RetiredUnitedHealthcarePolicy CS329LA.E

Percutaneous patent foramen ovale (PFO) closure

Policy governs percutaneous PFO closure for prevention of recurrent ischemic (cryptogenic) stroke and related neurological indications for UnitedHealthcare members in Louisiana; excludes individuals under 18 and does not apply to atrial septal defect closure.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous patent foramen ovale (PFO) closure

Policy CodePolicy CS329LA.E

Change TypeRetired / Documentation update

Effective DateMarch 1, 2026 - March 31, 2026

Next Review DateN/A

Key ActionObtain prior authorization with medical record documentation showing FDA-labeled indications and that all clinical criteria are met (including cardiologist and neurologist agreement and exclusion of other causes).

SourceLink

POLICY UPDATE CHANGES

Policy retired for Louisiana plan membership effective 04/01/2026 and medical records documentation language added on 03/01/2026.

18-60age range for covered indication

Retired Apr 1, 2026policy status/date retired

93580example CPT listed

Louisianaapplicable state

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Coverage Criteria for PFO Closure

Covered indications (Initial therapy)

Percutaneous PFO closure is proven and medically necessary when ALL of the following are met:

PFO closure coverage criteria: History of cryptogenic stroke confirmed by imaging; and a cardiologist and a neurologist agree that the stroke is likely embolic in nature; and other causes of ischemic stroke have been ruled out (eg, carotid disease, hypercoagulable states, atrial fibrillation); and individual is 18 to 60 years of age; and FDA-labeled indications, contraindications, warnings, and precautions are followed.age 18-60

From coverage rationale.

Not medically necessary / Unproven indications

Not covered / not medically necessary when the following apply:

Unproven or not medically necessary: 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, transient ischemic attacks (TIA), and migraine prevention (insufficient evidence).

From coverage rationale and migraine evidence summaries.

PFO closure for secondary prevention of cryptogenic ischemic stroke

Covered when ALL of the following are met (per cited guideline recommendations and device indications):

Primary coverage criteria: Patient is an adult (commonly age 18–60); experienced a nonlacunar cryptogenic ischemic stroke with an embolic-appearing infarct; no other identified cause of stroke after thorough evaluation; and PFO exhibits high-risk features (eg, large shunt or atrial septal aneurysm).age 18-60

Recommendations from AHA/ASA and AAN and device labeling indicate these features identify patients most likely to benefit from closure.

Multidisciplinary determination: Cryptogenic stroke attributed to presumed paradoxical embolism as determined by a neurologist and a cardiologist following evaluation including prolonged monitoring for atrial fibrillation and exclusion of other causes.

Consistent with FDA device indication and guideline recommendations.

PFO closure for migraine

Considered investigational/unsupported or not routinely recommended for migraine except in select subgroups:

Migraine with aura subgroup: Evidence from randomized trials and pooled analyses is mixed: some analyses show reduced migraine days or complete cessation in select individuals with migraine with aura (especially frequent aura defined as aura in ≥50% of attacks), but primary endpoints of many RCTs were not consistently met; guideline panels suggest against routine use of PFO closure for migraine without prior PFO-associated stroke.frequent aura = ≥ 50% of attacks

Trials include MIST, PRIMA, PREMIUM; SCAI suggests against routine closure for migraine without prior PFO-associated stroke.

This policy explicitly excludes pediatric patients and atrial septal defect procedures. It does not apply to individuals under 18 years of age, and it does not apply to atrial septal defect closure. These exclusions are intended to distinguish percutaneous patent foramen ovale (PFO) closure for secondary prevention of cryptogenic ischemic stroke from procedures performed for congenital atrial septal defects or care of minors.

Percutaneous PFO closure is not recommended for the primary prevention of stroke in asymptomatic patients who have a PFO. Guideline authors note uncertainty about the low absolute risk of initial stroke attributable to a PFO and potential harms of invasive therapy; therefore PFO closure for primary prevention of stroke in asymptomatic individuals is not recommended. Similarly, guideline panels and specialty societies caution against routine use of closure for migraine without a prior PFO-associated stroke, emphasizing that closure is intended for secondary prevention in selected patients after multidisciplinary evaluation.

PFO closure is considered medically necessary only when the documented clinical criteria for secondary prevention of cryptogenic ischemic stroke are met. Key requirements include a history of cryptogenic stroke confirmed by imaging, agreement by a cardiologist and a neurologist that the stroke is likely embolic, exclusion of other causes of ischemic stroke (for example, carotid disease, hypercoagulable states, or atrial fibrillation), and that the individual is between 18 and 60 years of age. Device use must follow FDA-labeled indications, contraindications, warnings, and precautions. Closure for primary prevention, TIA-only indications, routine migraine prevention, or other neurological indications outside these criteria is not medically necessary due to insufficient evidence of efficacy.

Evidence supporting percutaneous PFO closure for recurrent migraine is limited and inconsistent. Systematic reviews and randomized trials have largely failed to meet primary endpoints for migraine cessation or consistent reduction in migraine burden; NICE concluded the evidence for migraine is inadequate in quality and quantity. Professional society guidance (SCAI) suggests against routine closure for migraine in patients without a prior PFO-associated stroke. Thus, PFO closure for recurrent migraine is not routinely recommended and should be considered investigational or reserved for exceptional, well-documented circumstances.

Coding and Code References

Applicable procedure codes (reference only)CPT

93580

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

Device product code (FDA informational)mixed

MLV	Transcatheter septal occluders (FDA product code for device classification)

Frequent aura definition — inv-11

DefinitionFrequent aura is defined as aura occurring in ≥ 50% of migraine attacks.

Context of useDefined and used in pooled analyses and subgroup analyses of migraine trials (PRIMA and PREMIUM) to identify patients who may have greater benefit from PFO closure.

Trial relevanceUsed as a prespecified subgroup in individual-level pooled analysis by Mojadidi et al. (2021) assessing PFO closure efficacy for migraine at 12 months.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous patent foramen ovale (PFO) closure. Requests must include documentation that the FDA-labeled indications, contraindications, warnings, and precautions are met and that all clinical criteria in the policy (e.g., history of cryptogenic stroke confirmed by imaging; cardiology and neurology agreement that the stroke is likely embolic; exclusion of other causes; age 18–60) are satisfied.

Prior authorization required prior to scheduling or performing PFO closure
Submit supporting medical records demonstrating that FDA-labeled indications and all clinical criteria in the policy are met
Applicable code(s) for reference: 93580 (percutaneous transcatheter closure of congenital interatrial communication)

Note

Authorization and Plan Verification

Coverage determinations are subject to verification against the member's federal, state, or contractual benefit plan. Before proceeding, providers should verify member eligibility, benefit coverage, and any plan-specific requirements (including state mandates). Authorization approvals may be conditional on submission of complete medical records or additional documentation.

Background

A patent foramen ovale (PFO) is a persistent opening in the atrial septum that can permit passage of venous thrombi into the arterial circulation, potentially causing a cryptogenic ischemic stroke. Prevention strategies include antithrombotic medical therapy (antiplatelet or anticoagulation) and, in selected adults with cryptogenic stroke attributed to presumed paradoxical embolism, percutaneous transcatheter closure using implantable occluder devices. The procedure is performed via catheter placement without open-heart surgery and is intended primarily for secondary prevention of recurrent ischemic stroke in appropriately selected patients.

Definitions

Cryptogenic stroke — inv-21

DefinitionCryptogenic stroke: an ischemic stroke in which a specific cause is not found after appropriate evaluation.

Clinical noteCryptogenic strokes may be due to paradoxical embolism through a PFO when no other cause is identified.

Management relevanceEvaluation to establish cryptogenic stroke is required before considering PFO closure as secondary prevention.

PFO — inv-22

DefinitionPatent foramen ovale (PFO): a persistent fetal opening between the right and left atria that can permit paradoxical embolism.

AnatomyNormal fetal atrial septal opening that typically closes after birth but may remain patent in adulthood.

OpenPayer