ModifiedCentenePolicy CP.MP.147

Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention

This policy governs coverage and medical necessity criteria for FDA‑approved percutaneous LAA occlusion devices to reduce stroke risk in adults with non‑valvular atrial fibrillation, and applies to Centene-affiliated health plans and their providers.

Policy Summary

PayerCentene

PolicyPercutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Policy CodePolicy CP.MP.147

Change TypeCriteria revised to include additional FDA‑approved devicescontraindication list trimmed

Effective Date

Next Review Date

Key ActionObtain prior authorization and document non‑valvular AF, elevated stroke risk, contraindication to long‑term anticoagulation, and ability to tolerate short‑term anticoagulation.

SourceLink

POLICY UPDATE CHANGES

Criteria I and II updated to include all FDA‑approved percutaneous devices for occlusion of the LAA (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet).

Removed contraindications I.B.1–I.B.11 and added criterion I.C 'Ability to tolerate short-term anticoagulants'.

Clarified that anticoagulation therapy recommended is use (language edits in criteria I.A and I.B).

3FDA‑approved percutaneous LAA devices named

99%Amulet registry procedural success

3.2%Major adverse events (Amulet)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Ischemic stroke/systemic embolism (18 mo)

≈10%Early adverse events (original WATCHMAN)

multipleEvidence & guideline sources

Coverage and Medical Necessity Criteria

Medical necessity for FDA‑approved devices

Covered when ALL of the following are met

Policy coverage criteria: (1) Adult with non‑valvular atrial fibrillation

Policy coverage criteria: (2) Increased risk for stroke or systemic embolism based on CHADS2 or CHA2DS2‑VASc where long‑term anticoagulation is recommended

Policy coverage criteria: (3) Contraindication to or unacceptable high bleeding risk with long‑term oral anticoagulants

Policy coverage criteria: (4) Ability to tolerate short‑term anticoagulation

Policy coverage criteria: (5) Use of an FDA‑approved percutaneous LAA occlusion device: WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet

These five conditions must all be satisfied.

Percutaneous left atrial appendage (LAA) occlusion is intended as a non‑pharmacologic alternative to long‑term oral anticoagulation for stroke prevention in adults with non‑valvular atrial fibrillation who have elevated stroke risk. Policy coverage is contingent on documentation that the member has an elevated stroke risk based on CHADS2 or CHA2DS2‑VASc such that long‑term anticoagulation would ordinarily be recommended, but that long‑term anticoagulation is contraindicated, not tolerated, or associated with unacceptable bleeding risk. The policy also requires that the patient be able to tolerate short‑term anticoagulation around the time of the procedure and that a currently FDA‑approved percutaneous LAA device is used (see device list).

This policy limits coverage to the three currently FDA‑approved percutaneous LAA occlusion devices: WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet. Use of any other percutaneous LAA occlusion device is considered not medically necessary because available research does not support their long‑term safety and efficacy and they are not FDA approved for this indication.

Coverage determinations under this policy are subject to the member’s specific health plan contract terms, including all plan exclusions, limitations, and administrative rules. Where applicable, state Medicaid requirements and other legal or regulatory provisions take precedence over this clinical policy. Providers should verify benefits and prior authorization requirements with the Health Plan prior to scheduling the procedure.

Billing and Coding

Referenced CPT CodeCPT

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

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous transcatheter left atrial appendage (LAA) closure (CPT 33340). Approval is contingent on meeting all policy criteria and submission of required documentation. Verify applicable Medicare NCDs/LCDs and Health Plan rules prior to requesting authorization.

Affected CPT code: 33340

Documentation Required

Required Clinical Documentation and Expectations

Requests must include documentation demonstrating: non‑valvular atrial fibrillation; an elevated stroke risk (documented CHA2DS2‑VASc score); and a contraindication or unacceptable high bleeding risk to long‑term oral anticoagulation, or intolerance to anticoagulation therapy. Include the device IFU (if applicable), procedural notes, imaging (pre‑ and post‑procedure as available), and prior anticoagulation history and rationale for discontinuation. Apply documentation expectations consistent with the evidence base and any relevant Medicare NCDs/LCDs.

Document non‑valvular AF diagnosis

Definitions and Clinical Scores

CHA2DS2‑VASc — stroke risk score components and age thresholds

Score componentsCHA2DS2‑VASc includes Congestive heart failure, Hypertension, Age, Diabetes mellitus, prior Stroke/TIA/thromboembolism, Vascular disease, and Sex category

Age thresholds and weightingAge ≥75 years scores 2 points (doubled); age 65–74 years scores 1 point

Clinical useRecommended to estimate stroke risk and guide decisions about oral anticoagulation in patients with atrial fibrillation

Therapeutic thresholdOral anticoagulation is a class I recommendation for patients with prior stroke/TIA or CHA2DS2‑VASc ≥2

Percutaneous LAA occlusion devices — description of device type and approach

Device categoryEndocardial plug devices placed percutaneously to occlude the ostium of the left atrial appendage

Clinical Background and Evidence Summary

Atrial fibrillation substantially increases the risk of thromboembolic stroke. Stroke risk stratification using scores such as CHA2DS2‑VASc guides the recommendation for long‑term anticoagulation in patients with AF. Some patients who would otherwise benefit from anticoagulation have absolute or relative contraindications, intolerance, or adherence barriers. For those patients, percutaneous LAA occlusion — performed with FDA‑approved endocardial plug devices such as WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet — offers a mechanical means to exclude the left atrial appendage and reduce embolic stroke risk. Professional society guidance supports consideration of LAA occlusion in patients at increased stroke risk who have contraindications to long‑term anticoagulation, though randomized trials and registries also document periprocedural adverse events and the need for careful patient selection and shared decision making.

Policy Summary

PayerCentene

PolicyPercutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Policy CodePolicy CP.MP.147

Change TypeCriteria revised to include additional FDA‑approved devicescontraindication list trimmed

Effective Date

Next Review Date

Key ActionObtain prior authorization and document non‑valvular AF, elevated stroke risk, contraindication to long‑term anticoagulation, and ability to tolerate short‑term anticoagulation.

SourceLink

On This Page

Provide CHA2DS2‑VASc score and supporting clinical data

Document contraindication/intolerance to long‑term oral anticoagulation

Include prior anticoagulation therapies tried and reasons for discontinuation

Attach device IFU and procedural/imaging records

Documentation Required

Consideration of Anticoagulation

Per guideline recommendations, candidates should have been evaluated for and — unless contraindicated — trialed on guideline‑recommended anticoagulation based on CHA2DS2‑VASc score (oral anticoagulation is Class I for CHA2DS2‑VASc ≥2). The policy expects documentation of the consideration and/or trial of anticoagulation and the clinical reasoning for why long‑term anticoagulation is not acceptable (e.g., major prior bleeding, high bleeding risk with contraindications).

Documented assessment of anticoagulation suitability per CHA2DS2‑VASc
Explicit clinical rationale for withholding long‑term anticoagulation when applicable

Denial Risk

Device Approval Status

Non‑FDA approved LAA occlusion devices are not supported by this policy. Requests proposing use of devices that are not FDA‑approved for LAA occlusion may be denied; include justification and supporting evidence if an investigational or non‑approved device is proposed.

Use FDA‑approved devices for the indication when possible
Non‑FDA devices: provide justification and supporting evidence; may be denied

Note

Coverage Limits and Medicare/State Consistency

Ensure review of plan coverage documents and state Medicaid provisions; state requirements take precedence where they conflict with this policy. For Medicare members, verify and comply with applicable NCDs/LCDs and Medicare Coverage Articles when applying policy criteria.

State Medicaid coverage provisions may supersede this policy
Verify Medicare NCDs/LCDs for Medicare members before approval

Access approachTypically delivered via transseptal puncture (catheter-based percutaneous approach)

FDA‑approved examplesWATCHMAN, WATCHMAN FLX, and Amplatzer Amulet are the currently FDA‑approved percutaneous LAA closure devices

Left atrial appendage occlusion/closure — procedural definition and examples

Procedural definitionA percutaneous, catheter-based procedure to exclude the left atrial appendage from circulation to reduce thromboembolic stroke risk in atrial fibrillation

Mechanisms/examplesIncludes endocardial plug devices that occlude the LAA ostium and epicardial ligation procedures to exclude the LAA

Devices referenced in evidence/guidanceWATCHMAN series and Amplatzer Amulet are studied in randomized trials and registries; professional society guidance and HTAs address LAA occlusion