AHA urges HRSA to block Eli Lilly’s 340B data demands: 5 things to know

By Alan Condon / April 28, 2026

The American Hospital Association has called on federal regulators to intervene after Eli Lilly sent warning letters to 340B hospitals threatening to cut off discounted drug pricing unless they submit detailed claims-level data through a third-party platform. The move is the latest flashpoint in a broader regulatory battle over the future of the 340B program. 

Five things to know:

1. In a letter sent to 340B-covered entities in April, Eli Lilly warned that hospitals must submit claims-level data through the 340B ESP platform — operated by a company called Second Sight Solutions — “without further delay” or lose access to 340B ceiling prices on Eli Lilly drugs. The letter states that data must be submitted within 45 days of product dispensing for most drugs, or within 60 days for a specific list of medications including Kisunla, Omvoh and Cyramza. More than 1,000 covered entities have already registered with the platform, according to Eli Lilly. 

2. In an April 27 letter to HHS’ Health Resources and Services Administration, the AHA described Eli Lilly’s data-submission requirements as unlawful and called on the agency to issue civil monetary penalties to enforce the 340B statute. The association represents more than 2,000 hospitals and health systems that participate in the program. “Our members tell us that these drug company policies are forcing them to operate under serious cost, chaos and confusion,” AHA General Counsel Chad Golder wrote. “The longer this situation goes on without any response from HRSA, 340B hospitals will be unsure whether they should not comply with these policies because HRSA might one day step in, or whether they should incur hundreds of thousands of dollars in wasteful compliance costs because they cannot count on HRSA to act.”

3. The AHA said it first raised concerns about drug company claims-data policies in a January 26 letter and has repeatedly asked HRSA to intervene since. The association noted that HRSA moved quickly in 2024 to push back on drug company rebate policies but has taken no visible action on the claims-data demands. “HRSA’s inaction here stands in stark contrast to the speed with which it acted in 2024,” Mr. Golder wrote, adding that the agency’s silence has raised questions within the regulated community about “whether HRSA has now tacitly blessed these unilateral claims-data policies.”

4. The Eli Lilly warning letter arrives amid wider turbulence surrounding the 340B program. On April 20, the AHA urged HRSA to abandon its consideration of a 340B rebate model pilot program, arguing the approach “is flawed in both conception and design” and would impose more than $1 billion in annual costs on the hospitals the program was designed to benefit. HRSA had previously attempted a similar rebate pilot before abandoning it following litigation brought by the AHA, the Maine Hospital Association and four safety-net health systems. A federal court vacated that pilot program in February on procedural grounds.

5. A federal court last month vacated a 2013 HRSA policy tied to the so-called GPO prohibition — which governed hospital drug purchasing — finding the agency failed to adequately justify its reasoning under the Administrative Procedure Act. Some hospitals had reported annual compliance costs tied to that policy ranging from $500,000 to $1.6 million. The ruling left room for HRSA to revisit the issue with sufficient legal justification, but did not resolve the underlying policy question, leaving hospitals in continued uncertainty about the program’s direction.

“To prevent fraud, waste and abuse in the 340B program, Lilly extended its long-standing collection of claims data to all pharmacy purchases. This is part of our commitment to ensuring that the reduced prices offered through the 340B program help vulnerable patients, rather than hospitals and their for-profit partners,” a spokesperson for the company said in a statement provided to Becker’s. “Lilly’s extension of its claims data policy is consistent with decades of agency guidance, two federal courts of appeals decisions, and does not impose any new burdens. We continue to communicate with covered entities about this change to offer assistance with compliance.”