On April 24, 2025, the Senate Health, Education, Labor & Pensions (HELP) Committee, led by Sen. Bill Cassidy (R-La.), released a report on its investigation into the 340B program. The investigation, which began in 2023, sought information from a group of eight 340B program participants — comprising two covered entities, contract pharmacies, third-party administrations (TPAs), and drug manufacturers — in order “to gain a comprehensive understanding of where the dollars generated by … the program flow and how such revenue benefits patients.”
Despite only targeting eight participants, the HELP Committee gathered substantial information on 340B program operations through participant responses to narrative questions and other disclosed information, including PBM agreements, network pharmacy participation agreements, and 340B drug spending data. Much of this material is included in the Report’s Appendix. Although the Report did not propose any specific legislative language, it includes a number of recommendations for Congress, including:
- Requiring covered entities to provide detailed annual reporting on how 340B revenue is used to ensure direct savings for patients, providing a more transparent link between program savings and patient benefit.
- Addressing potential logistical challenges caused by increased administrative complexity, leading to burdens that may impede patient benefit from the program.
- Investigating the types of financial benefits contract pharmacies and TPAs receive for administering the 340B program to ensure that increasing fees do not disadvantage covered entities and patients.
- Requiring transparency and data reporting for entities supporting participants in the 340B program (i.e., contract pharmacies and TPAs).
- Providing clear guidelines to ensure that manufacturer discounts actually benefit 340B-eligible patients, including examining legislative changes to the definition of “eligible patient” and contract pharmacies’ use of the inventory replenishment model.
Given the lack of proposed federal 340B Program legislation, and no mention of the program in President Trump’s FY 2026 Budget Proposal, it is unclear what shape potential federal 340B program reform will take. As a result, all eyes appear to be shifting back to HHS and HRSA as we await further implementation of the 340B rebate model.