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    OpenPayerPolicy UpdatesCardiologyPremera Blue Cross LAAC Coverage Update | OpenPaye…
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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 coverage of FDA-approved percutaneous left atrial appendage closure or occlusion devices for stroke prevention in individuals with non-valvular atrial fibrillation, including documentation and coding requirements.

    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 DateFebruary 5, 2027
    Next Review DateN/A
    Key ActionBefore LAAC, verify the device's FDA Premarket Approval and indication, required stroke-risk criteria, anticoagulation status, qualified care setting and operator, multidisciplinary care, and registry enrollment.
    SourceLink
    POLICY UPDATE CHANGES

    The policy was revised to add specific medical-necessity criteria for percutaneous left atrial appendage closure, including nonvalvular atrial fibrillation, elevated CHA₂DS₂-VASc stroke risk, candidacy for long-term anticoagulation, a nonreversible contraindication to oral anticoagulation, and elevated HAS-BLED bleeding risk.

    The FDA-approved Amplatzer Amulet device was added to the policy statements.

    The current policy replaced policy 2.02.26 effective for dates of service on or after February 5, 2027.

    2FDA-approved device types identified
    CHA₂DS₂-VASc ≥2/≥3Stroke-risk threshold
    HAS-BLED ≥3Elevated bleeding-risk threshold
    2027-02-05Effective date

    Medical Necessity and Coverage Requirements

    FDA-approved percutaneous left atrial appendage closure

    Covered as medically necessary when ALL of the following are met.

    Medical necessity for FDA-approved percutaneous LAAC/LAAO: The individual has non-valvular atrial fibrillation; 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; is a candidate for long-term anticoagulation based on 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 HAS-BLED score of at least 3.CHA₂DS₂-VASc ≥2 in males or ≥3 in females; HAS-BLED ≥3

    The procedure must use a percutaneous endovascular closure or occlusion device that has received FDA Premarket Approval (PMA).

    Other percutaneous devices

    Investigational when any of the following applies.

    Investigational percutaneous left atrial appendage closure devices: The device is not an FDA-approved percutaneous left atrial appendage closure device for stroke prevention, including but not limited to the Lariat or Amplatzer Cardiac Plug devices.

    The Amplatzer Cardiac Plug is FDA-approved for atrial septal defect closure but not for left atrial appendage closure; the Percutaneous LAA Transcatheter Occlusion device has not received FDA approval.

    FDA-approved percutaneous LAAC coverage requirements

    LAAC devices are covered when the device has FDA Premarket Approval for the device's FDA-approved indication and all applicable conditions are met.

    Covered LAAC requirements

    • Patient eligibility: The patient has a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3; completes a formal shared decision-making interaction with an independent non-interventional physician using an evidence-based oral-anticoagulation decision tool, with the interaction documented in the medical record; is suitable for short-term warfarin but is unable to take long-term oral anticoagulation after shared decision-making; and is managed by a cohesive multidisciplinary team.CHADS2 ≥2 or CHA2DS2-VASc ≥3

      LAAC is covered as a second-line therapy to oral anticoagulation.

    • Facility and procedural setting: The procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program.
    • Operator qualifications: The procedure is performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who has completed manufacturer-prescribed training before performing LAAC, has performed at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum, and continues to perform at least 25 such procedures, including at least 12 LAAC procedures, over a 2-year period.≥25 prior; ≥25 ongoing over 2 years, including ≥12 LAAC
    • Registry participation: The individual is enrolled in an approved registry that tracks outcomes for the procedure and device.

    Clinical selection considerations

    Clinical guidance supports LAAC for selected patients with nonvalvular AF and high thromboembolic risk who are unsuitable for long-term oral anticoagulation.

    Clinical circumstances supporting consideration of LAAC

    • Nonreversible bleeding contraindication: Severe bleeding due to a nonreversible gastrointestinal, pulmonary, or genitourinary cause; spontaneous intracranial or intraspinal bleeding due to a nonreversible cause; or serious bleeding related to recurrent falls when the cause of falls is not treatable.
    • Adequate expected benefit: The patient has adequate life expectancy, described by HRS consensus as a minimum greater than 1 year, and sufficient quality of life to benefit from LAAC.>1 year quality life expectancy

    Percutaneous left atrial appendage closure devices without FDA approval for this indication are considered investigational and are not covered as medically necessary. This includes the Lariat and Amplatzer Cardiac Plug; the Amplatzer Cardiac Plug is approved for atrial septal defect closure, not left atrial appendage closure.

    Percutaneous LAAC devices other than the Watchman or Amplatzer Amulet, including the Lariat and Amplatzer Cardiac Plug, are not supported by sufficient evidence to demonstrate improvement in net health outcomes. These devices also lack FDA approval for LAAC and therefore are considered investigational.

    Devices not approved in the United States for the percutaneous LAAC indication are excluded from the FDA-approved regulatory pathway. This includes the Lariat Loop Applicator, which is cleared for surgical soft-tissue suture placement, and the Amplatzer Cardiac Plug and WaveCrest, which have European CE approval but are not currently approved in the United States for percutaneous LAAC.

    This medical policy does not apply to Medicare Advantage. Coverage remains subject to the applicable member benefit plan, including its limitations and conditions.

    Coding, Risk Scores, and Regulatory Identifiers

    Covered CPT CodeCPTCovered
    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 and Regulatory Identifiersmixed
    NGVFDA product code for left atrial appendage closure devices
    P130013Watchman LAA Closure first-generation device; FDA Premarket Approval (PMA)
    P130013/S035Watchman FLX LAA Closure Device; FDA PMA supplement
    P130013/S057Watchman FLX Pro LAA Closure Device; FDA PMA supplement
    P130013/S074Watchman FLX Pro LAA Closure Device; FDA PMA supplement for July 2025 label expansion to include post-ablation individuals
    P200049Amplatzer Amulet LAA Occluder; FDA Premarket Approval (PMA)
    Historical Coding UpdatesCPT
    0281TAdded December 29, 2011; subsequently terminated January 1, 2017
    33340Added effective January 1, 2017; replaced CPT 0281T
    33999Removed in the 2018 annual coding update
    93799Removed in the 2018 annual coding update
    CHA₂DS₂-VASc Stroke-Risk Score
    CHA₂DS₂-VASc stroke-risk threshold≥ 2 in males or ≥ 3 in females
    HAS-BLED Bleeding-Risk Score
    HAS-BLED bleeding-risk threshold≥ 3
    Medicare Coverage Risk Thresholds
    CHADS2 score≥ 2
    Medicare Coverage Risk Thresholds
    CHA₂DS₂-VASc score≥ 3
    Operator Experience Requirements
    Prior transseptal operator experience≥ 25 qualifying interventional cardiac procedures involving transseptal puncture through an intact septum
    Operator Experience Requirements
    Ongoing transseptal operator experience≥ 25 qualifying interventional cardiac procedures involving transseptal puncture through an intact septum over a 2-year period
    Operator Experience Requirements
    Ongoing LAAC operator experienceAt least 12 of the qualifying procedures over 2 years must be LAAC procedures
    Current Revised Risk Thresholds
    CHA₂DS₂-VASc stroke-risk threshold≥ 2 in males or ≥ 3 in females
    Current Revised Risk Thresholds
    HAS-BLED bleeding-risk threshold≥ 3

    Documentation and Review Requirements

    Documentation Required

    Verify FDA-Approved LAAC Eligibility

    Verify that the requested percutaneous left atrial appendage closure (pLAAC/LAAC) device has received FDA Premarket Approval (PMA) for the proposed indication. Confirm non-valvular atrial fibrillation (NVAF), the applicable stroke-risk threshold, suitability for short-term warfarin, inability to take long-term oral anticoagulation, and all other medical-necessity requirements.

    • Confirm elevated stroke risk: CHADS2 score ≥ 2 or CHA₂DS₂-VASc score ≥ 3 under the applicable coverage criteria.
    • Confirm contraindication to long-term oral anticoagulation (OAC) is due to a nonreversible cause and HAS-BLED score is ≥ 3.
    Documentation Required

    Oral Anticoagulation Considered First

    Document that oral anticoagulation was considered before LAAC. LAAC is a second-line therapy for a patient who is suitable for short-term warfarin but, after shared decision-making, is unable to take long-term OAC.

    • Document the rationale that the patient is unable to continue long-term OAC.
    • Do not present LAAC as first-line therapy when the patient can take long-term OAC.
    Documentation Required

    Required Medical Records

    Submit medical records showing that all medical-necessity criteria are met and identifying the FDA-approved device to be used.

    • FDA device name
    • Diagnosis of NVAF
    • CHA₂DS₂-VASc score: ≥ 2 in males or ≥ 3 in females, as specified in the documentation requirements
    • Contraindication to long-term OAC due to a nonreversible cause
    • HAS-BLED score ≥ 3 documenting high risk of major bleeding on long-term OAC
    Documentation Required

    Document Patient Selection and Shared Decision-Making

    Document patient selection and shared decision-making before LAAC. The record must show the applicable stroke-risk score and a formal discussion about oral anticoagulation with an independent, non-interventional physician using an evidence-based decision tool.

    • Record the CHADS2 or CHA₂DS₂-VASc score supporting elevated embolic-stroke risk.
    • Document the independent non-interventional physician interaction and conclusion that the patient is suitable for short-term warfarin but unable to take long-term OAC.
    • Retain the shared decision-making documentation in the medical record.
    Documentation Required

    Document Program and Registry Requirements

    Document that the patient is managed by a cohesive multidisciplinary team and that the procedure will be performed in a qualified hospital program. Enrollment in an approved outcomes registry is also required.

    • Patient must be under the care of a multidisciplinary team before and after the procedure.
    • Hospital must have an established structural heart disease (SHD) and/or electrophysiology (EP) program.
    • Enroll the individual in an approved registry tracking procedure and device outcomes.
    Documentation Required

    Document Operator Qualifications

    Verify and document operator qualifications before the procedure. The interventional cardiologist, electrophysiologist, or cardiovascular surgeon must meet the manufacturer-training and procedural-experience requirements.

    • Manufacturer training on safe and effective device use completed before LAAC.
    • At least 25 interventional cardiac procedures involving transseptal puncture through an intact septum performed.
    • Continues to perform at least 25 such transseptal procedures over a 2-year period, including at least 12 LAAC procedures.
    Denial Risk

    Failure to Meet Medical Necessity Criteria

    Expect denial when the patient does not meet the medical-necessity criteria for pLAAC. The record must establish NVAF, the required stroke risk, candidacy for anticoagulation, a nonreversible contraindication to long-term OAC, and high bleeding risk.

    • NVAF not documented
    • Stroke-risk threshold not met
    • Not a candidate for anticoagulation based on stroke or systemic thromboembolism risk
    • No nonreversible contraindication to long-term OAC
    • HAS-BLED score is below 3 or high bleeding risk is not documented
    Denial Risk

    Non-FDA-Approved Device

    Percutaneous LAAC performed with a device that lacks FDA approval for the LAAC indication is considered investigational, regardless of whether the device has another FDA-cleared or FDA-approved use.

    • Confirm FDA PMA for the device’s percutaneous LAAC indication before authorization.
    • The Amplatzer Cardiac Plug is FDA-approved for atrial septal defect closure, not for LAAC.
    • The Lariat and other devices without FDA approval for percutaneous LAAC are investigational under this policy.
    Denial Risk

    Insufficient Supporting Documentation

    Incomplete supporting records may delay review or result in denial. Submit documentation linking the requested device to the diagnosis, stroke-risk assessment, anticoagulation status, contraindication, and bleeding-risk assessment.

    • Missing FDA device name
    • Missing NVAF diagnosis or stroke-risk score
    • Missing documentation supporting long-term anticoagulation candidacy
    • Missing nonreversible OAC contraindication
    • Missing HAS-BLED score or documentation of high bleeding risk
    Denial Risk

    Confirm Device Support

    For percutaneous LAAC, identify the requested device and confirm that it is FDA-approved for this indication. Watchman and Amplatzer Amulet are supported examples; other devices are denial risks when they lack FDA approval or adequate supporting evidence.

    • Supported devices: Watchman and Amplatzer Amulet
    • Other devices may be denied as non-FDA-approved or insufficiently supported for percutaneous LAAC
    • Evidence for devices such as Lariat and Amplatzer Cardiac Plug is insufficient to establish improvement in net health outcomes
    Denial Risk

    Patient Selection Requirements Not Met

    Flag the request when patient-selection or shared-decision-making requirements are absent. LAAC coverage requires the applicable stroke-risk threshold, a formal documented discussion with an independent non-interventional physician, and confirmation that the patient is suitable for short-term warfarin but cannot take long-term OAC.

    • CHADS2 ≥ 2 or CHA₂DS₂-VASc ≥ 3, as applicable
    • Formal shared decision-making using an evidence-based OAC decision tool
    • Documented conclusion that LAAC is second-line therapy for a patient unable to take long-term OAC
    Denial Risk

    Facility, Team, or Operator Requirements Not Met

    Flag deficiencies in the hospital program, multidisciplinary care, or operator qualifications. The procedure must be performed in a hospital with an established SHD and/or EP program by a qualified operator meeting training and experience requirements.

    • Cohesive multidisciplinary team not documented
    • Qualified SHD/EP hospital program not documented
    • Manufacturer training or required transseptal and LAAC experience not documented
    Prior Authorization

    Registry Enrollment Required

    Require enrollment in an approved registry that tracks outcomes for the LAAC procedure and device. Missing registry enrollment is a coverage and review risk.

    • Document the approved registry in which the individual is enrolled.
    • Confirm registry participation covers the requested procedure and device.
    Denial Risk

    Requested Device Lacks US LAAC Approval

    Flag devices that do not have US approval for percutaneous LAAC. The Lariat Loop Applicator, Amplatzer Cardiac Plug, and WaveCrest are not currently approved in the US for this indication and present denial or investigational-use risks.

    • Lariat Loop Applicator: cleared through 510(k) for surgical soft-tissue suture placement, not percutaneous LAAC.
    • Amplatzer Cardiac Plug: FDA-approved for atrial septal defect closure, not LAAC.
    • WaveCrest: has European CE approval for LAAC but is not currently approved in the US for this indication.

    Clinical Background

    Atrial fibrillation can cause blood stasis within the atria, increasing the risk of thrombus formation, particularly in the left atrial appendage. A thrombus that embolizes can cause an ischemic stroke. The left atrial appendage is estimated to be the source of approximately 90% of atrial thrombi in this setting, making it an important target for stroke-prevention treatment.

    Definitions and Abbreviations

    Definition
    ProcedurePercutaneous left atrial appendage closure or occlusion
    TechniqueA catheter-based procedure that places a device to seal or occlude the left atrial appendage
    Clinical purposeProvides a nonpharmacologic alternative to long-term anticoagulation for stroke prevention in atrial fibrillation
    Definition
    ScoreCHA₂DS₂-VASc
    PurposeEstimates annual thromboembolic, primarily ischemic stroke, risk
    Clinical useUsed in non-anticoagulated individuals with nonvalvular atrial fibrillation
    Definition
    ScoreHAS-BLED
    Scoring range0 to 9
    Clinical useEvaluates clinical characteristics associated with significant bleeding in individuals receiving anticoagulation
    Definition
    ScoreCHADS2
    Congestive heart failure and hypertensionIncluded clinical components
    Additional componentsAge greater than 75 years, diabetes, and prior stroke, transient ischemic attack, or thromboembolism
    Definition
    ScoreCHA2DS2-VASc
    Core componentsCongestive heart failure, hypertension, age 65 years or older, and diabetes
    Additional componentsPrior stroke, transient ischemic attack, or thromboembolism; vascular disease; and female sex category
    Definition
    TermNonvalvular atrial fibrillation (NVAF)
    DefinitionAtrial fibrillation not associated with a mechanical heart valve
    Additional exclusionNot associated with moderate-to-severe mitral stenosis
    Definition
    TermLeft atrial appendage closure (LAAC)
    ProcedurePercutaneous exclusion or closure of the left atrial appendage
    PurposeReduce thromboembolic stroke risk in atrial fibrillation
    Definition
    TermNonvalvular atrial fibrillation
    DefinitionAtrial fibrillation not caused by a diseased or prosthetic heart valve
    AbbreviationNVAF
    Definition
    AbbreviationLAA
    MeaningLeft atrial appendage
    Clinical contextThe appendage targeted by left atrial appendage closure or occlusion procedures
    Definition
    AbbreviationOAC
    MeaningOral anticoagulant
    Policy contextLong-term OAC is the therapy that may be contraindicated when LAAC is considered
    Definition
    AbbreviationPMA
    MeaningPremarket Approval
    Regulatory pathwayFDA approval pathway identified for the Watchman and Amplatzer Amulet devices
    Definition
    AbbreviationRCT
    MeaningRandomized controlled trial
    Policy contextThe optimal study design for evaluating percutaneous LAAC efficacy is an RCT with clinically relevant health outcomes
    Definition
    Product codeNGV
    AuthorityFDA product code
    ApplicationListed for the LAAC devices discussed in the regulatory tables, including the Amplatzer Amulet device
    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 DateFebruary 5, 2027
    Next Review DateN/A
    Key ActionBefore LAAC, verify the device's FDA Premarket Approval and indication, required stroke-risk criteria, anticoagulation status, qualified care setting and operator, multidisciplinary care, and registry enrollment.
    SourceLink
    On This Page
    Medical Necessity and Coverage RequirementsCoding, Risk Scores, and Regulatory IdentifiersDocumentation and Review RequirementsClinical BackgroundDefinitions and Abbreviations

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