HHS Announces 340B Drug Rebate Pilot Program

On Aug. 1, the Office of Pharmacy Affairs (OPA), which oversees the 340B program within the Health Resources and Services Administration (HRSA) at HHS, announced a new voluntary pilot program to test post-purchase rebates for drugs subject to Medicare’s Maximum Fair Price (MFP).

Set to launch in 2026, the pilot allows 340B covered entities to buy the 10 drugs subject to Medicare negotiated prices at commercial prices and receive post-sale rebates from manufacturers rather than receiving upfront discounts.

The pilot is designed to improve transparency; help address inappropriately duplicated discounts; and to evaluate the feasibility, fairness, and transparency of rebate models. It includes strict requirements for data collection, reporting, and rebate processing, and prohibits rebate denials for diversion or duplicate discounts.