HRSA Announces 9 Drugs for 340B Pilot
November 03, 2025
The Health Resources and Services Administration (HRSA) last week announced the nine approved drugs to participate in the federal government’s 340B Rebate Model Pilot Program.
HAP and the hospital community have expressed significant concerns about the rebate model proposal and have called on the federal government to consider alternatives. The abrupt transition from the current 340B upfront drug discount model to a claims-based rebate model will put severe financial strain on hospitals that serve our most vulnerable populations.
“Hospitals now have to manage a whole new set of administrative burdens, requiring more bureaucracy and more paperwork, with no benefit to patients’ ability to access discounted drugs,” said Jennifer DeCubellis, president and CEO, America’s Essential Hospitals, in a statement last week. “We urge the administration to abandon these 340B rebate models and instead work to strengthen the 340B program.”
The plans for participation in the 340B Rebate Model Pilot Program with a January 1, 2026, start date:
- Bristol Myers Squibb, Eliquis
- Immunex Corporation, Enbrel
- Astra Zeneca Ab, Farxiga
- Pharmacyclics, Imbruvica
- Merck Sharp Dohme, Januvia
- Boehringer Ingelheim, Jardiance
- Novo Nordisk Inc., Novolog; Novolog Flexpen; Novolog Penfill; Fiasp; Fiasp Flextouch; Fiasp Penfill
- Janssen Biotech, Inc., Stelara
- Janssen Pharmaceuticals, Inc., Xarelto
In a comment letter, HAP outlined significant concerns about the proposed model and the ways it would put serious financial and operational impacts on Pennsylvania’s 340B hospitals. It also called for the federal agency to delay the implementation timeline due to the scope of the proposed changes.
“HAP is deeply concerned that guidance provided by HRSA gives drug manufacturers the opportunity to unilaterally make programmatic changes that will substantially impact the ability of these hospitals to remain afloat, jeopardize covered entities’ ability to maintain 340B programs and significantly limit patient access to care,” the letter noted.
See HAP’s comment letter to HRSA with additional feedback on the proposed model. Additional information—including updated frequently asked questions on the program—is available online.