In the past few months, the Senate and House have both seen 340B reform proposals.
- Senate: Bill Cassidy's 340B Drug Pricing Integrity and Affordability for Patients Act. Released June 25, 2026, as a discussion draft, not a formal bill. Stakeholder comments open through August 28, 2026.
- House: The bipartisan SECURE 340B Act (H.R. 9599), introduced July 6, 2026, by Reps. Scott Peters and John Joyce. A real bill, already referred to committee.
Neither has become law yet, but both point in a consistent direction.
Two Proposals, Two Philosophies
The two proposals have very different starting assumptions about 340B.
Cassidy's discussion draft starts from an overt suspicion toward how covered entities use 340B revenue. The draft highlights claims that some 340B covered entities direct revenue to wealthy areas while reducing services in low-income communities. It also suggests that the 340B program has drifted from its initial purpose of serving low-income and underserved patients, and aims to prevent gaming of the program.
The House bill approaches the issue from a different angle. It doesn’t assume that many covered entities are misusing the program, but it claims that the statute itself isn’t in stride with how the current program operates. The bill identifies the program's legal ambiguity as the root problem and focuses on preserving the program's basic mechanics while closing the gaps that have invited litigation and manufacturer pushback.
Where They Stand on Rebates
The two proposals have very different views on rebates.
- Senate draft: Allows manufacturers to choose how they deliver 340B pricing. They can opt for an upfront discount, a retrospective rebate, or a claims-based repository administered by HHS. Ultimately, the decision is up to them.
- House bill: Pauses the transition to a rebate model for four years. Manufacturers must continue providing the 340B price as an upfront discount during this time. Meanwhile, HHS will contract with an independent clearinghouse to validate claims data. The upfront discount requirement only lapses once HHS certifies the clearinghouse has met defined performance benchmarks. Ultimately, the moratorium's real length depends on how fast that infrastructure gets built.
Where They Stand on Contract Pharmacies
The Senate draft and House bill are also split on contract pharmacy structure.
- Senate draft: Caps disproportionate share hospitals, freestanding cancer hospitals, and rural referral centers at five contract pharmacy arrangements, generally requiring those pharmacies to sit within the covered entity's service area.
- House bill: Requires no numeric cap. Instead, HHS reviews and approves written contract pharmacy agreements. Those arrangement details are posted publicly and include each pharmacy's location, dispensing volume, and whether it operates as mail-order or specialty.
Where They Agree
Despite their structural differences, the two proposals agree on several points relating to planning purposes, such as:
- A statutory patient definition. Both proposals would narrow and formalize the definition of a 340B patient, and generally require a documented provider-patient relationship and an outpatient encounter within the previous 24 months.
- Higher documentation standards for TPA and contract pharmacy arrangements. Both proposals require a program to formalize TPA relationships in a way most contracts currently do not.
- New patient affordability requirements. Both proposals focus on demonstrating patient benefit, ensuring 340B savings translate more directly into reduced patient costs.
What It All Means
Neither proposal is guaranteed to pass in its current form. They’ll go through changes, and Congress could easily reconcile the two into something that resembles neither. But whatever happens with either proposal, the direction has been set. A statutory patient definition, formal TPA documentation standards, and direct patient-affordability requirements are no longer hypothetical ideas circulating in policy papers. They are sitting in two separate legislative texts, backed by a Senate committee investigation on one side and bipartisan House sponsorship on the other.
Covered entities that treat this moment as a normal news cycle, just something to maybe keep an eye on, are underestimating how much the underlying environment has already shifted just in the past few weeks.