ModifiedPremera Blue Cross of WashingtonPolicy 2.02.26

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

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This policy governs medical necessity and coverage of percutaneous left atrial appendage closure devices for stroke prevention in individuals with atrial fibrillation. FDA-approved devices may be medically necessary when stroke risk warrants systemic anticoagulation but the long-term risks of anticoagulation outweigh the risks of device implantation; other devices are investigational.

Policy Summary

PayerPremera Blue Cross of Washington

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

Policy CodePolicy 2.02.26

Change TypeModified

Effective DateNov 1, 2026

Last ReviewAug 1, 2025

Next Review DateN/A

Key ActionDocument the patient's stroke-risk score, shared decision-making, anticoagulation rationale, and FDA-approved device before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Policy 2.02.26 was deleted and replaced by Premera policy 2.02.519 for percutaneous left atrial appendage closure devices for stroke prevention in atrial fibrillation.

The policy history records that the FDA-approved Amplatzer Amulet left atrial appendage closure device was added to the policy statements.

2FDA-approved device families

CHADS2 ≥2 or CHA2DS2-VASc ≥3Medicare stroke-risk threshold

HAS-BLED ≥3

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ModifiedPremera Blue Cross of WashingtonPolicy 2.02.26

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

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Sign up for premerabluecrossofwashington Policy 2.02.26 alerts

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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 2.02.26

Change TypeModified

Effective DateNov 1, 2026

Last ReviewAug 1, 2025

Next Review DateN/A

Key ActionDocument the patient's stroke-risk score, shared decision-making, anticoagulation rationale, and FDA-approved device before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Policy 2.02.26 was deleted and replaced by Premera policy 2.02.519 for percutaneous left atrial appendage closure devices for stroke prevention in atrial fibrillation.

The policy history records that the FDA-approved Amplatzer Amulet left atrial appendage closure device was added to the policy statements.

2FDA-approved device families

CHADS2 ≥2 or CHA2DS2-VASc ≥3Medicare stroke-risk threshold

HAS-BLED ≥3

High bleeding-risk score

90%Left atrial thrombi occurring in the appendage

Medical Necessity and Coverage Criteria

FDA-approved device

An FDA-approved percutaneous left atrial appendage closure device may be considered medically necessary for prevention of stroke in individuals with atrial fibrillation when all of the following are met.

Medical necessity for FDA-approved device: The individual has atrial fibrillation, increased risk of stroke and systemic embolism based on a CHADS2 or CHA2DS2-VASc score, and a recommendation for systemic anticoagulation therapy; and the long-term risks of systemic anticoagulation outweigh the risks of device implantation.CHADS2 or CHA2DS2-VASc score documenting increased stroke and systemic embolism risk

FDA-approved examples include the Watchman and Amplatzer Amulet devices.

Other percutaneous left atrial appendage closure devices

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

Investigational devices: The percutaneous left atrial appendage closure device, including but not limited to the Lariat or Amplatzer Cardiac Plug, is used for stroke prevention in an individual with atrial fibrillation.

Other percutaneous left atrial appendage closure devices are considered investigational.

FDA-approved LAAC coverage criteria

FDA-approved percutaneous LAAC is covered when all applicable patient, device, provider, facility, and documentation requirements are met.

Patient and device eligibility: The patient has nonvalvular atrial fibrillation, increased risk of stroke and systemic embolism based on a CHADS2 or CHA2DS2-VASc score, and an FDA-approved Watchman or Amplatzer Amulet device is used for its FDA-approved indication.CHADS2 ≥2 or CHA2DS2-VASc ≥3

The FDA-approved indication includes a recommendation for anticoagulation therapy, suitability for anticoagulation therapy, and an appropriate rationale for seeking a nonpharmacologic alternative.

Anticoagulation alternative: The patient is suitable for short-term warfarin but is unable to take long-term oral anticoagulation following formal shared decision-making, and LAAC is used as second-line therapy to oral anticoagulants.Suitable for short-term warfarin; unable to take long-term oral anticoagulation

Shared decision-making must be conducted with an independent non-interventional physician using an evidence-based oral-anticoagulation decision tool and documented in the medical record.

Non-approved or insufficiently evidenced LAAC devices

Other percutaneous LAAC devices are not supported for coverage when they lack U.S. FDA approval for the LAAC indication or sufficient evidence of improved net health outcome.

Insufficiently supported device: The device is a percutaneous LAAC device other than Watchman or Amplatzer Amulet, such as Lariat, Amplatzer Cardiac Plug, or WaveCrest, and lacks U.S. FDA approval for percutaneous LAAC or has insufficient evidence to establish improvement in net health outcome.

The Lariat is FDA-cleared as a suture delivery device for surgical applications rather than specifically approved for percutaneous LAAC. Amplatzer Cardiac Plug and WaveCrest are not currently approved in the United States for this indication.

Use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat and Amplatzer Cardiac Plug devices, is considered investigational for stroke prevention in individuals with atrial fibrillation.

Percutaneous left atrial appendage closure using devices without U.S. FDA approval for the LAAC indication is excluded or unsupported. Examples include Lariat, Amplatzer Cardiac Plug, and WaveCrest. The Lariat is FDA-cleared for surgical suture-delivery applications rather than specifically for LAAC, while Amplatzer Cardiac Plug and WaveCrest are not currently approved in the United States for this indication.

This medical policy does not apply to Medicare Advantage. Coverage for Medicare Advantage members is subject to the applicable plan benefits and coverage requirements.

A percutaneous LAAC device other than Watchman or Amplatzer Amulet is not medically necessary when the available evidence is insufficient to demonstrate an improvement in net health outcome.

Coding and Clinical Thresholds

CPTCPT

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 CodeHCPCS

NGV	FDA product code for left atrial appendage closure devices

Historical coding changesCPT

0281T	Code added in policy history and later terminated
33340	Replacement code for 0281T
33999	Code removed from the policy
93799	Code removed from the policy

HAS-BLED bleeding risk score

High-risk thresholdHAS-BLED scores of 3 or greater are associated with high bleeding risk.

Score rangeThe HAS-BLED score ranges from 0 to 9.

Clinical useA score of 3 or greater may signal the need for closer monitoring and consideration of anticoagulant or aspirin dose selection.

CHADS2 score

Minimum scoreCHADS2 score ≥ 2.

Risk assessedThe score documents increased risk of stroke and systemic embolism for Medicare LAAC coverage.

Provider Requirements and Documentation

Prior Authorization

Confirm Medicare LAAC Eligibility

For Medicare coverage, confirm that the LAAC device has FDA Premarket Approval (PMA) for the applicable FDA-approved indication and that all Medicare coverage conditions are satisfied.

CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3.
The patient has increased risk of stroke and systemic embolism and is recommended for anticoagulation therapy.
A formal shared decision-making interaction with an independent, non-interventional physician using an evidence-based oral-anticoagulation decision tool occurred before LAAC and is documented.
The patient is suitable for short-term warfarin but unable to take long-term oral anticoagulation; LAAC is covered only as second-line therapy to oral anticoagulants.
The patient is managed by a cohesive multidisciplinary team before and after the procedure, and the procedure is performed in a hospital with an established structural heart disease and/or electrophysiology program.
The case meets applicable Medicare coverage-with-evidence-development and outcomes-registry requirements.

Clinical Background

Atrial fibrillation promotes blood stasis in the left atrium, particularly in the left atrial appendage, where thrombi commonly form. These thrombi may embolize and cause ischemic stroke. Systemic anticoagulation is the usual stroke-prevention treatment, but it can increase bleeding risk and require monitoring. Percutaneous left atrial appendage closure provides a nonpharmacologic alternative by occluding the appendage, although anticoagulation is generally used during the postimplantation period.

Key Terms and Measures

Atrial fibrillation

DefinitionAn irregular and often rapid rhythm of the heart's upper chambers.

Blood flow effectThe irregular rhythm promotes blood pooling in the upper chambers, particularly the left atrial appendage.

Clot riskPooling blood can promote clot formation; a clot that embolizes may cause a stroke.

Percutaneous left atrial appendage closure device

DefinitionA device implanted percutaneously to occlude the left atrial appendage.

Clinical purposeThe device is intended to prevent thrombus formation in the left atrial appendage.

Intended benefit

Policy Summary

PayerPremera Blue Cross of Washington

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

Policy CodePolicy 2.02.26

Change TypeModified

Effective DateNov 1, 2026

Last ReviewAug 1, 2025

Next Review DateN/A

Key ActionDocument the patient's stroke-risk score, shared decision-making, anticoagulation rationale, and FDA-approved device before requesting coverage.

SourceLink

On This Page

Care setting, team, and registry: The procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program, and the patient is managed preoperatively and postoperatively by a cohesive multidisciplinary team.

The patient must be enrolled in an approved outcomes registry tracking procedure and device outcomes.

Qualified operator: The procedure is performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who has received manufacturer-prescribed training on safe and effective device use and meets the required transseptal and LAAC procedure-volume requirements.At least 25 prior interventional cardiac procedures involving transseptal puncture through an intact septum, and at least 25 such procedures over 2 years including at least 12 LAAC procedures

Use in coverage criteriaA CHADS2 score is one accepted basis for establishing increased stroke and systemic embolism risk.

CHA2DS2-VASc score

Minimum scoreCHA2DS2-VASc score ≥ 3.

Risk assessedThe score documents increased risk of stroke and systemic embolism for Medicare LAAC coverage.

Use in coverage criteriaA CHA2DS2-VASc score is one accepted basis for establishing increased stroke and systemic embolism risk.

Prior transseptal procedure experience

Lifetime experienceAt least 25 interventional cardiac procedures involving transseptal puncture through an intact septum.

Required clinicianThe procedure must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon.

TrainingThe performing clinician must complete manufacturer-prescribed training on safe and effective device use before performing LAAC.

Continuing operator experience

Two-year transseptal volumeAt least 25 interventional cardiac procedures involving transseptal puncture through an intact septum over a 2-year period.

Two-year LAAC volumeAt least 12 of those procedures must be LAAC procedures.

Requirement typeThe operator must continue to perform these procedure volumes over the 2-year period.

Life expectancy

Minimum expected durationMore than 1 year of expected life expectancy.

Clinical contextLAAC is appropriate for patients with adequate life expectancy to benefit from the procedure.

Additional considerationQuality of life should also be adequate to benefit from LAAC.

Documentation Required

Use a Qualified LAAC Operator

The LAAC procedure must be performed by a qualified interventional cardiologist, electrophysiologist, or cardiovascular surgeon who meets the required training and experience standards.

Completed manufacturer-prescribed training on safe and effective use of the device before performing LAAC.
Performed at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum.
Continues to perform at least 25 such transseptal procedures over a 2-year period, including at least 12 LAAC procedures.

Documentation Required

Document Anticoagulation Rationale and Short-Term Suitability

Document that systemic anticoagulation is recommended and that LAAC is being considered as a nonpharmacologic alternative or second-line therapy—not as routine first-line treatment. Because the device may be more thrombogenic during the postimplantation period, confirm that the patient is suitable for the required short-term anticoagulation regimen, including short-term warfarin when applicable.

The long-term risks of systemic anticoagulation must outweigh the risks of device implantation.
Document the conclusion that the patient cannot take long-term oral anticoagulation after shared decision-making.
Most evidence evaluated patients eligible for anticoagulation; explain the clinical rationale when LAAC is selected.

Documentation Required

Submit Required Medical Records

Submit medical records demonstrating that medical-necessity criteria are met and identifying the exact FDA-approved device proposed for implantation.

Name of the FDA-approved device to be used, such as Watchman or Amplatzer Amulet.
CHADS2 or CHA2DS2-VASc score documenting increased risk of stroke and systemic embolism.
Documentation that systemic anticoagulation is recommended.
Documentation that the long-term risks of systemic anticoagulation outweigh the risks of device implantation.
Supporting records for the shared decision-making interaction, anticoagulation suitability, medical necessity, and all applicable facility and operator requirements.

Documentation Required

Document Eligibility and Shared Decision-Making

Before LAAC, document a formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool addressing oral anticoagulation in nonvalvular atrial fibrillation.

Record the patient’s CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3 for Medicare coverage.
Document that the patient is suitable for short-term warfarin but unable to take long-term oral anticoagulation.
Document the discussion of anticoagulation and the rationale for choosing LAAC as a second-line, nonpharmacologic alternative.

Documentation Required

Document Facility and Multidisciplinary-Team Requirements

Document that the patient is under the care of a cohesive multidisciplinary team before and after the procedure and that the procedure will occur in an appropriate hospital program.

Hospital has an established structural heart disease program and/or electrophysiology program.
Preoperative and postoperative care is provided by a cohesive multidisciplinary team of medical professionals.
Identify the participating disciplines and their roles in evaluation, implantation, anticoagulation management, and follow-up.

Documentation Required

Retain Operator Qualification Records

Maintain records showing that the operator meets the Medicare qualification requirements before performing LAAC.

Manufacturer training completion for the specific device.
At least 25 prior interventional cardiac procedures involving transseptal puncture through an intact septum.
Ongoing volume of at least 25 qualifying transseptal procedures over 2 years, including at least 12 LAAC procedures.
Retain training certificates, procedure logs, and other records supporting operator eligibility.

Denial Risk

Non-FDA-Approved Device: Investigational

Do not submit Lariat, Amplatzer Cardiac Plug, or another device without FDA approval for percutaneous LAAC as covered FDA-approved LAAC therapy. Use of these devices for stroke prevention in atrial fibrillation is considered investigational.

Lariat is a suture delivery system cleared under 510(k) for surgical soft-tissue approximation or ligation, not FDA-approved for percutaneous LAAC.
Amplatzer Cardiac Plug is not FDA-approved in the United States for this indication.

Denial Risk

Medical Necessity Criteria Not Met

Expect denial when the submitted records do not establish the policy’s medical-necessity requirements for an FDA-approved LAAC device.

No increased risk of stroke and systemic embolism based on the required CHADS2 or CHA2DS2-VASc assessment.
Systemic anticoagulation is not recommended.
The long-term risks of systemic anticoagulation do not outweigh the risks of device implantation.
The patient is not suitable for short-term anticoagulation or has not been shown to be unable to take long-term oral anticoagulation.
Required shared decision-making, documentation, facility, team, or other eligibility conditions are absent.

Denial Risk

Non-Approved LAAC Device: Insufficient Evidence

LAAC with a device other than FDA-approved Watchman or Amplatzer Amulet is not supported for coverage because the available evidence is insufficient to demonstrate improvement in net health outcomes.

Other devices, including Lariat, Amplatzer Cardiac Plug, and WaveCrest, are not currently approved in the United States for percutaneous LAAC.
Evidence for non-approved devices consists primarily of nonrandomized or uncontrolled observational studies and reports procedural complications.
Do not treat CE approval or an FDA 510(k) clearance for a different surgical use as FDA approval for the LAAC indication.

Prior Authorization

Meet Facility, Team, and Registry Requirements

For Medicare cases, verify and document compliance with the required facility, team, registry, and operator infrastructure before scheduling LAAC.

Use a hospital with an established structural heart disease and/or electrophysiology program.
Ensure cohesive multidisciplinary-team care before and after the procedure.
Confirm enrollment or reporting through the applicable CMS-approved Medicare outcomes registry under coverage with evidence development.
Use an operator who completed manufacturer training and meets the transseptal and LAAC procedure-volume requirements.
Retain records supporting registry participation, facility program status, team involvement, and operator qualifications.

By occluding the appendage, the device provides a nonpharmacologic alternative to anticoagulation for reducing embolic stroke risk.

FDA-approved LAAC device

FDA-approved devicesWatchman and Amplatzer Amulet.

IndicationBoth device families are identified as FDA-approved for percutaneous left atrial appendage closure for stroke prevention in individuals with atrial fibrillation.

Amplatzer Amulet statusThe Amplatzer Amulet received FDA approval in August 2021.

CHADS2

CCongestive heart failure — 1 point.

HHypertension — 1 point.

A₂Age greater than 75 years — 1 point.

DDiabetes — 1 point.

S₂Prior stroke, transient ischemic attack, or thromboembolism — 2 points.

CHA2DS2-VASc

CCongestive heart failure — 1 point.

HHypertension — 1 point.

A₂Age 65 years or older — 2 points.

DDiabetes — 1 point.

S₂, V, ScPrior stroke, transient ischemic attack, or thromboembolism — 2 points; vascular disease — 1 point; sex category — 1 point.

Nonvalvular atrial fibrillation

DefinitionAtrial fibrillation not caused by a mechanical heart valve, moderate-to-severe mitral stenosis, or another excluded valvular condition.

Mechanical valveA mechanical heart valve is excluded from the nonvalvular atrial fibrillation definition.

Mitral stenosisModerate-to-severe mitral stenosis is excluded from the nonvalvular atrial fibrillation definition.

Percutaneous LAAC

DefinitionPercutaneous closure of the left atrial appendage using a device intended and approved for that indication.

Approved devicesThe Watchman and Amplatzer Amulet are identified as approved devices for percutaneous LAAC.

Unapproved examplesLariat, Amplatzer Cardiac Plug, and WaveCrest are not currently approved in the United States for the percutaneous LAAC indication.