Medical Policy
Subject:  Implantable Cardioverter-Defibrillator (ICD)
Policy #: SURG.00033 Current Effective Date: 05/07/2007
Status:    Reviewed Last Review Date: 03/08/2007

Description/Scope

This policy addresses the use of an implantable cardioverter-defibrillator to monitor heart rhythm and deliver an electrical shock when a life threatening ventricular arrhythmia is detected.

Policy Statement


Medically Necessary:


The use of an implantable cardioverter-defibrillator (ICD) is considered medically necessary for the treatment of ventricular tachyarrhythmias and for the prevention of sudden cardiac death when one of the following indications is present:

  1. History of cardiac arrest due to ventricular fibrillation (VF) or ventricular tachycardia (VT) and which is not due to reversible or transient causes; or
  2. Spontaneous sustained VT, in patients with structural heart disease; or
  3. Spontaneous sustained VT, in patients without structural heart disease, that is not amenable to other treatments; or
  4. Syncope of undetermined origin with clinically relevant, hemodynamically significant, sustained VT or VF induced at electrophysiological study when drug therapy is ineffective, not tolerated, or not preferred; or
  5. Familial or inherited conditions with a high risk for life-threatening ventricular tachyarrhythmias such as long QT syndrome or hypertrophic cardiomyopathy; or
  6. Previous myocardial infarction and coronary artery disease (CAD), at least 40 days post myocardial infarction and three months post coronary artery revascularization surgery with an ejection fraction equal to or less than 35% after maximal medical therapy; or  
  7. Ischemic dilated cardiomyopathy (IDCM) with NYHA Class II or III heart failure, documented prior myocardial infarction (MI), at least 40 days post MI, and measured left ventricular ejection fraction (LVEF) less than or equal to 35%; or  
  8. Non-ischemic dilated cardiomyopathy (NIDCM) greater than 9 months duration,  NYHA Class II or III heart failure, and measured LVEF less than or equal to 35%.

Note: For use of combined ICD/Biventricular pacing (CRT-ICD) devices, in cases of NYHA Class IV heart failure and for other indications, see  SURG.00064 Cardiac Resynchronization Therapy (CRT), with or without an Implantable Cardioverter Defibrillator (CRT/ICD) for the Treatment of Heart Failure.

Investigational/Not Medically Necessary:

The use of an implantable cardioverter-defibrillator is considered investigational/not medically necessary for any other diagnosis not listed above as medically necessary.

Rationale


Implantable cardioverter-defibrillators (ICD) are an important treatment option for patients with a history of life-threatening ventricular arrhythmias. Randomized clinical trials have shown that ICD use significantly reduces mortality rates for those patients with CAD and/or a prior myocardial infarction who have poor ventricular function. Although ICDs for the treatment of atrial fibrillation have been used in studies, evidence on efficacy and long term outcome is limited and thus clear conclusions concerning the efficacy of this treatment modality cannot be drawn.

 

Available literature indicates implantable cardioverter-defibrillators (ICDs) are now widely used for the secondary prevention of sudden cardiac death, due to ventricular fibrillation (VF) or ventricular tachycardia (VT).  ICD implantation is the generally accepted treatment for patients who have experienced an episode of VF not accompanied by an acute myocardial infarction or other transient or reversible cause. Accepted guidelines prefer this treatment in patients with sustained VT, causing syncope or hemodynamic compromise. As primary prevention, the literature shows that ICD use is superior to conventional antiarrhythmic drug therapy in patients who have survived a myocardial infarction and who have spontaneous, non-sustained VT, a low ejection fraction, and inducible VT at electrophysiological study.

 

Two prospective, randomized, controlled trials compared the use of ICDs to that of conventional therapy: the Multi-Center Automatic Defibrillator Implantation Trial (MADIT; n=196) and the Multi-Center Automatic Defibrillator Implantation Trial II (MADIT II; n= 1,232). Both trials were conducted on patients with coronary artery disease (CAD) who had experienced myocardial infarctions (MIs) and who had reduced left ventricular ejection fractions (LVEFs). Both trials were well designed and of good quality. The observed all-cause mortality rate in the conventionally treated group was somewhat lower in MADIT II (19.8%, with average follow-up at 20 months) than in MADIT (38.6%, with average follow-up at 27 months), suggesting some differences in the baseline mortality risk between these two populations. Both trials reported that ICD treatment resulted in more statistically significant reductions in all-cause mortality (primary endpoint) than conventional therapy did. The MADIT and MADIT II trials provide consistent evidence that patients with CAD, prior MI and reduced LVEF who meet selection criteria for either trial have significantly reduced mortality when treated with ICDs than when given conventional therapy (Moss, 1996).

 

The Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial was a prospective, randomized study to test the hypothesis that an ICD will reduce the risk of sudden death in patients with non-ischemic cardiomyopathy and moderate-to-severe left ventricular dysfunction. Inclusion criteria were: LVEF < 36%, the presence of ambient arrhythmias, a history of symptomatic heart failure, and the presence of non-ischemic dilated cardiomyopathy. The primary endpoint was death from any cause; the secondary endpoint was sudden death from arrhythmia. A total of 458 patients were enrolled: 229 were randomly assigned to receive standard medical therapy and 229 to receive standard medical therapy plus a single-chamber ICD. Results of the study included 68 deaths, 28 of which occurred in the ICD group, as compared to 40 in the standard therapy group (hazard ratio - 0.65; 95% confidence interval - 0.40-1.06; p= 0.08). The mortality rate at two years was 14.1% in the standard therapy group (annual mortality rate, 7%) and 7.9% in the ICD group. There were 17 sudden deaths from arrhythmia: three in the ICD group and 14 in the standard therapy group (hazard ratio - 0.20; 95%; confidence interval - 0.06 to 0.71; P= 0.006). The researchers noted that fewer patients died in the ICD group than in the standard therapy group (28 vs. 40), but that the difference in survival was not significant (p= 0.08). The researchers concluded that this was still a well-supported study, based on the p value results (Schaechter, 2003).

 

The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) was conducted to test whether amiodarone therapy or an implantable cardioverter-defibrillator will improve survival, compared to a placebo in patients with systolic dysfunction from ischemic dilated cardiomyopathy (IDCM) or non-ischemic dilated cardiomyopathy (NIDCM) who also have NYHA class II or class III heart failure, chronic stable congestive heart failure (CHF) and reduced LVEF less than or equal to 35%. A total of 2,521 patients were randomly assigned: 847 received placebo plus conventional heart failure therapy; 845 received amiodarone plus conventional heart failure therapy; and 829 received single-lead ICD plus conventional heart failure therapy. The results of the trial showed a significant reduction in mortality in the ICD group, compared to the placebo group: (hazard ratio compared to control = 0.77; 97.5% CI = 0.62-0.96; p = 0.007).

 

For patients with IDCM, there was a reduction in the mortality hazard ratio for ICD therapy, compared to the control (hazard ratio=0.79; 97.5% CI=0.60-1.04). For patients with NIDCM, there was a reduction in the mortality hazard ratio for ICD therapy compared to the control (hazard ratio=0.73; 97.5% CI= 0.50-1.07). Amiodarone therapy did not improve survival. The results of this study showed that overall mortality was lower forpatients with NIDCMthan for patients with IDCM. The authors concluded that ICD placement is safe and effective for the treatment of ischemic and non-ischemic cardiomyopathy (Bardy, 2005).

 

In 2006, the American College of Cardiology (ACC), in conjunction with the American Heart Association (AHA), the European Society of Cardiology (ESC), the European Heart Rhythm Association (EHRA), and the Heart Rhythm Society (HRS) published practice guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death (SCD).  The guidelines, which were based on published evidence, expert opinion, and medical consensus, provide recommendations for use of ICDs, in addition to other recommendations related to diagnostics and medical/surgical treatment options for a variety of cardiac conditions.  These most recent guidelines update and combine previously published recommendations into one consensus document which provides detailed clinical indications for ICD implantation, according to classification and level of evidence.  Current SURG.00033 contains criteria for ICD use that are consistent with this updated ACC/AHA/ESC document (Zipes, 2006).

 

The Centers for Medicare and Medicaid Services (CMS) expanded its national coverage determination policy (January 27, 2005), to include patients with ischemic dilated cardiomyopathy (IDCM) and non-ischemic dilated cardiomyopathy (NIDCM), subject to additional policy limitations and requirements regarding data collection.  This expanded policy is based on the results of recently published trials data, as described above. 

 

Background/Overview

 

Description of Relevant Disease

Sudden cardiac death (also called sudden arrest) is defined as unexpected death resulting from an abrupt loss of heart function (cardiac arrest). All known heart diseases can lead to cardiac arrest and sudden cardiac death.  Most of the cardiac arrests that lead to sudden death occur when the electrical impulses in the diseased heart become rapid (ventricular tachycardia) or chaotic (ventricular fibrillation) or both. This irregular rhythm causes the heart to suddenly stop beating.  Some cardiac arrests are due to extreme slowing of the heart (bradycardia). Brain death and permanent death start to occur in just four to six minutes after someone experiences cardiac arrest. Cardiac arrest is reversible in most victims if it is treated within a few minutes with an electrical shock to the heart to restore a normal heartbeat (defibrillation). Cardiovascular mortality as a consequence of VF or VT continues to be a major health problem, despite advances in the overall management of cardiovascular disease. Sudden cardiac death kills approximately 400,000 people per year, with survival rates for cardiac arrest less than 5% in most industrialized countries.      If the cardiac arrest was due to ventricular tachycardia or ventricular fibrillation, survivors are at risk for another arrest, especially if they have underlying heart disease.

 

Description of Implantable Defibrillators (ICD)

Defibrillation is a process in which an electronic device gives an electric shock to the heart. This helps reestablish normal contraction rhythms in a heart having dangerous arrhythmia or in cardiac arrest. A surgically implanted cardioverter-defibrillator (ICD) is a device used in patients at high risk for sudden cardiac death due to arrhythmia, usually due to sustained ventricular tachyarrhythmia. The device is connected to leads positioned inside the heart or on its surface. These leads are used to deliver electrical shocks, sense the cardiac rhythm and sometimes pace the heart, as needed. The various leads are connected to a pulse generator, which is implanted in a pouch beneath the skin of the chest or abdomen.  The ICD is designed to continuously monitor an individual’s heart rate, recognize ventricular fibrillation or ventricular tachycardia, and deliver an electric shock to terminate these arrhythmias, in order to reduce the risk of sudden death. Multiple ICD devices have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approal (PMA) process, subject to FDA-approved labeling indications.

 

Definitions

 

Arrhythmia: (or dysrhythmia): problems that affect the electrical system of the heart muscle, producing abnormal heart rhythms.  May be classified as either atrial or ventricular, depending on which part of the heart they originate from.

 

Atrial fibrillation: a condition in which the atrium (the heart’s two upper chambers) produce uncoordinated electrical signals.

 

Cardiomyopathy: a disease in which the heart muscle becomes inflamed and doesn’t work as well as it should.  There are three main types of cardiomyopathy:

  • Dilated -  This is the most common form, in which the heart cavity is enlarged and stretched (cardiac dilation). The heart is weak and doesn't pump normally, and most patients develop congestive heart failure. Abnormal heart rhythms and disturbances in the heart's electrical conduction also may occur.
  • Hypertrophic -  In this condition, the muscle mass of the left ventricle enlarges or "hypertrophies." In one form of the disease, the wall between the two pumping chambers becomes enlarged and obstructs the blood flow from the left ventricle. In the other form of the disease, non-obstructive hypertrophic cardiomyopathy, the enlarged muscle doesn't obstruct blood flow.
  • Restrictive -  This is the least common type in the United States. The myocardium (heart muscle) of the ventricles becomes excessively "rigid," making it more difficult for the ventricles to fill with blood between heartbeats. This type of cardiomyopathy is usually due to another disease process.

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 tissues.

Coronary artery disease (CAD): refers to heart problems caused by narrowed heart arteries; when arteries are narrowed, less blood and oxygen reaches the heart; this 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 to re-establish normal contraction rhythms in a heart that is not properly beating.  This may be done using an external device or by a device implanted in the body.

 

Ejection fraction (EF): the percentage of blood ejected from the left ventricle with each heartbeat; normal readings would be in the 58-70% range and lower values would indicate ventricular dysfunction.

 

Electrophysiology studies: performed in the cardiac catheterization laboratory; such studies evaluate electro- physiological properties of the heart, such as automaticity, conduction, and  whether the condition is refractory to management with medications.  Additional capabilities of this testing include: ability to initiate and terminate tachycardia; to map activation sequences; and to evaluate patients for various forms of therapy and judge response to therapy.

 

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 stopped.

 

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: refers to a portion of an electrocardiogram (EKG) reading, which represents the spread of the electrical impulse through the ventricles.

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

 

Ventricular tachyarrhythmias: a medical term for a rapid heartbeat that may be regular or irregular and arises 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, (i.e., the ventricles "flutter" 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.

 

Coding

 

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 or these services at it applies to an individual member.

 

When services may be Medically Necessary, when criteria are met:

 

CPT

00534

Anesthesia for transvenous insertion or replacement of pacing cardioverter-defibrillator

33202

Insertion of epicardial electrode(s); open incision (e.g., thoracotomy, median sternotomy, subxiphoid approach)

33203

Insertion of epicardial electrode(s); endoscopic approach (e.g., thoracoscopy, pericardioscopy)

33216

Insertion of a transvenous electrode; single chamber (one electrode) permanent pacemaker or single chamber pacing cardioverter-defibrillator [when specified as ICD]

33217

Insertion of a transvenous electrode; dual chamber (two electrodes) permanent pacemaker or dual chamber pacing cardioverter-defibrillator [when specified as ICD]

33240

Insertion of single or dual chamber pacing cardioverter-defibrillator pulse generator

33249

Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator

 

HCPCS

G0297

Insertion of single chamber pacing cardioverter-defibrillator pulse generator

G0298

Insertion of dual chamber pacing cardioverter-defibrillator pulse generator

G0299

Insertion or repositioning of electrode lead for single chamber pacing cardioverter-defibrillator and insertion of pulse generator

G0300

Insertion or repositioning of electrode lead(s) for dual chamber pacing cardioverter-defibrillator and insertion of pulse generator

 

ICD-9 Procedure

37.94

Implantation or replacement of automatic cardioverter-defibrillator, total system (ICD)

37.95

Implantation of automatic cardioverter-defibrillator lead(s) only

37.96

Implantation of automatic cardioverter-defibrillator pulse generator only

 

ICD-9 Diagnosis

 

See policy section for criteria

 

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above specified as ICD, when the criteria are not met and in all other cases.

 

References

 

Peer Reviewed Publications:

  1. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter–defibrillator for congestive heart failure. N Engl J Med. 2005; 352(3):225-37.
  2. Boehmer JP. Device Therapy for Heart Failure. American Journal of Cardiology. 2003; 91 (6A):53D-59D. 
  3. 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; 350:2140-50.
  4. Buxton AE, Sweeney MO, Wathen MS, et al. QRS duration does not predict occurrence of ventricular tachyarrhythmias in patients with implanted cardioverter-defibrillators. J Am Coll Cardiol. 2005; 46(2):310-16.
  5. Buxton AE, Lee KL, Fisher JD, et al.. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med. 1999; 341:1882-90.
  6. Chow AW, Lane RE, Cowie MR. New pacing technologies for heart failure. BMJ. 2003; 326:(7398)1073-1077. 
  7. Cook JR, Rizo-Paton C, et al. Effect of surgical revascularization in patients with coronary artery disease and ventricular tachycardia or fibrillation in the antiarrhythmias versus implantable defibrillation registry. Am Heart J. 2002; 143(5):821-826.
  8. Cooper JM, Katcher MS, Orlov MV. Current concepts: implantable devices for the treatment of atrial fibrillation. N Eng J Med. 2002; 346(26):2062-2028.
  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. Desai AS, Fang JC, Maisel WH, et al. Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy: a meta-analysis of randomized controlled trials.  JAMA. 2004; 292(23):2874-9.
  11. Engelstein ED. Prevention and management of chronic heart failure with electrical therapy. Am J Cardiol. 2003; 91(9):62.
  12. Exner DV, Klen GJ, Prytowsky EN. Primary prevention of sudden cardiac death with implantable defibrillator therapy in patients with cardiac disease: can we afford to do it? (Can We Afford Not To?). Circ. 2001; 104(13):1564-1570.
  13. Ezekowitz JA, Armstrong PW, McAlister FA. Implantable cardioverter-defibrillators in primary and secondary prevention: A systemic review of randomized, controlled trials. Ann Intern Med. 2003; 138(6):445-452. 
  14. Heidenreich PA, Keefe B, McDonald KM, et al. Overview of randomized trials of antiarrhythmic drugs and devices for the prevention of sudden cardiac death. Am Heart J. 2002; 144(3):422-430.
  15. Hlatky MA. Evidence-based use of cardiac procedures and devices. N Engl J Med. 2004;350:2126-8.
  16. Hodgkinson KA, Parfrey PS, Bassett AS, et al. The impact of implantable cardioverter-defibrillator therapy on survival in autosomal-dominant arrhythmogenic right ventricular cardiomyopathy (ARVD5). J Am Col Cardiol. 2005; 45(3):400-408.
  17. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004; 351:2481-8.
  18. Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy.N Engl J Med. 2004; 350:2151-8.
  19. Kupersmith J. The past, present, and future of the implantable cardioverter-defibrillator. Am J Med. 2002; 113(1); 82-84.
  20. Kusumoto, FM, Goldschlager N. Device therapy for cardiac arrhythmias. JAMA. 2002; 287(14):1848-1852.
  21. McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med. 2005; 352:222-4.
  22. Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators.  N Engl J Med. 1996; 335:1933-40.
  23. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002; 346:877-83.
  24. Nanthakumar K, et al. Is inappropriate implantable defibrillator shock therapy predictable? Journal of Interventional Cardiac Electrophysiology. 8, 215-220.
  25. Parkes JB, Milne AR. Implantable cardioverter-defibrillators in arrhythmias: a rapid and systematic review of effectiveness. Heart. 2002; 87(5):438-442.
  26. Raviele A, Bongiorni MG, Brignole M, et al. Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment.  The Beta-blocker Strategy plus ICD trial.  Europace. 2005; 7(4):327-37.
  27. Schaechter A, Kadish AH, et al. DEFibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE).  Card Electrophysiol Rev. 2003; 7(4):457-62.
  28. Schlapfer J, Rapp F, Kappenberger L, et al. Electrophysiologically guided amiodarone therapy versus the implantable cardioverter-defibrillator for sustained ventricular tachyarrhythmias after myocardial infarction: Results of long-term follow-up. J Am Coll Cardiol. 2002; 39(11):1813-1819.
  29. Steinberg JS, Martins J, et al. Antiarrhythmic drug use in the implantable defibrillator arm of the antiarrhythmics versus implantable defibrillator (AVID) study. Am Heart J. 2001; 142(3):520-529.
  30. Swygman C, Wang PJ, Link MS, et al. Advances in implantable cardioverter-defibrillators. Curr Op Card. 2002; 17(1):24-28.
  31. Wilber DJ, Zareba W, Hall WJ, et al.  Time dependence of mortality risk and defibrillator benefit after myocardial infarction. Circulation. 2004; 109:1082-4.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Heart Association (AHA) web site: Sudden cardiac death. 2005b.  Available at:  http://www.americanheart.org/presenter.jhtml?identifier=4741.  Accessed on  January 26, 20076.
  2. Blue Cross and Blue Shield Association. Use of implantable Cardioverter-Defibrillators for Prevention of Sudden Death in Patients at High Risk for Ventricular Arrhythmia. TEC Assessment, 2004; 19, (19).
  3. Blue Cross and Blue Shield Association.  Implantable Cardioverter Defibrillators for Primary Prevention of Sudden Death in Patients at High Risk for Ventricular Arrhythmia. TEC Assessment, 2002; 17, (10).
  4. Centers for Medicare & Medicaid Services. National Coverage Determination: Implantable Automatic Defibrillators. NCD#20.4.  Effective 01/27/2005.  Available at:  http://www.cms.hhs.gov  Accessed on   January 26, 2007.
  5. Gregoratos G, Abrams J, Epstein AE, et al. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmic devices: a Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/ NASPE Committee on Pacemaker Implantation). 2002.  Available at:  http://www.acc.org/  Accessed on January 26, 2007.
  6. Hunt SA, Abraham WT, Chin MH, 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).  J Am Coll Cardiol. 2005; 46(6):e1-82. Available at:  http://www.acc.org/  Accessed on  January 26, 2007.
  7. Hayes Inc. Hayes Medical Technical Directory.™  Implanted Cardioverter Defibrillators for Primary Prevention of Sudden Cardiac Death. Lansdale, PA: Hayes, Inc; December 9, 2005.
  8. Hayes Inc.  Hayes Medical Technical Directory.™  Implanted Cardioverter Defibrillators for Secondary Prevention of Sudden Cardiac Death. Lansdale, PA: Hayes, Inc; November 28, 2005. Search updated November 30, 2006.
  9. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health.  Implantable Cardioverter Defibrillators.  Available at:  http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm  Accessed on January 26, 2007.
  10. 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).  Circ. 2006; 114:1088-1132.  Available at:  http://www.acc.org.  Accessed on January 26, 2007.

Web Sites for Additional Information

  1. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health.  FDA Preliminary Public Health Notification: Guidant Ventak Prizm 2 DR and Contak Renewal Implantable Cardioverter Defibrillators. July 14, 2005.  Available at:    http://www.fda.gov/cdrh/safety.html  Accessed on: January 26, 2007.  
  2. National Institute for Clinical Excellence (NICE) Technology Appraisal Guidance No. 11.  Guidance on the use of implantable cardioverter defibrillators for arrhythmias.  London, UK. NICE; 2000.  Available at:     http://www.ccad.org.uk/ccadweb.nsf/567ea171555599d280256aff00536d2d/ $FILE/Nice+DEFIBRILATOR++guidance.pdf.  Accessed on January 26, 2007.
  3. Heart failure. Available at:  http://www.heartfailure.org/  Accessed on January 26, 2007.

Index

 

Automatic Defibrillator
ICD

Implantable Cardioverter-Defibrillator

 

Policy History

 

Status

Date

Action

Reviewed 03/08/2007 Medical Policy & Technology Assessment Committee (MPTAC) review.  No change to policy criteria/stance.  Rationale, References, and Coding sections have been updated. Published on web 05/04/2007.
Reviewed 01/01/2007 Updated coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 33245, 33246 deleted 12/31/2006.
Reviewed 03/23/2006 MPTAC review. No change in policy stance.  References were updated to include the recently released updated TEC Assessment Directories (2) and additional published articles. Published on web 04/18/2006.
11/18/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

04/28/2005

MPTAC review. Revision based on Policy Harmonization: Pre-merger Anthem and Pre-merger WellPoint.

 

Pre-Merger Organization

Last Review Date

Policy Number

Title

Anthem, Inc.

 

09/19/2003

SURG.00033

Automatic Implantable Cardioverter-Defibrillator (AICD), Cardiac Resynchronization Therapy Defibrillator (CRT-D), Biventricular Pacemakers

WellPoint Health Networks, Inc

06/24/2004

9.04.03

Implantable Cardioverter-Defibrillators

 

 


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.

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