CurrentCapital BluecrossPolicy MP 1.039

Closure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD)

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This policy governs when percutaneous transcatheter closure devices for PFO and ASD are considered medically necessary or investigational for Capital Bluecross members; it applies to use of FDA‑approved devices and describes clinical indications and limits.

Policy Summary

PayerCapital Bluecross

PolicyClosure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD)

Policy CodePolicy MP 1.039

Change TypeNo material change

Effective DateJul 1, 2026

Last ReviewFeb 12, 2026

Next Review DateFeb 12, 2026

Key ActionObtain prior authorization to confirm the patient meets clinical criteria (age, documented cryptogenic stroke with exclusion of other causes, and echocardiographic shunt criteria).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25%PFO prevalence

>1.5:1Qp:Qs threshold

4 devicesFDA‑approved devices

higherAF risk in trials

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CurrentCapital BluecrossPolicy MP 1.039

Closure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD)

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Policy Summary

PayerCapital Bluecross

PolicyClosure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD)

Policy CodePolicy MP 1.039

Change TypeNo material change

Effective DateJul 1, 2026

Last ReviewFeb 12, 2026

Next Review DateFeb 12, 2026

Key ActionObtain prior authorization to confirm the patient meets clinical criteria (age, documented cryptogenic stroke with exclusion of other causes, and echocardiographic shunt criteria).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25%PFO prevalence

>1.5:1Qp:Qs threshold

4 devicesFDA‑approved devices

higherAF risk in trials

2026-02-12Last review

Coverage Criteria for PFO and ASD Closure

PFO closure — medically necessary

Covered when ALL of the following are met

Age: Between 18 and 60 years of ageage 18-60

PFO with right-to-left shunt: Diagnosis of patent foramen ovale with a right-to-left interatrial shunt confirmed by echocardiography with at least one of: microbubbles in the left atrium within 3 cardiac cycles after opacification of the right atrium OR atrial septal aneurysm with septum primum excursion >10 mmmicrobubbles within 3 cardiac cycles; ASA excursion >10 mm

Stroke history and specialist evaluation: Documented history of cryptogenic ischemic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following evaluation to exclude other identifiable causes of stroke (including large vessel atherosclerotic disease and small vessel occlusive disease)documented specialist determination

Absence of exclusions: Individual has none of the following: uncontrolled vascular risk factors (including uncontrolled diabetes or uncontrolled hypertension); other sources of right-to-left shunt (including an atrial septal defect and/or fenestrated septum); active endocarditis or other untreated infections; inferior vena cava filter.no listed exclusions present

ASD closure — medically necessary

Transcatheter closure of ASD may be considered medically necessary when using an FDA‑approved device for either of the following

Fontan fenestration closure: Closure of a fenestration created as part of the Fontan procedure

Ostium secundum ASD with RV volume overload or paradoxical embolism: Echocardiographic evidence of ostium secundum atrial septal defect AND one of: clinical evidence of right ventricular volume overload (eg, Qp:Qs ≥ 1.5:1 or right ventricular enlargement) OR clinical evidence of paradoxical embolismQp:Qs >= 1.5:1 or RV enlargement

ASD closure — investigational

Other indications: Transcatheter closure of atrial septal defects is considered investigational for all other indications not meeting the above criteria

Insufficient evidence to support general benefit

Covered with criteria — PFO for cryptogenic stroke; ASD with left-to-right shunt/right ventricular overload

Covered when criteria described in the evidence summary are met

PFO closure for cryptogenic stroke: Device-based PFO closure is supported by multiple randomized trials and meta-analyses showing reduced recurrent ischemic events in selected patients when other causes of cryptogenic stroke have been excluded; some trials reported higher rates of atrial fibrillation.use of appropriate patient selection to exclude other causes

Evidence sufficient to determine meaningful improvement in net health outcome

ASD closure: Transcatheter ASD closure is effective for patients with ASD and evidence of left-to-right shunt or right ventricular volume overload; nonrandomized and single-arm studies demonstrate high closure success rates and low complication rates, with percutaneous approach preferred when feasible.echocardiographic evidence of secundum ASD and clinical evidence of right ventricular volume overload (eg, Qp:Qs > 1.5:1)

Evidence sufficient to determine improved outcomes

Unproven / Insufficient Evidence

Not covered as proven for other indications without sufficient evidence

PFO closure for migraine has not demonstrated consistent benefit in randomized trials (including a sham-controlled trial) and evidence is insufficient to determine improvement in health outcomes.

Evidence insufficient

PFO closure for other associated conditions: Use of PFO closure for conditions such as platypnea-orthodeoxia syndrome, decompression illness, high-altitude pulmonary edema, myocardial infarction with normal coronaries, obstructive sleep apnea, and other PFO-associated conditions is supported only by small case series and case reports; evidence is insufficient to determine effects on health outcomes.

Evidence insufficient

Other sources of right-to-left interatrial shunt are exclusionary for percutaneous PFO closure. Specifically, PFO closure is not appropriate when there is an alternative anatomic shunt such as an atrial septal defect (ASD) or a fenestrated septum. The policy also lists additional exclusions that must be absent prior to considering PFO closure, including active endocarditis or other untreated infections, presence of an inferior vena cava (IVC) filter, and uncontrolled vascular risk factors (for example uncontrolled diabetes or uncontrolled hypertension).

Providers must ensure these exclusionary conditions are evaluated and documented, since their presence would preclude coverage for device‑based PFO closure under this policy.

Use of PFO closure to treat migraine or other PFO‑associated conditions outside of cryptogenic ischemic stroke is not supported by sufficient evidence. Randomized and sham‑controlled trials have not demonstrated consistent clinically meaningful reductions in migraine frequency or symptoms after PFO closure, and nonrandomized studies report highly variable results; overall the evidence is insufficient to determine net health outcome benefit for migraine.

Similarly, for other conditions associated with PFO (for example platypnea‑orthodeoxia syndrome, decompression illness, high‑altitude pulmonary edema, myocardial infarction with normal coronary arteries, or obstructive sleep apnea), the available evidence consists primarily of small case series and case reports and is insufficient to support these indications for transcatheter PFO closure.

The policy history and coding administrative entries are recorded in the document and reflect prior additions, removals, and updates to coding and administrative sections. Historical edits include the 07/27/2020 minor review (which revised microbubble observation language), administrative additions and later removals of procedure codes (e.g., codes added 11/17/2020 and removed 01/06/2021), and subsequent consensus and administrative reviews through 07/09/2025. These history entries do not themselves introduce additional clinical exclusion criteria.

Because coding lists in the policy may change over time, the presence of a code in the coding section does not guarantee coverage; coding and coverage are subject to member benefit terms and the documented medical necessity criteria in the policy.

Transcatheter closure of atrial septal defects (ASD) is considered medically necessary only for the specific indications listed in the policy (closure of a Fontan fenestration OR ostium secundum ASD with clinical evidence of right ventricular volume overload — e.g., Qp:Qs ≥ 1.5:1 — or clinical evidence of paradoxical embolism). For all other indications that do not meet these criteria, transcatheter ASD closure is considered investigational because there is insufficient evidence to support a general conclusion regarding health outcomes or benefit.

PFO closure specifically for the treatment of migraine is not supported by sufficient evidence to establish a health benefit. The available randomized trials, including a sham‑controlled study and a blinded trial with endpoint evaluation, did not demonstrate consistent reductions in migraine symptoms or days; therefore PFO closure for migraine is considered not supported / insufficient evidence for coverage under this policy.

Minor administrative and editorial items referenced in the policy history have been recorded (for example, wording edits to microbubble criteria and periodic coding updates). The chunks reviewed do not add further clinical coverage language in this section; clinical coverage and documentation requirements remain those specified in the main policy statements and criteria above.

Coding and Regulatory Codes

Regulatory codesmixed

FDA product code MLV	Regulatory product code referenced for PFO and ASD occluder devices
FDA product code OZG	Additional FDA product code referenced for some ASD devices

Covered when Medically Necessary - Procedure CodesCPT | HCPCS

93580	Transcatheter closure of intracardiac shunt device placement (procedure code listed in policy)
C1817	Catheter occlusion device (listed in policy coding section)

ICD-10-CM Diagnosis CodesICD-10

Q21.10	Atrial septal defect, unspecified
Q21.11	Secundum atrial septal defect
Q21.12	Patent foramen ovale
Q21.13	Coronary sinus atrial septal defect
Q21.14	Superior sinus venosus atrial septal defect
Q21.15	Inferior sinus venosus atrial septal defect
Q21.16	Sinus venosis atrial septal defect, unspecified
Q21.20	Atrioventricular septal defect, unspecified as to partial or complete
Q21.21	Partial atrioventricular septal defect
Q21.22	Transitional atrioventricular septal defect

1–10 of 15

1/2

Historically added/removed and updated codes referenced in policy historymixed

33741	code added then removed per history
33745	code added then removed per history
33746	code added then removed per history
I50.1	ICD-10 code added to policy per 07/11/2022 update
I21.B	ICD-10 code added per 09/07/2023 administrative update

inv-17: Pulmonary-to-systemic flow ratio (Qp:Qs) — threshold value

Pulmonary-to-systemic flow ratio (Qp:Qs)> 1.5:1

Use for ASD repair indicationRepair recommended when Qp:Qs exceeds 1.5:1

Measurement contextDetermined by echocardiographic or hemodynamic assessment to document left-to-right shunt

Provider Requirements and Authorization

Prior Authorization

Obtain prior authorization to verify FDA‑approved device indications

Prior authorization is required to confirm the patient meets the policy’s FDA‑approved device indications (age 18–60 for PFO closure; documented cryptogenic ischemic stroke with exclusion of other causes; echocardiographic confirmation of right‑to‑left shunt criteria; or ASD indications such as Qp:Qs >1.5:1, RV volume overload, Fontan fenestration closure, or paradoxical embolism).

Establish age and specialist determinations (neurologist and cardiologist) that stroke is cryptogenic and presumed due to paradoxical embolism.
Document echocardiographic shunt: microbubbles in left atrium within 3 cardiac cycles OR atrial septal aneurysm with septum primum excursion >10 mm.
For ASD, document Qp:Qs ≥1.5:1 or RV enlargement, or Fontan fenestration indication.

Background

A patent foramen ovale (PFO) is a persistent fetal interatrial communication that remains present postnatally in a substantial minority of adults—approximately 25% of the population—and has been associated with cryptogenic ischemic stroke by permitting paradoxical embolism.

Definitions

inv-31: Patent foramen ovale (PFO) — short definition

DefinitionPersistent communication between the right and left atrium present postnatally (patent foramen ovale), present in about 25% of asymptomatic adults

PhysiologyRepresents postnatal persistence of fetal foramen ovale that normally closes as left atrial pressure increases after birth

Clinical significanceMay allow paradoxical embolism and is associated with cryptogenic ischemic stroke in selected patients

inv-32: Atrial septal defect (ASD) — short definition including ostium secundum/primum/sinus venosus

DefinitionAn anatomic defect in atrial septal development allowing free communication between the atria (atrial septal defect)

Common typesIncludes ostium secundum (mid-septal, near fossa ovalis), ostium primum (adjacent to AV valves), and sinus venosus (high in atrial septum, often with pulmonary venous anomalies)

Policy Summary

PayerCapital Bluecross

PolicyClosure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD)

Policy CodePolicy MP 1.039

Change TypeNo material change

Effective DateJul 1, 2026

Last ReviewFeb 12, 2026

Next Review DateFeb 12, 2026

Key ActionObtain prior authorization to confirm the patient meets clinical criteria (age, documented cryptogenic stroke with exclusion of other causes, and echocardiographic shunt criteria).

SourceLink

On This Page

Use listed procedure codes but confirm coverage per member benefits

Procedure and diagnosis codes are listed in the coding section (eg, CPT 93580; HCPCS C1817), but identification of a code in the policy does not guarantee coverage — benefits and prior authorization requirements determine payment.

Use listed procedure codes when submitting claims, but verify member benefit terms and prior authorization requirements before scheduling.
Not all listed codes imply separate reimbursement; confirm eligibility and coverage rules with member’s benefit program.

Prior Authorization

Policy history lists coding/administrative updates but not explicit PA workflow

The policy history and administrative sections document coding and administrative updates but do not specify an independent, explicit prior authorization process in the provided history snippets. Providers should follow payer prior‑authorization processes as applicable.

Policy history shows code additions/removals and administrative updates; it does not replace payer prior authorization workflows.
Follow current payer/provider portal or phone prior‑authorization procedures for the member’s benefit plan.

Step Therapy

Trial of antiplatelet therapy for ASD-related cryptogenic stroke prior to closure consideration

For patients with ASD and a history of cryptogenic stroke, initial medical management is typically antiplatelet therapy; device closure is considered when the policy’s ASD criteria are met.

Document that antiplatelet therapy was used when applicable.
If considering closure, document echocardiographic evidence and clinical indications per ASD criteria (eg, Qp:Qs ≥1.5:1 or paradoxical embolism).

Note

Unlabeled provider action notes are not independent requirements — follow explicit policy statements

Some inventory entries in the document reference provider actions or annotations without explicit labeled requirements in the provided chunks; rely on the policy’s stated clinical criteria, coding notes, and authorization guidance rather than unlabeled placeholders.

Do not treat unlabeled inventory notes as independent authorization triggers.
Follow the explicit prior authorization, documentation, coding, and coverage conditionality statements in the policy when managing cases.

Note

Placeholder provider notes do not add requirements — use stated policy criteria and coding guidance

Certain inventory entries are present as placeholders without explicit actionable requirements in the provided snippets; ensure all clinical and administrative requirements used for authorization and claims are taken from the policy’s stated criteria, coding section, and documentation notes.

Confirm clinical eligibility per policy criteria prior to request for authorization.
Use coding and documentation guidance from the policy when preparing authorizations and claims.

Documentation Required

Include neurologist and cardiologist determinations and echocardiographic findings in documentation

Document that neurologist and cardiologist have determined the index stroke was cryptogenic and presumed due to paradoxical embolism, and document echocardiographic confirmation of a right‑to‑left shunt (microbubbles within 3 cardiac cycles or atrial septal aneurysm with septum primum excursion >10 mm).

Include written determinations by both neurologist and cardiologist in the record.
Include TEE or other echocardiography report specifying microbubble timing or ASA excursion measurement.

Documentation Required

Document medical necessity and use coding lists only as submission guidance

Providers should document medical necessity in the chart and submit appropriate procedure and diagnosis codes with claims; presence of a code in the policy’s coding list does not by itself indicate coverage and not all listed services are separately reimbursable.

Maintain documentation supporting each coverage criterion (age, specialist determination, echocardiography, absence of exclusions).
Use the policy’s coding lists for claim submission but verify coverage and separate reimbursement rules with the member’s benefit program.

Denial Risk

Risk of denial if policy clinical criteria or exclusion absence not documented

Denial is likely if the patient does not meet the policy criteria — for example, falls outside the age range, lacks a documented cryptogenic ischemic stroke with specialist evaluations excluding other causes, or lacks required echocardiographic evidence of a right‑to‑left shunt; listed exclusions (eg, other right‑to‑left shunts, uncontrolled vascular risk factors, active infection, IVC filter) also risk denial.

Verify patient age is between 18 and 60 for PFO closure.
Ensure documented specialist (neurologist and cardiologist) evaluation excluding other stroke causes.
Confirm echocardiographic criteria (microbubbles within 3 cycles or ASA >10 mm) and absence of listed exclusions.

Note

Confirm member benefits and eligibility; coverage is conditional

Coverage and payment are subject to the member’s benefit program, eligibility on the date of service, and a determination that the services are medically necessary and appropriate per the policy and contract terms.

Verify member eligibility and benefit coverage for device placement prior to procedure.
Obtain required authorizations and document medical necessity to support payment.

Documentation Required

Policy history updated coding/documentation but does not alter core documentation requirements

Documentation and coding language in the policy have been reviewed and updated multiple times per the policy history, but the provided history does not add additional explicit documentation requirements beyond the clinical criteria and coding notes already stated in the policy. Continue to follow current documentation requirements when requesting authorization or submitting claims.

Policy history documents code changes and administrative updates (eg, code additions/removals, ICD‑10 updates) but does not change core documentation expectations.
Keep records of specialist determinations, echocardiography, and absence of exclusions consistent with the policy’s clinical criteria.

Clinical impactCan cause left-to-right shunting leading to right ventricular volume overload, exercise intolerance, atrial fibrillation, and risk of paradoxical emboli

inv-33: Fontan fenestration — definition

DefinitionA surgically created small atrial septal defect (fenestration) used in the Fontan procedure to permit limited right-to-left shunting and reduce early postoperative pressure and complications

PurposeReduces right atrial and cavopulmonary pressures, improves preload to the single ventricle, and decreases need for mechanical ventilation and pleural effusion early postoperatively

Trade-offProvides hemodynamic benefits at the expense of mild to moderate arterial desaturation

inv-34: CRYPTOGENIC STROKE — definition

DefinitionAn ischemic stroke occurring in the absence of identifiable cardiac, pulmonary, vascular, or neurologic sources—i.e., no other cause found after evaluation

Context in policyPFO closure indications require documented cryptogenic ischemic stroke presumed due to paradoxical embolism after specialist evaluation

Documentation requirementNeurologist and cardiologist determinations that stroke was cryptogenic and presumed paradoxical embolism should be documented

inv-35: Guideline sources — key cited guideline and review documents

Primary guideline sourcesAmerican Heart Association/American Stroke Association 2021 Guideline for Prevention of Stroke (Kleindorfer et al., 2021)

Neurology practice advisoryAmerican Academy of Neurology practice advisory on PFO and secondary stroke prevention (Messe et al., 2020)

Reviews and device literatureKey reviews and device/closure literature (e.g., Tobis & Shenoda; multiple observational and device studies cited) and BCBS Association policy reference manual (2024)