On Wednesday, drugmaker Ardelyx (ARDX.O) announced it has initiated legal action against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) regarding their proposal to incorporate its kidney disease drug, Xphozah, into the Medicare payment bundle system.
The lawsuit contends that CMS’s decision to include Xphozah and other oral-only phosphate lowering therapies in the End-Stage Renal Disease Prospective Payment System (ESRD PPS) will severely impact patient access to essential medications. Ardelyx argues that such drugs, including Xphozah, are not typically administered during dialysis and therefore should not be subject to bundled payment regulations meant for dialysis services.
Xphozah, which received U.S. approval last year for the treatment of elevated phosphate levels in chronic kidney disease patients, falls into a category of therapies that are crucial but distinct from those administered directly during dialysis sessions.
CMS’s updated regulations, set to take effect on January 1, 2025, aim to include oral-only ESRD drugs and therapies within the bundled payment framework, a move intended to streamline reimbursement processes for renal dialysis services.
Ardelyx’s legal challenge underscores concerns about the potential adverse impact on patient choice and timely access to specialized medications in managing chronic kidney disease. The outcome of the lawsuit will likely influence the regulatory landscape concerning reimbursement policies for non-dialysis-related treatments within the Medicare system.