Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Percutaneous Left Atrial Appendage (LAA) Closure for Non-Valvular Atrial Fibrillation (NVAF)
Policy #:MA11.013b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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
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.
Policy 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.

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 non-valvular 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 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. While 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 or greater), 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 randomized controlled trial (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 US and Europe and were randomized in a device-to-control ratio of two to one. Device individuals were treated with warfarin until day 45 to allow for endothelialization; thereafter, warfarin was discontinued. Individuals were followed 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 percent. 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 four years 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 of greater than 99.9 percent. The study reported 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 Watchman™ group individuals had lower all-cause mortality than anticoagulation group individuals.

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 seven days of post-randomization. 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 post-procedure. 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, Homes 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 versus 0.96 events per 100 patient-years); cardiovascular/unexplained death (1.1 versus 2.3 events per 100 patient-years); and nonprocedural bleeding (6 percent versus 11.9 percent) compared with warfarin. There were more ischemic strokes in the device group (1.6 versus 0.9 events per 100 patient-years). In conclusion, the analysis suggests, 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 patients 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, there were no controlled trials 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.
References

Centers for Medicare & Medicaid Services (CMS). Coverage with evidence development. Percutaneous Left Atrial Appendage Closure (LAAC). [CMS Web site]. 01/26/2018. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/LAAC.html. Accessed April 10, 2018

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 April 10, 2018.

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 April 10, 2018.

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 April 10, 2018.

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%3d%3d& Accessed April 10, 2018.

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. Assessed April 10, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

33340


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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


Misc Code

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 References




Policy History

MA11.013b:
11/20/2019This policy has been reissued in accordance with the Company's annual review process.
10/01/2019This 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


MA11.013a:
05/09/2018The 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.
11/22/2017The 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.
01/01/2017This 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


MA11.013
01/01/2016The 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: 10/01/2019
Version Issued Date: 10/03/2019
Version Reissued Date: 11/22/2019