Health Care Watch: October 13, 2025

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 6 - October 11.  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 October 9, Ways & Means Ranking Member Richard Neal (D-MA) and Energy & Commerce Ranking Member Frank Pallone (D-NJ) sent a letter to Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz raising criticisms of disruption and confusion caused by the Administration’s guidance regarding claims processing under expired Medicare telehealth authority and hospital at home waivers.  

Senate 

• On October 6, the Senate voted for the 5th time on H.R. 5371, the continuing resolution for Fiscal Year 2026 that would fund the government until November 21. The resolution failed by a vote of 52-42, with 60 votes needed to overcome the filibuster to pass the measure. As with previous votes, Democrats Catherine Cortez Masto (D-NV) and John Fetterman (D-PA) joined Independent Senator Angus King (I-ME) to vote for the measure. Six Senators were absent.  Subsequently, on October 8 and 9, the Senate voted for the 6th and 7th times on H.R. 5371.  The resolution failed by a vote of 54-45 both times. One Senator was absent for both votes.  

• On October 6, Health, Education, Labor and Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) sent a letter to the President of the American Medical Association (AMA) asking a number of critical questions about the AMA’s ownership of the Current Procedural Terminology (CPT) coding system, specifically the fees AMA charges to health care professionals to use the system. The letter requests a response by October 20, 2025. 

• On October 7, the Senate approved 107 Trump nominees in a party-line block vote, including Brian Christine as Assistant Secretary for Health, Michael Stuart as General Counsel, Gustav Chiarello as Assistant Secretary for Financial Resources, and Alex Adams as Assistant Secretary for Family Support. 

• On October 8, the Aging Committee held a hearing entitled “Bad Medicine; Closing Loopholes that Kill American Patients.”  Witnesses included: Tony Sardella, Founder & Chair, API Innovation Center, Washington University; Tony Paquin, President and CEO, iRemedy Healthcare, Inc.; Andrew Rechenberg, Economist, Coalition for a Prosperous America; Marta Wosinska, Senior Fellow, Center on Health Policy, The Brookings Institution.  The hearing explored the issue of securing the safety of our nation’s drug supply and U.S. reliance on active pharmaceutical ingredients and generic drugs manufactured outside the US. The hearing followed a previous hearing last month entitled “Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans.”  In his opening statement, Chairman Rick Scott (R-FL) highlighted his October 3 letter to Secretary of Commerce Lutnick and U.S. Trade Ambassador Greer calling for a Section 232 investigation into US dependence on imported pharmaceuticals.

• On October 9, a group of 51 Republican Senators sent a letter to HHS Secretary Kennedy and Food & Drug Administration (FDA) Commissioner Dr. Marty Makary requesting suspension of the approval of new generic versions of abortion pill mifepristone until the FDA completes its review of the medicine’s safety program. Sens. Lisa Murkowski (R-AK) and Susan Collins (R-ME) were the two Republican Senators who did not sign the letter. 

• On October 9, the HELP Committee held a hearing entitled “AI’s Potential to Support Patient’s, Workers, Children and Families.”  Witnesses included: Dr. Russ Altman, Stanford Institute for Human-Centered AI and Professor of Computer Science; John Bailey, Nonresident Senior Fellow, American Enterprise Institute; Harriet Pearson, Managing Principal, Axia Advisory; Dr. Juliet Schor, Professor, Boston College; and Carlos Aramayo, President UNITE HERE Local 26.  The hearing explored how AI could benefit, and pose risks to, healthcare, workforce development, child welfare, and family wellbeing.  

• On October 10,  Senate Finance Committee Ranking Member Ron Wyden (D-OR), Senate HELP Committee Ranking Member Bernie Sanders (I-VT), along with Senators Elizabeth Warren (D-MA) and Raphael G. Warnock (D-GA) sent identical letters to four of the largest contractors that build state Medicaid eligibility, enrollment, and information management systems across the country expressing “concern that thousands of eligible Medicaid beneficiaries are erroneously denied coverage each year due to eligibility systems plagued by errors.” The letters were sent to Conduent, Deloitte, General Dynamics Information Technology (GDIT) and Gainwell Technologies and ask the companies to detail their contracted payment structures, the documentation individuals are required to provide for Medicaid eligibility through their systems, any penalties that states may levy for wrongful terminations, their ability to update systems following the identification of errors, and more data and information related to the companies’ performance in administering these systems across the country. Responses are requested by October 31, 2025.  Earlier this year, Senators Wyden and Warren sent a similar inquiry to another contractor, Maximus. 

REGULATORY UPDATE

• On October 3, FDA announced a new pilot program offering priority review for ANDA applications from companies that manufacture and test their generic drugs in the United States.  The initiative seeks to incentivize onshoring by rewarding applicants that produce both finished dosage forms and APIs domestically and conduct bioequivalence studies in the U.S. 

• On October 6, the Third Circuit Court of Appeals ruled that CMS lawfully grouped Novo Nordisk’s six insulin products under the Medicare Drug Price Negotiation Program, rejecting the manufacturer’s constitutional and statutory claims.  Judge Thomas Hardiman said CMS correctly followed federal statute and that the Inflation Reduction Act, which created the program, does not allow the courts to weigh in on Medicare’s selection of drugs.  

• On October 6, the Centers for Disease Control and Prevention (CDC) formally adopted Advisory Committee on Immunization Practices (ACIP) recommendations shifting to “individual-based decision-making” for COVID-19 vaccination, endorsing physician consultation rather than issuing a blanket recommendation.  CDC also adopted ACIP’s recommendation that the MMRV vaccine be split up, with the MMR and varicella vaccine provided separately, for the youngest children. 

• On October 8, CDC announced a multi-year review of the U.S. childhood vaccine schedule, tasking a new Childhood and Adolescent Immunization Schedule Workgroup under ACIP to evaluate the timing, order, and ingredients of recommended shots.  The group will also compare U.S. and international vaccine schedules and assess potential effects on children with medical vulnerabilities. 

• On October 8, HHS Secretary Kennedy posted on social media that the Coalition for Health AI (CHAI) “must not build a regulatory cartel,” intensifying the Trump administration’s criticism of the tech-backed group.  CHAI was formed to shape standards for AI in health care but now faces mounting criticism from senior officials, including Deputy Secretary Jim O’Neill and FDA Commissioner Dr. Marty Makary, who accuse it of entrenching “Big Tech” power and stifling startups. 

• On October 9, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously endorsed a trivalent influenza vaccine for the 2025–2026 season.  The vote proceeded despite the government shutdown.  

• On October 10, HHS confirmed that employees across multiple divisions have received reduction-in-force notices as part of the Trump administration’s layoffs tied to the ongoing government shutdown.  HHS spokesperson Andrew Nixon said affected workers were designated “non-essential” adding that the agency is closing “wasteful and duplicative entities” that are “at odds with the Trump Administration's Make America Healthy Again (MAHA) agenda." 

WHITE HOUSE

• October 6, the White House issued a Child Health Day statement underscoring concerns that SSRIs, antipsychotics, mood stabilizers, and weight-loss drugs are overprescribed to children.  The statement says that the MAHA Commission will examine overprescribing with plans for an HHS working group to review prescription patterns and for NIH to conduct research while FDA updates labels for older generics. 

• On October 8, the White House maintained that the administration is not planning to impose Section 232 tariffs on generic pharmaceuticals, despite earlier threats to levy 100% tariffs on name-brand drugs.  Spokesman Kush Desai said the administration and Commerce Department are aligned in excluding generics from the ongoing national security-based tariff probe. 

• On October 10, President Trump announced a second Most-Favored-Nation (MFN) pricing agreement to align U.S. drug prices with the lowest prices paid by other developed nations.  The agreement with AstraZeneca largely mirrors the MFN agreement framework first established with Pfizer.  In exchange for a three-year grace period from Section 232 tariffs, AstraZeneca made the following commitments:

• MFN in Medicaid: Every State Medicaid program will gain access to MFN prices on AstraZeneca products.

• MFN for New Medicines: AstraZeneca will guarantee MFN prices on all new innovative medicines it brings to market in the U.S.

• Repatriation of Foreign Revenue: AstraZeneca must repatriate increased foreign revenue from existing products, arising from Trump Administration trade policies, for the benefit of American patients.

• DTC Discounts (TrumpRx): The agreement requires AstraZeneca to offer medicines at a deep discount off list price when selling directly to American patients.  These medicines will be available for direct purchase through the government’s TrumpRx platform and include Bevespi Aerosphere (COPD), Breztri (COPD), and Airsupra (Asthma).  

• U.S. Manufacturing and Investment Commitment: AstraZeneca will invest $50 billion in U.S. manufacturing and research and development by 2030.  

• 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

• 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

• 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

• 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

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

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Comparative Clinical Studies; Draft Guidance for Industry; Availability; Notice; 10/8/25

REPORTS 

Office of Inspector General (OIG)

• On October 6, OIG released its list of False Claims Act case settlements according to its risk spectrum for FY 2025 Q1 – Q4. 

• On October 7, OIG released a report on behavioral health provider networks and inactive providers in Medicare Advantage and Medicaid Managed Care Plans. OIG found that many plans had limited networks of behavioral health providers, the networks were further limited by inactive providers, and most of the inactive providers should not have been listed as network providers. OIG found that providers cited administrative burden and low payment rates as factors affecting their willingness to work with managed care plans.  OIG recommends that CMS: use data to monitor networks and take steps to improve the accuracy of network directories in MA; work with states to improve network directory accuracy in Medicaid managed care; and continue exploring how a nationwide directory could reduce inaccuracies and increase administrative efficiencies.  

ADDITIONAL POLICY NEWS

• On October 6, Amgen announced AmgenNow, a direct-to-patient program offering Repatha at nearly a 60% discount for Medicare, Medicaid, and uninsured patients.  According to Amgen, the price also will be listed on the White House’s TrumpRx website.

• A new study published by the Lown Institute Hospitals Index reported that US hospitals performed more than more than 200,000 unnecessary back surgeries on older adults that cost taxpayers $1.9 billion, based on an analysis of Medicare and Medicare Advantage claims data. 

• Peter Marks, former Director of FDA’s Center for Biologics Evaluation and Research is joining Lilly as Senior Vice President of Molecule Discovery and Head of Infectious Disease

• The Medicare Payment Advisory Commission (MedPAC) October public meeting originally scheduled for October 9 - 10 was cancelled because of the ongoing government shutdown.