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 requirements for percutaneous left atrial appendage closure or occlusion devices used to prevent stroke in individuals with non-valvular atrial fibrillation. FDA-approved devices may be covered when specified stroke, anticoagulation, contraindication, and bleeding-risk criteria are met; other devices are considered investigational.

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

Last ReviewOct 13, 2026

Next Review DateN/A

Key ActionSubmit records documenting the FDA device name, non-valvular atrial fibrillation, qualifying CHA₂DS₂-VASc score, nonreversible contraindication to long-term oral anticoagulation, and HAS-BLED score of at least 3.

SourceLink

POLICY UPDATE CHANGES

Medical-necessity criteria were revised to specify non-valvular atrial fibrillation, sex-specific CHA₂DS₂-VASc thresholds, candidacy for long-term anticoagulation, a nonreversible contraindication to long-term oral anticoagulation, and HAS-BLED score of at least 3.

Policy 2.02.519 replaced policy 2.02.26, Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.

Tables were added for CHA₂DS₂-VASc annual stroke-risk estimates and FDA-cleared Watchman and Amplatzer Amulet devices.

≥2 male / ≥3 femaleStroke-risk threshold

HAS-BLED ≥3

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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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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

Last ReviewOct 13, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Policy 2.02.519 replaced policy 2.02.26, Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.

Tables were added for CHA₂DS₂-VASc annual stroke-risk estimates and FDA-cleared Watchman and Amplatzer Amulet devices.

≥2 male / ≥3 femaleStroke-risk threshold

HAS-BLED ≥3

Bleeding-risk threshold

FDA PMACovered device status

CPT 33340Procedure code

InvestigationalOther device status

Medical Necessity and Coverage Criteria

Medically Necessary — FDA-Approved LAAC Device

Percutaneous endovascular closure (occlusion) of the left atrial appendage using a device that has received FDA Premarket Approval (PMA) for the indication is medically necessary when ALL of the following criteria are met:

ALL of the following

The individual has non-valvular atrial fibrillation.
The individual has an elevated annual risk of stroke based on a CHA₂DS₂-VASc score.≥ 2 in males or ≥ 3 in females
The individual is a candidate for long-term anticoagulation therapy based upon the estimated risk of stroke and other systemic thromboembolic events.
The individual has a contraindication to long-term oral anticoagulation (OAC) due to a nonreversible cause.
The individual has a high risk of major bleeding on long-term OAC, as indicated by a HAS-BLED score.≥ 3

Other Percutaneous LAAC Devices

The use of other percutaneous left atrial appendage closure devices is considered investigational.

Any percutaneous left atrial appendage closure device other than an FDA-approved device for the LAAC indication, including but not limited to the Lariat and Amplatzer Cardiac Plug devices, is considered investigational.

Medicare National Coverage Conditions

Under Medicare's national coverage determination, FDA-approved percutaneous LAAC devices are covered when ALL applicable national coverage conditions are met:

ALL of the following

The device has received FDA Premarket Approval (PMA) for the device's FDA-approved indication.
The patient has at least ONE of the following stroke-risk scores
- CHADS₂ score≥ 2
- CHA₂DS₂-VASc score≥ 3
A formal shared decision-making interaction occurs with an independent, non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with nonvalvular atrial fibrillation (NVAF), and the interaction is documented in the medical record.

Device Evidence and Coverage Stance

The evidence supports coverage of FDA-approved Watchman and Amplatzer Amulet devices for appropriately selected individuals with atrial fibrillation who are at increased risk for embolic stroke. The evidence is insufficient to support coverage of other percutaneous LAAC devices.

Applicable evidence and coverage stance

Watchman and Amplatzer Amulet devices: randomized controlled trials, systematic reviews, and observational evidence support an improvement in net health outcome, including noninferior protection compared with anticoagulation and reduced nonprocedure-related bleeding. Coverage should use shared decision-making that weighs bleeding reduction against the potential for higher ischemic stroke risk relative to direct oral anticoagulant therapy.
Other percutaneous LAAC devices, such as Lariat or Amplatzer Cardiac Plug: evidence includes limited randomized and observational studies, reports procedural complications, and does not establish an improvement in net health outcome; these devices also lack FDA approval for LAAC.

Medically Necessary

ALL of the following revised medical-necessity criteria

The individual has non-valvular atrial fibrillation.
The individual has an elevated annual risk of stroke based on a CHA₂DS₂-VASc score.≥ 2 in males or ≥ 3 in females
The individual is a candidate for long-term anticoagulation therapy based upon the estimated risk of stroke and other systemic thromboembolic events.
The individual has a contraindication to long-term oral anticoagulation (OAC) due to a nonreversible cause.
The individual has a high risk of major bleeding on long-term OAC, as indicated by a HAS-BLED score.≥ 3

Percutaneous left atrial appendage closure (LAAC/LAAO) using a device that does not have FDA approval for the indication is considered investigational, regardless of whether the device is used for stroke prevention in an individual with atrial fibrillation.

The use of a device with FDA approval for percutaneous LAAC, such as the Watchman or Amplatzer Amulet, in individuals who do not meet the applicable medical-necessity criteria is not covered as medically necessary.

The use of percutaneous LAAC devices other than the Watchman or Amplatzer Amulet, including the Lariat and Amplatzer Cardiac Plug devices, is considered investigational and not medically necessary. The Amplatzer Cardiac Plug is FDA-approved for closure of atrial septal defects, but not for LAAC.

These devices do not have FDA approval for the LAAC indication, and the available evidence is insufficient to determine that their use improves net health outcomes.

Coding and Threshold Reference

Covered CPT CodesCPTCovered

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

FDA Product Codemixed

NGV	FDA product code

CHA₂DS₂-VASc threshold

ScoreCHA₂DS₂-VASc

Coverage thresholdAt least 2 in males or at least 3 in females

Clinical useEstimates annual thromboembolic, primarily ischemic stroke, risk in non-anticoagulated individuals with non-valvular atrial fibrillation

HAS-BLED threshold

ScoreHAS-BLED

Coverage thresholdAt least 3

Clinical significance

Provider Requirements and Coverage Risks

Denial Risk

Qualified Facility and Operator Required

Perform percutaneous LAAC only in a hospital with an established structural-heart-disease (SHD) and/or electrophysiology (EP) program, with the patient under the care of a cohesive multidisciplinary team. The operator must meet manufacturer training and experience requirements.

Hospital has an established SHD and/or EP program.
Patient is managed preoperatively and postoperatively by a cohesive, multidisciplinary team.
Interventional cardiologist, electrophysiologist, or cardiovascular surgeon has completed manufacturer-prescribed training on safe and effective device use.
Operator has performed at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum.
Operator continues to perform at least 25 such procedures over a 2-year period, including at least 12 LAAC procedures.

Documentation Required

Clinical Background

Atrial fibrillation can cause blood stasis in the left atrium, particularly within the left atrial appendage. This stasis increases the risk that a thrombus will form and cause a thromboembolic event, including ischemic stroke. Because most embolic strokes originate in the left atrial appendage, percutaneous closure or occlusion of the appendage may provide a nonpharmacologic alternative to anticoagulant medication for reducing stroke risk.

Definitions and Abbreviations

Percutaneous LAAC/LAAO

ProcedurePercutaneous left atrial appendage closure or occlusion

MethodPercutaneous endovascular closure or occlusion using a catheter-delivered device

Clinical purposeReduces the risk of stroke in individuals with atrial fibrillation

FDA Premarket Approval

DesignationPremarket Approval

RegulatorU.S. Food and Drug Administration

Policy relevanceRegulatory approval for a device used for percutaneous left atrial appendage closure

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

Last ReviewOct 13, 2026

Next Review DateN/A

SourceLink

On This Page

Therapy and care requirements

The patient is suitable for short-term warfarin but is unable to take long-term oral anticoagulation after shared decision-making; LAAC is covered only as a second-line therapy to oral anticoagulants.
The patient is under the care of a cohesive, multidisciplinary team of medical professionals before and after the procedure.
The procedure is furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.

Operator requirements

The procedure is performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who has received manufacturer-prescribed training on the safe and effective use of the device before performing LAAC.
The operator has performed interventional cardiac procedures involving transseptal puncture through an intact septum.≥ 25 procedures
The operator continues to perform interventional cardiac procedures involving transseptal puncture through an intact septum, including LAAC procedures, over a 2-year period.≥ 25 procedures, of which at least 12 are LAAC

Individuals are enrolled in approved registries that track outcomes for procedures and devices.

Scores of 3 or greater are associated with high bleeding risk on anticoagulation

CHADS2 Medicare threshold

ScoreCHADS2

Medicare thresholdAt least 2

Coverage roleOne of the two qualifying Medicare stroke-risk thresholds; the alternative is CHA2DS2-VASc of at least 3

CHA2DS2-VASc Medicare threshold

ScoreCHA2DS2-VASc

Medicare thresholdAt least 3

Coverage roleOne of the two qualifying Medicare stroke-risk thresholds; the alternative is CHADS2 of at least 2

Prior transseptal procedures

RequirementAt least 25 qualifying interventional cardiac procedures

Procedure characteristicEach procedure involves transseptal puncture through an intact septum

Applies toThe operator before performing LAAC

Ongoing operator volume

Required volumeAt least 25 qualifying interventional cardiac procedures over a 2-year period

Required LAAC volumeAt least 12 of those procedures must be LAAC procedures

Procedure characteristicThe qualifying procedures involve transseptal puncture through an intact septum

Revised CHA₂DS₂-VASc threshold

ScoreCHA₂DS₂-VASc

Revised policy thresholdAt least 2 in males or at least 3 in females

PurposeDefines elevated annual stroke risk for the medically necessary criteria

Revised HAS-BLED threshold

ScoreHAS-BLED

Revised policy thresholdAt least 3

PurposeIndicates elevated risk of major bleeding on long-term oral anticoagulation

LAAC Is a Second-Line Alternative to Anticoagulation

LAAC is covered only as a second-line therapy after consideration of oral anticoagulation. The patient must be suitable for short-term warfarin but, after shared decision-making, be determined unable to take long-term oral anticoagulation.

Document suitability for short-term warfarin.
Document why long-term oral anticoagulation is not suitable, including a nonreversible contraindication when required by the policy criteria.
Use LAAC as an alternative only after oral anticoagulation has been considered through shared decision-making.

Unsupported block type: documentation

Documentation Required

Complete Required Medical-Record Documentation

The submitted medical record must establish the indication and all applicable medical-necessity requirements for the planned procedure.

Name the FDA-approved device to be used.
Document nonvalvular atrial fibrillation and the CHA₂DS₂-VASc score: at least 2 in males or at least 3 in females.
Document that the stroke-risk assessment supports candidacy for long-term anticoagulation.
Document a contraindication to long-term oral anticoagulation due to a nonreversible cause.
Document high risk of major bleeding on long-term OAC, with HAS-BLED score at least 3.

Billing Rule

Registry Enrollment Required

Enroll the individual in an approved registry that tracks outcomes for the LAAC procedure and the device used.

Confirm registry enrollment before or in connection with the procedure.
Registry must track procedure and device outcomes.

Denial Risk

Failure to Meet All Coverage Criteria Risks Denial

Failure to satisfy every applicable coverage and medical-necessity condition creates a denial risk. Use an FDA-approved device for its approved indication and verify the clinical, documentation, facility, operator, multidisciplinary-team, and registry requirements before the procedure.

Nonvalvular atrial fibrillation.
Required stroke-risk threshold: CHA₂DS₂-VASc at least 2 in males or at least 3 in females under the policy criteria; Medicare also specifies CHADS₂ at least 2 or CHA₂DS₂-VASc at least 3.
Candidacy for anticoagulation, nonreversible contraindication to long-term OAC, and HAS-BLED at least 3 where required by the policy criteria.
Formal, documented shared decision-making with an independent non-interventional physician using an evidence-based tool.
Suitability for short-term warfarin but inability to take long-term OAC; LAAC used only as second-line therapy.
Qualified hospital, multidisciplinary team, trained and experienced operator, and approved registry enrollment.

Denial Risk

Non-FDA-Approved Device Is Investigational

A percutaneous LAAC device without FDA Premarket Approval for the LAAC indication is considered investigational and does not meet the FDA-approval condition for coverage.

FDA approval for another use does not establish FDA approval for LAAC; the Amplatzer Cardiac Plug is approved for atrial septal defect closure, not LAAC.
Devices studied in research but lacking FDA approval for LAAC remain investigational for this indication.

Denial Risk

Other LAAC Devices Are Not Covered

Evidence is insufficient to establish improvement in net health outcomes for LAAC devices other than Watchman or Amplatzer Amulet, and these devices lack FDA approval for LAAC. Use of such devices is therefore investigational and not covered under the policy.

Examples include the Lariat and Amplatzer Cardiac Plug.
Observational evidence reports procedural success but also numerous complications; relevant comparative evidence remains insufficient.
Verify that the planned device is Watchman or Amplatzer Amulet, or otherwise has FDA PMA for the LAAC indication.

Denial Risk

Coverage Conditions Must All Be Satisfied

Medicare coverage may be denied when any required condition is absent, including the qualifying stroke-risk score, documented shared decision-making, second-line anticoagulation requirements, qualified facility or operator, multidisciplinary care, FDA-approved indication, or registry enrollment.

Patient has CHADS₂ at least 2 or CHA₂DS₂-VASc at least 3 under Medicare criteria.
Shared decision-making is performed by an independent non-interventional physician, uses an evidence-based oral-anticoagulation tool, and is documented.
Patient is suitable for short-term warfarin but unable to take long-term OAC after the discussion.
Procedure is performed by a trained operator meeting transseptal and LAAC volume requirements in a hospital with an established SHD and/or EP program.
Patient receives cohesive multidisciplinary care and is enrolled in an approved outcomes registry.
Device has FDA PMA for the FDA-approved LAAC indication.

HAS-BLED score

Score range0 to 9

ComponentsHypertension; abnormal renal or liver function; stroke; bleeding; labile INR; elderly status; and drugs or alcohol use

High-risk thresholdScores of 3 or greater are associated with high bleeding risk

CHA₂DS₂-VASc score

ScoreCHA₂DS₂-VASc

PurposeEstimates annual thromboembolic, primarily ischemic stroke, risk

PopulationNon-anticoagulated individuals with non-valvular atrial fibrillation

Percutaneous LAAC

ProcedurePercutaneous left atrial appendage closure

MechanismA device-based procedure intended to occlude the left atrial appendage

Clinical purposeReduces thromboembolic stroke risk in people with atrial fibrillation

Nonvalvular atrial fibrillation

AbbreviationNVAF

DefinitionAtrial fibrillation not caused by a mechanical heart valve or another valvular condition specified in the device indication

Policy relevanceThe FDA Watchman indications in this policy apply to individuals with NVAF

Oral anticoagulation

AbbreviationOAC

DefinitionMedication-based prevention of thromboembolism

ExamplesWarfarin and direct oral anticoagulants

LAA

AbbreviationLAA

MeaningLeft atrial appendage

Policy contextThe appendage targeted by percutaneous closure or occlusion procedures

NVAF

AbbreviationNVAF

MeaningNonvalvular atrial fibrillation

Clinical contextAtrial fibrillation without the valvular conditions specified in the device indication

OAC

AbbreviationOAC

MeaningOral anticoagulant

Policy contextMedication-based thromboembolism prevention, including warfarin and direct oral anticoagulants

PMA

AbbreviationPMA

MeaningPremarket Approval

Regulatory contextFDA approval designation referenced for LAAC devices

RCT

AbbreviationRCT

MeaningRandomized controlled trial

Evidence contextA study design referenced in the policy’s evidence review

IDE

AbbreviationIDE

MeaningInvestigational Device Exemption

Regulatory contextA term listed in the policy’s device and evidence information