Four major hospital associations are calling on federal regulators to intervene after Eli Lilly followed through on its threat to cut off 340B drug pricing to hospitals that refused to comply with its in-house pharmacy claims reporting requirements.
Eli Lilly began denying 340B discounts to an initial group of noncompliant hospitals on June 18, after giving them a five-business-day window to submit claims data following a June 1 letter to the Health Resources and Services Administration. The company said it intends to extend the same enforcement to additional covered entities in the weeks ahead.
The American Hospital Association called Lilly’s move unlawful and urged Congress to use its oversight authority to demand HHS take a position. “HRSA and HHS cannot continue to stand by while Eli Lilly and others rewrite the rules for their own benefit and skirt their obligations,” AHA President and CEO Rick Pollack said in a June 18 statement.
America’s Essential Hospitals called on HRSA to levy civil monetary penalties against Lilly and restore 340B pricing access for all covered entities, arguing the company lacks statutory justification or HRSA approval to unilaterally suspend access, according to a June 18 letter.
340B Health, which represents more than 1,600 participating hospitals, urged HRSA to warn Lilly it faces enforcement action, calling the move “an unprecedented attempt to rewrite the 340B rules without congressional approval,” 340B Health President and CEO Maureen Testoni said in a June 18 statement.
The Association of American Medical Colleges had previously flagged the threat, writing to HRSA that Lilly’s demands raised concerns about the impact on academic medical centers and teaching hospitals, according to a June 5 statement.
Lilly has said approximately 70% of covered entities — about 2,350 — organizations, have already complied with the data requirement, and that the information is needed to identify duplicate discounts and comply with Inflation Reduction Act obligations. “We hope these hospitals reconsider their decision and submit claims data to accept Lilly’s offer of 340B pricing,” the company said in a June 18 statement to Becker’s.
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