Health Care Watch: June 30, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 22 – June 28. 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 Appropriations Committee voted, 35-27, to advance the Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations Act. The legislation provides $6.8 billion to FDA for FY 2026.
On June 24, the Energy & Commerce Health Subcommittee held a hearing entitled Fiscal Year 2026 Department of Health and Human Services (HHS) Budget. HHS Secretary Robert F. Kennedy, Jr. testified before the subcommittee. Members asked questions regarding targeted waste fraud and abuse at the agency, National Institutes of Health (NIH) funding cuts, reductions in force (RIFs), vaccines and the Centers for Disease Control & Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), and Secretary Kennedy’s vision for the future of the agency.
On June 24, Rep. Chip Roy (R-TX) led a group of 23 House Republicans in sending a letter to Congressional Republican Leadership, urging Senate Republicans to include provisions related to health savings accounts in the Senate’s reconciliation package.
On June 26, the Appropriations Committee voted 34-28 to advance the FY 2026 Legislative Branch Appropriations Act.
Senate
On June 23, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) called for this week’s ACIP meeting to be delayed, citing their lack of experience and potential bias against some vaccines. Chairman Cassidy stated that with a relatively small panel, and no CDC Director in place to approve the panel's recommendations, the meeting should not proceed.
On June 25, HELP Committee Ranking Member Bernie Sanders (I-VT) released a report detailing the impact of the Big, Beautiful Bill Act on the U.S. health care system. The report finds that the bill would increase the number of uninsured Americans in every state in the country and nearly double the uninsured rate in some states — including Florida, Louisiana, Massachusetts and Washington.
On June 26, the Senate Parliamentarian ruled that some of the major Medicaid provisions, as currently drafted, included in the Senate’s reconciliation package would be subject to the Byrd rule and require a 60-vote threshold for passage. Provisions subject to a 60-vote Byrd rule point of order include: 1) provider tax reforms; 2) disallowing premium tax credit during periods of Medicaid ineligibility due to immigrant status; 3) permitting premium tax credits only for certain individuals; 4) expansion of FMAP for certain states providing payments for health care furnished to certain individuals; 5) prohibiting federal financial participation under Medicaid and CHIP for individuals without verified citizenship, nationality or satisfactory immigration status; 6) immigrant Medicaid Eligibility; 7) spread pricing in Medicaid; 8) prohibiting Federal Medicaid and Children’s Health Insurance Program (CHIP) Funding for Gender Affirming Care; and 9) limiting Medicare coverage of certain individuals. Senate staff have indicated that many of these policies can be cured by making minor changes to the legislative text.
On June 27, the Senate GOP released a revised draft reconciliation bill. A summary of the Medicaid and tax provisions can be found here. Major health policy changes, relative to the prior bill, include delaying the Medicaid provider tax reforms until 2028, inclusion of a Medicare “doc fix” in 2026, increasing the rural health care fund to $25 billion, and dropping a provision that would end pharmacy benefit manager spread pricing in Medicaid.
Late on June 28, the Senate voted to approve the motion to proceed on its reconciliation bill, clearing a key procedural hurdle after hours of uncertainty. The motion passed 51-49 to start debate on the legislation. Sens. Rand Paul (R-KY) and Thom Tillis (R-NC) joined Democrats to oppose advancing the bill. Senate Democrats are expected to force a full reading of the nearly 1,000-page bill, which could delay further action for several hours. If the Senate passes the bill, which would likely be on Monday, the House would need to take up the Senate version mid-to-late next week, potentially Wednesday or Thursday, in order to meet President Trump’s goal of signing the bill into law by Friday, July 4. Significant work remains to secure the necessary GOP support to meet that deadline. A handful of GOP Senators are unhappy with the bill’s Medicaid provisions, with some saying it cuts too much while others say it does not go far enough. A sufficient number of GOP House members have the same diverging concerns while also being concerned about various tax policies and have indicated they cannot support the Senate bill, in its current form.
REGULATORY UPDATE
On June 18, the Centers for Medicare & Medicaid Services (CMS) announced updated 2026 commissions for Medicare agents and brokers. Agents and brokers will receive $694 for signing up new Medicare Advantage (MA) enrollees and $347 plan renewals. Both figures are 11% higher than 2025 commissions. Agents and brokers will also receive $114 for helping new fee-for-service (FFS) Medicare enrollees pick a prescription drug plan and $57 for renewing a beneficiaries’ Medicare drug plan. These figures are 5% and 4% higher than 2025 rates, respectively.
On June 20, CMS released the Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability Final Rule. The rule sets standards for the Health Insurance Marketplaces and finalizes additional safeguards to protect consumers from improper enrollments and changes to their health care coverage, lowering individual health insurance premiums by approximately 5% on average. Key finalized policies include revised standards relating to strengthening income verification processes; modifying eligibility redetermination procedures; removing Deferred Action for Childhood Arrivals (DACA) recipients from the definition of “lawfully present” for eligibility and enrollment in Exchanges and Basic Health Program (BHP) coverage in states that elect to operate a BHP; and pre-enrollment verification for special enrollment periods (SEPs) aimed at reducing improper enrollments and improving the risk pool. A number of these policies are temporary through plan year 2026. CMS is finalizing changes to the annual open enrollment period (OEP) beginning with the OEP for plan year 2027. Each OEP must start no later than November 1 and end no later than December 31, and the OEP may not exceed 9 calendar weeks. A fact sheet detailing the final rule can be found here.
On June 23, HHS Secretary Kennedy and CMS Administrator Dr. Mehmet Oz met with industry leaders to discuss their pledge to voluntarily streamline and improve the prior authorization processes for services covered by Medicare Advantage, Medicaid Managed Care, the Health Insurance Marketplace, and commercial plans. Health insurers pledged six key reforms: 1) standardize electronic prior authorization submissions using Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces; 2) reduce the volume of medical services subject to prior authorization by January 1, 2026; 3) honor existing authorizations during insurance transitions to ensure continuity of care; 4) enhance transparency and communication around authorization decisions and appeals; 5) expand real-time responses to minimize delays in care with real-time approvals for most requests by 2027; and 6) ensure medical professionals review all clinical denials.
On June 23, Dr. Jacqueline Corrigan-Curay, Acting Director of FDA’s Center for Drug Evaluation and Research (CDER) announced that she will retire from the agency in July 2025.
On June 24, the Health Resources Services Administration (HRSA) issued updated award terms for HRSA-funded health centers, requiring them to provide insulin and injectable epinephrine to low-income patients at or below the 340B acquisition price paid by the center.
On June 24, it was announced that Dr. Mike Davis will return to FDA as Deputy Director of CDER. Davis worked in the Office of New Drugs’ psychiatry division from 2016 to 2022.
On June 24, HHS Secretary Kennedy announced that the United States won’t contribute to Gavi, the Vaccine Alliance, until the global health organization has “re-earned the public trust.” Secretary Kennedy called on Gavi to justify the $8 billion that the United States has provided in funding since 2001.
On June 24, HHS Secretary Kennedy announced that the agency will soon launch “one of the biggest advertising campaigns in HHS history” to promote wearable health technologies such as continuous glucose monitors (CGMs). Framing wearables as a tool to help Americans “take control” of their health, Kennedy emphasized their potential to improve diet, exercise, and chronic disease management.
On June 25 and 26, CDC’s ACIP met for the first time since HHS Secretary Kennedy’s removal of all 17 members – currently only 8 new members have been appointed. The meeting discussed the COVID-19 vaccine, RSV vaccines, influenza vaccines, and the thimerosal containing influenza vaccine. The Committee also reviewed childhood vaccines as well as vaccines not studied in more than seven years. Lyn Redwood, founder of the World Mercury Project, the predecessor group to Children’s Health Defense, delivered a presentation on thimerosal. ACIP voted 5-1 to recommend that no children, pregnant women, or adult receive any flu vaccine containing thimerosal. The Committee also voted 5-2 to approve Merck’s Clesrovimab immunization to protect infants under 8 months from Respiratory Syncytial Virus (RSV).
On June 26, FDA announced that the agency will begin the reauthorization process for its medical device user fee program by holding a public meeting on August 4, 2025.
On June 27, CMS’ Center for Medicare & Medicaid Innovation (CMMI) announced a new model called the Wasteful and Inappropriate Service Reduction (WISeR) Model, which aims to reduce low-value, unnecessary, and potentially fraudulent services in Original Medicare through an enhanced, technology-enabled prior authorization process. The six-year voluntary model will launch on January 1, 2026, and operate in select states across four MAC jurisdictions. Model participants will be technology vendors with demonstrated expertise in claims analytics and prior authorization, including work with Medicare Advantage (MA). These vendors will partner with CMS to streamline prior authorization for specific high-risk services, with payments based on demonstrated reductions in spending for medically unnecessary or non-covered items or services, calculated as a percentage of the savings directly attributed to their model participation. A fact sheet on the model can be found here.
WHITE HOUSE
On June 23, Michael Kratsios, Director of the Office of Science and Technology Policy, issued guidance to federal agencies on incorporating Gold Standard Science tenets into their research activities in accordance with President Trump’s Executive Order (EO) entitled Restoring Gold Standard Science. The guidance asks agencies to incorporate nine tenets into their scientific work including: reproducing work, increasing transparency, questioning findings and assumptions, and conducting science without conflicts of interest
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
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
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
REPORTS
Government Accountability Office (GAO)
On June 25, GAO issued a report detailing Medicaid and Children’s Health Insurance disenrollment after COVID-19. GAO found that, of the 89 million completed redeterminations by states, about 27 million individuals were disenrolled during the first year and a half of unwinding. Enrollment nationwide was around 79 million as of October 2024, about 10% higher than prior to the pandemic. GAO also found significant variation across states in the percentage of individuals disenrolled during unwinding, with several factors potentially contributing to those differences.
ADDITIONAL POLICY NEWS
On June 25, the Medicare Payment Advisory Commission (MedPAC) released staff presentations from the AcademyHealth Annual Research Meeting. Presentations included the following topics: MA enrollees’ home health utilization, use of MA Encounter data for analyzing supplemental benefits, impact of diagnostic coding intensity on Part D payments, use of prior authorization in MA, and the effect of MA on hospital profitability. Presentations can be found here.