Foley & Lardner LLP partner Anil Shankar is quoted in the Fierce Healthcare article, “‘Stunning’ court ruling broadens hospitals’ 340B use, calls HRSA’s enforcement authority into question,” discussing the U.S. District Court of South Carolina’s recent decision in Genesis Healthcare, Inc. v. Becerra.
The decision establishes that “at least some of [the] interpretative policies surrounding the 340B definition of patient are inconsistent with the 340B statute,” Shankar explained.
“This is a stunning decision that will have the attention of every 340B stakeholder,” Shankar said. “This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA)] audit processes will need to change.”
“The willingness of courts to depart from HRSA’s positions will cause uncertainty and exploration similar to what existed when the program was new,” he added. Due to the doubts introduced by the decision, the health care industry is “likely to see new litigation around other interpretive policies HRSA has developed over the years.”