A woman picks up a medicine at a hospital outpatient pharmacy. She has an autoimmune condition. Her hospital bought that medicine through a federal program built to help institutions serving vulnerable patients stretch their resources further.
She doesn't know that. She isn't told what the program generated, or whether any part of it reached her. She knows one thing: what she was asked to pay.
That is the 340B Drug Pricing Program as most patients experience it. This month, Senate HELP Committee Chairman Bill Cassidy released a discussion draft — the 340B Drug Pricing Integrity and Affordability for Patients Act — that would change it in real ways. Patients Rising submitted 21 recommendations to the Chairman.
They come down to four questions. We think every 340B reform proposal should have to answer them.
We want to be clear before we get to the gaps: this is the most serious congressional effort on 340B we have seen, and three provisions in particular deserve real credit.
Section 7 puts a ceiling on what patients pay. Hospitals in the program would have to establish a sliding fee scale capping eligible patients' out-of-pocket costs for a 340B medicine — and for self-administered medicines, the cap applies right at the counter. That is new. For more than thirty years, 340B has run on an assumption that savings retained by an institution would eventually reach the patients it serves. Section 7 begins to make that explicit.
Section 6 makes the money visible. Covered entities would report their 340B margin — including at satellite sites and through contract pharmacies — and the largest hospitals would report charity care and who their 340B patients actually are. HHS would publish it annually, by institution, by name.
Section 9 stops rewarding bigger discounts. Today the administrators and pharmacies handling 340B transactions are often paid a percentage, so their compensation rises with the size of the discount, consuming resources before they can support patient care. The draft would require flat fees, capped, with real penalties.
Now the four questions.
Not if she's on Medicare or Medicaid.
Section 7's protections apply to an "applicable patient." Read the definition closely and it reaches uninsured patients, and patients with modest incomes who hold certain kinds of private coverage. Medicare and Medicaid beneficiaries appear to satisfy neither prong — they have minimum essential coverage, and their public coverage isn't among the private categories the draft lists.
The consequence is hard to defend. A Medicare beneficiary living below the poverty guidelines, receiving an infusion for cancer or a chronic autoimmune condition at a 340B hospital and facing significant coinsurance, could receive nothing. An uninsured patient at the same counter could qualify for substantial help. Same medicine. Same discount to the hospital. Same inability to pay.
As we put it to the Chairman: a patient's need for help does not disappear because of the name on their insurance card.
Medicare beneficiaries are among the heaviest users of exactly the outpatient therapies that drive 340B volume, and cost-sharing on those therapies is one of the most common reasons patients tell us they walked away from treatment. If the exclusion is unintended, it should be corrected. If it's intentional, it should be reconsidered.
Right now, no — and the draft only partly fixes it.
The bill asks health centers how they used their 340B margin. It doesn't ask hospitals. One provision requires covered entities to report how the margin was actually spent — on care, on sliding fee discounts, on transportation, on case management. It applies to federally funded grantees: community health centers, Ryan White clinics, hemophilia treatment centers. Hospitals report a margin figure, and the largest also report charity care and payer mix. None of them report how the margin was used.
The scale matters here. Of the $81.4 billion in 340B purchases HRSA reported for 2024, roughly $70.1 billion — about 86% — went to hospital covered entities. Grantees accounted for about 14%. Requiring the 14% to explain how margin is used while not asking the same question of the 86% creates the wrong accountability structure.
We asked the Committee to extend that requirement to hospitals, with categories that fit the hospital setting. And we said plainly that transparency is not a penalty. It is a reasonable obligation for institutions participating in a federal program meant to support care for vulnerable patients — and hospitals already assemble comparable information for community benefit and Medicare cost reporting.
Data disclosure is also not the same as patient transparency. A searchable public file of margins, cost-report fields, and payer mix is genuinely valuable to policymakers, researchers, and reporters. It is unlikely to help a patient understand the hospital treating her.
So we proposed a Patient Benefit Disclosure: a standardized, plain-language summary for every reporting entity, searchable by name or location, showing what an institution generated through 340B and what it did with it. The underlying data should stay available to analysts. Patients deserve a translation layer built for them.
And nothing in the draft tells an individual patient anything about her own medicine. Every disclosure obligation runs upward — to the Secretary, to manufacturers, into an aggregate file. None runs to the person the program is meant to help.
We know patient-level notification is operationally complicated. It touches claims systems, pharmacy workflow, timing, and privacy. That argues for careful design and piloting, not for leaving the patient permanently outside the information flow. If a benefit is generated through a patient's medicine, that patient should not be the only participant in the transaction who cannot see it.
This is the question that gets lost when 340B is debated as an accounting dispute, and it matters enormously to the people we hear from.
The draft tightens rules on the number, geography, and use of contract pharmacies. For many patients that will change nothing they notice. For others — patients with rare diseases, oncology diagnoses, limited-distribution products, mobility barriers, or long travel distances — a network change becomes a treatment-access problem.
Diversion and duplicate discounting are legitimate integrity concerns. We aren't arguing against addressing them. We asked for a patient safety valve: a narrow, transparent exception when the limits would materially impair access to a needed therapy; advance notice and transition help when a patient's pharmacy relationship changes; and public monitoring of access effects by state and rurality during the first two years, so Congress can catch and fix problems quickly.
We asked for the same protection around eligibility itself. A patient in the middle of treatment should not lose access to an affordable medicine because an administrative status changed. Program integrity can be enforced without abruptly interrupting treatment.
The draft creates penalties and directs the HHS Inspector General to study whether eligible patients actually receive assistance. Both are useful. Neither returns a dollar to a patient who was improperly charged. The program's existing dispute process was built for fights between manufacturers and covered entities — not for patients.
If Congress creates an enforceable patient affordability protection, patients need an enforceable remedy when it fails: a simple way to report violations, automatic refunds with interest of anything improperly charged, and public reporting of substantiated violations. Civil penalties may deter misconduct. They do not make an overcharged patient whole.
340B has grown into a program approaching $100 billion a year in discounted purchases without a corresponding system that lets patients or the public see what it delivers to the people it's meant to help.
The measure of 340B reform shouldn't ultimately be how manufacturers, hospitals, pharmacies, or intermediaries fare under a new set of rules. It should be whether a patient can afford the medicine, understand the benefit being generated, access treatment without unnecessary disruption, and get meaningful help when the system fails.
A discussion draft is not a bill. The Chairman asked for input, and he is receiving a great deal of it — most from organizations with money in this fight. The patient voice in this process is small, and it needs to be loud.
If you've been surprised by what you were charged for a medicine at a hospital or its pharmacy, we want to hear about it. Those experiences are what turn a $100 billion abstraction into something a Senate office cannot look away from. Share your story.