Health Care Watch: April 7, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 30 – April 5. 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 April 1, the Energy & Commerce Health Subcommittee held a hearing entitled Examining the Food and Drug Administration’s (FDA’s) Regulation of Over-the-Counter Monograph Drugs. The hearing discussed the Over-the-Counter Monograph Drug User Fee Program (OMUFA) and heard testimony from various patient groups and research organizations.
On April 2, Energy & Commerce Committee Chairman Brett Guthrie (R-KY) stated that Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr.’s staff will brief the committee on the department’s restructuring next week.
On April 2, the Energy & Commerce Committee delayed a markup of more than two dozen pieces of legislation, including the SUPPORT Act reauthorization which would extend programs and funding to address mental health and substance use disorders. The markup will now take place on April 8.
The House is expected to consider a revised budget resolution the week of April 7.
Senate
On March 28, Finance Committee Ranking Member Ron Wyden (D-OR) and Judiciary Committee Chairman Chuck Grassley (R-IA) sent letters to Centers for Medicare & Medicaid Services (CMS) Acting Administrator Stephanie Carlton and Health Resources and Services Administration (HRSA) Administrator Thomas Engels regarding a reported increase in organs allocated out of sequence from the organ waiting lists. The letters cite a New York Times report finding that, in 2024, officials bypassed patients on organ waiting lists in nearly 20% of transplants from deceased donors.
On March 31, Senate Appropriations Committee Ranking Member Patty Murray (D-WA), House Appropriations Committee Ranking Member Rosa DeLauro (D-CT), Senate Appropriations Labor, Health and Human Services, and Education Subcommittee Ranking Member Tammy Baldwin (D-WI) sent a letter to HHS Secretary Kennedy demanding information about HHS’ announced restructuring. The Senators also released a fact sheet detailing the recent layoffs at HHS.
On April 1, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) and Ranking Member Bernie Sanders (I-VT) sent a letter to HHS Secretary Kennedy inviting him to participate in a HELP Committee hearing on HHS’ restructuring. Committee leadership noted that during his confirmation process, Secretary Kennedy committed to coming before the HELP Committee on a quarterly basis upon request from the chair.
On April 1, Democratic Leader Chuck Schumer (D-NY), Finance Committee Ranking Member Wyden, HELP Committee Ranking Member Sanders, and Sen. Mark Warner (D-VA) led 34 Senate Democrats in sending a letter to HHS Secretary Kennedy demanding answers regarding the reductions in force (RIF) at HHS.
On April 2, the Finance Committee voted, 14-13, to advance the nomination of Frank Bisignano to be Commissioner of the Social Security Administration (SSA).
On April 3, the Senate voted 53-45 to confirm Dr. Mehmet Oz to serve as the next CMS Administrator.
On April 3, the Judiciary Committee advanced six bipartisan pieces of legislation aimed at lowering the cost of prescription drugs. Legislation advanced includes: S. 527, Prescription Pricing for the People Act of 2025; S. 1040, Drug Competition Enhancement Act; S.1041, Affordable Prescriptions for Patients Act, S. 1097, Interagency Patent Coordination and Improvement Act of 2025; S. 1095, Stop STALLING Act; and S. 1096, Preserve Access to Affordable Generics and Biosimilars Act.
On April 5, the Senate voted 51-48 on a revised budget resolution. Sens. Susan Collins (R-ME) and Rand Paul (R-KY) joined all Democrats in opposing the resolution. The budget resolution provides each chamber’s committees separate spending targets, with a floor of $4 billion in spending cuts for the Senate as compared to $1.5 trillion for the House allow a $5 trillion debt limit increase for the Senate in contrast to the $4 trillion debt limit increase allowed for the House, and set a $1.5 trillion cap for Senate tax writers above the extension of current law tax cuts. However, the budget proposal has garnered pushback from House Budget Committee Chairman Jodey Arrington (R-TX), stating that he “can’t imagine any world where deficit hawks in the House would ever walk away from the reconciliation process with the deficit going up at the rate it would with that framework.” Both chambers will have to adopt the same budget before beginning work on the reconciliation package.
REGULATORY UPDATE
On March 31, the Trump Administration paused the Federal Trade Commission’s (FTC) lawsuit against the three largest pharmacy benefit managers (PBMs), CVS Caremark, OptumRx and Express Scripts. FTC issued a stay in the case, stating that “there are currently no sitting Commissioners able to participate in this matter." The stay follows the firing of two Democratic commissioners, Alvaro Bedoya and Rebecca Slaughter. Both Republican commissioners Andrew Ferguson and Melissa Holyoak were recused.
On March 31, a federal judge overturned a 2024 FDA final rule, the Medical Devices; Laboratory Developed Tests Final Rule, which would have classified laboratory-developed tests as medical devices. FDA had argued that the final rule was necessary to ensure the safety and effectiveness of complex laboratory tests, but the court vacated and set aside the final rule in its entirety.
On April 1, HHS began its restructuring by sending out RIF notifications to various employees of the department. Employees who received a RIF notification have been placed on immediate administrative leave. Many offices within CMS received RIF notices including the Medicare-Medicaid Coordination Office, Office of Communications, Center for Program Integrity, Office of Healthcare Experience and Interoperability, Office of Minority Health, Office of Equal Opportunity and Civil Rights, and Office of Acquisition and Grants Management. Regional offices were also notified of closure with the regional offices in Boston, New York, San Francisco, Seattle, and Chicago set to close.
On April 3, HHS Secretary Kennedy stated that HHS will reinstate some employees and programs that were cut during the department’s restructuring. Kennedy told reporters that “at DOGE, we talked about this from the beginning … we’re going to do 80% cuts, but 20% of those are going to have to be reinstalled, because we’ll make mistakes.”
On April 4, CMS released the Contract Year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly final rule. The rule finalizes a provision that will restrict plans’ ability to reopen and modify a previously approved inpatient hospital decision based on information gathered after the approval. The final rule also includes codification of several Inflation Reduction Act (IRA) provisions including: removing cost sharing for an adult vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) and covered under Part D; eliminating Part D deductibles as applied to covered insulin products; and offering Part D enrollees the option to pay their out-of-pocket (OOP) prescription drug costs in the form of monthly payments over the course of the year instead of all at once at the pharmacy. Notably, the rule did not finalize a proposal by the Biden Administration that would have expanded Medicare Part D and Medicaid coverage of anti-obesity medications (AOMs). A fact sheet dealing the final rule can be found here.
WHITE HOUSE
On April 2, Politico reported that President Trump told his inner circle, including members of his cabinet, that Elon Musk will be stepping back in the coming weeks. White House Press Secretary Karoline Leavitt rejected the report, saying on social media: “This 'scoop' is garbage. Elon Musk and President Trump have both publicly stated that Elon will depart from public service as a special government employee when his incredible work at DOGE is complete.” Musk deemed the report "fake news.”
On April 2, President Trump issued an Executive Order (EO) instating a baseline 10% tariffs on all U.S. imports which will go into effect on April 5. He also announced higher tariffs for countries the White House deems as “bad actors on trade.” China will see a 34% tariff, the European Union a 20% tariff, Vietnam a 46% tariff, and Taiwan a 32% tariff. A list of all countries with higher tariffs can be found here. These larger tariffs will go into effect on April 9. A White House spokesperson confirmed that the 10% tariff and the larger country-specific levies exempt pharmaceuticals. However, the EO notes that pharmaceuticals may be “subject to future Section 232 tariffs.” On the same day, the Senate voted 51-48 to pass a resolution to block President Trump’s tariffs on Canada. Republican Sens. Collins, Mitch McConnell (R-KY), Lisa Murkowski (R-AK), and Paul voted with Democratic senators to block the tariffs on Canada.
On April 3, the Trump Administration circulated a memo to lawmakers explaining the mass RIF at HHS. The memo states that the RIF was needed to reign in increases in the bureaucracy and spending that occurred during the Biden Administration.
On April 3, the White House Office of National Drug Control Policy (ONDCP) outlined six priorities for the Trump Administration: (1) reduce the number of overdose fatalities, with a focus on fentanyl; (2) secure the global supply chain against drug trafficking; (3) stop the flow of drugs across borders and into communities; (4) prevent drug use before it starts; (5) provide treatment that leads to long-term recovery; and (6) innovate in research and data to support drug control strategies.
HHS Secretary Kennedy is considering HRSA Administrator Tom Engels to head the new HHS agency, the Administration for a Healthy America (AHA).
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
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2026 Rates (CMS-1833); Proposed Rule; 2/14/25
FY 2026 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1835); Proposed Rule; 2/20/25
FY 2026 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1831); Proposed Rule; 3/7/25
FY 2026 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1829); Proposed Rule; 3/7/25
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); Proposed Rule; 3/7/25
HEARINGS
House
Ways & Means Committee
Health Subcommittee
April 8; 10:00 AM; 1100 Longworth
Lowering Costs for Patients: The Health of the Biosimilar Market
April 9; 10:00 AM; 1100 Longworth
Trump Administration’s 2025 Trade Policy Agenda
Witness: United States Trade Representative Jamieson Greer
Appropriations Committee
April 9; 10:30 AM; 2358-C Rayburn
Labor, Health and Human Services, and Education Public Witness Day
Witnesses: Jessica Pescatore, Clinical Director, Alabama Poison Information Center, America's Poison Centers; Jennifer Carroll, Assistant Director, Community Action Partnership of North Alabama; Michelle Sie Whitten, Executive Director, The Global Down Syndrome Foundation; Christopher French, Co-Chair and Senior Vice President, Alliance for Biosecurity; Christopher M Kramer, President, American College of Cardiology; Rey Saldaña, President and CEO, Communities in Schools; Teresa Sokol, LA State Epidemiologist; Board Member, Council of State and Territorial Epidemiologists; Sara Schapiro, Executive Director Alliance for Learning Innovation; Dr. Scott Harris, State Health Officer of the Alabama Department of Public Health, President, Association of State and Territorial Health Officials; Dr. Colleen Kelly Chair, HIV Medicine Association
April 9; 9:00 AM; 2359 Rayburn
Budget Hearing: Government Accountability Office, Congressional Budget Office, United States Government Publishing Office
Witnesses: The Honorable Gene Dodaro, Comptroller General of the United States; Phillip Swagel, Director, Congressional Budget Office; The Honorable Hugh Nathanial Halpern, Director, Government Publishing Office
Energy & Commerce Committee
April 8; 10:00 AM; 2123 Rayburn
Legislation to be considered: Among other pieces of legislation, the Committee will consider, H.R. 1717, Communications Security Act; H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act of 2025; H.R. 1520, Charlotte Woodward Organ Transplant Discrimination Prevention Act; H.R. 2319, Women and Lung Cancer Research and Preventive Services Act of 2025; H.R. 1669, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program; H.R. 1082, Shandra Eisenga Human Cell and Tissue Product Safety Act; H.R. 2484, Seniors’ Access to Critical Medications Act
Oversight and Government Reform Committee
April 9; 10:00 AM; HVC-210
Restoring Trust in FDA: Rooting Out Illicit Products
Senate
Finance Committee
April 8; 10:00 AM; 215 Dirksen
The President’s 2025 Trade Policy Agenda
Witness: Jamieson Greer, United States Trade Representative
Health, Education, Labor & Pensions (HELP) Committee
TBD; Potentially April 10
Hearing on HHS Restructuring and Layoffs
Potential Witness: HHS Secretary Kennedy
ADDITIONAL POLICY NEWS
On March 31, the National Treasury Employees Union, a union of federal workers which represents some HHS employees, filed a lawsuit against the Trump Administration stating that President Trump's EO exempting some agencies from collective bargaining obligations violates federal workers' labor rights and the Constitution.
On April 4, sixteen state attorneys general filed a lawsuit in a Boston federal district court challenging the Trump Administration's cancellation of millions of dollars in National Institutes of Health (NIH) medical research grants. The lawsuit alleges that since March, NIH has sent hundreds of letters to researchers informing them that their research projects "no longer effectuate agency priorities.”
On April 10 and 11, the Medicare Payment Advisory Commission (MedPAC) will host its April 2025 public meetings. More information on times and topics of discussion can be found here.