Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program.
All facilities must at least meet CMS’s standards in order to receive coverage for carotid artery stenting for high risk patients.
Standards to determine competency will include specific physician training standards, facility support requirements and data collection to evaluate outcomes during a required reevaluation.ĬMS has created a list of minimum standards modeled in part on professional society statements on competency. In addition, CMS has determined that CAS with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes. If the stenosis is determined to be less than 70% by angiography, then CAS should not proceed. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient medical records. The determination that a patient is at high risk for CEA and the patient’s symptoms of carotid artery stenosis should be available in the patient medical records prior to performing any procedure. Patients who have had a disabling stroke (modified Rankin scale ≥ 3) would be excluded from coverage. Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurologic dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale < 3 with symptoms for 24 hours or more), 1 and transient monocular blindness (amaurosis fugax). other conditions that were used to determine patients at high risk for CEA in the prior carotid artery stenting trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.prior radiation treatment to the neck and.left ventricular ejection fraction (LVEF) congestive heart failure (CHF) class III/IV.Significant comorbid conditions include but are not limited to: Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA in the opinion of a surgeon.
Coverage is limited to procedures performed using FDA approved carotid artery stenting systems and embolic protection devices Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70%.The Centers for Medicare and Medicaid Services (CMS) has determined that the evidence is adequate to conclude that carotid artery stenting (CAS) with embolic protection is reasonable and necessary for the following: