HHS Sends Letter to Eli Lilly Expressing Concern on Efforts to Limit 340B Contract Pharmacy Arrangements for Hospitals and Clinics
(Sept. 25, 2020) – The U.S. Department of Health and Human Services sent a letter to drug manufacturer Eli Lilly, which calls into question recent actions that would limit 340B covered entities and their use of 340B contract pharmacy arrangements. The letter by HHS was sent as a response to a pre-enforcement advisory inquiry by Eli Lilly.
The letter specifies that the Health Resources and Services Administration has "significant initial concerns with Lilly’s new policy," and is continuing to review the policy with a final determination to be forthcoming.
In addition, HHS warns Eli Lilly that potential litigation is possible if the drug manufacturer "knowingly violates a material condition of the program that results in over-charges to grantees and contractors."
KHA and the American Hospital Association view this response from the HHS general counsel as a positive development in our advocacy to stop drug manufacturers from taking these actions.