Implantable Cardioverter Defibrillators

CMS NCA document | source_status=Closed | review_type=4th Recon | public_comment_open=False | document_id=CAG-00157R4

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that the use of implantable cardioverter defibrillators (ICDs, also referred to as defibrillators) is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act. CMS is finalizing relatively minimal changes to the ICD NCD from the 2005 reconsideration. We summarize the changes below and fully explain the changes in the Analysis section of the NCD decision memo. Patient Criteria Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF); Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months; Require a patient shared decision making (SDM) interaction prior to ICD implantation for certain patients. Additional Patient Criteria Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT). Exceptions to Waiting Periods Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD; Add an exception for patients with an existing ICD and qualifying replacement. Registry Requirement End the data collection requirement. We are finalizing changes to the 20.4 NCD that reflect the 2005 reconsideration as described below: Covered Indications Patients with a personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Patients must have demonstrated: An episode of sustained ventricular tachyarrhythmia, either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction and not due to a transient or reversible cause; or An episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause. Patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Patients must not have: New York Heart Association (NYHA) classification IV heart failure; Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) 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 ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%. Additionally, patients must not have: Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) 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 sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have New York Heart Association (NYHA) Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy (OMT) for at least 3 months. Additionally, patients must not have: Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or Had a myocardial infarction 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) 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 tachyarrhytmias (sustained ventricular tachycardia or ventricular fibrillation), 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)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) 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 these groups listed above, the following additional criteria must also be met: Patients must be clinically stable (e.g., not in shock, from any etiology); Left ventricular ejection fraction (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 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 coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months, or had a myocardial infarction 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 device in one procedure at the time the pacemaker is clinically indicated; Replacement of ICDs: Patients with an existing ICD may receive a ICD replacement if it is required due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction. Other Indications: For patients who 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 IDE trials (42 CFR 405.201). See Appendix B for the NCD manual language.