Total Artificial Heart

This policy covers use of the temporary SynCardia Total Artificial Heart (including the 50cc device and the SynCardia Freedom portable driver) as a bridge to cardiac transplantation for transplant‑eligible patients with NYHA Class IV, non‑reversible biventricular heart failure who are listed for transplant, at imminent risk of death, ineligible for other ventricular support devices, and able to maintain adequate anticoagulation (with smaller‑stature patients eligible when T10/chest cavity measurements permit). Major limitations/requirements: TAH is covered only as a temporary bridge to transplant (not destination therapy), is FDA‑approved only for bridge use with outpatient discharge enabled only after Freedom driver approval, has limited comparative evidence versus LVADs, and device size selection is guided by T10/chest measurements (patients with T10 ≥10 cm should be considered for the 70cc device).

"Temporary SynCardia Total Artificial Heart is medically necessary as a bridge to heart transplantation when the policy's specified criteria are met."