HRSA Revives 340B Rebate Model Pilot: What Covered Entities Need to Know for 2027

Takeaways

• Manufacturers seeking to participate must submit plans by August 24, 2026, addressing HRSA requirements for rebates, data, reporting, security, and other operational issues.
• Covered entities could face significant operational and cash-flow impacts as 340B discounts on participating drugs shift from upfront pricing to post-purchase rebates.
• 340B covered entities should assess their readiness now, including purchasing, claims data, pharmacy operations, Medicaid billing, rebate reconciliation, and liquidity.

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On July 31, 2026, the Health Resources and Services Administration (“HRSA”) made available for public inspection a notice reviving the 340B Rebate Model Pilot Program. After HRSA’s initial move to implement a rebate model, a U.S. District Court preliminary injunction stalled the pilot just before it was set to take effect; HHS subsequently opted to withdraw the 2025 rebate pilot rather than continue its appeal. Eight months later, HRSA has signaled unmistakably that it intends to move forward—despite covered entity and contract pharmacy objections regarding cash flow and liquidity, administrative costs, and operational burdens.

Notably different from the first model, which implicated only 10 drugs, the current iteration of the Rebate Pilot extends to those drugs from years 2026 and 2027 included on the CMS Medicare Drug Price Negotiation Selected Drug List, implicating up to 25 products from 13 manufacturers.[1] The Pilot is scheduled to take effect for those selected drugs on January 1, 2027, leaving manufacturers and covered entities limited time to prepare. Manufacturers seeking to participate must submit plans satisfying HRSA-defined criteria no later than August 24, 2026. Those plans must address the following:

General Plan Requirements

1. Plan must identify the IT platform to be used for covered entity data submission and include assurances that all costs for IT platform used for data submission, be borne by the manufacturer.
2. Plan must allow for 90 calendar days’ notice to covered entities and other impacted stakeholders before implementing an approved rebate pilot plan, with instructions for registering for any IT platforms. Changes to approved plans must be submitted to Office of Pharmacy Affairs (“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. 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.
3. Plan must allow for covered entities to order the selected drugs under existing distribution mechanisms (e.g., 340B wholesaler accounts with WAC prices loaded) to ensure purchases flow through existing infrastructure.
4. Plan must provide technical assistance/customer service component and ensure that opportunities to engage directly with the manufacturer in good faith regarding questions or concerns are made available to covered entities through both the IT platform and provide a point of contact at the manufacturer.
5. Plan must ensure that the IT platform has assurances in place to ensure that the data is secure and protected, and collection of the data is limited to the elements listed below that are necessary for providing 340B rebates pursuant to section 340B(a)(1) of the PHSA.
6. Plan must ensure that the manufacturer and the IT platform have mechanisms in place to protect the privacy and security of PHI or other PII, which is required to be safeguarded in a manner consistent with any applicable federal privacy and data security laws, including HIPAA.
7. Plan must describe whether an exception that would not apply broadly to all covered entities, and if any, will be communicated to both HRSA and affected covered entities (e.g., covered entities without access to a third-party administrator or rural hospitals or health centers).

Reporting Requirements

1. Plan must ensure that covered entities are allowed to submit and report data (as detailed below), at a minimum, up to 45 calendar days from date of dispense, with allowances for extenuating circumstances and other exceptions, including adjustments when a 340B status change occurs on a claim.
2. Plan must ensure that the IT platform will have the capacity to receive data from all applicable covered entities and to filter and use only the data required to effectuate the rebate (e.g., if drugs other than a selected drug for initial price applicability year 2026 or 2027 during its price applicability period under the MDPNP are submitted, the platform will be able to identify and discard unneeded data).
3. Plan must ensure that the IT platform will have the capability to provide real-time reconciliation reports for covered entities to be informed of the rebate status of submitted claims.
4. Plan must ensure that a quarterly 340B price file for each of the manufacturer’s 11-digit NDCs is made available to covered entities, so that covered entities may use the price file in conjunction with pharmacy billing systems to appropriately account for actual acquisition cost (i.e., post rebate price) for Medicaid billing and also to assist with sliding fee scales or cost sharing with patients.
5. Plan must require the manufacturer to provide HRSA/OPA with periodic reports consistent with the information outlined in this Notice, in a format and manner specified by HRSA/OPA (instructions forthcoming). Such data should detail data on purchases provided through rebates, information related to claim denials, and other information that may evaluate the effectiveness of the rebate model.

Rebates

1. Plan must include the rebate calculation equal to the wholesale acquisition cost (“WAC”) less the 340B ceiling price on the day of dispense.
2. Plan must specify that rebates are paid at the unit level.
3. Plan must include details to accommodate up to two unreplenished accumulated packages during the implementation phase. Covered entities shall have a 15-calendar-day grace period, in which they may submit rebate requests for up to two unreplenished accumulated packages prior to the Pilot’s effective date. For example, a covered entity may request a rebate for up to two packages of a product dispensed from its neutral inventory on December 16, even though the effective date for the product’s participation in the pilot is January 1. The request for such rebates should still be made within 45 days of dispense.
4. Plan must ensure that all rebates are paid to the covered entity (or denied, with documentation to support) within 10 calendar days of completed data submission. If the submission is returned for incomplete data, the 10-day clock for rebate payment will restart when all necessary data is submitted.
5. Plan must ensure that 340B rebates are not denied based on eligibility or compliance concerns with diversion or Medicaid duplicate discounts, pursuant to section 340B(a)(5)(A) and (B) of the Public Health Service Act and should provide for rationale and specific documentation for reasons claims are denied (e.g., nonduplication of discounts for a selected drug for which the MFP is required under the MDPNP or 340B rebate provided to another covered entity on the same claim). Rebates may not be denied for perceived lack of WAC purchases. If a manufacturer has concerns regarding Medicaid duplicate discounts, diversion, eligibility, or insufficient WAC purchases to support rebate requests, the manufacturer must raise those concerns directly with HRSA/OPA or utilize the 340B statutory mechanisms, such as audits and administrative dispute resolution, for addressing such issues. Covered entities are also afforded opportunities to raise concerns with HRSA/OPA if there are issues with rebate denials through reporting tools sent to 340Bpricing@hrsa.gov.
6. Plan must ensure that its implementation of the Pilot is limited to using the 340B rebates model only on sales of active selected drugs for the initial price applicability years 2026 or 2027, as included on the CMS Medicare Drug Price Negotiation Selected Drug List (“List”), regardless of payer, or indication, and only during the selected drug’s effective dates of negotiated prices. The NDC-11s of the selected drug are included in the Pilot only to the extent they are on the List, and the selected drug is in its price applicability period in the MDPNP.

Data

1. All data requested as part of the Plan should be limited to only the following claim fields:

Pharmacy Claims Data Fields	Medical Claims Data Fields
Date of Service	Date of Service
Date Prescribed	Claim Line Number
Rx number	Claim Number
Fill Number	Unit of Measure
NDC-11	NDC-11
Quantity Dispensed	Quantity
Prescriber ID	Rendering Physician ID
Service Provider ID	Service Provider ID
340B ID	340B ID
Rx BIN	Health Plan Name
Rx PCN	Health Plan ID
	Health Plan ID Qualifier (if available)

With a fast-approaching January 1, 2027, effective date, and HRSA’s clear intent to move forward regardless of stakeholder concerns, covered entities should take stock now of where they stand operationally and assess their preparedness before the Pilot becomes a reality.

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[1] Medicare Drug Price Negotiation Selected Drug List, available at https://www.cms.gov/files/zip/selected-druglist-negotiated-prices-also-known-maximum-fair-prices-statutezip.zip.