Transcatheter pulmonary valve implantation with a Food and Drug Administration-approved valve is considered medically necessary for individuals with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:
Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation;
Individuals with native or patched RVOT with at least moderate pulmonic regurgitation;
Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); or
Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg).
Transcatheter pulmonary valve implantation is considered investigational for all other indications.
