Health Care Watch: December 15, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 15 – December 20. Where available, hyperlinks are included to 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) Subsidies
On December 16, House Speaker Mike Johnson (R-LA) and the Rules Committee declined to grant a GOP moderate-backed amendment vote to extend the enhanced ACA subsidies for one or two years as part of a broader health care package.
On December 17, the House passed a Republican-led health care bill as the House leadership response to concerns about coverage and cost. The bill included provisions to expand association health plans, allow employers to provide pre-tax money to employees who purchase health coverage on their own, fund ACA cost-sharing reduction subsidies, increase pharmacy benefit manager transparency and oversight, and other provisions. The bill passed by a vote of 216-211. The bill does not extend enhanced ACA premium tax credits.
On December 17, moderate House Republican Reps. Brian Fitzpatrick (R-PA), Mike Lawler (R-NY), Rob Bresnahan (R-PA), and Ryan Mackenzie (R-PA) joined all Democrats in signing House Minority Leader Hakeem Jeffries’ (D-NY) discharge petition to force the House to consider a standalone three-year extension of enhanced subsidies. Their support brought the petition to the required 218 signatures. This policy already failed in the Senate on December 12 which suggests that further negotiations are needed if the subsidies are to be extended prior to a looming January 30, 2026, deadline to fund the government and extend a host of other expiring health care policies.
On December 18, Congress adjourned for the remainder of the year.
House
On December 18, 26 Republicans sent a letter to President Trump urging him not to reclassify marijuana from a Schedule I to a Schedule III controlled substance. On December 17, a group of 22 Republican senators sent a similar letter to President Donald Trump. The lawmakers argued that relaxing marijuana to Schedule III would pose public health and workforce risks, citing concerns related to mental health, pregnancy outcomes, and worker productivity. On December 18, President Trump issued the Executive Order (EO) anyway, stating that reclassification could expand opportunities for marijuana research by easing regulatory barriers.
On December 19, Rep. Elise Stefanik (R-NY) announced that she was ending her campaign for governor and that she would not run for her House seat in 2026.
Senate
On December 17, Finance Committee Ranking Member Ron Wyden (D-OR) released draft legislation aimed at reforming the organ transplant system by strengthening national standards for organ procurement organizations and clarifying Centers for Medicare & Medicaid Services (CMS) certification authority.
On December 17, Sens. Ted Budd (R-NC) and Maggie Hassan (D-NH) introduced the bipartisan Biosimilar Inspection Modernization Act to modernize FDA inspections for biosimilar drugs and address inspection-related delays.
On December 18, the Senate failed to overturn a U.S. Department of Health & Human Services (HHS) rule via a Congressional Review Act resolution (S.J. Res. 82) by a vote of 50-50. The Senate attempted to overturn HHS’ removal of the Richardson waiver which allows the Agency, in certain circumstances, to bypass notice-and-comment requirements under the Administrative Procedure Act for rules related to grants, benefits, or contracts. The vote largely split along party lines, with Sens. Collins, Murkowski, and Thom Tillis (R-NC) voting in favor alongside Democrats.
On December 19, Sen. Cynthia Lummis (R-WY) announced that she will not seek re-election.
REGULATORY UPDATE
On December 15, CMS published the 2025 Measures Under Consideration (MUC) List on the Measures Management System (MMS) Hub. The MUC List is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. This year there are 24 unique measures included for consideration, of which ten are currently implemented in Medicare programs. Public comments are due by January 6, 2026.
On December 15, the Food & Drug Administration (FDA) awarded a National Priority Voucher to teclistamab in combination with daratumumab for relapsed or refractory multiple myeloma under the Commissioner’s National Priority Voucher (CNPV) pilot program. The decision followed the release of Phase 3 clinical trial data showing improved progression-free and overall survival, with results published in the New England Journal of Medicine.
On December 15, FDA Commissioner Dr. Marty Makary stated that the agency has no plans to add a black box warning to COVID-19 vaccines, refuting reports suggesting a potential label change. Makary noted that safety concerns tied to early dosing schedules, such as myocarditis risks when doses were administered three months apart, do not necessarily apply to the current annual dosing regimen.
On December 15, FDA issued new guidance allowing certain drug and medical device applications to rely on real-world evidence (RWE) without requiring identifiable individual patient data in all cases. The agency stated it will assess the strength of submitted evidence on an application-by-application basis, expanding the potential use of large de-identified datasets such as registries, claims data, and electronic health records.
On December 15, HHS Secretary Robert F. Kennedy, Jr. convened Lyme disease patients, clinicians, researchers, and lawmakers for a roundtable discussion on diagnostic challenges and clinical needs related to Lyme disease. HHS also announced that CMS issued guidance clarifying support for Medicare beneficiaries with Lyme disease through the Chronic Care Management program.
On December 16, the Centers for Disease Control and Prevention (CDC) updated its hepatitis B vaccination guidance to recommend shared clinical decision-making for newborns whose mothers test negative for the virus. Newborns at higher risk will continue to receive the vaccine at birth, consistent with prior recommendations.
On December 16, HHS Secretary Kennedy approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. The panel serves as guidance for states when determining which conditions to include in newborn screening programs.
On December 18, the CDC announced the award of approximately $1.6 million over five years to the University of Southern Denmark to support a randomized controlled trial evaluating the effects of neonatal monovalent hepatitis B vaccination in Guinea-Bissau. The study aims to generate evidence on the broader health impacts of the hepatitis B birth dose, which are less well understood than those of other vaccines commonly administered at birth in low-income settings.
On December 18, CMS’ Center for Medicare & Medicaid Innovation (CMMI) announced the Long-term Enhanced Accountable Care Organization (ACO) Design (LEAD) Model, a new voluntary ACO model set to launch following the conclusion of ACO REACH at the end of 2026. The LEAD Model will run for a 10-year performance period from January 1, 2027, through December 31, 2036, and is designed to address financial and administrative barriers that have limited provider participation in ACOs, including for smaller, independent, rural, and specialty practices. CMS stated that applications to participate will open through a Request for Applications (RFA) beginning in March 2026.
On December 19, CMMI issued proposed rules announcing two new drug pricing models: the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model for Part D drugs and the Global Benchmark for Efficient Drug Pricing (GLOBE) Model for Part B drugs. These 5-year models will test alternative inflation rebate amounts for selected drugs when domestic prices exceed those in economically comparable countries. Participation would be mandatory for all manufacturers of selected drugs under the models. The models would be implemented in selected geographic areas representing approximately 25 percent of beneficiaries. Implementation is scheduled to begin October 1, 2026, for GLOBE and January 1, 2027, for GUARD. Comments on the proposals are due by February 23, 2026.
On December 19, HHS issued a Request for Information (RFI) on Accelerating the Adoption and Use of Artificial Intelligence as part of Clinical Care. The RFI seeks feedback on how HHS can accelerate the adoption of AI in clinical settings through regulatory, reimbursement, and research and development policy levers. Comments are due by February 21, 2026.
On December 19, FDA awarded two National Priority Vouchers under the CNPV pilot program to enlicitide decanoate, an oral PCSK9 inhibitor for lowering LDL cholesterol, and sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate. FDA stated the products were selected for their potential to improve affordability and access for patients, bringing the total number of products receiving a voucher under the program to 18 since its launch in June 2025.
WHITE HOUSE
On December 16, President Donald Trump signed an EO classifying fentanyl as a weapon of mass destruction, citing its lethality and its role in funding transnational criminal organizations. The EO provides the federal government with additional legal authorities to combat fentanyl trafficking and frames the issue as a national security threat.
On December 17, the Trump administration terminated several federal grants awarded to the American Academy of Pediatrics, including funding for programs focused on sudden infant death syndrome, rural access to care, and fetal alcohol syndrome. HHS stated the grants no longer aligned with departmental priorities, while the organization warned the decision could impact child and family health programs nationwide.
On December 19, the White House announced new voluntary Most Favored Nation (MFN) agreements with nine drug manufacturers, bringing the total number of participating companies to 14. The agreements include commitments to provide MFN pricing in Medicaid, guarantee MFN pricing for new medicines, offer discounted direct-to-consumer pricing through TrumpRx.gov, invest collectively at least $150 billion in U.S. manufacturing, and contribute active pharmaceutical ingredients to the Strategic Active Pharmaceutical Ingredients Reserve. President Trump stated that three remaining manufacturers that received MFN requests have not yet signed agreements and indicated additional announcements are expected soon.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
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
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
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
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability; Notice; 12/17/25
Medical Devices with Indications Associated with Weight Loss--Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 12/18/25
REPORTS
HHS Office of the Inspector General (OIG)
On December 12, the OIG released an evaluation examining trends in dual-eligible enrollees’ access to prescription drugs under Medicare Part D from 2011 through 2025. The OIG found that most Part D plans covered almost all of the drugs that dual-eligible enrollees commonly use since 2011, and coverage of these drugs has exceeded 90 percent over the last 10 years, reaching 98% in 2025.
On December 12, the OIG published a report assessing how excluding noncovered self-administered versions of Stelara biosimilars when setting Medicare Part B payment amounts would have affected fourth-quarter 2025 Part B rates. The report found that excluding these self-administered versions that are not covered under Part B would have lowered Stelara biosimilar payment amounts by 59 to 87 percent, representing savings of up to $3,765 per vial. The OIG recommends that CMS exercise its authority to remove these versions from future payment amount calculations.
On December 15, the OIG released a Medicare home health agency provider compliance audit of Guardian Home Care, LLC, assessing compliance with applicable Medicare requirements.
On December 16, the OIG issued an audit examining whether selected health centers received duplicate reimbursement from HHS’ Health Resources and Services Administration (HRSA) for COVID-19 testing services.
Congressional Research Service (CRS)
On December 16, CRS released an In Focus report providing an overview of the Medicare Wasteful and Inappropriate Service Reduction (WISeR) Model. The report describes the model’s purpose and design and places it in the context of CMS efforts to reduce wasteful or inappropriate services under Medicare.
On December 16, CRS published a report outlining the rules governing Medicare fee-for-service (FFS) payment schedules and related resources. The report describes how payment schedules are established and maintained and identifies key statutory and regulatory resources relevant to Medicare FFS payment policies.
Government Accountability Office (GAO)
On December 19, GAO released a report examining barriers people with disabilities may face in accessing health care and reviewing federal data collection and oversight efforts related to accessibility. GAO identified barriers such as inaccessible diagnostic equipment and sensory challenges in care settings and found that HHS does not collect national-level data from people with disabilities on health care accessibility. The report also found that CMS and HHS’ Office for Civil Rights oversee aspects of accessibility compliance, but that oversight and information sharing have been limited. GAO made five recommendations, including that HHS develop plans to collect national-level accessibility data and strengthen oversight efforts.
ADDITIONAL POLICY NEWS
On December 16, 32BJ Health Fund and Northwell Direct announced a direct health care contract covering approximately 170,000 participants that expands access to the Northwell Direct provider network. Under the agreement, 32BJ Health Fund estimates first-year savings of approximately $46 million (20%) driven by lower negotiated prices and reduced administrative costs, while lowering member cost sharing and maintaining access to the existing Anthem network.