Health Care Watch: November 22, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 22 – November 29. 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 25, Energy & Commerce Ranking Member Frank Pallone, Jr. (D-NJ), Ways & Means Ranking Member Richard Neal (D-MA), and Education & Workforce Ranking Member Bobby Scott (D-VA) issued a joint statement opposing the Trump administration’s proposal to alter the enhanced and expanded Affordable Care Act (ACA) premium subsidies, calling it unworkable and warned of premium increases.
On December 1, the House will consider H.R. 4313, legislation that would extend the Hospital-at-Home demonstration through FY2030. CBO estimates this legislation would increase spending by less than $500,000 over 10 years.
REGULATORY UPDATE
On November 21, the Centers for Medicare & Medicaid Services (CMS) filed a notice of appeal in its ongoing Risk Adjustment Data Validation (RADV) litigation, seeking reversal of a federal district court decision vacating the 2023 RADV rule. The appeal to the Fifth Circuit occurs as CMS continues broader efforts to address Medicare Advantage (MA) payments and strengthen audit oversight.
On November 24, CMS issued the Information Collection Request (ICR) for the Initial Price Applicability Year (IPAY) 2028 Drug Price Negotiation Program, with comments due December 24. The ICR includes the Negotiation Data Elements Form, which outlines the data CMS will consider when developing offers and counteroffers, as well as the required and optional submissions from manufacturers and the public. It also includes the Drug Price Negotiation and Renegotiation Process Counteroffer Form, which specifies the information CMS will evaluate if a manufacturer submits a counteroffer.
On November 25, CMS announced the negotiated prices for the IPAY 2027 selected drugs under the Medicare Drug Price Negotiation Program, which will take effect January 1, 2027. CMS estimates that it saved $8.5 billion, or 36%, compared to what it would have paid last year had the negotiated prices been in effect. Out-of-pocket savings for Medicare enrollees with drug coverage is estimated to be $685 million in 2027.
On November 25, CMS issued a memo announcing that Entresto, Stelara, and Xarelto will be removed from the Medicare Drug Price Negotiation Program’s selected drug list effective January 1, 2027. CMS determined that each drug now has at least one bona fide marketed generic or biosimilar competitor, triggering removal under the program. As a result, all three drugs will remain selected drugs through 2026, and their agreed-upon maximum fair prices will continue to apply through December 31, 2026.
On November 25, CMS issued the Contract Year (CY) 2027 Medicare Advantage (MA) and Part D Proposed Rule, outlining updates to quality measurement, enrollment processes, and the long-term direction of the MA program. The proposal includes major changes to the Part C and Part D Star Ratings system, improvements to streamline the enrollment experience, a new special enrollment period (SEP) for provider terminations, and codification of key Inflation Reduction Act Part D benefit reforms, among other proposals. Finally, the rule seeks public feedback through three RFIs on MA modernization, chronic condition special needs plans (C-SNPs), and well-being/nutrition policies. Comment to the rule are due by January 26, 2026. A fact sheet on the rule can be found here.
On November 25, CMS issued an HPMS memorandum clarifying that MA organizations must implement National Coverage Determinations (NCDs) with Coverage with Evidence Development (CED) requirements “without alteration or supplementation.” The memo reiterates that MA plans may not narrow, expand, or otherwise modify an NCD with CED criteria through internal policies.
On November 25, FDA approved Otsuka’s VOYXACT (sibeprenlimab-szsi) for adults with Immunoglobulin A nephropathy (IgAN) at risk for disease progression, making it the first therapy specifically indicated to reduce proteinuria in this population. VOYXACT is a self-administered, subcutaneous injection dosed every four weeks.
On November 28, CMS released the 2026 Home Health Prospective Payment System final rule. CMS estimates that that Medicare payments to home health agencies will decrease by an estimated 1.3% ($220 million) in CY 2026 compared to CY 2025, based on the finalized policies. CMS also finalized changes to the durable medical equipment competitive bidding program. Program prices and supplier contract awards will be announced in late summer/early fall 2027 for implementation by January 1, 2028.
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
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
Medicaid Managed Care – State Directed Payments (HHS-CMS RIN 0938-AV69); Proposed Rule; Withdrawn; Completed 11/21/25
Clarifying Statutory Limitation on Disability as it Applies to Gender Identity and Dysphoria (HHS-OCR RIN 0945-AA27); Proposed Rule; Received 11/24/25
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
Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability (HHS-FDA RIN 0910-ZC62); Notice; Consistent with Change; Completed 11/21/25
Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability (HHS-FDA RIN 0910-ZC63); Notice; Consistent with Change; Completed 11/21/25
HEARINGS
House
Ways & Means Oversight Subcommittee
Lives at Stake: Holding Tax-Exempt Organ Procurement Organizations Accountable
December 2; 10:00AM; 1100 Longworth
Witnesses: TBD
Senate
HELP Committee
Making Health Care Affordable Again: Healing a Broken System
December 3; 10:00AM; 430 Dirksen
Witnesses: TBD
Examining the Future of the U.S. Organ Procurement and Transplantation Network
December 11; 10:00AM; 430 Dirksen
Witnesses: TBD
Aging Committee
Aging in Place: The Impact of Community during the Holidays
December 3; 3:00PM; Hart 216
Witnesses: John Offerdahl, President, Offerdahl’s Hand-Off Foundation; Jason Resendez, CEO, National Alliance for Caregiving; Alison Barkoff; Professor, George Washington University; Emily Ladau, Disability Rights Advocate
REPORTS
Office of the Inspector General (OIG)
On November 24, the OIG updated its Heightened Scrutiny findings related to CVS Pharmacy, Inc.
On November 25, the OIG updated its EMTALA/Patient Dumping materials and separately updated its guidance on Civil Monetary Penalties and Affirmative Exclusions.
On November 26, the OIG issued a report titled Medicare Payments for Continuous Glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices, Indicating Medicare Can Save At Least Tens of Millions of Dollars in One Year (OEI-04-23-00430), along with an accompanying video on combating durable medical equipment fraud.
On November 28, the OIG released a report titled Gaps in NIH’s Oversight Put Millions in Funding for Other Transactions at Greater Risk of Fraud, Waste, or Abuse.