CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Defines medical necessity criteria, coding, and prior authorization recommendations for percutaneous left atrial appendage closure (LAAC) devices (e.g., Watchman) for stroke prevention in patients with atrial fibrillation for BCBSRI Commercial products; notes Medicare/clinical trial billing guidance for Medicare Advantage.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPercutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Policy CodePolicy N/A

Change Typeclarified

Effective DateFeb 1, 2019

Next Review Date

Key ActionPrior authorization is recommended and obtained via the online tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

Policy states Watchman (FDA-approved device) may be considered medically necessary when specified criteria are met; other devices without FDA approval (eg, Lariat, Amplatzer) are considered not medically necessary.

1Approved device example (Watchman) mentioned

2CPT codes listed for procedure

1Prior authorization requirement (Commercial)

1Medicare clinical trial coverage statement

Coverage Summary

This policy provides medical necessity criteria for percutaneous left atrial appendage closure (LAAC) devices for stroke prevention in atrial fibrillation and takes a mixed coverage stance. The policy specifies that the FDA-approved Watchman device may be considered medically necessary for Commercial Products when all criteria are met, and that other percutaneous devices without FDA approval (for example, the Lariat and Amplatzer) are considered not medically necessary. Effective date: 02/01/2019; Policy last reviewed/updated: 07/21/2021.

Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPercutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Coverage stanceMixed — FDA‑approved Watchman may be medically necessary when criteria met; other devices not medically necessary

Example approved deviceWatchman (FDA‑approved)

Not medically necessary devicesLariat; Amplatzer (and other non‑FDA‑approved devices)

Prior authorization (Commercial)Recommended via online tool

Relevant CPT codes (when criteria met)33267, 33269, 33340

Medical Necessity Criteria

Commercial Products - Medical Necessity Criteria for Percutaneous LAAC

Covered when ALL of the following are met:

ALL of the following

Increased stroke risk: There is an increased risk of stroke and systemic embolism based on CHADS2 score, or CHA2DS2-VASc scoreCHADS2 or CHA2DS2-VASc: increased risk per score (no numeric cutoff specified)
Refer to policy thresholds for score interpretation (no numeric cutoff specified).
Anticoagulation recommended: Systemic anticoagulation therapy is recommended
Document recommendation for systemic anticoagulation.
Bleeding risk vs device risk:

Not Medically Necessary / Experimental Devices

Commercial Products - Not Medically Necessary

The following is considered not medically necessary:

Non‑FDA-approved devices not covered: Use of other percutaneous left atrial appendage closure devices (including but not limited to the Lariat and Amplatzer) for stroke prevention in atrial fibrillation because these devices do not have FDA approval for LAA closure and evidence is insufficient

These devices lack FDA approval for LAAC and available evidence is insufficient to determine effects on health outcomes.

This device-specific stance reflects the policy change to distinguish FDA-approved devices from non-FDA-approved devices: the Watchman (FDA-approved) may be covered when the stated medical necessity criteria are met, whereas other devices that lack FDA approval for left atrial appendage closure are considered not medically necessary.

Coding

Commercial Products - Medically Necessary Codes (when criteria met)CPTCovered

33267	Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)
33269	Exclusion of left atrial appendage, thoracoscopic, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)
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

Medicare Advantage - Codes allowed as part of a CMS-approved clinical studyCPTCovered

33267	Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)
33269	Exclusion of left atrial appendage, thoracoscopic, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)
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

Devices considered not medically necessary (by device)mixedNot Covered

No codes listed

Provider Actions / Billing

Prior Authorization

Prior authorization recommended for Commercial Products

Prior authorization is recommended for Commercial Products and is obtained via the online tool for participating providers.

Use online prior authorization tool

Billing Rule

Clinical trial billing modifiers for Medicare Advantage

Claims for services rendered as part of a CMS-approved clinical study must be billed with an appropriate modifier Q0 (investigational clinical service in an approved study) or Q1 (routine clinical service in an approved study). Medicare claims filed without the Q0 modifier will deny as not medically necessary.

Background & Evidence

Percutaneous LAAC devices occlude the left atrial appendage (LAA) — the primary source of thrombi in atrial fibrillation — and offer a non-pharmacologic alternative to systemic anticoagulation for stroke prevention. Anticoagulation remains standard care but carries bleeding risks; device implantation has periprocedural thrombogenicity, so patients typically receive temporary anticoagulation after implantation (commonly warfarin or alternatives for approximately 1 to 2 months followed by antiplatelet therapy). Definitions: LAAC = Left atrial appendage closure; Watchman = FDA-approved percutaneous left atrial appendage closure device (Boston Scientific).

Evidence	Summary
FDA approval	Watchman approved via premarket approval (PROTECT AF trial)
Key RCTs / studies cited	PROTECT AF, PREVAIL, multiple meta-analyses and registries (references listed)

Medicare Determinations

Name	Number	Type	Effective Date
PERCUTANEOUS Left Atrial Appendage Closure (LAAC)	20.34	NCD

Definitions & Thresholds

Definitions and Thresholds

LAACLeft atrial appendage closure

WatchmanFDA‑approved percutaneous left atrial appendage closure device (Boston Scientific)

CHADS2/CHA2DS2‑VAScIncreased risk of stroke/systemic embolism based on CHADS2 or CHA2DS2‑VASc (no numeric cutoff specified in policy)

HAS‑BLEDScore ≥3 is considered high bleeding risk (background discussion; not an explicit coverage threshold)

Revision History

policy_changeLatest

Policy distinguishes device-specific coverage: the FDA-approved Watchman device may be considered medically necessary when specified criteria are met; other percutaneous LAA closure devices without FDA approval (e.g., Lariat, Amplatzer) are considered not medically necessary.