Health Care Watch: December 6, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 6 – December 12. Where available, hyperlinks are included in the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
Enhanced Affordable Care Act (ACA) Premium Subsidies
Two relevant discharge petitions were filed in the House that are currently supported by enough Republicans that, if most Democrats signed, could pass the House. The discharge petition is a way to force a vote on legislation even if it is opposed by leadership if the petition secures 218 signatures. It is not yet clear if the Senate would consider either bill if one were to pass the House.
On December 10, Rep. Brian Fitzpatrick (R-PA) filed a discharge petition to force a House vote on the Bipartisan Health Insurance Affordability Act, which would extend the enhanced ACA premium subsidies for two years for those earning less than 700% of poverty, charge a minimum monthly premium, adopt pharmacy benefit manager (PBM) reforms (including a ban on Medicaid spread pricing and passing through the full rebate at the point of sale), strengthen insurance broker oversight, and expand Health Savings Accounts (HSAs). There are currently 24 Members signed onto the discharge petition, equally divided between Republicans and Democrats.
On December 10, Rep. Josh Gottheimer (D-NJ) filed a separate discharge petition for the Common Ground for Affordable Health Care Act, which would extend the enhanced ACA premium subsidies for one year for those making less than 1,000% of poverty and includes the same PBM and insurance broker reforms as the Fitzpatrick bill. There are currently 39 Members signed onto the discharge petition, consisting of 11 Republicans and 28 Democrats.
On December 11, Senators defeated the GOP health care plan that would have funded health savings accounts as an alternative to the expiring subsidies for those under 700% of poverty ($1,000 for those aged 18 to 49 and $1,500 for those aged 50-64), appropriate money for ACA marketplace cost sharing reduction subsidies, extend eligibility for marketplace Copper level plans, and reduce funding to states that provide coverage for illegal immigrants. The bill failed by a vote of 51-48; 60 votes were needed to advance the legislation. Senator Paul (R-KY), joined with all Democrats and Senator King (I-ME) in voting no. The Senate Democrats’ bill to extend the Covid-era enhanced subsidies for three years also failed by a 51-48 vote. Four Republicans joined with all Democrats and Senator King in voting yes: Senators Collins (R-ME, Hawley (R-MO), Murkowski (R-AK), and Sullivan (R-AK)
On December 12, House GOP leadership released health care legislation, which it expects to consider the week of December 15, that does not include an extension of the enhanced subsidies. However, there are discussions that an amendment to extend the subsidies will be offered to the bill by GOP moderates. The legislation would fund the ACA cost-sharing reduction subsidies starting in 2027, increase PBM oversight and transparency, expand Association Health Plans (AHPs) to allow small businesses and self-employed to join together and purchase group coverage, allow employers to offer defined contributions to their employees to purchase coverage on their own with pre-tax dollars, and provide stop-loss insurance to small and mid-size employers against catastrophic health claims. It is unclear right now if this bill can pass the House and, if it does, what its prospects are in the Senate.
House
On December 10, the Ways & Means Committee held a markup to consider various bills, including H.R. 4993, the Joe Fiandra Access to Home Infusion Act of 2025, which would allow certain infusion pumps and their associated drugs to be administered at home under Medicare and require the U.S. Department of Health and Human Services (HHS) to notify beneficiaries of any cost-sharing differences between home and facility-based infusion. Lawmakers raised concerns about higher out-of-pocket costs for home infusion, with discussion highlighting the lack of a cost-sharing cap for home-based services compared to hospital settings. An amendment to cap drug prices for home infusion at levels paid in peer countries failed and the committee ultimately advanced the bill unanimously (41–0).
During the week of December 15, the House is expected to consider H.R. 498, the Do No Harm in Medicaid Act, which would prohibit federal funding of gender transition procedures for minors in the Medicaid program.
Senate
On December 11, the HELP Committee held a hearing on “Examining the Future of the U.S. Organ Procurement and Transplantation Network” and looked into the current state of the transplantation network and discussed ways it can be improved.
On December 11, Finance Committee Ranking Member Ron Wyden (D-OR) led seven Democratic senators in letters to AstraZeneca, Lilly, Novo Nordisk, and Pfizer asking for specific pricing information on which drugs will be affected by the drug pricing agreements announced with President Trump, what the “most favored nation” price is for those drugs, and what state Medicaid programs will pay in the wake of these announcements. The Senators asked for responses by January 30, 2026.
REGULATORY UPDATE
On December 8, the Centers for Medicare & Medicaid Services (CMS) released new guidance detailing how states must implement the community engagement requirements (aka “work requirements) established under the One Big Beautiful Bill Act. The policy requires states to connect able-bodied, working-age adults with work or community engagement activities as a condition of Medicaid coverage. States must comply no later than January 1, 2027. CMS indicated it is currently drafting an interim final rule and that it will issue additional guidance and rulemaking by June 2026.
On December 9, the Food & Drug Administration (FDA) granted the first approval under the Commissioner’s National Priority Voucher (CNPV) pilot program to Augmentin XR (amoxicillin-clavulanate potassium), completing the review in just two months. FDA noted that the Augmentin XR application demonstrated alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. FDA added that the approval will also help address antibiotic shortages in the U.S.
On December 9, FDA announced the qualification of its first artificial intelligence (AI)-driven drug development tool, intended for use in metabolic dysfunction-associated steatohepatitis (MASH) clinical trials. The tool leverages AI to optimize dose selection and trial design, potentially improving the efficiency and predictability of clinical development programs.
On December 9, National Institutes of Health (NIH) designated Richard Woychik, a longtime NIH leader and former environmental health chief, as Senior Adviser for the Make America Healthy Again (MAHA) strategy, a cross-agency initiative under HHS Secretary Robert F. Kennedy Jr. aimed at addressing chronic disease and strengthening preventive health research. In this role, Woychik will help coordinate research priorities across NIH institutes and centers, emphasizing data-driven prevention, health resilience, and scientific approaches to chronic disease burden.
On December 9, Director of FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad and senior CBER officials published a perspective in the medical journal JAMA outlining a significant shift in the agency’s evidentiary expectations for new CAR-T cell therapies. The article states that while single-arm trials may still support accelerated approval in settings with limited treatment options, traditional approval will now generally require randomized controlled trials demonstrating the superiority of the investigational CAR-T therapy over existing products.
On December 9, FDA initiated a fresh safety review of recently approved RSV prevention therapies for infants, including Sanofi/AstraZeneca’s Beyfortus and Merck’s Enflonsia, following external criticism and questions about potential safety signals.
On December 9, FDA approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for Wiskott–Aldrich syndrome in patients six months and older who are eligible for hematopoietic stem cell transplant but lack a suitable HLA-matched related donor. The therapy uses genetically modified autologous stem cells to correct the underlying immune defect and is expected to carry a very high upfront cost typical of one-time gene therapies.
On December 10, CMS released a transmittal detailing the Calendar Year 2026 Home Health Prospective Payment System rate update, including payment instructions and policy changes effective for the upcoming calendar year.
On December 11, FDA approved Flow Neuroscience’s FL-100, the first at-home, non-drug device for treating moderate to severe major depressive disorder in adults – offering an alternative to typical antidepressants. The headset delivers low-intensity transcranial direct current stimulation (tDCS) to mood-related brain regions and is intended for prescription use at home, either as monotherapy or adjunctive therapy for patients who are not treatment-refractory to medications.
On December 11, CMS published a proposed rule to update the Increasing Organ Transplant Access (IOTA) Model for Performance Year 2. CMS is proposing to revise IOTA performance measures (including risk adjustment for composite graft survival), transparency requirements, beneficiary protections, equity planning, repayment policies, and monitoring actions based on early implementation experience and stakeholder feedback. CMS is accepting public comments through February 9, 2026.
On December 11, CMS’ Center for Medicare & Medicaid Innovation (CMMI) unveiled MAHA ELEVATE, a voluntary model that will provide $100 million in three-year cooperative agreements to up to 30 awardees to test evidence-based, whole-person interventions not currently covered by Original Medicare. The model aims to build an evidence base around functional and lifestyle medicine approaches to address chronic disease and may inform future Medicare coverage decisions. The model is launching on September 1, 2026 with a Notice of Funding Opportunity (NOFO) expected in early 2026. Eligible applicants include medical practices, health systems, ACOs, academic research organizations, FQHCs/RHCs, and community-based organizations.
On December 11, CMS issued two transmittals related to National Coverage Determination (NCD) 20.40, which addresses Medicare coverage for renal denervation (RDN) for uncontrolled hypertension. The transmittals provide implementation instructions and effective dates associated with the updated NCD.
On December 11, CMS issued a transmittal instructing Medicare Administrative Contractors to provide education regarding the Review Choice Demonstration (RCD) for Inpatient Rehabilitation Facilities providers physically located in and bill to Texas and to then expand education efforts to IRFs who bill to all the states in Jurisdiction H (AR, CO, LA, MS, NM, OK, TX).
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth (CMS-2451); Proposed Rule; 7/18/25
Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children (CMS TBD); Proposed Rule; 8/7/25
Transparency in Coverage (CMS-9882); Proposed Rule; 8/20/25
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/21/25
Ensuring Safety through Domestic Security with Made in America PPE and Essential Medicine Procurement by Medicare Providers and Suppliers (CMS-1516); Prerule; 9/12/25
Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545); Proposed Rule; 9/25/25
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546); Proposed Rule; 10/2/25
HHS Notice of Benefit and Payment Parameters for 2027 (CMS-9883); Proposed Rule, 11/14/25
Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole (CMS-2448); Final Rule, 11/17/25
Advance Notice of Methodological Changes for Calendar Year (CY) 2027 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies; Notice; 12/04/25
FDA
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Notice; 7/10/25
Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability; Notice; 8/21/25
Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 9/9/25
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry (final guidance); Notice; 9/12/25
New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability; Notice; 11/26/25
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Notice; 12/01/25
Substances Generally Recognized as Safe; Proposed Rule; 12/01/25
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval; Notice; 12/05/25
REPORTS
Office of the Inspector General (OIG)
On December 9, OIG issued a report concluding that the Indian Health Service (IHS) did not ensure that background investigations for Commissioned Corps officers consistently complied with federal requirements.
On December 9, OIG released a report finding that Arkansas could improve oversight of Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs) to ensure compliance with federal requirements related to life safety, emergency preparedness, and infection control.
On December 10, OIG released a report finding that NIH generally implemented the federal Safe Workplace reporting requirement, but identified opportunities to improve reporting consistency, documentation, and monitoring processes.
Government Accountability Office (GAO)
On December 10, GAO released testimony summarizing preliminary results from its ongoing review of fraud risk management in the Advance Premium Tax Credit (APTC) under the Affordable Care Act. GAO’s covert testing found that the federal Marketplace approved subsidized coverage for nearly all fictitious applicants submitted for plan years 2024 and 2025, consistent with similar findings from GAO’s 2014–2016 reviews.
On December 12, GAO issued a report entitled VA Electronic Health Record Modernization:
Critical Actions Needed to Support Accelerated System Deployments. GAO has made a total of 18 recommendations in prior reports to VA to improve its EHRM efforts, 12 of which were deemed “priority recommendations.” GAO found that the VA fully implemented two of its 18 recommendations and partially implemented one priority recommendation.
Congressional Research Service (CRS)
On December 9, CRS released a report examining recent developments related to the NIH indirect cost policies for research grants. The analysis reviews congressional actions, appropriations directives, and legislative proposals affecting indirect cost reimbursement rates, as well as ongoing debates over transparency, institutional equity, and federal oversight.
On December 10, CRS published a frequently asked questions report addressing how the scheduled expiration of enhanced ACA premium tax credits may affect Marketplace premiums in 2026. The report summarizes how premium tax credits were expanded under recent legislation and explains how changes in subsidy levels could influence net premiums, enrollment, and plan affordability across income groups.
On December 11, CRS released a report comparing work and community engagement requirements in Medicaid and the Supplemental Nutrition Assistance Program (SNAP) following enactment of Public Law 119-21. The report outlines key similarities and differences in eligibility standards, exemptions, enforcement mechanisms, and administrative processes, and places the new Medicaid requirements in the context of longstanding SNAP work policies.
ADDITIONAL POLICY NEWS
On December 11, the Indiana Senate voted against a proposed congressional redistricting plan that would have altered the state’s current district boundaries with the goal of netting two additional GOP House seats. The proposal was supported by President Trump and his allies.