Health Care Watch: June 9, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 1 – June 7. 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 June 4, the House voted 366-57 to reauthorize the SUPPORT for Patients and Communities Reauthorization Act of 2025through fiscal year 2030. The legislation would reauthorize billions of dollars in funding to address the opioid crisis and would build on the original legislation Congress passed in 2018.
On June 4, the Appropriations Committee released the Fiscal Year (FY) 2026 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Bill. In total, the bill provides a discretionary allocation of $25.523 billion, which is $1.163 billion (4.2%) below the FY 2025 enacted level. The bill directs $6.8 billion to FDA. On June 5, the Committee advanced the legislation in a 9-7 party line vote.
The House will consider S. 231, the HALT Fentanyl Act, the week of June 9. This bill passed the Senate 84-16 on March 14.
Senate
On June 4, the Congressional Budget Office (CBO) sent a letter to Senate Finance Committee Ranking Member Ron Wyden (D-OR), and House Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ) and House Ways & Means Committee Chairman Richard Neal (D-MA) detailing its estimates of how several policies within CBO’s current-law baseline or contained in H.R. 1, the One Big Beautiful Bill Act would change the number of people without health insurance. CBO estimates that the combination of current laws, proposed regulations, and policies included in the reconciliation bill would increase the number of uninsured by 16 million in 2034. The letter states that the expiring Expanded Premium Tax Credits and a proposed marketplace regulation would increase the uninsured by 5.1 million. CBO estimates that the provisions related to Medicaid would increase the number of uninsured by 7.8 million in 2034, including 4.8 million from proposed work requirements (5.2 million losing Medicaid coverage), 400,000 from the moratorium on new or increased provider taxes, and 700,000 from more frequent eligibility determinations. CBO estimates that the provisions related to the ACA health insurance marketplaces would increase the number of uninsured by 3.6 million in 2034. With interactions between provisions, the total increase in uninsured from the reconciliation bill is estimated at 11.9 million in 2034.
On June 4, the Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled Reauthorization of the Over-the-Counter Monograph Drug User Fee Program. The hearing included testimony from Dr. Jacqueline Corrigan-Curay, Acting Director of the Center for Drug Evaluation and Research (CDER).
On June 5, the Senate voted 52-43 to confirm the nomination of Jim O’Neill to serve as the Deputy Secretary at the Department of Health & Human Services (HHS).
On June 5, it was reported that Senate Republicans are considering possible Medicare provisions to help offset the cost of the reconciliation package. Senate Majority Leader John Thune (R-SD) did not shut the idea down, stating that he thinks “anything that is waste, fraud, and abuse are obviously open to discussions.” Sen. Bill Cassidy’s No UPCODE Act, which would reduce payments to Medicare Advantage (MA) plans by reforming plan coding practices, is under consideration.
REGULATORY UPDATE
On May 31, the Food & Drug Administration (FDA) approved Moderna’s mNEXSPIKE (mRNA-1283) vaccine, a new vaccine that prevents against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor.
On June 2, Drew Snyder, Director and Deputy Administrator of the Center for Medicaid and CHIP Services (CMCS) and the Centers for Medicare & Medicaid Services (CMS), resigned. Snyder previously served as Mississippi State’s Medicaid director. Caprice Knapp is serving as Interim Acting Director of CMCS.
On June 2, Deputy Director of FDA’s Center for Biologics Evaluation and Research (CBER) Julie Tierney resigned. Tierney previously served as Chief of Staff to former Commissioner Dr. Robert Califf and Acting Commissioner Dr. Janet Woodcock
On June 2, FDA launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees work more efficiently. Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.
On June 3, HHS and CMS announced that they are rescinding July 2022 guidance from CMS entitled Reinforcement of Emergency Medical Treatment and Labor Act (EMTALA) Obligations specific to patients who are Pregnant or are Experiencing Pregnancy Loss and the accompanying letter from the former HHS Secretary. CMS stated that it will continue to enforce EMTALA and will work to rectify any perceived legal confusion and instability created by the former administration’s actions.
On June 3, it was announced that Dr. Thomas Keane will serve as HHS Assistant Secretary for Technology Policy. Keane worked at HHS from 2018 to 2023, first as a senior adviser to the deputy secretary and more recently as an adviser in the Office of the National Coordinator for Health Information Technology
On June 4, Dr. Lakshmi Panagiotakopoulos, co-leader of a working group that advises CDC’s Advisory Committee on Immunization Practices on COVID-19 vaccines, announced that she is stepping down from her position.
On June 4, CMS held a listening session to discuss its Health Technology Ecosystem Request for Information (RFI) and ways to use health technology innovations to enhance patient care and promote efficiencies in the healthcare system. During the meeting, CMS announced its commitment to move forward on the following initiatives: 1) building a dynamic, interoperable national provider directory; 2) bringing modern identity verification processes to Medicare.gov to streamline credentials across the healthcare system; 3) expanding functionality of CMS’ Blue Button 2.0 patient access application programming interface (API); 4) transitioning CMS’ Data at the Point of Care pilot to general availability; and 5) enhancing CMS’ participation in trusted data exchange
On June 4, HHS announced the appointment of Paula Stannard as Director of HHS’ Office for Civil Rights (OCR).
On June 5, FDA hosted its first roundtable series on regulatory modernization with drug company CEOs at its Silver Spring, Maryland headquarters.
On June 5, Principal Deputy Director of the National Institutes of Health (NIH) Matthew Memoli announced that NIH plans to build an AI strategy to combat chronic disease. He also announced a Request for Information (RFI), entitled Inviting Comments on the NIH Artificial Intelligence (AI) Strategy. The RFI invites public comment on themes, pillars, and specific actions that should shape the forthcoming NIH AI Strategic Plan and its early one-year action plan.
On June 5, the Health Resources and Services Administration (HRSA) announced the new 34-member Board of Directors for the Organ Procurement and Transplantation Network (OPTN). A list of all new members can be found here.
WHITE HOUSE
On June 3, President Trump sent his $9.4 billion rescissions package to Congress. The official request asks that Congress claw back $9.4 billion in already appropriated funding, following the Department of Government Efficiency’s (DOGE) findings. Congress now has 45 days to act on the proposed rescissions package and only requires a simple majority in each chamber for passage. If a bill rescinding some or all of the funding is not passed within 45 days of continuous session, the President must release the funding. The House is expected to consider recissions legislation the week of June 9.
On June 6, President Trump instructed HHS Secretary Robert F. Kennedy, Jr., to ensure that Medicaid reimbursement rates do not exceed Medicare rates. This action appears to be an effort to limit spending increases associated with state provider taxes and State Directed Payments.
A list of all administrative and health care-related EOs can be found here. FHP Strategies will update this document, as needed.
HEARINGS
Senate
Appropriations Committee
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
June 10; 10:00 AM; 124 Dirksen
A Review of the President’s Fiscal Year 2026 Budget Request for the National Institutes of Health
Witness: Dr. Jayanta Bhattacharya, Director, National Institutes of Health
House
Energy & Commerce Committee
Health Subcommittee
June 11; 10:00 AM; 2123 Rayburn
Made in America: Strengthening Domestic Manufacturing and Our Health Care Supply Chain
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 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1830); Proposed Rule; 4/24/25
CY 2026 Home Health Prospective Payment System Rate and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Updates (CMS-1828); Proposed Rule; 4/25/25
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
Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability (CMS-9884); Final Rule; 5/2/25
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
FDA
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension; Proposed Rule; 5/27/25
HRSA
340B Rebate Guidance; Notice; 6/1/25
REPORTS
Office of Inspector General (OIG)
On June 2, OIG released its semiannual report to Congress. The report notes that OIG’s total monetary impact during the reporting period was $16.61 billion with $3.51 billion in investigable receivables, $451 million in audit receivables, and $12.65 billion in potential cost savings. The report discusses various topics including the opioid epidemic, drug and medical device safety, improper payments, Medicare and Medicaid program integrity, beneficiary safety, and cybersecurity. Regarding Medicare and Medicaid, OIG stated that audits, evaluations, and investigations consistently identify a high risk of fraud, waste, and abuse in the MA risk adjustment program. OIG also stated that it estimates that 46% of the 5,879 hospitals that were required to comply with the Hospital Price Transparency rule did not. OIG concluded by stating that the recommendations issued during the reporting period could potentially save $12.84 billion by identifying $12.65 billion in funds put to better use and $189 million in questioned costs.
Congressional Budget Office (CBO)
On June 4, CBO released the estimated budgetary effects of H.R. 1, the One Big Beautiful Bill Act. CBO estimates that the legislation would grow the federal deficit by $2.4 trillion, resulting in 11 million people going uninsured, and causing 7.8 million to lose Medicaid coverage.
ADDITIONAL POLICY NEWS
On May 29, Gene Dodaro, Comptroller General and head of the Government Accountability Office (GAO), announced the appointment of two new members to the Medicare Payment Advisory Commission (MedPAC). He also reappointed four current members and appointed one other current member as Vice Chair. The newly appointed members are Dr. Thomas Diller (AdventHealth) and Gokhan Metan (WiseCareAI). Their terms will expire in April 2028. Reappointed members include Dr. Robert Cherry, Kenny Kan, Gregory Poulsen, and Dr. Scott Sarran. Their terms will expire in April 2028. Betty Rambur was appointed as Vice Chair and will serve through 2026.
On June 2, CVS Health and Cigna filed lawsuits to stop Arkansas from enforcing a law that largely prohibits pharmacy benefit managers from owning retail pharmacies in the state. Both lawsuits argue that the Arkansas policy violates the Constitution's Dormant Commerce Clause.
On June 2, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the United States. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA®* (denosumab) and Prolia®* (denosumab), respectively.
On June 6, CEO of the Federation of American Hospitals, Chip Kahn announced that he will be stepping down at the end of the year.