DESCRIPTION
A wearable cardioverter defibrillator (WCD) is an external device that monitors cardiac rhythm and delivers an electrical shock if a life threatening ventricular arrhythmia is detected. The device consists of vest that is worn continuously next to the skin. 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 a belt. The monitor contains the electronics that interpret the cardiac rhythm and determines when a counter shock is necessary. When the device detects an arrhythmia the alarm module alerts the individual by lights or voice messages prior to delivering a shock. This allows a conscious individual to disarm the shock by pressing buttons. If the individual is unconscious and releases the buttons, the device releases a gel over the therapy electrodes. The device can deliver up to five electrical shocks to restore normal rhythm.
POLICY
A wearable cardioverter defibrillator for the prevention of sudden cardiac death is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
A wearable cardioverter defibrillator for treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also:
Automatic Implantable Cardioverter Defibrillator for the Prevention of Sudden Death
Ventricular Assist Devices (VAD) and Total Artificial Hearts (TAH)
MEDICAL APPROPRIATENESS
A wearable cardioverter defibrillator for the prevention of sudden cardiac death is considered medically appropriate if ANY ONE of the following criteria are met:
The individual meets ANY ONE of the following criteria for an automatic implantable cardioverter-defibrillator:
Primary prevention for ANY ONE of the following:
Symptomatic ischemic dilated cardiomyopathy with a history of myocardial infarction at least 40 days before automatic implantable cardioverter defibrillator (AICD) treatment and left ventricular ejection fraction (EF) of 35% or less (Note: Symptomatic heart failure is defined as the presence of dyspnea on exertion, angina, palpitations, or fatigue)
Symptomatic nonischemic dilated cardiomyopathy for more than nine months duration and left ventricular EF of 35% or less
Hypertrophic cardiomyopathy (HCM) with ANY ONE of the following:
Judged to be at high risk for sudden cardiac death by a physician experienced in the care of individuals with HCM
ANY ONE of the following major risk factors for sudden cardiac death exist:
History of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years
Left ventricular hypertrophy greater than 30 mm
One or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring
Prior unexplained syncope inconsistent with neurocardiogenic origin
Secondary prevention for an individual with a history of a life-threatening clinical event associated with ventricular dysrhythmias such as sustained ventricular tachyarrhythmia
Post acute myocardial infarction as a bridge during 40 days post event while awaiting automatic implantable cardioverter defibrillator
Post revascularization by coronary artery bypass grafting or PTCA as a bridge during 90 days post intervention while awaiting automatic implantable cardioverter defibrillator
Documentation of infection that temporarily prevents implantation of an automatic implantable cardioverter defibrillator
IMPORTANT REMINDER
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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
No controlled studies were found in the published literature that evaluate the efficacy compared to alternatives or the application or the long-term health outcomes of wearable cardioverter defibrillators for the treatment of other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2010). Wearable cardioverter-defibrillators as a bridge to implantable cardioverter-defibrillator placement (2.02.15). Retrieved October 12, 2010 from BlueWeb. (13 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2009). Implantable cardioverter defibrillator (7.01.44). Retrieved October 12, 2010 from BlueWeb. (12 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. March 2006.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2007, September). Wearable external cardioverter defibrillator for detection and treatment of ventricular arrhythmia. Retrieved April 29, 2008 from ECRI Institute. (9 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Premarket approval. WCD® 2000 System - P010030. Retrieved October 12, 2010 from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083949.htm.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LMRPs/LCDs for CIGNA Government Services. (2006, June). LCD for Automatic External Defibrillators (L13877). Retrieved October 12, 2010 from http://www.cms.gov/mcd/viewlcd.asp?lcd_id=13877&lcd_version=49&show=all.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 11/11/2010
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.
This document has been classified as public information.