POLICY BRIEFINGS
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.
THIS WEEK'S BRIEFING - MARCH 14, 2022
- Congress Passes $1.5 Trillion Omnibus Bill
- House to Consider Standalone COVID Bill This Week
- HELP Leadership Introduces ARPA-H, Pandemic Preparedness Legislation
- House Democrats Meet for Policy Retreat
- Senate Democrats to Hold Hearings on Cost-Cutting Proposals
- Grassley Asks FTC to Reconsider PBM Study
- Wyden Continues AbbVie Investigation
- Lawmakers Request Money for Long COVID Research
- Democrats Push for Public Option in FY23 WH Budget
- Lawmakers Push for Value-Based Care Incentives
- E&C Members Request Information on COVID-19 and Mental Health
- Schultz, DeGette Urge FDA to Deny E-Cig Applications
- DeLauro, Obama Announce Breakthrough COVID Cases
- MDUFA V Framework Submitted to Congress
- OSHA to Increase Inspections of High Hazard Health Facilities
- Moderna to Coordinate with COVAX to Supply Vaccine
- Upcoming Congressional Hearings and Markups
- Recently Introduced Health Legislation
Congress Passes $1.5 Trillion Omnibus Bill
Congress has passed a $1.5 trillion spending bill (H.R. 2471) that will fund the federal government through the remainder of the fiscal year (FY) 2022 and includes $13.6 trillion to respond to Russia’s invasion of Ukraine. The defense portion of the package passed on a 361 to 69 vote in the House of Representatives and the domestic agency funding passed on a 260 to 171 vote. The package later cleared the Senate in a 68-31 vote. The legislation provides $730 billion for non- defense discretionary spending, a 6.7% increase, and features the first earmark spending since the practice was banned in 2011. The bill includes at least 2,727 earmarks totaling $4.2 billion. Democrats had pushed to include $15.6 billion in emergency COVID-19 funding in the omnibus package, but that money was ultimately struck from the bill in response to disagreements over how to offset its cost. The initially proposed legislation would have clawed back $7 billion in an unused state and local coronavirus aid.
Under the spending bill, the U.S. Department of Health and Human Services (HHS) will receive $108.3 billion, an $11.3 billion increase over FY21. The National Institutes of Health would receive $45 billion in funding, a $2.25 billion increase compared to FY21 enacted levels. The government spending deal includes $1 billion to fund the Advanced Research Projects Agency for Health (APRA-H). The bill also provides the Food and Drug Administration (FDA) with new authority to regulate synthetic nicotine and e-cigarette products. The bill includes an extension of many Medicare telehealth waiver authorities, such as the expansion of originating sites and eligible practitioners, an extension of telehealth services to Federally Qualified Health Centers (FQHCs) and Rural Health Centers (RHCs), and use of telehealth in recertification for hospice care five months beyond the conclusion of the current public health emergency (PHE). The omnibus also includes a temporary measure to allow employers to resume covering telehealth for employees with health savings accounts (HSAs) before annual deductibles are met. Such flexibility was instituted through prior COVID response legislation but expired at the end of 2021. The new provision will not cover the first quarter of 2022 and applies only to the period from April 1 through December 31, 2022. The omnibus also provides for a mandated Medicare Payment Advisory Commission (MedPAC) study on the impact of telehealth on Medicare spending and beneficiary care.
Congress also passed a four-day stopgap spending bill to extend government funding beyond the expiration of the prior continuing resolution (CR) at midnight on March 11. This stopgap through March 15 was signed into law by President Joe Biden on Friday, providing time for the 2,700-page omnibus bill to be proofread, printed, and signed into law.
House to Consider Standalone COVID Bill This Week
Democrats will vote this week on a $15.6 billion standalone measure (H.R. 7007) providing money for pandemic testing and treatment. The COVID Supplemental Appropriations Act would be partially offset by rescinding $8.6 billion in unobligated money from previous pandemic relief laws, including $4.85 billion from the Paycheck Protection Program. It includes $10.6 billion for the Public Health and Social Services Emergency Fund, much of which will be made available to the Biomedical Advanced Research and Development Authority (BARDA) to procure vaccines and therapeutics. $750 million would be allocated for the development of vaccines targeting emerging coronavirus variants, and $4.45 billion would go toward global health programs. An additional $425 million would be set aside for international disaster assistance. The bill’s potential to pass the evenly divided Senate remains unclear. Republicans have asked for more information on previously appropriated, unspent funds before they will agree to provide more money for COVID-19 relief. The bill will not be fully offset, as the initially proposed state and local clawback has been stripped from the legislation. The administration has stated that this $15 billion request will only be enough to support COVID operations in the short term and that an additional funding request should be expected.
HELP Leadership Introduces ARPA-H, Pandemic Preparedness Legislation
Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.) introduced legislation last week to establish the Advanced Research Projects Authority for Health (ARPA-H). The ARPA-H Act would house the new agency within the National Institutes of Health (NIH). ARPA-H, which was first proposed in President Joe Biden’s fiscal year (FY) 2022 budget, would focus on transforming and advancing cutting-edge biomedical research. The latest omnibus government funding bill included $1 billion for the creation of ARPA-H.
Murry and Burr also officially introduced the PREVENT Pandemics Act last week, ahead of the bill’s scheduled markup on March 15. The bill includes several measures that were not a part of the previously released discussion draft, including a provision to strengthen security in high-level biocontainment labs. It also adds a proposal to prevent undue foreign influence in biomedical research, adding a statutory requirement for researchers funded by the NIH to disclose participation in foreign talent programs.
House Democrats Meet for Policy Retreat
House Democratic lawmakers convened in Philadelphia last week for a caucus retreat to prioritize their legislative agenda before the November midterm elections. The caucus discussed the pursuit of various parts of their Build Back Better tax and social spending package, legislation focused on U.S. competitiveness with China, and a voting rights bill that is less comprehensive than the legislation Congress failed to pass earlier this year. Lawmakers are considering restarting negotiations on a scaled-back version of Build Back Better, which could be passed through the budget reconciliation process requiring only a simple majority to clear the Senate.
Senate Democrats to Hold Hearings on Cost-Cutting Proposals
In a Dear Colleague letter sent last week, Senate Majority Leader Chuck Schumer (D-N.Y.) announced that many Senate committees will hold hearings and mark ups in March and April on Democrats’ cost-cutting proposals. The Senate Finance Committee has already scheduled a March 16 hearing on lowering the cost of prescription drugs. Witnesses from the American Action Forum, Information Technology and Innovation Foundation, and National Multiple Sclerosis Society are set to testify.
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