Health Care Watch: August 11, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 3 – August 9. 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
The House will return from recess on September 2.
Senate
On August 4, Judiciary Committee Chairman Chuck Grassley (R-IA) and Sen. Sheldon Whitehouse (D-RI) introduced bipartisan legislation to reauthorize the Comprehensive Opioid, Stimulant and Substance Use Program (COSSUP). The program was established in 2016 by the Grassley-Whitehouse Comprehensive Addiction and Recovery Act (CARA). COSSUP provides resources for law enforcement, first-responder programs, and family and drug courts to assist individuals suffering from substance use disorder.
On August 4, Finance Committee Ranking Member Ron Wyden (D-OR) led a group of Senate Democrats in introducing the Protecting Healthcare And Lowering Costs Act, legislation that would repeal the health care cuts included in the recently passed reconciliation package and permanently extend the enhanced Affordable Care Act premium tax credits.
On August 5, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) and Sen. Maggie Hassan (D-NH) sent a letter to UnitedHealth Group (UHG) CEO Stephen Hemsley stating concerns regarding the company’s continued failure to defend against cyberattacks and protect patients’ sensitive health data. The letter states that the recently reported hack of Episource, a subsidiary of UHG, raises significant questions about UHG’s efforts to safeguard patient information, and requests information regarding UHG’s knowledge of the attack. On August 6, Finance Committee Ranking Member Wyden and Sen. Elizabeth Warren (D-MA) sent a letter to Hemsley in response to reports that the company is padding revenue by deploying a number of incentive programs that encourage nursing homes across the country to cut health care expenditures for residents enrolled in UHG institutional special needs plans (I-SNPs). The letter requests detailed information about UHG’s reported incentive programming and its impact on residents.
The Senate will return from recess on September 2.
REGULATORY UPDATE
On August 4, the Food & Drug Administration (FDA) announced that Sean Keveney was appointed to serve as Chief Counsel. Keveney most recently served as Acting General Counsel of the Department of Health & Human Services (HHS).
On August 5, HHS announced the beginning of a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations.
On August 7, FDA announced the launch of FDA PreCheck, a new program designed to boost U.S. pharmaceutical manufacturing by increasing regulatory predictability and facilitating the construction of domestic drug production facilities. The program responds to President Trump’s Executive Order (EO) from earlier in the year, which directs FDA to streamline regulatory oversight for domestic production of critical medicines. The program introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities:
Facility Readiness Phase: Offers enhanced FDA engagement during facility design, construction, and pre-production. It encourages submission of a Type V Drug Master File (DMF) with site-specific information (e.g., facility layout, quality systems, and maturity practices).
Application Submission Phase: Focuses on streamlining the Chemistry, Manufacturing, and Controls (CMC) section of drug applications via pre-application meetings and early feedback.
FDA will present the PreCheck draft framework at a public meeting at the FDA White Oak Campus on September 30, 2025.
On August 7, HHS Secretary Robert F. Kennedy, Jr., endorsed a recommendation from the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), that individuals in the U.S. ages 6 months and older should receive a flu shot for the upcoming season.
On August 7, the Department of Justice’s (DOJ) antitrust division filed a proposed settlement in the acquisition of Amedisys by UHG. The settlement requires broad divestitures to resolve challenge to UHG’s $3.3 billion acquisition of Amedisys Inc and would require Amedisys to pay a $1.1 million civil penalty for falsely certifying that it had provided “true, correct, and complete” responses under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
On August 7, DOJ reached a legal settlement with Feds for Freedom, a federal employee group that challenged the Biden-era federal employee COVID-19 vaccine mandate. As part of the settlement, the federal government must expunge COVID-19 vaccine status records, prohibit discrimination based on vaccine status, and reimburse a portion of Feds for Freedom’s legal fees.
Late last week, news reports indicated that CMS’ Center for Medicare and Medicaid Innovation (CMMI) is planning on conducting a five-year experiment that would allow Medicare Part D plans and state Medicaid programs to voluntarily cover GLP-1 drugs for weight management. The model is expected to launch in April 2026 for Medicaid and January 1, 2027, for Medicare Part D. As reported, the model would also require participating plans to offer diet and exercise support and would require participating Part D plans to offer the drugs to all eligible enrollees.
WHITE HOUSE
On August 5, in a CNBC interview, President Trump stated that pharmaceutical tariffs could reach up to 250%. He discussed the potential of a stepwise series of pharmaceutical tariffs that could reach 150% within a year and a half, rising to 250% shortly after.
The Trump Administration’s Make America Healthy Again Commission is expected to release its final report next week. The report will detail a national strategy for combatting chronic disease and is expected to discuss ultra-processed food, exposure to chemicals, a lack of exercise, mental health issues and the overprescribing of drugs.
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
Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children; Proposed Rule; 8/7/25
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
Medical Devices; Laboratory Developed Tests; Rescission; Final Rule; 8/6/25
REPORTS
Office of Inspector General (OIG)
On August 5, OIG issued a report examining Medicare Part B drug payments. OIG found that CMS’ application of its price-substitution policy to drugs identified and referred by OIG has saved Medicare and its enrollees $76 million since 2013, including $1.6 million for 2023. However, OIG stated that potential errors in the average manufacturer price (AMP) data submitted to CMS prevented OIG from determining whether 35 drugs qualified for a price substitution. OIG encourages CMS to continue working with manufacturers to review and respond to potential errors in the drug data identified by OIG each quarter to bolster the effectiveness of the price-substitution policy. OIG stated that these potential errors could limit the effectiveness of the price-substitution policy by reducing the number of drugs eligible for a price substitution because of concerns about the accuracy of the underlying data.
Government Accountability Office (GAO)
On August 5, GAO issued a report finding that the National Institutes of Health (NIH) violated the Impoundment Control Act of 1974 (ICA) after canceling 1,800 grants following a series of EOs. GAO also noted that HHS issued a memorandum directing its agencies to cease the publication of grant review meeting notices in the Federal Register. GAO stated that NIH's actions to carry out these EOs, coupled with publicly available data showing a decline in NIH's obligations and expenditures, establishes that NIH intended to withhold budget authority from obligation and expenditure without regard to the process provided for by the ICA. In its response to GAO, HHS indicated that it had lifted the pause relating to the publication of Federal Register notice submissions and resumed scheduling meetings. However, HHS's response did not include information regarding current obligations of NIH funds for FY 2025. GAO stated that it will continue to monitor any litigation related to the delay in the obligation and disbursement of NIH funds.
ADDITIONAL POLICY NEWS
On August 6, a federal appeals court agreed with a lower court’s decision surrounding the Dayton Area and Ohio Chambers of Commerce’s ability to challenge the Medicare drug price negotiation program. The court agreed that the entities are too detached from the litigation’s focus to challenge the law.
On August 7, a federal appeals court rejected Boehringer Ingelheim’s attempt to block the Medicare drug price negotiation program, agreeing with a lower court’s ruling that Boehringer Ingelheim could not demonstrate irreparable harm as a result of the negotiations. The appeals court also agreed that the company’s claims of unconstitutionality were not proven in their argument.