POLICY . . . . . . . . PG-0224 EFFECTIVE . . . . . .06/01/09 LAST REVIEW . . . 09/23/16

MEDICAL POLICY Cardioverter Defibrillators

GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

DESCRIPTION Cardioverter defibrillators discussed in this policy are: 1. Transvenous implantable cardioverter defibrillators 2. Subcutaneous implantable cardioverter defibrillators 3. Wearable cardioverter defibrillators 4. Automatic external defibrillators (AED) Transvenous Implantable Cardioverter Defibrillator The automatic transvenous implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient’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 ICD implantation can be broadly subdivided into: 5. Secondary prevention, i.e., their use in patients who have experienced a potentially life-threatening episode of VT (near sudden cardiac death) 6. Primary prevention, i.e., their use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or VF The standard ICD involves placement of a generator in the subcutaneous tissue of the chest wall. Transvenous leads are attached to the generator and threaded intravenously into the endocardium. The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized. Several automatic ICDs are approved by the U.S. Food and Drug Administration (FDA) through the premarket application (PMA) approval process. The FDA-labeled indications generally include patients who have experienced life-threatening VT associated with cardiac arrest or VT associated with hemodynamic compromise and resistance to pharmacologic treatment. Devices manufactured by Guidant are approved by the FDA for use “in patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least 1 of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); or a prior myocardial infarction (MI) , left ventricular ejection fraction of less than or equal to 35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia.” On July 18, 2002, the FDA expanded the approved indications for the Guidant ICD devices to include the prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is less than or equal to 30%. This expanded indication is based on the results of the second Multicenter Automatic Defibrillator Implantation Trial (MADIT II trial), which is discussed here. Medtronic devices are approved “to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.” Other devices have approval language similar to that of Medtronic. Subcutaneous Implantable Cardioverter Defibrillator The S-ICD System (Subcutaneous Implantable Cardioverter Defibrillator; Boston Scientific Corp.) is the first subcutaneous ICD on the market and is designed to monitor and treat cardiac arrhythmias and to reduce the risks of SCA and sudden cardiac death. The S-ICD System is a new generation of the ICD that does not require transvenous (TV) insertion; instead, the S-ICD system electrode is inserted under the skin and implanted outside of the rib cage. The S-ICD System includes an implantable lead, an implantable pulse generator, a lead insertion tool, and a programming device that communicates wirelessly with the pulse generator. Unlike the conventional TV-ICD, implantation of the S-ICD does not require fluoroscopy or contrast agents and is usually inserted using local anesthesia with sedation. The pulse generator is placed in a subcutaneous pocket along the sixth rib in the left axillary area. When the device detects an arrhythmia, it confirms the finding, charges, and delivers 1 or more 80-

Joule shocks to the heart. Interrogation of the device allows the cardiologist to assess the history of treated and untreated episodes of ventricular arrhythmias. The device is inserted by a cardiologist, electrophysiologist, or cardiac surgeon and patients are generally hospitalized overnight. Wearable Cardioverter Defibrillator A wearable cardioverter defibrillator (WCD) is a temporary, external device that is an alternative to an ICD. It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for a period of time during which the need for a permanent implantable device is uncertain. A WCD is intended to perform the same tasks as an ICD, without requiring invasive procedures. It consists of a vest that is 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 that is 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. The U.S. Food and Drug Administration (FDA) gave clearance to the Lifecor WCD® 2000 system via premarket application approval in December 2001 for "Adult patients who are at risk for sudden cardiac arrest and are either not candidates for or refuse an implantable defibrillator." The trade name of the WCD 2000 System was changed to LifeVest™ in 2002, and the LIFECOR business was acquired by ZOLL Medical Corporation (Philadelphia, PA) in 2006. Automated external defibrillators (AED) Automated external defibrillators (AED) are portable electronic devices that allow minimally trained individuals to provide electric shock to prevent death due to sudden cardiac arrest. These devices monitor heart rhythm and can, if needed, deliver an electric shock to the chest wall much like a traditional (paddle) defibrillator in a hospital.

POLICY HMO, PPO, Individual Marketplace, Elite Wearable cardioverter defibrillators (K0606) require prior authorization. Transvenous implantable cardioverter defibrillators (33216-33218, 33220, 33223-33225, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262-33264, 93745) & subcutaneous implantable cardioverter defibrillators (33270, 33271, 33272, 33273, 93260, 93261, & 93644) do not require prior authorization. HCPCS codes K0607-K0609 do not require prior authorization. Automatic external defibrillators (AED) (E0617) do not require prior authorization. Advantage Wearable cardioverter defibrillators (K0606) require prior authorization. Transvenous implantable cardioverter defibrillators (33216-33218, 33220, 33223-33225, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262-33264, 93745) & subcutaneous implantable cardioverter defibrillators (33270, 33271, 33272, 33273, 93260, 93261, & 93644) do not require prior authorization. HCPCS codes K0607-K0609 are non-covered. Automatic external defibrillators (AED) (E0617) are non-covered. Paramount covers wearable cardioverter defibrillators (LifeVest) when it is medically necessary for: 1. Patients who have an ICD placed for secondary prevention and that ICD is either removed for infection or malfunctioning 2. Patients who have an ICD and have received appropriate therapy from the device, and that ICD is either removed for infection or malfunctioning 3. Patients who have suffered a cardiac arrest or hemodynamically significant ventricular arrhythmias and cannot have an ICD placed because of infection or vascular issues 4. Patients with high-risk features such as syncope and-or structural or genetic cardiomyopathies, in whom ventricular arrhythmias are strongly suspected

Paramount may strongly consider coverage for wearable cardioverter defibrillators (LifeVest) for: 1. Patients who have a markedly depressed ejection fraction (EF) (certainly < 25%); this patient population is known to receive more appropriate shocks in large ICD trials 2. Patients who have long runs of symptomatic nonsustained ventricular tachycardia (NSVT) that falls short of being hemodynamically unstable or causing syncope 3. Patients who suffered cardiogenic shock as part of their initial presentation with a depressed EF 4. Patients who had a large anterior wall MI either in the past or as part of their presentation Paramount considers FDA approved transvenous implantable cardioverter defibrillators and subcutaneous implantable cardioverter defibrillators medically necessary when: 1. Sudden cardiac death survivors from spontaneously occurring ventricular fibrillation and ventricular tachycardia OR 2. Spontaneously occurring syncopal (hypotensive) ventricular tachycardia and .structural heart disease OR 3. Unexplainable syncope, by history and clinical circumstances due to a symptomatic ventricular tachyarrhythmia in the presence of structural heart disease OR 4. Cardiomyopathy with EF (ejection fraction)