Health Care Watch: February 10, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 2 – February 8. 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 February 5, Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ), Ways & Means Committee Ranking Member Richard Neal (D-MA), and Education & Workforce Committee Ranking Member Bobby Scott (D-VA) sent a letter to the Comptroller General requesting that the Government Accountability Office (GAO) actively monitor the Medicare Drug Price Negotiation Program under the Trump Administration.
On February 6, the House passed the HALT Fentanyl Act in a 312 to 108 vote. The legislation would make permanent the temporary class-wide scheduling order for fentanyl related substances (FRS).
House GOP leaders continue to work on their budget proposal which is expected to contain reconciliation instructions that would set in motion a process to reduce funding for Medicaid and possibly Medicare. Their hopes of marking up a budget the week of February 10 appear to be dimming as the party has yet to agree on overall spending numbers.
Senate
On February 3, Finance Committee Chairman Mike Crapo (R-ID) and Ranking Member Ron Wyden (D-OR) announcedsubcommittee assignments for the 119th Congress. Sen. Todd Young (R-IN) will serve as Chairman of the Subcommittee on Health Care.
On February 3, Finance Committee Chairman Crapo, Ranking Member Wyden, and Committee Members Michael Bennet (D-CO) and Tim Scott (R-SC) reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act. The legislation would ensure that Medicare beneficiaries have access to tests capable of detecting multiple types of cancer before symptoms appear. Bipartisan companion legislation, H.R. 842, was introduced in the House by Reps. Jodey Arrington (R-TX) and Terri Sewell (D-AL).
On February 3, Judiciary Committee Chairman Chuck Grassley (R-IA) and Ranking Member Dick Durbin (D-IL)announced subcommittee assignments for the 119th Congress.
On February 4, the Finance Committee voted 14-13 to advance the nomination of Robert F. Kennedy, Jr. (RFK Jr.) to serve as the Secretary of the Department of Health & Human Services (HHS). On February 6, the Senate voted 52-47 to move to executive session on RFK Jr.’s nomination to serve as HHS Secretary. The Senate will hold a confirmation vote for Kennedy the week of February 10.
On February 4, Sens. Elizabeth Warren (D-MA) and Tim Kaine (D-VA) sent a letter to HHS Secretary Nominee RFK Jr. asking that he either forfeit his financial interest in all cases he’s referred to the law firm Wisner Baum that involve HHS-regulated entities or accept a lump sum unrelated to their outcomes.
On February 6, in a 53-47 vote, the Senate confirmed Russ Vought to serve as Director of the White House Office of Management and Budget (OMB).
On February 7, Budget Committee Chair Lindsey Graham (R-SC) announced that the Committee will meet next week onFebruary 12 and February 13 to debate and vote on the proposed budget resolution. Chairman Graham also released thetext of the proposed budget resolution which includes budget floors of $1 billion for the Energy & Commerce and Senate Finance Committees.
REGULATORY UPDATE
On February 3, HHS announced that, in alignment with President Trump’s Executive Order (EO) on Additional Measures to Combat Anti-Semitism, and as part of the task force announced by the U.S. Department of Justice, HHS’ Office for Civil Rights (OCR) initiated compliance reviews of four medical schools.
On February 4, the Food & Drug Administration (FDA) approved an Investigational New Drug application (IND) to initiate a clinical study of United Therapeutic's investigational UKidney™ derived from a 10 gene-edited source pig. The first ever FDA-approved xenotransplantation clinical study will enroll an initial cohort of six end-stage renal disease (ESRD) patients, expanding to up to 50 participants, and is intended to support a Biologics License Application (BLA) with FDA.
On February 4, the Trump Administration announced that Shana Weir will serve as the HHS Principal Deputy Assistant Secretary for Administration. She will also serve as a Senior Advisor to HHS Chief of Staff Heather Flick.
On February 7, NIH released Supplemental Guidance to the 2024 NIH Grants Policy Statement stating that for all new grants and all existing grants to institutions of higher education, retroactive to the date of the announcement, award recipients are subject to a 15% indirect cost rate. This rate would replace the previous negotiated rates for indirect costs, also known as “facilities & administration.”
WHITE HOUSE
On February 3, President Donald Trump announced that he had reached an agreement with Canada and Mexico to put a hold on proposed tariffs for one month.
On February 4, the Trump Administration announced that thousands of employees of the U.S. Agency for International Development (USAID) will be placed on leave beginning on Friday, February 7, 2025, at 11:59 PM EST. A Trump-appointed federal judge later blocked this move.
On February 7, representatives of the Department of Government Efficiency (DOGE) were granted access to the Centers for Medicare & Medicaid Services (CMS) systems and technology. On February 8, it was reported that CMS Deputy Administrator and Chief Operating Officer Kim Brandt and Deputy Administrator and Chief Policy Officer John Brooks will serve as the agency liaisons to DOGE, including monitoring DOGE’s access to CMS’ systems and technology.
REPORTS
Office of Inspector General (OIG)
On February 4, OIG released a report examining West Virginia invoice rebates for physician-administered drugs. OIG found that West Virginia did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs. Specifically, OIG found that West Virginia did not invoice for, and collect from manufacturers, rebates totaling $2.2 million. Of this amount, $2.2 million was for single-source drugs and $14,514 was fortop-20 multiple-source drugs. OIG made five recommendations to West Virginia, including that West Virginia: 1) refund to the Federal Government the $2.2 million for single-source drugs; 2) refund to the Federal Government the $14,514 for top-20 multiple-source drugs; 3) work with CMS to determine and refund the unallowable portion of the $488,185 for other multiple-source physician-administered drugs that may have been ineligible for Federal reimbursement and consider invoicing drug manufacturers for rebates for those drugs; 4) strengthen internal controls for non-crossover claims going forward, to better use collected data to invoice manufacturers and collect rebates; and 5) consider revising West Virginia’s payment methodology going forward for crossover claims.
HEARINGS
House
Ways & Means Committee
Subcommittee on Health
February 11; 2:00 PM; 1100 Longworth
Modernizing American Health Care: Creating Healthy Options and Better Incentives
Oversight and Government Reform Committee
Delivering on Government Efficiency Subcommittee
February 12; 10:00 AM; 2247 Rayburn
The War on Waste: Stamping Out the Scourge of Improper Payments and Fraud
Senate
Budget Committee
February 12; 10:00 AM; Dirksen 608
Markup of Fiscal Year 2025 Budget Resolution – Day 1
February 13; 10:00 AM; Dirksen 608
Markup of Fiscal Year 2025 Budget Resolution – Day 2
ADDITIONAL POLICY NEWS
On February 3, health data firm IQVIA released a report finding that of the 118 biologics with expiring patient protections in the next decade, only 12 have biosimilars in development as of last June, presenting a $232 billion opportunity for biosimilars.
On February 4, Doctors for America filed a lawsuit against the Office of Personnel Management (OPM), Centers for Disease Control and Prevention (CDC), FDA, and HHS, alleging that the agencies’ removal of data deprives physicians and researchers of access to information that is necessary for treating patients and creates a dangerous gap in the scientific data for public health emergencies.
On February 6, Senior District Judge George O’Toole temporarily blocked the Trump Administration's offer of buyouts to federal workers. Judge O’Toole extended a deadline that was set to kick in at the end of the day on February 6 to allow time for additional legal briefs to be submitted ahead of a hearing at 2:00 PM ET on Monday, February 10. He also instructed the Trump Administration to immediately notify workers of the order freezing implementation of the deferred resignation program.
On February 6, Maryland Governor Wes Moore (D) announced that Dr. Meena Seshamani will serve as Secretary of the Maryland Department of Health. Dr. Seshamani previously served as Deputy Administrator and Director at CMS’ Center for Medicare.