21st Century Cures bill, NSF Reauthorization among bills winning approval
The 114th Congress has gone out with a bang, after spending most of its tenure in hyper-partisan gridlock. The passage of several important pieces of legislation in December was a welcome cap to a difficult and contentious legislative session.
21st Century Cures – Crafted by bipartisan teams in the House and Senate, and signed by President Obama on December 13, H.R. 34 authorizes several Obama Administration initiatives at the National Institutes of Health (NIH) and seeks to speed the drug approval process at the Food and Drug Administration (FDA). The bill would provide $4.8 billion for initiatives at the NIH for Fiscal Years (FY) 2017-2026, including $1.4 billion for the Precision Medicine Initiative, $1.564 billion for the BRAIN Initiative, $1.802 billion for cancer research (the Cancer Moonshot was named in the bill for Vice President Joe Biden’s son Beau, a victim of brain cancer) and $30 million to expand clinical research for regenerative medicine using adult stem cells. In 2013, President Obama launched the BRAIN Initiative with the goal of helping researchers find new ways to treat, cure and prevent brain disorders, such as Alzheimer's disease, epilepsy and traumatic brain injury. In 2015, he launched the Precision Medicine Initiative to pioneer a new model of patient-centered research that promises to accelerate biomedical discoveries and provide clinicians with new knowledge and tools to select which treatments will work best for which patients.
In 2016, the American Psychological Association (APA) has advocated for a larger role for the behavioral and social sciences in the Cancer Moonshot. See this recent article from Psychological Science Agenda for more details.
Funding for the Cures bill would be drawn from the Prevention and Public Health Fund (which was created as part of the Affordable Care Act) and from sales from the Strategic Petroleum Reserve. While the Appropriations Committees will have to vote to release these funds, they are separate from the pool of funds the Appropriations Committees allocate each year, and thus are not subject to the budget caps that dictate the overall amount of defense and non-defense spending allowed.
In addition to medical research funding, the Cures legislation includes $500 million over 10 years for the FDA. The bill takes multiple steps to speed the drug development process. As the Statement of Administration Policy on the Cures bill explains, “It enhances the ongoing efforts to better incorporate patients' voices into the Food and Drug Administration's (FDA) decision-making processes; supports FDA's efforts to modernize clinical trial design; and improves FDA's ability to hire and retain scientific experts. The legislation includes strong protections for individuals' health data, as well as provisions preventing unnecessary restrictions on the sharing of health information technology data with patients and providers.”
Opioid Provisions --21st Century Cures includes vital provisions to bolster the national response to the opioid addiction and overdose epidemic. The legislation authorizes $1 billion over two years in grants for states to both implement and evaluate comprehensive responses that include prevention, treatment and prescription drug monitoring programs. The $500 million for FY 2017 was included in the continuing resolution that will fund the government through April, but legislators will have to act next year to appropriate funds for FY 2018.
The bill aims to strengthen prevention, treatment and recovery efforts by increasing healthcare workforce training, encouraging integration of care within primary care for individuals with substance use or mental health disorders, and authorizing $12.5 million to improve community crisis response systems. It also improves the criminal justice response to the epidemic by creating a federal drug court as well as a new program to establish alternatives to incarceration for individuals with substance use disorders. In addition, it reauthorizes the STOP Act (Sober Truth on Preventing Underage Drinking) to continue to address underage drinking and adds new prevention, screening and intervention provisions.
Mental Health Reform -- Included as part of the Cures Act was the bipartisan Helping Families in Mental Health Crisis Reform Act, whose passage APA commended. The bill provides important reforms and enhancements to mental health and substance use administration, services and supports. The bill strengthens mental health parity oversight and reporting; provides important supports for training programs including the Minority Fellowship Program ($12.7 million) and Graduate Psychology Education Program ($15 million); eliminates the Medicaid “same day exclusion;” enhances mental health and substance use treatment for children and families, including through the National Child Traumatic Stress Network; provides support for suicide prevention activities including through the Garrett Lee Smith Memorial Act ($5.9 million); and encourages expansion of the National Violent Death Reporting System, a key surveillance tool to monitor all forms of violent deaths in the United States.
National Science Foundation authorization -- Both the House and Senate passed the American Innovation and Competitiveness Act (AICA, S. 3084) and sent the bill to President Obama, whose signature is expected. AICA reflects a compromise between the Senate Committee on Commerce, Science and Transportation and the House Committee on Science, Space and Technology (which passed an earlier bill through the full House which was not welcomed by the scientific community). It is designed to bolster federal research at the National Science Foundation (NSF) and the White House Office of Science and Technology Policy, among other agencies. Notably, the final AICA bill removes funding reauthorization levels and cuts to NSF directorates that served as the primary sticking points for APA and other scientific organizations, but retains language adding "in the national interest" to NSF's broader impacts criterion in merit review.
What’s coming? -- The 115th Congress begins in early January. The APA is working hard to help support psychological science and practice in legislation that is expected to be introduced. For example, health organizations are bracing for a repeal of the Affordable Care Act, and APA is active in coalitions to help preserve access to health and mental health care, as well as coalitions supporting the Patient-Centered Outcomes Research Institute and Prevention and Public Health Fund, which were enacted as part of ACA. We’ll tell you more in January.
With a growing number of states passing laws allowing recreational and/or medical marijuana use, APA has also been thinking about ways to help reduce the regulatory burden on psychologists and other scientists interested in conducting research on marijuana and its constituents. One legislative vehicle designed to do just that, the Medical Marijuana Research Act of 2016, was introduced this past summer by Rep. Andy Harris of Maryland, who worked previously as a physician and scientist, and while the House ran out of time to act on it during this session, APA working with the Friends of NIDA coalition on an effort seeking organizational endorsements of the bill urging its immediate reintroduction in the 115th Congress.
Stay tuned for updates on these and other initiatives in 2017.
Happy New Year to All!