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DESCRIPTIONThe success of coronary artery angioplasty and stenting prompted interest in applications of catheter-based endovascular intervention in carotid artery disease. Combined with optimal medical management, carotid angioplasty with or without associated stenting has been investigated as minimally invasive alternative to open carotid endarterectomy (CEA), currently considered the gold standard of treatment of patients with significantly obstructing carotid atherosclerosis. Carotid angioplasty and stenting (CAS) involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices through the femoral artery and into the carotid artery. The procedure typically takes 20-40 minutes and is performed with the patient fully awake and without sedation. Interventionalists almost uniformly use a distally placed embolic protection (DEP) device that is designed to reduce the risk of peri-procedural stroke caused by thromboembolic material dislodged during CAS. Carotid angioplasty rarely is performed without stent placement.
Proposed advantages of CAS in contrarst to carotid endarterectomy include:
The U.S. Food and Drug Administration (FDA) has approved carotid artery stents and DEP devices from various manufacturers:
Each FDA-approved carotid stent system is indicated for combined use with a EPDs device to reduce stroke risk in patients considered to be increased risk for periprocedureal complications from CEA who are symptomatic with >= 50% stenosis, or asymptomatic with >= 80% stenosis. Patients are considered high risk for CEA complications if affected by any item from a list of anatomical features and comorbid conditions included in each stent system’s "Information for Prescribers." CAS with these devices for patients outside these indications is an off-label use.
FDA-approved stents and EPDs differ in the deployment methods used once they reach the target lesion, with the RX (rapid exchange) devices designed for more rapid stent and filter expansion. The Precise® and AngioGuard® devices were studied in a randomized, controlled trial (the SAPPHIRE trial). Other devices were approved based on uncontrolled, single-arm trials or registries, and comparison to historical controls. The FDA has mandated post-marketing studies for these devices, including longer follow-up for patients already reported to the FDA and additional registry studies primarily to compare outcomes as a function of clinician training and facility experience. Each manufacturer's system is available in various configurations (e.g., straight or tapered) and sizes (diameters and lengths) to match the vessel lumen that will receive the stent.
POLICYCarotid angioplasty with associated stenting and embolic protection may be considered medically necessary in patients with:
Carotid angioplasty with or without associated stenting and embolic protection is considered investigational for all other indications, including but not limited to, patients with carotid stenosis who are suitable candidates for CEA and patients with carotid artery dissection.
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 HISTORY11/1998: Approved by Medical Policy Advisory Committee (MPAC)
2/11/2002: Investigational definition added
3/13/2002: Code Reference section completed, CPT 0005T, 0006T, 0007T added
4/18/2002: Type of Service and Place of Service deleted
5/17/2002: BCBSA policy added to "Sources" and Code Reference section updated, CPT 35475, 36100, 37205, 37206, 75960 added, ICD-9 procedure code 39.50, 39.90 added
3/17/2003: Code Reference section updated, HCPCS S2211 added
4/15/2004: Policy reviewed, Description revised to be consistent with BCBSA policy # 7.01.68, FEP exception added
10/14/2004: Code Reference section reviewed, CPT 35475, 36100, 37205, 37206, 75960 deleted, ICD-9 procedure code 39.50 description revised
1/11/2005: Code Reference section updated, CPT 0005T, 0006T, 0007T deletion date of 12/31/2004 added, CPT 37215, 37216 added
2/18/2005: Policy reviewed, Sources updated
8/1/2005: Code Reference section updated, ICD-9 procedure code 00.63 added, ICD-9 procedure code 39.90 Note "for services on or after 1/1/2005, see 00.63" added, HCPCS S2211 deletion date of 12/31/2004 added
11/11/2005: Code Reference section updated, ICD9 procedure codes 00.40-00.48 added
3/16/2006: Policy reviewed, no changes
9/13/2006: Coding updated. ICD9 2006 revisions added to policy
2/22/2007: Policy reviewed, description section updated
5/15/2007: Policy reviewed, description section updated. Added distal embolic protection to investigational policy statement. CPT codes 0075T and 0076T added to non-covered table
6/24/2008: Policy reviewed, no changes
9/30/2009: Code reference section updated. Code description updated for ICD procedure code 39.90.
01/08/2010: Description section updated. Policy Statement revised as follows: Carotid angioplasty with associated stenting and embolic protection may be considered medically necessary in patients with specific indications when used with a FDA-approved stent/device. There are no Policy Exceptions since there are medically necessary indications. Coding Section revised as follows: A Covered Codes Table was added. CPT4 codes 0075T, 0076T and 37215 were moved from the Non-Covered Codes Table to Covered. ICD-9 Procedure Code 00.61 was added to Covered Codes Table. ICD-9 Procedure Code 00.63 was moved from the Non-Covered Table to Covered. Deleted ICD-9 Procedure Codes 00.40 - 00.48 from Non-Covered Codes Table and added as a cross-reference under ICD-9 Procedure codes 00.61 and 00.63; ICD-9 Procedure codes 39.50 and 39.90 were deleted. Added ICD-9 Diagnosis Codes: 362.34, 433.10 – 433.11, 433.30 – 433.31, 435.8, 435.9, V15.3 and V44.0 to Covered Codes Table. Verbiage, "This is not intended to be a comprehensive list of covered codes. Some codes may be variable, and coverage will be based on the clinical indication for the service.", "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section."
06/13/2011: Policy reviewed. Updated the description regarding available devices. Added FEP verbiage to the Policy Exceptions section. Removed outdated references from the Sources section.
04/26/2012: Investigational policy statement expanded to state the following: Carotid angioplasty with or without associated stenting and embolic protection is considered investigational for all other indications, including but not limited to, patients with carotid stenosis who are suitable candidates for CEA and patients with carotid artery dissection. It previously stated the following: Carotid angioplasty with or without associated stenting and distal embolic protection is considered investigational for all other indications.
07/29/2013: Policy reviewed; no changes to policy statement. Changed ICD-9 procedure code 00.60 to 00.61. Description of code unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy #7.01.68
This 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.