November 13, 2014—The Health Resources and Services Administration is withdrawing its planned comprehensive 340B program regulation tomorrow morning and instead will issue guidance early next year revising policies for key program elements.[ms-protect-content id=”2799″]
HRSA sent its proposed “mega-reg” to the White House Office of Management and Budget last April for clearance prior to publication in the Federal Register. At a minimum, it was expected to address the 340B definition of patient, contract pharmacy arrangements, hospital eligibility requirements, and enrollment of hospital offsite facilities. The rule appeared to be on track for publication in July, and HRSA had even announced there would be a 60-day comment period.
In May, however, a federal district judge ruled in a suit filed by drug manufacturers that Congress did not grant HRSA authority under the 340B statute to promulgate substantive regulations to implement the Affordable Care Act’s 340B orphan drug exclusion. That ruling immediately called into question whether HRSA could issue regulations that have the force of law for the program elements being addressed in its mega-reg.
In response to the court ruling, HRSA published an interpretive rule in late July stating that it interprets the 340B statute’s orphan drug language to exclude 340B pricing on orphan drugs purchased by rural and freestanding cancer hospitals only when those drugs are used for the rare condition or disease for which the drug received its orphan designation.
It is not known whether the forthcoming 340B guidance also will be issued as interpretative rules or under some other designation.
Safety Net Hospitals for Pharmaceutical Access, which represents 340B hospitals, said in a statement that it looks forward to commenting on the upcoming 340B program guidance.
“We support the Secretary of Health and Human Services’ continued work to implement the 340B program and urge the administration to draw upon our member hospitals’ experience caring for low-income and other vulnerable patient populations,” SNHPA said. The forthcoming guidance, it continued, “should be written in a way that enables our member hospitals to continue” stretching their resources so they can serve more patients and provide more comprehensive services, “just as Congress intended.”[/ms-protect-content]