MM10865

=== Page 1 === mIn MATTERS® KNOWLEDGE • RESOURCES • TRAINING # NCD 20.4 Implantable Cardiac Defibrillators (ICDs) MLN Matters Number: MM10865 Revised Related CR Release Date: February 15, 2019 Effective Date: February 15, 2018 Related CR Transmittal Number: R213NCD Implementation Date: March 26, 2019 - MAC local edits Note: We revised this article on March 3, 2020, to add a reference to MLN Matters Article SE20006, which updates providers on Medicare coverage rules and policies for ICDs and outlines the coding requirements (including the heart failure codes). All other information is unchanged. # PROVIDER TYPES AFFECTED This MLN Matters Article is for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. # PROVIDER ACTION NEEDED # BACKGROUND An ICD is an electronic device designed to diagnose and treat life-threatening Ventricular Tachyarrhythmias (VTs). The device consists of a pulse generator and electrodes for sensing and defibrillating. This therapy has been shown in trials to improve survival and reduce sudden cardiac death in patients with certain clinical characteristics. Section 20.4 of the Medicare NCD Manual establishes conditions of coverage for ICDs. In 1986, CMS first issued an NCD providing limited coverage of ICDs and the policy has been expanded over the years. CMS last reconsidered this NCD in 2005. Effective for claims with dates of service on or after February 15, 2018, CMS will cover ICDs for the following patient indications: CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network === Page 2 === MLN Matters: MM10865 1. Patients with a personal history of sustained 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; or - An episode of cardiac arrest due to VF, not due to a transient or reversible cause. 2. 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 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. 3. Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have New York Heart Association (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 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. 4. 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%, and been on optimal medical therapy for at least 3 months. Additionally, patients must not have: - Had a CABG or PCI with angioplasty and/or stenting, within the past 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. 5. 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. 6. 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 these patients identified in items 2 through 5 above, a formal shared decision-making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network === Page 3 === MLN Matters: MM10865 the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 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. For each of the 6 covered indications above, the following additional criteria must also be met: 1. Patients must be clinically stable (for example, not in shock, from any etiology); 2. LVEF must be measured by echocardiography, radionuclide (nuclear medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter angiography; 3. Patients must not have: - Significant, irreversible brain damage; or, - Any disease, other than cardiac disease (for example, cancer, renal failure, liver failure) associated with a likelihood of survival less than 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 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 NCD 20.4 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. For patients that are candidates for heart transplantation on the United Network for Organ Sharing (UNOS) transplant list awaiting a donor heart, as with cardiac resynchronization therapy, when used as a bridge-to-transplant to prolong survival until a donor becomes available, MACs determine coverage of ICDs. All other indications for ICDs not currently covered in accordance with this decision may be covered under Category B investigational device exemption (IDE) trials per regulation at 42 CFR 405.201. # ADDITIONAL INFORMATION If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list. CMS CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare Learning Network === Page 4 === MLN Matters: MM10865 DOCUMENT HISTORY | Date of Change | Description | | --- | --- | | March 3, 2020 | We revised this article to add a reference to MLN Matters Article SE20006, which updates providers on Medicare coverage rules and policies for ICDs and outlines the coding requirements (including the heart failure codes). | | February 26, 2019 | We revised this article to reflect a revised CR10865 issued on February 15. CMS revised the CR to change the implementation date to March 26, 2019, and we revised the article accordingly. Also, we revised the CR release date, transmittal number, and the Web address of the CR. All other information is unchanged. | | December 17, 2018 | The article was revised to reflect a revised CR10865 issued on December 13. In the article, two sentences are added at the end of the Provider Action Needed section to emphasize that this coverage policy no longer requires trial-related coding on claims for dates of service on or after February 15, 2018. Also, the CR release date, transmittal number, and the Web address of the CR are revised. All other information is unchanged. | | December 3, 2018 | This article was revised on December 3, 2018, to correct the implementation date in the banner above. That date should be February 26, 2019. | | November 29, 2018 | Initial article released. | Disclaimer: This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2017 American Medical Association. All rights reserved. Copyright © 2018, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes a

Covered for patients with a history of life-threatening ventricular arrhythmias. Indicated for patients with symptomatic heart failure and reduced ejection fraction. Implantable Defibrillators (ICDs) are covered for patients with life-threatening Ventricular Tachyarrhythmias (VTs). ICDs improve survival and reduce sudden cardiac death in patients with specific clinical characteristics. ICDs are covered for patients who meet specific criteria established by CMS for their use. Patients with a personal history of sustained VT or cardiac arrest due to VF must have demonstrated either an episode of sustained VT, either spontaneous or induced, not due to a transient cause, or an episode of cardiac arrest due to VF, not due to a transient cause. Patients with a prior MI and LVEF ≤ 0.30 must not have NYHA class IV heart failure, recent CABG or PCI within the last 3 months, recent MI within the past 40 days, or symptoms indicating need for revascularization. Patients with severe ischemic dilated cardiomyopathy, NYHA Class II or III heart failure, LVEF ≤ 35%, without history of sustained VT or cardiac arrest. Patients with severe non-ischemic dilated cardiomyopathy, NYHA Class II or III heart failure, LVEF ≤ 35%, without history of cardiac arrest or sustained VT, and on optimal medical therapy for at least 3 months. Patients with documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias, including long QT syndrome or hypertrophic cardiomyopathy. Patients with an existing ICD may receive a replacement if required due to end of battery life, elective replacement indicator (ERI), or device/lead malfunction. Medically necessary when evidence-based decision tool criteria are met for initial ICD implantation. Patients must have a left ventricular ejection fraction (LVEF) measured by acceptable methods. Patients are eligible if clinically stable and not experiencing shock. Patients meeting CMS coverage requirements for cardiac pacemakers and NCD 20.4 criteria for an ICD may receive both devices in one procedure. Patients with an existing ICD may receive a replacement for end of battery life, ERI, or lead malfunction. Candidates for heart transplantation on the UNOS list may have ICD coverage when used as a bridge-to-transplant. Coverage for Implantable Cardioverter Defibrillators (ICDs) based on clinical guidelines. Heart failure codes are included as necessary for proper coding.

Not covered for patients with prior cardiac arrest due to reversible causes. Not indicated for patients who are not likely to survive more than a year regardless of the device. Coverage is no longer contingent on participation in a trial/study/registry for claims with Date of Service on or after February 15, 2018. Not covered if patient had CABG or PCI within the past 3 months. Not covered if patient had an MI within the past 40 days. Not covered if clinical symptoms indicate a candidate for coronary revascularization. Formal shared decision-making encounter must occur between the patient and a physician for the eligible patients. Not eligible if significant irreversible brain damage is present. Not covered for patients with any disease associated with a survival likelihood of less than 1 year. Not covered if the patient has poorly controlled supraventricular tachycardia. Coverage for ICDs not included under this decision may be covered under Category B IDE trials. MACs determine coverage for provisional ICDs in transplant candidates. No longer requires trial-related coding on claims for services on or after February 15, 2018.

Clinical documentation must include evidence of life-threatening arrhythmias. Must provide documentation of symptoms and ejection fraction measurements. Documentation of familial or genetic disorders related to tachyarrhythmias. Clinical notes supporting the necessity for ICD replacement. Shared decision-making encounter documentation. Evidence-based decision tool utilization prior to ICD implantation. Clinical documentation demonstrating the patient's clinical stability. LVEF measurement results from acceptable imaging modalities. Medical records must include clinical documentation supporting the necessity for ICD.