Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that effective March 17, 2005, Medicare covers PTA of the carotid artery concurrent with the 
placement of an FDA-approved carotid stent with embolic protection for the following: 
 
    Patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis = 70%. 
Coverage is limited to procedures performed using FDA-approved carotid artery stenting (CAS) systems and 
FDA-approved or -cleared (effective December 9, 2009) embolic protection devices. If deployment of the 
embolic protection device is not technically possible, and not performed, then the procedure is not covered by 
Medicare (effective December 9, 2009); 
    Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70%, 
in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the 
clinical trials policy (Medicare National Coverage Determination (NCD) Manual 310.1), or in accordance with 
the NCD on (CAS) post-approval studies (Medicare NCD Manual 20.7); 
Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis = 80%, in accordance with 
the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy 
(Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post- approval studies (Medicare 
NCD Manual 20.7). 
 
Coverage is limited to procedures performed using an FDA-approved CAS, stents and FDA-approved or -
cleared embolic protection devices. 
 
The use of an FDA-approved or cleared embolic protection device is required. If deployment of the embolic 
protection device is not technically possible, and not performed, then the procedure is not covered by Medicare. 
 
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. Significant 
comorbid conditions include but are not limited to: 
 
    Congestive heart failure (CHF) class III/IV; 
    Left ventricular ejection fraction (LVEF) < 30 %; 
    Unstable angina; 
    Contralateral carotid occlusion; 
    Recent myocardial infarction (MI);     Previous CEA with recurrent stenosis; 
    Prior radiation treatment to the neck; and 
    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. 
 
Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurological 
dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified 
Rankin scale < 3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). 
Patients who have had a disabling stroke (modified Rankin scale = 3) shall be excluded from coverage. 
 
The determination that a patient is at high risk for CEA and the patientfs symptoms of carotid artery stenosis 
shall be available in the patient medical records prior to performing any procedure. 
 
The degree of carotid artery stenosis shall be measured by duplex Doppler ultrasound or carotid artery 
angiography and recorded in the patient's medical records. 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. If the 
stenosis is determined to be < 70% by angiography, then CAS should not proceed. 
 
You can find this information in the National Coverage Determination (NCD) Percutaneous Transluminal 
Angioplasty (PTA) 20.7. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.