Implantable Automatic Defibrillators

The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

A - Covered Indications

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause (effective July 1, 1991);
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause (effective July 1, 1999);
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy (effective July 1, 1999);

Additional indications effective for services performed on or after October 1, 2003:

4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction ≤0.35, and inducible, sustained VT or VF at EP study.   (The MI must have occurred more than 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.);
5. Documented prior MI and a measured left ventricular ejection fraction ≤0.30 and a QRS duration of  >120 milliseconds.  Patients must not have:
   • New York Heart Association classification IV;
   • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
   • Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months;
   • Had an enzyme-positive MI within past month;
   • Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
   • Any disease, other than cardiac disease (e.g.cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

B - All patients considered for implantation of a defibrillator must not have irreversible brain damage, disease or dysfunction that precludes the ability to give informed consent.

C - MIs must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram.  Ejection fractions must be measured by angiography, radionuclide scanning,or echocardiography. 

D - All other indications remain noncovered except in Category B IDE clinical trials (60 CFR 48417) or as a routine cost in clinical trials defined under section 310.1 of the NCD Manual.

See Defibrillator Flow Chart.

08/2003 - Expanded coverage for coronary artery disease with a documented prior myocardial infarction (MI), a measured left ventricular ejection fraction ≤  0.35, and inducible, sustained ventricular tachyarrhythmia or ventricular fibrillation at electrophysiology study; or documented prior MI and a measured left ventricular ejection fraction ≤ 0.30 and a QRS duration of  >120 milliseconds.  All other indications for defibrillators not otherwise specified remain noncovered except when furnished in accordance with FDA-approved protocols governing Category B Investigational Device Exemption clinical trials as stated in 42 FR Part 405. Effective and implementation dates 10/01/2003. (TN 173) (CR 2880)

04/1999 - Expanded coverage for additional types of cardiac patients. Effective and implementation dates 07/01/1999. (TN 115) (CR 825)

01/1986 - Provided coverage to treat life-threatening ventricular tachyarrhythmias. Effective date 01/24/1986. (TN 3)