Endovascular therapy may be used as an alternative or adjunct to conventional management for cerebral aneurysms, carotid artery stenosis, atherosclerotic stenosis, dissections, and/or aneurysms

These therapies may include one (1) of the following United States (U.S.) Food and Drug Administration (FDA) approved devices:

• Carotid angioplasty with stenting with embolic protection; or
• Percutaneous intracranial balloon angioplasty; or
• Mechanical embolectomy; or
• Intracranial flow diverting device; or
• Percutaneous transluminal angioplasty with or without stenting.

Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)

Intracranial Stent Placement

Intracranial stent placement may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms for individuals when surgical treatment is not appropriate and standard endovascular techniques do not allow for complete isolation of the aneurysm, e.g., wide-neck aneurysm (greater than or equal to four (4) mm) or sack-to-neck ratio less than two-to-one (2:1).

Intracranial Flow Diverting Stents

Intracranial flow-diverting stents with U.S. FDA approval for the treatment of large or giant wide-necked intracranial aneurysms, with a size of ten (10) mm or more and a neck diameter of four (4) mm or more or a dome-to-neck ratio less than two (2), in the internal carotid artery from the petrous to the superior hypophyseal segments may be considered medically necessary as part of endovascular treatment of intracranial aneurysms that are not amenable to surgical treatment or standard endovascular therapy.

Intracranial stent placement in the treatment of intracranial aneurysms not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, not covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Percutaneous Intracranial Transluminal Angioplasty

Intracranial percutaneous transluminal angioplasty with or without stenting for the treatment of atherosclerotic cerebrovascular disease is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Mechanical Embolectomy

The use of endovascular mechanical embolectomy with an U.S. FDA approved device for the treatment of acute ischemic stroke may be considered medically necessary for individuals who meet ALL of the following criteria:

• Individual is 18 years of age or older; and
• Can receive endovascular mechanical embolectomy:
  • Within 12 hours of symptom onset; or
  • Within 24 hours of symptom onset if there is evidence of a mismatch between specific clinical and imaging criteria; and
• Have evidence of substantial and clinically significant neurological deficits:
  • NIH Stroke Scale (NIHSS) score of two (2) or greater; and
• Have salvageable brain tissue in the affected vascular territory; and
• Have no evidence of intracranial hemorrhage or arterial dissection on computed tomography (CT) or magnetic resonance imaging (MRI); and
• Have a demonstrated occlusion within the proximal intracranial anterior circulation including ANY of the following:
  • Intracranial internal carotid artery; or
  • M1 or M2 segments of the middle cerebral artery; or
  • A1 or A2 segments of the anterior cerebral artery; or
  • Basilar artery.

Endovascular mechanical embolectomy with a U.S. FDA approved device for the treatment of acute ischemic stroke not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Percutaneous Intracranial Cerebrovascular Artery Angioplasty

Percutaneous intracranial cerebrovascular artery angioplasty with or without stenting may be considered medically necessary for the following U.S. FDA-approved Humanitarian Device Exemption (HDE) indication:

• For individuals with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with greater than or equal to 50 percent stenosis that are accessible to the stent system.

Percutaneous intracranial cerebrovascular artery angioplasty is considered medically necessary for the following U.S. FDA-approved HDE indication:

• For improving cerebral artery lumen diameter in individuals who have intracranial atherosclerotic disease that is refractory to medical therapy in intracranial vessels with greater than or equal to 50 percent stenosis that are accessible to the stent system.

Percutaneous intracranial cerebrovascular artery angioplasty device for any HDE indications not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

An HDE may only be used in facilities that have an Institutional Review Board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the U.S. FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

Extracranial Artery Angioplasty/Stenting

Carotid Angioplasty with Associated Stenting (CAS) and Embolic Protection

CAS and embolic protection may be considered medically necessary in individuals with ALL of the following indications:

• 50 percent to 99 percent stenosis (North American Symptomatic Carotid Endarterectomy Trial [NASCET] measurement); and
• Symptoms of focal cerebral ischemia (transient ischemic attack or monocular blindness) in previous 120 days, symptom duration less than 24 hours, or non-disabling stroke; and
• Anatomic contraindication for carotid endarterectomy (e.g., prior radiation treatment or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy). 

Contraindications:

• Contraindication for CAS and embolic protection may include, but is not limited to, the following:
  •  Individuals with carotid stenosis who are suitable candidates for carotid endarterectomy; or
  •  Individuals with carotid artery dissection.

Carotid angioplasty with or without associated stenting and embolic protection not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Endovascular Therapy for Extracranial Vertebral Artery Disease

Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, for the management of extracranial vertebral artery diseases is considered experimental/investigational and therefore non-covered because the safety and effectiveness of this service cannot be established by the available published peer-reviewed literature.