Anthem Blue Cross Connecticut SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices for Stroke Prevention Form

This document addresses the transcatheter closure of patent foramen ovale and transcatheter or open left atrial appendage (LAA) closure when performed to prevent stroke using cardiac occlusion devices.

Note: This document does not address the percutaneous transcatheter closure of atrial septal defects (ASDs).

Note: This document does not address surgical ligation or amputation of the LAA when the surgical method does not involve use of an LAA device.

Note: Please see the following related document for additional information:

• SURG.00096 Surgical and Ablative Treatments for Chronic Headaches

Position Statement

Medically Necessary:

Transcatheter closure of a patent foramen ovale (PFO) using a U.S. Food and Drug Administration (FDA) approved device approved for that indication is considered medically necessary for:

1. The prevention of subsequent stroke in individuals with a history of cryptogenic stroke who:
   1. have failed conventional drug therapy (for example, warfarin); or
   2. are not candidates for conventional drug therapy; or
2. Individuals 60 years old and younger with a history of cryptogenic stroke who have:
   1. an atrial septal aneurysm; or
   2. a large interatrial shunt (see definition section).

Transcatheter closure of left atrial appendage (LAA) is considered medically necessary in individuals with non-valvular atrial fibrillation for the prevention of stroke when the following criteria are met:

1. Individual is a candidate for long-term anticoagulation therapy based upon their estimated risk of stroke and other thromboembolic events; and
2. Individual is ineligible for long-term oral anticoagulation therapy (for example, a direct oral anticoagulant [apixaban, dabigatran, edoxaban, or rivaroxaban] or warfarin) due to the presence of contraindication(s) (for example, an increased risk of bleeding), but is expected to be able to tolerate short-term oral anticoagulation necessary for device implantation.

Investigational and Not Medically Necessary:

Transcatheter closure of a patent foramen ovale for the prevention of stroke is considered investigational and not medically necessary when the criteria above are not met.

Transcatheter closure of a left atrial appendage is considered investigational and not medically necessary when the criteria above are not met.

Left atrial appendage closure via surgical (non-percutaneous) implantation of a device is considered investigational and not medically necessary for all indications.