CurrentUnitedHealthcarePolicy CS329NJ.D

Percutaneous Patent Foramen Ovale (PFO) Closure (for New Jersey Only)

Medical policy governing percutaneous PFO closure for prevention of recurrent ischemic cryptogenic stroke in New Jersey members; excludes ASD closure and individuals under 18. Applies to UnitedHealthcare New Jersey.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure (for New Jersey Only)

Policy CodePolicy CS329NJ.D

Change TypeNo material changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing neurologist and cardiologist agreement that the stroke is likely embolic, imaging-confirmed cryptogenic stroke, and that other causes have been excluded.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18-60age range for which PFO closure is considered medically necessary

3,627pooled participants in referenced meta-analysis

≈5×increased AF risk after PFO closure

1,829participants allocated to closure in meta-analysis

not recommended

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

PFO closure not routinely supported for migraine

Coverage Criteria for Percutaneous PFO Closure

Medically necessary indications

Covered when ALL of the following are met:

PFO closure coverage criteria: A cardiologist and a neurologist agree that the stroke is likely embolic in nature; History of cryptogenic stroke confirmed by imaging; Other causes of ischemic stroke have been ruled out (including but not limited to carotid disease, hypercoagulable states, or atrial fibrillation); Individual is 18-60 years of age.all four required

Also must be used according to FDA-labeled indications, contraindications, warnings, and precautions.

Indication: Secondary prevention of recurrent ischemic stroke

Covered when ALL of the following are met (reflecting major guideline-aligned indications):

Primary coverage criteria: Age predominantly between 18 and 60 years; non-lacunar cryptogenic ischemic stroke with an embolic-appearing infarct; no other identified mechanism of stroke after thorough evaluation including prolonged monitoring for atrial fibrillation where appropriate; decision made following multidisciplinary evaluation by neurologist and cardiologist.

Sourced from AHA/ASA and AAN guideline statements and FDA device indications.

Indication: Migraine

Not routinely covered / recommended for migraine management given current evidence:

Migraine indication summary: Percutaneous PFO closure for treatment or prevention of migraine (with or without aura) is not supported for routine use due to inadequate or inconsistent evidence of clinically meaningful benefit across randomized trials and systematic reviews; guideline statements (SCAI, NICE) and trial data (MIST, PRIMA, PREMIUM, CLOSE-MIG sub-study) do not demonstrate consistent migraine benefit.

Considered not medically necessary for routine migraine management.

This policy does not apply to individuals under 18 years of age and specifically excludes atrial septal defect (ASD) closure. Percutaneous PFO closure coverage and medical necessity determinations are limited to the indications and patient population described in the policy and do not extend to ASD repair procedures or pediatric patients.

Percutaneous PFO closure is considered unproven and not medically necessary for stroke- or neurologic-related indications other than the prevention of recurrent ischemic cryptogenic stroke. This includes, but is not limited to, primary prevention of stroke, transient ischemic attacks (TIA), and migraine prevention, because current evidence is insufficient to support efficacy for these uses.

For individuals with a PFO who have not had a prior ischemic stroke, closure for primary prevention of stroke is not recommended. Guidelines and evidence reviews advise against routine PFO closure in persons without a prior PFO-associated stroke due to the low absolute risk of first stroke and uncertainty about net benefit.

Use of percutaneous PFO closure for indications other than reduction of recurrent ischemic cryptogenic stroke is not supported and is considered not medically necessary. Examples include primary stroke prevention, interventions for TIA without confirmed cryptogenic stroke, and other neurologic presentations where the causal role of PFO is not established.

PFO closure to treat migraine (with or without aura) is not routinely covered and is considered not medically necessary. Multiple randomized trials (MIST, PRIMA, PREMIUM, CLOSE-MIG sub-study) and systematic reviews have not consistently demonstrated clinically significant benefits for migraine outcomes, and major society guidance advises against routine use for migraine prevention.

Coding and Age Parameters

Applicable/procedure codes (reference)CPT

93580

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

Device classificationmixed

MLV	Transcatheter septal occluders (FDA product code) - informational about device regulation

Age — applicable age range for consideration

Applicable age range18-60 years

Policy exclusion - minorsPolicy does not apply to individuals under 18 years of age

Age requirement in coverage criteriaIndividual must be 18-60 years to meet medically necessary criteria for PFO closure

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous PFO closure. Requests must be submitted and approved before scheduling the procedure unless otherwise specified by the benefit plan or applicable law.

Prior authorization required for PFO closure procedures
Ensure submission includes clinical documentation described below

Prior Authorization

Prior Authorization — PFO Closure: Multidisciplinary Evaluation and Indications

Prior authorization for PFO closure will be approved only when the request documents that the multidisciplinary evaluation and indication criteria are met. Percutaneous PFO closure is considered medically necessary when: a cardiologist and a neurologist agree the stroke was likely embolic, the member has a cryptogenic ischemic stroke confirmed by imaging, other causes of ischemic stroke have been excluded (eg, carotid disease, hypercoagulable states, atrial fibrillation), and the member is 18–60 years of age. FDA-labeled indications and device-specific contraindications, warnings, and precautions must be followed.

Background and Evidence Summary

A cryptogenic ischemic stroke is an ischemic stroke in which a specific cause cannot be identified after appropriate evaluation. A patent foramen ovale (PFO) is a persistent interatrial communication that can permit paradoxical embolism from the venous to the arterial circulation. Prevention of recurrent cryptogenic stroke may be achieved with antithrombotic therapy or, in selected patients who meet strict criteria and FDA-labeled indications, with percutaneous transcatheter PFO closure.

Key Definitions

Cryptogenic stroke — definition

DefinitionAn ischemic stroke in which a specific cause is not found (cryptogenic stroke); may be due to paradoxical embolism through a PFO

Confirmation requiredHistory of cryptogenic stroke must be confirmed by imaging to meet coverage criteria

Evaluation contextOther causes of ischemic stroke (eg, carotid disease, hypercoagulable states, atrial fibrillation) must be ruled out

Patent foramen ovale (PFO) — definition

DefinitionA persistent opening in the atrial septum that may allow right-to-left shunt of blood and emboli (patent foramen ovale)

Clinical relevanceIn some people, venous thrombi may cross a PFO and cause ischemic stroke

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure (for New Jersey Only)

Policy CodePolicy CS329NJ.D

Change TypeNo material changes

Effective DateApr 1, 2025

Next Review DateN/A

SourceLink

On This Page

Multidisciplinary agreement (cardiologist + neurologist) documented

Cryptogenic ischemic stroke confirmed by imaging

Documentation of exclusion of other stroke etiologies

Age documented and within 18–60 years

Note

Conservative Therapy Consideration

Medical management (antiplatelet and/or anticoagulation therapy) should be considered and documented as part of the evaluation prior to PFO closure. The decision to proceed with closure should reflect individualized assessment of risks and benefits and alignment with current guideline recommendations.

Document prior or attempted conservative medical therapy when applicable
Clearly state rationale for choosing device closure over continued medical therapy

Note

Medical Therapy Consideration

When considering PFO closure, documentation should address guideline-based medical therapy options. References support antiplatelet or anticoagulation therapy as reasonable alternatives in many situations; the choice of agent should be individualized based on clinical factors and risks.

Document whether antiplatelet or anticoagulant therapy was used, contraindications, and treatment response
If medical therapy was selected instead of closure, document rationale and follow-up plan

Documentation Required

Required Clinical Documentation

The prior authorization request must include clear clinical documentation demonstrating agreement between the treating cardiologist and neurologist that the index event was a cryptogenic ischemic stroke likely due to paradoxical embolism through a PFO, and that alternative causes have been reasonably excluded.

Signed or dated consult notes from both a neurologist and a cardiologist stating agreement on etiology
Neuroimaging report confirming ischemic stroke and description supporting cryptogenic etiology
Documentation of workup to exclude other causes (eg, carotid imaging, rhythm monitoring for AF, hypercoagulable evaluation as indicated)

Documentation Required

Required Clinical Evaluation and Documentation

The clinical evaluation must include assessments by both a cardiologist and a neurologist prior to authorization. Each specialist should document their independent evaluation, the multidisciplinary conclusion regarding stroke mechanism, and the indication for closure versus medical therapy.

Neurologist evaluation: description of stroke, imaging interpretation, exclusion of other neurologic causes
Cardiologist evaluation: PFO characterization (eg, shunt assessment) and device suitability
Multidisciplinary statement that PFO closure is indicated and that FDA-labeled device criteria are met

Denial Risk

Triggers for Denial

Requests may be denied when key eligibility or documentation requirements are not met. Common triggers for denial include: member age <18 years, indication limited to atrial septal defect (ASD) closure rather than PFO closure, insufficient evidence of cryptogenic stroke or lack of neurocardiology agreement, failure to document exclusion of other stroke etiologies, or request for PFO closure for unsupported indications (eg, primary prevention, migraine without stroke).

Age under 18 years — not covered under this policy
ASD closure indications — refer to ASD-specific policies
Insufficient documentation of cryptogenic stroke, multidisciplinary agreement, or exclusion of other causes
Indications such as primary prevention of stroke or migraine without prior PFO-associated stroke

Treatment optionsPrevention of recurrent cryptogenic stroke in people with a PFO may include antithrombotic/anticoagulation therapy or percutaneous PFO closure

PFO occluder device — definition and FDA product code reference

DefinitionA transcatheter septal occluder device used for percutaneous transcatheter closure of PFO to reduce recurrent ischemic stroke in selected patients

FDA product codeMLV (transcatheter septal occluders)

Regulatory contextPFO occluder devices are regulated via FDA premarket approval (PMA); example: Amplatzer PFO Occluder (P120021) indicated predominantly for patients 18-60 years

Embolic-appearing infarct — definition

DefinitionAn ischemic infarct with imaging features considered consistent with embolism (embolic-appearing infarct), supporting consideration of PFO closure when no other mechanism is identified

Clinical implicationPresence of an embolic-appearing infarct plus no other identified mechanism (eg, non-lacunar stroke) aligns with guideline-based patient selection for closure

Guideline referenceAAN and AHA/ASA guidance support closure consideration in patients <60 with an embolic-appearing infarct and no other mechanism detected