340B Program Alert: HRSA Approves Manufacturer Rebate Models for Pilot Program Participation

In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’s Office of Pharmacy Affairs (“OPA”) opted late last week to approve eight manufacturer plans for participation in the 340B Rebate Model Pilot Program (“Pilot”). These approved plans, which will take effect on January 1, 2026 and remain in operation for at least one year, will ostensibly be used to test the efficacy of 340B rebate models and could serve as the basis for a larger sea change in how 340B covered entities receive 340B Program benefit moving forward.

Background

Historically, drug manufacturers have been required to offer covered outpatient drugs at discounted prices to participating 340B-eligible providers (“covered entities”). Under a rebate model, however, covered entities must purchase drugs at an upfront wholesale cost, and would only be reimbursed for the difference between the price paid and the discounted 340B Program price once a rebate request is approved by the manufacturer. As detailed further in a previous article, manufacturer efforts to move toward a rebate model have been extremely contentious. 

With that historical backdrop in mind, OPA announced the Pilot back in August 2025 as a voluntary mechanism that will professedly be used to gauge the viability of rebate models in the 340B space. The Pilot is limited to the 10 medications included in the initial round of the Medicare Pricing Negotiation Program, with OPA allowing applicable manufacturers for those drugs to submit proposed rebate programs that meet OPA-established parameters. Manufacturer plans for participation in the Pilot were required to be submitted no later than September 15, 2025, with a tentative approval deadline set for October 15, 2025. However–presumably as a result of the ongoing federal government shutdown–this deadline came and went without any indication from the HRSA as to which plans had been approved or whether the Pilot would be delayed.

HRSA-Approved Programs

On October 30, 2025, OPA announced the approval of eight (8) proposed rebate models by drug manufacturers for participation in the Pilot,¹ which will take effect at the start of 2026. Approved manufacturers, and the specific medications included in the Pilot, can be found in the table below:

While HRSA did not provide detailed overviews of the approved plans, it generally indicated that the plans “met all the requirements as stated” in its initial Notice related to the Pilot, and that approved manufacturers would be reaching out to covered entities with additional information for effectuating the plans. With that said, key aspects of the approved plans based on OPA’s updated Pilot website landing page include the following:

• Applicable to all covered entity types (i.e., hospitals and grantees)
• Applicable to drugs billed via a patient’s pharmacy benefit and a patient’s medical benefit. Relatedly, OPA approved inclusion of additional medical claim field submission requirements even though they were not included in OPA’s original parameters in its Pilot Notice.
• All manufacturers will utilize the Beacon Platform to effectuate their rebate programs. Beacon is operated by the same parent company as 340B ESP, the platform utilized by numerous manufacturers to manage their ongoing contract pharmacy restrictions and associated reporting requirements.
• Manufacturers are required to submit a rebate within 10 days of a covered entity appropriately submitting required claim information, and are not permitted to reject rebate requests based solely on suspicion of 340B diversion or violation of the Medicaid duplicate discount prohibition.
• Covered entities can report instances where it does not receive a rebate within 10 days to OPA, and OPA reserves the right to revoke its rebate plan approval for a manufacturer if it observed “trends” of inappropriate delays.

Importantly, OPA reserves the right to “consider expanding the rebate pilot to other drugs purchased under the 340B Program that have not been selected for negotiation,” leaving the door wide open for potential expansion of the rebate model to other medications in the future. If you have questions or would like to discuss potential impact of the Pilot and 340B rebate models in general on your organization, please reach out to your contact at Quarles or:

• Brenda Maloney Shafer: 602-229-5774 / brenda.shafer@quarles.com
• Richard Davis: 414-277-5844 / richard.davis@quarles.com
• Michael French: 312-715-5261 / michael.french@quarles.com
• Jake Pallotta: 317-399-2810 / jake.pallotta@quarles.com

END NOTES

¹ 340B Rebate Model Pilot Program, available here.