Latest Review Date: May 2024

Category: Surgery      

POLICY:

Effective for dates of service September 16, 2024, and after:

Carotid artery stenting with distal embolic protection may be considered medically necessary in individuals with:

• 50 to 99 % stenosis of the internal or common carotid artery and symptoms of focal cerebral ischemia (transient ischemic attack or monocular blindness) within the previous 120 days or non-disabling stroke; or
• 80% or greater stenosis of the internal or common carotid artery and without neurologic symptoms;

AND

• Anatomic contraindication for carotid endarterectomy:

• Prior radiation treatment to the neck or oropharynx
• Ipsilateral radical or modified radical neck dissection,
• Distal internal carotid stenosis that is surgically inaccessible
• Current tracheostomy
• Severe immobility of the cervical spine
• Restenosis following previous ipsilateral endarterectomy 

Carotid artery stenting in any individual who is a candidate for surgical carotid endarterectomy is considered investigational. 

Carotid artery stenting without distal cerebral protection is considered investigational.

Effective for dates of service prior to  September 16, 2024:

Extracranial carotid angioplasty with associated stenting and embolic protection may be considered medically necessary when the procedure is performed by providers and hospital facilities who have demonstrated competence in performing the evaluation, procedure, and necessary follow-up care, in individuals:

• who are symptomatic with equal to or >50% stenosis, OR
• asymptomatic with equal to or >80% stenosis of the extracranial carotid artery

   AND who are at high risk for carotid endarterectomy based on the presence of one or more of the following:

1. Congestive heart failure-New York Heart Association Class III or IV or left ventricular ejection fraction <30%
2. Myocardial infarction within past 30 days, unstable angina, known severe coronary artery disease (left main coronary artery or 2 or more major arteries with stenosis ≥ 70%), or concurrent requirement for open heart surgery within 30 days
3. Severe chronic obstructive pulmonary disease
4. Contralateral carotid artery occlusion
5. Contralateral laryngeal nerve palsy
6. Previous radiation therapy to the neck or radical neck dissection
7. Previous ipsilateral endarterectomy with restenosis
8. Surgically inaccessible lesion (e.g. target lesion above C2)
9. Inability to move the neck to a suitable position for surgery
10. Tracheostomy
11. Cranial nerve injury
12. Unstable angina with anatomically uncorrectable CAD
13. TIA in previous 120 days with symptom duration <24 hours
14. Transient monocular blindness in previous 120 days with symptom duration <24 hours
15. Non-disabling stroke

The procedure will be covered in individuals meeting these criteria when the procedure is performed by providers and hospital facilities who have demonstrated competence in performing the evaluation, procedure, and necessary follow-up care. Determination of competency for purposes of coverage of the procedure will be based on published clinical guidelines that outline physician training standards and hospital facility support requirements for carotid artery stenting.

The American College of Cardiology (ACC), American College of Physicians (ACP), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Vascular Medicine and Biology (SVMB), and the Society for Vascular Surgery (SVS) published a joint Clinical Competence Statement on Vascular Medicine and Catheter-Based Peripheral Vascular Interventions in August 2004. The consensus document lays out in detail the expertise a physician should have before performing carotid artery stenting: 1) extensive knowledge of carotid disease, including risk assessment, diagnosis, and alternative therapies; 2) technical proficiency in carotid angiography and stenting, including the use of special catheters, stents, and new protection devices that catch blood clots and pieces of plaque before they can circulate to the brain; and 3) the clinical skills needed to manage patient care before and after the procedure. The consensus document further outlines steps to ensure quality and patient safety as new physicians become trained in carotid stenting. It calls for extensive reporting of procedural results and ongoing analysis of patient outcomes.

Additionally, the hospital should offer a broad range of services that can treat more complex medical conditions. These hospitals are better equipped to manage complications, should they occur. Ultimately, credentialing committees at individual hospitals will decide which physicians are qualified to perform carotid stenting at their institution.

Extracranial carotid angioplasty with associated stenting without the use of embolic protection is considered investigational.

Extracranial carotid angioplasty with stenting and embolic protection is considered investigational in 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.

Extracranial 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.

DESCRIPTION OF PROCEDURE OR SERVICE:

Carotid artery angioplasty with stenting (CAS) 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). 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.

Proposed advantages of CAS in contrast to carotid endarterectomy include the following:

• General anesthesia is not used (although CEA can be performed under local/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.

KEY POINTS:

The most recent update with literature review covers the period through April 9, 2024.

Summary of Evidence

For individuals who have carotid artery stenosis who receive carotid artery stenting, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are overall survival, morbid events, treatment-related mortality, and treatment-related morbidity. A substantial body of RCT evidence compares outcomes of CAS with CEA for symptomatic and asymptomatic patients with carotid stenosis. The evidence does not support use of CAS in carotid artery disease for the average risk patient, since early adverse events are higher with CAS and long-term outcomes are similar between the 2 procedures. Data from RCTs and large database studies established that the risk of death or stroke with CAS exceeds the threshold set to indicate overall benefit from the procedure. Therefore, for individuals with carotid stenosis who are suitable candidates for CEA, CAS does not improve health outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have carotid artery stenosis who receive transcarotid artery revascularization (TCAR), the evidence includes systematic reviews, nonrandomized trials, and observational studies. Relevant outcomes are overall survival, morbid events, and treatment-related mortality and morbidity. There is a lack of a body of evidence comprised of RCTs. The evidence on the effectiveness and safety of TCAR procedures is limited to nonrandomized and observational studies. A systematic review found no statistically significant difference was found between TCAR and CEA for reduction in composite incidence of stroke, death, or myocardial infarction; a reduction in incidence of myocardial infarction and cranial nerve injury was found with TCAR versus CEA. Another systematic review comparing TCAR and CAS found no statistically significant differences were observed for rates of stroke or death, stroke, or stroke/death/MI with TCAR; however, the risk of death alone was significantly elevated with TCAR. Key nonrandomized trials also highlighted safety outcomes of the TCAR procedure, and observational comparative studies found similar results to what the systematic reviews reported. . The evidence is insufficient that TCAR is equivalent or superior to carotid endarterectomy.

Practice Guidelines and Position Statements

American Heart Association and American Stroke Association

The American Heart Association and the American Stroke Association (2021) issued guidance for the prevention of stroke in patients with stroke and transient ischemic attack (TIA). They recommended that for patients with severe extracranial carotid artery stenosis ipsilateral to a nondisabling stroke or TIA, the choice between carotid endarterectomy (CEA) and CAS in patients who are candidates for intervention should be patient specific. Specific recommendations for CAS or CEA are summarized below:

Table 1. Guidelines for CAS/CEA in Extracranial Carotid Stenosis

Recommendation	CORa	LOEb
In patients with a TIA or nondisabling ischemic stroke within the past 6 months and ipsilateral severe (70%-99%) carotid artery stenosis, CEA is recommended to reduce the risk of future stroke, provided that perioperative morbidity and mortality risk is estimated to be <6%.	1	A
In patients with recent TIA or ischemic stroke and ipsilateral moderate (50%-69%) carotid stenosis as documented by catheter-based imaging or noninvasive imaging, CEA is recommended to reduce the risk of future stroke, depending on patient-specific factors such as age, sex, and comorbidities, if the perioperative morbidity and mortality risk is estimated to be <6%.	1	B-R
In patients ≥70 years of age with stroke or TIA in whom carotid revascularization is being considered, it is reasonable to select CEA over CAS to reduce the periprocedural stroke rate.	2a	B-R
In patients in whom revascularization is planned within 1 week of the index stroke, it is reasonable to choose CEA over CAS to reduce the periprocedural stroke rate.	2a	B-R
In patients with symptomatic severe stenosis (≥70%) in whom anatomic or medical conditions are present that increase the risk for surgery(such as radiation-induced stenosis or restenosis after CEA) it is reasonable to choose CAS to reduce the periprocedural complication rate.	2a	C-LD
In symptomatic patients at average or low risk of complications associated with endovascular intervention, when the ICA stenosis is ≥70%by noninvasive imaging or >50% by catheter-based imaging and the anticipated rate of periprocedural stroke or death is <6%, CAS may be considered as an alternative to CEA for stroke prevention, particularly in patients with significant cardiovascular comorbidities predisposing to cardiovascular complications with endarterectomy.	2b	A

CAS: carotid artery angioplasty with stenting; CEA: carotid endarterectomy; COR: class of recommendation; ICA: internal carotid artery; LOE: level of evidence; TIA; transient ischemic attack.

aClass I: benefit >>> risk; Class IIa: benefit >> risk; Class IIb: benefit ≥ risk.

bLevel A (data derived from multiple randomized controlled trials, meta-analyses of high-quality RCTs, or RCT corroborated by high-quality registry study); level B-R (data derived from ≥1 randomized controlled trial of moderate quality or meta-analysis of such trials); level C-LD (randomized or nonrandomized observational or registry studies with limitations of design or execution, meta-analyses of such studies, or physiological or mechanistic studies in human subjects).

Society for Vascular Surgery

The Society for Vascular Surgery published updated guidelines for management of extracranial cerebrovascular disease in 2022. They recommended CEA over transfemoral CAS (TF-CAS) in low- and standard-risk patients with more than 50% symptomatic artery stenosis (strong evidence of high quality). The guidelines note that while present data are inadequate to make a recommendation on the role of transcarotid arterial revascularization (TCAR) in low surgical risk patients with symptomatic carotid stenosis, TCAR is superior or preferable to TF-CAS or CEA for patients with high anatomic and/or physiologic surgical risk.

American Stroke Association 

The American Stroke Association (2011), along with 13 other medical societies, issued guidelines on the management of extracranial carotid and vertebral artery diseases, which are summarized in Table 2.

Table 2. Guidelines on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease

Class	Level of Evidence
Class I Benefit >>> Risk
CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated with endovascular intervention when the diameter of the lumen of the internal carotid artery is reduced by >70%, as documented by noninvasive imaging or >50% as documented by catheter angiography and the anticipated rate of periprocedural stroke or mortality is <6% (360)	B
Selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences	C
Class IIa Benefit >> Risk
It is reasonable to choose CEA over CAS when revascularization is indicated in older patients, particularly when arterial pathoanatomy is unfavorable for endovascular intervention	B
It is reasonable to choose CAS over CEA when revascularization is indicated in patients with neck anatomy unfavorable for arterial surgery	B
When revascularization is indicated for patients with TIA or stroke and there are no contraindications to early revascularization, intervention within 2 wk of the index event is reasonable rather than delaying surgery	B
Class IIb Benefit ≥ Risk
Prophylactic CAS might be considered in highly selected patients with asymptomatic carotid stenosis (minimum 60% by angiography, 70% by validated Doppler ultrasound), but its effectiveness compared with medical therapy alone in this situation is not well established	B
In symptomatic or asymptomatic patients at high risk of complications for carotid revascularization by either CEA or CAS because of comorbidities, the effectiveness of revascularization versus medical therapy alone is not well established	B
Carotid angioplasty and stenting might be considered when ischemic neurologic symptoms have not responded to antithrombotic therapy after acute carotid dissection	C
Class III: No Benefit
Except in extraordinary circumstances, carotid revascularization by either CEA or CAS is not recommended when atherosclerosis narrows the lumen by <50%	A
Carotid revascularization is not recommended for patients with chronic total occlusion of the targeted carotid artery	C
Carotid revascularization is not recommended for patients with severe disability caused by cerebral infarction that precludes preservation of useful function	C

CAS: carotid artery angioplasty with stenting; CEA: carotid endarterectomy. Levels of evidence: A (data derived from multiple randomized controlled trials or meta-analyses; multiple populations evaluated); B (data derived from a single randomized controlled trial or nonrandomized studies; limited populations evaluated); C (only consensus opinion of experts, case studies, or standard of care; very limited populations evaluated).

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force recommends against screening for asymptomatic carotid artery stenosis in the general adult population (Grade D; reaffirmed in 2021).

KEY WORDS:

Carotid angioplasty, carotid stenting, endarterectomy, revascularization, ACCULINK™, RX ACCULINK™, ACCUNET™, RX ACCUNET™, Xact® RX, Emboshield® , Precise®, AngioGuard™ XP, RX emboli capture guidewire, NexStent®, Endotex, FilterWire EZ™, ProtegeRx®, SpideRX®, Carotid Wallstent®, GORE®, Mo.Ma®, ENROUTE™,Wirion, Paladin, Transcarotid

APPROVED BY GOVERNING BODIES:

A number of carotid artery stents and EPDs have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) or the 510(k) process. Table 3 lists the original PMAs with product code NIM and Table 4 lists 510(k) approvals with product code NTE.

Table 3. FDA Premarket Approvals for Carotid Artery Stents and Embolic Protection Devices

Manufacturer	Device	PMA	PMA Date
Cordis Corp.	Cordis Precise Nitinol Stent System	P030047	Sept 2006
Abbott Vascular	Acculink Carotid Stent System and Rx Acculink Carotid Stent System	P040012	Aug 2004
Abbott Vascular	XACT Carotid Stent System	P040038	Sep 2005
Boston Scientific Corp.	Carotid Wallstent Monorail Endoprosthesis	P050019	Oct 2008
Boston Scientific Corp.	Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System	P050025	Oct 2006
Medtronic Vascular	jProtege GPS and Protege Rx Carotid Stent Systems	P060001	Jan 2007
Medtronic Vascular	Exponent Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System	P070012	Oct 2007
Silk Road Medical, Inc.	Enroute Transcarotid Stent System	P140026	May 2015
	Enroute Transcarotid Stent System	P140026 S016	Apr 2022
W. L Gore & Associates, Inc GoreCarotid Stent	Gore Carotid Stent	P180010	Nov 2018

Table 4. FDA 510(k) Carotid Artery Stents and Embolic Protection Devices

Manufacturer	Stents and Devices	510(k)Number	PMA/510(k)Date
Guidant, now AbbottVascular	Accunet and RX AccunetEmbolic protection system	K042218	Aug 2004
Guidant, now AbbottVascular	Rx Accunet 2 Embolic Protection System	K042908	Nov 2004
Guidant, now AbbottVascular	Rx Accunet 2 Embolic Protection System	K052165	Aug 2005
Abbott Vascular	Emboshield® embolic protection system	K052454	Sept 2005
Cordis Corp.	AngioGuardä XP and RX emboli capture guidewire systems	K062531	Sept 2006
Boston Scientific	FilterWire EZ™ embolic protection system	K063313	Dec 2006
EV3 Inc	Spiderx	K052659	Feb 2007
EV3 Inc	Spiderx	K063204	Nov 2007
GORE	GORE® Flow Reversal System	K083300	Feb 2009
GORE	GORE® Embolic Filter	K103500	May 2011
Medtronic/Invatec	Mo.Ma® Ultra Proximal Cerebral Protection Device	K092177	Oct 2009
Silk Road Medical	ENROUTE™ Transcarotid Stent System and ENROUTE Transcarotid Neuroprotection System	K143072	Feb 2015
Gardia Medical	Wirion	K143570	Jun 2015
Abbott Vascular	Rx Accunet Embolic Protection System	K153086	Nov 2015
Silk Road Medical, Inc.	Enroute Transcarotid Neuroprotection System	K153485	Mar 2016
Gardia Medical Ltd.	Wirion	K180023	Mar 2018
Contego Medical, LLC	Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection (Paladin System)	K181128	Sept 2018
Contego Medical, LLC	Vanguard lep Peripheral Balloon Angioplasty System With Integrated Embolic Protection	K181529	Dec 2018
Abbott Vascular	Emboshield Nav6 Embolic Protection System, Barewire Filter Delivery Wires	K191173	Jul 2019
Cardiovascular Systems	Wirion	K200198	Mar 2020
Cardiovascular Systems	Wirion Embolic Protection System	K210282	Mar 2021
Cordis Corporation	Angioguard Xp Emboli Capture Guidewire, Angioguard Rx Emboli Capture Guidewire	K220654	Apr 2022
Contego Medical Inc.	Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection	K221339	Jun 2022
Silk Road Medical	Enroute® Transcarotid Neuroprotection System	K230402	Apr 2023

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

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 FDA has mandated postmarketing 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, Inc.) through the 510(k) process. The 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT:

37215	Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous. Including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection
37216	Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous including angioplasty, when performed, and radiological supervision and interpretation; without distal embolic protection
37217	Transcatheter placement of an intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment, open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation

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38. Hopkins LN, Roubin GS, Chakhtoura EY et al. The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis 2010; 19(2):153-162.
39. Howard G, Roubin GS, Jansen O, et al. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting: a meta-analysis of pooled patient data from four randomised trials. Lancet. Mar 26 2016; 387(10025):1305-1311.
40. Howard VJ, Meschia JF, Lal BK, et al. Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials. Int J Stroke. Oct 2017; 12(7): 770-778.
41. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
42. Jordan WD, Jr., Voellinger DC, Fisher WS et al. A comparison of carotid angioplasty with stenting versus endarterectomy with regional anesthesia. J Vasc Surg 1998; 28(3):397-402; discussion 402-403.
43. Kashyap VS, Schneider PA, Foteh M, et al. Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease. Stroke. Sep 2020; 51(9): 2620-2629.
44. Kleindorfer DO, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. Jul 2021; 52(7): e364-e467.
45. Krist AH, Davidson KW, Mangione CM, et al. Screening for Asymptomatic Carotid Artery Stenosis: US Preventive Services Task Force Recommendation Statement. JAMA. Feb 02 2021; 325(5): 476-481.
46. Kuliha M, Roubec M, Prochazka V, et al. Randomized clinical trial comparing neurological outcomes after carotid endarterectomy or stenting. Br J Surg. Feb 2015; 102(3):194-201.
47. Kwolek CJ, Jaff MR, Leal JI, et al. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. Nov 2015; 62(5): 1227-34.
48. Lal BK, Beach KW, Roubin GS et al. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomized controlled trial. Lancet Neurol 2012; 11(9):755-63.
49. Lee VH, Brown RD, Jr., Mandrekar JN et al. Incidence and outcome of cervical artery dissection: a population-based study. Neurology 2006; 67(10):1809-1812.
50. Lewis SC, Warlow CP, Bodenham AR et al. General anesthesia versus local anesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial. Lancet 2008; 372(9656):2132-2142.
51. Li FM, Zhong JX, Jiang X, et al. Therapeutic effect of carotid artery stenting versus endarterectomy for patients with high-risk carotid stenosis. Int J Clin Exp Med. 2014; 7(9):2895-2900.
52. Liang P, Cronenwett JL, Secemsky EA, et al. Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk. JAMA Neurol. May 01 2023;80(5): 437-444.
53. Malas MB, Dakour-Aridi H, Kashyap VS, et al. TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project. Ann Surg. Aug 01 2022; 276(2): 398-403.
54. Marquardt L, Geraghty OC, Mehta Z et al. Low risk of ipsilateral stroke in patients with asymptomatic carotid stenosis on best medical treatment. A prospective, population-based study. Stroke 2010 Jan; 41(1):e11-7.
55. Mas JL, Arquizan C, Calvet D, et al. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. Sep 2014; 45(9):2750-2756.  
56. Mas JL, Chatellier G, Beyssen B et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006; 355(16):1660-1671.
57. Mas JL, Trinquart L, Leys D et al. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol 2008; 7(10):885-892.
58. Mayberg MR, Wilson SE, Yatsu F et al. Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis. Veterans Affairs Cooperative Studies Program 309 Trialist Group. JAMA 1991; 266(23):3289-3294.
59. Meschia JF, Brott TG, Voeks J, et al. Stroke Symptoms as a Surrogate in Stroke Primary Prevention Trials: The CREST Experience.Neurology. Nov 22 2022; 99(21): e2378-e2384.
60. MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet 1991; 337(8752):1235-1243.
61. Muller MD, Lyrer P, Brown MM, et al. Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis. Cochrane Database Syst Rev. Feb 25 2020; 2: CD000515.
62. Murad MH, Shahrour A, Shah ND et al. A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting. J Vasc Surg 2011; 53(3):792-797.
63. Naazie IN, Cui CL, Osaghae I, et al. A Systematic Review and Meta-Analysis of Transcarotid Artery Revascularization with Dynamic Flow Reversal Versus Transfemoral Carotid Artery Stenting and Carotid Endarterectomy. Ann Vasc Surg. Nov 2020; 69: 426-436.
64. Nallamothu BK, Gurm HS, Ting HH et al. Operator experience and carotid stenting outcomes in Medicare beneficiaries. JAMA 2011; 306(12):1338-1343.
65. Naylor AR. SPACE: not the final frontier. Lancet 2006; 368(9543):1215-1216.
66. Naylor AR, Bell PR. Treatment of asymptomatic carotid disease with stenting: con. Semin Vasc Surg 2008; 21(2):101-107.
67. Ohta H, Natarajan SK, Hauck EF et al. Endovascular stent therapy for extracranial and intracranial carotid artery dissection: single-center experience. J Neurosurg 2011; 115(1):91-100.
68. Paraskevas KI, Lazaridis C, Andrews CM, et al. Comparison of cognitive function after carotid artery stenting versus carotid endarterectomy. Eur J Vasc Endovasc Surg. Mar 2014; 47(3):221-231.
69. Ramsay I, Burks J, Lu V, et al.  Perioperative Outcomes in Transcarotid Artery Revascularization Versus Carotid Endarterectomy or Stenting Nationwide.  Oper Neurosurg. 2023 Nov1;25(5):453-460.
70. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet 1998; 351(9113):1379-1387.
71. Reiff T, Eckstein HH, Mansmann U, et al. Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2. Int J Stroke. Mar 15 2019: 1747493019833017.
72. Reiff T, Eckstein HH, Mansmann U, et al. Carotid endarterectomy or stenting or best medical treatment alone for moderate-to-severe asymptomatic carotid artery stenosis: 5-year results of a multicentre, randomised controlled trial. Lancet Neurol. Oct 2022; 21(10): 877-888.
73. Ringleb PA, Allenberg J, Bruckmann H et al. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet 2006; 368(9543):1239-1247.
74. Roffi M, Sievert H, Gray WA et al. Carotid artery stenting versus surgery: adequate comparisons? Lancet Neurol 2010; 9(4):339-341; author reply 341-342.
75. Rosenfield K, Matsumura JS, Chaturvedi S, et al. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. Mar 17 2016; 374(11):1011-1020.
76. Rothwell PM. Carotid stenting: more risky than endarterectomy and often no better than medical treatment alone. Lancet 2010; 375(9719):957-959.
77. Salzler GG, Farber A, Rybin DV, et al. The association of Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and Centers for Medicare and Medicaid Services Carotid Guideline Publication on utilization and outcomes of carotid stenting among "high-risk" patients. J Vasc Surg. Jul 2017;66(1):104-111 e101.
78. Schirmer CM, Atalay B, Malek AM. Endovascular recanalization of symptomatic flow-limiting cervical carotid dissection in an isolated hemisphere. Neurosurg Focus 2011; 30(6):E16.
79. Silver FL, Mackey A, Clark WM et al. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke 2011; 42(3):675-680.
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82. Tendera M, Aboyans V, Bartelink ML et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 2011; 32(22):2851-2906.
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POLICY HISTORY:

Medical Policy Group, February 2005 (4)

Medical Review Committee, February 2005

Medical Policy Administration Committee, February 2005

Available for comment April 13-May 27, 2005

Key Points Updated, FDA approval list updated, March 2008 (1)

Medical Policy Group, May 2008

Medical Policy Group, March 2012 (1): Update to Key Points and References related to MPP update; no change in policy statement.

Medical Policy Group, March 2013

Medical Policy Group, March 2013 (4): Update to Key Points and References related to MPP update; no change in policy statement.

Medical Policy Group, December 2013 (3): 2014 Coding Update – added code 37217 to current coding (effective 01/01/14)

Medical Policy Panel March 2014

Medical Policy Group March 2014 (4): Updated Description, Key Points and References.  There were no changes to the policy statement at this time.

Medical Policy Group, November 2014: 2015 Annual Coding update.  Added code 37218 to current coding; changed wording on 37215, 37216, & 37217. Also, changed verbiage to 0075T & 0076T by removing ‘or intrathoracic carotid’ and adding ‘open or’.

Medical Policy Group, February 2015 (4): Removed CPT codes 0075T and 0076T from this policy and added the codes to new MP#579- Endovascular Therapies for Extracranial Vertebral Artery Disease.

Medical Policy Panel, March 2015

Medical Policy Group, May 2015 (4):  Updates to Key Points, Key Words, Approved Governing Bodies, and References.  Removed CPT code 37218 from Coding Section included erroneously previously. Policy section: updated first policy statement to include embolic protection, cranial nerve injury and severe uncorrectable CAD.

Medical Policy Panel, June 2016

Medical Policy Group, July 2016 (4): Updates to Key Points, Approved Governing Bodies, and References. Policy statement updated to state “Extracranial carotid angioplasty with associated stenting and embolic protection”.  Removed investigational statement regarding intrathoracic carotid artery. Added investigational statement regarding embolic protection. Also added TIA and Transient monocular blindness to list of conditions.  Updated investigational policy statement to include “in all other indications, including but not limited to, patients with carotid stenosis who are suitable candidates for carotid endarterectomy and patients with carotid artery dissection”.

Medical Policy Administration Committee, July 2016

Available for comment July 16 through August 29, 2016

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4): Updates to Description, Key Points, Key Words, Approved by Governing Bodies, and References.  Updates to policy statement by adding “previous 120 days, symptom duration less than 24 hours” and “nondisabling stroke” to high risk for carotid endarterectomy section. Separated investigational statements for carotid angioplasty with and without stenting for clarification purposes.

Medical Policy Administrative Committee, May 2017

Available for Comment May 17 through June 30, 2017

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Key Points, and References.  No change to policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Key Points.  No change to policy statements.

Medical Policy Group, March 2020 (4): Clarification made to policy statement.  Updated “Severe uncorrectable CAD” to “Unstable angina with anatomically uncorrectable CAD.”  Removed policy statements effective for dates of service prior to August 30, 2016.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points, Approved by Governing Bodies, and References. No change to policy statements.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021:  Updates to Key Points, Approved by Governing Bodies, and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent. Policy statements effective for dates of service on or after August 30, 2016 and prior to July 1, 2017 removed. Removed the following References: Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis; Biller J, Feniberg WM, Castaldo JE, et al. Guidelines for carotid endarterectomy; Hobson RW, Howard VJ, et al. Carotid artery stenting is associated with increased complications in octogenarians; Reimers B, Schluter M, Castriota F, et al. Routine use of cerebral protection during carotid artery stenting; Reimers B, Sievert H, Schuler GC, et al. Proximal endovascular flow blockage for cerebral protection during carotid artery stenting.

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Description, Key Points, and References.  No change to policy statement.

Medical Policy Panel, May 2023

Medical Policy Group, May 2023 (4): Updates to Key Points, Governing Bodies, Practice Guidelines, Key Words, Benefit Application, USPSTF and References.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Policy section, Description, Key Points, Key Words (Transcarotid), and References. Added investigational statement for transcarotid artery revascularization.

Medical Policy Administration Committee, May 2024

Available for Comment: June 1, 2024 through July 31, 2024

Medical Policy Group, July 2024 (4): Updates to Policy section and Key Points. Removed IV policy statement regarding TCAR. Updated to CAS is considered medically necessary for >50% with specific neurologic symptoms or >80% without neurological symptoms and anatomic conditions that are a contraindication for CEA.  Candidates for CEA, and CAS without distal cerebral protection remain IV.

Medical Policy Administration Committee: August 2024

Available for Comment: August 1, 2024 – September 15, 2024

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.