On June 1, drug manufacturer Eli Lilly sent a letter to Health Resources and Services Administration (HRSA) Administrator Thomas Engels stating that it would withhold 340B pricing to covered entities (PDF) that refuse to comply with its in-house pharmacy claims data collection requirements. Eli Lilly began requiring 340B covered entities to submit claims-level data for all 340B drugs, including those dispensed through in-house pharmacies, starting Feb. 1. A total of nine drug manufacturers now require 340B covered entities to report in-house pharmacy claims data, with some exemptions for covered entities in states that have 340B-related laws in place.
In its letter, Eli Lilly noted that while the majority of covered entities have submitted claims data, it will give five business days to the remaining covered entities to comply before withholding 340B pricing.
The AAMC has previously urged HRSA to communicate to drug manufacturers that their actions run afoul of the 340B statute (PDF) and to use the enforcement mechanisms at the agency’s disposal to follow through if manufacturers fail to comply with their obligation to provide 340B discounts [refer to Washington Highlights, Feb. 6].
- Washington Highlights