Health Care Watch: September 22, 2025

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 22 through September 27. 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 September 23, it was reported that the bipartisan Problem Solvers Caucus members have discussed placing an income limit on the enhanced and expanded premium tax credits for Affordable Care Act (ACA) marketplace coverage. These subsidies, which are more generous and extend to higher income individuals than the original ACA subsidies, expire on January 1. A growing small number of Congressional Republicans have expressed an interest in extending these subsidies for an additional year. Congressional Democrats are seeking a permanent extension, at a cost of $350 billion over 10 years. Action to extend the subsidies in some form, most likely for one or two years, is expected to occur before the end of the year.

Senate

On September 22, Senate Finance Committee Ranking Member Ron Wyden (D-OR), Aging Committee Ranking Member Kirsten Gillibrand (D-NY), and Investigations Subcommittee Ranking Member Richard Blumenthal (D-CT) sent a letter to Centers for Medicare & Medicaid Services (CMS) leadership expressing concerns about the agency’s WISeR model. This model will allow third-party vendors to use AI to assist make prior authorization decisions for beneficiaries in traditional Medicare in AZ, NJ, OH, OK, TX, and WA.

While Congress has been in recess for the last week, little, if any, progress has been made in negotiations between Republicans and Democrats to fund the federal government beyond the September 30 deadline. On September 19, the House passed a bill, largely along party lines, that would fund the government at current levels through November 21. This legislation also included extensions of various expiring health care policies through November 21, including the Medicare telehealth flexibilities and delaying proposed cuts to Medicaid Disproportionate Share Hospitals. The package also includes longer-term extensions such as reauthorization of the Food & Drug Administration’s (FDA) Over-the-Counter Monograph Drug User Fee Program for five years. On September 19, Senate Democrats rejected the House-passed bill and offered a bill that would fund the government through October 31, repeal Medicaid cuts contained in One Big Beautiful Bill Act, and permanently extend the enhanced and expanded ACA premium tax credits, which was opposed by Senate Republicans.

REGULATORY UPDATE

On September 22, CMS confirmed in a Health Plan Management System (HPMS) email to plans that it has expanded the display of Medicare Advantage (MA) supplemental benefits on the Medicare Plan Finder (MPF), completing an update first announced in late August. With the expansion, the MPF now provides additional detail for 33 additional benefits, including in-network and out-of-network cost-sharing, authorization requirements, and plan limits. CMS also added six supplemental benefits with expanded details on the MPF: wigs for chemotherapy-related hair loss, weight management programs, home-based palliative care, readmission prevention, post-discharge in-home medication reconciliation, and adult day health services.

On September 22, NIH launched the $50 million Autism Data Science Initiative (ADSI) to investigate the causes of autism and improve outcomes. The program will fund 13 projects that integrate genetic, biological, and environmental data, using advanced tools such as machine learning, exposome-wide analyses, and organoid models to study gene-environment interactions. Research will address factors ranging from prenatal exposures to adult outcomes, with findings validated through independent replication hubs. NIH emphasized that the initiative will work closely with the autism community to ensure the research reflects lived experiences.

On September 22, the FDA approved Wellcovorin (leucovorin), reauthorizing a branded version of a drug that had been withdrawn from the market more than 25 years ago. The Trump administration announced the decision at a White House event on autism, with President Trump and HHS Secretary Kennedy highlighting leucovorin’s potential use as an autism therapy. The drug is currently made only by generic producers but reviving the brand-name approval is necessary to add an indication. Glaxo Smith Kline said in a statement that it is submitting a supplemental New Drug Application to FDA, at the agency’s request, that would update the label to include treatment of cerebral folate deficiency as an indication.

On September 23, the Trump administration extended Georgia’s Medicaid 1115 waiver, allowing its partial expansion with work requirements to continue through December 31, 2026. The extension will run until national Medicaid work requirements under the One Big Beautiful Bill take effect on January 1, 2027.

On September 24, a federal judge declined to reinstate eight inspectors general fired by President Trump earlier this year, though she found the dismissals violated the Inspector General Act. U.S. District Judge Ana C. Reyes ruled that Trump failed to give Congress the required 30-day notice or valid reasons for removal but said reinstatement would be moot since the president could later lawfully remove them. The lawsuit was brought by eight of the 17 inspectors general dismissed in January, including HHS Inspector General Christi Grimm.

On September 24, reports indicated that the White House Office of Management and Budget (OMB) directed federal agencies to prepare reduction-in-force (RIF) plans in anticipation of a possible government shutdown. According to reports, OMB instructed agencies to identify programs that would lose discretionary funding on October 1 and draft plans for permanent job cuts in those areas. OMB Director Russ Vought framed the move as aligning the federal workforce with President Trump’s priorities, warning that programs without mandatory funding would face the deepest cuts.

On September 25, CMS sent to OMB for review a proposed rule entitled the Global Benchmark for Efficient Drug Pricing (GLOBE) Model. The GLOBE Model appears to be the Most Favored Nation (MFN) drug pricing model that President Trump has warned the administration would pursue if manufacturers do not voluntarily agree to MFN pricing. In recent letters to drug company CEOs, President Trump set a September 29 deadline to comply with voluntary MFN pricing or the administration “will deploy every tool in our arsenal to protect Americans from abusive drug pricing practices.”

On September 25, President Trump threatened to impose a 100% tariff on "branded or patented" pharmaceutical products starting October 1 unless companies are building their "Pharmaceutical Manufacturing Plant in America." He specified that "building" will be defined as “breaking ground” or “under construction” to qualify for exemption. While drugmakers have pledged major U.S. investments in recent weeks, many projects remain in early stages, prompting uncertainty about the policy’s scope.

On September 25, the U.S. District Court for the Northern District of Texas overturned a February 2023 final rule that eliminated the use of an adjuster in risk adjustment data validation (RADV) audits. Plaintiffs argued the rule was arbitrary and capricious and that CMS improperly applied it retroactively, and the court agreed.

On September 26, AstraZeneca announced a new direct-to-consumer platform offering discounts of up to 70% on Farxiga and Airsupra, with plans to also sell its FluMist vaccine. The move comes days ahead of President Trump’s September 29 deadline for drug manufacturers to significantly lower U.S. prices, part of his broader MFN pricing push. AstraZeneca joins Bristol Myers Squibb and Pfizer in unveiling similar platforms in recent weeks.

On September 26, the White House Office of Science and Technology Policy (OSTP) issued a request for information seeking input on federal statutes, regulations, and policies that may hinder AI development, deployment, or adoption. OSTP specifically asked stakeholders to identify outdated or unclear rules, underutilized administrative tools, and structural barriers that constrain AI applications. Comments are due by October 27, 2025.

On September 26, CMS announced that average premiums, benefits, and plan choices for MA and the Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026. CMS notes that it releases this information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025 to December 7, 2025.

WHITE HOUSE

On September 23, President Trump canceled a meeting with Democratic leadership on a short-term government funding agreement, stating in a social media post that Democrats’ demands to repeal Medicaid reforms in the One Big Beautiful law were “unserious” and “ridiculous” and that Democrats would bear responsibility if a shutdown occurs.

On September 24, the Trump administration disclosed two new national security investigations that could lead to tariffs on robotics, industrial machinery, and medical devices. The probes, launched under Section 232 of the Trade Expansion Act, aim to reduce reliance on foreign imports and build domestic stockpiles of critical products. Potentially affected goods include syringes, gloves, masks, and a range of factory equipment, with stakeholders given 21 days to submit public comments.

A list of all administrative and health care-related EOs can be found here. FHP Strategies will update this document, as needed.

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

Pending Review

CMS

CY 2026 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1832); Final Rule;9/25/25

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

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

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability; Notice; 7/21/25

Post approval 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

REPORTS

On September 22, GAO issued a report, Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation. The report found that physician practices have become increasingly consolidated in the last decade. Such consolidation may be leading to higher spending and prices without increasing care quality.

ADDITIONAL POLICY NEWS

On September 22, Walmart announced it will begin home delivery of refrigerated prescriptions, including GLP-1 drugs such as Ozempic, insulin, and other commonly used medications. The service allows customers to receive prescriptions alongside groceries and other products in as little as 30 minutes. Walmart stated that refrigerated medicines account for about 30% of its prescriptions and that the expansion enables delivery of 90% of prescription drugs in 49 states, excluding mostly controlled substances.

Pharmacy benefit managers (PBMs) will reportedly shop a proposal to the Trump Administration to voluntarily change some of their business practices in the hopes of avoiding Congressional and regulatory reform efforts. The proposal reportedly includes policies to ensure insured patients do not pay more than those without insurance, increase biosimilar utilization, and increase reimbursements to rural and independent pharmacies.