While the 340B world remains in wait-and-see mode regarding the remaining two contract pharmacy court decisions, the contours of the battle over the future of the program have become clear. This is a fight being waged on two fronts — one in the states, which are growing more emboldened, and the other in Congress, at the federal level.

Federal 340B reform

The big news is the request for information put out by the bipartisan “group of six” U.S. senators as part of their draft legislation known as the SUSTAIN 340B Act, explaining in an accompanying letter that they “believe it is necessary” to pass reform legislation this year “that provides clarity, transparency, and accountability in the 340B program in order to ensure the program remains strong, long into the future.”

The senators established a deadline of April 1 for submitting feedback. We are working to compile comments from The Craneware Group and encourage those of you reading to make your voices heard as well.

The lawmakers last year issued a similar RFI and received more than 250 responses. “We are committed to addressing the concerns that have been raised by stakeholders as part of this process, including HRSA’s authorities and resources; contract pharmacy arrangements; the role of PBMs in the program; duplicate discounts; and the promotion of transparency and program integrity,” they wrote in an accompanying letter.

Not surprisingly, transparency figures prominently. For now, the senators propose requiring covered entities to report things like their amount of program savings and how they use it, the number of patients who received 340B drugs and their demographics, number of contract pharmacies, and so on. In many cases, gathering this information would be burdensome on teams already spread thin, and making the information public makes a lot of entities nervous, since it could be used to determine the basic outlines of contracts with payers. Read more >