Clarian Health West, LLC v. Hargan, No. 16-5307 (D.C. Cir. 2017)Annotate this Case
The DC Circuit reversed the district court's grant of summary judgment in favor of Clarian in an action challenging the legality of HHS's decision to set forth certain policies regarding the means of calculating reimbursements for Medicare providers in an instruction manual without engaging in notice and comment rulemaking. The court held that the Manual instructions embodied a general statement of policy, not a legislative rule, setting forth HHS's enforcement priorities; policy statements did not establish binding norms; they were not "rules" that must be issued through notice and comment rulemaking; nor were the instructions subject to the Medicare Act's independent notice and comment requirement because they did not establish or change a substantive legal standard. Therefore, neither the Administrative Procedure Act nor the Medicare Act required that the Manual instructions be established by regulation.