ModifiedArkansas Blue Cross and Blue ShieldPolicy 2011008

Left Atrial Appendage Occlusion, Closure

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This policy governs coverage of percutaneous endovascular left atrial appendage closure or occlusion using an FDA Premarket Approval device, such as Watchman or Amplatzer Amulet. Coverage applies when members with atrial fibrillation meet the specified stroke-risk and bleeding-risk or anticoagulation-ineligibility criteria.

Policy Summary

PayerArkansas Blue Cross and Blue Shield

PolicyLeft Atrial Appendage Occlusion, Closure

Policy CodePolicy 2011008

Change TypeModified

Effective DateFeb 1, 2027

Next Review DateN/A

Key ActionVerify atrial fibrillation, the applicable sex-specific CHA₂DS₂-VASc threshold, and elevated bleeding risk or ineligibility for long-term oral anticoagulation before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for percutaneous endovascular left atrial appendage occlusion or closure using FDA Premarket Approval devices were updated.

CHA₂DS₂-VASc ≥2Male stroke-risk threshold

CHA₂DS₂-VASc ≥3Female stroke-risk threshold

HAS-BLED ≥3Elevated bleeding-risk threshold

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ModifiedArkansas Blue Cross and Blue ShieldPolicy 2011008

Left Atrial Appendage Occlusion, Closure

Customize your policy alerts

Sign up for arkansas_blue_cross_blue_shield Policy 2011008 alerts

Get alerted when Policy 2011008 changes without checking for updates manually.

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Policy Summary

PayerArkansas Blue Cross and Blue Shield

PolicyLeft Atrial Appendage Occlusion, Closure

Policy CodePolicy 2011008

Change TypeModified

Effective DateFeb 1, 2027

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for percutaneous endovascular left atrial appendage occlusion or closure using FDA Premarket Approval devices were updated.

CHA₂DS₂-VASc ≥2Male stroke-risk threshold

CHA₂DS₂-VASc ≥3Female stroke-risk threshold

HAS-BLED ≥3Elevated bleeding-risk threshold

Percutaneous Left Atrial Appendage Occlusion or Closure

Percutaneous left atrial appendage occlusion or closure

Covered when all of the following are met for percutaneous endovascular left atrial appendage occlusion or closure using an FDA Premarket Approval device, such as Watchman or Amplatzer Amulet.

Required coverage criteria

Atrial fibrillation: The individual has atrial fibrillation.
Elevated thromboembolic risk: The individual has an elevated annual risk of stroke or other systemic thromboembolic events.CHA₂DS₂-VASc score ≥2 in males or ≥3 in females
The applicable sex-specific threshold must be met.
Bleeding risk or anticoagulation ineligibility
- Elevated bleeding risk: The individual has an elevated risk of bleeding while on anticoagulation as calculated by a validated risk model, such as HAS-BLED.HAS-BLED score ≥3 is an example threshold
- Ineligible for long-term oral anticoagulation: The individual is ineligible for long-term oral anticoagulation therapy because of contraindications or other clinically relevant patient-specific risk factors for complications of oral anticoagulation use.
  Examples include nonreversible gastrointestinal, pulmonary, or genitourinary bleeding; nonreversible spontaneous intracranial or intraspinal bleeding; or untreatable recurrent falls that cause serious bleeding.

Clinical Score Thresholds

CHA₂DS₂-VASc Score for Males

ThresholdCHA₂DS₂-VASc score greater than or equal to 2

CHA₂DS₂-VASc Score for Females

ThresholdCHA₂DS₂-VASc score greater than or equal to 3

HAS-BLED Score

ThresholdHAS-BLED score greater than or equal to 3

Coverage Limitations and Denial Risk

Denial Risk

Failure to Meet Coverage Criteria

Coverage may be denied when percutaneous endovascular left atrial appendage closure (pLAAC/LAAO) does not meet the applicable coverage criteria. The procedure must use a U.S. FDA Premarket Approval (PMA) device and satisfy all required clinical criteria.

Use an FDA PMA device (e.g., Watchman or Amplatzer Amulet); devices without the required FDA regulatory status do not meet coverage criteria.
The individual must have atrial fibrillation.
The individual must have an elevated annual risk of stroke or systemic thromboembolic events: CHA₂DS₂-VASc score ≥2 in males or ≥3 in females.
The individual must have either an elevated bleeding risk on anticoagulation, such as a validated HAS-BLED score ≥3, or be ineligible for long-term oral anticoagulation because of contraindications or clinically relevant patient-specific risk factors.
Qualifying anticoagulation-related factors include nonreversible gastrointestinal, pulmonary, or genitourinary bleeding; nonreversible spontaneous intracranial or intraspinal bleeding; or untreatable recurrent falls causing serious bleeding. Failure to document these requirements may result in denial.

Policy Background

This policy addresses percutaneous endovascular left atrial appendage occlusion or closure (pLAAC/LAAO) for individuals with atrial fibrillation who have an elevated annual risk of stroke or other systemic thromboembolic events. Coverage is limited to procedures performed with a device that has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA), such as the Watchman or Amplatzer Amulet, and requires the applicable stroke-risk threshold plus either elevated bleeding risk while on anticoagulation or ineligibility for long-term oral anticoagulation because of contraindications or clinically relevant patient-specific risks.

Procedure Definition

pLAAC/LAAO

DefinitionPercutaneous endovascular closure or occlusion of the left atrial appendage using a device that has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA).