Health Care Watch: July 14, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 6 – July 12. 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 July 10, Rep. Buddy Carter (R-GA) introduced bipartisan legislation that would overhaul pharmacy benefit manager (PBM) practices by instating a ban on spread-pricing in Medicaid and introducing a survey requirement for retail pharmacies to report their drug-acquisition costs. The legislation would also limit pharmacy steering of Medicare Part D beneficiaries and delink PBM compensation from drug costs.
On July 15, the Energy & Commerce Committee will hold a meeting to formally appoint new Subcommittee Chairs, Vice Chairs, and Subcommittee membership after former Health Subcommittee Chairman Buddy Carter stepped down to focus on his run for Senate. Rep. Morgan Griffth (R-VA) will be the new Health Subcommittee Chairman.
The House returns from recess on July 14.
Senate
On July 9, the Health, Education, Labor & Pensions (HELP) Committee voted 12-11 to advance the nomination of Susan Monarez to serve as Director of the Centers for Disease Control & Prevention (CDC). The nomination will now move to the Senate floor for a final vote.
On July 10, the Appropriations Committee advanced, by a unanimous vote, the Fiscal Year (FY) 2026 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations Act. The bill provides $27.1 billion in discretionary funding, with $3.6 billion for the FDA.
The Senate is expected to consider President Trump’s rescissions package next week, ahead of the July 18 deadline. President Trump has threatened to withhold endorsements for Republican Senators who do not support the bill.
REGULATORY UPDATE
On July 8, HHS declared a Public Health Emergency (PHE) in response to Texas flooding. The declaration enables HHS to waive certain Medicare and Medicaid requirements to help ensure continued access to care in impacted areas. CMS has issued an initial set of waivers and flexibilities under the PHE.
On July 8, the Supreme Court, in an 8-1 ruling, stated that the Trump Administration can enforce an Executive Order (EO) and memo from the Office of Management and Budget (OMB) implementing mass layoffs across the federal government. The ruling allows the Trump Administration to move forward with its restructuring of many federal agencies.
On July 9, the National Institutes of Health (NIH) announced that it will cap how much publishers can charge NIH-supported scientists to make their research findings publicly accessible.
On July 9, the FDA sent a letter to industry leaders calling for increased attention to product recall communications, specifically for industry leaders involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children. In the letter, FDA Commissioner Dr. Marty Makary asks food industry leaders to join him in committing to radical transparency, with a focus on ensuring the safety and wellbeing of infants and children
On July 9, Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. postponed a meeting of the U.S. Preventive Services Task Force (USPSTF) originally scheduled for the following day. No reason for the cancellation was provided. The cancellation follows a Supreme Court decision asserting that Secretary Kennedy has the power to hire and fire members of the Task Force at will and to review, delay, or veto the recommendations of the Task Force.
On July 10, the FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to FDA for approval of drugs or biological products between 2020 and 2024. The initial batch of published decision letters associated with since-approved applications is accessible here.
On July 10, FDA approved Moderna’s COVID-19 vaccine, Spikevax, for children 6 months through 11 years of age who are at increased risk for COVID-19.
On July 10, HHS’ Advanced Research Projects Agency for Health (ARPA-H) announced its Functional Repair of Neocortical Tissue (FRONT) program, an initiative that will use cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions. The FRONT program supports several key priorities of the Trump Administration, including: 1) combating chronic disease; 2) economic growth and innovation; 3) veteran and military support; and 4) societal impact.
On July 10, HHS announced a policy shift, formally rescinding a 1998 interpretation of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) which extended certain federal public benefits to undocumented immigrants. The new policy applies PRWORA’s plain-language definition of “Federal public benefit,” reverses exclusions, affirms that programs serving individuals, households, or families are subject to eligibility restrictions, and clarifies that no HHS programs have been formally exempted under PRWORA’s limited exceptions.
On July 11, FDA Commissioner Makary, in an interview on Bloomberg Television’s Wall Street Week, stated that the agency may fast-track new drugs from pharmaceutical companies that equalize the cost of their medicines between the U.S. and other countries. Specifically, Commissioner Makary stated that FDA “can issue a national priority review voucher for companies that are promising to equalize the price. We want to incentivize good behavior in the marketplace, and these priority vouchers are worth a lot of money.”
WHITE HOUSE
On July 7, President Trump issued an EO entitled Extending the Modification of Reciprocal Tariff Rates. The EO extends the suspension of additional ad valorem rate of duties for products of the foreign trading partners effectuated by EO 14266 until 12:01 a.m. eastern daylight time on August 1, 2025. With respect to China, the separate tariff suspension effectuated by EO 14298 of May 12, 2025, remains in effect and is not impacted.
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
CY 2026 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1834); Proposed Rule; 4/21/25
CY 2026 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1832); Proposed Rule; 4/25/25
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
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2026 Rates (CMS-1833); Final rule; 6/20/25
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
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Interim Final Rule; 7/9/25
FY 2026 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1835); Final Rule; 7/10/25
FY 2026 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1827); Final Rule; 7/10/25
FY 2026 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1829); Final Rule; 7/10/25
FY 2026 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1831); Final Rule; 7/10/25
FDA
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension; Proposed Rule; 5/27/25
Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance; Notice; 6/17/25
Ultra-Processed Foods; Request for Information; Notice; 6/30/35
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
HRSA
340B Rebate Guidance; Notice; 6/1/25
HEARINGS
House
Energy & Commerce Committee
Full Committee
July 15; 10:15 AM; 2123 Rayburn
Notification of changes to Subcommittee Chairs, Vice Chairs, and Subcommittee membership
Health Subcommittee
July 16; 10:00 AM; 2123 Rayburn
Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines
Legislation to be considered:
H.R. 4273, Over-the-Counter Monograph Drug User Fee Amendments (Reps. Latta and DeGette)
H.R. 3686, SAFE Sunscreen Standards Act (Reps. Joyce of PA and Dingell)
H.R. 2821, FDA Modernization Act 3.0 (Reps. Carter of GA and Barragán)
H.R. ____, [Title VII Reauthorization]
H.R. ____, [Title VIII Reauthorization]
H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025 (Reps. Carter of GA and Figures)
H.R. 3419, To amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs. (Reps. Valadao and Gray)
H.R. 3302, Healthy Start Reauthorization Act of 2025 (Reps. Ocasio-Cortez and Malliotakis)
H.R. 2846, To amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries). (Reps. Houlahan and Bacon)
H.R. ____, [Newborn Screening Saves Lives Reauthorization Act of 2025]
Appropriations Committee
Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
July 21; 5:00 PM
Subcommittee Markup of FY 2026 Labor, HHS, Education, and Related Agencies Bill
July 24; 10:00 AM; 2359 Rayburn
Full Committee Markup of FY 2026 Labor, HHS, Education, and Related Agencies Bill
Ways & Means Committee
Health and Oversight Subcommittees
Week of July 21
Hearing on Medicare Advantage past, present, and future
Senate
Homeland Security and Governmental Affairs Committee
Subcommittee on Investigations
July 15; 3:00 PM; 216 Hart
Witnesses: Robert Sullivan, Polly Tommey, Emily Tarsell, Krystle Cordingley, Serese Marotta, and Eric Stein
HELP Committee
July 16; 10:00 AM; 430 Dirksen
Nominations of Crystal Carey to be General Counsel of the National Labor Relations Board, Brian Christine to be Assistant Secretary for Health, Department of Health and Human Services, and Brittany Panuccio to be a Member of the Equal Employment Opportunity Commission
Witnesses: Crystal Carey, Brian Christine, and Brittany Panuccio
ADDITIONAL POLICY NEWS
On July 7, FDA approved KalVista Pharmaceutical’s EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE.
On July 7, a coalition of doctor’s groups led by the American Academy of Pediatrics, filed a lawsuit against HHS Secretary Kennedy over his decision, earlier this year, to stop recommending COVID-19 vaccines for healthy children and pregnant people. The lawsuit states that the directive signed in May is arbitrary and capricious because it did not follow longstanding federal vaccine setting policy.