CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Defines medical necessity, coverage, coding, and prior authorization expectations for percutaneous LAA closure devices (e.g., Watchman) for stroke prevention in patients with atrial fibrillation for Blue Cross & Blue Shield of Rhode Island commercial products and notes Medicare-specific considerations.

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 TypeNo material changes

Effective Date02|01

Next Review DateN/A

Key ActionPrior authorization is recommended for commercial products and CPT 33340 should be included in authorization requests when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

WatchmanDevice medically necessary

Lariat/AmplatzerNot medically necessary

33340CPT listed

RecommendedPrior auth

>=3

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Coverage Criteria

Commercial product medical necessity criteria

Covered when ALL of the following are met for Commercial Products:

Stroke risk and anticoagulation indication: There is an increased risk of stroke and systemic embolism based on CHADS2 or CHADS2-VASc scoreas per CHADS2/CHADS2-VASc

Refer to documented CHADS2 or CHADS2‑VASc score in the medical record

Anticoagulation recommended: Systemic anticoagulation therapy is recommended

Patient would otherwise be a candidate for anticoagulation unless contraindicated; documentation required

Anticoagulation risks: The risks of systemic anticoagulation outweigh the risks of device implantation

Clinical judgment and supporting documentation must be in the chart

Medicare coverage condition

BlueCHiP for Medicare:

CMS‑approved clinical trial enrollment: Percutaneous left atrial appendage closure may be considered medically necessary for patients enrolled in a CMS‑approved clinical trial

Follow applicable CMS national and local coverage determinations and billing rules

The policy explicitly states that the use of other percutaneous left atrial appendage (LAA) closure devices — including but not limited to the Lariat and Amplatzer — for stroke prevention in atrial fibrillation is considered not medically necessary. The rationale documented in the source is that these devices do not have FDA approval for LAA closure and the available evidence is insufficient to determine their effect on health outcomes.

Member-specific subscriber agreements, member certificates, and/or employer agreements take precedence over this medical policy and will supersede its provisions for coverage and payment determinations. For member-specific benefits and eligibility, providers should contact the payer’s provider call center. If services are determined to be not medically necessary (or are medically necessary but are non-covered benefits under the member’s agreement), the provider may not bill the member unless the member has been informed and has provided written agreement in advance to accept financial responsibility.

Devices that lack FDA approval for left atrial appendage closure — specifically cited examples include the Lariat and Amplatzer — are categorized in this policy as not medically necessary for stroke prevention in atrial fibrillation. The policy identifies lack of regulatory approval and insufficient evidence as the basis for this determination.

When a service is determined to be not medically necessary (or is a medically necessary service that is a non-covered benefit under a member’s specific agreement), the service may not be payable by the plan. Providers should not assume coverage and must verify member benefits; billing the member for such services is permitted only if the provider has informed the member and obtained written agreement in advance to accept financial responsibility.

Coding

Covered CPT CodesCPTCovered

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

Covered CPT Codes (Medicare)CPTCovered

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

Modifiers for Clinical Studies (Medicare)Modifier

Q0	Modifier: Investigational clinical service provided in clinical research study that is in an approved research study (Medicare claims filed without the Q0 modifier will deny as not medically necessary)
Q1	Modifier: Routine clinical service provided in clinical research study that is in an approved clinical research study

inv-09: HAS-BLED high risk threshold — numeric threshold

HAS-BLED high-risk numeric threshold>= 3

Score range0–9

PurposeEstimate annual risk of significant bleeding in patients with AF on anticoagulation

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for participating providers and must be obtained via the payer's online tool. See Related Policies for details.

Affected code: CPT 33340
Obtain authorization via the web-based tool for participating providers

Denial Risk

Modifier-related Denial Risk for Medicare Clinical Study Billing

Claims for services rendered as part of a CMS-approved clinical study must include the appropriate modifier. Medicare claims filed without the required modifier may be denied as not medically necessary.

Modifier Q0 — Investigational clinical service provided in a clinical research study (required for study-related investigational services)
Modifier Q1 — Routine clinical service provided in a clinical research study

Background

Stroke associated with atrial fibrillation is predominantly embolic, and clinical evidence indicates that a majority of cardiac thrombi in nonvalvular atrial fibrillation originate in the left atrial appendage (LAA). Anticoagulation is the established primary strategy for stroke prevention, but some patients have an elevated bleeding risk or contraindications to long-term anticoagulant therapy. Percutaneous left atrial appendage closure devices were developed as a non-pharmacologic alternative to reduce stroke risk in selected patients who are at increased thromboembolic risk or for whom systemic anticoagulation risks outweigh benefits.

Definitions

inv-19: LAAC / LAA closure — definition of left atrial appendage closure

DefinitionPercutaneous implantation of an occlusion device into the left atrial appendage (LAA) to prevent thrombus formation and embolic stroke

MechanismOcclusion/exclusion of the LAA to prevent thrombus formation and subsequent systemic embolism

Typical contextDeveloped as a non-pharmacologic alternative to anticoagulation for stroke prevention in atrial fibrillation

inv-20: HAS-BLED — bleeding risk score definition and threshold

HAS-BLED score definitionBleeding risk score based on clinical characteristics (hypertension, renal/liver function, stroke history, bleeding history, labile INR, age, drugs/alcohol)

Score range0–9