HRSA Announces Approved 340B Rebate Model Pilot Plans

The Health Resources and Services Administration (HRSA) announced, on Oct. 30 which products will be included in the upcoming 340B rebate model pilot program. HRSA approved eight manufacturers' plans, covering nine of the ten products eligible for the pilot. Under the program, 340B covered entities will be required to initially purchase drugs above the 340B ceiling price and later receive rebates for after the drugs are dispensed to qualifying patients.

HRSA also amended the requirements of the pilot program. Covered entities must provide additional claims information to manufacturers to receive 340B discounts. While the prior notice limited manufacturers to 11 "readily available" pharmacy claims fields, the new announcement permits manufacturers to require additional medical claims data fields as well. The announcement further notes that all manufacturers have selected the same program administration software-the Beacon Platform-to manage claims. Although manufacturers were not required to include all covered entity types in their submitted plans, HRSA's announcement notes that the approved plans apply to all covered entity types.

The Oct. 30 announcement came 15 days later than scheduled; however, HRSA still complied with its own directive to provide covered entities with 60 days' notice before implementation. Under HRSA's regulations, rebates are permitted for the nine approved drugs beginning Jan. 1, 2026.

One eligible manufacturer, Novartis, was not included in the Oct. 30 notice., The manufacturer may later opt to join the pilot, though must still apply and provide 60 days of prior notice to covered entities before implementation, according to HRSA's prior FAQ.

Contact Policy Analyst Evan Schweikert at [email protected] or 202.585.0124 with questions.