ModifiedArizona Complete HealthPolicy CP.MP.147

Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Covers medical necessity and coverage criteria for FDA‑approved percutaneous left atrial appendage (LAA) occlusion devices to reduce stroke risk in adults with non‑valvular atrial fibrillation, and identifies non‑approved devices as lacking sufficient evidence.

Policy Summary

PayerArizona Complete Health

PolicyPercutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Policy CodePolicy CP.MP.147

Change TypeCriteria revisedmaterial additions and removals

Effective Date

Next Review Date

Key ActionObtain prior authorization for CPT 33340 and document non‑valvular AF, elevated stroke risk, contraindication or unacceptable bleeding risk to long‑term anticoagulation, and ability to tolerate short‑term anticoagulants.

SourceLink

POLICY UPDATE CHANGES

Changed criteria I to require ALL of the following rather than BOTH.

Removed contraindications I.B.1.-I.B.11 previously listed in the policy.

Added criterion I.C: 'Ability to tolerate short-term anticoagulants'.

Updated criteria to include all FDA‑approved percutaneous devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet).

3FDA‑approved percutaneous LAA devices named

33340Referenced CPT procedure code

≈10%Early adverse event rate (WATCHMAN)

99%

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Procedural success (Amulet registry)

~30Bibliography references

Coverage Criteria for Percutaneous LAA Occlusion

Medically necessary coverage criteria

Covered when ALL of the following are met for adults with non‑valvular atrial fibrillation:

Policy I: 1) Device is an FDA‑approved percutaneous left atrial appendage (LAA) occlusion device: WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet.

Derived from policy criteria I; names of approved devices updated in revision history.

Policy I: 2) Member has increased risk for stroke or systemic embolism based on CHADS2 or CHA2DS2‑VASc scoring, and long‑term anticoagulation therapy is recommended by guideline-directed assessment.CHA2DS2‑VASc > 2 referenced as guideline threshold for anticoagulation

See guideline-based stroke risk assessment in policy background.

Policy I: 3) Member has a contraindication to, or an unacceptable high risk of bleeding with, long‑term oral anticoagulant therapy.

Contraindication or unacceptable bleeding risk required per clinical criteria.

Policy I: 4) Member is able to tolerate short‑term anticoagulation as part of the peri‑procedural and immediate post‑implant management plan.

Criterion added in recent revision to ensure peri‑procedural anticoagulation tolerance.

Devices lacking sufficient evidence

Not covered / insufficient evidence:

Policy II: Percutaneous devices other than the FDA‑approved devices named above (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) are not supported due to paucity of evidence regarding long‑term safety and efficacy and are not considered appropriate for LAA occlusion for stroke prevention in adults with non‑valvular atrial fibrillation at this time.

Requests for non‑FDA‑approved devices may be denied; policy was revised to expand named FDA‑approved devices and to state lack of evidence for others.

Use of percutaneous left atrial appendage (LAA) occlusion devices for stroke prevention is limited to the FDA‑approved endocardial implants named in this policy. Specifically, coverage is reserved for WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet when all clinical criteria are met (increased stroke risk by CHADS2/CHA2DS2‑VASc with recommendation for long‑term anticoagulation, contraindication or unacceptable bleeding risk with long‑term anticoagulation, and ability to tolerate short‑term anticoagulation). Devices other than those listed lack sufficient evidence regarding long‑term safety and efficacy and therefore are not supported by this policy.

This clinical policy is a guide to medical necessity and assistance in coverage decisions; it does not supersede member benefit documents or legal requirements. When there is a conflict between this policy and applicable state Medicaid coverage provisions, state Medicaid provisions take precedence and should be followed for Medicaid members.

Percutaneous LAA occlusion using devices that are not FDA‑approved for this indication is considered unsupported by current research. The policy states there is a paucity of evidence regarding long‑term safety and efficacy for all other percutaneous devices, and therefore such devices are not considered appropriate for stroke risk reduction in adults with non‑valvular atrial fibrillation at this time.

Within the provided policy text and administrative reminders, no device‑specific conditions are explicitly listed under a 'not medically necessary' designation beyond the general statement excluding non‑FDA‑approved percutaneous devices. Reviewers and implementers should therefore apply the policy’s general exclusion for non‑approved devices rather than expecting a separate, device‑specific 'not medically necessary' list in these sections.

Application and administrative criteria

Policy is intended as a medical necessity guide and should be applied consistent with member benefits and applicable regulations.

Policy application: Apply the clinical criteria in this policy together with the member's coverage terms, state Medicaid provisions (which take precedence when they conflict with this policy), and any applicable Medicare NCDs/LCDs prior to authorization or payment decisions.

Providers must reconcile policy criteria with benefit documents, state and federal requirements, and Health Plan administrative policies; policy is a guide, not a guarantee of payment.

Policy application: Prior authorization for percutaneous transcatheter closure of the LAA (CPT 33340) may be required by the Health Plan; authorization should confirm all applicable policy criteria and required documentation (non‑valvular AF diagnosis, stroke risk score, contraindication to long‑term anticoagulation, ability to tolerate short‑term anticoagulation, and chosen FDA‑approved device).

Documentation expectations summarized from policy and prior authorization module.

Coding and Identifiers

Referenced CPT CodesCPT

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

Referenced device documents and identifiersmixed

P200049C

Amplatzer Amulet Left Atrial Appendage Occluder Instructions for Use (FDA document identifier referenced)

CHA2DS2‑VASc score threshold (inv-10)

CHA2DS2-VASc threshold> 2 (class I recommendation for oral anticoagulation per guideline)

Applicable populationAdults with non-valvular atrial fibrillation

Guideline sourceACC/AHA/HRS Guideline for the Management of Patients with Atrial Fibrillation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Guidance

Prior authorization may be required by the Health Plan for percutaneous left atrial appendage (LAA) closure (CPT 33340) and associated device implantation. This clinical policy is a medical necessity guide; providers must follow the Health Plan's prior authorization procedures and submit requests per payer-specific instructions before scheduling elective procedures.

Affected code: CPT 33340 (Percutaneous transcatheter closure of the left atrial appendage)
Follow payer-specific prior authorization workflows and timelines

Denial Risk

Denial Risk Due to Benefit or Regulatory Conflicts

Coverage is subject to the member's benefit plan, contract exclusions, limitations, and applicable state or federal requirements. Requests for devices that are not FDA‑approved for LAA occlusion (i.e., devices other than WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet) may be considered investigational/experimental and may be denied. Conflicts between this clinical policy and state Medicaid provisions or Medicare NCDs/LCDs will be resolved in favor of the applicable regulatory or benefit requirement.

Definitions and Key Terms

Stroke risk scoring system (CHA2DS2‑VASc) components (inv-20)

Congestive heart failure1 point

Hypertension1 point

Age ≥75 years2 points (doubled)

Diabetes mellitus1 point

Prior stroke/TIA/thromboembolism2 points (doubled)

Vascular disease1 point

Age 65–74 years1 point

Sex category (female)

Clinical Background

Atrial fibrillation increases the risk of thromboembolic stroke and most thrombi in non‑valvular AF originate in the left atrial appendage (LAA). Oral anticoagulation is the standard of care guided by stroke risk assessment (e.g., CHA2DS2‑VASc), but some patients have contraindications or unacceptable bleeding risk with long‑term anticoagulants. For these patients, catheter‑based LAA occlusion with an FDA‑approved device provides a mechanical alternative intended to reduce stroke risk, though procedural risks (including early pericardial bleeding) and device‑specific outcomes should be considered when evaluating candidacy.

Policy Summary

PayerArizona Complete Health

PolicyPercutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Policy CodePolicy CP.MP.147

Change TypeCriteria revisedmaterial additions and removals

Effective Date

Next Review Date

SourceLink

On This Page

Only FDA‑approved devices for LAA occlusion (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) are supported by this policy
Non‑FDA‑approved devices for this indication are generally considered experimental and may be denied
Medicaid state provisions supersede this policy when in conflict

Documentation Required

Documentation and Applicability

Document submission should demonstrate the clinical rationale and applicability to the member, including evidence of non‑valvular atrial fibrillation, objective stroke risk assessment (CHADS2 or CHA2DS2‑VASc), recommendation for long‑term anticoagulation, and documented contraindication or unacceptable bleeding risk to long‑term oral anticoagulants. Include documentation of the member’s ability to tolerate short‑term anticoagulation and any relevant prior therapies or specialist evaluations. For Medicare members, review and include applicable NCDs/LCDs as part of the prior authorization documentation.

Evidence of non‑valvular AF and CHA2DS2‑VASc or CHADS2 score
Documentation that long‑term anticoagulation is recommended but contraindicated or carries unacceptable bleeding risk
Evidence of ability to tolerate short‑term anticoagulation
Include applicable Medicare NCDs/LCDs for Medicare members

Step Therapy

Therapy Sequencing Expectation

Long‑term oral anticoagulation is the expected first‑line therapy for stroke prevention in non‑valvular AF per guideline recommendations. Percutaneous LAA occlusion is intended for selected patients with elevated stroke risk for whom long‑term anticoagulation is contraindicated or carries an unacceptable bleeding risk, and who can tolerate short‑term anticoagulation.

Therapy sequencing: attempt/consider guideline‑recommended long‑term anticoagulation first when appropriate
LAA occlusion is for patients with elevated stroke risk and contraindication to long‑term anticoagulation

FDA‑approved percutaneous LAA occlusion devices referenced (inv-21)

WATCHMANTranscatheter endocardial LAA occlusion device (original WATCHMAN) — deployed percutaneously via transseptal puncture

WATCHMAN FLXNewer-generation WATCHMAN FLX with distal rounded edge and double row stabilizing anchors; FDA approved

Amplatzer AmuletAmulet (Amplatzer) left atrial appendage occluder — FDA approved (2021) with design advances and high procedural success

Left atrial appendage occlusion (LAAO) definition (inv-22)

DefinitionA catheter-based procedure to exclude the left atrial appendage from systemic circulation to reduce thromboembolic stroke risk in patients with atrial fibrillation.

PurposeMechanical exclusion of LAA to prevent thrombus formation and reduce stroke/systemic embolism risk when long-term anticoagulation is contraindicated or not tolerated

ApproachPercutaneous transseptal access with endocardial implant placement (device-specific deployment techniques vary)