Ardelyx Sues HHS, CMS Over Addition of Drug to Bundled Payment System

Ardelyx, manufacturer of the drug Xphozah, has filed a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). The American Association of Kidney Patients and the National Minority Quality Forum joined Ardelyx in the lawsuit.

The company asserts that oral-only, phosphate-lowering therapies such as Xphozah should be kept separate from the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), a bundled payment system to reimburse facilities that provide renal dialysis services to Medicare beneficiaries. The ESRD PPS adjusts treatment costs at the patient and facility level for dialysis treatment at an ESRD facility or in a patient’s home. Ardelyx states that drugs like Xphozah are not administered by dialysis providers and cannot be taken during the delivery of maintenance dialysis.

CMS updated regulations to include oral-only ESRD drugs and therapies in the bundled payment system starting January 1, 2025. The lawsuit claims that adding these therapies to the ESRD PPS will “significantly and negatively impact patient choice of and timely access to important medications.”

Xphozah was approved in the United States in 2023 to treat high phosphate levels in patients with chronic kidney disease. Phosphate-lowering therapies are often used in ESRD patients to treat mineral and bone disorders.