Health Care Watch: March 31, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 23 – March 29. 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 March 25, Reps. Ayanna Pressley (D-MA), Dan Goldman (D-NY), Diana DeGette (D-CO), Linda Sánchez (D-CA), and Troy Carter (D-LA) introduced the Data Of Government health Entities must be Protected from Overreach by Unelected Nonsecure Disruption Act (DOGE POUND Act). The legislation would allow only Department of Health & Human Services (HHS) officers, employees, and contractors to access HHS systems with individually identifiable health information if they were eligible to access the data before January 20, 2025.
On March 26, Reps. Kristen McDonald Rivet (D-MI), Buddy Carter (R-GA), Rob Menendez (D-NJ), and John James (R-MI) introduced the Prescription Drug Transparency and Affordability Act. The legislation would require pharmacy benefit managers (PBMs) to disclose financial transactions related to prescription drug pricing and would impose penalties on PBMs of up to $100,000 per violation for failing to report the transactions.
Senate
On March 25, the Finance Committee voted along party lines to advance the nomination of Dr. Mehmet Oz to serve as the Administrator of the Centers for Medicare & Medicaid Services (CMS). Prior to the vote, the Committee released Dr. Oz’s written responses to questions for the record for senators to consider. The full Senate is expected to vote on his nomination in the coming weeks.
On March 25, the Senate voted, 56-44, to confirm Dr. Marty Makary to serve as Commissioner of the Food & Drug Administration (FDA). The Senate also voted, 53-47, to confirm Dr. Jay Bhattacharya to serve as Director of the National Institutes of Health (NIH).
On March 25, Finance Committee Ranking Member Ron Wyden (D-OR) released a report detailing an investigation into the marketing practices of health insurance companies that sell Medicare Advantage (MA) plans, with a focus on third-party marketing organizations (TPMOs). The report found that spending on agents and brokers fees and commissions by the insurance companies investigated increased from $2.4 billion to $6.9 billion from 2018 to 2023.
On March 25, Judiciary Committee Chairman Chuck Grassley (R-IA) and Ranking Member Richard Durbin (D-IL), along with Committee members Thom Tillis (R-NC), Peter Welch (D-VT), and Chris Coons (D-DE), introduced the Interagency Patent Coordination and Improvement Act. The bipartisan legislation would establish a task force between FDA and the United States Patent and Trademark Office (USPTO) to improve communication and coordination in implementing each agency’s activities related to pharmaceutical patents.
On March 26, Chairman Grassley and Sen. Amy Klobuchar (D-MN) introduced the Preserve Access to Affordable Generics and Biosimilars Act which would limit “pay-for-delay” deals. The Senators also introduced the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) which would deter branded pharmaceutical companies from filing citizen petitions with the FDA.
On March 27, Chairman Grassley and Commerce Committee Ranking Member Maria Cantwell (D-WA) introduced the Opioid Overdose Data Collection Enhancement Act. This legislation would provide Department of Justice (DOJ) grants to states, cities, law enforcement units and tribes that operate overdose data collection programs, such as the Overdose Detection Mapping Application Program (ODMAP).
Next week, the Senate is expected to consider a variation of the House-passed budget resolution, which envisions tax, energy, immigration, and Medicaid reforms all within one bill. However, the Senate GOP resolution is likely to contain smaller savings target “floors” for the Senate committees while retaining the higher spending targets for House committees from the more aggressive House budget resolution. If the Senate can pass its resolution next week, House Budget Committee Chairman Jodey Arrington (R-TX) has suggested the House would then consider the same resolution the following week. These bifurcated reconciliation instructions defer decisions over the size of spending cuts for later in the legislative process, but allow that process to begin, setting the stage for significant reforms to the tax code and Medicaid program, and potentially changes to the Medicare program as well.
REGULATORY UPDATE
On March 24, HHS announced that it is closing its Long COVID Office. According to an internal email sent by Ian Simon, the Office’s Director, the office will be closing this coming week as part of the Administration’s reorganization of HHS.
On March 24, Centers for Disease Control & Prevention (CDC) leaders received an email recommending termination of panels of experts not mandated by law. The email gave CDC leaders a deadline of 10:00 PM the same day to justify why the panels should not be terminated but was shortly followed by another email stating that no response was required at this time.
On March 27, HHS Secretary Robert F. Kennedy Jr. (RFK Jr.) announced a major restructuring of the Department. The planned changes include a reduction of 10,000 jobs across the department. Specifically, FDA will decrease its workforce by 3,500 full-time employees, CDC by 2,400 employees, NIH by 1,200 employees, and CMS by 300 employees. The restructuring will also result in the closure of five regional offices, the consolidation of 28 divisions into 15, and a centralization of information technology, procurement, external affairs, and policy. Secretary RFK Jr. also announced the creation of a new subdivision called the Administration for a Healthy America which will focus on chronic disease prevention programs and will consolidate the Office of the Assistant Secretary for Health (OASH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Toxic Substances and Disease Registry (ATSDR), and National Institute for Occupational Safety and Health (NIOSH). A factsheet detailing the reorganization can be found here. In combination with other downsizing efforts, the Department estimates it will shrink the HHS workforce from 82,000 to 62,000 employees.
On March 28, it was reported that Art Kleinschmidt will serve as SAMHSA’s Deputy Assistant Secretary. Kleinschmidt served as the Deputy Director of the White House Office of National Drug Control Policy (ONDCP) and Senior Advisor for health and addiction on the Domestic Policy Council and SAMHDS during the first Trump Administration.
On March 28, Dr. Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) abruptly resignedstating in his resignation letter that HHS Secretary RFK Jr.’s aggressive stance on vaccines posed a danger to the public. Dr. Marks wrote, “it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies.” Dr. Marks joined the FDA in 2012 and led the CBER division that authorized and monitored the safety of vaccines and a wide array of other treatments, including cell and gene therapies. It has been reported that Dr. Marks resigned after he was summoned to HHS and told that he could either quit or be fired.
WHITE HOUSE
On March 24, President Trump nominated Susan Monarez to serve as CDC Director. Monarez is currently serving as CDC’s Acting Director and previously served as Deputy Director of the Advanced Research Projects Agency for Health (ARPA-H).
On March 24, President Trump nominated Alex Adams to serve as Assistant Secretary for Family Support at HHS. Adams currently serves as Idaho’s Department of Health and Welfare Director.
On March 24, President Trump said he will soon announce tariffs targeting pharmaceuticals and other industries. Specifically, he noted: “We’ll be announcing pharmaceuticals at some point … because we have to have pharmaceuticals.” On March 27, President Trump specifically singled out Ireland's pharmaceutical industry as a target for tariffs stating that the U.S. “doesn't make anything … it's in other countries, largely made in China, a lot of it made in Ireland. Ireland was very smart. We love Ireland. But we're going to have that."
On March 25, President Trump announced that Sara Carter, a Fox News contributor, will be the Director of ONDCP.
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
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Final Rule; 3/6/25
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
Energy & Commerce Committee
Health Subcommittee
April 1; 10:15 AM; 2123 Rayburn
Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs
Education & Workforce
Subcommittee on Health, Employment, Labor, and Pensions
April 2; 2:00 PM; 2175 Rayburn
A Healthy Workforce: Expanding Access and Affordability in Employer-Sponsored Health Care