Transcatheter Pulmonary Valve Implantation (CPB 0821, reviewed 2026-04-22)
Summary
Aetna considers transcatheter pulmonary valve implantation with FDA-approved devices (Harmony Transcatheter Pulmonary Valve System, Melody Transcatheter Pulmonary Valve, and SAPIEN S3 valve) medically necessary for three indications: dysfunctional right ventricular outflow tract (RVOT) conduits whose pulmonary valve is stenotic (mean RVOT gradient 35 mm Hg or greater) or regurgitant (moderate or more severe), where the conduit is full circumferential and 16 mm or greater in diameter; dysfunctional non-conduit, patch-repaired RVOT; and pulmonary insufficiency with progressive right ventricular dilation after failed pulmonary valvulectomy. Aetna considers transcatheter pulmonary valve implantation for other indications, such as valve-in-valve implantation in a degenerated bioprosthetic valve, experimental, investigational, or unproven because its effectiveness for these indications has not been established.
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