NCPA submits comments to HRSA on 340B pilot program

NCPA September 8, 2025

NCPA submitted comments to the Health Resources and Services Administration (HRSA) on its proposed 340B rebate pilot program, calling for timely reimbursement to pharmacies and stipulating that no additional administrative costs of running the rebate model be imposed on pharmacies.

The rebate as envisioned by HRSA pertains to the transaction between the manufacturer and the covered entity (CE). The rebate program would be voluntary for the manufacturer, and the manufacturer would need to apply to HRSA to use such a rebate. Approvals will be made by Oct. 15, 2025, for a Jan. 1, 2026, effective date. The pilot program will apply to the NDC–11s of the first 10 drugs in the Medicare Drug Price Negotiation Program, regardless of payer. The pilot program will last for a minimum of one year.

Basically, the rebate would be a reimbursement made from the manufacturer to the CE in the amount of the acquisition cost less the 340B ceiling price. The 340B covered entities would have to purchase these drugs at the going rate and wait for the manufacturers to receive a rebate.

NCPA