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21st Century Cures Act

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21st Century Cures Act
Great Seal of the United States
Other short titlesHelping Families in Mental Health Crisis Reform Act of 2016
Increasing Choice, Access, and Quality in Health Care for Americans Act
Long titleAn Act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
Enacted bythe114th United States Congress
Citations
Public lawPub. L.Tooltip Public Law (United States)114–255 (text)(PDF)
Legislative history

The21st Century Cures Actis a United States law enacted by the114th United States Congressin December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for theNational Institutes of Health.[1]The act was supported especially by largepharmaceutical manufacturersand was opposed especially by someconsumer organizations.[2]

The approval of drugs and devices would be streamlined, according to supporters, and treatments would reach the market more quickly. The argument made by opponents was that it would allow the marketing of riskier or less effective treatments by allowing the approval of drugs and devices on the basis of flimsier evidence, bypassing randomized, controlled trials.[3]

The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-CongressmanTim Murphy,R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders.[4][5]

Content

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Research and drug development

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Division A, titled "21st Century Cures," contains provisions related toNational Institutes of Healthfunding and administration, reducingopioidabuse, medical research, and drug development.[6]

Opioid epidemic

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See also:Opioid crisisandFederal drug policy of the United States

TheComprehensive Addiction and Recovery Act (CARA)was passed a few months earlier. This act authorized many harm-reduction strategies, including increased access to the overdose reversal drugnaloxone[7]for the opioid crisis, but didn't provide any federal funding for implementation.[8]The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic.[8][9]The money may be used to improveprescription drug monitoring programs,[9]to make treatment programs more accessible, to train healthcare professionals in best practices of addiction treatment, and to research the most effective approaches to preventdependency.[8][9]

FDA drug approval process

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The 21st Century Cures Act modified theFDA Drug Approval process.It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking forFDAapproval on new products or new indications on existing drugs. For instance, under certain conditions, the act allows companies to provide "data summaries" and "real world evidence" such asobservational studies,insurance claims data, patient input, and anecdotal data rather than fullclinical trialresults.[8][10][11]

Targeted drugs for rare diseases

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The 21st Century Cures Act facilitates the development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases.[12]

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In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent"in cases where clinical testing of drugs or devices" poses no more than minimal risk "and" includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. "[12]

One example is a high-tech bandage that monitors blood flow. Standard procedure requires researchers to obtain the patient's permission before testing any new device on them. However, in this example, researchers might want to test the bandage on unconscious patients. In such circumstances, researchers may waive an informed consent requirement since the patient is still getting the standard, medically accepted care of blood pressure and heart rate monitoring. Researchers would still need to obey standard research protocols includinginstitutional review boardsto approve their research design and ethics.[8]

Human research subject protections

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The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between theHHSHuman Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order "to reduce regulatory duplication and unnecessary delays" and "modernize such provisions in the context of multisite and cooperative research projects."

Section 3023 provides for joint or shared review of research, review by institutional review boards other than that of the sponsor of research, and use of other means "to avoid duplication of effort."[12]

Medical research

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The act allocates $4.8 billion to theNational Institutes of Healthfor precision medicine and biomedical research.[1][8][10]Of this, $1.5 billion is earmarked for research on brain disease.[1]In October 2016, the Cohort Program[clarification needed]was renamed as theAll of Us Research Program.[13][14][15]

Another $1.8 billion is dedicated to cancer research in what is called the "Beau Biden Cancer Moonshot" initiative, named in honor of Vice PresidentJoe Biden's sonBeau Biden,who died ofbrain cancerin 2015.[1][8][16][17]The initiative aimed to reduce cancer death rates by half.[18]

When Joe Biden became president, his administration revived the cancer initiative.[clarification needed][citation needed]On the 60th anniversary of theJohn F. Kennedy moonshot speech,President Biden gave a speech at theJFK library,promoting the revival of the Beau Biden Cancer Moonshot, including the newAdvanced Research Projects Agency for Health.[19]

In May 2024, Congress voted against renewing funding to the program.[20]The 2024 budget passed by Congress was tight, due to Republican control of the house, deficit concerns, and Republican desire to deny Biden a win soon before the election.[18]The White House said it was "well prepared to take forward the cancer moonshot in a tough funding cycle;" mandatory moonshot funding was included in Biden's fiscal year 2025 budget request.[18]

Healthcare

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Electronic health records information blocking

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The Act defined interoperability and prohibited[21]information blocking.[22]Information blocking is defined as a practice that interferes with or prevents access toelectronic health information,that is, information about a patient's medical history or treatment.[12][23]

Under section 4004, information blocking can expose entities to fines of up to $1 million per violation.[12]

Medical software

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Medical software is regulated as a medical device by the FDA in theFederal Food, Drug, and Cosmetic Act.[24]Section 3060 of the 21st Century Cures Act was created as an amendment to section 520 of the FD&C Act, which addressed how medical devices are defined.[25][26]It outlined software functions that would be exempt from FDA regulation, such as those used for administrative purposes, encouraging a healthy lifestyle,electronic health records,clinical laboratory test results and related information, and clinical decision tools.[6][27]

Healthcare access and quality improvement

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Division C, titled "Increasing Choice, Access, and Quality in Health Care for Americans," concernsMedicareprograms andfederal tax lawsrelated to health plans for small employers.[28]

The Small Business HRA (QSEHRA)
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The 21st Century Cures Act also included provisions that created a QSEHRA (Qualified Small Employer Health Reimbursement Arrangement), a more efficient way for small businesses and non-profits to offer health insurance to their employees.[citation needed]

Behavioral health

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Division B, titled "Helping Families in Mental Health Crisis," addresses the prevention and treatment of mental illnesses and substance abuse, treatment coverage, communication permitted byHIPAA,and interactions with law enforcement and the criminal justice system.[29]

The law strengthensmental health parityregulation,[9]which requireinsurancecompanies to cover mental health treatments to the same extent and in the same way as medical treatments. It also includes grants to provide community mental health resources,suicide preventionand intervention programs, andde-escalationtraining for law enforcement.[8]It also provides five-year grants for a demonstration program in which psychiatry residents and other mental health clinicians will practice in underserved areas.[9]Provisions for reform of HIPAA, elevating the standing of families in commitment decisions, and reforms of procedures for challenging release decisions, were not included in the final bill.

Some of these provisions were originally proposed in earlier bills, including the Mental Health Reform Act of 2016 (S. 2680); the Mental Health and Safe Communities Act of 2015 (H.R. 3722,S. 2002); the Helping Families in Mental Health Crisis Act of 2016 (H.R. 2646); the Comprehensive Justice and Mental Health Act of 2015 (H.R. 1854,S. 993); the Mental Health Awareness and Improvement Act of 2015 (H.R. 5327,S. 1893); the Justice and Mental Health Collaboration Act of 2015 (H.R. 731); and the Behavioral Health Care Integration Act of 2016 (H.R. 4388).[30]

Strategic Petroleum Reserve sales

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The act requires sale of 25 million barrels of crude oil (10,000,000 in 2017, 9,000,000 in 2018, and 6,000,000 in 2019) from theStrategic Petroleum Reserve.[31][32]Revenue from these sales will provide part of the NIH funding provided in the law.[33]

Legislative history

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The 21st Century Cures Act was originally introduced asH.R. 6byFred Upton(R–MI) on May 19, 2015. It passed the House on July 10, 2015, but did not pass in the Senate.[34][35]

More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations,[11]mostly pharmaceutical companies.[10]

Of 455 organizations registered to lobby on the bill, the top five by number of reports and specific issues according toOpenSecretswere:

The bill passed the House first by a wide margin.[37]Only five senators voted against it:Elizabeth Warrenof Massachusetts;Bernie Sandersof Vermont;Ron WydenandJeff Merkley,both of Oregon, all Democrats; andMike Lee,a Republican of Utah.[38]Warren, Sanders, and Merkley, in particular, objected to the pharmaceutical industry's influence on the bill.[2]In early December 2016, the act had support from both houses of congress.[39][40]

President Obama signed the act on December 13, 2016.[41]The reasons stated for his support included combattingopioid abuse,advancingcancer research,advancing theBRAIN Initiative,advancing thePrecision Medicine Initiative,and addressing bipartisan health issues.[41]

Reception

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Stakeholders who praised the passing of the act include drug companies;medical device manufacturers;the National Institutes of Health; people advocating for lowered barriers to collectinghuman subject researchdata; RepresentativesFred Upton(R-MI),Diana DeGette(D-CO),Timothy F. Murphy(R-PA); SenatorLamar Alexander(R-TN); and Vice PresidentJoe Biden.[10]Hospitals and universities,[11]as well as theAmerican Cancer SocietyAction Network,Research!America,andFasterCuressupported the bill for its commitment toward funding research.[10]TheAmerican Psychological Associationsupported the bill due to its mental health provisions.[42]TheAdvanced Medical Technology Associationsupported the bill for easing the process of introducing new medical technologies.[10]TheAmerican Society of Human Genetics(ASHG) commended the passage of the bill for strengthenedgenetic privacyfor research participants.[43][44][45]Prison Fellowshipsupported the bill due to its inclusion of the Comprehensive Justice and Mental Health Act, a portion designed to encourage collaboration among criminal justice, juvenile justice, mental health treatment, and substance abuse systems.[46][47]

Stakeholders who criticized the passing of the act include theFDA,advocates for strong protections inclinical research,consumer organizations,and advocates ofregenerative medicine.[10]The expedited drug approval process has been one topic of concern and debate.[1]ThePublic Citizen's Health Research Group and theNational Center for Health Researchcampaigned against the Cures Act in fear that it will endanger public health by weakening FDA standards.[10]SenatorElizabeth Warrensaid that the bill had been "hijacked" by the pharmaceutical industry. She said the legislation watered down safety requirements for new drugs and devices and then, as a trade-off, called for research funding — at levels that must be appropriated on an annual basis.[10]John LaMattina, former head ofPfizerresearch and development and current commentator on thepharmaceutical industry,said that fullclinical trialsare necessary to prove effectiveness, and suggests some drugs may now be approved based on early data and only later proved ineffective.[11]The Public Citizen's Health Research Group says the designation of "breakthrough" devices is too broad, and could lead to clearance of devices that aren't ready for the market.[10]

Lupkin points out that the NIH's funding will need to be appropriated each year through the normal budget process, and therefore may be reduced from what this bill promised.[11]The NIH funding was actually less than many advocates hoped for,[10][11]and earlier versions of the bill had promised.[citation needed]

One of the goals of the bill was streamlining approval, butJerry AvornandAaron Kesselheimpointed out that a third of medicines are approved from a single clinical trial averaging fewer than 700 patients;[48]ultimately, however, the law did not allow real-world evidence for approving drugs, but rather for label expansions.[49]

See also

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References

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  1. ^abcde"Learn from Cures Act bipartisanship".Editorial.Asbury Park Press.Asbury Park, NJ: Gannett. 17 December 2016.Retrieved31 December2016.
  2. ^abMukherjee, Sy (7 December 2016)."Everything You Need to Know About the Massive Health Reform Law That Just Passed Congress".Fortune.Retrieved14 December2016.
  3. ^With media watchdogs on the sidelines, pharma-funded advocacy groups pushed Cures Act to the finish line.Trudy Lieberman, HealthNewsReview, December 6, 2016
  4. ^Congress Is on the Verge of Passing a Landmark Mental Health Bill
  5. ^"House Passes Most Significant Mental Health Reform Bill in Decades".NBC News.17 July 2016.Archivedfrom the original on 2022-12-25.
  6. ^abH.R. 34Division A—21st Century Cures
  7. ^"The Comprehensive Addiction and Recovery Act (CARA)".Community Anti-Drug Coalitions of America.Retrieved14 October2020.
  8. ^abcdefghJacoby, Sarah (December 16, 2016)."What The Controversial 21st Century Cures Act Means For You".Refinery29.Retrieved31 December2016.
  9. ^abcdeLevin, Aaron (December 30, 2016). "Obama Signs Landmark Legislation With Major Mental Health Provisions".Psychiatric News.52(1): 1.doi:10.1176/appi.pn.2017.1a10.
  10. ^abcdefghijkKaplan, Sheila (5 December 2016)."Winners and losers of the 21st Century Cures Act".STAT News.Retrieved31 December2016.
  11. ^abcdefFranz, Julia (December 25, 2016)."America's new 21st Century Cures Act will speed up drug approvals. Is that a good thing?".PRI.Retrieved2016-12-31.
  12. ^abcde"PUBLIC LAW 114–255—DEC. 13, 2016"(PDF).www.govinfo.gov.U.S. Government Publishing Office.Retrieved2 October2021.
  13. ^"All of Us (project web page)".U.S. Department of Health & Human Services - National Institutes of Health. 2018.Retrieved20 January2018.
  14. ^Muoio, Dave (7 November 2017)."Fitbit wearables will help power NIH's All of Us Research Program".MobiHealthNews.Retrieved20 January2018.
  15. ^"NIH Partners With 14 Community Groups, Healthcare Associations on Outreach for All of Us Program".GenomeWeb.17 November 2017.Retrieved20 January2018.
  16. ^Biden, Joe;Obama, Barack(13 December 2016)."Remarks by the President and the Vice President at the 21st Century Cures Act Bill Signing"(Press release). Washington, DC: The White House, Office of the Press Secretary.Retrieved31 December2016.
  17. ^"AACR Commends President Obama for Signing the 21st Century Cures Act"(Press release). Philadelphia, PA: American Association for Cancer Research. 13 December 2016.Retrieved2016-12-31.
  18. ^abcSchumaker, Erin (29 April 2024)."Beating cancer used to be bipartisan. What happened?".Politico.
  19. ^Jessica Bartlett (September 12, 2022)."Channeling JFK in Boston visit, Biden breathes new life into cancer 'moonshot'".The Boston Globe.
  20. ^Lew, Dr Thomas K."Congress voted against funding a cure for cancer just to block a win for Biden".USA TODAY.Retrieved2024-07-25.
  21. ^21st Century Cures Act, 42 USC § 300jj-52(a)(1)(A) (2016).
  22. ^Black, Jennifer R.; Hulkower, Rachel L.; Ramanathan, Tara (2018-08-22)."Health Information Blocking: Responses Under the 21st Century Cures Act".Public Health Reports.133(5): 610–613.doi:10.1177/0033354918791544.ISSN0033-3549.PMC6134556.PMID30134128.
  23. ^"What is an electronic health record (EHR)? | HealthIT.gov".www.healthit.gov.Retrieved2 October2021.
  24. ^Health, Center for Devices and Radiological (2020-09-09)."What are examples of Software as a Medical Device?".FDA.
  25. ^Guidance for Industry and Food and Drug Administration Staff."Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act".Food and Drug Administration.
  26. ^Health, Center for Devices and Radiological (2019-09-30)."Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act".U.S. Food and Drug Administration.Retrieved2020-12-05.
  27. ^Evans, Barbara; Ossorio, Pilar (2018-08-14)."The Challenge of Regulating Clinical Decision Support Software After 21st Century Cures".American Journal of Law & Medicine.44(2–3): 237–251.doi:10.1177/0098858818789418.PMID30106648.S2CID52006753.
  28. ^H.R. 34Division C—Increasing Choice, Access, and Quality in Health Care for Americans
  29. ^H.R. 34Division B—Helping Families in Mental Health Crisis
  30. ^"H.R. 34 (114th): 21st Century Cures Act".GovTrack.Civic Impulse, LLC.RetrievedJanuary 10,2017.
  31. ^"This Week in Petroleum".US Department of Energy. 21 December 2016.Retrieved21 December2016.
  32. ^H.R. 34,Sec. 5010. Strategic Petroleum Reserve Drawdown.
  33. ^Lupkin, Sydney (25 November 2016)."Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy".Shots: Health News from NPR.National Public Radio.
  34. ^"Actions - H.R.6 - 114th Congress (2015-2016): 21st Century Cures Act".Congress.gov.Library of Congress. July 13, 2015.Retrieved2017-01-10.
  35. ^"21st Century Cures Act (Public Law 114-255)".SciPol.org.2016-12-14.Retrieved2020-12-05.
  36. ^"Lobbying Spending Database H.R.6, 2014 | OpenSecrets".
  37. ^Kaplan, Sheila (30 November 2016)."House approves the 21st Century Cures Act, sending landmark bill to Senate".Stat.
  38. ^Roll call vote 157,via Senate.gov
  39. ^Pear, Robert (8 December 2016)."Cures Act Gains Bipartisan Support That Eluded Obama Health Law".The New York Times.Retrieved14 December2016.
  40. ^Ornstein, Norm (2015-07-13)."Congress Achieves a Rare Bipartisan Victory for Science".The Atlantic.Retrieved2016-12-14.
  41. ^abSomanader, Tanya (13 December 2016)."3 Letters That Explain Why President Obama Is Signing the Cures Act".whitehouse.gov.Retrieved2016-12-14– viaNational Archives.
  42. ^Sliwa, Jim (1 December 2016)."APA Hails House Passage Of Mental Health Provisions In 21st Century Cures Act"(Press release). Washington, DC: American Psychological Association.Retrieved31 December2016.
  43. ^Padmanabhan, Nalini (7 December 2016)."ASHG Supports Genetic Privacy Provisions in 21st Century Cures Act"(Press release). Bethesda, MD: American Society of Human Genetics.Retrieved2 January2017.
  44. ^Thompson, Dennis (8 December 2016)."Congress passes 21st Century Cures Act with billions for new research, treatments".CBS News.CBS Interactive Inc.Retrieved2 January2017.
  45. ^Enzi, Mike(15 December 2016)."Congress acts to protect the most personal data – genetic information".Opinion.Pine Bluffs Post.Vol. 108, no. 50. Pine Bluffs, WY.Retrieved2 January2017.
  46. ^DeRoche, Craig (29 November 2016)."Urgent need for support for 21st Century Cures Act".PrisonTalk.com.Retrieved22 February2017.
  47. ^DeRoche, Craig (14 December 2016)."Dear Scotty".New Abolitionists Radio.Retrieved22 February2017.
  48. ^Avorn, Jerry; Kesselheim, Aaron S. (2015-06-25). "The 21st Century Cures Act — Will It Take Us Back in Time?".New England Journal of Medicine.372(26): 2473–2475.doi:10.1056/nejmp1506964.ISSN0028-4793.PMID26039522.
  49. ^"The Politics of the 21st Century Cures Act".In the Pipeline.2016-12-09.Retrieved2018-11-25.
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