A bipartisan group of over 70 members of Congress sent a July 1 letter to Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., and Health Resources and Services Administration (HRSA) Administrator Thomas Engels (PDF) raising concerns about Eli Lilly and Company’s (Lilly) recent decision to terminate 340B pricing for covered entities that do not comply with its new claims submission requirement for in-house pharmacies. Lilly first announced the policy in February and began notifying noncompliant covered entities on June 1 of its intention to cut off 340B pricing within five business days [refer to Washington Highlights, June 5]. Since Lilly first announced this policy, eleven other pharmaceutical manufacturers have imposed similar data submission requirements for in-house pharmacies.
The letter, led by Reps. Doris Matsui (D-Calif.) and Jack Bergman (R-Mich.), emphasized that Lilly’s actions are inconsistent with congressional intent, noting, “Allowing manufacturers to condition statutory discounts on compliance with unilateral reporting requirements risks establishing a precedent that could fundamentally alter the operation of the program without congressional authorization.” To address this concern, the letter urges HHS and HRSA to pursue immediate enforcement action against Lilly and restore impacted covered entities’ access to 340B pricing for Lilly products.
The AAMC also submitted a letter to HRSA echoing these concerns and urging the agency to pursue enforcement action against Lilly [refer to related story].
- Washington Highlights