McDermott+ Check-Up: September 19, 2025 - McDermott+

McDermott+ Check-Up: September 19, 2025

THIS WEEK’S DOSE


  • House passes CR. The continuing resolution (CR) then moved to the Senate.
  • Former top CDC officials testify at Senate HELP Committee. Former Centers for Disease Control and Prevention (CDC) Director Monarez and former CDC Chief Medical Officer Houry told the committee that they were pressured to sign off on policies that weren’t scientifically supported.
  • House Ways and Means Oversight Subcommittee examines nonprofit hospitals. Members sought to address gaps between hospital profits and the use of hospitals’ community benefit.
  • House Energy and Commerce Committee advances health bills. The six health bills passed unanimously.
  • House Ways and Means Committee, Energy and Commerce Health Subcommittee take action on healthcare innovation bills. Both committees examined bills related to Medicare coverage of breakthrough technologies, with the Energy and Commerce Health Subcommittee holding a legislative hearing and the Ways and Means Committee advancing four bills with bipartisan support.
  • Senate Aging Committee holds hearing on drug supply chains. Discussion focused on facility oversight and domestic manufacturing.
  • ACIP updates vaccine schedule. The Advisory Committee on Immunization Practices (ACIP) reviewed several vaccinations and made recommendations.
  • OPTN scrutiny continues. The US Department of Health and Human Services continues efforts to address safety concerns within the organ procurement and transplantation network (OPTN).
  • CMS continues implementing Rural Health Transformation Program. The Centers for Medicare & Medicaid Services (CMS) released additional details about the application process.
  • CMS releases MA and Part D final rule. This is the second final rule to address proposals that would make policy and technical changes to the Medicare Advantage (MA) and Medicare Part D programs and were released in December 2024.

CONGRESS


House passes CR. As the clock ticks down to the September 30, 2025, government funding deadline, the House unveiled a stopgap CR this week that would extend funding through November 21, 2025. The CR would also extend several expiring health programs, including Medicare telehealth flexibilities, community health center funding, and the Medicare-dependent hospital program. The House voted 217 – 212 along mostly party lines to pass the bill on September 19, 2025. The CR then went to the Senate, where it needs at least seven Democratic votes to achieve the 60 votes necessary to overcome the threat of a filibuster.

Democrats have spoken out against the CR, as they are advocating that it must also address healthcare access issues and they say that Republicans have refused to negotiate with them on that front. Democrats introduced their own alternative CR, S. 2882, that would extend government funding through October 31, 2025, and make permanent the enhanced advanced premium tax credits (APTCs), which are set to expire at the end of the year, resulting in Marketplace premium increases if left unaddressed. The Democrats’ draft also includes other priorities, such as the repeal of all healthcare provisions in the One Big Beautiful Bill Act (OBBBA). Both CRs were voted on in the Senate today (September 19, 2025), and both bills failed to achieve the necessary 60 votes, mostly along party lines. For now, a stalemate remains, and Congress is scheduled to be in recess next week. Whether they come back sooner than that remains to be seen.

In response to a request from Senate Democrats, the Congressional Budget Office (CBO) officially released an analysis on extension of the enhanced APTCs that was previously shared with Congress informally by email. The CBO document also analyzes repeal of OBBBA’s healthcare provisions and the nullification of the June 2025 Marketplace rule.

The enhanced APTCs have not been a completely partisan issue. Earlier this month, a group of moderate House members introduced H.R. 5145, a bill to extend the enhanced APTCs for another year, and this week Sen. Murkowski (R-AK) introduced S. 2824, a bill to extend them for two years. It also has been reported that some Senate Republicans, including Sens. Tuberville (R-AL) and Sullivan (R-AK), have been discussing potential APTC policy changes. Finally, while reinforcing that the current CR should not include such a change, CMS Administrator Oz this week highlighted ways the administration could implement the policy if Congress were to act later this fall. It is possible that members could strike a deal to extend the enhanced APTCs alongside government funding and a shutdown would be averted; it is also possible that the disagreement will lead to a shutdown.

Former CDC officials testify at Senate HELP Committee. During the hearing, former CDC Director Monarez told the Senate Health, Education, Labor, and Pensions (HELP) Committee that she was fired because US Department of Health and Human Services (HHS) Secretary Kennedy asked her to commit to firing career CDC officials and approving ACIP recommendations without evaluating them independently first, and she refused. Republican members focused on restoring public trust in the CDC through radical transparency and emphasized the need for accountability in vaccine policy decisions. Democratic members highlighted the need to protect scientific integrity and public health, and argued that Monarez was fired for refusing to support anti-vaccine policies and warning against the dangers of politicizing science and spreading misinformation. Chair Cassidy (R-LA) stayed neutral between Secretary Kennedy and former Director Monarez but emphasized the president’s call for transparency. He also spoke in support of keeping the recommendation for the Hepatitis B vaccine at birth, which contradicted the views of some Republicans on the committee.

House Ways and Means Oversight Subcommittee examines nonprofit hospitals. Republican members focused on gender-affirming care services; diversity, equity, and inclusion initiatives; and climate initiatives as a violation of nonprofit hospitals’ community benefit and an improper use of funds. While members from rural districts from both sides of the aisle agreed nonprofit hospitals were important, some Republican members emphasized that profits did not match the care they provided to the needy. Democratic members drew attention to the Trump administration’s cuts to Medicaid and resistance to extending the APTCs and emphasized that those programs go together with nonprofit care to protect patients’ health, especially in rural and underserved communities. Witnesses generally noted that more competition in the hospital market would help maintain nonprofit hospitals’ community benefit as intended.

House Energy and Commerce Committee advances health bills. The markup included seven bills; six were health-related and were unanimously advanced by the full committee:

  • H.R. 2493, the Improving Care in Rural America Reauthorization Act of 2025.
  • H.R. 3419, to amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs.
  • H.R. 3302, the Healthy Start Reauthorization Act of 2025.
  • H.R. 2846, to amend Title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under Title 10, US Code, to commissioned officers of the Army (or their beneficiaries).
  • H.R. 1262, the Give Kids a Chance Act of 2025.
  • H.R. 1843, to amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

House Ways and Means Committee, Energy and Commerce Health Subcommittee take action on healthcare innovation bills. The House Energy and Commerce Health Subcommittee held a legislative hearing on several policies related to Medicare coverage of breakthrough medical technologies:

  • H.R. 842, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer early detection screening tests.
  • H.R. 5343, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, which would provide a Medicare coverage pathway for breakthrough devices.
  • Discussion draft to amend Title XVIII of the Social Security Act to ensure transparency in the national coverage determination process under the Medicare program and to make certain adjustments to Medicare local coverage determinations.
  • H.R. 3826, the Expanding Access to Diabetes Self-Management Training Act of 2025, which would expand coverage for diabetes outpatient self-management training services and would require the CMS Innovation Center to test a model covering the services virtually.

The House Ways and Means Committee also advanced H.R. 842 (unanimously) and H.R. 5343 (in a 38 – 3 vote). In the same markup, the committee also advanced the following bills unanimously:

  • H.R. 4313, the Hospital Inpatient Services Modernization Act, which would extend the acute hospital at home waiver flexibilities through 2030.
  • H.R. 5347, the Health Care Efficiency Through Flexibility Act, which would modernize accountable care organization quality reporting requirements.

Senate Aging Committee holds hearing on drug supply chains. Both witnesses and committee members agreed that changes were needed to the generic supply chain. Committee members agreed that US Food and Drug Administration inspectors need more support in order to investigate potential violations, especially in foreign countries. Chair Scott (R-FL) emphasized the power China has over the United States because of its supply of pharmaceuticals, and stressed the importance of domestically manufacturing drugs.

ADMINISTRATION


ACIP updates vaccine schedule. Prior to the ACIP meeting, HHS Secretary Kennedy appointed five more members to the committee. The meeting agenda included discussion on measles, mumps, rubella, and varicella (MMRV); hepatitis B; and COVID-19 vaccine recommendations. ACIP also announced the establishment of a working group to review shots typically recommended during pregnancy.

Because of concerns about these changes, a bicameral group of Democratic health committee leaders introduced the Protecting Free Vaccines Act, which would require all health plans to continue covering vaccines recommended by ACIP as of October 2024 without cost sharing. Currently, health plans are required to cover all ACIP-recommended vaccines without cost sharing, which means that if ACIP changes recommendations, patients may newly face cost sharing on certain vaccines.

OPTN scrutiny continues. For the first time, HHS will decertify an organ procurement organization midcycle in response to allegations of unsafe practices and chronic underperformance. The OPTN board of directors will also designate an OPTN patient safety director, and each organ procurement organization will appoint an OPTN patient safety officer. In a press conference, HHS also announced significant investments in programs for living donors and research to find alternatives to organ donation.

In related news, bipartisan House Energy and Commerce Committee leaders requested a briefing from the Health Resources and Services Administration on its ongoing oversight of patient safety in OPTN.

CMS continues implementing Rural Health Transformation Program. CMS announced that the application deadline for states is November 5, 2025, with an optional letter of intent due by September 30, 2025. The notice of funding opportunity (NOFO) stresses that states are the only eligible applicants, but notes that states can partner with other entities. States are required to submit a project summary, a project narrative, a budget narrative, a governor’s endorsement, and other supporting materials and attachments. Per the NOFO, application scoring details and factors include:

  • Rural population size in the state.
  • Proportion of rural health facilities in the state.
  • Uncompensated care in the state.
  • Percentage of the state population located in rural areas.
  • Metrics defining a state as being a frontier state.
  • Total area (square miles) of the state.
  • Percentage of hospitals in the state receiving Medicaid disproportionate share hospital payments.

The NOFO also details technical score factors, including population health clinical infrastructure, health and lifestyle initiatives, Supplemental Nutrition Assistance Program waivers, continuing medical education related to nutrition, strategic partnerships, emergency medical services, Medicaid provider payment incentives, data on dual-eligibles, data infrastructure, and consumer-facing technology and digital health tools. Awardees will be announced by December 31, 2025.

CMS releases MA and Part D final rule. The final rule only addresses submission of provider directory information for inclusion on the Medicare Plan Finder website and states that, beginning January 1, 2026, MA plans will be required to:

  • Submit provider directory data to CMS for online publication in accordance with guidance from CMS or HHS.
  • Update provider directory data within 30 days of the date that the plan becomes aware of changes to data previously submitted.
  • Attest (at least annually) that the submitted provider directory information is accurate.

In the December 2024 proposed rule, CMS had also proposed to require that plans attest that submitted provider directory information is consistent with data submitted as part of meeting MA network adequacy standards. CMS is not finalizing that proposal, as the agency believes plans already attest to meeting network adequacy requirements. A number of additional provisions from the proposed rule remained unaddressed, including items relating to internal coverage criteria used in prior authorization decisions, star ratings, the use of debit cards to administer supplemental benefits, and pharmacy contracting for Part D plans.

In related news, after announcing in August 2025 that data on MA plan provider directories would be added to Medicare Plan Finder in advance of the 2026 annual enrollment period, CMS informed plans last week that individuals who enroll through Medicare Plan Finder and later learn that the provider directory information on the site was incorrect will be permitted a special enrollment period in 2026. CMS expects to release information on 2026 plan options on October 1, 2025, and the annual enrollment period will begin on October 15, 2025.

QUICK HITS


  • GAO releases studies on Medicaid Section 1115 demonstrations. One US Government Accountability Office (GAO) study, requested by Republican members of Congress, calls for CMS to fully implement 2002 GAO recommendation for budget neutrality. Another report evaluates Georgia’s work requirement demonstration and calls for CMS to implement 2019 GAO recommendations to account for administrative costs and improve federal oversight.
  • HHS takes steps to stop youth vaping. HHS released a Youth Vaping Resource Guide with actionable steps geared towards parents and caregivers, educators, healthcare providers, researchers, regulators, and retailers to combat the ongoing youth vaping epidemic.
  • MACPAC holds September public meeting. The Medicaid and CHIP Payment and Access Commission (MACPAC) agenda included sessions on Medicaid work requirements, home- and community-based services, children and youth with special healthcare needs coverage transitions, healthcare access for children in foster care, Medicaid for justice-involved youth, and Medicare-Medicaid plan transition.
  • House passes veterans telehealth bill. H.R. 1107, the Protecting Veteran Access to Telemedicine Services Act of 2025, passed the House by voice vote. The bill would extend the current exemption that allows Veterans Affairs health professionals to prescribe medically necessary controlled substances to veterans via telemedicine under certain conditions, without an in-person medical examination.

NEXT WEEK’S DIAGNOSIS


Congress is scheduled to be in recess next week, although this could change depending on government funding negotiations.