Health Care Watch: November 8, 2025

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 8 – November 16. 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

Federal Government Shutdown Update

• On November 10, the Senate voted 60-40 to approve a continuing resolution to fund much of the government through January 30, 2026, paired with a three-bill minibus that funds Agriculture-FDA, Military Construction-VA, and the Legislative Branch through September 30, 2026. Eight Democrats broke with their party to join Republicans in supporting the measure, while one Republican opposed it. The package also reversed layoffs for federal workers that occurred during the shutdown and barred future reductions in force through January. Senate Minority Leader Chuck Schumer (D-NY) opposed the package and drew criticism from progressives for failing to secure an extension of the enhanced and expanded Affordable Care Act (ACA) premium subsidies that expire at the end of this year.  Instead, Senate Majority Leader John Thune (R-SD) committed to hold a vote on extending the subsidies, in a manner chosen by Senate Democrats, in December.  

• On November 12, the House passed the bill by a 222-209 vote, with six Democrats supporting and two Republicans opposing. President Trump signed the bill that evening, officially ending a record 43-day shutdown. 

• Reports suggest that White House officials are exploring ways to provide financial assistance to those impacted by the expiration of the enhanced and expanded ACA subsidies, including by sending direct payments to these individuals rather than sending the subsidies to their insurance companies. The late timing and complexity of such an arrangement may deem this alternative unworkable.

House

• On November 8, Energy & Commerce Committee Chairman Brett Guthrie (R-KY), responded to the U.S. Department of Health & Human Services’ (HHS’) recall of ByHeart Whole Nutrition Infant Formula due to an outbreak of infant botulism. Chairman Guthrie emphasized the Committee’s history of oversight on infant formula safety and supply, praised President Trump’s Food & Drug Administration (FDA) for its work through Operation Stork Speed, and expressed gratitude to HHS Secretary Robert F. Kennedy, Jr., and FDA Commissioner Marty Makary, MD, for advancing efforts to protect children and mothers. 

• On November 11, Budget Committee Chairman and Ways & Means Committee member Jodey Arrington (R-TX) announced that he will not seek re-election. Rep. Lloyd Smucker (R-PA) has expressed his interest in replacing Chairman Arrington as the top Republican on the committee.  

• On November 12, Rep. Adelita Grijalva (D-AZ) was sworn into Congress, concluding a period marked by legal disputes and procedural tensions over her seating after she won a special election to replace her late father in the seat. 

• On November 12, Democratic leaders introduced a discharge petition to advance legislation extending expiring ACA subsidies for three years. Led by House Minority Leader Hakeem Jeffries (D-NY), the effort seeks to secure 218 signatures, which would need support from moderate Republicans, to bring the measure to the floor despite opposition from House GOP leadership. The proposal centers on maintaining financial assistance for health coverage, with the petition serving as a procedural tool to ensure consideration of the legislation.

REGULATORY UPDATE

• On November 10, FDA released a fact sheet on menopausal hormone replacement therapy products and asked manufacturers to remove longstanding black box warnings on hormone therapy products for menopausal women, citing updated evidence of cardiovascular and other health benefits. Specifically, the agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.  

• On November 12, FDA Commissioner Makary announced that Richard Pazdur, MD, will lead the Center for Drug Evaluation and Research (CDER) following Dr. George Tidmarsh’s resignation. Dr. Pazdur, a 26-year agency veteran and head of the Oncology Center of Excellence, is credited with advancing integrated review approaches and streamlining cancer drug approvals. He will continue to oversee oncology until a successor is named.  

• On November 12, CMS announced the issuance of the revised Medicare Drug Selection Information Collection Request (ICR) for IPAY 2028. The Drug Selection ICR includes three parts: (1) Small Biotech Exception that includes the information necessary for CMS to determine if a qualifying single source drug meets the requirements to be excluded from negotiation; (2) Biosimilar Delay that includes the information necessary for CMS to determine if the reference product of a biosimilar qualifies for a delay of inclusion as a negotiation-eligible drug; and (3) Renegotiation-Eligible Drugs that includes a voluntary submission of data from Primary Manufacturers of selected drugs to inform CMS’ determinations of which selected drugs qualify as a renegotiation-eligible drug and may be selected for renegotiation. Responses are due by December 12, 2025.  

• On November 12, FDA Commissioner Makary and FDA Chief Medical and Scientific Officer Vinay Prasad published a roadmap in the New England Journal of Medicine detailing how the agency plans to expand approval of custom gene-editing treatments. The new “plausible mechanism pathway” would allow companies or research groups to gain FDA approval to produce bespoke gene editors for multiple patients under one authorization, rather than requiring separate approvals for each drug. They noted that the new pathway will prioritize rare diseases, particularly those that are fatal or associated with severe disability in childhood. 

• On November 12, CDC announced that the Advisory Committee on Immunization Practices (ACIP) will meet December 4-5 to discuss vaccine safety, childhood and adolescent immunization schedules, and hepatitis B vaccines, including the controversial recommendation for universal Hepatitis B vaccination at birth.  

WHITE HOUSE

• On November 12, the Official MAHA Summit was held, bringing together federal health officials and industry leaders to discuss topics including psychedelics, food as medicine, and aging. Vice President JD Vance attended and participated in a public conversation with HHS Secretary Kennedy, while the remainder of the summit sessions were conducted privately.

HEARINGS 

Senate 

• Finance Committee 

November 19, 10:00 AM, 215 Dirksen

The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans

Witnesses:  Douglas Holtz-Eakin, President, American Action Forum; Jason Levitis, Senior Fellow, Health Policy Division, Urban Institute; Brian Blase, President, Paragon Health Institute; and Bartley Armitage, Exchange plan enrollee.

• Health, Education, Labor and Pensions Committee 

November 19, 10:00 AM, 430 Dirksen

Examining the Future of the U.S. Organ Procurement and Transplant Network

House 

• Ways and Means Committee

Subcommittee on Health

November 19; 2:00 PM

Modernizing Care Coordination to Prevent and Treat Chronic Disease

RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)

Pending Review

CMS

• Medicaid Managed Care – State Directed Payments (CMS-2449); Proposed Rule; 6/9/25

• 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

• Medicare and Medicaid Programs; Repeal of Minimum Staffing Standards for Long-Term Care Facilities; Interim Final Rule; 8/22/25

• Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs (CMS-4212); Proposed Rule; 9/4/25

• 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

• CY 2026 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1830); Final Rule; 10/8/25

• CY 2026 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1834), Final Rule, 10/9/25

• CY 2026 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8090); Notice; 10/22/25

• CY 2026 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8089); Notice; 10/22/25

• Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2026 (CMS-8091); Notice; 10/22/25

• CY 2026 Home Health Prospective Payment System Rate and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Updates (CMS-1828); Final Rule, 10/24/25

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

• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability; Notice; 9/2/25

• 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

• Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability; Notice; 9/29/25

• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability; Notice; 9/29/25

• Monoclonal Antibodies: Streamlined Nonclinical Safety Studies; Draft Guidance for Industry; Availability; Notice, 11/03/25

REPORTS

Office of the Inspector General (OIG)

• On November 10, the OIG issued a memo transmitting to the Center for Medicaid and CHIP Services the findings of the Kentucky State Auditor’s report, How Kentucky Failed to Prevent Over $800 Million of Medicaid Waste. 

ADDITIONAL POLICY NEWS

• On November 8, ByHeart announced a voluntarily recall of two batches of ByHeart Whole Nutrition Infant Formula following notification from the FDA of a broader ongoing investigation into a recent outbreak of infant botulism.

• On November 11, Children’s Health Defense, formerly led by HHS Secretary Kennedy, outlined plans to challenge vaccine requirements and expand transparency on adverse events. The group’s agenda emphasizes cultural and policy change around vaccine access and communication.  

• On November 12, U.S. Catholic bishops voted to make official a ban on gender-affirming care for transgender patients at Catholic hospitals. The step formalizes a years-long process for the U.S. church to address transgender health care. The bishops overwhelmingly approved revisions to their ethical and religious directives that guide the nation’s thousands of Catholic health careinstitutions and providers.