NCD - Implantable Cardioverter Defibrillators (ICDs) (20.4)

htmlRequired meta tagsNCD - Implantable Cardioverter Defibrillators (ICDs) (20.4)Bootstrap is used with permission under the MIT license: https://github.com/twbs/bootstrap/blob/master/LICENSEjQuery is used with permission under the MIT license: https://jquery.org/license/New RelicThe page could not be loaded. The CMS.gov Web site currently does not fully support browsers with"JavaScript" disabled. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with"JavaScript" disabled.Instructions for enabling "JavaScript" can be found here.Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available.Skip to main contentAn official website of the United States governmentHere's how you knowHere's how you knowThe .gov means it's official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.The site is secure.Thehttps://ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.Resource NavigationSearchReportsDownloadsArchiveAPIopens in new window<button id="toggle-mobile-search" class="mobile-search-btn" aria-expanded="false"><span class="ds-u-visibility--screen-reader">Toggle Mobile Search</span></button>Close SearchCenters for Medicare & Medicaid ServicesMain headerAbout UsNewsroomData & ResearchMCDMedicare Coverage DatabaseSearchReportsNational CoverageWhat's New ReportAnnual ReportNCA/CAL ReportsNCA/CAL Status ReportNCA/CAL Open for Public Comment ReportNCD ReportMedicare Coverage Documents ReportsMedicare Coverage Documents ReportMed Cov Docs Open for Public Comment ReportOther National Coverage ReportsMEDCAC Meetings ReportTechnology Assessments ReportLocal CoverageWhat's New ReportFinal LCD ReportsFinal LCDs by Contractor ReportFinal LCDs by State ReportFinal LCDs Alphabetical ReportProposed LCD ReportsProposed LCDs by Contractor ReportProposed LCDs by State ReportProposed LCDs Alphabetical ReportArticle ReportsArticles by Contractor ReportArticles by State ReportArticles Alphabetical ReportSAD Exclusion List ReportMAC Contacts ReportDownloadsHelp & ResourcesPage HelpTour the SearchTour the ReportsContact UsReset Search DataArchiveAPIContentsTracking InformationPublication NumberManual Section NumberManual Section TitleVersion NumberEffective Date of this VersionEnding Effective Date of this VersionImplementation DateImplementation QR Modifier DateDescription InformationBenefit CategoryItem/Service DescriptionIndications and Limitations of CoverageCross ReferenceClaims Processing InstructionsTransmittal InformationTransmittal NumberCoverage Transmittal LinkRevision HistoryOtherNational Coverage Analyses (NCAs)Coding Analyses for Labs (CALs)Additional InformationOther VersionsCPT Copyright StatementReasons for DenialNational Coverage Determination (NCD)Implantable Cardioverter Defibrillators (ICDs)20.4Expand All|Collapse AllEmail DocumentDownloadAdd to basketTracking InformationPublication Number100-3Manual Section Number20.4Manual Section TitleImplantable Cardioverter Defibrillators (ICDs)Version Number4Effective Date of this Version02/15/2018Ending Effective Date of this Version07/31/2023Implementation Date03/26/2019Implementation QR Modifier DateDescription InformationBenefit CategoryProsthetic DevicesPlease Note:This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.Item/Service DescriptionA. GeneralAn ICD is an electronic device designed to diagnose and treat life-threatening ventricular tachyarrhythmias.Indications and Limitations of CoverageB. Nationally Covered IndicationsEffective for services performed on or after February 15, 2018, CMS has determined that the evidence is sufficient to conclude that the use of ICDs, (also referred to as defibrillators) is reasonable and necessary:Patients with a personal history of sustained Ventricular Tachyarrhythmia (VT) or cardiac arrest due to Ventricular Fibrillation (VF). Patients must have demonstrated:An episode of sustained 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; orAn episode of cardiac arrest due to VF, not due to a transient or reversible cause.Patients with a prior MI and a measured Left Ventricular Ejection Fraction (LVEF)  0.30. Patients must not have:New York Heart Association (NYHA) classification IV heart failure; or,Had a Coronary Artery Bypass Graft (CABG), or Percutaneous Coronary Intervention (PCI) with angioplasty and/or stenting, within the past three (3) months; or,Had an MI within the past 40 days; or,Clinical symptoms and findings that would make them a candidate for coronary revascularization.For these patients identified in B2, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Social Security Act (the Act))or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.Patients who have severe, ischemic, dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have NYHA Class II or III heart failure, LVEF  35%. Additionally, patients must not have:Had a CABG, or PCI with angioplasty and/or stenting, within the past three (3) months; or,Had an MI within the past 40 days; or,Clinical symptoms and findings that would make them a candidate for coronary revascularization.For these patients identified in B3, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.Patients who have severe, non-ischemic, dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF  35%, been on optimal medical therapy for at least three (3) months. Additionally, patients must not have:Had a CABG or PCI with angioplasty and/or stenting, within the past three (3) months; or,Had an MI within the past 40 days; or,Clinical symptoms and findings that would make them a candidate for coronary revascularization.For these patients identified in B4, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.Patients with documented, familial or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained VT or VF, to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy.For these patients identified in B5, a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, Elective Replacement Indicator (ERI), or device/lead malfunction.For each of the six (6) covered indications above, the following additional criteria must also be met:Patients must be clinically stable (e.g., not in shock, from any etiology);LVEF must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac Magnetic Resonance Imaging (MRI), or catheter angiography;Patients must not have:Significant, irreversible brain damage; or,Any disease, other than cardiac disease (e.g., cancer, renal failure, liver failure) associated with a likelihood of survival less than one (1) year; or,Supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate.Exceptions to waiting periods for patients that have had a CABG, or PCI with angioplasty and/or stenting, within the past three (3) months, or had an MI within the past 40 days:Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in this national coverage determination for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated;Replacement of ICDs: Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, ERI, or device/lead malfunction.C. Nationally Non-Covered IndicationsN/AD. OtherFor patients that are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor becomes available, is determined by the local Medicare Administrative Contractors (MACs).All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B Investigational Device Exemption (IDE) trials (42 CFR 405.201).(This NCD last reviewed February 2018.)Cross ReferenceClaims Processing InstructionsTransmittal InformationTransmittal Number211Coverage Transmittal Linkhttps://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R213NCD.pdfRevision History