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DESCRIPTIONIt is estimated that intracranial atherosclerosis causes about 8% of all ischemic strokes. Intracranial stenosis may contribute to stroke in two ways: either due to embolism or low flow ischemia in the absence of collateral circulation. Recurrent annual stroke rates are estimated at 4%–12% per year with atherosclerosis of the intracranial anterior circulation, and 2.5%–15% per year with lesions of the posterior (vertebrobasilar) circulation. Medical treatment typically includes either anticoagulant therapy (i.e., warfarin) or antiplatelet therapy (i.e., aspirin); the relative efficacy of these two drugs in preventing stroke is currently under study in the randomized WASID trial (Warfarin-Aspirin Symptomatic Intracranial Disease). In addition, if symptoms are attributed to low flow ischemia, agents to increase mean arterial blood pressure and avoidance of orthostatic hypotension may be recommended. However, medical therapy is considered less than optimal. For example, in patients with persistent symptoms despite antithrombotic therapy, the subsequent rate of stroke or death is extremely high, estimated in one study at 45%, with recurrent events occurring within a month of the initial recurrence. Surgical approaches have met with limited success. The widely quoted Extracranial-Intracranial (EC/IC) Bypass study randomized 1,377 patients with symptomatic atherosclerosis of the internal carotid or middle cerebral arteries to medical care or EC/IC bypass. The outcomes in the two groups were similar, suggesting the EC/IC bypass is ineffective in preventing cerebral ischemia. Due to inaccessibility, surgical options for the posterior circulation are even more limited.
Percutaneous transluminal angioplasty (PTA) has been approached cautiously in the intracranial circulation, due to technical difficulties in catheter and stent design, and the risk of embolism, which may result in devastating complications if occurring in the posterior fossa or brain stem. However, improvement in catheter trackability, allowing catheterization of tortuous veins, and the increased use of stents, has created ongoing interest in exploring PTA as a minimally invasive treatment of this difficult-to-treat population. The bulk of published studies of intracranial PTA has focused on the vertebrobasilar circulation.
Currently 2 devices have received approval from the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) process. This form of FDA approval is available for devices used to treat conditions with an incidence of 4,000 or less per year and the FDA only requires data showing “probable safety and effectiveness.” Devices with their labeled indications are as follows:
Neurolink System® (Guidant, Santa Clara, CA)
Wingspan™ Stent System (Boston Scientific, Fremont, CA)
Two stents have received FDA approval though the Humanitarian Device Exemption (HDE) program for treatment of intracranial aneurysms. In 2002, based on a series of approximately 30 patients with 6-month follow-up, the Neuroform Microdelivery Stent System was approved (HDE) for use with embolic coils for treatment of wide-neck intracranial aneurysms that cannot be treated by surgical clipping (H020002). Similarly, in 2007, based on a series of approximately 30 patients with 6-month follow-up, the Enterprise Vascular Reconstruction Device and Delivery System (Cordis Neurovascular, Inc.) was approved (HDE) for use with embolic coils for treatment of wide-neck, intracranial, saccular or fusiform aneurysms (H060001).
POLICYIntracranial 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 more) or sack-to-neck ratio less than 2:1.
Intracranial stent placement is considered investigational in the treatment of intracranial aneurysms except as noted above.
Intracranial percutaneous transluminal angioplasty with or without stenting is considered investigational in the treatment of atherosclerotic cerebrovascular disease.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/2003: Approved by Medical Policy Advisory Committee (MPAC)
11/11/2005: Code Reference section updated, CPT codes 35475, 36100, 36215-36218 added, 37799 deleted; ICD9 procedure codes 00.40-00.43 added
3/10/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
3/10/2006: Policy reviewed, no changes
5/24/2006: Coding update. 36100, 36215-36218 deleted
9/22/2006: Coding updated. ICD9 2006 revisions added to policy
5/10/2007: Policy reviewed, description section updated
8/19/2009: Policy reviewed, no changes
8/18/2010: Policy reviewed. Removed CPT code 35475 from the Non-Covered Codes Table based on the policy statement.
08/11/2011: Policy titled changed from "Percutaneous Transluminal Angioplasty of Intracranial Atherosclerotic Stenoses With or Without Stenting" to "Endovascular Procedures (Angioplasty and/or Stenting) for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)" to reflect the wider scope of the policy. Policy description updated. Added a new policy statement to indicate that the use of stents may be considered medically necessary for treatment of selected patients with intracranial aneurysms. Use is generally reserved for cases where successful occlusion of the aneurysm cannot be obtained with standard endovascular techniques, e.g., wide-neck aneurysms. FEP verbiage added to the Policy Exceptions section. Added a Covered Codes table and moved the following codes from non-covered to covered: 61630, 61635, 00.40, 00.41, 00.42, 00.43, 00.44. Added the following codes to the Code Reference section: 00.45, 00.46, 00.47, 00.48, 00.62, 00.65, 430, 431, 437.3 and 747.81. Deleted 39.50 from the Code Reference section. Deleted the Non-Covered codes table.
06/06/2012: Policy reviewed; no changes.
08/09/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.54
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.