Ardelyx challenges CMS’s statutory overreach

US biopharma firm Ardelyx (Nasdaq: ARDX) has filed a lawsuit against the US Department of Health and Human Services DHSS) and the Centers for Medicare and Medicaid Services (CMS), claiming that CMS’s plan to include Xphozah (tenapanor) in the bundled payment system for dialysis recipients will significantly and negatively impact patient choice of and timely access to important medications.

The filing is in partnership with the American Association of Kidney Patients (AAKP), the nation’s largest independent kidney patient organization, and the National Minority Quality Forum (NMQF), the nation's largest minority healthcare research, education and advocacy organization.

The lawsuit claims that CMS has violated its statutory and regulatory authority under the Medicare Improvements for Patients and Providers Act (MIPPA), which established the End-Stage Renal Disease Prospective Payment System (ESRD) bundled payment system for dialysis services in 2008.