NCA - Implantable Defibrillators (CAG-00157R2)

NCA - Implantable Defibrillators (CAG-00157R2) - Proposed 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=139&fromdb=true) [### Contents **](#) National Coverage Analysis (NCA)ProposedDecision Memo # Implantable Defibrillators CAG-00157R2 [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 has determined that the evidence is adequate to conclude that an implantable cardioverter-defibrillator (ICD) is reasonable and necessary for the following: 1. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI) and measured left ventricular ejection fraction (LVEF) ≤ 30%. 2. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months and measured LVEF ≤ 30%. The following criteria must be also met: 1. Patients must be able to give informed consent. 2. Patients must not have: * New York Heart Association classification IV; * 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 month; * 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](#P47_1925) In addition, CMS has determined that the use of ICDs for primary prevention of sudden cardiac death (SCD) is reasonable and necessary only if the beneficiary receiving the ICD implantation is enrolled in either an FDA-approved category B IDE clinical trial or a qualifying national database (registry). A registry must include criteria that ensure: 1. Hospitals and providers are certified as competent in the ICD implantation. 2. Participating hospitals and providers report data on all patients undergoing ICD implantation for primary prevention. 3. Hospitals and providers who do not comply with the data collection requirements are removed from the system. 4. The data set includes elements with the following characteristics: * Baseline patient characteristics, * Device type and characteristics, * Facility and provider characteristics, * Extent of disease progression, * Periodic device interrogation for firing data, * Long-term patient outcomes. * Specific hypotheses are addressed. Data elements will be refined in the process of developing the national database. Specific hypotheses should be predefined and based upon analyses of combined data from all previous ICD trials. CMS strongly recommends that the sponsors and principal inves

Implantable defibrillators are covered for patients with a history of life-threatening ventricular arrhythmias. Coverage is granted for patients with certain cardiomyopathies and reduced ejection fraction. Services are covered when medically necessary for the diagnosis or treatment of a condition. Coverage applies specifically to patients with defined clinical criteria. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), and measured left ventricular ejection fraction (LVEF) ≤ 30%. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months and measured LVEF ≤ 30%. Patients must be able to give informed consent. Patients are eligible for coverage unless they have conditions defined in the limitations. Ejection fractions must be measured by an approved method before treatment. Use of ICDs for primary prevention of sudden cardiac death is covered if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial or a qualifying national database.

Not covered for patients who do not meet the defined criteria for ventricular arrhythmias. Coverage is limited to specific indications as outlined in national guidelines. Services not covered if deemed not medically necessary. Limitations apply to frequency of service provision as specified. Patients with New York Heart Association classification IV are not eligible. Patients experiencing cardiogenic shock or symptomatic hypotension while stable are excluded. Patients who have undergone CABG or PTCA within the last 3 months are not covered. Patients who have had an acute MI within the past month are excluded. Any patient with clinical symptoms indicating a need for coronary revascularization will not be covered. Patients with irreversible brain damage or any other diseases with a survival likelihood of less than one year are excluded. Coverage is limited to hospitals and providers certified as competent in ICD implantation. Data collection non-compliance by hospitals and providers results in removal from the registry.

Clinical evidence supporting the history of arrhythmias must be provided. Documentation of ejection fraction must be included. Clinical notes supporting the necessity of service. Prior authorization forms as required for coverage. Myocardial infarctions must be documented according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee. Documentation must include baseline patient characteristics, device type, facility and provider characteristics, extent of disease progression, periodic device interrogation data, and long-term patient outcomes.