Health Care Watch: September 15, 2025

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 14 – September 20. 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 16, House GOP leaders released text of a stopgap funding bill that would keep federal agencies funded through November 21. The package includes extensions of various health care rules through November 21, including the Medicare telehealth flexibilities and delaying 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. The House passed the continuing resolution (CR) on September 19 by a vote of 217-215, largely along party lines. A section-by-section summary of the bill can be found here.

On September 16, Appropriations Committee Chairman Tom Cole (R-OK) stated that talks with the Senate are going well to reach agreement on full-year funding for Agriculture-FDA, Military Construction-VA and Legislative Branch. He stated that he expects to have bills by the end of the week but noted that they are not likely to be attached to the stopgap funding package.

On September 16, the Ways & Means Oversight Subcommittee held a hearing entitled Virtue Signaling vs. Vital Services: Where Tax-Exempt Hospitals are Spending Your Tax Dollars. The hearing discussed the tax-exempt status of nonprofit hospitals, urban to rural reclassification of hospitals, the 340B program, diversity, equity, and inclusion (DEI) and gender affirming care (GAC) services, the recently passed reconciliation package and impacts of its Medicaid cuts on nonprofit hospitals

On September 16, Energy & Commerce Committee Chairman Brett Guthrie (R-KY) and Ranking Member Frank Pallone (D-NJ) along with Subcommittee on Oversight and Investigations Chairman John Joyce (R-PA) and Ranking Member Yvette Clarke (D-NY) sent a letter to HHS’ Health Resources and Services Administration (HRSA) requesting a briefing on its ongoing oversight of patient safety in the nation’s organ procurement and transplant system.

On September 17, House and Senate Democrats released their own identical versions of a stopgap spending bill. The proposal funds the government through October 31, 2025 and links the funding to priorities such as permanent extension of the Affordable Care Act (ACA) enhanced premium tax credits, repeal of Medicaid provisions in the recently enacted One Big Beautiful Bill Act, and limits on President Trump’s ability to roll back funds previously approved by Congress. A section-by-section summary of the bill can be found here.

On September 17, the Ways & Means Committee held a markup of various health care related legislation, including: H.R. 5343, the Ensuring Patient Access to Critical Breakthrough Products Act; H.R. 5347, the Health Care Efficiency Through Flexibility Act; H.R. 4313, the Hospital Inpatient Services Modernization Act; and H.R. 842, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act. All legislation was advanced out of Committee.

On September 17, the Energy & Commerce Committee held a markup of various health care related legislation, including: H.R.1843, legislation to amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; H.R. 2493, the improving Care in Rural America Reauthorization Act of 2025; H.R. 3419, legislation to amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs; H.R. 1272, the Give Kids a Chance Act, and H.R. 3302, the Healthy Start Reauthorization Act of 2025. All legislation was advanced out of Committee.

On September 18, the Energy & Commerce Health Subcommittee held a hearing entitled Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies. The hearing discussed various legislation including the Ensuring Patient Access to Critical Breakthrough Products Act of 2025 as well as legislation to increase transparency in Medicare’s national coverage determinations.

Senate

On September 12, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) sent a letter to HHS Secretary Kennedy asking him to support the whooping cough vaccine like he did for the measles outbreak in Texas earlier this year. Chairman Cassidy stated that Louisiana is experiencing the worst whooping cough outbreak in 35 years.

On September 15, it was announced that a group of GOP senators, including Sen. Lisa Murkowski (R-AK), are working on legislation to extend the ACA enhanced premium tax credits. The group has received technical assistance from the Finance Committee. On September 16, Sen. Murkowski introduced legislation to temporarily extend the tax credits.

On September 15, Finance Committee Ranking Member Ron Wyden (D-OR) and Subcommittee on Fiscal Responsibility and Economic Growth Ranking Member Tina Smith (D-MN) sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro, asking GAO to examine how CMS will award the Rural Health Transformation funding and whether it will make sure funds are distributed in a transparent manner, what steps it will take to ensure states spend taxpayer dollars as they have pledged, and how CMS will define and claw back improperly used dollars from states.

On September 17, the HELP Committee held a hearing where former CDC Director Susan Monarez testified. Monarez stated that she was ousted from the agency for “holding the line on scientific integrity” and refusing to approve vaccine recommendations made by the newly appointed Advisory Committee on Immunization Practices (ACIP). She also alleged that HHS Secretary Kennedy had instructed her not to speak with members of Congress while in her role.

On September 18, HELP Committee Chairman Sen. Bill Cassidy (R-LA) invited HHS Secretary Kennedy to testify before the Committee and respond to the statements made by former CDC Director Susan Monarez about her firing.

On September 18, the Senate passed the SUPPORT for Patients and Communities Reauthorization Act, legislation which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness.

On September 19, the Senate failed to pass two government funding bills. The Democrats offered a bill that would fund the government through October 31, repeal Medicaid cuts contained in OBBBA, and permanently extend the enhanced and expanded ACA premium tax credits. The Senate GOP offered the House-passed bill, which also failed to get the needed 60 votes. Unless Congress acts, the federal government will shut down on October 1.

REGULATORY UPDATE

On September 15, the Centers for Medicare & Medicaid Services (CMS) announced details on how states can apply to receive funding from the $50 billion Rural Health Transformation Program created under the Working Families Tax Cuts Act. The $50 billion program funding will be allocated to approved states over five years, with $10 billion available each year beginning in federal fiscal year 2026. Half of the funding will be evenly distributed to all states with an approved application. The other half will be awarded to approved states based on individual state metrics and applications that reflect the greatest potential for and scale of impact on the health of rural communities. The deadline for states to apply is November 5, 2025. There is only one opportunity to apply for funding and one application period for this program. CMS will announce awardees by December 31, 2025.

On September 15, HHS and the Centers for Disease Control and Prevention (CDC) announced the appointment of five new members to CDC’s ACIP. The newly appointed members are: Catherine M. Stein, Ph.D., Professor, Department of Population & Quantitative Health, Case Western Reserve University; Evelyn Griffin, M.D., Obstetrician and Gynecologist, Baton Rouge General Hospital, Baton Rouge, Louisiana; Hillary Blackburn, PharmD, M.B.A., Director of Medication Access and Affordability, AscensionRx; Kirk Milhoan, M.D., Ph.D., Medical Director, For Hearts and Souls Free Medical Clinic; and Raymond Pollak, M.D., F.A.C.S., F.R.C.S., a surgeon, transplant immunobiologist, and transplant specialist.

On September 16, FDA released 40 cease-and-desist letters and 35 warning letters as part of a crackdown on “false and misleading” pharmaceutical TV ads, naming major manufacturers as well as telehealth firms like Hims & Hers. The letters give recipients 15 working days to justify their ads and warn that failure to correct could lead to escalated enforcement, up to injunctions or other sanctions. FDA also said it will move to rewrite advertising rules by targeting the 1997 “adequate provision” policy and will expand enforcement beyond TV to social media, influencers, and telehealth, prioritizing egregious violations and deploying AI for surveillance.

On September 18 and 19, CDC’s ACIP met to consider a variety of vaccines including the COVID-19, hepatitis, and mumps measles, and rubella (MMR) vaccines. The meeting comes one day after former CDC Director Susan Monarez testified before Congress and just three days after HHS Secretary Kennedy announced the appointment of five new members to ACIP. On September 18, ACIP voted, 8 to 3, to recommend that toddlers through age three be immunized for varicella (chickenpox) through standalone vaccination rather than through the combination measles, mumps, rubella, and varicella (MMRV) vaccine.

On September 18, HHS held a press conference entitled Expanding Organ Access to Patients. The press conference announced the decertification of an organ procurement organization (OPO) mid-cycle, the Life Alliance Organ Recovery Agency, as well as discussing various actions HHS is taking to improve the organ donation and transplantation system.

On September 18, CMS released the CY 2026 Medicare Advantage (MA)/Part D Technical Rule. Specifically, the rule finalizes the proposal for MA provider directory data to be submitted to CMS for publication online in accordance with CMS guidance. CMS is also finalizing the proposal that MA provider directory data be updated within 30 days of the date an MA organization becomes aware of changes to that data, as well as the proposal to require MA organizations to attest at least annually that the MA provider directory information is accurate. CMS is not finalizing the portion of the proposal that would have required MA organizations to attest that their MA provider directory data are consistent with data submitted to comply with CMS' MA network adequacy requirements. The changes made in the final rule are applicable January 1, 2026.

On September 18, HHS Secretary Kennedy convened patients, caregivers, medical professionals, and advocates for two Long COVID roundtables, one centered on patient experiences and one on research. As part of the event, HHS announced new actions aimed at improving care for Long COVID: 1) a public awareness and education campaign; 2) an open-source medical resource platform; and 3) an Agency for Healthcare Research and Quality (AHRQ) report.

WHITE HOUSE

On September 19, reports indicated that the Trump administration is considering creating a Trump-branded prescription drug website, potentially called TrumpRx, to connect patients directly with discounted medicines. The initiative is linked to the Administration’s push for drugmakers to align U.S. prices with those in other developed countries, with a September 29 deadline for compliance.

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

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 Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Providers and Suppliers (CMS-1516); Proposed Rule; 9/12/25

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

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; 9/9/25

Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability; Notice; 9/17/25

Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability; Notice; 9/17/25

REPORTS

Office of Inspector General (OIG)

On September 16, OIG issued a report detailing the Patient Safety Organization (PSO) Program. OIG found that the PSO program has fallen short in facilitating patient safety learning and improvement on a national scale. Although PSOs have helped some hospitals and health systems improve, OIG identified key challenges that hold the program back from achieving the progress envisioned in the Patient Safety and Quality Improvement Act of 2005. OIG made four recommendations: 1) increase alignment of the PSO program with other HHS patient safety efforts; 2) promote opportunities to involve patients and families in PSO activities; 3) clarify cybersecurity protections and data use limitations for patient safety work product submitted to the Network of Patient Safety Databases (NPSD); and 4) take steps to harness technologies and new data sources that could help address barriers facing the NPSD.

Congressional Budget Office (CBO)

On September 18, CBO issued a report examining permanent extension of the ACA enhanced premium tax credits (EPTC). CBO estimates that permanently extending the expanded premium tax credit, nullifying a marketplace final rule, and repealing policies in the 2025 reconciliation act would increase deficits and the number of people with health insurance. Specifically, CBO estimates that permanently expanding the premium tax credit structure would increase the deficit by $350 billion from 2026 to 2035 and the number of people with health insurance by 3.8 million in 2035.

ADDITIONAL POLICY NEWS

On September 16, the Wisconsin Department of Health Services announced that it will continue to recommend the COVID-19 vaccine to patients 6 months and older, breaking with new FDA guidance.