Health Care Watch: September 2, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 24 – August 30. 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 August 26, at the request of Budget Committee Chairman Arrington, Majority Leader Steve Scalise (R-LA), Oversight and Accountability Chairman James Comer (R-KY), and Rep. Victoria Spartz (R-IN), the Government Accountability Office (GAO) issued a report detailing federal spending that was unauthorized in the 2023 omnibus funding bill. The report found that Congress provides funding for over 1,300 programs despite the program authorizations having expired.
On August 28, House Oversight Committee Chairman Comer sent letters to Cigna and Optum Rx seeking documents and information about the pharmacy benefit managers’ group purchasing organizations that are headquartered overseas.
The House will return from recess on September 2.
Senate
On August 25, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) and Sen. Maggie Hassan (D-NH) sent a letter to Aflac following a recent cyberattack on their internal data systems. The letter comes amid increasing cyberattacks on the health care sector with over 700 large data breaches impacting approximately 276 million Americans in 2024. The letter requests information detailing Aflac’s cybersecurity protocols and practices.
On August 28, HELP Committee Chairman Cassidy called for the Department of Health & Human Services (HHS) Advisory Committee on Immunization Practices (ACIP) to indefinitely postpone their September 18th meeting following the removal of the Centers for Disease Control and Prevention’s (CDC) Director Susan Monarez. Earlier on August 28, CDC announced that ACIP will September 18 – 19 to discuss COVID-19, hepatitis B, MMRV, and RSV vaccines, with potential recommendation votes.
On August 28, HELP Committee Ranking Member Bernie Sanders (I-VT) called for a bipartisan congressional investigation into the recent firing of CDC Director Dr. Susan Monarez.
On August 29, reports stated that Sen. Jonie Ernst (R-IA) will not seek re-election. Rep. Ashley Hinson (R-IA) is expected to run for the seat.
The Senate will return from recess on September 2.
REGULATORY UPDATE
On August 22, 2025, the Food & Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023. CBER’s decision is based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients.
On August 26, HHS’ Administration for Children and Families (ACF) demanded that 46 states and territories remove all references to gender ideology in their federally-funded Personal Responsibility Education Program (PREP) educational materials within 60 days. Last week, ACF terminated California’s PREP grant after the state failed to remove gender ideology from its educational materials.
On August 26, HHS and CDC identified an instance of a traveler-associated human case of New World screwworm (NWS) in the United States. The U.S. Department of Agriculture (USDA) reaffirmed its robust surveillance and trapping strategy, confirming there have been no detections of NWS in U.S. livestock.
On August 27, HHS and the Department of Education (DOE) announced an initiative urging America’s leading medical education organizations to immediately implement comprehensive nutrition education and training. The effort is part of the Trump Administration and HHS Secretary Kennedy’s Make America Healthy Again (MAHA) agenda. HHS and DOE are calling for nutrition education requirements to be embedded across the six critical areas of: 1) pre-medical standards; 2) medical school curricula integration; 3) medical licensing examination; 4) residency requirements; 5) board certification; and 6) continuing education.
On August 27, FDA approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax for all seniors but narrowed their use for younger adults and children to those with at least one high-risk health condition. FDA revoked the remaining emergency use authorizations for the COVID-19 vaccine. HHS Secretary Kennedy announced the revocations in a social media post, stating that children at higher risk from COVID-19 can still obtain an immunization as FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+).
On August 27, CDC Director Susan Monarez was fired from the agency just weeks after her confirmation. HHS Secretary Kennedy announced Monarez’s departure in a post on social media. In addition, on August 27, it was announced that four high ranking CDC officials resigned including: CDC Chief Medical Officer Debra Houry; National Center for Immunization and Respiratory Diseases Director Demetre Daskalakis; National Center for Emerging and Zoonotic Infectious Diseases Director Daniel Jernigan; and Director of the CDC Office of Public Health Data, Surveillance and Technology Jen Layden. HHS Deputy Jim O’Neill will take over as acting CDC director for the time being.
On August 27, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it is awarding $19 million in new supplemental funding, through the Community Mental Health Services Block Grant for efforts to address the intersection of homelessness and serious mental illness (SMI).
WHITE HOUSE
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
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
Development of Non-Opioid Analgesics for Chronic Pain, 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
HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
September 3, 10:15 AM; 2123 Rayburn
Appropriations Committee
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
September 2; 5:00 PM; H-140 Capitol
Markup of FY 2026 Labor, Health and Human Services, Education, and Related Agencies Bill
Senate
Finance Committee
September 4; 10:00 AM; 215 Dirksen
The President’s 2026 Health Care Agenda
Witness: HHS Secretary Kennedy
REPORTS
Congressional Budget Office (CBO)
On August 25, the Congressional Budget Office (CBO) responded to a request from Budget Committee Chairman Jodey Arrington (R-TX), Energy & Commerce Committee Chairman Brett Guthrie (R-KY), and Ways & Means Committee Chairman Jason Smith (R-MO) regarding how H.R. 1 is expected to affect the ability of certain groups of people to obtain health insurance coverage through the Affordable Care Act (ACA) marketplaces. CBO estimates that requiring people to actively affirm their eligibility to enroll in marketplace coverage and to claim the premium tax credit will increase the number of uninsured by 700,000 in 2034. CBO estimates that the changes to the special enrollment period for people whose income is at or below 150% of the federal poverty line will increase the number of uninsured by 400,000 in 2034. Additionally, CBO estimates that the number of people without coverage due to noncitizen eligibility will increase by 900,000 in 2034.
Office of Inspector General (OIG)
On August 28, OIG issued a report detailing billing for remote patient monitoring in Medicare. OIG found that the use of remote patient monitoring continued to grow in 2024, with Medicare payments exceeding $500 million. OIG also developed several measures to monitor billing for remote patient monitoring including: 1) billing for a high proportion of enrollees who have no prior history with the medical practice; and 2) billing for multiple monitoring devices a month for an enrollee.
ADDITIONAL POLICY NEWS
On August 26, the Medicare Payment Advisory Commission (MedPAC) announced its public meeting schedule for the 2025-2026 cycle. MedPAC also released the September 4-5, 2025 public meeting schedule which can be found here. Meeting topics will include Medicare payment operations and improving payment accuracy, oversight needed to ensure Medicare’s sustainability, context for Medicare payment policy, access to hospice and certain hospice benefits, and the association between changes in MA enrollment and hospital finances.
On August 26, MedPAC released its comment letter on the Calendar Year 2026 home health prospective payment system proposed rule. The letter addresses proposals in the rule related to Medicare payment policies for home health agencies (HHAs), including the proposed CY 2026 home health payment update and proposed CY 2026 permanent and temporary budget-neutrality adjustments.