Carotid Artery Stenting Coverage Policies
Commercial and Other Third Party Payor Coverage Policies
Coverage varies regionally and providers should verify insurance coverage before performing procedures. Please contact individual insurance carriers to determine eligibility.
Medicare (CMS) Coverage
Medicare’s National Coverage Decision (NCD Manual Section 20.7) covers inpatient carotid artery stenting procedures including TCAR in select patient populations as follows:
Patients who are at high risk for CEA and have
- symptomatic carotid artery stenosis ≥70%, or
- symptomatic carotid artery stenosis 50-70%*, or
- asymptomatic carotid artery stenosis ≥80%*.
*Patients in categories 2 and 3 above are only covered if procedures are performed:
- In accordance with the NCD on carotid artery stenting post-approval studies (TCAR Surveillance Project, ROADSTER 2, and CREST-2 Registry) or
- In accordance with Category B IDE clinical trials regulation (CREST-2), or
- As a routine cost under Medicare’s clinical trials policy.
CMS Definition of Symptomatic
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.
CMS Definition of Stenosis Measurement
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.
CMS Definitions of High Surgical Risk
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. 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.
The definitions used to determine patients at high risk for CEA include those criteria used in the prior carotid artery stenting trials and studies. An amalgamation of the “High Risk for CEA” inclusion criteria of those studies is as follows7; patients must have one or more criteria:
1. Age ≥75
2. Congestive Heart Failure
3. Left Ventricular Ejection Fraction ≤35%
4. Two or more diseased coronary arteries with ≥70% stenosis
5. Unstable angina
6. Myocardial infarction within 6 weeks
7. Abnormal stress test
8. Need for open heart surgery
9. Need for major surgery (including vascular)
10. Uncontrolled diabetes
11. Severe pulmonary disease
12. History of liver failure with elevated prothrombin time
1. Prior head/neck surgery or irradiation
2. Spinal immobility
3. At risk for wound infection
4. Restenosis post CEA
5. Tracheostomy or tracheostoma
6. Surgically inaccessible lesion
7. Laryngeal palsy; Laryngectomy; Permanent contralateral cranial nerve injury
8. Contralateral occlusion
9. Severe tandem lesions
10. Bilateral stenosis requiring treatment
- TCAR is only reimbursed by Medicare when performed in the Inpatient setting.
- Carotid artery stenting without distal embolic protection is not covered by Medicare and by definition precludes the use of the ENROUTE Transcarotid NPS which is required for both transcarotid access and distal embolic protection.
- Medicare will only cover TCAR in facilities certified to have met CMS’s minimum facility standards for performing carotid artery stenting, which include local credentialing requirements. A list of certified facilities is viewable here and more information on the certification process is here.
- Claims billed under a Category B IDE (identified by a six-digit IDE number preceded by a “G,” e.g., G123456); or a billed under an FDA-approved post-approval study (identified by a six digit PMA number preceded by a “P,” e.g., P123456) are not subject to the approved facility list.
- Coverage is limited to procedures performed using FDA-approved carotid artery stents and FDA-approved or cleared embolic protection devices.
- The ENROUTE Transcarotid Stent System is an FDA-approved carotid artery stent and the ENROUTE Transcarotid Neuroprotection System is an FDA-cleared embolic protection device.
- ROADSTER 2 is an FDA-approved protocol and is in accordance with the NCD on carotid artery stenting post-approval studies.