340B: Are Patients at the Table or on the Menu? Reflections on the HELP Committee Hearing on 340B

It was a busy few weeks for 340B in the nation’s capitol, on Thursday October 30th, The Health and Human Resources Administration (HRSA) announced it had approved nine drugs for its Rebate Model Pilot. Last Thursday October 23rd, the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Committee convened a full-committee hearing titled “The 340B Program: Examining Its Growth and Impact on Patients” to examine the rapid expansion of the 340B program and its implications for patients and taxpayers alike. For those who are working toward a reformed 340B program, this was a crucial moment: the program was created to help low-income and uninsured patients, yet representation at the witness table provided the glaring reminder, when we are not at the table, we are on the menu. 

Good Intentions

The hearing was convened last Thursday following a broad investigative effort led by Louisiana Senator Bill Cassidy, M.D., Chairman of the HELP Committee, whose majority-staff report released in April 2025 laid bare serious transparency and oversight concerns in the 340B program, and the recent Congressional Budget Office’s report on the growth of the 340B program.  At the hearing, Senators from both parties expressed strong support for reform of the program. Senators called for more transparency regarding how 340B revenues are used and how the program has grown far beyond its original intent. Chairman Cassidy’s opening remarks underscored the tension: “It’s a well-intentioned program … but people judge you by your actions, not your intentions.” He pointed to findings that as 340B has grown, so have health care costs. 

Longstanding Issues Raised

The hearing began with a table of witnesses deemed as experts on the program’s inner workings and challenges: Michelle Rosenberg, U.S. Government Accountability Office, Aditi Sen, Ph.D., Congressional Budget Office, and William B. Feldman, MD, DPhil, MPH, University of California. All three witnesses' testimony reflected on the program's explosive growth, the challenges faced in 340B’s impact on spending at the federal level, its financial impact on state Medicaid programs, and the need for modern reform of legislation to bring it into the 21st century. In between partisan shots for screen time, witnesses and Senators highlighted:

• Lack of transparency: The April report found that some large hospital systems generated hundreds of millions of dollars through 340B, yet could not clearly demonstrate that savings were passed directly to patients. 

• Program growth beyond original intent: The 340B program, established in 1992 to help safety-net providers stretch federal resources and serve more eligible patients, has grown to cover over 60,000 participating entities. That scale raises questions about whether the program still reflects its original purpose.

• Cost-shifting and unintended consequences: The Senators flagged that the Congressional Budget Office found that 340B’s expansion “encourages behaviors … that tend to increase federal spending.”

• Disconnect between revenue and patient benefit: The investigative report suggests that in many cases 340B revenue is being used for facility capital improvements or general operations rather than directly reducing out-of-pocket burdens for low‐income patients.

• Contract pharmacy and administrative complexities: The role of contract pharmacies and third‐party administrators (TPAs) was called out for potential erosion of intended benefit, and the investigation recommends more scrutiny. 

The Missing Witness

For all the laudable questioning of the program’s mechanics, what was striking at the hearing was the absence of direct patient voices. While policy makers, hospital executives, pharmacies and manufacturers were discussed, one would look in vain for the witness table to include someone whose story is the core rationale for 340B — a low-income patient trying to access a drug or services that otherwise would be out-of-reach.

This gap in experience in witnesses matters deeply:

• Patients are the raison d’être of 340B. The statute allows eligible providers to purchase outpatient drugs at a discounted rate so they “reach more eligible patients and provide more comprehensive services.”  If we cannot hear from those very patients, we risk losing sight of whether the program is delivering on its intent.

• Policy without lived experience lacks accountability. Reforms that focus exclusively on revenue flows, auditing, definitions and transparency can overlook whether the end result is better access, lower cost, fewer barriers. The missing patient perspective means we lack insight into whether the “front-line” outcomes are improving.

• Reform risks being mechanical, not human. If hearings remain focused on numbers (how many providers, how many dollars, what audits) and not on the personal hardship of people for whom drug access matters, then reform may fix the mechanics—not the mission.

While the hearing continued its focus to the numbers instead of patients, the need for transparency in light of various reports including the North Carolina Treasurer's report, the growing evidence of abuse such as Bon Secours Mercy Health, and how for-profit corporations have continued to siphon the 340B program’s value from it’s intended purpose, it made apparent the partisan divide of the issues, but the agreement that this program has lost it’s way and needs to be meaningfully reformed to ensure that the support of scarce federal resources this program provides is vital to the safety net. 

Looking Forward

Thursday’s hearing was a meaningful spotlight on a program ready for reform—but it should not be the headline byline. The real story needs to be: how is 340B reaching patients, how are those patients faring? Reform should not just scrutinize how many dollars 340B moves; it must ask: How many patients paid less? How many accessed care they previously could not? And how many were left behind because the program has shifted focus away from them?

As we continue to experience the circus that is 340B policy in the coming weeks and months, we must insist that patient voices are at the table, not just provider executives and lobbyists. We must craft measurable guardrails that ensure 340B savings are not invisible dollars but tangible patient impact. And we must be unafraid to hold stakeholders accountable when the data show a disconnect between program growth and patient benefit. The 340B program is at a crossroads. Last week’s HELP Committee’s hearing signals that change is coming. We must focus that change so it works for the people, not just the institutions—and ensure we bring patient voices from the margins into the center of the conversation so it works for the people, not just the institutions—and ensure we bring patient voices from the margins into the center of the conversation.