Transcatheter Heart Valve Procedures - (0501)

Cigna covers FDA‑labeled transcatheter valve therapies when criteria are met—including SAPIEN 3 with Alterra for severe pulmonary regurgitation, MitraClip and PASCAL for degenerative (primary) MR in prohibitive surgical‑risk patients (and MitraClip for selected secondary MR per supplemental labeling), TAVR and valve‑in‑valve procedures—while native mitral valve replacement, many transcatheter tricuspid procedures, and other uses lacking sufficient evidence are considered investigational or contraindicated. Coverage requires documented anatomic/device suitability and disease severity by echo/CT/MRI, multidisciplinary heart‑team assessment and surgical‑risk determination, absence of active infection or intracardiac/venous thrombus, ability to tolerate anticoagulation/antiplatelet therapy, and, for secondary MR, maximally tolerated guideline‑directed medical therapy plus LVEF/LVESD within specified limits.

"Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent: FDA approval (PMA P200015/S011, Dec 2021) "for the management of pediatric and adult patients with severe pulmo..."