On a short list of drugs the 340B discount becomes a rebate, and the hospital pays the undiscounted price first
The 340B discount has always been a discount. On a small set of drugs it is about to become a refund.
The Health Resources and Services Administration filed a notice on Friday morning announcing a 340B Rebate Model Pilot Program, under which a qualifying manufacturer may deliver the statutory 340B ceiling price as a rebate paid after the fact rather than as a lower price at purchase. The agency says the statute has always permitted this, and that rebates will be used instead of upfront discounts within the pilot. The notice is effective immediately as published, which is scheduled for Monday.
The programme it touches is large. As of 1 April 2026 it counted 15,249 covered entities and 49,214 associated sites, and it reached $100 billion in purchases at 340B prices in 2025.
The scope is narrow on purpose
The pilot does not cover the 340B catalogue.
It covers only the eleven-digit codes of drugs on the Medicare Drug Price Negotiation Selected Drug List for initial price applicability years 2026 and 2027, regardless of payer or indication, and only while a selected drug's negotiated price is in force. That limit doubles as the invitation list: the call for plans runs only to manufacturers holding one of those drugs. Plans are due to the Office of Pharmacy Affairs by 24 August. Approvals, if any come, arrive by 24 September, for a start on 1 January 2027 and a minimum of one year. No manufacturer may run a plan without approval.
The terms sit on the manufacturer
The rebate is wholesale acquisition cost less the 340B ceiling price on the day the drug is dispensed, paid per unit rather than per package.
Payment is due within 10 calendar days of a completed data submission, and the clock restarts if HRSA's required fields are missing. The manufacturer pays for the IT platform. Covered entities get at least 45 days from dispense to submit, a quarterly price file for every eleven-digit code, and real-time reconciliation. Data requests are capped at an enumerated list of claim fields, purchasing and encounter data are off the table for now, and nothing collected may be aggregated, shared or licensed for any other use.
One clause does more work than the rest. A manufacturer may not deny a rebate over eligibility, diversion, Medicaid duplicate discounts, or a suspicion that too little was bought at wholesale price. Those objections go to HRSA, or into an audit, or into administrative dispute resolution.
The argument the notice has to answer
Commenters told HRSA that paying full price first would strain rural and safety net providers.
The agency does not dispute the mechanism, only the size. It cites an IQVIA analysis putting the interest cost of a rebate model at 0.19 percent for entity-owned pharmacy purchases, no larger than the replenishment model those pharmacies use now, and 0.03 percent for contract pharmacies, staying under 1.2 percent even on unfavourable assumptions. It points to a 2021 study by 3 Axis Advisors reaching a similar conclusion for contract pharmacies. Its own mitigation is the 10-day clock, which it says is meant to land the money before the wholesaler invoice comes due, plus unit-level payment and a 15-day grace window for up to two packages held in inventory at the changeover.
Whether that holds is what the pilot is for.