Posted: 2:28 pm Sunday, November 27th, 2016
By Jamie Dupree
While most Americans were more focused on family gatherings, turkey dinners, football and Black Friday shopping trips, Republicans in the Congress quietly unveiled a massive health policy initiative over the Thanksgiving break – what seems to be a legislative Christmas tree on health policy – that lawmakers hope to speed through the House and Senate before wrapping up work for the year.
Known as the “21st Century Cures Act,” the $6.3 billion plan is designed to spur new medical innovation and research by the federal government – but at almost 1,000 pages of legislative text – it’s also rapidly become a magnet for action on other varied health-related issues in the Congress.
While Republicans have been promising action on this plan for the last few weeks, the details of the 996 page measure were not made public until after 5 pm on Thanksgiving Friday – a vote has been set for the plan on Wednesday in the House.
One legislative note – the provisions of this measure will be attached to a separate bill that deals with tsunami warnings.
Among the many highlights in this new medical plan:
+ The main goal of the bill is fostering new health innovation and research at the National Institutes of Health and the Food and Drug Administration.
+ NIH would get $4.8 billion extra over 10 years new efforts at cancer research, brain research, precision medicine and more.
+ The FDA would get $500 million over 10 years to expedite approval of new drugs and medical devices, while not sacrificing safety.
+ The bill also includes $1 billion in new grants over two years to help states deal with opioid abuse.
+ Also added to the plan were new legislative reforms for the nation’s health care system, including $14 million in grants to help change how services are provided by states
+ $12.5 million in grants would be made available to help states better maintain a database of available treatment facilities for those facing mental health issues
+ Another $10 million would be used to help attract medical residents and others to practice psychiatry and follow career paths in other mental health professions
My 1st thoughts on today's draft of 21st Century Cures: some bad provisions are gone, some remain, & some to watch. https://t.co/u6A2fI7yUu
— Rachel Sachs (@RESachs) November 26, 2016
That’s just a small view into this almost one thousand page measure, which has a summary that runs 44 pages, while the table of contents for the legislation consumes almost 10 pages, which I have listed below.
Just reading through all of the programs, the grants, and the sheer volume of different issues, it’s obvious that this plan has been the subject of very heavy lobbying – and has all sorts of different provisions dealing with health and more.
Take a read:
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.
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.
Subtitle A—Patient-Focused Drug Development
Sec. 3001. Patient experience data.
Sec. 3002. Patient-focused drug development guidance.
Sec. 3003. Streamlining patient input.
Sec. 3004. Report on patient experience drug development.
Subtitle B—Advancing New Drug Therapies
Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.
Subtitle C—Modern Trial Design And Evidence Development
Sec. 3021. Novel clinical trial designs.
Sec. 3022. Real world evidence.
Sec. 3023. Protection of human research subjects.
Sec. 3024. Informed consent waiver or alteration for clinical investigations.
Subtitle D—Patient Access To Therapies And Information
Sec. 3031. Summary level review.
Sec. 3032. Expanded access policy.
Sec. 3033. Accelerated approval for regenerative advanced therapies.
Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies.
Sec. 3035. Report on regenerative advanced therapies.
Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies.
Sec. 3037. Health care economic information.
Sec. 3038. Combination product innovation.
Subtitle E—Antimicrobial Innovation And Stewardship
Sec. 3041. Antimicrobial resistance monitoring.
Sec. 3042. Limited population pathway.
Sec. 3043. Prescribing authority.
Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices.
Subtitle F—Medical Device Innovations
Sec. 3051. Breakthrough devices.
Sec. 3052. Humanitarian device exemption.
Sec. 3053. Recognition of standards.
Sec. 3054. Certain class I and class II devices.
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.
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. Streamlining transfers used for educational purposes.
Sec. 4010. Improving Medicare local coverage determinations.
Sec. 4011. Medicare pharmaceutical and technology ombudsman.
Sec. 4012. Medicare site-of-service price transparency.
Sec. 4013. Telehealth services in Medicare.
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
Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and Mental Health Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.
Subtitle B—Oversight And Accountability
Sec. 6021. Improving oversight of mental and substance use disorders programs through the Assistant Secretary for Planning and Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.
Subtitle C—Interdepartmental Serious Mental Illness Coordinating Committee
Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee.
TITLE VII—ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY
Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs and practices.
Sec. 7003. Priority mental health needs of regional and national significance.
Sec. 7004. Priority substance use disorder treatment needs of regional and national significance.
Sec. 7005. Priority substance use disorder prevention needs of regional and national significance.
TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse prevention and treatment block grant and the community mental health services block grant.
TITLE IX—PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER CARE
Subtitle A—Helping Individuals And Families
Sec. 9001. Grants for treatment and recovery for homeless individuals.
Sec. 9002. Grants for jail diversion programs.
Sec. 9003. Promoting integration of primary and behavioral health care.
Sec. 9004. Projects for assistance in transition from homelessness.
Sec. 9005. National Suicide Prevention Lifeline Program.
Sec. 9006. Connecting individuals and families with care.
Sec. 9007. Strengthening community crisis response systems.
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
Sec. 9009. Adult suicide prevention.
Sec. 9010. Mental health awareness training grants.
Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska Native youth within suicide prevention programs.
Sec. 9012. Evidence-based practices for older adults.
Sec. 9013. National violent death reporting system.
Sec. 9014. Assisted outpatient treatment.
Sec. 9015. Assertive community treatment grant program.
Sec. 9016. Sober truth on preventing underage drinking reauthorization.
Sec. 9017. Center and program repeals.
Subtitle B—Strengthening The Health Care Workforce
Sec. 9021. Mental and behavioral health education and training grants.
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. Department of Veterans Affairs patients’ rights.
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 D—CHILD AND FAMILY SERVICES AND SUPPORT
Sec. 19000. Short title.
TITLE XIX—INVESTING IN PREVENTION AND FAMILY SERVICES
Sec. 19001. Purpose.
Subtitle A—Prevention Activities Under Title IV–E
Sec. 19011. Foster care prevention services and programs.
Sec. 19012. Foster care maintenance payments for children with parents in a licensed residential family-based treatment facility for substance abuse.
Sec. 19013. Title IV–E payments for evidence-based kinship navigator programs.
Subtitle B—Enhanced Support Under Title IV–B
Sec. 19021. Elimination of time limit for family reunification services while in foster care and permitting time-limited family reunification services when a child returns home from foster care.
Sec. 19022. Reducing bureaucracy and unnecessary delays when placing children in homes across State lines.
Sec. 19023. Enhancements to grants to improve well-being of families affected by substance abuse.
Sec. 19031. Reviewing and improving licensing standards for placement in a relative foster family home.
Sec. 19032. Development of a statewide plan to prevent child abuse and neglect fatalities.
Sec. 19033. Modernizing the title and purpose of title IV–E.
Sec. 19034. Effective dates.
TITLE XX—ENSURING THE NECESSITY OF A PLACEMENT THAT IS NOT IN A FOSTER FAMILY HOME
Sec. 20001. Limitation on Federal financial participation for placements that are not in foster family homes.
Sec. 20002. Assessment and documentation of the need for placement in a qualified residential treatment program.
Sec. 20003. Protocols to prevent inappropriate diagnoses.
Sec. 20004. Additional data and reports regarding children placed in a setting that is not a foster family home.
Sec. 20005. Effective dates; application to waivers.
TITLE XXI—CONTINUING SUPPORT FOR CHILD AND FAMILY SERVICES
Sec. 21001. Supporting and retaining foster families for children.
Sec. 21002. Extension of child and family services programs.
Sec. 21003. Improvements to the John H. Chafee foster care independence program and related provisions.
TITLE XXII—CONTINUING INCENTIVES TO STATES TO PROMOTE ADOPTION AND LEGAL GUARDIANSHIP
Sec. 22001. Reauthorizing adoption and legal guardianship incentive programs.
TITLE XXIII—TECHNICAL CORRECTIONS
Sec. 23001. Technical corrections to data exchange standards to improve program coordination.
Sec. 23002. Technical corrections to State requirement to address the developmental needs of young children.
TITLE XXIV—ENSURING STATES REINVEST SAVINGS RESULTING FROM INCREASE IN ADOPTION ASSISTANCE
Sec. 24001. Delay of adoption assistance phase-in.
Sec. 24002. GAO study and report on State reinvestment of savings resulting from increase in adoption assistance.
TITLE XXV—SOCIAL IMPACT PARTNERSHIPS TO PAY FOR RESULTS
Sec. 25001. Short title.
Sec. 25002. Social Impact Partnerships to Pay for Results.
Sec. 25003. Extension of TANF program.
Sec. 25004. Strengthening welfare research and evaluation and development of a What Works Clearinghouse.
Sec. 25005. Technical corrections to data exchange standards to improve program coordination.
What’s obvious from all of that? This plan has clearly been the subject of a lobbying blitz.