CurrentCapital BluecrossPolicy MP 1.039

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

Defines medical necessity and investigational indications for percutaneous transcatheter PFO and ASD closure devices approved by the FDA for Capital BlueCross products; affects providers seeking authorization for these procedures.

Policy Summary

PayerCapital Bluecross

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

Policy CodePolicy MP 1.039

Change TypeNo material clinical or coverage changes

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization referencing FDA‑approved device indications and the policy’s patient selection criteria before scheduling transcatheter PFO or ASD closure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2PFO devices

5 FDA-approvedASD devices

>1.5:1Qp:Qs threshold

25%Prevalence of PFO

Coverage Criteria

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inv-01: PFO Closure — Medically Necessary

Covered when ALL of the following are met:

PFO closure main criteria: 1) Age between 18 and 60 years; 2) Diagnosed patent foramen ovale (PFO) with a right-to-left interatrial shunt confirmed by echocardiography with at least one of the following: (a) observation of microbubbles in the left atrium within three cardiac cycles after opacification of the right atrium; or (b) atrial septal aneurysm on transesophageal examination with septum primum excursion >10 mm; 3) Documented history of cryptogenic ischemic stroke due to presumed paradoxical embolism, as determined by a neurologist and a cardiologist after evaluation to exclude other identifiable causes of stroke (including large-vessel atherosclerotic disease and small-vessel occlusive disease); 4) No exclusion criteria present (e.g., uncontrolled vascular risk factors, other sources of right-to-left shunt such as ASD or fenestrated septum, active untreated infection, or inferior vena cava filter).

References FDA‑approved device indications (e.g., Amplatzer PFO Occluder; GORE CARDIOFORM Septal Occluder).

inv-02: ASD Closure — Medically Necessary

Covered when ANY of the following apply:

ASD closure criteria: - Closure of a fenestration resulting from a prior Fontan procedure; OR - Echocardiographic evidence of an ostium secundum atrial septal defect AND one of the following: (a) clinical evidence of right ventricular volume overload (e.g., pulmonary-to-systemic flow ratio Qp:Qs >= 1.5:1 or right ventricular enlargement); (b) clinical evidence of paradoxical embolism.Qp:Qs >= 1.5:1 for RV volume overload

Devices must be FDA‑approved for ASD closure (e.g., Amplatzer Septal Occluder, GORE CARDIOFORM ASD Occluder).

inv-03: ASD Closure — Investigational

Not covered (investigational) when the following apply:

ASD investigational uses: Transcatheter closure of atrial septal defects is considered investigational for all other indications not meeting the medically necessary criteria above.

Insufficient evidence to support health outcomes for other indications.

inv-04: Coverage by Indication

Coverage stance summarized by clinical indication:

PFO with cryptogenic stroke: PFO closure with a transcatheter device is supported by multiple randomized controlled trials and meta-analyses showing reduction in recurrent events compared with medical therapy in appropriately selected patients; use of strict patient selection criteria to exclude other causes of cryptogenic stroke contributed to positive trial results.appropriate patient selection per trial criteria

Some trials and meta-analyses reported higher rates of atrial fibrillation after closure.

PFO for migraine: Closure of PFO for treatment of migraine is not supported: sham‑controlled randomized trials did not demonstrate significant improvements in migraine symptoms and evidence is insufficient to determine health outcomes.not met

Nonrandomized studies show variable results.

PFO and other associated conditions:

inv-05: Evidence informing coverage

Coverage is informed by guideline and prior policy sources:

Evidence base: Multiple guideline and evidence sources inform coverage decisions, including AHA/ACC and AHA/ASA stroke prevention guidelines, systematic reviews, and the BCBS Association medical policy reviews and referenced randomized trials and observational studies.

References cited in the policy (e.g., items 43–56) and policy history supported the coverage stance.

Coverage is contingent on absence of specific exclusionary conditions. Procedures will be denied if the individual has uncontrolled vascular risk factors (for example, uncontrolled diabetes or uncontrolled hypertension), other sources of right-to-left shunt (such as an atrial septal defect or fenestrated septum), active endocarditis or other untreated infections, or the presence of an inferior vena cava filter.

The evidence does not support PFO closure for migraine or for other non-cryptogenic-stroke indications. Randomized controlled trials and a sham-controlled trial failed to demonstrate consistent, statistically significant improvement in migraine outcomes after PFO closure, and nonrandomized studies report highly variable results; therefore the evidence is insufficient to determine a net health benefit for migraine or other PFO-associated conditions outside of cryptogenic stroke.

Administrative updates to this policy were recorded in the policy history. Most recently, an administrative update on 07/09/2025 removed the Benefit Variations section; providers should consult member benefit documents or contact the payer for any remaining plan-specific variations.

PFO closure for migraine is considered investigational. A available sham-controlled randomized trial and other RCTs did not demonstrate convincing benefit for migraine symptoms; therefore closure for migraine remains unsupported by randomized evidence and is investigational outside of cryptogenic stroke. Small case series for other PFO-associated conditions (e.g., platypnea-orthodeoxia, decompression illness) provide only limited evidence and are insufficient to establish effectiveness.

Closure of a patent foramen ovale solely to treat migraine is not medically necessary based on available randomized evidence, including sham-controlled trials that did not show significant improvement in migraine outcomes after closure.

The policy history entries cite multiple administrative and consensus reviews with no change to the core policy statement; the document extract does not include separate, explicit line items labeled 'Not Medically Necessary' beyond the summarized investigational statements for migraine and other non-cryptogenic indications.

Provider Actions & Documentation

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for percutaneous transcatheter PFO and ASD closure devices. Verify member benefits and obtain prior authorization as required by the member's benefit plan before scheduling the procedure.

Prior authorization requirements are determined by the member's benefit program — contact Provider Services to verify.
Obtain PA prior to procedure when member benefits mandate authorization to avoid claim denials.

Billing Rule

Use Current Codes for Authorization

Use current procedure and diagnosis codes when requesting authorization and submitting claims. The coding listed in this policy may not be comprehensive and is subject to change; always apply up-to-date CPT/HCPCS and ICD-10 codes.

Ensure PA requests reference the same codes that will appear on the claim.
Monitor policy history and coding updates (see Policy History) and document the codes used in the authorization request.

Note

Coverage Contingent on Benefits and Medical Necessity

Coverage for PFO/ASD closure is contingent upon the member's benefit plan and a determination that the service is medically necessary. This policy guides medical necessity but does not guarantee coverage or payment.

Final coverage depends on eligibility and the member's contract terms, including exclusions and limitations.
Payment is subject to medical necessity review and benefit verification.

Denial Risk

Denial Risk from Noncompliance with Updated Coding/Criteria

Failure to follow updated coding standards or the policy's clinical criteria can result in claim denials or delayed payment.

Denials commonly occur when selection criteria (e.g., age limits, confirmed right-to-left shunt, documented cryptogenic stroke workup) are not met or documented.
Ensure claims and prior authorization requests reflect any recent policy or code changes to reduce denial risk.

Documentation Required

Coding and Documentation Note

Code lists in this policy are illustrative and may not be all-inclusive. Identification of a code here does not ensure coverage; coverage is determined by member benefits.

Verify that the codes you use are current and appropriate for the service.
If a code is not listed, contact Provider Services for guidance prior to billing.

Documentation Required

Documentation of Updated Coding and Criteria

Document the codes and policy criteria used at the time of authorization and on the claim. Maintain documentation of any updates to coding or clinical criteria reflected in the authorization.

Include the specific CPT/HCPCS and ICD-10 codes used in the authorization request.
Record the policy version/effective date and any relevant policy history entries when submitting documentation.

Note

Patient Selection Required

Careful patient selection is required prior to PFO closure. Confirm age range, echocardiographic evidence of a right-to-left interatrial shunt, and a documented cryptogenic ischemic stroke with an evaluation that excludes other causes of stroke.

Confirm patient is between 18 and 60 years of age when PFO closure is being considered.
Provide echocardiographic documentation of right-to-left shunt (microbubbles within 3 cardiac cycles or atrial septal aneurysm with septum primum excursion >10 mm).
Include neurologist and cardiologist evaluations documenting exclusion of other identifiable stroke causes (large vessel atherosclerosis, small vessel disease, etc.).

Definitions

Patent Foramen Ovale (PFO)

DefinitionA residual communication between the right and left atria that persists postnatally and can function as a potential right-to-left shunt.

PrevalenceApproximately 25% of asymptomatic adults have a PFO.

Clinical relevanceAssociated with cryptogenic stroke and migraine in some patients; requires echocardiographic confirmation for closure decisions.

Atrial Septal Defect (ASD)

DefinitionA congenital abnormal communication between the atria; ostium secundum defects are mid-septal near the fossa ovalis and are commonly amenable to percutaneous closure.

Clinical featuresSymptoms depend on defect size and ventricular compliance and may include exercise intolerance, dyspnea, atrial fibrillation, and right heart failure signs.

Indications for closureClosure recommended when associated with right ventricular volume overload or paradoxical embolism; Qp:Qs > 1.5:1 supports repair.

Fontan fenestration

DefinitionA surgically created small atrial septal defect made during the Fontan procedure to allow a limited right-to-left shunt and reduce early postoperative pressure and complications.

PurposeReduces right atrial pressure, improves preload of the single ventricle, and decreases early postoperative low cardiac output and pleural effusion risk.

Later managementFenestrations may be closed later if clinically indicated; fenestration closure has been described in the literature and prior policy history.

ANTICOAGULANT

DefinitionAn agent that delays or prevents blood coagulation.

Clinical roleUsed to reduce thromboembolic risk in various cardiac conditions per clinician judgment.

Examples (not exhaustive)Includes vitamin K antagonists and direct oral anticoagulants as classes of agents.

ATRIA

DefinitionThe upper chambers of the heart (right and left atria).

Relation to policyAtrial anatomy and function are central to descriptions of PFOs, ASDs, and fenestrations.

Clinical relevanceAtrial abnormalities (e.g., atrial septal aneurysm) are part of imaging criteria used to assess shunt significance.

CRYPTOGENIC STROKE

DefinitionAn ischemic stroke occurring in the absence of potential cardiac, pulmonary, vascular, or neurologic sources.

Use in policyTerm used to identify patients for whom PFO closure may be considered when cryptogenic stroke is confirmed after exclusion of other causes.

Diagnostic implicationRequires neurologist and cardiologist assessment to exclude other stroke etiologies before closure is authorized.

Fontan fenestration (alternate)

DefinitionA surgically created communication (fenestration) in the atrial septum during the Fontan procedure to permit a small right-to-left shunt.

Prior policy noteFenestration closure following the Fontan procedure has been considered in prior medical necessity criteria and is discussed in literature reports.

Clinical consequenceFenestration balances early postoperative hemodynamic benefits against mild-to-moderate desaturation; later closure may be indicated for complications or optimization.

Revision History

2025-07-09administrative_updateLatest

Removed Benefit Variations section and updated Disclaimer.

2025-05-02consensus_review

Consensus review with no change in policy statement; updated policy guidelines, cross-references, and regulatory status; coding reviewed with no changes.

2024-06-05consensus_review

Consensus review with no change in policy statement; references updated and coding reviewed with no changes.

2023-09-07administrative_update

Added ICD-10 code I21.B to the policy.

2023-06-20consensus_review

Consensus review with no change in policy statement; references updated and coding reviewed with no changes.

2022-08-01administrative_update

ICD-10 codes updated.

2022-07-11minor_review

Added criterion for closure of Fontan fenestration as medically necessary for ASD and added ICD-10 code I50.1; cross references and definitions updated; literature review and references updated.

2021-06-04consensus_review

Consensus review with no change in policy statement; references updated and coding reviewed.

2021-01-06administrative_update

Removal of previously added procedure codes 33741, 33745, 33746 from the policy.

2020-11-17administrative_update

Added procedure codes 33741, 33745, 33746 to the policy.

2020-07-27minor_review

Minor review changing PFO shunt assessment language from '30 microbubbles' to 'observation of microbubbles' and updates to tables and references.

OpenPayer

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

Coverage Criteria

Coding

Provider Actions & Documentation

Background

Definitions

Revision History