The report continues, "This further heightens concerns about HRSA's current approach to oversight. With the number of hospitals in the 340B program increasing significantly in recent years—from 591 in 2005 to 1,673 in 2011—and nearly a third of all hospitals in the U.S. currently participating, some stakeholders, such as drug manufacturers, have questioned whether all of these hospitals are in need of a discount drug program."
Feldpush concedes that safety net hospitals are frustrated by the relatively "informal" administration of the program.
"We look at Medicare and Medicaid and those programs are run by the agency giving guidance to hospitals through formal rule making processes and through codified regulations. The 340B program has been largely run through informal guidance. HRSA has used things like—and I am not making this up, 'frequently asked questions' posted on its Web site to provide official guidance on the program."
"That has been a challenge for hospitals," she said, "because they are by their nature highly regulated and they do want to make sure that they are following the program in the right way. So, it's very hard to make sure that if you are following the program guidance to a 'T' without that formal rulemaking process."
HRSA is now reforming its rulemaking process to include formal notice and comment periods and those reforms should be made public this summer, which Feldpush says "is very much a good step forward."