340B Rebate Model Pilot Program

OPA will collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in the Notice (PDF - 212 KB). 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. 

OPA reviewed manufacturers’ plans and has approved the data fields summarized on the OPA website. After review of justifications provided as outlined in the Federal Register Notice (PDF - 212 KB), HRSA did approve a limited set of additional fields regarding medical claims and those are outlined on the website. Only these approved data fields may be requested by manufacturers for covered entities to submit. 

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. 

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. 

Please refer to the notices provided by each manufacturer and available resources on the IT vendors’ website for data definitions and operational FAQs.  

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

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 our website once the plans are approved by HRSA.

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 HRSA observes trends toward a manufacturer not paying rebates within 10 days of data submissions, OPA reserves the right to revoke the rebate model approval for that manufacturer.

Approvals of the plans received by September 15, 2025, will have 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, and manufacturers would be required to provide covered entities 60 days' notice after HRSA approval.

OPA may consider expanding the rebate pilot to other drugs purchased under the 340B Program that have not been selected for negotiation.

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.

Covered entities should only order drugs included in the 340B Rebate Model Pilot Program through their current 340B wholesale account. Manufacturers, with approved 340B rebate models, will update price files with their wholesalers to appropriately reflect the WAC price in the 340B account, so that once the rebate is paid, the 340B ceiling price is effectuated.  This will decrease burden on covered entities to place 340B orders to multiple accounts, create a standard rebate amount for all 340B purchases made through the rebate model, allow manufacturers some assurance that the appropriate pre-rebate amount was charged for drugs subject to rebates, and allow OPA to maintain visibility into drugs purchased as part of the 340B Program.  Rebates should only be requested by covered entities after a purchase is made in the 340B wholesale account.

Covered entities should not order drugs on any other accounts (e.g. WAC account or GPO account) to the extent they want to request a rebate on that drug.  This will help ensure compliance with the GPO prohibition and ensure that the rebate amount paid will result in the effectuation of the 340B ceiling price.

It should be noted that if there is not an approved 340B rebate model for a manufacturer in place, WAC should not be loaded into the 340B wholesale account, but rather the 340B ceiling price should be loaded into the 340B wholesale accounts.   

Rebates will be calculated as WAC minus the 340B ceiling price on the date of dispense (date of service).  The date of dispense is used in lieu of purchase date due to the limitation of data submitted by covered entities for each rebate claim.   As the pilot progresses, OPA will evaluate potential incorporation of certain purchase data. 

Covered entities should work to replenish accumulations made prior to the implementation of the 340B Rebate Model Pilot Program.  For accumulations that occurred that were unable to be replenished prior to January 1, 2026, please refer to each manufacturer’s notice to covered entities on how those 340B ceiling prices will be effectuated.  

As with all 340B Program requirements, auditable records should be maintained for both covered entities and manufacturers and OPA will incorporate compliance with the rebate model in audits of both covered entities and manufacturers. Covered entities are expected to maintain auditable records of purchases and rebate requests to ensure that only purchases made in the 340B wholesale account at the WAC price are subject to rebate requests. Rebates may not be requested on purchases made at the GPO price. OPA and manufacturers have audit authority to review for covered entity compliance under the rebate model.  

Covered entities who are not receiving rebates within the 10-day timeframe after submitting complete and accurate data, should first contact the manufacturer and IT platform vendor to report concerns. If after attempting to work with the manufacturer a covered entity cannot resolve the issue with the manufacturer, the covered entity should email 340BPricing@hrsa.gov with the details of its concern. A manufacturer that is consistently unable to timely resolve rebate reimbursement issues may have its participation in the pilot program revoked.

Participating manufacturers have committed to supplying a 340B ceiling price file for the covered outpatient drugs under the rebate model pilot.  This file will be available for download on the rebate model’s IT platform. The file may also be used to feed pharmacy billing systems to assist with sliding fees and Medicaid billing at acquisition cost. The 340B OPAIS pricing component is also available for verification of the accuracy of the manufacturer provided files.  

While the upfront purchase will occur at WAC, the cost of a 340B eligible purchase is expected to be the 340B ceiling price, once the rebate is paid. Participating manufacturers have committed to supplying a 340B ceiling price file for the covered outpatient drugs under the rebate model pilot.  This file will be available for download on the rebate model’s IT platform. The file may be used to feed pharmacy billing systems to assist with Medicaid billing at acquisition cost. The 340B OPAIS pricing component is also available for verification of the accuracy of the manufacturer provided files. 

 Covered entities should work with state Medicaid agencies to determine best practices for billing.