Drug Maker Sues CMS Over Plan To Shift Oral-Only Drugs To ESRD Bundle

By Gabrielle Wanneh / July 18, 2024 at 7:05 PM
Drug maker Ardelyx and two prominent patient groups sued CMS Wednesday (July 17) over its proposal to move certain oral-only drugs out of Medicare Part D and into the end-stage renal disease bundled payment system beginning Jan. 1, 2025, arguing the move will limit access to Ardelyx’s recently approved XPHOZAH and other oral drugs that are currently available to patients under outpatient pharmacy. The phosphate-lowering drugs are viewed as essential for positive ESRD patient outcomes. But the suit notes that...


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