Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention
Customize your policy alerts
Sign up for Arizona Complete Health Policy CP.MP.147 alerts
Get alerted when Policy CP.MP.147 changes without checking for updates manually.
Monitor payer policy activity
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.
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).
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:
Derived from policy criteria I; names of approved devices updated in revision history.
See guideline-based stroke risk assessment in policy background.
Contraindication or unacceptable bleeding risk required per clinical criteria.
Criterion added in recent revision to ensure peri‑procedural anticoagulation tolerance.
Devices lacking sufficient evidence
Not covered / insufficient evidence:
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.
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.
Documentation expectations summarized from policy and prior authorization module.
Coding and Identifiers
| 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 |
| P200049C | Amplatzer Amulet Left Atrial Appendage Occluder Instructions for Use (FDA document identifier referenced) |
Provider Actions, Prior Authorization, and Documentation
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 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.
- 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 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
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
Definitions and Key Terms
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.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.