The Department of Health and Human Services (HHS) is seeking fresh input on a potential overhaul of its 340B drug pricing program, following a series of court decisions that halted the agency’s initial attempt to shift to a rebate-based model. The Health Resources and Services Administration (HRSA) issued a request for information (RFI) on February 13, 2026, initiating a latest period of public comment that will remain open through March 19, 2026.
The move comes after the U.S. District Court for the District of Maine issued a preliminary injunction on December 29, blocking the proposed changes. The 1st U.S. Circuit Court of Appeals subsequently denied the government’s request for a stay on January 7. HHS formally conceded the legal challenges on February 5, filing a notice stating that further litigation would not be “fruitful” and requesting the court to remand the issue back to HRSA. The district court then vacated and remanded the program and related approvals to HHS on February 10.
The original pilot program, announced in August 2025, aimed to transition 340B hospitals from receiving upfront discounts on drug purchases to a system where they would pay full market prices and later seek reimbursement through manufacturer rebates. This change sparked immediate opposition, with the American Hospital Association (AHA) and other plaintiffs filing a lawsuit arguing the shift would impose substantial financial burdens and potentially compromise care for vulnerable populations in rural and underserved communities.
Aimee Kuhlman, vice president of advocacy and grassroots at the AHA, stated the organization “welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model.” However, Kuhlman also emphasized the need for HHS to “reconsider policies that shift costs to hospitals serving vulnerable communities,” according to a statement released by the AHA.
The 340B program, established in 1992, allows eligible healthcare organizations, primarily hospitals serving a high proportion of low-income and uninsured patients, to purchase outpatient drugs at reduced prices. The program’s intent is to enable these hospitals to stretch limited resources and provide more affordable care. However, the program has faced increasing scrutiny from pharmaceutical manufacturers concerned about its impact on drug pricing and innovation.
Any new rebate program developed by HHS would be subject to a public notice period, a formal comment period, and a delayed effective date of at least 90 days following the announcement of manufacturer approvals.
