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Carotid artery angioplasty with stenting is a treatment for carotid stenosis that is intended to prevent future stroke. It is an alternative to medical therapy and a less-invasive alternative to carotid endarterectomy (CEA).
Combined with optimal medical management, carotid angioplasty with or without stenting has been evaluated as an alternative to carotid endarterectomy (CEA). Carotid angioplasty and stenting (CAS) involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices. The procedure is most often performed through the femoral artery, but a transcervical approach can also be used to avoid traversing the aortic arch. The procedure typically takes 20-40 minutes. Interventionalists almost uniformly use an embolic protection device (EPD) designed to reduce the risk of stroke caused by thromboembolic material dislodged during CAS. EPDs can be deployed proximally (with flow reversal) or distally (using a filter). Carotid angioplasty rarely is performed without stent placement.
Proposed advantages of CAS over carotid endarterectomy include:
The U.S. Food and Drug Administration (FDA) has approved carotid artery stents and EPDs from various manufacturers:
Each FDA-approved carotid stent system is indicated for combined use with an EPD to reduce stroke risk in patients considered to be at increased risk for periprocedureal complications from CEA who are symptomatic with >= 50% stenosis, or asymptomatic with >= 80% stenosis--with degree of stenosis being assessed by ultrasound or angiogram with computed tomography (CT) angiography also sometimes used. Patients are considered at increased risk for CEA complications if affected by any item from a list of anatomic features and comorbid conditions included in each stent system’s Information for Prescribers.
The RX Acculink™ Carotid Stent System is also approved for use in conventional risk patients (not considered at increased risk for complications during CEA) with symptoms and 70% or more stenosis by ultrasound or 50% or more stenosis by angiogram, and asymptomatic patients with 70% or more stenosis by ultrasound or 60% or more stenosis by angiogram.
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 (RCT) (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.
In February 2015, FDA cleared for marketing the Enroute Transcarotid NPS (Silk Road Medical, Sunnyvale, CA), through the 510(k) process. The Enroute is a flow-reversal device designed to be placed via direct carotid access. Clearance was based on results of the Roadster trial (NCT01685567), a single-arm phase 3 pivotal trial to evaluate outcomes after CAS with the Enroute device among 283 subjects with symptomatic or asymptomatic carotid stenosis. Full results of the Roadster trial have not yet been published. The manufacturer has also submitted a premarket approval application for the Enroute transcarotid stent system, an optimized stent delivery system for use with the Enroute NPS.
Carotid 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.
Federal 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.
The intent of the policy statement is that carotid angioplasty with embolic protection but without stenting is investigational. There may be unique situations where the original intent of surgery was to perform carotid angioplasty with stenting and embolic protection but anatomic or other considerations prohibited placement of the stent.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
11/1998: 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.
04/29/2014: Policy reviewed; description updated regarding FDA-approved carotid artery stents and EPDs. Policy statement unchanged.
12/31/2014: Code Reference section updated to revise the description of the following CPT codes: 0075T, 0076T, 37215, and 37216. Effective 1/1/15. Added the following new 2015 CPT codes to the Code Reference section: 37218.
04/07/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to clarify intent of investigational policy statement and add medically necessary and investigative definitions.
08/28/2015: Code Reference section updated for ICD-10.
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.