In a recent decision, U.S. District Senior Judge Beryl A. Howell dismissed a complaint related to Medicare’s drug-classification process. The case centered around the classification of Ardelyx Inc.’s drug, Xphozah, as a renal dialysis service. Judge Howell’s ruling emphasized that federal law restricts jurisdictional review of the agency’s drug classification decisions. This case has drawn attention to the limitations on judicial oversight in the context of federal health regulations, especially following the “Loper Bright” decision, which has been invoked in similar legal disputes.
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