This page tracks the federal and state developments reshaping the 340B Drug Pricing Program, including the new rebate pilot, contract pharmacy litigation and manufacturer data requirements. We revisit it every quarter, and sooner if something material changes. If you're looking for our take on why 340B compliance deserves board-level attention, read FQHCs: Your biggest supply chain risk isn't a vendor. It's 340B.
The rebate pilot is back, with a new design.
On July 31, 2026, the Health Resources and Services Administration (HRSA) announced a revised 340B Rebate Model Pilot Program. A Federal Register notice followed on August 3. Here's the shape of it:
The mechanical shift is the part worth sitting with. Today, the 340B discount is built into the price a covered entity pays at purchase. Under the pilot, a covered entity pays wholesale acquisition cost first, dispenses the drug, submits a claim and then receives a rebate for the difference. The discount still lands, but the timing and the paperwork both change.
HRSA has built in some cushion compared to the withdrawn 2025 version. Manufacturers must now give covered entities 90 days' notice before implementation, up from 60, and must identify the technology platform they'll use for data submission. Rebates are also restricted to the unit level, and manufacturers are barred from denying a rebate based on eligibility concerns or a perceived lack of wholesale acquisition cost purchases. Those disputes now have to go through HRSA's Office of Pharmacy Affairs or the program's statutory mechanisms instead of being resolved unilaterally by the manufacturer. None of this changes the fundamental cash flow problem, but it does close off some of the ways covered entities lost rebates outright under the earlier design.
Why this attempt may hold up where the last one didn't.
Health centers that followed the 2025 pilot may assume this version will meet the same fate. It might not, and the reasoning matters.
HRSA's first rebate pilot was halted by a federal court in Maine and later withdrawn, on administrative record grounds rather than on the substance of the policy. Covered entities had sued in December 2025 to block implementation, and the court's order paused the pilot for every covered entity and the nine manufacturers already approved to participate. Rather than continue defending that record, HRSA withdrew the pilot and started over.
That restart included a request for information in February 2026 that drew more than 2,400 public comments from hospitals, health centers, manufacturers, pharmacies and patient advocates. The revised pilot responds directly to that record: it adds formal notice requirements, a dispute resolution process, resubmission rights, a grace period, unit-level payments and claims-level transparency. It also arrives through a Federal Register notice rather than a formal rulemaking, which is itself a procedural choice attorneys are watching closely. Some legal commentary has noted that labeling the pilot a notice, rather than a proposed rule subject to another comment period, may not resolve whether a court eventually treats it as a substantive rule requiring full notice-and-comment rulemaking.
None of this guarantees survival. The AHA has said it is considering all available options, so further litigation remains possible, and covered entities were broadly critical of the rebate model in their comments even as manufacturers and some purchaser coalitions supported it. But the specific procedural weaknesses that sank the 2025 version, thin administrative justification and insufficient stakeholder engagement, have been addressed this time. That's the meaningful difference, and it'swhy this pilot is more likely to survive a challenge built on the same grounds as the last one.
What it means for a health center, specifically.
For a template comment letter and ongoing advocacy resources built specifically for health centers, see the National Association of Community Health Centers' (NACHC) 340B rebate pilot page, listed below.
Contract pharmacy: It depends on your state, and on the most recent ruling.
Contract pharmacy access remains the most fragmented part of the 340B landscape. Your position depends on your state and on whichever court ruled most recently. A few examples from 2026 show the range:
This list isn't comprehensive, and it isn't meant to be. For ongoing tracking, 340B Report maintains contract pharmacy trackers by state, and your state primary care association is typically the fastest source for what a ruling means for members in your state.
Manufacturer data requirements are expanding past contract pharmacy.
A quieter but consequential shift: several manufacturers have extended claims data requirements to in-house pharmacies, not just contract pharmacy arrangements. That's a documentation burden that lands directly on health center staff, regardless of whether your center uses contract pharmacies at all. Of everything covered here, this is the change most likely to add work to someone's week no matter how the rebate pilot resolves.
Federal legislation: A watch item, not news yet.
The SUSTAIN 340B Act, a bipartisan discussion draft from six senators, including Thune, Baldwin, Moran, Capito, Cardin and Stabenow, remains the leading compromise vehicle for federal 340B reform. Formal introduction has stalled amid the rebate pilot debate. It's worth knowing the name and the sponsors. It isn't yet worth building a compliance plan around.
Resources
For the governance side of 340B, including how to bring contract pharmacy and TPA relationships into one connected system instead of tracking them by hand, see FQHCs: Your biggest supply chain risk isn’t a vendor. It’s 340B.
