Health Care Watch: November 29, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 29 – December 6. 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
Advance Premium Tax Credits
On December 3, Sen. Josh Hawley (R-MO) announced the No Taxes on Healthcare Act that would allow all taxpayers to deduct up to $25,000 per person in medical expenses, including out-of-pocket premium costs. The plan would expand eligibility beyond current rules, which limit medical expense deductions to itemizers whose costs exceed 7.5% of adjusted gross income. This is intended to serve as an alternative to extending the expanded ACA premium subsidies.
On December 4, Sen. Lisa Blunt Rochester (D-DE) introduced the Restoring Patient Protections and Affordability Act. The legislation would renew the enhanced premium tax credits for 3 years, extend the 2026 Open Enrollment period, reduce paperwork for families, and lower out-of-pocket caps.
On December 4, Senate leaders continued negotiations over how to address the December 31 expiration of the Affordable Care Act (ACA) enhanced and expanded advance premium tax credits (APTCs), with party leaders preparing for a December 11 floor vote while acknowledging that a bipartisan agreement on a long-term approach has not yet emerged.
On December 4, Senate Minority Leader Chuck Schumer (D-NY) announced that Senate Democrats will offer a three-year “clean” extension of the enhanced APTCs during the upcoming floor vote, while some Senate Republicans signaled openness to short-term extensions paired with broader affordability reforms.
House Speaker Mike Johnson (R-LA) said the House GOP is expected to release legislation early in the week of December 8 to address health insurance affordability. This bill is rumored to include reforms to Health Savings Accounts (HSAs) and pharmacy benefit managers (PBMs), among other policies. The plan is for the House to consider this legislation in December, with the goal of this bill giving Republicans something to support in lieu of extending the enhanced ACA premium subsidies.
House
On December 2, the Ways & Means Oversight Subcommittee held a hearing titled Lives at Stake: Holding Tax-Exempt Organ Procurement Organizations (OPOs) Accountable which examined oversight challenges and performance variation among OPOs. Members discussed audit findings, accountability gaps, and potential policy updates to improve transparency and ensure timely access to organ donation and transplantation services.
Senate
On December 3, the Health, Education, and Labor (HELP) Committee held a hearing titled Making Health Care Affordable Again: Healing a Broken System which focused on factors contributing to high health care costs and opportunities to improve affordability for patients. Witnesses and Senators raised issues including insurance coverage, payment system incentives, and barriers that limit access to lower-cost care options.
On December 3, the Aging Committee held a hearing titled Aging in Place: The Impact of Community during the Holidays which explored how social connection, caregiving support, and community-based resources affect older adults’ ability to remain safely at home. Witnesses highlighted challenges faced by caregivers, gaps in long-term services and supports, and opportunities to strengthen community infrastructure during high-need periods such as the holiday season.
On December 4, Finance Committee Ranking Member Ron Wyden, (D-OR) introduced the Fast Track Apprenticeship Act that would help address the ongoing health care labor shortage by making it easier for health care employers to create new registered apprenticeship programs to train the next generation of health professionals.
On December 4, Finance Committee Chairman Mike Crapo (R-ID) and Ranking Member Wyden introduced the bipartisan Pharmacy Benefit Manager Price Transparency and Accountability Act, which would delink PBM compensation from rebate amounts, increase reporting requirements, and direct more transparent pass-through of payments to pharmacies in federal programs.
REGULATORY UPDATE
On November 29, a leaked internal FDA memo from the agency’s top vaccine regulator, Vinay Prasad, indicated that the agency is considering significant changes to its vaccine regulatory framework. The memo outlines a proposal to require larger pre-market randomized clinical trials that directly measure clinical outcomes for most new vaccines, and states that vaccines for use in pregnancy would no longer be approved based on surrogate endpoints alone. The memo also references internal analyses of voluntary reports submitted to the Vaccine Adverse Event Reporting System (VAERS); however, FDA historically cautions that VAERS reports do not establish causality.
On December 1, CMMI announced a new 10-year voluntary model, the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, which will test a new outcome-aligned payment approach in Original Medicare for certain Medicare Part B-enrolled organizations to expand access to technology-supported care options that help people prevent and manage chronic disease. Beginning July 2026, participating Part B organizations will receive recurring payments that are tied to measurable patient outcomes rather than service volume. ACCESS includes four clinical tracks addressing common chronic conditions: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health. Organizations must apply by April 1, 2026, to join the initial performance period.
On December 1, Kirk Milhoan was named as the new chair of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and Robert Malone was named as the Vice Chair. Martin Kulldorff, the previous Chair has been appointed as chief science officer for the Department of Health & Human Services’ (HHS’) Office of the Assistant Secretary for Planning and Evaluation.
On December 2, FDA issued an RFI soliciting feedback on scientific, regulatory, and practical strategies to increase patient access to nonprescription drugs approved through the new drug application (NDA) pathway. The agency is specifically seeking input on development challenges, new data sources to support approvals, and therapeutic areas suitable for prescription-to-OTC switching in preparation for a public meeting planned for 2026.
On December 2, Richard Pazdur resigned as Director of the Center for Drug Evaluation and Research (CDER), reportedly following disagreements with FDA Commissioner Marty Makary over the National Priority Voucher program. On December 3, Tracy Beth Høeg, a sports medicine physician who currently serves as a senior deputy to Makary, was appointed to replace Pazdur. Høeg becomes the fifth leader of CDER this year and has previously drawn attention for questioning the safety and effectiveness of COVID-19 vaccines.
On December 2, it was reported that FDA removed Theresa Michele, longtime director of the Office of Nonprescription Drugs, from her position and reassigned her to a leadership role within the agency’s medical devices center. An HHS official confirmed the change and indicated that the move aligns with efforts to refocus the office’s work on affordability under Commissioner Makary’s direction.
On December 2, HHS repealed provisions of the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting Final Rule, originally finalized by CMS. HHS takes this action after determining the final rule imposed by the Biden Administration disproportionately burdened facilities, especially those serving rural and Tribal communities, and jeopardized patient’s access to care.
On December 4, HHS unveiled a department-wide artificial intelligence (AI) strategy outlining a “One HHS” approach to AI governance, infrastructure, workforce development, research, and delivery-system modernization, with an emphasis on risk management, transparency, and reproducibility.
On December 5, ACIP voted 8-3 to eliminate the universal recommendation for the Hepatitis B vaccine birth dose, revising guidance to “suggest” that infants of mothers who test negative receive the shot no earlier than two months. The birth dose recommendation remains only for infants whose mothers test positive or have an unknown status. The meeting deviated from standard protocol, with presentations delivered by outside researchers rather than career CDC subject matter experts, drawing criticism from dissenting panel members and medical associations who characterized the proceedings as political rather than scientific.
On December 5, FDA announced a new pilot program called the TEMPO (Technology-Enabled Meaningful Patient Outcomes) Pilot designed to operate in parallel with the new CMMI ACCESS Model. Under the TEMPO Pilot, manufacturers of digital technologies participating in the ACCESS Model may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data during ACCESS participation and use it to support future FDA submissions. FDA will initially select up to ten manufacturers per clinical use area, focusing on four clinical tracks aligned with ACCESS as listed above. FDA will collect statements of interest for participation in the TEMPO pilot beginning January 2, 2026.
WHITE HOUSE
On December 1, President Trump signed the SUPPORT for Patients and Communities Reauthorization Act into law. This bill reauthorizes and updates federal programs aimed at addressing substance use disorders, including measures to expand naloxone access, strengthen prescription drug monitoring programs, and support treatment and recovery services.
On December 1, the Administration announced a new pharmaceutical trade agreement between the U.S. and the U.K. Under the deal, the U.K. committed to increasing the net price the National Health Service (NHS) pays for new medicines by 25% and reducing rebate repayment rates under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) to 15% starting in 2026. In return, the U.S. will exempt U.K.-origin pharmaceutical products from Section 232 tariffs, refrain from targeting U.K. pricing practices in Section 301 investigations, and support access to advanced medicines for U.K. patients.
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
Center for Medicare & Medicaid Innovation Payment Models (CMS-5544); Proposed Rule; 8/19/25
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
HEARINGS
House
Energy & Commerce Committee
December 12; 9:00AM; 2123 Rayburn
Senate
HELP Committee
Examining the Future of the U.S. Organ Procurement and Transplantation Network
December 11; 10:00AM; 430 Dirksen
Witnesses: TBD
REPORTS
Office of the Inspector General (OIG)
On December 3, the OIG issued a report finding that podiatrists’ claims for evaluation and management services did not comply with Medicare requirements.
On December 2, the OIG issued a report concluding that the Florida Retina Institute generally met Medicare requirements for ophthalmology services provided on the same day as eye injections.
On December 2, the OIG issued a report finding that New Jersey did not ensure providers complied with Federal and State requirements at all 20 adult day health services facilities audited.
On December 1, the OIG issued a report determining that Medicare improperly paid selected optometrists for services provided to enrollees at nursing facilities.
REPORTS
Government Accountability Office (GAO)
On December 3, GAO issued a preliminary report on its covert efforts to identify fraud within the ACA premium subsidies. GAO found that the federal Marketplace approved coverage for nearly all of GAO's fictitious applicants in plan years 2024 and 2025, which was largely consistent with its findings in plan years 2014 through 2016. GAO cautioned that its covert testing is illustrative and cannot be generalized to the enrollee population. This finding will likely bolster the GOP’s general opposition to extending the enhanced and expanded premium subsidies that expire at the end of the year.
ADDITIONAL POLICY NEWS
On December 1, Lilly announced that it is reducing cash prices for single-dose vials of its weight-loss medication Zepbound on its LillyDirect platform to between $299 and $449 per month, depending on dose, as part of broader efforts to expand affordability and access to GLP-1 therapies.
On December 2, MedPAC and MACPAC released an updated data book on Medicare–Medicaid dually eligible beneficiaries using 2022 data, including new information on Medicaid service use and spending for individuals enrolled in comprehensive Medicaid managed care and highlighting the diversity of needs within this population.
On December 3, a new advocacy organization representing independent physicians launched. The new group called IndeMed plans to focus on issues such as prior authorization, reimbursement transparency, practice model innovation, and implementation of the No Surprises Act through a nonprofit structure and affiliated PAC.
On December 4, the American Hospital Association and multiple health systems filed suit against the administration seeking to halt the 340B Rebate Model Pilot Program slated to begin on January 1, 2026. The lawsuit contends that the mandatory shift to rebates violates administrative law and would inflict substantial financial damage on safety-net providers by requiring them to purchase drugs at full wholesale price and absorb administrative costs while awaiting reimbursement.