This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Transcatheter Pulmonary Valve Implantation may be considered medically necessary for use as an adjunct to surgery in the management of pediatric and adult patients 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.
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.