Closure Devices for Patent Foramen Ovale and Atrial Septal Defects

This policy covers transcatheter closure devices for patent foramen ovale (PFO) and ostium secundum atrial septal defects (ASD) — e.g., FDA‑approved PFO/ASD occluders such as Amplatzer and GORE CARDIOFORM — when used to reduce recurrent ischemic stroke in adults or to close secundum ASDs causing significant left‑to‑right shunts, right ventricular volume overload, or paradoxical embolism. Coverage is limited to patients meeting strict criteria (typically age 18–60 for PFO closure, echocardiographic proof of a qualifying right‑to‑left shunt or septal aneurysm or ASD with Qp:Qs ≥1.5), requires neurologist and cardiologist confirmation that the stroke was cryptogenic with other causes excluded, and applies only to FDA‑approved devices/labelled indications (off‑label, investigational devices, age out of range, uncontrolled risk factors, or non‑stroke indications are excluded).

"Transcatheter closure of a patent foramen ovale (PFO) with an FDA‑approved device to reduce risk of recurrent ischemic stroke when ALL of the following are met: patient is 18–60 years of age; PFO w..."