Extracranial Carotid Artery Stenting

POLICY NUMBER

A.7.01.68

DESCRIPTION

Carotid artery angioplasty with stenting and transcarotid artery revascularization are treatments for carotid stenosis that are intended to prevent a future stroke. They are 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). Carotidartery 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 to 40 minutes. Interventionalists almost uniformly use an embolic protection device (EPD) to reduce the risk of stroke caused by thromboembolic material dislodged during CAS. Embolic protection devices can be deployed proximally (with flow reversal) or distally (using a filter). Carotid angioplasty rarely is performed without stent placement.

The proposed advantages of CAS over CEA include the following:

• General anesthesia is not used (although CEA can be performed under local or regional anesthesia).

• Cranial nerve palsies are infrequent sequelae (although almost all following CEA resolve over time).

• Simultaneous procedures may be performed on the coronary and carotid arteries.

Transcarotid artery revascularization (TCAR) is another option among individuals with carotid stenosis who were defined as high risk (includes both clinical and anatomic characteristics). The procedure involves a stenting technique that incorporates direct cervical carotid artery exposure and flow-reversal embolic protection.

A number of carotid artery stents and embolic protection devices (EPDs) have been approved by the U.S. Food and Drug Administration (FDA)through the premarket approval or the 510(k) process. Table 1 lists the original PMA's with product code NIM and Table 2 lists 510(k) approvals with product code NTE.

Table 1. FDA Premarket Approvals for Carotid Artery Stents and Embolic Protection Devices

FDA: Food and Drug Administration; PMA: Premarket approval.Table 2. FDA 510(k) Carotid Artery Stents and Embolic Protection Devices

Each FDA-approved carotid stent system is indicated for combined use with an EPD to reduce stroke risk in patients considered at increased risk for periprocedural complications from carotid endarterectomy (CEA) who are symptomatic with greater than 50% stenosis, or asymptomatic with greater than 80% stenosis with the degree of stenosis assessed by ultrasound or angiogram, with computed tomography angiography also used. Patients are considered at increased risk for complications during CEA 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.

The FDA-approved stents and EPDs differ in the deployment methods used once they reach the target lesion, with the rapid exchange devices designed for more rapid stent and filter expansion. The FDA has mandated post-marketing studies for EPDs, 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 2015, the ENROUTE™ Transcarotid Neuroprotection System was cleared for marketing by the FDA through the 510(k) process. ENROUTE is a flow reversal device designed to be placed via direct carotid access. In April 2022, the ENROUTE® Transcarotid Stent System received expanded approval for use in the treatment of individuals at standard risk of complications from CEA. For those with neurological symptoms, criteria include 70% or more stenosis by ultrasound or 50% or more stenosis by angiogram. For asymptomatic individuals, criteria include 70% or more stenosis by ultrasound or 60% or more stenosis by angiogram. The carotid bifurcation location must be a minimum of 5 cm above the clavicle to allow for the placement of the ENROUTE Transcarotid Neuroprotection System.

FDA product codes: NIM (stents) and NTE (EPDs).

POLICY

Carotid angioplasty with associated stenting and embolic protection may be considered medically necessary in individuals with:

• 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 the previous 120 days, symptom duration less than 24 hours, or non-disabling stroke; AND

• anatomic contraindication for carotid endarterectomy (such as prior radiotherapy or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy).

Carotid angioplasty with associated stenting and embolic protection is considered investigational for all other indications, including but not limited to, individuals with carotid stenosis who are suitable candidates for carotid endarterectomy and individuals with carotid artery dissection.

Carotid angioplasty without associated stenting and embolic protection is considered investigational for all indications, including but not limited to, individuals with carotid stenosis who are suitable candidates for carotid endarterectomy and individuals with carotid artery dissection.

Transcarotid artery revascularization is considered investigational for all indications.

POLICY EXCEPTIONS

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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The intent of the second investigational 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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

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.

05/31/2016: Policy number A.7.01.68 added.

06/21/2016: Policy title changed from "Extracranial Carotid Angioplasty and Stenting" to "Extracranial Carotid Artery Stenting." Policy description updated regarding devices. Policy statements unchanged.

09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 037H346, 037H356, 037H35Z, 037H366, 037H36Z, 037H376, 037H37Z, 037H3D6, 037H3E6, 037H3EZ, 037H3F6, 037H3FZ, 037H3G6, 037H3GZ, 037H3Z6, 037J346, 037J356, 037J35Z, 037J366, 037J36Z, 037J376, 037J37Z, 037J3D6, 037J3E6, 037J3EZ, 037J3F6, 037J3FZ, 037J3G6, 037J3GZ, 037J3Z6, 037K346, 037K356, 037K35Z, 037K366, 037K36Z, 037K376, 037K37Z, 037K3D6, 037K3E6, 037K3EZ, 037K3F6, 037K3FZ, 037K3G6, 037K3GZ, 037K3Z6, 037L346, 037L356, 037L35Z, 037L366, 037L36Z, 037L376, 037L37Z, 037L3D6, 037L3E6, 037L3EZ, 037L3F6, 037L3FZ, 037L3G6, 037L3GZ, 037L3Z6, 037M346, 037M356, 037M35Z, 037M366, 037M36Z, 037M376, 037M37Z, 037M3D6, 037M3E6, 037M3EZ, 037M3F6, 037M3FZ, 037M3G6, 037M3GZ, 037M3Z6, 037N346, 037N356, 037N35Z, 037N366, 037N36Z, 037N376, 037N37Z, 037N3D6, 037N3E6, 037N3EZ, 037N3F6, 037N3FZ, 037N3G6, 037N3GZ, and 037N3Z6.

06/21/2017: Policy description updated regarding devices. Medically necessary policy statement updated to change "radiation therapy" to "radiotherapy." Investigational policy statement revised to separate carotid angioplasty with or without associated stenting. Policy Guidelines updated regarding the intent of the second investigational policy statement.

06/18/2018: Policy reviewed; no changes.

06/10/2019: Policy reviewed; no changes.

09/30/2019: Code Reference section updated regarding deleted ICD-10 procedure codes.

07/07/2020: Policy description updated regarding devices. Policy statements unchanged.

08/10/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 procedure codes 037H346, 037H356, 037H366, 037H376, 037H3D6, 037H3E6, 037H3F6, 037H3G6, 037H3Z6, 037J346, 037J356, 037J366, 037J376, 037J3D6, 037J3E6, 037J3F6, 037J3G6, 037J3Z6, 037K346, 037K356, 037K366, 037K376, 037K3D6, 037K3E6, 037K3F6, 037K3G6, 037K3Z6, 037L346, 037L356, 037L366, 037L376, 037L3D6, 037L3E6, 037L3F6, 037L3G6, 037L3Z6, 037M346, 037M356, 037M366, 037M376, 037M3D6, 037M3E6, 037M3F6, 037M3G6, 037M3Z6, 037N346, 037N356, 037N366, 037N376, 037N3D6, 037N3E6, 037N3F6, 037N3G6, and 037N3Z6.

06/22/2022: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals."

07/17/2023: Policy description updated regarding devices. Policy statement updated to change "patients" to "individuals."

07/29/2024: Policy description updated regarding transcarotid artery revascularization. Added policy statement that transcarotid artery revascularization is considered investigational for all indications.

SOURCE(S)

Blue Cross Blue Shield Association policy #7.01.68

CODE REFERENCE

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.

Covered Codes

Investigational Codes

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