Percutaneous Left Atrial Appendage Closure Form

1

Percutaneous Left Atrial Appendage Closure - Medical Policy
Updated Revision Effective: March 1, 2025 Policy Number:

UM633POL

Approval Date: 12/19/2024

Line(s) of Business:

FF
SF
Medicare
MedSupp-G
MedSupp-I
Medicaid

Description

Atrial fibrillation (AF) is an irregular heart rhythm that increases patient’s risk of stroke. The left atrial appendage (LAA) is a tubular structure that opens into the left atrium and has been shown to be one potential source for blood clots that can cause strokes. While thinning the blood with anticoagulant medications has been proven to prevent strokes, percutaneous LAA closure (LAAC) has been studied as a non-pharmacologic alternative for patients with AF. The WATCHMAN (largely replaced by the second-generation WATCHMAN FLX), the Amplatzer Cardiac Plug, and the Amplatzer Amulet are the leading implanted LAA endovascular devices worldwide. The WATCHMAN, WATCHMAN FLX, and Amulet devices are approved by the United States Food and Drug Administration (FDA). Among the available percutaneous LAA closure devices, the WATCHMAN is the only device for which randomized trials have shown comparable efficacy and safety with long-term warfarin for the prevention of stroke and systemic embolization.

 Line of Business

Commercial:

 Refer to criteria under Policy section in this medical policy.

Medicaid – BeHealthy:

 Refer to criteria under Policy section in this medical policy.

 There are no MassHealth guidelines for Percutaneous Left Atrial Appendage Closure.

2

Medicare:

 Health New England follows National Coverage Determination (NCD) Percutaneous Left Atrial Appendage Closure (LAAC) (20.34) for the Medicare line of business https://www.cms.gov/medicare- coverage-database/search.aspx.

Policy

I. Criteria for Approval of Left Atrial Appendage Closure for Commercial and Medicaid:

A. Percutaneous left atrial appendage (LAA) closure using the Watchman device is considered MEDICALLY NECESSARY to reduce the risk of thromboembolism from the LAA in individuals with nonvalvular atrial fibrillation when documentation confirms ALL the following:

1. Member is at increased risk for stroke (e.g. CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3) and systemic embolism; AND
2. Member is recommended for anticoagulation therapy; AND
3. Member is deemed by their physicians to be suitable for post procedure short-term warfarin; AND

4. Member has an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

   II. Criteria for Approval of Left Atrial Appendage Closure for Medicare:

    Health New England follows National Coverage Determination (NCD) Percutaneous Left Atrial Appendage Closure (LAAC) (20.34). NCD - Percutaneous Left Atrial Appendage Closure (LAAC) (20.34) (cms.gov)

   III. Left Atrial Appendage Closure for conditions that do not meet the above criteria are considered not medically necessary.

   IV. Percutaneous left atrial appendage closure using any device other than the Watchman device (e.g. Amplatzer Cardiac Plug [ACP], Amplatzer Amulet and Lariat suture delivery device) is considered experimental/investigational.

   Policy Guidelines and Definitions

   Definitions:

   CHADS2 score: Consists of Congestive heart failure (1 point), Hypertension (1 point), Age ≥ 75 (1 point), Diabetes (1 point), and Stroke/TIA (2 points). This score estimates stroke risk in patients with atrial fibrillation.

   https://www.mdcalc.com/chads2-score-atrial-fibrillation-stroke-risk

   CHA2DS2-VASc score: Consist of Congestive heart failure (1 point), Hypertension (1 point), Age (> 65 = 1 point, > 75 = 2 points), Diabetes (1 point), previous Stroke/transient ischemic attack (2 points), VASc stands for vascular disease (peripheral arterial disease, previous myocardial infarction, aortic atheroma)

3

(1 point), and sex category (female gender, 1 point). Most commonly utilized scoring method to predict thromboembolic risk in atrial fibrillation.

https://clincalc.com/Cardiology/Stroke/CHADSVASC.aspx

Coding Guidance

Code
Description
33340 Percutaneous transcatheter closure of 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

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (LAAC) (20.34).

https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=367&ncdver=1&bc=AAAAgAAAAAAA&

Holmes, Jr, D. R., MD, Kar, S., MD, Price, M. J., MD, Whisenant, B., MD, Sievert, H., MD, Doshi, S. K., MD, . . . Reddy, V. Y., MD. (2014, July 8). Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy: The PREVAIL Trial.

https://pubmed.ncbi.nlm.nih.gov/24998121/

Saw, J., MD. (2017, December 19). Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman.

https://pubmed.ncbi.nlm.nih.gov/29104013/

Ahmed, M., MD. (2016, December 6). Watchman Device – Explained and FAQ’s Answered by a Cardiologist.

https://myheart.net/articles/watchman-device-explained-and-faqs-answered-by-a-cardiologist/

Percutaneous Left Appendage Closure to Reduce Stroke Risk in Patients with Atrial Fibrillation, Hayes (Review Feb. 13, 2018), Sign in and credentials required.

  https://evidence.hayesinc.com/report/dir.percutaneous2367

Dukkipati, S, Kar, S, Holmes, D, Doshi, S, et. al. Device Related Thrombus After Left Atrial Appendage Closure, Circulation AHA (24 July 2018).

4

  https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.035090

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 9/2017 Policy original effective date 11/2023 NCD added for Medicare line of business. 12/2024 Annual Review Criteria for commercial and MassHealth updated.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at the time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.