Dear TPCA members,
There have been several developments regarding 340B in recent weeks, including data requests from drug manufacturers and the refusal of drug manufacturers to ship 340B drugs to contract pharmacies. These developments occurred around the same time as an Executive Order from the Trump administration require FQHCs to provide EpiPens and insulin to low-income patients, and potentially others, at the prices health centers pay for the products in the 340B program.
We received a communication from NACHC regarding recent data requests from drug manufacturers Merck and Sanofi. Drug manufacturers, including Merck and Sanofi have recently taken actions targeting health centers,’ and other 340B providers’ ability to use contract pharmacies to distribute drugs purchased under 340B. As you know, Merck and Sanofi sent letters to 340B providers requesting contract pharmacy claims data. Merck has set August 14 as the deadline for FQHCs to register on their data collection platform. Drug manufacturer Sanofi has made a similar request, although with a later deadline.
Please note that for legal reasons, NACHC cannot recommend how health centers should respond to these requests. To assist health centers in evaluating their options, NACHC has distributed a couple of documents, including a memo from NACHC's legal counsel. Please review the attached documents, including the original communication from NACHC's Chief Strategy Officer, Steve Carey.
Among other points, the memo states that “The manufacturers have no right to the data requested, and 340B program covered entities have no obligation” to share the requested data.”
The letter discusses the "good faith efforts" of health centers in their collaboration with manufacturers; data reporting on drugs leading to discriminatory contracting; and NACHC's request to meet with Merck.
