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 when percutaneous left atrial appendage closure devices are medically necessary for stroke prevention in individuals with atrial fibrillation and specifies provider 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 2.02.26

Change TypeModified

Effective DateNovember 1, 2026

Last ReviewOct 13, 2026

Next Review DateN/A

Key ActionDocument the FDA-approved device name and the patient's CHADS2 or CHA2DS2-VASc stroke-risk score with the medical necessity request.

SourceLink

POLICY UPDATE CHANGES

The policy statements were updated to include the FDA-approved Amplatzer Amulet device.

The historical coding update removed terminated code 0281T and replaced it with code 33340.

This policy is scheduled to be deleted and replaced by policy 2.02.519.

2FDA-approved device families

CPT 33340Covered procedure code

CHADS2 or CHA2DS2-VAScRequired stroke-risk assessment

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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 DateNovember 1, 2026

Last ReviewOct 13, 2026

Next Review DateN/A

Key ActionDocument the FDA-approved device name and the patient's CHADS2 or CHA2DS2-VASc stroke-risk score with the medical necessity request.

SourceLink

POLICY UPDATE CHANGES

The policy statements were updated to include the FDA-approved Amplatzer Amulet device.

The historical coding update removed terminated code 0281T and replaced it with code 33340.

This policy is scheduled to be deleted and replaced by policy 2.02.519.

2FDA-approved device families

CPT 33340Covered procedure code

CHADS2 or CHA2DS2-VAScRequired stroke-risk assessment

Insufficient evidenceOther-device evidence conclusion

CHADS2 ≥2 or CHA2DS2-VASc ≥3Medicare coverage threshold

Medical Necessity and Coverage Criteria

FDA-approved device—medical necessity

The use of an FDA-approved percutaneous left atrial appendage closure device may be considered medically necessary when all of the following are met.

Medical necessity for FDA-approved device

Required criteria
- The individual has atrial fibrillation and is undergoing percutaneous left atrial appendage closure for prevention of stroke.
- There is an increased risk of stroke and systemic embolism based on a CHADS2 or CHA2DS2-VASc score, and systemic anticoagulation therapy is recommended.CHADS2 or CHA2DS2-VASc risk assessment
- The long-term risks of systemic anticoagulation outweigh the risks of device implantation.
  The risk-benefit balance must be assessed individually.

Other devices—investigational

Other percutaneous left atrial appendage closure devices are not covered as medically necessary.

Investigational devices

Use of a percutaneous left atrial appendage closure device other than an FDA-approved device, including but not limited to the Lariat and Amplatzer Cardiac Plug devices, for stroke prevention in an individual with atrial fibrillation is considered investigational.

FDA-approved LAAC indication

FDA-approved Watchman and Amplatzer Amulet devices are indicated for patients who meet all of the following.

FDA-approved device indication

The patient has nonvalvular atrial fibrillation and is being treated with an FDA-approved LAAC device within its FDA-approved indication.
The Watchman and Amplatzer Amulet devices are identified as FDA-approved devices.
Clinical indication
- The patient is at increased risk for stroke and systemic embolism based on a CHADS2 or CHA2DS2-VASc score.CHADS2 or CHA2DS2-VASc risk basis
- The patient is recommended for anticoagulation therapy.
- The patient is deemed by the treating physicians to be suitable for anticoagulation therapy.

Medicare coverage conditions

Medicare covers percutaneous LAAC when all of the following requirements are met.

Medicare LAAC coverage conditions

The device has received FDA Premarket Approval (PMA) for the device's FDA-approved indication.
Stroke-risk threshold
- 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 with an independent non-interventional physician is completed before LAAC using an evidence-based decision tool on oral anticoagulation in patients with nonvalvular atrial fibrillation, and the interaction is documented in the medical record.

Other devices: insufficient evidence

The evidence is insufficient to establish improved net health outcomes for percutaneous LAAC devices other than Watchman and Amplatzer Amulet.

Other percutaneous LAAC devices

The device is a percutaneous left atrial appendage closure device other than Watchman or Amplatzer Amulet, including devices such as Lariat or Amplatzer Cardiac Plug.
These devices do not have US FDA approval for percutaneous LAAC, and the available evidence is insufficient to determine improvement in net health outcomes.

Other percutaneous left atrial appendage closure devices, including but not limited to Lariat and Amplatzer Cardiac Plug, are considered investigational for stroke prevention in individuals with atrial fibrillation and are not covered as medically necessary.

The Lariat Loop Applicator is FDA-cleared for surgical suture delivery but is not specifically approved for percutaneous left atrial appendage closure; unlike endocardial devices, it is a non-implant epicardial device. The Amplatzer Cardiac Plug and WaveCrest have approval for left atrial appendage closure in Europe but are not currently approved in the United States for this indication.

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

Percutaneous left atrial appendage closure with devices other than Watchman or Amplatzer Amulet is not supported by sufficient evidence to establish improvement in net health outcomes. Available evidence includes nonrandomized and observational studies, and these devices lack US FDA approval for percutaneous left atrial appendage closure.

Coding and Risk-Assessment Requirements

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 for left atrial appendage closure devices

Terminated and Replacement CPT CodesCPT

0281T	Terminated effective 01/01/2017; replaced by CPT 33340
33340	Replacement code for terminated CPT 0281T, effective 01/01/2017

Removed Historical CPT CodesCPT

33999	Unlisted cardiovascular service; removed from coding
93799	Unlisted cardiovascular service; removed from coding

HAS-BLED Bleeding Risk

High bleeding risk thresholdHAS-BLED score ≥ 3

HAS-BLED Score Range

HAS-BLED score range0–9

CHADS2 Score

Medicare CHADS2 thresholdCHADS2 score ≥ 2

CHA2DS2-VASc Score

Medicare CHA2DS2-VASc thresholdCHA2DS2-VASc score ≥ 3

Provider Documentation and Denial Risks

Documentation Required

Second-Line Therapy Required

LAAC is covered as a second-line therapy to oral anticoagulants, not as an initial alternative. The patient must be suitable for short-term warfarin but unable to take long-term oral anticoagulation after shared decision-making.

Documentation Required

Complete Preprocedure Decision-Making and Program Requirements

Before LAAC, document 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. The patient must then be managed by a cohesive multidisciplinary team, and the procedure must be performed in a hospital with an established structural heart disease and/or electrophysiology program.

Documentation Required

Document Anticoagulation Suitability

Clinical Background

Atrial fibrillation is an irregular rhythm of the upper chambers of the heart that can cause blood to pool, particularly in the left atrial appendage. This stasis increases the risk of thrombus formation; embolization of a thrombus can cause ischemic stroke or systemic embolism. Systemic anticoagulation is the usual approach to stroke prevention, but its bleeding risk may make it unsuitable for some individuals. Percutaneous left atrial appendage closure offers a nonpharmacologic alternative by occluding the appendage and reducing the opportunity for thrombus to enter the bloodstream.

Definitions and Clinical Terms

Atrial fibrillation

DefinitionA heart rhythm disorder in which the heart's upper chambers beat irregularly and often rapidly.

Blood-flow effectBecause blood is not pumped out normally, blood tends to pool in the upper chambers.

Clinical riskPooling increases the risk of blood clots in the left atrial appendage, which can travel to the brain and cause a stroke.

Percutaneous left atrial appendage closure device

DefinitionA percutaneously implanted device that occludes the left atrial appendage.

Clinical purposeProvides a nonpharmacologic alternative to systemic anticoagulation for stroke prevention in atrial fibrillation.

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 DateNovember 1, 2026

Last ReviewOct 13, 2026

Next Review DateN/A

Key ActionDocument the FDA-approved device name and the patient's CHADS2 or CHA2DS2-VASc stroke-risk score with the medical necessity request.

SourceLink

On This Page

The patient has an appropriate rationale to seek a nonpharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared with anticoagulation therapy.

The patient is suitable for short-term warfarin but is deemed unable to take long-term oral anticoagulation following shared decision-making.

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

Before and after the procedure, the patient is under the care of a cohesive, multidisciplinary team of medical professionals.

The procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program.

Operator qualifications

The operator has received manufacturer-prescribed training on the safe and effective use of the device before performing LAAC.
The operator has performed at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum.≥25 prior procedures
Over a 2-year period, the operator continues to perform at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum, including at least 12 LAAC procedures.≥25 procedures over 2 years, including ≥12 LAAC procedures

The patient is enrolled in an approved registry that tracks outcomes for procedures and devices.

Prior Transseptal Procedures

Prior transseptal proceduresAt least 25 interventional cardiac procedures involving transseptal puncture through an intact septum

Ongoing Operator Volume

Ongoing operator volumeAt least 25 interventional cardiac procedures involving transseptal puncture through an intact septum over a 2-year period, including at least 12 LAAC procedures

Document that the patient is suitable for short-term warfarin but is unable to take long-term oral anticoagulation following shared decision-making. LAAC is covered only when used as second-line therapy to oral anticoagulants.

Documentation Required

Identify the FDA-Approved Device

The medical record must identify the specific FDA-approved LAAC device to be used, such as the Watchman or Amplatzer Amulet.

Documentation Required

Document Stroke-Risk Score

Document the patient’s increased risk of stroke and systemic embolism using the applicable score.

CHADS2 score ≥ 2
CHA2DS2-VASc score ≥ 3

Documentation Required

Document the Anticoagulation Risk-Benefit Assessment

The record must document that systemic anticoagulation therapy is recommended and that the long-term risks of systemic anticoagulation outweigh the risks of device implantation.

Documentation Required

Document Shared Decision-Making

Document the formal shared decision-making interaction in the medical record. It must be conducted before LAAC by an independent non-interventional physician using an evidence-based decision tool addressing oral anticoagulation in patients with nonvalvular atrial fibrillation.

Documentation Required

Document Patient Selection and Anticoagulation Rationale

Document why the patient meets LAAC selection requirements: elevated stroke and systemic-embolism risk, a recommendation for systemic anticoagulation, inability to take long-term oral anticoagulation despite suitability for short-term warfarin, and long-term anticoagulation risks that exceed the risks of implantation.

Documentation Required

Document Facility, Team, and Registry Requirements

Document that the patient is under the care of a cohesive multidisciplinary team before and after the procedure, that the procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program, and that the patient is enrolled in an approved registry tracking procedure and device outcomes.

Documentation Required

Document Operator Qualification

The operator record must show manufacturer-prescribed training on safe and effective device use before performing LAAC, at least 25 interventional cardiac procedures involving transseptal puncture through an intact septum, and ongoing performance of at least 25 such procedures over a 2-year period, including at least 12 LAAC procedures.

Denial Risk

Non-FDA-Approved Device

Use of a device without FDA approval for percutaneous LAAC is not covered as medically necessary and may be denied as investigational for stroke prevention.

Denial Risk

Medical Necessity Criteria Not Met

Coverage may be denied when the patient does not meet the required stroke-risk threshold, systemic anticoagulation is not recommended, the long-term risks of anticoagulation do not outweigh implantation risks, or the patient-selection and anticoagulation rationale is not documented.

CHADS2 score must be ≥ 2 or CHA2DS2-VASc score must be ≥ 3
Systemic anticoagulation must be recommended
Long-term anticoagulation risks must outweigh device-implantation risks

Denial Risk

Use of a Non-Approved LAAC Device

Devices other than the Watchman or Amplatzer Amulet, including the Lariat and Amplatzer Cardiac Plug, are considered investigational for stroke prevention in individuals with atrial fibrillation and may be denied.

Lariat Loop Applicator
Amplatzer Cardiac Plug
WaveCrest

Denial Risk

FDA PMA and Approved Indication Required

Medicare coverage requires that the LAAC device have FDA Premarket Approval (PMA) for the specific FDA-approved indication. A device that lacks FDA PMA or is used outside its approved indication does not satisfy the coverage requirement.

Denial Risk

Failure to Meet Medicare Procedural Requirements

Medicare coverage may be denied when required procedural documentation or program conditions are missing, including shared decision-making documentation, multidisciplinary-team care, an established hospital structural heart disease and/or electrophysiology program, approved-registry enrollment, or qualified operator training and volume.

How it worksOcclusion of the left atrial appendage helps prevent thrombus formation and blocks a clot from entering the bloodstream.

HAS-BLED score

DefinitionA clinical risk score ranging from 0 to 9.

Clinical purposeEstimates significant bleeding risk during systemic anticoagulation, including warfarin treatment in individuals with atrial fibrillation.

Factors includedHypertension; abnormal renal and liver function; stroke; bleeding; labile international normalized ratios; age; and drug or alcohol use.

CHA2DS2-VASc score

DefinitionA scoring system used to estimate thromboembolic risk in atrial fibrillation.

Component factorsCongestive heart failure, hypertension, age, diabetes, prior stroke, transient ischemic attack, or thromboembolism, vascular disease, and sex category.

Medicare thresholdA score of ≥3 meets the stated Medicare stroke-risk threshold for LAAC coverage.

CHADS2 score

DefinitionA scoring system used to estimate thromboembolic risk in atrial fibrillation.

Component factorsCongestive heart failure, hypertension, age over 75, diabetes, and prior stroke, transient ischemic attack, or thromboembolism.

Medicare thresholdA score of ≥2 meets the stated Medicare stroke-risk threshold for LAAC coverage.

Percutaneous left atrial appendage closure (LAAC)

Procedure definitionClosure of the left atrial appendage using a catheter-delivered device.

Clinical purposeReduces thromboembolism in patients with nonvalvular atrial fibrillation.

Coverage contextMedicare coverage treats LAAC as a second-line therapy for patients suitable for short-term warfarin but unable to take long-term oral anticoagulation.