This policy addresses biventricular cardiac pacing to deliver cardiac resynchronization therapy (CRT) to alleviate the symptoms of moderate to severe congestive heart failure associated with left ventricular dyssynchrony.  It also addresses a hybrid device that combines CRT with an implantable cardioverter defibrillator (ICD).  In the combined device (CRT/ICD), the CRT component promotes coordinated contraction of both ventricles, while the ICD portion detects dangerous arrhythmias and shocks the heart back into a normal rhythm.

Medically Necessary:

FDA-approved biventricular pacemakers for cardiac resynchronization therapy (CRT) are considered medically necessary for individuals who meet all of the following criteria:

1. NYHA functional Class III or ambulatory Class IV symptoms, secondary to heart failure who remain symptomatic despite recommended, optimal medical therapy;* and
2. Who have cardiac dyssynchrony, (which is currently defined as a QRS duration > 120 ms); and
3. Left ventricular ejection fraction (LVEF) < (less than or equal to) 35%; and
4. Are in sinus rhythm. 

The use of an FDA-approved ICD, in combination with cardiac resynchronization therapy (CRT/ICD), is considered medically necessary when the criteria listed above for CRT therapy AND the criteria within SURG.00033 Implantable Cardioverter-Defibrillator (ICD) are met.

*Optimal drug therapy may include use of the following medications either individually or in combination, unless contraindicated: angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, beta-blockers, digoxin, diuretics, and aldosterone antagonists, when appropriate.

Investigational/Not Medically Necessary:

Biventricular pacemakers for cardiac resynchronization therapy (CRT), or combined biventricular pacemaker-defibrillator devices (CRT/ICD), are considered investigational/not medically necessary for all other indications.
 

CRT

There are a number of FDA approved devices currently  manufactured by Medtronic, Inc., Guidant Corporation, and St. Jude Medical that are designed to provide biventricular pacing/resynchronization therapy (CRT) without or with an implantable cardioverter defibrillator device (CRT/ICD). One such device, the InSync® Biventricular Pacing System (Medtronic, Minneapolis, MN) provides biventricular pacing alone.  It received FDA approval in August 2001 and is indicated for the treatment of patients with New York Heart Association (NYHA) functional class III or IV heart failure, who remain symptomatic despite stable, optimal medical therapy, who additionally have a QRS duration of greater than or equal to 130 milliseconds, and  a left ventricular ejection fraction (LVEF) of less than or equal to 35%. The FDA approval was based on data collected in the Multi-Center InSync Randomized Clinical Evaluation (MIRACLE) trial. This trial controlled for placebo effect by implanting all 574 subjects with the biventricular pacing system and randomly allocating them to either active or inactive cardiac resynchronization therapy (CRT) groups.  Overall, 68% of active CRT subjects, versus 35% of those whose device was turned off, demonstrated improvement in primary endpoints, including quality of life, 6-minute hall walk, and NYHA functional class. The treatment group also reported increases in a variety of cardiodynamic measures, including peak oxygen consumption, LV end diastolic dimension, and left ventricular ejection fraction (Abraham 2002).

A recently completed multicenter, international, randomized trial, the Cardiac Resynchronization – Heart Failure (CARE-HF) trial, compared the effect on  risk of complications and death between  standard pharmacologic therapy alone and  that of a  combination of standard therapy with  cardiac resynchronization (without a defibrillator) in patients with left ventricular systolic dysfunction, cardiac dyssynchrony, and symptomatic heart failure (Cleland 2005). A total of 813 patients were enrolled and followed for a mean of 29.4 months. Patient selection criteria included NYHA class III or IV despite receipt of optimal drug therapy, LVEF of 35% or less and a QRS interval of at least 120 msec. The primary endpoint, a composite of death from any cause or an unplanned hospitalization for a major cardiovascular event, was reached by 159 patients in the CRT group, as compared with 224 patients in the medical therapy group (39% vs. 55%; hazard ratio 0.63; 95% CI, 0.51 to 0.77; p < 0.001).  There were 82 deaths in the CRT group, as compared with 120 in the medical therapy group (20% vs. 30%; hazard ratio 0.64; 95% CI, 0.48 to 0.85; p< 0.002).  As compared with medical therapy, CRT reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and the quality of life (p<0.01 for all comparisons).

CRT/ICD

In May of 2002, the FDA approved the first hybrid device that combines CRT with an implantable cardioverter defibrillator (ICD), the CONTAK CD® (Guidant Corp., St. Paul, MN). The device is indicated for patients at high-risk of sudden death due to ventricular arrhythmias and who have moderate to severe heart failure (NYHA Class III/IV), including left ventricular dysfunction (LVEF less than or equal to 35 %) and QRS duration greater than or equal to 120 milliseconds, and who remain symptomatic despite stable, optimal heart failure drug therapy. In July of 2002, the FDA approved a second device, the InSync® ICD/CRT (Medtronic) with similar criteria including a QRS duration equal to or greater than 130 milliseconds.  In June of 2004, the FDA approved additional devices, the Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with cardiac resynchronization therapy (St Jude Medical® Inc., Sunnyvale, CA) for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  This device has similar criteria to the others, including a QRS duration equal to or greater than 150 milliseconds.

In September of 2004, the FDA expanded the indications for the CONTAK® RENEWAL™ combined CRT/ICD devices to include ischemic and nonischemic heart failure patients with LVEF ≤ 35% and a QRS duration ≥ 120 milliseconds, who meet standards for New York Heart Association Class III/IV functional status and remain symptomatic despite optimal medical management. Candidates for biventricular cardiac pacing are no longer required to clinically demonstrate increased risk for sudden cardiac death to qualify for treatment with a CRT/ICD device. Previously, only a subgroup of these patients–those with a history of myocardial infarction and those with induced or spontaneous arrhythmias–were considered by the FDA to be appropriate for implantation with a CRT/ICD device. An estimated 30,000 to 35,000 more individuals each year may now be candidates for a CRT/ICD device. The FDA decision (Sept. 2004) to expand the indications and usage labeling is based on data from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial.

The COMPANION trial was a multicenter, randomized, controlled trial to test the hypothesis that prophylactic cardiac-resynchronization therapy with a biventricular pacemaker (CRT) or a pacemaker-defibrillator (CRT/ICD) would reduce the risk of death and hospitalization among patients with advanced chronic heart failure and intra-ventricular conduction delays (Bristow, 2004). A total of 1,520 patients who had advanced heart failure (NYHA class III or IV), due to ischemic or non-ischemic cardiomyopathies and a QRS interval of at least 120 msec, were randomly assigned in a 1:2:2 ratio to receive optimal pharmacologic therapy, (e.g., diuretics, angiotensin-converting enzyme inhibitors, beta-blockers and spironolactone) alone or in combination with CRT or CRT/ICD. The primary composite endpoint was the time-to-death from, or hospitalization for, any cause. The results showed that, compared to optimal pharmacological therapy alone, CRT with a pacemaker decreased the risk of the primary endpoint (hazard ratio, 0.81; p=0.014), as did CRT/ICD (hazard ratio, 0.80; p=0.01). The risk of the combined endpoint of death from, or hospitalization for, heart failure was reduced by 34% in the pacemaker group (p<0.002) and by 40% in the pacemaker-defibrillator group (p<0.001 for the comparison with the pharmacological therapy group). CRT therapy reduced the risk of the secondary endpoint of death from any cause by 24% (p=0.059), and CRT/ICD therapy reduced the risk by 36% (p=0.003). The researchers concluded that, in patients with advanced heart failure and a prolonged QRS interval, CRT decreases the combined risk of death from any cause or of first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.

On August 16, 2005 the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation, issued a 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult (Hunt, et al).  This guideline provides clinical recommendations for the use of CRT and CRT/ICD therapy, in addition to conventional medical treatment for heart failure, and notes that there is strong evidence to support use of CRT to improve symptoms, exercise capacity, quality of life, LVEF, and survival for patients with symptomatic heart failure, despite optimal medical therapy.

The ACC/AHA document further notes that, with few exceptions, resynchronization trials have enrolled patients in normal sinus rhythm.  Also, although entry criteria for these trials have specified that the QRS duration needs to be over 120 ms., the average QRS duration in the large trials was more than 150 ms. with less information demonstrating benefit in patients with lesser prolongation of QRS. 

The ACC/AHA Task Force also addressed other potential indications for CRT.  It was noted that two small studies, one randomized (Leclercq, et al) and the other observational (Leon, et al), evaluated the potential benefit of CRT in heart failure patients with ventricular dyssynchrony and atrial fibrillation.  Although both studies demonstrated benefit from CRT, the total number of patients examined (fewer than 100) precludes a recommendation for CRT in otherwise eligible patients with atrial fibrillation.  To date, only a small number of patients with “pure” right bundle-branch block have been enrolled in CRT trials, and the effect in these patients is currently unknown.  Similarly, the prolonged QRS duration associated with right ventricular pacing has also been associated with ventricular dyssynchrony that may be improved by CRT, but no studies have addressed this situation, as yet.  Therefore, recommendations regarding CRT for patients with right bundle-branch block, atrial fibrillation, minor conduction abnormality, and pacemaker dependence, in addition to inadequate medical therapy, must await the completion of ongoing or future trials.

Description of Relevant Disease

Approximately 5 million Americans are currently diagnosed with heart failure, and more than 500,000 new cases are diagnosed each year. Congestive heart failure (CHF) is a clinical condition characterized by the heart’s inability to generate a cardiac output sufficient to meet the body’s circulatory demands. Patients with CHF have intra-ventricular conduction delays, evidenced by a wide QRS interval on electrocardiogram (EKG), which can worsen left ventricular systolic dysfunction through asynchronous ventricular contraction. There is inadequate filling of the left ventricle, as well as a backflow of blood into the left atrium, both resulting in decreased cardiac output and increased symptoms for the patient. This abnormality appears to be associated with increased morbidity and mortality. The most frequently used index of cardiac function is the left ventricular ejection fraction (LVEF). Normal LVEF readings are in the 58-70% range at rest.  Severe heart failure can reduce LVEF to less than 35%.

Medical therapy for CHF includes a combination of diuretics, digoxin, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), beta-blockers and aldosterone antagonists. Some patients may remain symptomatic, despite medical therapy. Current recommendations advise the optimization of pharmacological therapy before initiating cardiac resynchronization therapy.

Description of Biventricular Pacemakers and Cardiac Resynchronization Therapy

A biventricular pacemaker is a type of implantable pacemaker designed to treat heart failure. In approximately 30% of heart failure patients, the walls of the left ventricle, which is the heart’s main pumping chamber, are no longer synchronized or pumping together, as they normally would. A biventricular pacemaker is designed to resynchronize the pumping action of the left ventricle. This type of pacing is called cardiac resynchronization therapy (CRT). Standard pacemakers pace the right side of the heart. In contrast, biventricular pacemakers pace both the right and left sides of the heart. They do not increase heart rate, but instead, stimulate the left and right ventricles simultaneously. This enables the left ventricle to pump blood more efficiently. Biventricular pacemakers use three leads (one in the right atrium, one in each ventricle) and have been investigated as a technique to coordinate the contraction of the ventricles, thus, improving the hemodynamic status of the patient.

Biventricular pacemakers are manufactured as  “stand alone” devices (CRT) or with a built-in implantable cardioverter defibrillator (CRT/ICD). The combination devices provide treatment of ventricular dyssynchrony and ventricular tachyarrhythmias associated with sudden cardiac death, (e.g., V Tach and V Fib).

Arrhythmia: irregular heartbeat; can be either atrial or ventricular arrhythmias depending on which part of the heart they originate from.

Congestive heart failure (CHF): or heart failure: a condition in which the heart can't pump enough blood to the body's other organs. The "failing" heart keeps working but not as efficiently as it should.  As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the vital tissues.

Coronary artery disease (CAD): refers to heart problems caused by narrowed heart arteries; when arteries are narrowed or partially blocked by fatty plaque formation, less blood and oxygen reaches the heart muscle itself. This is also called coronary artery disease or coronary heart disease and can ultimately lead to a heart attack (myocardial infarction).

Defibrillation:  a process in which an electronic device (a defibrillator) gives the heart an electric shock; helping reestablish normal contraction rhythms in a heart that is not properly beating; and may be done using an external device or by a device implanted in the body, an implantable cardioverter defibrillator (ICD).

Electrophysiology studies: performed in the cardiac catheterization laboratory; such studies evaluate electrophysiological properties such as automaticity, conduction, and response to medications given during the testing. Additional capabilities of EPS studies include initiation and termination of tachycardia; mapping of activation sequences; evaluation of various forms of therapy; and therapeutic response.

Left Ventricular Ejection Fraction (LVEF): the measurement of the heart's ability to pump blood through the body; normal LVEF readings would be in the 58-70% range and lower values would indicate ventricular dysfunction.

Myocardial infarction (MI): the medical term for heart attack; a heart attack occurs when the blood supply to part of the heart muscle (the myocardium) is severely reduced or blocked.

New York Heart Association (NYHA) definitions:
The NYHA classification of heart failure is a 4-tier system that categorizes patients based on subjective impression of the degree of functional compromise. The four NYHA functional classes are as follows: 

• Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Symptoms only occur on severe exertion.
• Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity (e.g., moderate physical exertion such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain.
• Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. 
• Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

QRS complex: in an electrocardiogram it represents the spread of the electrical impulse through the ventricles.

Sudden cardiac death: is death resulting from an abrupt loss of heart function (also known as cardiac arrest).

Ventricular tachyarrhythmias: a medical term for a 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) a 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) is a fast regular heart rate that starts in the lower chambers (ventricles). VT may result from serious heart disease and usually requires prompt treatment.

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:
For the procedure codes listed above, when the criteria are not met, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Peer Reviewed Publications:

1. Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure: The Multicenter InSync Randomized Clinical Evaluation (MIRACLE). N Engl J Med. 2002; 346(24):1845-53.
2. Abraham WT, Hayes DL. Cardiac resynchronization therapy for heart failure. Circulation. 2003; 108(21):2596-2603.
3. Boehmer JP. Device therapy for heart failure. Am J Cardiol. 2003;91(6A):53D-59D.
4. Breithardt OA, Stellbrink C, Franke A, et al. Acute effects of cardiac resynchronization therapy on left ventricular Doppler indices in patients with congestive heart failure. Am Heart J. 2002; 143(1):34-44.
5. Bradley DJ, Bradley EA, Baughman KL, et al. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA. 2003:289(6):730-740.
6. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004; 350(21):2140-2150. 
7. Casey C, Knight BP. Cardiac resynchronization pacing therapy. Cardiology. 2004; 101(1-3):72-78.
8. Cleland JGF, Daubert JC, Erdmann E, et al. for the Cardiac Resynchronization – Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005; 352(15):1539-49.
9. David Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the dual chamber and VVI implantable defibrillator (DAVID) trial. JAMA. 2002; 288(24):3115.
10. Engelstein ED. Prevention and management of chronic heart failure with electrical therapy. Am J Cardiol. 2003; 91(9A):62F-73F.
11. Garrigue S, Bordachar P, Reuter S. et al. Comparison of permanent left ventricular and biventricular pacing in patients with heart failure and chronic atrial fibrillation: prospective haemodynamic study. Heart. 2002; 87(6):529-534.
12. Gold MR, Auricchio A, Hummel JD, et al. Comparison of stimulation sites within left ventricular veins on the acute hemodynamic effects of cardiac resynchronization therapy. Heart Rhythm. 2005; 2(4):376-381.
13. Hlatky MA. Evidence-based use of cardiac procedures and devices. N Engl J Med. 2004;350(21):2126-2128.
14. Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004; 350(21):2151-2158.
15. Kadish A. Prophylactic defibrillator implantation – toward an evidence based approach. (Editorial) N Engl J Med. 2004; 352:285-286.
16. Kalinchak DM, Schoenfeld MH. Cardiac resynchronization: a brief synopsis part I: patient selection and results from clinical trials. J Interv Card Electrophysiol. 2003; 9(2):155-161.
17. Leclercq C, Walker S, Linde C, et al. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J. 2002; 23:1780-1787.
18. Leon AR, Greenberg JM, Kanuru N, et al. Cardiac resynchronization in patients with congestive heart failure and chronic atrial fibrillation: effect of upgrading to biventricular pacing after chronic right ventricular pacing.  J Am Coll Cardiol. 2002; 39:1258-1263.
19. Linde C, Braunschweig F, Gadler F, et al. Long-term improvements in quality of life by biventricular pacing in patients with chronic heart failure; results from the Multisite Stimulation in cardiomyopathy (MUSTIC) study (MUSTIC). Am J Cardiol. 2003; 91(9):1090-1095.
20. Penicka M, Bartunek J, Be Bruyne B, et al. Improvement of left ventricular function after cardiac resynchronization therapy is predicted by tissue doppler imaging echocardiography. Circulation. 2004; 109(8):978-983.
21. Saxon LA, Boehmer JP, Hummel J, et al. The VIGOR CHF and VENTAK CHF investigators. Biventricular pacing in patients with congestive heart failure; two prospective randomized trials. Am J Cardiol. 1999; 83(5B):120D-123D.
22. Strickberger SA, Conti J, Daoud EG, et al. AHA Science Advisory: Patient selection for cardiac resynchronization therapy. Council on Clinical Cardiology Subcommittee on Electrocardiography and Arrhythmias and the Quality of Care and Outcomes Research Interdisciplinary Working Group, in collaboration with the Heart Rhythm Society and endorsed by the American College of Cardiology Foundation. Circulation. 2005; 111(16):2146-2150.
23. Sweeney MO, Ellenbogen KA, Casavant D, et al. Multicenter prospective randomized safety and efficacy study of a new atrial-based managed ventricular pacing mode (MVP) in dual chamber ICDs. J Cardiovasc Electrophysiol. 2005; 16(8):811-817.
24. Valderrabano M, Shivkumar K. Cardiac resynchronization therapy improves quality of life and functional status in people with chronic heart failure undergoing implantable cardioverter defibrillator therapy. Evidence-based Cardiovascular Medicine. 2003; 7(4):191-192.
25. Willerson JT, Kereiakes DJ. Cardiac resynchronization therapy: helpful now in selected patients with CHF. Circulation. 2004; 109(3):309-309.
26. Woo GW, Petersen-Stejskal S, Johnson JW, et al. Ventricular reverse remodeling and 6-month outcomes in patients receiving cardiac resynchronization therapy: analysis of the MIRACLE study. J Interv Card Electrophysiol. 2005; 12(2):107-113.
27. Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003; 289(20):2685-2694.

Government Agency, Medical Society, and other Authoritative Publications:

1. Hunt SA, Abraham WT, Chin MH, Feldman AM, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Available at: http://www.acc.org/. Accessed on February 9, 2007.
2. Gregoratos G, Abrams J, Epstein AE, et al. American College of Cardiology (ACC). ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and anti-arrhythmia devices: summary article: a report of the Am College of Cardiology/ American Heart Association task force on practice guidelines (Committee on pacemaker implantation). Available at:   http://www.acc.org/. Accessed on February 9, 2007.
3. Centers for Medicare and Medicaid Services. National Coverage Determination for Cardiac Pacemakers. NCD#20.8. Effective April 30, 2004. Available at: http://www.cms.hhs.gov. Accessed on February 9, 2007.
4. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Summary of Safety and Effectiveness for Medtronic InSync Biventricular Pacing System. Available at: http://www.fda.gov/cdrh/pdf/P010015b.pdf.  Accessed on February 9, 2007.
5. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Approved labeling indications for Medtronic InSync Biventricular Pacing System. Available at: http://www.fda.gov/cdrh/pdf/P010015c.pdf. Accessed on February 9, 2007.
6. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Guidant cardiac resynchronization therapy defibrillator system CONTAK renewal TR system. Available at: http://www.fda.gov/cdrh/mda/docs/p030005.html. Accessed on February 9, 2007.
7. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. St. Jude Medical® Epic™ and Atlas® + HF dual chamber implantable cardioverter defibrillator systems with cardiac resynchronization therapy. Available at: http://www.fda.gov/cdrh/mda/docs/p030054.html. Accessed on February 9, 2007.
8. Hayes Inc. Hayes Medical Technology Directory.™ Cardiac Resynchronization Therapy for Heart Failure. Lansdale, PA:  Hayes, Inc; January 15, 2002. Search updated May 6, 2006.
9. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death). Circulation. 2006; 114(10):1088-1132. Available at: http://www.acc.org. Accessed on January 26, 2007.

1. Heart disease.  Available at: http://www.fda.gov/hearthealth.  Accessed on February 9, 2007. 
2. Heart failure. Available at: http://www.heartfailure.org/.  Accessed on February 9, 2007. 
3. Heart Rhythm Society- Cardiac Resychronization Therapy.  Available at: http://www.hrspatients.org/patients/treatments/resync.asp.  Accessed on February 9, 2007. 
4. National Heart, Lung and Blood Institute available at:  Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Hf/HF_WhatIs.html.  Accessed on February 9, 2007.

Atlas® + HF
Biventricular Pacemaker
CONTAK®RENEWAL™
Epic™ HF
InSync® Biventricular Pacing System
InSync® ICD Dual Chamber ICD with CRT

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association