Health Care Watch: June 23, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 15 – June 21. 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 23, the House will consider H.R. 1520, Charlotte Woodward Organ Transplant Discrimination Prevention Act.
Senate
On June 13, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bernie Sanders (I-VT) sent a letter to HELP Committee Chairman Bill Cassidy (R-LA) asking that he open an investigation into Department of Health & Human Services (HHS) Secretary Kennedy’s removal of all 17 members of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP).
On June 16, Finance Committee Chairman Mike Crapo (R-ID) released his portion of the budget reconciliation text. The bill text includes various health care-related provisions that differ from the initial House passed legislation, namely a reduction in the safe harbor amount a state can levy in Medicaid provider taxes from 6% to 3.5% in states that expanded Medicaid under the Affordable Care Act with an exception for nursing facilities and intermediate care facilities, removal of a provision from the House bill that would exempt more drugs from Medicare drug price negotiations, and a limit on state-directed payments (SDPs) to 100% of the Medicare payment rate in expansion states and 110% in non-expansion states. A section-by-section summary of the legislation can be found here. Changes are expected to address the concerns by some Senate Republicans about the size of the Medicaid cuts included in the proposal.
On June 18, HELP Committee Chairman Cassidy, HELP Committee Ranking Member Sanders, and Sens. Lisa Murkowski (R-AK), Tammy Baldwin (D-WI), Markwayne Mullin (R-OK), Maggie Hassan (D-NH), Tommy Tuberville (R-AL), and John Hickenlooper (D-CO) reintroduced the SUPPORT for Patients and Communities Reauthorization Act. This legislation bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Originally signed into law by President Trump in 2018, the SUPPORT Act reauthorization expired September 30, 2023. The House passed its version of the SUPPORT Act on June 5.
On June 18, HELP Committee Chairman Cassidy and Ranking Member Sanders along with Sens. Rick Scott (R-FL), Kirsten Gillibrand (D-NY), Susan Collins (R-ME), Tim Kaine (D-VA), Markwayne Mullin (R-OK), Ed Markey (D-MA), Lisa Murkowski (R-AK), and Ben Ray Lujan (D-NM) reintroduced the Older Americans Act (OAA) Reauthorization Act. This legislation would reauthorize OAA programs through fiscal year 2030 and make improvements to promote innovation and flexibility, strengthen program integrity, and better support family caregivers and direct care workers.
Majority Leader John Thune (R-SD) has targeted July 4 for the Senate to have completed consideration of its bill, although that could slip to the following week given the recess schedule. President Trump has asked that both chambers pass identical legislation by July 4, which is highly unlikely given the key differences between the House-passed bill and the Senate’s recently released text. Majority Leader Thune has stated that he is aiming for a vote on the Senate reconciliation package mid next week.
REGULATORY UPDATE
On June 17, the Food & Drug Administration (FDA) announced its Commissioner’s National Priority Voucher (CNPV) program. The new voucher may be redeemed by drug developers to participate in a novel priority program by FDA that shortens review times from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting. While FDA has stated it plans to issue a limited number of vouchers in the first year, the criteria for obtaining a voucher have not yet been fully defined. The agency has outlined only general priorities for eligibility, such as alignment with “national health priorities” which encompass addressing public health crises, delivering innovative cures, meeting unmet health needs, and enhancing domestic drug manufacturing.
On June 18, it was announced that Vinay Prasad, current Director of FDA’s Center for Biologics Evaluation and Research (CBER), will take on an additional role as the agency’s Chief Medical and Scientific Officer.
On June 18, FDA approved Gilead’s drug Yeztugo® (lenacapavir) to prevent HIV infection with a shot taken twice a year. The company’s injectable HIV-1 capsid inhibitor is the first and only twice-yearly option available in the United States for people who need or want PrEP.
On June 18, CDC’s ACIP released an agenda for its committee meeting next week. The agenda includes two separate votes, one on influenza vaccines and one on influenza vaccines that contain thimerosal.
On June 18, FDA announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other countries for genetic engineering and subsequent infusion back into U.S. patients. FDA stated that this action follows mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments.
On June 18, the annual Medicare & Social Security Trustees Reports were released. The Medicare Trustees estimate the Medicare Hospital Insurance (Part A) trust fund will be insolvent by 2033, at which point Medicare Part A payments would be reduced by 11% absent Congressional actions or economic or behavioral changes that extend solvency. The Social Security Trustees estimate the Social Security Old-Age and Survivors Insurance trust fund will deplete its reserves by 2033 and the Social Security Disability Insurance trust fund will remain solvent at least through 2099; the theoretically combined Social Security trust funds will be insolvent by 2034, at which point all beneficiaries regardless of age, income, or need will face a 19% benefit cut.
On June 18, the National Institutes of Health (NIH) announced that it is suspending funding for gain-of-function research. An NIH directive immediately terminated funding and other support for gain-of-function research conducted by foreign entities in countries of concern or foreign countries where there is not adequate oversight. The order didn’t explicitly name the targeted groups and countries.
On June 18, FDA placed two of the top cell and gene therapy regulators from the Center for Biologics Evaluation and Research (CBER) on administrative leave. CBER Office of Therapeutic Products (OTP) Director Nicole Verdun and Deputy Director Rachael Anatol were placed on leave.
On June 23, HHS and CMS are expected to announce actions that insurance plans have agreed to take to voluntarily reform their use of prior authorization.
WHITE HOUSE
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 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
Medicaid Managed Care-State Directed Payments (CMS-2449); Proposed Rule; 6/9/25
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
HRSA
340B Rebate Guidance; Notice; 6/1/25
HEARINGS
House
Ways & Means Committee
Health Subcommittee
June 25; 9:00 AM; 1100 Longworth
Health Subcommittee Hearing on Health at Your Fingertips: Harnessing the Power of Digital Health Data
Energy & Commerce
Health Subcommittee
June 24; 10:00 AM; 2123 Rayburn
The Fiscal Year 2026 Department of Health and Human Services Budget
Witness: HHS Secretary Kennedy
Senate
HELP Committee
June 25; 10:00 AM; 430 Dirksen
Nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention, Department of Health and Human Services
Witness: Dr. Susan Monarez
Special Committee on Aging
June 25; 3:30 PM; SD-G50
Lessons from the Field: How Sports Medicine Can Improve Health Outcomes for Seniors
Witnesses: Dr. E. Lyle Cain Jr., Orthopedic Surgeon, Team Physician, Andrews Sports Medicine & Orthopedic Center, University of Alabama; Dr. Paul Legg, Orthopedic Surgeon and Team Physician, University of Charleston; Matt Hasselbeck, Former NFL Quarterback; Jennifer Raymond, Chief Strategy Office, AgeSpan.
REPORTS
Office of Inspector General (OIG)
On June 18, OIG released a report examining Part D Plan drugs commonly used by dually eligible beneficiaries. OIG found that a majority of 2025 Part D plan formularies covered almost all commonly used drugs, and only a small number of commonly used drugs were not covered by most formularies. OIG concluded that dual-eligible enrollees can expect to have access to most drugs in 2025, regardless of the Part D plan in which they are enrolled.
ADDITIONAL POLICY NEWS
On June 16, A federal judge in Boston stated that the Trump Administration violated federal law by arbitrarily canceling more than $1 billion in NIH grants because of their perceived connection to diversity, equity and inclusion initiatives.
On June 18, the Supreme Court ruled 6-3, to uphold Tennessee’s ban on gender-affirming care for minors, stating that the ban does not constitute sex-based discrimination.