The US Health Resources and Services Administration (HRSA) revealed the initial nine drugs to be included in the 340B rebate model. The decision comes after pharma companies filed suit in regard to how 340B eligible hospitals should handle drug payments.1

What is the 340B rebate model pilot program?

According to a statement on HRSA’s website, the 340B Rebate Model Pilot Program includes a select group of drugs from certain manufacturers who have submitted plans meeting specific criteria approved by HRSA. The statement continues to mention that the pilot program aims at assisting the development process for approving future models that are consistent with the 340B statute and Administration’s goals.1 The pilot program is scheduled to start on January 1, 2026.

“Under the 340B Rebate Model Pilot Program, covered entities must continue to make purchases through their 340B wholesaler account and must ensure they are only requesting rebates on the above drugs dispensed to 340B eligible patients after a purchase is made,” said HRSA, in a statement on its website. “Manufacturers should work with their distributor partners to ensure the WAC price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.”

What drugs are included in the 340B rebate model pilot program?

HRSA announced the following nine company’s drugs are set to be included in the rebate pilot program.

• Bristol Myers Squibb, Eliquis
• Immunex Corporation, Enbrel
• Astra Zeneca AB, Farxiga
• Pharmacyclics, Imbruvica
• Merck Sharp Dohme, Januvia
• Boehringer Ingelheim, Jardiance
• Novo Nordisk Inc., Novolog; Flexpen, Penfill, Fiasp; Flextouch, Penfill
• Janssen Biotech, Inc., Stelara
• Janssen Pharmaceuticals, Inc., Xarelto

What lead to HRSA approving a 340B rebate model?

Back in December 2024, Johnson & Johnson, Bristol Myers Squibb, and Eli Lilly sued HRSA, challenging the agency’s ability to review and approve 340B program rebate models. In the suit, the companies proposed a plan to implement cash rebates for 340B drug purchases, resulting in HRSA sending each drug manufacturer warning letters in regard to the manufacturers abilities to unilaterally implement a rebate model without first submitting the model to the agency for review.3 Additionally, the lawsuit challenges the implementation of a rebate model, of the drug manufactures discretion, along with challenging the requirement to obtain prior approval from the agency before implementation.

Why was the 340b drug pricing program originally created?

In 1992, the 340B Drug Pricing Program was created with the goal of being able to incentivize safety net hospitals and clinics that support the low-income and underserved populations by discounting outpatient drug costs.2 By providing the ability to dispense discounted drugs, these facilities are able to directly impact more patients, in the form of additional health care services and programs.

Sources

1. 340B Rebate Model Pilot Program Health Resources and Services Administration date accessed October 31, 2025 https://www.hrsa.gov/opa/340b-model-pilot-program
2. Study Highlights Need for Greater Transparency in 340B Drug Pricing Program Pharmaceutical Executive November 28, 2023 https://www.pharmexec.com/view/study-highlights-need-for-greater-transparency-in-340b-drug-pricing-program
3. The 340B Program Rebate Bait-and-Switch Feldesan December 4, 2024 https://www.feldesman.com/the-340b-program-rebate-bait-and-switch/