Skip to main content

Advanced Search

Advanced Search

Current Filters

Filter your query

Publication Types



Newsletter Article


340B Discount Drug Program Guidance is Unveiled

By Kerry Young, CQ Roll Call

August 28, 2015 -- A broad and much anticipated draft guidance document for the 340B federal drug discount program was unveiled Thursday.

The Health Resources and Services Administration (HRSA) is seeking to address some of the bitter disputes between hospitals and drugmakers over the effort. Created in the 1990s, the 340B program was designed to give hospitals that serve the poor extra funds to support needed services. The proposed guidance is considered the first major attempt to overhaul the program.

The American Hospital Association said in a Thursday statement that it's reviewing the proposed guidance notice, which runs to roughly 90 pages.

"We want to make certain that the new requirements do not overburden hospitals and strike a balance between hospitals and pharmaceutical companies for ensuring program integrity," said Ashley Thompson, acting senior executive for policy, at the AHA in a statement.

Lori Reilly, executive vice president of policy and research for the Pharmaceutical Research and Manufacturers of America (PhRMA), said that her group also is reviewing the proposal.

"PhRMA has long maintained the 340B drug discount program should be targeted to true safety net hospitals and the recipients of federal grants, which rely on the program to serve vulnerable patients," she said.

Debate about the 340B program may continue even after HRSA finalizes this guidance. The expansion of the program has drawn more congressional scrutiny of it in recent years, with longtime health spending watchdog Sen. Charles E. Grassley, R-Iowa, taking a particular interest in it. 

Hospitals and medical organizations that treat large numbers of people living in poverty spent more than $7 billion on 340B drugs in 2013, three times what they spent in 2005, according to the Medicare Payment Advisory Commission. MedPAC in May delivered to Congress a special report that had been requested about the discount program. In its separate June report, GAO said about 40 percent of hospitals in the United States participate in the program.

Publication Details