CurrentUnitedHealthcarePolicy CS329KY.07

Percutaneous Patent Foramen Ovale (PFO) Closure (for Kentucky Only) – Community Plan Medical Policy

Policy governs medical necessity coverage for percutaneous PFO closure in Kentucky community plan members aged 18-60 for prevention of recurrent ischemic cryptogenic stroke when FDA-labeled device indications and specified clinical criteria are met. Excludes individuals <18 years and atrial septal defect closure; migraine and other indications are considered not medically necessary except as noted.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure (for Kentucky Only) – Community Plan Medical Policy

Policy CodePolicy CS329KY.07

Change TypeDocumentation clarificationevidence and references updated

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure the patient medical record contains legible documentation supporting medical necessity (history, physical exam, diagnostic test/procedure results) and make it available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language about medical records documentation used for reviews and clarified that documentation does not guarantee coverage.

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

1State-specific policy (Kentucky only)

18-60Age range for covered indication

1Required specialty concurrence (cardiology + neurology)

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93580Example referenced CPT code

Multiple trials/guidelinesKey evidence sources cited

Coverage Summary

Percutaneous patent foramen ovale (PFO) closure is covered for Kentucky community plan members aged 18 to 60 years to prevent recurrent cryptogenic ischemic stroke when performed in accordance with FDA‑labeled device indications and warnings and ALL of the listed clinical criteria are met (history of imaging‑confirmed cryptogenic stroke, specialist concurrence of cardiology and neurology that the stroke is likely embolic, and exclusion of other causes of ischemic stroke). This policy does not apply to individuals <18 years of age or to atrial septal defect closure, and indications such as primary prevention, transient ischemic attack alone, migraine prevention, or other stroke/neurologic indications that do not meet the specified criteria are considered not medically necessary. Benefit coverage is determined by applicable federal, state, or contractual requirements and applicable law, medical record documentation may be required for review but does not guarantee coverage, and UnitedHealthcare uses InterQual for primary medical/surgical criteria (or alternate UnitedHealthcare guidelines approved by the Kentucky Department for Medicaid Services when InterQual is not applicable).

Quick Facts / Key Thresholds

Age range for covered indication18-60 years

State-specific policyKentucky only

Required specialty concurrenceCardiology and Neurology agreement that stroke is likely embolic

Example referenced CPT code93580 (Percutaneous transcatheter closure of congenital interatrial communication)

Key evidence sources summaryMultiple RCTs and meta-analyses (e.g., RESPECT, REDUCE, CLOSE, DEFENSE-PFO) and society guidelines (AAN, AHA/ASA, SCAI) show reduced recurrent ischemic stroke in selected patients but increased new-onset atrial fibrillation; evidence does not support primary prevention or routine migraine treatment.

Medical-Necessity Criteria

Medically Necessary (FDA-labeled indications) for Prevention of Recurrent Ischemic Stroke

Percutaneous PFO closure is proven and medically necessary when used according to FDA labeled indications, contraindications, warnings, and precautions and ALL of the following criteria are met:

ALL of the following

History of cryptogenic stroke confirmed by imaging
Specialist concurrence: A cardiologist and a neurologist agree that the stroke is likely embolic in nature
Documentation required that a cardiologist and a neurologist agree the stroke is likely embolic in nature.
Exclusion of other causes: Other causes of ischemic stroke have been ruled out, including but not limited to carotid disease, hypercoagulable states, or atrial fibrillation
Documentation required that other causes of ischemic stroke have been ruled out.

Provider Actions & Prior Authorization

Documentation Required

Medical record documentation required

The patient's medical record must contain documentation that fully supports medical necessity. Documentation may be required for review and must be made available upon request. Required elements include relevant medical history, findings from the physical examination, and results of pertinent diagnostic tests or procedures that demonstrate the cryptogenic stroke and support the indication for PFO closure. Records should be maintained in the patient's chart and presented when requested for utilization review.

Relevant medical history supporting cryptogenic stroke
Physical examination findings
Results of pertinent diagnostic tests/procedures (e.g., brain imaging, cardiac evaluation, vascular imaging, rhythm monitoring)
Must be legible, maintained in the medical record, and made available upon request

Documentation Required

Specialist concurrence

Documentation must indicate that both a cardiologist and a neurologist have evaluated the case and agree the stroke is likely embolic in nature. This specialist concurrence is a required element for meeting the policy's clinical criteria for PFO closure.

Coding

Applicable Procedure Code(s) (reference only)CPT

93580

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

Codes referenced (none listed in this part)mixed

No codes listed

Background, Evidence & Definitions

Percutaneous PFO closure devices are transcatheter implants introduced via catheter to occlude a patent foramen ovale and thereby reduce paradoxical embolization into the cerebral circulation. Randomized trials and systematic reviews demonstrate a reduction in recurrent ischemic stroke in selected patients (particularly those with cryptogenic embolic stroke and high‑risk PFO features), but the procedure is associated with an increased incidence of new‑onset atrial fibrillation. PFO closure has not been proven effective for primary prevention of stroke and is not routinely recommended as a treatment for migraine.

Key evidence sources include multiple systematic reviews, randomized controlled trials, and society guideline statements that support benefit in selected patients: systematic reviews and meta‑analyses of RCTs and observational studies (e.g., Kolokathis et al., Ntaios et al., Hamodat et al., Asghar et al.), and guideline statements from AAN, AHA/ASA, SCAI, NICE, and the American Society of Echocardiography.

Notable trials referenced include RESPECT, REDUCE, CLOSE, DEFENSE‑PFO, the PC Trial, CLOSURE I, and others; these trials and subsequent meta‑analyses informed guideline endorsements that PFO closure may be reasonable to reduce recurrent ischemic stroke in appropriately selected patients (generally aged 18–60 years) while noting increased atrial fibrillation risk and limited or insufficient evidence for migraine or primary prevention.

Quick evidence highlights

Revision History

2026-03-01addedLatest

Added language detailing medical records documentation required for reviews: benefit coverage determined by federal/state/contractual requirements; medical records may be required to assess clinical criteria but do not guarantee coverage; documentation must fully support medical necessity and include relevant history, physical exam, and diagnostic test/procedure results; documentation should be legible and made available upon request.

2026-03-01updatedLatest

Archived previous policy version CS329KY.06 and updated Clinical Evidence, FDA, and References sections to reflect the most current information.

Policy Summary

PayerUnitedHealthcare

PolicyPercutaneous Patent Foramen Ovale (PFO) Closure (for Kentucky Only) – Community Plan Medical Policy

Policy CodePolicy CS329KY.07

Change TypeDocumentation clarificationevidence and references updated

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure the patient medical record contains legible documentation supporting medical necessity (history, physical exam, diagnostic test/procedure results) and make it available upon request.

SourceLink

On This Page

Age: Individual is 18 to 60 years of age18-60 years

Age threshold per FDA and guideline recommendations.

FDA indication: Device used according to FDA labeled indications, contraindications, warnings, and precautions

FDA approvals note predominance of individuals between ages 18 and 60 and requirement of neurologist and cardiologist determination.

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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:

ANY of the following

Primary prevention of stroke
AHA/ASA guidelines recommend no treatment for primary prevention of stroke in patients with a PFO.
TIA as sole indication: Transient ischemic attacks (as sole indication)
Policy lists TIA as not medically necessary as sole indication.
Migraine prevention
Evidence is insufficient to support PFO closure for routine migraine treatment.
Other not meeting criteria: Any other stroke or related neurological indication not meeting the medically necessary criteria above

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Applicability / Exclusions

Age exclusion: Policy does not apply to individuals < 18 years of age<18 years
ASD exclusion: Policy does not apply to atrial septal defect closure
Procedures for atrial septal defects (ASD) are excluded from this policy; see applicable codes (e.g., CPT 93580 covers ASD closure procedures).
State-specific: Policy applies only to the state of Kentucky
This Medical Policy only applies to the state of Kentucky.

Documentation / General Instructions

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the service requested:

Documentation requirements: Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws and medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage.

Supportive documentation: The patient's medical record must contain documentation that fully supports the medical necessity for the requested services, including but not limited to relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation should be legible, maintained in the patient's medical record, and must be made available upon request.

Legibility and availability: Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request.

InterQual allowance: UnitedHealthcare uses InterQual for primary medical/surgical criteria; if InterQual does not have applicable criteria, UnitedHealthcare may use UnitedHealthcare Medical Policies, Coverage Determination Guidelines, and/or Utilization Review Guidelines approved by the Kentucky Department for Medicaid Services.

Per Kentucky Medicaid rules and Instructions for Use.

Documentation does not guarantee coverage: Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage of the services requested.

Explicit statements or consult notes from a cardiologist and a neurologist documenting agreement that the stroke is likely embolic

Documentation Required

Exclusion of other causes

Documentation must show that other potential causes of ischemic stroke have been evaluated and excluded. The record should list the evaluations performed and their results to rule out alternative etiologies prior to PFO closure consideration.

Evaluation and exclusion of carotid (extracranial or intracranial) atherosclerotic disease
Assessment for hypercoagulable or thrombophilia states as indicated
Cardiac rhythm monitoring or other evaluation to exclude atrial fibrillation

Documentation Required

Medical record documentation required for review

Providers must ensure the medical record contains legible documentation that fully supports medical necessity (including relevant history, physical exam, and diagnostic test/procedure results) and make those records available upon request. Submission of documentation for review does not guarantee coverage; benefit coverage is determined by federal, state, or contractual requirements and applicable laws.

Records must be legible and maintained in the patient's medical record
Documentation may be requested for utilization review
Providing documentation for review does not guarantee service coverage

Prior Authorization

Use InterQual criteria for coverage determination

UnitedHealthcare uses InterQual® as the primary source for medical/surgical criteria when determining coverage. If InterQual does not have applicable criteria for a specific request, UnitedHealthcare may use its own Medical Policies, Coverage Determination Guidelines, and/or Utilization Review Guidelines that have been approved by the Kentucky Department for Medicaid Services.

InterQual® is the primary medical/surgical criteria source
If InterQual lacks applicable criteria, alternate UnitedHealthcare guidelines approved by the Kentucky Department for Medicaid Services may be used