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    OpenPayerPolicy UpdatesCardiologyPremera LAAC Device Coverage Update | OpenPayer
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    ModifiedPremera Blue Cross of WashingtonPolicy 2.02.519

    Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

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    This policy governs medical necessity and documentation for percutaneous endovascular left atrial appendage closure or occlusion devices used to reduce stroke risk in individuals with nonvalvular atrial fibrillation. It applies to providers submitting these services for coverage review.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyPercutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation
    Policy CodePolicy 2.02.519
    Change TypeModified
    Effective DateFeb 5, 2027
    Last ReviewOct 13, 2026
    Next Review DateNot specified
    Key ActionUse an FDA Premarket Approval-approved LAAC device for its FDA-approved indication and confirm the required stroke-risk score.
    SourceLink
    POLICY UPDATE CHANGES

    Medical-necessity criteria were revised to add specific clinical and risk-score requirements.

    Policy 2.02.519 replaced policy 2.02.26.

    Policy statements were clarified and specific medical-necessity criteria were added.

    FDA PMA requiredDevice regulatory requirement
    CHA₂DS₂-VASc ≥2/≥3Stroke-risk threshold
    HAS-BLED ≥3Bleeding-risk threshold
    ≥25 proceduresPrior operator experience
    33340Listed procedure code

    Medical Necessity and Coverage Criteria

    FDA-approved percutaneous LAAC — medically necessary

    Percutaneous endovascular closure or occlusion of the left atrial appendage using an FDA Premarket Approval-approved device is medically necessary when ALL of the following criteria are met.

    All medical-necessity criteria

    • Clinical and risk criteria: The individual has nonvalvular atrial fibrillation; has an elevated annual stroke risk based on a CHA₂DS₂-VASc score of at least 2 in males or at least 3 in females; is a candidate for long-term anticoagulation therapy based on the estimated risk of stroke and other systemic thromboembolic events; has a contraindication to long-term oral anticoagulation due to a nonreversible cause; and has a high risk of major bleeding on long-term oral anticoagulation with a HAS-BLED score of at least 3.CHA₂DS₂-VASc ≥2 in males or ≥3 in females; HAS-BLED ≥3

      All listed clinical and risk criteria are required.

    FDA-approved device requirement

    The procedure must use a percutaneous left atrial appendage closure device with FDA Premarket Approval for stroke prevention in atrial fibrillation.

    FDA-approved device requirement: The device used for percutaneous left atrial appendage closure has received FDA Premarket Approval for this indication.FDA PMA

    Qualifying devices identified in the policy include the Watchman system, including Watchman FLX, and the Amplatzer Amulet.

    Other percutaneous LAAC devices — investigational

    Other percutaneous left atrial appendage closure devices are considered investigational and are not supported for coverage under this policy.

    Investigational device exclusion: The procedure does not use a percutaneous left atrial appendage closure device other than an FDA-approved device for LAAC.

    Devices identified as examples include the Lariat and Amplatzer Cardiac Plug. The Amplatzer Cardiac Plug is FDA-approved for atrial septal defect closure, but not for LAAC; the Percutaneous LAA Transcatheter Occlusion device also has not received FDA approval.

    CMS coverage conditions for percutaneous LAAC

    CMS covers an FDA-PMA-approved LAAC device for its FDA-approved indication when ALL applicable conditions below are met.

    All CMS coverage conditions

    • ONE of the following stroke-risk thresholds

      • The patient has a CHADS2 score of at least 2.CHADS2 ≥2
      • The patient has a CHA2DS2-VASc score of at least 3.CHA2DS2-VASc ≥3
    • A formal shared decision-making interaction occurs with an independent non-interventional physician using an evidence-based oral-anticoagulation decision tool for patients with nonvalvular atrial fibrillation, and the interaction is documented in the medical record.
    • The patient is suitable for short-term warfarin but is deemed unable to take long-term oral anticoagulation after shared decision-making; LAAC is used as second-line therapy to oral anticoagulants.
    • The patient is under the care of a cohesive multidisciplinary team before and after the procedure, and the procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program.
    • The procedure is performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who has completed manufacturer-prescribed training on safe and effective device use before performing LAAC and has performed at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum.≥25 prior transseptal procedures
    • The operator continues to perform at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum over a 2-year period, including at least 12 LAAC procedures.≥25 over 2 years, including ≥12 LAAC procedures
    • The individual is enrolled in an approved registry tracking outcomes for the procedure and device.

    Watchman FDA-approved indication

    The Watchman device is indicated when ALL of the following conditions are met.

    • Population: The individual has nonvalvular atrial fibrillation.
    • Stroke risk and anticoagulation: The individual is at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and is recommended for anticoagulation therapy.
    • Warfarin suitability: The individual is deemed suitable for warfarin.
    • Rationale for nonpharmacologic alternative: The physician determines that there is an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared with warfarin.

    Medically necessary criteria

    The revised medically necessary criteria require ALL of the following clinical and risk conditions.

    Revised medical-necessity criteria

    • Nonvalvular atrial fibrillation: The individual has nonvalvular atrial fibrillation.
    • Elevated annual stroke risk: The individual has an elevated annual risk of stroke based on a CHA₂DS₂-VASc score of at least 2 in males or at least 3 in females.CHA₂DS₂-VASc ≥2 in males or ≥3 in females
    • Candidacy for anticoagulation: The individual is a candidate for long-term anticoagulation therapy based on the estimated risk of stroke and other systemic thromboembolic events.
    • Nonreversible contraindication: The individual has a contraindication to long-term oral anticoagulation due to a nonreversible cause.
    • High major-bleeding risk: The individual has a high risk of major bleeding on long-term oral anticoagulation, with a HAS-BLED score of at least 3.HAS-BLED ≥3

    Percutaneous left atrial appendage closure using a device without FDA Premarket Approval (PMA) for LAAC is considered investigational. Coverage is limited to devices approved for percutaneous LAAC for stroke prevention and to individuals who meet all applicable medical-necessity criteria.

    Devices that do not have FDA approval for percutaneous LAAC are not supported for coverage. Policy examples include the Lariat and Amplatzer Cardiac Plug; evidence for these devices is insufficient to establish improvement in net health outcomes, and they may be denied when used for percutaneous LAAC.

    Coding and Threshold Reference

    Covered CPT CodesCPTCovered
    33340Percutaneous 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
    FDA Product Codemixed
    NGVFDA product code
    CHA₂DS₂-VASc score
    ThresholdCHA₂DS₂-VASc score ≥2 in males or ≥3 in females
    Applies toIndividuals with non-valvular atrial fibrillation
    PurposeDocuments elevated annual stroke risk supporting medical necessity for percutaneous left atrial appendage closure
    HAS-BLED score
    ThresholdHAS-BLED score ≥3
    Risk assessedHigh risk of major bleeding while receiving long-term oral anticoagulation
    Score range0 to 9
    CHADS2 score
    CMS thresholdCHADS2 score ≥2
    Alternative thresholdMay be met instead with a CHA2DS2-VASc score ≥3
    UseSupports Medicare coverage for percutaneous left atrial appendage closure when other conditions are met
    CHA2DS2-VASc score
    CMS thresholdCHA2DS2-VASc score ≥3
    Alternative thresholdMay be met instead with a CHADS2 score ≥2
    UseEstablishes qualifying stroke risk for Medicare coverage when other conditions are met
    Prior transseptal procedures
    Minimum experienceAt least 25 qualifying procedures
    Procedure typeInterventional cardiac procedures involving transseptal puncture through an intact septum
    Operator requirementMust be performed by an eligible interventional cardiologist, electrophysiologist, or cardiovascular surgeon trained by the manufacturer
    Continuing transseptal procedure volume
    Two-year volumeAt least 25 qualifying transseptal cardiac procedures over a 2-year period
    LAAC volumeAt least 12 of the procedures must be LAAC procedures
    Procedure typeTransseptal puncture through an intact septum
    CHA₂DS₂-VASc stroke-risk score
    Revised thresholdCHA₂DS₂-VASc score ≥2 in males or ≥3 in females
    Risk measuredElevated annual risk of stroke
    Policy applicationSupports the revised medical-necessity criteria for percutaneous left atrial appendage closure
    HAS-BLED bleeding-risk score
    Revised thresholdHAS-BLED score ≥3
    Risk measuredHigh risk of major bleeding on long-term oral anticoagulation
    Policy applicationSupports the revised medical-necessity criteria for percutaneous left atrial appendage closure

    Provider Requirements and Denial Risks

    Prior Authorization

    Use an FDA-Approved Device and Confirm Stroke Risk

    Use a percutaneous left atrial appendage closure device with FDA Premarket Approval (PMA) for the FDA-approved indication, such as Watchman or Amplatzer Amulet. Confirm the applicable stroke-risk threshold before requesting coverage: CHA₂DS₂-VASc must be at least 2 in males or at least 3 in females; Medicare may also require CHADS₂ ≥2 or CHA₂DS₂-VASc ≥3.

    • Confirm the selected device has US FDA PMA for percutaneous LAAC.
    • Document nonvalvular atrial fibrillation and the applicable stroke-risk score.
    Documentation Required

    Complete Shared Decision-Making Before LAAC

    Before LAAC, arrange a formal shared decision-making interaction with an independent non-interventional physician using an evidence-based oral-anticoagulation decision tool for patients with nonvalvular atrial fibrillation. Document the interaction and ensure the patient is suitable for short-term warfarin but unable to take long-term oral anticoagulation.

    • The discussion must occur before LAAC and be documented in the medical record.
    • LAAC is covered only as a second-line therapy to oral anticoagulants.
    Prior Authorization

    Meet Team and Facility Requirements

    Ensure the patient is managed preoperatively and postoperatively by a cohesive, multidisciplinary team of medical professionals. The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.

    • Document the multidisciplinary team overseeing the patient.
    • Confirm the facility has an established SHD and/or EP program.

    Unsupported block type: documentation

    Unsupported block type: prior_auth

    Unsupported block type: prior_auth

    Unsupported block type: documentation

    Documentation Required

    Include All Required Medical Record Elements

    Submit medical records demonstrating that all medical-necessity criteria are met. The record must identify the FDA-approved device and document the diagnosis, stroke-risk score, long-term OAC indication, nonreversible long-term OAC contraindication, and elevated bleeding risk.

    • Name of the FDA device to be used.
    • Nonvalvular atrial fibrillation with CHA₂DS₂-VASc ≥2 in males or ≥3 in females.
    • Contraindication to long-term OAC due to a nonreversible cause.
    • HAS-BLED score ≥3 indicating high major-bleeding risk on long-term OAC.
    Documentation Required

    Document Shared Decision-Making

    Document the formal shared decision-making interaction in the medical record, including that it was conducted by an independent non-interventional physician using an evidence-based decision tool addressing oral anticoagulation in nonvalvular atrial fibrillation.

    • Identify the independent physician and the evidence-based tool used.
    • Record the discussion and conclusion before LAAC.
    Documentation Required

    Document Anticoagulation Suitability and Rationale

    Document both the patient’s suitability for short-term warfarin and the clinical rationale for determining that the patient cannot take long-term oral anticoagulation. The long-term OAC contraindication must be attributable to a nonreversible cause.

    • Record suitability for short-term warfarin.
    • Record the nonreversible contraindication to long-term OAC.
    • Support the rationale for LAAC as second-line therapy.
    Prior Authorization

    Complete Required Registry Enrollment

    When Medicare national coverage requirements apply, document enrollment in an approved registry that tracks outcomes for the procedure and device.

    • Confirm registry enrollment before or as required for the procedure.
    • Retain documentation of the approved registry.
    Denial Risk

    Failure to Meet All Criteria May Result in Denial

    Coverage is at risk when any medical-necessity or Medicare coverage condition is not met. Before the procedure, verify and document every applicable patient, decision-making, anticoagulation, team, facility, operator, volume, and registry requirement.

    • All applicable coverage conditions must be satisfied.
    • Missing or insufficient documentation may result in denial.
    Denial Risk

    Unapproved or Investigational Device

    Percutaneous LAAC using an unapproved or investigational device is not covered as medically necessary. Devices without FDA PMA for the FDA-approved percutaneous LAAC indication are considered investigational.

    • Do not submit unapproved or investigational LAAC devices as covered services.
    • The Lariat and Amplatzer Cardiac Plug are examples identified as investigational for this indication.
    Denial Risk

    Non-FDA-Approved LAAC Devices Are Not Covered

    Do not use a percutaneous LAAC device other than Watchman or Amplatzer Amulet for covered stroke prevention unless the device has the required US FDA approval for this indication. Other devices, including Lariat and Amplatzer Cardiac Plug, are not approved for percutaneous LAAC in the US.

    • Watchman and Amplatzer Amulet are the identified FDA-approved device examples.
    • Lariat and Amplatzer Cardiac Plug are non-FDA-approved alternatives for percutaneous LAAC.
    Denial Risk

    Failure to Meet Coverage Conditions

    Medicare coverage may be denied when any required coverage condition is absent, including the applicable stroke-risk threshold, independent physician shared decision-making, short-term warfarin suitability, inability to take long-term OAC, cohesive multidisciplinary care, qualified facility and operator requirements, ongoing procedural volume, or approved registry enrollment.

    • Review all Medicare national coverage conditions before scheduling LAAC.
    • Use the medical record to demonstrate compliance with each applicable condition.
    Denial Risk

    Use Only Devices Approved in the US for Percutaneous LAAC

    Devices that do not have US approval for percutaneous LAAC present denial risk. The Lariat Loop Applicator was cleared through 510(k) for surgical soft-tissue suture placement, not percutaneous LAAC; Amplatzer Cardiac Plug and WaveCrest have had European CE approval but are not currently approved in the US for this indication.

    • Do not treat FDA 510(k) clearance for another surgical use as approval for percutaneous LAAC.
    • Do not use devices lacking US approval for percutaneous LAAC as covered devices.

    Clinical Background

    Atrial fibrillation is an irregular, often rapid atrial rhythm that can cause blood to pool, particularly in the left atrial appendage, where thrombus may form. If thrombus embolizes into the systemic circulation, it can cause an ischemic or embolic stroke. Percutaneous left atrial appendage closure is a nonpharmacologic approach intended to prevent thrombus from entering the circulation when long-term oral anticoagulation is unsuitable because of bleeding risk or a nonreversible contraindication.

    Definitions and Abbreviations

    Atrial fibrillation (AF)
    DefinitionAn irregular heart rhythm in which the atria beat irregularly and often rapidly
    Clinical consequenceIncreases the risk of blood pooling, thrombus formation, and embolic stroke
    Policy populationThe policy addresses individuals with atrial fibrillation who may receive left atrial appendage closure for stroke prevention
    Percutaneous left atrial appendage closure/occlusion (pLAAC/LAAO)
    ProcedurePercutaneous endovascular closure or occlusion of the left atrial appendage
    PurposePrevents thrombus from entering the systemic circulation and causing stroke
    Alternative namesPercutaneous left atrial appendage closure or occlusion, abbreviated pLAAC/LAAO
    CHA₂DS₂-VASc
    DefinitionA risk score used to estimate annual thromboembolic, primarily ischemic stroke, risk
    PopulationIndividuals with nonvalvular atrial fibrillation
    Scored factorsCongestive heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, vascular disease, and sex category
    HAS-BLED
    DefinitionA bleeding-risk score used to assess annual risk of significant bleeding in individuals with atrial fibrillation treated with warfarin
    Score range0 to 9
    Factors evaluatedHypertension, abnormal renal or liver function, stroke, bleeding, labile INR, age, and drugs or alcohol use
    Long-term oral anticoagulation (OAC)
    DefinitionOral anticoagulant treatment used to reduce the risk of stroke and systemic thromboembolism in atrial fibrillation
    Policy requirementThe individual must have a contraindication to long-term oral anticoagulation due to a nonreversible cause
    Coverage contextLeft atrial appendage closure is used as a second-line therapy when the patient is unable to take long-term oral anticoagulation
    CHADS2
    DefinitionA clinical risk score for stroke and systemic embolism in atrial fibrillation
    FactorsCongestive heart failure, hypertension, age, diabetes, and prior stroke, transient ischemic attack, or thromboembolism
    CMS thresholdA score of ≥2 qualifies as one pathway for Medicare coverage of percutaneous left atrial appendage closure
    CHA2DS2-VASc
    DefinitionA clinical risk score for stroke and systemic embolism in atrial fibrillation
    FactorsCongestive heart failure, hypertension, age, diabetes, prior stroke, transient ischemic attack, or thromboembolism, vascular disease, and sex category
    CMS thresholdA score of ≥3 qualifies as one pathway for Medicare coverage of percutaneous left atrial appendage closure
    Nonvalvular atrial fibrillation (NVAF)
    DefinitionAtrial fibrillation not caused by a mechanical heart valve or moderate-to-severe mitral stenosis
    AbbreviationNVAF
    Policy useThe population described in the FDA-approved Watchman indications and Medicare coverage conditions
    Percutaneous left atrial appendage closure (LAAC)
    DefinitionA percutaneous procedure that closes or occludes the left atrial appendage
    PurposeReduces embolic stroke risk in atrial fibrillation
    Treatment roleProvides a nonpharmacologic alternative to oral anticoagulant medications for selected individuals
    LAA
    AbbreviationLAA
    ExpansionLeft atrial appendage
    Clinical relevanceThe cardiac structure targeted by percutaneous closure or occlusion to reduce embolic stroke risk
    NVAF
    AbbreviationNVAF
    ExpansionNonvalvular atrial fibrillation
    Policy contextThe population addressed by the FDA-approved indications for left atrial appendage closure devices
    OAC
    AbbreviationOAC
    ExpansionOral anticoagulant
    Policy contextOral anticoagulation is considered before left atrial appendage closure and may be contraindicated for a nonreversible cause
    PMA
    AbbreviationPMA
    ExpansionPremarket Approval
    Policy requirementThe device must have received FDA Premarket Approval for percutaneous left atrial appendage closure
    RCT
    AbbreviationRCT
    ExpansionRandomized controlled trial
    Policy contextIdentified as the optimal study design for evaluating the efficacy of percutaneous left atrial appendage closure for stroke prevention
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyPercutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation
    Policy CodePolicy 2.02.519
    Change TypeModified
    Effective DateFeb 5, 2027
    Last ReviewOct 13, 2026
    Next Review DateNot specified
    Key ActionUse an FDA Premarket Approval-approved LAAC device for its FDA-approved indication and confirm the required stroke-risk score.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaCoding and Threshold ReferenceProvider Requirements and Denial RisksClinical BackgroundDefinitions and Abbreviations

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.