Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Percutaneous Transluminal Angioplasty (PTA) Concurrent with or without Stenting of the Extracranial Carotid Artery or Intracranial Artery

Policy #:11.02.12i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE EXTRACRANIAL CAROTID ARTERY CONCURRENT WITH EXTRACRANIAL CAROTID ARTERY STENTING (CAS)

MEDICALLY NECESSARY
PTA of the extracranial carotid artery (pre-carotid bifurcation) concurrent with extracranial (pre-carotid bifurcation) CAS with a US Food and Drug Administration (FDA)-approved carotid stent with embolic protection is considered medically necessary and, therefore, covered for individuals who are at high risk for complications from a carotid endarterectomy (CEA) related to anatomical considerations such as, but not limited to, prior radiation treatment or neck surgery, lesions that are surgically inaccessible, spinal immobility, or tracheostomy, when any of the following conditions are present:
  • Symptomatic carotid artery stenosis equal to or greater than 70 percent
  • Symptomatic carotid artery stenosis between 50 percent and 70 percent in CAS post-approval studies
  • Asymptomatic carotid artery stenosis equal to or greater than 80 percent in CAS post-approval studies

NOT MEDICALLY NECESSARY
Percutaneous transcatheter placement of a carotid artery stent without embolic protection is considered not medically necessary and, therefore, not covered, given the risks of CAS without embolic protection.

EXPERIMENTAL/INVESTIGATIONAL
All other uses for PTA of the extracranial carotid artery (pre-carotid bifurcation) with or without associated stenting and embolic protection are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

PTA OF THE INTRACRANIAL ARTERY AND INTRACRANIAL ARTERY STENTING

HUMANITARIAN DEVICE EXEMPTION (HDE)
PTA and intracranial stenting of the intracranial cerebrovascular artery with the Neurolink® Stent & Delivery Catheter and Neurolink® Balloon Dilatation Catheter System is covered for the following FDA-approved humanitarian device exemption (HDE) indication:
  • For individuals with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with greater than or equal to 50 percent stenosis that are accessible to the stent system

PTA and intracranial stenting of the intracranial cerebrovascular artery with the Wingspan Stent System with Gateway PTA Balloon Catheter is covered for improving cerebral artery lumen diameter and intracranial perfusion for individuals between 22 and 80 years old with the all following FDA-approved HDE indications:
  • The individual has had two or more strokes despite aggressive medical management (e.g., antithrombic agents).
  • The most recent stroke occurred more than seven days prior to planned treatment with Wingspan placement.
  • The individual has intracranial atherosclerotic disease with 70 percent to 99 percent stenosis related to the recurrent strokes.
  • The individual has made good recovery from previous stroke and has a modified Rankin score (scale that measures the degree of disability in stroke individuals) of three or less prior to treatment with Wingspan placement.

An HDE may only be used in facilities that have an Institutional Review Board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

Experimental/Investigational

The use of the Neurolink System and the Wingspan Stent System with Gateway PTA Balloon Catheter for any HDE indication not listed above is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of those uses cannot be established by review of the available published peer-reviewed literature.

Not Medically Necessary --- Absolute Contraindications

PTA of the intracranial cerebrovascular artery with the Neurolink® Stent & Delivery Catheter and Neurolink® Balloon Dilatation Catheter System is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • Individuals who have intracranial lesions that are highly calcified or otherwise could prevent access or appropriate expansion of the stent
  • Individuals in whom anticoagulant and/or antiplatelet therapy is contraindicated

PTA of the intracranial cerebrovascular artery with the Wingspan Stent System with Gateway PTA Balloon Catheter is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • Individuals who have a lesion that prevents effective angioplasty
  • Individuals in whom antiplatelet and or coagulation therapy is contraindicated
  • For Wingspan Stent System, treatment of a stroke with an onset of symptoms within seven days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

Individuals at high risk for complications from a carotid endarterectomy (CEA) are defined as having significant comorbidities and/or anatomic risk factors (e.g., recurrent stenosis, previous radical neck dissection) and may be poor candidates for CEA. Significant comorbid conditions include, but are not limited to:
  • Congestive heart failure (CHF) class III/IV
  • Left ventricular ejection fraction (LVEF) less than 30 percent
  • Unstable angina
  • Contralateral carotid occlusion
  • Recent myocardial infarction (MI)
  • Previous CEA with recurrent stenosis
  • Prior radiation treatment to the neck
  • Other conditions that were used to determine individuals at high risk for CEA in the prior carotid artery stenting trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II

Given the risks of percutaneous transcatheter placement of a carotid artery stent without embolic protection, current professional literature states that a CAS procedure is usually aborted if deployment of the embolic protection device in not technically possible.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, percutaneous transluminal angioplasty (PTA) concurrent with stenting of the extracranial carotid artery or intracranial artery is covered under the medical benefits of the Company’s products when the medical necessity criteria in the medical policy are met. However, when PTA of the intracranial cerebrovascular artery is performed on an individual who has any of the absolute contraindications listed in the policy, it is considered not medically necessary and, therefore, not covered.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

Description

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENTING OF THE EXTRACRANIAL CAROTID ARTERIES

Stenosis of the carotid arteries is a major cause of cerebrovascular disease and stroke. The standard treatment for carotid artery stenosis is carotid endarterectomy (CEA), an open surgical procedure in which plaque is excised from the lining of the carotid vessel wall. Percutaneous transluminal angioplasty (PTA) of the carotid arteries is a procedure for treating carotid artery stenosis that avoids some of the risks associated with the open surgery. With PTA, a balloon-tipped catheter is inserted into a narrow or occluded blood vessel. When the balloon inflates, it dilates the vessel, thereby flattening fatty plaque deposits against the vessel wall. PTA with carotid artery stenting (CAS) is used as an alternative to CEA for individuals who are at high risk for surgical complications, including those who have significant comorbidities and/or anatomic risk factors (e.g., recurrent stenosis, previous radical neck dissection, surgically inaccessible lesions). Carotid artery stenting 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. Interventional cardiologists almost uniformly use an embolic protection device (EPD) designed 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.

Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurologic dysfunction persisting less than 24 hours); focal cerebral ischemia that produces a nondisabling stroke (Modified Rankin Scale of less than 3 with symptoms for 24 hours or more); and transient monocular blindness (amaurosis fugax). The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and confirmed by angiography prior to the start of a percutaneous procedure.

The US Food and Drug Administration (FDA) has approved several devices for use in extracranial carotid arteries, including the Acculink™ Carotid Stent System and the Rx Acculink™ Carotid Stent System (Guidant Corporation; Santa Clara, CA, now Abbott Vascular), which use an embolic protection device to trap particles of atherosclerotic plaque that might become dislodged during the procedure. The Rx Acculink™ Carotid Stent System features a filter basket that is laser-cut from nitinol with a polyurethane filter. In February 2015, FDA cleared for marketing the ENROUTE Transcarotid Neuroprotection System (NPS), (Silk Road Medical Inc., Sunnyvale, CA) through the 510(k) process. The ENROUTE is a flow-reversal device designed to be used with ENROUTE Transcarotid Stent System (Silk Road Medical Inc., Sunnyvale, CA) which received FDA premarket approval application (PMA) approval in May 2015. The ENROUTE Transcarotid NPS is a system used to directly access the common carotid artery through an incision in the neck, and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE™ Transcarotid Stent.

A substantial body of randomized controlled (RCT) evidence compares outcomes of CAS with CEA for symptomatic and asymptomatic individuals with carotid stenosis. The evidence does not support use of CAS in carotid artery disease for the average risk individual. Studies establish that the risk of CAS exceeds the threshold set to indicate overall benefit from the procedure.

PTA AND STENTING OF THE INTRACRANIAL ARTERIES

Intracranial (post-carotid bifurcation) stenting is a procedure used to treat intracranial artery stenosis (narrowing of an artery within the skull). Intracranial artery stenosis causes approximately 8 to 10 percent of ischemic cerebrovascular accidents (CVAs or strokes) by restricting blood flow and/or causing embolism. The most common treatment is the use of blood thinners such as antiplatelets (e.g., aspirin) or anticoagulants (e.g., Coumadin®). Other alternative treatments may include bypass surgery, angioplasty, and stenting. With bypass surgery, normal blood flow is restored to the area by bypassing the blocked artery with a graft of blood vessels taken from another part of the body.

The purpose of angioplasty is to open blocked arteries to increase blood flow. Angioplasty involves the feeding of a balloon catheter through a blood vessel (usually in the groin or arm) and the injection of contrast dye, which allows the physician to visualize the artery. Once the professional provider is able to visualize the artery, the balloon is moved to the narrow part of the blood vessel and is inflated, pressing the fatty deposits against the wall and stretching the artery. A stent is placed in the artery to keep it open.

The FDA has granted a Humanitarian Device Exemption (HDE) to two intracranial arterial stent systems. The Neurolink System (Guidant Corp; Menlo Park, CA) was approved on August 11, 2002 based on the Stenting of Symptomatic Atherosclerosis Lesions in the Vertebral or Intracranial Arteries (SSYLVIA) study, a prospective, nonrandomized, multicenter, international study of 61 individuals. The SSYLVIA study reported an all-stroke rate of 13.1 percent of subjects over a mean follow-up of 216 days. The Wingspan Stent System with Gateway PTA Balloon Catheter (Boston Scientific; Natick, MA) was approved on August 3, 2005 based on a prospective study of 45 individuals enrolled at 12 international centers. The Wingspan study reported an all-stroke rate of 9.5 percent over a mean follow up of 174 days.

HDE approval for the Neurolink System (Guidant Corp; Menlo Park, CA) was granted for individuals with recurrent intracranial stroke attributable to atherosclerotic disease that is refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with greater than or equal to 50 percent stenosis that are accessible to the stent system.

HDE approval for the Wingspan Stent System with Gateway PTA Balloon Catheter (Boston Scientific; Natick, MA) was originally granted for individuals with recurrent intracranial stroke attributable to atherosclerotic disease that is refractory to medical therapy in intracranial vessels with greater than or equal to 50 percent stenosis that are accessible to the stent system. The indications for use and labeling for the Wingspan Stent System with Gateway PTA Balloon Catheter (Boston Scientific; Natick, MA) have changed to limit the use of Wingspan to a narrow, select group of individuals and conditions. These changes are based on analysis of the original Humanitarian Device Exemption (HDE) clinical study, data from studies performed after the HDE approval was granted, and data from a clinical trial called the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (HDE) process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Since clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

The FDA may require sponsors to perform a post-approval study (or studies) at the time of approval of an HDE application to help ensure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device.
References


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US Food and Drug Administration (FDA). Center for Devices and Radiological Health. NEUROLINKO Stent & Delivery Catheter and NEUROLINKO Balloon Dilatation Catheter. Summary of safety and probable benefit. [FDA Web site]. 08/09/2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H010004b.pdf Accessed July 26, 2016.

US Food and Drug Administration (FDA). Department of Health and Human Services. Wingspan Stent System with Gateway PTA Balloon Catheter. HDE approval order. [FDA Web site]. 08/03/2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/h050001a.pdf. Accessed January 05, 2018.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

37215, 37218, 61630, 61635

NOT MEDICALLY NECESSARY
37216



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY


I65.21 Occlusion and stenosis of right carotid artery

I65.22 Occlusion and stenosis of left carotid artery

I65.23 Occlusion and stenosis of bilateral carotid arteries

I63.231 Cerebral infarction due to unspecified occlusion or stenosis of right carotid arteries

I63.232 Cerebral infarction due to unspecified occlusion or stenosis of left carotid arteries

I63.233 Cerebral infarction due to unspecified occlusion or stenosis of bilateral carotid arteries

I65.29 Occlusion and stenosis of unspecified carotid artery


COVERED FOR HUMANITARIAN DEVICE EXEMPTION (HDE) INDICATIONS

FOR HDE COVERAGE MULTIPLE DIAGNOSES ARE REQUIRED
I67.2 Cerebral atherosclerosis

AND ONE OF THE FOLLOWING:

I63.211 Cerebral infarction due to unspecified occlusion or stenosis of right vertebral artery

I63.212 Cerebral infarction due to unspecified occlusion or stenosis of left vertebral artery

I63.213 Cerebral infarction due to unspecified occlusion or stenosis of bilateral vertebral arteries

I63.219 Cerebral infarction due to unspecified occlusion or stenosis of unspecified vertebral artery

I63.22 Cerebral infarction due to unspecified occlusion or stenosis of basilar artery

163.29 Cerebral infarction due to unspecified occlusion or stenosis of other precerebral arteries

I63.511 Cerebral infarction due to unspecified occlusion or stenosis of right middle cerebral artery

I63.512 Cerebral infarction due to unspecified occlusion or stenosis of left middle cerebral artery

I63.513 Cerebral infarction due to unspecified occlusion or stenosis of bilateral middle cerebral arteries

I63.521 Cerebral infarction due to unspecified occlusion or stenosis of right anterior cerebral artery

I63.522 Cerebral infarction due to unspecified occlusion or stenosis of left anterior cerebral artery

I63.523 Cerebral infarction due to unspecified occlusion or stenosis of bilateral anterior cerebral arteries

I63.531 Cerebral infarction due to unspecified occlusion or stenosis of right posterior cerebral artery

I63.532 Cerebral infarction due to unspecified occlusion or stenosis of left posterior cerebral artery

I63.533 Cerebral infarction due to unspecified occlusion or stenosis of bilateral posterior cerebral arteries

I63.541 Cerebral infarction due to unspecified occlusion or stenosis of right cerebellar artery

I63.542 Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery

I63.543 Cerebral infarction due to unspecified occlusion or stenosis of bilateral cerebellar arteries

I63.59 Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery

I65.01 Occlusion and stenosis of right vertebral artery

I65.02 Occlusion and stenosis of left vertebral artery

I65.03 Occlusion and stenosis of bilateral vertebral arteries

I65.1 Occlusion and stenosis of basilar artery

I66.01 Occlusion and stenosis of right middle cerebral artery

I66.02 Occlusion and stenosis of left middle cerebral artery

I66.03 Occlusion and stenosis of bilateral middle cerebral arteries

I66.09 Occlusion and stenosis of unspecified middle cerebral artery

I66.11 Occlusion and stenosis of right anterior cerebral artery

I66.12 Occlusion and stenosis of left anterior cerebral artery

I66.13 Occlusion and stenosis of bilateral anterior cerebral arteries

I66.19 Occlusion and stenosis of unspecified anterior cerebral artery

I66.21 Occlusion and stenosis of right posterior cerebral artery

I66.22 Occlusion and stenosis of left posterior cerebral artery

I66.23 Occlusion and stenosis of bilateral posterior cerebral arteries

I66.29 Occlusion and stenosis of unspecified posterior cerebral artery

I66.3 Occlusion and stenosis of cerebellar arteries

I66.8 Occlusion and stenosis of other cerebral arteries

I66.9 Occlusion and stenosis of unspecified cerebral artery

I67.82 Cerebral ischemia

I67.858 Other hereditary cerebrovascular disease




HCPCS Level II Code Number(s)

C1884 Embolization protective system


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.02.12i:
10/01/2018The following ICD-10 CM narratives have been revised in this policy:

I63.219

FROM: Cerebral infarction due to unspecified occlusion or stenosis of unspecified vertebral arteries
TO: Cerebral infarction due to unspecified occlusion or stenosis of unspecified vertebral artery

The following ICD-10 CM code has been added to this policy:
I67.858 Other hereditary cerebrovascular disease



11.02.12h
01/31/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on percutaneous transluminal angioplasty (PTA) concurrent with or without stenting of the extracranial carotid artery or intracranial artery .
11/22/2017This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 10/01/2018
Version Issued Date: 10/01/2018
Version Reissued Date: N/A

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