DESCRIPTION
Cardioverter defibrillators are designed to monitor an individual’s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT) and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death. Indications for cardioverter defibrillators include (1) secondary prevention in individuals who have experienced a potentially life-threatening episode of VT (near sudden death) and (2) primary prevention for use in individuals who are considered at high risk for sudden cardiac death (SCD) but who have not yet experienced life-threatening VT or VF.
A wearable cardioverter defibrillator (WCD) is an external device intended for temporary conditions when an implantable device is contraindicated. The WCD consists of a vest that is worn continuously underneath the individual’s clothing. The vest includes an 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 that is worn on the individual’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 individual to certain conditions by lights or voice messages. The Lifecor WCD® 2000 system received FDA approval in December 2001. The vest was renamed and is now called the Zoll® LifeVest.
POLICY
Wearable cardioverter-defibrillator (WCD) for the prevention of sudden cardiac death is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Wearable cardioverter-defibrillator is medically appropriate when ANY ONE of the following are met:
Initial request for cardioverter-defibrillator is indicated for ALL of the following:
Individual is not a candidate for transvenous or subcutaneous implantable cardioverter for ANY ONE of the following reasons:
Individual approved for heart transplant and on wait list
Previously implanted ICD requires explantation due to infection with waiting period before ICD reinsertion
Individual with temporary infectious process that precludes initial implantation of an ICD
Ejection fraction 35 or less and documentation of ANY ONE of the following:
Individual is within 40 days of myocardial infarction
Revascularization (CABG or percutaneous coronary intervention [PCI]) within the last 90 days
Myocarditis
Secondary cardiomyopathy
Documented nonischemic dilated cardiomyopathy if ALL of the following are met:
New diagnosis
Individual has been started on guideline-directed medical therapy
No contraindications present as indicated by ALL of the following:
No condition limiting life expectancy to less than 1 year (e.g., advanced malignancy)
No history of significant nonadherence with medical therapy and follow-up
Request for extended use of cardioverter-defibrillator is indicated for ALL of the following:
Reassessment prior to 90 days for consideration of an extension (e.g., to determine prognosis, to determine if individual remains a candidate for life vest or to determine if individual should receive implantable cardioverter defibrillator based on prognosis)
Continued high risk of sudden cardiac death as evidenced by ejection fraction 35 or less
Documentation of compliance with use of wearable cardioverter-defibrillator
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There is a lack of relevant published evidence to determine the net health outcome of the wearable cardioverter defibrillator for any other indications.
SOURCES
American College of Cardiology Foundation, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computer Tomography and Society for Cardiovascular Magnetic Resonance. (2013). ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy. Retrieved February 14, 2014 from https://www.heartrhythmjournal.com/pb/assets/raw/Health%20Advance/journals/hrthm/Else_HRTHM_5178.pdf.
American College of Cardiology, American Heart Association Task Force on Clinical Practice Guidelines, Heart Rhythm Society. (2017). 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Retrieved June 11, 2019 from https://www.acc.org/guidelines.
American Heart Association, American College of Cardiology. (2020). 2020 AHA/ACC guideline for the diagnosis and treatment of hypertrophic cardiomyopathy. Retrieved April 29, 2021 from https://www.acc.org/guidelines.
BlueCross BlueShield Association. (6:2023). Wearable cardioverter defibrillators (2.02.15). Retrieved October 6, 2023 from https://www.evidencepositioningsystem.com/. (32 articles and/or guidelines reviewed)
CGS Administrators, LLC. (2020, January). LCD for automatic external defibrillators (L33690). Retrieved July 6, 2022 from www.cms.gov.
Duncker, D., König, T., Hohmann, S., Bauersachs, J., & Veltmann, C. (2017). Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: insights from the PROLONG study. Clinical Cardiology, 2017 Mar 23. Doi: 10.1002/clc.22706. [Epub ahead of print]. Abstract retrieved July 19, 2017 from PubMed database.
Duncker, D., König, T., Hohmann, S., Bauersachs, J., & Veltmann, C. (2017). Avoiding untimely implantable cardioverter/defibrillator implantation by intensified heart failure therapy optimization supported by the wearable cardioverter/defibrillator – The PROLONG study. Journal of the American Heart Association, 6 (1). Pii: e004512. Abstract retrieved July 19, 2017 from PubMed database.
European Society of Cardiology. (2015). 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Retrieved March 16, 2016 from http://eurheartj.oxfordjournals.org.
Kao, A., Krause, S., Handa, R., Karia, D., Reyes, G., Bianco, N., et al. (2012). Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BMC Cardiovascular Disorders, 12 (123), 1-7. (Level 3 evidence)
Kutyifa, V., Moss, A., Klein, H., Biton, Y., McNitt, S., Mackecknie, B., Zareba, W., & Goldenberg, I. (2015). Use of the wearable cardioverter defibrillator in high-risk cardiac patients. Circulation, 132, 1613-1619. (Level 1 evidence)
Masri, A., Altibi, AM., Erquo, S., Zmaili, MA., Saleh, A., Al-Adham, R., et al. (2019). Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: A systematic review and meta-analysis. JACC Clinical Electrophysiology, 5 (2), 152-161. (Level 2 evidence)
Piccini, J.P. Sr., Allen, L.A., Kudenchuk, P.J., Page, R.L., Patel, M.R., Turakhia, M.P.; on behalf of the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: a science advisory from the American Heart Association. Circulation, 2016, 133: 1715-1727. DOI 10.1161/CIR.0000000000000394.
Salehi, N., Nasiri, M., Bianco, N., Opreanu, M., Singh, V., Satija, V., et al. (2016). The wearable cardioverter defibrillator in nonischemic cardiomyopathy: a US national database analysis. Canadian Journal of Cardiology, 32 (10), 1247. Abstract retrieved July 19, 2017 from PubMed database.
U.S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Pre-market approval decisions for December 2001. P010030 Wearable cardioverter defibrillator (WCD) 2000 Lifevest. Retrieved November 30, 2015 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p010030.
ORIGINAL EFFECTIVE DATE: 6/13/2015
MOST RECENT REVIEW DATE: 11/9/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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