Health Care Watch: June 16, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 8 – June 13. 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 10, a group of 38 House Republicans, led by Budget Committee Vice Chair Lloyd Smucker (R-PA), sent a letter to Senate Majority Leader Thune stating that any additional tax cuts in the One Big Beautiful Bill Act must be matched dollar for-dollar by real, enforceable spending reductions.
On June 12, in a 214-212 vote, the House passed President Trump’s rescissions bill. The legislation would clawback $9.4 billion worth of funds that Congress appropriated to various agencies. The package now heads to the Senate where it only requires a simple majority to pass.
On June 12, the House passed the HALT Fentanyl Act in a 321-104 procedural vote. The House and Senate both passed the legislation earlier, but the chambers had to resolve minor differences before final passage. The legislation now heads to President Trump’s desk for final approval.
Senate
Majority Leader John Thune (R-SD) has targeted July 4 for the Senate to have completed consideration of the One Big Beautiful Bill Act, 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, an unlikely proposition. Senate Finance Committee Chairman Mike Crapo (R-ID) has indicated that the Senate is unlikely to make material changes to the House-passed Medicaid policies, while changes to the tax provisions – namely the SALT cap and green energy tax phase outs – are likely. The first round of the Finance Committee’s legislative text is expected to be released on June 16.
On June 10, the Health, Education, Labor & Pensions (HELP) Committee released its part of the reconciliation text. The text funds cost-sharing reduction payments to insurers in Affordable Care Act marketplaces and includes various policies targeting higher education. A section-by-section summary of the text can be found here.
On June 10, Finance Committee Ranking Member Ron Wyden (D-OR) and Senator Chuck Grassley (R-IA) released a report detailing their bipartisan investigation into Organ Procurement Organizations (OPO). The report highlights various key findings in two categories: 1) pancreata; and 2) conflicts of interest. The report makes four recommendations: 1) CMS should clarify the requirements and expectations of OPOs reporting pancreata to be counted toward certification or recertification, to ensure OPOs are following the law and congressional intent; 2) CMS should further clarify OPO conflict of interest policies to make clear that OPO governing boards and medical advisory boards, as well as CMS surveyors, monitor actual and potential conflicts; 3) OPOs should clearly define policy coverage, scope of conflicts and disclosure procedures; and 4) OPOs should ensure board involvement, oversight, and recording.
On June 10, the Appropriations Committee held a hearing entitled A Review of the President’s Fiscal Year 2026 Budget Request for the National Institutes of Health (NIH). NIH Director Jay Bhattacharya testified before the committee, offering a defense of the 40% cut the Administration has proposed to the agency, stating that the budget is a collaboration between Congress and the Administration.
On June 10, Sens. Wyden and Elizabeth Warren (D-MA) sent a letter to Maximus, the largest contractor for Medicaid eligibility determinations, regarding concerns about the company’s potential profiteering under proposed Medicaid reforms. The letter requests that Maximus respond to various questions regarding its business practices by June 16.
On June 11, HELP Committee Ranking Member Bernie Sanders (I-VT), alongside all Democratic members of the HELP Committee, sent a letter to committee Chairman Bill Cassidy (R-LA) urging him to schedule hearings with patients and health care providers to discuss the impact of the One Big Beautiful Bill Act.
On June 11, it was reported that HELP Committee Chairman Cassidy is floating a proposal for the Senate's reconciliation package that would allow Medicare to clawback money from drug companies that sell branded drugs to other countries at a lower price than in the U.S. The proposal appears to be a scaled-back version of the Trump Administration’s most-favored-nation (MFN) drug pricing policy, but Sen. Cassidy’s policy would only apply to a list of the 50 highest cost drugs to Medicare and would be updated once every three years. The clawback amount would be based on other countries’ GDP. Sen. Cassidy also shopped a policy that would target Medicare Advantage plans’ coding practices that would reduce spending by more than $250 billion over 10 years. That proposal is highly unlikely to be included in the reconciliation bill.
On June 12, Sens. Ed Markey (D-MA), Chuck Schumer (D-NY), Wyden, and Jeff Merkley (D-OR) sent a letter to President Trump and Republican Congressional leadership detailing data from the Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill concluding that Republican reconciliation health care cuts could place over 300 rural hospitals across the U.S. at disproportionate risk of closure, conversion, or service reductions.
On June 12, HELP Committee Ranking Member Sanders and Sen. Angus King (I-ME) introduced the End Prescription Drug Ads Now Act. The legislation would ban prescription drug advertising on television, radio, print, digital platforms, and social media.
On June 12, HELP Committee Ranking Member Sanders requested information from health care providers across the country on the impact of the One Big Beautiful Bill Act. Responses must be submitted by June 20. More information on submissions can be found here.
REGULATORY UPDATE
On June 9, Jim O’Neill was sworn in as Deputy Secretary of the Department of Health & Human Services (HHS).
On June 9, HHS Secretary Robert F. Kennedy, Jr., removed all 17 members of the Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC). In announcing the removals, Secretary Kennedy stated that “a clean sweep is necessary to reestablish public confidence in vaccine science.” Subsequently on June 11, Secretary Kennedy announced eight new appointments to ACIP. Secretary Kennedy stated that the new appointees will attend the ACIP meeting scheduled for June 25, 2025. New members announced include:
Joseph R. Hibbeln, former acting chief of the Section of Nutritional Neurosciences at the National Institute on Alcohol Abuse and Alcoholism;
Martin Kulldorff, former professor of medicine at Harvard University;
Retsef Levi, professor of operations management at the MIT Sloan; School of Management;
Robert W. Malone, former professor of pathology at the University of California, Davis;
Cody Meissner, professor of pediatrics at Geisel School of Medicine at Dartmouth;
James Pagano, an emergency medicine physician;
Vicky Pebsworth, board member of the National Vaccine Information Center; and
Michael A. Ross, an obstetrician-gynecologist.
On June 9, the Food & Drug Administration (FDA) approved Merck’s ENFLONSIA™ (clesrovimab-cfor ) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.
On June 10, FDA Commissioner Dr. Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad announced that the agency plans to launch a pilot program to review certain drugs within weeks of receiving a company’s final application. Commissioner Makary stated that for efficiency, the pathway will ask sponsors to submit much of the paperwork to FDA in advance of their final application, enabling regulators to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete. Makary also noted that FDA is reevaluating legacy requirements that may stifle innovation, such as outdated monographs and unnecessary animal testing.
On June 11, the Federal Trade Commission (FTC) and Department of Justice (DOJ) announced that they would hold “listening sessions” focused on lowering prices “by increasing generic and biosimilar availability and promoting competition through drug formularies and benefits.” The sessions will cover anticompetitive practices as well as eliminating regulatory barriers and will inform the FTC and DOJ’s joint report on combatting anticompetitive practices in pharmaceutical markets, as mandated by President Trump’s Executive Order.
On June 11, CDC in an email to staff, announced that it is rehiring more than 400 people who had received layoff notices earlier this year. About half of the rehired employees are in the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, and a third are in the National Center for Environmental Health.
On June 12, FDA approved Moderna’s mRESVIA® (mRNA-1345) respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.
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
HRSA
340B Rebate Guidance; Notice; 6/1/25
REPORTS
Office of Inspector General (OIG)
On June 9, OIG issued a report detailing CMS use of staffing data to inform state oversight of nursing homes. OIG found that although States reported that the Payroll Based Journal (PBJ) data have been useful, CMS did not provide states with all the information they need to effectively oversee the minimum requirement to provide 8 RN hours every day, as well as the broader requirement to provide sufficient staffing to meet residents’ needs. OIG recommends that CMS: 1) inform states of nursing homes that appear from PBJ data to violate the required number of daily RN staffing hours; and 2) provide states additional nursing home staffing analysis and guidance to identify potential insufficient staffing.
Congressional Budget Office (CBO)
On June 12, CBO responded to a request from Sen. Merkley for information regarding how federal deficits and debt-service costs would be affected by enacting H.R. 1, the One Big Beautiful Bill Act. CBO and the Joint Committee on Taxation (JCT) estimate that enacting the bill would increase deficits over the 2025–2034 period by $2.4 trillion, excluding any macroeconomic or debt‑service effects. JCT has estimated that permanently enacting 16 of the tax provisions that would sunset under H.R. 1 at the end of 2028 or 2029 would increase primary deficits over the 2025–2034 period by an additional $1.4 trillion. CBO estimates that if those provisions were made permanent, the additional debt-service costs would total $687 billion over the 10‑year period. That change would increase the cumulative deficit to $4.5 trillion. As a result, and net of any changes in borrowing for federal credit programs, CBO estimates that debt held by the public at the end of 2034 would increase from the January 2025 baseline projection of 117.1% to 127.7% of gross domestic product.
Medicare Payment Advisory Commission (MedPAC)
On June 9, MedPAC released four comment letters on CMS proposed rules. MedPAC issued comment letters on the fiscal year (FY) 2026 inpatient prospective payment system (IPPS), inpatient rehabilitation facility (IRF), skilled nursing facilities (SNF), and hospice proposed rules.
On June 12, MedPAC issued its June 2025 report to Congress. The report details improvements to Medicare payment systems and issues affecting the Medicare program, including changes to health care delivery and the market for health care services. The seven chapters of the June 2025 report cover the following topics: 1) reforming physician fee schedule updates and improving the accuracy of relative payment rates; 2) supplemental benefits in Medicare Advantage (MA); 3) examining home health care use among MA enrollees; 4) Part D prescription drug plans for beneficiaries in fee-for-service Medicare and MA; 5) Medicare beneficiaries in nursing homes; 6) Medicare’s measurement of rural provider quality; and 7) reducing beneficiary cost sharing for outpatient services at critical access hospitals.
Medicaid and CHIP Payment and Access Commission (MACPAC)
On June 10, MACPAC released its June 2025 Report to Congress, addressing a range of Medicaid policy priorities. The report includes recommendations on improving transitions from pediatric to adult care for children and youth with special health care needs and examines access to residential behavioral health services for children. Additional chapters cover access to medications for opioid use disorder (MOUD), the Program of All-Inclusive Care for the Elderly (PACE), and self-direction within home- and community-based services (HCBS).