CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

This policy governs coverage and medical necessity criteria for percutaneous LAA closure devices (e.g., Watchman) as an alternative to systemic anticoagulation for stroke prevention in patients with atrial fibrillation, for Blue Cross & Blue Shield of Rhode Island commercial members and notes BlueCHiP for Medicare distinctions.

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 clinical or coverage changes

Effective Date02/01

Next Review DateN/A

Key ActionObtain prior authorization for commercial members (use CPT 33340 when criteria are met) via the web-based tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Watchman™FDA-approved device named in policy

33340CPT code specified for LAA closure

CHADS2 / CHA2DS2‑VAScStroke risk scores referenced

HAS-BLEDBleeding risk score

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Policy last reviewed

Coverage and Medical Necessity Criteria

Commercial medical necessity

Covered when ALL of the following are met:

Commercial coverage criteria: There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2‑VASc score

From Commercial Products; applies to FDA‑approved devices (e.g., Watchman).

Commercial coverage criteria: Systemic anticoagulation therapy is recommended

From Commercial Products; indicates candidate for stroke prevention therapy

Commercial coverage criteria: The risks of systemic anticoagulation outweigh the risks of device implantation

Clinical judgment required to balance bleeding vs procedural risks; applies to FDA‑approved devices such as the Watchman

BlueCHiP for Medicare (clinical trial coverage)

Medicare-specific coverage and clinical trial distinctions:

Medicare coverage context: Percutaneous left atrial appendage closure approved by the FDA may be considered medically necessary for patients enrolled in a CMS‑approved clinical trial

BlueCHiP for Medicare must follow CMS national and local coverage determinations; benefits may differ from commercial products

Medicare billing requirements: Claims for services rendered as part of a CMS‑approved clinical study must be billed with the appropriate modifier (eg, Q0 for investigational clinical service or Q1 for routine clinical service); claims filed without required modifiers may deny

Follow procedures in the Clinical Trials BlueCHiP for Medicare policy and use indicated modifiers on claims

Coding: CPT code 33340 describes the percutaneous transcatheter closure of the left atrial appendage with endocardial implant and may be allowed as part of a CMS‑approved clinical study per CMS guidance

Use CPT 33340 when criteria met and per Medicare clinical trial billing rules

The policy specifically addresses other percutaneous left atrial appendage (LAA) closure devices such as the Lariat and Amplatzer. These devices are distinguished from the FDA‑approved device named in this policy (eg, Watchman) and are discussed because they have been used for percutaneous LAA closure in clinical practice and publications.

Coverage determinations under this medical policy are subject to the member's specific benefit documents. The member's subscriber agreement, member certificate, or employer agreement supersedes the provisions of this medical policy, and providers should verify member benefits and eligibility with the payer prior to performing services.

Use of other percutaneous LAA closure devices without FDA approval (including but not limited to the Lariat and Amplatzer) for stroke prevention in atrial fibrillation is considered not medically necessary because these devices do not have FDA approval for LAA closure and the available evidence is insufficient to establish clinical benefit.

Services determined to be not medically necessary (or medically necessary services that are non‑covered benefits) are not payable unless the member has provided a written agreement to pay. Providers should confirm member‑specific coverage and obtain any necessary authorizations prior to providing services.

Billing and 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

Clinical trial billing modifiersModifier

Q0	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	Routine clinical service provided in clinical research study that is in an approved clinical research study

Provider Responsibilities and Billing Actions

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for participating providers and should be obtained via the payer's online prior authorization tool prior to scheduling the procedure.

Prior authorization recommended
Obtain via online prior authorization tool for participating providers
Affected CPT when criteria met: 33340

Note

Verify Member Benefits and Eligibility

Verify member-specific benefits, eligibility, and any prior authorization or coverage requirements with Blue Cross Blue Shield of Rhode Island before performing services.

Contact the provider call center for member-specific benefits and eligibility
Confirm whether services are covered under the member's plan and any applicable prior authorization status

Clinical Background

Atrial fibrillation (AF) substantially increases the risk of thromboembolic stroke, and the left atrial appendage (LAA) is the most common site of thrombus formation in nonvalvular AF. Systemic anticoagulation is the standard strategy for stroke prevention but carries bleeding risk; percutaneous LAA closure devices were developed as a nonpharmacologic alternative to reduce stroke risk in patients for whom long‑term anticoagulation is problematic. Some devices (eg, Watchman) have FDA approval and may require short‑term postimplant anticoagulation followed by long‑term antiplatelet therapy, whereas other devices and approaches have not received FDA approval and lack sufficient evidence to determine effects on health outcomes.

Definitions and Key Terms

Watchman — definition / identifier

Device nameWatchman Left Atrial Appendage System (Boston Scientific)

Device typeSelf-expanding nitinol (nickel‑titanium) endocardial occlusion device with polyester covering and fixation barbs

Implant approachPercutaneous catheter delivery via venous access and transseptal puncture into the left atrium

Post‑implant therapyShort‑term anticoagulation (approximately 1–2 months) followed by long‑term antiplatelet therapy (eg, aspirin and/or clopidogrel)

Regulatory status noted in policyIdentified as an FDA‑approved device for percutaneous LAA closure

Procedure (CPT 33340) — definition and brief description

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 clinical or coverage changes

Effective Date02/01

Next Review DateN/A

Key ActionObtain prior authorization for commercial members (use CPT 33340 when criteria are met) via the web-based tool for participating providers.

SourceLink

On This Page

Billing Rule

Medicare Billing Modifier Requirement

When treating BlueCHiP for Medicare members as part of a CMS‑approved clinical study, submit Medicare claims with the appropriate study modifier; failure to use the correct modifier can result in claim denial.

Modifier Q0 — Investigational clinical service provided in a clinical research study that is in an approved research study (Medicare claims filed without the Q0 modifier may deny as not medically necessary)
Modifier Q1 — Routine clinical service provided in a clinical research study that is in an approved clinical research study
Applicable code: CPT 33340 when criteria are met

Denial Risk

Potential Denial and Provider Liability

If services are determined to be not medically necessary or are non‑covered benefits under the member's plan, the provider may be financially responsible unless the member has been informed and has agreed in writing to accept financial liability prior to receiving services.

Obtain written agreement from the member if proceeding with non‑covered or not medically necessary services
Refer to your provider participation agreement for applicable provisions

Procedure namePercutaneous transcatheter closure of the left atrial appendage with endocardial implant

Included componentsIncludes fluoroscopy, transseptal puncture, catheter placement(s), left atrial and left atrial appendage angiography when performed, and radiological supervision and interpretation

Clinical contextPerformed percutaneously through a catheter delivery system with venous access and transseptal puncture to enter the left atrium

Devices and trials referenced

Randomized trials/registries citedPROTECT AF; PREVAIL; ASAP; EWOLUTION registry

Primary device(s) referencedWATCHMAN device (Boston Scientific)

Other devices/approaches discussedAMPLATZER Cardiac Plug / Amulet devices; LARIAT suture‑based ligation device; transcatheter suture ligation techniques

Additional devices evaluated in studiesPercutaneous LAA Transcatheter Occlusion device (ev3); Occlutech LAA Occluder; Cardioblate closure device (investigational)