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.
B. Covered Indications
Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria:
C. Other Indications
All other indications for implantable automatic defibrillators not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR §405.201) and the CMS routine clinical trials policy (NCD §310.1).
(This NCD last reviewed February 2005.)
1 Alpert and Thygesen et al., 2000. Criteria for acute, evolving or recent MI.
Either one of the following criteria satisfies the diagnosis for an acute, evolving or recent MI:
Criteria for established MI.
Any one of the following criteria satisfies the diagnosis for established MI:
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)
3/2005 - Expanded national coverage by including new indications. Effective and implementation dates 01/27/2005. (TN 29) (CR 3604)
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.