HHS announces new 340B Rebate Model Pilot Program

The Department of Health and Human Services today issued a notice announcing a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all 340B-covered entities. 
 
The notice said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, is inviting certain drug manufacturers to apply for participation in the pilot program for a minimum of one year. HRSA said the pilot program will be limited to the NDC-11s included on the Centers for Medicare & Medicaid Services’ Medicare Drug Price Negotiation Selected Drug List regardless of payer. 
 
HRSA said manufacturers must submit applications to participate in the pilot program by Sept. 15, and approvals will be made by Oct. 15 for a Jan. 1, 2026, effective date. 
 
In a statement shared with the media following release of the notice, AHA Vice President of Advocacy and Grassroots Aimee Kuhlman said, “The AHA looks forward to reviewing HRSA’s 340B rebate guidance in more detail and working with the agency on this issue. However, we are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future. This pilot program is a response to a nonexistent program integrity problem that the drug manufacturers have manufactured in the public discourse.  
 
“Nevertheless, we appreciate HRSA’s efforts to impose strict guardrails on its limited pilot program. Going forward, it will be essential that HRSA makes certain that the drug companies bear all the costs of implementing these rebate models and that those companies provide discounts expeditiously. Anything else will pose serious financial risks to patients, communities and the hospitals that care for them.” 
 
The agency is soliciting comments on the structure and application process of the 340B Rebate Model Pilot Program. Those comments are due Aug. 31. AHA 340B members will receive a Regulatory Advisory with more details on the notice. 
 
The rebate issue is the subject of multiple ongoing court cases in which drug companies have sued HHS for denying their requests to impose rebate models rather than following the longstanding upfront discount model that HHS has allowed since the outset of the program. The AHA has filed several amicus briefs in these cases, and it intends to file another brief in the United States Court of Appeals for the D.C. Circuit next week. 
 
In addition, the AHA May 9 sent a letter to HHS urging the agency to deny drug companies’ requests to approve their “unlawful rebate models,” as they would “come at the expense of America’s most vulnerable patients and communities.”