Akebia sues CMS over action rescinding Medicare part D coverage of Auryxia
Akebia Therapeutics, Inc. filed a complaint in federal district court against the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services. The lawsuit challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia, Akebia's FDA-approved drug, when used for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. The legal action also seeks to reverse a related decision by CMS that imposed a prior authorization requirement for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis. In the complaint, Akebia asks the court to restore coverage of Auryxia for the IDA Indication and to remove the prior authorization requirement for the Hyperphosphatemia Indication.