The page could not be loaded. The CMS.gov Web site currently does not fully support browsers with
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
Additional indications effective for services performed on or after October 1, 2003:
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.
01/1986 - Provided coverage to treat life-threatening ventricular tachyarrhythmias. Effective date 01/24/1986. (TN 3)
04/1999 - Expanded coverage for additional types of cardiac patients. Effective and implementation dates 07/01/1999. (TN 115) (CR 825)
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)
This NCD has been or is currently being reviewed under the National Coverage
Determination process. The following are existing associations with NCAs, from the National
Coverage Analyses database.