Description

Transcatheter Pulmonary Valve Implantation is used to repair a stenosed or regurgitant pulmonary heart valve that has previously been replaced to correct congenital heart defects. This technology provides a less-invasive means to extend the life of a failed Right Ventricular Outflow Tract (RVOT) conduit.

Criteria

Transcatheter Pulmonary Valve Implantation may be considered medically necessary for use as an adjunct to surgery in the management of pediatric and adult individuals in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration (FDA) for the treatment of patients with the following FDA approved clinical conditions:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16mm in diameter when originally implanted; and
• Dysfunctional RVOT conduits with a clinical indication for intervention, and EITHER ONE of the following:
  • Regurgitation: greater than or equal to moderate regurgitation; or
  • Stenosis: mean RVOT gradient greater than or equal to 35 mmHg.

Services that do not meet the above criteria are not considered medically necessary.

Procedure Codes

Diagnoses Codes