Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices.