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Cardiac Devices and Procedures for Occlusion of the Left Atrial Appendage
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Defines Aetna's medical necessity, experimental/investigational exclusions, provider and site requirements, and coding guidance for left atrial appendage closure (LAAC) devices and procedures in patients with non-valvular atrial fibrillation.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Medical necessity criteria
Covered when ALL of the following are met:
Coverage-related candidate selection
Consider device-based LAA occlusion when ALL of the following are met (per trial populations and expert commentary):
supported by trial enrollment criteria
randomized trials enrolled warfarin-eligible patients while many registries enrolled warfarin-ineligible patients
Maisel and other series noted higher complications at less-experienced centers
multiple studies used TEE at set intervals
Coverage rationale and considerations
Covered when ALL of the following are met (clinical context supported by cited studies and guidance):
Patient selection
- Anticoagulation suitability: Either patient is a candidate for anticoagulation but seeks an alternative to long-term warfarin OR patient has contraindication/intolerance to long-term oral anticoagulationas described in ASAP and expert statements
Documented in trials and reviews
Aetna considers exclusion of the left atrial appendage (LAA) performed alone during open heart surgery (for example, clip, excision, stapling, ligation, oversewing, or plication performed as a standalone procedure) to be experimental and investigational for stroke prevention in atrial fibrillation. This determination does not apply when an FDA‑approved percutaneous LAA closure device is used in conjunction with cardiac surgery for treatment of non‑valvular atrial fibrillation; however, standalone surgical exclusion without supporting evidence is not covered.
Percutaneous left atrial appendage closure using devices other than the Amplatzer Amulet or the Watchman device (for example, the Amplatzer Cardiac Plug, AtriClip, or Lariat Suture Delivery Device) is considered experimental and investigational and is not supported for coverage based on the available evidence and device approvals.
Routine use of LAA occlusion techniques outside of controlled research or special arrangements is not recommended until longer‑term safety and effectiveness are established. Multiple reviewers and commentators have highlighted major safety concerns, incomplete data, and the need for larger randomized trials before substituting device‑based LAA occlusion for standard anticoagulation in broad populations.
For primary stroke prevention in patients who are eligible for and tolerating anticoagulation, percutaneous LAA closure lacks convincing randomized controlled trial evidence of benefit versus anticoagulation; major assessments have concluded that RCT data do not demonstrate clear noninferiority or superiority to anticoagulation for patients without contraindications. Therefore, device therapy should not routinely replace anticoagulation in patients who can receive and tolerate medical therapy.
Devices used off‑label for LAA occlusion (for example, the LARIAT system) do not have FDA approval specifically for LAA closure and have documented safety concerns reported by regulatory agencies and in the literature. Use of such off‑label devices for LAAO is considered investigational and may be excluded from coverage.
Results from randomized trials (e.g., Watchman PROTECT AF/PREVAIL) enrolled patients who were able to tolerate short‑term oral anticoagulation and therefore do not necessarily generalize to patients with true contraindications to long‑term anticoagulation. Caution is warranted when extrapolating trial findings to patients who could not have met the original trial eligibility criteria.
Evidence is insufficient to evaluate the efficacy and safety of surgically implanted LAA clips (for example, AtriClip) as a substitute for anticoagulation. Systematic reviews and health‑technology assessments report heterogeneous techniques, variable success rates, and limited high‑quality comparative data; therefore, surgical clipping for stroke prevention lacks sufficient evidence to support routine coverage as a primary therapy.
Device placement is contraindicated and would likely preclude coverage when there is evidence of intracardiac thrombus, active endocarditis or other infections producing bacteremia, or when placement would interfere with other intracardiac or intravascular structures; these contraindications are specified for the Amplatzer Amulet device labeling.
Current guidelines do not recommend interventional or surgical LAA occlusion as a management strategy specifically for patients with documented NOAC failure; the role of occlusion in the setting of NOAC failure remains uncertain and requires further study and guideline development.
The provided excerpt does not list additional explicit coverage exclusions beyond those already stated, and notes that some authoritative reviews (for example, an UpToDate review) do not mention the AtriClip/clipping device as a standard management option.
A published statement in the literature emphasizes that left atrial appendage occlusion does not eliminate the need for warfarin; device‑based strategies should not be assumed to obviate anticoagulation without careful consideration of the evidence and clinical context.
Cardiac devices and procedures for occlusion of the left atrial appendage that do not meet the stated medical necessity criteria are considered experimental and investigational. This includes technologies and indications beyond those explicitly identified as FDA‑approved (Watchman, Amplatzer Amulet) and supported by trial evidence.
Overall, LAA occlusion is not supported as a routine alternative to warfarin by conclusive long‑term evidence for most patients and remains investigational except in carefully selected patients (for example, those with contraindications to long‑term anticoagulation) or within clinical trials. Ongoing and future randomized studies are needed to define the role of LAAO versus contemporary anticoagulants.
Routine adoption of novel LAA occlusion techniques without randomized comparative evidence and longer‑term outcome data is not supported. Case series are subject to selection bias and limited follow‑up; safety signals and procedural complications underscore the need for randomized trials before broad dissemination of new techniques.
For Medicare beneficiaries, routine percutaneous LAA closure is considered not reasonable and necessary outside approved clinical trials per the CMS National Coverage Determination; CMS allows coverage only under specified clinical trial (CED) conditions given current evidence limitations.
Evidence is limited regarding LAAO use in patients who are completely contraindicated to oral anticoagulation; registries and observational series suggest potential benefit but are insufficient to support broad application without more robust studies specifically enrolling this population.
Incomplete or variable surgical LAA closure techniques (for example, stapler exclusion and some suture methods) have demonstrated high failure rates and may be associated with continued stroke risk; procedures with known low success rates are considered unsupported until better evidence or technique standardization is available.
Use of AtriClip and other epicardial clipping devices is not consistently mentioned in authoritative reviews and guidelines as a standard management option; therefore, routine use outside of established indications or trials is not supported by this policy excerpt.
The excerpted policy text included in this section does not explicitly state any additional interventions as not medically necessary beyond the investigational and not medically necessary determinations already described.
Billing and Coding
| 33267 | Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) [not covered for open heart surgery] |
| 33268 | Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (List separately) [not covered for open heart surgery] |
| 33269 | Exclusion of left atrial appendage, thoracoscopic, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) [not covered for open heart surgery] |
| 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 |
| 93318 | Echocardiography, transesophageal (TEE) for monitoring purposes, including probe placement, real time 2-dimensional image acquisition and interpretation |
| I48.0 | Paroxysmal atrial fibrillation |
| I48.11 | Persistent atrial fibrillation |
| I48.19 | Other persistent atrial fibrillation |
| I48.20 | Chronic atrial fibrillation |
| I48.21 | Permanent atrial fibrillation |
| I48.91 | Unspecified atrial fibrillation |
| I63.30-I63.9 | Cerebral infarction [stroke] (listed as not covered for indications in the CPB) |
| I66.01-I66.9 | Occlusion and stenosis of cerebral arteries, not resulting in cerebral infarction [stroke] (listed as not covered for indications in the CPB) |
| No codes listed |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior Authorization Required for Listed Codes: Prior authorization is required for the CPT/HCPCS codes listed in this policy. CPT codes (for example, 33340 and related procedure codes) are covered only when all applicable selection and medical necessity criteria in this policy are met.
- Prior authorization required for listed CPT/HCPCS codes
- CPT codes covered only if policy selection criteria are met
Prior Authorization and Center/Operator Expertise
Prior authorization should document facility and operator expertise. Devices and procedures for LAA occlusion carry significant procedural risks and have a learning curve; prior authorization should confirm that the procedure will be performed at a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program and by operators who meet manufacturer training and minimum procedure-volume expectations.
- Procedure furnished in hospital with established SHD and/or EP program
- Operator has manufacturer-prescribed training
- Operator meets volume criteria (≥25 transseptal procedures and ≥12 LAAC procedures over 2 years)
Preauthorization — Evidence and Trial Considerations
Preauthorization should reflect the current evidence base and ongoing trials. Given limited definitive randomized trial evidence and ongoing large trials (eg, LAAOS III, PREVAIL/PROTECT AF meta-analyses, Amplatzer Amulet trials), prior authorization should document indications, prior anticoagulation history, and whether the patient would meet trial criteria or CMS coverage-with-evidence-development requirements.
- Document prior anticoagulation trials, contraindications, and rationale for device therapy
- Note ongoing trials (LAAOS III, Amulet trial, PRAGUE-17, ASAP-TOO) and CMS clinical trial/CED status
Prior Authorization / Coverage Confirmation Recommended
Confirm payer/CMS coverage policies before scheduling. Coverage for LAA closure devices may be restricted (eg, CMS NCD limits routine coverage and allows coverage only in certain trials/CED); obtain prior authorization or confirm trial eligibility when applicable.
- CMS NCD may limit routine coverage — coverage may be allowed only within qualifying trials or CED
- Obtain payer prior authorization/coverage confirmation before scheduling
Prior Authorization — Ability to Tolerate Short-term OAC
Document ability to tolerate short-term oral anticoagulation when indicated. Many pivotal trials required that patients be able to tolerate short-term OAC (eg, warfarin for 45 days followed by antiplatelet therapy); preauthorization should document the patient’s ability to tolerate required short-term anticoagulation or provide justification if not possible.
- Document capacity to tolerate short-term OAC (eg, warfarin for initial weeks) when indicated by device instructions or trial regimens
- If unable, provide clinical justification and reference to relevant evidence/trial enrollment
Prior Authorization for LAAO Device Procedures
Prior authorization for LAAO device procedures should include device type, indication (NVAF with specified risk scores or contraindication to long-term OAC), documentation of shared decision-making, and imaging suitability (TEE/CTA).
- Specify device to be implanted (eg, Watchman, Amplatzer Amulet)
- Document CHADS2/CHA2DS2-VASc and HAS-BLED scores
- Attach shared decision-making documentation and MDT note
- Include pre-procedure imaging demonstrating suitable LAA anatomy (TEE/CTA)
Prior Authorization — Amplatzer Amulet (Confirm Indication/Contraindications)
Amplatzer Amulet specific prior authorization considerations: confirm that the patient meets FDA-indicated criteria (NVAF, increased stroke risk by CHADS2/CHA2DS2-VASc, suitable for short-term anticoagulation, seeking non-pharmacologic alternative) and that contraindications are absent.
- Confirm FDA indication: NVAF, increased stroke risk, suitable for short-term anticoagulation, and rationale to seek non-pharmacologic alternative
- Contraindications to exclude: presence of intra-cardiac thrombus; active endocarditis or bacteremia; where device placement would interfere with intra-cardiac or intra-vascular structures
Pre-procedure Multidisciplinary Selection and Documentation
Pre-procedure multidisciplinary selection and documentation is required. The member must be under care of a cohesive multidisciplinary team (MDT), and a formal shared decision-making interaction with an independent non-interventional physician using an evidence-based tool must be documented.
- Document MDT involvement (cardiology, electrophysiology, cardiac surgery, imaging specialists as applicable)
- Document formal shared decision-making using evidence-based tool and independent non-interventional physician note
Prior Authorization — Administrative Details
Prior authorization specifics not specified in excerpt: Some administrative prior authorization requirements (exact forms, submission portals, and code-specific instructions) are not detailed in the provided excerpts; follow payer-specific prior authorization instructions and coding guides.
- Follow Aetna prior authorization submission processes and include clinical documentation as outlined above
- See full policy/coding appendix for exact CPT/HCPCS grouping and billing guidance
Denial Triggers
Triggers for Denial: Lack of required clinical documentation, failure to meet risk-score thresholds, absence of documented shared decision-making, inability to demonstrate MDT care or facility/operator requirements, missing imaging, or unaddressed contraindications can result in denial.
- Denial risk if CHADS2/CHA2DS2-VASc or HAS-BLED thresholds not met
- Denial risk if shared decision-making not documented
- Denial risk if facility/operator qualifications not documented
- Denial risk if pre-procedure imaging or evidence of contraindications absent
Incomplete LAA Exclusion — Denial/Harm Risk
Incomplete LAA exclusion and low rates of echocardiographic-confirmed occlusion have been associated with uncertain or potentially harmful outcomes. Prior authorization and documentation should address technical feasibility and imaging plans to minimize incomplete exclusion.
- Document pre-procedure imaging and plan to confirm complete exclusion (intra-procedural TEE/fluoroscopy and post-procedure TEE/CTA)
- Acknowledge risk of incomplete occlusion and plan for follow-up imaging and management
Insufficient RCT Evidence May Prompt Denial
Insufficient randomized controlled trial evidence may prompt noncoverage decisions. Payers may consider there is inadequate evidence of benefit compared with anticoagulation (particularly NOACs); prior authorization should provide best-available evidence and rationale when seeking coverage.
- Provide RCT and registry evidence applicable to the clinical scenario
- If device is sought for patients who were excluded from trials (eg, unable to tolerate any OAC), justify applicability of existing evidence
Evidence from Trials — Patient OAC Tolerance Requirement
Evidence from pivotal trials required patients able to tolerate OAC. Many randomized trials (eg, PROTECT AF, PREVAIL) enrolled patients able to receive short-term OAC; when requesting coverage for patients truly unable to take OAC, provide specific supporting evidence or consider trial enrollment pathways.
- Indicate whether patient met trial-like eligibility (ability to tolerate short-term OAC) or provide clinical rationale if not
- Consider trial/CED enrollment if patient characteristics fall outside trial populations
Evidence Insufficiency — Authorization Context
Evidence insufficiency noted: systematic reviews and health-technology assessments have concluded current evidence is insufficient to prove percutaneous LAAC is as effective and safe as OAC, and comparative studies versus NOACs are lacking. Use this context in authorization justification.
- Cite HTA conclusions and comparative-evidence limitations when submitting request
- Explain why device therapy is preferred for this patient despite evidence gaps
Contraindications That Preclude Device Placement
Contraindications that preclude device placement must be documented and will preclude approval: presence of intra-cardiac thrombus, active endocarditis or bacteremia, or anatomy where device placement would interfere with intra-cardiac or intra-vascular structures.
- Exclude intra-cardiac thrombus by imaging (TEE/CTA) prior to authorization
- Confirm absence of active endocarditis or bacteremia
- Document that device placement will not interfere with intracardiac/vascular structures
Procedural Authorization — Not Specified in Excerpt
No procedural authorization rules present in the provided excerpts: The excerpts do not list specific per-procedure administrative rules (eg, prior authorization time windows, exact forms). Follow payer-specific procedural authorization instructions.
- Follow Aetna administrative guides for procedural authorization and coding
- Include clinical documentation described elsewhere in this section
No Explicit Authorization/Denial Rules in Excerpt
No explicit authorization or denial triggers presented in some parts of the excerpt: while many clinical triggers are described, certain administrative thresholds or exception pathways are not explicit; contact medical policy or prior authorization services for clarification.
- Contact Aetna medical policy/prior authorization for unclear cases or exceptions
- Provide comprehensive documentation to avoid administrative denials
Provider and Facility Documentation
Provider and Facility Documentation Expectations: Document provider training (manufacturer training), prior procedure counts, multidisciplinary care, facility program status (SHD/EP), and device-specific training and credentialing.
- Document manufacturer-prescribed device training and operator procedural volumes (≥25 transseptal; ≥12 LAAC in 2 years)
- Document hospital SHD/EP program status and MDT oversight
Imaging Confirmation Required
Imaging Confirmation Required: Pre-procedure TEE and/or CTA are required to evaluate LAA anatomy and exclude intra-cardiac thrombus. Intra-procedural imaging (TEE/fluoroscopy) and scheduled post-procedure imaging (eg, 45 days, 1–3 months, and as clinically indicated) should be documented.
- Pre-procedure TEE or CTA to assess anatomy and exclude thrombus
- Intra-procedural TEE/fluoroscopy to confirm deployment
- Post-procedure TEE/CTA at recommended intervals (eg, ~45 days, 1–3 months) to confirm occlusion and evaluate for device thrombus or leak
Procedure and Follow-up Documentation
Procedure and Follow-up Documentation: Authorization requests and medical records should document device type, procedural success/complications, discharge antithrombotic regimen, and follow-up imaging/clinical visits.
- Record device make/model and implant details
- Record immediate procedural outcomes and any complications
- Document discharge medication plan (eg, short-term OAC or antiplatelet regimen) and follow-up imaging schedule
Imaging and Follow-up Documentation
Imaging and Follow-up Documentation: Trials and registries used serial imaging (TEE, CTA) to assess device position, residual leak, and device thrombus; prior authorization and follow-up care plans should include these imaging checkpoints and responsible providers.
- Include plan for TEE/CTA assessments (eg, 45 days, 1–3 months, and later intervals as indicated)
- Plan for managing residual leaks or device thrombus discovered on follow-up imaging
Peri-procedural and TEE Follow-up Documentation
Peri-procedural and TEE Follow-up Documentation: Document intra-procedural imaging findings, peri-procedural adverse events (eg, pericardial effusion, device embolization), and core-lab or echocardiographic confirmation of occlusion at follow-up.
- Document peri-procedural adverse events and interventions (eg, pericardiocentesis, surgical conversion)
- Attach TEE/CTA reports showing occlusion metrics (residual jet <3 mm where applicable)
Post-procedure Imaging and Anticoagulation Documentation
Post-procedure Imaging and Anticoagulation Documentation: Trials used short-term anticoagulation (eg, warfarin for initial weeks) and transition to antiplatelet therapy; document the planned and actual post-implant antithrombotic regimen and imaging confirmation prior to discontinuing OAC when applicable.
- Document intended post-implant antithrombotic regimen and monitoring plan
- Provide imaging confirmation (eg, 45-day TEE) before major changes to antithrombotic therapy
Risk Score Documentation
Risk Score Documentation: Include CHADS2, CHA2DS2-VASc, and HAS-BLED scores in the authorization request and medical record to support stroke risk assessment and bleeding-risk rationale for LAAO.
- Provide CHADS2 and/or CHA2DS2-VASc score
- Provide HAS-BLED score and explanation if ≥3
Step Therapy Requirement and Therapy Sequencing
Step Therapy and Therapy Sequencing Expectations: LAAC is considered a second-line therapy to oral anticoagulation. Document that first-line medical therapy (VKAs or NOACs) was considered and reasons the patient is an appropriate candidate for device therapy (eg, contraindication, major bleed, thromboembolism on anticoagulant, high HAS-BLED).
- Document trial and intolerance/contraindication to long-term OAC when applicable
- State that LAAC is being considered after shared decision-making and MDT review
Randomized Evidence and Consideration of Medical Therapy First
Randomized Evidence and Medical Therapy Considerations: Randomized trials compared percutaneous LAA closure to warfarin; selection for device-based therapy should consider trial eligibility, comparator limitations (warfarin vs NOACs), and shared decision-making outcomes.
- Acknowledge that pivotal trials compared devices to warfarin, not routinely to NOACs
- Document how trial findings apply to the individual patient
Post-procedure Pharmacotherapy Expectations
Post-procedure Pharmacotherapy Expectations: Trials commonly used short-term warfarin followed by dual antiplatelet therapy and then single antiplatelet therapy; authorization and discharge plans should state the expected regimen and monitoring.
- Expect short-term anticoagulation (eg, warfarin for ~6 weeks) then dual antiplatelet therapy to 6 months in many trial protocols
- If alternative regimens are planned (eg, antiplatelet-only), document rationale and supporting evidence
Consideration of Anticoagulation and Alternatives
Consideration of Anticoagulation and Alternatives: Surgical LAAO is often adjunctive at time of cardiac surgery; evidence does not support replacing anticoagulation broadly. For surgical approaches (AtriClip), document that use is adjunctive and post-operative anticoagulation plans are specified.
- Document whether LAAO is concomitant to cardiac surgery or standalone thoracoscopic procedure
- For surgical AtriClip, document intraoperative confirmation and post-op anticoagulation plan
No Additional Step Therapy Requirements Presented
No step therapy requirements were presented in parts of the excerpt beyond the policy statement that LAAC is second-line to oral anticoagulation; when administrative step-therapy rules are unclear, follow payer-specific prior authorization pathways.
- LAAC considered second-line to OAC per policy
- Follow Aetna step-therapy/prior authorization rules if present
Policy History and Review Dates
Policy History and Review Dates: Document versioning and review dates when submitting or referencing policy decisions.
- Effective date: 2009-07-24
- Last review: 01/09/2024; Next review: 09/12/2024
Definitions and Device Glossary
Policy Dates and Revision History
Policy last reviewed on 01/09/2024; reflects current coverage criteria and supporting evidence summaries.
Policy originally became effective on 07/24/2009 establishing coverage criteria for left atrial appendage occlusion devices and procedures.
Policy last reviewed on 01/09/2024; prior authorization requirements are noted elsewhere in the full policy and are not specified in the provided excerpt.
Policy originally became effective on 07/24/2009; see full policy for coding and prior authorization details.
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