Health Policy Report (5/23)

Capitol Hill Update

The Senate will reconvene for legislative business on Tuesday to close out the May work period. Absent a breakthrough deal on COVID-related funding packages for health care and small businesses, it is likely that senators will primarily focus on confirming pending Biden administration nominees for the balance of the week. The Small Business COVID Relief Act (S. 4008) — which would provide roughly $48 billion toward additional relief aid for restaurants and other small business industries that have been adversely impacted by the COVID-19 pandemic — failed to meet the 60-vote threshold to advance in the evenly-divided chamber late last week. While the supplemental funding package for Ukraine was able to clear with strong bipartisan support, funding measures to support health-related pandemic needs and small businesses have struggled to gain traction in the 50-50 Senate. 

Meanwhile, negotiations on a new COVID-19 funding bill for health care needs are expected to continue this week as House Democratic leadership pushes for a vote as soon as possible. Reports out of Capitol Hill suggest that House Democrats are poised to introduce a new COVID-19 funding package for health care needs as the Senate’s Bipartisan COVID Supplemental Appropriations Act remains on ice. While it is not yet clear what the structure of the new legislation will look like, both parties will need to navigate wide divisions over funding offsets before additional funding for testing, therapeutics, vaccines, and more can be passed in both chambers.

In addition to potential votes on a COVID-19 supplemental funding bill, House lawmakers are scheduled to consider: (1) a bill that would reauthorize programs under the Workforce Innovation and Opportunity Act (WIOA); (2) legislation that seeks to give the President additional authority to prevent energy pricing hikes during an “energy emergency;” and (3) an act that would provide an increased allocation of funding under certain programs for areas of persistent poverty.

Energy and Commerce Marks Up User Fee, Mental Health Packages

On Wednesday, the House Energy and Commerce Subcommittee on Health held a markup (TRP analysis) of six bills, including a bill to reauthorize user fees and a bipartisan package to reauthorize several programs administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). All six pieces of legislation passed out of the Subcommittee and are expected to be considered by the full Committee next week. Notably, the Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education (KIDS CARE) Act and the South Asian Heart Health Awareness Act of 2021 were approved with additional changes to the underlying bill.

While some lawmakers called for the inclusion of some amendments — such as those that would require remanufacturing guidance from the Food and Drug Administration (FDA), oversight of medical device shortages, patient-focused drug development, and lifting the inmate limitation on benefits under the Medicaid program, among other provisions — Full Committee Chair Frank Pallone (D-NJ) explained that he plans to avoid altering the bill in any way that could risk losing bipartisan agreement. Some lawmakers offered amendments to raise awareness for certain issues, though they ultimately withdrew the revisions.

HHS Urges States to Prepare for End of PHE

On Tuesday, the Department of Health and Human Services (HHS) sent a letter to state governors urging them to prepare for the end of the COVID-19 public health emergency (PHE). The timing of the letter falls just before HHS would need to provide states with 60-days’ notice ahead of a decision to terminate the PHE, as the agency promised earlier this year. Experts remain on the fence in handicapping a PHE extension with 60-days’ notice, with a plethora of predictions making it difficult to discern a consensus. Despite the uncertainty, many insiders — including Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) Commissioner Tricia Brooks — are confident that the PHE will be extended. HHS’s letter to governors comes as several stakeholders are urging the Biden administration to extend the PHE until October. 

Notably, an end to the PHE would require states to commence a Medicaid redetermination process. Congress passed a maintenance-of-effort requirement in the first year of the pandemic as a means to prevent beneficiaries from losing coverage during COVID-19. However, advocacy groups are concerned that over 16 million Medicaid and CHIP beneficiaries could lose coverage once HHS terminates the PHE. State Medicaid agencies will have 14 months to complete the determination process, though HHS’s letter notes that states can maintain certain PHE flexibilities to ease the potential coverage losses. Specifically, HHS outlined that suspending premiums, limiting cost-sharing, increasing provider payments, and altering provider enrollment requirements can mitigate the impact of redetermination on beneficiaries. 

House Labor, HHS Committee Evaluates Programs Related to Aging Adults

On Wednesday, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing (TRP analysis) entitled, “Healthy Aging: Maximizing the Independence, Wellbeing, and Health of Older Adults.” Throughout the hearing, members asked questions related to the prevention of falls, nutrition, mental health, and elder justice for aging adults to improve the quality of life as they age and require greater assistance. After witnesses provided statistical evidence and examples of the varied needs of older adults, bipartisan support arose for stronger investments in cost-effective federal senior-specific programs.

Additionally, witnesses raised concerns about the expiration of COVID-19 relief funds, affordability of prescription medications, and shortages in the health care workforce. Notably, witnesses assured members that there is enough data for Congress to be able to evaluate current federal mechanisms for seniors to see how such mechanisms may need to be extended, expanded, and implemented in different areas.

FDA Rolls Out Program to Develop Rare Disease Therapies

Last week, the Food and Drug Administration (FDA) launched the Accelerating Rare disease Cures (ARC) Program (press release) to expedite the development of rare disease treatments. FDA’s Center for Drug Evaluation and Research (CDER) launched this program as lawmakers in Congress have increasingly requested policies to improve upon rare disease drug development. FDA notes that many of these challenges include difficulty in designing clinical trials and in selecting clinical endpoints. The first year of the ARC Program will be centered around strengthening the agency’s partnerships, ranging from those within FDA to the private sector.

House Appropriations Committee Considers President’s FY 2023 Budget Request for NIH

Yesterday, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing (TRP analysis) to consider President Joe Biden’s fiscal year (FY) 2023 budget request (TRP analysis) for the National Institutes of Health (NIH). In late March, the Biden administration released its FY 2023 request, which includes a $49 billion funding request for the NIH.

Throughout the hearing, members heard from a panel of witnesses who oversee Centers and Institutes within the NIH on their intent to research maternal and child health, cancer, COVID-19, and opioid use, as well as how the agency plans to incorporate diversity and inclusion into such efforts. Also of interest to lawmakers were details on the proposed Advanced Research Projects Agency for Health (ARPA-H), President Biden’s “Cancer Moonshot” initiative, and mental health and substance use disorder (SUD) research. Notably, during the hearing, Acting Director Lawrence Tabak confirmed that march-in rights are currently under consideration by the NIH in the context of a broader plan that the Department of Health and Human Services (HHS) has for lowering drug prices.