AHA urges HRSA to act as Eli Lilly threatens 340B discounts over claims data submission policy

The AHA again is asking the Health Resources and Services Administration to take action after Eli Lilly warned hospitals that they could lose access to discounted drug prices unless they comply with new data submission requirements.

The AHA said Eli Lilly recently issued a letter to hospitals participating in the 340B Drug Pricing Program threatening the “imminent loss” of discounted pricing if claims data are not submitted “without further delay.”

The AHA for months has raised concerns with HRSA about these practices.

“Unfortunately, we are not aware of any action that HRSA has taken to address these unlawful drug company claims-data policies, even as more and more companies have announced policies similar to Lilly’s,” the AHA wrote. “HRSA’s inaction here stands in stark contrast to the speed with which it acted in 2024 when the drug companies announced their unlawful rebate policies.”

In its letter, the AHA said hospitals have shared that the drug company policies are creating operational and financial strain. “And 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.”

The AHA reiterated its ask for HRSA to prohibit the claims-data policies outright, or if the agency is not going to act, “it should announce and explain its decision to provide greater clarity to the regulated community.”