Sec. 1. SHORT TITLE; TABLE OF CONTENTS
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## SECTION 1 SHORT TITLE; TABLE OF CONTENTS **[**[42 U.S.C. 201 note](/us/usc/t42/s201)**]** ###
(a)Short Title This Act may be cited as the “21st Century Cures Act”. ###
(b)Table of Contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. DIVISION A—21ST CENTURY CURES Sec. 1000. Short title. TITLE I—INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Sec. 1002. FDA innovation projects. Sec. 1003. Account for the state response to the opioid abuse crisis.11Does not conform with the section heading for section 1003. See the amendment made by section 1273 of division FF of Public Law 117-328. Sec. 1004. Budgetary treatment. TITLE II—DISCOVERY Subtitle A—National Institutes of Health Reauthorization Sec. 2001. National Institutes of Health Reauthorization. Sec. 2002. EUREKA prize competitions. Subtitle B—Advancing Precision Medicine Sec. 2011. Precision Medicine Initiative. Sec. 2012. Privacy protection for human research subjects. Sec. 2013. Protection of identifiable and sensitive information. Sec. 2014. Data sharing. Subtitle C—Supporting Young Emerging Scientists Sec. 2021. Investing in the next generation of researchers. Sec. 2022. Improvement of loan repayment program. Subtitle D—National Institutes of Health Planning and Administration Sec. 2031. National Institutes of Health strategic plan. Sec. 2032. Triennial reports. Sec. 2033. Increasing accountability at the National Institutes of Health. Sec. 2034. Reducing administrative burden for researchers. Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements. Sec. 2036. High-risk, high-reward research. Sec. 2037. National Center for Advancing Translational Sciences. Sec. 2038. Collaboration and coordination to enhance research. Sec. 2039. Enhancing the rigor and reproducibility of scientific research. Sec. 2040. Improving medical rehabilitation research at the National Institutes of Health. Sec. 2041. Task force on research specific to pregnant women and lactating women. Sec. 2042. Streamlining National Institutes of Health reporting requirements. Sec. 2043. Reimbursement for research substances and living organisms. Sec. 2044. Sense of Congress on increased inclusion of underrepresented populations in clinical trials. Subtitle E—Advancement of the National Institutes of Health Research and Data Access Sec. 2051. Technical updates to clinical trials database. Sec. 2052. Compliance activities reports. Sec. 2053. Updates to policies to improve data. Sec. 2054. Consultation. Subtitle F—Facilitating Collaborative Research Sec. 2061. National neurological conditions surveillance system. Sec. 2062. Tick-borne diseases. Sec. 2063. Accessing, sharing, and using health data for research purposes. Subtitle G—Promoting Pediatric Research Sec. 2071. National pediatric research network. Sec. 2072. Global pediatric clinical study network. TITLE III—DEVELOPMENT Subtitle A—Patient-Focused Drug Development Sec. 3001. Patient experience data. Sec. 3002. Patient-focused drug development guidance. Sec. 3003. Streamlining patient input. Sec. 3004. Report on patient experience drug development. Subtitle B—Advancing New Drug Therapies Sec. 3011. Qualification of drug development tools. Sec. 3012. Targeted drugs for rare diseases. Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases. Sec. 3014. GAO study of priority review voucher programs. Sec. 3015. Amendments to the Orphan Drug grants. Sec. 3016. National Centers of Excellence in Advanced and Continuous Pharmaceutical 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. Subtitle G—Improving Scientific Expertise and Outreach at FDA Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. Sec. 3072. Hiring authority for scientific, technical, and professional personnel. Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes. Sec. 3074. Scientific engagement. Sec. 3075. Drug surveillance. Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration. Subtitle H—Medical Countermeasures Innovation Sec. 3081. Medical countermeasure guidelines. Sec. 3082. Clarifying BARDA contracting authority. Sec. 3083. Countermeasure budget plan. Sec. 3084. Medical countermeasures innovation. Sec. 3085. Streamlining Project BioShield procurement. Sec. 3086. Encouraging treatments for agents that present a national security threat. Sec. 3087. Paperwork Reduction Act waiver during a public health emergency. Sec. 3088. Clarifying Food and Drug Administration emergency use authorization. Subtitle I—Vaccine Access, Certainty, and Innovation Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices. Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations. Sec. 3093. Encouraging vaccine innovation. Subtitle J—Technical Corrections Sec. 3101. Technical corrections. Sec. 3102. Completed studies. TITLE IV—DELIVERY Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients. Sec. 4002. Transparent reporting on usability, security, and functionality. Sec. 4003. Interoperability. Sec. 4004. Information blocking. Sec. 4005. Leveraging electronic health records to improve patient care. Sec. 4006. Empowering patients and improving patient access to their electronic health information. Sec. 4007. GAO study on patient matching. Sec. 4008. GAO study on patient access to health information. Sec. 4009. Improving Medicare local coverage determinations. Sec. 4010. Medicare pharmaceutical and technology ombudsman. Sec. 4011. Medicare site-of-service price transparency. Sec. 4012. Telehealth services in Medicare. TITLE V—SAVINGS Sec. 5001. Savings in the Medicare Improvement Fund. Sec. 5002. Medicaid reimbursement to States for durable medical equipment. Sec. 5003. Penalties for violations of grants, contracts, and other agreements. Sec. 5004. Reducing overpayments of infusion drugs. Sec. 5005. Increasing oversight of termination of Medicaid providers. Sec. 5006. Requiring publication of fee-for-service provider directory. Sec. 5007. Fairness in Medicaid supplemental needs trusts. Sec. 5008. Eliminating Federal financial participation with respect to expenditures under Medicaid for agents used for cosmetic purposes or hair growth. Sec. 5009. Amendment to the Prevention and Public Health Fund. Sec. 5010. Strategic Petroleum Reserve drawdown. Sec. 5011. Rescission of portion of ACA territory funding. Sec. 5012. Medicare coverage of home infusion therapy. DIVISION B—HELPING FAMILIES IN MENTAL HEALTH CRISIS Sec. 6000. Short title. 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 Committee22Section 1121(c)(2)(B)(ii) of division FF of Public Law 117-328 repealed the item relating to section 6031 in the table of sections. There are no other items remaining in subtitle C. TITLE VII—ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY Sec. 7001. Encouraging innovation and evidence-based programs. Sec. 7002. Promoting access to information on evidence-based programs and practices. Sec. 7003. Priority mental health needs of regional and national significance. Sec. 7004. Priority substance use disorder treatment needs of regional and national significance. Sec. 7005. Priority substance use disorder prevention needs of regional and national significance. TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS Sec. 8001. Community mental health services block grant. Sec. 8002. Substance abuse prevention and treatment block grant. Sec. 8003. Additional provisions related to the block grants. Sec. 8004. Study of distribution of funds under the substance abuse prevention and treatment block grant and the community mental health services block grant. TITLE IX—PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER CARE Subtitle A—Helping Individuals and Families Sec. 9001. Grants for treatment and recovery for homeless individuals. Sec. 9002. Grants for jail diversion programs. Sec. 9003. Promoting integration of primary and behavioral health care. Sec. 9004. Projects for assistance in transition from homelessness. Sec. 9005. National Suicide Prevention Lifeline Program. Sec. 9006. Connecting individuals and families with care. Sec. 9007. Strengthening community crisis response systems. Sec. 9008. Garrett Lee Smith Memorial Act reauthorization. Sec. 9009. Adult suicide prevention. Sec. 9010. Mental health awareness training grants. Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska Native youth within suicide prevention programs. Sec. 9012. Evidence-based practices for older adults. Sec. 9013. National violent death reporting system. Sec. 9014. Assisted outpatient treatment. Sec. 9015. Assertive community treatment grant program. Sec. 9016. Sober truth on preventing underage drinking reauthorization. Sec. 9017. Center and program repeals. Subtitle B—Strengthening the Health Care Workforce Sec. 9021. Mental and behavioral health education and training grants. Sec. 9022. Strengthening the mental and substance use disorders workforce. Sec. 9023. Clarification on current eligibility for loan repayment programs. Sec. 9024. Minority fellowship program. Sec. 9025. Liability protections for health professional volunteers at community health centers. Sec. 9026. Reports. Subtitle C—Mental Health on Campus Improvement Sec. 9031. Mental health and substance use disorder services on campus. Sec. 9032. Interagency Working Group on College Mental Health. Sec. 9033. Improving mental health on college campuses. TITLE X—STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR CHILDREN AND ADOLESCENTS Sec. 10001. Programs for children with a serious emotional disturbance. Sec. 10002. Increasing access to pediatric mental health care. Sec. 10003. Substance use disorder treatment and early intervention services for children and adolescents. Sec. 10004. Children’s recovery from trauma. Sec. 10005. Screening and treatment for maternal depression. Sec. 10006. Infant and early childhood mental health promotion, intervention, and treatment. TITLE XI—COMPASSIONATE COMMUNICATION ON HIPAA Sec. 11001. Sense of Congress. Sec. 11002. Confidentiality of records. Sec. 11003. Clarification on permitted uses and disclosures of protected health information. Sec. 11004. Development and dissemination of model training programs. TITLE XII—MEDICAID MENTAL HEALTH COVERAGE Sec. 12001. Rule of construction related to Medicaid coverage of mental health services and primary care services furnished on the same day. Sec. 12002. Study and report related to Medicaid managed care regulation. Sec. 12003. Guidance on opportunities for innovation. Sec. 12004. Study and report on Medicaid emergency psychiatric demonstration project. Sec. 12005. Providing EPSDT services to children in IMDs. Sec. 12006. Electronic visit verification system required for personal care services and home health care services under Medicaid. TITLE XIII—MENTAL HEALTH PARITY Sec. 13001. Enhanced compliance with mental health and substance use disorder coverage requirements. Sec. 13002. Action plan for enhanced enforcement of mental health and substance use disorder coverage. Sec. 13003. Report on investigations regarding parity in mental health and substance use disorder benefits. Sec. 13004. GAO study on parity in mental health and substance use disorder benefits. Sec. 13005. Information and awareness on eating disorders. Sec. 13006. Education and training on eating disorders. Sec. 13007. Clarification of existing parity rules. TITLE XIV—MENTAL HEALTH AND SAFE COMMUNITIES Subtitle A—Mental Health and Safe Communities Sec. 14001. Law enforcement grants for crisis intervention teams, mental health purposes. Sec. 14002. Assisted outpatient treatment programs. Sec. 14003. Federal drug and mental health courts. Sec. 14004. Mental health in the judicial system. Sec. 14005. Forensic assertive community treatment initiatives. Sec. 14006. Assistance for individuals transitioning out of systems. Sec. 14007. Co-occurring substance abuse and mental health challenges in drug courts. Sec. 14008. Mental health training for Federal uniformed services. Sec. 14009. Advancing mental health as part of offender reentry. Sec. 14010. School mental health crisis intervention teams. Sec. 14011. Active-shooter training for law enforcement. Sec. 14012. Co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs. Sec. 14013. Mental health and drug treatment alternatives to incarceration programs. Sec. 14014. National criminal justice and mental health training and technical assistance. Sec. 14015. Improving Department of Justice data collection on mental illness involved in crime. Sec. 14016. Reports on the number of mentally ill offenders in prison. Sec. 14017. Codification of due process for determinations by secretary of veterans affairs of mental capacity of beneficiaries. Sec. 14018. Reauthorization of appropriations. Subtitle B—Comprehensive Justice and Mental Health Sec. 14021. Sequential intercept model. Sec. 14022. Prison and jails. Sec. 14023. Allowable uses. Sec. 14024. Law enforcement training. Sec. 14025. Federal law enforcement training. Sec. 14026. GAO report. Sec. 14027. Evidence based practices. Sec. 14028. Transparency, program accountability, and enhancement of local authority. Sec. 14029. Grant accountability. DIVISION C—INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR AMERICANS Sec. 15000. Short title. TITLE XV—PROVISIONS RELATING TO MEDICARE PART A Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for similar hospital services. Sec. 15002. Establishing beneficiary equity in the Medicare hospital readmission program. Sec. 15003. Five-year extension of the rural community hospital demonstration program. Sec. 15004. Regulatory relief for LTCHs. Sec. 15005. Savings from IPPS MACRA pay-for through not applying documentation and coding adjustments. Sec. 15006. Extension of certain LTCH Medicare payment rules. Sec. 15007. Application of rules on the calculation of hospital length of stay to all LTCHs. Sec. 15008. Change in Medicare classification for certain hospitals. Sec. 15009. Temporary exception to the application of the Medicare LTCH site neutral provisions for certain spinal cord specialty hospitals. Sec. 15010. Temporary extension to the application of the Medicare LTCH site neutral provisions for certain discharges with severe wounds. TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B Sec. 16001. Continuing Medicare payment under HOPD prospective payment system for services furnished by mid-build off-campus outpatient departments of providers. Sec. 16002. Treatment of cancer hospitals in off-campus outpatient department of a provider policy. Sec. 16003. Treatment of eligible professionals in ambulatory surgical centers for meaningful use and MIPS. Sec. 16004. Continuing Access to Hospitals Act of 2016. Sec. 16005. Delay of implementation of Medicare fee schedule adjustments for wheelchair accessories and seating systems when used in conjunction with complex rehabilitation technology
(CRT)wheelchairs. Sec. 16006. Allowing physical therapists to utilize locum tenens arrangements under Medicare. Sec. 16007. Extension of the transition to new payment rates for durable medical equipment under the Medicare program. Sec. 16008. Requirements in determining adjustments using information from competitive bidding programs. TITLE XVII—OTHER MEDICARE PROVISIONS Sec. 17001. Delay in authority to terminate contracts for Medicare Advantage plans failing to achieve minimum quality ratings. Sec. 17002. Requirement for enrollment data reporting for Medicare. Sec. 17003. Updating the Welcome to Medicare package. Sec. 17004. No payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area. Sec. 17005. Preservation of Medicare beneficiary choice under Medicare Advantage. Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a Medicare Advantage plan. Sec. 17007. Improvements to the assignment of beneficiaries under the Medicare Shared Savings Program. TITLE XVIII—OTHER PROVISIONS Sec. 18001. Exception from group health plan requirements for qualified small employer health reimbursement arrangements. ### DIVISION A 21ST CENTURY CURES
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