CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Policy governing medical necessity and coverage for percutaneous left atrial appendage closure devices (e.g., Watchman, Amplatzer Amulet) for stroke prevention in patients with atrial fibrillation; affects Commercial and Medicare Advantage plan members of BCBSRI as specified.

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 change

Effective DateJan 12, 2022

Next Review DateN/A

Key ActionPrior authorization is recommended for commercial products and should be obtained via the payer's online tool when criteria for CPT 33340 are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved devices named

33340CPT code medically necessary when criteria met

90%LAA thrombi proportion

CHA2DS2‑VAScRequired stroke risk scores

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Commercial medical necessity

Covered when ALL of the following are met

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

Commercial LAAC criteria: Systemic anticoagulation therapy is recommended

Commercial LAAC criteria: The long‑term risks of systemic anticoagulation outweigh the risks of the device implantation

Applies to FDA‑approved percutaneous LAAC devices (e.g., Watchman, Amplatzer Amulet).

FDA‑based indication

Indications per FDA approvals (device labeling summary)

Device labeling: Devices (Watchman, Amplatzer Amulet) are indicated to reduce thromboembolism from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation who are at increased risk for stroke or systemic embolism based on CHADS2 or CHA2DS2‑VASc scores and are recommended for anticoagulation therapy

Device labeling: Patients are deemed by their physicians to be suitable for anticoagulation therapy

Device labeling: Patients have an appropriate rationale to seek a nonpharmacologic alternative to anticoagulation therapy, considering safety and effectiveness of the device compared to anticoagulation

Reflects FDA approval language referenced in policy.

Medicare Advantage clinical trial coverage

Covered when ALL of the following are met

Medicare Advantage clinical trial criteria: Percutaneous LAAC approved by the U.S. Food and Drug Administration (FDA) may be considered medically necessary for patients enrolled in a CMS‑approved clinical trial

BCBSRI must follow CMS guidelines; Medicare Advantage plans may differ from Commercial products.

Medicare Advantage clinical trial criteria: Claims for services rendered as part of a CMS‑approved clinical study must follow CMS billing and coding procedures, including billing with the appropriate modifier (Q0 for investigational clinical service or Q1 for routine clinical service)

Claims filed without the Q0 modifier for investigational clinical services will deny as not medically necessary.

The policy states that the use of other percutaneous left atrial appendage closure (LAAC) devices that do not have U.S. Food and Drug Administration (FDA) approval for LAA closure is considered not medically necessary for stroke prevention in atrial fibrillation. Examples explicitly noted include the Lariat and Amplatzer Cardiac Plug, and the document also indicates that several additional devices are being evaluated but are not approved in the U.S. for percutaneous LAAC.

This medical policy is provided for informational purposes and is not a guarantee of payment. Coverage determinations are governed by the member's subscriber agreement, member certificate, and/or the employer agreement, which supersede the policy. Providers should verify member-specific benefits and eligibility with the provider call center.

Devices that lack FDA approval for percutaneous LAA closure are considered not medically necessary for stroke prevention in atrial fibrillation due to insufficient evidence and the absence of U.S. approval for this indication. The policy specifically lists the Lariat and Amplatzer Cardiac Plug as examples and notes that other investigational devices (e.g., WaveCrest and others under evaluation) are not approved in the U.S. for LAAC.

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

Billing Modifiers for Clinical StudiesModifier

Q0	Investigational clinical service provided in a 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 a clinical research study that is in an approved clinical research study

Commercial Products - Medically necessary when criteria metCPTCovered

33340

HAS-BLED high bleeding risk — Score threshold

HAS-BLED high bleeding risk thresholdScore ≥ 3

HAS-BLED score range0 to 9 based on clinical characteristics (hypertension, renal/liver function, prior stroke, bleeding history, labile INR, age, drugs/alcohol)

Clinical implication of score ≥3Associated with high risk of bleeding; may prompt closer monitoring or alternative anticoagulation strategies

Provider Requirements and Actions

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for Commercial Products and should be obtained via the payer's online prior authorization tool for participating providers. Documentation supporting medical necessity should be provided as part of the prior authorization request.

Affected code: CPT 33340 — Percutaneous transcatheter closure of the left atrial appendage (endocardial implant).
Providers should verify member benefits and eligibility; coverage is subject to the member's subscriber agreement or employer agreement.

Billing Rule

Clinical Study Billing Modifiers

When treating Medicare Advantage members enrolled in a CMS-approved clinical study, use the appropriate clinical trial billing modifiers. Claims filed without the correct modifier may be denied.

Modifier Q0 — Investigational clinical service provided in an approved research study (failure to append Q0 may result in denial).
Modifier Q1 — Routine clinical service provided in an approved clinical research study.

Denial Risk

Medical Necessity Requirement

Services are covered only when medical necessity criteria are met. CPT code 33340 is considered medically necessary for Commercial Products only when the policy clinical criteria are satisfied. Failure to meet criteria may result in claim denial.

CPT 33340 is medically necessary for Commercial Products only when all clinical criteria are met.
Services not meeting medical necessity criteria may be denied.

Documentation Required

Benefit Verification and Related Procedures

Providers should verify benefits and eligibility prior to performing services and follow related payer procedures and related policies (e.g., Clinical Trials Medicare Advantage Plans; Prior Authorization via Web-Based Tool for Procedures).

Verify member-specific benefits with the provider call center when needed.
Follow payer-specific prior authorization and documentation procedures.

Step Therapy

Step Therapy Not Applicable

Step therapy does not apply to this policy; there are no medication trial sequencing requirements specified.

Definitions and Device Terms

Left atrial appendage closure (LAAC) — definition of the procedure

DefinitionPercutaneous placement of an occlusion device in the left atrial appendage to prevent thrombus formation and reduce risk of thromboembolic stroke in patients with atrial fibrillation.

Access routeImplantation performed percutaneously through a catheter delivery system using venous access and transseptal puncture to enter the left atrium.

Imaging guidanceTransesophageal echocardiography and fluoroscopy are used to guide the procedure.

RoleOffers a nonpharmacologic alternative to anticoagulant medications for stroke prevention in selected patients with AF.

Watchman FLX / Watchman — FDA‑approved endocardial LAA occlusion devices description

Devices describedWatchman and Watchman FLX are FDA‑approved self‑expanding endocardial LAA occlusion devices for stroke prevention in AF.

Watchman characteristicsSelf-expanding nitinol device with polyester covering and fixation barbs for endocardial attachment; implanted percutaneously.

Watchman FLX characteristicsNext-generation Watchman that is fully recapturable and repositionable and designed to occlude a wider range of LAA sizes.

Regulatory referencesFDA summaries and approval letters document indications for reducing thromboembolism from the LAA in nonvalvular AF patients.

Procedure (CPT 33340) — description of percutaneous transcatheter closure including imaging and transseptal puncture

Procedure CPT descriptionPercutaneous 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.

Key componentsIncludes catheter delivery, transseptal puncture to access left atrium, device placement in LAA, and intra-procedural imaging (fluoroscopy, TEE).

Associated device typesTypically used with FDA‑approved endocardial occlusion devices such as Watchman and Watchman FLX.

OpenPayer

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

Coverage Criteria for Left Atrial Appendage Closure

Billing and Coding

Provider Requirements and Actions

Clinical Background

Definitions and Device Terms