The administration published its list online Thursday, ahead of the pilot’s start in just three months. It includes major names like Pfizer, AbbVie, Merck and AstraZeneca, and is a more expansive list of participants and products than HRSA was planning during the effort’s first go-around.
The pilot is set to swap out statutory upfront discounts for safety-net providers with rebates that are coordinated by the participating drug manufacturers. Hospitals and other covered entities will, for at least a year, have up to 45 days from dispensation (with some exceptions) to submit claims-level data to the drugmakers through an IT system maintained by the latter in order to receive their discounts.
Providers have overwhelming panned the change, whose legal opposition to HRSA’s first attempt at the pilot led a judge to block its initial Jan. 1, 2026 launch. HRSA subsequently dropped that program and restarted the process (with an extended comment period) earlier this year, and finalized the plans for version two in July despite continued provider pushback.
Drugmakers who have backed the pilot, and 340B rebate models in general, assert that the switch-up will allow greater oversight and prevent double-dipping on discounts from other government programs. Providers, meanwhile, have said those integrity concerns are exaggerated and that HRSA’s experiment will bring more than a billion dollars of collective administrative costs, liquidity issues for cash-strapped organizations and the possibility that manufacturers could improperly withhold funds.
“The [American Hospital Association] remains deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” a spokesperson for the country’s largest hospital lobby said. “We are reviewing today’s materials and are considering all available options to prevent this flawed program from going into effect.”
HRSA specified in its final program guidance that manufacturers must provide “rationale and specific documentation for reasons claims are denied.” It had also floated as many as 25 products (selected from the 2026 Medicare Drug Price Negotiation Program) from 13 companies could be eligible for the pilot, and noted that these potential selections represented less than 5.5% of the 340B program’s total sales in 2025.
Separately, the Centers for Medicare and Medicaid Services launched a Medicare Part D Claims Data 340B Repository, where covered entities, their third-party administrators and others may submit certain claim-level data.
The process is voluntary for now, though the agency said in the 2027 Physician Fee Schedule proposed rule that it plans to make the submissions mandatory at the top of 2027.
CMS said it needs the data in order to comply with 2022’s Inflation Reduction Act and the Medicare Part D Inflation Rebate Program, under which drugmakers must pay the agency a rebate if the price of certain drugs rises faster than inflation. CMS is required by statute to nix 340B drugs from the calculations, prompting the need for information on dispensed 340B drugs.
CMS described (PDF) the opening months as a “testing period” in which it will assess the usability and reliability of the data submitted to the repository. For providers, it said that it has designed the data repository “to facilitate submission with minimal burden” and to allow covered entities to “leverage data files they already have.”