or biological described in subpara9 graph (D)(i) furnished on or after January 1, 2017)’’ 

10 after ‘‘2005’’; and 

11 (2) in subparagraph (D)— 

12 (A) by striking ‘‘infusion drugs’’ and insert13 ing ‘‘infusion drugs or biologicals’’ each place it 

14 appears; and 

15 (B) in clause (i)— 

16 (i) by striking ‘‘2004’’ and inserting 

17 ‘‘2004, and before January 1, 2017’’; and 

18 (ii) by striking ‘‘for such drug’’. 

19 (b) NONINCLUSION OF DME INFUSION DRUGS UNDER

20 DME COMPETITIVE ACQUISITION PROGRAMS.— 

21 (1) IN GENERAL.—Section 1847(a)(2)(A) of the 

22 Social Security Act (42 U.S.C. 1395w–3(a)(2)(A)) is 

23 amended— 

24 (A) by striking ‘‘and excluding’’ and insert25 ing ‘‘, excluding’’; and 
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•HR 34 EAH 

1 (B) by inserting before the period at the end 

2 the following: ‘‘, and excluding drugs and 

3 biologicals described in section 1842(o)(1)(D)’’. 

4 (2) CONFORMING AMENDMENT.—Section 

5 1842(o)(1)(D)(ii) of the Social Security Act (42 

6 U.S.C. 1395u(o)(1)(D)(ii)) is amended by striking 

7 ‘‘2007’’ and inserting ‘‘2007, and before the date of 

8 the enactment of the 21st Century Cures Act.’’. 

9 SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF 

10 MEDICAID PROVIDERS. 

11 (a) INCREASED OVERSIGHT AND REPORTING.— 

12 (1) STATE REPORTING REQUIREMENTS.—Section 

13 1902(kk) of the Social Security Act (42 U.S.C. 

14 1396a(kk)) is amended— 

15 (A) by redesignating paragraph (8) as 

16 paragraph (9); and 

17 (B) by inserting after paragraph (7) the fol18 lowing new paragraph: 

19 ‘‘(8) PROVIDER TERMINATIONS.— 

20 ‘‘(A) IN GENERAL.—Beginning on July 1, 

21 2018, in the case of a notification under sub22 section (a)(41) with respect to a termination for 

23 a reason specified in section 455.101 of title 42, 

24 Code of Federal Regulations (as in effect on No25 vember 1, 2015) or for any other reason specified 
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1 by the Secretary, of the participation of a pro2 vider of services or any other person under the 

3 State plan (or under a waiver of the plan), the 

4 State, not later than 30 days after the effective 

5 date of such termination, submits to the Sec6 retary with respect to any such provider or per7 son, as appropriate— 

8 ‘‘(i) the name of such provider or per9 son; 

10 ‘‘(ii) the provider type of such provider 

11 or person; 

12 ‘‘(iii) the specialty of such provider’s 

13 or person’s practice; 

14 ‘‘(iv) the date of birth, Social Security 

15 number, national provider identifier (if ap16 plicable), Federal taxpayer identification 

17 number, and the State license or certifi18 cation number of such provider or person (if 

19 applicable); 

20 ‘‘(v) the reason for the termination; 

21 ‘‘(vi) a copy of the notice of termi22 nation sent to the provider or person; 

23 ‘‘(vii) the date on which such termi24 nation is effective, as specified in the notice; 

25 and 
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1 ‘‘(viii) any other information required 

2 by the Secretary. 

3 ‘‘(B) EFFECTIVE DATE DEFINED.—For pur4 poses of this paragraph, the term ‘effective date’ 

5 means, with respect to a termination described 

6 in subparagraph (A), the later of— 

7 ‘‘(i) the date on which such termi8 nation is effective, as specified in the notice 

9 of such termination; or 

10 ‘‘(ii) the date on which all appeal 

11 rights applicable to such termination have 

12 been exhausted or the timeline for any such 

13 appeal has expired.’’. 

14 (2) CONTRACT REQUIREMENT FOR MANAGED

15 CARE ENTITIES.—Section 1932(d) of the Social Secu16 rity Act (42 U.S.C. 1396u–2(d)) is amended by add17 ing at the end the following new paragraph: 

18 ‘‘(5) CONTRACT REQUIREMENT FOR MANAGED

19 CARE ENTITIES.—With respect to any contract with a 

20 managed care entity under section 1903(m) or 

21 1905(t)(3) (as applicable), no later than July 1, 2018, 

22 such contract shall include a provision that providers 

23 of services or persons terminated (as described in sec24 tion 1902(kk)(8)) from participation under this title, 

25 title XVIII, or title XXI shall be terminated from par-
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1 ticipating under this title as a provider in any net2 work of such entity that serves individuals eligible to 

3 receive medical assistance under this title.’’. 

4 (3) TERMINATION NOTIFICATION DATABASE.— 

5 Section 1902 of the Social Security Act (42 U.S.C. 

6 1396a) is amended by adding at the end the following 

7 new subsection: 

8 ‘‘(ll) TERMINATION NOTIFICATION DATABASE.—In the 

9 case of a provider of services or any other person whose 

10 participation under this title or title XXI is terminated (as 

11 described in subsection (kk)(8)), the Secretary shall, not 

12 later than 30 days after the date on which the Secretary 

13 is notified of such termination under subsection (a)(41) (as 

14 applicable), review such termination and, if the Secretary 

15 determines appropriate, include such termination in any 

16 database or similar system developed pursuant to section 

17 6401(b)(2) of the Patient Protection and Affordable Care 

18 Act (42 U.S.C. 1395cc note; Public Law 111–148).’’. 

19 (4) NO FEDERAL FUNDS FOR ITEMS AND SERV20 ICES FURNISHED BY TERMINATED PROVIDERS.—Sec21 tion 1903 of the Social Security Act (42 U.S.C. 

22 1396b) is amended— 

23 (A) in subsection (i)(2)— 
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1 (i) in subparagraph (A), by striking 

2 the comma at the end and inserting a semi3 colon; 

4 (ii) in subparagraph (B), by striking 

5 ‘‘or’’ at the end; and 

6 (iii) by adding at the end the following 

7 new subparagraph: 

8 ‘‘(D) beginning on July 1, 2018, under the 

9 plan by any provider of services or person whose 

10 participation in the State plan is terminated (as 

11 described in section 1902(kk)(8)) after the date 

12 that is 60 days after the date on which such ter13 mination is included in the database or other 

14 system under section 1902(ll); or’’; and 

15 (B) in subsection (m), by inserting after 

16 paragraph (2) the following new paragraph: 

17 ‘‘(3) No payment shall be made under this title to a 

18 State with respect to expenditures incurred by the State for 

19 payment for services provided by a managed care entity 

20 (as defined under section 1932(a)(1)) under the State plan 

21 under this title (or under a waiver of the plan) unless the 

22 State— 

23 ‘‘(A) beginning on July 1, 2018, has a contract 

24 with such entity that complies with the requirement 

25 specified in section 1932(d)(5); and 
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•HR 34 EAH 

1 ‘‘(B) beginning on January 1, 2018, complies 

2 with the requirement specified in section 

3 1932(d)(6)(A).’’. 

4 (5) DEVELOPMENT OF UNIFORM TERMINOLOGY

5 FOR REASONS FOR PROVIDER TERMINATION.—Not 

6 later than July 1, 2017, the Secretary of Health and 

7 Human Services shall, in consultation with the heads 

8 of State agencies administering State Medicaid plans 

9 (or waivers of such plans), issue regulations estab10 lishing uniform terminology to be used with respect to 

11 specifying reasons under subparagraph (A)(v) of 

12 paragraph (8) of section 1902(kk) of the Social Secu13 rity Act (42 U.S.C. 1396a(kk)), as added by para14 graph (1), for the termination (as described in such 

15 paragraph (8)) of the participation of certain pro16 viders in the Medicaid program under title XIX of 

17 such Act or the Children’s Health Insurance Program 

18 under title XXI of such Act. 

19 (6) CONFORMING AMENDMENT.—Section 

20 1902(a)(41) of the Social Security Act (42 U.S.C. 

21 1396a(a)(41)) is amended by striking ‘‘provide that 

22 whenever’’ and inserting ‘‘provide, in accordance with 

23 subsection (kk)(8) (as applicable), that whenever’’. 

24 (b) INCREASING AVAILABILITY OF MEDICAID PRO25 VIDER INFORMATION.— 
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1 (1) FFS PROVIDER ENROLLMENT.—Section 

2 1902(a) of the Social Security Act (42 U.S.C. 

3 1396a(a)) is amended by inserting after paragraph 

4 (77) the following new paragraph: 

5 ‘‘(78) provide that, not later than January 1, 

6 2017, in the case of a State that pursuant to its State 

7 plan or waiver of the plan for medical assistance 

8 pays for medical assistance on a fee-for-service basis, 

9 the State shall require each provider furnishing items 

10 and services to, or ordering, prescribing, referring, or 

11 certifying eligibility for, services for individuals eligi12 ble to receive medical assistance under such plan to 

13 enroll with the State agency and provide to the State 

14 agency the provider’s identifying information, includ15 ing the name, specialty, date of birth, Social Security 

16 number, national provider identifier (if applicable), 

17 Federal taxpayer identification number, and the 

18 State license or certification number of the provider 

19 (if applicable);’’. 

20 (2) MANAGED CARE PROVIDER ENROLLMENT.— 

21 Section 1932(d) of the Social Security Act (42 U.S.C. 

22 1396u–2(d)), as amended by subsection (a)(2), is 

23 amended by adding at the end the following new 

24 paragraph: 
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•HR 34 EAH 

1 ‘‘(6) ENROLLMENT OF PARTICIPATING PRO2 VIDERS.— 

3 ‘‘(A) IN GENERAL.—Beginning not later 

4 than January 1, 2018, a State shall require that, 

5 in order to participate as a provider in the net6 work of a managed care entity that provides 

7 services to, or orders, prescribes, refers, or cer8 tifies eligibility for services for, individuals who 

9 are eligible for medical assistance under the 

10 State plan under this title (or under a waiver of 

11 the plan) and who are enrolled with the entity, 

12 the provider is enrolled consistent with section 

13 1902(kk) with the State agency administering 

14 the State plan under this title. Such enrollment 

15 shall include providing to the State agency the 

16 provider’s identifying information, including the 

17 name, specialty, date of birth, Social Security 

18 number, national provider identifier, Federal 

19 taxpayer identification number, and the State li20 cense or certification number of the provider. 

21 ‘‘(B) RULE OF CONSTRUCTION.—Nothing in 

22 subparagraph (A) shall be construed as requiring 

23 a provider described in such subparagraph to 

24 provide services to individuals who are not en-
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1 rolled with a managed care entity under this 

2 title.’’. 

3 (c) COORDINATION WITH CHIP.— 

4 (1) IN GENERAL.—Section 2107(e)(1) of the So5 cial Security Act (42 U.S.C. 1397gg(e)(1)) is amend6 ed— 

7 (A) by redesignating subparagraphs (B), 

8 (C), (D), (E), (F), (G), (H), (I), (J), (K), (L), 

9 (M), (N), and (O) as subparagraphs (D), (E), 

10 (F), (G), (H), (I), (J), (K), (M), (N), (O), (P), 

11 (Q), and (R), respectively; 

12 (B) by inserting after subparagraph (A) the 

13 following new subparagraphs: 

14 ‘‘(B) Section 1902(a)(39) (relating to termi15 nation of participation of certain providers). 

16 ‘‘(C) Section 1902(a)(78) (relating to enroll17 ment of providers participating in State plans 

18 providing medical assistance on a fee-for-service 

19 basis).’’; 

20 (C) by inserting after subparagraph (K) (as 

21 redesignated by subparagraph (A)) the following 

22 new subparagraph: 

23 ‘‘(L) Section 1903(m)(3) (relating to limi24 tation on payment with respect to managed 

25 care).’’; and 
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1 (D) in subparagraph (P) (as redesignated 

2 by subparagraph (A)), by striking ‘‘(a)(2)(C) 

3 and (h)’’ and inserting ‘‘(a)(2)(C) (relating to 

4 Indian enrollment), (d)(5) (relating to contract 

5 requirement for managed care entities), (d)(6) 

6 (relating to enrollment of providers participating 

7 with a managed care entity), and (h) (relating 

8 to special rules with respect to Indian enrollees, 

9 Indian health care providers, and Indian man10 aged care entities)’’. 

11 (2) EXCLUDING FROM MEDICAID PROVIDERS EX12 CLUDED FROM CHIP.—Section 1902(a)(39) of the So13 cial Security Act (42 U.S.C. 1396a(a)(39)) is amend14 ed by striking ‘‘title XVIII or any other State plan 

15 under this title’’ and inserting ‘‘title XVIII, any other 

16 State plan under this title (or waiver of the plan), or 

17 any State child health plan under title XXI (or waiv18 er of the plan) and such termination is included by 

19 the Secretary in any database or similar system de20 veloped pursuant to section 6401(b)(2) of the Patient 

21 Protection and Affordable Care Act’’. 

22 (d) RULE OF CONSTRUCTION.—Nothing in this section 

23 shall be construed as changing or limiting the appeal rights 

24 of providers or the process for appeals of States under the 

25 Social Security Act. 
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•HR 34 EAH 

1 (e) OIG REPORT.—Not later than March 31, 2020, the 

2 Inspector General of the Department of Health and Human 

3 Services shall submit to Congress a report on the implemen4 tation of the amendments made by this section. Such report 

5 shall include the following: 

6 (1) An assessment of the extent to which pro7 viders who are included under subsection (ll) of sec8 tion 1902 of the Social Security Act (42 U.S.C. 

9 1396a) (as added by subsection (a)(3)) in the data10 base or similar system referred to in such subsection 

11 are terminated (as described in paragraph (8) of sub12 section (kk) of such section, as added by subsection 

13 (a)(1)) from participation in all State plans under 

14 title XIX of such Act (or waivers of such plans). 

15 (2) Information on the amount of Federal finan16 cial participation paid to States under section 1903 

17 of such Act in violation of the limitation on such pay18 ment specified in subparagraph (D) of subsection 

19 (i)(2) of such section and paragraph (3) of subsection 

20 (m) of such section, as added by subsection (a)(4). 

21 (3) An assessment of the extent to which con22 tracts with managed care entities under title XIX of 

23 such Act comply with the requirement specified in 

24 paragraph (5) of section 1932(d) of such Act, as 

25 added by subsection (a)(2). 
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1 (4) An assessment of the extent to which pro2 viders have been enrolled under section 1902(a)(78) or 

3 1932(d)(6)(A) of such Act (42 U.S.C. 1396a(a)(78), 

4 1396u–2(d)(6)(A)) with State agencies administering 

5 State plans under title XIX of such Act (or waivers 

6 of such plans). 

7 SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE 

8 PROVIDER DIRECTORY. 

9 (a) IN GENERAL.—Section 1902(a) of the Social Secu10 rity Act (42 U.S.C. 1396a(a)) is amended— 

11 (1) in paragraph (81), by striking ‘‘and’’ at the 

12 end; 

13 (2) in paragraph (82), by striking the period at 

14 the end and inserting ‘‘; and’’; and 

15 (3) by inserting after paragraph (82) the fol16 lowing new paragraph: 

17 ‘‘(83) provide that, not later than January 1, 

18 2017, in the case of a State plan (or waiver of the 

19 plan) that provides medical assistance on a fee-for20 service basis or through a primary care case-manage21 ment system described in section 1915(b)(1) (other 

22 than a primary care case management entity (as de23 fined by the Secretary)), the State shall publish (and 

24 update on at least an annual basis) on the public 

25 website of the State agency administering the State 
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•HR 34 EAH 

1 plan, a directory of the physicians described in sub2 section (mm) and, at State option, other providers de3 scribed in such subsection that— 

4 ‘‘(A) includes— 

5 ‘‘(i) with respect to each such physi6 cian or provider— 

7 ‘‘(I) the name of the physician or 

8 provider; 

9 ‘‘(II) the specialty of the physi10 cian or provider; 

11 ‘‘(III) the address at which the 

12 physician or provider provides services; 

13 and 

14 ‘‘(IV) the telephone number of the 

15 physician or provider; and 

16 ‘‘(ii) with respect to any such physi17 cian or provider participating in such a 

18 primary care case-management system, in19 formation regarding— 

20 ‘‘(I) whether the physician or pro21 vider is accepting as new patients in22 dividuals who receive medical assist23 ance under this title; and 

24 ‘‘(II) the physician’s or provider’s 

25 cultural and linguistic capabilities, in-
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•HR 34 EAH 

1 cluding the languages spoken by the 

2 physician or provider or by the skilled 

3 medical interpreter providing interpre4 tation services at the physician’s or 

5 provider’s office; and 

6 ‘‘(B) may include, at State option, with re7 spect to each such physician or provider— 

8 ‘‘(i) the Internet website of such physi9 cian or provider; or 

10 ‘‘(ii) whether the physician or provider 

11 is accepting as new patients individuals 

12 who receive medical assistance under this 

13 title.’’. 

14 (b) DIRECTORY PHYSICIAN OR PROVIDER DE15 SCRIBED.—Section 1902 of the Social Security Act (42 

16 U.S.C. 1396a), as amended by section 5005(a)(3), is further 

17 amended by adding at the end the following new subsection: 

18 ‘‘(mm) DIRECTORY PHYSICIAN OR PROVIDER DE19 SCRIBED.—A physician or provider described in this sub20 section is— 

21 ‘‘(1) in the case of a physician or provider of a 

22 provider type for which the State agency, as a condi23 tion on receiving payment for items and services fur24 nished by the physician or provider to individuals el25 igible to receive medical assistance under the State 
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1 plan, requires the enrollment of the physician or pro2 vider with the State agency, a physician or a pro3 vider that— 

4 ‘‘(A) is enrolled with the agency as of the 

5 date on which the directory is published or up6 dated (as applicable) under subsection (a)(83); 

7 and 

8 ‘‘(B) received payment under the State plan 

9 in the 12-month period preceding such date; and 

10 ‘‘(2) in the case of a physician or provider of a 

11 provider type for which the State agency does not re12 quire such enrollment, a physician or provider that 

13 received payment under the State plan (or a waiver 

14 of the plan) in the 12-month period preceding the 

15 date on which the directory is published or updated 

16 (as applicable) under subsection (a)(83).’’. 

17 (c) RULE OF CONSTRUCTION.— 

18 (1) IN GENERAL.—The amendment made by sub19 section (a) shall not be construed to apply in the case 

20 of a State (as defined for purposes of title XIX of the 

21 Social Security Act) in which all the individuals en22 rolled in the State plan under such title (or under a 

23 waiver of such plan), other than individuals described 

24 in paragraph (2), are enrolled with a medicaid man25 aged care organization (as defined in section 
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1 1903(m)(1)(A) of such Act (42 U.S.C. 

2 1396b(m)(1)(A))), including prepaid inpatient health 

3 plans and prepaid ambulatory health plans (as de4 fined by the Secretary of Health and Human Serv5 ices). 

6 (2) INDIVIDUALS DESCRIBED.—An individual 

7 described in this paragraph is an individual who is 

8 an Indian (as defined in section 4 of the Indian 

9 Health Care Improvement Act (25 U.S.C. 1603)) or 

10 an Alaska Native. 

11 (d) EXCEPTION FOR STATE LEGISLATION.—In the case 

12 of a State plan under title XIX of the Social Security Act 

13 (42 U.S.C. 1396 et seq.), which the Secretary of Health and 

14 Human Services determines requires State legislation in 

15 order for the respective plan to meet one or more additional 

16 requirements imposed by amendments made by this section, 

17 the respective plan shall not be regarded as failing to com18 ply with the requirements of such title solely on the basis 

19 of its failure to meet such an additional requirement before 

20 the first day of the first calendar quarter beginning after 

21 the close of the first regular session of the State legislature 

22 that begins after the date of enactment of this Act. For pur23 poses of the previous sentence, in the case of a State that 

24 has a 2-year legislative session, each year of the session shall 
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1 be considered to be a separate regular session of the State 

2 legislature. 

3 SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS 

4 TRUSTS. 

5 (a) IN GENERAL.—Section 1917(d)(4)(A) of the Social 

6 Security Act (42 U.S.C. 1396p(d)(4)(A)) is amended by in7 serting ‘‘the individual,’’ after ‘‘for the benefit of such indi8 vidual by’’. 

9 (b) EFFECTIVE DATE.—The amendment made by sub10 section (a) shall apply to trusts established on or after the 

11 date of the enactment of this Act. 

12 SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPA13 TION WITH RESPECT TO EXPENDITURES 

14 UNDER MEDICAID FOR AGENTS USED FOR 

15 COSMETIC PURPOSES OR HAIR GROWTH. 

16 (a) IN GENERAL.—Section 1903(i)(21) of the Social 

17 Security Act (42 U.S.C. 1396b(i)(21)) is amended by in18 serting ‘‘section 1927(d)(2)(C) (relating to drugs when used 

19 for cosmetic purposes or hair growth), except where medi20 cally necessary, and’’ after ‘‘drugs described in’’. 

21 (b) EFFECTIVE DATE.—The amendment made by sub22 section (a) shall apply with respect to calendar quarters 

23 beginning on or after the date of the enactment of this Act. 
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1 SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC 

2 HEALTH FUND. 

3 Section 4002(b) of the Patient Protection and Afford4 able Care Act (42 U.S.C. 300u–11(b)) is amended— 

5 (1) in paragraph (3), by striking 

6 ‘‘$1,250,000,000’’ and inserting ‘‘$900,000,000’’; 

7 (2) in paragraph (4), by striking 

8 ‘‘$1,500,000,000’’ and inserting ‘‘$1,000,000,000’’; 

9 and 

10 (3) by striking paragraph (5) and inserting the 

11 following: 

12 ‘‘(5) for fiscal year 2022, $1,500,000,000; 

13 ‘‘(6) for fiscal year 2023, $1,000,000,000; 

14 ‘‘(7) for fiscal year 2024, $1,700,000,000; and 

15 ‘‘(8) for fiscal year 2025 and each fiscal year 

16 thereafter, $2,000,000,000.’’. 

17 SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN. 

18 (a) DRAWDOWN AND SALE.— 

19 (1) IN GENERAL.—Notwithstanding section 161 

20 of the Energy Policy and Conservation Act (42 U.S.C. 

21 6241), except as provided in subsections (b) and (c), 

22 the Secretary of Energy shall drawdown and sell from 

23 the Strategic Petroleum Reserve— 

24 (A) 10,000,000 barrels of crude oil during 

25 fiscal year 2017; 
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1 (B) 9,000,000 barrels of crude oil during 

2 fiscal year 2018; and 

3 (C) 6,000,000 barrels of crude oil during 

4 fiscal year 2019. 

5 (2) DEPOSIT OF AMOUNTS RECEIVED FROM

6 SALE.—Amounts received from a sale under para7 graph (1) shall be deposited in the general fund of the 

8 Treasury during the fiscal year in which the sale oc9 curs. 

10 (b) EMERGENCY PROTECTION.—The Secretary shall 

11 not draw down and sell crude oil under this section in 

12 quantities that would limit the authority to sell petroleum 

13 products under section 161(h) of the Energy Policy and 

14 Conservation Act (42 U.S.C. 6241(h)) in the full quantity 

15 authorized by that subsection. 

16 (c) STRATEGIC PETROLEUM DRAWDOWN LIMITA17 TIONS.—Subparagraphs (C) and (D) of section 161(h)(2) 

18 of the Energy Policy and Conservation Act (42 U.S.C. 

19 6241(h)(2)(C) and (D)) are both amended by striking 

20 ‘‘500,000,000’’ and inserting ‘‘450,000,000’’. 

21 SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY 

22 FUNDING. 

23 Of the unobligated amounts available under section 

24 1323(c)(1) of the Patient Protection and Affordable Care 
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1 Act (42 U.S.C. 18043(c)(1)), $464,000,000 is rescinded im2 mediately upon the date of the enactment of this Act. 

3 SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THER4 APY. 

5 (a) IN GENERAL.—Section 1861 of the Social Security 

6 Act (42 U.S.C. 1395x) is amended— 

7 (1) in subsection (s)(2)— 

8 (A) by striking ‘‘and’’ at the end of sub9 paragraph (EE); 

10 (B) by inserting ‘‘and’’ at the end of sub11 paragraph (FF); and 

12 (C) by inserting at the end the following 

13 new subparagraph: 

14 ‘‘(GG) home infusion therapy (as defined in sub15 section (iii)(1));’’; and 

16 (2) by adding at the end the following new sub17 section: 

18 ‘‘(iii) HOME INFUSION THERAPY.—(1) The term ‘home 

19 infusion therapy’ means the items and services described 

20 in paragraph (2) furnished by a qualified home infusion 

21 therapy supplier (as defined in paragraph (3)(D)) which 

22 are furnished in the individual’s home (as defined in para23 graph (3)(B)) to an individual— 

24 ‘‘(A) who is under the care of an applicable pro25 vider (as defined in paragraph (3)(A)); and 
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1 ‘‘(B) with respect to whom a plan prescribing 

2 the type, amount, and duration of infusion therapy 

3 services that are to be furnished such individual has 

4 been established by a physician (as defined in sub5 section (r)(1)) and is periodically reviewed by a phy6 sician (as so defined) in coordination with the fur7 nishing of home infusion drugs (as defined in para8 graph (3)(C)) under part B. 

9 ‘‘(2) The items and services described in this para10 graph are the following: 

11 ‘‘(A) Professional services, including nursing 

12 services, furnished in accordance with the plan. 

13 ‘‘(B) Training and education (not otherwise 

14 paid for as durable medical equipment (as defined in 

15 subsection (n)), remote monitoring, and monitoring 

16 services for the provision of home infusion therapy 

17 and home infusion drugs furnished by a qualified 

18 home infusion therapy supplier. 

19 ‘‘(3) For purposes of this subsection: 

20 ‘‘(A) The term ‘applicable provider’ means— 

21 ‘‘(i) a physician; 

22 ‘‘(ii) a nurse practitioner; and 

23 ‘‘(iii) a physician assistant. 
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1 ‘‘(B) The term ‘home’ means a place of residence 

2 used as the home of an individual (as defined for pur3 poses of subsection (n)). 

4 ‘‘(C) The term ‘home infusion drug’ means a 

5 parenteral drug or biological administered intra6 venously, or subcutaneously for an administration pe7 riod of 15 minutes or more, in the home of an indi8 vidual through a pump that is an item of durable 

9 medical equipment (as defined in subsection (n)). 

10 Such term does not include the following: 

11 ‘‘(i) Insulin pump systems. 

12 ‘‘(ii) A self-administered drug or biological 

13 on a self-administered drug exclusion list. 

14 ‘‘(D)(i) The term ‘qualified home infusion ther15 apy supplier’ means a pharmacy, physician, or other 

16 provider of services or supplier licensed by the State 

17 in which the pharmacy, physician, or provider or 

18 services or supplier furnishes items or services and 

19 that— 

20 ‘‘(I) furnishes infusion therapy to individ21 uals with acute or chronic conditions requiring 

22 administration of home infusion drugs; 

23 ‘‘(II) ensures the safe and effective provision 

24 and administration of home infusion therapy on 

25 a 7-day-a-week, 24-hour-a-day basis; 
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1 ‘‘(III) is accredited by an organization des2 ignated by the Secretary pursuant to section 

3 1834(u)(5); and 

4 ‘‘(IV) meets such other requirements as the 

5 Secretary determines appropriate, taking into 

6 account the standards of care for home infusion 

7 therapy established by Medicare Advantage plans 

8 under part C and in the private sector. 

9 ‘‘(ii) A qualified home infusion therapy supplier 

10 may subcontract with a pharmacy, physician, pro11 vider of services, or supplier to meet the requirements 

12 of this subparagraph.’’. 

13 (b) PAYMENT AND RELATED REQUIREMENTS FOR

14 HOME INFUSION THERAPY.—Section 1834 of the Social Se15 curity Act (42 U.S.C. 1395m), as amended by section 4011, 

16 is further amended by adding at the end the following new 

17 subsection: 

18 ‘‘(u) PAYMENT AND RELATED REQUIREMENTS FOR

19 HOME INFUSION THERAPY.— 

20 ‘‘(1) PAYMENT.— 

21 ‘‘(A) SINGLE PAYMENT.— 

22 ‘‘(i) IN GENERAL.—Subject to clause 

23 (iii) and subparagraphs (B) and (C), the 

24 Secretary shall implement a payment sys25 tem under which a single payment is made 
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1 under this title to a qualified home infusion 

2 therapy supplier for items and services de3 scribed in subparagraphs (A) and (B) of 

4 section 1861(iii)(2)) furnished by a quali5 fied home infusion therapy supplier (as de6 fined in section 1861(iii)(3)(D)) in coordi7 nation with the furnishing of home infusion 

8 drugs (as defined in section 1861(iii)(3)(C)) 

9 under this part. 

10 ‘‘(ii) UNIT OF SINGLE PAYMENT.—A 

11 unit of single payment under the payment 

12 system implemented under this subpara13 graph is for each infusion drug administra14 tion calendar day in the individual’s home. 

15 The Secretary shall, as appropriate, estab16 lish single payment amounts for types of in17 fusion therapy, including to take into ac18 count variation in utilization of nursing 

19 services by therapy type. 

20 ‘‘(iii) LIMITATION.—The single pay21 ment amount determined under this sub22 paragraph after application of subpara23 graph (B) and paragraph (3) shall not ex24 ceed the amount determined under the fee 

25 schedule under section 1848 for infusion 
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1 therapy services furnished in a calendar 

2 day if furnished in a physician office set3 ting, except such single payment shall not 

4 reflect more than 5 hours of infusion for a 

5 particular therapy in a calendar day. 

6 ‘‘(B) REQUIRED ADJUSTMENTS.—The Sec7 retary shall adjust the single payment amount 

8 determined under subparagraph (A) for home in9 fusion therapy services under section 1861(iii)(1) 

10 to reflect other factors such as— 

11 ‘‘(i) a geographic wage index and other 

12 costs that may vary by region; and 

13 ‘‘(ii) patient acuity and complexity of 

14 drug administration. 

15 ‘‘(C) DISCRETIONARY ADJUSTMENTS.— 

16 ‘‘(i) IN GENERAL.—Subject to clause 

17 (ii), the Secretary may adjust the single 

18 payment amount determined under sub19 paragraph (A) (after application of sub20 paragraph (B)) to reflect outlier situations 

21 and other factors as the Secretary deter22 mines appropriate. 

23 ‘‘(ii) REQUIREMENT OF BUDGET NEU24 TRALITY.—Any adjustment under this sub-
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1 paragraph shall be made in a budget neu2 tral manner. 

3 ‘‘(2) CONSIDERATIONS.—In developing the pay4 ment system under this subsection, the Secretary may 

5 consider the costs of furnishing infusion therapy in 

6 the home, consult with home infusion therapy sup7 pliers, consider payment amounts for similar items 

8 and services under this part and part A, and consider 

9 payment amounts established by Medicare Advantage 

10 plans under part C and in the private insurance 

11 market for home infusion therapy (including average 

12 per treatment day payment amounts by type of home 

13 infusion therapy). 

14 ‘‘(3) ANNUAL UPDATES.— 

15 ‘‘(A) IN GENERAL.—Subject to subpara16 graph (B), the Secretary shall update the single 

17 payment amount under this subsection from year 

18 to year beginning in 2022 by increasing the sin19 gle payment amount from the prior year by the 

20 percentage increase in the Consumer Price Index 

21 for all urban consumers (United States city av22 erage) for the 12-month period ending with June 

23 of the preceding year. 

24 ‘‘(B) ADJUSTMENT.—For each year, the 

25 Secretary shall reduce the percentage increase de-
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1 scribed in subparagraph (A) by the productivity 

2 adjustment described in section 

3 1886(b)(3)(B)(xi)(II). The application of the pre4 ceding sentence may result in a percentage being 

5 less than 0.0 for a year, and may result in pay6 ment being less than such payment rates for the 

7 preceding year. 

8 ‘‘(4) AUTHORITY TO APPLY PRIOR AUTHORIZA9 TION.—The Secretary may, as determined appro10 priate by the Secretary, apply prior authorization for 

11 home infusion therapy services under section 

12 1861(iii)(1). 

13 ‘‘(5) ACCREDITATION OF QUALIFIED HOME INFU14 SION THERAPY SUPPLIERS.— 

15 ‘‘(A) FACTORS FOR DESIGNATION OF AC16 CREDITATION ORGANIZATIONS.—The Secretary 

17 shall consider the following factors in desig18 nating accreditation organizations under sub19 paragraph (B) and in reviewing and modifying 

20 the list of accreditation organizations designated 

21 pursuant to subparagraph (C): 

22 ‘‘(i) The ability of the organization to 

23 conduct timely reviews of accreditation ap24 plications. 
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1 ‘‘(ii) The ability of the organization to 

2 take into account the capacities of suppliers 

3 located in a rural area (as defined in sec4 tion 1886(d)(2)(D)). 

5 ‘‘(iii) Whether the organization has es6 tablished reasonable fees to be charged to 

7 suppliers applying for accreditation. 

8 ‘‘(iv) Such other factors as the Sec9 retary determines appropriate. 

10 ‘‘(B) DESIGNATION.—Not later than Janu11 ary 1, 2021, the Secretary shall designate orga12 nizations to accredit suppliers furnishing home 

13 infusion therapy. The list of accreditation orga14 nizations so designated may be modified pursu15 ant to subparagraph (C). 

16 ‘‘(C) REVIEW AND MODIFICATION OF LIST

17 OF ACCREDITATION ORGANIZATIONS.— 

18 ‘‘(i) IN GENERAL.—The Secretary shall 

19 review the list of accreditation organiza20 tions designated under subparagraph (B) 

21 taking into account the factors under sub22 paragraph (A). Taking into account the re23 sults of such review, the Secretary may, by 

24 regulation, modify the list of accreditation 
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1 organizations designated under subpara2 graph (B). 

3 ‘‘(ii) SPECIAL RULE FOR ACCREDITA4 TIONS DONE PRIOR TO REMOVAL FROM LIST

5 OF DESIGNATED ACCREDITATION ORGANIZA6 TIONS.—In the case where the Secretary re7 moves an organization from the list of ac8 creditation organizations designated under 

9 subparagraph (B), any supplier that is ac10 credited by the organization during the pe11 riod beginning on the date on which the or12 ganization is designated as an accreditation 

13 organization under subparagraph (B) and 

14 ending on the date on which the organiza15 tion is removed from such list shall be con16 sidered to have been accredited by an orga17 nization designated by the Secretary under 

18 subparagraph (B) for the remaining period 

19 such accreditation is in effect. 

20 ‘‘(D) RULE FOR ACCREDITATIONS MADE

21 PRIOR TO DESIGNATION.—In the case of a sup22 plier that is accredited before January 1, 2021, 

23 by an accreditation organization designated by 

24 the Secretary under subparagraph (B) as of Jan25 uary 1, 2019, such supplier shall be considered 
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1 to have been accredited by an organization des2 ignated by the Secretary under such paragraph 

3 as of January 1, 2023, for the remaining period 

4 such accreditation is in effect. 

5 ‘‘(6) NOTIFICATION OF INFUSION THERAPY OP6 TIONS AVAILABLE PRIOR TO FURNISHING HOME INFU7 SION THERAPY.—Prior to the furnishing of home in8 fusion therapy to an individual, the physician who 

9 establishes the plan described in section 1861(iii)(1) 

10 for the individual shall provide notification (in a 

11 form, manner, and frequency determined appropriate 

12 by the Secretary) of the options available (such as 

13 home, physician’s office, hospital outpatient depart14 ment) for the furnishing of infusion therapy under 

15 this part.’’. 

16 (c) CONFORMING AMENDMENTS.— 

17 (1) PAYMENT REFERENCE.—Section 1833(a)(1) 

18 of the Social Security Act (42 U.S.C. 1395l(a)(1)) is 

19 amended— 

20 (A) by striking ‘‘and’’ before ‘‘(AA)’’; and 

21 (B) by inserting before the semicolon at the 

22 end the following: ‘‘, and (BB) with respect to 

23 home infusion therapy, the amount paid shall be 

24 an amount equal to 80 percent of the lesser of the 
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1 actual charge for the services or the amount de2 termined under section 1834(u)’’. 

3 (2) DIRECT PAYMENT.—The first sentence of sec4 tion 1842(b)(6) of the Social Security Act (42 U.S.C. 

5 1395u(b)(6)) is amended— 

6 (A) by striking ‘‘and’’ before ‘‘(H)’’; and 

7 (B) by inserting before the period at the end 

8 the following: ‘‘, and (I) in the case of home in9 fusion therapy, payment shall be made to the 

10 qualified home infusion therapy supplier’’. 

11 (3) EXCLUSION FROM HOME HEALTH SERV12 ICES.—Section 1861(m) of the Social Security Act 

13 (42 U.S.C. 1395x(m)) is amended, in the first sen14 tence, by inserting the following before the period at 

15 the end: ‘‘and home infusion therapy (as defined in 

16 subsection (iii)(i))’’. 

17 (d) EFFECTIVE DATE.—The amendments made by this 

18 section shall apply to items and services furnished on or 

19 after January 1, 2021. 

20 DIVISION B—HELPING FAMILIES 

21 IN MENTAL HEALTH CRISIS 

22 SEC. 6000. SHORT TITLE. 

23 This division may be cited as the ‘‘Helping Families 

24 in Mental Health Crisis Reform Act of 2016’’. 
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1 TITLE VI—STRENGTHENING 

2 LEADERSHIP AND ACCOUNT3 ABILITY 

4 Subtitle A—Leadership 

5 SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH 

6 AND SUBSTANCE USE. 

7 (a) ASSISTANT SECRETARY.—Section 501(c) of the 

8 Public Health Service Act (42 U.S.C. 290aa(c)) is amended 

9 to read as follows: 

10 ‘‘(c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT

11 SECRETARY.— 

12 ‘‘(1) ASSISTANT SECRETARY.—The Administra13 tion shall be headed by an official to be known as the 

14 Assistant Secretary for Mental Health and Substance 

15 Use (hereinafter in this title referred to as the ‘Assist16 ant Secretary’) who shall be appointed by the Presi17 dent, by and with the advice and consent of the Sen18 ate. 

19 ‘‘(2) DEPUTY ASSISTANT SECRETARY.—The As20 sistant Secretary, with the approval of the Secretary, 

21 may appoint a Deputy Assistant Secretary and may 

22 employ and prescribe the functions of such officers 

23 and employees, including attorneys, as are necessary 

24 to administer the activities to be carried out through 

25 the Administration.’’. 
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1 (b) TRANSFER OF AUTHORITIES.—The Secretary of 

2 Health and Human Services shall delegate to the Assistant 

3 Secretary for Mental Health and Substance Use all duties 

4 and authorities that— 

5 (1) as of the day before the date of enactment of 

6 this Act, were vested in the Administrator of the Sub7 stance Abuse and Mental Health Services Administra8 tion; and 

9 (2) are not terminated by this Act. 

10 (c) CONFORMING AMENDMENTS.—Title V of the Public 

11 Health Service Act (42 U.S.C. 290aa et seq.), as amended 

12 by the previous provisions of this section, is further amend13 ed— 

14 (1) by striking ‘‘Administrator of the Substance 

15 Abuse and Mental Health Services Administration’’ 

16 each place it appears and inserting ‘‘Assistant Sec17 retary for Mental Health and Substance Use’’; and 

18 (2) by striking ‘‘Administrator’’ or ‘‘ADMINIS19 TRATOR’’ each place it appears (including in any 

20 headings) and inserting ‘‘Assistant Secretary’’ or 

21 ‘‘ASSISTANT SECRETARY’’, respectively, except where 

22 the term ‘‘Administrator’’ appears— 

23 (A) in each of subsections (e) and (f) of sec24 tion 501 of such Act (42 U.S.C. 290aa), includ-
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1 ing the headings of such subsections, within the 

2 term ‘‘Associate Administrator’’; 

3 (B) in section 507(b)(6) of such Act (42 

4 U.S.C. 290bb(b)(6)), within the term ‘‘Adminis5 trator of the Health Resources and Services Ad6 ministration’’; 

7 (C) in section 507(b)(6) of such Act (42 

8 U.S.C. 290bb(b)(6)), within the term ‘‘Adminis9 trator of the Centers for Medicare & Medicaid 

10 Services’’; 

11 (D) in section 519B(c)(1)(B) of such Act 

12 (42 U.S.C. 290bb–25b(c)(1)(B)), within the term 

13 ‘‘Administrator of the National Highway Traffic 

14 Safety Administration’’; or 

15 (E) in each of sections 519B(c)(1)(B), 

16 520C(a), and 520D(a) of such Act (42 U.S.C. 

17 290bb–25b(c)(1)(B), 290bb–34(a), 290bb–35(a)), 

18 within the term ‘‘Administrator of the Office of 

19 Juvenile Justice and Delinquency Prevention’’. 

20 (d) REFERENCES.—After executing subsections (a), 

21 (b), and (c), any reference in statute, regulation, or guid22 ance to the Administrator of the Substance Abuse and Men23 tal Health Services Administration shall be construed to be 

24 a reference to the Assistant Secretary for Mental Health and 

25 Substance Use. 
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1 SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUB2 STANCE ABUSE AND MENTAL HEALTH SERV3 ICES ADMINISTRATION. 

4 Section 501 of the Public Health Service Act (42 

5 U.S.C. 290aa), as amended by section 6001, is further 

6 amended— 

7 (1) in subsection (b)— 

8 (A) in the subsection heading, by striking 

9 ‘‘AGENCIES’’ and inserting ‘‘CENTERS’’; and 

10 (B) in the matter preceding paragraph (1), 

11 by striking ‘‘entities’’ and inserting ‘‘Centers’’; 

12 (2) in subsection (d)— 

13 (A) in paragraph (1)— 

14 (i) by striking ‘‘agencies’’ each place 

15 the term appears and inserting ‘‘Centers’’; 

16 and 

17 (ii) by striking ‘‘such agency’’ and in18 serting ‘‘such Center’’; 

19 (B) in paragraph (2)— 

20 (i) by striking ‘‘agencies’’ and insert21 ing ‘‘Centers’’; 

22 (ii) by striking ‘‘with respect to sub23 stance abuse’’ and inserting ‘‘with respect to 

24 substance use disorders’’; and 
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1 (iii) by striking ‘‘and individuals who 

2 are substance abusers’’ and inserting ‘‘and 

3 individuals with substance use disorders’’; 

4 (C) in paragraph (5), by striking ‘‘sub5 stance abuse’’ and inserting ‘‘substance use dis6 order’’; 

7 (D) in paragraph (6)— 

8 (i) by striking ‘‘the Centers for Disease 

9 Control’’ and inserting ‘‘the Centers for Dis10 ease Control and Prevention,’’; 

11 (ii) by striking ‘‘Administration de12 velop’’ and inserting ‘‘Administration, de13 velop’’; 

14 (iii) by striking ‘‘HIV or tuberculosis 

15 among substance abusers and individuals 

16 with mental illness’’ and inserting ‘‘HIV, 

17 hepatitis, tuberculosis, and other commu18 nicable diseases among individuals with 

19 mental or substance use disorders,’’; and 

20 (iv) by striking ‘‘illnesses’’ at the end 

21 and inserting ‘‘diseases or disorders’’; 

22 (E) in paragraph (7), by striking ‘‘abuse 

23 utilizing anti-addiction medications, including 

24 methadone’’ and inserting ‘‘use disorders, includ25 ing services that utilize drugs or devices ap-
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1 proved or cleared by the Food and Drug Admin2 istration for the treatment of substance use dis3 orders’’; 

4 (F) in paragraph (8)— 

5 (i) by striking ‘‘Agency for Health 

6 Care Policy Research’’ and inserting ‘‘Agen7 cy for Healthcare Research and Quality’’; 

8 and 

9 (ii) by striking ‘‘treatment and preven10 tion’’ and inserting ‘‘prevention and treat11 ment’’; 

12 (G) in paragraph (9)— 

13 (i) by inserting ‘‘and maintenance’’ 

14 after ‘‘development’’; 

15 (ii) by striking ‘‘Agency for Health 

16 Care Policy Research’’ and inserting ‘‘Agen17 cy for Healthcare Research and Quality’’; 

18 and 

19 (iii) by striking ‘‘treatment and pre20 vention services’’ and inserting ‘‘prevention, 

21 treatment, and recovery support services 

22 and are appropriately incorporated into 

23 programs carried out by the Administra24 tion’’; 
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1 (H) in paragraph (10), by striking ‘‘abuse’’ 

2 and inserting ‘‘use disorder’’; 

3 (I) by striking paragraph (11) and insert4 ing the following: 

5 ‘‘(11) work with relevant agencies of the Depart6 ment of Health and Human Services on integrating 

7 mental health promotion and substance use disorder 

8 prevention with general health promotion and disease 

9 prevention and integrating mental and substance use 

10 disorders treatment services with physical health 

11 treatment services;’’; 

12 (J) in paragraph (13)— 

13 (i) in the matter preceding subpara14 graph (A), by striking ‘‘this title, assure 

15 that’’ and inserting ‘‘this title or part B of 

16 title XIX, or grant programs otherwise 

17 funded by the Administration’’; 

18 (ii) in subparagraph (A)— 

19 (I) by inserting ‘‘require that’’ be20 fore ‘‘all grants’’; and 

21 (II) by striking ‘‘and’’ at the end; 

22 (iii) by redesignating subparagraph 

23 (B) as subparagraph (C); 

24 (iv) by inserting after subparagraph 

25 (A) the following: 
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1 ‘‘(B) ensure that the director of each Center 

2 of the Administration consistently documents the 

3 application of criteria when awarding grants 

4 and the ongoing oversight of grantees after such 

5 grants are awarded;’’; 

6 (v) in subparagraph (C), as so redesig7 nated— 

8 (I) by inserting ‘‘require that’’ be9 fore ‘‘all grants’’; and 

10 (II) in clause (ii), by inserting 

11 ‘‘and’’ after the semicolon at the end; 

12 and 

13 (vi) by adding at the end the following: 

14 ‘‘(D) inform a State when any funds are 

15 awarded through such a grant to any entity 

16 within such State;’’; 

17 (K) in paragraph (16), by striking ‘‘abuse 

18 and mental health information’’ and inserting 

19 ‘‘use disorder information, including evidence20 based and promising best practices for preven21 tion, treatment, and recovery support services for 

22 individuals with mental and substance use dis23 orders,’’; 

24 (L) in paragraph (17)— 
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1 (i) by striking ‘‘substance abuse’’ and 

2 inserting ‘‘substance use disorder’’; and 

3 (ii) by striking ‘‘and’’ at the end; 

4 (M) in paragraph (18), by striking the pe5 riod and inserting a semicolon; and 

6 (N) by adding at the end the following: 

7 ‘‘(19) consult with State, local, and tribal gov8 ernments, nongovernmental entities, and individuals 

9 with mental illness, particularly adults with a serious 

10 mental illness, children with a serious emotional dis11 turbance, and the family members of such adults and 

12 children, with respect to improving community-based 

13 and other mental health services; 

14 ‘‘(20) collaborate with the Secretary of Defense 

15 and the Secretary of Veterans Affairs to improve the 

16 provision of mental and substance use disorder serv17 ices provided by the Department of Defense and the 

18 Department of Veterans Affairs to members of the 

19 Armed Forces, veterans, and the family members of 

20 such members and veterans, including through the 

21 provision of services using the telehealth capabilities 

22 of the Department of Defense and the Department of 

23 Veterans Affairs; 

24 ‘‘(21) collaborate with the heads of relevant Fed25 eral agencies and departments, States, communities, 
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1 and nongovernmental experts to improve mental and 

2 substance use disorders services for chronically home3 less individuals, including by designing strategies to 

4 provide such services in supportive housing; 

5 ‘‘(22) work with States and other stakeholders to 

6 develop and support activities to recruit and retain 

7 a workforce addressing mental and substance use dis8 orders; 

9 ‘‘(23) collaborate with the Attorney General and 

10 representatives of the criminal justice system to im11 prove mental and substance use disorders services for 

12 individuals who have been arrested or incarcerated; 

13 ‘‘(24) after providing an opportunity for public 

14 input, set standards for grant programs under this 

15 title for mental and substance use disorders services 

16 and prevention programs, which standards may ad17 dress— 

18 ‘‘(A) the capacity of the grantee to imple19 ment the award; 

20 ‘‘(B) requirements for the description of the 

21 program implementation approach; 

22 ‘‘(C) the extent to which the grant plan sub23 mitted by the grantee as part of its application 

24 must explain how the grantee will reach the pop25 ulation of focus and provide a statement of need, 
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•HR 34 EAH 

1 which may include information on how the 

2 grantee will increase access to services and a de3 scription of measurable objectives for improving 

4 outcomes; 

5 ‘‘(D) the extent to which the grantee must 

6 collect and report on required performance meas7 ures; and 

8 ‘‘(E) the extent to which the grantee is pro9 posing to use evidence-based practices; and 

10 ‘‘(25) advance, through existing programs, the 

11 use of performance metrics, including those based on 

12 the recommendations on performance metrics from the 

13 Assistant Secretary for Planning and Evaluation 

14 under section 6021(d) of the Helping Families in 

15 Mental Health Crisis Reform Act of 2016.’’; and 

16 (3) in subsection (m), by adding at the end the 

17 following: 

18 ‘‘(4) EMERGENCY RESPONSE.—Amounts made 

19 available for carrying out this subsection shall remain 

20 available through the end of the fiscal year following 

21 the fiscal year for which such amounts are appro22 priated.’’. 
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1 SEC. 6003. CHIEF MEDICAL OFFICER. 

2 Section 501 of the Public Health Service Act (42 

3 U.S.C. 290aa), as amended by sections 6001 and 6002, is 

4 further amended— 

5 (1) by redesignating subsections (g) through (j) 

6 and subsections (k) through (o) as subsections (h) 

7 through (k) and subsections (m) through (q), respec8 tively; 

9 (2) in subsection (e)(3)(C), by striking ‘‘sub10 section (k)’’ and inserting ‘‘subsection (m)’’; 

11 (3) in subsection (f)(2)(C)(iii), by striking ‘‘sub12 section (k)’’ and inserting ‘‘subsection (m)’’; and 

13 (4) by inserting after subsection (f) the following: 

14 ‘‘(g) CHIEF MEDICAL OFFICER.— 

15 ‘‘(1) IN GENERAL.—The Assistant Secretary, 

16 with the approval of the Secretary, shall appoint a 

17 Chief Medical Officer to serve within the Administra18 tion. 

19 ‘‘(2) ELIGIBLE CANDIDATES.—The Assistant Sec20 retary shall select the Chief Medical Officer from 

21 among individuals who— 

22 ‘‘(A) have a doctoral degree in medicine or 

23 osteopathic medicine; 

24 ‘‘(B) have experience in the provision of 

25 mental or substance use disorder services; 
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1 ‘‘(C) have experience working with mental 

2 or substance use disorder programs; 

3 ‘‘(D) have an understanding of biological, 

4 psychosocial, and pharmaceutical treatments of 

5 mental or substance use disorders; and 

6 ‘‘(E) are licensed to practice medicine in 

7 one or more States. 

8 ‘‘(3) DUTIES.—The Chief Medical Officer shall— 

9 ‘‘(A) serve as a liaison between the Admin10 istration and providers of mental and substance 

11 use disorders prevention, treatment, and recovery 

12 services; 

13 ‘‘(B) assist the Assistant Secretary in the 

14 evaluation, organization, integration, and co15 ordination of programs operated by the Adminis16 tration; 

17 ‘‘(C) promote evidence-based and promising 

18 best practices, including culturally and linguis19 tically appropriate practices, as appropriate, for 

20 the prevention and treatment of, and recovery 

21 from, mental and substance use disorders, in22 cluding serious mental illness and serious emo23 tional disturbances; 

24 ‘‘(D) participate in regular strategic plan25 ning with the Administration; 
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1 ‘‘(E) coordinate with the Assistant Sec2 retary for Planning and Evaluation to assess the 

3 use of performance metrics to evaluate activities 

4 within the Administration related to mental and 

5 substance use disorders; and 

6 ‘‘(F) coordinate with the Assistant Sec7 retary to ensure mental and substance use dis8 orders grant programs within the Administra9 tion consistently utilize appropriate performance 

10 metrics and evaluation designs.’’. 

11 SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL 

12 HEALTH PROGRAMS. 

13 Section 505 of the Public Health Service Act (42 

14 U.S.C. 290aa–4), as amended by section 6001(c), is amend15 ed— 

16 (1) by striking the section designation and head17 ing and inserting the following: 

18 ‘‘SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS 

19 AND QUALITY.’’; 

20 (2) by redesignating subsections (a) through (d) 

21 as subsections (b) through (e), respectively; 

22 (3) before subsection (b), as redesignated by 

23 paragraph (2), by inserting the following: 

24 ‘‘(a) IN GENERAL.—The Assistant Secretary shall 

25 maintain within the Administration a Center for Behav-
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1 ioral Health Statistics and Quality (in this section referred 

2 to as the ‘Center’). The Center shall be headed by a Director 

3 (in this section referred to as the ‘Director’) appointed by 

4 the Secretary from among individuals with extensive expe5 rience and academic qualifications in research and analysis 

6 in behavioral health care or related fields.’’; 

7 (4) in subsection (b), as redesignated by para8 graph (2)— 

9 (A) by redesignating paragraphs (1) and 

10 (2) as subparagraphs (A) and (B), respectively; 

11 (B) by striking ‘‘The Secretary, acting’’ and 

12 all that follows through ‘‘year on—’’ and insert13 ing ‘‘The Director shall— 

14 ‘‘(1) coordinate the Administration’s integrated 

15 data strategy, including by collecting data each year 

16 on—’’; 

17 (C) in the subparagraph (B), as redesig18 nated by subparagraph (A), by striking ‘‘Assist19 ant Secretary’’ and inserting ‘‘Director’’; and 

20 (D) by adding at the end the following new 

21 paragraphs: 

22 ‘‘(2) provide statistical and analytical support 

23 for activities of the Administration; 
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•HR 34 EAH 

1 ‘‘(3) recommend a core set of performance 

2 metrics to evaluate activities supported by the Admin3 istration; and 

4 ‘‘(4) coordinate with the Assistant Secretary, the 

5 Assistant Secretary for Planning and Evaluation, 

6 and the Chief Medical Officer appointed under section 

7 501(g), as appropriate, to improve the quality of serv8 ices provided by programs of the Administration and 

9 the evaluation of activities carried out by the Admin10 istration.’’. 

11 (5) in subsection (c), as so redesignated— 

12 (A) by striking ‘‘With respect to the activi13 ties’’ and inserting ‘‘MENTAL HEALTH.—With 

14 respect to the activities’’; 

15 (B) by striking ‘‘Assistant Secretary’’ each 

16 place it appears and inserting ‘‘Director’’; and 

17 (C) by striking ‘‘subsection (a)’’ and insert18 ing ‘‘subsection (b)(1)’’; 

19 (6) in subsection (d), as so redesignated— 

20 (A) by striking the subsection designation 

21 and all that follows through ‘‘With respect to the 

22 activities’’ and inserting the following: 

23 ‘‘(d) SUBSTANCE ABUSE.— 

24 ‘‘(1) IN GENERAL.—With respect to the activi25 ties’’; 
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1 (B) in paragraph (1)— 

2 (i) in the matter before subparagraph 

3 (A)— 

4 (I) by striking ‘‘subsection (a)’’ 

5 and inserting ‘‘subsection (b)(1)’’; and 

6 (II) by striking ‘‘Assistant Sec7 retary’’ each place it appears and in8 serting ‘‘Director’’; and 

9 (ii) in subparagraph (B), by inserting 

10 ‘‘in coordination with the Centers for Dis11 ease Control and Prevention’’ before the 

12 semicolon at the end; and 

13 (C) in paragraph (2), by striking ‘‘ANNUAL

14 SURVEYS’’ and inserting ‘‘ANNUAL SURVEYS; 

15 PUBLIC AVAILABILITY OF DATA.—Annual sur16 veys’’; and 

17 (7) in subsection (e), as so redesignated— 

18 (A) by striking ‘‘After consultation’’ and in19 serting ‘‘CONSULTATION.—After consultation’’; 

20 and 

21 (B) by striking ‘‘Assistant Secretary shall 

22 develop’’ and inserting ‘‘Assistant Secretary shall 

23 use existing standards and best practices to de24 velop’’. 
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1 SEC. 6005. STRATEGIC PLAN. 

2 Section 501 of the Public Health Service Act (42 

3 U.S.C. 290aa), as amended by sections 6001 through 6003, 

4 is further amended by inserting after subsection (k), as re5 designated by section 6003, the following: 

6 ‘‘(l) STRATEGIC PLAN.— 

7 ‘‘(1) IN GENERAL.—Not later than September 30, 

8 2018, and every 4 years thereafter, the Assistant Sec9 retary shall develop and carry out a strategic plan in 

10 accordance with this subsection for the planning and 

11 operation of activities carried out by the Administra12 tion, including evidence-based programs. 

13 ‘‘(2) COORDINATION.—In developing and car14 rying out the strategic plan under this subsection, the 

15 Assistant Secretary shall take into consideration the 

16 findings and recommendations of the Assistant Sec17 retary for Planning and Evaluation under section 

18 6021(d) of the Helping Families in Mental Health 

19 Crisis Reform Act of 2016 and the report of the Inter20 departmental Serious Mental Illness Coordinating 

21 Committee under section 6031 of such Act. 

22 ‘‘(3) PUBLICATION OF PLAN.—Not later than 

23 September 30, 2018, and every 4 years thereafter, the 

24 Assistant Secretary shall— 

25 ‘‘(A) submit the strategic plan developed 

26 under paragraph (1) to the Committee on En-
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1 ergy and Commerce and the Committee on Ap2 propriations of the House of Representatives and 

3 the Committee on Health, Education, Labor, and 

4 Pensions and the Committee on Appropriations 

5 of the Senate; and 

6 ‘‘(B) post such plan on the Internet website 

7 of the Administration. 

8 ‘‘(4) CONTENTS.—The strategic plan developed 

9 under paragraph (1) shall— 

10 ‘‘(A) identify strategic priorities, goals, and 

11 measurable objectives for mental and substance 

12 use disorders activities and programs operated 

13 and supported by the Administration, including 

14 priorities to prevent or eliminate the burden of 

15 mental and substance use disorders; 

16 ‘‘(B) identify ways to improve the quality 

17 of services for individuals with mental and sub18 stance use disorders, and to reduce homelessness, 

19 arrest, incarceration, violence, including self-di20 rected violence, and unnecessary hospitalization 

21 of individuals with a mental or substance use 

22 disorder, including adults with a serious mental 

23 illness or children with a serious emotional dis24 turbance; 
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•HR 34 EAH 

1 ‘‘(C) ensure that programs provide, as ap2 propriate, access to effective and evidence-based 

3 prevention, diagnosis, intervention, treatment, 

4 and recovery services, including culturally and 

5 linguistically appropriate services, as appro6 priate, for individuals with a mental or sub7 stance use disorder; 

8 ‘‘(D) identify opportunities to collaborate 

9 with the Health Resources and Services Adminis10 tration to develop or improve— 

11 ‘‘(i) initiatives to encourage individ12 uals to pursue careers (especially in rural 

13 and underserved areas and with rural and 

14 underserved populations) as psychiatrists, 

15 including child and adolescent psychiatrists, 

16 psychologists, psychiatric nurse practi17 tioners, physician assistants, clinical social 

18 workers, certified peer support specialists, 

19 licensed professional counselors, or other li20 censed or certified mental health or sub21 stance use disorder professionals, including 

22 such professionals specializing in the diag23 nosis, evaluation, or treatment of adults 

24 with a serious mental illness or children 

25 with a serious emotional disturbance; and 
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1 ‘‘(ii) a strategy to improve the recruit2 ment, training, and retention of a workforce 

3 for the treatment of individuals with mental 

4 or substance use disorders, or co-occurring 

5 disorders; 

6 ‘‘(E) identify opportunities to improve col7 laboration with States, local governments, com8 munities, and Indian tribes and tribal organiza9 tions (as such terms are defined in section 4 of 

10 the Indian Self-Determination and Education 

11 Assistance Act); and 

12 ‘‘(F) specify a strategy to disseminate evi13 dence-based and promising best practices related 

14 to prevention, diagnosis, early intervention, 

15 treatment, and recovery services related to men16 tal illness, particularly for adults with a serious 

17 mental illness and children with a serious emo18 tional disturbance, and for individuals with a 

19 substance use disorder.’’. 

20 SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES 

21 AND PROGRESS. 

22 (a) IN GENERAL.—Section 501 of the Public Health 

23 Service Act (42 U.S.C. 290aa), as so amended, is further 

24 amended by amending subsection (m), as redesignated by 

25 section 6003, to read as follows: 
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1 ‘‘(m) BIENNIAL REPORT CONCERNING ACTIVITIES AND

2 PROGRESS.—Not later than September 30, 2020, and every 

3 2 years thereafter, the Assistant Secretary shall prepare and 

4 submit to the Committee on Energy and Commerce and the 

5 Committee on Appropriations of the House of Representa6 tives and the Committee on Health, Education, Labor, and 

7 Pensions and the Committee on Appropriations of the Sen8 ate, and post on the Internet website of the Administration, 

9 a report containing at a minimum— 

10 ‘‘(1) a review of activities conducted or sup11 ported by the Administration, including progress to12 ward strategic priorities, goals, and objectives identi13 fied in the strategic plan developed under subsection 

14 (l); 

15 ‘‘(2) an assessment of programs and activities 

16 carried out by the Assistant Secretary, including the 

17 extent to which programs and activities under this 

18 title and part B of title XIX meet identified goals and 

19 performance measures developed for the respective 

20 programs and activities; 

21 ‘‘(3) a description of the progress made in ad22 dressing gaps in mental and substance use disorders 

23 prevention, treatment, and recovery services and im24 proving outcomes by the Administration, including 
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1 with respect to serious mental illnesses, serious emo2 tional disturbances, and co-occurring disorders; 

3 ‘‘(4) a description of the manner in which the 

4 Administration coordinates and partners with other 

5 Federal agencies and departments related to mental 

6 and substance use disorders, including activities re7 lated to— 

8 ‘‘(A) the implementation and dissemination 

9 of research findings into improved programs, in10 cluding with respect to how advances in serious 

11 mental illness and serious emotional disturbance 

12 research have been incorporated into programs; 

13 ‘‘(B) the recruitment, training, and reten14 tion of a mental and substance use disorders 

15 workforce; 

16 ‘‘(C) the integration of mental disorder serv17 ices, substance use disorder services, and physical 

18 health services; 

19 ‘‘(D) homelessness; and 

20 ‘‘(E) veterans; 

21 ‘‘(5) a description of the manner in which the 

22 Administration promotes coordination by grantees 

23 under this title, and part B of title XIX, with State 

24 or local agencies; and 
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•HR 34 EAH 

1 ‘‘(6) a description of the activities carried out 

2 under section 501A(e), with respect to mental and 

3 substance use disorders, including— 

4 ‘‘(A) the number and a description of 

5 grants awarded; 

6 ‘‘(B) the total amount of funding for grants 

7 awarded; 

8 ‘‘(C) a description of the activities sup9 ported through such grants, including outcomes 

10 of programs supported; and 

11 ‘‘(D) information on how the National Men12 tal Health and Substance Use Policy Laboratory 

13 is consulting with the Assistant Secretary for 

14 Planning and Evaluation and collaborating with 

15 the Center for Substance Abuse Treatment, the 

16 Center for Substance Abuse Prevention, the Cen17 ter for Behavioral Health Statistics and Quality, 

18 and the Center for Mental Health Services to 

19 carry out such activities; and 

20 ‘‘(7) recommendations made by the Assistant 

21 Secretary for Planning and Evaluation under section 

22 6021 of the Helping Families in Mental Health Crisis 

23 Reform Act of 2016 to improve programs within the 

24 Administration, and actions taken in response to such 
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1 recommendations to improve programs within the Ad2 ministration. 

3 The Assistant Secretary may meet reporting requirements 

4 established under this title by providing the contents of such 

5 reports as an addendum to the biennial report established 

6 under this subsection, notwithstanding the timeline of other 

7 reporting requirements in this title. Nothing in this sub8 section shall be construed to alter the content requirements 

9 of such reports or authorize the Assistant Secretary to alter 

10 the timeline of any such reports to be less frequent than 

11 biennially, unless as specified in this title.’’. 

12 (b) CONFORMING AMENDMENT.—Section 508(p) of the 

13 Public Health Service Act (42 U.S.C. 290bb–1(p)) is 

14 amended by striking ‘‘section 501(k)’’ and inserting ‘‘sec15 tion 501(m)’’. 

16 SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL 

17 HEALTH SERVICES, SUBSTANCE ABUSE PRE18 VENTION, AND SUBSTANCE ABUSE TREAT19 MENT. 

20 (a) CENTER FOR MENTAL HEALTH SERVICES.—Sec21 tion 520(b) of the Public Health Service Act (42 U.S.C. 

22 290bb–31(b)) is amended— 

23 (1) by redesignating paragraphs (3) through (15) 

24 as paragraphs (4) through (16), respectively; 
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1 (2) by inserting after paragraph (2) the fol2 lowing: 

3 ‘‘(3) collaborate with the Director of the National 

4 Institute of Mental Health and the Chief Medical Of5 ficer, appointed under section 501(g), to ensure that, 

6 as appropriate, programs related to the prevention 

7 and treatment of mental illness and the promotion of 

8 mental health and recovery support are carried out in 

9 a manner that reflects the best available science and 

10 evidence-based practices, including culturally and lin11 guistically appropriate services, as appropriate;’’; 

12 (3) in paragraph (5), as so redesignated, by in13 serting ‘‘, including through programs that reduce 

14 risk and promote resiliency’’ before the semicolon; 

15 (4) in paragraph (6), as so redesignated, by in16 serting ‘‘in collaboration with the Director of the Na17 tional Institute of Mental Health,’’ before ‘‘develop’’; 

18 (5) in paragraph (8), as so redesignated, by in19 serting ‘‘, increase meaningful participation of indi20 viduals with mental illness in programs and activi21 ties of the Administration,’’ before ‘‘and protect the 

22 legal’’; 

23 (6) in paragraph (10), as so redesignated, by 

24 striking ‘‘professional and paraprofessional personnel 
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1 pursuant to section 303’’ and inserting ‘‘health para2 professional personnel and health professionals’’; 

3 (7) in paragraph (11), as so redesignated, by in4 serting ‘‘and tele-mental health’’ after ‘‘rural mental 

5 health’’; 

6 (8) in paragraph (12), as so redesignated, by 

7 striking ‘‘establish a clearinghouse for mental health 

8 information to assure the widespread dissemination of 

9 such information’’ and inserting ‘‘disseminate mental 

10 health information, including evidence-based prac11 tices,’’; 

12 (9) in paragraph (15), as so redesignated, by 

13 striking ‘‘and’’ at the end; 

14 (10) in paragraph (16), as so redesignated, by 

15 striking the period and inserting ‘‘; and’’; and 

16 (11) by adding at the end the following: 

17 ‘‘(17) ensure the consistent documentation of the 

18 application of criteria when awarding grants and the 

19 ongoing oversight of grantees after such grants are 

20 awarded.’’. 

21 (b) DIRECTOR OF THE CENTER FOR SUBSTANCE

22 ABUSE PREVENTION.—Section 515 of the Public Health 

23 Service Act (42 U.S.C. 290bb–21) is amended— 

24 (1) in the section heading, by striking ‘‘OFFICE’’ 

25 and inserting ‘‘CENTER’’; 
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1 (2) in subsection (a)— 

2 (A) by striking ‘‘an Office’’ and inserting 

3 ‘‘a Center’’; and 

4 (B) by striking ‘‘The Office’’ and inserting 

5 ‘‘The Prevention Center’’; and 

6 (3) in subsection (b)— 

7 (A) in paragraph (1), by inserting ‘‘through 

8 the reduction of risk and the promotion of resil9 iency’’ before the semicolon; 

10 (B) by redesignating paragraphs (3) 

11 through (11) as paragraphs (4) through (12), re12 spectively; 

13 (C) by inserting after paragraph (2) the fol14 lowing: 

15 ‘‘(3) collaborate with the Director of the National 

16 Institute on Drug Abuse, the Director of the National 

17 Institute on Alcohol Abuse and Alcoholism, and States 

18 to promote the study of substance abuse prevention 

19 and the dissemination and implementation of re20 search findings that will improve the delivery and ef21 fectiveness of substance abuse prevention activities;’’; 

22 (D) in paragraph (4), as so redesignated, by 

23 striking ‘‘literature on the adverse effects of co24 caine free base (known as crack)’’ and inserting 

25 ‘‘educational information on the effects of drugs 
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•HR 34 EAH 

1 abused by individuals, including drugs that are 

2 emerging as abused drugs’’; 

3 (E) in paragraph (6), as so redesignated— 

4 (i) by striking ‘‘substance abuse coun5 selors’’ and inserting ‘‘health professionals 

6 who provide substance use and misuse pre7 vention and treatment services’’; and 

8 (ii) by striking ‘‘drug abuse education, 

9 prevention,’’ and inserting ‘‘illicit drug use 

10 education and prevention’’; 

11 (F) by amending paragraph (7), as so re12 designated, to read as follows: 

13 ‘‘(7) in cooperation with the Director of the Cen14 ters for Disease Control and Prevention, develop and 

15 disseminate educational materials to increase aware16 ness for individuals at greatest risk for substance use 

17 disorders to prevent the transmission of commu18 nicable diseases, such as HIV, hepatitis, tuberculosis, 

19 and other communicable diseases;’’; 

20 (G) in paragraph (9), as so redesignated— 

21 (i) by striking ‘‘to discourage’’ and in22 serting ‘‘that reduce the risk of’’; and 

23 (ii) by inserting before the semicolon 

24 ‘‘and promote resiliency’’; 
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1 (H) in paragraph (11), as so redesignated, 

2 by striking ‘‘and’’ after the semicolon; 

3 (I) in paragraph (12), as so redesignated, 

4 by striking the period and inserting a semicolon; 

5 and 

6 (J) by adding at the end the following: 

7 ‘‘(13) ensure the consistent documentation of the 

8 application of criteria when awarding grants and the 

9 ongoing oversight of grantees after such grants are 

10 awarded; and 

11 ‘‘(14) assist and support States in preventing il12 licit drug use, including emerging illicit drug use 

13 issues.’’. 

14 (c) DIRECTOR OF THE CENTER FOR SUBSTANCE

15 ABUSE TREATMENT.—Section 507 of the Public Health 

16 Service Act (42 U.S.C. 290bb) is amended— 

17 (1) in subsection (a)— 

18 (A) by striking ‘‘treatment of substance 

19 abuse’’ and inserting ‘‘treatment of substance use 

20 disorders’’; and 

21 (B) by striking ‘‘abuse treatment systems’’ 

22 and inserting ‘‘use disorder treatment systems’’; 

23 and 

24 (2) in subsection (b)— 
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•HR 34 EAH 

1 (A) in paragraph (1), by striking ‘‘abuse’’ 

2 and inserting ‘‘use disorder’’; 

3 (B) in paragraph (3), by striking ‘‘abuse’’ 

4 and inserting ‘‘use disorder’’; 

5 (C) in paragraph (4), by striking ‘‘individ6 uals who abuse drugs’’ and inserting ‘‘individ7 uals who illicitly use drugs’’; 

8 (D) in paragraph (9), by striking ‘‘carried 

9 out by the Director’’; 

10 (E) by striking paragraph (10); 

11 (F) by redesignating paragraphs (11) 

12 through (14) as paragraphs (10) through (13), 

13 respectively; 

14 (G) in paragraph (12), as so redesignated, 

15 by striking ‘‘; and’’ and inserting a semicolon; 

16 and 

17 (H) by striking paragraph (13), as so redes18 ignated, and inserting the following: 

19 ‘‘(13) ensure the consistent documentation of the 

20 application of criteria when awarding grants and the 

21 ongoing oversight of grantees after such grants are 

22 awarded; and 

23 ‘‘(14) work with States, providers, and individ24 uals in recovery, and their families, to promote the 
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•HR 34 EAH 

1 expansion of recovery support services and systems of 

2 care oriented toward recovery.’’. 

3 SEC. 6008. ADVISORY COUNCILS. 

4 Section 502(b) of the Public Health Service Act (42 

5 U.S.C. 290aa–1(b)) is amended— 

6 (1) in paragraph (2)— 

7 (A) in subparagraph (E), by striking ‘‘and’’ 

8 after the semicolon; 

9 (B) by redesignating subparagraph (F) as 

10 subparagraph (J); and 

11 (C) by inserting after subparagraph (E), 

12 the following: 

13 ‘‘(F) the Chief Medical Officer, appointed 

14 under section 501(g); 

15 ‘‘(G) the Director of the National Institute 

16 of Mental Health for the advisory councils ap17 pointed under subsections (a)(1)(A) and 

18 (a)(1)(D); 

19 ‘‘(H) the Director of the National Institute 

20 on Drug Abuse for the advisory councils ap21 pointed under subsections (a)(1)(A), (a)(1)(B), 

22 and (a)(1)(C); 

23 ‘‘(I) the Director of the National Institute 

24 on Alcohol Abuse and Alcoholism for the advi-
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1 sory councils appointed under subsections 

2 (a)(1)(A), (a)(1)(B), and (a)(1)(C); and’’; and 

3 (2) in paragraph (3), by adding at the end the 

4 following: 

5 ‘‘(C) Not less than half of the members of 

6 the advisory council appointed under subsection 

7 (a)(1)(D)— 

8 ‘‘(i) shall— 

9 ‘‘(I) have a medical degree; 

10 ‘‘(II) have a doctoral degree in 

11 psychology; or 

12 ‘‘(III) have an advanced degree in 

13 nursing or social work from an accred14 ited graduate school or be a certified 

15 physician assistant; and 

16 ‘‘(ii) shall specialize in the mental 

17 health field. 

18 ‘‘(D) Not less than half of the members of 

19 the advisory councils appointed under sub20 sections (a)(1)(B) and (a)(1)(C)— 

21 ‘‘(i) shall— 

22 ‘‘(I) have a medical degree; 

23 ‘‘(II) have a doctoral degree; or 

24 ‘‘(III) have an advanced degree in 

25 nursing, public health, behavioral or 
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•HR 34 EAH 

1 social sciences, or social work from an 

2 accredited graduate school or be a cer3 tified physician assistant; and 

4 ‘‘(ii) shall have experience in the provi5 sion of substance use disorder services or the 

6 development and implementation of pro7 grams to prevent substance misuse.’’. 

8 SEC. 6009. PEER REVIEW. 

9 Section 504(b) of the Public Health Service Act (42 

10 U.S.C. 290aa–3(b)) is amended by adding at the end the 

11 following: ‘‘In the case of any such peer review group that 

12 is reviewing a grant, cooperative agreement, or contract re13 lated to mental illness treatment, not less than half of the 

14 members of such peer review group shall be licensed and 

15 experienced professionals in the prevention, diagnosis, or 

16 treatment of, or recovery from, mental illness or co-occur17 ring mental illness and substance use disorders and have 

18 a medical degree, a doctoral degree in psychology, or an 

19 advanced degree in nursing or social work from an accred20 ited program, and the Secretary, in consultation with the 

21 Assistant Secretary, shall, to the extent possible, ensure such 

22 peer review groups include broad geographic representation, 

23 including both urban and rural representatives.’’. 
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1 Subtitle B—Oversight and 

2 Accountability 

3 SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUB4 STANCE USE DISORDERS PROGRAMS 

5 THROUGH THE ASSISTANT SECRETARY FOR 

6 PLANNING AND EVALUATION. 

7 (a) IN GENERAL.—The Secretary of Health and 

8 Human Services, acting through the Assistant Secretary for 

9 Planning and Evaluation, shall ensure efficient and effec10 tive planning and evaluation of mental and substance use 

11 disorders prevention and treatment programs and related 

12 activities. 

13 (b) EVALUATION STRATEGY.—In carrying out sub14 section (a), the Assistant Secretary for Planning and Eval15 uation shall, not later than 180 days after the date of enact16 ment of this Act, develop a strategy for conducting ongoing 

17 evaluations that identifies priority programs to be evalu18 ated by the Assistant Secretary for Planning and Evalua19 tion and priority programs to be evaluated by other rel20 evant offices and agencies within the Department of Health 

21 and Human Services. The strategy shall— 

22 (1) include a plan for evaluating programs re23 lated to mental and substance use disorders, including 

24 co-occurring disorders, across agencies, as appro25 priate, including programs related to— 
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1 (A) prevention, intervention, treatment, and 

2 recovery support services, including such services 

3 for adults with a serious mental illness or chil4 dren with a serious emotional disturbance; 

5 (B) the reduction of homelessness and incar6 ceration among individuals with a mental or 

7 substance use disorder; and 

8 (C) public health and health services; and 

9 (2) include a plan for assessing the use of per10 formance metrics to evaluate activities carried out by 

11 entities receiving grants, contracts, or cooperative 

12 agreements related to mental and substance use dis13 orders prevention and treatment services under title V 

14 or title XIX of the Public Health Service Act (42 

15 U.S.C. 290aa et seq.; 42 U.S.C. 300w et seq.). 

16 (c) CONSULTATION.—In carrying out this section, the 

17 Assistant Secretary for Planning and Evaluation shall con18 sult, as appropriate, with the Assistant Secretary for Men19 tal Health and Substance Use, the Chief Medical Officer 

20 of the Substance Abuse and Mental Health Services Admin21 istration appointed under section 501(g) of the Public 

22 Health Service Act (42 U.S.C. 290aa(g)), as amended by 

23 section 6003, the Behavioral Health Coordinating Council 

24 of the Department of Health and Human Services, other 

25 agencies within the Department of Health and Human 
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•HR 34 EAH 

1 Services, and other relevant Federal departments and agen2 cies. 

3 (d) RECOMMENDATIONS.—In carrying out this section, 

4 the Assistant Secretary for Planning and Evaluation shall 

5 provide recommendations to the Secretary of Health and 

6 Human Services, the Assistant Secretary for Mental Health 

7 and Substance Use, and the Congress on improving the 

8 quality of prevention and treatment programs and activi9 ties related to mental and substance use disorders, including 

10 recommendations for the use of performance metrics. The 

11 Assistant Secretary for Mental Health and Substance Use 

12 shall include such recommendations in the biennial report 

13 required by subsection 501(m) of the Public Health Service 

14 Act, as redesignated by section 6003 of this Act. 

15 SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY 

16 ORGANIZATIONS. 

17 (a) PUBLIC AVAILABILITY OF REPORTS.—Section 

18 105(a)(7) of the Protection and Advocacy for Individuals 

19 with Mental Illness Act (42 U.S.C. 10805(a)(7)) is amended 

20 by striking ‘‘is located a report’’ and inserting ‘‘is located, 

21 and make publicly available, a report’’. 

22 (b) DETAILED ACCOUNTING.—Section 114(a) of the 

23 Protection and Advocacy for Individuals with Mental Ill24 ness Act (42 U.S.C. 10824(a)) is amended— 
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1 (1) in paragraph (3), by striking ‘‘and’’ at the 

2 end; 

3 (2) in paragraph (4), by striking the period at 

4 the end and inserting ‘‘; and’’; and 

5 (3) by adding at the end the following: 

6 ‘‘(5) using data from the existing required an7 nual program progress reports submitted by each sys8 tem funded under this title, a detailed accounting for 

9 each such system of how funds are spent, 

10 disaggregated according to whether the funds were re11 ceived from the Federal Government, the State govern12 ment, a local government, or a private entity.’’. 

13 SEC. 6023. GAO STUDY. 

14 (a) IN GENERAL.—Not later than 18 months after the 

15 date of enactment of this Act, the Comptroller General of 

16 the United States, in consultation with the Secretary of 

17 Health and Human Services and the Assistant Secretary 

18 for Mental Health and Substance Use, shall conduct an 

19 independent evaluation, and submit a report, to the Com20 mittee on Health, Education, Labor, and Pensions of the 

21 Senate and the Committee on Energy and Commerce of the 

22 House of Representatives, on programs funded by allot23 ments made under title I of the Protection and Advocacy 

24 for Individuals with Mental Illness Act (42 U.S.C. 10801 

25 et seq.). 
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1 (b) CONTENTS.—The report and evaluation required 

2 under subsection (a) shall include— 

3 (1) a review of the programs described in such 

4 subsection that are carried out by State agencies and 

5 such programs that are carried out by private, non6 profit organizations; and 

7 (2) a review of the compliance of the programs 

8 described in subsection (a) with statutory and regu9 latory responsibilities, such as— 

10 (A) responsibilities relating to family en11 gagement; 

12 (B) responsibilities relating to the grievance 

13 procedure for clients or prospective clients of the 

14 system to assure that individuals with mental 

15 illness have full access to the services of the sys16 tem, for individuals who have received or are re17 ceiving mental health services, and for family 

18 members of such individuals with mental illness, 

19 or representatives of such individuals or family 

20 members, to assure that the eligible system is op21 erating in compliance with the provisions of the 

22 Protection and Advocacy for Individuals with 

23 Mental Illness Act, as required to be established 

24 by section 105(a)(9) of such Act (42 U.S.C. 

25 10805(a)(9)); 
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1 (C) investigation of alleged abuse and ne2 glect of persons with mental illness; 

3 (D) availability of adequate medical and 

4 behavioral health treatment; 

5 (E) denial of rights for persons with mental 

6 illness; and 

7 (F) compliance with the Federal prohibition 

8 on lobbying. 

9 Subtitle C—Interdepartmental Seri10 ous Mental Illness Coordinating 

11 Committee 

12 SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILL13 NESS COORDINATING COMMITTEE. 

14 (a) ESTABLISHMENT.— 

15 (1) IN GENERAL.—Not later than 3 months after 

16 the date of enactment of this Act, the Secretary of 

17 Health and Human Services, or the designee of the 

18 Secretary, shall establish a committee to be known as 

19 the Interdepartmental Serious Mental Illness Coordi20 nating Committee (in this section referred to as the 

21 ‘‘Committee’’). 

22 (2) FEDERAL ADVISORY COMMITTEE ACT.—Ex23 cept as provided in this section, the provisions of the 

24 Federal Advisory Committee Act (5 U.S.C. App.) 

25 shall apply to the Committee. 
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1 (b) MEETINGS.—The Committee shall meet not fewer 

2 than 2 times each year. 

3 (c) RESPONSIBILITIES.—Not later than 1 year after 

4 the date of enactment of this Act, and 5 years after such 

5 date of enactment, the Committee shall submit to Congress 

6 and any other relevant Federal department or agency a re7 port including— 

8 (1) a summary of advances in serious mental ill9 ness and serious emotional disturbance research re10 lated to the prevention of, diagnosis of, intervention 

11 in, and treatment and recovery of serious mental ill12 nesses, serious emotional disturbances, and advances 

13 in access to services and support for adults with a se14 rious mental illness or children with a serious emo15 tional disturbance; 

16 (2) an evaluation of the effect Federal programs 

17 related to serious mental illness have on public health, 

18 including public health outcomes such as— 

19 (A) rates of suicide, suicide attempts, inci20 dence and prevalence of serious mental illnesses, 

21 serious emotional disturbances, and substance 

22 use disorders, overdose, overdose deaths, emer23 gency hospitalizations, emergency room board24 ing, preventable emergency room visits, inter-
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•HR 34 EAH 

1 action with the criminal justice system, home2 lessness, and unemployment; 

3 (B) increased rates of employment and en4 rollment in educational and vocational pro5 grams; 

6 (C) quality of mental and substance use dis7 orders treatment services; or 

8 (D) any other criteria as may be deter9 mined by the Secretary; and 

10 (3) specific recommendations for actions that 

11 agencies can take to better coordinate the administra12 tion of mental health services for adults with a serious 

13 mental illness or children with a serious emotional 

14 disturbance. 

15 (d) COMMITTEE EXTENSION.—Upon the submission of 

16 the second report under subsection (c), the Secretary shall 

17 submit a recommendation to Congress on whether to extend 

18 the operation of the Committee. 

19 (e) MEMBERSHIP.— 

20 (1) FEDERAL MEMBERS.—The Committee shall 

21 be composed of the following Federal representatives, 

22 or the designees of such representatives— 

23 (A) the Secretary of Health and Human 

24 Services, who shall serve as the Chair of the 

25 Committee; 
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•HR 34 EAH 

1 (B) the Assistant Secretary for Mental 

2 Health and Substance Use; 

3 (C) the Attorney General; 

4 (D) the Secretary of Veterans Affairs; 

5 (E) the Secretary of Defense; 

6 (F) the Secretary of Housing and Urban 

7 Development; 

8 (G) the Secretary of Education; 

9 (H) the Secretary of Labor; 

10 (I) the Administrator of the Centers for 

11 Medicare & Medicaid Services; and 

12 (J) the Commissioner of Social Security. 

13 (2) NON-FEDERAL MEMBERS.—The Committee 

14 shall also include not less than 14 non-Federal public 

15 members appointed by the Secretary of Health and 

16 Human Services, of which— 

17 (A) at least 2 members shall be an indi18 vidual who has received treatment for a diag19 nosis of a serious mental illness; 

20 (B) at least 1 member shall be a parent or 

21 legal guardian of an adult with a history of a 

22 serious mental illness or a child with a history 

23 of a serious emotional disturbance; 

24 (C) at least 1 member shall be a representa25 tive of a leading research, advocacy, or service 
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•HR 34 EAH 

1 organization for adults with a serious mental ill2 ness; 

3 (D) at least 2 members shall be— 

4 (i) a licensed psychiatrist with experi5 ence in treating serious mental illnesses; 

6 (ii) a licensed psychologist with experi7 ence in treating serious mental illnesses or 

8 serious emotional disturbances; 

9 (iii) a licensed clinical social worker 

10 with experience treating serious mental ill11 nesses or serious emotional disturbances; or 

12 (iv) a licensed psychiatric nurse, nurse 

13 practitioner, or physician assistant with ex14 perience in treating serious mental illnesses 

15 or serious emotional disturbances; 

16 (E) at least 1 member shall be a licensed 

17 mental health professional with a specialty in 

18 treating children and adolescents with a serious 

19 emotional disturbance; 

20 (F) at least 1 member shall be a mental 

21 health professional who has research or clinical 

22 mental health experience in working with mi23 norities; 

24 (G) at least 1 member shall be a mental 

25 health professional who has research or clinical 
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•HR 34 EAH 

1 mental health experience in working with medi2 cally underserved populations; 

3 (H) at least 1 member shall be a State cer4 tified mental health peer support specialist; 

5 (I) at least 1 member shall be a judge with 

6 experience in adjudicating cases related to crimi7 nal justice or serious mental illness; 

8 (J) at least 1 member shall be a law en9 forcement officer or corrections officer with exten10 sive experience in interfacing with adults with a 

11 serious mental illness, children with a serious 

12 emotional disturbance, or individuals in a men13 tal health crisis; and 

14 (K) at least 1 member shall have experience 

15 providing services for homeless individuals and 

16 working with adults with a serious mental ill17 ness, children with a serious emotional disturb18 ance, or individuals in a mental health crisis. 

19 (3) TERMS.—A member of the Committee ap20 pointed under subsection (e)(2) shall serve for a term 

21 of 3 years, and may be reappointed for 1 or more ad22 ditional 3-year terms. Any member appointed to fill 

23 a vacancy for an unexpired term shall be appointed 

24 for the remainder of such term. A member may serve 
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1 after the expiration of the member’s term until a suc2 cessor has been appointed. 

3 (f) WORKING GROUPS.—In carrying out its functions, 

4 the Committee may establish working groups. Such working 

5 groups shall be composed of Committee members, or their 

6 designees, and may hold such meetings as are necessary. 

7 (g) SUNSET.—The Committee shall terminate on the 

8 date that is 6 years after the date on which the Committee 

9 is established under subsection (a)(1). 

10 TITLE VII—ENSURING MENTAL 

11 AND SUBSTANCE USE DIS12 ORDERS PREVENTION, 

13 TREATMENT, AND RECOVERY 

14 PROGRAMS KEEP PACE WITH 

15 SCIENCE AND TECHNOLOGY 

16 SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE17 BASED PROGRAMS. 

18 Title V of the Public Health Service Act (42 U.S.C. 

19 290aa et seq.) is amended by inserting after section 501 

20 (42 U.S.C. 290aa) the following: 

21 ‘‘SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE 

22 USE POLICY LABORATORY. 

23 ‘‘(a) IN GENERAL.—There shall be established within 

24 the Administration a National Mental Health and Sub-
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1 stance Use Policy Laboratory (referred to in this section 

2 as the ‘Laboratory’). 

3 ‘‘(b) RESPONSIBILITIES.—The Laboratory shall— 

4 ‘‘(1) continue to carry out the authorities and 

5 activities that were in effect for the Office of Policy, 

6 Planning, and Innovation as such Office existed prior 

7 to the date of enactment of the Helping Families in 

8 Mental Health Crisis Reform Act of 2016; 

9 ‘‘(2) identify, coordinate, and facilitate the im10 plementation of policy changes likely to have a sig11 nificant effect on mental health, mental illness, recov12 ery supports, and the prevention and treatment of 

13 substance use disorder services; 

14 ‘‘(3) work with the Center for Behavioral Health 

15 Statistics and Quality to collect, as appropriate, in16 formation from grantees under programs operated by 

17 the Administration in order to evaluate and dissemi18 nate information on evidence-based practices, includ19 ing culturally and linguistically appropriate services, 

20 as appropriate, and service delivery models; 

21 ‘‘(4) provide leadership in identifying and co22 ordinating policies and programs, including evidence23 based programs, related to mental and substance use 

24 disorders; 
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•HR 34 EAH 

1 ‘‘(5) periodically review programs and activities 

2 operated by the Administration relating to the diag3 nosis or prevention of, treatment for, and recovery 

4 from, mental and substance use disorders to— 

5 ‘‘(A) identify any such programs or activi6 ties that are duplicative; 

7 ‘‘(B) identify any such programs or activi8 ties that are not evidence-based, effective, or effi9 cient; and 

10 ‘‘(C) formulate recommendations for coordi11 nating, eliminating, or improving programs or 

12 activities identified under subparagraph (A) or 

13 (B) and merging such programs or activities 

14 into other successful programs or activities; and 

15 ‘‘(6) carry out other activities as deemed nec16 essary to continue to encourage innovation and dis17 seminate evidence-based programs and practices. 

18 ‘‘(c) EVIDENCE-BASED PRACTICES AND SERVICE DE19 LIVERY MODELS.— 

20 ‘‘(1) IN GENERAL.—In carrying out subsection 

21 (b)(3), the Laboratory— 

22 ‘‘(A) may give preference to models that im23 prove— 

24 ‘‘(i) the coordination between mental 

25 health and physical health providers; 
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•HR 34 EAH 

1 ‘‘(ii) the coordination among such pro2 viders and the justice and corrections sys3 tem; and 

4 ‘‘(iii) the cost effectiveness, quality, ef5 fectiveness, and efficiency of health care 

6 services furnished to adults with a serious 

7 mental illness, children with a serious emo8 tional disturbance, or individuals in a men9 tal health crisis; and 

10 ‘‘(B) may include clinical protocols and 

11 practices that address the needs of individuals 

12 with early serious mental illness. 

13 ‘‘(2) CONSULTATION.—In carrying out this sec14 tion, the Laboratory shall consult with— 

15 ‘‘(A) the Chief Medical Officer appointed 

16 under section 501(g); 

17 ‘‘(B) representatives of the National Insti18 tute of Mental Health, the National Institute on 

19 Drug Abuse, and the National Institute on Alco20 hol Abuse and Alcoholism, on an ongoing basis; 

21 ‘‘(C) other appropriate Federal agencies; 

22 ‘‘(D) clinical and analytical experts with 

23 expertise in psychiatric medical care and clin24 ical psychological care, health care management, 
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•HR 34 EAH 

1 education, corrections health care, and mental 

2 health court systems, as appropriate; and 

3 ‘‘(E) other individuals and agencies as de4 termined appropriate by the Assistant Secretary. 

5 ‘‘(d) DEADLINE FOR BEGINNING IMPLEMENTATION.— 

6 The Laboratory shall begin implementation of this section 

7 not later than January 1, 2018. 

8 ‘‘(e) PROMOTING INNOVATION.— 

9 ‘‘(1) IN GENERAL.—The Assistant Secretary, in 

10 coordination with the Laboratory, may award grants 

11 to States, local governments, Indian tribes or tribal 

12 organizations (as such terms are defined in section 4 

13 of the Indian Self-Determination and Education As14 sistance Act), educational institutions, and nonprofit 

15 organizations to develop evidence-based interventions, 

16 including culturally and linguistically appropriate 

17 services, as appropriate, for— 

18 ‘‘(A) evaluating a model that has been sci19 entifically demonstrated to show promise, but 

20 would benefit from further applied development, 

21 for— 

22 ‘‘(i) enhancing the prevention, diag23 nosis, intervention, and treatment of, and 

24 recovery from, mental illness, serious emo-
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•HR 34 EAH 

1 tional disturbances, substance use disorders, 

2 and co-occurring illness or disorders; or 

3 ‘‘(ii) integrating or coordinating phys4 ical health services and mental and sub5 stance use disorders services; and 

6 ‘‘(B) expanding, replicating, or scaling evi7 dence-based programs across a wider area to en8 hance effective screening, early diagnosis, inter9 vention, and treatment with respect to mental 

10 illness, serious mental illness, serious emotional 

11 disturbances, and substance use disorders, pri12 marily by— 

13 ‘‘(i) applying such evidence-based pro14 grams to the delivery of care, including by 

15 training staff in effective evidence-based 

16 treatments; or 

17 ‘‘(ii) integrating such evidence-based 

18 programs into models of care across special19 ties and jurisdictions. 

20 ‘‘(2) CONSULTATION.—In awarding grants under 

21 this subsection, the Assistant Secretary shall, as ap22 propriate, consult with the Chief Medical Officer, ap23 pointed under section 501(g), the advisory councils 

24 described in section 502, the National Institute of 

25 Mental Health, the National Institute on Drug Abuse, 
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•HR 34 EAH 

1 and the National Institute on Alcohol Abuse and Al2 coholism, as appropriate. 

3 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

4 There are authorized to be appropriated— 

5 ‘‘(A) to carry out paragraph (1)(A), 

6 $7,000,000 for the period of fiscal years 2018 

7 through 2020; and 

8 ‘‘(B) to carry out paragraph (1)(B), 

9 $7,000,000 for the period of fiscal years 2018 

10 through 2020.’’. 

11 SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVI12 DENCE-BASED PROGRAMS AND PRACTICES. 

13 Part D of title V of the Public Health Service Act (42 

14 U.S.C. 290dd et seq.) is amended by inserting after section 

15 543 of such Act (42 U.S.C. 290dd–2) the following: 

16 ‘‘SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVI17 DENCE-BASED PROGRAMS AND PRACTICES. 

18 ‘‘(a) IN GENERAL.—The Assistant Secretary shall, as 

19 appropriate, improve access to reliable and valid informa20 tion on evidence-based programs and practices, including 

21 information on the strength of evidence associated with such 

22 programs and practices, related to mental and substance 

23 use disorders for States, local communities, nonprofit enti24 ties, and other stakeholders, by posting on the Internet 

25 website of the Administration information on evidence- 
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•HR 34 EAH 

1 based programs and practices that have been reviewed by 

2 the Assistant Secretary in accordance with the requirements 

3 of this section. 

4 ‘‘(b) APPLICATIONS.— 

5 ‘‘(1) APPLICATION PERIOD.—In carrying out 

6 subsection (a), the Assistant Secretary may establish 

7 a period for the submission of applications for evi8 dence-based programs and practices to be posted pub9 licly in accordance with subsection (a). 

10 ‘‘(2) NOTICE.—In establishing the application 

11 period under paragraph (1), the Assistant Secretary 

12 shall provide for the public notice of such application 

13 period in the Federal Register. Such notice may so14 licit applications for evidence-based programs and 

15 practices to address gaps in information identified by 

16 the Assistant Secretary, the National Mental Health 

17 and Substance Use Policy Laboratory established 

18 under section 501A, or the Assistant Secretary for 

19 Planning and Evaluation, including pursuant to the 

20 evaluation and recommendations under section 6021 

21 of the Helping Families in Mental Health Crisis Re22 form Act of 2016 or priorities identified in the stra23 tegic plan under section 501(l). 

24 ‘‘(c) REQUIREMENTS.—The Assistant Secretary may 

25 establish minimum requirements for the applications sub-
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•HR 34 EAH 

1 mitted under subsection (b), including applications related 

2 to the submission of research and evaluation. 

3 ‘‘(d) REVIEW AND RATING.— 

4 ‘‘(1) IN GENERAL.—The Assistant Secretary 

5 shall review applications prior to public posting in 

6 accordance with subsection (a), and may prioritize 

7 the review of applications for evidence-based pro8 grams and practices that are related to topics in9 cluded in the notice provided under subsection (b)(2). 

10 ‘‘(2) SYSTEM.—In carrying out paragraph (1), 

11 the Assistant Secretary may utilize a rating and re12 view system, which may include information on the 

13 strength of evidence associated with the evidence-based 

14 programs and practices and a rating of the methodo15 logical rigor of the research supporting the applica16 tions. 

17 ‘‘(3) PUBLIC ACCESS TO METRICS AND RATING.— 

18 The Assistant Secretary shall make the metrics used 

19 to evaluate applications under this section, and any 

20 resulting ratings of such applications, publicly avail21 able.’’. 

22 SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL 

23 AND NATIONAL SIGNIFICANCE. 

24 Section 520A of the Public Health Service Act (42 

25 U.S.C. 290bb–32) is amended— 
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•HR 34 EAH 

1 (1) in subsection (a)— 

2 (A) in paragraph (4), by inserting before 

3 the period ‘‘, which may include technical assist4 ance centers’’; and 

5 (B) in the flush sentence following para6 graph (4)— 

7 (i) by inserting ‘‘, contracts,’’ before 

8 ‘‘or cooperative agreements’’; and 

9 (ii) by striking ‘‘Indian tribes and 

10 tribal organizations’’ and inserting ‘‘Indian 

11 tribes or tribal organizations (as such terms 

12 are defined in section 4 of the Indian Self13 Determination and Education Assistance 

14 Act), health facilities, or programs operated 

15 by or in accordance with a contract or 

16 grant with the Indian Health Service, or’’; 

17 and 

18 (2) by amending subsection (f) to read as follows: 

19 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are 

20 authorized to be appropriated to carry out this section 

21 $394,550,000 for each of fiscal years 2018 through 2022.’’. 
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1 SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREAT2 MENT NEEDS OF REGIONAL AND NATIONAL 

3 SIGNIFICANCE. 

4 Section 509 of the Public Health Service Act (42 

5 U.S.C. 290bb–2) is amended— 

6 (1) in subsection (a)— 

7 (A) in the matter preceding paragraph (1), 

8 by striking ‘‘abuse’’ and inserting ‘‘use dis9 order’’; 

10 (B) in paragraph (3), by inserting before 

11 the period ‘‘that permit States, local govern12 ments, communities, and Indian tribes and trib13 al organizations (as the terms ‘Indian tribes’ 

14 and ‘tribal organizations’ are defined in section 

15 4 of the Indian Self-Determination and Edu16 cation Assistance Act) to focus on emerging 

17 trends in substance abuse and co-occurrence of 

18 substance use disorders with mental illness or 

19 other conditions’’; and 

20 (C) in the flush sentence following para21 graph (3)— 

22 (i) by inserting ‘‘, contracts,’’ before 

23 ‘‘or cooperative agreements’’; and 

24 (ii) by striking ‘‘Indian tribes and 

25 tribal organizations,’’ and inserting ‘‘In26 dian tribes or tribal organizations (as such 
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•HR 34 EAH 

1 terms are defined in section 4 of the Indian 

2 Self-Determination and Education Assist3 ance Act), health facilities, or programs op4 erated by or in accordance with a contract 

5 or grant with the Indian Health Service, 

6 or’’; 

7 (2) in subsection (b)— 

8 (A) in paragraph (1), by striking ‘‘abuse’’ 

9 and inserting ‘‘use disorder’’; and 

10 (B) in paragraph (2), by striking ‘‘abuse’’ 

11 and inserting ‘‘use disorder’’; 

12 (3) in subsection (e), by striking ‘‘abuse’’ and in13 serting ‘‘use disorder’’; and 

14 (4) in subsection (f), by striking ‘‘$300,000,000’’ 

15 and all that follows through the period and inserting 

16 ‘‘$333,806,000 for each of fiscal years 2018 through 

17 2022.’’. 

18 SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVEN19 TION NEEDS OF REGIONAL AND NATIONAL 

20 SIGNIFICANCE. 

21 Section 516 of the Public Health Service Act (42 

22 U.S.C. 290bb–22) is amended— 

23 (1) in the section heading, by striking ‘‘ABUSE’’ 

24 and inserting ‘‘USE DISORDER’’; 

25 (2) in subsection (a)— 
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1 (A) in the matter preceding paragraph (1), 

2 by striking ‘‘abuse’’ and inserting ‘‘use dis3 order’’; 

4 (B) in paragraph (3), by inserting before 

5 the period ‘‘, including such programs that focus 

6 on emerging drug abuse issues’’; and 

7 (C) in the flush sentence following para8 graph (3)— 

9 (i) by inserting ‘‘, contracts,’’ before 

10 ‘‘or cooperative agreements’’; and 

11 (ii) by striking ‘‘Indian tribes and 

12 tribal organizations,’’ and inserting ‘‘In13 dian tribes or tribal organizations (as such 

14 terms are defined in section 4 of the Indian 

15 Self-Determination and Education Assist16 ance Act), health facilities, or programs op17 erated by or in accordance with a contract 

18 or grant with the Indian Health Service,’’; 

19 (3) in subsection (b)— 

20 (A) in paragraph (1), by striking ‘‘abuse’’ 

21 and inserting ‘‘use disorder’’; and 

22 (B) in paragraph (2)— 

23 (i) in subparagraph (A), by striking ‘‘; 

24 and’’ at the end and inserting ‘‘;’’; 

25 (ii) in subparagraph (B)— 
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•HR 34 EAH 

1 (I) by striking ‘‘abuse’’ and in2 serting ‘‘use disorder’’; and 

3 (II) by striking the period and in4 serting ‘‘; and’’; and 

5 (iii) by adding at the end the fol6 lowing: 

7 ‘‘(C) substance use disorder prevention 

8 among high-risk groups.’’; 

9 (4) in subsection (e), by striking ‘‘abuse’’ and in10 serting ‘‘use disorder’’; and 

11 (5) in subsection (f), by striking ‘‘$300,000,000’’ 

12 and all that follows through the period and inserting 

13 ‘‘$211,148,000 for each of fiscal years 2018 through 

14 2022.’’. 

15 TITLE VIII—SUPPORTING STATE 

16 PREVENTION ACTIVITIES AND 

17 RESPONSES TO MENTAL 

18 HEALTH AND SUBSTANCE USE 

19 DISORDER NEEDS 

20 SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK 

21 GRANT. 

22 (a) FORMULA GRANTS.—Section 1911(b) of the Public 

23 Health Service Act (42 U.S.C. 300x(b)) is amended— 

24 (1) by redesignating paragraphs (1) through (3) 

25 as paragraphs (2) through (4), respectively; and 
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•HR 34 EAH 

1 (2) by inserting before paragraph (2) (as so re2 designated) the following: 

3 ‘‘(1) providing community mental health services 

4 for adults with a serious mental illness and children 

5 with a serious emotional disturbance as defined in ac6 cordance with section 1912(c);’’. 

7 (b) STATE PLAN.—Section 1912(b) of the Public 

8 Health Service Act (42 U.S.C. 300x–1(b)) is amended— 

9 (1) in paragraph (3), by redesignating subpara10 graphs (A) through (C) as clauses (i) through (iii), re11 spectively, and realigning the margins accordingly; 

12 (2) by redesignating paragraphs (1) through (5) 

13 as subparagraphs (A) through (E), respectively, and 

14 realigning the margins accordingly; 

15 (3) in the matter preceding subparagraph (A) 

16 (as so redesignated), by striking ‘‘With respect to’’ 

17 and all that follows through ‘‘are as follows:’’ and in18 serting ‘‘In accordance with subsection (a), a State 

19 shall submit to the Secretary a plan every two years 

20 that, at a minimum, includes each of the following:’’; 

21 (4) by inserting before subparagraph (A) (as so 

22 redesignated) the following: 

23 ‘‘(1) SYSTEM OF CARE.—A description of the 

24 State’s system of care that contains the following:’’; 
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•HR 34 EAH 

1 (5) by striking subparagraph (A) (as so redesig2 nated) and inserting the following: 

3 ‘‘(A) COMPREHENSIVE COMMUNITY-BASED

4 HEALTH SYSTEMS.—The plan shall— 

5 ‘‘(i) identify the single State agency to 

6 be responsible for the administration of the 

7 program under the grant, including any 

8 third party who administers mental health 

9 services and is responsible for complying 

10 with the requirements of this part with re11 spect to the grant; 

12 ‘‘(ii) provide for an organized commu13 nity-based system of care for individuals 

14 with mental illness, and describe available 

15 services and resources in a comprehensive 

16 system of care, including services for indi17 viduals with co-occurring disorders; 

18 ‘‘(iii) include a description of the man19 ner in which the State and local entities 

20 will coordinate services to maximize the ef21 ficiency, effectiveness, quality, and cost-ef22 fectiveness of services and programs to 

23 produce the best possible outcomes (includ24 ing health services, rehabilitation services, 

25 employment services, housing services, edu-
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•HR 34 EAH 

1 cational services, substance use disorder 

2 services, legal services, law enforcement serv3 ices, social services, child welfare services, 

4 medical and dental care services, and other 

5 support services to be provided with Fed6 eral, State, and local public and private re7 sources) with other agencies to enable indi8 viduals receiving services to function outside 

9 of inpatient or residential institutions, to 

10 the maximum extent of their capabilities, 

11 including services to be provided by local 

12 school systems under the Individuals with 

13 Disabilities Education Act; 

14 ‘‘(iv) include a description of how the 

15 State promotes evidence-based practices, in16 cluding those evidence-based programs that 

17 address the needs of individuals with early 

18 serious mental illness regardless of the age 

19 of the individual at onset, provide com20 prehensive individualized treatment, or in21 tegrate mental and physical health services; 

22 ‘‘(v) include a description of case man23 agement services; 

24 ‘‘(vi) include a description of activities 

25 that seek to engage adults with a serious 
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•HR 34 EAH 

1 mental illness or children with a serious 

2 emotional disturbance and their caregivers 

3 where appropriate in making health care 

4 decisions, including activities that enhance 

5 communication among individuals, fami6 lies, caregivers, and treatment providers; 

7 and 

8 ‘‘(vii) as appropriate to, and reflective 

9 of, the uses the State proposes for the block 

10 grant funds, include— 

11 ‘‘(I) a description of the activities 

12 intended to reduce hospitalizations and 

13 hospital stays using the block grant 

14 funds; 

15 ‘‘(II) a description of the activi16 ties intended to reduce incidents of sui17 cide using the block grant funds; 

18 ‘‘(III) a description of how the 

19 State integrates mental health and pri20 mary care using the block grant funds, 

21 which may include providing, in the 

22 case of individuals with co-occurring 

23 mental and substance use disorders, 

24 both mental and substance use dis25 orders services in primary care settings 
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•HR 34 EAH 

1 or arrangements to provide primary 

2 and specialty care services in commu3 nity-based mental and substance use 

4 disorders settings; and 

5 ‘‘(IV) a description of recovery 

6 and recovery support services for 

7 adults with a serious mental illness 

8 and children with a serious emotional 

9 disturbance.’’; 

10 (6) in subparagraph (B) (as so redesignated)— 

11 (A) by striking ‘‘The plan contains’’ and 

12 inserting ‘‘The plan shall contain’’; and 

13 (B) by striking ‘‘presents quantitative tar14 gets to be achieved in the implementation of the 

15 system described in paragraph (1)’’ and insert16 ing ‘‘present quantitative targets and outcome 

17 measures for programs and services provided 

18 under this subpart’’; 

19 (7) in subparagraph (C) (as so redesignated)— 

20 (A) by striking ‘‘serious emotional disturb21 ance’’ in the matter preceding clause (i) (as so 

22 redesignated) and all that follows through ‘‘sub23 stance abuse services’’ in clause (i) (as so redes24 ignated) and inserting the following: ‘‘a serious 

25 emotional disturbance (as defined pursuant to 
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1 subsection (c)), the plan shall provide for a sys2 tem of integrated social services, educational 

3 services, child welfare services, juvenile justice 

4 services, law enforcement services, and substance 

5 use disorder services’’; 

6 (B) by striking ‘‘Education Act);’’ and in7 serting ‘‘Education Act).’’; and 

8 (C) by striking clauses (ii) and (iii) (as so 

9 redesignated); 

10 (8) in subparagraph (D) (as so redesignated), by 

11 striking ‘‘plan describes’’ and inserting ‘‘plan shall 

12 describe’’; 

13 (9) in subparagraph (E) (as so redesignated)— 

14 (A) in the subparagraph heading by strik15 ing ‘‘SYSTEMS’’ and inserting ‘‘SERVICES’’; 

16 (B) in the first sentence, by striking ‘‘plan 

17 describes’’ and all that follows through ‘‘and pro18 vides for’’ and inserting ‘‘plan shall describe the 

19 financial resources available, the existing mental 

20 health workforce, and the workforce trained in 

21 treating individuals with co-occurring mental 

22 and substance use disorders, and shall provide 

23 for’’; and 

24 (C) in the second sentence— 
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1 (i) by striking ‘‘further describes’’ and 

2 inserting ‘‘shall further describe’’; and 

3 (ii) by striking ‘‘involved.’’ and insert4 ing ‘‘involved, and the manner in which the 

5 State intends to comply with each of the 

6 funding agreements in this subpart and 

7 subpart III.’’; 

8 (10) by striking the flush matter at the end; and 

9 (11) by adding at the end the following: 

10 ‘‘(2) GOALS AND OBJECTIVES.—The establish11 ment of goals and objectives for the period of the plan, 

12 including targets and milestones that are intended to 

13 be met, and the activities that will be undertaken to 

14 achieve those targets.’’. 

15 (c) EARLY SERIOUS MENTAL ILLNESS.—Section 1920 

16 of the Public Health Service Act (42 U.S.C. 300x–9) is 

17 amended by adding at the end the following: 

18 ‘‘(c) EARLY SERIOUS MENTAL ILLNESS.— 

19 ‘‘(1) IN GENERAL.—Except as provided in para20 graph (2), a State shall expend not less than 10 per21 cent of the amount the State receives for carrying out 

22 this section for each fiscal year to support evidence23 based programs that address the needs of individuals 

24 with early serious mental illness, including psychotic 
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1 disorders, regardless of the age of the individual at 

2 onset. 

3 ‘‘(2) STATE FLEXIBILITY.—In lieu of expending 

4 10 percent of the amount the State receives under this 

5 section for a fiscal year as required under paragraph 

6 (1), a State may elect to expend not less than 20 per7 cent of such amount by the end of such succeeding fis8 cal year.’’. 

9 (d) ADDITIONAL PROVISIONS.—Section 1915(b) of the 

10 Public Health Service Act (42 U.S.C. 300x–4(b)) is amend11 ed— 

12 (1) in paragraph (3)— 

13 (A) by striking ‘‘The Secretary’’ and insert14 ing the following: 

15 ‘‘(A) IN GENERAL.—The Secretary’’; 

16 (B) by striking ‘‘paragraph (1) if’’ and in17 serting ‘‘paragraph (1) in whole or in part if’’; 

18 (C) by striking ‘‘State justify the waiver.’’ 

19 and inserting ‘‘State in the fiscal year involved 

20 or in the previous fiscal year justify the waiver’’; 

21 and 

22 (D) by adding at the end the following: 

23 ‘‘(B) DATE CERTAIN FOR ACTION UPON RE24 QUEST.—The Secretary shall approve or deny a 

25 request for a waiver under this paragraph not 
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1 later than 120 days after the date on which the 

2 request is made. 

3 ‘‘(C) APPLICABILITY OF WAIVER.—A waiver 

4 provided by the Secretary under this paragraph 

5 shall be applicable only to the fiscal year in6 volved.’’; and 

7 (2) in paragraph (4)— 

8 (A) in subparagraph (A)— 

9 (i) by inserting after the subparagraph 

10 designation the following: ‘‘IN GENERAL.— 

11 ’’; 

12 (ii) by striking ‘‘In making a grant’’ 

13 and inserting the following: 

14 ‘‘(i) DETERMINATION.—In making a 

15 grant’’; and 

16 (iii) by inserting at the end the fol17 lowing: 

18 ‘‘(ii) ALTERNATIVE.—A State that has 

19 failed to comply with paragraph (1) and 

20 would otherwise be subject to a reduction in 

21 the State’s allotment under section 1911 

22 may, upon request by the State, in lieu of 

23 having the amount of the allotment under 

24 section 1911 for the State reduced for the 

25 fiscal year of the grant, agree to comply 
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1 with a negotiated agreement that is ap2 proved by the Secretary and carried out in 

3 accordance with guidelines issued by the 

4 Secretary. If a State fails to enter into or 

5 comply with a negotiated agreement, the 

6 Secretary may take action under this para7 graph or the terms of the negotiated agree8 ment.’’; and 

9 (B) in subparagraph (B)— 

10 (i) by inserting after the subparagraph 

11 designation the following: ‘‘SUBMISSION OF

12 INFORMATION TO THE SECRETARY.—’’; and 

13 (ii) by striking ‘‘subparagraph (A)’’ 

14 and inserting ‘‘subparagraph (A)(i)’’. 

15 (e) APPLICATION FOR GRANT.—Section 1917(a) of the 

16 Public Health Service Act (42 U.S.C. 300x–6(a)) is amend17 ed— 

18 (1) in paragraph (1), by striking ‘‘1941’’ and in19 serting ‘‘1942(a)’’; and 

20 (2) in paragraph (5), by striking 

21 ‘‘1915(b)(3)(B)’’ and inserting ‘‘1915(b)’’. 

22 (f) FUNDING.—Section 1920 of the Public Health Serv23 ice Act (42 U.S.C. 300x–9) is amended— 

24 (1) in subsection (a)— 
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1 (A) by striking ‘‘section 505’’ and inserting 

2 ‘‘section 505(c)’’; and 

3 (B) by striking ‘‘$450,000,000’’ and all that 

4 follows through the period and inserting 

5 ‘‘$532,571,000 for each of fiscal years 2018 

6 through 2022.’’; and 

7 (2) in subsection (b)(2) by striking ‘‘sections 505 

8 and’’ and inserting ‘‘sections 505(c) and’’. 

9 SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREAT10 MENT BLOCK GRANT. 

11 (a) FORMULA GRANTS.—Section 1921(b) of the Public 

12 Health Service Act (42 U.S.C. 300x–21(b)) is amended— 

13 (1) by inserting ‘‘carrying out the plan developed 

14 in accordance with section 1932(b) and for’’ after ‘‘for 

15 the purpose of’’; and 

16 (2) by striking ‘‘abuse’’ and inserting ‘‘use dis17 orders’’. 

18 (b) OUTREACH TO PERSONS WHO INJECT DRUGS.— 

19 Section 1923(b) of the Public Health Service Act (42 U.S.C. 

20 300x–23(b)) is amended— 

21 (1) in the subsection heading, by striking ‘‘RE22 GARDING INTRAVENOUS SUBSTANCE ABUSE’’ and in23 serting ‘‘TO PERSONS WHO INJECT DRUGS’’; and 

24 (2) by striking ‘‘for intravenous drug abuse’’ and 

25 inserting ‘‘for persons who inject drugs’’. 
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1 (c) REQUIREMENTS REGARDING TUBERCULOSIS AND

2 HUMAN IMMUNODEFICIENCY VIRUS.—Section 1924 of the 

3 Public Health Service Act (42 U.S.C. 300x–24) is amend4 ed— 

5 (1) in subsection (a)(1)— 

6 (A) in the matter preceding subparagraph 

7 (A), by striking ‘‘substance abuse’’ and inserting 

8 ‘‘substance use disorders’’; and 

9 (B) in subparagraph (A), by striking ‘‘such 

10 abuse’’ and inserting ‘‘such disorders’’; 

11 (2) in subsection (b)— 

12 (A) in paragraph (1)(A), by striking ‘‘sub13 stance abuse’’ and inserting ‘‘substance use dis14 orders’’; 

15 (B) in paragraph (2), by inserting ‘‘and 

16 Prevention’’ after ‘‘Disease Control’’; 

17 (C) in paragraph (3)— 

18 (i) in the paragraph heading, by strik19 ing ‘‘ABUSE’’ and inserting ‘‘USE DIS20 ORDERS’’; and 

21 (ii) by striking ‘‘substance abuse’’ and 

22 inserting ‘‘substance use disorders’’; and 

23 (D) in paragraph (6)(B), by striking ‘‘sub24 stance abuse’’ and inserting ‘‘substance use dis25 orders’’; 
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1 (3) by striking subsection (d); and 

2 (4) by redesignating subsection (e) as subsection 

3 (d). 

4 (d) GROUP HOMES.—Section 1925 of the Public 

5 Health Service Act (42 U.S.C. 300x–25) is amended— 

6 (1) in the section heading, by striking ‘‘RECOV7 ERING SUBSTANCE ABUSERS’’ and inserting 

8 ‘‘PERSONS IN RECOVERY FROM SUBSTANCE

9 USE DISORDERS’’; and 

10 (2) in subsection (a), in the matter preceding 

11 paragraph (1), by striking ‘‘recovering substance 

12 abusers’’ and inserting ‘‘persons in recovery from sub13 stance use disorders’’. 

14 (e) ADDITIONAL AGREEMENTS.—Section 1928 of the 

15 Public Health Service Act (42 U.S.C. 300x–28) is amend16 ed— 

17 (1) in subsection (a), by striking ‘‘(relative to 

18 fiscal year 1992)’’; 

19 (2) by striking subsection (b) and inserting the 

20 following: 

21 ‘‘(b) PROFESSIONAL DEVELOPMENT.—A funding 

22 agreement for a grant under section 1921 is that the State 

23 involved will ensure that prevention, treatment, and recov24 ery personnel operating in the State’s substance use dis25 order prevention, treatment, and recovery systems have an 
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1 opportunity to receive training, on an ongoing basis, con2 cerning— 

3 ‘‘(1) recent trends in substance use disorders in 

4 the State; 

5 ‘‘(2) improved methods and evidence-based prac6 tices for providing substance use disorder prevention 

7 and treatment services; 

8 ‘‘(3) performance-based accountability; 

9 ‘‘(4) data collection and reporting requirements; 

10 and 

11 ‘‘(5) any other matters that would serve to fur12 ther improve the delivery of substance use disorder 

13 prevention and treatment services within the State.’’; 

14 and 

15 (3) in subsection (d)(1), by striking ‘‘substance 

16 abuse’’ and inserting ‘‘substance use disorders’’. 

17 (f) REPEAL.—Section 1929 of the Public Health Serv18 ice Act (42 U.S.C. 300x–29) is repealed. 

19 (g) MAINTENANCE OF EFFORT.—Section 1930 of the 

20 Public Health Service Act (42 U.S.C. 300x–30) is amend21 ed— 

22 (1) in subsection (c)(1), by striking ‘‘in the State 

23 justify the waiver’’ and inserting ‘‘exist in the State, 

24 or any part of the State, to justify the waiver’’; and 
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1 (2) in subsection (d), by inserting at the end the 

2 following: 

3 ‘‘(3) ALTERNATIVE.—A State that has failed to 

4 comply with this section and would otherwise be sub5 ject to a reduction in the State’s allotment under sec6 tion 1921, may, upon request by the State, in lieu of 

7 having the State’s allotment under section 1921 re8 duced, agree to comply with a negotiated agreement 

9 that is approved by the Secretary and carried out in 

10 accordance with guidelines issued by the Secretary. If 

11 a State fails to enter into or comply with a negotiated 

12 agreement, the Secretary may take action under this 

13 paragraph or the terms of the negotiated agreement.’’. 

14 (h) RESTRICTIONS ON EXPENDITURES.—Section 

15 1931(b)(1) of the Public Health Service Act (42 U.S.C. 

16 300x–31(b)(1)) is amended by striking ‘‘substance abuse’’ 

17 and inserting ‘‘substance use disorders’’. 

18 (i) APPLICATION.—Section 1932 of the Public Health 

19 Service Act (42 U.S.C. 300x–32) is amended— 

20 (1) in subsection (a)— 

21 (A) in the matter preceding paragraph (1), 

22 by striking ‘‘subsections (c) and (d)(2)’’ and in23 serting ‘‘subsection (c)’’; and 
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1 (B) in paragraph (5), by striking ‘‘the in2 formation required in section 1929, the informa3 tion required in section 1930(c)(2), and’’; 

4 (2) in subsection (b)— 

5 (A) by striking paragraph (1) and inserting 

6 the following: 

7 ‘‘(1) IN GENERAL.—In order for a State to be in 

8 compliance with subsection (a)(6), the State shall sub9 mit to the Secretary a plan that, at a minimum, in10 cludes the following: 

11 ‘‘(A) A description of the State’s system of 

12 care that— 

13 ‘‘(i) identifies the single State agency 

14 responsible for the administration of the 

15 program, including any third party who 

16 administers substance use disorder services 

17 and is responsible for complying with the 

18 requirements of the grant; 

19 ‘‘(ii) provides information on the need 

20 for substance use disorder prevention and 

21 treatment services in the State, including 

22 estimates on the number of individuals who 

23 need treatment, who are pregnant women, 

24 women with dependent children, individuals 

25 with a co-occurring mental health and sub-
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1 stance use disorder, persons who inject 

2 drugs, and persons who are experiencing 

3 homelessness; 

4 ‘‘(iii) provides aggregate information 

5 on the number of individuals in treatment 

6 within the State, including the number of 

7 such individuals who are pregnant women, 

8 women with dependent children, individuals 

9 with a co-occurring mental health and sub10 stance use disorder, persons who inject 

11 drugs, and persons who are experiencing 

12 homelessness; 

13 ‘‘(iv) provides a description of the sys14 tem that is available to provide services by 

15 modality, including the provision of recov16 ery support services; 

17 ‘‘(v) provides a description of the 

18 State’s comprehensive statewide prevention 

19 efforts, including the number of individuals 

20 being served in the system, target popu21 lations, and priority needs, and provides a 

22 description of the amount of funds from the 

23 prevention set-aside expended on primary 

24 prevention; 
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1 ‘‘(vi) provides a description of the fi2 nancial resources available; 

3 ‘‘(vii) describes the existing substance 

4 use disorders workforce and workforce 

5 trained in treating co-occurring substance 

6 use and mental disorders; 

7 ‘‘(viii) includes a description of how 

8 the State promotes evidence-based practices; 

9 and 

10 ‘‘(ix) describes how the State integrates 

11 substance use disorder services and primary 

12 health care, which in the case of those indi13 viduals with co-occurring mental health and 

14 substance use disorders may include pro15 viding both mental health and substance use 

16 disorder services in primary care settings or 

17 providing primary and specialty care serv18 ices in community-based mental health and 

19 substance use disorder service settings. 

20 ‘‘(B) The establishment of goals and objec21 tives for the period of the plan, including targets 

22 and milestones that are intended to be met, and 

23 the activities that will be undertaken to achieve 

24 those targets. 
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1 ‘‘(C) A description of how the State will 

2 comply with each funding agreement for a grant 

3 under section 1921 that is applicable to the 

4 State, including a description of the manner in 

5 which the State intends to expend grant funds.’’; 

6 and 

7 (B) in paragraph (2)— 

8 (i) in the paragraph heading, by strik9 ing ‘‘AUTHORITY OF SECRETARY REGARDING

10 MODIFICATIONS’’ and inserting ‘‘MODIFICA11 TIONS’’; 

12 (ii) by striking ‘‘As a condition’’ and 

13 inserting the following: 

14 ‘‘(A) AUTHORITY OF SECRETARY.—As a 

15 condition;’’; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(B) STATE REQUEST FOR MODIFICA19 TION.—If the State determines that a modifica20 tion to such plan is necessary, the State may re21 quest the Secretary to approve the modification. 

22 Any such modification shall be in accordance 

23 with paragraph (1) and section 1941.’’; and 
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1 (C) in paragraph (3), by inserting, ‘‘, in2 cluding any modification under paragraph (2)’’ 

3 after ‘‘subsection (a)(6)’’; and 

4 (3) in subsection (e)(2), by striking ‘‘section 

5 1922(c)’’ and inserting ‘‘section 1922(b)’’. 

6 (j) DEFINITIONS.—Section 1934 of the Public Health 

7 Service Act (42 U.S.C. 300x–34) is amended— 

8 (1) in paragraph (3), by striking ‘‘substance 

9 abuse’’ and inserting ‘‘substance use disorders’’; and 

10 (2) in paragraph (7), by striking ‘‘substance 

11 abuse’’ and inserting ‘‘substance use disorders’’. 

12 (k) FUNDING.—Section 1935 of the Public Health 

13 Service Act (42 U.S.C. 300x–35) is amended— 

14 (1) in subsection (a)— 

15 (A) by striking ‘‘section 505’’ and inserting 

16 ‘‘section 505(d)’’; and 

17 (B) by striking ‘‘$2,000,000,000 for fiscal 

18 year 2001, and such sums as may be necessary 

19 for each of the fiscal years 2002 and 2003’’ and 

20 inserting ‘‘$1,858,079,000 for each of fiscal years 

21 2018 through 2022.’’; and 

22 (2) in subsection (b)(1)(B) by striking ‘‘sections 

23 505 and’’ and inserting ‘‘sections 505(d) and’’. 
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1 SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE 

2 BLOCK GRANTS. 

3 Subpart III of part B of title XIX of the Public Health 

4 Service Act (42 U.S.C. 300x–51 et seq.) is amended— 

5 (1) in section 1943(a)(3) (42 U.S.C. 300x– 

6 53(a)(3)), by striking ‘‘section 505’’ and inserting 

7 ‘‘subsections (c) and (d) of section 505’’; 

8 (2) in section 1953(b) (42 U.S.C. 300x–63(b)), 

9 by striking ‘‘substance abuse’’ and inserting ‘‘sub10 stance use disorder’’; and 

11 (3) by adding at the end the following: 

12 ‘‘SEC. 1957. PUBLIC HEALTH EMERGENCIES. 

13 ‘‘In the case of a public health emergency (as deter14 mined under section 319), the Secretary, on a State by 

15 State basis, may, as the circumstances of the emergency rea16 sonably require and for the period of the emergency, grant 

17 an extension, or waive application deadlines or compliance 

18 with any other requirement, of a grant authorized under 

19 section 521, 1911, or 1921 or an allotment authorized under 

20 Public Law 99–319 (42 U.S.C. 10801 et seq.). 

21 ‘‘SEC. 1958. JOINT APPLICATIONS. 

22 ‘‘The Secretary, acting through the Assistant Secretary 

23 for Mental Health and Substance Use, shall permit a joint 

24 application to be submitted for grants under subpart I and 

25 subpart II upon the request of a State. Such application 

26 may be jointly reviewed and approved by the Secretary 
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1 with respect to such subparts, consistent with the purposes 

2 and authorized activities of each such grant program. A 

3 State submitting such a joint application shall otherwise 

4 meet the requirements with respect to each such subpart.’’. 

5 SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE 

6 SUBSTANCE ABUSE PREVENTION AND TREAT7 MENT BLOCK GRANT AND THE COMMUNITY 

8 MENTAL HEALTH SERVICES BLOCK GRANT. 

9 (a) IN GENERAL.—The Secretary of Health and 

10 Human Services, acting through the Assistant Secretary for 

11 Mental Health and Substance Use, shall through a grant 

12 or contract, or through an agreement with a third party, 

13 conduct a study on the formulas for distribution of funds 

14 under the substance abuse prevention and treatment block 

15 grant, and the community mental health services block 

16 grant, under part B of title XIX of the Public Health Serv17 ice Act (42 U.S.C. 300x et seq.) and recommend changes 

18 if necessary. Such study shall include— 

19 (1) an analysis of whether the distributions 

20 under such block grants accurately reflect the need for 

21 the services under the grants in the States; 

22 (2) an examination of whether the indices used 

23 under the formulas for distribution of funds under 

24 such block grants are appropriate, and if not, alter25 natives recommended by the Secretary; 
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1 (3) where recommendations are included under 

2 paragraph (2) for the use of different indices, a de3 scription of the variables and data sources that should 

4 be used to determine the indices; 

5 (4) an evaluation of the variables and data 

6 sources that are being used for each of the indices in7 volved, and whether such variables and data sources 

8 accurately represent the need for services, the cost of 

9 providing services, and the ability of the States to 

10 pay for such services; 

11 (5) the effect that the minimum allotment re12 quirements for each such block grant have on each 

13 State’s final allotment and the effect of such require14 ments, if any, on each State’s formula-based allot15 ment; 

16 (6) recommendations for modifications to the 

17 minimum allotment provisions to ensure an appro18 priate distribution of funds; and 

19 (7) any other information that the Secretary de20 termines appropriate. 

21 (b) REPORT.—Not later than 2 years after the date 

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

23 Human Services shall submit to the Committee on Health, 

24 Education, Labor, and Pensions of the Senate and the Com25 mittee on Energy and Commerce of the House of Represent-
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•HR 34 EAH 

1 atives, a report containing the findings and recommenda2 tions of the study conducted under subsection (a) and the 

3 study conducted under section 9004(g). 

4 TITLE IX—PROMOTING ACCESS 

5 TO MENTAL HEALTH AND 

6 SUBSTANCE USE DISORDER 

7 CARE 

8 Subtitle A—Helping Individuals 

9 and Families 

10 SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR 

11 HOMELESS INDIVIDUALS. 

12 Section 506 of the Public Health Service Act (42 

13 U.S.C. 290aa–5) is amended— 

14 (1) in subsection (a), by striking ‘‘substance 

15 abuse’’ and inserting ‘‘substance use disorder’’; 

16 (2) in subsection (b)— 

17 (A) in paragraphs (1) and (3), by striking 

18 ‘‘substance abuse’’ each place the term appears 

19 and inserting ‘‘substance use disorder’’; and 

20 (B) in paragraph (4), by striking ‘‘sub21 stance abuse’’ and inserting ‘‘a substance use 

22 disorder’’; 

23 (3) in subsection (c)— 
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1 (A) in paragraph (1), by striking ‘‘sub2 stance abuse disorder’’ and inserting ‘‘substance 

3 use disorder’’; and 

4 (B) in paragraph (2)— 

5 (i) in subparagraph (A), by striking 

6 ‘‘substance abuse’’ and inserting ‘‘a sub7 stance use disorder’’; and 

8 (ii) in subparagraph (B), by striking 

9 ‘‘substance abuse’’ and inserting ‘‘substance 

10 use disorder’’; and 

11 (4) in subsection (e), by striking ‘‘, $50,000,000 

12 for fiscal year 2001, and such sums as may be nec13 essary for each of the fiscal years 2002 and 2003’’ 

14 and inserting ‘‘$41,304,000 for each of fiscal years 

15 2018 through 2022’’. 

16 SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS. 

17 Section 520G of the Public Health Service Act (42 

18 U.S.C. 290bb–38) is amended— 

19 (1) by striking ‘‘substance abuse’’ each place such 

20 term appears and inserting ‘‘substance use disorder’’; 

21 (2) in subsection (a)— 

22 (A) by striking ‘‘Indian tribes, and tribal 

23 organizations’’ and inserting ‘‘and Indian tribes 

24 and tribal organizations (as the terms ‘Indian 

25 tribes’ and ‘tribal organizations’ are defined in 
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1 section 4 of the Indian Self-Determination and 

2 Education Assistance Act)’’; and 

3 (B) by inserting ‘‘or a health facility or 

4 program operated by or in accordance with a 

5 contract or grant with the Indian Health Serv6 ice,’’ after ‘‘entities,’’; 

7 (3) in subsection (c)(2)(A)(i), by striking ‘‘the 

8 best known’’ and inserting ‘‘evidence-based’’; 

9 (4) by redesignating subsections (d) through (i) 

10 as subsections (e) through (j), respectively; 

11 (5) by inserting after subsection (c) the fol12 lowing: 

13 ‘‘(d) SPECIAL CONSIDERATION REGARDING VET14 ERANS.—In awarding grants under subsection (a), the Sec15 retary shall, as appropriate, give special consideration to 

16 entities proposing to use grant funding to support jail di17 version services for veterans.’’; 

18 (6) in subsection (e), as so redesignated— 

19 (A) in paragraph (3), by striking ‘‘; and’’ 

20 and inserting a semicolon; 

21 (B) in paragraph (4), by striking the period 

22 and inserting ‘‘; and’’; and 

23 (C) by adding at the end the following: 

24 ‘‘(5) develop programs to divert individuals 

25 prior to booking or arrest.’’; and 
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•HR 34 EAH 

1 (7) in subsection (j), as so redesignated, by strik2 ing ‘‘$10,000,000 for fiscal year 2001, and such sums 

3 as may be necessary for fiscal years 2002 through 

4 2003’’ and inserting ‘‘$4,269,000 for each of fiscal 

5 years 2018 through 2022’’. 

6 SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BE7 HAVIORAL HEALTH CARE. 

8 Section 520K of the Public Health Service Act (42 

9 U.S.C. 290bb–42) is amended to read as follows: 

10 ‘‘SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOP11 ERATIVE AGREEMENTS. 

12 ‘‘(a) DEFINITIONS.—In this section: 

13 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible enti14 ty’ means a State, or other appropriate State agency, 

15 in collaboration with 1 or more qualified community 

16 programs as described in section 1913(b)(1) or 1 or 

17 more community health centers as described in section 

18 330. 

19 ‘‘(2) INTEGRATED CARE.—The term ‘integrated 

20 care’ means collaborative models or practices offering 

21 mental and physical health services, which may in22 clude practices that share the same space in the same 

23 facility. 

24 ‘‘(3) SPECIAL POPULATION.—The term ‘special 

25 population’ means— 
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•HR 34 EAH 

1 ‘‘(A) adults with a mental illness who have 

2 co-occurring physical health conditions or chron3 ic diseases; 

4 ‘‘(B) adults with a serious mental illness 

5 who have co-occurring physical health conditions 

6 or chronic diseases; 

7 ‘‘(C) children and adolescents with a serious 

8 emotional disturbance with co-occurring physical 

9 health conditions or chronic diseases; or 

10 ‘‘(D) individuals with a substance use dis11 order. 

12 ‘‘(b) GRANTS AND COOPERATIVE AGREEMENTS.— 

13 ‘‘(1) IN GENERAL.—The Secretary may award 

14 grants and cooperative agreements to eligible entities 

15 to support the improvement of integrated care for pri16 mary care and behavioral health care in accordance 

17 with paragraph (2). 

18 ‘‘(2) PURPOSES.—A grant or cooperative agree19 ment awarded under this section shall be designed 

20 to— 

21 ‘‘(A) promote full integration and collabora22 tion in clinical practices between primary and 

23 behavioral health care; 

24 ‘‘(B) support the improvement of integrated 

25 care models for primary care and behavioral 
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1 health care to improve the overall wellness and 

2 physical health status of adults with a serious 

3 mental illness or children with a serious emo4 tional disturbance; and 

5 ‘‘(C) promote integrated care services re6 lated to screening, diagnosis, prevention, and 

7 treatment of mental and substance use disorders, 

8 and co-occurring physical health conditions and 

9 chronic diseases. 

10 ‘‘(c) APPLICATIONS.— 

11 ‘‘(1) IN GENERAL.—An eligible entity seeking a 

12 grant or cooperative agreement under this section 

13 shall submit an application to the Secretary at such 

14 time, in such manner, and accompanied by such in15 formation as the Secretary may require, including the 

16 contents described in paragraph (2). 

17 ‘‘(2) CONTENTS.—The contents described in this 

18 paragraph are— 

19 ‘‘(A) a description of a plan to achieve fully 

20 collaborative agreements to provide services to 

21 special populations; 

22 ‘‘(B) a document that summarizes the poli23 cies, if any, that serve as barriers to the provi24 sion of integrated care, and the specific steps, if 
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1 applicable, that will be taken to address such 

2 barriers; 

3 ‘‘(C) a description of partnerships or other 

4 arrangements with local health care providers to 

5 provide services to special populations; 

6 ‘‘(D) an agreement and plan to report to 

7 the Secretary performance measures necessary to 

8 evaluate patient outcomes and facilitate evalua9 tions across participating projects; and 

10 ‘‘(E) a plan for sustainability beyond the 

11 grant or cooperative agreement period under sub12 section (e). 

13 ‘‘(d) GRANT AND COOPERATIVE AGREEMENT

14 AMOUNTS.— 

15 ‘‘(1) TARGET AMOUNT.—The target amount that 

16 an eligible entity may receive for a year through a 

17 grant or cooperative agreement under this section 

18 shall be $2,000,000. 

19 ‘‘(2) ADJUSTMENT PERMITTED.—The Secretary, 

20 taking into consideration the quality of the applica21 tion and the number of eligible entities that received 

22 grants under this section prior to the date of enact23 ment of the Helping Families in Mental Health Cri24 sis Reform Act of 2016, may adjust the target amount 
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•HR 34 EAH 

1 that an eligible entity may receive for a year through 

2 a grant or cooperative agreement under this section. 

3 ‘‘(3) LIMITATION.—An eligible entity receiving 

4 funding under this section may not allocate more 

5 than 10 percent of funds awarded under this section 

6 to administrative functions, and the remaining 

7 amounts shall be allocated to health facilities that 

8 provide integrated care. 

9 ‘‘(e) DURATION.—A grant or cooperative agreement 

10 under this section shall be for a period not to exceed 5 years. 

11 ‘‘(f) REPORT ON PROGRAM OUTCOMES.—An eligible 

12 entity receiving a grant or cooperative agreement under this 

13 section shall submit an annual report to the Secretary that 

14 includes— 

15 ‘‘(1) the progress made to reduce barriers to inte16 grated care as described in the entity’s application 

17 under subsection (c); and 

18 ‘‘(2) a description of functional outcomes of spe19 cial populations, including— 

20 ‘‘(A) with respect to adults with a serious 

21 mental illness, participation in supportive hous22 ing or independent living programs, attendance 

23 in social and rehabilitative programs, participa24 tion in job training opportunities, satisfactory 

25 performance in work settings, attendance at 
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1 scheduled medical and mental health appoint2 ments, and compliance with prescribed medica3 tion regimes; 

4 ‘‘(B) with respect to individuals with co-oc5 curring mental illness and physical health condi6 tions and chronic diseases, attendance at sched7 uled medical and mental health appointments, 

8 compliance with prescribed medication regimes, 

9 and participation in learning opportunities re10 lated to improved health and lifestyle practices; 

11 and 

12 ‘‘(C) with respect to children and adoles13 cents with a serious emotional disturbance who 

14 have co-occurring physical health conditions and 

15 chronic diseases, attendance at scheduled medical 

16 and mental health appointments, compliance 

17 with prescribed medication regimes, and partici18 pation in learning opportunities at school and 

19 extracurricular activities. 

20 ‘‘(g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAV21 IORAL HEALTH CARE INTEGRATION.— 

22 ‘‘(1) IN GENERAL.—The Secretary may provide 

23 appropriate information, training, and technical as24 sistance to eligible entities that receive a grant or co25 operative agreement under this section, in order to 
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1 help such entities meet the requirements of this sec2 tion, including assistance with— 

3 ‘‘(A) development and selection of integrated 

4 care models; 

5 ‘‘(B) dissemination of evidence-based inter6 ventions in integrated care; 

7 ‘‘(C) establishment of organizational prac8 tices to support operational and administrative 

9 success; and 

10 ‘‘(D) other activities, as the Secretary deter11 mines appropriate. 

12 ‘‘(2) ADDITIONAL DISSEMINATION OF TECHNICAL

13 INFORMATION.—The information and resources pro14 vided by the Secretary under paragraph (1) shall, as 

15 appropriate, be made available to States, political 

16 subdivisions of States, Indian tribes or tribal organi17 zations (as defined in section 4 of the Indian Self-De18 termination and Education Assistance Act), out19 patient mental health and addiction treatment cen20 ters, community mental health centers that meet the 

21 criteria under section 1913(c), certified community 

22 behavioral health clinics described in section 223 of 

23 the Protecting Access to Medicare Act of 2014, pri24 mary care organizations such as Federally qualified 

25 health centers or rural health clinics as defined in sec-
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1 tion 1861(aa) of the Social Security Act, other com2 munity-based organizations, or other entities engag3 ing in integrated care activities, as the Secretary de4 termines appropriate. 

5 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—To carry 

6 out this section, there are authorized to be appropriated 

7 $51,878,000 for each of fiscal years 2018 through 2022.’’. 

8 SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION 

9 FROM HOMELESSNESS. 

10 (a) FORMULA GRANTS TO STATES.—Section 521 of the 

11 Public Health Service Act (42 U.S.C. 290cc–21) is amended 

12 by striking ‘‘1991 through 1994’’ and inserting ‘‘2018 

13 through 2022’’. 

14 (b) PURPOSE OF GRANTS.—Section 522 of the Public 

15 Health Service Act (42 U.S.C. 290cc–22) is amended— 

16 (1) in subsection (a)(1)(B), by striking ‘‘sub17 stance abuse’’ and inserting ‘‘a substance use dis18 order’’; 

19 (2) in subsection (b)(6), by striking ‘‘substance 

20 abuse’’ and inserting ‘‘substance use disorder’’; 

21 (3) in subsection (c), by striking ‘‘substance 

22 abuse’’ and inserting ‘‘a substance use disorder’’; 

23 (4) in subsection (e)— 
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1 (A) in paragraph (1), by striking ‘‘sub2 stance abuse’’ and inserting ‘‘a substance use 

3 disorder’’; and 

4 (B) in paragraph (2), by striking ‘‘sub5 stance abuse’’ and inserting ‘‘substance use dis6 order’’; 

7 (5) by striking subsection (g) and redesignating 

8 subsections (h) and (i) as (g) and (h), accordingly; 

9 and 

10 (6) in subsection (g), as redesignated by para11 graph (5), by striking ‘‘substance abuse’’ each place 

12 such term appears and inserting ‘‘substance use dis13 order’’. 

14 (c) DESCRIPTION OF INTENDED EXPENDITURES OF

15 GRANT.—Section 527 of the Public Health Service Act (42 

16 U.S.C. 290cc–27) is amended by striking ‘‘substance abuse’’ 

17 each place such term appears and inserting ‘‘substance use 

18 disorder’’. 

19 (d) TECHNICAL ASSISTANCE.—Section 530 of the Pub20 lic Health Service Act (42 U.S.C. 290cc–30) is amended 

21 by striking ‘‘through the National Institute of Mental 

22 Health, the National Institute of Alcohol Abuse and Alco23 holism, and the National Institute on Drug Abuse’’ and in24 serting ‘‘acting through the Assistant Secretary’’. 
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1 (e) DEFINITIONS.—Section 534(4) of the Public Health 

2 Service Act (42 U.S.C. 290cc–34(4)) is amended to read as 

3 follows: 

4 ‘‘(4) SUBSTANCE USE DISORDER SERVICES.—The 

5 term ‘substance use disorder services’ has the meaning 

6 given the term ‘substance abuse services’ in section 

7 330(h)(5)(C).’’. 

8 (f) FUNDING.—Section 535(a) of the Public Health 

9 Service Act (42 U.S.C. 290cc–35(a)) is amended by striking 

10 ‘‘$75,000,000 for each of the fiscal years 2001 through 

11 2003’’ and inserting ‘‘$64,635,000 for each of fiscal years 

12 2018 through 2022’’. 

13 (g) STUDY CONCERNING FORMULA.— 

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

15 the date of enactment of this Act, the Assistant Sec16 retary for Mental Health and Substance Use (referred 

17 to in this section as the ‘‘Assistant Secretary’’) shall 

18 conduct a study concerning the formula used under 

19 section 524 of the Public Health Service Act (42 

20 U.S.C. 290cc–24) for making allotments to States 

21 under section 521 of such Act (42 U.S.C. 290cc–21). 

22 Such study shall include an evaluation of quality in23 dicators of need for purposes of revising the formula 

24 for determining the amount of each allotment for the 

25 fiscal years following the submission of the study. 
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1 (2) REPORT.—In accordance with section 

2 8004(b), the Assistant Secretary shall submit to the 

3 committees of Congress described in such section a re4 port concerning the results of the study conducted 

5 under paragraph (1). 

6 SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PRO7 GRAM. 

8 Subpart 3 of part B of title V of the Public Health 

9 Service Act (42 U.S.C. 290bb–31 et seq.) is amended by in10 serting after section 520E–2 (42 U.S.C. 290bb–36b) the fol11 lowing: 

12 ‘‘SEC. 520E–3. NATIONAL SUICIDE PREVENTION LIFELINE 

13 PROGRAM. 

14 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

15 Assistant Secretary, shall maintain the National Suicide 

16 Prevention Lifeline program (referred to in this section as 

17 the ‘program’), authorized under section 520A and in effect 

18 prior to the date of enactment of the Helping Families in 

19 Mental Health Crisis Reform Act of 2016. 

20 ‘‘(b) ACTIVITIES.—In maintaining the program, the 

21 activities of the Secretary shall include— 

22 ‘‘(1) coordinating a network of crisis centers 

23 across the United States for providing suicide preven24 tion and crisis intervention services to individuals 

25 seeking help at any time, day or night; 
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•HR 34 EAH 

1 ‘‘(2) maintaining a suicide prevention hotline to 

2 link callers to local emergency, mental health, and so3 cial services resources; and 

4 ‘‘(3) consulting with the Secretary of Veterans 

5 Affairs to ensure that veterans calling the suicide pre6 vention hotline have access to a specialized veterans’ 

7 suicide prevention hotline. 

8 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 

9 out this section, there are authorized to be appropriated 

10 $7,198,000 for each of fiscal years 2018 through 2022.’’. 

11 SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH 

12 CARE. 

13 Subpart 3 of part B of title V of the Public Health 

14 Service Act (42 U.S.C. 290bb–31 et seq.), as amended by 

15 section 9005, is further amended by inserting after section 

16 520E–3 the following: 

17 ‘‘SEC. 520E–4. TREATMENT REFERRAL ROUTING SERVICE. 

18 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

19 Assistant Secretary, shall maintain the National Treatment 

20 Referral Routing Service (referred to in this section as the 

21 ‘Routing Service’) to assist individuals and families in lo22 cating mental and substance use disorders treatment pro23 viders. 
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1 ‘‘(b) ACTIVITIES OF THE SECRETARY.—To maintain 

2 the Routing Service, the activities of the Assistant Secretary 

3 shall include administering— 

4 ‘‘(1) a nationwide, telephone number providing 

5 year-round access to information that is updated on 

6 a regular basis regarding local behavioral health pro7 viders and community-based organizations in a man8 ner that is confidential, without requiring individuals 

9 to identify themselves, is in languages that include at 

10 least English and Spanish, and is at no cost to the 

11 individual using the Routing Service; and 

12 ‘‘(2) an Internet website to provide a searchable, 

13 online treatment services locator of behavioral health 

14 treatment providers and community-based organiza15 tions, which shall include information on the name, 

16 location, contact information, and basic services pro17 vided by such providers and organizations. 

18 ‘‘(c) REMOVING PRACTITIONER CONTACT INFORMA19 TION.—In the event that the Internet website described in 

20 subsection (b)(2) contains information on any qualified 

21 practitioner that is certified to prescribe medication for 

22 opioid dependency under section 303(g)(2)(B) of the Con23 trolled Substances Act, the Assistant Secretary— 

24 ‘‘(1) shall provide an opportunity to such practi25 tioner to have the contact information of the practi-
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•HR 34 EAH 

1 tioner removed from the website at the request of the 

2 practitioner; and 

3 ‘‘(2) may evaluate other methods to periodically 

4 update the information displayed on such website. 

5 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec6 tion shall be construed to prevent the Assistant Secretary 

7 from using any unobligated amounts otherwise made avail8 able to the Administration to maintain the Routing Serv9 ice.’’. 

10 SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE 

11 SYSTEMS. 

12 Section 520F of the Public Health Service Act (42 

13 U.S.C. 290bb–37) is amended to read as follows: 

14 ‘‘SEC. 520F. STRENGTHENING COMMUNITY CRISIS RE15 SPONSE SYSTEMS. 

16 ‘‘(a) IN GENERAL.—The Secretary shall award com17 petitive grants to— 

18 ‘‘(1) State and local governments and Indian 

19 tribes and tribal organizations, to enhance commu20 nity-based crisis response systems; or 

21 ‘‘(2) States to develop, maintain, or enhance a 

22 database of beds at inpatient psychiatric facilities, 

23 crisis stabilization units, and residential community 

24 mental health and residential substance use disorder 

25 treatment facilities, for adults with a serious mental 
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1 illness, children with a serious emotional disturbance, 

2 or individuals with a substance use disorder. 

3 ‘‘(b) APPLICATIONS.— 

4 ‘‘(1) IN GENERAL.—To receive a grant under 

5 subsection (a), an entity shall submit to the Secretary 

6 an application, at such time, in such manner, and 

7 containing such information as the Secretary may re8 quire. 

9 ‘‘(2) COMMUNITY-BASED CRISIS RESPONSE

10 PLAN.—An application for a grant under subsection 

11 (a)(1) shall include a plan for— 

12 ‘‘(A) promoting integration and coordina13 tion between local public and private entities en14 gaged in crisis response, including first respond15 ers, emergency health care providers, primary 

16 care providers, law enforcement, court systems, 

17 health care payers, social service providers, and 

18 behavioral health providers; 

19 ‘‘(B) developing memoranda of under20 standing with public and private entities to im21 plement crisis response services; 

22 ‘‘(C) addressing gaps in community re23 sources for crisis intervention and prevention; 

24 and 
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1 ‘‘(D) developing models for minimizing hos2 pital readmissions, including through appro3 priate discharge planning. 

4 ‘‘(3) BEDS DATABASE PLAN.—An application for 

5 a grant under subsection (a)(2) shall include a plan 

6 for developing, maintaining, or enhancing a real7 time, Internet-based bed database to collect, aggregate, 

8 and display information about beds in inpatient psy9 chiatric facilities and crisis stabilization units, and 

10 residential community mental health and residential 

11 substance use disorder treatment facilities to facilitate 

12 the identification and designation of facilities for the 

13 temporary treatment of individuals in mental or sub14 stance use disorder crisis. 

15 ‘‘(c) DATABASE REQUIREMENTS.—A bed database de16 scribed in this section is a database that— 

17 ‘‘(1) includes information on inpatient psy18 chiatric facilities, crisis stabilization units, and resi19 dential community mental health and residential sub20 stance use disorder facilities in the State involved, in21 cluding contact information for the facility or unit; 

22 ‘‘(2) provides real-time information about the 

23 number of beds available at each facility or unit and, 

24 for each available bed, the type of patient that may 

25 be admitted, the level of security provided, and any 
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•HR 34 EAH 

1 other information that may be necessary to allow for 

2 the proper identification of appropriate facilities for 

3 treatment of individuals in mental or substance use 

4 disorder crisis; and 

5 ‘‘(3) enables searches of the database to identify 

6 available beds that are appropriate for the treatment 

7 of individuals in mental or substance use disorder 

8 crisis. 

9 ‘‘(d) EVALUATION.—An entity receiving a grant under 

10 subsection (a)(1) shall submit to the Secretary, at such time, 

11 in such manner, and containing such information as the 

12 Secretary may reasonably require, a report, including an 

13 evaluation of the effect of such grant on— 

14 ‘‘(1) local crisis response services and measures 

15 for individuals receiving crisis planning and early 

16 intervention supports; 

17 ‘‘(2) individuals reporting improved functional 

18 outcomes; and 

19 ‘‘(3) individuals receiving regular followup care 

20 following a crisis. 

21 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are 

22 authorized to be appropriated to carry out this section, 

23 $12,500,000 for the period of fiscal years 2018 through 

24 2022.’’. 
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1 SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHOR2 IZATION. 

3 (a) SUICIDE PREVENTION TECHNICAL ASSISTANCE

4 CENTER.—Section 520C of the Public Health Service Act 

5 (42 U.S.C. 290bb–34), as amended by section 6001, is fur6 ther amended— 

7 (1) in the section heading, by striking ‘‘YOUTH

8 INTERAGENCY RESEARCH, TRAINING, AND

9 TECHNICAL ASSISTANCE CENTERS’’ and insert10 ing ‘‘SUICIDE PREVENTION TECHNICAL ASSIST11 ANCE CENTER’’; 

12 (2) in subsection (a), by striking ‘‘acting through 

13 the Assistant Secretary for Mental Health and Sub14 stance Use’’ and all that follows through the period at 

15 the end of paragraph (2) and inserting ‘‘acting 

16 through the Assistant Secretary, shall establish a re17 search, training, and technical assistance resource 

18 center to provide appropriate information, training, 

19 and technical assistance to States, political subdivi20 sions of States, federally recognized Indian tribes, 

21 tribal organizations, institutions of higher education, 

22 public organizations, or private nonprofit organiza23 tions regarding the prevention of suicide among all 

24 ages, particularly among groups that are at a high 

25 risk for suicide.’’; 

26 (3) by striking subsections (b) and (c); 
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•HR 34 EAH 

1 (4) by redesignating subsection (d) as subsection 

2 (b); 

3 (5) in subsection (b), as so redesignated— 

4 (A) in the subsection heading, by striking 

5 ‘‘ADDITIONAL CENTER’’ and inserting ‘‘RESPON6 SIBILITIES OF THE CENTER’’; 

7 (B) in the matter preceding paragraph (1), 

8 by striking ‘‘The additional research’’ and all 

9 that follows through ‘‘nonprofit organizations 

10 for’’ and inserting ‘‘The center established under 

11 subsection (a) shall conduct activities for the 

12 purpose of’’; 

13 (C) by striking ‘‘youth suicide’’ each place 

14 such term appears and inserting ‘‘suicide’’; 

15 (D) in paragraph (1)— 

16 (i) by striking ‘‘the development or 

17 continuation of’’ and inserting ‘‘developing 

18 and continuing’’; and 

19 (ii) by inserting ‘‘for all ages, particu20 larly among groups that are at a high risk 

21 for suicide’’ before the semicolon at the end; 

22 (E) in paragraph (2), by inserting ‘‘for all 

23 ages, particularly among groups that are at a 

24 high risk for suicide’’ before the semicolon at the 

25 end; 
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•HR 34 EAH 

1 (F) in paragraph (3), by inserting ‘‘and 

2 tribal’’ after ‘‘statewide’’; 

3 (G) in paragraph (5), by inserting ‘‘and 

4 prevention’’ after ‘‘intervention’’; 

5 (H) in paragraph (8), by striking ‘‘in 

6 youth’’; 

7 (I) in paragraph (9), by striking ‘‘and be8 havioral health’’ and inserting ‘‘health and sub9 stance use disorder’’; and 

10 (J) in paragraph (10), by inserting ‘‘con11 ducting’’ before ‘‘other’’; and 

12 (6) by striking subsection (e) and inserting the 

13 following: 

14 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

15 purpose of carrying out this section, there are authorized 

16 to be appropriated $5,988,000 for each of fiscal years 2018 

17 through 2022. 

18 ‘‘(d) ANNUAL REPORT.—Not later than 2 years after 

19 the date of enactment of this subsection, the Secretary shall 

20 submit to Congress a report on the activities carried out 

21 by the center established under subsection (a) during the 

22 year involved, including the potential effects of such activi23 ties, and the States, organizations, and institutions that 

24 have worked with the center.’’. 
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1 (b) YOUTH SUICIDE EARLY INTERVENTION AND PRE2 VENTION STRATEGIES.—Section 520E of the Public Health 

3 Service Act (42 U.S.C. 290bb–36) is amended— 

4 (1) in paragraph (1) of subsection (a) and in 

5 subsection (c), by striking ‘‘substance abuse’’ each 

6 place such term appears and inserting ‘‘substance use 

7 disorder’’; 

8 (2) in subsection (b)— 

9 (A) in paragraph (2)— 

10 (i) by striking ‘‘ensure that each State 

11 is awarded only 1 grant or cooperative 

12 agreement under this section’’ and inserting 

13 ‘‘ensure that a State does not receive more 

14 than 1 grant or cooperative agreement 

15 under this section at any 1 time’’; and 

16 (ii) by striking ‘‘been awarded’’ and 

17 inserting ‘‘received’’; and 

18 (B) by adding after paragraph (2) the fol19 lowing: 

20 ‘‘(3) CONSIDERATION.—In awarding grants 

21 under this section, the Secretary shall take into con22 sideration the extent of the need of the applicant, in23 cluding the incidence and prevalence of suicide in the 

24 State and among the populations of focus, including 

25 rates of suicide determined by the Centers for Disease 
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•HR 34 EAH 

1 Control and Prevention for the State or population of 

2 focus.’’; 

3 (3) in subsection (g)(2), by striking ‘‘2 years 

4 after the date of enactment of this section,’’ and insert 

5 ‘‘2 years after the date of enactment of Helping Fam6 ilies in Mental Health Crisis Reform Act of 2016,’’; 

7 and 

8 (4) by striking subsection (m) and inserting the 

9 following: 

10 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For the 

11 purpose of carrying out this section, there are authorized 

12 to be appropriated $30,000,000 for each of fiscal years 2018 

13 through 2022.’’. 

14 SEC. 9009. ADULT SUICIDE PREVENTION. 

15 Subpart 3 of part B of title V of the Public Health 

16 Service Act (42 U.S.C. 290bb–31 et seq.) is amended by 

17 adding at the end the following: 

18 ‘‘SEC. 520L. ADULT SUICIDE PREVENTION. 

19 ‘‘(a) GRANTS.— 

20 ‘‘(1) IN GENERAL.—The Assistant Secretary 

21 shall award grants to eligible entities described in 

22 paragraph (2) to implement suicide prevention and 

23 intervention programs, for individuals who are 25 

24 years of age or older, that are designed to raise 

25 awareness of suicide, establish referral processes, and 
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•HR 34 EAH 

1 improve care and outcomes for such individuals who 

2 are at risk of suicide. 

3 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re4 ceive a grant under this section, an entity shall be a 

5 community-based primary care or behavioral health 

6 care setting, an emergency department, a State men7 tal health agency (or State health agency with mental 

8 or behavioral health functions), public health agency, 

9 a territory of the United States, or an Indian tribe 

10 or tribal organization (as the terms ‘Indian tribe’ and 

11 ‘tribal organization’ are defined in section 4 of the 

12 Indian Self-Determination and Education Assistance 

13 Act). 

14 ‘‘(3) USE OF FUNDS.—The grants awarded 

15 under paragraph (1) shall be used to implement pro16 grams, in accordance with such paragraph, that in17 clude one or more of the following components: 

18 ‘‘(A) Screening for suicide risk, suicide 

19 intervention services, and services for referral for 

20 treatment for individuals at risk for suicide. 

21 ‘‘(B) Implementing evidence-based practices 

22 to provide treatment for individuals at risk for 

23 suicide, including appropriate followup services. 

24 ‘‘(C) Raising awareness and reducing stig25 ma of suicide. 
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1 ‘‘(b) EVALUATIONS AND TECHNICAL ASSISTANCE.— 

2 The Assistant Secretary shall— 

3 ‘‘(1) evaluate the activities supported by grants 

4 awarded under subsection (a), and disseminate, as 

5 appropriate, the findings from the evaluation; and 

6 ‘‘(2) provide appropriate information, training, 

7 and technical assistance, as appropriate, to eligible 

8 entities that receive a grant under this section, in 

9 order to help such entities to meet the requirements of 

10 this section, including assistance with selection and 

11 implementation of evidence-based interventions and 

12 frameworks to prevent suicide. 

13 ‘‘(c) DURATION.—A grant under this section shall be 

14 for a period of not more than 5 years. 

15 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

16 are authorized to be appropriated to carry out this section 

17 $30,000,000 for the period of fiscal years 2018 through 

18 2022.’’. 

19 SEC. 9010. MENTAL HEALTH AWARENESS TRAINING 

20 GRANTS. 

21 Section 520J of the Public Health Service Act (42 

22 U.S.C. 290bb–41) is amended— 

23 (1) in the section heading, by inserting ‘‘MEN24 TAL HEALTH AWARENESS’’ before ‘‘TRAINING’’; 

25 and 
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1 (2) in subsection (b)— 

2 (A) in the subsection heading, by striking 

3 ‘‘ILLNESS’’ and inserting ‘‘HEALTH’’; 

4 (B) in paragraph (1), by inserting ‘‘vet5 erans, law enforcement, and other categories of 

6 individuals, as determined by the Secretary,’’ 

7 after ‘‘emergency services personnel’’; 

8 (C) in paragraph (5)— 

9 (i) in the matter preceding subpara10 graph (A), by striking ‘‘to’’ and inserting 

11 ‘‘for evidence-based programs that provide 

12 training and education in accordance with 

13 paragraph (1) on matters including’’; and 

14 (ii) by striking subparagraphs (A) 

15 through (C) and inserting the following: 

16 ‘‘(A) recognizing the signs and symptoms of 

17 mental illness; and 

18 ‘‘(B)(i) resources available in the commu19 nity for individuals with a mental illness and 

20 other relevant resources; or 

21 ‘‘(ii) safely de-escalating crisis situations 

22 involving individuals with a mental illness.’’; 

23 and 

24 (D) in paragraph (7), by striking ‘‘, 

25 $25,000,000’’ and all that follows through the pe-
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•HR 34 EAH 

1 riod at the end and inserting ‘‘$14,693,000 for 

2 each of fiscal years 2018 through 2022.’’. 

3 SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMER4 ICAN INDIANS AND ALASKA NATIVE YOUTH 

5 WITHIN SUICIDE PREVENTION PROGRAMS. 

6 (a) FINDINGS.—The Congress finds as follows: 

7 (1) Suicide is the eighth leading cause of death 

8 among American Indians and Alaska Natives across 

9 all ages. 

10 (2) Among American Indians and Alaska Na11 tives who are 10 to 34 years of age, suicide is the sec12 ond leading cause of death. 

13 (3) The suicide rate among American Indian 

14 and Alaska Native adolescents and young adults ages 

15 15 to 34 (17.9 per 100,000) is approximately 1.3 

16 times higher than the national average for that age 

17 group (13.3 per 100,000). 

18 (b) SENSE OF CONGRESS.—It is the sense of Congress 

19 that the Secretary of Health and Human Services, in car20 rying out suicide prevention and intervention programs, 

21 should prioritize programs and activities for populations 

22 with disproportionately high rates of suicide, such as Amer23 ican Indians and Alaska Natives. 
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•HR 34 EAH 

1 SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER 

2 ADULTS. 

3 Section 520A(e) of the Public Health Service Act (42 

4 U.S.C. 290bb–32(e)) is amended by adding at the end the 

5 following: 

6 ‘‘(3) GERIATRIC MENTAL DISORDERS.—The Sec7 retary shall, as appropriate, provide technical assist8 ance to grantees regarding evidence-based practices 

9 for the prevention and treatment of geriatric mental 

10 disorders and co-occurring mental health and sub11 stance use disorders among geriatric populations, as 

12 well as disseminate information about such evidence13 based practices to States and nongrantees throughout 

14 the United States.’’. 

15 SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM. 

16 The Secretary of Health and Human Services, acting 

17 through the Director of the Centers for Disease Control and 

18 Prevention, is encouraged to improve, particularly through 

19 the inclusion of additional States, the National Violent 

20 Death Reporting System as authorized by title III of the 

21 Public Health Service Act (42 U.S.C. 241 et seq.). Partici22 pation in the system by the States shall be voluntary. 

23 SEC. 9014. ASSISTED OUTPATIENT TREATMENT. 

24 Section 224 of the Protecting Access to Medicare Act 

25 of 2014 (42 U.S.C. 290aa note) is amended— 
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•HR 34 EAH 

1 (1) in subsection (e), by striking ‘‘and 2018,’’ 

2 and inserting ‘‘2018, 2019, 2020, 2021, and 2022,’’; 

3 and 

4 (2) in subsection (g)— 

5 (A) in paragraph (1), by striking ‘‘2018’’ 

6 and inserting ‘‘2022’’; and 

7 (B) in paragraph (2), by striking ‘‘is au8 thorized to be appropriated to carry out this sec9 tion $15,000,000 for each of fiscal years 2015 

10 through 2018’’ and inserting ‘‘are authorized to 

11 be appropriated to carry out this section 

12 $15,000,000 for each of fiscal years 2015 through 

13 2017, $20,000,000 for fiscal year 2018, 

14 $19,000,000 for each of fiscal years 2019 and 

15 2020, and $18,000,000 for each of fiscal years 

16 2021 and 2022’’. 

17 SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT 

18 PROGRAM. 

19 Part B of title V of the Public Health Service Act (42 

20 U.S.C. 290bb et seq.), as amended by section 9009, is further 

21 amended by adding at the end the following: 

22 ‘‘SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT 

23 PROGRAM. 

24 ‘‘(a) IN GENERAL.—The Assistant Secretary shall 

25 award grants to eligible entities— 
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•HR 34 EAH 

1 ‘‘(1) to establish assertive community treatment 

2 programs for adults with a serious mental illness; or 

3 ‘‘(2) to maintain or expand such programs. 

4 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive a 

5 grant under this section, an entity shall be a State, political 

6 subdivision of a State, Indian tribe or tribal organization 

7 (as such terms are defined in section 4 of the Indian Self8 Determination and Education Assistance Act), mental 

9 health system, health care facility, or any other entity the 

10 Assistant Secretary deems appropriate. 

11 ‘‘(c) SPECIAL CONSIDERATION.—In selecting among 

12 applicants for a grant under this section, the Assistant Sec13 retary may give special consideration to the potential of 

14 the applicant’s program to reduce hospitalization, homeless15 ness, and involvement with the criminal justice system 

16 while improving the health and social outcomes of the pa17 tient. 

18 ‘‘(d) ADDITIONAL ACTIVITIES.—The Assistant Sec19 retary shall— 

20 ‘‘(1) not later than the end of fiscal year 2021, 

21 submit a report to the appropriate congressional com22 mittees on the grant program under this section, in23 cluding an evaluation of— 
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1 ‘‘(A) any cost savings and public health 

2 outcomes such as mortality, suicide, substance 

3 use disorders, hospitalization, and use of services; 

4 ‘‘(B) rates of involvement with the criminal 

5 justice system of patients; 

6 ‘‘(C) rates of homelessness among patients; 

7 and 

8 ‘‘(D) patient and family satisfaction with 

9 program participation; and 

10 ‘‘(2) provide appropriate information, training, 

11 and technical assistance to grant recipients under this 

12 section to help such recipients to establish, maintain, 

13 or expand their assertive community treatment pro14 grams. 

15 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

16 ‘‘(1) IN GENERAL.—To carry out this section, 

17 there is authorized to be appropriated $5,000,000 for 

18 the period of fiscal years 2018 through 2022. 

19 ‘‘(2) USE OF CERTAIN FUNDS.—Of the funds ap20 propriated to carry out this section in any fiscal 

21 year, not more than 5 percent shall be available to the 

22 Assistant Secretary for carrying out subsection (d).’’. 
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1 SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE 

2 DRINKING REAUTHORIZATION. 

3 Section 519B of the Public Health Service Act (42 

4 U.S.C. 290bb–25b) is amended— 

5 (1) in subsection (c)(3), by striking ‘‘fiscal year 

6 2007’’ and all that follows through the period at the 

7 end and inserting ‘‘each of the fiscal years 2018 

8 through 2022.’’; 

9 (2) in subsection (d)(4), by striking ‘‘fiscal year 

10 2007’’ and all that follows through the period at the 

11 end and inserting ‘‘each of the fiscal years 2018 

12 through 2022.’’; 

13 (3) in subsection (e)(1)(I), by striking ‘‘fiscal 

14 year 2007’’ and all that follows through the period at 

15 the end and inserting ‘‘each of the fiscal years 2018 

16 through 2022.’’; 

17 (4) in subsection (f)(2), by striking ‘‘$6,000,000 

18 for fiscal year 2007’’ and all that follows through the 

19 period at the end and inserting ‘‘$3,000,000 for each 

20 of the fiscal years 2018 through 2022’’; and 

21 (5) by adding at the end the following new sub22 section: 

23 ‘‘(g) REDUCING UNDERAGE DRINKING THROUGH

24 SCREENING AND BRIEF INTERVENTION.— 

25 ‘‘(1) GRANTS TO PEDIATRIC HEALTH CARE PRO26 VIDERS TO REDUCE UNDERAGE DRINKING.—The As-
559 

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1 sistant Secretary may make grants to eligible entities 

2 to increase implementation of practices for reducing 

3 the prevalence of alcohol use among individuals under 

4 the age of 21, including college students. 

5 ‘‘(2) PURPOSES.—Grants under this subsection 

6 shall be made to improve— 

7 ‘‘(A) screening children and adolescents for 

8 alcohol use; 

9 ‘‘(B) offering brief interventions to children 

10 and adolescents to discourage such use; 

11 ‘‘(C) educating parents about the dangers 

12 of, and methods of discouraging, such use; 

13 ‘‘(D) diagnosing and treating alcohol use 

14 disorders; and 

15 ‘‘(E) referring patients, when necessary, to 

16 other appropriate care. 

17 ‘‘(3) USE OF FUNDS.—An entity receiving a 

18 grant under this subsection may use such funding for 

19 the purposes identified in paragraph (2) by— 

20 ‘‘(A) providing training to health care pro21 viders; 

22 ‘‘(B) disseminating best practices, including 

23 culturally and linguistically appropriate best 

24 practices, as appropriate, and developing and 

25 distributing materials; and 
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•HR 34 EAH 

1 ‘‘(C) supporting other activities, as deter2 mined appropriate by the Assistant Secretary. 

3 ‘‘(4) APPLICATION.—To be eligible to receive a 

4 grant under this subsection, an entity shall submit an 

5 application to the Assistant Secretary at such time, 

6 and in such manner, and accompanied by such infor7 mation as the Assistant Secretary may require. Each 

8 application shall include— 

9 ‘‘(A) a description of the entity; 

10 ‘‘(B) a description of activities to be com11 pleted; 

12 ‘‘(C) a description of how the services speci13 fied in paragraphs (2) and (3) will be carried 

14 out and the qualifications for providing such 

15 services; and 

16 ‘‘(D) a timeline for the completion of such 

17 activities. 

18 ‘‘(5) DEFINITIONS.—For the purpose of this sub19 section: 

20 ‘‘(A) BRIEF INTERVENTION.—The term 

21 ‘brief intervention’ means, after screening a pa22 tient, providing the patient with brief advice 

23 and other brief motivational enhancement tech24 niques designed to increase the insight of the pa25 tient regarding the patient’s alcohol use, and any 
561 

•HR 34 EAH 

1 realized or potential consequences of such use, to 

2 effect the desired related behavioral change. 

3 ‘‘(B) CHILDREN AND ADOLESCENTS.—The 

4 term ‘children and adolescents’ means any per5 son under 21 years of age. 

6 ‘‘(C) ELIGIBLE ENTITY.—The term ‘eligible 

7 entity’ means an entity consisting of pediatric 

8 health care providers and that is qualified to 

9 support or provide the activities identified in 

10 paragraph (2). 

11 ‘‘(D) PEDIATRIC HEALTH CARE PRO12 VIDER.—The term ‘pediatric health care pro13 vider’ means a provider of primary health care 

14 to individuals under the age of 21 years. 

15 ‘‘(E) SCREENING.—The term ‘screening’ 

16 means using validated patient interview tech17 niques to identify and assess the existence and 

18 extent of alcohol use in a patient.’’. 

19 SEC. 9017. CENTER AND PROGRAM REPEALS. 

20 Part B of title V of the Public Health Service Act (42 

21 U.S.C. 290bb et seq.) is amended by striking section 506B 

22 (42 U.S.C. 290aa–5b), the second section 514 (42 U.S.C. 

23 290bb–9) relating to methamphetamine and amphetamine 

24 treatment initiatives, and each of sections 514A, 517, 519A, 

25 519C, 519E, 520B, 520D, and 520H (42 U.S.C. 290bb–8, 
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•HR 34 EAH 

1 290bb–23, 290bb–25a, 290bb–25c, 290bb–25e, 290bb–33, 

2 290bb–35, and 290bb–39). 

3 Subtitle B—Strengthening the 

4 Health Care Workforce 

5 SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION 

6 AND TRAINING GRANTS. 

7 Section 756 of the Public Health Service Act (42 

8 U.S.C. 294e–1) is amended— 

9 (1) in subsection (a)— 

10 (A) in the matter preceding paragraph (1), 

11 by striking ‘‘of higher education’’; and 

12 (B) by striking paragraphs (1) through (4) 

13 and inserting the following: 

14 ‘‘(1) accredited institutions of higher education 

15 or accredited professional training programs that are 

16 establishing or expanding internships or other field 

17 placement programs in mental health in psychiatry, 

18 psychology, school psychology, behavioral pediatrics, 

19 psychiatric nursing (which may include master’s and 

20 doctoral level programs), social work, school social 

21 work, substance use disorder prevention and treat22 ment, marriage and family therapy, occupational 

23 therapy, school counseling, or professional counseling, 

24 including such programs with a focus on child and 

25 adolescent mental health and transitional-age youth; 
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•HR 34 EAH 

1 ‘‘(2) accredited doctoral, internship, and post2 doctoral residency programs of health service psy3 chology (including clinical psychology, counseling, 

4 and school psychology) for the development and im5 plementation of interdisciplinary training of psy6 chology graduate students for providing behavioral 

7 health services, including substance use disorder pre8 vention and treatment services, as well as the develop9 ment of faculty in health service psychology; 

10 ‘‘(3) accredited master’s and doctoral degree pro11 grams of social work for the development and imple12 mentation of interdisciplinary training of social work 

13 graduate students for providing behavioral health 

14 services, including substance use disorder prevention 

15 and treatment services, and the development of faculty 

16 in social work; and 

17 ‘‘(4) State-licensed mental health nonprofit and 

18 for-profit organizations to enable such organizations 

19 to pay for programs for preservice or in-service train20 ing in a behavioral health-related paraprofessional 

21 field with preference for preservice or in-service train22 ing of paraprofessional child and adolescent mental 

23 health workers.’’; 

24 (2) in subsection (b)— 

25 (A) by striking paragraph (5); 
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•HR 34 EAH 

1 (B) by redesignating paragraphs (1) 

2 through (4) as paragraphs (2) through (5), re3 spectively; 

4 (C) by inserting before paragraph (2), as so 

5 redesignated, the following: 

6 ‘‘(1) an ability to recruit and place the students 

7 described in subsection (a) in areas with a high need 

8 and high demand population;’’; 

9 (D) in paragraph (3), as so redesignated, by 

10 striking ‘‘subsection (a)’’ and inserting ‘‘para11 graph (2), especially individuals with mental 

12 disorder symptoms or diagnoses, particularly 

13 children and adolescents, and transitional-age 

14 youth’’; 

15 (E) in paragraph (4), as so redesignated, by 

16 striking ‘‘;’’ and inserting ‘‘; and’’; and 

17 (F) in paragraph (5), as so redesignated, by 

18 striking ‘‘; and’’ and inserting a period; 

19 (3) in subsection (c), by striking ‘‘authorized 

20 under subsection (a)(1)’’ and inserting ‘‘awarded 

21 under paragraphs (2) and (3) of subsection (a)’’; 

22 (4) by amending subsection (d) to read as fol23 lows: 

24 ‘‘(d) PRIORITY.—In selecting grant recipients under 

25 this section, the Secretary shall give priority to— 
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•HR 34 EAH 

1 ‘‘(1) programs that have demonstrated the abil2 ity to train psychology, psychiatry, and social work 

3 professionals to work in integrated care settings for 

4 purposes of recipients under paragraphs (1), (2), and 

5 (3) of subsection (a); and 

6 ‘‘(2) programs for paraprofessionals that empha7 size the role of the family and the lived experience of 

8 the consumer and family-paraprofessional partner9 ships for purposes of recipients under subsection 

10 (a)(4).’’; and 

11 (5) by striking subsection (e) and inserting the 

12 following: 

13 ‘‘(e) REPORT TO CONGRESS.—Not later than 4 years 

14 after the date of enactment of the Helping Families in Men15 tal Health Crisis Reform Act of 2016, the Secretary shall 

16 include in the biennial report submitted to Congress under 

17 section 501(m) an assessment on the effectiveness of the 

18 grants under this section in— 

19 ‘‘(1) providing graduate students support for ex20 periential training (internship or field placement); 

21 ‘‘(2) recruiting students interested in behavioral 

22 health practice; 

23 ‘‘(3) recruiting students in accordance with sub24 section (b)(1); 
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•HR 34 EAH 

1 ‘‘(4) developing and implementing interprofes2 sional training and integration within primary care; 

3 ‘‘(5) developing and implementing accredited 

4 field placements and internships; and 

5 ‘‘(6) collecting data on the number of students 

6 trained in behavioral health care and the number of 

7 available accredited internships and field placements. 

8 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For each 

9 of fiscal years 2018 through 2022, there are authorized to 

10 be appropriated to carry out this section $50,000,000, to 

11 be allocated as follows: 

12 ‘‘(1) For grants described in subsection (a)(1), 

13 $15,000,000. 

14 ‘‘(2) For grants described in subsection (a)(2), 

15 $15,000,000. 

16 ‘‘(3) For grants described in subsection (a)(3), 

17 $10,000,000. 

18 ‘‘(4) For grants described in subsection (a)(4), 

19 $10,000,000.’’. 

20 SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE 

21 USE DISORDERS WORKFORCE. 

22 Part D of title VII of the Public Health Service Act 

23 (42 U.S.C. 294 et seq.) is amended by adding at the end 

24 the following: 
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•HR 34 EAH 

1 ‘‘SEC. 760. TRAINING DEMONSTRATION PROGRAM. 

2 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

3 training demonstration program to award grants to eligible 

4 entities to support— 

5 ‘‘(1) training for medical residents and fellows to 

6 practice psychiatry and addiction medicine in under7 served, community-based settings that integrate pri8 mary care with mental and substance use disorders 

9 prevention and treatment services; 

10 ‘‘(2) training for nurse practitioners, physician 

11 assistants, health service psychologists, and social 

12 workers to provide mental and substance use disorders 

13 services in underserved community-based settings that 

14 integrate primary care and mental and substance use 

15 disorders services; and 

16 ‘‘(3) establishing, maintaining, or improving 

17 academic units or programs that— 

18 ‘‘(A) provide training for students or fac19 ulty, including through clinical experiences and 

20 research, to improve the ability to be able to rec21 ognize, diagnose, and treat mental and substance 

22 use disorders, with a special focus on addiction; 

23 or 

24 ‘‘(B) develop evidence-based practices or rec25 ommendations for the design of the units or pro-
568 

•HR 34 EAH 

1 grams described in subparagraph (A), including 

2 curriculum content standards. 

3 ‘‘(b) ACTIVITIES.— 

4 ‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.— 

5 A recipient of a grant under subsection (a)(1)— 

6 ‘‘(A) shall use the grant funds— 

7 ‘‘(i)(I) to plan, develop, and operate a 

8 training program for medical psychiatry 

9 residents and fellows in addiction medicine 

10 practicing in eligible entities described in 

11 subsection (c)(1); or 

12 ‘‘(II) to train new psychiatric residents 

13 and fellows in addiction medicine to pro14 vide and expand access to integrated mental 

15 and substance use disorders services; and 

16 ‘‘(ii) to provide at least 1 training 

17 track that is— 

18 ‘‘(I) a virtual training track that 

19 includes an in-person rotation at a 

20 teaching health center or in a commu21 nity-based setting, followed by a vir22 tual rotation in which the resident or 

23 fellow continues to support the care of 

24 patients at the teaching health center 

25 or in the community-based setting 
569 

•HR 34 EAH 

1 through the use of health information 

2 technology and, as appropriate, tele3 health services; 

4 ‘‘(II) an in-person training track 

5 that includes a rotation, during which 

6 the resident or fellow practices at a 

7 teaching health center or in a commu8 nity-based setting; or 

9 ‘‘(III) an in-person training track 

10 that includes a rotation during which 

11 the resident practices in a community12 based setting that specializes in the 

13 treatment of infants, children, adoles14 cents, or pregnant or postpartum 

15 women; and 

16 ‘‘(B) may use the grant funds to provide 

17 additional support for the administration of the 

18 program or to meet the costs of projects to estab19 lish, maintain, or improve faculty development, 

20 or departments, divisions, or other units nec21 essary to implement such training. 

22 ‘‘(2) TRAINING FOR OTHER PROVIDERS.—A re23 cipient of a grant under subsection (a)(2)— 

24 ‘‘(A) shall use the grant funds to plan, de25 velop, or operate a training program to provide 
570 

•HR 34 EAH 

1 mental and substance use disorders services in 

2 underserved, community-based settings, as ap3 propriate, that integrate primary care and men4 tal and substance use disorders prevention and 

5 treatment services; and 

6 ‘‘(B) may use the grant funds to provide 

7 additional support for the administration of the 

8 program or to meet the costs of projects to estab9 lish, maintain, or improve faculty development, 

10 or departments, divisions, or other units nec11 essary to implement such program. 

12 ‘‘(3) ACADEMIC UNITS OR PROGRAMS.—A recipi13 ent of a grant under subsection (a)(3) shall enter into 

14 a partnership with organizations such as an edu15 cation accrediting organization (such as the Liaison 

16 Committee on Medical Education, the Accreditation 

17 Council for Graduate Medical Education, the Com18 mission on Osteopathic College Accreditation, the Ac19 creditation Commission for Education in Nursing, 

20 the Commission on Collegiate Nursing Education, the 

21 Accreditation Council for Pharmacy Education, the 

22 Council on Social Work Education, American Psycho23 logical Association Commission on Accreditation, or 

24 the Accreditation Review Commission on Education 
571 

•HR 34 EAH 

1 for the Physician Assistant) to carry out activities 

2 under subsection (a)(3). 

3 ‘‘(c) ELIGIBLE ENTITIES.— 

4 ‘‘(1) TRAINING FOR RESIDENTS AND FELLOWS.— 

5 To be eligible to receive a grant under subsection 

6 (a)(1), an entity shall— 

7 ‘‘(A) be a consortium consisting of— 

8 ‘‘(i) at least one teaching health center; 

9 and 

10 ‘‘(ii) the sponsoring institution (or 

11 parent institution of the sponsoring institu12 tion) of— 

13 ‘‘(I) a psychiatry residency pro14 gram that is accredited by the Accredi15 tation Council of Graduate Medical 

16 Education (or the parent institution of 

17 such a program); or 

18 ‘‘(II) a fellowship in addiction 

19 medicine, as determined appropriate 

20 by the Secretary; or 

21 ‘‘(B) be an entity described in subpara22 graph (A)(ii) that provides opportunities for 

23 residents or fellows to train in community-based 

24 settings that integrate primary care with mental 
572 

•HR 34 EAH 

1 and substance use disorders prevention and 

2 treatment services. 

3 ‘‘(2) TRAINING FOR OTHER PROVIDERS.—To be 

4 eligible to receive a grant under subsection (a)(2), an 

5 entity shall be— 

6 ‘‘(A) a teaching health center (as defined in 

7 section 749A(f)); 

8 ‘‘(B) a Federally qualified health center (as 

9 defined in section 1905(l)(2)(B) of the Social Se10 curity Act); 

11 ‘‘(C) a community mental health center (as 

12 defined in section 1861(ff)(3)(B) of the Social 

13 Security Act); 

14 ‘‘(D) a rural health clinic (as defined in 

15 section 1861(aa) of the Social Security Act); 

16 ‘‘(E) a health center operated by the Indian 

17 Health Service, an Indian tribe, a tribal organi18 zation, or an urban Indian organization (as de19 fined in section 4 of the Indian Health Care Im20 provement Act); or 

21 ‘‘(F) an entity with a demonstrated record 

22 of success in providing training for nurse practi23 tioners, physician assistants, health service psy24 chologists, and social workers. 
573 

•HR 34 EAH 

1 ‘‘(3) ACADEMIC UNITS OR PROGRAMS.—To be eli2 gible to receive a grant under subsection (a)(3), an 

3 entity shall be a school of medicine or osteopathic 

4 medicine, a nursing school, a physician assistant 

5 training program, a school of pharmacy, a school of 

6 social work, an accredited public or nonprofit private 

7 hospital, an accredited medical residency program, or 

8 a public or private nonprofit entity which the Sec9 retary has determined is capable of carrying out such 

10 grant. 

11 ‘‘(d) PRIORITY.— 

12 ‘‘(1) IN GENERAL.—In awarding grants under 

13 subsection (a)(1) or (a)(2), the Secretary shall give 

14 priority to eligible entities that— 

15 ‘‘(A) demonstrate sufficient size, scope, and 

16 capacity to undertake the requisite training of 

17 an appropriate number of psychiatric residents, 

18 fellows, nurse practitioners, physician assistants, 

19 or social workers in addiction medicine per year 

20 to meet the needs of the area served; 

21 ‘‘(B) demonstrate experience in training 

22 providers to practice team-based care that inte23 grates mental and substance use disorder preven24 tion and treatment services with primary care 

25 in community-based settings; 
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•HR 34 EAH 

1 ‘‘(C) demonstrate experience in using health 

2 information technology and, as appropriate, tele3 health to support— 

4 ‘‘(i) the delivery of mental and sub5 stance use disorders services at the eligible 

6 entities described in subsections (c)(1) and 

7 (c)(2); and 

8 ‘‘(ii) community health centers in inte9 grating primary care and mental and sub10 stance use disorders treatment; or 

11 ‘‘(D) have the capacity to expand access to 

12 mental and substance use disorders services in 

13 areas with demonstrated need, as determined by 

14 the Secretary, such as tribal, rural, or other un15 derserved communities. 

16 ‘‘(2) ACADEMIC UNITS OR PROGRAMS.—In 

17 awarding grants under subsection (a)(3), the Sec18 retary shall give priority to eligible entities that— 

19 ‘‘(A) have a record of training the greatest 

20 percentage of mental and substance use disorders 

21 providers who enter and remain in these fields or 

22 who enter and remain in settings with inte23 grated primary care and mental and substance 

24 use disorder prevention and treatment services; 
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•HR 34 EAH 

1 ‘‘(B) have a record of training individuals 

2 who are from underrepresented minority groups, 

3 including native populations, or from a rural or 

4 disadvantaged background; 

5 ‘‘(C) provide training in the care of vulner6 able populations such as infants, children, ado7 lescents, pregnant and postpartum women, older 

8 adults, homeless individuals, victims of abuse or 

9 trauma, individuals with disabilities, and other 

10 groups as defined by the Secretary; 

11 ‘‘(D) teach trainees the skills to provide 

12 interprofessional, integrated care through col13 laboration among health professionals; or 

14 ‘‘(E) provide training in cultural com15 petency and health literacy. 

16 ‘‘(e) DURATION.—Grants awarded under this section 

17 shall be for a minimum of 5 years. 

18 ‘‘(f) STUDY AND REPORT.— 

19 ‘‘(1) STUDY.— 

20 ‘‘(A) IN GENERAL.—The Secretary, acting 

21 through the Administrator of the Health Re22 sources and Services Administration, shall con23 duct a study on the results of the demonstration 

24 program under this section. 
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•HR 34 EAH 

1 ‘‘(B) DATA SUBMISSION.—Not later than 90 

2 days after the completion of the first year of the 

3 training program and each subsequent year that 

4 the program is in effect, each recipient of a grant 

5 under subsection (a) shall submit to the Sec6 retary such data as the Secretary may require 

7 for analysis for the report described in para8 graph (2). 

9 ‘‘(2) REPORT TO CONGRESS.—Not later than 1 

10 year after receipt of the data described in paragraph 

11 (1)(B), the Secretary shall submit to Congress a re12 port that includes— 

13 ‘‘(A) an analysis of the effect of the dem14 onstration program under this section on the 

15 quality, quantity, and distribution of mental 

16 and substance use disorders services; 

17 ‘‘(B) an analysis of the effect of the dem18 onstration program on the prevalence of un19 treated mental and substance use disorders in the 

20 surrounding communities of health centers par21 ticipating in the demonstration; and 

22 ‘‘(C) recommendations on whether the dem23 onstration program should be expanded. 
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•HR 34 EAH 

1 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 $10,000,000 for each of fiscal years 2018 through 2022.’’. 

4 SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR 

5 LOAN REPAYMENT PROGRAMS. 

6 The Administrator of the Health Resources and Serv7 ices Administration shall clarify the eligibility pursuant to 

8 section 338B(b)(1)(B) of the Public Health Service Act (42 

9 U.S.C. 254l–1(b)(1)(B)) of child and adolescent psychia10 trists for the National Health Service Corps Loan Repay11 ment Program under subpart III of part D of title III of 

12 such Act (42 U.S.C. 254l et seq.). 

13 SEC. 9024. MINORITY FELLOWSHIP PROGRAM. 

14 Title V of the Public Health Service Act (42 U.S.C. 

15 290aa et seq.) is amended by adding at the end the fol16 lowing: 

17 ‘‘PART K—MINORITY FELLOWSHIP PROGRAM 

18 ‘‘SEC. 597. FELLOWSHIPS. 

19 ‘‘(a) IN GENERAL.—The Secretary shall maintain a 

20 program, to be known as the Minority Fellowship Program, 

21 under which the Secretary shall award fellowships, which 

22 may include stipends, for the purposes of— 

23 ‘‘(1) increasing the knowledge of mental and sub24 stance use disorders practitioners on issues related to 

25 prevention, treatment, and recovery support for indi-
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•HR 34 EAH 

1 viduals who are from racial and ethnic minority pop2 ulations and who have a mental or substance use dis3 order; 

4 ‘‘(2) improving the quality of mental and sub5 stance use disorder prevention and treatment services 

6 delivered to racial and ethnic minority populations; 

7 and 

8 ‘‘(3) increasing the number of culturally com9 petent mental and substance use disorders profes10 sionals who teach, administer services, conduct re11 search, and provide direct mental or substance use 

12 disorder services to racial and ethnic minority popu13 lations. 

14 ‘‘(b) TRAINING COVERED.—The fellowships awarded 

15 under subsection (a) shall be for postbaccalaureate training 

16 (including for master’s and doctoral degrees) for mental 

17 and substance use disorder treatment professionals, includ18 ing in the fields of psychiatry, nursing, social work, psy19 chology, marriage and family therapy, mental health coun20 seling, and substance use disorder and addiction counseling. 

21 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 

22 out this section, there are authorized to be appropriated 

23 $12,669,000 for each of fiscal years 2018 through 2022.’’. 
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•HR 34 EAH 

1 SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFES2 SIONAL VOLUNTEERS AT COMMUNITY 

3 HEALTH CENTERS. 

4 Section 224 of the Public Health Service Act (42 

5 U.S.C. 233) is amended by adding at the end the following: 

6 ‘‘(q)(1) For purposes of this section, a health profes7 sional volunteer at a deemed entity described in subsection 

8 (g)(4) shall, in providing a health professional service eligi9 ble for funding under section 330 to an individual, be 

10 deemed to be an employee of the Public Health Service for 

11 a calendar year that begins during a fiscal year for which 

12 a transfer was made under paragraph (4)(C). The pre13 ceding sentence is subject to the provisions of this sub14 section. 

15 ‘‘(2) In providing a health service to an individual, 

16 a health care practitioner shall for purposes of this sub17 section be considered to be a health professional volunteer 

18 at an entity described in subsection (g)(4) if the following 

19 conditions are met: 

20 ‘‘(A) The service is provided to the individual at 

21 the facilities of an entity described in subsection 

22 (g)(4), or through offsite programs or events carried 

23 out by the entity. 

24 ‘‘(B) The entity is sponsoring the health care 

25 practitioner pursuant to paragraph (3)(B). 
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1 ‘‘(C) The health care practitioner does not receive 

2 any compensation for the service from the individual, 

3 the entity described in subsection (g)(4), or any third4 party payer (including reimbursement under any in5 surance policy or health plan, or under any Federal 

6 or State health benefits program), except that the 

7 health care practitioner may receive repayment from 

8 the entity described in subsection (g)(4) for reasonable 

9 expenses incurred by the health care practitioner in 

10 the provision of the service to the individual, which 

11 may include travel expenses to or from the site of 

12 services. 

13 ‘‘(D) Before the service is provided, the health 

14 care practitioner or the entity described in subsection 

15 (g)(4) posts a clear and conspicuous notice at the site 

16 where the service is provided of the extent to which the 

17 legal liability of the health care practitioner is lim18 ited pursuant to this subsection. 

19 ‘‘(E) At the time the service is provided, the 

20 health care practitioner is licensed or certified in ac21 cordance with applicable Federal and State laws re22 garding the provision of the service. 

23 ‘‘(F) At the time the service is provided, the enti24 ty described in subsection (g)(4) maintains relevant 
581 

•HR 34 EAH 

1 documentation certifying that the health care practi2 tioner meets the requirements of this subsection. 

3 ‘‘(3) Subsection (g) (other than paragraphs (3) and 

4 (5)) and subsections (h), (i), and (l) apply to a health care 

5 practitioner for purposes of this subsection to the same ex6 tent and in the same manner as such subsections apply to 

7 an officer, governing board member, employee, or contractor 

8 of an entity described in subsection (g)(4), subject to para9 graph (4), and subject to the following: 

10 ‘‘(A) The first sentence of paragraph (1) applies 

11 in lieu of the first sentence of subsection (g)(1)(A). 

12 ‘‘(B) With respect to an entity described in sub13 section (g)(4), a health care practitioner is not a 

14 health professional volunteer at such entity unless the 

15 entity sponsors the health care practitioner. For pur16 poses of this subsection, the entity shall be considered 

17 to be sponsoring the health care practitioner if— 

18 ‘‘(i) with respect to the health care practi19 tioner, the entity submits to the Secretary an ap20 plication meeting the requirements of subsection 

21 (g)(1)(D); and 

22 ‘‘(ii) the Secretary, pursuant to subsection 

23 (g)(1)(E), determines that the health care practi24 tioner is deemed to be an employee of the Public 

25 Health Service. 
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•HR 34 EAH 

1 ‘‘(C) In the case of a health care practitioner 

2 who is determined by the Secretary pursuant to sub3 section (g)(1)(E) to be a health professional volunteer 

4 at such entity, this subsection applies to the health 

5 care practitioner (with respect to services performed 

6 on behalf of the entity sponsoring the health care 

7 practitioner pursuant to subparagraph (B)) for any 

8 cause of action arising from an act or omission of the 

9 health care practitioner occurring on or after the date 

10 on which the Secretary makes such determination. 

11 ‘‘(D) Subsection (g)(1)(F) applies to a health 

12 care practitioner for purposes of this subsection only 

13 to the extent that, in providing health services to an 

14 individual, each of the conditions specified in para15 graph (2) is met. 

16 ‘‘(4)(A) Amounts in the fund established under sub17 section (k)(2) shall be available for transfer under subpara18 graph (C) for purposes of carrying out this subsection. 

19 ‘‘(B)(i) Not later than May 1 of each fiscal year, the 

20 Attorney General, in consultation with the Secretary, shall 

21 submit to the Congress a report providing an estimate of 

22 the amount of claims (together with related fees and ex23 penses of witnesses) that, by reason of the acts or omissions 

24 of health professional volunteers, will be paid pursuant to 
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1 this section during the calendar year that begins in the fol2 lowing fiscal year. 

3 ‘‘(ii) Subsection (k)(1)(B) applies to the estimate 

4 under clause (i) regarding health professional volunteers to 

5 the same extent and in the same manner as such subsection 

6 applies to the estimate under such subsection regarding offi7 cers, governing board members, employees, and contractors 

8 of entities described in subsection (g)(4). 

9 ‘‘(iii) The report shall include a summary of the data 

10 relied upon for the estimate in clause (i), including the 

11 number of claims filed and paid from the previous calendar 

12 year. 

13 ‘‘(C) Not later than December 31 of each fiscal year, 

14 the Secretary shall transfer from the fund under subsection 

15 (k)(2) to the appropriate accounts in the Treasury an 

16 amount equal to the estimate made under subparagraph (B) 

17 for the calendar year beginning in such fiscal year, subject 

18 to the extent of amounts in the fund. 

19 ‘‘(5)(A) This subsection shall take effect on October 1, 

20 2017, except as provided in subparagraph (B) and para21 graph (6). 

22 ‘‘(B) Effective on the date of the enactment of this sub23 section— 

24 ‘‘(i) the Secretary may issue regulations for car25 rying out this subsection, and the Secretary may ac-
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1 cept and consider applications submitted pursuant to 

2 paragraph (3)(B); and 

3 ‘‘(ii) reports under paragraph (4)(B) may be 

4 submitted to Congress. 

5 ‘‘(6) Beginning on October 1, 2022, this subsection 

6 shall cease to have any force or effect.’’. 

7 SEC. 9026. REPORTS. 

8 (a) WORKFORCE DEVELOPMENT REPORT.— 

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

10 the date of enactment of this Act, the Administrator 

11 of the Health Resources and Services Administration, 

12 in consultation with the Assistant Secretary for Men13 tal Health and Substance Use, shall conduct a study 

14 and publicly post on the appropriate Internet website 

15 of the Department of Health and Human Services a 

16 report on the adult and pediatric mental health and 

17 substance use disorder workforce in order to inform 

18 Federal, State, and local efforts related to workforce 

19 enhancement. 

20 (2) CONTENTS.—The report under this subsection 

21 shall contain— 

22 (A) national and State-level projections of 

23 the supply and demand of the mental health and 

24 substance use disorder health workforce, 

25 disaggregated by profession; 
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1 (B) an assessment of the mental health and 

2 substance use disorder workforce capacity, 

3 strengths, and weaknesses as of the date of the re4 port, including the extent to which primary care 

5 providers are preventing, screening, or referring 

6 for mental and substance use disorder services; 

7 (C) information on trends within the men8 tal health and substance use disorder provider 

9 workforce, including the number of individuals 

10 expected to enter the mental health workforce 

11 over the next 5 years; and 

12 (D) any additional information determined 

13 by the Administrator of the Health Resources 

14 and Services Administration, in consultation 

15 with the Assistant Secretary for Mental Health 

16 and Substance Use, to be relevant to the mental 

17 health and substance use disorder provider work18 force. 

19 (b) PEER-SUPPORT SPECIALIST PROGRAMS.— 

20 (1) IN GENERAL.—The Comptroller General of 

21 the United States shall conduct a study on peer-sup22 port specialist programs in up to 10 States that re23 ceive funding from the Substance Abuse and Mental 

24 Health Services Administration. 
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1 (2) CONTENTS OF STUDY.—In conducting the 

2 study under paragraph (1), the Comptroller General 

3 of the United States shall examine and identify best 

4 practices, in the States selected pursuant to such 

5 paragraph, related to training and credential require6 ments for peer-support specialist programs, such as— 

7 (A) hours of formal work or volunteer expe8 rience related to mental and substance use dis9 orders conducted through such programs; 

10 (B) types of peer-support specialist exams 

11 required for such programs in the selected States; 

12 (C) codes of ethics used by such programs in 

13 the selected States; 

14 (D) required or recommended skill sets for 

15 such programs in the selected States; and 

16 (E) requirements for continuing education. 

17 (3) REPORT.—Not later than 2 years after the 

18 date of enactment of this Act, the Comptroller General 

19 of the United States shall submit to the Committee on 

20 Health, Education, Labor, and Pensions of the Senate 

21 and the Committee on Energy and Commerce of the 

22 House of Representatives a report on the study con23 ducted under paragraph (1). 
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1 Subtitle C—Mental Health on 

2 Campus Improvement 

3 SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DIS4 ORDER SERVICES ON CAMPUS. 

5 Section 520E–2 of the Public Health Service Act (42 

6 U.S.C. 290bb–36b) is amended— 

7 (1) in the section heading, by striking ‘‘AND BE8 HAVIORAL HEALTH’’ and inserting ‘‘HEALTH AND

9 SUBSTANCE USE DISORDER’’; 

10 (2) in subsection (a)— 

11 (A) by striking ‘‘Services,’’ and inserting 

12 ‘‘Services and’’; 

13 (B) by striking ‘‘and behavioral health 

14 problems’’ and inserting ‘‘health or substance use 

15 disorders’’; 

16 (C) by striking ‘‘substance abuse’’ and in17 serting ‘‘substance use disorders’’; and 

18 (D) by adding after, ‘‘suicide attempts,’’ the 

19 following: ‘‘prevent mental and substance use 

20 disorders, reduce stigma, and improve the identi21 fication and treatment for students at risk,’’; 

22 (3) in subsection (b)— 

23 (A) in the matter preceding paragraph (1), 

24 by striking ‘‘for—’’ and inserting ‘‘for one or 

25 more of the following:’’; and 
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1 (B) by striking paragraphs (1) through (6) 

2 and inserting the following: 

3 ‘‘(1) Educating students, families, faculty, and 

4 staff to increase awareness of mental and substance 

5 use disorders. 

6 ‘‘(2) The operation of hotlines. 

7 ‘‘(3) Preparing informational material. 

8 ‘‘(4) Providing outreach services to notify stu9 dents about available mental and substance use dis10 order services. 

11 ‘‘(5) Administering voluntary mental and sub12 stance use disorder screenings and assessments. 

13 ‘‘(6) Supporting the training of students, faculty, 

14 and staff to respond effectively to students with men15 tal and substance use disorders. 

16 ‘‘(7) Creating a network infrastructure to link 

17 institutions of higher education with health care pro18 viders who treat mental and substance use disorders. 

19 ‘‘(8) Providing mental and substance use dis20 orders prevention and treatment services to students, 

21 which may include recovery support services and pro22 gramming and early intervention, treatment, and 

23 management, including through the use of telehealth 

24 services. 
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1 ‘‘(9) Conducting research through a counseling 

2 or health center at the institution of higher education 

3 involved regarding improving the behavioral health of 

4 students through clinical services, outreach, preven5 tion, or academic success, in a manner that is in 

6 compliance with all applicable personal privacy laws. 

7 ‘‘(10) Supporting student groups on campus, in8 cluding athletic teams, that engage in activities to 

9 educate students, including activities to reduce stigma 

10 surrounding mental and behavioral disorders, and 

11 promote mental health. 

12 ‘‘(11) Employing appropriately trained staff. 

13 ‘‘(12) Developing and supporting evidence-based 

14 and emerging best practices, including a focus on cul15 turally and linguistically appropriate best prac16 tices.’’; 

17 (4) in subsection (c)(5), by striking ‘‘substance 

18 abuse’’ and inserting ‘‘substance use disorder’’; 

19 (5) in subsection (d)— 

20 (A) in the matter preceding paragraph (1), 

21 by striking ‘‘An institution of higher education 

22 desiring a grant under this section’’ and insert23 ing ‘‘To be eligible to receive a grant under this 

24 section, an institution of higher education’’; 
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1 (B) by striking paragraph (1) and insert2 ing— 

3 ‘‘(1) A description of the population to be tar4 geted by the program carried out under the grant, in5 cluding veterans whenever possible and appropriate, 

6 and of identified mental and substance use disorder 

7 needs of students at the institution of higher edu8 cation.’’; 

9 (C) in paragraph (2), by inserting ‘‘, which 

10 may include, as appropriate and in accordance 

11 with subsection (b)(7), a plan to seek input from 

12 relevant stakeholders in the community, includ13 ing appropriate public and private entities, in 

14 order to carry out the program under the grant’’ 

15 before the period at the end; and 

16 (D) by adding after paragraph (5) the fol17 lowing new paragraphs: 

18 ‘‘(6) An outline of the objectives of the program 

19 carried out under the grant. 

20 ‘‘(7) For an institution of higher education pro21 posing to use the grant for an activity described in 

22 paragraph (8) or (9) of subsection (b), a description 

23 of the policies and procedures of the institution of 

24 higher education that are related to applicable laws 

25 regarding access to, and sharing of, treatment records 
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1 of students at any campus-based mental health center 

2 or partner organization, including the policies and 

3 State laws governing when such records can be 

4 accessed and shared for non-treatment purposes and 

5 a description of the process used by the institution of 

6 higher education to notify students of these policies 

7 and procedures, including the extent to which written 

8 consent is required. 

9 ‘‘(8) An assurance that grant funds will be used 

10 to supplement and not supplant any other Federal, 

11 State, or local funds available to carry out activities 

12 of the type carried out under the grant.’’; 

13 (6) in subsection (e)(1), by striking ‘‘and behav14 ioral health problems’’ and inserting ‘‘health and sub15 stance use disorders’’; 

16 (7) in subsection (f)(2)— 

17 (A) by striking ‘‘and behavioral health’’ and 

18 inserting ‘‘health and substance use disorder’’; 

19 and 

20 (B) by striking ‘‘suicide and substance 

21 abuse’’ and inserting ‘‘suicide and substance use 

22 disorders’’; 

23 (8) by redesignating subsection (h) as subsection 

24 (i); 
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1 (9) by inserting after subsection (g) the following 

2 new subsection: 

3 ‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may 

4 provide technical assistance to grantees in carrying out this 

5 section.’’; and 

6 (10) in subsection (i), as redesignated by para7 graph (8), by striking ‘‘$5,000,000 for fiscal year 

8 2005’’ and all that follows through the period at the 

9 end and inserting ‘‘$7,000,000 for each of fiscal years 

10 2018 through 2022.’’. 

11 SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE 

12 MENTAL HEALTH. 

13 (a) PURPOSE.—It is the purpose of this section to pro14 vide for the establishment of a College Campus Task Force 

15 to discuss mental and behavioral health concerns on cam16 puses of institutions of higher education. 

17 (b) ESTABLISHMENT.—The Secretary of Health and 

18 Human Services (referred to in this section as the ‘‘Sec19 retary’’) shall establish a College Campus Task Force (re20 ferred to in this section as the ‘‘Task Force’’) to discuss 

21 mental and behavioral health concerns on campuses of insti22 tutions of higher education. 

23 (c) MEMBERSHIP.—The Task Force shall be composed 

24 of a representative from each Federal agency (as appointed 

25 by the head of the agency) that has jurisdiction over, or 
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1 is affected by, mental health and education policies and 

2 projects, including— 

3 (1) the Department of Education; 

4 (2) the Department of Health and Human Serv5 ices; 

6 (3) the Department of Veterans Affairs; and 

7 (4) such other Federal agencies as the Assistant 

8 Secretary for Mental Health and Substance Use, in 

9 consultation with the Secretary, determines to be ap10 propriate. 

11 (d) DUTIES.—The Task Force shall— 

12 (1) serve as a centralized mechanism to coordi13 nate a national effort to— 

14 (A) discuss and evaluate evidence and 

15 knowledge on mental and behavioral health serv16 ices available to, and the prevalence of mental 

17 illness among, the age population of students at18 tending institutions of higher education in the 

19 United States; 

20 (B) determine the range of effective, feasible, 

21 and comprehensive actions to improve mental 

22 and behavioral health on campuses of institu23 tions of higher education; 

24 (C) examine and better address the needs of 

25 the age population of students attending institu-
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1 tions of higher education dealing with mental ill2 ness; 

3 (D) survey Federal agencies to determine 

4 which policies are effective in encouraging, and 

5 how best to facilitate outreach without dupli6 cating, efforts relating to mental and behavioral 

7 health promotion; 

8 (E) establish specific goals within and 

9 across Federal agencies for mental health pro10 motion, including determinations of account11 ability for reaching those goals; 

12 (F) develop a strategy for allocating respon13 sibilities and ensuring participation in mental 

14 and behavioral health promotion, particularly in 

15 the case of competing agency priorities; 

16 (G) coordinate plans to communicate re17 search results relating to mental and behavioral 

18 health amongst the age population of students at19 tending institutions of higher education to enable 

20 reporting and outreach activities to produce 

21 more useful and timely information; 

22 (H) provide a description of evidence-based 

23 practices, model programs, effective guidelines, 

24 and other strategies for promoting mental and 
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1 behavioral health on campuses of institutions of 

2 higher education; 

3 (I) make recommendations to improve Fed4 eral efforts relating to mental and behavioral 

5 health promotion on campuses of institutions of 

6 higher education and to ensure Federal efforts 

7 are consistent with available standards, evidence, 

8 and other programs in existence as of the date of 

9 enactment of this Act; 

10 (J) monitor Federal progress in meeting 

11 specific mental and behavioral health promotion 

12 goals as they relate to settings of institutions of 

13 higher education; and 

14 (K) examine and disseminate best practices 

15 related to intracampus sharing of treatment 

16 records; 

17 (2) consult with national organizations with ex18 pertise in mental and behavioral health, especially 

19 those organizations working with the age population 

20 of students attending institutions of higher education; 

21 and 

22 (3) consult with and seek input from mental 

23 health professionals working on campuses of institu24 tions of higher education as appropriate. 

25 (e) MEETINGS.— 
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1 (1) IN GENERAL.—The Task Force shall meet not 

2 fewer than three times each year. 

3 (2) ANNUAL CONFERENCE.—The Secretary shall 

4 sponsor an annual conference on mental and behav5 ioral health in settings of institutions of higher edu6 cation to enhance coordination, build partnerships, 

7 and share best practices in mental and behavioral 

8 health promotion, data collection, analysis, and serv9 ices. 

10 (f) DEFINITION.—In this section, the term ‘‘institution 

11 of higher education’’ has the meaning given such term in 

12 section 101 of the Higher Education Act of 1965 (20 U.S.C. 

13 1001). 

14 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

15 out this section, there are authorized to be appropriated 

16 $1,000,000 for the period of fiscal years 2018 through 2022. 

17 SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAM18 PUSES. 

19 Part D of title V of the Public Health Service Act (42 

20 U.S.C. 290dd et seq.) is amended by adding at the end the 

21 following: 

22 ‘‘SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH 

23 AND EDUCATION ON COLLEGE CAMPUSES. 

24 ‘‘(a) PURPOSE.—It is the purpose of this section to in25 crease access to, and reduce the stigma associated with, 
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1 mental health services to ensure that students at institutions 

2 of higher education have the support necessary to success3 fully complete their studies. 

4 ‘‘(b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The 

5 Secretary, acting through the Assistant Secretary and in 

6 collaboration with the Director of the Centers for Disease 

7 Control and Prevention, shall convene an interagency, pub8 lic-private sector working group to plan, establish, and 

9 begin coordinating and evaluating a targeted public edu10 cation campaign that is designed to focus on mental and 

11 behavioral health on the campuses of institutions of higher 

12 education. Such campaign shall be designed to— 

13 ‘‘(1) improve the general understanding of men14 tal health and mental disorders; 

15 ‘‘(2) encourage help-seeking behaviors relating to 

16 the promotion of mental health, prevention of mental 

17 disorders, and treatment of such disorders; 

18 ‘‘(3) make the connection between mental and be19 havioral health and academic success; and 

20 ‘‘(4) assist the general public in identifying the 

21 early warning signs and reducing the stigma of men22 tal illness. 

23 ‘‘(c) COMPOSITION.—The working group convened 

24 under subsection (b) shall include— 
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1 ‘‘(1) mental health consumers, including students 

2 and family members; 

3 ‘‘(2) representatives of institutions of higher edu4 cation; 

5 ‘‘(3) representatives of national mental and be6 havioral health associations and associations of insti7 tutions of higher education; 

8 ‘‘(4) representatives of health promotion and pre9 vention organizations at institutions of higher edu10 cation; 

11 ‘‘(5) representatives of mental health providers, 

12 including community mental health centers; and 

13 ‘‘(6) representatives of private-sector and public14 sector groups with experience in the development of ef15 fective public health education campaigns. 

16 ‘‘(d) PLAN.—The working group under subsection (b) 

17 shall develop a plan that— 

18 ‘‘(1) targets promotional and educational efforts 

19 to the age population of students at institutions of 

20 higher education and individuals who are employed 

21 in settings of institutions of higher education, includ22 ing through the use of roundtables; 

23 ‘‘(2) develops and proposes the implementation of 

24 research-based public health messages and activities; 
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1 ‘‘(3) provides support for local efforts to reduce 

2 stigma by using the National Health Information 

3 Center as a primary point of contact for information, 

4 publications, and service program referrals; and 

5 ‘‘(4) develops and proposes the implementation of 

6 a social marketing campaign that is targeted at the 

7 population of students attending institutions of higher 

8 education and individuals who are employed in set9 tings of institutions of higher education. 

10 ‘‘(e) DEFINITION.—In this section, the term ‘institu11 tion of higher education’ has the meaning given such term 

12 in section 101 of the Higher Education Act of 1965 (20 

13 U.S.C. 1001). 

14 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry 

15 out this section, there are authorized to be appropriated 

16 $1,000,000 for the period of fiscal years 2018 through 

17 2022.’’. 

18 TITLE X—STRENGTHENING MEN19 TAL AND SUBSTANCE USE 

20 DISORDER CARE FOR CHIL21 DREN AND ADOLESCENTS 

22 SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS 

23 EMOTIONAL DISTURBANCE. 

24 (a) COMPREHENSIVE COMMUNITY MENTAL HEALTH

25 SERVICES FOR CHILDREN WITH A SERIOUS EMOTIONAL
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1 DISTURBANCE.—Section 561(a)(1) of the Public Health 

2 Service Act (42 U.S.C. 290ff(a)(1)) is amended by inserting 

3 ‘‘, which may include efforts to identify and serve children 

4 at risk’’ before the period. 

5 (b) REQUIREMENTS WITH RESPECT TO CARRYING

6 OUT PURPOSE OF GRANTS.—Section 562(b) of the Public 

7 Health Service Act (42 U.S.C. 290ff–1(b)) is amended by 

8 striking ‘‘will not provide an individual with access to the 

9 system if the individual is more than 21 years of age’’ and 

10 inserting ‘‘will provide an individual with access to the sys11 tem through the age of 21 years’’. 

12 (c) ADDITIONAL PROVISIONS.—Section 564(f) of the 

13 Public Health Service Act (42 U.S.C. 290ff–3(f)) is amend14 ed by inserting ‘‘(and provide a copy to the State involved)’’ 

15 after ‘‘to the Secretary’’. 

16 (d) GENERAL PROVISIONS.—Section 565 of the Public 

17 Health Service Act (42 U.S.C. 290ff–4) is amended— 

18 (1) in subsection (b)(1)— 

19 (A) in the matter preceding subparagraph 

20 (A), by striking ‘‘receiving a grant under section 

21 561(a)’’ and inserting ‘‘, regardless of whether 

22 such public entity is receiving a grant under sec23 tion 561(a)’’; and 

24 (B) in subparagraph (B), by striking ‘‘pur25 suant to’’ and inserting ‘‘described in’’; 
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1 (2) in subsection (d)(1), by striking ‘‘not more 

2 than 21 years of age’’ and inserting ‘‘through the age 

3 of 21 years’’; and 

4 (3) in subsection (f)(1), by striking 

5 ‘‘$100,000,000 for fiscal year 2001, and such sums as 

6 may be necessary for each of the fiscal years 2002 and 

7 2003’’ and inserting ‘‘$119,026,000 for each of fiscal 

8 years 2018 through 2022’’. 

9 SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL 

10 HEALTH CARE. 

11 Title III of the Public Health Service Act is amended 

12 by inserting after section 330L of such Act (42 U.S.C. 254c– 

13 18) the following new section: 

14 ‘‘SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS 

15 GRANTS. 

16 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

17 Administrator of the Health Resources and Services Admin18 istration and in coordination with other relevant Federal 

19 agencies, shall award grants to States, political subdivi20 sions of States, and Indian tribes and tribal organizations 

21 (for purposes of this section, as such terms are defined in 

22 section 4 of the Indian Self-Determination and Education 

23 Assistance Act (25 U.S.C. 450b)) to promote behavioral 

24 health integration in pediatric primary care by— 
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1 ‘‘(1) supporting the development of statewide or 

2 regional pediatric mental health care telehealth access 

3 programs; and 

4 ‘‘(2) supporting the improvement of existing 

5 statewide or regional pediatric mental health care 

6 telehealth access programs. 

7 ‘‘(b) PROGRAM REQUIREMENTS.— 

8 ‘‘(1) IN GENERAL.—A pediatric mental health 

9 care telehealth access program referred to in sub10 section (a), with respect to which a grant under such 

11 subsection may be used, shall— 

12 ‘‘(A) be a statewide or regional network of 

13 pediatric mental health teams that provide sup14 port to pediatric primary care sites as an inte15 grated team; 

16 ‘‘(B) support and further develop organized 

17 State or regional networks of pediatric mental 

18 health teams to provide consultative support to 

19 pediatric primary care sites; 

20 ‘‘(C) conduct an assessment of critical be21 havioral consultation needs among pediatric pro22 viders and such providers’ preferred mechanisms 

23 for receiving consultation, training, and tech24 nical assistance; 
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•HR 34 EAH 

1 ‘‘(D) develop an online database and com2 munication mechanisms, including telehealth, to 

3 facilitate consultation support to pediatric prac4 tices; 

5 ‘‘(E) provide rapid statewide or regional 

6 clinical telephone or telehealth consultations 

7 when requested between the pediatric mental 

8 health teams and pediatric primary care pro9 viders; 

10 ‘‘(F) conduct training and provide technical 

11 assistance to pediatric primary care providers to 

12 support the early identification, diagnosis, treat13 ment, and referral of children with behavioral 

14 health conditions; 

15 ‘‘(G) provide information to pediatric pro16 viders about, and assist pediatric providers in 

17 accessing, pediatric mental health care providers, 

18 including child and adolescent psychiatrists, and 

19 licensed mental health professionals, such as psy20 chologists, social workers, or mental health coun21 selors and in scheduling and conducting tech22 nical assistance; 

23 ‘‘(H) assist with referrals to specialty care 

24 and community or behavioral health resources; 

25 and 
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1 ‘‘(I) establish mechanisms for measuring 

2 and monitoring increased access to pediatric 

3 mental health care services by pediatric primary 

4 care providers and expanded capacity of pedi5 atric primary care providers to identify, treat, 

6 and refer children with mental health problems. 

7 ‘‘(2) PEDIATRIC MENTAL HEALTH TEAMS.—In 

8 this subsection, the term ‘pediatric mental health 

9 team’ means a team consisting of at least one case co10 ordinator, at least one child and adolescent psychia11 trist, and at least one licensed clinical mental health 

12 professional, such as a psychologist, social worker, or 

13 mental health counselor. Such a team may be region14 ally based. 

15 ‘‘(c) APPLICATION.—A State, political subdivision of 

16 a State, Indian tribe, or tribal organization seeking a grant 

17 under this section shall submit an application to the Sec18 retary at such time, in such manner, and containing such 

19 information as the Secretary may require, including a plan 

20 for the comprehensive evaluation of activities that are car21 ried out with funds received under such grant. 

22 ‘‘(d) EVALUATION.—A State, political subdivision of 

23 a State, Indian tribe, or tribal organization that receives 

24 a grant under this section shall prepare and submit an 

25 evaluation of activities that are carried out with funds re-
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1 ceived under such grant to the Secretary at such time, in 

2 such manner, and containing such information as the Sec3 retary may reasonably require, including a process and 

4 outcome evaluation. 

5 ‘‘(e) ACCESS TO BROADBAND.—In administering 

6 grants under this section, the Secretary may coordinate 

7 with other agencies to ensure that funding opportunities are 

8 available to support access to reliable, high-speed Internet 

9 for providers. 

10 ‘‘(f) MATCHING REQUIREMENT.—The Secretary may 

11 not award a grant under this section unless the State, polit12 ical subdivision of a State, Indian tribe, or tribal organiza13 tion involved agrees, with respect to the costs to be incurred 

14 by the State, political subdivision of a State, Indian tribe, 

15 or tribal organization in carrying out the purpose described 

16 in this section, to make available non-Federal contributions 

17 (in cash or in kind) toward such costs in an amount that 

18 is not less than 20 percent of Federal funds provided in 

19 the grant. 

20 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

21 out this section, there are authorized to be appropriated, 

22 $9,000,000 for the period of fiscal years 2018 through 

23 2022.’’. 
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1 SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND 

2 EARLY INTERVENTION SERVICES FOR CHIL3 DREN AND ADOLESCENTS. 

4 The first section 514 of the Public Health Service Act 

5 (42 U.S.C. 290bb–7), relating to substance abuse treatment 

6 services for children and adolescents, is amended— 

7 (1) in the section heading, by striking ‘‘ABUSE

8 TREATMENT’’ and inserting ‘‘USE DISORDER

9 TREATMENT AND EARLY INTERVENTION’’; 

10 (2) by striking subsection (a) and inserting the 

11 following: 

12 ‘‘(a) IN GENERAL.—The Secretary shall award grants, 

13 contracts, or cooperative agreements to public and private 

14 nonprofit entities, including Indian tribes or tribal organi15 zations (as such terms are defined in section 4 of the Indian 

16 Self-Determination and Education Assistance Act), or 

17 health facilities or programs operated by or in accordance 

18 with a contract or grant with the Indian Health Service, 

19 for the purpose of— 

20 ‘‘(1) providing early identification and services 

21 to meet the needs of children and adolescents who are 

22 at risk of substance use disorders; 

23 ‘‘(2) providing substance use disorder treatment 

24 services for children, including children and adoles25 cents with co-occurring mental illness and substance 

26 use disorders; and 
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1 ‘‘(3) providing assistance to pregnant women, 

2 and parenting women, with substance use disorders, 

3 in obtaining treatment services, linking mothers to 

4 community resources to support independent family 

5 lives, and staying in recovery so that children are in 

6 safe, stable home environments and receive appro7 priate health care services.’’; 

8 (3) in subsection (b)— 

9 (A) by striking paragraph (1) and inserting 

10 the following: 

11 ‘‘(1) apply evidence-based and cost-effective 

12 methods;’’; 

13 (B) in paragraph (2)— 

14 (i) by striking ‘‘treatment’’; and 

15 (ii) by inserting ‘‘substance abuse,’’ 

16 after ‘‘child welfare,’’; 

17 (C) in paragraph (3), by striking ‘‘sub18 stance abuse disorders’’ and inserting ‘‘substance 

19 use disorders, including children and adolescents 

20 with co-occurring mental illness and substance 

21 use disorders,’’; 

22 (D) in paragraph (5), by striking ‘‘treat23 ment;’’ and inserting ‘‘services; and’’; 
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1 (E) in paragraph (6), by striking ‘‘sub2 stance abuse treatment; and’’ and inserting 

3 ‘‘treatment.’’; and 

4 (F) by striking paragraph (7); and 

5 (4) in subsection (f), by striking ‘‘$40,000,000’’ 

6 and all that follows through the period and inserting 

7 ‘‘$29,605,000 for each of fiscal years 2018 through 

8 2022.’’. 

9 SEC. 10004. CHILDREN’S RECOVERY FROM TRAUMA. 

10 The first section 582 of the Public Health Service Act 

11 (42 U.S.C. 290hh–1; relating to grants to address the prob12 lems of persons who experience violence related stress) is 

13 amended— 

14 (1) in subsection (a), by striking ‘‘developing 

15 programs’’ and all that follows through the period at 

16 the end and inserting the following: ‘‘developing and 

17 maintaining programs that provide for— 

18 ‘‘(1) the continued operation of the National 

19 Child Traumatic Stress Initiative (referred to in this 

20 section as the ‘NCTSI’), which includes a cooperative 

21 agreement with a coordinating center, that focuses on 

22 the mental, behavioral, and biological aspects of psy23 chological trauma response, prevention of the long24 term consequences of child trauma, and early inter-
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1 vention services and treatment to address the long2 term consequences of child trauma; and 

3 ‘‘(2) the development of knowledge with regard to 

4 evidence-based practices for identifying and treating 

5 mental, behavioral, and biological disorders of chil6 dren and youth resulting from witnessing or experi7 encing a traumatic event.’’; 

8 (2) in subsection (b)— 

9 (A) by striking ‘‘subsection (a) related’’ and 

10 inserting ‘‘subsection (a)(2) (related’’; 

11 (B) by striking ‘‘treating disorders associ12 ated with psychological trauma’’ and inserting 

13 ‘‘treating mental, behavioral, and biological dis14 orders associated with psychological trauma)’’; 

15 and 

16 (C) by striking ‘‘mental health agencies and 

17 programs that have established clinical and basic 

18 research’’ and inserting ‘‘universities, hospitals, 

19 mental health agencies, and other programs that 

20 have established clinical expertise and research’’; 

21 (3) by redesignating subsections (c) through (g) 

22 as subsections (g) through (k), respectively; 

23 (4) by inserting after subsection (b), the fol24 lowing: 
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1 ‘‘(c) CHILD OUTCOME DATA.—The NCTSI coordi2 nating center described in subsection (a)(1) shall collect, 

3 analyze, report, and make publicly available, as appro4 priate, NCTSI-wide child treatment process and outcome 

5 data regarding the early identification and delivery of evi6 dence-based treatment and services for children and families 

7 served by the NCTSI grantees. 

8 ‘‘(d) TRAINING.—The NCTSI coordinating center shall 

9 facilitate the coordination of training initiatives in evi10 dence-based and trauma-informed treatments, interven11 tions, and practices offered to NCTSI grantees, providers, 

12 and partners. 

13 ‘‘(e) DISSEMINATION AND COLLABORATION.—The 

14 NCTSI coordinating center shall, as appropriate, collabo15 rate with— 

16 ‘‘(1) the Secretary, in the dissemination of evi17 dence-based and trauma-informed interventions, 

18 treatments, products, and other resources to appro19 priate stakeholders; and 

20 ‘‘(2) appropriate agencies that conduct or fund 

21 research within the Department of Health and 

22 Human Services, for purposes of sharing NCTSI ex23 pertise, evaluation data, and other activities, as ap24 propriate. 
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1 ‘‘(f) REVIEW.—The Secretary shall, consistent with the 

2 peer-review process, ensure that NCTSI applications are re3 viewed by appropriate experts in the field as part of a con4 sensus-review process. The Secretary shall include review 

5 criteria related to expertise and experience in child trauma 

6 and evidence-based practices.’’; 

7 (5) in subsection (g) (as so redesignated), by 

8 striking ‘‘with respect to centers of excellence are dis9 tributed equitably among the regions of the country’’ 

10 and inserting ‘‘are distributed equitably among the 

11 regions of the United States’’; 

12 (6) in subsection (i) (as so redesignated), by 

13 striking ‘‘recipient may not exceed 5 years’’ and in14 serting ‘‘recipient shall not be less than 4 years, but 

15 shall not exceed 5 years’’; and 

16 (7) in subsection (j) (as so redesignated), by 

17 striking ‘‘$50,000,000’’ and all that follows through 

18 ‘‘2006’’ and inserting ‘‘$46,887,000 for each of fiscal 

19 years 2018 through 2022’’. 

20 SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL 

21 DEPRESSION. 

22 Part B of title III of the Public Health Service Act 

23 (42 U.S.C. 243 et seq.) is amended by inserting after section 

24 317L (42 U.S.C. 247b–13) the following: 
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•HR 34 EAH 

1 ‘‘SEC. 317L–1. SCREENING AND TREATMENT FOR MATERNAL 

2 DEPRESSION. 

3 ‘‘(a) GRANTS.—The Secretary shall make grants to 

4 States to establish, improve, or maintain programs for 

5 screening, assessment, and treatment services, including 

6 culturally and linguistically appropriate services, as appro7 priate, for women who are pregnant, or who have given 

8 birth within the preceding 12 months, for maternal depres9 sion. 

10 ‘‘(b) APPLICATION.—To seek a grant under this sec11 tion, a State shall submit an application to the Secretary 

12 at such time, in such manner, and containing such infor13 mation as the Secretary may require. At a minimum, any 

14 such application shall include explanations of— 

15 ‘‘(1) how a program, or programs, will increase 

16 the percentage of women screened and treated, as ap17 propriate, for maternal depression in 1 or more com18 munities; and 

19 ‘‘(2) how a program, or programs, if expanded, 

20 would increase access to screening and treatment serv21 ices for maternal depression. 

22 ‘‘(c) PRIORITY.—In awarding grants under this sec23 tion, the Secretary may give priority to States proposing 

24 to improve or enhance access to screening services for mater25 nal depression in primary care settings. 
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1 ‘‘(d) USE OF FUNDS.—The activities eligible for fund2 ing through a grant under subsection (a)— 

3 ‘‘(1) shall include— 

4 ‘‘(A) providing appropriate training to 

5 health care providers; and 

6 ‘‘(B) providing information to health care 

7 providers, including information on maternal 

8 depression screening, treatment, and followup 

9 support services, and linkages to community10 based resources; and 

11 ‘‘(2) may include— 

12 ‘‘(A) enabling health care providers (includ13 ing obstetrician-gynecologists, pediatricians, psy14 chiatrists, mental health care providers, and 

15 adult primary care clinicians) to provide or re16 ceive real-time psychiatric consultation (in-per17 son or remotely) to aid in the treatment of preg18 nant and parenting women; 

19 ‘‘(B) establishing linkages with and among 

20 community-based resources, including mental 

21 health resources, primary care resources, and 

22 support groups; and 

23 ‘‘(C) utilizing telehealth services for rural 

24 areas and medically underserved areas (as de25 fined in section 330I(a)). 
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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

2 out this section, there are authorized to be appropriated 

3 $5,000,000 for each of fiscal years 2018 through 2022.’’. 

4 SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL 

5 HEALTH PROMOTION, INTERVENTION, AND 

6 TREATMENT. 

7 Part Q of title III of the Public Health Service Act 

8 (42 U.S.C. 280h et seq.) is amended by adding at the end 

9 the following: 

10 ‘‘SEC. 399Z–2. INFANT AND EARLY CHILDHOOD MENTAL 

11 HEALTH PROMOTION, INTERVENTION, AND 

12 TREATMENT. 

13 ‘‘(a) GRANTS.—The Secretary shall— 

14 ‘‘(1) award grants to eligible entities to develop, 

15 maintain, or enhance infant and early childhood 

16 mental health promotion, intervention, and treatment 

17 programs, including— 

18 ‘‘(A) programs for infants and children at 

19 significant risk of developing, showing early 

20 signs of, or having been diagnosed with mental 

21 illness, including a serious emotional disturb22 ance; and 

23 ‘‘(B) multigenerational therapy and other 

24 services that support the caregiving relationship; 

25 and 
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•HR 34 EAH 

1 ‘‘(2) ensure that programs funded through grants 

2 under this section are evidence-informed or evidence3 based models, practices, and methods that are, as ap4 propriate, culturally and linguistically appropriate, 

5 and can be replicated in other appropriate settings. 

6 ‘‘(b) ELIGIBLE CHILDREN AND ENTITIES.—In this sec7 tion: 

8 ‘‘(1) ELIGIBLE CHILD.—The term ‘eligible child’ 

9 means a child from birth to not more than 12 years 

10 of age who— 

11 ‘‘(A) is at risk for, shows early signs of, or 

12 has been diagnosed with a mental illness, includ13 ing a serious emotional disturbance; and 

14 ‘‘(B) may benefit from infant and early 

15 childhood intervention or treatment programs or 

16 specialized preschool or elementary school pro17 grams that are evidence-based or that have been 

18 scientifically demonstrated to show promise but 

19 would benefit from further applied development. 

20 ‘‘(2) ELIGIBLE ENTITY.—The term ‘eligible enti21 ty’ means a human services agency or nonprofit insti22 tution that— 

23 ‘‘(A) employs licensed mental health profes24 sionals who have specialized training and expe25 rience in infant and early childhood mental 
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1 health assessment, diagnosis, and treatment, or 

2 is accredited or approved by the appropriate 

3 State agency, as applicable, to provide for chil4 dren from infancy to 12 years of age mental 

5 health promotion, intervention, or treatment 

6 services; and 

7 ‘‘(B) provides services or programs de8 scribed in subsection (a) that are evidence-based 

9 or that have been scientifically demonstrated to 

10 show promise but would benefit from further ap11 plied development. 

12 ‘‘(c) APPLICATION.—An eligible entity seeking a grant 

13 under subsection (a) shall submit to the Secretary an appli14 cation at such time, in such manner, and containing such 

15 information as the Secretary may require. 

16 ‘‘(d) USE OF FUNDS FOR EARLY INTERVENTION AND

17 TREATMENT PROGRAMS.—An eligible entity may use 

18 amounts awarded under a grant under subsection (a)(1) to 

19 carry out the following: 

20 ‘‘(1) Provide age-appropriate mental health pro21 motion and early intervention services or mental ill22 ness treatment services, which may include specialized 

23 programs, for eligible children at significant risk of 

24 developing, showing early signs of, or having been di25 agnosed with a mental illness, including a serious 
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•HR 34 EAH 

1 emotional disturbance. Such services may include so2 cial and behavioral services as well as 

3 multigenerational therapy and other services that 

4 support the caregiving relationship. 

5 ‘‘(2) Provide training for health care profes6 sionals with expertise in infant and early childhood 

7 mental health care with respect to appropriate and 

8 relevant integration with other disciplines such as 

9 primary care clinicians, early intervention special10 ists, child welfare staff, home visitors, early care and 

11 education providers, and others who work with young 

12 children and families. 

13 ‘‘(3) Provide mental health consultation to per14 sonnel of early care and education programs (includ15 ing licensed or regulated center-based and home-based 

16 child care, home visiting, preschool special education, 

17 and early intervention programs) who work with chil18 dren and families. 

19 ‘‘(4) Provide training for mental health clini20 cians in infant and early childhood in promising and 

21 evidence-based practices and models for infant and 

22 early childhood mental health treatment and early 

23 intervention, including with regard to practices for 

24 identifying and treating mental illness and behav25 ioral disorders of infants and children resulting from 
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•HR 34 EAH 

1 exposure or repeated exposure to adverse childhood ex2 periences or childhood trauma. 

3 ‘‘(5) Provide age-appropriate assessment, diag4 nostic, and intervention services for eligible children, 

5 including early mental health promotion, interven6 tion, and treatment services. 

7 ‘‘(e) MATCHING FUNDS.—The Secretary may not 

8 award a grant under this section to an eligible entity unless 

9 the eligible entity agrees, with respect to the costs to be in10 curred by the eligible entity in carrying out the activities 

11 described in subsection (d), to make available non-Federal 

12 contributions (in cash or in kind) toward such costs in an 

13 amount that is not less than 10 percent of the total amount 

14 of Federal funds provided in the grant. 

15 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry 

16 out this section, there are authorized to be appropriated 

17 $20,000,000 for the period of fiscal years 2018 through 

18 2022.’’. 

19 TITLE XI—COMPASSIONATE 

20 COMMUNICATION ON HIPAA 

21 SEC. 11001. SENSE OF CONGRESS. 

22 (a) FINDINGS.—Congress finds the following: 

23 (1) According to the National Survey on Drug 

24 Use and Health, in 2015, there were approximately 
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1 9,800,000 adults in the United States with serious 

2 mental illness. 

3 (2) The Substance Abuse and Mental Health 

4 Services Administration defines the term ‘‘serious 

5 mental illness’’ as an illness affecting individuals 18 

6 years of age or older as having, at any time in the 

7 past year, a diagnosable mental, behavioral, or emo8 tional disorder that results in serious functional im9 pairment and substantially interferes with or limits 

10 one or more major life activities. 

11 (3) In reporting on the incidence of serious men12 tal illness, the Substance Abuse and Mental Health 

13 Services Administration includes major depression, 

14 schizophrenia, bipolar disorder, and other mental dis15 orders that cause serious impairment. 

16 (4) Adults with a serious mental illness are at 

17 a higher risk for chronic physical illnesses and pre18 mature death. 

19 (5) According to the World Health Organization, 

20 adults with a serious mental illness have lifespans 

21 that are 10 to 25 years shorter than those without se22 rious mental illness. The vast majority of these deaths 

23 are due to chronic physical medical conditions, such 

24 as cardiovascular, respiratory, and infectious dis25 eases, as well as diabetes and hypertension. 
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1 (6) According to the World Health Organization, 

2 the majority of deaths of adults with a serious mental 

3 illness that are due to physical medical conditions are 

4 preventable. 

5 (7) Supported decision making can facilitate 

6 care decisions in areas where serious mental illness 

7 may impact the capacity of an individual to deter8 mine a course of treatment while still allowing the in9 dividual to make decisions independently. 

10 (8) Help should be provided to adults with a se11 rious mental illness to address their acute or chronic 

12 physical illnesses, make informed choices about treat13 ment, and understand and follow through with appro14 priate treatment. 

15 (9) There is confusion in the health care commu16 nity regarding permissible practices under the regula17 tions promulgated under the Health Insurance Port18 ability and Accountability Act of 1996 (commonly 

19 known as ‘‘HIPAA’’). This confusion may hinder ap20 propriate communication of health care information 

21 or treatment preferences with appropriate caregivers. 

22 (b) SENSE OF CONGRESS.—It is the sense of Congress 

23 that clarification is needed regarding the privacy rule pro24 mulgated under section 264(c) of the Health Insurance 

25 Portability and Accountability Act of 1996 (42 U.S.C. 
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1 1320d–2 note) regarding existing permitted uses and disclo2 sures of health information by health care professionals to 

3 communicate with caregivers of adults with a serious men4 tal illness to facilitate treatment. 

5 SEC. 11002. CONFIDENTIALITY OF RECORDS. 

6 Not later than 1 year after the date on which the Sec7 retary of Health and Human Services (in this title referred 

8 to as the ‘‘Secretary’’) first finalizes regulations updating 

9 part 2 of title 42, Code of Federal Regulations, relating to 

10 confidentiality of alcohol and drug abuse patient records, 

11 after the date of enactment of this Act, the Secretary shall 

12 convene relevant stakeholders to determine the effect of such 

13 regulations on patient care, health outcomes, and patient 

14 privacy. 

15 SEC. 11003. CLARIFICATION ON PERMITTED USES AND DIS16 CLOSURES OF PROTECTED HEALTH INFOR17 MATION. 

18 (a) IN GENERAL.—The Secretary, acting through the 

19 Director of the Office for Civil Rights, shall ensure that 

20 health care providers, professionals, patients and their fam21 ilies, and others involved in mental or substance use dis22 order treatment have adequate, accessible, and easily com23 prehensible resources relating to appropriate uses and dis24 closures of protected health information under the regula25 tions promulgated under section 264(c) of the Health Insur-
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1 ance Portability and Accountability Act of 1996 (42 U.S.C. 

2 1320d–2 note). 

3 (b) GUIDANCE.— 

4 (1) ISSUANCE.—In carrying out subsection (a), 

5 not later than 1 year after the date of enactment of 

6 this section, the Secretary shall issue guidance clari7 fying the circumstances under which, consistent with 

8 regulations promulgated under section 264(c) of the 

9 Health Insurance Portability and Accountability Act 

10 of 1996, a health care provider or covered entity may 

11 use or disclose protected health information. 

12 (2) CIRCUMSTANCES ADDRESSED.—The guidance 

13 issued under this section shall address circumstances 

14 including those that— 

15 (A) require the consent of the patient; 

16 (B) require providing the patient with an 

17 opportunity to object; 

18 (C) are based on the exercise of professional 

19 judgment regarding whether the patient would 

20 object when the opportunity to object cannot 

21 practicably be provided because of the incapacity 

22 of the patient or an emergency treatment cir23 cumstance; and 

24 (D) are determined, based on the exercise of 

25 professional judgment, to be in the best interest 
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1 of the patient when the patient is not present or 

2 otherwise incapacitated. 

3 (3) COMMUNICATION WITH FAMILY MEMBERS

4 AND CAREGIVERS.—In addressing the circumstances 

5 described in paragraph (2), the guidance issued under 

6 this section shall clarify permitted uses or disclosures 

7 of protected health information for purposes of— 

8 (A) communicating with a family member 

9 of the patient, caregiver of the patient, or other 

10 individual, to the extent that such family mem11 ber, caregiver, or individual is involved in the 

12 care of the patient; 

13 (B) in the case that the patient is an adult, 

14 communicating with a family member of the pa15 tient, caregiver of the patient, or other indi16 vidual involved in the care of the patient; 

17 (C) in the case that the patient is a minor, 

18 communicating with the parent or caregiver of 

19 the patient; 

20 (D) involving the family members or care21 givers of the patient, or others involved in the 

22 patient’s care or care plan, including facilitating 

23 treatment and medication adherence; 
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•HR 34 EAH 

1 (E) listening to the patient, or receiving in2 formation with respect to the patient from the 

3 family or caregiver of the patient; 

4 (F) communicating with family members of 

5 the patient, caregivers of the patient, law en6 forcement, or others when the patient presents a 

7 serious and imminent threat of harm to self or 

8 others; and 

9 (G) communicating to law enforcement and 

10 family members or caregivers of the patient 

11 about the admission of the patient to receive care 

12 at, or the release of a patient from, a facility for 

13 an emergency psychiatric hold or involuntary 

14 treatment. 

15 SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL 

16 TRAINING PROGRAMS. 

17 (a) INITIAL PROGRAMS AND MATERIALS.—Not later 

18 than 1 year after the date of the enactment of this Act, the 

19 Secretary, in consultation with appropriate experts, shall 

20 identify the following model programs and materials, or (in 

21 the case that no such programs or materials exist) recognize 

22 private or public entities to develop and disseminate each 

23 of the following: 

24 (1) Model programs and materials for training 

25 health care providers (including physicians, emer-
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•HR 34 EAH 

1 gency medical personnel, psychiatrists, including 

2 child and adolescent psychiatrists, psychologists, 

3 counselors, therapists, nurse practitioners, physician 

4 assistants, behavioral health facilities and clinics, 

5 care managers, and hospitals, including individuals 

6 such as general counsels or regulatory compliance 

7 staff who are responsible for establishing provider pri8 vacy policies) regarding the permitted uses and dis9 closures, consistent with the standards governing the 

10 privacy and security of individually identifiable 

11 health information promulgated by the Secretary 

12 under part C of title XI of the Social Security Act 

13 (42 U.S.C. 1320d et seq.) and regulations promul14 gated under section 264(c) of the Health Insurance 

15 Portability and Accountability Act of 1996 (42 

16 U.S.C. 1320d–2 note) and such part C, of the pro17 tected health information of patients seeking or un18 dergoing mental or substance use disorder treatment. 

19 (2) A model program and materials for training 

20 patients and their families regarding their rights to 

21 protect and obtain information under the standards 

22 and regulations specified in paragraph (1). 

23 (b) PERIODIC UPDATES.—The Secretary shall— 
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•HR 34 EAH 

1 (1) periodically review and update the model 

2 programs and materials identified or developed under 

3 subsection (a); and 

4 (2) disseminate the updated model programs and 

5 materials to the individuals described in subsection 

6 (a). 

7 (c) COORDINATION.—The Secretary shall carry out 

8 this section in coordination with the Director of the Office 

9 for Civil Rights within the Department of Health and 

10 Human Services, the Assistant Secretary for Mental Health 

11 and Substance Use, the Administrator of the Health Re12 sources and Services Administration, and the heads of other 

13 relevant agencies within the Department of Health and 

14 Human Services. 

15 (d) INPUT OF CERTAIN ENTITIES.—In identifying, re16 viewing, or updating the model programs and materials 

17 under subsections (a) and (b), the Secretary shall solicit the 

18 input of relevant national, State, and local associations; 

19 medical societies; licensing boards; providers of mental and 

20 substance use disorder treatment; organizations with exper21 tise on domestic violence, sexual assault, elder abuse, and 

22 child abuse; and organizations representing patients and 

23 consumers and the families of patients and consumers. 

24 (e) FUNDING.—There are authorized to be appro25 priated to carry out this section— 
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1 (1) $4,000,000 for fiscal year 2018; 

2 (2) $2,000,000 for each of fiscal years 2019 and 

3 2020; and 

4 (3) $1,000,000 for each of fiscal years 2021 and 

5 2022. 

6 TITLE XII—MEDICAID MENTAL 

7 HEALTH COVERAGE 

8 SEC. 12001. RULE OF CONSTRUCTION RELATED TO MED9 ICAID COVERAGE OF MENTAL HEALTH SERV10 ICES AND PRIMARY CARE SERVICES FUR11 NISHED ON THE SAME DAY. 

12 Nothing in title XIX of the Social Security Act (42 

13 U.S.C. 1396 et seq.) shall be construed as prohibiting sepa14 rate payment under the State plan under such title (or 

15 under a waiver of the plan) for the provision of a mental 

16 health service or primary care service under such plan, with 

17 respect to an individual, because such service is— 

18 (1) a primary care service furnished to the indi19 vidual by a provider at a facility on the same day 

20 a mental health service is furnished to such indi21 vidual by such provider (or another provider) at the 

22 facility; or 

23 (2) a mental health service furnished to the indi24 vidual by a provider at a facility on the same day 
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•HR 34 EAH 

1 a primary care service is furnished to such individual 

2 by such provider (or another provider) at the facility. 

3 SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID 

4 MANAGED CARE REGULATION. 

5 (a) STUDY.—The Secretary of Health and Human 

6 Services, acting through the Administrator of the Centers 

7 for Medicare & Medicaid Services, shall conduct a study 

8 on coverage under the Medicaid program under title XIX 

9 of the Social Security Act (42 U.S.C. 1396 et seq.) of serv10 ices provided through a medicaid managed care organiza11 tion (as defined in section 1903(m) of such Act (42 U.S.C. 

12 1396b(m)) or a prepaid inpatient health plan (as defined 

13 in section 438.2 of title 42, Code of Federal Regulations 

14 (or any successor regulation)) with respect to individuals 

15 over the age of 21 and under the age of 65 for the treatment 

16 of a mental health disorder in institutions for mental dis17 eases (as defined in section 1905(i) of such Act (42 U.S.C. 

18 1396d(i))). Such study shall include information on the fol19 lowing: 

20 (1) The extent to which States, including the 

21 District of Columbia and each territory or possession 

22 of the United States, are providing capitated pay23 ments to such organizations or plans for enrollees who 

24 are receiving services in institutions for mental dis25 eases. 
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1 (2) The number of individuals receiving medical 

2 assistance under a State plan under such title XIX, 

3 or a waiver of such plan, who receive services in in4 stitutions for mental diseases through such organiza5 tions and plans. 

6 (3) The range of and average number of months, 

7 and the length of stay during such months, that such 

8 individuals are receiving such services in such insti9 tutions. 

10 (4) How such organizations or plans determine 

11 when to provide for the furnishing of such services 

12 through an institution for mental diseases in lieu of 

13 other benefits (including the full range of community14 based services) under their contract with the State 

15 agency administering the State plan under such title 

16 XIX, or a waiver of such plan, to address psychiatric 

17 or substance use disorder treatment. 

18 (5) The extent to which the provision of services 

19 within such institutions has affected the capitated 

20 payments for such organizations or plans. 

21 (b) REPORT.—Not later than 3 years after the date 

22 of the enactment of this Act, the Secretary shall submit to 

23 Congress a report on the study conducted under subsection 

24 (a). 
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1 SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVA2 TION. 

3 Not later than 1 year after the date of the enactment 

4 of this Act, the Administrator of the Centers for Medicare 

5 & Medicaid Services shall issue a State Medicaid Director 

6 letter regarding opportunities to design innovative service 

7 delivery systems, including systems for providing commu8 nity-based services, for adults with a serious mental illness 

9 or children with a serious emotional disturbance who are 

10 receiving medical assistance under title XIX of the Social 

11 Security Act (42 U.S.C. 1396 et seq.). The letter shall in12 clude opportunities for demonstration projects under section 

13 1115 of such Act (42 U.S.C. 1315) to improve care for such 

14 adults and children. 

15 SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY 

16 PSYCHIATRIC DEMONSTRATION PROJECT. 

17 (a) COLLECTION OF INFORMATION.—The Secretary of 

18 Health and Human Services, acting through the Adminis19 trator of the Centers for Medicare & Medicaid Services, 

20 shall, to the extent practical and data is available, with 

21 respect to each State that has participated in the dem22 onstration project established under section 2707 of the Pa23 tient Protection and Affordable Care Act (42 U.S.C. 1396a 

24 note), collect from each such State information on the fol25 lowing: 
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•HR 34 EAH 

1 (1) The number of institutions for mental dis2 eases (as defined in section 1905(i) of the Social Secu3 rity Act (42 U.S.C. 1396d(i))) and beds in such insti4 tutions that received payment for the provision of 

5 services to individuals who receive medical assistance 

6 under a State plan under the Medicaid program 

7 under title XIX of the Social Security Act (42 U.S.C. 

8 1396 et seq.) (or under a waiver of such plan) 

9 through the demonstration project in each such State 

10 as compared to the total number of institutions for 

11 mental diseases and beds in the State. 

12 (2) The extent to which there is a reduction in 

13 expenditures under the Medicaid program under title 

14 XIX of the Social Security Act (42 U.S.C. 1396 et 

15 seq.) or other spending on the full continuum of phys16 ical or mental health care for individuals who receive 

17 treatment in an institution for mental diseases under 

18 the demonstration project, including outpatient, inpa19 tient, emergency, and ambulatory care, that is attrib20 utable to such individuals receiving treatment in in21 stitutions for mental diseases under the demonstration 

22 project. 

23 (3) The number of forensic psychiatric hospitals, 

24 the number of beds in such hospitals, and the number 

25 of forensic psychiatric beds in other hospitals in such 
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•HR 34 EAH 

1 State, based on the most recent data available, to the 

2 extent practical, as determined by such Adminis3 trator. 

4 (4) The amount of any disproportionate share 

5 hospital payments under section 1923 of the Social 

6 Security Act (42 U.S.C. 1396r–4) that institutions 

7 for mental diseases in the State received during the 

8 period beginning on July 1, 2012, and ending on 

9 June 30, 2015, and the extent to which the dem10 onstration project reduced the amount of such pay11 ments. 

12 (5) The most recent data regarding all facilities 

13 or sites in the State in which any adults with a seri14 ous mental illness who are receiving medical assist15 ance under a State plan under the Medicaid program 

16 under title XIX of the Social Security Act (42 U.S.C. 

17 1396 et seq.) (or under a waiver of such plan) are 

18 treated during the period referred to in paragraph 

19 (4), to the extent practical, as determined by the Ad20 ministrator, including— 

21 (A) the types of such facilities or sites (such 

22 as an institution for mental diseases, a hospital 

23 emergency department, or other inpatient hos24 pital); 
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•HR 34 EAH 

1 (B) the average length of stay in such a fa2 cility or site by such an individual, 

3 disaggregated by facility type; and 

4 (C) the payment rate under the State plan 

5 (or a waivers of such plan) for services furnished 

6 to such an individual for that treatment, 

7 disaggregated by facility type, during the period 

8 in which the demonstration project is in oper9 ation. 

10 (6) The extent to which the utilization of hos11 pital emergency departments during the period in 

12 which the demonstration project was is in operation 

13 differed, with respect to individuals who are receiving 

14 medical assistance under a State plan under the Med15 icaid program under title XIX of the Social Security 

16 Act (42 U.S.C. 1396 et seq.) (or under a waiver of 

17 such plan), between— 

18 (A) those individuals who received treat19 ment in an institution for mental diseases under 

20 the demonstration project; 

21 (B) those individuals who met the eligibility 

22 requirements for the demonstration project but 

23 who did not receive treatment in an institution 

24 for mental diseases under the demonstration 

25 project; and 
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1 (C) those adults with a serious mental ill2 ness who did not meet such eligibility require3 ments and did not receive treatment for such ill4 ness in an institution for mental diseases. 

5 (b) REPORT.—Not later than 2 years after the date 

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

7 Human Services shall submit to Congress a report that 

8 summarizes and analyzes the information collected under 

9 subsection (a). Such report may be submitted as part of 

10 the report required under section 2707(f) of the Patient Pro11 tection and Affordable Care Act (42 U.S.C. 1396a note) or 

12 separately. 

13 SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN 

14 IMDS. 

15 (a) IN GENERAL.—Section 1905(a)(16) of the Social 

16 Security Act (42 U.S.C. 1396d(a)(16)) is amended— 

17 (1) by striking ‘‘effective January 1, 1973’’ and 

18 inserting ‘‘(A) effective January 1, 1973’’; and 

19 (2) by inserting before the semicolon at the end 

20 the following: ‘‘, and, (B) for individuals receiving 

21 services described in subparagraph (A), early and 

22 periodic screening, diagnostic, and treatment services 

23 (as defined in subsection (r)), whether or not such 

24 screening, diagnostic, and treatment services are fur-
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1 nished by the provider of the services described in 

2 such subparagraph’’. 

3 (b) EFFECTIVE DATE.—The amendments made by sub4 section (a) shall apply with respect to items and services 

5 furnished in calendar quarters beginning on or after Janu6 ary 1, 2019. 

7 SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM RE8 QUIRED FOR PERSONAL CARE SERVICES AND 

9 HOME HEALTH CARE SERVICES UNDER MED10 ICAID. 

11 (a) IN GENERAL.—Section 1903 of the Social Security 

12 Act (42 U.S.C. 1396b) is amended by inserting after sub13 section (k) the following new subsection: 

14 ‘‘(l)(1) Subject to paragraphs (3) and (4), with respect 

15 to any amount expended for personal care services or home 

16 health care services requiring an in-home visit by a pro17 vider that are provided under a State plan under this title 

18 (or under a waiver of the plan) and furnished in a calendar 

19 quarter beginning on or after January 1, 2019 (or, in the 

20 case of home health care services, on or after January 1, 

21 2023), unless a State requires the use of an electronic visit 

22 verification system for such services furnished in such quar23 ter under the plan or such waiver, the Federal medical as24 sistance percentage shall be reduced— 

25 ‘‘(A) in the case of personal care services— 
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1 ‘‘(i) for calendar quarters in 2019 and 

2 2020, by .25 percentage points; 

3 ‘‘(ii) for calendar quarters in 2021, by .5 

4 percentage points; 

5 ‘‘(iii) for calendar quarters in 2022, by .75 

6 percentage points; and 

7 ‘‘(iv) for calendar quarters in 2023 and 

8 each year thereafter, by 1 percentage point; and 

9 ‘‘(B) in the case of home health care services— 

10 ‘‘(i) for calendar quarters in 2023 and 

11 2024, by .25 percentage points; 

12 ‘‘(ii) for calendar quarters in 2025, by .5 

13 percentage points; 

14 ‘‘(iii) for calendar quarters in 2026, by .75 

15 percentage points; and 

16 ‘‘(iv) for calendar quarters in 2027 and 

17 each year thereafter, by 1 percentage point. 

18 ‘‘(2) Subject to paragraphs (3) and (4), in imple19 menting the requirement for the use of an electronic visit 

20 verification system under paragraph (1), a State shall— 

21 ‘‘(A) consult with agencies and entities that pro22 vide personal care services, home health care services, 

23 or both under the State plan (or under a waiver of 

24 the plan) to ensure that such system— 

25 ‘‘(i) is minimally burdensome; 
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1 ‘‘(ii) takes into account existing best prac2 tices and electronic visit verification systems in 

3 use in the State; and 

4 ‘‘(iii) is conducted in accordance with the 

5 requirements of HIPAA privacy and security 

6 law (as defined in section 3009 of the Public 

7 Health Service Act); 

8 ‘‘(B) take into account a stakeholder process that 

9 includes input from beneficiaries, family caregivers, 

10 individuals who furnish personal care services or 

11 home health care services, and other stakeholders, as 

12 determined by the State in accordance with guidance 

13 from the Secretary; and 

14 ‘‘(C) ensure that individuals who furnish per15 sonal care services, home health care services, or both 

16 under the State plan (or under a waiver of the plan) 

17 are provided the opportunity for training on the use 

18 of such system. 

19 ‘‘(3) Paragraphs (1) and (2) shall not apply in the 

20 case of a State that, as of the date of the enactment of this 

21 subsection, requires the use of any system for the electronic 

22 verification of visits conducted as part of both personal care 

23 services and home health care services, so long as the State 

24 continues to require the use of such system with respect to 

25 the electronic verification of such visits. 
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1 ‘‘(4)(A) In the case of a State described in subpara2 graph (B), the reduction under paragraph (1) shall not 

3 apply— 

4 ‘‘(i) in the case of personal care services, for cal5 endar quarters in 2019; and 

6 ‘‘(ii) in the case of home health care services, for 

7 calendar quarters in 2023. 

8 ‘‘(B) For purposes of subparagraph (A), a State de9 scribed in this subparagraph is a State that demonstrates 

10 to the Secretary that the State— 

11 ‘‘(i) has made a good faith effort to comply with 

12 the requirements of paragraphs (1) and (2) (includ13 ing by taking steps to adopt the technology used for 

14 an electronic visit verification system); and 

15 ‘‘(ii) in implementing such a system, has en16 countered unavoidable system delays. 

17 ‘‘(5) In this subsection: 

18 ‘‘(A) The term ‘electronic visit verification sys19 tem’ means, with respect to personal care services or 

20 home health care services, a system under which visits 

21 conducted as part of such services are electronically 

22 verified with respect to— 

23 ‘‘(i) the type of service performed; 

24 ‘‘(ii) the individual receiving the service; 

25 ‘‘(iii) the date of the service; 
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1 ‘‘(iv) the location of service delivery; 

2 ‘‘(v) the individual providing the service; 

3 and 

4 ‘‘(vi) the time the service begins and ends. 

5 ‘‘(B) The term ‘home health care services’ means 

6 services described in section 1905(a)(7) provided 

7 under a State plan under this title (or under a waiv8 er of the plan). 

9 ‘‘(C) The term ‘personal care services’ means 

10 personal care services provided under a State plan 

11 under this title (or under a waiver of the plan), in12 cluding services provided under section 1905(a)(24), 

13 1915(c), 1915(i), 1915(j), or 1915(k) or under a 

14 wavier under section 1115. 

15 ‘‘(6)(A) In the case in which a State requires personal 

16 care service and home health care service providers to utilize 

17 an electronic visit verification system operated by the State 

18 or a contractor on behalf of the State, the Secretary shall 

19 pay to the State, for each quarter, an amount equal to 90 

20 per centum of so much of the sums expended during such 

21 quarter as are attributable to the design, development, or 

22 installation of such system, and 75 per centum of so much 

23 of the sums for the operation and maintenance of such sys24 tem. 
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1 ‘‘(B) Subparagraph (A) shall not apply in the case 

2 in which a State requires personal care service and home 

3 health care service providers to utilize an electronic visit 

4 verification system that is not operated by the State or a 

5 contractor on behalf of the State.’’. 

6 (b) COLLECTION AND DISSEMINATION OF BEST PRAC7 TICES.—Not later than January 1, 2018, the Secretary of 

8 Health and Human Services shall, with respect to electronic 

9 visit verification systems (as defined in subsection (l)(5) of 

10 section 1903 of the Social Security Act (42 U.S.C. 1396b), 

11 as inserted by subsection (a)), collect and disseminate best 

12 practices to State Medicaid Directors with respect to— 

13 (1) training individuals who furnish personal 

14 care services, home health care services, or both under 

15 the State plan under title XIX of such Act (or under 

16 a waiver of the plan) on such systems and the oper17 ation of such systems and the prevention of fraud 

18 with respect to the provision of personal care services 

19 or home health care services (as defined in such sub20 section (l)(5)); and 

21 (2) the provision of notice and educational mate22 rials to family caregivers and beneficiaries with re23 spect to the use of such electronic visit verification 

24 systems and other means to prevent such fraud. 

25 (c) RULES OF CONSTRUCTION.— 
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1 (1) NO EMPLOYER-EMPLOYEE RELATIONSHIP ES2 TABLISHED.—Nothing in the amendment made by 

3 this section may be construed as establishing an em4 ployer-employee relationship between the agency or 

5 entity that provides for personal care services or home 

6 health care services and the individuals who, under a 

7 contract with such an agency or entity, furnish such 

8 services for purposes of part 552 of title 29, Code of 

9 Federal Regulations (or any successor regulations). 

10 (2) NO PARTICULAR OR UNIFORM ELECTRONIC

11 VISIT VERIFICATION SYSTEM REQUIRED.—Nothing in 

12 the amendment made by this section shall be con13 strued to require the use of a particular or uniform 

14 electronic visit verification system (as defined in sub15 section (l)(5) of section 1903 of the Social Security 

16 Act (42 U.S.C. 1396b), as inserted by subsection (a)) 

17 by all agencies or entities that provide personal care 

18 services or home health care under a State plan under 

19 title XIX of the Social Security Act (or under a waiv20 er of the plan) (42 U.S.C. 1396 et seq.). 

21 (3) NO LIMITS ON PROVISION OF CARE.—Nothing 

22 in the amendment made by this section may be con23 strued to limit, with respect to personal care services 

24 or home health care services provided under a State 

25 plan under title XIX of the Social Security Act (or 
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1 under a waiver of the plan) (42 U.S.C. 1396 et seq.), 

2 provider selection, constrain beneficiaries’ selection of 

3 a caregiver, or impede the manner in which care is 

4 delivered. 

5 (4) NO PROHIBITION ON STATE QUALITY MEAS6 URES REQUIREMENTS.—Nothing in the amendment 

7 made by this section shall be construed as prohibiting 

8 a State, in implementing an electronic visit 

9 verification system (as defined in subsection (l)(5) of 

10 section 1903 of the Social Security Act (42 U.S.C. 

11 1396b), as inserted by subsection (a)), from estab12 lishing requirements related to quality measures for 

13 such system. 

14 TITLE XIII—MENTAL HEALTH 

15 PARITY 

16 SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL 

17 HEALTH AND SUBSTANCE USE DISORDER 

18 COVERAGE REQUIREMENTS. 

19 (a) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.— 

20 Section 2726(a) of the Public Health Service Act (42 U.S.C. 

21 300gg–26(a)) is amended by adding at the end the fol22 lowing: 

23 ‘‘(6) COMPLIANCE PROGRAM GUIDANCE DOCU24 MENT.— 
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1 ‘‘(A) IN GENERAL.—Not later than 12 

2 months after the date of enactment of the Help3 ing Families in Mental Health Crisis Reform 

4 Act of 2016, the Secretary, the Secretary of 

5 Labor, and the Secretary of the Treasury, in 

6 consultation with the Inspector General of the 

7 Department of Health and Human Services, the 

8 Inspector General of the Department of Labor, 

9 and the Inspector General of the Department of 

10 the Treasury, shall issue a compliance program 

11 guidance document to help improve compliance 

12 with this section, section 712 of the Employee 

13 Retirement Income Security Act of 1974, and 

14 section 9812 of the Internal Revenue Code of 

15 1986, as applicable. In carrying out this para16 graph, the Secretaries may take into consider17 ation the 2016 publication of the Department of 

18 Health and Human Services and the Depart19 ment of Labor, entitled ‘Warning Signs - Plan 

20 or Policy Non-Quantitative Treatment Limita21 tions (NQTLs) that Require Additional Analysis 

22 to Determine Mental Health Parity Compliance’. 

23 ‘‘(B) EXAMPLES ILLUSTRATING COMPLIANCE

24 AND NONCOMPLIANCE.— 
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1 ‘‘(i) IN GENERAL.—The compliance 

2 program guidance document required under 

3 this paragraph shall provide illustrative, 

4 de-identified examples (that do not disclose 

5 any protected health information or indi6 vidually identifiable information) of pre7 vious findings of compliance and non8 compliance with this section, section 712 of 

9 the Employee Retirement Income Security 

10 Act of 1974, or section 9812 of the Internal 

11 Revenue Code of 1986, as applicable, based 

12 on investigations of violations of such sec13 tions, including— 

14 ‘‘(I) examples illustrating require15 ments for information disclosures and 

16 nonquantitative treatment limitations; 

17 and 

18 ‘‘(II) descriptions of the violations 

19 uncovered during the course of such in20 vestigations. 

21 ‘‘(ii) NONQUANTITATIVE TREATMENT

22 LIMITATIONS.—To the extent that any ex23 ample described in clause (i) involves a 

24 finding of compliance or noncompliance 

25 with regard to any requirement for non-
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1 quantitative treatment limitations, the ex2 ample shall provide sufficient detail to fully 

3 explain such finding, including a full de4 scription of the criteria involved for approv5 ing medical and surgical benefits and the 

6 criteria involved for approving mental 

7 health and substance use disorder benefits. 

8 ‘‘(iii) ACCESS TO ADDITIONAL INFOR9 MATION REGARDING COMPLIANCE.—In de10 veloping and issuing the compliance pro11 gram guidance document required under 

12 this paragraph, the Secretaries specified in 

13 subparagraph (A)— 

14 ‘‘(I) shall enter into interagency 

15 agreements with the Inspector General 

16 of the Department of Health and 

17 Human Services, the Inspector General 

18 of the Department of Labor, and the 

19 Inspector General of the Department of 

20 the Treasury to share findings of com21 pliance and noncompliance with this 

22 section, section 712 of the Employee 

23 Retirement Income Security Act of 

24 1974, or section 9812 of the Internal 
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1 Revenue Code of 1986, as applicable; 

2 and 

3 ‘‘(II) shall seek to enter into an 

4 agreement with a State to share infor5 mation on findings of compliance and 

6 noncompliance with this section, sec7 tion 712 of the Employee Retirement 

8 Income Security Act of 1974, or section 

9 9812 of the Internal Revenue Code of 

10 1986, as applicable. 

11 ‘‘(C) RECOMMENDATIONS.—The compliance 

12 program guidance document shall include rec13 ommendations to advance compliance with this 

14 section, section 712 of the Employee Retirement 

15 Income Security Act of 1974, or section 9812 of 

16 the Internal Revenue Code of 1986, as applica17 ble, and encourage the development and use of 

18 internal controls to monitor adherence to appli19 cable statutes, regulations, and program require20 ments. Such internal controls may include illus21 trative examples of nonquantitative treatment 

22 limitations on mental health and substance use 

23 disorder benefits, which may fail to comply with 

24 this section, section 712 of the Employee Retire25 ment Income Security Act of 1974, or section 
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1 9812 of the Internal Revenue Code of 1986, as 

2 applicable, in relation to nonquantitative treat3 ment limitations on medical and surgical bene4 fits. 

5 ‘‘(D) UPDATING THE COMPLIANCE PROGRAM

6 GUIDANCE DOCUMENT.—The Secretary, the Sec7 retary of Labor, and the Secretary of the Treas8 ury, in consultation with the Inspector General 

9 of the Department of Health and Human Serv10 ices, the Inspector General of the Department of 

11 Labor, and the Inspector General of the Depart12 ment of the Treasury, shall update the compli13 ance program guidance document every 2 years 

14 to include illustrative, de-identified examples 

15 (that do not disclose any protected health infor16 mation or individually identifiable information) 

17 of previous findings of compliance and non18 compliance with this section, section 712 of the 

19 Employee Retirement Income Security Act of 

20 1974, or section 9812 of the Internal Revenue 

21 Code of 1986, as applicable.’’. 

22 (b) ADDITIONAL GUIDANCE.—Section 2726(a) of the 

23 Public Health Service Act (42 U.S.C. 300gg–26(a)), as 

24 amended by subsection (a), is further amended by adding 

25 at the end the following: 
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1 ‘‘(7) ADDITIONAL GUIDANCE.— 

2 ‘‘(A) IN GENERAL.—Not later than 12 

3 months after the date of enactment of the Help4 ing Families in Mental Health Crisis Reform 

5 Act of 2016, the Secretary, the Secretary of 

6 Labor, and the Secretary of the Treasury shall 

7 issue guidance to group health plans and health 

8 insurance issuers offering group or individual 

9 health insurance coverage to assist such plans 

10 and issuers in satisfying the requirements of this 

11 section, section 712 of the Employee Retirement 

12 Income Security Act of 1974, or section 9812 of 

13 the Internal Revenue Code of 1986, as applica14 ble. 

15 ‘‘(B) DISCLOSURE.— 

16 ‘‘(i) GUIDANCE FOR PLANS AND

17 ISSUERS.—The guidance issued under this 

18 paragraph shall include clarifying informa19 tion and illustrative examples of methods 

20 that group health plans and health insur21 ance issuers offering group or individual 

22 health insurance coverage may use for dis23 closing information to ensure compliance 

24 with the requirements under this section, 

25 section 712 of the Employee Retirement In-
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1 come Security Act of 1974, or section 9812 

2 of the Internal Revenue Code of 1986, as 

3 applicable, (and any regulations promul4 gated pursuant to such sections, as applica5 ble). 

6 ‘‘(ii) DOCUMENTS FOR PARTICIPANTS, 

7 BENEFICIARIES, CONTRACTING PROVIDERS, 

8 OR AUTHORIZED REPRESENTATIVES.—The 

9 guidance issued under this paragraph shall 

10 include clarifying information and illus11 trative examples of methods that group 

12 health plans and health insurance issuers 

13 offering group or individual health insur14 ance coverage may use to provide any par15 ticipant, beneficiary, contracting provider, 

16 or authorized representative, as applicable, 

17 with documents containing information 

18 that the health plans or issuers are required 

19 to disclose to participants, beneficiaries, 

20 contracting providers, or authorized rep21 resentatives to ensure compliance with this 

22 section, section 712 of the Employee Retire23 ment Income Security Act of 1974, or sec24 tion 9812 of the Internal Revenue Code of 

25 1986, as applicable, compliance with any 
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1 regulation issued pursuant to such respec2 tive section, or compliance with any other 

3 applicable law or regulation. Such guidance 

4 shall include information that is compara5 tive in nature with respect to— 

6 ‘‘(I) nonquantitative treatment 

7 limitations for both medical and sur8 gical benefits and mental health and 

9 substance use disorder benefits; 

10 ‘‘(II) the processes, strategies, evi11 dentiary standards, and other factors 

12 used to apply the limitations described 

13 in subclause (I); and 

14 ‘‘(III) the application of the limi15 tations described in subclause (I) to en16 sure that such limitations are applied 

17 in parity with respect to both medical 

18 and surgical benefits and mental 

19 health and substance use disorder bene20 fits. 

21 ‘‘(C) NONQUANTITATIVE TREATMENT LIMI22 TATIONS.—The guidance issued under this para23 graph shall include clarifying information and 

24 illustrative examples of methods, processes, strat25 egies, evidentiary standards, and other factors 
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1 that group health plans and health insurance 

2 issuers offering group or individual health insur3 ance coverage may use regarding the develop4 ment and application of nonquantitative treat5 ment limitations to ensure compliance with this 

6 section, section 712 of the Employee Retirement 

7 Income Security Act of 1974, or section 9812 of 

8 the Internal Revenue Code of 1986, as applica9 ble, (and any regulations promulgated pursuant 

10 to such respective section), including— 

11 ‘‘(i) examples of methods of deter12 mining appropriate types of nonquantita13 tive treatment limitations with respect to 

14 both medical and surgical benefits and men15 tal health and substance use disorder bene16 fits, including nonquantitative treatment 

17 limitations pertaining to— 

18 ‘‘(I) medical management stand19 ards based on medical necessity or ap20 propriateness, or whether a treatment 

21 is experimental or investigative; 

22 ‘‘(II) limitations with respect to 

23 prescription drug formulary design; 

24 and 
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1 ‘‘(III) use of fail-first or step ther2 apy protocols; 

3 ‘‘(ii) examples of methods of deter4 mining— 

5 ‘‘(I) network admission standards 

6 (such as credentialing); and 

7 ‘‘(II) factors used in provider re8 imbursement methodologies (such as 

9 service type, geographic market, de10 mand for services, and provider sup11 ply, practice size, training, experience, 

12 and licensure) as such factors apply to 

13 network adequacy; 

14 ‘‘(iii) examples of sources of informa15 tion that may serve as evidentiary stand16 ards for the purposes of making determina17 tions regarding the development and appli18 cation of nonquantitative treatment limita19 tions; 

20 ‘‘(iv) examples of specific factors, and 

21 the evidentiary standards used to evaluate 

22 such factors, used by such plans or issuers 

23 in performing a nonquantitative treatment 

24 limitation analysis; 
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1 ‘‘(v) examples of how specific evi2 dentiary standards may be used to deter3 mine whether treatments are considered ex4 perimental or investigative; 

5 ‘‘(vi) examples of how specific evi6 dentiary standards may be applied to each 

7 service category or classification of benefits; 

8 ‘‘(vii) examples of methods of reaching 

9 appropriate coverage determinations for 

10 new mental health or substance use disorder 

11 treatments, such as evidence-based early 

12 intervention programs for individuals with 

13 a serious mental illness and types of med14 ical management techniques; 

15 ‘‘(viii) examples of methods of reaching 

16 appropriate coverage determinations for 

17 which there is an indirect relationship be18 tween the covered mental health or sub19 stance use disorder benefit and a traditional 

20 covered medical and surgical benefit, such 

21 as residential treatment or hospitalizations 

22 involving voluntary or involuntary commit23 ment; and 

24 ‘‘(ix) additional illustrative examples 

25 of methods, processes, strategies, evidentiary 
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1 standards, and other factors for which the 

2 Secretary determines that additional guid3 ance is necessary to improve compliance 

4 with this section, section 712 of the Em5 ployee Retirement Income Security Act of 

6 1974, or section 9812 of the Internal Rev7 enue Code of 1986, as applicable. 

8 ‘‘(D) PUBLIC COMMENT.—Prior to issuing 

9 any final guidance under this paragraph, the 

10 Secretary shall provide a public comment period 

11 of not less than 60 days during which any mem12 ber of the public may provide comments on a 

13 draft of the guidance.’’. 

14 (c) AVAILABILITY OF PLAN INFORMATION.— 

15 (1) SOLICITATION OF PUBLIC FEEDBACK.—Not 

16 later than 6 months after the date of enactment of this 

17 Act, the Secretary of Health and Human Services, the 

18 Secretary of Labor, and the Secretary of the Treasury 

19 shall solicit feedback from the public on how the dis20 closure request process for documents containing in21 formation that health plans or health insurance 

22 issuers are required under Federal or State law to 

23 disclose to participants, beneficiaries, contracting pro24 viders, or authorized representatives to ensure compli25 ance with existing mental health parity and addic-
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1 tion equity requirements can be improved while con2 tinuing to ensure consumers’ rights to access all infor3 mation required by Federal or State law to be dis4 closed. 

5 (2) PUBLIC AVAILABILITY.—Not later than 12 

6 months after the date of the enactment of this Act, the 

7 Secretary of Health and Human Services, the Sec8 retary of Labor, and the Secretary of the Treasury 

9 shall make such feedback publicly available. 

10 (3) NAIC.—The Secretary of Health and 

11 Human Services, the Secretary of Labor, and the Sec12 retary of the Treasury shall share feedback obtained 

13 pursuant to paragraph (1) directly with the National 

14 Association of Insurance Commissioners to the extent 

15 such feedback includes recommendations for the devel16 opment of simplified information disclosure tools to 

17 provide consistent information for consumers. Such 

18 feedback may be taken into consideration by the Na19 tional Association of Insurance Commissioners and 

20 other appropriate entities for the voluntary develop21 ment and voluntary use of common templates and 

22 other sample standardized forms to improve consumer 

23 access to plan information. 

24 (d) IMPROVING COMPLIANCE.— 
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•HR 34 EAH 

1 (1) IN GENERAL.—In the case that the Secretary 

2 of Health and Human Services, the Secretary of 

3 Labor, or the Secretary of the Treasury determines 

4 that a group health plan or health insurance issuer 

5 offering group or individual health insurance cov6 erage has violated, at least 5 times, section 2726 of 

7 the Public Health Service Act (42 U.S.C. 300gg–26), 

8 section 712 of the Employee Retirement Income Secu9 rity Act of 1974 (29 U.S.C. 1185a), or section 9812 

10 of the Internal Revenue Code of 1986, respectively, the 

11 appropriate Secretary shall audit plan documents for 

12 such health plan or issuer in the plan year following 

13 the Secretary’s determination in order to help im14 prove compliance with such section. 

15 (2) RULE OF CONSTRUCTION.—Nothing in this 

16 subsection shall be construed to limit the authority, as 

17 in effect on the day before the date of enactment of 

18 this Act, of the Secretary of Health and Human Serv19 ices, the Secretary of Labor, or the Secretary of the 

20 Treasury to audit documents of health plans or health 

21 insurance issuers. 

22 SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT 

23 OF MENTAL HEALTH AND SUBSTANCE USE 

24 DISORDER COVERAGE. 

25 (a) PUBLIC MEETING.— 
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1 (1) IN GENERAL.—Not later than 6 months after 

2 the date of enactment of this Act, the Secretary of 

3 Health and Human Services shall convene a public 

4 meeting of stakeholders described in paragraph (2) to 

5 produce an action plan for improved Federal and 

6 State coordination related to the enforcement of sec7 tion 2726 of the Public Health Service Act (42 U.S.C. 

8 300gg–26), section 712 of the Employee Retirement 

9 Income Security Act of 1974 (29 U.S.C. 1185a), and 

10 section 9812 of the Internal Revenue Code of 1986, 

11 and any comparable provisions of State law (in this 

12 section such sections and provisions are collectively 

13 referred to as ‘‘mental health parity and addiction eq14 uity requirements’’). 

15 (2) STAKEHOLDERS.—The stakeholders described 

16 in this paragraph shall include each of the following: 

17 (A) The Federal Government, including rep18 resentatives from— 

19 (i) the Department of Health and 

20 Human Services; 

21 (ii) the Department of the Treasury; 

22 (iii) the Department of Labor; and 

23 (iv) the Department of Justice. 

24 (B) State governments, including— 
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1 (i) State health insurance commis2 sioners; 

3 (ii) appropriate State agencies, includ4 ing agencies on public health or mental 

5 health; and 

6 (iii) State attorneys general or other 

7 representatives of State entities involved in 

8 the enforcement of mental health parity and 

9 addiction equity requirements. 

10 (C) Representatives from key stakeholder 

11 groups, including— 

12 (i) the National Association of Insur13 ance Commissioners; 

14 (ii) health insurance issuers; 

15 (iii) providers of mental health and 

16 substance use disorder treatment; 

17 (iv) employers; and 

18 (v) patients or their advocates. 

19 (b) ACTION PLAN.—Not later than 6 months after the 

20 conclusion of the public meeting under subsection (a), the 

21 Secretary of Health and Human Services shall finalize the 

22 action plan described in such subsection and make it plain23 ly available on the Internet website of the Department of 

24 Health and Human Services. 
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1 (c) CONTENT.—The action plan under this section 

2 shall— 

3 (1) take into consideration the recommendations 

4 of the Mental Health and Substance Use Disorder 

5 Parity Task Force in its final report issued in Octo6 ber of 2016, and any subsequent Federal and State 

7 actions in relation to such recommendations; 

8 (2) reflect the input of the stakeholders partici9 pating in the public meeting under subsection (a); 

10 (3) identify specific strategic objectives regarding 

11 how the various Federal and State agencies charged 

12 with enforcement of mental health parity and addic13 tion equity requirements will collaborate to improve 

14 enforcement of such requirements; 

15 (4) provide a timeline for implementing the ac16 tion plan; and 

17 (5) provide specific examples of how such objec18 tives may be met, which may include— 

19 (A) providing common educational infor20 mation and documents, such as the Consumer 

21 Guide to Disclosure Rights, to patients about 

22 their rights under mental health parity and ad23 diction equity requirements; 

24 (B) facilitating the centralized collection of, 

25 monitoring of, and response to patient com-
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•HR 34 EAH 

1 plaints or inquiries relating to mental health 

2 parity and addiction equity requirements, which 

3 may be through the development and adminis4 tration of— 

5 (i) a single, toll-free telephone number; 

6 and 

7 (ii) a new parity website— 

8 (I) to help consumers find the ap9 propriate Federal or State agency to 

10 assist with their parity complaints, 

11 appeals, and other actions; and 

12 (II) that takes into consideration, 

13 but is not duplicative of, the parity 

14 beta site being tested, and released for 

15 public comment, by the Department of 

16 Health and Human Services as of the 

17 date of the enactment of this Act; 

18 (C) Federal and State law enforcement 

19 agencies entering into memoranda of under20 standing to better coordinate enforcement respon21 sibilities and information sharing— 

22 (i) including whether such agencies 

23 should make the results of enforcement ac24 tions related to mental health parity and 
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1 addiction equity requirements publicly 

2 available; and 

3 (ii) which may include State Policy 

4 Academies on Parity Implementation for 

5 State Officials and other forums to bring to6 gether national experts to provide technical 

7 assistance to teams of State officials on 

8 strategies to advance compliance with men9 tal health parity and addiction equity re10 quirements in both the commercial market, 

11 and in the Medicaid program under title 

12 XIX of the Social Security Act and the 

13 State Children’s Health Insurance Program 

14 under title XXI of such Act; and 

15 (D) recommendations to the Congress re16 garding the need for additional legal authority 

17 to improve enforcement of mental health parity 

18 and addiction equity requirements, including the 

19 need for additional legal authority to ensure that 

20 nonquantitative treatment limitations are ap21 plied, and the extent and frequency of the appli22 cations of such limitations, both to medical and 

23 surgical benefits and to mental health and sub24 stance use disorder benefits in a comparable 

25 manner. 
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1 SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PAR2 ITY IN MENTAL HEALTH AND SUBSTANCE USE 

3 DISORDER BENEFITS. 

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

5 of enactment of this Act, and annually thereafter for the 

6 subsequent 5 years, the Assistant Secretary of Labor of the 

7 Employee Benefits Security Administration, in collabora8 tion with the Administrator of the Centers for Medicare & 

9 Medicaid Services and the Secretary of the Treasury, shall 

10 submit to the Committee on Energy and Commerce of the 

11 House of Representatives and the Committee on Health, 

12 Education, Labor, and Pensions of the Senate a report sum13 marizing the results of all closed Federal investigations 

14 completed during the preceding 12-month period with find15 ings of any serious violation regarding compliance with 

16 mental health and substance use disorder coverage require17 ments under section 2726 of the Public Health Service Act 

18 (42 U.S.C. 300gg–26), section 712 of the Employee Retire19 ment Income Security Act of 1974 (29 U.S.C. 1185a), and 

20 section 9812 of the Internal Revenue Code of 1986. 

21 (b) CONTENTS.—Subject to subsection (c), a report 

22 under subsection (a) shall, with respect to investigations de23 scribed in such subsection, include each of the following: 

24 (1) The number of closed Federal investigations 

25 conducted during the covered reporting period. 
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1 (2) Each benefit classification examined by any 

2 such investigation conducted during the covered re3 porting period. 

4 (3) Each subject matter, including compliance 

5 with requirements for quantitative and nonquantita6 tive treatment limitations, of any such investigation 

7 conducted during the covered reporting period. 

8 (4) A summary of the basis of the final decision 

9 rendered for each closed investigation conducted dur10 ing the covered reporting period that resulted in a 

11 finding of a serious violation. 

12 (c) LIMITATION.—Any individually identifiable infor13 mation shall be excluded from reports under subsection (a) 

14 consistent with protections under the health privacy and 

15 security rules promulgated under section 264(c) of the 

16 Health Insurance Portability and Accountability Act of 

17 1996 (42 U.S.C. 1320d–2 note). 

18 SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH 

19 AND SUBSTANCE USE DISORDER BENEFITS. 

20 Not later than 3 years after the date of enactment of 

21 this Act, the Comptroller General of the United States, in 

22 consultation with the Secretary of Health and Human 

23 Services, the Secretary of Labor, and the Secretary of the 

24 Treasury, shall submit to the Committee on Energy and 

25 Commerce of the House of Representatives and the Com-
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1 mittee on Health, Education, Labor, and Pensions of the 

2 Senate a report detailing the extent to which group health 

3 plans or health insurance issuers offering group or indi4 vidual health insurance coverage that provides both medical 

5 and surgical benefits and mental health or substance use 

6 disorder benefits, medicaid managed care organizations 

7 with a contract under section 1903(m) of the Social Secu8 rity Act (42 U.S.C. 1396b(m)), and health plans provided 

9 under the State Children’s Health Insurance Program 

10 under title XXI of the Social Security Act (42 U.S.C. 

11 1397aa et seq.) comply with section 2726 of the Public 

12 Health Service Act (42 U.S.C. 300gg–26), section 712 of 

13 the Employee Retirement Income Security Act of 1974 (29 

14 U.S.C. 1185a), and section 9812 of the Internal Revenue 

15 Code of 1986, including— 

16 (1) how nonquantitative treatment limitations, 

17 including medical necessity criteria, of such plans or 

18 issuers comply with such sections; 

19 (2) how the responsible Federal departments and 

20 agencies ensure that such plans or issuers comply 

21 with such sections, including an assessment of how 

22 the Secretary of Health and Human Services has used 

23 its authority to conduct audits of such plans to ensure 

24 compliance; 
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1 (3) a review of how the various Federal and 

2 State agencies responsible for enforcing mental health 

3 parity requirements have improved enforcement of 

4 such requirements in accordance with the objectives 

5 and timeline described in the action plan under sec6 tion 13002; and 

7 (4) recommendations for how additional enforce8 ment, education, and coordination activities by re9 sponsible Federal and State departments and agencies 

10 could better ensure compliance with such sections, in11 cluding recommendations regarding the need for addi12 tional legal authority. 

13 SEC. 13005. INFORMATION AND AWARENESS ON EATING 

14 DISORDERS. 

15 (a) INFORMATION.—The Secretary of Health and 

16 Human Services, acting through the Director of the Office 

17 on Women’s Health, may— 

18 (1) update information, related fact sheets, and 

19 resource lists related to eating disorders that are 

20 available on the public Internet website of the Na21 tional Women’s Health Information Center sponsored 

22 by the Office on Women’s Health, to include— 

23 (A) updated findings and current research 

24 related to eating disorders, as appropriate; and 
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1 (B) information about eating disorders, in2 cluding information related to males and fe3 males; 

4 (2) incorporate, as appropriate, and in coordi5 nation with the Secretary of Education, information 

6 from publicly available resources into appropriate 

7 obesity prevention programs developed by the Office 

8 on Women’s Health; and 

9 (3) make publicly available (through a public 

10 Internet website or other method) information, related 

11 fact sheets, and resource lists, as updated under para12 graph (1), and the information incorporated into ap13 propriate obesity prevention programs under para14 graph (2). 

15 (b) AWARENESS.—The Secretary of Health and 

16 Human Services may advance public awareness on— 

17 (1) the types of eating disorders; 

18 (2) the seriousness of eating disorders, including 

19 prevalence, comorbidities, and physical and mental 

20 health consequences; 

21 (3) methods to identify, intervene, refer for treat22 ment, and prevent behaviors that may lead to the de23 velopment of eating disorders; 

24 (4) discrimination and bullying based on body 

25 size; 
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1 (5) the effects of media on self-esteem and body 

2 image; and 

3 (6) the signs and symptoms of eating disorders. 

4 SEC. 13006. EDUCATION AND TRAINING ON EATING DIS5 ORDERS. 

6 The Secretary of Health and Human Services may fa7 cilitate the identification of model programs and materials 

8 for educating and training health professionals in effective 

9 strategies to— 

10 (1) identify individuals with eating disorders; 

11 (2) provide early intervention services for indi12 viduals with eating disorders; 

13 (3) refer patients with eating disorders for ap14 propriate treatment; 

15 (4) prevent the development of eating disorders; 

16 and 

17 (5) provide appropriate treatment services for 

18 individuals with eating disorders. 

19 SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES. 

20 If a group health plan or a health insurance issuer 

21 offering group or individual health insurance coverage pro22 vides coverage for eating disorder benefits, including resi23 dential treatment, such group health plan or health insur24 ance issuer shall provide such benefits consistent with the 

25 requirements of section 2726 of the Public Health Service 
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1 Act (42 U.S.C. 300gg–26), section 712 of the Employee Re2 tirement Income Security Act of 1974 (29 U.S.C. 1185a), 

3 and section 9812 of the Internal Revenue Code of 1986. 

4 TITLE XIV—MENTAL HEALTH 

5 AND SAFE COMMUNITIES 

6 Subtitle A—Mental Health and Safe 

7 Communities 

8 SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS 

9 INTERVENTION TEAMS, MENTAL HEALTH 

10 PURPOSES. 

11 (a) EDWARD BYRNE MEMORIAL JUSTICE ASSISTANCE

12 GRANT PROGRAM.—Section 501(a)(1) of title I of the Om13 nibus Crime Control and Safe Streets Act of 1968 (42 

14 U.S.C. 3751(a)(1)) is amended by adding at the end the 

15 following: 

16 ‘‘(H) Mental health programs and related 

17 law enforcement and corrections programs, in18 cluding behavioral programs and crisis interven19 tion teams.’’. 

20 (b) COMMUNITY ORIENTED POLICING SERVICES PRO21 GRAM.—Section 1701(b) of title I of the Omnibus Crime 

22 Control and Safe Streets Act of 1968 (42 U.S.C. 3796dd(b)) 

23 is amended— 

24 (1) in paragraph (17), by striking ‘‘and’’ at the 

25 end; 
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1 (2) by redesignating paragraph (18) as para2 graph (22); 

3 (3) by inserting after paragraph (17) the fol4 lowing: 

5 ‘‘(18) to provide specialized training to law en6 forcement officers to— 

7 ‘‘(A) recognize individuals who have a men8 tal illness; and 

9 ‘‘(B) properly interact with individuals who 

10 have a mental illness, including strategies for 

11 verbal de-escalation of crises; 

12 ‘‘(19) to establish collaborative programs that en13 hance the ability of law enforcement agencies to ad14 dress the mental health, behavioral, and substance 

15 abuse problems of individuals encountered by law en16 forcement officers in the line of duty; 

17 ‘‘(20) to provide specialized training to correc18 tions officers to recognize individuals who have a 

19 mental illness; 

20 ‘‘(21) to enhance the ability of corrections officers 

21 to address the mental health of individuals under the 

22 care and custody of jails and prisons, including spe23 cialized training and strategies for verbal de-esca24 lation of crises; and’’; and 
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1 (4) in paragraph (22), as redesignated, by strik2 ing ‘‘through (17)’’ and inserting ‘‘through (21)’’. 

3 (c) MODIFICATIONS TO THE STAFFING FOR ADEQUATE

4 FIRE AND EMERGENCY RESPONSE GRANTS.—Section 

5 34(a)(1)(B) of the Federal Fire Prevention and Control Act 

6 of 1974 (15 U.S.C. 2229a(a)(1)(B)) is amended by inserting 

7 before the period at the end the following: ‘‘and to provide 

8 specialized training to paramedics, emergency medical serv9 ices workers, and other first responders to recognize individ10 uals who have mental illness and how to properly intervene 

11 with individuals with mental illness, including strategies 

12 for verbal de-escalation of crises’’. 

13 SEC. 14002. ASSISTED OUTPATIENT TREATMENT PRO14 GRAMS. 

15 (a) IN GENERAL.—Section 2201 of title I of the Omni16 bus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 

17 3796ii) is amended in paragraph (2)(B), by inserting be18 fore the semicolon the following: ‘‘, or court-ordered assisted 

19 outpatient treatment when the court has determined such 

20 treatment to be necessary’’. 

21 (b) DEFINITIONS.—Section 2202 of title I of the Omni22 bus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 

23 3796ii—1) is amended— 

24 (1) in paragraph (1), by striking ‘‘and’’ at the 

25 end; 
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1 (2) in paragraph (2), by striking the period at 

2 the end and inserting a semicolon; and 

3 (3) by adding at the end the following: 

4 ‘‘(3) the term ‘court-ordered assisted outpatient 

5 treatment’ means a program through which a court 

6 may order a treatment plan for an eligible patient 

7 that— 

8 ‘‘(A) requires such patient to obtain out9 patient mental health treatment while the pa10 tient is not currently residing in a correctional 

11 facility or inpatient treatment facility; and 

12 ‘‘(B) is designed to improve access and ad13 herence by such patient to intensive behavioral 

14 health services in order to— 

15 ‘‘(i) avert relapse, repeated hospitaliza16 tions, arrest, incarceration, suicide, prop17 erty destruction, and violent behavior; and 

18 ‘‘(ii) provide such patient with the op19 portunity to live in a less restrictive alter20 native to incarceration or involuntary hos21 pitalization; and 

22 ‘‘(4) the term ‘eligible patient’ means an adult, 

23 mentally ill person who, as determined by a court— 

24 ‘‘(A) has a history of violence, incarcer25 ation, or medically unnecessary hospitalizations; 
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1 ‘‘(B) without supervision and treatment, 

2 may be a danger to self or others in the commu3 nity; 

4 ‘‘(C) is substantially unlikely to voluntarily 

5 participate in treatment; 

6 ‘‘(D) may be unable, for reasons other than 

7 indigence, to provide for any of his or her basic 

8 needs, such as food, clothing, shelter, health, or 

9 safety; 

10 ‘‘(E) has a history of mental illness or a 

11 condition that is likely to substantially deterio12 rate if the person is not provided with timely 

13 treatment; or 

14 ‘‘(F) due to mental illness, lacks capacity to 

15 fully understand or lacks judgment to make in16 formed decisions regarding his or her need for 

17 treatment, care, or supervision.’’. 

18 SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS. 

19 (a) DEFINITIONS.—In this section— 

20 (1) the term ‘‘eligible offender’’ means a person 

21 who— 

22 (A)(i) previously or currently has been di23 agnosed by a qualified mental health professional 

24 as having a mental illness, mental retardation, 
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1 or co-occurring mental illness and substance 

2 abuse disorders; or 

3 (ii) manifests obvious signs of mental ill4 ness, mental retardation, or co-occurring mental 

5 illness and substance abuse disorders during ar6 rest or confinement or before any court; 

7 (B) comes into contact with the criminal 

8 justice system or is arrested or charged with an 

9 offense that is not— 

10 (i) a crime of violence, as defined 

11 under applicable State law or in section 

12 3156 of title 18, United States Code; or 

13 (ii) a serious drug offense, as defined 

14 in section 924(e)(2)(A) of title 18, United 

15 States Code; and 

16 (C) is determined by a judge to be eligible; 

17 and 

18 (2) the term ‘‘mental illness’’ means a 

19 diagnosable mental, behavioral, or emotional dis20 order— 

21 (A) of sufficient duration to meet diagnostic 

22 criteria within the most recent edition of the Di23 agnostic and Statistical Manual of Mental Dis24 orders published by the American Psychiatric 

25 Association; and 
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1 (B) that has resulted in functional impair2 ment that substantially interferes with or limits 

3 1 or more major life activities. 

4 (b) ESTABLISHMENT OF PROGRAM.—Not later than 1 

5 year after the date of enactment of this Act, the Attorney 

6 General shall establish a pilot program to determine the ef7 fectiveness of diverting eligible offenders from Federal pros8 ecution, Federal probation, or a Bureau of Prisons facility, 

9 and placing such eligible offenders in drug or mental health 

10 courts. 

11 (c) PROGRAM SPECIFICATIONS.—The pilot program 

12 established under subsection (b) shall involve— 

13 (1) continuing judicial supervision, including 

14 periodic review, of program participants who have a 

15 substance abuse problem or mental illness; and 

16 (2) the integrated administration of services and 

17 sanctions, which shall include— 

18 (A) mandatory periodic testing, as appro19 priate, for the use of controlled substances or 

20 other addictive substances during any period of 

21 supervised release or probation for each program 

22 participant; 

23 (B) substance abuse treatment for each pro24 gram participant who requires such services; 
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1 (C) diversion, probation, or other supervised 

2 release with the possibility of prosecution, con3 finement, or incarceration based on noncompli4 ance with program requirements or failure to 

5 show satisfactory progress toward completing 

6 program requirements; 

7 (D) programmatic offender management, 

8 including case management, and aftercare serv9 ices, such as relapse prevention, health care, edu10 cation, vocational training, job placement, hous11 ing placement, and child care or other family 

12 support services for each program participant 

13 who requires such services; 

14 (E) outpatient or inpatient mental health 

15 treatment, as ordered by the court, that carries 

16 with it the possibility of dismissal of charges or 

17 reduced sentencing upon successful completion of 

18 such treatment; 

19 (F) centralized case management, includ20 ing— 

21 (i) the consolidation of all cases, in22 cluding violations of probations, of the pro23 gram participant; and 

24 (ii) coordination of all mental health 

25 treatment plans and social services, includ-
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1 ing life skills and vocational training, hous2 ing and job placement, education, health 

3 care, and relapse prevention for each pro4 gram participant who requires such serv5 ices; and 

6 (G) continuing supervision of treatment 

7 plan compliance by the program participant for 

8 a term not to exceed the maximum allowable sen9 tence or probation period for the charged or rel10 evant offense and, to the extent practicable, con11 tinuity of psychiatric care at the end of the su12 pervised period. 

13 (d) IMPLEMENTATION; DURATION.—The pilot program 

14 established under subsection (b) shall be conducted— 

15 (1) in not less than 1 United States judicial dis16 trict, designated by the Attorney General in consulta17 tion with the Director of the Administrative Office of 

18 the United States Courts, as appropriate for the pilot 

19 program; and 

20 (2) during fiscal year 2017 through fiscal year 

21 2021. 

22 (e) CRITERIA FOR DESIGNATION.—Before making a 

23 designation under subsection (d)(1), the Attorney General 

24 shall— 
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1 (1) obtain the approval, in writing, of the 

2 United States Attorney for the United States judicial 

3 district being designated; 

4 (2) obtain the approval, in writing, of the chief 

5 judge for the United States judicial district being des6 ignated; and 

7 (3) determine that the United States judicial dis8 trict being designated has adequate behavioral health 

9 systems for treatment, including substance abuse and 

10 mental health treatment. 

11 (f) ASSISTANCE FROM OTHER FEDERAL ENTITIES.— 

12 The Administrative Office of the United States Courts and 

13 the United States Probation Offices shall provide such as14 sistance and carry out such functions as the Attorney Gen15 eral may request in monitoring, supervising, providing 

16 services to, and evaluating eligible offenders placed in a 

17 drug or mental health court under this section. 

18 (g) REPORTS.—The Attorney General, in consultation 

19 with the Director of the Administrative Office of the United 

20 States Courts, shall monitor the drug and mental health 

21 courts under this section, and shall submit a report to Con22 gress on the outcomes of the program at the end of the period 

23 described in subsection (d)(2). 
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1 SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM. 

2 Part V of title I of the Omnibus Crime Control and 

3 Safe Streets Act of 1968 (42 U.S.C. 3796ii et seq.) is 

4 amended by inserting at the end the following: 

5 ‘‘SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL 

6 SYSTEM. 

7 ‘‘(a) PRETRIAL SCREENING AND SUPERVISION.— 

8 ‘‘(1) IN GENERAL.—The Attorney General may 

9 award grants to States, units of local government, ter10 ritories, Indian Tribes, nonprofit agencies, or any 

11 combination thereof, to develop, implement, or expand 

12 pretrial services programs to improve the identifica13 tion and outcomes of individuals with mental illness. 

14 ‘‘(2) ALLOWABLE USES.—Grants awarded under 

15 this subsection may be may be used for— 

16 ‘‘(A) behavioral health needs and risk 

17 screening of defendants, including verification of 

18 interview information, mental health evaluation, 

19 and criminal history screening; 

20 ‘‘(B) assessment of risk of pretrial mis21 conduct through objective, statistically validated 

22 means, and presentation to the court of rec23 ommendations based on such assessment, includ24 ing services that will reduce the risk of pre-trial 

25 misconduct; 
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1 ‘‘(C) followup review of defendants unable 

2 to meet the conditions of pretrial release; 

3 ‘‘(D) evaluation of process and results of 

4 pre-trial service programs; 

5 ‘‘(E) supervision of defendants who are on 

6 pretrial release, including reminders to defend7 ants of scheduled court dates; 

8 ‘‘(F) reporting on process and results of pre9 trial services programs to relevant public and 

10 private mental health stakeholders; and 

11 ‘‘(G) data collection and analysis necessary 

12 to make available information required for as13 sessment of risk. 

14 ‘‘(b) BEHAVIORAL HEALTH ASSESSMENTS AND INTER15 VENTION.— 

16 ‘‘(1) IN GENERAL.—The Attorney General may 

17 award grants to States, units of local government, ter18 ritories, Indian Tribes, nonprofit agencies, or any 

19 combination thereof, to develop, implement, or expand 

20 a behavioral health screening and assessment program 

21 framework for State or local criminal justice systems. 

22 ‘‘(2) ALLOWABLE USES.—Grants awarded under 

23 this subsection may be used for— 

24 ‘‘(A) promotion of the use of validated as25 sessment tools to gauge the criminogenic risk, 
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1 substance abuse needs, and mental health needs 

2 of individuals; 

3 ‘‘(B) initiatives to match the risk factors 

4 and needs of individuals to programs and prac5 tices associated with research-based, positive out6 comes; 

7 ‘‘(C) implementing methods for identifying 

8 and treating individuals who are most likely to 

9 benefit from coordinated supervision and treat10 ment strategies, and identifying individuals who 

11 can do well with fewer interventions; and 

12 ‘‘(D) collaborative decision-making among 

13 the heads of criminal justice agencies, mental 

14 health systems, judicial systems, substance abuse 

15 systems, and other relevant systems or agencies 

16 for determining how treatment and intensive su17 pervision services should be allocated in order to 

18 maximize benefits, and developing and utilizing 

19 capacity accordingly. 

20 ‘‘(c) USE OF GRANT FUNDS.—A State, unit of local 

21 government, territory, Indian Tribe, or nonprofit agency 

22 that receives a grant under this section shall, in accordance 

23 with subsection (b)(2), use grant funds for the expenses of 

24 a treatment program, including— 
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1 ‘‘(1) salaries, personnel costs, equipment costs, 

2 and other costs directly related to the operation of the 

3 program, including costs relating to enforcement; 

4 ‘‘(2) payments for treatment providers that are 

5 approved by the State or Indian Tribe and licensed, 

6 if necessary, to provide needed treatment to program 

7 participants, including aftercare supervision, voca8 tional training, education, and job placement; and 

9 ‘‘(3) payments to public and nonprofit private 

10 entities that are approved by the State or Indian 

11 Tribe and licensed, if necessary, to provide alcohol 

12 and drug addiction treatment to offenders partici13 pating in the program. 

14 ‘‘(d) SUPPLEMENT OF NON-FEDERAL FUNDS.— 

15 ‘‘(1) IN GENERAL.—Grants awarded under this 

16 section shall be used to supplement, and not supplant, 

17 non-Federal funds that would otherwise be available 

18 for programs described in this section. 

19 ‘‘(2) FEDERAL SHARE.—The Federal share of a 

20 grant made under this section may not exceed 50 per21 cent of the total costs of the program described in an 

22 application under subsection (e). 

23 ‘‘(e) APPLICATIONS.—To request a grant under this 

24 section, a State, unit of local government, territory, Indian 

25 Tribe, or nonprofit agency shall submit an application to 
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1 the Attorney General in such form and containing such in2 formation as the Attorney General may reasonably require. 

3 ‘‘(f) GEOGRAPHIC DISTRIBUTION.—The Attorney Gen4 eral shall ensure that, to the extent practicable, the distribu5 tion of grants under this section is equitable and includes— 

6 ‘‘(1) each State; and 

7 ‘‘(2) a unit of local government, territory, In8 dian Tribe, or nonprofit agency— 

9 ‘‘(A) in each State; and 

10 ‘‘(B) in rural, suburban, Tribal, and urban 

11 jurisdictions. 

12 ‘‘(g) REPORTS AND EVALUATIONS.—For each fiscal 

13 year, each grantee under this section during that fiscal year 

14 shall submit to the Attorney General a report on the effec15 tiveness of activities carried out using such grant. Each re16 port shall include an evaluation in such form and con17 taining such information as the Attorney General may rea18 sonably require. The Attorney General shall specify the 

19 dates on which such reports shall be submitted. 

20 ‘‘(h) ACCOUNTABILITY.—Grants awarded under this 

21 section shall be subject to the following accountability provi22 sions: 

23 ‘‘(1) AUDIT REQUIREMENT.— 

24 ‘‘(A) DEFINITION.—In this paragraph, the 

25 term ‘unresolved audit finding’ means a finding 
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1 in the final audit report of the Inspector General 

2 of the Department of Justice under subpara3 graph (C) that the audited grantee has used 

4 grant funds for an unauthorized expenditure or 

5 otherwise unallowable cost that is not closed or 

6 resolved within 1 year after the date on which 

7 final audit report is issued. 

8 ‘‘(B) AUDITS.—Beginning in the first fiscal 

9 year beginning after the date of enactment of 

10 this section, and in each fiscal year thereafter, 

11 the Inspector General of the Department of Jus12 tice shall conduct audits of grantees under this 

13 section to prevent waste, fraud, and abuse of 

14 funds by grantees. The Inspector General shall 

15 determine the appropriate number of grantees to 

16 be audited each year. 

17 ‘‘(C) FINAL AUDIT REPORT.—The Inspector 

18 General of the Department of Justice shall sub19 mit to the Attorney General a final report on 

20 each audit conducted under subparagraph (B). 

21 ‘‘(D) MANDATORY EXCLUSION.—Grantees 

22 under this section about which there is an unre23 solved audit finding shall not be eligible to re24 ceive a grant under this section during the 2 fis-
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1 cal years beginning after the end of the 1-year 

2 period described in subparagraph (A). 

3 ‘‘(E) PRIORITY.—In making grants under 

4 this section, the Attorney General shall give pri5 ority to applicants that did not have an unre6 solved audit finding during the 3 fiscal years be7 fore submitting an application for a grant under 

8 this section. 

9 ‘‘(F) REIMBURSEMENT.—If an entity re10 ceives a grant under this section during the 2- 

11 fiscal-year period during which the entity is pro12 hibited from receiving grants under subpara13 graph (D), the Attorney General shall— 

14 ‘‘(i) deposit an amount equal to the 

15 amount of the grant that was improperly 

16 awarded to the grantee into the General 

17 Fund of the Treasury; and 

18 ‘‘(ii) seek to recoup the costs of the re19 payment under clause (i) from the grantee 

20 that was erroneously awarded grant funds. 

21 ‘‘(2) NONPROFIT AGENCY REQUIREMENTS.— 

22 ‘‘(A) DEFINITION.—For purposes of this 

23 paragraph and the grant program under this 

24 section, the term ‘nonprofit agency’ means an or25 ganization that is described in section 501(c)(3) 
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1 of the Internal Revenue Code of 1986 (26 U.S.C. 

2 501(c)(3)) and is exempt from taxation under 

3 section 501(a) of the Internal Revenue Code of 

4 1986 (26 U.S.C. 501(a)). 

5 ‘‘(B) PROHIBITION.—The Attorney General 

6 may not award a grant under this section to a 

7 nonprofit agency that holds money in an offshore 

8 account for the purpose of avoiding paying the 

9 tax described in section 511(a) of the Internal 

10 Revenue Code of 1986 (26 U.S.C. 511(a)). 

11 ‘‘(C) DISCLOSURE.—Each nonprofit agency 

12 that is awarded a grant under this section and 

13 uses the procedures prescribed in regulations to 

14 create a rebuttable presumption of reasonableness 

15 for the compensation of its officers, directors, 

16 trustees, and key employees, shall disclose to the 

17 Attorney General, in the application for the 

18 grant, the process for determining such com19 pensation, including the independent persons in20 volved in reviewing and approving such com21 pensation, the comparability data used, and con22 temporaneous substantiation of the deliberation 

23 and decision. Upon request, the Attorney General 

24 shall make the information disclosed under this 

25 subparagraph available for public inspection. 
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1 ‘‘(3) CONFERENCE EXPENDITURES.— 

2 ‘‘(A) LIMITATION.—Not more than $20,000 

3 of the amounts made available to the Depart4 ment of Justice to carry out this section may be 

5 used by the Attorney General, or by any indi6 vidual or entity awarded a grant under this sec7 tion to host, or make any expenditures relating 

8 to, a conference unless the Deputy Attorney Gen9 eral provides prior written authorization that 

10 the funds may be expended to host the conference 

11 or make such expenditure. 

12 ‘‘(B) WRITTEN APPROVAL.—Written ap13 proval under subparagraph (A) shall include a 

14 written estimate of all costs associated with the 

15 conference, including the cost of all food, bev16 erages, audio-visual equipment, honoraria for 

17 speakers, and entertainment. 

18 ‘‘(C) REPORT.—The Deputy Attorney Gen19 eral shall submit an annual report to the Com20 mittee on the Judiciary of the Senate and the 

21 Committee on the Judiciary of the House of Rep22 resentatives on all conference expenditures ap23 proved under this paragraph. 

24 ‘‘(4) ANNUAL CERTIFICATION.—Beginning in the 

25 first fiscal year beginning after the date of enactment 
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1 of this subsection, the Attorney General shall submit 

2 to the Committee on the Judiciary and the Committee 

3 on Appropriations of the Senate and the Committee 

4 on the Judiciary and the Committee on Appropria5 tions of the House of Representatives an annual cer6 tification— 

7 ‘‘(A) indicating whether— 

8 ‘‘(i) all final audit reports issued by 

9 the Office of the Inspector General under 

10 paragraph (1) have been completed and re11 viewed by the appropriate Assistant Attor12 ney General or Director; 

13 ‘‘(ii) all mandatory exclusions required 

14 under paragraph (1)(D) have been issued; 

15 and 

16 ‘‘(iii) any reimbursements required 

17 under paragraph (1)(F) have been made; 

18 and 

19 ‘‘(B) that includes a list of any grantees ex20 cluded under paragraph (1)(D) from the pre21 vious year. 

22 ‘‘(i) PREVENTING DUPLICATIVE GRANTS.— 

23 ‘‘(1) IN GENERAL.—Before the Attorney General 

24 awards a grant to an applicant under this section, 

25 the Attorney General shall compare the possible grant 
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1 with any other grants awarded to the applicant 

2 under this Act to determine whether the grants are for 

3 the same purpose. 

4 ‘‘(2) REPORT.—If the Attorney General awards 

5 multiple grants to the same applicant for the same 

6 purpose, the Attorney General shall submit to the 

7 Committee on the Judiciary of the Senate and the 

8 Committee on the Judiciary of the House of Rep9 resentatives a report that includes— 

10 ‘‘(A) a list of all duplicate grants awarded, 

11 including the total dollar amount of any such 

12 grants awarded; and 

13 ‘‘(B) the reason the Attorney General 

14 awarded the duplicate grants.’’. 

15 SEC. 14005. FORENSIC ASSERTIVE COMMUNITY TREATMENT 

16 INITIATIVES. 

17 Section 2991 of the Omnibus Crime Control and Safe 

18 Streets Act of 1968 (42 U.S.C. 3797aa) is amended by— 

19 (1) redesignating subsection (j) as subsection (o); 

20 and 

21 (2) inserting after subsection (i) the following: 

22 ‘‘(j) FORENSIC ASSERTIVE COMMUNITY TREATMENT

23 (FACT) INITIATIVE PROGRAM.— 

24 ‘‘(1) IN GENERAL.—The Attorney General may 

25 make grants to States, units of local government, ter-
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1 ritories, Indian Tribes, nonprofit agencies, or any 

2 combination thereof, to develop, implement, or expand 

3 Assertive Community Treatment initiatives to develop 

4 forensic assertive community treatment (referred to in 

5 this subsection as ‘FACT’) programs that provide 

6 high intensity services in the community for individ7 uals with mental illness with involvement in the 

8 criminal justice system to prevent future incarcer9 ations. 

10 ‘‘(2) ALLOWABLE USES.—Grant funds awarded 

11 under this subsection may be used for— 

12 ‘‘(A) multidisciplinary team initiatives for 

13 individuals with mental illnesses with criminal 

14 justice involvement that address criminal justice 

15 involvement as part of treatment protocols; 

16 ‘‘(B) FACT programs that involve mental 

17 health professionals, criminal justice agencies, 

18 chemical dependency specialists, nurses, psychia19 trists, vocational specialists, forensic peer spe20 cialists, forensic specialists, and dedicated ad21 ministrative support staff who work together to 

22 provide recovery oriented, 24/7 wraparound serv23 ices; 

24 ‘‘(C) services such as integrated evidence25 based practices for the treatment of co-occurring 
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1 mental health and substance-related disorders, 

2 assertive outreach and engagement, community3 based service provision at participants’ residence 

4 or in the community, psychiatric rehabilitation, 

5 recovery oriented services, services to address 

6 criminogenic risk factors, and community ten7 ure; 

8 ‘‘(D) payments for treatment providers that 

9 are approved by the State or Indian Tribe and 

10 licensed, if necessary, to provide needed treat11 ment to eligible offenders participating in the 

12 program, including behavioral health services 

13 and aftercare supervision; and 

14 ‘‘(E) training for all FACT teams to pro15 mote high-fidelity practice principles and tech16 nical assistance to support effective and con17 tinuing integration with criminal justice agency 

18 partners. 

19 ‘‘(3) SUPPLEMENT AND NOT SUPPLANT.—Grants 

20 made under this subsection shall be used to supple21 ment, and not supplant, non-Federal funds that 

22 would otherwise be available for programs described 

23 in this subsection. 

24 ‘‘(4) APPLICATIONS.—To request a grant under 

25 this subsection, a State, unit of local government, ter-
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1 ritory, Indian Tribe, or nonprofit agency shall submit 

2 an application to the Attorney General in such form 

3 and containing such information as the Attorney 

4 General may reasonably require.’’. 

5 SEC. 14006. ASSISTANCE FOR INDIVIDUALS TRANSITIONING 

6 OUT OF SYSTEMS. 

7 Section 2976(f) of title I of the Omnibus Crime Control 

8 and Safe Streets Act of 1968 (42 U.S.C. 3797w(f)) is 

9 amended— 

10 (1) in paragraph (5), by striking ‘‘and’’ at the 

11 end; 

12 (2) in paragraph (6), by striking the period at 

13 the end and inserting a semicolon; and 

14 (3) by adding at the end the following: 

15 ‘‘(7) provide mental health treatment and transi16 tional services for those with mental illnesses or with 

17 co-occurring disorders, including housing placement 

18 or assistance; and’’. 

19 SEC. 14007. CO-OCCURRING SUBSTANCE ABUSE AND MEN20 TAL HEALTH CHALLENGES IN DRUG COURTS. 

21 Part EE of title I of the Omnibus Crime Control and 

22 Safe Streets Act of 1968 (42 U.S.C. 3797u et seq.) is amend23 ed— 

24 (1) in section 2951(a)(1) (42 U.S.C. 

25 3797u(a)(1)), by inserting ‘‘, including co-occurring 
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1 substance abuse and mental health problems,’’ after 

2 ‘‘problems’’; and 

3 (2) in section 2959(a) (42 U.S.C. 3797u–8(a)), 

4 by inserting ‘‘, including training for drug court per5 sonnel and officials on identifying and addressing co6 occurring substance abuse and mental health prob7 lems’’ after ‘‘part’’. 

8 SEC. 14008. MENTAL HEALTH TRAINING FOR FEDERAL UNI9 FORMED SERVICES. 

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

11 date of enactment of this Act, the Secretary of Defense, the 

12 Secretary of Homeland Security, the Secretary of Health 

13 and Human Services, and the Secretary of Commerce shall 

14 provide the following to each of the uniformed services (as 

15 that term is defined in section 101 of title 10, United States 

16 Code) under their direction: 

17 (1) TRAINING PROGRAMS.—Programs that offer 

18 specialized and comprehensive training in procedures 

19 to identify and respond appropriately to incidents in 

20 which the unique needs of individuals with mental ill21 nesses are involved. 

22 (2) IMPROVED TECHNOLOGY.—Computerized in23 formation systems or technological improvements to 

24 provide timely information to Federal law enforce25 ment personnel, other branches of the uniformed serv-
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1 ices, and criminal justice system personnel to improve 

2 the Federal response to mentally ill individuals. 

3 (3) COOPERATIVE PROGRAMS.—The establish4 ment and expansion of cooperative efforts to promote 

5 public safety through the use of effective intervention 

6 with respect to mentally ill individuals encountered 

7 by members of the uniformed services. 

8 SEC. 14009. ADVANCING MENTAL HEALTH AS PART OF OF9 FENDER REENTRY. 

10 (a) REENTRY DEMONSTRATION PROJECTS.—Section 

11 2976(f) of title I of the Omnibus Crime Control and Safe 

12 Streets Act of 1968 (42 U.S.C. 3797w(f)), as amended by 

13 section 14006, is amended— 

14 (1) in paragraph (3)(C), by inserting ‘‘mental 

15 health services,’’ before ‘‘drug treatment’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(8) target offenders with histories of homeless18 ness, substance abuse, or mental illness, including a 

19 prerelease assessment of the housing status of the of20 fender and behavioral health needs of the offender 

21 with clear coordination with mental health, substance 

22 abuse, and homelessness services systems to achieve 

23 stable and permanent housing outcomes with appro24 priate support service.’’. 
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1 (b) MENTORING GRANTS.—Section 211(b)(2) of the 

2 Second Chance Act of 2007 (42 U.S.C. 17531(b)(2)) is 

3 amended by inserting ‘‘, including mental health care’’ after 

4 ‘‘community’’. 

5 SEC. 14010. SCHOOL MENTAL HEALTH CRISIS INTERVEN6 TION TEAMS. 

7 Section 2701(b) of title I of the Omnibus Crime Con8 trol and Safe Streets Act of 1968 (42 U.S.C. 3797a(b)) is 

9 amended— 

10 (1) by redesignating paragraphs (4) and (5) as 

11 paragraphs (5) and (6), respectively; and 

12 (2) by inserting after paragraph (3) the fol13 lowing: 

14 ‘‘(4) The development and operation of crisis 

15 intervention teams that may include coordination 

16 with law enforcement agencies and specialized train17 ing for school officials in responding to mental health 

18 crises.’’. 

19 SEC. 14011. ACTIVE-SHOOTER TRAINING FOR LAW EN20 FORCEMENT. 

21 The Attorney General, as part of the Preventing Vio22 lence Against Law Enforcement and Ensuring Officer Re23 silience and Survivability Initiative (VALOR) of the De24 partment of Justice, may provide safety training and tech-
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1 nical assistance to local law enforcement agencies, including 

2 active-shooter response training. 

3 SEC. 14012. CO-OCCURRING SUBSTANCE ABUSE AND MEN4 TAL HEALTH CHALLENGES IN RESIDENTIAL 

5 SUBSTANCE ABUSE TREATMENT PROGRAMS. 

6 Section 1901(a) of title I of the Omnibus Crime Con7 trol and Safe Streets Act of 1968 (42 U.S.C. 3796ff(a)) is 

8 amended— 

9 (1) in paragraph (1), by striking ‘‘and’’ at the 

10 end; 

11 (2) in paragraph (2), by striking the period at 

12 the end and inserting ‘‘; and’’; and 

13 (3) by adding at the end the following: 

14 ‘‘(3) developing and implementing specialized 

15 residential substance abuse treatment programs that 

16 identify and provide appropriate treatment to in17 mates with co-occurring mental health and substance 

18 abuse disorders or challenges.’’. 

19 SEC. 14013. MENTAL HEALTH AND DRUG TREATMENT AL20 TERNATIVES TO INCARCERATION PROGRAMS. 

21 Title I of the Omnibus Crime Control and Safe Streets 

22 Act of 1968 (42 U.S.C. 3711 et seq.) is amended by striking 

23 part CC and inserting the following: 
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1 ‘‘PART CC—MENTAL HEALTH AND DRUG TREAT2 MENT ALTERNATIVES TO INCARCERATION 

3 PROGRAMS 

4 ‘‘SEC. 2901. MENTAL HEALTH AND DRUG TREATMENT AL5 TERNATIVES TO INCARCERATION PROGRAMS. 

6 ‘‘(a) DEFINITIONS.—In this section— 

7 ‘‘(1) the term ‘eligible entity’ means a State, 

8 unit of local government, Indian tribe, or nonprofit 

9 organization; and 

10 ‘‘(2) the term ‘eligible participant’ means an in11 dividual who— 

12 ‘‘(A) comes into contact with the criminal 

13 justice system or is arrested or charged with an 

14 offense that is not— 

15 ‘‘(i) a crime of violence, as defined 

16 under applicable State law or in section 

17 3156 of title 18, United States Code; or 

18 ‘‘(ii) a serious drug offense, as defined 

19 in section 924(e)(2)(A) of title 18, United 

20 States Code; 

21 ‘‘(B) has a history of, or a current— 

22 ‘‘(i) substance use disorder; 

23 ‘‘(ii) mental illness; or 

24 ‘‘(iii) co-occurring mental illness and 

25 substance use disorder; and 
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1 ‘‘(C) has been approved for participation in 

2 a program funded under this section by the rel3 evant law enforcement agency, prosecuting attor4 ney, defense attorney, probation official, correc5 tions official, judge, representative of a mental 

6 health agency, or representative of a substance 

7 abuse agency, as required by law. 

8 ‘‘(b) PROGRAM AUTHORIZED.—The Attorney General 

9 may make grants to eligible entities to develop, implement, 

10 or expand a treatment alternative to incarceration program 

11 for eligible participants, including— 

12 ‘‘(1) pre-booking treatment alternative to incar13 ceration programs, including— 

14 ‘‘(A) law enforcement training on substance 

15 use disorders, mental illness, and co-occurring 

16 mental illness and substance use disorders; 

17 ‘‘(B) receiving centers as alternatives to in18 carceration of eligible participants; 

19 ‘‘(C) specialized response units for calls re20 lated to substance use disorders, mental illness, 

21 or co-occurring mental illness and substance use 

22 disorders; and 

23 ‘‘(D) other arrest and pre-booking treatment 

24 alternatives to incarceration models; or 
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1 ‘‘(2) post-booking treatment alternative to incar2 ceration programs, including— 

3 ‘‘(A) specialized clinical case management; 

4 ‘‘(B) pre-trial services related to substances 

5 use disorders, mental illness, and co-occurring 

6 mental illness and substance use disorders; 

7 ‘‘(C) prosecutor and defender based pro8 grams; 

9 ‘‘(D) specialized probation; 

10 ‘‘(E) treatment and rehabilitation pro11 grams; and 

12 ‘‘(F) problem-solving courts, including men13 tal health courts, drug courts, co-occurring men14 tal health and substance abuse courts, DWI 

15 courts, and veterans treatment courts. 

16 ‘‘(c) APPLICATION.— 

17 ‘‘(1) IN GENERAL.—An eligible entity desiring a 

18 grant under this section shall submit an application 

19 to the Attorney General— 

20 ‘‘(A) that meets the criteria under para21 graph (2); and 

22 ‘‘(B) at such time, in such manner, and ac23 companied by such information as the Attorney 

24 General may require. 
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1 ‘‘(2) CRITERIA.—An eligible entity, in submit2 ting an application under paragraph (1), shall— 

3 ‘‘(A) provide extensive evidence of collabora4 tion with State and local government agencies 

5 overseeing health, community corrections, courts, 

6 prosecution, substance abuse, mental health, vic7 tims services, and employment services, and with 

8 local law enforcement agencies; 

9 ‘‘(B) demonstrate consultation with the Sin10 gle State Authority for Substance Abuse of the 

11 State (as that term is defined in section 201(e) 

12 of the Second Chance Act of 2007); 

13 ‘‘(C) demonstrate that evidence-based treat14 ment practices will be utilized; and 

15 ‘‘(D) demonstrate that evidence-based 

16 screening and assessment tools will be used to 

17 place participants in the treatment alternative 

18 to incarceration program. 

19 ‘‘(d) REQUIREMENTS.—Each eligible entity awarded a 

20 grant for a treatment alternative to incarceration program 

21 under this section shall— 

22 ‘‘(1) determine the terms and conditions of par23 ticipation in the program by eligible participants, 

24 taking into consideration the collateral consequences 

25 of an arrest, prosecution or criminal conviction; 
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•HR 34 EAH 

1 ‘‘(2) ensure that each substance abuse and men2 tal health treatment component is licensed and quali3 fied by the relevant jurisdiction; 

4 ‘‘(3) for programs described in subsection (b)(2), 

5 organize an enforcement unit comprised of appro6 priately trained law enforcement professionals under 

7 the supervision of the State, Tribal, or local criminal 

8 justice agency involved, the duties of which shall in9 clude— 

10 ‘‘(A) the verification of addresses and other 

11 contact information of each eligible participant 

12 who participates or desires to participate in the 

13 program; and 

14 ‘‘(B) if necessary, the location, apprehen15 sion, arrest, and return to custody of an eligible 

16 participant in the program who has absconded 

17 from the facility of a treatment provider or has 

18 otherwise significantly violated the terms and 

19 conditions of the program, consistent with Fed20 eral and State confidentiality requirements; 

21 ‘‘(4) notify the relevant criminal justice entity if 

22 any eligible participant in the program absconds 

23 from the facility of the treatment provider or other24 wise violates the terms and conditions of the program, 
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•HR 34 EAH 

1 consistent with Federal and State confidentiality re2 quirements; 

3 ‘‘(5) submit periodic reports on the progress of 

4 treatment or other measured outcomes from participa5 tion in the program of each eligible participant in the 

6 program to the relevant State, Tribal, or local crimi7 nal justice agency, including mental health courts, 

8 drug courts, co-occurring mental health and substance 

9 abuse courts, DWI courts, and veterans treatment 

10 courts; 

11 ‘‘(6) describe the evidence-based methodology and 

12 outcome measurements that will be used to evaluate 

13 the program, and specifically explain how such meas14 urements will provide valid measures of the impact of 

15 the program; and 

16 ‘‘(7) describe how the program could be broadly 

17 replicated if demonstrated to be effective. 

18 ‘‘(e) USE OF FUNDS.—An eligible entity shall use a 

19 grant received under this section for expenses of a treatment 

20 alternative to incarceration program, including— 

21 ‘‘(1) salaries, personnel costs, equipment costs, 

22 and other costs directly related to the operation of the 

23 program, including the enforcement unit; 

24 ‘‘(2) payments for treatment providers that are 

25 approved by the relevant State or Tribal jurisdiction 
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•HR 34 EAH 

1 and licensed, if necessary, to provide needed treatment 

2 to eligible offenders participating in the program, in3 cluding aftercare supervision, vocational training, 

4 education, and job placement; and 

5 ‘‘(3) payments to public and nonprofit private 

6 entities that are approved by the State or Tribal ju7 risdiction and licensed, if necessary, to provide alco8 hol and drug addiction treatment to eligible offenders 

9 participating in the program. 

10 ‘‘(f) SUPPLEMENT NOT SUPPLANT.—An eligible entity 

11 shall use Federal funds received under this section only to 

12 supplement the funds that would, in the absence of those 

13 Federal funds, be made available from other Federal and 

14 non-Federal sources for the activities described in this sec15 tion, and not to supplant those funds. The Federal share 

16 of a grant made under this section may not exceed 50 per17 cent of the total costs of the program described in an appli18 cation under subsection (d). 

19 ‘‘(g) GEOGRAPHIC DISTRIBUTION.—The Attorney Gen20 eral shall ensure that, to the extent practicable, the geo21 graphical distribution of grants under this section is equi22 table and includes a grant to an eligible entity in— 

23 ‘‘(1) each State; 

24 ‘‘(2) rural, suburban, and urban areas; and 

25 ‘‘(3) Tribal jurisdictions. 
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1 ‘‘(h) REPORTS AND EVALUATIONS.—Each fiscal year, 

2 each recipient of a grant under this section during that fis3 cal year shall submit to the Attorney General a report on 

4 the outcomes of activities carried out using that grant in 

5 such form, containing such information, and on such dates 

6 as the Attorney General shall specify. 

7 ‘‘(i) ACCOUNTABILITY.—All grants awarded by the At8 torney General under this section shall be subject to the fol9 lowing accountability provisions: 

10 ‘‘(1) AUDIT REQUIREMENT.— 

11 ‘‘(A) DEFINITION.—In this paragraph, the 

12 term ‘unresolved audit finding’ means a finding 

13 in the final audit report of the Inspector General 

14 of the Department of Justice that the audited 

15 grantee has utilized grant funds for an unau16 thorized expenditure or otherwise unallowable 

17 cost that is not closed or resolved within 12 

18 months from the date on which the final audit 

19 report is issued. 

20 ‘‘(B) AUDITS.—Beginning in the first fiscal 

21 year beginning after the date of enactment of 

22 this subsection, and in each fiscal year there23 after, the Inspector General of the Department of 

24 Justice shall conduct audits of recipients of 

25 grants under this section to prevent waste, fraud, 
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•HR 34 EAH 

1 and abuse of funds by grantees. The Inspector 

2 General shall determine the appropriate number 

3 of grantees to be audited each year. 

4 ‘‘(C) MANDATORY EXCLUSION.—A recipient 

5 of grant funds under this section that is found 

6 to have an unresolved audit finding shall not be 

7 eligible to receive grant funds under this section 

8 during the first 2 fiscal years beginning after the 

9 end of the 12-month period described in subpara10 graph (A). 

11 ‘‘(D) PRIORITY.—In awarding grants under 

12 this section, the Attorney General shall give pri13 ority to eligible applicants that did not have an 

14 unresolved audit finding during the 3 fiscal 

15 years before submitting an application for a 

16 grant under this section. 

17 ‘‘(E) REIMBURSEMENT.—If an entity is 

18 awarded grant funds under this section during 

19 the 2-fiscal-year period during which the entity 

20 is barred from receiving grants under subpara21 graph (C), the Attorney General shall— 

22 ‘‘(i) deposit an amount equal to the 

23 amount of the grant funds that were im24 properly awarded to the grantee into the 

25 General Fund of the Treasury; and 
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•HR 34 EAH 

1 ‘‘(ii) seek to recoup the costs of the re2 payment to the fund from the grant recipi3 ent that was erroneously awarded grant 

4 funds. 

5 ‘‘(2) NONPROFIT ORGANIZATION REQUIRE6 MENTS.— 

7 ‘‘(A) DEFINITION.—For purposes of this 

8 paragraph and the grant programs under this 

9 part, the term ‘nonprofit organization’ means an 

10 organization that is described in section 

11 501(c)(3) of the Internal Revenue Code of 1986 

12 and is exempt from taxation under section 

13 501(a) of such Code. 

14 ‘‘(B) PROHIBITION.—The Attorney General 

15 may not award a grant under this part to a 

16 nonprofit organization that holds money in off17 shore accounts for the purpose of avoiding pay18 ing the tax described in section 511(a) of the In19 ternal Revenue Code of 1986. 

20 ‘‘(C) DISCLOSURE.—Each nonprofit organi21 zation that is awarded a grant under this section 

22 and uses the procedures prescribed in regulations 

23 to create a rebuttable presumption of reasonable24 ness for the compensation of its officers, direc25 tors, trustees, and key employees, shall disclose to 
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•HR 34 EAH 

1 the Attorney General, in the application for the 

2 grant, the process for determining such com3 pensation, including the independent persons in4 volved in reviewing and approving such com5 pensation, the comparability data used, and con6 temporaneous substantiation of the deliberation 

7 and decision. Upon request, the Attorney General 

8 shall make the information disclosed under this 

9 subparagraph available for public inspection. 

10 ‘‘(3) CONFERENCE EXPENDITURES.— 

11 ‘‘(A) LIMITATION.—No amounts made 

12 available to the Department of Justice under this 

13 section may be used by the Attorney General, or 

14 by any individual or entity awarded discre15 tionary funds through a cooperative agreement 

16 under this section, to host or support any ex17 penditure for conferences that uses more than 

18 $20,000 in funds made available by the Depart19 ment of Justice, unless the head of the relevant 

20 agency or department, provides prior written 

21 authorization that the funds may be expended to 

22 host the conference. 

23 ‘‘(B) WRITTEN APPROVAL.—Written ap24 proval under subparagraph (A) shall include a 

25 written estimate of all costs associated with the 
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•HR 34 EAH 

1 conference, including the cost of all food, bev2 erages, audio-visual equipment, honoraria for 

3 speakers, and entertainment. 

4 ‘‘(C) REPORT.—The Deputy Attorney Gen5 eral shall submit an annual report to the Com6 mittee on the Judiciary of the Senate and the 

7 Committee on the Judiciary of the House of Rep8 resentatives on all conference expenditures ap9 proved under this paragraph. 

10 ‘‘(4) ANNUAL CERTIFICATION.—Beginning in the 

11 first fiscal year beginning after the date of enactment 

12 of this subsection, the Attorney General shall submit, 

13 to the Committee on the Judiciary and the Committee 

14 on Appropriations of the Senate and the Committee 

15 on the Judiciary and the Committee on Appropria16 tions of the House of Representatives, an annual cer17 tification— 

18 ‘‘(A) indicating whether— 

19 ‘‘(i) all audits issued by the Office of 

20 the Inspector General under paragraph (1) 

21 have been completed and reviewed by the 

22 appropriate Assistant Attorney General or 

23 Director; 
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1 ‘‘(ii) all mandatory exclusions required 

2 under paragraph (1)(C) have been issued; 

3 and 

4 ‘‘(iii) all reimbursements required 

5 under paragraph (1)(E) have been made; 

6 and 

7 ‘‘(B) that includes a list of any grant re8 cipients excluded under paragraph (1) from the 

9 previous year. 

10 ‘‘(5) PREVENTING DUPLICATIVE GRANTS.— 

11 ‘‘(A) IN GENERAL.—Before the Attorney 

12 General awards a grant to an applicant under 

13 this section, the Attorney General shall compare 

14 potential grant awards with other grants award15 ed under this Act to determine if duplicate grant 

16 awards are awarded for the same purpose. 

17 ‘‘(B) REPORT.—If the Attorney General 

18 awards duplicate grants to the same applicant 

19 for the same purpose the Attorney General shall 

20 submit to the Committee on the Judiciary of the 

21 Senate and the Committee on the Judiciary of 

22 the House of Representatives a report that in23 cludes— 
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•HR 34 EAH 

1 ‘‘(i) a list of all duplicate grants 

2 awarded, including the total dollar amount 

3 of any duplicate grants awarded; and 

4 ‘‘(ii) the reason the Attorney General 

5 awarded the duplicate grants.’’. 

6 SEC. 14014. NATIONAL CRIMINAL JUSTICE AND MENTAL 

7 HEALTH TRAINING AND TECHNICAL ASSIST8 ANCE. 

9 Part HH of title I of the Omnibus Crime Control and 

10 Safe Streets Act of 1968 (42 U.S.C. 3797aa et seq.) is 

11 amended by adding at the end the following: 

12 ‘‘SEC. 2992. NATIONAL CRIMINAL JUSTICE AND MENTAL 

13 HEALTH TRAINING AND TECHNICAL ASSIST14 ANCE. 

15 ‘‘(a) AUTHORITY.—The Attorney General may make 

16 grants to eligible organizations to provide for the establish17 ment of a National Criminal Justice and Mental Health 

18 Training and Technical Assistance Center. 

19 ‘‘(b) ELIGIBLE ORGANIZATION.—For purposes of sub20 section (a), the term ‘eligible organization’ means a na21 tional nonprofit organization that provides technical assist22 ance and training to, and has special expertise and broad, 

23 national-level experience in, mental health, crisis interven24 tion, criminal justice systems, law enforcement, translating 

25 evidence into practice, training, and research, and edu-
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•HR 34 EAH 

1 cation and support of people with mental illness and the 

2 families of such individuals. 

3 ‘‘(c) USE OF FUNDS.—Any organization that receives 

4 a grant under subsection (a) shall collaborate with other 

5 grant recipients to establish and operate a National Crimi6 nal Justice and Mental Health Training and Technical As7 sistance Center to— 

8 ‘‘(1) provide law enforcement officer training re9 garding mental health and working with individuals 

10 with mental illnesses, with an emphasis on de-esca11 lation of encounters between law enforcement officers 

12 and those with mental disorders or in crisis, which 

13 shall include support the development of in-person 

14 and technical information exchanges between systems 

15 and the individuals working in those systems in sup16 port of the concepts identified in the training; 

17 ‘‘(2) provide education, training, and technical 

18 assistance for States, Indian tribes, territories, units 

19 of local government, service providers, nonprofit orga20 nizations, probation or parole officers, prosecutors, 

21 defense attorneys, emergency response providers, and 

22 corrections institutions to advance practice and 

23 knowledge relating to mental health crisis and ap24 proaches to mental health and criminal justice across 

25 systems; 
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•HR 34 EAH 

1 ‘‘(3) provide training and best practices to men2 tal health providers and criminal justice agencies re3 lating to diversion initiatives, jail and prison strate4 gies, reentry of individuals with mental illnesses into 

5 the community, and dispatch protocols and triage ca6 pabilities, including the establishment of learning 

7 sites; 

8 ‘‘(4) develop suicide prevention and crisis inter9 vention training and technical assistance for criminal 

10 justice agencies; 

11 ‘‘(5) develop a receiving center system and pilot 

12 strategy that provides, for a jurisdiction, a single 

13 point of entry into the mental health and substance 

14 abuse system for assessments and appropriate place15 ment of individuals experiencing a crisis; 

16 ‘‘(6) collect data and best practices in mental 

17 health and criminal health and criminal justice ini18 tiatives and policies from grantees under this part, 

19 other recipients of grants under this section, Federal, 

20 State, and local agencies involved in the provision of 

21 mental health services, and nongovernmental organi22 zations involved in the provision of mental health 

23 services; 

24 ‘‘(7) develop and disseminate to mental health 

25 providers and criminal justice agencies evaluation 
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•HR 34 EAH 

1 tools, mechanisms, and measures to better assess and 

2 document performance measures and outcomes relat3 ing to the provision of mental health services; 

4 ‘‘(8) disseminate information to States, units of 

5 local government, criminal justice agencies, law en6 forcement agencies, and other relevant entities about 

7 best practices, policy standards, and research findings 

8 relating to the provision of mental health services; 

9 and 

10 ‘‘(9) provide education and support to individ11 uals with mental illness involved with, or at risk of 

12 involvement with, the criminal justice system, includ13 ing the families of such individuals. 

14 ‘‘(d) ACCOUNTABILITY.—Grants awarded under this 

15 section shall be subject to the following accountability provi16 sions: 

17 ‘‘(1) AUDIT REQUIREMENT.— 

18 ‘‘(A) DEFINITION.—In this paragraph, the 

19 term ‘unresolved audit finding’ means a finding 

20 in the final audit report of the Inspector General 

21 of the Department of Justice under subpara22 graph (C) that the audited grantee has used 

23 grant funds for an unauthorized expenditure or 

24 otherwise unallowable cost that is not closed or 
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•HR 34 EAH 

1 resolved within 1 year after the date on which 

2 the final audit report is issued. 

3 ‘‘(B) AUDITS.—Beginning in the first fiscal 

4 year beginning after the date of enactment of 

5 this section, and in each fiscal year thereafter, 

6 the Inspector General of the Department of Jus7 tice shall conduct audits of grantees under this 

8 section to prevent waste, fraud, and abuse of 

9 funds by grantees. The Inspector General shall 

10 determine the appropriate number of grantees to 

11 be audited each year. 

12 ‘‘(C) FINAL AUDIT REPORT.—The Inspector 

13 General of the Department of Justice shall sub14 mit to the Attorney General a final report on 

15 each audit conducted under subparagraph (B). 

16 ‘‘(D) MANDATORY EXCLUSION.—Grantees 

17 under this section about which there is an unre18 solved audit finding shall not be eligible to re19 ceive a grant under this section during the 2 fis20 cal years beginning after the end of the 1-year 

21 period described in subparagraph (A). 

22 ‘‘(E) PRIORITY.—In making grants under 

23 this section, the Attorney General shall give pri24 ority to applicants that did not have an unre25 solved audit finding during the 3 fiscal years be-
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1 fore submitting an application for a grant under 

2 this section. 

3 ‘‘(F) REIMBURSEMENT.—If an entity re4 ceives a grant under this section during the 2- 

5 fiscal-year period during which the entity is pro6 hibited from receiving grants under subpara7 graph (D), the Attorney General shall— 

8 ‘‘(i) deposit an amount equal to the 

9 amount of the grant that was improperly 

10 awarded to the grantee into the General 

11 Fund of the Treasury; and 

12 ‘‘(ii) seek to recoup the costs of the re13 payment under clause (i) from the grantee 

14 that was erroneously awarded grant funds. 

15 ‘‘(2) NONPROFIT AGENCY REQUIREMENTS.— 

16 ‘‘(A) DEFINITION.—For purposes of this 

17 paragraph and the grant program under this 

18 section, the term ‘nonprofit agency’ means an or19 ganization that is described in section 501(c)(3) 

20 of the Internal Revenue Code of 1986 (26 U.S.C. 

21 501(c)(3)) and is exempt from taxation under 

22 section 501(a) of the Internal Revenue Code of 

23 1986 (26 U.S.C. 501(a)). 

24 ‘‘(B) PROHIBITION.—The Attorney General 

25 may not award a grant under this section to a 
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1 nonprofit agency that holds money in an offshore 

2 account for the purpose of avoiding paying the 

3 tax described in section 511(a) of the Internal 

4 Revenue Code of 1986 (26 U.S.C. 511(a)). 

5 ‘‘(C) DISCLOSURE.—Each nonprofit agency 

6 that is awarded a grant under this section and 

7 uses the procedures prescribed in regulations to 

8 create a rebuttable presumption of reasonableness 

9 for the compensation of its officers, directors, 

10 trustees, and key employees, shall disclose to the 

11 Attorney General, in the application for the 

12 grant, the process for determining such com13 pensation, including the independent persons in14 volved in reviewing and approving such com15 pensation, the comparability data used, and con16 temporaneous substantiation of the deliberation 

17 and decision. Upon request, the Attorney General 

18 shall make the information disclosed under this 

19 subparagraph available for public inspection. 

20 ‘‘(3) CONFERENCE EXPENDITURES.— 

21 ‘‘(A) LIMITATION.—No amounts made 

22 available to the Department of Justice under this 

23 section may be used by the Attorney General, or 

24 by any individual or entity awarded discre25 tionary funds through a cooperative agreement 
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•HR 34 EAH 

1 under this section, to host or support any ex2 penditure for conferences that uses more than 

3 $20,000 in funds made available by the Depart4 ment of Justice, unless the head of the relevant 

5 agency or department, provides prior written 

6 authorization that the funds may be expended to 

7 host the conference. 

8 ‘‘(B) WRITTEN APPROVAL.—Written ap9 proval under subparagraph (A) shall include a 

10 written estimate of all costs associated with the 

11 conference, including the cost of all food, bev12 erages, audio-visual equipment, honoraria for 

13 speakers, and entertainment. 

14 ‘‘(C) REPORT.—The Deputy Attorney Gen15 eral shall submit an annual report to the Com16 mittee on the Judiciary of the Senate and the 

17 Committee on the Judiciary of the House of Rep18 resentatives on all conference expenditures ap19 proved under this paragraph. 

20 ‘‘(4) ANNUAL CERTIFICATION.—Beginning in the 

21 first fiscal year beginning after the date of enactment 

22 of this subsection, the Attorney General shall submit 

23 to the Committee on the Judiciary and the Committee 

24 on Appropriations of the Senate and the Committee 

25 on the Judiciary and the Committee on Appropria-
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•HR 34 EAH 

1 tions of the House of Representatives an annual cer2 tification— 

3 ‘‘(A) indicating whether— 

4 ‘‘(i) all final audit reports issued by 

5 the Office of the Inspector General under 

6 paragraph (1) have been completed and re7 viewed by the appropriate Assistant Attor8 ney General or Director; 

9 ‘‘(ii) all mandatory exclusions required 

10 under paragraph (1)(D) have been issued; 

11 and 

12 ‘‘(iii) any reimbursements required 

13 under paragraph (1)(F) have been made; 

14 and 

15 ‘‘(B) that includes a list of any grantees ex16 cluded under paragraph (1)(D) from the pre17 vious year. 

18 ‘‘(5) PREVENTING DUPLICATIVE GRANTS.— 

19 ‘‘(A) IN GENERAL.—Before the Attorney 

20 General awards a grant to an applicant under 

21 this section, the Attorney General shall compare 

22 potential grant awards with other grants award23 ed under this Act to determine if duplicate grant 

24 awards are awarded for the same purpose. 
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1 ‘‘(B) REPORT.—If the Attorney General 

2 awards duplicate grants to the same applicant 

3 for the same purpose the Attorney General shall 

4 submit to the Committee on the Judiciary of the 

5 Senate and the Committee on the Judiciary of 

6 the House of Representatives a report that in7 cludes— 

8 ‘‘(i) a list of all duplicate grants 

9 awarded, including the total dollar amount 

10 of any duplicate grants awarded; and 

11 ‘‘(ii) the reason the Attorney General 

12 awarded the duplicate grants.’’. 

13 SEC. 14015. IMPROVING DEPARTMENT OF JUSTICE DATA 

14 COLLECTION ON MENTAL ILLNESS INVOLVED 

15 IN CRIME. 

16 (a) IN GENERAL.—Notwithstanding any other provi17 sion of law, on or after the date that is 90 days after the 

18 date on which the Attorney General promulgates regulations 

19 under subsection (b), any data prepared by, or submitted 

20 to, the Attorney General or the Director of the Federal Bu21 reau of Investigation with respect to the incidences of homi22 cides, law enforcement officers killed, seriously injured, and 

23 assaulted, or individuals killed or seriously injured by law 

24 enforcement officers shall include data with respect to the 

25 involvement of mental illness in such incidences, if any. 
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1 (b) REGULATIONS.—Not later than 90 days after the 

2 date of the enactment of this Act, the Attorney General shall 

3 promulgate or revise regulations as necessary to carry out 

4 subsection (a). 

5 SEC. 14016. REPORTS ON THE NUMBER OF MENTALLY ILL 

6 OFFENDERS IN PRISON. 

7 (a) REPORT ON THE COST OF TREATING THE MEN8 TALLY ILL IN THE CRIMINAL JUSTICE SYSTEM.—Not later 

9 than 12 months after the date of enactment of this Act, the 

10 Comptroller General of the United States shall submit to 

11 Congress a report detailing the cost of imprisonment for 

12 individuals who have serious mental illness by the Federal 

13 Government or a State or unit of local government, which 

14 shall include— 

15 (1) the number and type of crimes committed by 

16 individuals with serious mental illness each year; and 

17 (2) detail strategies or ideas for preventing 

18 crimes by those individuals with serious mental ill19 ness from occurring. 

20 (b) DEFINITION.—For purposes of this section, the At21 torney General, in consultation with the Assistant Sec22 retary of Mental Health and Substance Use Disorders, shall 

23 define ‘‘serious mental illness’’ based on the ‘‘Health Care 

24 Reform for Americans with Severe Mental Illnesses: Report’’ 
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•HR 34 EAH 

1 of the National Advisory Mental Health Council, American 

2 Journal of Psychiatry 1993; 150:1447–1465. 

3 SEC. 14017. CODIFICATION OF DUE PROCESS FOR DETER4 MINATIONS BY SECRETARY OF VETERANS AF5 FAIRS OF MENTAL CAPACITY OF BENE6 FICIARIES. 

7 (a) IN GENERAL.—Chapter 55 of title 38, United 

8 States Code, is amended by inserting after section 5501 the 

9 following new section: 

10 ‘‘§ 5501A. Beneficiaries’ rights in mental competence 

11 determinations 

12 ‘‘The Secretary may not make an adverse determina13 tion concerning the mental capacity of a beneficiary to 

14 manage monetary benefits paid to or for the beneficiary by 

15 the Secretary under this title unless such beneficiary has 

16 been provided all of the following, subject to the procedures 

17 and timelines prescribed by the Secretary for determina18 tions of incompetency: 

19 ‘‘(1) Notice of the proposed adverse determina20 tion and the supporting evidence. 

21 ‘‘(2) An opportunity to request a hearing. 

22 ‘‘(3) An opportunity to present evidence, includ23 ing an opinion from a medical professional or other 

24 person, on the capacity of the beneficiary to manage 
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•HR 34 EAH 

1 monetary benefits paid to or for the beneficiary by the 

2 Secretary under this title. 

3 ‘‘(4) An opportunity to be represented at no ex4 pense to the Government (including by counsel) at 

5 any such hearing and to bring a medical professional 

6 or other person to provide relevant testimony at any 

7 such hearing.’’. 

8 (b) CLERICAL AMENDMENT.—The table of sections at 

9 the beginning of such chapter 55 is amended by inserting 

10 after the item relating to section 5501 the following new 

11 item: 

‘‘5501A. Beneficiaries’ rights in mental competence determinations’’. 

12 (c) EFFECTIVE DATE.—Section 5501A of title 38, 

13 United States Code, as added by subsection (a), shall apply 

14 to determinations made by the Secretary of Veterans Affairs 

15 on or after the date of the enactment of this Act. 

16 SEC. 14018. REAUTHORIZATION OF APPROPRIATIONS. 

17 Subsection (o) of section 2991 of the Omnibus Crime 

18 Control and Safe Streets Act of 1968 (42 U.S.C. 3797aa), 

19 as redesignated by section 14006, is amended— 

20 (1) in paragraph (1)(C), by striking ‘‘2009 

21 through 2014’’ and inserting ‘‘2017 through 2021’’; 

22 and 

23 (2) by adding at the end the following: 

24 ‘‘(3) LIMITATION.—Not more than 20 percent of the 

25 funds authorized to be appropriated under this section may 
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1 be used for purposes described in subsection (i) (relating 

2 to veterans).’’. 

3 Subtitle B—Comprehensive Justice 

4 and Mental Health 

5 SEC. 14021. SEQUENTIAL INTERCEPT MODEL. 

6 Section 2991 of title I of the Omnibus Crime Control 

7 and Safe Streets Act of 1968 (42 U.S.C. 3797aa), as amend8 ed by section 14005, is amended by inserting after sub9 section (j), the following: 

10 ‘‘(k) SEQUENTIAL INTERCEPT GRANTS.— 

11 ‘‘(1) DEFINITION.—In this subsection, the term 

12 ‘eligible entity’ means a State, unit of local govern13 ment, Indian tribe, or tribal organization. 

14 ‘‘(2) AUTHORIZATION.—The Attorney General 

15 may make grants under this subsection to an eligible 

16 entity for sequential intercept mapping and imple17 mentation in accordance with paragraph (3). 

18 ‘‘(3) SEQUENTIAL INTERCEPT MAPPING; IMPLE19 MENTATION.—An eligible entity that receives a grant 

20 under this subsection may use funds for— 

21 ‘‘(A) sequential intercept mapping, which— 

22 ‘‘(i) shall consist of— 

23 ‘‘(I) convening mental health and 

24 criminal justice stakeholders to— 
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•HR 34 EAH 

1 ‘‘(aa) develop a shared un2 derstanding of the flow of justice3 involved individuals with mental 

4 illnesses through the criminal jus5 tice system; and 

6 ‘‘(bb) identify opportunities 

7 for improved collaborative re8 sponses to the risks and needs of 

9 individuals described in item 

10 (aa); and 

11 ‘‘(II) developing strategies to ad12 dress gaps in services and bring inno13 vative and effective programs to scale 

14 along multiple intercepts, including— 

15 ‘‘(aa) emergency and crisis 

16 services; 

17 ‘‘(bb) specialized police-based 

18 responses; 

19 ‘‘(cc) court hearings and dis20 position alternatives; 

21 ‘‘(dd) reentry from jails and 

22 prisons; and 

23 ‘‘(ee) community supervision, 

24 treatment and support services; 

25 and 
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•HR 34 EAH 

1 ‘‘(ii) may serve as a starting point for 

2 the development of strategic plans to achieve 

3 positive public health and safety outcomes; 

4 and 

5 ‘‘(B) implementation, which shall— 

6 ‘‘(i) be derived from the strategic plans 

7 described in subparagraph (A)(ii); and 

8 ‘‘(ii) consist of— 

9 ‘‘(I) hiring and training per10 sonnel; 

11 ‘‘(II) identifying the eligible enti12 ty’s target population; 

13 ‘‘(III) providing services and sup14 ports to reduce unnecessary penetra15 tion into the criminal justice system; 

16 ‘‘(IV) reducing recidivism; 

17 ‘‘(V) evaluating the impact of the 

18 eligible entity’s approach; and 

19 ‘‘(VI) planning for the sustain20 ability of effective interventions.’’. 

21 SEC. 14022. PRISON AND JAILS. 

22 Section 2991 of title I of the Omnibus Crime Control 

23 and Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amend24 ed by inserting after subsection (k), as added by section 

25 14021, the following: 
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•HR 34 EAH 

1 ‘‘(l) CORRECTIONAL FACILITIES.— 

2 ‘‘(1) DEFINITIONS.— 

3 ‘‘(A) CORRECTIONAL FACILITY.—The term 

4 ‘correctional facility’ means a jail, prison, or 

5 other detention facility used to house people who 

6 have been arrested, detained, held, or convicted 

7 by a criminal justice agency or a court. 

8 ‘‘(B) ELIGIBLE INMATE.—The term ‘eligible 

9 inmate’ means an individual who— 

10 ‘‘(i) is being held, detained, or incar11 cerated in a correctional facility; and 

12 ‘‘(ii) manifests obvious signs of a men13 tal illness or has been diagnosed by a quali14 fied mental health professional as having a 

15 mental illness. 

16 ‘‘(2) CORRECTIONAL FACILITY GRANTS.—The At17 torney General may award grants to applicants to 

18 enhance the capabilities of a correctional facility— 

19 ‘‘(A) to identify and screen for eligible in20 mates; 

21 ‘‘(B) to plan and provide— 

22 ‘‘(i) initial and periodic assessments of 

23 the clinical, medical, and social needs of in24 mates; and 
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•HR 34 EAH 

1 ‘‘(ii) appropriate treatment and serv2 ices that address the mental health and sub3 stance abuse needs of inmates; 

4 ‘‘(C) to develop, implement, and enhance— 

5 ‘‘(i) post-release transition plans for el6 igible inmates that, in a comprehensive 

7 manner, coordinate health, housing, med8 ical, employment, and other appropriate 

9 services and public benefits; 

10 ‘‘(ii) the availability of mental health 

11 care services and substance abuse treatment 

12 services; and 

13 ‘‘(iii) alternatives to solitary confine14 ment and segregated housing and mental 

15 health screening and treatment for inmates 

16 placed in solitary confinement or segregated 

17 housing; and 

18 ‘‘(D) to train each employee of the correc19 tional facility to identify and appropriately re20 spond to incidents involving inmates with men21 tal health or co-occurring mental health and sub22 stance abuse disorders.’’. 

23 SEC. 14023. ALLOWABLE USES. 

24 Section 2991(b)(5)(I) of title I of the Omnibus Crime 

25 Control and Safe Streets Act of 1968 (42 U.S.C. 
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1 3797aa(b)(5)(I)) is amended by adding at the end the fol2 lowing: 

3 ‘‘(v) TEAMS ADDRESSING FREQUENT

4 USERS OF CRISIS SERVICES.—Multidisci5 plinary teams that— 

6 ‘‘(I) coordinate, implement, and 

7 administer community-based crisis re8 sponses and long-term plans for fre9 quent users of crisis services; 

10 ‘‘(II) provide training on how to 

11 respond appropriately to the unique 

12 issues involving frequent users of crisis 

13 services for public service personnel, 

14 including criminal justice, mental 

15 health, substance abuse, emergency 

16 room, healthcare, law enforcement, cor17 rections, and housing personnel; 

18 ‘‘(III) develop or support alter19 natives to hospital and jail admissions 

20 for frequent users of crisis services that 

21 provide treatment, stabilization, and 

22 other appropriate supports in the least 

23 restrictive, yet appropriate, environ24 ment; and 
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•HR 34 EAH 

1 ‘‘(IV) develop protocols and sys2 tems among law enforcement, mental 

3 health, substance abuse, housing, cor4 rections, and emergency medical serv5 ice operations to provide coordinated 

6 assistance to frequent users of crisis 

7 services.’’. 

8 SEC. 14024. LAW ENFORCEMENT TRAINING. 

9 Section 2991(h) of title I of the Omnibus Crime Con10 trol and Safe Streets Act of 1968 (42 U.S.C. 3797aa(h)) 

11 is amended— 

12 (1) in paragraph (1), by adding at the end the 

13 following: 

14 ‘‘(F) ACADEMY TRAINING.—To provide sup15 port for academy curricula, law enforcement offi16 cer orientation programs, continuing education 

17 training, and other programs that teach law en18 forcement personnel how to identify and respond 

19 to incidents involving persons with mental 

20 health disorders or co-occurring mental health 

21 and substance abuse disorders.’’; and 

22 (2) by adding at the end the following: 

23 ‘‘(4) PRIORITY CONSIDERATION.—The Attorney 

24 General, in awarding grants under this subsection, 

25 shall give priority to programs that law enforcement 
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•HR 34 EAH 

1 personnel and members of the mental health and sub2 stance abuse professions develop and administer coop3 eratively.’’. 

4 SEC. 14025. FEDERAL LAW ENFORCEMENT TRAINING. 

5 Not later than 1 year after the date of enactment of 

6 this Act, the Attorney General shall provide direction and 

7 guidance for the following: 

8 (1) TRAINING PROGRAMS.—Programs that offer 

9 specialized and comprehensive training, in procedures 

10 to identify and appropriately respond to incidents in 

11 which the unique needs of individuals who have a 

12 mental illness are involved, to first responders and 

13 tactical units of— 

14 (A) Federal law enforcement agencies; and 

15 (B) other Federal criminal justice agencies 

16 such as the Bureau of Prisons, the Administra17 tive Office of the United States Courts, and other 

18 agencies that the Attorney General determines 

19 appropriate. 

20 (2) IMPROVED TECHNOLOGY.—The establishment 

21 of, or improvement of existing, computerized informa22 tion systems to provide timely information to employ23 ees of Federal law enforcement agencies, and Federal 

24 criminal justice agencies to improve the response of 
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1 such employees to situations involving individuals 

2 who have a mental illness. 

3 SEC. 14026. GAO REPORT. 

4 No later than 1 year after the date of enactment of 

5 this Act, the Comptroller General of the United States, in 

6 coordination with the Attorney General, shall submit to 

7 Congress a report on— 

8 (1) the practices that Federal first responders, 

9 tactical units, and corrections officers are trained to 

10 use in responding to individuals with mental illness; 

11 (2) procedures to identify and appropriately re12 spond to incidents in which the unique needs of indi13 viduals who have a mental illness are involved, to 

14 Federal first responders and tactical units; 

15 (3) the application of evidence-based practices in 

16 criminal justice settings to better address individuals 

17 with mental illnesses; and 

18 (4) recommendations on how the Department of 

19 Justice can expand and improve information sharing 

20 and dissemination of best practices. 

21 SEC. 14027. EVIDENCE BASED PRACTICES. 

22 Section 2991(c) of title I of the Omnibus Crime Con23 trol and Safe Streets Act of 1968 (42 U.S.C. 3797aa(c)) 

24 is amended— 
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•HR 34 EAH 

1 (1) in paragraph (3), by striking ‘‘or’’ at the 

2 end; 

3 (2) by redesignating paragraph (4) as para4 graph (6); and 

5 (3) by inserting after paragraph (3), the fol6 lowing: 

7 ‘‘(4) propose interventions that have been shown 

8 by empirical evidence to reduce recidivism; 

9 ‘‘(5) when appropriate, use validated assessment 

10 tools to target preliminarily qualified offenders with 

11 a moderate or high risk of recidivism and a need for 

12 treatment and services; or’’. 

13 SEC. 14028. TRANSPARENCY, PROGRAM ACCOUNTABILITY, 

14 AND ENHANCEMENT OF LOCAL AUTHORITY. 

15 (a) IN GENERAL.—Section 2991(a) of title I of the 

16 Omnibus Crime Control and Safe Streets Act of 1968 (42 

17 U.S.C. 3797aa(a)) is amended— 

18 (1) in paragraph (7)— 

19 (A) in the heading, by striking ‘‘MENTAL

20 ILLNESS’’ and inserting ‘‘MENTAL ILLNESS; 

21 MENTAL HEALTH DISORDER’’; and 

22 (B) by striking ‘‘term ‘mental illness’ 

23 means’’ and inserting ‘‘terms ‘mental illness’ 

24 and ‘mental health disorder’ mean’’; and 
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•HR 34 EAH 

1 (2) by striking paragraph (9) and inserting the 

2 following: 

3 ‘‘(9) PRELIMINARILY QUALIFIED OFFENDER.— 

4 ‘‘(A) IN GENERAL.—The term ‘prelimi5 narily qualified offender’ means an adult or ju6 venile accused of an offense who— 

7 ‘‘(i)(I) previously or currently has been 

8 diagnosed by a qualified mental health pro9 fessional as having a mental illness or co10 occurring mental illness and substance 

11 abuse disorders; 

12 ‘‘(II) manifests obvious signs of mental 

13 illness or co-occurring mental illness and 

14 substance abuse disorders during arrest or 

15 confinement or before any court; or 

16 ‘‘(III) in the case of a veterans treat17 ment court provided under subsection (i), 

18 has been diagnosed with, or manifests obvi19 ous signs of, mental illness or a substance 

20 abuse disorder or co-occurring mental ill21 ness and substance abuse disorder; 

22 ‘‘(ii) has been unanimously approved 

23 for participation in a program funded 

24 under this section by, when appropriate— 

25 ‘‘(I) the relevant— 
733 

•HR 34 EAH 

1 ‘‘(aa) prosecuting attorney; 

2 ‘‘(bb) defense attorney; 

3 ‘‘(cc) probation or corrections 

4 official; and 

5 ‘‘(dd) judge; and 

6 ‘‘(II) a representative from the 

7 relevant mental health agency de8 scribed in subsection (b)(5)(B)(i); 

9 ‘‘(iii) has been determined, by each 

10 person described in clause (ii) who is in11 volved in approving the adult or juvenile 

12 for participation in a program funded 

13 under this section, to not pose a risk of vio14 lence to any person in the program, or the 

15 public, if selected to participate in the pro16 gram; and 

17 ‘‘(iv) has not been charged with or con18 victed of— 

19 ‘‘(I) any sex offense (as defined in 

20 section 111 of the Sex Offender Reg21 istration and Notification Act (42 

22 U.S.C. 16911)) or any offense relating 

23 to the sexual exploitation of children; 

24 or 
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•HR 34 EAH 

1 ‘‘(II) murder or assault with in2 tent to commit murder. 

3 ‘‘(B) DETERMINATION.—In determining 

4 whether to designate a defendant as a prelimi5 narily qualified offender, the relevant pros6 ecuting attorney, defense attorney, probation or 

7 corrections official, judge, and mental health or 

8 substance abuse agency representative shall take 

9 into account— 

10 ‘‘(i) whether the participation of the 

11 defendant in the program would pose a sub12 stantial risk of violence to the community; 

13 ‘‘(ii) the criminal history of the defend14 ant and the nature and severity of the of15 fense for which the defendant is charged; 

16 ‘‘(iii) the views of any relevant victims 

17 to the offense; 

18 ‘‘(iv) the extent to which the defendant 

19 would benefit from participation in the pro20 gram; 

21 ‘‘(v) the extent to which the community 

22 would realize cost savings because of the de23 fendant’s participation in the program; and 

24 ‘‘(vi) whether the defendant satisfies 

25 the eligibility criteria for program partici-
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•HR 34 EAH 

1 pation unanimously established by the rel2 evant prosecuting attorney, defense attor3 ney, probation or corrections official, judge 

4 and mental health or substance abuse agen5 cy representative.’’. 

6 (b) TECHNICAL AND CONFORMING AMENDMENT.—Sec7 tion 2927(2) of title I of the Omnibus Crime Control and 

8 Safe Streets Act of 1968 (42 U.S.C. 3797s–6(2)) is amended 

9 by striking ‘‘has the meaning given that term in section 

10 2991(a).’’ and inserting ‘‘means an offense that— 

11 ‘‘(A) does not have as an element the use, 

12 attempted use, or threatened use of physical force 

13 against the person or property of another; or 

14 ‘‘(B) is not a felony that by its nature in15 volves a substantial risk that physical force 

16 against the person or property of another may be 

17 used in the course of committing the offense.’’. 

18 SEC. 14029. GRANT ACCOUNTABILITY. 

19 Section 2991 of title I of the Omnibus Crime Control 

20 and Safe Streets Act of 1968 (42 U.S.C. 3797aa) is amend21 ed by inserting after subsection (l), as added by section 

22 14022, the following: 

23 ‘‘(m) ACCOUNTABILITY.—All grants awarded by the 

24 Attorney General under this section shall be subject to the 

25 following accountability provisions: 
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•HR 34 EAH 

1 ‘‘(1) AUDIT REQUIREMENT.— 

2 ‘‘(A) DEFINITION.—In this paragraph, the 

3 term ‘unresolved audit finding’ means a finding 

4 in the final audit report of the Inspector General 

5 of the Department of Justice that the audited 

6 grantee has utilized grant funds for an unau7 thorized expenditure or otherwise unallowable 

8 cost that is not closed or resolved within 12 

9 months from the date when the final audit report 

10 is issued. 

11 ‘‘(B) AUDITS.—Beginning in the first fiscal 

12 year beginning after the date of enactment of 

13 this subsection, and in each fiscal year there14 after, the Inspector General of the Department of 

15 Justice shall conduct audits of recipients of 

16 grants under this section to prevent waste, fraud, 

17 and abuse of funds by grantees. The Inspector 

18 General shall determine the appropriate number 

19 of grantees to be audited each year. 

20 ‘‘(C) MANDATORY EXCLUSION.—A recipient 

21 of grant funds under this section that is found 

22 to have an unresolved audit finding shall not be 

23 eligible to receive grant funds under this section 

24 during the first 2 fiscal years beginning after the 
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•HR 34 EAH 

1 end of the 12-month period described in subpara2 graph (A). 

3 ‘‘(D) PRIORITY.—In awarding grants under 

4 this section, the Attorney General shall give pri5 ority to eligible applicants that did not have an 

6 unresolved audit finding during the 3 fiscal 

7 years before submitting an application for a 

8 grant under this section. 

9 ‘‘(E) REIMBURSEMENT.—If an entity is 

10 awarded grant funds under this section during 

11 the 2-fiscal-year period during which the entity 

12 is barred from receiving grants under subpara13 graph (C), the Attorney General shall— 

14 ‘‘(i) deposit an amount equal to the 

15 amount of the grant funds that were im16 properly awarded to the grantee into the 

17 General Fund of the Treasury; and 

18 ‘‘(ii) seek to recoup the costs of the re19 payment to the fund from the grant recipi20 ent that was erroneously awarded grant 

21 funds. 

22 ‘‘(2) NONPROFIT ORGANIZATION REQUIRE23 MENTS.— 

24 ‘‘(A) DEFINITION.—For purposes of this 

25 paragraph and the grant programs under this 
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•HR 34 EAH 

1 part, the term ‘nonprofit organization’ means an 

2 organization that is described in section 

3 501(c)(3) of the Internal Revenue Code of 1986 

4 and is exempt from taxation under section 

5 501(a) of such Code. 

6 ‘‘(B) PROHIBITION.—The Attorney General 

7 may not award a grant under this part to a 

8 nonprofit organization that holds money in off9 shore accounts for the purpose of avoiding pay10 ing the tax described in section 511(a) of the In11 ternal Revenue Code of 1986. 

12 ‘‘(C) DISCLOSURE.—Each nonprofit organi13 zation that is awarded a grant under this section 

14 and uses the procedures prescribed in regulations 

15 to create a rebuttable presumption of reasonable16 ness for the compensation of its officers, direc17 tors, trustees, and key employees, shall disclose to 

18 the Attorney General, in the application for the 

19 grant, the process for determining such com20 pensation, including the independent persons in21 volved in reviewing and approving such com22 pensation, the comparability data used, and con23 temporaneous substantiation of the deliberation 

24 and decision. Upon request, the Attorney General 
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•HR 34 EAH 

1 shall make the information disclosed under this 

2 subparagraph available for public inspection. 

3 ‘‘(3) CONFERENCE EXPENDITURES.— 

4 ‘‘(A) LIMITATION.—No amounts made 

5 available to the Department of Justice under this 

6 section may be used by the Attorney General, or 

7 by any individual or entity awarded discre8 tionary funds through a cooperative agreement 

9 under this section, to host or support any ex10 penditure for conferences that uses more than 

11 $20,000 in funds made available by the Depart12 ment of Justice, unless the head of the relevant 

13 agency or department, provides prior written 

14 authorization that the funds may be expended to 

15 host the conference. 

16 ‘‘(B) WRITTEN APPROVAL.—Written ap17 proval under subparagraph (A) shall include a 

18 written estimate of all costs associated with the 

19 conference, including the cost of all food, bev20 erages, audio-visual equipment, honoraria for 

21 speakers, and entertainment. 

22 ‘‘(C) REPORT.—The Deputy Attorney Gen23 eral shall submit an annual report to the Com24 mittee on the Judiciary of the Senate and the 

25 Committee on the Judiciary of the House of Rep-
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•HR 34 EAH 

1 resentatives on all conference expenditures ap2 proved under this paragraph. 

3 ‘‘(4) ANNUAL CERTIFICATION.—Beginning in the 

4 first fiscal year beginning after the date of enactment 

5 of this subsection, the Attorney General shall submit, 

6 to the Committee on the Judiciary and the Committee 

7 on Appropriations of the Senate and the Committee 

8 on the Judiciary and the Committee on Appropria9 tions of the House of Representatives, an annual cer10 tification— 

11 ‘‘(A) indicating whether— 

12 ‘‘(i) all audits issued by the Office of 

13 the Inspector General under paragraph (1) 

14 have been completed and reviewed by the 

15 appropriate Assistant Attorney General or 

16 Director; 

17 ‘‘(ii) all mandatory exclusions required 

18 under paragraph (1)(C) have been issued; 

19 and 

20 ‘‘(iii) all reimbursements required 

21 under paragraph (1)(E) have been made; 

22 and 

23 ‘‘(B) that includes a list of any grant re24 cipients excluded under paragraph (1) from the 

25 previous year. 
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•HR 34 EAH 

1 ‘‘(n) PREVENTING DUPLICATIVE GRANTS.— 

2 ‘‘(1) IN GENERAL.—Before the Attorney General 

3 awards a grant to an applicant under this section, 

4 the Attorney General shall compare potential grant 

5 awards with other grants awarded under this Act to 

6 determine if duplicate grant awards are awarded for 

7 the same purpose. 

8 ‘‘(2) REPORT.—If the Attorney General awards 

9 duplicate grants to the same applicant for the same 

10 purpose the Attorney General shall submit to the 

11 Committee on the Judiciary of the Senate and the 

12 Committee on the Judiciary of the House of Rep13 resentatives a report that includes— 

14 ‘‘(A) a list of all duplicate grants awarded, 

15 including the total dollar amount of any dupli16 cate grants awarded; and 

17 ‘‘(B) the reason the Attorney General 

18 awarded the duplicate grants.’’. 

19 DIVISION C—INCREASING 

20 CHOICE, ACCESS, AND QUAL21 ITY IN HEALTH CARE FOR 

22 AMERICANS 

23 SEC. 15000. SHORT TITLE. 

24 This division may be cited as the ‘‘Increasing Choice, 

25 Access, and Quality in Health Care for Americans Act’’. 
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1 TITLE XV—PROVISIONS 

2 RELATING TO MEDICARE PART A 

3 SEC. 15001. DEVELOPMENT OF MEDICARE HCPCS VERSION 

4 OF MS–DRG CODES FOR SIMILAR HOSPITAL 

5 SERVICES. 

6 Section 1886 of the Social Security Act (42 U.S.C. 

7 1395ww) is amended by adding at the end the following 

8 new subsection: 

9 ‘‘(t) RELATING SIMILAR INPATIENT AND OUTPATIENT

10 HOSPITAL SERVICES.— 

11 ‘‘(1) DEVELOPMENT OF HCPCS VERSION OF MS– 

12 DRG CODES.—Not later than January 1, 2018, the 

13 Secretary shall develop HCPCS versions for MS– 

14 DRGs that are similar to the ICD–10–PCS for such 

15 MS–DRGs such that, to the extent possible, the MS– 

16 DRG assignment shall be similar for a claim coded 

17 with the HCPCS version as an identical claim coded 

18 with a ICD–10–PCS code. 

19 ‘‘(2) COVERAGE OF SURGICAL MS–DRGS.—In 

20 carrying out paragraph (1), the Secretary shall de21 velop HCPCS versions of MS–DRG codes for not 

22 fewer than 10 surgical MS–DRGs. 

23 ‘‘(3) PUBLICATION AND DISSEMINATION OF THE

24 HCPCS VERSIONS OF MS–DRGS.— 
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1 ‘‘(A) IN GENERAL.—The Secretary shall de2 velop a HCPCS MS–DRG definitions manual 

3 and software that is similar to the definitions 

4 manual and software for ICD–10–PCS codes for 

5 such MS–DRGs. The Secretary shall post the 

6 HCPCS MS–DRG definitions manual and soft7 ware on the Internet website of the Centers for 

8 Medicare & Medicaid Services. The HCPCS 

9 MS–DRG definitions manual and software shall 

10 be in the public domain and available for use 

11 and redistribution without charge. 

12 ‘‘(B) USE OF PREVIOUS ANALYSIS DONE BY

13 MEDPAC.—In developing the HCPCS MS–DRG 

14 definitions manual and software under subpara15 graph (A), the Secretary shall consult with the 

16 Medicare Payment Advisory Commission and 

17 shall consider the analysis done by such Commis18 sion in translating outpatient surgical claims 

19 into inpatient surgical MS–DRGs in preparing 

20 chapter 7 (relating to hospital short-stay policy 

21 issues) of its ‘Medicare and the Health Care De22 livery System’ report submitted to Congress in 

23 June 2015. 

24 ‘‘(4) DEFINITION AND REFERENCE.—In this sub25 section: 
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1 ‘‘(A) HCPCS.—The term ‘HCPCS’ means, 

2 with respect to hospital items and services, the 

3 code under the Healthcare Common Procedure 

4 Coding System (HCPCS) (or a successor code) 

5 for such items and services. 

6 ‘‘(B) ICD–10–PCS.—The term ‘ICD–10– 

7 PCS’ means the International Classification of 

8 Diseases, 10th Revision, Procedure Coding Sys9 tem, and includes any subsequent revision of 

10 such International Classification of Diseases, 

11 Procedure Coding System.’’. 

12 SEC. 15002. ESTABLISHING BENEFICIARY EQUITY IN THE 

13 MEDICARE HOSPITAL READMISSION PRO14 GRAM. 

15 (a) TRANSITIONAL ADJUSTMENT FOR DUAL ELIGIBLE

16 POPULATION.—Section 1886(q)(3) of the Social Security 

17 Act (42 U.S.C. 1395ww(q)(3)) is amended— 

18 (1) in subparagraph (A), by inserting ‘‘subject to 

19 subparagraph (D),’’ after ‘‘purposes of paragraph 

20 (1),’’; and 

21 (2) by adding at the end the following new sub22 paragraph: 

23 ‘‘(D) TRANSITIONAL ADJUSTMENT FOR

24 DUAL ELIGIBLES.— 
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1 ‘‘(i) IN GENERAL.—In determining a 

2 hospital’s adjustment factor under this 

3 paragraph for purposes of making pay4 ments for discharges occurring during and 

5 after fiscal year 2019, and before the appli6 cation of clause (i) of subparagraph (E), the 

7 Secretary shall assign hospitals to groups 

8 (as defined by the Secretary under clause 

9 (ii)) and apply the applicable provisions of 

10 this subsection using a methodology in a 

11 manner that allows for separate comparison 

12 of hospitals within each such group, as de13 termined by the Secretary. 

14 ‘‘(ii) DEFINING GROUPS.—For pur15 poses of this subparagraph, the Secretary 

16 shall define groups of hospitals, based on 

17 their overall proportion, of the inpatients 

18 who are entitled to, or enrolled for, benefits 

19 under part A, and who are full-benefit dual 

20 eligible individuals (as defined in section 

21 1935(c)(6)). In defining groups, the Sec22 retary shall consult the Medicare Payment 

23 Advisory Commission and may consider the 

24 analysis done by such Commission in pre25 paring the portion of its report submitted to 
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•HR 34 EAH 

1 Congress in June 2013 relating to readmis2 sions. 

3 ‘‘(iii) MINIMIZING REPORTING BURDEN

4 ON HOSPITALS.—In carrying out this sub5 paragraph, the Secretary shall not impose 

6 any additional reporting requirements on 

7 hospitals. 

8 ‘‘(iv) BUDGET NEUTRAL DESIGN METH9 ODOLOGY.—The Secretary shall design the 

10 methodology to implement this subpara11 graph so that the estimated total amount of 

12 reductions in payments under this sub13 section equals the estimated total amount of 

14 reductions in payments that would other15 wise occur under this subsection if this sub16 paragraph did not apply.’’. 

17 (b) CHANGES IN RISK ADJUSTMENT.—Section 

18 1886(q)(3) of the Social Security Act (42 U.S.C. 

19 1395ww(q)(3)), as amended by subsection (a), is further 

20 amended by adding at the end the following new subpara21 graph: 

22 ‘‘(E) CHANGES IN RISK ADJUSTMENT.— 

23 ‘‘(i) CONSIDERATION OF RECOMMENDA24 TIONS IN IMPACT REPORTS.—The Secretary 

25 may take into account the studies conducted 
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1 and the recommendations made by the Sec2 retary under section 2(d)(1) of the IMPACT 

3 Act of 2014 (Public Law 113–185; 42 

4 U.S.C. 1395lll note) with respect to the ap5 plication under this subsection of risk ad6 justment methodologies. Nothing in this 

7 clause shall be construed as precluding con8 sideration of the use of groupings of hos9 pitals. 

10 ‘‘(ii) CONSIDERATION OF EXCLUSION

11 OF PATIENT CASES BASED ON V OR OTHER

12 APPROPRIATE CODES.—In promulgating 

13 regulations to carry out this subsection with 

14 respect to discharges occurring after fiscal 

15 year 2018, the Secretary may consider the 

16 use of V or other ICD-related codes for re17 moval of a readmission. The Secretary may 

18 consider modifying measures under this 

19 subsection to incorporate V or other ICD-re20 lated codes at the same time as other 

21 changes are being made under this subpara22 graph. 

23 ‘‘(iii) REMOVAL OF CERTAIN READMIS24 SIONS.—In promulgating regulations to 

25 carry out this subsection, with respect to 
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1 discharges occurring after fiscal year 2018, 

2 the Secretary may consider removal as a re3 admission of an admission that is classified 

4 within one or more of the following: trans5 plants, end-stage renal disease, burns, trau6 ma, psychosis, or substance abuse. The Sec7 retary may consider modifying measures 

8 under this subsection to remove readmis9 sions at the same time as other changes are 

10 being made under this subparagraph.’’. 

11 (c) MEDPAC STUDY ON READMISSIONS PROGRAM.— 

12 The Medicare Payment Advisory Commission shall conduct 

13 a study to review overall hospital readmissions described 

14 in section 1886(q)(5)(E) of the Social Security Act (42 

15 U.S.C. 1395ww(q)(5)(E)) and whether such readmissions 

16 are related to any changes in outpatient and emergency 

17 services furnished. The Commission shall submit to Con18 gress a report on such study in its report to Congress in 

19 June 2018. 

20 SEC. 15003. FIVE-YEAR EXTENSION OF THE RURAL COMMU21 NITY HOSPITAL DEMONSTRATION PROGRAM. 

22 (a) EXTENSION.—Section 410A of the Medicare Pre23 scription Drug, Improvement, and Modernization Act of 

24 2003 (Public Law 108–173; 42 U.S.C. 1395ww note) is 

25 amended— 
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1 (1) in subsection (a)(5), by striking ‘‘5-year ex2 tension period’’ and inserting ‘‘10-year extension pe3 riod’’; and 

4 (2) in subsection (g)— 

5 (A) in the subsection heading, by striking 

6 ‘‘FIVE-YEAR’’ and inserting ‘‘TEN-YEAR’’; 

7 (B) in paragraph (1), by striking ‘‘addi8 tional 5-year’’ and inserting ‘‘additional 10- 

9 year’’; 

10 (C) by striking ‘‘5-year extension period’’ 

11 and inserting ‘‘10-year extension period’’ each 

12 place it appears; 

13 (D) in paragraph (4)(B)— 

14 (i) in the matter preceding clause (i), 

15 by inserting ‘‘each 5-year period in’’ after 

16 ‘‘hospital during’’; and 

17 (ii) in clause (i), by inserting ‘‘each 

18 applicable 5-year period in’’ after ‘‘the first 

19 day of’’; and 

20 (E) by adding at the end the following new 

21 paragraphs: 

22 ‘‘(5) OTHER HOSPITALS IN DEMONSTRATION

23 PROGRAM.—During the second 5 years of the 10-year 

24 extension period, the Secretary shall apply the provi25 sions of paragraph (4) to rural community hospitals 
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•HR 34 EAH 

1 that are not described in paragraph (4) but are par2 ticipating in the demonstration program under this 

3 section as of December 30, 2014, in a similar manner 

4 as such provisions apply to rural community hos5 pitals described in paragraph (4). 

6 ‘‘(6) EXPANSION OF DEMONSTRATION PROGRAM

7 TO RURAL AREAS IN ANY STATE.— 

8 ‘‘(A) IN GENERAL.—The Secretary shall, 

9 notwithstanding subsection (a)(2) or paragraph 

10 (2) of this subsection, not later than 120 days 

11 after the date of the enactment of this paragraph, 

12 issue a solicitation for applications to select up 

13 to the maximum number of additional rural 

14 community hospitals located in any State to 

15 participate in the demonstration program under 

16 this section for the second 5 years of the 10-year 

17 extension period without exceeding the limitation 

18 under paragraph (3) of this subsection. 

19 ‘‘(B) PRIORITY.—In determining which 

20 rural community hospitals that submitted an 

21 application pursuant to the solicitation under 

22 subparagraph (A) to select for participation in 

23 the demonstration program, the Secretary— 

24 ‘‘(i) shall give priority to rural com25 munity hospitals located in one of the 20 
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•HR 34 EAH 

1 States with the lowest population densities 

2 (as determined by the Secretary using the 

3 2015 Statistical Abstract of the United 

4 States); and 

5 ‘‘(ii) may consider— 

6 ‘‘(I) closures of hospitals located 

7 in rural areas in the State in which 

8 the rural community hospital is lo9 cated during the 5-year period imme10 diately preceding the date of the enact11 ment of this paragraph; and 

12 ‘‘(II) the population density of the 

13 State in which the rural community 

14 hospital is located.’’. 

15 (b) CHANGE IN TIMING FOR REPORT.—Subsection (e) 

16 of such section 410A is amended— 

17 (1) by striking ‘‘Not later than 6 months after 

18 the completion of the demonstration program under 

19 this section’’ and inserting ‘‘Not later than August 1, 

20 2018’’; and 

21 (2) by striking ‘‘such program’’ and inserting 

22 ‘‘the demonstration program under this section’’. 

23 SEC. 15004. REGULATORY RELIEF FOR LTCHS. 

24 (a) TECHNICAL CHANGE TO THE MEDICARE LONG25 TERM CARE HOSPITAL MORATORIUM EXCEPTION.— 
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1 (1) IN GENERAL.—Section 114(d)(7) of the Medi2 care, Medicaid, and SCHIP Extension Act of 2007 

3 (42 U.S.C. 1395ww note), as amended by sections 

4 3106(b) and 10312(b) of Public Law 111–148, section 

5 1206(b)(2) of the Pathway for SGR Reform Act of 

6 2013 (division B of Public Law 113–67), and section 

7 112 of the Protecting Access to Medicare Act of 2014 

8 (Public Law 113–93), is amended by striking ‘‘The 

9 moratorium under paragraph (1)(A)’’ and inserting 

10 ‘‘Any moratorium under paragraph (1)’’. 

11 (2) EFFECTIVE DATE.—The amendment made by 

12 paragraph (1) shall take effect as if included in the 

13 enactment of section 112 of the Protecting Access to 

14 Medicare Act of 2014. 

15 (b) MODIFICATION TO MEDICARE LONG-TERM CARE

16 HOSPITAL HIGH COST OUTLIER PAYMENTS.—Section 

17 1886(m) of the Social Security Act (42 U.S.C. 1395ww(m)) 

18 is amended by adding at the end the following new para19 graph: 

20 ‘‘(7) TREATMENT OF HIGH COST OUTLIER PAY21 MENTS.— 

22 ‘‘(A) ADJUSTMENT TO THE STANDARD FED23 ERAL PAYMENT RATE FOR ESTIMATED HIGH

24 COST OUTLIER PAYMENTS.—Under the system 

25 described in paragraph (1), for fiscal years be-
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1 ginning on or after October 1, 2017, the Sec2 retary shall reduce the standard Federal pay3 ment rate as if the estimated aggregate amount 

4 of high cost outlier payments for standard Fed5 eral payment rate discharges for each such fiscal 

6 year would be equal to 8 percent of estimated ag7 gregate payments for standard Federal payment 

8 rate discharges for each such fiscal year. 

9 ‘‘(B) LIMITATION ON HIGH COST OUTLIER

10 PAYMENT AMOUNTS.—Notwithstanding subpara11 graph (A), the Secretary shall set the fixed loss 

12 amount for high cost outlier payments such that 

13 the estimated aggregate amount of high cost 

14 outlier payments made for standard Federal 

15 payment rate discharges for fiscal years begin16 ning on or after October 1, 2017, shall be equal 

17 to 99.6875 percent of 8 percent of estimated ag18 gregate payments for standard Federal payment 

19 rate discharges for each such fiscal year. 

20 ‘‘(C) WAIVER OF BUDGET NEUTRALITY.— 

21 Any reduction in payments resulting from the 

22 application of subparagraph (B) shall not be 

23 taken into account in applying any budget neu24 trality provision under such system. 
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1 ‘‘(D) NO EFFECT ON SITE NEUTRAL HIGH

2 COST OUTLIER PAYMENT RATE.—This paragraph 

3 shall not apply with respect to the computation 

4 of the applicable site neutral payment rate under 

5 paragraph (6).’’. 

6 SEC. 15005. SAVINGS FROM IPPS MACRA PAY-FOR THROUGH 

7 NOT APPLYING DOCUMENTATION AND COD8 ING ADJUSTMENTS. 

9 Section 7(b)(1)(B) of the TMA, Abstinence Education, 

10 and QI Programs Extension Act of 2007 (Public Law 110– 

11 90), as amended by section 631(b) of the American Tax12 payer Relief Act of 2012 (Public Law 112–240) and section 

13 414(1)(B)(iii) of the Medicare Access and CHIP Reauthor14 ization Act of 2015 (Public Law 114–10), is amended in 

15 clause (iii) by striking ‘‘an increase of 0.5 percentage points 

16 for discharges occurring during each of fiscal years 2018 

17 through 2023’’ and inserting ‘‘an increase of 0.4588 per18 centage points for discharges occurring during fiscal year 

19 2018 and 0.5 percentage points for discharges occurring 

20 during each of fiscal years 2019 through 2023’’. 

21 SEC. 15006. EXTENSION OF CERTAIN LTCH MEDICARE PAY22 MENT RULES. 

23 (a) 25–PERCENT PATIENT THRESHOLD PAYMENT AD24 JUSTMENT.—Section 114(c)(1)(A) of the Medicare, Med25 icaid, and SCHIP Extension Act of 2007 (42 U.S.C. 
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1 1395ww note), as amended by section 4302(a) of division 

2 B of the American Recovery and Reinvestment Act (Public 

3 Law 111–5), sections 3106(a) and 10312(a) of Public Law 

4 111–148, and section 1206(b)(1)(B) of the Pathway for 

5 SGR Reform Act of 2013 (division B of Public Law 113– 

6 67), is amended by striking ‘‘for a 9-year period’’ and in7 serting ‘‘through June 30, 2016, and for discharges occur8 ring on or after October 1, 2016, and before October 1, 

9 2017’’. 

10 (b) PAYMENT FOR HOSPITALS-WITHIN-HOSPITALS.— 

11 Section 114(c)(2) of the Medicare, Medicaid, and SCHIP 

12 Extension Act of 2007 (42 U.S.C. 1395ww note), as amend13 ed by section 4302(a) of division B of the American Recov14 ery and Reinvestment Act (Public Law 111–5), sections 

15 3106(a) and 10312(a) of Public Law 111–148, and section 

16 1206(b)(1)(A) of the Pathway for SGR Reform Act of 2013 

17 (division B of Public Law 113–67), is amended— 

18 (1) in subparagraph (A), by inserting ‘‘or any 

19 similar provision,’’ after ‘‘Regulations,’’; 

20 (2) in subparagraph (B)— 

21 (A) in clause (i), by inserting ‘‘or any simi22 lar provision,’’ after ‘‘Regulations,’’; and 

23 (B) in clause (ii), by inserting ‘‘, or any 

24 similar provision,’’ after ‘‘Regulations’’; and 
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1 (3) in subparagraph (C), by striking ‘‘for a 9- 

2 year period’’ and inserting ‘‘through June 30, 2016, 

3 and for discharges occurring on or after October 1, 

4 2016, and before October 1, 2017’’. 

5 SEC. 15007. APPLICATION OF RULES ON THE CALCULATION 

6 OF HOSPITAL LENGTH OF STAY TO ALL 

7 LTCHS. 

8 (a) IN GENERAL.—Section 1206(a)(3) of the Pathway 

9 for SGR Reform Act of 2013 (division B of Public Law 

10 113–67; 42 U.S.C. 1395ww note) is amended— 

11 (1) by striking subparagraph (B); 

12 (2) by striking ‘‘SITE NEUTRAL BASIS.—’’ and 

13 all that follows through ‘‘For discharges occurring’’ 

14 and inserting ‘‘SITE NEUTRAL BASIS.—For discharges 

15 occurring’’; 

16 (3) by striking ‘‘subject to subparagraph (B),’’; 

17 and 

18 (4) by redesignating clauses (i) and (ii) as sub19 paragraphs (A) and (B), respectively, and moving 

20 each of such subparagraphs (as so redesignated) 2 ems 

21 to the left. 

22 (b) EFFECTIVE DATE.—The amendments made by sub23 section (a) shall be effective as if included in the enactment 

24 of section 1206(a)(3) of the Pathway for SGR Reform Act 
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1 of 2013 (division B of Public Law 113–67; 42 U.S.C. 

2 1395ww note). 

3 SEC. 15008. CHANGE IN MEDICARE CLASSIFICATION FOR 

4 CERTAIN HOSPITALS. 

5 (a) IN GENERAL.—Subsection (d)(1)(B)(iv) of section 

6 1886 of the Social Security Act (42 U.S.C. 1395ww) is 

7 amended— 

8 (1) in subclause (I), by striking ‘‘or’’ at the end; 

9 (2) in subclause (II)— 

10 (A) by striking ‘‘, or’’ at the end and insert11 ing a semicolon; 

12 (B) by redesignating such subclause as 

13 clause (vi) and by moving it to immediately fol14 low clause (v); and 

15 (C) in clause (v), by striking the semicolon 

16 at the end and inserting ‘‘, or’’; and 

17 (3) by striking ‘‘(iv)(I) a hospital’’ and inserting 

18 ‘‘(iv) a hospital’’. 

19 (b) CONFORMING PAYMENT REFERENCES.—The second 

20 sentence of subsection (d)(1)(B) of such section is amend21 ed— 

22 (1) by inserting ‘‘(as in effect as of such date)’’ 

23 after ‘‘clause (iv)’’; and 

24 (2) by inserting ‘‘(or, in the case of a hospital 

25 described in clause (iv)(II), as so in effect, shall be 
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1 classified under clause (vi) on and after the effective 

2 date of such clause (vi) and for cost reporting periods 

3 beginning on or after January 1, 2015, shall not be 

4 subject to subsection (m) as of the date of such classi5 fication)’’ after ‘‘so classified’’. 

6 (c) APPLICATION.— 

7 (1) IN GENERAL.—For cost reporting periods be8 ginning on or after January 1, 2015, in the case of 

9 an applicable hospital (as defined in paragraph (3)), 

10 the following shall apply: 

11 (A) Payment for inpatient operating costs 

12 shall be made on a reasonable cost basis in the 

13 manner provided in section 412.526(c)(3) of title 

14 42, Code of Federal Regulations (as in effect on 

15 January 1, 2015) and in any subsequent modi16 fications. 

17 (B) Payment for capital costs shall be made 

18 in the manner provided by section 412.526(c)(4) 

19 of title 42, Code of Federal Regulations (as in ef20 fect on such date). 

21 (C) Claims for payment for Medicare bene22 ficiaries who are discharged on or after January 

23 1, 2017, shall be processed as claims which are 

24 paid on a reasonable cost basis as described in 
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1 section 412.526(c) of title 42, Code of Federal 

2 Regulations (as in effect on such date). 

3 (2) APPLICABLE HOSPITAL DEFINED.—In this 

4 subsection, the term ‘‘applicable hospital’’ means a 

5 hospital that is classified under clause (iv)(II) of sec6 tion 1886(d)(1)(B) of the Social Security Act (42 

7 U.S.C. 1395ww(d)(1)(B)) on the day before the date 

8 of the enactment of this Act and which is classified 

9 under clause (vi) of such section, as redesignated and 

10 moved by subsection (a), on or after such date of en11 actment. 

12 (d) CONFORMING TECHNICAL AMENDMENTS.— 

13 (1) Section 1899B(a)(2)(A)(iv) of the Social Se14 curity Act (42 U.S.C. 1395lll(a)(2)(A)(iv)) is amend15 ed by striking ‘‘1886(d)(1)(B)(iv)(II)’’ and inserting 

16 ‘‘1886(d)(1)(B)(vi)’’. 

17 (2) Section 1886(m)(5)(F) of such Act (42 

18 U.S.C. 1395ww(m)(5)(F)) is amended in each of 

19 clauses (i) and (ii) by striking ‘‘(d)(1)(B)(iv)(II)’’ 

20 and inserting ‘‘(d)(1)(B)(vi)’’. 
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1 SEC. 15009. TEMPORARY EXCEPTION TO THE APPLICATION 

2 OF THE MEDICARE LTCH SITE NEUTRAL PRO3 VISIONS FOR CERTAIN SPINAL CORD SPE4 CIALTY HOSPITALS. 

5 (a) EXCEPTION.—Section 1886(m)(6) of the Social Se6 curity Act (42 U.S.C. 1395ww(m)(6)) is amended— 

7 (1) in subparagraph (A)(i), by striking ‘‘and 

8 (E)’’ and inserting ‘‘, (E), and (F)’’; and 

9 (2) by adding at the end the following new sub10 paragraph: 

11 ‘‘(F) TEMPORARY EXCEPTION FOR CERTAIN

12 SPINAL CORD SPECIALTY HOSPITALS.—For dis13 charges in cost reporting periods beginning dur14 ing fiscal years 2018 and 2019, subparagraph 

15 (A)(i) shall not apply (and payment shall be 

16 made to a long-term care hospital without regard 

17 to this paragraph) if such discharge is from a 

18 long-term care hospital that meets each of the fol19 lowing requirements: 

20 ‘‘(i) NOT-FOR-PROFIT.—The long-term 

21 care hospital was a not-for-profit long-term 

22 care hospital on June 1, 2014, as deter23 mined by cost report data. 

24 ‘‘(ii) PRIMARILY PROVIDING TREAT25 MENT FOR CATASTROPHIC SPINAL CORD OR

26 ACQUIRED BRAIN INJURIES OR OTHER
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1 PARALYZING NEUROMUSCULAR CONDI2 TIONS.—Of the discharges in calendar year 

3 2013 from the long-term care hospital for 

4 which payment was made under this sec5 tion, at least 50 percent were classified 

6 under MS–LTCH–DRGs 28, 29, 52, 57, 

7 551, 573, and 963. 

8 ‘‘(iii) SIGNIFICANT OUT-OF-STATE AD9 MISSIONS.— 

10 ‘‘(I) IN GENERAL.—The long-term 

11 care hospital discharged inpatients (in12 cluding both individuals entitled to, or 

13 enrolled for, benefits under this title 

14 and individuals not so entitled or en15 rolled) during fiscal year 2014 who 

16 had been admitted from at least 20 of 

17 the 50 States, determined by the States 

18 of residency of such inpatients and 

19 based on such data submitted by the 

20 hospital to the Secretary as the Sec21 retary may require. 

22 ‘‘(II) IMPLEMENTATION.—Not23 withstanding any other provision of 

24 law, the Secretary may implement sub-
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1 clause (I) by program instruction or 

2 otherwise. 

3 ‘‘(III) NON-APPLICATION OF PA4 PERWORK REDUCTION ACT.—Chapter 

5 35 of title 44, United States Code, shall 

6 not apply to data collected under this 

7 clause.’’. 

8 (b) STUDY AND REPORT ON THE STATUS AND VIABIL9 ITY OF CERTAIN SPINAL CORD SPECIALTY LONG-TERM

10 CARE HOSPITALS.— 

11 (1) STUDY.—The Comptroller General of the 

12 United States shall conduct a study on long-term care 

13 hospitals described in section 1886(m)(6)(F) of the 

14 Social Security Act, as added by subsection (a). Such 

15 report shall include an analysis of the following: 

16 (A) The impact on such hospitals of the 

17 classification and facility licensure by State 

18 agencies of such hospitals. 

19 (B) The Medicare payment rates for such 

20 hospitals. 

21 (C) Data on the number and health care 

22 needs of Medicare beneficiaries who have been di23 agnosed with catastrophic spinal cord or ac24 quired brain injuries or other paralyzing neuro25 muscular conditions (as described within the dis-
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1 charge classifications specified in clause (ii) of 

2 such section) who are receiving services from 

3 such hospitals. 

4 (2) REPORT.—Not later than October 1, 2018, 

5 the Comptroller General shall submit to Congress a 

6 report on the study conducted under paragraph (1), 

7 including recommendations for such legislation and 

8 administrative action as the Comptroller General de9 termines appropriate. 

10 SEC. 15010. TEMPORARY EXTENSION TO THE APPLICATION 

11 OF THE MEDICARE LTCH SITE NEUTRAL PRO12 VISIONS FOR CERTAIN DISCHARGES WITH SE13 VERE WOUNDS. 

14 (a) IN GENERAL.—Section 1886(m)(6) of the Social 

15 Security Act (42 U.S.C. 1395ww(m)(6)), as amended by 

16 section 15009, is further amended— 

17 (1) in subparagraph (A)(i) by striking ‘‘and 

18 (F)’’ and inserting ‘‘(F), and (G)’’; 

19 (2) in subparagraph (E)(i)(I)(aa), by striking 

20 ‘‘the amendment made’’ and all that follows before the 

21 semicolon and inserting ‘‘the last sentence of sub22 section (d)(1)(B)’’; and 

23 (3) by adding at the end the following new sub24 paragraph: 
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1 ‘‘(G) ADDITIONAL TEMPORARY EXCEPTION

2 FOR CERTAIN SEVERE WOUND DISCHARGES FROM

3 CERTAIN LONG-TERM CARE HOSPITALS.— 

4 ‘‘(i) IN GENERAL.—For a discharge oc5 curring in a cost reporting period begin6 ning during fiscal year 2018, subparagraph 

7 (A)(i) shall not apply (and payment shall 

8 be made to a long-term care hospital with9 out regard to this paragraph) if such dis10 charge— 

11 ‘‘(I) is from a long-term care hos12 pital identified by the last sentence of 

13 subsection (d)(1)(B); 

14 ‘‘(II) is classified under MS– 

15 LTCH–DRG 602, 603, 539, or 540; 

16 and 

17 ‘‘(III) is with respect to an indi18 vidual treated by a long-term care hos19 pital for a severe wound. 

20 ‘‘(ii) SEVERE WOUND DEFINED.—In 

21 this subparagraph, the term ‘severe wound’ 

22 means a wound which is a stage 3 wound, 

23 stage 4 wound, unstageable wound, non24 healing surgical wound, or fistula as identi-
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1 fied in the claim from the long-term care 

2 hospital. 

3 ‘‘(iii) WOUND DEFINED.—In this sub4 paragraph, the term ‘wound’ means an in5 jury involving division of tissue or rupture 

6 of the integument or mucous membrane 

7 with exposure to the external environment.’’. 

8 (c) STUDY AND REPORT TO CONGRESS.— 

9 (1) STUDY.—The Comptroller General of the 

10 United States shall, in consultation with relevant 

11 stakeholders, conduct a study on the treatment needs 

12 of individuals entitled to benefits under part A of title 

13 XVIII of the Social Security Act or enrolled under 

14 part B of such title who require specialized wound 

15 care, and the cost, for such individuals and the Medi16 care program under such title, of treating severe 

17 wounds in rural and urban areas. Such study shall 

18 include an assessment of— 

19 (A) access of such individuals to appro20 priate levels of care for such cases; 

21 (B) the potential impact that section 

22 1886(m)(6)(A)(i) of such Act (42 U.S.C. 

23 1395ww(m)(6)(A)(i)) will have on the access, 

24 quality, and cost of care for such individuals; 

25 and 
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1 (C) how to appropriately pay for such care 

2 under the Medicare program under such title. 

3 (2) REPORT.—Not later than October 1, 2020, 

4 the Comptroller General shall submit to Congress a 

5 report on the study conducted under paragraph (1), 

6 including recommendations for such legislation and 

7 administrative action as the Comptroller General de8 termines appropriate. 

9 TITLE XVI—PROVISIONS 

10 RELATING TO MEDICARE PART B 

11 SEC. 16001. CONTINUING MEDICARE PAYMENT UNDER 

12 HOPD PROSPECTIVE PAYMENT SYSTEM FOR 

13 SERVICES FURNISHED BY MID-BUILD OFF14 CAMPUS OUTPATIENT DEPARTMENTS OF 

15 PROVIDERS. 

16 (a) IN GENERAL.—Section 1833(t)(21) of the Social 

17 Security Act (42 U.S.C. 1395l(t)(21)) is amended— 

18 (1) in subparagraph (B)— 

19 (A) in clause (i), by striking ‘‘clause (ii)’’ 

20 and inserting ‘‘the subsequent provisions of this 

21 subparagraph’’; and 

22 (B) by adding at the end the following new 

23 clauses: 

24 ‘‘(iii) DEEMED TREATMENT FOR

25 2017.—For purposes of applying clause (ii) 
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1 with respect to applicable items and services 

2 furnished during 2017, a department of a 

3 provider (as so defined) not described in 

4 such clause is deemed to be billing under 

5 this subsection with respect to covered OPD 

6 services furnished prior to November 2, 

7 2015, if the Secretary received from the pro8 vider prior to December 2, 2015, an attesta9 tion (pursuant to section 413.65(b)(3) of 

10 title 42 of the Code of Federal Regulations) 

11 that such department was a department of 

12 a provider (as so defined). 

13 ‘‘(iv) ALTERNATIVE EXCEPTION BEGIN14 NING WITH 2018.—For purposes of para15 graph (1)(B)(v) and this paragraph with 

16 respect to applicable items and services fur17 nished during 2018 or a subsequent year, 

18 the term ‘off-campus outpatient department 

19 of a provider’ also shall not include a de20 partment of a provider (as so defined) that 

21 is not described in clause (ii) if— 

22 ‘‘(I) the Secretary receives from 

23 the provider an attestation (pursuant 

24 to such section 413.65(b)(3)) not later 

25 than December 31, 2016 (or, if later, 
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1 60 days after the date of the enactment 

2 of this clause), that such department 

3 met the requirements of a department 

4 of a provider specified in section 

5 413.65 of title 42 of the Code of Fed6 eral Regulations; 

7 ‘‘(II) the provider includes such 

8 department as part of the provider on 

9 its enrollment form in accordance with 

10 the enrollment process under section 

11 1866(j); and 

12 ‘‘(III) the department met the 

13 mid-build requirement of clause (v) 

14 and the Secretary receives, not later 

15 than 60 days after the date of the en16 actment of this clause, from the chief 

17 executive officer or chief operating offi18 cer of the provider a written certifi19 cation that the department met such 

20 requirement. 

21 ‘‘(v) MID-BUILD REQUIREMENT DE22 SCRIBED.—The mid-build requirement of 

23 this clause is, with respect to a department 

24 of a provider, that before November 2, 2015, 

25 the provider had a binding written agree-
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1 ment with an outside unrelated party for 

2 the actual construction of such department. 

3 ‘‘(vii) AUDIT.—Not later than Decem4 ber 31, 2018, the Secretary shall audit the 

5 compliance with requirements of clause (iv) 

6 with respect to each department of a pro7 vider to which such clause applies. If the 

8 Secretary finds as a result of an audit 

9 under this clause that the applicable re10 quirements were not met with respect to 

11 such department, the department shall not 

12 be excluded from the term ‘off-campus out13 patient department of a provider’ under 

14 such clause. 

15 ‘‘(viii) IMPLEMENTATION.—For pur16 poses of implementing clauses (iii) through 

17 (vii): 

18 ‘‘(I) Notwithstanding any other 

19 provision of law, the Secretary may 

20 implement such clauses by program in21 struction or otherwise. 

22 ‘‘(II) Subchapter I of chapter 35 

23 of title 44, United States Code, shall 

24 not apply. 
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1 ‘‘(III) For purposes of carrying 

2 out this subparagraph with respect to 

3 clauses (iii) and (iv) (and clause (vii) 

4 insofar as it relates to clause (iv)), 

5 $10,000,000 shall be available from the 

6 Federal Supplementary Medical Insur7 ance Trust Fund under section 1841, 

8 to remain available until December 31, 

9 2018.’’; and 

10 (2) in subparagraph (E), by adding at the end 

11 the following new clause: 

12 ‘‘(iv) The determination of an audit 

13 under subparagraph (B)(vii).’’. 

14 (b) EFFECTIVE DATE.—The amendments made by this 

15 section shall be effective as if included in the enactment of 

16 section 603 of the Bipartisan Budget Act of 2015 (Public 

17 Law 114–74). 

18 SEC. 16002. TREATMENT OF CANCER HOSPITALS IN OFF19 CAMPUS OUTPATIENT DEPARTMENT OF A 

20 PROVIDER POLICY. 

21 (a) IN GENERAL.—Section 1833(t)(21)(B) of the So22 cial Security Act (42 U.S.C. 1395l(t)(21)(B)), as amended 

23 by section 16001(a), is amended— 

24 (1) by inserting after clause (v) the following 

25 new clause: 
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1 ‘‘(vi) EXCLUSION FOR CERTAIN CANCER

2 HOSPITALS.—For purposes of paragraph 

3 (1)(B)(v) and this paragraph with respect 

4 to applicable items and services furnished 

5 during 2017 or a subsequent year, the term 

6 ‘off-campus outpatient department of a pro7 vider’ also shall not include a department of 

8 a provider (as so defined) that is not de9 scribed in clause (ii) if the provider is a 

10 hospital described in section 

11 1886(d)(1)(B)(v) and— 

12 ‘‘(I) in the case of a department 

13 that met the requirements of section 

14 413.65 of title 42 of the Code of Fed15 eral Regulations after November 1, 

16 2015, and before the date of the enact17 ment of this clause, the Secretary re18 ceives from the provider an attestation 

19 that such department met such require20 ments not later than 60 days after 

21 such date of enactment; or 

22 ‘‘(II) in the case of a department 

23 that meets such requirements after such 

24 date of enactment, the Secretary re25 ceives from the provider an attestation 
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1 that such department meets such re2 quirements not later than 60 days 

3 after the date such requirements are 

4 first met with respect to such depart5 ment.’’; 

6 (2) in clause (vii), by inserting after the first 

7 sentence the following: ‘‘Not later than 2 years after 

8 the date the Secretary receives an attestation under 

9 clause (vi) relating to compliance of a department of 

10 a provider with requirements referred to in such 

11 clause, the Secretary shall audit the compliance with 

12 such requirements with respect to the department.’’; 

13 and 

14 (3) in clause (viii)(III), by adding at the end the 

15 following: ‘‘For purposes of carrying out this sub16 paragraph with respect to clause (vi) (and clause 

17 (vii) insofar as it relates to such clause), $2,000,000 

18 shall be available from the Federal Supplementary 

19 Medical Insurance Trust Fund under section 1841, to 

20 remain available until expended.’’. 

21 (b) OFFSETTING SAVINGS.—Section 1833(t)(18) of the 

22 Social Security Act (42 U.S.C. 1395l(t)(18)) is amended— 

23 (1) in subparagraph (B), by inserting ‘‘, subject 

24 to subparagraph (C),’’ after ‘‘shall’’; and 
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1 (2) by adding at the end the following new sub2 paragraph: 

3 ‘‘(C) TARGET PCR ADJUSTMENT.—In apply4 ing section 419.43(i) of title 42 of the Code of 

5 Federal Regulations to implement the appro6 priate adjustment under this paragraph for serv7 ices furnished on or after January 1, 2018, the 

8 Secretary shall use a target PCR that is 1.0 per9 centage points less than the target PCR that 

10 would otherwise apply. In addition to the per11 centage point reduction under the previous sen12 tence, the Secretary may consider making an ad13 ditional percentage point reduction to such tar14 get PCR that takes into account payment rates 

15 for applicable items and services described in 

16 paragraph (21)(C) other than for services fur17 nished by hospitals described in section 

18 1886(d)(1)(B)(v). In making any budget neu19 trality adjustments under this subsection for 

20 2018 or a subsequent year, the Secretary shall 

21 not take into account the reduced expenditures 

22 that result from the application of this subpara23 graph.’’. 

24 (c) EFFECTIVE DATE.—The amendments made by this 

25 section shall be effective as if included in the enactment of 
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1 section 603 of the Bipartisan Budget Act of 2015 (Public 

2 Law 114–74). 

3 SEC. 16003. TREATMENT OF ELIGIBLE PROFESSIONALS IN 

4 AMBULATORY SURGICAL CENTERS FOR 

5 MEANINGFUL USE AND MIPS. 

6 Section 1848(a)(7)(D) of the Social Security Act (42 

7 U.S.C. 1395w–4(a)(7)(D)) is amended— 

8 (1) by striking ‘‘HOSPITAL-BASED ELIGIBLE PRO9 FESSIONALS’’ and all that follows through ‘‘No pay10 ment’’ and inserting the following: ‘‘HOSPITAL-BASED

11 AND AMBULATORY SURGICAL CENTER-BASED ELIGI12 BLE PROFESSIONALS.— 

13 ‘‘(i) HOSPITAL-BASED.—No payment’’; 

14 and 

15 (2) by adding at the end the following new 

16 clauses: 

17 ‘‘(ii) AMBULATORY SURGICAL CENTER18 BASED.—Subject to clause (iv), no payment 

19 adjustment may be made under subpara20 graph (A) for 2017 and 2018 in the case of 

21 an eligible professional with respect to 

22 whom substantially all of the covered profes23 sional services furnished by such profes24 sional are furnished in an ambulatory sur25 gical center. 
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1 ‘‘(iii) DETERMINATION.—The deter2 mination of whether an eligible professional 

3 is an eligible professional described in 

4 clause (ii) may be made on the basis of— 

5 ‘‘(I) the site of service (as defined 

6 by the Secretary); or 

7 ‘‘(II) an attestation submitted by 

8 the eligible professional. 

9 Determinations made under subclauses (I) 

10 and (II) shall be made without regard to 

11 any employment or billing arrangement be12 tween the eligible professional and any other 

13 supplier or provider of services. 

14 ‘‘(iv) SUNSET.—Clause (ii) shall no 

15 longer apply as of the first year that begins 

16 more than 3 years after the date on which 

17 the Secretary determines, through notice 

18 and comment rulemaking, that certified 

19 EHR technology applicable to the ambula20 tory surgical center setting is available.’’. 

21 SEC. 16004. CONTINUING ACCESS TO HOSPITALS ACT OF 

22 2016. 

23 (a) EXTENSION OF ENFORCEMENT INSTRUCTION ON

24 SUPERVISION REQUIREMENTS FOR OUTPATIENT THERA25 PEUTIC SERVICES IN CRITICAL ACCESS AND SMALL RURAL
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1 HOSPITALS THROUGH 2016.—Section 1 of Public Law 

2 113–198, as amended by section 1 of Public Law 114–112, 

3 is amended— 

4 (1) in the heading, by striking ‘‘2014 AND 2015’’ 

5 and inserting ‘‘2016’’; and 

6 (2) by striking ‘‘and 2015’’ and inserting ‘‘, 

7 2015, and 2016’’. 

8 (b) REPORT.—Not later than 1 year after the date of 

9 the enactment of this Act, the Medicare Payment Advisory 

10 Commission (established under section 1805 of the Social 

11 Security Act (42 U.S.C. 1395b–6)) shall submit to Congress 

12 a report analyzing the effect of the extension of the enforce13 ment instruction under section 1 of Public Law 113–198, 

14 as amended by section 1 of Public Law 114–112 and sub15 section (a) of this section, on the access to health care by 

16 Medicare beneficiaries, on the economic impact and the im17 pact upon hospital staffing needs, and on the quality of 

18 health care furnished to such beneficiaries. 
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1 SEC. 16005. DELAY OF IMPLEMENTATION OF MEDICARE FEE 

2 SCHEDULE ADJUSTMENTS FOR WHEELCHAIR 

3 ACCESSORIES AND SEATING SYSTEMS WHEN 

4 USED IN CONJUNCTION WITH COMPLEX RE5 HABILITATION TECHNOLOGY (CRT) WHEEL6 CHAIRS. 

7 Section 2(a) of the Patient Access and Medicare Pro8 tection Act (42 U.S.C. 1305 note) is amended by striking 

9 ‘‘January 1, 2017’’ and inserting ‘‘July 1, 2017’’. 

10 SEC. 16006. ALLOWING PHYSICAL THERAPISTS TO UTILIZE 

11 LOCUM TENENS ARRANGEMENTS UNDER 

12 MEDICARE. 

13 (a) IN GENERAL.—The first sentence of section 

14 1842(b)(6) of the Social Security Act (42 U.S.C. 

15 1395u(b)(6)), as amended by section 5012, is further 

16 amended— 

17 (1) by striking ‘‘and’’ before ‘‘(I)’’; and 

18 (2) by inserting before the period at the end the 

19 following: ‘‘, and (J) in the case of outpatient phys20 ical therapy services furnished by physical therapists 

21 in a health professional shortage area (as defined in 

22 section 332(a)(1)(A) of the Public Health Service 

23 Act), a medically underserved area (as designated 

24 pursuant to section 330(b)(3)(A) of such Act), or a 

25 rural area (as defined in section 1886(d)(2)(D)), sub26 paragraph (D) of this sentence shall apply to such 
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1 services and therapists in the same manner as such 

2 subparagraph applies to physicians’ services fur3 nished by physicians’’. 

4 (b) EFFECTIVE DATE; IMPLEMENTATION.— 

5 (1) EFFECTIVE DATE.—The amendments made 

6 by subsection (a) shall apply to services furnished be7 ginning not later than six months after the date of the 

8 enactment of this Act. 

9 (2) IMPLEMENTATION.—The Secretary of Health 

10 and Human Services may implement subparagraph 

11 (J) of section 1842(b)(6) of the Social Security Act 

12 (42 U.S.C. 1395u(b)(6)), as added by subsection 

13 (a)(2), by program instruction or otherwise. 

14 SEC. 16007. EXTENSION OF THE TRANSITION TO NEW PAY15 MENT RATES FOR DURABLE MEDICAL EQUIP16 MENT UNDER THE MEDICARE PROGRAM. 

17 (a) IN GENERAL.—The Secretary of Health and 

18 Human Services shall extend the transition period de19 scribed in clause (i) of section 414.210(g)(9) of title 42, Code 

20 of Federal Regulations, from June 30, 2016, to December 

21 31, 2016 (with the full implementation described in clause 

22 (ii) of such section applying to items and services furnished 

23 with dates of service on or after January 1, 2017). 

24 (b) STUDY AND REPORT.— 

25 (1) STUDY.— 
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1 (A) IN GENERAL.—The Secretary of Health 

2 and Human Services shall conduct a study that 

3 examines the impact of applicable payment ad4 justments upon— 

5 (i) the number of suppliers of durable 

6 medical equipment that, on a date that is 

7 not before January 1, 2016, and not later 

8 than December 31, 2016, ceased to conduct 

9 business as such suppliers; and 

10 (ii) the availability of durable medical 

11 equipment, during the period beginning on 

12 January 1, 2016, and ending on December 

13 31, 2016, to individuals entitled to benefits 

14 under part A of title XVIII of the Social Se15 curity Act (42 U.S.C. 1395 et seq.) or en16 rolled under part B of such title. 

17 (B) DEFINITIONS.—For purposes of this 

18 subsection, the following definitions apply: 

19 (i) SUPPLIER; DURABLE MEDICAL

20 EQUIPMENT.—The terms ‘‘supplier’’ and 

21 ‘‘durable medical equipment’’ have the 

22 meanings given such terms by section 1861 

23 of the Social Security Act (42 U.S.C. 

24 1395x). 
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1 (ii) APPLICABLE PAYMENT ADJUST2 MENT.—The term ‘‘applicable payment ad3 justment’’ means a payment adjustment de4 scribed in section 414.210(g) of title 42, 

5 Code of Federal Regulations, that is phased 

6 in by paragraph (9)(i) of such section. For 

7 purposes of the preceding sentence, a pay8 ment adjustment that is phased in pursuant 

9 to the extension under subsection (a) shall 

10 be considered a payment adjustment that is 

11 phased in by such paragraph (9)(i). 

12 (2) REPORT.—The Secretary of Health and 

13 Human Services shall, not later than January 12, 

14 2017, submit to the Committees on Ways and Means 

15 and on Energy and Commerce of the House of Rep16 resentatives, and to the Committee on Finance of the 

17 Senate, a report on the findings of the study con18 ducted under paragraph (1). 

19 SEC. 16008. REQUIREMENTS IN DETERMINING ADJUST20 MENTS USING INFORMATION FROM COMPETI21 TIVE BIDDING PROGRAMS. 

22 (a) IN GENERAL.—Section 1834(a)(1)(G) of the Social 

23 Security Act (42 U.S.C. 1395m(a)(1)(G)) is amended by 

24 adding at the end the following new sentence: ‘‘In the case 

25 of items and services furnished on or after January 1, 2019, 
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1 in making any adjustments under clause (ii) or (iii) of sub2 paragraph (F), under subsection (h)(1)(H)(ii), or under 

3 section 1842(s)(3)(B), the Secretary shall— 

4 ‘‘(i) solicit and take into account stake5 holder input; and 

6 ‘‘(ii) take into account the highest 

7 amount bid by a winning supplier in a 

8 competitive acquisition area and a com9 parison of each of the following with respect 

10 to non-competitive acquisition areas and 

11 competitive acquisition areas: 

12 ‘‘(I) The average travel distance 

13 and cost associated with furnishing 

14 items and services in the area. 

15 ‘‘(II) The average volume of items 

16 and services furnished by suppliers in 

17 the area. 

18 ‘‘(III) The number of suppliers in 

19 the area.’’. 

20 (b) CONFORMING AMENDMENTS.—(1) Section 

21 1834(h)(1)(H)(ii) of the Social Security Act (42 U.S.C. 

22 1395m(h)(1)(H)(ii)) is amended by striking ‘‘the Sec23 retary’’ and inserting ‘‘subject to subsection (a)(1)(G), the 

24 Secretary’’. 
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1 (2) Section 1842(s)(3)(B) of the Social Security Act 

2 (42 U.S.C. 1395m(s)(3)(B)) is amended by striking ‘‘the 

3 Secretary’’ and inserting ‘‘subject to section 1834(a)(1)(G), 

4 the Secretary’’. 

5 TITLE XVII—OTHER MEDICARE 

6 PROVISIONS 

7 SEC. 17001. DELAY IN AUTHORITY TO TERMINATE CON8 TRACTS FOR MEDICARE ADVANTAGE PLANS 

9 FAILING TO ACHIEVE MINIMUM QUALITY RAT10 INGS. 

11 (a) FINDINGS.—Consistent with the studies provided 

12 under the IMPACT Act of 2014 (Public Law 113–185), it 

13 is the intent of Congress— 

14 (1) to continue to study and request input on the 

15 effects of socioeconomic status and dual-eligible popu16 lations on the Medicare Advantage STARS rating 

17 system before reforming such system with the input of 

18 stakeholders; and 

19 (2) pending the results of such studies and input, 

20 to provide for a temporary delay in authority of the 

21 Centers for Medicare & Medicaid Services (CMS) to 

22 terminate Medicare Advantage plan contracts solely 

23 on the basis of performance of plans under the 

24 STARS rating system. 
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1 (b) DELAY IN MA CONTRACT TERMINATION AUTHOR2 ITY FOR PLANS FAILING TO ACHIEVE MINIMUM QUALITY

3 RATINGS.—Section 1857(h) of the Social Security Act (42 

4 U.S.C. 1395w–27(h)) is amended by adding at the end the 

5 following new paragraph: 

6 ‘‘(3) DELAY IN CONTRACT TERMINATION AU7 THORITY FOR PLANS FAILING TO ACHIEVE MINIMUM

8 QUALITY RATING.—During the period beginning on 

9 the date of the enactment of this paragraph and 

10 through the end of plan year 2018, the Secretary may 

11 not terminate a contract under this section with re12 spect to the offering of an MA plan by a Medicare Ad13 vantage organization solely because the MA plan has 

14 failed to achieve a minimum quality rating under the 

15 5-star rating system under section 1853(o)(4).’’. 

16 SEC. 17002. REQUIREMENT FOR ENROLLMENT DATA RE17 PORTING FOR MEDICARE. 

18 Section 1874 of the Social Security Act (42 U.S.C. 

19 1395kk) is amended by adding at the end the following new 

20 subsection: 

21 ‘‘(g) REQUIREMENT FOR ENROLLMENT DATA REPORT22 ING.— 

23 ‘‘(1) IN GENERAL.—Each year (beginning with 

24 2016), the Secretary shall submit to the Committees 

25 on Ways and Means and Energy and Commerce of 
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1 the House of Representatives and the Committee on 

2 Finance of the Senate a report on Medicare enroll3 ment data (and, in the case of part A, on data on in4 dividuals receiving benefits under such part) as of a 

5 date in such year specified by the Secretary. Such 

6 data shall be presented— 

7 ‘‘(A) by Congressional district and State; 

8 and 

9 ‘‘(B) in a manner that provides for such 

10 data based on— 

11 ‘‘(i) fee-for-service enrollment (as de12 fined in paragraph (2)); 

13 ‘‘(ii) enrollment under part C (includ14 ing separate for aggregate enrollment in 

15 MA–PD plans and aggregate enrollment in 

16 MA plans that are not MA–PD plans); and 

17 ‘‘(iii) enrollment under part D. 

18 ‘‘(2) FEE-FOR-SERVICE ENROLLMENT DE19 FINED.—For purpose of paragraph (1)(B)(i), the term 

20 ‘fee-for-service enrollment’ means aggregate enrollment 

21 (including receipt of benefits other than through en22 rollment) under— 

23 ‘‘(A) part A only; 

24 ‘‘(B) part B only; and 

25 ‘‘(C) both part A and part B.’’. 
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1 SEC. 17003. UPDATING THE WELCOME TO MEDICARE PACK2 AGE. 

3 (a) IN GENERAL.—Not later than 12 months after the 

4 last day of the period for the request of information de5 scribed in subsection (b), the Secretary of Health and 

6 Human Services shall, taking into consideration informa7 tion collected pursuant to subsection (b), update the infor8 mation included in the Welcome to Medicare package to in9 clude information, presented in a clear and simple manner, 

10 about options for receiving benefits under the Medicare pro11 gram under title XVIII of the Social Security Act (42 

12 U.S.C. 1395 et seq.), including through the original medi13 care fee-for-service program under parts A and B of such 

14 title (42 U.S.C. 1395c et seq., 42 U.S.C. 1395j et seq.), Medi15 care Advantage plans under part C of such title (42 U.S.C. 

16 1395w–21 et seq.), and prescription drug plans under part 

17 D of such title (42 U.S.C. 1395w–101 et seq.)). The Sec18 retary shall make subsequent updates to the information in19 cluded in the Welcome to Medicare package as appropriate. 

20 (b) REQUEST FOR INFORMATION.—Not later than 6 

21 months after the date of the enactment of this Act, the Sec22 retary of Health and Human Services shall request infor23 mation, including recommendations, from stakeholders (in24 cluding patient advocates, issuers, and employers) on infor25 mation included in the Welcome to Medicare package, in-
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1 cluding pertinent data and information regarding enroll2 ment and coverage for Medicare eligible individuals. 

3 SEC. 17004. NO PAYMENT FOR ITEMS AND SERVICES FUR4 NISHED BY NEWLY ENROLLED PROVIDERS OR 

5 SUPPLIERS WITHIN A TEMPORARY MORATO6 RIUM AREA. 

7 (a) MEDICARE.—Section 1866(j)(7) of the Social Secu8 rity Act (42 U.S.C. 1395cc(j)(7)) is amended— 

9 (1) in the paragraph heading, by inserting ‘‘; 

10 NONPAYMENT’’ before the period; and 

11 (2) by adding at the end the following new sub12 paragraph: 

13 ‘‘(C) NONPAYMENT.— 

14 ‘‘(i) IN GENERAL.—No payment may 

15 be made under this title or under a pro16 gram described in subparagraph (A) with 

17 respect to an item or service described in 

18 clause (ii) furnished on or after October 1, 

19 2017. 

20 ‘‘(ii) ITEM OR SERVICE DESCRIBED.— 

21 An item or service described in this clause 

22 is an item or service furnished— 

23 ‘‘(I) within a geographic area 

24 with respect to which a temporary 
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1 moratorium imposed under subpara2 graph (A) is in effect; and 

3 ‘‘(II) by a provider of services or 

4 supplier that meets the requirements of 

5 clause (iii). 

6 ‘‘(iii) REQUIREMENTS.—For purposes 

7 of clause (ii), the requirements of this clause 

8 are that a provider of services or supplier— 

9 ‘‘(I) enrolls under this title on or 

10 after the effective date of such tem11 porary moratorium; and 

12 ‘‘(II) is within a category of pro13 viders of services and suppliers (as de14 scribed in subparagraph (A)) subject to 

15 such temporary moratorium. 

16 ‘‘(iv) PROHIBITION ON CHARGES FOR

17 SPECIFIED ITEMS OR SERVICES.—In no case 

18 shall a provider of services or supplier de19 scribed in clause (ii)(II) charge an indi20 vidual or other person for an item or service 

21 described in clause (ii) furnished on or after 

22 October 1, 2017, to an individual entitled to 

23 benefits under part A or enrolled under part 

24 B or an individual under a program speci25 fied in subparagraph (A).’’. 
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1 (b) CONFORMING AMENDMENTS.— 

2 (1) MEDICAID.— 

3 (A) IN GENERAL.—Section 1903(i)(2) of the 

4 Social Security Act (42 U.S.C. 1396b(i)(2)), as 

5 amended by section 5005(a)(4), is further 

6 amended— 

7 (i) in subparagraph (C), by striking 

8 ‘‘or’’ at the end; and 

9 (ii) by adding at the end the following 

10 new subparagraph: 

11 ‘‘(E) with respect to any amount expended 

12 for such an item or service furnished during cal13 endar quarters beginning on or after October 1, 

14 2017, subject to section 1902(kk)(4)(A)(ii)(II), 

15 within a geographic area that is subject to a 

16 moratorium imposed under section 1866(j)(7) by 

17 a provider or supplier that meets the require18 ments specified in subparagraph (C)(iii) of such 

19 section, during the period of such moratorium; 

20 or’’. 

21 (B) EXCEPTION WITH RESPECT TO AC22 CESS.—Section 1902(kk)(4)(A)(ii) of the Social 

23 Security Act (42 U.S.C. 1396a(kk)(4)(A)(ii)) is 

24 amended to read as follows: 

25 ‘‘(ii) EXCEPTIONS.— 
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1 ‘‘(I) COMPLIANCE WITH MORATO2 RIUM.—A State shall not be required 

3 to comply with a temporary morato4 rium described in clause (i) if the 

5 State determines that the imposition of 

6 such temporary moratorium would ad7 versely impact beneficiaries’ access to 

8 medical assistance. 

9 ‘‘(II) FFP AVAILABLE.—Notwith10 standing section 1903(i)(2)(E), pay11 ment may be made to a State under 

12 this title with respect to amounts ex13 pended for items and services described 

14 in such section if the Secretary, in con15 sultation with the State agency admin16 istering the State plan under this title 

17 (or a waiver of the plan), determines 

18 that denying payment to the State 

19 pursuant to such section would ad20 versely impact beneficiaries’ access to 

21 medical assistance. ’’. 

22 (C) STATE PLAN REQUIREMENT WITH RE23 SPECT TO LIMITATION ON CHARGES TO BENE24 FICIARIES.—Section 1902(kk)(4)(A) of the Social 

25 Security Act (42 U.S.C. 1396a(kk)(4)(A)) is 
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1 amended by adding at the end the following new 

2 clause: 

3 ‘‘(iii) LIMITATION ON CHARGES TO

4 BENEFICIARIES.—With respect to any 

5 amount expended for items or services fur6 nished during calendar quarters beginning 

7 on or after October 1, 2017, the State pro8 hibits, during the period of a temporary 

9 moratorium described in clause (i), a pro10 vider meeting the requirements specified in 

11 subparagraph (C)(iii) of section 1866(j)(7) 

12 from charging an individual or other per13 son eligible to receive medical assistance 

14 under the State plan under this title (or a 

15 waiver of the plan) for an item or service 

16 described in section 1903(i)(2)(E) furnished 

17 to such an individual.’’. 

18 (2) CORRECTING AMENDMENTS TO RELATED

19 PROVISIONS.— 

20 (A) SECTION 1866(J).—Section 1866(j) of the 

21 Social Security Act (42 U.S.C. 1395cc(j)) is 

22 amended— 

23 (i) in paragraph (1)(A)— 

24 (I) by striking ‘‘paragraph (4)’’ 

25 and inserting ‘‘paragraph (5)’’; 
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1 (II) by striking ‘‘moratoria in ac2 cordance with paragraph (5)’’ and in3 serting ‘‘moratoria in accordance with 

4 paragraph (7)’’; and 

5 (III) by striking ‘‘paragraph (6)’’ 

6 and inserting ‘‘paragraph (9)’’; and 

7 (ii) by redesignating the second para8 graph (8) (redesignated by section 1304(1) 

9 of Public Law 111–152) as paragraph (9). 

10 (B) SECTION 1902(KK).—Section 1902(kk) of 

11 such Act (42 U.S.C. 1396a(kk)) is amended— 

12 (i) in paragraph (1), by striking ‘‘sec13 tion 1886(j)(2)’’ and inserting ‘‘section 

14 1866(j)(2)’’; 

15 (ii) in paragraph (2), by striking ‘‘sec16 tion 1886(j)(3)’’ and inserting ‘‘section 

17 1866(j)(3)’’; 

18 (iii) in paragraph (3), by striking 

19 ‘‘section 1886(j)(4)’’ and inserting ‘‘section 

20 1866(j)(5)’’; and 

21 (iv) in paragraph (4)(A), by striking 

22 ‘‘section 1886(j)(6)’’ and inserting ‘‘section 

23 1866(j)(7)’’. 
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1 SEC. 17005. PRESERVATION OF MEDICARE BENEFICIARY 

2 CHOICE UNDER MEDICARE ADVANTAGE. 

3 Section 1851(e)(2) of the Social Security Act (42 

4 U.S.C. 1395w–21(e)(2)) is amended— 

5 (1) in subparagraph (C)— 

6 (A) in the heading, by inserting ‘‘FROM 2011

7 THROUGH 2018’’ after ‘‘45-DAY PERIOD’’; and 

8 (B) by inserting ‘‘and ending with 2018’’ 

9 after ‘‘beginning with 2011’’; and 

10 (2) by adding at the end the following new sub11 paragraph: 

12 ‘‘(G) CONTINUOUS OPEN ENROLLMENT AND

13 DISENROLLMENT FOR FIRST 3 MONTHS IN 2016

14 AND SUBSEQUENT YEARS.— 

15 ‘‘(i) IN GENERAL.—Subject to clause 

16 (ii) and subparagraph (D)— 

17 ‘‘(I) in the case of an MA eligible 

18 individual who is enrolled in an MA 

19 plan, at any time during the first 3 

20 months of a year (beginning with 

21 2019); or 

22 ‘‘(II) in the case of an individual 

23 who first becomes an MA eligible indi24 vidual during a year (beginning with 

25 2019) and enrolls in an MA plan, dur26 ing the first 3 months during such 
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1 year in which the individual is an MA 

2 eligible individual; 

3 such MA eligible individual may change the 

4 election under subsection (a)(1). 

5 ‘‘(ii) LIMITATION OF ONE CHANGE

6 DURING OPEN ENROLLMENT PERIOD EACH

7 YEAR.—An individual may change the elec8 tion pursuant to clause (i) only once during 

9 the applicable 3-month period described in 

10 such clause in each year. The limitation 

11 under this clause shall not apply to changes 

12 in elections effected during an annual, co13 ordinated election period under paragraph 

14 (3) or during a special enrollment period 

15 under paragraph (4). 

16 ‘‘(iii) LIMITED APPLICATION TO PART

17 D.—Clauses (i) and (ii) of this subpara18 graph shall only apply with respect to 

19 changes in enrollment in a prescription 

20 drug plan under part D in the case of an 

21 individual who, previous to such change in 

22 enrollment, is enrolled in a Medicare Ad23 vantage plan. 

24 ‘‘(iv) LIMITATIONS ON MARKETING.— 

25 Pursuant to subsection (j), no unsolicited 
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1 marketing or marketing materials may be 

2 sent to an individual described in clause (i) 

3 during the continuous open enrollment and 

4 disenrollment period established for the in5 dividual under such clause, notwithstanding 

6 marketing guidelines established by the Cen7 ters for Medicare & Medicaid Services.’’. 

8 SEC. 17006. ALLOWING END-STAGE RENAL DISEASE BENE9 FICIARIES TO CHOOSE A MEDICARE ADVAN10 TAGE PLAN. 

11 (a) REMOVING PROHIBITION.— 

12 (1) IN GENERAL.—Section 1851(a)(3) of the So13 cial Security Act (42 U.S.C. 1395w–21(a)(3)) is 

14 amended— 

15 (A) by striking subparagraph (B); and 

16 (B) by striking ‘‘ELIGIBLE INDIVIDUAL’’ 

17 and all that follows through ‘‘In this title, subject 

18 to subparagraph (B),’’ and inserting ‘‘ELIGIBLE

19 INDIVIDUAL.—In this title,’’. 

20 (2) CONFORMING AMENDMENTS.— 

21 (A) Section 1852(b)(1) of the Social Secu22 rity Act (42 U.S.C. 1395w–22(b)(1)) is amend23 ed— 

24 (i) by striking subparagraph (B); and 
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1 (ii) by striking ‘‘BENEFICIARIES’’ and 

2 all that follows through ‘‘A 

3 Medicare+Choice organization’’ and insert4 ing ‘‘BENEFICIARIES.—A Medicare Advan5 tage organization’’. 

6 (B) Section 1859(b)(6) of the Social Secu7 rity Act (42 U.S.C. 1395w–28(b)(6)) is amended, 

8 in the last sentence, by striking ‘‘may waive’’ 

9 and all that follows through ‘‘subparagraph 

10 and’’. 

11 (3) EFFECTIVE DATE.—The amendments made 

12 by this subsection shall apply with respect to plan 

13 years beginning on or after January 1, 2021. 

14 (b) EXCLUDING COSTS FOR KIDNEY ACQUISITIONS

15 FROM MA BENCHMARK.—Section 1853 of the Social Secu16 rity Act (42 U.S.C. 1395w–23) is amended— 

17 (1) in subsection (k)— 

18 (A) in paragraph (1)— 

19 (i) in the matter preceding subpara20 graph (A), by striking ‘‘paragraphs (2) and 

21 (4)’’ and inserting ‘‘paragraphs (2), (4), 

22 and (5)’’; and 

23 (ii) in subparagraph (B)(i), by strik24 ing ‘‘paragraphs (2) and (4)’’ and inserting 

25 ‘‘paragraphs (2), (4), and (5)’’; and 
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1 (B) by adding at the end the following new 

2 paragraph: 

3 ‘‘(5) EXCLUSION OF COSTS FOR KIDNEY ACQUISI4 TIONS FROM CAPITATION RATES.—After determining 

5 the applicable amount for an area for a year under 

6 paragraph (1) (beginning with 2021), the Secretary 

7 shall adjust such applicable amount to exclude from 

8 such applicable amount the Secretary’s estimate of the 

9 standardized costs for payments for organ acquisi10 tions for kidney transplants covered under this title 

11 (including expenses covered under section 1881(d)) in 

12 the area for the year.’’; and 

13 (2) in subsection (n)(2)— 

14 (A) in subparagraph (A)(i), by inserting 

15 ‘‘and, for 2021 and subsequent years, the exclu16 sion of payments for organ acquisitions for kid17 ney transplants from the capitation rate as de18 scribed in subsection (k)(5)’’ before the semicolon 

19 at the end; 

20 (B) in subparagraph (E), in the matter 

21 preceding clause (i), by striking ‘‘subparagraph 

22 (F)’’ and inserting ‘‘subparagraphs (F) and 

23 (G)’’; and 

24 (C) by adding at the end the following new 

25 subparagraph: 
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1 ‘‘(G) APPLICATION OF KIDNEY ACQUISI2 TIONS ADJUSTMENT.—The base payment amount 

3 specified in subparagraph (E) for a year (begin4 ning with 2021) shall be adjusted in the same 

5 manner under paragraph (5) of subsection (k) as 

6 the applicable amount is adjusted under such 

7 subsection.’’. 

8 (c) FFS COVERAGE OF KIDNEY ACQUISITIONS.— 

9 (1) IN GENERAL.—Section 1852(a)(1)(B)(i) of 

10 the Social Security Act (42 U.S.C. 1395w– 

11 22(a)(1)(B)(i)) is amended by inserting ‘‘or coverage 

12 for organ acquisitions for kidney transplants, includ13 ing as covered under section 1881(d)’’ after ‘‘hospice 

14 care’’. 

15 (2) CONFORMING AMENDMENT.—Section 1851(i) 

16 of the Social Security Act (42 U.S.C. 1395w–21(i)) is 

17 amended by adding at the end the following new 

18 paragraph: 

19 ‘‘(3) FFS PAYMENT FOR EXPENSES FOR KIDNEY

20 ACQUISITIONS.—Paragraphs (1) and (2) shall not 

21 apply with respect to expenses for organ acquisitions 

22 for kidney transplants described in section 

23 1852(a)(1)(B)(i).’’. 
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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall apply with respect to plan 

3 years beginning on or after January 1, 2021. 

4 (d) EVALUATION OF QUALITY.— 

5 (1) IN GENERAL.—The Secretary of Health and 

6 Human Services (in this subsection referred to as the 

7 ‘‘Secretary’’) shall conduct an evaluation of whether 

8 the 5-star rating system based on the data collected 

9 under section 1852(e) of the Social Security Act (42 

10 U.S.C. 1395w–22(e)) should include a quality meas11 ure specifically related to care for enrollees in Medi12 care Advantage plans under part C of title XVIII of 

13 such Act determined to have end-stage renal disease. 

14 (2) PUBLIC AVAILABILITY.—Not later than April 

15 1, 2020, the Secretary shall post on the Internet 

16 website of the Centers for Medicare & Medicaid Serv17 ices the results of the evaluation under paragraph (1). 

18 (e) REPORT.—Not later than December 31, 2023, the 

19 Secretary of Health and Human Services (in this subsection 

20 referred to as the ‘‘Secretary’’) shall submit to Congress a 

21 report on the impact of the provisions of, and amendments 

22 made by, this section with respect to the following: 

23 (1) Spending under— 
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1 (A) the original Medicare fee-for-service pro2 gram under parts A and B of title XVIII of the 

3 Social Security Act; and 

4 (B) the Medicare Advantage program under 

5 part C of such title. 

6 (2) The number of enrollees determined to have 

7 end-stage renal disease— 

8 (A) in the original Medicare fee-for-service 

9 program; and 

10 (B) in the Medicare Advantage program. 

11 (3) The sufficiency of the amount of data under 

12 the original Medicare fee-for-service program for indi13 viduals determined to have end-stage renal disease for 

14 purposes of determining payment rates for end-stage 

15 renal disease under the Medicare Advantage program. 

16 (f) IMPROVEMENTS TO RISK ADJUSTMENT UNDER

17 MEDICARE ADVANTAGE.— 

18 (1) IN GENERAL.—Section 1853(a)(1) of the So19 cial Security Act (42 U.S.C. 1395w–23(a)(1)) is 

20 amended— 

21 (A) in subparagraph (C)(i), by striking 

22 ‘‘The Secretary’’ and inserting ‘‘Subject to sub23 paragraph (I), the Secretary’’; and 

24 (B) by adding at the end the following new 

25 subparagraph: 
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1 ‘‘(I) IMPROVEMENTS TO RISK ADJUSTMENT

2 FOR 2019 AND SUBSEQUENT YEARS.— 

3 ‘‘(i) IN GENERAL.—In order to deter4 mine the appropriate adjustment for health 

5 status under subparagraph (C)(i), the fol6 lowing shall apply: 

7 ‘‘(I) TAKING INTO ACCOUNT TOTAL

8 NUMBER OF DISEASES OR CONDI9 TIONS.—The Secretary shall take into 

10 account the total number of diseases or 

11 conditions of an individual enrolled in 

12 an MA plan. The Secretary shall make 

13 an additional adjustment under such 

14 subparagraph as the number of dis15 eases or conditions of an individual in16 creases. 

17 ‘‘(II) USING AT LEAST 2 YEARS OF

18 DIAGNOSTIC DATA.—The Secretary 

19 may use at least 2 years of diagnosis 

20 data. 

21 ‘‘(III) PROVIDING SEPARATE AD22 JUSTMENTS FOR DUAL ELIGIBLE INDI23 VIDUALS.—With respect to individuals 

24 who are dually eligible for benefits 

25 under this title and title XIX, the Sec-
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1 retary shall make separate adjustments 

2 for each of the following: 

3 ‘‘(aa) Full-benefit dual eligi4 ble individuals (as defined in sec5 tion 1935(c)(6)). 

6 ‘‘(bb) Such individuals not 

7 described in item (aa). 

8 ‘‘(IV) EVALUATION OF MENTAL

9 HEALTH AND SUBSTANCE USE DIS10 ORDERS.—The Secretary shall evaluate 

11 the impact of including additional di12 agnosis codes related to mental health 

13 and substance use disorders in the risk 

14 adjustment model. 

15 ‘‘(V) EVALUATION OF CHRONIC

16 KIDNEY DISEASE.—The Secretary shall 

17 evaluate the impact of including the se18 verity of chronic kidney disease in the 

19 risk adjustment model. 

20 ‘‘(VI) EVALUATION OF PAYMENT

21 RATES FOR END-STAGE RENAL DIS22 EASE.—The Secretary shall evaluate 

23 whether other factors (in addition to 

24 those described in subparagraph (H)) 

25 should be taken into consideration 
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1 when computing payment rates under 

2 such subparagraph. 

3 ‘‘(ii) PHASED-IN IMPLEMENTATION.— 

4 The Secretary shall phase-in any changes to 

5 risk adjustment payment amounts under 

6 subparagraph (C)(i) under this subpara7 graph over a 3-year period, beginning with 

8 2019, with such changes being fully imple9 mented for 2022 and subsequent years. 

10 ‘‘(iii) OPPORTUNITY FOR REVIEW AND

11 PUBLIC COMMENT.—The Secretary shall 

12 provide an opportunity for review of the 

13 proposed changes to such risk adjustment 

14 payment amounts under this subparagraph 

15 and a public comment period of not less 

16 than 60 days before implementing such 

17 changes.’’. 

18 (2) STUDIES AND REPORTS.— 

19 (A) REPORTS ON THE RISK ADJUSTMENT

20 SYSTEM.— 

21 (i) MEDPAC EVALUATION AND RE22 PORT.— 

23 (I) EVALUATION.—The Medicare 

24 Payment Advisory Commission shall 

25 conduct an evaluation of the impact of 
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1 the provisions of, and amendments 

2 made by, this section on risk scores for 

3 enrollees in Medicare Advantage plans 

4 under part C of title XVIII of the So5 cial Security Act and payments to 

6 Medicare Advantage plans under such 

7 part, including the impact of such pro8 visions and amendments on the overall 

9 accuracy of risk scores under the Medi10 care Advantage program. 

11 (II) REPORT.—Not later than 

12 July 1, 2020, the Medicare Payment 

13 Advisory Commission shall submit to 

14 Congress a report on the evaluation 

15 under subclause (I), together with rec16 ommendations for such legislation and 

17 administrative action as the Commis18 sion determines appropriate. 

19 (ii) REPORTS BY SECRETARY OF

20 HEALTH AND HUMAN SERVICES.—Not later 

21 than December 31, 2018, and every 3 years 

22 thereafter, the Secretary of Health and 

23 Human Services shall submit to Congress a 

24 report on the risk adjustment model and the 

25 ESRD risk adjustment model under the 
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1 Medicare Advantage program under part C 

2 of title XVIII of the Social Security Act, in3 cluding any revisions to either such model 

4 since the previous report. Such report shall 

5 include information on how such revisions 

6 impact the predictive ratios under either 

7 such model for groups of enrollees in Medi8 care Advantage plans, including very high 

9 and very low cost enrollees, and groups de10 fined by the number of chronic conditions of 

11 enrollees. 

12 (B) STUDY AND REPORT ON FUNCTIONAL

13 STATUS.— 

14 (i) STUDY.—The Comptroller General 

15 of the United States (in this subparagraph 

16 referred to as the ‘‘Comptroller General’’) 

17 shall conduct a study on how to most accu18 rately measure the functional status of en19 rollees in Medicare Advantage plans and 

20 whether the use of such functional status 

21 would improve the accuracy of risk adjust22 ment payments under the Medicare Advan23 tage program under part C of title XVIII of 

24 the Social Security Act. Such study shall 

25 include an analysis of the challenges in col-
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1 lecting and reporting functional status in2 formation for Medicare Advantage plans 

3 under such part, providers of services and 

4 suppliers under the Medicare program, and 

5 the Centers for Medicare & Medicaid Serv6 ices. 

7 (ii) REPORT.—Not later than June 30, 

8 2018, the Comptroller General shall submit 

9 to Congress a report containing the results 

10 of the study under clause (i), together with 

11 recommendations for such legislation and 

12 administrative action as the Comptroller 

13 General determines appropriate. 

14 SEC. 17007. IMPROVEMENTS TO THE ASSIGNMENT OF BENE15 FICIARIES UNDER THE MEDICARE SHARED 

16 SAVINGS PROGRAM. 

17 Section 1899(c) of the Social Security Act (42 U.S.C. 

18 1395jjj(c)) is amended— 

19 (1) by striking ‘‘utilization of primary’’ and in20 serting ‘‘utilization of— 

21 ‘‘(1) in the case of performance years beginning 

22 on or after April 1, 2012, primary’’; 

23 (2) in paragraph (1), as added by paragraph (1) 

24 of this section, by striking the period at the end and 

25 inserting ‘‘; and’’; 
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1 (3) by adding at the end the following new para2 graph: 

3 ‘‘(2) in the case of performance years beginning 

4 on or after January 1, 2019, services provided under 

5 this title by a Federally qualified health center or 

6 rural health clinic (as those terms are defined in sec7 tion 1861(aa)), as may be determined by the Sec8 retary.’’. 

9 TITLE XVIII—OTHER 

10 PROVISIONS 

11 SEC. 18001. EXCEPTION FROM GROUP HEALTH PLAN RE12 QUIREMENTS FOR QUALIFIED SMALL EM13 PLOYER HEALTH REIMBURSEMENT ARRANGE14 MENTS. 

15 (a) AMENDMENTS TO THE INTERNAL REVENUE CODE

16 OF 1986 AND THE PATIENT PROTECTION AND AFFORDABLE

17 CARE ACT.— 

18 (1) IN GENERAL.—Section 9831 of the Internal 

19 Revenue Code of 1986 is amended by adding at the 

20 end the following new subsection: 

21 ‘‘(d) EXCEPTION FOR QUALIFIED SMALL EMPLOYER

22 HEALTH REIMBURSEMENT ARRANGEMENTS.— 

23 ‘‘(1) IN GENERAL.—For purposes of this title (ex24 cept as provided in section 4980I(f)(4) and notwith25 standing any other provision of this title), the term 
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1 ‘group health plan’ shall not include any qualified 

2 small employer health reimbursement arrangement. 

3 ‘‘(2) QUALIFIED SMALL EMPLOYER HEALTH RE4 IMBURSEMENT ARRANGEMENT.—For purposes of this 

5 subsection— 

6 ‘‘(A) IN GENERAL.—The term ‘qualified 

7 small employer health reimbursement arrange8 ment’ means an arrangement which— 

9 ‘‘(i) is described in subparagraph (B), 

10 and 

11 ‘‘(ii) is provided on the same terms to 

12 all eligible employees of the eligible em13 ployer. 

14 ‘‘(B) ARRANGEMENT DESCRIBED.—An ar15 rangement is described in this subparagraph if— 

16 ‘‘(i) such arrangement is funded solely 

17 by an eligible employer and no salary re18 duction contributions may be made under 

19 such arrangement, 

20 ‘‘(ii) such arrangement provides, after 

21 the employee provides proof of coverage, for 

22 the payment of, or reimbursement of, an eli23 gible employee for expenses for medical care 

24 (as defined in section 213(d)) incurred by 

25 the eligible employee or the eligible employ-
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1 ee’s family members (as determined under 

2 the terms of the arrangement), and 

3 ‘‘(iii) the amount of payments and re4 imbursements described in clause (ii) for 

5 any year do not exceed $4,950 ($10,000 in 

6 the case of an arrangement that also pro7 vides for payments or reimbursements for 

8 family members of the employee). 

9 ‘‘(C) CERTAIN VARIATION PERMITTED.—For 

10 purposes of subparagraph (A)(ii), an arrange11 ment shall not fail to be treated as provided on 

12 the same terms to each eligible employee merely 

13 because the employee’s permitted benefit under 

14 such arrangement varies in accordance with the 

15 variation in the price of an insurance policy in 

16 the relevant individual health insurance market 

17 based on— 

18 ‘‘(i) the age of the eligible employee 

19 (and, in the case of an arrangement which 

20 covers medical expenses of the eligible em21 ployee’s family members, the age of such 

22 family members), or 

23 ‘‘(ii) the number of family members of 

24 the eligible employee the medical expenses of 

25 which are covered under such arrangement. 
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1 The variation permitted under the preceding sen2 tence shall be determined by reference to the 

3 same insurance policy with respect to all eligible 

4 employees. 

5 ‘‘(D) RULES RELATING TO MAXIMUM DOL6 LAR LIMITATION.— 

7 ‘‘(i) AMOUNT PRORATED IN CERTAIN

8 CASES.—In the case of an individual who is 

9 not covered by an arrangement for the en10 tire year, the limitation under subpara11 graph (B)(iii) for such year shall be an 

12 amount which bears the same ratio to the 

13 amount which would (but for this clause) be 

14 in effect for such individual for such year 

15 under subparagraph (B)(iii) as the number 

16 of months for which such individual is cov17 ered by the arrangement for such year bears 

18 to 12. 

19 ‘‘(ii) INFLATION ADJUSTMENT.—In the 

20 case of any year beginning after 2016, each 

21 of the dollar amounts in subparagraph 

22 (B)(iii) shall be increased by an amount 

23 equal to— 

24 ‘‘(I) such dollar amount, multi25 plied by 
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1 ‘‘(II) the cost-of-living adjustment 

2 determined under section 1(f)(3) for 

3 the calendar year in which the taxable 

4 year begins, determined by substituting 

5 ‘calendar year 2015’ for ‘calendar year 

6 1992’ in subparagraph (B) thereof. 

7 If any dollar amount increased under the 

8 preceding sentence is not a multiple of $50, 

9 such dollar amount shall be rounded to the 

10 next lowest multiple of $50. 

11 ‘‘(3) OTHER DEFINITIONS.—For purposes of this 

12 subsection— 

13 ‘‘(A) ELIGIBLE EMPLOYEE.—The term ‘eli14 gible employee’ means any employee of an eligi15 ble employer, except that the terms of the ar16 rangement may exclude from consideration em17 ployees described in any clause of section 

18 105(h)(3)(B) (applied by substituting ‘90 days’ 

19 for ‘3 years’ in clause (i) thereof). 

20 ‘‘(B) ELIGIBLE EMPLOYER.—The term ‘eli21 gible employer’ means an employer that— 

22 ‘‘(i) is not an applicable large em23 ployer as defined in section 4980H(c)(2), 

24 and 
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1 ‘‘(ii) does not offer a group health plan 

2 to any of its employees. 

3 ‘‘(C) PERMITTED BENEFIT.—The term ‘per4 mitted benefit’ means, with respect to any eligi5 ble employee, the maximum dollar amount of 

6 payments and reimbursements which may be 

7 made under the terms of the qualified small em8 ployer health reimbursement arrangement for the 

9 year with respect to such employee. 

10 ‘‘(4) NOTICE.— 

11 ‘‘(A) IN GENERAL.—An employer funding a 

12 qualified small employer health reimbursement 

13 arrangement for any year shall, not later than 

14 90 days before the beginning of such year (or, in 

15 the case of an employee who is not eligible to 

16 participate in the arrangement as of the begin17 ning of such year, the date on which such em18 ployee is first so eligible), provide a written no19 tice to each eligible employee which includes the 

20 information described in subparagraph (B). 

21 ‘‘(B) CONTENTS OF NOTICE.—The notice re22 quired under subparagraph (A) shall include 

23 each of the following: 
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1 ‘‘(i) A statement of the amount which 

2 would be such eligible employee’s permitted 

3 benefit under the arrangement for the year. 

4 ‘‘(ii) A statement that the eligible em5 ployee should provide the information de6 scribed in clause (i) to any health insurance 

7 exchange to which the employee applies for 

8 advance payment of the premium assistance 

9 tax credit. 

10 ‘‘(iii) A statement that if the employee 

11 is not covered under minimum essential 

12 coverage for any month the employee may 

13 be subject to tax under section 5000A for 

14 such month and reimbursements under the 

15 arrangement may be includible in gross in16 come.’’. 

17 (2) LIMITATION ON EXCLUSION FROM GROSS IN18 COME.—Section 106 of such Code is amended by add19 ing at the end the following: 

20 ‘‘(g) QUALIFIED SMALL EMPLOYER HEALTH REIM21 BURSEMENT ARRANGEMENT.—For purposes of this section 

22 and section 105, payments or reimbursements from a quali23 fied small employer health reimbursement arrangement (as 

24 defined in section 9831(d)) of an individual for medical 

25 care (as defined in section 213(d)) shall not be treated as 
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1 paid or reimbursed under employer-provided coverage for 

2 medical expenses under an accident or health plan if for 

3 the month in which such medical care is provided the indi4 vidual does not have minimum essential coverage (within 

5 the meaning of section 5000A(f)).’’. 

6 (3) COORDINATION WITH HEALTH INSURANCE

7 PREMIUM CREDIT.—Section 36B(c) of such Code is 

8 amended by adding at the end the following new 

9 paragraph: 

10 ‘‘(4) SPECIAL RULES FOR QUALIFIED SMALL EM11 PLOYER HEALTH REIMBURSEMENT ARRANGEMENTS.— 

12 ‘‘(A) IN GENERAL.—The term ‘coverage 

13 month’ shall not include any month with respect 

14 to an employee (or any spouse or dependent of 

15 such employee) if for such month the employee is 

16 provided a qualified small employer health reim17 bursement arrangement which constitutes afford18 able coverage. 

19 ‘‘(B) DENIAL OF DOUBLE BENEFIT.—In the 

20 case of any employee who is provided a qualified 

21 small employer health reimbursement arrange22 ment for any coverage month (determined with23 out regard to subparagraph (A)), the credit oth24 erwise allowable under subsection (a) to the tax25 payer for such month shall be reduced (but not 
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1 below zero) by the amount described in subpara2 graph (C)(i)(II) for such month. 

3 ‘‘(C) AFFORDABLE COVERAGE.—For pur4 poses of subparagraph (A), a qualified small em5 ployer health reimbursement arrangement shall 

6 be treated as constituting affordable coverage for 

7 a month if— 

8 ‘‘(i) the excess of— 

9 ‘‘(I) the amount that would be 

10 paid by the employee as the premium 

11 for such month for self-only coverage 

12 under the second lowest cost silver plan 

13 offered in the relevant individual 

14 health insurance market, over 

‘‘(II) 1 15 ⁄12 of the employee’s per16 mitted benefit (as defined in section 

17 9831(d)(3)(C)) under such arrange18 ment, does not exceed— 

‘‘(ii) 1 19 ⁄12 of 9.5 percent of the employ20 ee’s household income. 

21 ‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH

22 REIMBURSEMENT ARRANGEMENT.—For purposes 

23 of this paragraph, the term ‘qualified small em24 ployer health reimbursement arrangement’ has 
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1 the meaning given such term by section 

2 9831(d)(2). 

3 ‘‘(E) COVERAGE FOR LESS THAN ENTIRE

4 YEAR.—In the case of an employee who is pro5 vided a qualified small employer health reim6 bursement arrangement for less than an entire 

7 year, subparagraph (C)(i)(II) shall be applied by 

8 substituting ‘the number of months during the 

9 year for which such arrangement was provided’ 

10 for ‘12’. 

11 ‘‘(F) INDEXING.—In the case of plan years 

12 beginning in any calendar year after 2014, the 

13 Secretary shall adjust the 9.5 percent amount 

14 under subparagraph (C)(ii) in the same manner 

15 as the percentages are adjusted under subsection 

16 (b)(3)(A)(ii).’’. 

17 (4) APPLICATION OF EXCISE TAX ON HIGH COST

18 EMPLOYER-SPONSORED HEALTH COVERAGE.— 

19 (A) IN GENERAL.—Section 4980I(f)(4) of 

20 such Code is amended by adding at the end the 

21 following: ‘‘Section 9831(d)(1) shall not apply 

22 for purposes of this section.’’. 

23 (B) DETERMINATION OF COST OF COV24 ERAGE.—Section 4980I(d)(2) of such Code is 

25 amended by redesignating subparagraph (D) as 
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1 subparagraph (E) and by inserting after sub2 paragraph (C) the following new subparagraph: 

3 ‘‘(D) QUALIFIED SMALL EMPLOYER HEALTH

4 REIMBURSEMENT ARRANGEMENTS.—In the case 

5 of applicable employer-sponsored coverage con6 sisting of coverage under any qualified small em7 ployer health reimbursement arrangement (as de8 fined in section 9831(d)(2)), the cost of coverage 

9 shall be equal to the amount described in section 

10 6051(a)(15).’’. 

11 (5) ENFORCEMENT OF NOTICE REQUIREMENT.— 

12 Section 6652 of such Code is amended by adding at 

13 the end the following new subsection: 

14 ‘‘(o) FAILURE TO PROVIDE NOTICES WITH RESPECT

15 TO QUALIFIED SMALL EMPLOYER HEALTH REIMBURSE16 MENT ARRANGEMENTS.—In the case of each failure to pro17 vide a written notice as required by section 9831(d)(4), un18 less it is shown that such failure is due to reasonable cause 

19 and not willful neglect, there shall be paid, on notice and 

20 demand of the Secretary and in the same manner as tax, 

21 by the person failing to provide such written notice, an 

22 amount equal to $50 per employee per incident of failure 

23 to provide such notice, but the total amount imposed on 

24 such person for all such failures during any calendar year 

25 shall not exceed $2,500.’’. 
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1 (6) REPORTING.— 

2 (A) W–2 REPORTING.—Section 6051(a) of 

3 such Code is amended by striking ‘‘and’’ at the 

4 end of paragraph (13), by striking the period at 

5 the end of paragraph (14) and inserting ‘‘, and’’, 

6 and by inserting after paragraph (14) the fol7 lowing new paragraph: 

8 ‘‘(15) the total amount of permitted benefit (as 

9 defined in section 9831(d)(3)(C)) for the year under 

10 a qualified small employer health reimbursement ar11 rangement (as defined in section 9831(d)(2)) with re12 spect to the employee.’’. 

13 (B) INFORMATION REQUIRED TO BE PRO14 VIDED BY EXCHANGE SUBSIDY APPLICANTS.— 

15 Section 1411(b)(3) of the Patient Protection and 

16 Affordable Care Act is amended by redesignating 

17 subparagraph (B) as subparagraph (C) and by 

18 inserting after subparagraph (A) the following 

19 new subparagraph: 

20 ‘‘(B) CERTAIN INDIVIDUAL HEALTH INSUR21 ANCE POLICIES OBTAINED THROUGH SMALL EM22 PLOYERS.—The amount of the enrollee’s per23 mitted benefit (as defined in section 

24 9831(d)(3)(C) of the Internal Revenue Code of 

25 1986) under a qualified small employer health 
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1 reimbursement arrangement (as defined in sec2 tion 9831(d)(2) of such Code).’’. 

3 (7) EFFECTIVE DATES.— 

4 (A) IN GENERAL.—Except as otherwise pro5 vided in this paragraph, the amendments made 

6 by this subsection shall apply to years beginning 

7 after December 31, 2016. 

8 (B) TRANSITION RELIEF.—The relief under 

9 Treasury Notice 2015–17 shall be treated as ap10 plying to any plan year beginning on or before 

11 December 31, 2016. 

12 (C) COORDINATION WITH HEALTH INSUR13 ANCE PREMIUM CREDIT.—The amendments made 

14 by paragraph (3) shall apply to taxable years be15 ginning after December 31, 2016. 

16 (D) EMPLOYEE NOTICE.— 

17 (i) IN GENERAL.—The amendments 

18 made by paragraph (5) shall apply to no19 tices with respect to years beginning after 

20 December 31, 2016. 

21 (ii) TRANSITION RELIEF.—For pur22 poses of section 6652(o) of the Internal Rev23 enue Code of 1986 (as added by this Act), 

24 a person shall not be treated as failing to 

25 provide a written notice as required by sec-
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1 tion 9831(d)(4) of such Code if such notice 

2 is so provided not later than 90 days after 

3 the date of the enactment of this Act. 

4 (E) W–2 REPORTING.—The amendments 

5 made by paragraph (6)(A) shall apply to cal6 endar years beginning after December 31, 2016. 

7 (F) INFORMATION PROVIDED BY EXCHANGE

8 SUBSIDY APPLICANTS.— 

9 (i) IN GENERAL.—The amendments 

10 made by paragraph (6)(B) shall apply to 

11 applications for enrollment made after De12 cember 31, 2016. 

13 (ii) VERIFICATION.—Verification under 

14 section 1411 of the Patient Protection and 

15 Affordable Care Act of information provided 

16 under section 1411(b)(3)(B) of such Act 

17 shall apply with respect to months begin18 ning after October 2016. 

19 (iii) TRANSITIONAL RELIEF.—In the 

20 case of an application for enrollment under 

21 section 1411(b) of the Patient Protection 

22 and Affordable Care Act made before April 

23 1, 2017, the requirement of section 

24 1411(b)(3)(B) of such Act shall be treated as 

25 met if the information described therein is 
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1 provided not later than 30 days after the 

2 date on which the applicant receives the no3 tice described in section 9831(d)(4) of the 

4 Internal Revenue Code of 1986. 

5 (8) SUBSTANTIATION REQUIREMENTS.—The Sec6 retary of the Treasury (or his designee) may issue 

7 substantiation requirements as necessary to carry out 

8 this subsection. 

9 (b) AMENDMENTS TO THE EMPLOYEE RETIREMENT

10 INCOME SECURITY ACT OF 1974.— 

11 (1) IN GENERAL.—Section 733(a)(1) of the Em12 ployee Retirement Income Security Act of 1974 (29 

13 U.S.C. 1191b(a)(1)) is amended by adding at the end 

14 the following: ‘‘Such term shall not include any quali15 fied small employer health reimbursement arrange16 ment (as defined in section 9831(d)(2) of the Internal 

17 Revenue Code of 1986).’’. 

18 (2) EXCEPTION FROM CONTINUATION COVERAGE

19 REQUIREMENTS, ETC.—Section 607(1) of such Act (29 

20 U.S.C. 1167(1)) is amended by adding at the end the 

21 following: ‘‘Such term shall not include any qualified 

22 small employer health reimbursement arrangement 

23 (as defined in section 9831(d)(2) of the Internal Rev24 enue Code of 1986).’’. 
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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall apply to plan years beginning 

3 after December 31, 2016. 

4 (c) AMENDMENTS TO THE PUBLIC HEALTH SERVICE

5 ACT.— 

6 (1) IN GENERAL.—Section 2791(a)(1) of the 

7 Public Health Service Act (42 U.S.C. 300gg–91(a)(1)) 

8 is amended by adding at the end the following: ‘‘Ex9 cept for purposes of part C of title XI of the Social 

10 Security Act (42 U.S.C. 1320d et seq.), such term 

11 shall not include any qualified small employer health 

12 reimbursement arrangement (as defined in section 

13 9831(d)(2) of the Internal Revenue Code of 1986).’’. 

14 (2) EXCEPTION FROM CONTINUATION COVERAGE

15 REQUIREMENTS.—Section 2208(1) of the Public 

16 Health Service Act (42 U.S.C. 300bb–8(1)) is amend17 ed by adding at the end the following: ‘‘Such term 

18 shall not include any qualified small employer health 

19 reimbursement arrangement (as defined in section 

20 9831(d)(2) of the Internal Revenue Code of 1986).’’. 
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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall apply to plan years beginning 

3 after December 31, 2016. 

Attest: 

Clerk. 

114TH CONGRESS 

2D SESSION H.R. 34 

HOUSE AMENDMENT TO 

SENATE AMENDMENT