Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Congress Adjourns for the Year with Passage of FY 2020 Funding

Congress successfully passed and the President signed legislation to fund the federal government until October 1, 2020, ahead of Friday’s deadline to avoid a government shutdown. The 12 fiscal year (FY) 2020 spending measures totaling $1.4 trillion were combined into two minibus packages for passage. The legislation increases spending by $49 billion across the entirety of the federal government.

The Labor, Health and Human Services, and Education; Agriculture; State and Foreign Operations; Military Construction and Veterans Affairs; Transportation and Housing and Urban Development; Energy and Water; Interior and Enviornment; and Legislative Branch package (H.R. 1865) contained $534.4 billion in discretionary spending. The Labor-HHS-Education portion of the bill totaled $184.9 billion in discretionary appropriations, an increase of $4.9 billion above fiscal 2019.

The legislation included repeal of the Affordable Care Act’s (ACA) 40 percent “Cadillac tax” on high-cost health plans, 2.3 percent medical device excise tax, and the annual fee on health insurers – all of which have been repeatedly suspended. Repeal of the taxes is not offset in the bill; the Congressional Budget Office (CBO) estimates that these provisions will cost the federal government $377 billion in lost revenue over the next decade. The minibus to fund non-defense agencies will also prevent the administration from ending automatic re-enrollment in ACA plans and health insurer silver loading.

H.R. 1865 includes the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which aims to address a tactic allegedly used by pharmaceutical manufacturers to delay generic competition. The bill would allow generic companies to sue innovators for the alleged misuse of Risk Evaluation and Mitigation Strategies (REMS) to withhold product samples from the generic firms. CREATES would help pay for a five-month delay of Medicaid disproportionate share hospital (DSH) cuts and a short-term extension of several federal health programs through May 22. Lawmakers hope to use this deadline to revisit the issues of surprise billing, drug pricing, and lowering health care costs more broadly.

Extenders contained in the funding package include community health centers; National Health Service Corps; Teaching Health Center Graduate Medical Education Program; Special Diabetes Program and Special Diabetes Program for Indians; Work Geographic Price Cost Index; State Health Insurance Assistance Programs; Area Agencies on Aging; Aging and Disability Resource Centers; Certified Community Behavioral Health Clinic demonstration, Money Follows the Person demo, and Health Profession Opportunity Grants. The bill would extend Medicaid funding for U.S. territories for an additional two years. The Patient-Centered Outcomes Research Trust Fund would be extended for 10 years and is directed to prioritize research in the areas of maternal mortality and intellectual and developmental disabilities.

The Food and Drug Administration (FDA) would receive a total of $5.87 billion in funding, an increase of $196.3 million above current levels. The domestic spending bundle would prevent products that are scheduled to transition from the drug to biological pathway in 2020 from receiving any additional exclusivity. The spending deal also includes a provision to raise the legal age for purchasing tobacco and nicotine vaping products to 21; the Agriculture-FDA report language calls for an analysis within 60 days of enactment of next steps to address reports of lung illnesses associated with the use of e-cigarette and vaping products.

The bill also increases funding for the National Institutes of Health (NIH) by $2.6 billion. The Centers for Disease Control and Prevention (CDC) and the NIH will each receive $12.5 million to research gun violence and ways to prevent it. It is the first time in more than 20 years that Congress has appropriated funds to study deaths and injuries from guns.

The bill also appropriates funding for opioid treatment, prevention, and research, including $1.5 billion for state opioid response grants, $475.6 million for opioid overdose prevention and surveillance through the CDC, and $89 million for medication-assisted treatment (MAT) programs.

The Substance Abuse and Mental Health Services Administration (SAMHSA) would receive $19 million for the Suicide Prevention Lifeline, an increase of $7 million over last year. An additional $7 million increase is provided for the Zero Suicide Program, which provides tools, training, and outreach to health care systems to adopt effective suicide prevention strategies.

The Veterans Health Administration (VHA) would receive $93.1 billion, including $87.6 billion in advance funds for fiscal 2021. The bill provides $8.91 billion in fiscal 2020 and $11.31 billion in fiscal 2021 to implement the VA MISSION Act and $1.5 billion, an increase of $393 million, for the VA’s new electronic health record (EHR) system. It also includes policy provisions to require the Department of Veterans Affairs (VA) to provide immediate assistance from trained professionals when veterans call the department’s toll-free suicide hotline and will bar the use of funds for certain medical research involving canines, felines, or nonhuman primates.

The bill provides $5.93 billion for HIV/AIDS programs at the State Department and would designate $1.56 billion for the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

The eight-bill minibus was passed by the House by a vote of 297-120 on Tuesday and by the Senate on Thursday by a vote of 71-23. Opposition came from lawmakers concerned about increasing the deficit. The bill was signed into law by the President on Friday.

The House of Representatives has adjourned for the year and will reconvene for the second session of the 116th Congress on January 7. The Senate will reconvene on January 3, but no roll call votes are scheduled until January 6.

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