Implantable Defibrillators

CMS NCA document | source_status=Closed | review_type=3rd Recon | public_comment_open=False | document_id=CAG-00157R3

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: Patients must be able to give informed consent; 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 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 collection systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria: Written protocol on file; Institutional Review Board review and approval, if required; Scientific review and approval by two or more qualified individuals who are not part of the research team; Certification that investigators have not been disqualified. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient medical record. CMS has determined that the evidence, though less compelling at this time, is adequate to conclude that an ICD is reasonable and necessary for patients with NIDCM > 3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met: Patients must be able to give informed consent; Patients must not have: Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; Had a CABG or 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; 2 The beneficiary receiving the ICD implantation for this indication 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 prospective data collection system meeting the following basic criteria: Written protocol on file; Institutional Review Board review and approval; Scientific review and approval by two or more qualified individuals who are not part of the research team; Certification that investigators have not been disqualified. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient medical record. All other indications for ICDs not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR 405.201) and the CMS routine clinical trials policy (CIM 30-1, NCD 130.1).