HRSA 340B Rebate Model Pilot Program FAQs

How will HRSA consider stakeholder comments and feedback on the effectiveness of the rebate model?

OPA will collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in the Notice. OPA will consider comments received but is under no obligation to respond to or act on the comments. Once the pilot program is implemented, OPA will provide a mechanism for 340B Program stakeholders to provide feedback on their experience utilizing the rebate model.

Will HRSA consider any other elements beyond those listed in the Notice when approving a manufacturer’s rebate model?

Manufacturers who submit plans may request to collect additional data but must provide compelling supporting information on why the additional data elements are needed to implement the rebate model. OPA will review such requests for additional data collection prior to implementation to ensure compliance with the 340B Program statute, policies, and guidance documents.

How will covered entities know which manufacturers are participating in the rebate model, what data they are requiring and for which drugs?

OPA will publish a summary of all approved rebate model plans on its website, prior to the plans’ implementation. Additionally, manufacturers are required to communicate details of their plans directly to covered entities no later than 60 days prior to implementation of their respective plans.

For this initial pilot period, which drugs specifically are eligible to be part of the rebate model pilot program? When will HRSA consider allowing other drugs to be eligible?

The initial group of drugs eligible to participate in the rebate model pilot program are the 10 that were selected for the Medicare Drug Price Negotiation Program (MDPNP) for initial price applicability year (IPAY) 2026. OPA may announce a call for plans from manufacturers with MDPNP Agreements for other applicability years, at a later time, after evaluation of the first year of the pilot program.

Is the rebate model only for drugs dispensed in a retail setting?

The 340B rebate model pilot is applicable to all selected drugs under IPAY 2026 to the extent they are covered outpatient drugs, including physician- or clinic-administered drugs.

Are all drugs that are not subject to the rebate still offered at the upfront 340B discount?

Yes, all covered outpatient drugs, without a rebate model approved by HHS, are subject to upfront discounted 340B prices.

Which entity types are subject to the rebate model pilot program?

Manufacturer plans may choose to include all covered entity types as part of their rebate models or limit to certain covered entity types. That information will be posted in summary form on HRSA’s website once the plans are approved.

Can you spell out what the reconciliation looks like? What protections are in place to ensure issues are resolved quickly?

Covered entities should have access to the real-time rebate status of a claim, so they can easily reconcile claims submitted with rebates paid. If a claim takes longer than 10 days for a rebate to be paid, covered entities and manufacturers should work to resolve the issue. If a manufacturer trends toward not paying rebates within 10 days of data submissions, OPA reserves the right to revoke the rebate model approval for that manufacturer.

Can a plan be submitted for consideration after September 15, 2025?

Approval of the plans received by September 15, 2025, will be transmitted to manufacturers by October 15, 2025, with an implementation date of January 1, 2026. Manufacturers who have drugs selected under IPAY 2026 with an agreed upon maximum fair price may submit plans for consideration after September 15, 2025, but any potential approval would have an effective date later than January 1, 2026.

Will submissions for non-MFP selected drugs be available at some point?

After assessment of the pilot, which will include OPA’s evaluation of data and reports received from the participating manufacturers on the effectiveness of the model and covered entity and other stakeholder feedback, OPA may consider expanding the rebate pilot to other drugs purchased under the 340B Program that have not been selected for negotiation.

How should manufacturers provide periodic reports to OPA?

Periodic reports should be sent electronically to include NDC-specific data for each rebate provided. More information and instructions regarding submission of data will be provided to manufacturers upon approval of individual plans.

Under what account should covered entities order 340B drugs subject to rebates?

Covered entities should order drugs included in the 340B Rebate Pilot Program through their 340B wholesale account, when available. Manufacturers with approved 340B rebate models should update price files with their wholesaler to appropriately reflect the WAC or other commercial acquisition price in the 340B account, so that once the rebate is paid, the 340B ceiling price is effectuated. If there is not an approved 340B rebate model for a manufacturer in place, WAC should not be loaded into the 340B wholesale account; instead, the 340B ceiling price should be loaded.

What should I do if I do not receive a rebate within 10 days of submitting claims data?

Covered entities who are not receiving rebates within the 10-day timeframe after submitting data should first contact the manufacturer and IT platform vendor. If the issue is not resolved, the covered entity should email [email protected]. A manufacturer that is unable to timely resolve rebate reimbursement issues may have its participation in the pilot program revoked.