On October 30, 2025, the Office of Pharmacy Affairs (OPA) posted information on its website announcing that they have approved 340B rebate models applicable to eight drug manufacturers. Consistent with the August Federal Register Notice announcing the 340B Rebate Model Pilot Program, the approved rebate models will apply to nine of the 10 drugs selected for the Inflation Reduction Act (IRA) negotiated drug prices for Medicare Part D, effective January 1, 2026. The rebate models announced on October 30 will also be effective January 1, 2026.
In addition to required claim level data fields to be submitted for the selected drugs when dispensed in a retail setting, OPA/HRSA has now provided information about the data fields that will be required for in-hospital dispensing of the selected drugs. A chart of the data fields that will be required for submission to manufacturers to obtain 340B rebates is now available on the OPA/HRSA website, linked above.
The information currently available about the rebate models from OPA/HRSA is quite limited. OPA/HRSA appears to be generally deferring to Beacon, the IT platform vendor that will be operationalizing all of the rebate models announced on October 30, to provide operational details of the rebate models. As of October 30, however, there was also very limited information available from the Beacon website.
The McDermott team is continuing to review the available information about the approved 340B rebate models, including how claims for drugs subject to the rebate models should be billed to state Medicaid programs.
Please do not hesitate to reach out to the author of this post with any questions or to schedule a call. We are happy to connect with you to further discuss what the approved 340B rebate models may mean for your organization and how best to respond to today’s announcement- as well as likely future developments in the 340B rebate model space.
