May 5, 2011— The White House Office of Management and Budget (OMB) has finished reviewing an important draft guidance document that will redefine the term “patient” for purposes of 340B drug discounts. Now that it has been cleared, the Health Resources and Services Administration (HRSA) could publish it in the Federal Register at any time.
At the same time as it issues the new definition, HRSA will formally withdraw a 2007 version that 340B provider organizations strongly opposed.
The contents of the new proposal are still unknown. OMB noted on its Web site that it approved the draft “with change.” About half the rules cleared by OMB get that notation, which covers everything from major rewrites to simple changes in punctuation. HRSA declined to say what was changed in the document during the review or when it anticipated releasing it to the public.
Debate Over Definition
How HRSA defines “patient” is crucial because it directly affects the amount of savings that hospitals and other providers derive from the 340B program.
National organizations representing 340B providers have argued that the 2007 proposed definition would have been so burdensome that many providers would have been unable to continue to serve their indigent and uninsured patients.
The drug industry, meanwhile, has long contended that 340B providers have stretched the current guidelines, which were issued in 1996, much too broadly, leading to impermissible drug diversion. The National Community Pharmacists Association (NCPA), which represents independent pharmacies, has taken a similar position, arguing that the definition should be strictly limited to indigent and uninsured patients. Not all independent pharmacies share this view, however, as many serve as 340B contract pharmacies.