NCA - Implantable Defibrillators (CAG-00157R3)

NCA - Implantable Defibrillators (CAG-00157R3) - 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 Defibrillators](https://www.cms.gov/medicare-coverage-database/view/nca.aspx?NCAId=148) [### Contents **](#) National Coverage Analysis (NCA)ProposedDecision Memo # Implantable Defibrillators CAG-00157R3 [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. CMS has determined that the evidence is adequate to conclude that an implantable cardioverter-defibrillator (ICD) is reasonable and necessary for the following: * Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) ≤ 35%; * Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%; * Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure; For each of these groups, the following additional criteria must also be met: 1. Patients must be able to give informed consent; 2. Patients must not have: * 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 the past 3 months; * Had an acute MI within the past 40 days; * Clinical symptoms or findings that would make them a candidate for coronary revascularization; * 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; * Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; * Myocardial infarctions must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction;[1](#1) * The beneficiary receiving the ICD implantation for primary prevention is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (NCD Manual §310.1) or a qualifying data collection system including approved clinical trials and registries. Initially, an ICD database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC)a Quality Improvement Organization (QIO) contractorfor determination of reasonable and necessary and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to the IFMC who will collect and maintain the database. Additional stakeholder-developed data col

Medically necessary for patients with a history of cardiac arrest due to ventricular fibrillation. Indicated for patients with significant left ventricular dysfunction (e.g., EF ≤ 35%) after a heart attack. ICD is reasonable and necessary for patients with ischemic dilated cardiomyopathy (IDCM) with prior myocardial infarction, NYHA Class II and III heart failure, and LVEF ≤ 35%. ICD is also necessary for patients with nonischemic dilated cardiomyopathy (NIDCM) for more than 9 months, NYHA Class II and III heart failure, and LVEF ≤ 35%. Patients with NYHA Class IV heart failure who meet CMS coverage requirements for a CRT device. Myocardial infarctions must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. Covered when the beneficiary is enrolled in an FDA-approved category B IDE clinical trial or a trial under the CMS Clinical Trial Policy. Coverage includes participation in approved clinical trials and registries.

Not covered for patients who are pregnant or have significant comorbidities that limit life expectancy. Excludes patients with non-ischemic cardiomyopathy unless specific criteria are met. Patients must be able to give informed consent. Not covered if patients have cardiogenic shock or symptomatic hypotension while in stable rhythm. Not covered if patients had CABG or PTCA within the past 3 months. Not covered if patients experienced an acute MI within the past 40 days. Not covered if patients have clinical symptoms indicating candidacy for coronary revascularization. Not covered if patients have irreversible brain damage from prior cerebral disease. Not covered if patients have any disease with a likelihood of survival less than one year.

Documentation of ventricular arrhythmias or significant left ventricular dysfunction. Clinical notes supporting the need for an implantable defibrillator. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography. Data submission to maintain an ICD database using the ICDA and transmitted via QNet. Clinical trial participation must be documented.