21st Century Cures Act
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations.
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.
The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy, R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders.
Content
Research and drug development
Division A, titled "21st Century Cures," contains provisions related to National Institutes of Health funding and administration, reducing opioid abuse, medical research, and drug development.Expanded access transparency
Section 3032 of the Act requires pharmaceutical manufacturers to make their policies regarding expanded access publicly available. A 2021 analysis of this provision found that while large companies with FDA-approved products have largely complied, significantly fewer small and pre-approval companies have made these policies public as required.Opioid epidemic
The Comprehensive Addiction and Recovery Act was passed a few months earlier. This act authorized many harm-reduction strategies, including increased access to the overdose reversal drug naloxone for the opioid crisis, but didn't provide any federal funding for implementation. The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic. The money may be used to improve prescription drug monitoring programs, to make treatment programs more accessible, to train healthcare professionals in best practices of addiction treatment, and to research the most effective approaches to prevent dependency.FDA drug approval process
The 21st Century Cures Act modified the FDA 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 for FDA approval 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 as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.Targeted drugs for rare diseases
The 21st Century Cures Act facilitates the development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases.Informed consent
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."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 including institutional review boards to approve their research design and ethics.
Human research subject protections
The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human 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."
Medical research
The act allocates $4.8 billion to the National Institutes of Health for precision medicine and biomedical research. Of this, $1.5 billion is earmarked for research on brain disease. In October 2016, the Cohort Program was renamed as the All of Us Research Program.Another $1.8 billion is dedicated to cancer research in what is called the "Beau Biden Cancer Moonshot" initiative, named in honor of Vice President Joe Biden's son Beau Biden, who died of brain cancer in 2015. The initiative aimed to reduce cancer death rates by half.
When Joe Biden became president, his administration revamped the cancer initiative. On the 60th anniversary of the John F. Kennedy moonshot speech, President Biden gave a speech at the JFK library, promoting the revival of the Beau Biden Cancer Moonshot, including the new Advanced Research Projects Agency for Health.
In May 2024, Congress voted against renewing funding to the program. 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. 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.
Healthcare
Electronic health records information blocking
The Act defined interoperability and prohibited information blocking. Information blocking is defined as a practice that interferes with or prevents access to electronic health information, that is, information about a patient's medical history or treatment.Under section 4004, information blocking can expose entities to fines of up to $1 million per violation.
Medical software
Medical software is regulated as a medical device by the FDA in the Federal Food, Drug, and Cosmetic Act. 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. 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.Healthcare access and quality improvement
Division C, titled "Increasing Choice, Access, and Quality in Health Care for Americans," concerns Medicare programs and federal tax laws related to health plans for small employers.The Small Business HRA (QSEHRA)
The 21st Century Cures Act also included provisions that created a QSEHRA, a more efficient way for small businesses and non-profits to offer health insurance to their employees.Behavioral health
Division B, titled "Helping Families in Mental Health Crisis," addresses the prevention and treatment of mental illnesses and substance abuse, treatment coverage, communication permitted by HIPAA, and interactions with law enforcement and the criminal justice system.The law strengthens mental health parity regulation, which require insurance companies 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 prevention and intervention programs, and de-escalation training for law enforcement. It also provides five-year grants for a demonstration program in which psychiatry residents and other mental health clinicians will practice in underserved areas. 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 ;
the Mental Health and Safe Communities Act of 2015 ;
the Helping Families in Mental Health Crisis Act of 2016 ;
the Comprehensive Justice and Mental Health Act of 2015 ;
the Mental Health Awareness and Improvement Act of 2015 ;
the Justice and Mental Health Collaboration Act of 2015 ; and
the Behavioral Health Care Integration Act of 2016.
Strategic Petroleum Reserve sales
The act requires sale of 25 million barrels of crude oil from the Strategic Petroleum Reserve. Revenue from these sales will provide part of the NIH funding provided in the law.Legislative history
The 21st Century Cures Act was originally introduced as by Fred Upton on May 19, 2015. It passed the House on July 10, 2015, but did not pass in the Senate.More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations, mostly pharmaceutical companies.
Of 455 organizations registered to lobby on the bill, the top five by number of reports and specific issues according to OpenSecrets were:
- Roche Holdings
- Blue Cross Blue Shield
- Pharmaceutical Research and Manufacturers of America PhRMA
- Amgen
- American Hospital Association.
President Obama signed the act on December 13, 2016. The reasons stated for his support included combatting opioid abuse, advancing cancer research, advancing the BRAIN Initiative, advancing the Precision Medicine Initiative, and addressing bipartisan health issues.