Congress Pushes Back on Eli Lilly 340B Claims Requirements

More than 70 bipartisan members of Congress are calling on the Department of Health and Human Services and the Health Resources and Services Administration to take action against Eli Lilly for withholding critical 340B pricing from safety-net hospitals that do not submit medical claims data to Lilly.

Congress initiated this letter as Lilly unilaterally cut critical 340B pricing to covered entities. ASHP and our allies advocated for members of the House to sign onto this letter and halt Lilly’s actions.

Congress made it clear in the letter that Lilly’s actions go against the intent of the program, saying:
Congress established 340B to enable safety-net providers to stretch scarce federal resources, expand access to care, and furnish more comprehensive services to vulnerable patients. The statute requires participating drug manufacturers to offer covered outpatient drugs to eligible covered entities at or below the statutory ceiling price as a condition of their participation in the Medicare and Medicaid programs. Congress did not authorize manufacturers to unilaterally impose additional reporting mandates or data-sharing requirements as a prerequisite for obtaining those discounts.

Lilly’s actions effectively condition participation in the 340B program on compliance with manufacturer-imposed requirements that extend beyond the statutory framework established by Congress. Such actions create significant administrative and operational burdens for covered entities, requiring hospitals, health centers, and clinics to devote substantial resources toward collecting, validating, and transmitting claims information rather than providing patient care. We believe this to be in direct opposition to the intention of the program.

ASHP will continue to work with our partners to protect access to the critical 340B program.