10/28/2025 – Senate HELP Committee Holds Hearing on 340B Program

On Thursday, October 23rd the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled “The 340B Program: Examining Is Growth and Impact on Patients.” Chair of the Senate Help Committee Bill Cassidy (R-LA), who called for the hearing, has been a vocal critic of the 340B program. In April, Senator Cassidy released a 195-page report calling for 340B “reform,” a culmination of a years-long partisan investigation into the 340B program.

Senator Cassidy’s opening remarks echoed his report’s conclusions and pharmaceutical manufacturer talking points. Cassidy claimed that the 340B program requires greater oversight and transparency, fails to benefit patients, and increases health care costs, reiterating that “for-profit” middlemen siphon program dollars that could be used for patient care and calling for Congress to pass legislation to “reform” the program.

Senator Tammy Baldwin (D-WI) provided opening remarks for Democrats in place of Ranking Member Bernie Sanders (I-VT). Senator Baldwin emphasized the critical lifeline the 340B program provides to covered entities to expand access to services, lower patient drug costs, and sustain operations. She emphasized her efforts with the bipartisan Senate 340B Working Group (informally known as the “gang of six”) to develop the Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN Act).

This bipartisan legislative effort – led by Senators Baldwin (D-WI), Moran (R-KS), Capito (R-WV), Kaine (D-VA), Mullin (R-OK), and Hickenlooper (D-CO) – aims to strike a balance between increasing program transparency and preserving program support for providers and those they serve. Over the last two years, the group enlisted all stakeholders to provide comment, met with dozens of groups, and publicly shared legislative language. The group’s work has been stalled given other more pressing issues this Congress, the current shutdown, and resolution of two significant SUSTAIN Act issues – patient definition and the rebate model.

Witnesses included Michelle Rosenberg with the U.S. Government Accountability Office (GAO), Aditi Sen with the Congressional Budget Office (CBO), and researcher William B. Feldman. Rosenberg’s comments focused on the need for greater oversight of the program by the Health Resources and Services Administration (HRSA). She emphasized that HRSA only implemented five of the twelve recommendations that GAO made to HRSA to improve program oversight. HRSA indicated that many of these reforms have not been implemented because the agency believes it lacks the authority to do so.

Dr. Sen’s remarks centered on the CBO’s recently released report on 340B program growth, citing increases in prescription drug spending, vertical integration, affiliations between hospitals and offsite clinics, and expanded program eligibility as drivers of growth in the 340B program. Notably, Dr. Sen stated that “CBO does not have sufficient data to quantify the contribution of each factor.” This lack of certainty regarding the report’s findings is consistent with the report itself, which couches its conclusions in several statements emphasizing the limitations of its data.

Dr. Feldman, like the other witnesses, emphasized the 340B program’s growth. However, he also detailed how community health centers “play an outsized role in the healthcare safety net” and how hospitals often treat patients in “rural communities with no other options” and the “sickest patients with the fewest resources.” He called for increased program transparency, greater use of audits by HRSA, and limits on child sites and contract pharmacies.

Throughout the hearing, Democrat and Republican Senators emphasized the importance of the 340B program in their states. Senator Collins (R-ME) detailed how changes to the 340B program could unintentionally limit access to essential medications for rural hospitals in Maine. Senator Hickenlooper (D-CO) explained how Colorado community health centers and hospitals provide care to the state’s uninsured and underinsured populations. Senator Kaine (D-VA) submitted a letter for the record from an FQHC in Virginia explaining how the FQHC uses 340B savings to provide OB-GYN care desperately needed in rural areas of the state. Senator Tuberville (R-AL) stated that 340B was the only “source of income for American hospitals that isn’t taxpayer-funded.”

Amid this support for the 340B program was also critique. Senator Marshall (R-KS) stated that “big monopolistic hospital systems abuse the system” and expressed that before Christmas, there should be legislation passed through Committee to reform the program. Senator Cassidy repeatedly touted reforms contained in his April report.

Many Democrats used the opportunity to criticize Republicans for undermining safety net providers and patients by allowing the Affordable Care Act (ACA) premium tax credit subsidies to expire – the centerpiece of the ongoing shutdown debate.

Powers will continue to monitor legislative developments surrounding the 340B program.