DESCRIPTION
An automatic implantable cardioverter defibrillator (AICD) is a device that monitors cardiac rhythm and delivers an electrical shock if a life threatening ventricular arrhythmia is detected. The device consists of an encased battery and pulse generator connected to insulated wires. The AICD is implanted under the skin near the shoulder. The wires are threaded through blood vessels to the heart.
NOTE: ICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or biventricular pacemakers designed to treat congestive heart failure. This policy addresses ICDs alone, when used solely to treat patients at risk for ventricular arrhythmias.
POLICY
The use of the automatic implantable cardioverter defibrillator for the prevention of sudden death is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of the automatic implantable cardioverter defibrillator for the treatment of other conditions / diseases including but not limited to ANY of the following is considered investigational:
Acute myocardial infarction less than 40 days before AICD implantation
New York Heart Association (NYHA) Class IV congestive heart failure (unless the individual is eligible to receive a combination cardiac resynchronization therapy ICD device)
Post cardiac revascularization procedure (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) within the past three months, or candidate for a cardiac revascularization procedure
Noncardiac disease with life expectancy less than one year
Irreversible brain damage from preexisting cerebral disease
Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm
Any implantable cardioverter defibrillator utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also:
Ventricular Assist Devices (VAD) and Total Artificial Hearts (TAH)
Wearable Cardioverter Defibrillator for the Prevention of Sudden Death
MEDICAL APPROPRIATENESS
The use of the automatic implantable cardioverter defibrillator for the prevention of sudden death is considered medically appropriate for ANY ONE of the following conditions:
Primary prevention with ANY ONE of the following:
Symptomatic ischemic dilated cardiomyopathy with a history of myocardial infarction at least 40 days before automatic implantable cardioverter defibrillator (AICD) treatment and left ventricular ejection fraction (EF) of 35% or less (Note: Symptomatic heart failure is defined as the presence of dyspnea on exertion, angina, palpitations, or fatigue)
Symptomatic nonischemic dilated cardiomyopathy for more than nine months' duration and left ventricular EF of 35% or less
Hypertrophic cardiomyopathy (HCM) with ANY ONE of the following:
Judged to be at high risk for sudden cardiac death by a physician experienced in the care of individuals with HCM
ANY ONE of the following major risk factors for sudden cardiac death:
History of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years
Left ventricular hypertrophy greater than 30 mm
One or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring
Prior unexplained syncope inconsistent with neurocardiogenic origin
Secondary prevention for individuals with a history of a life-threatening clinical event associated with ventricular dysrhythmias such as sustained ventricular tachyarrhythmia
ADDITIONAL INFORMATION
No controlled studies were found in the published literature to validate the application of automatic implantable cardioverter defibrillators for other conditions or diseases.
SOURCES
Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., et al. (2005). Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. The New England Journal of Medicine, 352 (3), 225-237. (Level 1 Evidence - Industry Sponsored).
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2007). Implantable cardioverter defibrillator (7.01.44). Retrieved April 2, 2008 from BlueWeb. (11 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2005, November). Implanted cardioverter defibrillators for secondary prevention of sudden cardiac death. Retrieved April 3, 2008 from https://www.hayesinc.com/subscribers/searchArticles.do. (39 articles and/or guidelines reviewed)
Maron, B. J., Spirito, P., Shen, W. K., Haas, T. S., Formisano, F., Link, M. S., et al. (2007). Implantable cardioverter-defibrillator and prevention of sudden cardiac death in hypertrophic cardiomyopathy. JAMA: The Journal of the American Medical Association, 298 (4), 405-412. (Level 2 Evidence - Industry sponsored)
National Guideline Clearinghouse. (2006). 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). Retrieved April 8, 2008 from http://www.guideline.gov/.
Technology Evaluation Center. (2005, March). Use of implantable cardioverter-defibrillator for prevention of sudden death in patients at high risk for ventricular arrhythmia (Vol. 19, No. 19). Chicago: BlueCross BlueShield Association. (90 articles and/or guidelines reviewed)
U.S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. National Coverage Analyses. (January, 2008). NCD for implantable automatic defibrillators (20.4). Retrieved April 4, 2008 from http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=20.4&ncd_version=3&basket=ncd%3A20%2E4%3A3%3AImplantable+Automatic+Defibrillators.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 6/12/2008
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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