The Health Resources and Services Administration (HRSA) on July 31 issued a public notice regarding the 340B Rebate Model Pilot Program. The program would allow participating pharmaceutical manufacturers to provide 340B Drug Pricing Program discounts through post-purchase rebates.
Manufacturers wishing to participate must submit pilot plans by Aug. 24 for a Jan. 1, 2027 launch date. Those with selected drugs for the Medicare Drug Price Negotiation Program in 2026 and 2027 are eligible.
The notice maintains HRSA’s position that the 340B statute gives the agency discretion over implemented 340B ceiling prices through either upfront discounts or rebates. The agency dismissed significant concerns voiced by providers and covered entities, largely by noting deferring statements made by pharmaceutical manufacturers.
The revised proposal is largely the same as the withdrawn 2025 pilot. Covered entities would continue to submit substantially the same claims-level data and participate in a manufacturer-administered rebate process. HRSA proposes limited adjustments to reduce variation between manufacturer submitted plans; however, covered entities’ obligations are largely unchanged from the withdrawn pilot.
As was the case in the withdrawn pilot, manufacturer plans must provide rebates within 10 calendar days of complete data submission. They may not deny rebates based solely on suspected diversion, duplicate discounts, covered entity eligibility, or wholesale acquisition cost purchasing concerns outside the statutory audit and administrative dispute resolution processes.
Questions? Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions or for more information.
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