Transcatheter Closure of Ventricular Septal Defects
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This policy governs coverage for transcatheter (percutaneous) closure of ventricular septal defects (VSDs) and excludes transmyocardial (perventricular) approaches; it applies to Blue Cross and Blue Shield of North Carolina members and their providers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Transcatheter VSD Closure
Medically necessary — transcatheter closure
Covered when ALL of the following are met
Main coverage criteria
- High‑risk anatomical factors (any one suffices): Requiring a left ventriculotomy or an extensive right ventriculotomy; failed previous VSD closure; multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"); or posterior apical VSD covered by trabeculae
Any one of these anatomic factors meets the high‑risk surgical criterion per FDA approvals
Use of non‑FDA‑approved devices is considered investigational and not covered
Transmyocardial (perventricular) device closure of ventricular septal defects is considered investigational and is not covered by BCBSNC. This approach — which accesses the defect via direct puncture of the right ventricular wall — is explicitly excluded from coverage in the policy and should not be billed as a covered transcatheter VSD closure procedure.
The use of devices that are not FDA-approved for transcatheter VSD closure is also considered investigational and is not covered.
Transcatheter closure of a ventricular septal defect for any indication that does not meet the policy’s specified high-risk or complex VSD coverage criteria is considered investigational and is not covered by BCBSNC.
Any device or indication not explicitly listed in the policy’s When covered section is considered investigational. In particular, the policy notes that use of non‑FDA‑approved devices for transcatheter VSD closure is investigational and not covered.
Transcatheter closure is contraindicated and therefore not appropriate in patients with any of the following procedural conditions: thrombus at or near the intended implant site (or documented venous thrombus in access vessels unless adequately protected), active endocarditis or other sources of bacteremia, inadequate vasculature to accommodate the delivery system, a defect too small to permit crossing by the access system, anatomy in which device delivery would interfere with intracardiac or intravascular structures (for example valves or pulmonary veins), or inability to take required antiplatelet/anticoagulant therapy such as aspirin, heparin, or coumadin.
Applicable Billing Codes
Provider Actions and Administrative Requirements
Confirm medical necessity meets policy criteria
Ensure the procedure meets the policy’s medical necessity criteria for transcatheter closure (use of an FDA‑approved device and high‑risk complex VSD anatomy or equivalent clinical justification) before scheduling or billing.
- Coverage limited to transcatheter closure using an FDA‑approved device for complex VSDs that meet the policy's 'When covered' criteria
- Transcatheter closure for indications not listed in the 'When covered' section is considered investigational and not covered
Medical records required for determinations
BCBSNC may request medical records to determine medical necessity; letters of support alone are not sufficient unless they include all specific information requested.
- Provide complete medical records when requested to support the medical necessity of transcatheter VSD closure
- If submitting letters of support, ensure they contain all specific information required for the determination
Denial risk for investigational devices or unsupported indications
Use of non‑FDA‑approved devices or performing transcatheter closure for indications that do not meet the policy’s coverage criteria may be considered investigational and can result in denial of coverage.
- Transmyocardial (perventricular) closure is considered investigational and is not covered
- Contraindications listed in the policy (e.g., thrombus at implant site, active endocarditis, inadequate vasculature, device interference with intracardiac structures, inability to take required antiplatelet/anticoagulant therapy) may lead to noncoverage
Background
A ventricular septal defect (VSD) is a persistent defect in the ventricular septum that permits left-to-right shunting of blood. Depending on size and hemodynamic effect, VSDs can lead to heart failure, pulmonary vascular disease, and increased risk of endocarditis. Management ranges from observation for small, asymptomatic defects to closure for larger or symptomatic defects; transcatheter closure places an occluding device via a vascular approach and may avoid cardiopulmonary bypass and a surgical ventriculotomy when anatomically appropriate.
Definitions
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