Health Care Watch: September 8, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 31 – September 6. 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. Thank you
LEGISLATIVE UPDATE
House
On September 2, the Appropriations Subcommittee on Labor, Health & Human Services (HHS), Education and Related Agencies voted, 11-7, to advance a $108 billion funding bill for HHS, a $7 billion decrease from fiscal year 2025
On September 3, Ways & Means Committee Chairman Jason Smith (R-MO) and Oversight Subcommittee Chairman David Schweikert (R-AZ) sent a letter to Network for Hope, a Kentucky-based tax exempt Organ Procurement Organization (OPO) demanding documents and records related to allegations of improper Medicare billing, financial conflicts of interest, and unsafe practices. The letter follows a public call for information, as well as ongoing reviews of the activities of other OPOs, as part of the Committee’s examination into whether these tax-exempt organizations are abiding by the existing laws and regulations that govern them.
On September 3, the Energy & Commerce Health Subcommittee held a hearing entitled Examining Opportunities to Advance American Health Care through the Use of Artificial Intelligence Technologies. Members discussed how AI could support doctors and other health care providers and reduce administrative burden. There were also reservations on the use of AI in health care but no consensus on how to implement AI guardrails.
On September 4, 10 moderate House Republicans introduced legislation that would extend the Affordable Care Act’s (ACA) expanded and enhanced premium tax credits for one year. The legislation is cosponsored by Republican Reps. Jenn Kiggans (VA), Reps. Brian Fitzpatrick (PA), Rob Bresnahan (PA), Young Kim (CA), David Valadao (CA), Jeff Hurd (CO), Carlos Gimenez (FL), Tom Kean (NJ), Juan Ciscomani (AZ), and Mike Lawler (NY). Without Congressional action, the expanded and enhanced subsidies will expire on January 1, 2026, and will revert back to the original ACA premium subsidy eligibility thresholds and amounts.
Federal funding expires on September 30. Discussions are underway to extend funding through a continuing resolution. While President Trump has asked for the CR to provide funding into the Spring, a short-term extension, perhaps weeks, is more likely. A temporary government shutdown is also a strong possibility.
Senate
On September 2, Minority Leader Chuck Schumer (D-NY), Finance Committee Ranking Member Ron Wyden (D-OR), and Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bernie Sanders (D-VT) sent aletter to insurers participating in the ACA Marketplaces asking a series of questions regarding the factors contributing to uncertainty in premiums for the 2026 plan year. Responses are due by September 15.
On September 4, the Finance Committee held a hearing entitled The President’s 2026 Health Care Agenda. HHS Secretary Kennedy testified before the Committee. Committee Democrats largely challenged the Secretary’s actions and opinions on vaccines, particularly the COVID vaccine. While Sens. Cassidy (R-LA) and Barrasso (R-WY) expressed similar concerns, most other GOP members praised the Administration’s efforts on health policy. Sens. Blackburn (R-TN) and Lankford (R-OK) discussed PBM reform. Secretary Kennedy stated that President Trump and HHS officials have met with PBMs as well as pharmaceutical companies regarding the Most Favored Nation (MFN) policy and noted that some of the MFN discussions have included talks of direct-to-consumer marketing which would remove middlemen from the process.
On September 4, the Finance Committee voted 14-13 to advance two health nominees: Gustav Chiarello to serve as HHS Assistant Secretary for Financial Resources and Michael Stuart as HHS General Counsel.
On September 4, Democratic members of the Finance Committee called on HHS Secretary Kennedy to resign from his position.
On September 4, Sens. Chuck Grassley (R-IA) and Maggie Hassan (D-NH) reintroduced the Open Payments Expansion Act. This legislation would require drug and device makers to disclose payments made to tax-exempt advocacy organizations.
REGULATORY UPDATE
On September 2, it was announced that Dr. Paul Offit is no longer a member of the Food & Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee. His term was set to expire in January 2027, however an HHS spokesperson stated that FDA notified certain members of its advisory panels that their status as special government employees had expired and therefore they could no longer participate in committee work.
On September 3, more than 1,000 current and former HHS employees signed onto a letter calling for HHS Secretary Kennedy to resign amid unrest across the department following the removal of Centers for Disease Control & Prevention (CDC) Director Susan Monarez and the shooting at CDC’s Atlanta headquarters.
On September 3, the FDA introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness. The RDEP, developed and implemented jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), will address the inherent uncertainties of rare disease drug development by assuring sponsors that reviews will encompass additional supportive data. Sponsors may apply to the process any time prior to the launch of a pivotal trial.
On September 3, HHS announced that HHS Secretary Kennedy has directed the Department to increase resources dedicated to curbing the practice of information blocking. HHS will take active enforcement against health care entities that restrict patients’ engagement in their care by blocking the access, exchange, and use of electronic health information.
On September 4, it was announced that HHS Secretary Kennedy is considering appointing seven members to CDC’s Advisory Committee on Immunization Practices (ACIP). Under consideration is Dr. Joseph Fraiman, an emergency medicine specialist in New Orleans and the lead author of a 2022 paper that suggested COVID vaccines posed a risk of serious adverse events based on a reanalysis of the drugmakers’ late-stage trial results. ACIP is slated to meet on September 18 and 19 and is expected to vote on updated COVID-19 vaccines and other immunizations.
On September 4, HHS announced that it is implementing measures to expand access to more affordable catastrophic health coverage through HHS’ new hardship exemption guidance. This guidance streamlines access to more affordable catastrophic coverage for consumers who are ineligible for advance payments of the premium tax credit (APTC) or cost-sharing reductions (CSRs). A fact sheet detailing the guidance can be found here.
On September 4, HHS’s Office for Civil Rights (OCR) issued a letter notifying state awardees of the Vaccines for Children Program (VCP) that participating immunization programs and program-registered providers must respect state religious and conscience exemptions from vaccine mandates.
On September 4, the Trump Administration released its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions. A list of all HHS regulations included in the agenda can be found here.
WHITE HOUSE
On September 1, in a social media post, President Trump urged pharmaceutical companies to justify the success of their COVID-19 drugs and vaccines. President Trump stated that he has been shown “information from Pfizer, and others, that is extraordinary,” but stated that these results have not been shown to the public. On September 3, in response to President Trump’s request, Pfizer, Moderna, and Novavax issued statements highlighting the safety and efficacy of their COVID-19 vaccines.
On September 2, following a court settlement, the Trump Administration agreed to restore a number of health agency websites and datasets that went dark in order to comply with executive orders on diversity, equity, and inclusion (DEI) and gender identity.
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 Eligibility Changes Under the Affordable Care Act of 2010; Giving States Freedom to Use Immigration Information to Determine State Residency for Medicaid Eligibility (CMS-2349); Final Rule; 5/27/25
Medicaid Managed Care-State Directed Payments (CMS-2449); Proposed Rule; 6/9/25
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Final Rule; 7/9/25
Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth (CMS-2451); Proposed Rule; 7/18/25
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
FDA
Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 6/30/25
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
Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Notice; 7/21/25
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability; Notice; 7/21/25
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
HEARINGS
House
Committee on Oversight and Government Reform
September 9; 2:00 PM ET; 2247 Rayburn
Better Meals, Fewer Pills: Making Our Children Healthy Again
Senate
Homeland Security and Governmental Affairs Committee
Permanent Subcommittee on Investigations
September 9; 2:00 PM; 216 Hart
How the Corruption of Science has Impacted Public Perception and Policies Regarding Vaccines
REPORTS
Office of Inspector General (OIG)
On September 3, OIG issued a report examining Medicaid Managed Care Plans referrals of potential provider fraud. OIG found that 10% of plans reported that they did not make any referrals of potential provider fraud, waste, or abuse in 2022. Additionally, OIG found that of the plans that reported making provider referrals in 2022, more than half made two or fewer referrals per 10,000 enrollees. OIG also found that plans that received training from the State or Medicaid Fraud Control Unit (MFCU) on the fraud referral process made more provider referrals. OIG recommended that CMS: 1) follow up with States that had Medicaid managed care plans with no referrals of potential provider fraud, waste, or abuse in 2022; and 2) encourage States to increase the number of Medicaid managed care plans that have received State-led training on the fraud referral process.
ADDITIONAL POLICY NEWS
On August 29, New Mexico’s health department issued an order for the department to work with the State's Board of Pharmacy to expand access to COVID-19 booster vaccines. New Mexico Health Secretary Gina DeBlassie stated that barriers to the administration of COVID-19 vaccines constitute a condition of public health importance.
On September 3, officials in California, Oregon, and Washington announced that the states will issue vaccine recommendations to residents. In a joint statement California Gov. Gavin Newsom (D), Washington Gov. Bob Ferguson (D), and Oregon Gov. Tina Kotek (D) announced that their health departments will coordinate to issue uniform recommendations on which vaccines individuals should receive and when.
On September 3, Florida Surgeon General Joseph Ladapo announced that the state is working to end all vaccine mandates.
On September 4, the Third Circuit Court of Appeals upheld a lower court’s decision rejecting Johnson & Johnson and Bristol Myers Squibb’s constitutional challenges to Medicare drug price negotiations. The majority ruled the program is voluntary, does not constitute an uncompensated taking, and does not compel speech, noting that companies remain free to decline participation or criticize the program publicly. Judge Thomas Hardiman dissented, arguing the IRA effectively forces manufacturers to comply through “ruinous excise tax liability.”