Implantable Cardioverter Defibrillators

NCA - Implantable Cardioverter Defibrillators (CAG-00157R4) - 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](https://www.cms.gov/medicare-coverage-database/view/nca.aspx?NCAId=288) [### Contents **](#) National Coverage Analysis (NCA)ProposedDecision Memo # Implantable Cardioverter Defibrillators CAG-00157R4 [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 ** 1. The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that the use of implantable cardioverter defibrillators (ICDs, also referred to as defibrillators) is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act. CMS is finalizing relatively minimal changes to the ICD NCD from the 2005 reconsideration. We summarize the changes below and fully explain the changes in the Analysis section of the NCD decision memo. * *Patient Criteria* * Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF); * Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months; * Require a patient shared decision making (SDM) interaction prior to ICD implantation for certain patients. * *Additional Patient Criteria* * Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT). * *Exceptions to Waiting Periods* * Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD; * Add an exception for patients with an existing ICD and qualifying replacement. * *Registry Requirement* * End the data collection requirement. We are finalizing changes to the 20.4 NCD that reflect the 2005 reconsideration as described below: 1. Covered Indications 1. Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated: * An episode of sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction and not due to a transient or reversible cause; or * An episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause. * Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Patients must not have: * New York Heart Association (NYHA) classification IV heart failure; * Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or * Had a myocardial infarction within the past 40 days; or * Clinical symptoms and findings that would make them a candidate for coronary revascularization. For these patients id

Cover for patients with a history of life-threatening ventricular arrhythmias. Indicated for patients with symptomatic heart failure with reduced ejection fraction. Coverage for screening for colorectal cancer in individuals aged 45 and over. Payable when there is a history of colorectal cancer or high-risk factors. The use of implantable cardioverter defibrillators (ICDs) is reasonable and necessary for the treatment of illness or injury. ICDs are covered to improve the functioning of a malformed body member. Cardiac MRI can be used to evaluate left ventricular ejection fraction (LVEF). Patients with severe non-ischemic dilated cardiomyopathy must have been on optimal medical therapy (OMT) for at least 3 months without a history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. A shared decision making (SDM) interaction is required prior to ICD implantation for certain patients. Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have had an episode of sustained ventricular tachyarrhythmia or an episode of cardiac arrest that is not due to a transient or reversible cause. Patients with prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30.

Not covered for individuals with non-life-threatening arrhythmias. Excluded for patients who are not candidates for defibrillation based on clinical evaluation. Not covered for individuals under 45 years of age. Will not cover more than one screening every 10 years. The Class IV heart failure requirement has been removed for cardiac resynchronization therapy (CRT). Exceptions for patients with an existing ICD and qualifying replacements are allowed. Not covered for patients with New York Heart Association (NYHA) classification IV heart failure. Not covered for patients who had a coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) with angioplasty and/or stenting within the past 3 months. Not covered for patients who had a myocardial infarction within the past 40 days. Not covered for patients with clinical symptoms and findings that would make them a candidate for coronary revascularization.

Clinical documentation supporting the diagnosis of arrhythmias. Evidence of prior heart failure hospitalizations. Clinical documentation supporting high-risk status. Proof of previous screenings if applicable. Documentation that patients meet the CMS coverage requirements for cardiac pacemakers and the criteria for an ICD.