340B Rebate Model Pilot Program

An earlier version of the rebate model pilot program was approved in late 2025 with a January 1, 2026, effective date, but HRSA was enjoined from implementing the first iteration of the pilot by the U.S. District Court for the District of Maine in December 2025. HHS subsequently withdrew that pilot, and the underlying notices and manufacturer approvals were formally vacated by the court on February 10, 2026. HRSA issued a Request for Information (RFI) to solicit feedback from interested parties regarding manufacturer rebate models under the 340B Program, including the standards and procedures that should govern the approval of manufacturer plans for a pilot program and evaluate the impacts on all stakeholders. HRSA developed a new Federal Register Notice to accept manufacturer applications for a 340B Rebate Pilot Program based on stakeholder feedback that HRSA received in response to the RFI.

Only the HRSA-approved data fields may be requested by manufacturers at this juncture for covered entities to submit.

No — the 340B Rebate Model Pilot Program applies to all selected drugs under IPAY 2026 and 2027 to the extent they are covered outpatient drugs, including physician- or clinic-administered drugs.

Yes. All covered outpatient drugs without a rebate model plan approved by HRSA for participation in the Pilot remain subject to upfront discounted 340B prices.

Manufacturers may choose to include all covered entity types as part of their rebate models or provide exceptions to certain covered entities. That information will be included in the respective manufacturers’ approved plan, which will be posted on OPA’s website.

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 calendar days for a rebate to be paid, covered entities should contact the manufacturer using the contact information included in their plan (which will be posted on OPA’s website) and work with the manufacturer to resolve the issue. If HRSA observes trends of a manufacturer not paying rebates within 10 calendar days of data submission, OPA reserves the right to revoke the rebate model plan approval for that manufacturer.

Rebates are calculated as WAC minus the 340B ceiling price on the date of dispense (i.e., 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 with all 340B Program requirements, auditable records should be maintained by both covered entities and manufacturers, and HRSA will incorporate rebate-model compliance into audits of both. 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 or other discounted price. HRSA and manufacturers have audit authority to review covered entity compliance with the diversion and duplicate discount prohibitions for all 340B purchases, including those under the rebate model.

Yes. In a replenishment model, a dispense takes place from a neutral inventory prior to the subsequent WAC purchase. For purposes of the rebate model, a dispense occurs and then the drug is replenished with a WAC purchase, followed by a request for a rebate. The product received through replenishment is then considered neutral inventory.

The Pilot does not modify the 340B ceiling price, covered entity eligibility requirements, or patient eligibility under the program. It changes only the mechanism and timing by which the 340B price is effectuated, shifting, for certain drugs, from an upfront discount to a post-dispense rebate that the statute expressly authorizes.

HRSA will publish a summary of all approved rebate model plans on its website prior to the plans' implementation. Manufacturers are also required to communicate details of their plans directly to covered entities no later than 90 days prior to implementation of their respective plans.

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

For fields that accept Alpha/Numeric responses, use "CASH". For fields that only accept numeric responses, such as BIN, use the designated value (e.g., 99999) in the data definitions of each manufacturer's plan.

Covered entities should only order drugs included in the Pilot through their current 340B wholesale account. Manufacturers with approved rebate model plans 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 decreases burden on covered entities to place orders to multiple accounts, creates a standard rebate amount for all 340B purchases made through the rebate model, gives manufacturers assurance that the appropriate pre-rebate amount was charged, and allows HRSA to maintain insight into drugs purchased under the 340B Program. Rebates should only be requested after a purchase is made in the 340B wholesale account.

Covered entities should not order drugs on any other account (e.g., WAC account or GPO account) if they intend to request a rebate on that drug — this helps ensure compliance with the GPO prohibition and that the rebate paid effectuates the 340B ceiling price.

Note: if there is no approved 340B rebate model plan in place for a manufacturer, WAC should not be loaded into the 340B wholesale account — the 340B ceiling price should be loaded instead.

Covered entities should work to replenish accumulations made prior to Pilot implementation. For accumulations that could not be replenished before the effective date, refer to each manufacturer's notice to covered entities on how those 340B ceiling prices will be effectuated. (See also the 15-calendar-day grace period for up to 2 unreplenished accumulated packages, described above.)

First contact the manufacturer and IT platform vendor to report the concern. If the issue cannot be resolved with the manufacturer after good-faith efforts, email 340BPricing@hrsa.gov with the details. A manufacturer unable to timely resolve rebate reimbursement issues may have its Pilot participation revoked.

Approved plans must include a 340B ceiling price file for drugs under the Pilot, available for download on the rebate model's IT platform. The file may also feed pharmacy billing systems to assist with sliding fees and Medicaid billing at acquisition cost. The 340B OPAIS pricing component is also available to verify the accuracy of manufacturer-provided files.

While the upfront purchase occurs at WAC, the cost of a 340B-eligible purchase is expected to be the 340B ceiling price once the rebate is paid. Participating manufacturers' quarterly ceiling price files (available on the IT platform) may be used to feed pharmacy billing systems for Medicaid billing at acquisition cost, and OPAIS is available for verification. Covered entities should work with state Medicaid agencies to determine best billing practices.

Covered entities will submit data to the rebate model IT platform utilized by manufacturers with HRSA-approved plans, which will be posted on this page. For plan-specific details, refer to each manufacturer's notice to covered entities.

Each manufacturer has committed to addressing these issues in good faith. Covered entities should work with the manufacturer's point(s) of contact and the rebate model IT platform vendor to resolve disputes. If the issue remains unresolved after good-faith efforts, covered entities are encouraged to report it to HRSA, by submitting a 340B Rebate Unavailable form (link forthcoming). Covered entities should be prepared to provide the following information on the 340B Rebate Unavailable Form:

1. Unique Claim Identifier
2. Claim Submission Date
3. 340B ID
4. NDC–11 Purchased
5. Date of Service (Dispense Date)
6. Quantity
7. Unit WAC Price
8. Unit 340B Price
9. Rebate Amount
10. Rebate Date Rejected
11. Rejection Reason (if applicable)

HRSA anticipates establishing mechanisms for ongoing stakeholder feedback throughout implementation of the Pilot, potentially including public listening sessions, advisory or technical working groups, and periodic opportunities for written input. Covered entities can also raise operational issues directly through the technical assistance and customer service channels each manufacturer is required to provide, including a designated point of contact and platform-based engagement. If an issue cannot be resolved with the manufacturer directly, covered entities may report it to 340BPricing@hrsa.gov.

HRSA is considering stakeholder recommendations on formal engagement processes as it develops procedures to monitor Pilot implementation and evaluate outcomes.

No. Manufacturers may not implement a rebate model plan without first receiving HRSA's approval, consistent with section 340B(a)(1) of the Public Health Service Act. 

Changes to approved plans must be submitted to OPA for review and approval prior to implementation, including the mechanism by which covered entities are to acquire drugs included in the rebate model pilot program. OPA will determine if the changes can take effect immediately or if they require a notification period to covered entities. Manufacturers will be expected to provide HRSA with a copy of their final approved plan for public posting on HRSA’s website to ensure consistency with what HRSA approved. Failure to seek approval prior to implementing changes to a manufacturer’s plan, may result in removal from the Pilot. 

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

All rebates should be paid within 10 calendar days of the covered entity's data submission. The clock starts when the data is submitted. If validation of the data is required, that time is included within the 10-day period prior to rebate payment. If the data is determined incomplete and must be resubmitted, the clock restarts when the data is resubmitted, and the rebate is due 10 days from that resubmission.

Manufacturers may not deny rebates based on compliance concerns with diversion or Medicaid duplicate discounts. As part of validating a dispensation, a manufacturer may confirm that the dispensing site is listed on 340B OPAIS.

Any changes to an approved plan require additional review and approval by HRSA. As part of its review, HRSA will determine whether the changes can take effect immediately or require a notification period to covered entities. Changes made without HRSA's approval may result in revocation of the manufacturer's approval to participate in the Pilot.

The scope of the Pilot is limited to the NDC–11s included on the CMS Medicare Drug Price Negotiation Selected Drug List ("List") for the applicable IPAY. If a manufacturer receives approval from CMS and the new NDC is added to the List, the manufacturer must notify HRSA before it can be included in the Pilot. 340B rebates may not be offered for any NDCs that do not appear on the List.

No. Manufacturers may not deny rebates if validation of WAC units purchased cannot be established. Manufacturers can monitor WAC units purchased and address concerns separately from rebate payment. HRSA will review compliance with the 10-day rebate payment requirement as part of the Pilot's evaluation and reserves the right to revoke approval of a manufacturer's plan at any time for noncompliance, including inability to timely resolve rebate reimbursement issues.

The data provided as part of the covered entities’ submissions will provide manufacturers with insight to some compliance concerns that may be monitored. For example, de-duplication of Maximum Fair Price refunds and 340B discounts will be evaluated from the data and is a purpose outside of providing the rebate but is still consistent with the Notice Regarding 340B Rebate Model Pilot Program (PDF - 316 KB). It is reasonable to assume that manufacturers may be monitoring submissions for other purposes, such as Medicaid duplicate discounts, although they may not deny rebates for that reason. 

Covered entity data that is handled by technology platforms and received by manufacturers as a part of this Pilot should not be used for any purpose other than those explicitly identified in the Pilot Notice. This limitation extends to any collecting, aggregating, sharing, or licensing of Pilot data by manufacturers or technology platforms.

All requests for rebates should be included in the manufacturer's periodic reporting to HRSA, regardless of whether a rebate was ultimately paid.

Participating manufacturers are required to submit purchase data reports to HRSA on an ongoing basis, including information on purchases made through rebates, claim denial data, and other metrics relevant to evaluating the Pilot's effectiveness. HRSA will use this data to assess adherence to the rebate framework and monitor its impact. HRSA also intends to share aggregate data — which will not include confidential or proprietary information — with the public to provide further transparency into the 340B Program, in its published evaluation by April 30, 2028.

Changes to an approved plan must be submitted to HRSA for review and approval prior to implementation. This includes changing the mechanism by which covered entities acquire drugs included in the Pilot.

The Pilot will provide a defined pathway for covered entities to challenge denied claims, including specified timeframes for review and response, and HRSA will make tools available for reporting rebate denials to be challenged. Tools will be available no later than 30 days after the Pilot's implementation. HRSA intends to make information about reported rebate denials and disputes public in its published evaluation by April 30, 2028.

HRSA will publish interim periodic summaries of implementation findings during the Pilot and a full evaluation by April 30, 2028, using quantitative data (rebate requests, payments, timeliness, denials, disputes) and qualitative stakeholder feedback. Public/aggregated data will exclude confidential, proprietary, or individually identifiable information.