Public Statement: Medical Policy Statement:

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1 Medical Policy Title: Cardioverter- ARBenefits Approval: 09/7/2011 Defibrillators Effective Date: 01/01/2012 Document: ARB0096 Revision Date: Code(s): C1721, C1722, C1777, C1882, C1895, C1896 and C1899 K0606, K0607,K0608, and K0609 E0617 Public Statement: Administered by: 1) External wearable cardioverter-defibrillators require pre-certification. 2) Either implanted or wearable, defibrillators are used in patients with unstable heart conditions who need protection from abnormal, fatal heart arrhythmias. 3) External defibrillator with integrated electrocardiogram analysis is not covered and is considered experimental and investigational. Medical Policy Statement: Implantable Cardioverter-Defibrillators FDA-approved implantable cardioverter-defibrillators (thoracotomy and nonthoracotomy systems) are considered medically necessary for the following indications: 1. Members after one or more episodes of spontaneously occurring and inducible ventricular fibrillation (VF) or syncopal or hypotensive ventricular tachycardia (VT) that is not associated with acute myocardial infarction; not due to a remediable cause (e.g., drug toxicity, electrolyte abnormalities, ischemia); and neither controlled by appropriate drug therapy after serial testing nor amenable to definitive therapy (e.g., surgical ablation); or 2. Members after spontaneously occurring but non-inducible documented syncopal or hypotensive VT that was not due to acute myocardial infarction; not controlled by appropriate drug therapy after serial testing; nor amenable to definitive therapy (e.g., surgical ablation); or 3. Members after VT/VF cardiac arrest that was not associated with an inducible ventricular arrhythmia, and not due to acute myocardial infarction; not controlled by appropriate drug therapy after serial testing; nor amenable to definitive therapy (e.g., surgical ablation); or Page 1 of 6

2 4. Members after surgery for VT or VF if the ventricular arrhythmia remains inducible; or 5. Members after one or more episodes of spontaneously occurring and inducible VF or syncopal or hypotensive VT that is associated with acute myocardial infarction (greater than 2 days after the infarct but less than 1 month); not due to a remediable cause; and neither controlled by appropriate drug therapy after multiple trials nor amenable to definitive therapy; or 6. Members after unexplained syncope, which by history and clinical circumstances was probably due to a ventricular tachyarrhythmia, and in the presence of reproducible inducible syncopal or hypotensive VT or VF that is not associated with acute myocardial infarction (greater than 2 days after the infarct but less than 1 month); not due to a remediable cause; and neither controlled by appropriate drug therapy after multiple trials nor amenable to definitive therapy; or 7. Members after VF or syncopal or hypotensive VT that is apparently controlled by drug, surgical, or ablative therapy, but in which the results of treatment are too unpredictable (e.g., when long-term effectiveness is in doubt or unknown; in the presence of side effects or toxicity leading to non-compliance; left ventricular (LV) ejection fraction less than or equal to 30% despite drug control) to justify withholding implantable cardioverter-defibrillator treatment; or 8. Members with familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmias such as long QT syndrome or hypertrophic cardiomyopathy; or 9. Members with ischemic dilated cardiomyopathy with a LV ejection fraction less than or equal to 35% and New York Heart Association (NYHA) Class II or III heart failure (see appendix) who have a history of heart attack; or 10. Members with non-ischemic dilated cardiomyopathy greater than 3 months duration, NYHA Class II or III heart failure (see appendix), and a LV ejection fraction less than or equal to 35%. Wearable Cardioverter-Defibrillators Requires pre-authorization. Wearable cardioverter-defibrillators (WCDs, LifeVest) (automatic external cardioverterdefibrillators that are worn under the member's clothing) are considered medically necessary durable medical equipment (DME) only for members who meet any of the following criteria: A documented episode of VF or a sustained, lasting 30 seconds or longer, VT (these dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but may not be due to a transient or reversible cause and not occur during the first 48 hours of an acute myocardial infarction); or Familial or inherited conditions with a high risk of life-threatening VT such as long QT syndrome or hypertrophic cardiomyopathy; or Page 2 of 6

3 Either documented prior myocardial infarction or dilated cardiomyopathy and a measured left ventricular ejection fraction less than or equal to 35%; or A previously implanted defibrillator now requires replacement. The maximum approval period is for 30 consecutive days. Additional days require recertification. Limits: Implantable cardioverter-defibrillators are not considered medically necessary in any of the following situations: 1. When other disease processes are present that clearly and severely limit the member's life expectancy; or 2. Member has asymptomatic VT or symptomatic VT/VF that is (i) associated with acute myocardial infarction within 2 days, (ii) due to a remediable cause, (iii) controlled by appropriate drug therapy, and (iv) amenable to definitive therapy (e.g., ablative procedures, surgery); or 3. Prophylactic use in members at high risk for sudden cardiac death (e.g., persons with mutations of desmoglein 2) who have not experienced a life threatening arrhythmia (other than members meeting criterion 9 or 10 above); Background: Available literature indicates implantable cardioverter-defibrillators (ICDs) are now widely used for the secondary prevention of sudden cardiac death due to VF or VT. Ventricular tachycardia or VF can be secondary to a variety of conditions: progression in underlying pathology (i.e., deterioration of left ventricular function or worsening of coronary artery disease), autonomic imbalance, electrolyte abnormalities or even pharmacological intervention. The ICD is generally accepted as treatment for patients who have experienced an episode of VF not accompanied by an acute myocardial infarction or other transient or reversible causes (e.g., drug toxicity, electrolyte abnormalities, and ischemia). Additionally, accepted guidelines prefer this treatment in patients with sustained VT causing syncope or hemodynamic compromise. As primary prevention, the literature shows the ICD is superior to conventional anti-arrhythmic drug therapy in patients who have survived a myocardial infarction and who have spontaneous, non-sustained VT, a low ejection fraction, inducible VT at electrophysiological study, and whose VT is not suppressed by procainamide. A number of well-designed studies have shown the effectiveness of the ICD in high-risk patients who have already experienced a myocardial infarction (MI). Schlapfer and colleagues (2002) compared the long-term survival rates of patients with sustained ventricular tachyarrhythmia after MI who were treated according to the results of EP study either with amiodarone or an ICD. They found that the long-term survival of Page 3 of 6

4 patients with sustained ventricular tachyarrhythmias after MI, with depressed LV function, is significantly better with an ICD than with amiodarone therapy, even when stratified according to the results of the EP study. In a randomized controlled study (n = 1232) to evaluate the effect of an implantable defibrillator on survival of patients with reduced LV function after MI, Moss et al (2002) concluded that in patients with a prior MI and advanced LV dysfunction, prophylactic implantation of a defibrillator improves survival and should be considered as a recommended therapy. CMS expanded coverage of implantable cardioverter defibrillators to persons with nonischemic dilated cardiomyopathy, based primarily on the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), a prospective randomized trial to determine whether amiodarone or an implantable cardioverter-defibrillator will improve survival compared to placebo in patients with NYHA Class II and Class III heart failure and reduced left ventricular ejection fraction less than 35 percent. The study included persons with non-ischemic dilated cardiomyopathy and patients with ischemic dilated cardiomyopathy. A total of 2521 patients were enrolled, 847 of whom were assigned to placebo plus conventional heart failure therapy, 845 to amiodarone plus conventional heart failure therapy, and 829 to single lead ICD plus conventional heart failure therapy. There was a significant reduction in all-cause mortality in the ICD group compared to the placebo group (hazard ratio compared to control = 0.77; 97.5% confidence intervals 0.62 to 0.96, p = 0.007). For patients with ischemic dilated cardiomyopathy, there was a reduction in mortality hazard ratio compared to control but it was not statistically significant (hazard ratio 0.79; 97.5% confidence interval 0.60 to 1.04). For patients with non-ischemic dilated cardiomyopathy, there was a reduction in the mortality hazard ratio for ICD therapy compared to control but it was also not statistically significant (hazard ratio 0.73; 97.5% confidence interval ). CMS noted that the absolute reduction in mortality was modest for a trial with a median follow-up of 45.5 months. References: 1. Center for Medicare and Medicaid Services (CMS). Decision Memo for Implantable Defibrtillators (CAG-00157R3). Medicare Coverage Database. Baltimore, MD: CMS; January 27, Available at: 2. Bardy GH, Lee KL, Mark DB, et al., and the SCD-HeFT Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352: Goldman L, Hashimoto B, Cook EF, et al. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: Advantages of a new specific activity scale. Circulation. 1981;64(6): Lee DS, Green LD, Liu PP, et al. Effectiveness of implantable defibrillators for preventing arrhythmic events and death: A meta-analysis. J Am Coll Cardiol. 2003;41(9): Page 4 of 6

5 5. Lee DSY, Green LD, Liu PP, et al. Implantable defibrillators vs antiarrhythmic drugs for left ventricular dysfunction. Cochrane Database Systematic Rev. 2002;2:CD Bryant J, Brodin H, Loveman E, et al. The clinical and cost-effectiveness of implantable cardioverter defibrillators: A systematic review. Health Technol Assess. 2005;9(36): Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Implantable cardioverter defibrillator: Prophylactic Use. Health Technology Literature Review: 2005 Update of 2003 Review. Toronto, ON: MAS; September Traub D, Ganz L. Implantable cardioverter-defibrillators for secondary prevention: Is it worth it in the elderly? Am J Geriatr Cardiol. 2006;15(2): Franz WM, Muller OJ, Katus HA. Cardiomyopathies: From genetics to the prospect of treatment. Lancet. 2001;358(9293): Pilichou K, Nava A, Basso C, et al. Mutations in desmoglein-2 gene are associated with arrhythmogenic right ventricular cardiomyopathy. Circulation. 2006;113(9): Makikallio TH, Huikuri HV. Association between usage of beta-blocking medication and benefit from implantable cardioverter therapy. Am J Cardiol. 2006;98(9): Buxton M, Caine N, Chase D, et al. A review of the evidence on the effects and costs of implantable cardioverter defibrillator therapy in different patient groups, and modelling of cost-effectiveness and cost-utility for these groups in a UK context. Health Technol Assess. 2006;10(27): Alcaraz A, Augustovski F, Pichon-Riviere A. Implantable cardioverter defibrillators [summary]. Report ITB No. 25. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); National Institute for Health and Clinical Excellence (NICE). Implantable cardioverter defibrillators for arrhythmias: Review of Technology Appraisal 11. Technology Appraisal 95. London, UK: NICE; Medical Services Advisory Committee (MSAC). Implantable cardioverter defibrillators for prevention of sudden cardiac death. MSAC Reference 32. Canberra, ACT: MSAC; Sharieff W, Kaulback K. Assessing automated external defibrillators in preventing deaths from sudden cardiac arrest: An economic evaluation. Int J Technol Assess Health Care. 2007;23(3): McAlister FA, Ezekowitz J, Dryden DM, et al. Cardiac resynchronization therapy and implantable cardiac defibrillators in left ventricular systolic dysfunction. Prepared by the University of Alberta Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ). AHRQ Publication No. 07- E009. Rockville, MD: AHRQ; June Van Brabandt H, Thiry N, Neyt M, et al. The implantable cardioverter defibrillator: A health technology assessment. KCE Reports 58C. Brussels, Belgium: Belgian Health Care Knolwedge Center (KCE); Blom NA. Implantable cardioverter-defibrillators in children. Pacing Clin Electrophysiol. 2008;31 Suppl 1:S32-S34. Page 5 of 6

6 20. Bardy GH, Lee KL, Mark DB, et al; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008;358(17): Tricenturion, LLC. Automatic external defibrillators. Local Coverage Determination No. L Durable Medical Equipment Program Safeguard Contractor (DME PSC). Columbia, SC: TriCenturion; revised July 1, Gula LJ, Massel D, Krahn AD, et al. Is defibrillation testing still necessary? A decision analysis and Markov model. J Cardiovasc Electrophysiol. 2008;19(4): Liu QM, Bai ZL, Liu ZJ, et al. Defibrillation threshold testing: Is it necessary during implantable cardioverter-defibrillator implantation? Med Hypotheses. 2009;72(2): Das M. Indications for ICD and cardiac resynchronization therapy for prevention of sudden cardiac death. Expert Rev Cardiovasc Ther. 2009;7(2): Exner DV. Implantable cardioverter defibrillator therapy for patients with less severe left ventricular dysfunction. Curr Opin Cardiol. 2009;24(1): Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Page 6 of 6