Humana Commercial Clinical Policy

Humana Carotid Revascularization Form

Effective Date

11/02/2023

Last Reviewed

NA

Original Document

  Reference



Description

Atherosclerosis is defined as the buildup of plaque (fats, cholesterol and other substances) in the arterial wall. Atherosclerotic plaque frequently leads to narrowing of the affected artery, which restricts the flow of arterial blood; can also ulcerate leading to distal embolization and/or thrombosis of the affected artery. Atherosclerosis of the carotid arteries increases the risk of stroke.

Carotid Revascularization

Carotid revascularization procedures are treatment options for carotid artery disease utilized to prevent a stroke by restoring blood flow in a narrowed or stenosed carotid artery that is responsible for supplying oxygenated blood flow to the brain. Severe carotid artery disease may lead to a stroke by blood clot blockage, reducing blood flow or ruptured plaque traveling to the brain.

Anatomically, there are two internal carotid arteries: one on the right side and one on the left of the neck. They both originate from their individual common carotid arteries from a point called the carotid bifurcation (division into two parts).

Carotid atherosclerosis

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Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 2 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Carotid atherosclerosis most frequently involves the origin of the internal carotid artery and the common carotid artery bifurcation.

Symptoms

  • Symptomatic carotid disease is defined as neurologic symptoms that are sudden in onset and referable to the appropriate internal carotid artery distribution (ipsilateral [same side of the body] to significant carotid atherosclerotic pathology), including one or more transient ischemic attacks (TIAs) characterized by focal neurologic dysfunction or transient monocular (in one eye) blindness, or one or more ischemic strokes.
  • Asymptomatic carotid atherosclerotic disease refers to the presence of atherosclerotic narrowing of the extracranial internal carotid artery in individuals without a history of ipsilateral carotid territory ischemic stroke or transient ischemic attack in the last 6 months.

Carotid revascularization treatment options include the following:

  • Carotid endarterectomy (CEA) is an open surgical procedure performed through an incision on the neck to access and open the affected carotid artery and remove the plaque buildup.
  • Carotid artery angioplasty and stenting (CAS) is a minimally invasive endovascular procedure that is considered as an alternative for an individual who is at high risk for a CEA. CAS can be performed percutaneously or through a small incision in the neck.
  • Percutaneous CAS vascular access is typically obtained via the right or left common femoral artery, but upper extremity access may also be used.
  • Transcarotid artery revascularization (TCAR) accesses the carotid artery through a short incision at the base of the neck over the proximal ipsilateral common carotid artery. Following placement of the guide wire and sheath, an embolic protection device (filter or flow reversal) is typically placed, the carotid artery stenosis is predilated (if needed), and the carotid stent positioned and then deployed. The stent is further expanded to ensure its full deployment and apposition against the arterial wall using an angioplasty balloon.

The embolic protection device is removed once imaging has confirmed proper positioning, deployment and expansion of the stent.

Drug eluting stents are fused with medication (e.g., paclitaxel, sirolimus) that is slowly released into surrounding tissue, via a drug delivery system, to prevent restenosis of a carotid artery. (Refer to Coverage Limitations section)

Coverage Determination

Carotid Endarterectomy

Humana members may be eligible under the Plan for CEA for symptomatic carotid artery disease when the following criteria are met:

  • Absence of any anatomical or clinical feature associated with a high operative risk; AND
  • Recent neurological symptoms (stroke or TIA) within the previous 6 months on same side as carotid stenosis; AND
  • Individual is receiving optimal medical therapy as appropriate (e.g., antihypertensive therapy, antithrombotic therapy, statin therapy, management of diabetes mellitus) under the direction of a healthcare professional; AND
  • Carotid stenosis 50% or greater by either noninvasive imaging (e.g., computed tomography [CT] angiogram, doppler ultrasound, magnetic resonance [MR] angiogram) or catheter-based imaging (e.g., angiography)

Humana members may be eligible under the Plan for CEA for asymptomatic carotid artery disease when the following criteria are met:

  • Absence of any anatomical or clinical feature associated with a high operative risk; AND
  • Absence of recent neurological symptoms (stroke or TIA) within the previous 6 months on same side as carotid stenosis; AND
  • Individual is receiving optimal medical therapy as appropriate (e.g., antihypertensive therapy, antithrombotic therapy, statin therapy, management of diabetes mellitus) under the direction of a healthcare professional; AND
  • Carotid stenosis 70% or greater by either noninvasive imaging (e.g., CT angiogram, doppler ultrasound, MR angiogram) or catheter-based imaging (e.g., angiography)
Carotid Artery Stenting

Humana members may be eligible under the Plan for CAS for symptomatic carotid artery disease when the following criteria are met:

  • The device is US Food & Drug Administration (FDA)-approved; AND
  • Absence of contraindications; AND
  • Recent neurological symptoms (stroke or TIA) within the previous 6 months on same side as carotid stenosis; AND
  • Individual is receiving optimal medical therapy as appropriate (e.g., antihypertensive therapy, antithrombotic therapy, statin therapy, management of diabetes mellitus) under the direction of a healthcare professional; AND
  • Presence of an anatomical or clinical feature associated with a high operative risk for CEA:
    • 80 years of age or older; OR
    • Angina pectoris class III/IV; OR
    • Atypical stenosis lesion (high or low) that is surgically inaccessible; OR
    • Concurrent tracheostomy; OR
    • Congestive heart failure class III/IV; OR
    • Contralateral vocal cord paralysis from prior CEA; OR
    • Coronary artery bypass needed within the next 6 weeks; OR
  • Dialysis-dependent renal failure; OR
  • Inability to flex neck beyond neutral or kyphotic deformity; OR
  • Left main coronary artery disease; OR
  • Left ventricular ejection fraction less than 30%; OR
  • Previous ipsilateral CEA; OR
  • Previous neck surgery or radiation therapy; OR
  • Recent coronary artery bypass grafting or valve repair; OR
  • Recent myocardial infarction (less or equal to 30 days); OR
  • Restenosis after previous CEA; OR
  • Severe lung disease (eg, chronic obstructive pulmonary disease); OR
  • Two or three vessel coronary artery disease; AND

Carotid stenosis 50% or greater by either noninvasive imaging (eg, CT angiogram, doppler ultrasound, MR angiogram) or catheter-based imaging (eg, angiography)

Humana members may be eligible under the Plan for CAS for asymptomatic carotid artery disease when the following criteria are met:

  • The device is FDA-approved; AND
  • Absence of contraindications; AND
  • Absence of recent neurological symptoms (stroke or TIA) within the previous 6 months on same side as carotid stenosis; AND
  • Individual is receiving optimal medical therapy as appropriate (eg, antihypertensive therapy, antithrombotic therapy, statin therapy, management of diabetes mellitus) under the direction of a healthcare professional; AND
  • Presence of an anatomical or clinical feature associated with a high operative risk for CEA:
    • 80 years of age or older; OR
    • Angina pectoris class III/IV; OR
    • Atypical stenosis lesion (high or low) that is surgically inaccessible; OR
    • Concurrent tracheostomy; OR
    • Congestive heart failure class III/IV; OR
    • Contralateral vocal cord paralysis from prior CEA; OR
    • Coronary artery bypass needed within the next 6 weeks; OR
    • Dialysis dependent renal failure; OR
    • Left main coronary artery disease; OR
    • Left ventricular ejection fraction less than 30%; OR
    • Previous ipsilateral CEA; OR
    • Previous neck surgery or radiation therapy; OR
    • Recent coronary artery bypass grafting or valve repair; OR
    • Recent myocardial infarction (less or equal to 30 days); OR
    • Restenosis after previous CEA; OR
    • Severe lung disease (eg, chronic obstructive pulmonary disease); OR
    • Two or three vessel coronary artery disease; AND

Carotid stenosis 70% or greater by either noninvasive imaging (eg, CT angiogram, doppler ultrasound, MR angiogram) or catheter-based imaging (eg, angiography)

The criteria for carotid artery stenting are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for CAS or CEA for the following:

  • Any stroke with severe disability that precludes preservation of useful function; OR
  • Carotid stenosis less than 50%; OR
Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 7 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Total occlusion (100%) of the relevant carotid artery

These are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for a CEA for any indications other than those listed above including, but not limited to, the following anatomical or clinical features associated with a high operative risk for CEA:

  • 80 years of age or older; OR
  • Angina pectoris class III/IV; OR
  • Atypical stenosis lesion (high or low) that is surgically inaccessible; OR
  • Concurrent tracheostomy; OR
  • Congestive heart failure class III/IV; OR
  • Contralateral vocal cord paralysis from prior CEA; OR
  • Coronary artery bypass needed within the next 6 weeks; OR
  • Dialysis dependent renal failure; OR
  • Inability to flex neck beyond neutral or kyphotic deformity; OR
  • Left main coronary artery disease; OR
  • Left ventricular ejection fraction less than 30%; OR
  • Previous ipsilateral CEA; OR
  • Previous neck surgery or radiation therapy; OR
  • Recent coronary artery bypass grafting or valve repair; OR
  • Recent myocardial infarction (less than or equal to 30 days); OR
  • Restenosis after previous CEA; OR
  • Severe lung disease (eg, chronic obstructive pulmonary disease); OR
  • Two or three vessel coronary artery disease

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 8 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for a CAS for any indications other than those listed above including, but may not be limited to, the following contraindications:

  • Active infection; OR
  • Concurrent tracheostomy for transcarotid access; OR
  • Inability to gain vascular access; OR
  • Visible thrombus within the carotid stenosis

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for drug eluting stents for carotid artery stenosis. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about carotid artery disease may be found from the following websites:

Background

  • American Stroke Association
  • National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 9 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Provider Claims Codes

  • CPT® Code(s)
    • 35301 - Thromboendarterectomy, including patch graft, if performed; carotid, vertebral, subclavian, by neck incision
    • 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 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
    • 37218 - Transcatheter placement of intravascular stent(s), intrathoracic common carotid artery or innominate artery, open or percutaneous antegrade approach, including angioplasty, when performed, and radiological supervision and interpretation
  • CPT® Category III Code(s)
    • No code(s) identified
  • HCPCS Code(s)
    • No code(s) identified
Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 10 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional information about carotid artery disease may be found from the following websites:

  • Agency for Healthcare Research and Quality (AHRQ). Technology Assessment Report. Management of asymptomatic carotid stenosis. Published August 27, 2012. Accessed October 23, 2023.
  • American Stroke Association (ASA). 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease. Published 2011. Accessed October 24, 2023.
  • Bagley JH, Priest R. Carotid revascularization: current practice and future directions. Semin Intervent Radiol. 2020;37(2):132-139. www.ncbi.nlm.nih.gov. Accessed October 17, 2023.
  • Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Percutaneous transluminal angioplasty (PTA)(20.7). www.cms.gov. Published March 11, 2013. Accessed October 23, 2023.
  • ClinicalKey. Arnold M, Perler B. Carotid endarterectomy. In: Sidawy A, Perler B. Rutherford’s Vascular Surgery and Endovascular Therapy, 2-Volume Set. 10th ed. Elsevier; 2023:1220-1240.e7. www.clinicalkey.com. Accessed October 23, 2023.
  • ClinicalKey. Deery S, Hicks C. Carotid artery stenting. In: Sidawy A, Perler B. Rutherford’s Vascular Surgery and Endovascular Therapy, 2-Volume Set. 10th ed.www.clinicalkey.com. Accessed October 23, 2023.

Elsevier; 2023:1241-1257.e4. https://www.clinicalkey.com. Accessed October 23, 2023.

ClinicalKey. Goldstein L. Treatment of noncoronary obstructive vascular disease. In: Libby P, Bonow R, Mann DL, et al. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:859-869. https://www.clinicalkey.com. Accessed October 23, 2023.

Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 11 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

ClinicalKey. Morrow D, de Lomos J. Stable ischemic heart disease. In: Libby P, Bonow R, Mann DL, et al. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:739-785. https://www.clinicalkey.com. Accessed October 23, 2023.

  1. MCG Health. Carotid artery stenting. 27th edition. https://www.mcg.com. Accessed August 30, 2023.
  2. MCG Health. Carotid endarterectomy. 27th edition. https://www.mcg.com. Accessed August 30, 2023.
  3. Society for Vascular Surgery (SVS). Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease. https://vascular.org. Published January 1, 2022. Accessed September 20, 2022.
  4. Society for Vascular Surgery (SVS). Updated Society for Vascular Surgery clinical practice guidelines for management of extracranial carotid disease. https://vascular.org. Published September 01, 2011. Accessed October 17, 2022.
  5. UpToDate, Inc. Carotid endarterectomy. https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
  6. UpToDate, Inc. Complications of carotid endarterectomy. https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
  7. UpToDate, Inc. Determining etiology and severity of heart failure or cardiomyopathy. https://www.uptodate.com. Updated September 2023. Accessed October 23, 2023.
  8. UpToDate, Inc. Management of asymptomatic extracranial carotid atherosclerotic disease. https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 12 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. UpToDate, Inc. Management of symptomatic carotid atherosclerotic disease. https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
  2. UpToDate, Inc. New therapies for angina pectoris. https://www.uptodate.com. Updated September 2023. Accessed October 23, 2023.
  3. UpToDate, Inc. Overview of carotid artery stenting.https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
  4. UpToDate, Inc. Transcarotid artery revascularization. https://www.uptodate.com. Updated September 2023. Accessed October 17, 2023.
Carotid Revascularization Effective Date: 11/02/2023
Revision Date: 11/02/2023
Review Date: 11/02/2023

Policy Number: HUM-0590-003 Page: 13 of 13

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Appendix A

Canadian Cardiovascular Society Grading of Angina Pectoris

  1. Class I - Angina only during strenuous or prolonged activity
  2. Class II - Slight limitation with angina only during vigorous physical activity
  3. Class III - Symptoms with everyday living activities (ie, moderate limitation)
  4. Class IV - Inability to perform any activity without angina or angina at rest (ie, severe limitation)

Appendix B

New York Heart Association (NYHA) Functional Classification System

  • Class I (mild) - Individual with cardiac disease, but without resulting limitations on physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.
  • Class II (mild) - Individual with cardiac disease resulting in slight limitations on physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
  • Class III (moderate) - Individual with cardiac disease resulting in marked limitations on physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
  • Class IV (severe) - Individual with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.