HRSA Announces 340B Rebate Pilot Beginning in 2027

Today, the Health Resources and Services Administration (HRSA) issued a Federal Register notice establishing the terms of its 2027 340B Rebate Model Pilot Program. The notice, which is scheduled to be published in the Federal Register on August 3, 2026, applies only to the 25 Medicare Part D drugs selected for negotiation for the 2026 and 2027 initial price applicability years. Notably, the notice was issued without an opportunity for public comment and states that it "will be effective immediately as published, unless revised by a future notice." HRSA also states that the pilot program will remain in effect for at least one year.

Under the pilot program, covered entities seeking to purchase one of the selected drugs would continue to order the drug through their existing supply chain. However, wholesalers would sell the drug to the covered entity at the wholesale acquisition cost (WAC), rather than at the 340B ceiling price. After the drug is dispensed, the covered entity would submit a rebate claim to the manufacturer for the difference between the WAC paid to the wholesaler and the applicable 340B ceiling price on the date of dispense.

Manufacturers must submit their rebate model proposals to HRSA for approval. HRSA will review the proposals, and manufacturers must provide approved proposals to covered entities at least 90 days before the pilot program begins.

The notice identifies the following key dates:

• Manufacturer rebate model proposals due to HRSA: August 24, 2026;
• HRSA approval of manufacturer proposals: September 24, 2026;
• Rebate model effective date: January 1, 2027; and
• Publication of HRSA's evaluation of the rebate model: By April 30, 2028.

Powers' attorneys will provide a more detailed analysis of HRSA's 340B Rebate Model Pilot Program during our upcoming 340B training sessions (see below).