The Controversial 340B Rebate Pilot Program Is Moving Forward

In a surprise move amid the federal government shutdown and outcry from safety net health care providers, pharmacies, and wholesalers, the Health Resources & Services Administration (HRSA) announced that it has approved plans for 9 of the 10 drugs subject to pricing under the Medicare Maximum Fair Price (MFP) negotiations for participation in the recently proposed 340B Rebate Model Pilot Program. The anticipated effective date for the rebate program is January 1, 2026.¹

For the approved products under the new model, instead of 340B-covered entities receiving the 340B price through an upfront discount at the time of purchase, the covered entities will be required to purchase the products at the manufacturer’s list price, known as the wholesale acquisition cost (WAC). The 340B-covered entities will then submit data to the applicable rebate platform after the drug is dispensed and receive a rebate for eligible 340B claims paid within 10 calendar days of data submission. All 9 drugs with approved plans are currently leveraging the same rebate platform. The rebate amount will be the greater of (a) the difference between the WAC paid and the 340B ceiling price and (b) the difference between the WAC paid and the MFP, if applicable.²

Conceptually, according to the announcement by HRSA in August 2025 that manufacturers could submit proposals for a rebate program, the primary stated goal of the 340B Rebate Model Pilot Program is to provide pharmaceutical manufacturers the data they need to “deduplicate” 340B discounts and MFP prices, since manufacturers are not required to provide access to both for the same dispense, effectively stacking the discounts. A secondary goal is to give manufacturers more data to prevent duplicate discounts with Medicaid and diversion (which, for 340B purposes, means providing 340B discounted products to patients who are not eligible to receive them).³

Concerns have been raised by numerous stakeholders (eg, the American Hospital Association, American Medical Group Association, National Rural Health Association and Ryan White Clinics for 340B Access) and a bipartisan group of legislators about the significant damage to the financial viability of many 340B-covered entities that the program represents by requiring covered entities to float the difference between WAC and the discounted price they are entitled to under the 340B statute. Lawmakers have also expressed concern about manufacturers leveraging aggressive tactics to delay or avoid paying rebates that are owed.^4-8 The feasibility of operationalizing this model across over 42,000 covered entities and over 32,000 contract pharmacy locations in just 2 months is also extremely questionable.

Nonetheless, as of today, the project is still moving forward. Although there is still plenty of time for legal or administrative action to pause implementation of the 340B Rebate Model Pilot Program, covered entities that have 340B dispenses of any of the 9 approved products should assess what they will need in terms of operational and financial resources to meet the data submission and other implementation requirements of the program and to buffer for a reduction in 340B revenue attributable to the 9 implicated products for any errors, delays, or glitches in the rollout of the program.

Table 1¹ reviews the products with approved 340B Rebate Model Pilot Program plans, along with links to the contact email for each manufacturer and the platform for submitting data.

Table 2¹ reviews the data elements covered entities will need to provide to claim 340B rebates for the products approved for the program.

About the Authors

Beth Siemer, JD, and Aurora Kammerer, JD, are attorneys in the St. Louis, Missouri, and Overland Park, Kansas, offices of Spencer Fane, respectively. For more information, visit spencerfane.com.

REFERENCES

1. 340B Rebate Model Pilot Program. Health Resources and Services Administration. Updated November 2025. Accessed December 1, 2025. https://www.hrsa.gov/opa/340b-model-pilot-program

2. Hall MJ, Frederick BT, Hunt A. HRSA announces 340B Rebate Model Pilot Program. Ropes & Gray. August 1, 2025. Accessed December 1, 2025. https://www.ropesgray.com/en/insights/alerts/2025/08/hrsa-announces-340b-rebate-model-pilot-program?utm_source=chatgpt.com

3. 340B program notice: application process for the 340B Rebate Model Pilot Program; Correction. Federal Register. 2025;90(150):38165-38167.

4. AHA Letter to HRSA Re: The 340B Rebate Model Pilot Program. American Hospital Association. September 30, 2025. Accessed December 1, 2025. https://www.aha.org/lettercomment/2025-09-30-aha-letter-hrsa-re-340b-rebate-model-pilot-program

5. Re: Application process for the 340B Rebate Model Pilot Program (HRSA-2025-14998). Advancing High Performance Health. September 8, 2025. Accessed December 1, 2025. https://www.amga.org/getmedia/9b26c90c-3166-4401-8344-cc9f1794540d/340b-model-amga-comments-letter-final.pdf

6. RE: 340B program notice: application process for the 340B Rebate Model Pilot Program. National Rural Health Association. September 8, 2025. Accessed December 1, 2025. https://www.ruralhealth.us/getmedia/1c5c0fd3-a1c8-4eec-89d9-fb13467264f8/NRHA-340B-Rebate-Pilot-Program-comment-9-8-25.pdf

7. RSV-340B urges HRSA to abandon rebate model pilot. News release. Ryan White Clinics for 340B Access. September 15, 2025. Accessed December 1, 2025. https://rwc340b.org/rwc-340b-urges-hrsa-to-abandon-rebate-model-pilo/

8. Congress of the United States House of Representatives. Letter to Secretary Robert F. Kennedy, Junior. September 8, 2025. Accessed December 1, 2025. https://matsui.house.gov/sites/evo-subsites/matsui.house.gov/files/evo-media-document/20250909-matsui-final-letter-to-hhs_340b-rebate-model-pilot.pdf