Reimbursement

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

  1. symptomatic carotid artery stenosis ≥70%, or
  2. symptomatic carotid artery stenosis 50-70%*, or
  3. asymptomatic carotid artery stenosis ≥80%*.

*Patients in categories 2 and 3 above are only covered if procedures are performed:

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:

  • Comorbid conditions:
    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

  • Anatomic conditions
    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
    11. Dissection

Notes:

  • TCAR is only reimbursed by Medicare when performed in the Inpatient setting.
  • Carotid artery stenting without embolic protection is not covered by Medicare. The ENROUTE Transcarotid NPS used in TCAR procedures provides flow reversal embolic protection, and therefore is defined as carotid artery stenting with 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.
7 National Coverage Determination (NCD) for PERCUTANEOUS TRANSLUMINAL Angioplasty (PTA) (20.7)
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
ACCULINK for Revascularization of Carotids in High-Risk patients (ARCHER)
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE)
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ (CABERNET)
FiberNet® Emboli Protection Device in Carotid Artery Stenting (EPIC)
Proximal Protection With The Mo.Ma Device During Carotid Stenting (ARMOUR)
GORE Embolic Protection With Reverse Flow (EMPiRE)
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)
Stroke. 2010;41:e102-e109. (The MAVERIC I and II trials were completed before July 2005 and therefore they not registered in a public clinical trials database.)
Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various sources and is subject to change without notice. Silk Road Medical cannot guarantee success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed September 9, 2016.
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