Health Care Watch: April 28, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 20 – April 26. 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 23, Rep. Jake Auchincloss (D-MA), in an interview, discussed President Trump’s recent drug pricing executive order (EO), stating that there are elements of that EO that he supports nothing specifically that “passing on savings to patients at the site of care for 340B drugs, for example, is generally in the right direction.”
The House is in recess until April 28.
Senate
On April 23, Sen. Dick Durbin (D-IL), Democrat Whip and Ranking Member of the Judiciary Committee, announced that he will not seek reelection for a sixth term in 2026. Democrat Reps. Raja Krishnamoorthi, Lauren Underwood, and Robin Kelly are rumored to be interested in the open Senate seat.
On April 24, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) released a report detailing findings from his investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Chairman Cassidy requested information from hospitals, Federally Qualified Health Centers (FQHCs), contract pharmacies, and drug manufacturers and found that:
Bon Secours Mercy Health and Cleveland Clinic generate hundreds of millions of dollars in 340B revenue, but do not pass 340B discounts directly to their patients;
Sun River and Yakima Valley, both FQHC covered entities, generate significant revenue from the 340B Program with a few therapeutic drug classes accounting for a majority of this revenue;
CVS Health and Walgreens charge covered entities a complex range of fees for using their pharmacy services to dispense 340B drugs to patients and charge administrative fees for Third Party Administrator (TPA) services; and
Drug manufacturers report significantly increasing 340B sales to contract pharmacies compared to direct sales to hospitals and grantees.
Within the report, Chairman Cassidy highlights potential reforms for Congress to improve 340B transparency including: (1) requiring covered entities to provide detailed annual reporting on how 340B revenue is used; (2) addressing potential logistical challenges caused by increased administrative complexity; (3) investigating the types of financial benefits contract pharmacies and TPAs receive; (4) requiring transparency and data reporting for entities supporting participants in the 340B Program; and (5) providing guidelines to ensure that manufacturer discounts actually benefit 340B-eligible patients
On April 24, HELP Committee Ranking Member Bernie Sanders (I-VT) and Reps. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI), announced that they will hold a press conference on April 29 with nurses, health care providers, and workers from around the nation to introduce the Medicare for All Act.
The Senate is in recess until April 28.
REGULATORY UPDATE
On April 22, two people familiar with internal Department of Health & Human (HHS) discussions stated that HHS Secretary Robert F. Kennedy, Jr., is considering removing the COVID-19 vaccine from the recommended childhood vaccine schedule.
On April 22, National Institutes of Health (NIH) Director Jay Bhattacharya provided a tentative timeline for research related to the causes of autism spectrum disorders. Following the initiative handed down by HHS Secretary Kennedy, Director Bhattacharya stated that he hopes to have the call for proposals out by September 2025, running contrary to Secretary Kennedy’s statement that HHS would have some answers as early as September.
On April 22, HHS and the Food & Drug Administration (FDA) announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply. FDA is taking the following actions: (1) establishing a national standard and timeline; (2) initiating the process to revoke authorization for two synthetic food colorings B; (3) working with industry to eliminate six remaining synthetic dyes; (4) authorizing four new natural color additives; (5) partnering with the NIH; and 6) requesting food companies to remove FD&C Red No. 3.
On April 23, Novavax announced that it has received formal communication from FDA in the form of an information request for a post-marketing commitment (PMC) to generate additional clinical data for the company’s COVID-19 vaccine.
On April 24, Deputy Centers for Medicare & Medicaid Services (CMS) Administrator Kimberly Brandt stated that the Trump Administration has created a “war room” dedicated to rooting out Medicare fraud, waste, and abuse at CMS. Deputy Administrator Brandt stated that tackling waste and fraud is a top priority for CMS Administrator Dr. Mehmet Oz and noted that the war room will rely on data analysts, law enforcement, and representatives from local contractors who process regional Medicare claims.
On April 25, Secretary Kennedy stated that 35 states have signed up to participate in CMMI’s new Cell and Gene Therapy (CGT) Access Model. The model, first announced by the Biden Administration, aims to improve health outcomes for people with Medicaid with sickle cell disease who could benefit from CGTs by supporting outcomes-based agreements between states and manufacturers. Secretary Kennedy notes that the level of participation in the voluntary model is “unprecedented” and represents a “real win-win” for states and patients with Medicaid. Secretary Kennedy indicated that CMS anticipates learning from the model and adapting it to future applications.
WHITE HOUSE
On April 18, the Office of Personnel Management (OPM) proposed a rule to create a new “Schedule Policy/Career” category of federal workers designed to identify members of the workforce the administration is likely to fire as it continues to eliminate government jobs it views as unnecessary or in opposition to its policymaking goals. The new category of federal worker makes employees that were considered to have “civil servant” careers but operate in a policymaking capacity easier for the Trump administration to terminate -- consistent with President Trump’s EO titled Restoring Accountability to Policy-Influencing Positions Within the Federal Workforce.
A list of all administrative and health care-related EOs can be found here. FHP Strategies will update this document, as needed.
HEARINGS
Senate
Appropriations Committee
April 30; 10:30 AM; 106 Dirksen
Biomedical Research: Keeping America’s Edge in Innovation
HELP Committee
HHS Secretary Kennedy to testify before the committee
TBD; Mid-May
House
Appropriations Committee
Agriculture, Rural Development, Food and Drug Administration Member Day
April 29; 10:30 AM; 2362 Rayburn
Witness: Rep. Harriet Hageman (R-WY)
Energy & Commerce Committee
April 29, 10:00 AM; 2123 Rayburn
Markup of the following bills:
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; and
H.R. 2484, Seniors’ Access to Critical Medications Act
Markup of policies related to budget resolution
TBD; Possibly May 7
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole (CMS-2448); Proposed Rule; 4/19/25
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Notice; 4/18/25
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance; Notice; 4/18/25
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
ADDITIONAL POLICY NEWS
On April 21, Walgreens agreed to a $300 million settlement with the federal government over allegations that the pharmacy illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act(CSA). Walgreens also signed an agreement with the Drug Enforcement Administration (DEA) and HHS’s Office of Inspector General (OIG) to implement certain compliance measures for the next seven years. As a result of the settlement, the U.S. will drop a complaint alleging that between August 2012 and March 2023, Walgreens knowingly filled millions of unlawful prescriptions for controlled substances, including opioids.
On April 21, the Supreme Court heard oral arguments on the constitutionality of the federal task force that decides which preventive services should be covered under theAffordable Care Act (ACA). The Trump Administration defended ACA’s preventive services coverage mandate, stating that the HHS Secretary has appropriate oversight over the task force.
On April 22, AstraZeneca rejoined PhRMA, with its CEO, Pascal Soriot, taking a seat on the board of directors.