Patent Foramen Ovale and Left Atrial Appendage Closure Devices
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Covers transcatheter closure of PFO and transcatheter or open left atrial appendage (LAA) closure devices for prevention of stroke; governs medical necessity determinations and coverage for BCBS North Carolina members and providers.
No material clinical or coverage changes in this revision.
Coverage Criteria for PFO and LAA Closure
PFO closure — Medically Necessary
Covered when ANY ONE of the following criteria sets are met:
Transcatheter closure must use an FDA‑approved device for PFO closure.
LAA closure — Medically Necessary
Covered when ALL of the following are met:
Device should be FDA‑approved for the indicated use when applicable.
PFO closure for secondary stroke prevention
Covered when ALL of the following are met (as supported by trials and guideline statements in these chunks):
Supported by randomized trials (eg, REDUCE), guideline advisories (AAN, ESO) and device PMA; device contraindication includes inability to take antiplatelet/anticoagulation.
Indications with insufficient evidence / not routinely recommended
Not covered/Not routinely recommended when ANY of the following apply:
Guideline panels and RCT evidence do not support routine closure for TIA alone, migraine, or DCS; selected exceptional cases may be considered individually with supporting documentation.
LAA closure: when to consider
Coverage considerations summarized from evidence and guideline context
FDA trials generally required suitability for a period of anticoagulation; CMS guidance specifies stroke‑risk thresholds and differs in wording regarding long‑term anticoagulation ineligibility.
PFO closure: migraine and POS
PFO closure for migraine and platypnea‑orthodeoxia considerations
Guideline statements (American Headache Society, SCAI) advise against routine closure for migraine.
Selection should be individualized and documented; evidence is limited.
LAAC appropriateness and procedural requirements
Covered when ALL of the following are met (per SCAI/HRS consensus and trial eligibility considerations):
SCAI/HRS consensus supports appropriateness in carefully selected patients.
Operator experience and adherence to device labeling are required per consensus statements.
Management should be tailored to bleeding risk and device‑specific recommendations.
Coverage summary
Coverage considerations summarized from evidence and guideline context:
Supported by guideline statements and trial/registry data.
Trial and registry outcomes should inform patient selection and counseling.
Surgical techniques and device use should be documented when performed as adjunct to other cardiac surgery.
Medically Necessary when criteria are met
Procedures may be considered medically necessary when documented clinical criteria in the policy are satisfied for the specified indications.
See coding and indication sections in the policy for device‑ and code‑specific details.
Medical necessity for transcatheter PFO closure (details not present)
Policy states medical necessity (MN) criteria for transcatheter PFO closure have been clarified (details not contained in these excerpts).
Refer to the full policy text for the explicit MN criteria and required documentation.
Medical Necessity Criteria (referenced)
Policy includes medical necessity (MN) criteria for PFO closure (referenced in revision history).
Excerpted chunks reference clarification but do not reproduce the full criteria.
Coverage position history
Document revision notes describing coverage stance changes
See revision entries for dates of clarification.
Detailed rationale and conditions for this designation are in the full policy history.
Policy position summaries
Policy‑level position changes noted in revision history
Consult full policy for current coverage stance and any exceptions.
Coverage positions (history)
Policy position history (partial):
Refer to the full policy body for explicit coverage criteria and decision logic.
Coverage overview / policy history
See full policy for detailed medical necessity criteria
This section summarizes history and does not replace the policy body.
This policy covers transcatheter closure of patent foramen ovale (PFO) and transcatheter or open left atrial appendage (LAA) closure using occlusion devices for prevention of stroke. The document does not address percutaneous transcatheter closure of atrial septal defects (ASDs), and it also excludes surgical ligation or amputation of the LAA when the technique does not involve placement of an LAA device (scope exclusions are noted in the policy description).
Certain device labeling explicitly lists contraindications. For example, the GORE CARDIOFORM Septal Occluder PMA specifies that the device is contraindicated in individuals who are unable to take antiplatelet or anticoagulation therapy. Such labeling should be followed when considering device implantation.
The policy states that evidence is insufficient to routinely support several non-stroke indications. Specifically, PFO closure for isolated TIA without imaging-confirmed infarction, routine closure for migraine (in the absence of a prior PFO-associated stroke), and closure to prevent decompression sickness (DCS) in divers lack adequate evidence of benefit and are not routinely recommended. The document’s position classifies many of these uses as investigational or not medically necessary.
Randomized trials and registries that formed the basis for LAA device evaluations generally excluded individuals who were contraindicated to warfarin; several post‑market registries likewise excluded warfarin‑contraindicated patients. This means many pivotal studies did not include people who could not receive anticoagulation, and trial eligibility should be reviewed when extrapolating results to such patients.
Federal and State law, as well as contract language and specific contract provisions or exclusions, take precedence over this Medical Policy. The member’s contract benefits in effect on the date of service must be used when determining eligibility for coverage; medical policy is used to assess medical efficacy but does not override applicable contractual or legal requirements.
There is insufficient evidence to support performing surgical LAA occlusion with a cardiac device as an adjunct to other open cardiac procedures for routine management of atrial fibrillation. The SCAI/HRS 2023 joint statement and the policy note that combined procedures with LAAC are not routinely recommended pending randomized trial data.
Open surgical exclusion of the left atrial appendage (for example, CPT 33267 and the corresponding open ICD-10-PCS approaches) is listed in the policy as investigational or excluded when indicated by the Position Statement, and surgical (non‑percutaneous) implantation of LAA devices is designated investigational and not medically necessary for all indications in the document history.
The policy contains explicit investigational (INV) and not medically necessary (NMN) statements for certain uses, including surgical non‑percutaneous LAA device implantation and other indications noted in the revision history. Where an INV/NMN designation applies, the procedure and associated codes are considered not covered unless changed by later evidence or policy revision.
This document focuses on PFO closure and LAA closure devices and does not address percutaneous transcatheter closure of atrial septal defects (ASDs). Related congenital or structural procedures (for example, certain VSD or ASD device closures) have been removed or transferred to other policies (see revision history and SURG.00123 for those topics).
Coding and Billing
| No codes listed |
| 93580 | Percutaneous transcatheter closure of congenital interatrial communication (ie, Fontan fenestration, atrial septal defect) with implant [ when specified as closure of patent foramen ovale ] |
| 33340 | Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation |
| 02U53JZ | Supplement atrial septum with synthetic substitute, percutaneous approach [ when specified as closure of patent foramen ovale ] |
| 02L73CK | Occlusion of left atrial appendage with extraluminal device, percutaneous approach |
| 02L73DK | Occlusion of left atrial appendage with intraluminal device, percutaneous approach |
| 02L74CK | Occlusion of left atrial appendage with extraluminal device, percutaneous endoscopic approach |
| 02L74DK | Occlusion of left atrial appendage with intraluminal device, percutaneous endoscopic approach |
| 33267 | Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) |
| G45.9 | Transient cerebral ischemic attack, unspecified |
| I25.3 | Aneurysm of heart |
| I51.0 | Cardiac septal defect, acquired |
| I63.81-I63.89 | Other cerebral infarction |
| I63.9 | Cerebral infarction, unspecified |
| Q21.12 | Patent foramen ovale |
| Z86.73 | Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits |
| I48.0 | Paroxysmal atrial fibrillation |
| I48.11-I48.19 | Persistent atrial fibrillation |
| I48.20-I48.21 | Chronic atrial fibrillation |
| I48.91 | Unspecified atrial fibrillation |
| 02L70CK | ICD-10-PCS code referenced in policy revisions |
| 02L70DK | ICD-10-PCS code referenced in policy revisions |
| 02L74CK | ICD-10-PCS code referenced in policy revisions |
| 02L74DK | ICD-10-PCS code referenced in policy revisions |
| P120021 | FDA PMA number for AMPLATZER PFO Occluder (reference) |
| P050006/S060 | FDA PMA number for GORE CARDIOFORM Septal Occluder (reference) |
| P130013 | FDA PMA number for WATCHMAN Left Atrial Appendage Closure Device (reference) |
| P130013/S035 | FDA PMA supplement for WATCHMAN FLX (reference) |
| 0281T | CPT code removed (deleted 12/31/2016) |
| I63.8 | ICD-10 code replaced (historical reference) |
| I63.81-I63.89 | ICD-10-CM codes added replacing I63.8 (per update) |
| 0281T | Deleted CPT code (deleted 12/31/2016) |
| 0281T | CPT code removed 12/31/2016 (referenced as deleted) |
| 0281T | Deleted 12/31/2016 (referenced in coding history) |
| 01/01/2012 CPT changes | Coding section updated to reflect CPT changes effective 01/01/2012 (specific CPT codes not listed in these chunks). |
| ICD-9 codes removed | ICD-9 codes were removed from the Coding section (specific codes not present in these chunks). |
| No codes listed |
| 01/01/2012 CPT changes | Coding section updated with 01/01/2012 CPT changes (exact CPT codes not listed in these chunks) |
| No codes listed |
Provider Actions, Prior Authorization, and Documentation
Denial risk when MN criteria unmet — supply required documentation
Expect denial if the policy’s medical necessity criteria are not met or if required documentation supporting MN criteria is omitted; services and listed codes will be denied as Not Medically Necessary in those cases.
- Transcatheter PFO or LAA closure is not medically necessary when the policy criteria are not met.
- Procedures and associated codes are considered Not Medically Necessary when coverage criteria are not satisfied; codes for other diagnoses may be Investigational and NMN.
Prior authorization for PFO closure — specialist evaluation required
For PFO closure, obtain prior authorization only for selected patients after comprehensive evaluation and specialist determination (neurology and cardiology) that the cryptogenic stroke is attributable to PFO and that medical necessity criteria are met.
- PFO closure indication requires evaluation by a neurologist and cardiologist to exclude other causes of ischemic stroke.
- Policy states PFO closure is considered for carefully selected patients (typically 18–60 years, with some societies extending to 65) after thorough evaluation.
Anticoagulation suitability & stroke‑risk documentation
Document stroke‑risk assessment and suitability for anticoagulation when seeking coverage for LAA devices; FDA labeling and CMS guidance restrict use to patients suitable for a period of anticoagulation and CMS specifies CHADS2 ≥2 or CHA2DS2‑VASc ≥3 for consideration.
- FDA labeling specifies patients should be deemed suitable for anticoagulation and a period of periprocedural anticoagulation.
- CMS has specified CHADS2 ≥2 or CHA2DS2‑VASc ≥3 as thresholds for consideration.
Prior authorization depends on member contract
Verify member coverage and any prior authorization requirements against the member’s contract in effect on the date of service; federal/state law and contract provisions take precedence over this policy.
- Federal and State law and contract language take precedence over Medical Policy.
- The member's contract benefits in effect on the date services are rendered must be used to determine eligibility.
Prior authorization recommended for LAAC
Recommend obtaining prior authorization for LAAC requests because evidence supports LAAC as an alternative in selected patients and authorization allows verification of stroke‑risk, anticoagulation status, and prior therapies.
- LAAC may be considered for NVAF patients at increased stroke risk who are poor candidates for long‑term anticoagulation; trials show noninferiority for thromboembolism and lower bleeding in selected populations.
- Prior authorization should require documentation of CHA2DS2‑VASc, contraindications or intolerance to long‑term anticoagulation, and prior therapies.
Prior authorization for device procedures — use listed codes
When requesting coverage, submit procedure and diagnosis codes that match the current coding section; prior authorization decisions may rely on the CPT/ICD‑10‑PCS codes listed in the policy.
Prior authorization not specified in these excerpts — confirm with payer
If authorization is being considered from the provided excerpts alone, note the policy header does not explicitly list a mandatory prior authorization process in these chunks; check the full policy or payer portal for authorization requirements.
- The policy header and excerpts do not explicitly list required prior authorization codes or a mandatory prior authorization process in the provided text.
- Providers should confirm local payer prior‑auth processes beyond the policy text.
Prior authorization likely required — verify and document MN criteria
Anticipate prior authorization is likely required when medical necessity criteria must be verified for coverage decisions; obtain authorization when criteria apply and submit supporting clinical documentation.
- The policy includes position statements and coverage determinations for PFO and LAA closure devices; providers should obtain prior authorization when coverage criteria apply.
- Providers must supply documentation demonstrating MN criteria are met per the policy.
Standard‑of‑care preference — OAC remains preferred
If LAA closure is sought for patients who are suitable for anticoagulation, note oral anticoagulation remains the preferred standard of care and such patients are not the primary intended candidates for device placement.
- Oral anticoagulation remains the preferred therapy for most patients with AF and elevated stroke risk.
- LAA occlusion is an alternative primarily for patients who are poor candidates for long‑term anticoagulation.
PFO pre‑procedure diagnostic work‑up — document comprehensive evaluation
Provide comprehensive pre‑procedure diagnostic work‑up for PFO closure requests: vascular imaging, bloodwork, transthoracic and transesophageal echocardiography, ECG and cardiac monitoring, and neurologist confirmation to exclude other stroke causes.
- Policy lists arterial investigations (MRA, CTA, or catheter arteriography), biological work‑up (CBC, ESR, CRP, coagulation tests, antiphospholipid antibodies), TTE and TEE, ECG and cardiac monitoring.
- PFO device labeling and trials require determination by a neurologist and cardiologist following evaluation to exclude known causes of ischemic stroke.
No step‑therapy program specified in excerpts
There are no step‑therapy requirements specified in the provided policy excerpts; do not assume mandatory step therapy beyond documentation of prior medical therapy where the MN criteria require failed or not‑candidate status.
- The policy and extracted sections state no step therapy rules are present in these chunks.
- For PFO, the policy references failure of or ineligibility for conventional drug therapy as part of MN criteria, not a formal step‑therapy program.
Background and Scope
Patent foramen ovale closure is used as a secondary prevention strategy to reduce recurrent ischemic stroke in selected patients with a cryptogenic stroke attributed to paradoxical embolism. Randomized trials and device PMA data support device closure plus antiplatelet therapy in appropriately selected individuals.
Definitions and Key Terms
Document Revision History
Policy published with header showing Published 2026-01-06 and Last review 2025-11-06.
Last review recorded in document header (Last review 2025-11-06).
Medically necessary (MN) criteria for transcatheter PFO closure clarified (document notes 'Clarified MN criteria for transcatheter closure of a PFO').
Coding section updated to reflect 01/01/2017 CPT changes and deleted CPT code 0281T (removed 12/31/2016).
Position statements for PFO clarified and an investigational/not medically necessary statement for LAA added (document history entry).
Position statements for PFO were clarified and an investigational/not medically necessary statement for left atrial appendage (LAA) closure was added.
Policy updated (02/02/2017) with clarified MN criteria for transcatheter PFO closure and updates to Rationale, Background, Index, References and Websites.
Most recent publication of the policy reflected in header (Published 2026-01-06) with prior position clarifications incorporated.
MPTAC review and title change noted in document history (changed title to 'Transcatheter Closure of Cardiac Defects' in historical entries).
Coding section updated with CPT changes effective 01/01/2012 (document history entry).
Document header shows latest publication date (Published 2026-01-06) and compiles prior revision history entries.
Left atrial appendage (LAA) closure was designated investigational and not medically necessary (document history entry).
MPTAC review recorded (08/19/2010) in which coverage statements including LAA were addressed in history entries.
Document history reiterates LAA investigational/NMN designation in compiled revision notes in the published policy header.
2022 SCAI guideline recommendations noted that routine PFO closure for migraine (without prior PFO-associated stroke) is not suggested (conditional recommendation).
Policy states insufficient clinical evidence to support PFO closure for migraine and references SCAI/American Headache Society guidance in document text and history.
CPT code 0281T was deleted effective 12/31/2016 and removed from the policy coding section (document notes removal).
Coding updates reflecting 01/01/2017 CPT changes were applied to the policy (document history entries).
Policy updated to reflect 01/01/2017 CPT coding changes (document history indicates Updated Coding section with 01/01/2017 CPT changes).
Deleted CPT code 0281T removed from coding lists as of 12/31/2016 (document history entry).
Coding section updated with 01/01/2017 CPT changes; deleted code 0281T noted as removed 12/31/2016.
Prior coding update reflected in history for 01/01/2012 CPT changes (document history entry).
Document history records coding section updates effective 01/01/2012 (CPT changes noted in revision history).
Coding section updated again for 01/01/2017 CPT changes and removal of deleted code 0281T (document history entries).
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