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Cardiac Resynchronization Therapy (Biventricular Pacing) Last Review Date: March 10, 2017 Number: MG.MM.SU.41eC Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Cardiac pacing modalities Treatment modalities that utilize biventricular or left ventricular stimulation to optimize cardiac pump function through synchronization of ventricular contraction are referred to as resynchronization or ventricular resynchronization therapies. The rationale for resynchronization is based on the clinical observation that congestive heart failure (CHF) patients with intraventricular conduction defects (IVCD) have mechanical desynchronization between the left and right ventricles throughout the cardiac cycle, which adversely affects left ventricular performance. Biventricular pacing simultaneously activates the left and right ventricles using a combination of conventional, dual-chamber pacing of the right atrium and ventricle and specialized pacing of the left ventricle through leads positioned via the coronary sinus. Ejection fraction (EF) or Left ventricular ejection fraction (LVEF) Percentage of blood ejected from the left ventricle with each heartbeat. Normal LVEF readings are in the 58-70% range. QRS complex Refers to a portion of a tracing within an electrocardiogram that represents the spread of the electrical impulse through the ventricles. A prolonged QRS interval indicates a dyssynchrony of the right and left ventricle and is an important selection criterion for a biventricular pacemaker. Ventricular tachyarrhythmias Rapid heartbeat that may be regular or irregular arising from the ventricle or pumping chamber of the heart. Two common tachyarrhythmias are ventricular tachycardia and ventricular fibrillation. Ventricular fibrillation (Vfib or VF) Condition in which the heart's electrical activity becomes disordered. When this happens, the heart's lower (pumping) chambers contract in a rapid, unsynchronized fashion (the ventricles "quiver" rather than beat) and the heart pumps little or no blood. Ventricular tachycardia (Vtach or VT) Fast regular heart rate that starts in the lower chambers (ventricles). VT may result from serious heart disease and usually requires prompt treatment. American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Stages of Heart Failure (HF) A: B: C: D: At high risk for HF but without structural heart disease or symptoms of HF Structural heart disease but without signs Structural heart disease with prior or current symptoms of HF Refractory HF requiring specialized interventions Resynchronization Therapy For Congestive Heart Failure Last Review: March 10, 2017 Page 2 of 4 New York Heart Association (NYHA) Functional Classification System Class Patient Symptoms Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Marked limitation of physical activity. Comfortable at rest, but less-than-ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe) Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Guideline Cardiac resynchronization therapy (CRT) using an FDA-approved biventricular pacemaker is considered medically necessary for members with moderate to severe symptomatic CHF (NYHA functional class II, III or ambulatory Class IV) with IVCD when the following criteria are met; all: 1. Presence of persistent symptoms despite guideline-directed medical therapy (GDMT) therapy; i.e.:: Angiotensin-converting enzyme (ACE) inhibitors Angiotensin receptor blockers Beta blockers 2. Left ventricular ejection fraction (LVEF) ≤ 35% 3. Presence of either: QRS ≥ 120–190 milliseconds (ms) and left bundle branch morphology QRS ≥ 150 ms and any QRS morphology 4. Sinus rhythm (or alternatively) when ablation of AV node or pharmacologic management of atrial fibrillation rate allows near 100% ventricular pacing) Note: EmblemHealth considers the use of a FDA-approved implantable cardioverter defibrillator (ICD) device, combined with cardiac resynchronization therapy (i.e., CRT/ICD), to be medically necessary when the plan’s ICD Medical Guideline criteria are met in addition to the CRT criteria above. Limitations/Exclusions Upgrades from a standard single-lead right ventricular device to resynchronization device (i.e., biventricular pacing achieved by adding left ventricular lead) is allowable for members who have heart failure (LVEF <35%) with symptomatic bradycardia (or heart block) who are pacing > 50% of the time with their current pacemaker. Biventricular pacemaker devices (as well as combined biventricular pacemaker-defibrillator devices [CRT/ICD]) are considered investigational and not medically necessary for any indication other than those listed above due to insufficient evidence of therapeutic value. Resynchronization Therapy For Congestive Heart Failure Last Review: March 10, 2017 Page 3 of 4 Applicable Procedure Codes 33206 Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial 33207 Insertion or replacement of permanent pacemaker with transvenous electrode(s); ventricular 33208 Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular 33212 Insertion or replacement of pacemaker pulse generator only; single chamber, atrial or ventricular 33213 Insertion or replacement of pacemaker pulse generator only; dual chamber 33214 Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator) 33215 Repositioning of previously implanted transvenous pacemaker or pacing cardioverter-defibrillator (right atrial or right ventricular) electrode 33216 Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator 33217 Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator 33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of generator) 33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including upgrade to dual chamber system) (List separately in addition to code for primary procedure) 33226 Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or replacement of generator) 33240 Insertion of single or dual chamber pacing cardioverter-defibrillator pulse generator 33241 Subcutaneous removal of single or dual chamber pacing cardioverter-defibrillator pulse generator 33243 Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy 33244 Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by transvenous extraction 33249 Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator Applicable ICD-10 Diagnosis Codes I09.81 Rheumatic heart failure I42.1 Obstructive hypertrophic cardiomyopathy I44.1 Atrioventricular block, second degree I44.2 I44.30 Atrioventricular block, complete Unspecified atrioventricular block I44.39 Other atrioventricular block I44.4 Left anterior fascicular block I44.5 Left posterior fascicular block I44.60 Unspecified fascicular block I44.69 Other fascicular block I44.7 Left bundle-branch block, unspecified I45.0 Right fascicular block I45.10 Unspecified right bundle-branch block I45.19 Other right bundle-branch block I45.2 Bifascicular block I45.3 Trifascicular block Resynchronization Therapy For Congestive Heart Failure Last Review: March 10, 2017 Page 4 of 4 I45.4 Nonspecific intraventricular block I45.5 Other specified heart block I49.5 I50.1 Sick sinus syndrome Left ventricular failure I50.20 Unspecified systolic (congestive) heart failure I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.30 Unspecified diastolic (congestive) heart failure I50.31 Acute diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.33 Acute on chronic diastolic (congestive) heart failure I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.9 Heart failure, unspecified Q24.6 Congenital heart block References Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346:1845. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. 2012. http://content.onlinejacc.org/article.aspx?articleid=1357576. Accessed March 15, 2016. Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005; 352:1539. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008; 117:e350. Gerber TC, Nishimura RA, Holmes DR, et al. Left ventricular and biventricular pacing in congestive heart failure. Mayo Clin Proc. 2001;76:803-812. Goldenberg I, Moss AJ, Hall WJ, et al. Predictors of response to cardiac resynchronization therapy in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). Circulation 2011; 124:1527. Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151-2158. Saxon LA, Bristow MR, Boehmer J, et al. Predictors of sudden cardiac death and appropriate shock in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial. Circulation 2006; 114:2766. Specialty-matched clinical peer review. Strickberger SA, Conti J, Daoud EG, et al. Patient selection for cardiac resynchronization therapy. Circulation. 2005;111:2146-2150. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013; 128:1810.