Oscar Wearable Cardioverter Defibrillator Devices (CG019) Form

External defibrillators are medical devices applied to the chest wall that can stimulate an electric current in the heart when cardiac arrest has occurred. When properly applied, free-standing external defibrillators such as automated external defibrillators (AEDs) have proven to be life-saving for individuals undergoing cardiac arrest. Wearable cardioverter-defibrillators are defibrillators worn under the clothing, usually contained within a garment such as a cloth vest, and function much in the same manner as an internal cardiac defibrillator (ICD) without requiring invasive implantation. Wearable cardioverter-defibrillators are appropriate for persons with certain life-threatening cardiac conditions to identify life-threatening ventricular tachycardia or fibrillation in a person wearing the device. The device can also apply an electric current when cardiac arrest is detected. Wearable cardioverter-defibrillators are designed to act as a bridge to prevent sudden cardiac death in patients during periods of high risk. In general, wearable cardioverter-defibrillators are no longer needed once a patient receives definitive treatment, such as permanent ICD insertion or a cardiac transplant, or once they have recovered from a previous high risk condition, such as a heart attack. There are two FDA approved wearable cardioverter-defibrillator in the United States. LifeVest® is manufactured by Zoll Medical Corporation, which received premarket approval by the Food and Drug 1 Administration (FDA) in 2001. The Zoll® LifeVest® Wearable Defibrillator was initially approved only for patients 18 years of age and older, but approval was extended to include children in 2015. ASSURE Wearable Cardioverter Defibrillator (WCD) System (ASSURE System), which is manufactured by Kestra Medical Technologies, Inc was approved in July 2021 and expected to be available in Fall 2021 in select markets. It is indicated for patients 18 years of age or older. Definitions “Wearable Cardioverter-Defibrillator” is a non-invasive external defibrillator that is used to prevent sudden cardiac death. It is worn under the clothing and is able to check the heart rhythm and can send an electric shock to the heart to try to restore a normal rhythm if needed. “Zoll® Lifevest®” refers to the LifeVest®, a type of wearable cardioverter-defibrillator made by Zoll Medical Corporation. This term refers to models 3000, 3100, and 4000. “Sudden Cardiac Arrest (SCA)” is a sudden, unexpected cessation of cardiac activity. “Sudden Cardiac Death” is a sudden, unexpected death caused by loss of heart function. “Automated External Defibrillator (AED)” is a portable device that checks the heart rhythm and can send an electric shock to the heart to try to restore a normal rhythm. It is typically applied by a bystander to a person undergoing cardiac arrest in an attempt to restore or correct a cardiac arrhythmia. “Cardiac Arrhythmia” is an abnormal heart rhythm that may lead to cardiac arrest. “Asystole” refers to cardiac arrest, or the cessation of cardiac (heart) activity, leading to death. “Implantable Cardioverter-Defibrillator (ICD)” consists of a lead placed transvenously into the heart attached to a generator implanted in the chest wall. Alternatively, a lead may be placed subcutaneously (below the skin) and attached to a generator implanted in the chest wall. “Subcutaneous Implantable Cardioverter defibrillator (SICD)” consists of a lead placed under the skin near the heart and the generator is implanted into a subcutaneous pocket or intramuscular that delivers heart-regulating electrical shocks. Clinical Indications The Plan considers a wearable cardioverter-defibrillator (WCD) medically necessary when ALL of the following are present: 1. The device is being ordered by a cardiologist (including electrophysiologist or heart failure specialist); and 2. The patient is at high risk for sudden cardiac death; and 2 3. The device can be properly fitted. For pediatric members the chest circumference must be at least 26 inches and body weight of 18.75 kilograms (41.3 lbs); and 4. The current request is for no more than 3 months for this authorization. For request of additional extended use beyond 3 months, please see "Authorization Period & Extension Requests" below. The total duration of device usage should not exceed 6 months; and 5. The member meets the following criteria in 5a, 5b, 5c, OR 5d: a. MCG (M-157) criteria for ICD Insertion is met, but a wearable cardioverter-defibrillator is needed as an interim treatment due to one of the following: i. ii. Awaiting scheduled placement of an ICD within 3-months; or Placement of the ICD is precluded by a temporary condition, such as a systemic infection requiring treatment; or iii. ICD requires temporary explantation due to an infection or mechanical complication; or iv. v. Listed for and awaiting heart transplantation; or Other medical contraindication to immediate ICD placement. b. The member has ALL of the following: i. ii. iii. Ischemic heart disease; and Documented left ventricular ejection fraction (LVEF) ≤35%; and Currently within 40 days of myocardial infarction (MI) and/or within 90 days of revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); and iv. The reevaluation of LVEF and functional class is scheduled for 1-2 months from the time of MI or for 3 months from the time of diagnosis of cardiomyopathy in the case of revascularization without MI; and v. Documentation provided from cardiologist that the member has been counseled regarding the estimated save rate, inappropriate shock rate, and the member is highly motivated to comply with the WCD; and vi. A provider is responsible for critical data transmissions from the monitoring function of the WCD; or c. The member has ALL of the following: i. ii. Non-ischemic cardiomyopathy (NICM) and class II-III HF; and ≤ LVEF of 35%, and HF is newly diagnosed (<3 months guideline-directed medical therapy (GDMT) or not on optimal GDMT); and iii. The reevaluation of LVEF and functional class is scheduled for approximately 3 months from the time of initial diagnosis of NICM, and guideline-directed medical therapy is initiated with a documented plan for follow-up to up-titrate to maximum tolerated GDMT within 90 days; and 3 iv. Documentation provided from cardiologist that the member has been counseled regarding the estimated save rate, inappropriate shock rate, and the member is highly motivated to comply with the WCD; and v. A provider is responsible for critical data transmissions from the monitoring function of the WCD; or d. The member had sudden cardiac death due to ventricular fibrillation, or sustained ventricular tachycardia, with LVEF more than 35%, when reversible cause is established and could be treated (electrolyte abnormalities, drug poisoning, etc.) Pediatric Patients Wearable cardioverter-defibrillators were recently approved by the FDA for usage in the pediatric population. There is currently insufficient information to evaluate the clinical efficacy and benefit of these devices in this population. The Plan understands the life threatening nature of sudden cardiac arrest and will consider medical necessity of wearable cardioverter-defibrillator in pediatric members on a case-by-case basis, assuming the following criteria necessary for safe fitting are met: ● Has a chest circumference of 26 inches or greater; and ● Weighs 18.75kg or greater; and ● Informed consent is provided by the parent or legal guardian. Authorization Period & Extension Requests When approved, authorizations are generally provided for up to a 90 day period. For bridge treatment, the initial time period begins at the date of discharge for the index event. Requests to extend the authorization period must be submitted with documentation of ≥70% compliance and continued medical necessity from the treating provider. Experimental or Investigational / Not Medically Necessary Wearable cardioverter-defibrillators are considered experimental, investigational, and/or not medically necessary for the following conditions, except when the specific criteria above are met: Wearable cardioverter-defibrillators are contraindicated for use in patients with an active ICD. A history of significant nonadherence with medical therapy and follow-up is a contraindication for wearable cardioverter-defibrillators. The Plan considers wearable cardioverter-defibrillators experimental and investigational for all other conditions as their safety and efficacy have not been established. The Plan considers wearable cardioverter-defibrillators experimental and investigational for members with life expectancy of <6 months. 4