Health Care Watch: August 17, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 10 – August 16. 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 14, staff for Republican Study Committee members were briefed by the Paragon Institute to hear about ways to further reducing health care spending. Some conservatives have called for passing a bill, via a second budget resolution, this fall that would further cut Medicaid and possibly Medicare, as well.
The House will return from recess on September 2.
Senate
The Senate will return from recess on September 2.
REGULATORY UPDATE
On August 8, Food & Drug Administration (FDA) Commissioner Dr. Marty Makary announced that the nationwide shortage of intravenous saline fluid is over and that sodium chloride 0.9% injection products have been removed from the agency's list of current shortages
On August 9, it was announced that Dr. Vinay Prasad will be returning to FDA to resume his role as Director of the Center for Biologics Evaluation and Research (CBER). Prasad left the agency two weeks ago, amid escalating tensions related to a gene therapy product for Duchenne’s muscular dystrophy made by Sarepta Therapeutics and a campaign to remove him from is role launched by right-wing influencer Laura Loomer.
On August 12, Noni Byrnes, Director of the National Institutes of Health’s (NIH) Center for Scientific Review, announced her retirement. Byrnes oversaw grant review and evaluation of NIH grant applications.
On August 12, FDA issued its annual report on the state of pharmaceutical quality. The report provides data, trends, and insights about FDA-registered drug manufacturers and the quality of the U.S. drug supply, including biological products regulated by the Center for Drug Evaluation and Research (CDER). The report lists 4,619 global manufacturing sites that make drugs for American patients and found that 62% of drug-quality assurance inspections were conducted at foreign sites.
On August 14, it was announced that Richard Forshee, Acting Director of CBER’s Office of Biostatistics and Pharmacovigilance, will step down from his role and serve, instead, in CDER’s Office of Surveillance and Epidemiology. CBER Director Prasad will assume Forshee’s previous duties overseeing vaccine adverse event data.
On August 14, the Department of Health & Human Services (HHS) announced the reinstatement of the Task Force on Safer Childhood Vaccines, a federal panel created by Congress to improve the safety, quality, and oversight of vaccines administered to American children. The Task Force was disbanded in 1998 after releasing a report with recommendations on vaccine safety. The Task Force is represented by senior leadership from the National Institutes of Health (NIH), FDA, and the Centers for Disease Control and Prevention. The NIH Director will serve as Chairman of the Task Force. The Task Force will work closely with the Advisory Commission on Childhood Vaccines to produce regular recommendations focused on: 1) the development, promotion, and refinement of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines currently on the market; and 2) improvements in vaccine development, production, distribution, and adverse reaction reporting.
On August 14, FDA approved Papzimeos, a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis (RRP).
WHITE HOUSE
On August 13, President Trump issued an Executive Order (EO) entitled Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). This EO builds on President Trump’s 2020 EO which sought to boost domestic production and identify vulnerabilities in making essential medicines and critical inputs. The EO directs the Office of the Assistant Secretary for Preparedness and Response (ASPR), within 30 days, to develop a list of approximately 26 critical drugs vital to national health and security, and ready the SAPIR repository to receive and maintain the Active Pharmaceutical Ingredients (APIs) used to make these critical drugs. The EO also charges ASPR with obtaining a 6-month supply of these critical APIs, with a preference for obtaining domestically manufactured APIs. Additionally, the EO instructs ASPR, within 90 days, to update the 2022 list of 86 essential medicines and propose a plan to obtain and store a 6-month API supply for these drugs. Finally, the EO directs ASPR to develop a proposal for opening a second SAPIR repository to further enhance pharmaceutical supply chain resilience. A fact sheet detailing the EO can be found here.
On August 15, a leaked document containing President Trump’s Make America Healthy Again (MAHA) Commission’s recommendations was released online. The document references a number of policies aimed at improving nutrition, increasing physical activity, reducing exposure to chemicals, reducing stress, and overprescribing to children. The report was originally scheduled to be released on August 12 and now is expected in September.
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 14, OIG issued a report comparing average sale prices (ASP) and average manufacture prices (AMP) in the first quarter of 2025. OIG found that in the first quarter of 2025, seven drug codes met CMS’ price-substitution criteria because their ASP exceeded their AMP by 5 percent or more for two consecutive quarters or three of the previous four quarters. OIG is providing the seven drug codes to CMS for its review and stated that CMS should review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs.
ADDITIONAL POLICY NEWS
On August 12, a federal judge temporarily blocked the Trump Administration from using personal data about Medicaid recipients obtained from certain states for immigration enforcement. U.S. District Judge Vince Chhabria agreed with the state of California’s argument that HHS’ decision to share Medicaid recipients’ personal data with immigration enforcement likely violated the federal Administrative Procedure Act.
On August 12, the Journal of the American Medical Association (JAMA) issued a report finding that fewer Medicare Advantage (MA) beneficiaries were enrolled in plans offering long-term support services (LTSS) in 2025 than in 2019. Specifically, the report found that the availability of LTSS benefits within MA plans in 2025 was 12.3%, essentially the same as it was when benefits were first introduced in 2019 (12.9%). However, the share of MA beneficiaries enrolled in a plan offering LTSS decreased by 14% over the same time frame.
On August 13, a Rhode Island district judge narrowed an injunction that had blocked the Trump Administration from conducting reductions-in-force (RIF) at the Centers for Disease Control & Prevention (CDC). The initial injunction blocked HHS from terminating any CDC employee, but the new narrowed injunction protects only six of the agency’s centers from RIFs.
On August 14, UnitedHealth Group’s $3.3 billion acquisition of Amedisys was finalized.
On August 14, Lilly announced plans to raise prices for certain drugs in certain European markets to help lower U.S. prices, in an apparent response to President Trump’s push for most-favored-nation (MFN) pricing. Lilly is working with some governments to implement price increases by September 1 while maintaining patient access, citing a deal with the UK to raise the list price of Mounjaro.