Subject:
Wearable Cardioverter-Defibrillators
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
A wearable cardioverter defibrillator (WCD) is a temporary, external device that is an alternative to an implantable cardioverter defibrillator (ICD). It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for the period during which the need for a permanent implantable device is uncertain.
| Populations | Interventions | Comparators | Outcomes |
Individuals:
- With a temporary contraindication to an implantable cardioverter defibrillator
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
Individuals:
- Who are in the immediate post myocardial infarction period
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
Individuals:
- Who are post coronary artery bypass graft surgery and are at high risk for lethal arrhythmias
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
Individuals:
- Who are awaiting heart transplantation and are at high risk for lethal arrhythmias
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
Individuals:
- With newly diagnosed nonischemic cardiomyopathy
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
Individuals:
- With peripartum cardiomyopathy
| Interventions of interest are:
- Wearable cardioverter defibrillator
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Morbid events
- Functional outcomes
- Treatment-related morbidity
|
BACKGROUND
Sudden Cardiac Arrest
Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease.
Treatment
The implantable cardioverter defibrillator (ICD) has proven effective in reducing mortality for survivors of SCA and for patients with documented malignant ventricular arrhythmias. More recently, use of ICDs has been broadened by studies reporting a reduction in mortality for patients at risk for ventricular arrhythmias, such as patients with prior myocardial infarction and reduced ejection fraction.
ICDs consist of implantable leads, which are placed percutaneously in the heart, that are connected to a pulse generator placed beneath the skin of the chest or abdomen. ICD placement is a minor surgical procedure. Potential adverse events of ICD placement are bleeding, infection, pneumothorax, and delivery of unnecessary counter shocks. See evidence review 7.01.44 for further information on ICDs.
The wearable cardioverter defibrillator (WCD) is an external device intended to perform the same tasks as an ICD, without invasive procedures. It consists of a vest worn continuously underneath the patient's clothing. Part of this vest is the "electrode belt" that contains the cardiac-monitoring electrodes and the therapy electrodes that deliver a counter shock. The vest is connected to a monitor with a battery pack and alarm module worn on the patient's belt. The monitor contains the electronics that interpret the cardiac rhythm and determines when a counter shock is necessary. The alarm module alerts the patient to certain conditions by lights or voice messages, during which time a conscious patient can abort or delay the shock.
U.S. Food and Drug Administration (FDA) labeled indications for the WCD are adults at risk for SCA and either are not candidates for or refuse an implantable ICD.1, Some experts have suggested that the indications for a WCD should be broadened to include other populations at high-risk for SCA.2, The potential indications include:
- Bridge to transplantation (ie, the WEARIT study population)
- Bridge to implantable device or clinical improvement (ie, the BIROAD study population)
- Post bypass with ejection fraction less than 30%
- Post bypass with ventricular arrhythmias or syncope within 48 hours of surgery
- Post myocardial infarction with ejection fraction less than 30%
- Post myocardial infarction with ventricular arrhythmias within 48 hours
- Drug-related arrhythmias (during drug washout or after, during evaluation of long-term risk)
- Patients awaiting revascularization
- Patients too ill to undergo device implantation
- Patients who refuse device therapy.
Regulatory Status
In 2001, the Lifecor WCD® 2000 system was approved by the FDA through the premarket approval process for "adult patients who are at risk for cardiac arrest and are either not candidates for or refuse an implantable defibrillator." The vest was renamed the Zoll LifeVestÒ.
In 2015, the FDA approved the LifeVest® for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent."
FDA product code: MVK.
Related Policies
- Implantable Cardioverter Defibrillator (ICD) (Policy #061 in the Surgery Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. The use of an automatic wearable external cardioverter defibrillator device is medically necessary for temporary or short-term use (generally up to 90 days) in members who meet the following criteria:
a. meet the criteria for an implantable cardioverter defibrillator (ICD) - please refer to the indications for an ICD listed below); and
b. immediate implantation of an ICD is contraindicated or not possible (e.g., presence of a systemic infection); or
c. previously implanted cardioverter defibrillator requires explantation (removal) and immediate reimplantation of another ICD is contraindicated or not possible (e.g. presence of a systemic infection).
Physicians requesting the use of this device beyond the 90 day period must submit documentation to determine continued medical necessity. Documentation should include, but is not limited to:
- physician notes;
- implantation status
(NOTE: Medically necessary indications for an ICD - also refer to a separate policy on 'Implantable Cardioverter Defibrillator' Policy #061 in the Surgery Section:
A. Adults - who meet any of the following criteria:
- ischemic cardiomyopathy with New York Heart Association (NYHA) functional Class II or Class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35% or less; or
- ischemic cardiomyopathy with NYHA functional Class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
- nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
- hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
a. history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years;
b. left ventricular hypertrophy greater than 30 mm;
c. 1 or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring;
d. prior unexplained syncope inconsistent with neurocardiogenic origin.
- diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see “Policy Guidelines”):
o congenital long QT syndrome; OR
o Brugada syndrome; OR
o short QT syndrome; OR
o catecholaminergic polymorphic ventricular tachycardia.
- Members with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded.
B. Pediatrics - who meet any of the following criteria:
- survivors of cardiac arrest, after reversible causes have been excluded;
- symptomatic, sustained ventricular tachycardia in association with congenital heart disease in pediatric members who have undergone hemodynamic and electrophysiologic evaluation; or
- congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.
- hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; massive left ventricular hypertrophy based on age-specific norms; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
- diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see “Policy Guidelines”):
o congenital long QT syndrome; OR
o Brugada syndrome; OR
o short QT syndrome; OR
o catecholaminergic polymorphic ventricular tachycardia.)
[INFORMATIONAL NOTE: The available data establish that the wearable cardioverter-defibrillator (WCD) device can detect lethal arrhythmias and can successfully deliver a countershock in most cases. There are a small number of patients who meet established criteria for an implantable cardioverter-defibrillator (ICD) but have a transient contraindication for an implantable device, most commonly an infectious process. In these patients, the WCD is considered medically necessary as an interim treatment. The evidence shows that these patients benefit from a cardioverter-defibrillator in general; and the WCD can detect and treat lethal arrhythmias in these patients.
The New York Heart Association (NYHA) Functional Classification
The table below describes the most commonly used classification system, the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity.
Class | Patient Symptoms |
I | No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). |
II | Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). |
III | Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. |
IV | Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.] |
2. The use of an automatic wearable external cardioverter defibrillator device is also considered medically necessary for temporary or short-term use as a bridge to potential implantable cardioverter-defibrillator placement for any of the following members who are considered at high risk for sudden cardiac death (SCD):
a. members with left ventricular ejection fraction (LVEF) less than or equal to 35% who are less than 40 days post-myocardial infarction;
b. members with LVEF less than or equal to 35% who have undergone revascularization with coronary artery bypass graft (CABG) surgery in the past 3 months;
c. members with LVEF less than or equal to 35% who have been newly diagnosed with potentially reversible cardiomyopathy or transient left ventricular dysfunction (e.g., tachycardia- or myocarditis-associated cardiomyopathy) in the past 3 months.
3. Other uses of an automatic wearable external cardioverter defibrillator device are considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Noridian Healthcare Services, LLC, the Local Medicare Carrier for jurisdiction JA, has determined that this service is covered when LCD L33690 Automatic External Defibrillators’ criteria is met. Please refer to LCD L33690 for eligibility and coverage. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33690&ContrId=389&ver=9&ContrVer=1&CntrctrSelected=389*1&Cntrctr=389&s=38&DocType=All&bc=AggAAAQAAAAAAA%3d%3d&.
Local Coverage Article: Automatic External Defibrillators - Policy Article (A52458). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Wearable Cardioverter-Defibrillators
Automatic Wearable External Cardioverter Defibrillator Device
Cardioverter Device, Wearable External
Defibrillator Device, Wearable External
External Cardioverter Defibrillator Device, Wearable
Lifecor WCD 2000 System
LifeVest
WCD 2000 System
WCD 3000 System
Zoll® LifeVest®
References:
1. Food and Drug Administration. Summary of Safety and Effectiveness Data, P010030, Lifecor, Inc. WCD 2000 System. 2001; https://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.pdf. Accessed March 19, 2020.
2. Beauregard LA. Personal security: Clinical applications of the wearable defibrillator. Pacing Clin Electrophysiol. Jan 2004; 27(1): 1-3. PMID 14720147
3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Wearable cardioverter-defibrillator as a bridge to implantable cardioverter-defibrillator treatment. TEC Assessments. 2010;Volume 25:Tab 2.
4. Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation. Am J Cardiol. May 15 1998; 81(10): 1253-6. PMID 9604964
5. Chung MK, Szymkiewicz SJ, Shao M, et al. Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival. J Am Coll Cardiol. Jul 13 2010; 56(3): 194-203. PMID 20620738
6. Tanawuttiwat T, Garisto JD, Salow A, et al. Protection from outpatient sudden cardiac death following ICD removal using a wearable cardioverter defibrillator. Pacing Clin Electrophysiol. May 2014; 37(5): 562-8. PMID 24762055
7. Mitrani RD, McArdle A, Slane M, et al. Wearable defibrillators in uninsured patients with newly diagnosed cardiomyopathy or recent revascularization in a community medical center. Am Heart J. Mar 2013; 165(3): 386-92. PMID 23453108
8. Kao AC, Krause SW, Handa R, et al. Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BMC Cardiovasc Disord. Dec 12 2012; 12: 123. PMID 23234574
9. Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. Jan 2004; 27(1): 4-9. PMID 14720148
10. Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry). Circulation. Oct 27 2015; 132(17): 1613-9. PMID 26316618
11. Gregoratos G, Cheitlin MD, Conill A, et al. ACC/AHA guidelines for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Pacemaker Implantation). J Am Coll Cardiol. Apr 1998; 31(5): 1175-209. PMID 9562026
12. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. Dec 09 2004; 351(24): 2481-8. PMID 15590950
13. Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N Engl J Med. Oct 08 2009; 361(15): 1427-36. PMID 19812399
14. Olgin JE, Pletcher MJ, Vittinghoff E, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. Sep 27 2018; 379(13): 1205-1215. PMID 30280654
15. Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. Nov 19 2013; 62(21): 2000-2007. PMID 23916930
16. Uyei J, Braithwaite RS. Effectiveness of wearable defibrillators: systematic review and quality of evidence. Int J Technol Assess Health Care. Apr 2014; 30(2): 194-202. PMID 24893969
17. Bigger JT. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. Nov 27 1997; 337(22): 1569-75. PMID 9371853
18. Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. Feb 2013; 6(1): 117-28. PMID 23275233
19. Opreanu M, Wan C, Singh V, et al. Wearable cardioverter-defibrillator as a bridge to cardiac transplantation: A national database analysis. J Heart Lung Transplant. Oct 2015; 34(10): 1305-9. PMID 26094085
20. Wassnig NK, Gunther M, Quick S, et al. Experience With the Wearable Cardioverter-Defibrillator in Patients at High Risk for Sudden Cardiac Death. Circulation. Aug 30 2016; 134(9): 635-43. PMID 27458236
21. Rao M, Goldenberg I, Moss AJ, et al. Wearable defibrillator in congenital structural heart disease and inherited arrhythmias. Am J Cardiol. Dec 01 2011; 108(11): 1632-8. PMID 21890075
22. Kadish A, Schaechter A, Subacius H, et al. Patients with recently diagnosed nonischemic cardiomyopathy benefit from implantable cardioverter-defibrillators. J Am Coll Cardiol. Jun 20 2006; 47(12): 2477-82. PMID 16781376
23. Salehi N, Nasiri M, Bianco NR, et al. The Wearable Cardioverter Defibrillator in Nonischemic Cardiomyopathy: A US National Database Analysis. Can J Cardiol. Oct 2016; 32(10): 1247.e1-1247.e6. PMID 26975224
24. Duncker D, Konig T, Hohmann S, et al. Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study. Clin Cardiol. Aug 2017; 40(8): 586-590. PMID 28333373
25. Duncker D, Konig T, Hohmann S, et al. Avoiding Untimely Implantable Cardioverter/Defibrillator Implantation by Intensified Heart Failure Therapy Optimization Supported by the Wearable Cardioverter/Defibrillator-The PROLONG Study. J Am Heart Assoc. Jan 17 2017; 6(1). PMID 28096098
26. Saltzberg MT, Szymkiewicz S, Bianco NR. Characteristics and outcomes of peripartum versus nonperipartum cardiomyopathy in women using a wearable cardiac defibrillator. J Card Fail. Jan 2012; 18(1): 21-7. PMID 22196837
27. Duncker D, Haghikia A, Konig T, et al. Risk for ventricular fibrillation in peripartum cardiomyopathy with severely reduced left ventricular function-value of the wearable cardioverter/defibrillator. Eur J Heart Fail. Dec 2014; 16(12): 1331-6. PMID 25371320
28. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. Sep 25 2018; 138(13): e272-e391. PMID 29084731
29. Piccini JP, Allen LA, Kudenchuk PJ, et al. Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Science Advisory From the American Heart Association. Circulation. Apr 26 2016; 133(17): 1715-27. PMID 27022063
30. Klein HU, Meltendorf U, Reek S, et al. Bridging a temporary high risk of sudden arrhythmic death. Experience with the wearable cardioverter defibrillator (WCD). Pacing Clin Electrophysiol. Mar 2010; 33(3): 353-67. PMID 19889186
31. Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in heart transplant candidates and considerations for ventricular assist devices: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates--2006. J Heart Lung Transplant. Sep 2006; 25(9): 1043-56. PMID 16962465
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |