Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention
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Defines medical necessity criteria and coding implications for FDA‑approved percutaneous LAA occlusion devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) for stroke prevention in adults with non‑valvular atrial fibrillation who are candidates for the procedure.
Criteria I updated to include all FDA‑approved percutaneous devices for occlusion of the LAA (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) and removed verbiage that the WATCHMAN is the only FDA approved device.
Added criterion I.C requiring ability to tolerate short‑term anticoagulants.
Removed previously listed contraindications I.B.1.-I.B.11 and a note that warfarin may be required.
Coverage Criteria — Percutaneous LAA Occlusion
Initial coverage criteria (FDA‑approved devices)
Covered when ALL of the following are met:
Devices must be FDA‑approved for LAA occlusion (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet).
Devices not supported by current research
Not supported / not covered devices:
Paucity of long‑term safety and efficacy data for other percutaneous LAA devices.
Percutaneous devices other than the specified FDA‑approved devices for left atrial appendage (LAA) occlusion are not supported. Current research does not support use of percutaneous devices other than WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet for LAA occlusion due to a paucity of long‑term safety and efficacy data.
When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence. For Medicare members, applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles should be reviewed and take precedence where applicable; review CMS guidance prior to applying this policy's criteria.
Use of any percutaneous LAA occlusion device that is not FDA‑approved for this indication is considered not medically necessary. The policy explicitly restricts covered devices to FDA‑approved devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) because evidence is insufficient to support other percutaneous devices for stroke prevention in non‑valvular atrial fibrillation.
Coding and Device References
| 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 |
| No codes listed |
Provider Actions, Prior Authorization, and Documentation
Obtain prior authorization showing all medical necessity criteria and device type
Prior authorization must be obtained and must document that the patient meets all medical necessity criteria: increased stroke/systemic embolism risk per CHADS2 or CHA2DS2‑VASc with recommendation for long‑term anticoagulation, contraindication or unacceptable high bleeding risk with long‑term oral anticoagulants, and ability to tolerate short‑term anticoagulation. The specific device requested (WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet) should be identified in the authorization request. CPT 33340 should be included when applicable.
- Demonstrate elevated stroke risk and that long‑term anticoagulation is recommended (CHADS2/CHA2DS2‑VASc).
- Document contraindication/unacceptable bleeding risk with long‑term oral anticoagulants.
- Document ability to tolerate short‑term anticoagulation.
- Specify device type (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) and include CPT 33340 for the procedure.
Follow plan-level prior authorization procedures and member benefit terms
Follow your plan's administrative procedures: coverage determinations must be reviewed against this clinical policy and the member's benefit terms, and prior authorization may be required per plan rules.
- Verify member benefit terms and any plan-specific prior authorization workflows before submitting requests.
- Adhere to plan-level administrative policies and procedures for authorizations.
Policy is an interventional alternative, not step therapy
This policy addresses percutaneous LAA occlusion as an interventional alternative when long‑term anticoagulation is contraindicated or not tolerated; it is not a step‑therapy medication sequence.
- Use the procedure when criteria (elevated stroke risk + anticoagulation contraindication/intolerance + short‑term anticoagulant tolerance) are met.
- Do not interpret this policy as requiring sequential medication trials prior to considering LAA occlusion.
No step therapy specified
No explicit step therapy requirements are specified in this clinical policy — the decision centers on meeting medical necessity criteria for device placement rather than following a medication‑step sequence.
- Document clinical justification for device placement per the policy criteria instead of documenting prior medication trials as a step‑therapy pathway.
Document non‑valvular AF, elevated stroke risk, anticoagulation contraindication/intolerance, and short‑term anticoagulant tolerance
Include documentation that the patient has non‑valvular atrial fibrillation, an elevated stroke risk based on CHADS2 or CHA2DS2‑VASc, a contraindication or unacceptable high bleeding risk to long‑term oral anticoagulation, and that the patient can tolerate short‑term anticoagulation. When billing, include the relevant procedural code (CPT 33340) and device information.
- Clinical diagnosis: non‑valvular atrial fibrillation.
- Stroke risk score and interpretation (CHADS2 or CHA2DS2‑VASc).
- Evidence of contraindication/intolerability to long‑term anticoagulation.
- Statement that short‑term anticoagulation is tolerable.
- Procedure coding: CPT 33340 and documentation of device used.
Follow plan coverage documents and applicable Medicaid/Medicare guidance when submitting claims
When submitting claims and authorizations, follow the Health Plan's coverage documents and applicable state Medicaid or Medicare NCD/LCD guidance; state Medicaid provisions take precedence when in conflict and Medicare NCDs/LCDs should be reviewed for Medicare members.
- Check state Medicaid manuals for Medicaid members if provisions conflict with this policy.
- Review applicable Medicare NCDs, LCDs, and Coverage Articles for Medicare members before applying policy criteria.
Do not request non‑FDA‑approved LAA devices — not supported / not medically necessary
Requests to cover percutaneous LAA occlusion devices that are not FDA‑approved for this indication (i.e., devices other than WATCHMAN, WATCHMAN FLX, or Amplatzer Amulet) are not supported by current research and will be considered not medically necessary.
- Do not request coverage for non‑FDA‑approved percutaneous LAA devices for stroke prevention — these are not supported and are considered not medically necessary.
Coverage decisions subject to coverage document terms, exclusions, and plan policies
Coverage decisions and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage document and applicable Health Plan administrative policies; legal and regulatory requirements govern if discrepancies exist.
- Ensure requests comply with the member's evidence of coverage/policy contract and applicable administrative rules.
- Expect denials or limitations if requests fall outside coverage document terms or applicable laws/regulations.
Clinical Background
Atrial fibrillation (AF) substantially increases the risk of ischemic stroke and systemic embolism. In patients with non‑valvular AF, most intracardiac thrombi originate in the left atrial appendage (LAA). Anticoagulation is the standard therapy to reduce stroke risk, but percutaneous LAA occlusion devices provide an interventional alternative for patients with an elevated stroke risk who have contraindications to or cannot tolerate long‑term oral anticoagulation.
Definitions and Terms
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