NCA - Implantable Cardioverter Defibrillators (ICDs) (CAG-00157N)

NCA - Implantable Cardioverter Defibrillators (ICDs) (CAG-00157N) - Decision Memo [Skip to main content](#skipNavTarget)  An official website of the United States government Here's how you know Here's how you know  **Official websites use .gov** A**.gov**website belongs to an official government organization in the United States.  **Secure .gov websites use HTTPS** A**lock**(LockLocked padlock icon) or**https://**means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. Resource Navigation [opens in new window](https://www.cms.gov) Close Search [](https://www.cms.gov) Centers for Medicare & Medicaid Services [MCD Medicare Coverage Database](https://www.cms.gov/medicare-coverage-database) [**](https://www.cms.gov/medicare-coverage-database/basket/basket.aspx) [**](#) * [Help & Resources](https://www.cms.gov/medicare-coverage-database/help/help-and-resources.aspx) * [Page Help](#) * [Tour the Search](#) * [Tour the Reports](#) * [Contact Us](#submitFeedbackModal) [**](#) * [Reset Search Data](#) [Archive**](#) [API**](#) **[Back to Implantable Cardioverter Defibrillators (ICDs) Tracking Sheet](https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=39&NcaName=Implantable+Cardioverter+Defibrillators+(ICDs)&MEDCACId=21&MCDId=5&CALId=182&CoverageSelection=National&IsPopup=y&=) [### Contents **](#) National Coverage Analysis (NCA)ProposedDecision Memo # Implantable Cardioverter Defibrillators (ICDs) CAG-00157N [Expand All](#)|[Collapse All](#)**Download Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. [**](https://www.cms.gov/medicare-coverage-database/) ## Decision Summary ** CMS determines that the evidence is adequate to conclude that an implantable defibrillator is reasonable and necessary for patients with 1. A documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause; 2. Documented sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with myocardial infarction (MI) and not due to a transient or reversible cause; 3. Documented familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmias, such as long QT syndrome or hypertrophic cardiomyopathy; 4. Coronary artery disease with a documented prior myocardial infarction, a measured left ventricular ejection fraction ≤ 0.35, and inducible, sustained ventricular tachycardia (VT) or VF at EP study. (The myocardial infarction must have occurred more than 4 weeks prior to implantable defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying myocardial infarction.) 5. CMS determines that the evidence is adequate to conclude that an implantable defibrillator is reasonable and necessary for patients with a documented prior myocardial infarction 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; have * 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 * Irreversible brain damage from preexisting cerebral disease; * Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year; and patients must be able to give informed consent. Myocardial infarctions must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram. Ejection fractions must be measured by angiography, radionuclide scanning or echocardiography. CMS determines that the evidence is not adequate to conclude that an implantable defibrillator is reasonable and necessary for all patients with a prior myocardial infarction, a left ventricular ejection fraction ≤≤ 0.30, and a QRS \> 120 ms. All other indications ar

Implantable cardioverter defibrillators are covered for patients who have life-threatening ventricular arrhythmias. Indicated for primary prevention of sudden cardiac death in patients with a history of myocardial infarction. Medically necessary for initial evaluation of suspected neurologic disorder including but not limited to seizures, stroke, or dementia. Covered for patients with unexplained neurological symptoms lasting more than 72 hours. Reasonable and necessary for patients with a documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause. Sustained ventricular tachyarrhythmia documented either spontaneously or induced by an electrophysiology study, not associated with myocardial infarction and not due to a transient or reversible cause. Familial or inherited conditions that carry a high risk of life-threatening ventricular tachyarrhythmias, such as long QT syndrome or hypertrophic cardiomyopathy. Coronary artery disease with a documented prior myocardial infarction, a left ventricular ejection fraction ≤ 0.35, and inducible, sustained ventricular tachycardia or ventricular fibrillation at electrophysiology study. Coverage is reasonable and necessary for patients with prior myocardial infarction and left ventricular ejection fraction ≤ 0.30, and QRS duration > 120 milliseconds. Myocardial infarctions must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram. Ejection fractions must be measured by angiography, radionuclide scanning or echocardiography.

Not covered in patients with only atrial fibrillation or flutter. Patients with non-life threatening arrhythmias are not eligible for coverage. Not covered for routine follow-up evaluations after treatment unless new symptoms arise. Limited to one comprehensive evaluation per patient every 12 months. The myocardial infarction must have occurred more than 4 weeks prior to the insertion of an implantable defibrillator. The electrophysiology test must be performed more than 4 weeks after the qualifying myocardial infarction. Not covered for patients with New York Heart Association classification IV. Not covered if patient is in cardiogenic shock or has symptomatic hypotension while in stable rhythm. Not covered for patients who had CABG or PTCA within the last 3 months. Not covered for patients with enzyme-positive MI within the last month. Not covered for patients with clinical symptoms or findings that would require coronary revascularization. Not covered for patients with irreversible brain damage from preexisting cerebral disease. Not covered for any patient with any disease (e.g., cancer, uremia, liver failure) that is likely to result in survival of less than one year. An implantable defibrillator is not reasonable and necessary for all patients with a prior myocardial infarction, a left ventricular ejection fraction ≤ 0.30, and a QRS > 120 ms.

Clinical documentation must demonstrate the need for an ICD implant based on specific criteria. Prior authorization is required to determine medical necessity. Documentation must include clinical history and neurological examination notes. Prior authorization required for evaluations exceeding standard limits. Patients must be able to provide informed consent. Documentation of myocardial infarction and cardiac enzyme levels or ECG findings. Measurement of ejection fraction through approved methods.