MEDICAL POLICY Cardioverter Defibrillators

Transcription

1 POLICY PG-0224 EFFECTIVE /01/09 LAST REVIEW... 01/27/17 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. Multiple ICD devices have been approved by the U. S. Food and Drug Administration (FDA) through the Premarket Approval (PMA) process. Manufacturers of ICD devices include Biotronik (Lake Oswego, OR), Boston Scientific (Natick, MA), Sorin Group (Arvada, CO), Medtronic (Minneapolis, MN), and St. Jude Medical (St. Paul, MN). 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

2 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 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 ( , 33220, , 33230, 33231, 33240, 33241, 33243, 33244, 33249, , 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 ( , 33220, , 33230, 33231, 33240, 33241, 33243, 33244, 33249, , 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 < 35%); 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 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) <35% and at least 40 days post myocardial infarction, or 90 days post revascularization (stent or bypass) OR 5. Symptomatic cardiomyopathy with EF <35% treated for at least 3 months with optimal medical therapy OR 6. Familial or inherited conditions with high risk of life threatened Ventricular Tachyarrhythmia, ex: prolong QT Syndrome or Hypertrophic Cardiomyopathy, sarcoidosis, Chagas disease, scleroderma, myotonic dystrophy and other conditions known to increase the risk of sudden cardiac death. Above approved if not due to remediable causes, or neither controlled by appropriate drug therapy nor amenable to definitive therapy AND Patients must not have the following: 1. New York Heart Association Class IV Cardiogenic Shock or Symptomatic Hypotension while in a stable baseline rhythm 2. CABG or PTCA within past 3 months, unless there is pacing indication 3. Acute MI in last 40 days 4. Clinical symptoms or findings to make them a candidate for revascularization 5. Irreversible brain damage (Glasgow coma scale 3) 6. Any disease, other than Cardiac Disease, with likelihood of survival less than 1 year 7. Ventricular tachycardia amenable to medical and or ablative treatment 8. Syncope in the absence of structural heart disease. HMO, PPO, Individual Marketplace, Elite An automatic external defibrillator (E0617) is covered if a previously implanted defibrillator now requires explantation OR the member has one of the following conditions AND implantation surgery is contraindicated: 1. A documented episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause 2. A sustained, lasting 30 seconds or longer, ventricular tachyarrhythmia, either spontaneous or induced during an electrophysiologic (EP) study, not associated with acute myocardial infarction, and not due to a transient or reversible cause 3. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrythmias such as long QT syndrome or hypertrophic cardiomyopathy 4. Coronary artery disease with a documented prior myocardial infarction with a measured left ventricular ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) during an EP study. To meet this criterion; a. The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator prescription; and, b. The EP test must have been performed more than 4 weeks after the qualifying myocardial infarction. 5. Documented prior myocardial infarction and a measured left ventricular ejection fraction less than or equal to Member must not have: a. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or, b. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or, c. Had an enzyme-positive MI within past month; or, d. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or, e. Irreversible brain damage from preexisting cerebral disease; or, f. Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year. 6. Members with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) 35%. 7. Members with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF 35% 8. Members who meet one of the previous criteria (1-7) and have NYHA Class IV heart failure A family member must get certified with basic CPR for an automatic external defibrillator (E0617) to be covered. Replacement supplies and accessories for use with K0606 are coded using K0607-K0609 as appropriate.

4 Advantage HCPCS codes K0607-K0609 are non-covered. Automatic external defibrillators (AED) (E0617) are non-covered. CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. HCPCS CODES C1721 Cardioverter-defibrillator, dual chamber (implantable) C1722 Cardioverter-defibrillator, single chamber (implantable) C1777 Lead, cardioverter-defibrillator, endocardial single coil (implantable) C1882 Cardioverter-defibrillator, other than single or dual chamber (implantable) C1895 Lead, cardioverter-defibrillator, endocardial dual coil (implantable) C1896 Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable) C1899 Lead, pacemaker/cardioverter-defibrillator combination (implantable) E0617 External defibrillator with integrated electrocardiogram analysis K0606 Automatic external defibrillator, with integrated electrocardiogram analysis, garment type K0607 Replacement battery for automated external defibrillator, each K0608 Replacement garment for use with automated external defibrillator, each K0609 Replacement electrodes for use with automated external defibrillator, each CPT CODES Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator Relocation of skin pocket for implantable defibrillator Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator) Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system) (List separately in addition to code for primary procedure) Insertion of implantable defibrillator pulse generator only; with existing dual leads Insertion of implantable defibrillator pulse generator only; with existing multiple leads Insertion of implantable defibrillator pulse generator only; with existing single lead Removal of implantable defibrillator pulse generator only Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by transvenous extraction Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; dual lead system Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed Insertion of subcutaneous implantable defibrillator electrode Removal of subcutaneous implantable defibrillator electrode Repositioning of previously implanted subcutaneous implantable defibrillator electrode Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the health care professional; implantable subcutaneous lead defibrillator system Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the health care professional; single lead transvenous implantable defibrillator system

5 93283 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the health care professional; dual lead transvenous implantable defibrillator system Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the health care professional; multiple lead transvenous implantable defibrillator system Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead implantable defibrillator system Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; wearable defibrillator system Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead implantable defibrillator system with interim analysis, review(s) and report(s) by a physician or other qualified health care professional Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator pulse generator Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters) Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters) Initial set-up and programming by a physician or other qualified health care professional of wearable cardioverter-defibrillator includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient instruction in wearing system and patient reporting of problems or events TAWG REVIEW DATES: 01/13/2005, 07/05/2006, 09/20/2007, 10/08/2008, 01/13/2010, 03/09/2011, 04/11/2012, 08/22/14, 09/17/2015, 09/23/2016, 01/27/2017 REVISION HISTORY EXPLANATION 08/22/14: Changed title from Wearable Cardioverter Defibrillator to Cardioverter Defibrillators. Added codes for ICD: C1721, C1722, C1777, C1882, C1895, C1896, C1899, 33216, 33217, 33218, 33220, 33223, 33224, 33225, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262, 33263, 33264, 93282, 93283, 93284, 93287, 93289, 93295, 93296, 93640, 93641, Added codes for S-ICD: 0319T, 0320T, 0321T, 0323T, 0325T, 0326T, 0327T, 0328T. Added more codes for wearable cardioverter defibrillators: & TAWG committee determined that subcutaneous implantable cardioverter defibrillators (0319T, 0320T, 0321T, 0323T, 0325T, 0326T, 0327T, 0328T) are covered without prior authorization for all product lines. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 04/14/15: Removed deleted 12/31/14 codes 0319T, 0320T, 0321T, 0323T, 0325T, 0326T, 0327T, & 0328T. Added effective 1/1/15 new codes 33270, 33271, 33272, 33273, 93260, 93261, & code description revisions made to , , 33230, 33231, 33240, 33241, & , , 93287, 93289, 93295, & Wearable cardioverter defibrillators (K0606) now require prior authorization. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 09/17/15: Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 09/23/16: Codes K0607-K0609 (replacement supplies and accessories for use with K0606) and automatic external defibrillators (AED) (E0617) are now covered for HMO, PPO, Individual Marketplace, Elite per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG). 01/27/17: Criteria for wearable cardioverter defibrillators (LifeVest) changed from <25% to <35% ejection fraction (EF) requirement. Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group (TAWG).

6 REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc.