April 1, 2008
Carotid Angioplasty with Stent Placement, Appropriate Documentation for Payment
According to CMS National Coverage Determination (NCD) 20.7, Percutaneous Transluminal Angioplasty (CMS IOM, Pub 100-3, NCD, sect 20.7), carotid angioplasty with stenting is covered only under certain circumstances. The facility where the procedure is performed must be an approved site; the device used must be an FDA-approved device; and, the patient must meet certain criteria as outlined in the NCD. Participation in an approved Category B IDE clinical trial, or participation in approved post-marketing studies also qualify for coverage.
If a patient is not in a clinical trial, the patient must be at high risk for carotid endarterectomy (CEA) and a poor risk for that surgery because of co-morbidities. If carotid PTA with stenting is undertaken, distal embolic protection must also be utilized. Additionally, the patient must meet one of 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 systems and embolic protection devices;
- 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 NCD Manual 310.1), or in accordance with the NCD on carotid artery stenting (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).
Further, 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.
The determination that a patient is at high risk for CEA and the patient’s symptoms of carotid artery stenosis shall be available in the patient medical records prior to performing any procedure.
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) shall be excluded from coverage.
Most claims for this procedure will be reviewed
to determine that all criteria are met. Providers performing these procedures
would be well advised to put a brief summary of the patient’s condition and
symptoms, reason for being high risk for CEA, and co-morbid conditions, along
with degree of stenosis as determined by angiography, in the introduction to
their operative note. This would reduce the amount of paper that must be sent
in upon request for records, make review much easier and speed payment. In
lieu of such documentation, the history and physical should be sent along with
the operative note so sufficient documentation will be available to make a
correct adjudication and payment.
Effective immediately
3-26-08
