A federal judge’s decision to temporarily shield drug manufacturer Eli Lilly from the 340B program’s administrative dispute resolution (ADR) process could cause the government to issue 340B ADR regulations all over again, health care attorneys say.
U.S. District Judge Sarah Evans Barker yesterday sided with Lilly, ruling that the U.S. Health and Human Services Department (HHS) disregarded statutory procedural requirements when in December it published a final rule creating a board to resolve health care providers’ claims they were overcharged for 340B drugs, and manufacturers’ claims that providers violated the statutory prohibition on diversion or duplicate discounts.
A federal judge’s decision to temporarily shield drug manufacturer Eli Lilly from the 340B program’s administrative dispute resolution (ADR) process could cause the government to issue 340B ADR regulations all over again, health care attorneys say.
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