03/09/2026 – RWC-340B Objects to Eli Lilly’s Claims Submission Mandate as Unprecedented, Violation of Federal Law

RWC-340B sent a letter to Eli Lilly’s CEO on February 18, 2026, objecting to the drug manufacturer’s policy requiring covered entities to submit claims-level data for all 340B utilization.

Eli Lilly’s policy, effective February 1, 2026, requires covered entities to submit claims-level data for “all dispenses,” regardless of whether an entity uses contract pharmacies.  Covered entities have 45 days from the date of dispense to submit this data, creating a deadline of March 15, 2026, for covered entities to comply.  If a covered entity fails to provide timely, complete, and accurate data for all 340B dispenses, the company may cancel 340B pricing for the entity.

RWC-340B’s letter details how Eli Lilly’s policy is an unprecedented and unequivocal violation of federal law. Eli Lilly violates the 340B statute and its pharmaceutical pricing agreement with the Secretary of Health and Human Services by overcharging covered entities that refuse to acquiesce to Eli Lilly’s conditions.  RWC-340B’s letter also details the significant administrative costs the policy will impose on covered entities and how the policy undermines RWCs’ ability to care for the patients they serve.

Eli Lilly responded to RWC-340B’s letter on February 25, 2026, and referred RWC-340B to its January 27, 2026 letter to the Health Resources and Services Administration (HRSA) defending its policy.

RWC-340B copied HRSA on the letter it sent to Eli Lilly and will meet with the agency later this month.  RWC-340B will keep members informed of next steps in opposing Eli Lilly’s policy and will continue to engage aggressively with HRSA, CMS, and drug manufacturers to defend the integrity of the 340B program for the patients and communities we serve.