Medicare Advantage

Medical Policy

Notification

Percutaneous Left Atrial Appendage (LAA) Closure for Non-Valvular Atrial Fibrillation (NVAF)

Notification Issue Date:

This AmeriHealth New Jersey Medicare Advantage policy will become effective 01/01/2024.

Title:

Percutaneous Left Atrial Appendage (LAA) Closure for Non-Valvular Atrial Fibrillation (NVAF)

Policy #:

MA11.013c

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.

PERCUTANEOUS LEFT ATRIAL APPENDAGE (LAA) CLOSURE FOR NON-VALVULAR ATRIAL FIBRILLATION (NVAF)

EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, percutaneous left atrial appendage (LAA) closure for non-valvular atrial fibrillation (NVAF) is considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development (CED).

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Percutaneous LAA closure for NVAF is eligible for coverage consideration for individuals who meet all the requirements of Original Medicare's CED provisions and who are enrolled in a Medicare-approved clinical study for percutaneous LAA closure for NVAF, when the study is conducted at a facility specified by the approved registry.

BILLING REQUIREMENTS

Claims for percutaneous LAA for NVAF for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

Providers must report Modifier Q0 with procedure code 33340 to represent investigational clinical service provided in a Centers for Medicare & Medicaid Services (CMS)–approved clinical research study.

Guidelines

This policy is consistent with Medicare’s coverage determination for percutaneous left atrial appendage (LAA) closure for non-valvular atrial fibrillation (NVAF). The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, percutaneous LAA closure for NVAF is covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development (CED) listed in this medical policy are met.

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

A list of approved CED studies for percutaneous left atrial appendage closure are listed and maintained on the CMS website at:

https://www.cms.gov/medicare/coverage/evidence/left-atrial-closure

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Watchman™ LAA Closure Technology was approved by the FDA on March 13, 2015, for the prevention of stroke in individuals with atrial fibrillation (AF).

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder was approved by the FDA on August 14, 2021, for the prevention of stroke in individuals with AF.

Description

Individuals with atrial fibrillation (AF) are at increased risk of stroke due to blood clots that can form in the heart. Stroke prevention in AF is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Most embolic strokes, commonly associated with AF, originate from the left atrial appendage (LAA); therefore, occlusion of the LAA offers a nonpharmacologic alternative to anticoagulant medications for the prevention of stroke in individuals with nonvalvular AF (NVAF) using percutaneous LAA closure devices.

In clinical practice, individuals with NVAF with high stroke risk and high bleeding risk scores are considered the most suitable candidates for percutaneous LAA closure, CHADS₂, and HAS-BLED stratification tools, respectively. A commonly used stroke risk stratification tool, the CHADS₂ score, assigns one point each for the presence of congestive heart failure, hypertension, age 75 years or older, diabetes, prior stroke or transient ischemic attack (TIA). The preferred, more inclusive, CHADS₂-VASc score includes the presence of vascular disease, more age categories, and gender, in addition to the risk factors used in the CHADS₂ score. Warfarin is the predominant anticoagulant agent in clinical use. A number of newer anticoagulant medications, including dabigatran,

rivaroxaban, and

apixaban, have recently received US Food and Drug Administration (FDA) approval for stroke prevention in NVAF and have demonstrated noninferiority to warfarin in clinical trials and do not require frequent blood tests and dose adjustments like warfarin; however, they have not been tested against percutaneous LAA closure devices. Although anticoagulation is effective for stroke prevention, there is an increased risk of bleeding. Guidelines from the American College of Chest Physicians recommend the use of oral anticoagulation for individuals with AF who are at high risk of stroke (i.e., CHADS₂ score of ≥2), with a more individualized choice of antithrombotic therapy in individuals with lower stroke risk.

Multiple percutaneously deployed devices are being investigated for LAA closure. On March 13, 2015, an occlusion device, the Watchman™ LAA Closure Technology (Boston Scientific Corp., Marlborough, MA), received approval from the US Food and Drug Administration (FDA) for stroke prevention in individuals with AF. The Watchman™ LAA Closure Technology is indicated for stroke prevention in individuals with AF who are candidates for systemic anticoagulation. The most relevant evidence comes from two industry-sponsored randomized controlled trials (RCTs) that compared the Watchman™ device with anticoagulation. One trial reported noninferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after 2 years of follow-up, with continued benefits with the Watchman™ device after 4 years of follow-up.

PROTECT-AF, a multicenter, prospective RCT, was conducted to determine whether percutaneous LAA closure with a Watchman™ device was noninferior to warfarin for stroke prevention in NVAF. In the study, 707 individuals who were at least 18 years of age, with NVAF, a CHADS₂ score of one or greater, and with eligibility for long-term warfarin therapy were enlisted from 59 centers in the United States and Europe and were randomly assigned in a device-to-control ratio of two to one. Individuals receiving the device were treated with warfarin until day 45 to allow for

endothelialization; thereafter, warfarin was discontinued. Individuals were followed up with transesophageal echo at 45 days, 6 months, and 1 year, and were seen for clinical follow-up biannually for up to 5 years, and had regular international normalized ratio (INR) monitoring while on warfarin. Primary effectiveness composite endpoints were stroke, cardiovascular death, and systemic embolism.

The primary safety endpoints were life-threatening events, which included device embolization requiring retrieval and bleeding events such as pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitated a surgical procedure. The primary efficacy outcome occurred at a rate of 3.0 per 100 patient-years in the LAA closure group compared with 4.9 per 100 patient-years in the warfarin group. Based on these outcomes, the probability of noninferiority was greater than 99.9%. For the individual components of the primary outcome, cardiovascular/unexplained death and hemorrhagic stroke were higher in the warfarin group. In contrast, ischemic stroke was higher in the LAA closure group at 2.2 per 100 patient-years compared with 1.6 per 100 patient-years in the warfarin group. The primary safety outcome occurred more commonly in the LAA closure group, at a rate of 7.4 per 100 patient-years compared with 4.4 per 100 patient-years in the warfarin group. The excess adverse event rates of the LAA closure group were primarily the result of early adverse events associated with placement of the device. Outcomes through 4 years of follow-up were reported by Reddy et al. in 2014. The relative risk for the composite primary outcome in the Watchman™ group compared with anticoagulation was 0.60, which met the noninferiority criteria with a confidence interval (CI) of greater than 99.9%. The study reported that fewer hemorrhagic strokes occurred in the Watchman™ group, and fewer cardiovascular events occurred in the Watchman™ group. Rates of ischemic stroke did not differ significantly between the groups, but the study reported that Watchman™ group individuals had lower all-cause mortality than individuals in the anticoagulation group.

The second multicenter, prospective RCT, the PREVAIL study (reported by Holmes et al. in 2014), evaluated the safety and effectiveness of the Watchman™ device for stroke prevention in 461 individuals with NVAF who were deemed by their professional providers to be suitable for long-term warfarin therapy with a CHADS₂ score of two or greater. The study had three primary endpoints. The first primary endpoint included 18-month rates of the composite of stroke, systemic embolism, and cardiovascular or unexplained death. The second primary endpoint was the 18-month rates of ischemic stroke and systemic embolism excluding the first 7 days of postrandomization. The third primary endpoint was occurrence of death, ischemic stroke, systemic embolism, and procedure- or device-related complications requiring open cardiovascular surgery or major endovascular intervention in device group only. In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention of systemic embolism events greater than 7 days postprocedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. The study reports that procedural safety was significantly improved. This trial proposes to provide additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in individuals with NVAF who do not have an absolute contraindication to short-term warfarin therapy.

In 2015, Holmes et al. reported results of a meta-analysis, which included data from the PROTECT-AF and PREVAIL trials and their respective registries, which included a total of 2406 enrolled individuals;1877 treated with the Watchman™ device and 382 treated with warfarin alone. With a mean follow-up of 2.69 years, individuals receiving LAA closure with the Watchman™ device had fewer hemorrhagic strokes (0.15 vs 0.96 events per 100 patient-years); cardiovascular/unexplained death (1.1 vs 2.3 events per 100 patient-years); and nonprocedural bleeding (6% vs 11.9%) compared with warfarin. There were more ischemic strokes in the device group (1.6 vs 0.9 events per 100 patient-years). In conclusion, the analysis suggests that for individuals with NVAF at increased risk for stroke or bleeding who are candidates for long-term anticoagulation, LAA closure resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin.

For the use of the Watchman™ device for stroke prevention in individuals with AF who are not candidates for systemic anticoagulation, the evidence consists of relatively small case series. The data from these studies suggest that placement of the Watchman™ device with the use of antiplatelet therapy is feasible, but do not provide evidence of the comparative benefit of LAA closure in preventing strokes. Thus, the published evidence is insufficient to determine that the Watchman™ device improves the net health outcome for individuals with AF who are not candidates for systemic anticoagulation. For the use of other LAA closure devices, including the LARIAT® Suture Delivery Device (

SentreHEART, Inc., Redwood City, CA),

WaveCrest LAA occluder (

Coherex Medical Inc., Salt Lake City, UT), and Amplatzer™ Cardiac Plug (St. Jude Medical, Inc., St. Paul, MN) devices, for the prevention of stroke in AF, no controlled trials were identified. Case series of these devices report high procedural success, but also numerous complications. The risks and benefits of sole open surgical LAA occlusion have not been well studied. In addition, these devices do not have FDA approval for LAA closure.

On August 14, 2021, an occlusion device, the Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Abbott Medical, Plymouth, MN), received approval from the FDA for stroke prevention in individuals with AF. The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is intended to reduce the risk of thrombus embolization from the LAA in individuals who have nonvalvular AF and who are at increased risk for stroke and systemic embolism based on CHADS₂or CHA₂DS₂-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a nonpharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device. The most relevant evidence comes from an industry-sponsored prospective, multicenter RCT that compared the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder to the Watchman™ device.

The AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE), a multicenter world-wide, prospective RCT was conducted to evaluate the safety and effectiveness of the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. In the study, 1878 individuals who were at least 18 years of age, with documented paroxysmal, persistent, or permanent nonvalvular AF, a CHADS₂ score of two or greater or a CHA₂DS₂-VASc score of 3 or greater, and with eligibility for short-term warfarin therapy, were enlisted from 78 centers in the United States and 30 centers outside of the United States, and were randomly assigned (1:1) to undergo percutaneous implantation of an LAA occluder with the Amulet™ occlusion device (treatment) or Watchman® LAA closure device (control).

The primary endpoints included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion at 45 days. Pre-specified secondary endpoints included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the three primary endpoints. The Amulet™ occluder was noninferior to the Watchman™ device for the primary safety endpoint (14.5% vs 14.7%; difference= −0.14; 95% CI, −3.42–3.13; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% vs 10.0% and 3.9% vs 5.1%, respectively). Procedure-related complications were higher for the Amulet™ occluder (4.5% vs 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet™ occluder was noninferior to the Watchman™ device for the primary effectiveness endpoint (2.8% vs 2.8%; difference=0.00; 95% CI, −1.55–1.55; P<0.001 for noninferiority), and the composite of stroke, systemic embolism or cardiovascular/unexplained death (5.6% vs 7.7%; difference= −2.12; 95% CI, −4.45–0.21; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% vs 12.3%; difference= −0.71; 95% CI, −3.72–2.31; P=0.32 for superiority). LAA occlusion was higher for the Amulet™ occluder compared with the Watchman device (98.9% vs 96.8%; difference=2.03, 95% CI, 0.41–3.66; P<0.001 for noninferiority; P=0.003 for superiority). The Amulet™ occluder was noninferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman™ device, and superior for LAA occlusion. Procedure-related complications were higher with the Amulet™ device and decreased with operator experience.

References

Centers for Medicare & Medicaid Services (CMS). Coverage with evidence development. Percutaneous Left Atrial Appendage Closure (LAAC). [CMS Web site]. 04/22/2022. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/LAAC.html. Accessed February 4, 2025.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N). [CMS Web site]. 02/08/2016. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281. Accessed February 4, 2025.

Centers for Medicare & Medicaid Services (CMS). Mandatory reporting of national clinical trial (NCT) identifier numbers on Medicare claims – Qs & As. [CMS Web site]. 10/31/2014. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Downloads/Mandatory-Clinical-Trial-Identifier-Number-QsAs.pdf. Accessed February 4, 2025.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Effective April 1, 2020. MM11419 – International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)—April 2020 Update. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11491.pdf Accessed February 4, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Analysis (NCA) tracking sheet for percutaneous left atrial appendage (LAA) closure therapy (CAG-00445N). [CMS Web site]. 05/21/2015. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=281. Accessed February 4, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 20.34: Percutaneous Left Atrial Appendage Closure (LAAC). [CMS Web site]. 02/08/2016. Available at:
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=367&ncdver=1&bc=AAAAQAAAAAAAAA==&. Accessed February 4, 2025.

Holmes DR, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.

Lakkireddy D, Thaler D, Ellis CR, et al. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021;144(19):1543-1552.

National Cardiovascular Data Registry (NCDR®).Quality Improvement for Institutions: Participant Directory. [American College of Cardiology Web site]. Available at: https://cvquality.acc.org/NCDR-Home/participant-directory. Accessed February 4, 2025.

Price MJ, Reddy VY, Valderrabano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015; 8(15):1925-1932.

Reddy VY, Doshi SK, Sievert H, et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) Trial. Circulation. 2013;127(6):720-729.

Reddy VY, Holmes D, Doshi SK, et al. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.

Reddy VY, Möbius-Winkler S, Miller MA, et al. Left atrial appendage closure with the Watchman Device in patients with a contraindication for oral anticoagulation. The ASAP Study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61(25):2551-2556.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Approval Letter: Amplatzer Amulet Left Atrial Appendage Occluder. [FDA Web site]. 08/14/2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200049A.pdf. Accessed February 4, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Approval Letter: WATCHMAN LAA Closure Technology. Premarket Approval (PMA) Database. [FDA Web site]. 03/13/2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130013a.pdf. Accessed February 4, 2025.

Coding

CPT Procedure Code Number(s)

33340

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

I48.0 Paroxysmal atrial fibrillation

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation, unspecified

I48.21 Permanent atrial fibrillation

I48.91 Unspecified atrial fibrillation

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub
Modifiers

THE FOLLOWING MODIFIER MUST BE APPENDED TO 33340 IN ORDER TO BE CONSIDERED FOR REIMBURSEMENT:

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

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.013c:

04/01/2026	This policy has been reissued in accordance with the Company's annual review process.
04/02/2025	This policy has been reviewed and reissued to communicate the Company’s continuing position on percutaneous left atrial appendage (LAA) closure for nonvalvular atrial fibrillation (NVAF).

07/10/2024	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
09/25/2023	This version of the policy will become effective 09/25/2023. The intent of this policy remains unchanged; however, the Guidelines section of the policy has been revised: to incorporate the coverage with evidence (CED) link maintained on the Centers for Medicare & Medicaid Services (CMS) website. in consideration of the US Food and Drug Administration (FDA) labeling for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder. In addition, the decription section of the policy was revised to include the AMPLATZER™ Amulet™LAA Occluder Trial (Amulet IDE).

07/10/2024

This policy has been reissued in accordance with the Company's annual review process.

01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.

09/25/2023

This version of the policy will become effective 09/25/2023.

The intent of this policy remains unchanged; however, the Guidelines section of the policy has been revised:

to incorporate the coverage with evidence (CED) link maintained on the Centers for Medicare & Medicaid Services (CMS) website.
in consideration of the US Food and Drug Administration (FDA) labeling for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

In addition, the decription section of the policy was revised to include the AMPLATZER™ Amulet™LAA Occluder Trial (Amulet IDE).

Revisions From MA11.013b:

06/29/2022	This policy has been reissued in accordance with the Company's annual review process.
11/17/2021	This policy has been reissued in accordance with the Company's annual review process.
09/23/2020	This policy has been reissued in accordance with the Company's annual review process.
11/20/2019	This policy has been reissued in accordance with the Company's annual review process.
10/01/2019	This policy has been identified for the ICD-10 code update, effective 10/01/2019. The following ICD-10 codes has been added to this policy: I48.11 Longstanding persistent atrial fibrillation I48.19 Other persistent atrial fibrillation I48.20 Chronic atrial fibrillation, unspecified I48.21 Permanent atrial fibrillation The following ICD-10 codes has been deleted to this policy: I48.1 Persistent atrial fibrillation I48.2 Chronic atrial fibrillation

Revisions From MA11.013a:

05/09/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on percutaneous left atrial appendage (LAA) closure for non-valvular atrial fibrillation (NVAF) when the requirements for Coverage with Evidence Development (CED) are met.
11/22/2017	The policy has been reviewed and reissued to communicate the Company’s continuing position on percutaneous left atrial appendage (LAA) closure for non-valvular atrial fibrillation (NVAF) when the requirements for Coverage with Evidence Development (CED) are met.
01/01/2017	This version of the policy will become effective 01/01/2017. The following CPT code has been deleted from this policy: 0281T The following CPT code has been added to this policy: 33340

Revisions From MA11.013:

01/01/2016

The following new policy has been developed to communicate the the Company's coverage position on percutaneous left atrial appendage (LAA) closure for non-valvular atrial fibrillation (NVAF) when the requirements for Coverage with Evidence Development (CED) are met.

Version Effective Date:

1/1/2024

Version Issued Date: