AAMC Urges HRSA to Take Action Against 340B Claims Submission Requirements

The AAMC sent a June 29 letter to Health Resources and Services Administration (HRSA) Administrator Thomas Engels calling on the agency to take enforcement action against drug manufacturers with in-house pharmacy claims data reporting requirements that run afoul of the 340B statute and restrict access to 340B pricing. This development comes after Eli Lilly and Company (Lilly) warned covered entities earlier this month it would withhold 340B pricing for failure to comply with its in-house pharmacy claims data collection requirements [refer to Washington Highlights, June 5]. 

The AAMC shared with HRSA that several AAMC members have recently lost access to 340B pricing on Lilly drugs at in-house pharmacies because of drug manufacturer claims submission demands. 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 12 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. The AAMC continues to communicate to HRSA the importance of the 340B program to supporting safety-net providers, many of which are teaching hospitals [refer to Washington Highlights, Feb. 6].