Health Care Watch: November 17, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 17 – November 22. 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
House
On November 17, Energy & Commerce Committee Chairman Brett Guthrie (R-KY) and Oversight and Investigations Subcommittee Chairman John Joyce, M.D. (R-PA) sent a letter to the Centers for Medicare & Medicaid Services (CMS) requesting a briefing to better understand the Department of Health & Human Services’ (HHS) recent actions and ongoing work to enhance safety within the organ procurement and transplantation system.
On November 19, Ways & Means Committee Chairman Jason Smith (R-MO) and Oversight Subcommittee Chairman David Schweikert (R-AZ) requested documents and transcribed interviews with more than 30 employees and executives of the New Jersey Sharing Network (NJTO), an organ procurement organization under Committee’s investigation.
On November 19, the Ways & Means Health Subcommittee held a hearing on “Improving Care Coordination for Chronic Disease.” Members highlighted gaps in communication across care settings and emphasized the need for data-sharing reforms to reduce duplication and improve outcomes.
On November 20, Senate Health, Education, Labor, and Pensions Committee Ranking Member Bernie Sanders (I-VT) and Energy & Commerce Ranking Member Frank Pallone (D-NJ) sent a letter to the Food & Drug Administration (FDA) expressing their concerns and requesting additional information about the Commissioner’s National Priority Voucher (CNPV) program that the FDA announced on June 17, 2025.
On November 21, Ways & Means Committee member and co-chair of the Problem Solvers Caucus Rep. Brian Fitzpatrick (R-PA) proposed extending the expanded Affordable Care Act (ACA) premium subsidies with income limitations, eliminating $0 premiums, and reforms to health savings accounts. House GOP members will continue to discuss options to potentially extend the subsidies beyond 2025.
On November 21, Rep. Majorie Taylor Green (R-GA) announced that she will resign on January 5, 2026, following criticism and a primary threat from President Trump.
Senate
On November 17, as an alternative to extending the enhanced and expanded ACA marketplace premium subsidies, Sen. Bill Cassidy (R-LA) outlined a proposal to direct federal dollars into Health Savings Accounts (HSAs) to help offset rising premiums. The approach would encourage some marketplace enrollees to transition to lower-premium bronze plans while receiving additional HSA support.
On November 17, Finance Committee Ranking Member Ron Wyden (D-OR) and Minority Leader Chuck Schumer (D-NY), and seven Senate Democrats urged President Trump to release the list of the most recent Medicare-negotiated drug prices. These prices are due to be released by November 30.
On November 18, HELP Committee Ranking Member Sanders sent a letter to his Democratic colleagues urging them to come together around common sense health care policies to make health care more affordable and accessible for every American family, in addition to extending the ACA enhanced premium subsidies.
On November 19, the Finance Committee held a hearing on “The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans” and examined drivers of rising health care spending and costs and potential solutions. Witnesses pointed to prescription drug costs and provider consolidation as key contributors and urged long-term structural reforms.
On November 19, the Special Committee on Aging held a hearing on “Restoring Trust in U.S.-Made Medicines” and assessed efforts to strengthen domestic pharmaceutical manufacturing. Participants underscored the importance of supply chain resilience and incentives to expand U.S.-based production.
On November 20, Finance Committee Ranking Member Wyden and Sen. Mark Warner (D-VA) called on CMS to provide seniors enrolled in Medicare Advantage with more information when a significant number of doctors or hospitals leave a network mid-year.
REGULATORY UPDATE
On November 17, CMS issued an HPMS notice announcing that Congress has extended Part D coverage for prescription oral antivirals for COVID-19 that remain authorized under an Emergency Use Authorization (EUA). Under section 6211 of the newly enacted Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, these EUA-labeled products will continue to be treated as Part D drugs through January 30, 2026, with the extension retroactive to October 1, 2025.
On November 17, HRSA updated its website to indicate that Novartis is now participating in the 340B Rebate Model Pilot Program for Entresto, with its rebate model authorized to begin April 1, 2026. The pilot program is open only to drug manufacturers for drugs selected to be negotiated under the Medicare Drug Negotiation Program for Initial Price Applicability Year (IPAY) 2026. Novartis had been the only remaining IPAY 2026 manufacturer not yet participating.
On November 17, Novo Nordisk announced immediate price reductions for Ozempic and Wegovy to $349 per month for cash-paying customers. Prices are expected to decrease further over the next two years based on the Trump-administration’s Most Favored Nation (MFN) agreement with Novo Nordisk. In addition, Ozempic and Wegovy are “selected drugs” for IPAY 2027 Medicare price negotiation, with negotiated prices expected to be revealed later this month.
On November 17, the U.S. Supreme Court declined to review the FDA’s decision denying fast-track designation for Vanda Pharmaceuticals’ gastroparesis drug. A lower court previously ruled that FDA reasonably determined the drug did not meet expedited-approval criteria.
On November 17, CMS Administrator Mehmet Oz, MD, delivered remarks at the American Medical Association’s (AMA) semiannual meeting. His comments focused on health care policy and the role of artificial intelligence in clinical practice.
On November 18, CMS released the New Technology Add-on Payments (NTAP) tracking forms for technologies seeking NTAPs under the FY 2027 Inpatient Prospective Payment System (IPPS). In total, 36 technologies applied for NTAP for FY 2027: 12 under the Traditional Pathway and 24 under the Alternative Pathway (for Breakthrough Devices and certain qualified antimicrobial products). The forms provide preliminary details on each applicant as CMS begins its FY 2027 NTAP review process.
On November 19, CDC removed assurances on its website that vaccines don’t cause autism and added language suggesting a possible link. Various medical associations condemned the changes, including the AMA, the Infectious Diseases Society of America and the American Academy of Pediatrics.
On November 20, 2025, CMS issued the Calendar Year (CY) 2026 End-Stage Renal Disease Prospective Payment System (ESRD PPS) Final Rule. The Final Rule advances Medicare policy for dialysis providers for CY 2026, including fee-for-service payments and quality related programs. CMS estimates that the updates for CY 2026 would increase total payments to all ESRD facilities by 2.2%. CMS estimates aggregate Medicare payments under the ESRD PPS would increase by approximately $180 million in CY 2026 compared to CY 2025.
On November 21, 2025, CMS issued the CY 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule. The rule includes a 2.6% payment update for hospitals meeting quality reporting requirements for CY 2026. CMS finalizes several policy changes, including expanding the “site-neutral” volume control policy to drug administration services in excepted off-campus provider-based departments (PBDs), maintaining a 0.5% OPPS conversion factor reduction to offset prior 340B-related overpayments, and strengthening hospital price transparency requirements – among other policies. Notably, the rule also includes a significant change to the MS-DRG relative weight methodology under the Inpatient Prospective Payment System (IPPS) by shifting inpatient hospital payment to a market-based approach using Medicare Advantage (MA) negotiated rate data.
WHITE HOUSE
On November 17, the Trump administration proposed reinstating a policy allowing immigration officials to deny permanent residency to lawfully present immigrants who use or are expected to use Medicaid, food aid, or housing assistance. Officials said the goal is to promote self-sufficiency, while critics argued it could discourage access to needed programs. The Department of Homeland Security will accept public comments for 30 days before determining next steps.
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 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
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
CY 2026 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8090); Notice, 11/14/25
CY 2026 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8089); Notice, 11/14/25
Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2026 (CMS-8091); Notice, 11/14/25
CY 2026 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1830); Final Rule, 11/19/25
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, 11/20/25
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.
On November 17, the OIG issued a report finding that the National Institutes of Health needs to improve the cybersecurity of the All of Us Research Program to better protect participant data.
On November 18, the OIG issued a report on the comparison of average sales prices (ASP) and average manufacturer prices (AMP) for the second quarter of 2025.
On November 18, the OIG issued a report determining that nearly all skilled nursing services provided by Pinnacle Multicare Nursing and Rehabilitation Center did not meet Medicare payment requirements.
On November 20, the OIG issued a report finding that CMS put $11.2 billion at risk of fraud, waste, and abuse by not properly closing contracts.
On November 20, the OIG issued a report finding that dermatology providers generally met Medicare requirements for evaluation and management services performed on the same day as minor surgical procedures.
On November 21, the OIG issued an updated report on annual inflation updates to the annual cap on patient engagement tools and supports under 42 CFR § 1001.952(hh).
ADDITIONAL POLICY NEWS
On November 18, the Medicare Payment Advisory Commission (MedPAC) released its update payment basics document which outlines how various Medicare payment systems operate.
On November 19, a Mercer survey reported that average employer health coverage costs are expected to exceed $18,500 per employee in 2026. Employers anticipate cost pressures from increased drug spending, especially GLP-1 medications, and are exploring narrower provider networks and condition-specific programs.
On November 19, a federal appeals court ruled that more than 500 lawsuits alleging Tylenol causes autism may proceed, finding that a prior court may have improperly excluded expert testimony. The decision sends the case back for further review.
November 21, MedPAC announced its agenda for its meetings on December 4 and 5 which will primarily focus on Medicare payment adequacy.