Carotid angioplasty with stenting uses a catheter-based technique to treat carotid artery stenosis. Carotid artery stenosis is treated to prevent stroke.

Percutaneous intracranial balloon angioplasty has also been used as a treatment for reversing cerebral vasospasm that occurs after subarachnoid hemorrhage.

The Pipeline Embolization Device (PED) is a self-expanding blood flow diverter that is placed across the neck of an intracranial aneurysm to help form a biological seal of the aneurysm from the circulation.

Extracranial Artery Angioplasty/Stenting

Carotid angioplasty with associated stenting (CAS) and embolic protection may be considered medically necessary in patients with ALL of the following indications:

• 50% to 99% 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 (such as prior radiation treatment or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy). 

Carotid angioplasty with or without associated stenting and embolic protection is considered experimental/investigational and therefore not covered for all other indications, including but not limited to, patients with carotid stenosis who are suitable candidates for carotid endarterectomy (CEA) and patients with carotid artery dissection.

Coverage is limited to procedures performed using U.S. Food and Drug Administration (FDA) approved CAS systems and embolic protection devices. CAS without embolic protection is considered not medically necessary and, therefore, not covered, given the risks of CAS without embolic protection.

There are currently no endovascular therapies approved by the FDA specifically for the treatment of extracranial vertebral artery disease. Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered experimental/investigational, and therefore not covered, for the management of extracranial vertebral artery disease.

Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)

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

Intracranial flow diverting stents with FDA approval for the treatment of intracranial aneurysms may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms that meet anatomic criteria and are not amenable to surgical treatment or standard endovascular therapy. 

Anatomic criteria: Flow-diverting stents are indicated for the treatment of large or giant wide-necked intracranial aneurysms, with a size of 10 mm or more and a neck diameter of 4 mm or more, in the internal carotid artery from the petrous to the superior hypophyseal segments. 

Intracranial stent placement is considered experimental/investigational, and, therefore, not covered, in the treatment of intracranial aneurysms except as noted above. 

Intracranial percutaneous transluminal angioplasty with or without stenting is considered experimental/investigational, and, therefore, not covered, in the treatment of atherosclerotic cerebrovascular disease. 

The use of endovascular mechanical embolectomy with a device with FDA approval for the treatment of acute ischemic stroke may be considered medically necessary as part of the treatment of acute ischemic stroke for patients who meet ALL of the following criteria:

• Individual is 18 years of age or older; and
• Angiographic studies have confirmed proximal arterial occlusion of the anterior circulation of the brain, in ANY of the following anterior intracranial arteries:
  • Intracranial carotid; or
  • Middle cerebral artery (M1 or M2); or
  • Anterior cerebral artery (A1 or A2); and
• NIH Stroke Scale (NIHSS) score of 2 or greater; and
• CT or MRI scan has ruled out intracranial hemorrhage or arterial dissection.

All other uses of endovascular mechanical embolectomy with a device with FDA approval for the treatment of acute ischemic stroke is considered experimental/investigational, and, therefore, not covered because the safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

Required Documentation
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

Percutaneous intracranial cerebrovascular artery angioplasty with or without stenting may be considered medically necessary for the following 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 covered for the following 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.

The use of an intracranial cerebrovascular artery angioplasty device for any HDE indication not listed above is considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of those uses cannot be established by review of 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 FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

Absolute Contraindications
Percutaneous intracranial cerebrovascular artery angioplasty is considered not medically necessary and, therefore, not covered for individuals with ANY of the following absolute contraindications:

• Individuals who have intracranial lesions that are highly calcified or otherwise could prevent access or appropriate expansion of the stent; or
• Individuals who have a lesion that prevents effective angioplasty; or
• Individuals in whom anticoagulant and/or antiplatelet therapy is contraindicated.

Pipeline Embolization Device (flow diverting stent)
Large and giant intracranial aneurysms are uncommon, with an estimated rate in the US of approximately 2,000 per year. The Pipeline Embolization Device (PED) approved by the FDA April 6, 2011 may be medically necessary for individuals for endovascular treatment of adults (22 years of age or older) with rare large or giant wide-necked intracranial aneurysms (IA’s)(e.g., maximum fundus diameter 10-20 mm, giant (>25 mm) and wide necked ( ≥4 mm) in the internal carotid artery from the petrous, cavernous, paraophthalmic including paraclinoid ophthalmic and superior hypohyseal segments when ONE of the following conditions are met:

• Individuals with complex giant wide-neck intracranial aneurysms who have no other surgical intervention available to them whereby the potential benefit of PED offers the only possible means of treatment due to high risk of aneurysm rupture; or
• Individuals who have mass effect of aneurysms (i.e., headache, diplopia, nystagmus or other neurological dysfunction) or at high risk of future bleeding, and are unsuitable for either stent-coiling or surgical treatment;  

and 

• Individual is fit for general anesthesia and has the necessary mental capacity to participate and is willing and able to comply with prior  protocol requirements:
  • Prior protocol indications: aspirin 325 mg for two days and clopidogrel, 75 mg for 7 days, or a single 600 mg dose 1 day prior to placement of procedure.

Contraindications:

• Patients with an active bacterial infection; or
• Patients in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated; or
• Patients who have not received dual antiplatelet agents prior to the procedure; or
• Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.

Pipeline Embolization procedure is considered not medically necessary and, therefore, not covered for individuals with any of the above contraindications.