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March 16, 2021

Judge Enjoins 340B ADR Rule, But Only as Applied to Eli Lilly

A district court judge in Indiana today issued a narrow ruling enjoining the Department of Health and Human Services (HHS) from implementing a rule issued in December finalizing administrative dispute resolution (ADR) procedures for the 340B program. Eli Lilly argued that a convoluted and lengthy rulemaking process failed to satisfy the notice and comment procedures of the Administrative Procedure Act. The judge concluded that Eli Lilly was likely to prevail on its claim and enjoined enforcement of the ADR rule, but only as applied to Eli Lilly. The ADR rule remains in effect for all other entities, and the Eli Lilly case will now proceed to consider the validity of HHS’ contract pharmacy Advisory Opinion.