Patent Foramen Ovale: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter closure of a patent foramen ovale (PFO) using a cardiac occlusion device. As noted in the medical literature, PFO can be a benign finding, but in some patients, the PFO can be associated with stroke and systemic embolization. Percutaneous closure of the PFO in patients with cryptogenic stroke has been undertaken for a number of years. Recent randomized controlled clinical trials have demonstrated that closure of PFO in patients with cryptogenic stroke has been associated with reduced rates of recurrent stroke.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for a patent foramen ovales closure procedure. This patient has a history of patent foramen ovales and migraine. One group of authors conducted a meta-analysis on percutaneous patent foramen ovales closure for prevention of migraines utilizing three randomized control trials. The authors found that although there was no significant difference in complete resolution, there was a reduction in monthly migraine attacks and migraine days compared to the control group. This significant reduction also persisted in a subgroup of those with aura, such as the patient in this case. Another group of authors conducted a pool analysis of studies which used Amplatzer devices for patent foramen ovales closure.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary:A enrollee has requested authorization and coverage for transcatheter closure of patent foramen ovale (PFO) for treatment of the enrollee’s PFO. Findings: The physician reviewer found that Based on the records provided for review, the patient had a stroke and has been found to have a PFO with no documented recurrence since starting treatment with Plavix. Although there is an association with PFO and cryptogenic strokes and migraines, the peer-reviewed literature does not consistently demonstrate improved outcomes with PFO closure compared to medical therapy. For example, per the randomized prospective CLOSURE ONE trial, did not demonstrate relative benefit of PFO closure using a Starflex device compared to medical therapy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter closure of patent foramen ovale (PFO) and left atrial appendage. Findings: The physician reviewer found that the patient has a history of melanoma, renal stones, hyperlipidemia and a cryptogenic stroke. An echocardiogram was performed and reported a patent foramen ovale (PFO) and normal left ventricular function. A carotid ultrasound revealed no stenosis. A cardiology report refers to a brain magnetic resonance imaging that reported an embolic stroke in the left thalamus and right cerebellum. The patient has requested authorization and coverage for transcatheter closure of patent foramen ovale (PFO) and left atrial appendage. The Health Plan denied coverage for the PFO closure procedure.

These outcomes come from California’s external review program — an independent physician panel whose decision binds the insurer. Every state has an equivalent, and internal appeals succeed even more often. If your care for patent foramen ovale was denied, the published record says the denial is worth fighting.