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National Coverage Determination (NCD)

Implantable Automatic Defibrillators

20.4

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Tracking Information

Publication Number
100-3
Manual Section Number
20.4
Manual Section Title
Implantable Automatic Defibrillators
Version Number
2
Effective Date of this Version
10/01/2003
Ending Effective Date of this Version
01/27/2005
Implementation Date
10/01/2003
Implementation QR Modifier Date

Description Information

Benefit Category
Physicians' Services
Prosthetic Devices


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Indications and Limitations of Coverage

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:

  1. 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.);
  2. 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.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
173
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R173CIM.pdf
Revision History

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)
Other

National Coverage Analyses (NCAs)

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.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Implantable Cardioverter Defibrillators (ICDs) 5 07/31/2023 - N/A View
Implantable Cardioverter Defibrillators (ICDs) 4 02/15/2018 - 07/31/2023 View
Implantable Automatic Defibrillators 3 01/27/2005 - 02/15/2018 View
Implantable Automatic Defibrillators 2 10/01/2003 - 01/27/2005 You are here
Implantation of Automatic Defibrillators 1 07/01/1999 - 10/01/2003 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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