CurrentColorado Rocky Mountain Health PlansPolicy 2026T0606J

Percutaneous Patent Foramen Ovale (PFO) Closure

Defines UnitedHealthcare Commercial and Individual Exchange coverage rationale and clinical criteria for percutaneous PFO closure to prevent recurrent ischemic cryptogenic stroke; excludes individuals <18 years and atrial septal defect closure and states PFO closure is unproven for other neurologic indications including migraine prevention.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure

Policy CodePolicy 2026T0606J

Change TypeTemplate Update

Effective DateJan 1, 2026

Next Review Date

Key ActionMedical records must document history of cryptogenic stroke confirmed by imaging, agreement from both a cardiologist and a neurologist that the stroke is likely embolic, and documentation that other causes of ischemic stroke have been ruled out.

SourceLink

POLICY UPDATE CHANGES

01/01/2026 Template Update created shared policy version to support application to Oxford plan membership.

1Coverage Indication (cryptogenic stroke with criteria)

1Excluded Indication (migraine prevention)

18-60

Coverage Summary

This policy (Effective 2026-01-01) defines UnitedHealthcare Commercial and Individual Exchange coverage for percutaneous Patent Foramen Ovale (PFO) closure to prevent recurrent ischemic cryptogenic stroke. Coverage is mixed: PFO closure is considered proven and medically necessary when used according to FDA-labeled indications, contraindications, warnings, and precautions and when additional clinical criteria are met (including imaging-confirmed cryptogenic stroke, multidisciplinary specialist agreement that the stroke is likely embolic, exclusion of other causes, and the age range 18–60 years). The policy excludes individuals under 18 years and excludes atrial septal defect closure. For other neurological indications (for example, primary prevention of stroke, transient ischemic attacks, and migraine prevention) PFO closure is unproven and not medically necessary. Documentation requirements for reviews have been updated (see Medical Records Documentation Used for Reviews).

Key thresholds and quick facts

Age range threshold18-60 years

Policy number2026T0606J

Effective dateJanuary 1, 2026

Brief evidence highlightMultiple RCTs and meta-analyses show reduction in recurrent ischemic stroke with PFO closure but increased incidence of new-onset atrial fibrillation; evidence mixed for net clinical benefit.

Medically Necessary (FDA-labeled indications and additional criteria)

Percutaneous patent foramen ovale closure for the prevention of recurrent ischemic stroke is proven and medically necessary when used according to FDA labeled indications, contraindications, warnings, and precautions and all of the following criteria are met:

Medically Necessary Criteria

History of cryptogenic stroke confirmed by imaging
Specialist agreement: A cardiologist and a neurologist agree that the stroke is likely embolic in nature
Other causes ruled out: Other causes of ischemic stroke have been ruled out, including but not limited to carotid disease, hypercoagulable states, or atrial fibrillation
Age: Individual is 18 to 60 years of age

Not Medically Necessary / Unproven Indications

Percutaneous PFO closure is unproven and not medically necessary for all other stroke or related neurological indications, including but not limited to:

Primary prevention of stroke
TIA: Transient ischemic attacks (TIAs)
Migraine prevention
Other indications: Any other stroke or related neurological indication not meeting the above medically necessary criteria

Provider Requirements and Prior Authorization

Documentation Required

Specialist agreement and diagnostic documentation required

Medical records must document that the individual had a cryptogenic stroke confirmed by imaging, that both a cardiologist and a neurologist agree the stroke is likely embolic, and that other causes of ischemic stroke have been ruled out.

Agreement from a cardiologist and a neurologist that the stroke is likely embolic in nature
Imaging-confirmed history of cryptogenic stroke
Documentation that other causes of ischemic stroke have been ruled out (e.g., carotid disease, hypercoagulable states, atrial fibrillation)

Documentation Required

Medical Records Documentation Used for Reviews - required elements

Providers must supply specific and recent medical record documentation to support review of medical necessity for percutaneous PFO closure. Required elements include details of the condition prompting the procedure, clinical history and comorbidities, symptom characterization, recent imaging, and recent testing to exclude alternative causes.

Relevant Procedure Codes

Applicable Procedure Code (reference only)CPT

93580

Percutaneous transcatheter closure of congenital interatrial communication (i.e., Fontan fenestration, atrial septal defect) with implant

Background and Evidence

A cryptogenic ischemic stroke is an ischemic stroke in which no specific cause is identified after appropriate evaluation; in some cases a venous thrombus may cross a patent foramen ovale (PFO) from the right to left atrium and embolize to the cerebral circulation. A PFO is a fetal atrial septal communication that may persist into adulthood and can permit paradoxical embolism. Percutaneous transcatheter PFO closure uses catheter-delivered septal occluder devices to seal the interatrial communication without open-heart surgery, preventing passage of blood and potentially embolic material between the atria.

FDA-regulated devices for PFO occlusion are classified as transcatheter septal occluders (product code MLV) and have received premarket approval for reducing the risk of recurrent ischemic stroke in appropriately selected patients. Examples of FDA-approved devices and approvals cited in this policy include the Amplatzer™ PFO Occluder (PMA P120021, approved October 28, 2016 and supplemented by the Amplatzer Talisman S020), and the GORE® CARDIOFORM Septal Occluder (P050006/S060, approved July 31, 2017). The policy requires consistency with FDA labeled indications, contraindications, warnings, and precautions as a condition of coverage.

Evidence Summary

Definitions

Revision History

01/01/2026revisedLatest

Template Update created shared policy version to support application to Oxford plan membership. Updated Medical Records Documentation Used for Reviews: added 'condition requiring procedure'; replaced several documentation phrases to require 'history of the medical condition(s) requiring treatment and comorbidities', 'signs and symptoms including onset, duration, and frequency', 'relevant recent diagnostic imaging report(s)', and 'results of recent diagnostic testing performed to rule out other causes including, but not limited to, carotid disease, hypercoagulable states, or atrial fibrillation'. Updated Clinical Evidence, FDA, and References sections and archived previous policy versions 2025T0606I and SURGERY 114.9.