ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0606J

Percutaneous Patent Foramen Ovale (PFO) Closure

Clinical coverage policy for percutaneous PFO closure for prevention of recurrent ischemic stroke and other neurological indications, applicable to UnitedHealthcare Commercial and Individual Exchange benefit plans and adults aged 18–60 when criteria are met.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure

Policy CodePolicy 2026T0606J

Change TypeDocumentation and template updates

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required medical records demonstrating imaging-confirmed cryptogenic stroke, multidisciplinary (cardiology and neurology) concurrence, exclusion of other stroke causes, and age eligibility.

SourceLink

POLICY UPDATE CHANGES

Updated list of medical records documentation used for reviews, including adding 'condition requiring procedure' and refining required history, symptoms, and diagnostic reporting language.

Created shared policy version to support application to Oxford plan membership.

18-60age range for proven medical necessity

Atrial fibrillationadverse event more frequent with PFO closure

3 RCTsRCTs referenced for migraine

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2previous policy versions archived

Coverage Criteria and Clinical Indications

Medically Necessary Coverage Criteria

Covered when ALL of the following are met:

Medically necessary coverage criteria: History of cryptogenic stroke confirmed by imaging;

Medically necessary coverage criteria: A cardiologist and a neurologist agree that the stroke is likely embolic in nature;

Medically necessary coverage criteria: Other causes of ischemic stroke have been ruled out, including but not limited to carotid disease, hypercoagulable states, or atrial fibrillation;

Medically necessary coverage criteria: Individual is 18 to 60 years of age;

Medically necessary coverage criteria: Procedure is used according to FDA-labeled indications, contraindications, warnings, and precautions;

Must follow FDA labeling and multidisciplinary agreement

PFO closure for secondary prevention of recurrent ischemic stroke

Covered when ALL of the following are met (secondary stroke prevention scenario based on guideline and device indications):

Secondary stroke prevention criteria: Age generally between 18 and 60 years;

Derived from FDA device labeling and guideline recommendations

Secondary stroke prevention criteria: Nonlacunar (embolic-appearing) ischemic stroke;

Secondary stroke prevention criteria: No other identified cause of stroke after a thorough evaluation, including prolonged monitoring to exclude atrial fibrillation;

Evaluation should include assessment for carotid disease, hypercoagulable states, and prolonged rhythm monitoring

Secondary stroke prevention criteria: High-risk PFO features or large right-to-left shunt when applicable;

PFO closure for migraine

Coverage for PFO closure to treat migraine (including migraine with aura) is conditional and limited by mixed evidence:

Migraine-related considerations: Evidence from randomized trials and meta-analyses is mixed: some pooled analyses and subgroup data (notably migraine with frequent aura) report reductions in migraine days and higher rates of complete cessation, but multiple RCTs failed to meet primary endpoints and guideline panels (SCAI/NICE) advise against routine use for migraine without prior PFO-associated stroke;

Consider PFO closure for migraine only in the context of research, specialized evaluation, or shared decision-making with clear documentation of expected uncertainty

PFO closure is considered unproven and not medically necessary for stroke- or neurologic-related indications other than the prevention of recurrent ischemic cryptogenic stroke. The policy specifies that percutaneous PFO closure is not supported for primary prevention, transient ischemic attacks, migraine prevention, or other stroke-related indications outside the listed FDA‑labeled use and multidisciplinary criteria for secondary stroke prevention.

Routine PFO closure for primary prevention of stroke in individuals with a PFO is not recommended. AHA/ASA guidance states no treatment is recommended for primary prevention given uncertainties and the relatively low risk of initial stroke from a PFO. Similarly, evidence for PFO closure to treat migraine is insufficient: multiple randomized, including sham‑controlled, trials have failed to meet primary endpoints, and SCAI provides a conditional recommendation against routine closure for migraine in patients without prior PFO‑associated stroke.

Percutaneous PFO closure is considered not medically necessary when used for indications other than prevention of recurrent ischemic cryptogenic stroke that meet the policy's listed criteria. SCAI guidance emphasizes individualized, multidisciplinary decision‑making and recommends closure for prevention of recurrent PFO‑associated stroke, but not for other unproven neurologic indications.

The routine use of PFO closure for treatment of migraine in patients who do not have a prior PFO‑associated stroke is not supported. Randomized and sham‑controlled migraine trials have largely failed to show benefit on primary endpoints, and the 2022 SCAI guideline issues a conditional recommendation against routine closure for migraine without prior PFO‑associated stroke.

This Medical Policy is intended to assist interpretation of UnitedHealthcare standard benefit plans and is informational. Member‑specific benefit plan documents and any applicable federal or state mandates govern final coverage determinations. The policy does not apply to individuals younger than 18 years or to atrial septal defect closure; coverage decisions must follow FDA‑labeled indications and the clinical criteria described in the policy.

Billing and Coding

Applicable CPT CodesCPT

93580

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

Device product code (informational)mixed

MLV	Transcatheter septal occluders (FDA product code)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous PFO closure when performed for prevention of recurrent ischemic stroke. The prior authorization request must document that the procedure meets FDA-labeled indications/contraindications and include all clinical criteria described in the policy (imaging-confirmed cryptogenic stroke, specialist determinations, exclusion of other causes, and age range).

Document FDA device indication and applicable PMA information
Confirm patient is 18–60 years of age unless justification per guideline-based evaluation
Provide specialist (cardiologist and neurologist) determination that stroke is likely embolic in nature

Prior Authorization

Prior Authorization — Stroke Prevention Specifics

Prior authorization for PFO closure for stroke prevention must specifically demonstrate: patient age; imaging-confirmed nonlacunar/embolic-appearing infarct consistent with a cryptogenic stroke; exclusion of alternative stroke mechanisms (e.g., carotid disease, atrial fibrillation, hypercoagulable state); and, when applicable, documentation of high‑risk PFO anatomy (large shunt, atrial septal aneurysm as relevant).

Clinical Background and Scope

A cryptogenic ischemic stroke is an ischemic stroke without an identified cause after standard evaluation. A patent foramen ovale (PFO) is a persistent interatrial opening that can permit right‑to‑left shunting and paradoxical embolism, potentially allowing venous thromboemboli to enter the arterial circulation and cause stroke. Randomized trials and guideline statements support transcatheter PFO closure to reduce recurrent cryptogenic ischemic stroke in carefully selected adults—typically those aged 18 to 60 years with a nonlacunar (embolic‑appearing) infarct—after exclusion of other causes and multidisciplinary agreement between neurologist and cardiologist.

Key Definitions

Patent Foramen Ovale (PFO) — definition and clinical note

DefinitionA persistent opening in the atrial septum present from fetal development that can remain patent into adulthood and, in some individuals, permit right-to-left shunting with potential for paradoxical embolism.

Clinical significanceIn people with a PFO, venous thrombi may cross to the arterial circulation and cause ischemic stroke (cryptogenic stroke may be due to PFO-mediated paradoxical embolism).

Treatment optionsPrevention of recurrent cryptogenic stroke related to PFO may include antithrombotic/anticoagulation therapy, rarely surgery, or percutaneous (transcatheter) PFO closure.

Procedure descriptionPercutaneous/transcatheter PFO closure uses catheter technology to place an occluding device across the atrial septum without open-heart surgery.

Cryptogenic stroke — definition

Definition

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure

Policy CodePolicy 2026T0606J

Change TypeDocumentation and template updates

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

Presence of large shunt increases likelihood of benefit per guideline statements

Secondary stroke prevention criteria: Decision made by a multidisciplinary team and documented by both a neurologist and a cardiologist;

Shared decision-making and documentation of specialist concurrence expected

Age documented in medical record
Recent brain imaging report confirming cryptogenic stroke characteristics
Results of diagnostic testing to exclude other causes (carotid imaging, prolonged cardiac monitoring, hypercoagulability testing)
Echocardiographic documentation of PFO anatomy and shunt size when available

Documentation Required

Required Documentation with Prior Authorization

Submit the complete medical records and diagnostic test results listed under policy documentation requirements with the prior authorization request. Incomplete documentation may result in denial.

Condition requiring procedure and relevant history of the medical condition(s) requiring treatment
Signs and symptoms including onset, duration, and frequency
Relevant recent diagnostic imaging reports (brain MRI/CT)
Results of recent diagnostic testing performed to rule out other causes (carotid studies, prolonged cardiac monitoring for atrial fibrillation, hypercoagulable evaluation)
Complete echocardiography/TCD reports detailing PFO characteristics

Documentation Required

Required Clinical Evaluation

A thorough clinical evaluation is required prior to approval: a neurologist and a cardiologist must evaluate the patient and concur that the stroke is likely embolic, and other causes of ischemic stroke must be actively excluded per guideline recommendations.

Neurology and cardiology consultation notes documenting agreement on stroke etiology
Documentation of tests used to exclude other stroke mechanisms and their results
Records of prolonged cardiac rhythm monitoring to exclude occult atrial fibrillation

Note

Medical Therapy Alternative

Medical therapy (antiplatelet or anticoagulation) is an alternative to PFO closure. Consideration of medical therapy versus device closure should follow FDA labeling, clinical trial evidence, and guideline-based shared decision-making.

Document trials of medical therapy when clinically indicated and the rationale for choosing closure instead of continued medical management
Reference to antithrombotic/anticoagulation options and their risks/benefits discussed with the patient

Note

Guideline-Based Management Considerations

Coverage decisions should incorporate guideline-based management. Professional society guidance (AAN, AHA/ASA, SCAI) recommends individualized, multidisciplinary decision-making and consideration of patient age, stroke characteristics, shunt size/high-risk anatomy, and vascular risk factors when deciding between PFO closure and medical therapy.

Use shared decision-making documented in the record
Reference applicable guideline recommendations in the clinical rationale for closure

Step Therapy

Step Therapy / Denial Risk

There are no step therapy provisions specified for PFO closure in this policy; however, absence of required documentation or failure to meet FDA-labeled indications and guideline criteria may lead to denial of the request.

No formal step therapy required
Denial risk exists if clinical criteria or documentation requirements are unmet

An ischemic stroke in which a specific cause is not identified after a standard evaluation.

Relationship to PFOA cryptogenic stroke may be due to a paradoxical embolism through a PFO when no other cause is found.

Clinical implicationManagement options include medical therapy (antithrombotic/anticoagulation) or consideration of PFO closure when multidisciplinary evaluation supports a causal role for PFO.

Embolic-appearing infarct — definition used in guideline criteria

Definition used in guideline criteriaAn embolic-appearing infarct is a nonlacunar ischemic stroke pattern that suggests paradoxical embolism rather than intrinsic small-vessel disease and is used to identify patients likely to benefit from PFO closure.

Guideline relevanceAAN guidance recommends considering closure in patients younger than 60 with a PFO and an embolic-appearing infarct when no other mechanism is identified.

Associated imaging noteEmbolic-appearing infarcts are distinguished from single small, deep (lacunar) infarcts, which are less likely to benefit from closure.

Frequent aura — definition used in migraine subgroup analyses

Definition in pooled analysesFrequent aura is defined as aura occurring in 50% or more of migraine attacks in pooled analyses of migraine trials.

Trial subgroup relevanceThis subgroup (migraine with frequent aura) showed greater likelihood of benefit from PFO closure in some pooled analyses compared with participants without frequent aura.

Outcome contextIn pooled trial analyses, individuals with frequent aura had larger reductions in migraine days and higher rates of complete cessation in some comparisons.

Key evidence sources — randomized trials, systematic reviews, guidelines cited

Randomized trials (major stroke trials)RESPECT, REDUCE, and CLOSE randomized trials evaluating PFO closure versus medical therapy for secondary prevention of cryptogenic stroke.

Migraine trials and pooled analysesRandomized migraine trials include MIST, PRIMA, and PREMIUM; pooled analyses (e.g., Mojadidi et al.) and meta-analyses assess migraine outcomes after PFO closure.

Systematic reviews and meta-analysesSeveral systematic reviews and meta-analyses summarize RCT and observational evidence for PFO closure in stroke and migraine (e.g., Ntaios et al. 2018; Wang et al. 2022; Zhang et al. 2022; Silalahi & Hariyanto 2024).

GuidelinesSociety for Cardiovascular Angiography and Interventions (SCAI) 2022 guidelines and American Academy of Neurology (AAN) practice advisory inform selection for PFO closure.