On Wednesday, December 7, the Senate gave final approval to HR 34 the 21st Century Cures Act by a vote of 94 to five. The bill (which had temporarily served as a vehicle for passage of the Families First Act) is a compilation of National Institutes of Health (NIH) funding increases, changes in the drug approval process by the Food and Drug Administration (FDA), $1 billion over two years in drug treatment funds, and a reauthorization of the nation’s mental health services programs.
The White House supported the final package with the five votes in opposition coming from three Democrats opposed to the funding structure and the loosening of FDA requirements and Senator Ron Wyden (D-OR) because it stripped out Families First. They were joined by Senator Mike Lee (R-UT) for unspecified reasons.
The bill does not provide mandatory funding but was paid for by cuts to the prevention fund in the ACA and by selling oil in the US oil reserve. Appropriators must follow up on the NIH funding and some of that was included in the CR. Key parts of the legislation include:
- National Institutes of Health (NIH):
o Reauthorizes the NIH 2018-2020
o Over ten years provides NIH with $4.8 billion for expanded research including $1.8 billion for additional cancer research (Vice President Biden’s “moonshot”) $1.5 billion for a White House Precision Medicine Initiative and $1 billion for Brain Research.
o Creates a “Next Generation of Researchers Initiative” in the Office of the Director to coordinate, develop, modify, and prioritize policies/programs to improve opportunities for new researchers.
o Makes several other organizational and oversight changes to the NIH
- Food and Drug Administration (FDA)–Provides $500 million to the FDA over 10 years to move drugs and medical devices to patients more quickly
- Substance Use Funding:
o Provides $1 billion over 2 years for grants to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs, implementing prevention activities, training for health care providers, and expanding access to opioid treatment programs.
o Requires grantees to report on activities funded by the grant in the substance abuse block grant report.
- Mental Health Reauthorization:
o Establishes an Assistant Secretary for Mental Health and Substance Use to head the Substance Abuse and Mental Health Services Administration (SAMHSA). The authorities of the existing SAMHSA Administrator are transferred to the Assistant Secretary.
o Establishes a Chief Medical Officer (CMO) within SAMHSA to assist the Assistant Secretary in evaluating and organizing programs within the agency and to promote evidence-based and promising best practices emphasizing clinical focus.
o Reauthorizes the Priority Mental Health Needs of Regional and National Significance Program to support prevention, treatment, and rehabilitation of mental health services and other programs to target responses based on mental health needs. It reauthorizes the appropriation at the last appropriated level of $394,550,000 for fiscal years 2018-2022.
o Reauthorizes the Priority Substance Use Disorder Treatment Needs of Regional and National Significance Program and reauthorizes the appropriation at the last appropriated level of $333,806,000 for fiscal years 2018-2022.
o Reauthorizes the Priority Mental Health Needs of Regional and National Significance Program and reauthorizes the appropriation at the last appropriated level of $211,148,000 for fiscal years 2018-2022.
o Reauthorizes the Community Mental Health Services (CMHS) block grant at the last appropriated level of $532,571,000 for fiscal years 2018-2022. It also updates state plan requirements.
o Substance Abuse Prevention and Treatment Block Grant is reauthorized at the last appropriated level of $1,858,079,000 billion for fiscal years 2018-22. It modifies the state plan requirements.
o Authorizes HHS to establish a training demonstration program within the Health Resources and Services Administration (HRSA) to award five-year minimum grants for: medical residents, nurse practitioners, physician assistants, health service psychologists, and social workers to practice psychiatry and addiction medicine in underserved, community-based settings.
o Directs the Administrator of HRSA to clarify the existing eligibility of child and adolescent psychiatrists for the National Health Service Corps (NHSC) Loan Repayment Program.
o Reauthorizes programs for Children with Serious Emotional Disturbances at the last appropriated level of $119,026,000 for fiscal years 2018-2022.
o Reauthorizes Substance Use Disorder Treatment and Early Intervention Services for Children and Adolescents at the last appropriated level of $29.6 million for each of 2018-2022.
o Reauthorizes the National Child Traumatic Stress Initiative (NCTSI), which supports a national network of child trauma centers, including university, hospital, and community-based centers and affiliate members. Reauthorizes at the last appropriated level of $46.9 million for each of fiscal years 2018-22.
o NEW, Establishes Screening and Treatment for Maternal Depression grant program for states to establish, improve, or maintain programs for screening assessment and treatment services for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression. Authorizes the appropriation of $5 million for each of fiscal years 2017-2021.
o NEW, Establishes an Infant and Early Childhood Mental Health Promotion, Intervention, and Treatment grant program to develop, maintain, or enhance mental health prevention, intervention, and treatment programs for infants and children at significant risk of developing or showing early signs of mental disorders, including SED, or social or emotional disability. Authorizes $20 million for the period of fiscal years 2018-2022.