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Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)

Policy Number: MP-263

Latest Review Date: May 2022

Category:  Surgery                                                                

POLICY:

Intracranial stent placement may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms for patients when surgical treatment is not appropriate and standard endovascular techniques do not allow for complete isolation of the aneurysm (e.g., wide-neck aneurysm (4mm or more) or sack-to-neck ratio less than 2:1).

Intracranial flow diverting stents with FDA approval for the treatment of intracranial aneurysms may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms for patients with large or giant wide-necked intracranial aneurysms, with a size of 10mm or more and a neck diameter of 4mm or more, in the internal carotid artery from the petrous to the superior hypophyseal segments AND are not amenable to surgical treatment or standard endovascular therapy.

Intracranial stent placement is considered investigational in the treatment of intracranial aneurysms except as noted above.

Intracranial percutaneous transluminal angioplasty with or without stenting is investigational in the treatment of atherosclerotic cerebrovascular disease.

The use of endovascular mechanical embolectomy with an FDA approved device for the treatment of acute ischemic stroke may be considered medically necessary as part of the treatment of acute ischemic stroke for patients who meet ALL of the following criteria:

  • Have a demonstrated occlusion within the proximal intracranial anterior circulation (intracranial internal carotid artery, or M1 or M2 segments of the middle cerebral artery, or A1 or A2 segments of the anterior cerebral artery); AND
  • Can receive endovascular mechanical embolectomy:
    • within 12 hours of symptom onset OR
    • within 24 hours of symptom onset if there is evidence of a mismatch between specific clinical and imaging criteria which meets the following criteria:
      • 6 to 24 hours related to mismatch between severity of clinical deficit and infarct volume:
        • ≥80 years of age, score ≥10 on the NIHSS, and had an infarct volume <21 mL; OR
        • ≤80 years age, score of ≥10 on the NIHSS, and had an infarct volume <31 mL; OR
        • ≤80 years of age, had a score ≥20 on the NIHSS, and had an infarct volume of 31 to <51 mL

OR

  • 6 to 16 hours related to mismatch between severity of clinical deficit and infarct volume:
    • Infarct size of <70 mL; AND
    • Ratio of ischemic tissue volume to infarct volume of ≥1.8; AND
    • Ischemic penumbra of ≥15 cm3

AND

  • Have evidence of substantial and clinically significant neurological deficits (i.e. NIHSS score ≥2); AND
  • Have evidence of salvageable brain tissue in the affected vascular territory; AND
  • Have no evidence of intracranial hemorrhage or arterial dissection on computed tomography (CT) or magnetic resonance imaging.

Endovascular mechanical embolectomy is investigational for the treatment of acute ischemic stroke when the above criteria are not met.

Other endovascular interventions (angioplasty, stenting) are considered investigational for the treatment of acute ischemic stroke.

POLICY GUIDELINES:

  • Flow-diverting stents are indicated for the treatment of large or giant wide-necked intracranial aneurysms, with a size of 10 mm or more and a neck diameter of 4 mm or more, in the internal carotid artery from the petrous to the superior hypophyseal segments.
  • This policy only addresses endovascular therapies used on intracranial vessels.
  • These policy statements are not intended to address the use of rescue endovascular therapies, including intra-arterial vasodilator infusion and intracranial percutaneous transluminal angiography, in delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage.

DESCRIPTION OF PROCEDURE OR SERVICE:

Intracranial arterial disease includes thromboembolic events, vascular stenoses, and aneurysms. Endovascular techniques have been investigated for treatment of intracranial arterial disease. Endovascular therapy is used as an alternative or adjunct to intravenous tissue plasminogen activator (TPA) and supportive care for acute stenosis and as an alternative to risk factor modification for chronic stenosis. For cerebral aneurysms, stent-assisted coiling and the use of flow-diverting stents have been evaluated as an alternative to endovascular coiling in patients whose anatomy is not amenable to simple coiling.

Cerebrovascular diseases include a range of processes affecting the cerebral vascular system, including arterial thromboembolism, arterial stenosis, and arterial aneurysms, all of which can lead to restrictions in cerebral blood flow due to ischemia or hemorrhage. Endovascular techniques, including endovascular mechanical embolectomy; using one of several types of devices (i.e. stents), and angioplasty with or without stenting, have been investigated for treatment of cerebrovascular diseases.

Acute Stroke

Acute stroke is the third leading cause of death in the U.S., Canada, Europe and Japan and is the leading cause of adult disability in the U.S. Eighty-seven percent of strokes are ischemic and 13% hemorrhagic. Differentiation between the two types of stroke is necessary to determine the appropriate treatment. Ischemic stroke occurs when an artery to the brain is blocked by a blood clot, which forms in the artery (thrombotic), or when another substance (i.e., plaque, fatty material) or a blood clot travels to an artery in the brain causing a blockage (embolism). Recanalization of the vessel, particularly in the first few hours after occlusion, has been shown to reduce rates of disability and death.

Intracranial Arterial Stenosis

It is estimated that intracranial atherosclerosis causes about 8% of all ischemic strokes. Intracranial stenosis may contribute to stroke in two ways: either due to embolism or low flow ischemia in the absence of collateral circulation. Recurrent annual stroke rates are estimated at 4% to 12% per year with atherosclerosis of the intracranial anterior circulation and 2.5% to 15% per year with lesions of the posterior (vertebrobasilar) circulation.

Intracranial Aneurysms

Compared with acute ischemic stroke, cerebral aneurysms have a much lower incidence among the U.S. population, with prevalence between 0.5% and 6% of the population. However, they are associated with significant morbidity and mortality due to subarachnoid hemorrhage resulting from aneurysm rupture.

KEY POINTS:

The most recent update literature review through March 2, 2022.

Summary of Evidence

For individuals who have acute ischemic stroke due to occlusion of an anterior circulation vessel who receive endovascular mechanical embolectomy, the evidence includes RCTs comparing endovascular therapy with standard care and systematic reviews of these RCTs. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. From 2013 to 2015, 8 RCTs were published comparing endovascular therapies with noninterventional care for acute stroke in patients with anterior circulation occlusions. Several trials that were ongoing at the time of publication of these eight RCTs were stopped early, and results with the limited enrollment have been published. Trials published from 2014 to 2015 demonstrated a significant benefit regarding reduced disability at 90 days post treatment. The trials that demonstrated a benefit for endovascular therapy either exclusively used stent retriever devices or allowed the treating physician to select a device, mostly a stent retriever device, and had high rates of mechanical embolectomy device use in patients randomized to endovascular therapy. Studies that demonstrated a benefit for endovascular therapy required demonstration of a large vessel, anterior circulation occlusion for enrollment. In addition, they were characterized by fast time-to-treatment. Two trials published in 2018 demonstrated that it was possible to extend the window for mechanical thrombectomy up to about 24 hours for select patients. To achieve results in real-world settings similar to those in clinical trials, treatment times, clinical protocols, and patient selection criteria should be similar to those in RCTs. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have acute ischemic stroke due to basilar artery occlusion who receive endovascular mechanical embolectomy, the evidence includes an RCT. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. The RCT was terminated early due to high crossovers and poor recruitment. There was not a statistically significant difference in the proportion of participants with a modified Rankin Scale of 0 to 3 at 90 days or in 90-day mortality rates in the endovascular and standard therapy groups. Additional RCTs are ongoing. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic intracranial arterial stenosis who receive intracranial percutaneous transluminal angioplasty with or without stenting, the evidence includes a systematic review and two major RCTs. Relevant outcomes are overall survival, symptoms, morbid events, functional outcomes, and treatment-related mortality and morbidity. Both available RCTs have demonstrated no significant benefit with endovascular therapy. In particular, the SAMMPRIS trial was stopped early due to harms, because the rate of stroke or death at 30 days post treatment was higher in the endovascular arm, which received percutaneous angioplasty with stenting. Follow-up of SAMMPRIS subjects has demonstrated no long-term benefit from endovascular therapy. Although some nonrandomized studies have suggested a benefit from endovascular therapy, the available evidence from two RCTs does not suggest that intracranial percutaneous transluminal angioplasty with or without stenting improves outcomes for individuals with symptomatic intracranial stenosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have intracranial aneurysm(s) who receive endovascular coiling with intracranial stent placement or intracranial placement of a flow-diverting stent, the evidence includes RCTs, several nonrandomized comparative studies, and multiple single-arm studies. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. The available nonrandomized comparative studies have reported occlusion rates for stent-assisted coiling that are similar to or higher than coiling alone and recurrence rates that may be lower than those may for coiling alone. For stent-assisted coiling with self-expanding stents, some evidence has also shown that adverse event rates are relatively high, and a nonrandomized comparative trial has reported that mortality is higher with stent-assisted coiling than with coiling alone. For placement of flow-diverting stents, a pragmatic RCT and registry study have compared flow diversion with standard management (observation, coil embolization, or parent vessel occlusion) in patients for whom flow diversion was considered a promising treatment. The pragmatic study was stopped early after crossing a predefined safety boundary when 16% of patients treated with flow diversion were dead, dependent at 3 months, or later. Flow diversion was also not as effective as the investigators had hypothesized. A nonrandomized study comparing the flow-diverting stents with endovascular coiling for intracranial aneurysms has demonstrated higher rates of aneurysm obliteration in those treated with the Pipeline endovascular device than those treated with coiling, with similar rates of good clinical outcomes. The evidence does not provide high certainty whether stent-assisted coiling or placement of a flow-diverting stent improves outcomes for patients with intracranial aneurysms because the risk-benefit ratio cannot be adequately defined. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Society of Vascular and Interventional Neurology

In 2016, the Society of Vascular and Interventional Neurology (SVIN) published recommendations on comprehensive stroke center requirements and endovascular stroke systems of care. The recommendations were based on five multicenter, prospective, randomized, open-label, blinded end clinical trials that demonstrated the benefits of endovascular therapy with mechanical thrombectomy in acute ischemic strokes with large vessel occlusions. Their recommendation pertinent to this evidence review is:

“Endovascular mechanical thrombectomy, in addition to treatment with IV tPA [intravenous tissue plasminogen activator] in eligible patients, is recommended for anterior circulation large vessel occlusion ischemic strokes in patients presenting within 6 h of symptom onset.”

American Heart Association and American Stroke Association

In 2018, the AHA and the American Stroke Association (update 2019) published joint guidelines for the early management of patients with acute ischemic stroke. These guidelines include several recommendations relevant to the use of endovascular therapies for acute stroke:

Table 1. Recommendations on Use of Endovascular Therapies to Manage Acute Stroke

Recommendation

COR

LOE

“Mechanical thrombectomy requires the patient to be at an experienced stroke center with rapid access to cerebral angiography, qualified neurointerventionalists, and a comprehensive periprocedural care team. Systems should be designed, executed, and monitored to emphasize expeditious assessment and treatment. Outcomes for all patients should be tracked. Facilities are encouraged to define criteria that can be used to credential individuals who can perform safe and timely intra-arterial revascularization procedures.”

I

C

“Patients should receive mechanical thrombectomy with a stent retriever if they meet all the following criteria:

  • “Prestroke mRS score 0 to 1,
  • “Causative occlusion of the internal carotid artery or MCA (M1),
  • “Age ≥18 years,
  • NIHSS score of ≥6,
  • “ASPECTS of ≥6, and
  • “Treatment can be initiated (groin puncture) within 6 hours of symptom onset.”

I

A

In selected patients with acute ischemic stroke within 6 to 16 hours of last known normal who have LVO in the anterior circulation and meet other DAWN or DEFUSE 3 eligibility criteria, mechanical thrombectomy is recommended.

I

A

“The technical goal of the thrombectomy procedure should be a reperfusion to a modified TICI 2b/3 angiographic result to maximize the probability of a good functional clinical outcome.”

I

A

“As with intravenous alteplase, reduced time from symptom onset to reperfusion with endovascular therapies is highly associated with better clinical outcomes. To ensure benefit, reperfusion to TICI grade 2b/3 should be achieved as early as possible and within the therapeutic window.”

I

B-R

  • “Use of stent retrievers is indicated in preference to the MERCI device.”
  • “The use of mechanical thrombectomy devices other than stent retrievers may be reasonable in some circumstances.”

I

IIb

A
B-NR

“The use of proximal balloon guide catheter or a large bore distal access catheter rather than a cervical guide catheter alone in conjunction with stent retrievers may be beneficial. Future studies should examine which systems provide the highest recanalization rates with the lowest risk for nontarget embolization.”

IIa

C-LD

In selected patients with AIS within 16 to 24 hours of last known normal who have LVO in the anterior circulation and meet other DAWN eligibility criteria, mechanical thrombectomy is reasonable.

IIa

B-R

“In carefully selected patients with anterior circulation occlusion who have contraindications to intravenous r-tPA, endovascular therapy with stent retrievers completed within 6 hours of stroke onset is reasonable. There are inadequate data available at this time to determine the clinical efficacy of endovascular therapy with stent retrievers for those patients whose contraindications are time-based or non-time based (e.g., prior stroke, serious head trauma, hemorrhagic coagulopathy, or receiving anticoagulant medications).”

IIa

C

“Although the benefits are uncertain, use of mechanical thrombectomy with stent retrievers may be reasonable for carefully selected patients with acute ischemic stroke in whom treatment can be initiated (groin puncture) within 6 hours of symptom onset and who have causative occlusion of the M2 or M3 portion of the MCAs.”

IIb

B-R

“Although the benefits are uncertain, use of mechanical thrombectomy with stent retrievers may be reasonable for carefully selected patients with acute ischemic stroke in whom treatment can be initiated (groin puncture) within 6 hours of symptom onset and who have causative occlusion of the anterior cerebral arteries, vertebral arteries, basilar artery, or posterior cerebral arteries.”

IIb

C

“Although the benefits are uncertain, use of mechanical thrombectomy with stent retrievers may be reasonable for patients with acute ischemic stroke in whom treatment can be initiated (groin puncture) within 6 hours of symptom onset and who have prestroke mRS score of >1, ASPECTS <6, or NIHSS score <6 and causative occlusion of the internal carotid artery or proximal MCA (M1). Additional randomized trial data are needed.”

IIb

B-R

In patients under consideration for mechanical thrombectomy, observation after IV alteplase to assess for clinical response should not be performed.

III

B-R

“Use of salvage technical adjuncts including intra-arterial fibrinolysis may be reasonable to achieve these angiographic results”

IIb

C-LD

“Intra-arterial fibrinolysis initiated within 6 hours of stroke onset in carefully selected patients who have contraindications to the use of intravenous alteplase might be considered, but the consequences are unknown.”

IIb

C-EO

AIS: acute ischemic stroke; ASPECTS: Alberta Stroke Program Early Computed Tomography Score; COR: class of recommendation; LOE: level of recommendation; LVO: large vessel occlusion; MCA: middle cerebral artery; mRS: modified Rankin Scale; NIHSS: National Institutes of Health Stroke Scale; r-tPA: recombinant tissue plasminogen activator; TICI: Thrombolysis in Cerebral Infarction.

The two associations also published joint guidelines on the management of patients with unruptured intracranial aneurysms in 2015. These guidelines included the following recommendations relevant to the use of endovascular therapies for aneurysms (Table 2).

Table 2. Recommendations on Management of Unruptured Intracranial Aneurysms

Recommendation

COR

LOE

“...coil embolization may be superior to surgical clipping with respect to procedural morbidity and mortality, length of stay, and hospital costs, so it may be reasonable to choose endovascular therapy over surgical clipping in the treatment of select unruptured intracranial aneurysms, particularly in cases for which surgical morbidity is high, such as at the basilar apex and in the elderly”

IIb

B

“...coil embolization may be superior to surgical clipping with respect to procedural morbidity and mortality, length of stay, and hospital costs, so it may be reasonable to choose endovascular therapy over surgical clipping in the treatment of select unruptured intracranial aneurysms, particularly in cases for which surgical morbidity is high, such as at the basilar apex and in the elderly”

IIb

B

“Endovascular treatment of unruptured intracranial aneurysms is recommended to be performed at high-volume centers.”

I

B

COR: class of recommendation; LOE: level of recommendation.

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force (USPSTF) recommendations for treatment of intracranial arterial disease were identified. USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general population.

KEY WORDS:

intracranial stenting, flow diverting stent, intracranial angioplasty, Percutaneous Transluminal Angioplasty, mechanical embolectomy, stroke, cerebral aneurysm, revascularization, Intracranial Circulation, Vertebrobasilar Stenosis, Angioplasty, Merci® Retriever, Penumbra System®, Solitaire™, Trevo Pro Retriever™, Neurolink®, Neurolink System, Wingspan Stent System, Pipeline® Embolization Device, Neuroform ™ Microdelivery Stent System, Enterprise™, Low Profile Visualized Intraluminal Support Device, PulseRider, Surpass Streamline Flow Diverter, Surpass, EmboTrap®, EmboTrap® II Revascularization Device, Atlas Stent System, Tigertriever™ and Tigertriever 17 Revascularization Devices, ZOOM Reperfusion Catheter, ZOOM™ 71 Reperfusion Catheter, Embotrap® III Revascularization Device, Esperance™ Aspiration Catheter System

APPROVED BY GOVERNING BODIES:

Several devices for endovascular treatment of intracranial arterial disease have received clearance by FDA either through the 510(k) process or through the humanitarian device exemption (HDE) process. By indication, approved devices are as follows:

A summary of the devices with FDA clearance for the endovascular treatment of acute stroke is provided in Table 3.

Table 3: FDA-Cleared Mechanical Embolectomy Devices for Acute Stroke

Device

510(k) No. for Original Device

Approval Date for Original Device

Indications

Merci® Retriever (Concentric Medical, Mountain View, CA; acquired by Stryker Neurovascular, Kalamazoo, MI, in 2011)

K033736

Aug 2004 (modified device approved May 2006)

Patients with acute ischemic stroke and who are ineligible for or who fail IV tPA therapy

Penumbra System® (Penumbra, Alameda, CA)

K072718

Dec 2007

Patients with acute ischemic stroke secondary to intracranial large-vessel occlusive disease within 8 h of symptom onset

Tigertriever™ and Tigertriever 17 Revascularization Devices (Rapid Medical, Ltd)

 

K203592

 

Mar 2021

 

Patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA

 

ZOOM Reperfusion Catheter (Imperative Care, Inc)

 

K210996

 

April 2021

 

Patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA

 

ZOOM™ 71 Reperfusion Catheter (Imperative Care, Inc)

 

K211476

 

June 2021

 

 

Patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA

 

Embotrap® III Revascularization Device (Neuravi Ltd)

 

K211338

 

July 2021

 

 

Patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA

 

Esperance™ Aspiration Catheter System (Wallaby Medical)

 

K211697

 

Nov 2021

 

Patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA

 

Stent retrievers

 

 

 

Solitaire™ FR Revascularization Device (Covidien/ev3 Neurovascular, Irvine, CA)

K113455

Mar 2012

Patients with acute ischemic stroke due to large intracranial vessel occlusion who are ineligible for or who fail IV tPA

Trevo® Retriever device (Stryker Neurovascular, Kalamazoo, MI)

K122478

Aug 2012

Patients with acute ischemic stroke due to large intracranial vessel occlusion who are ineligible for or who fail IV tPA

EmboTrap® II Revascularization Device

K173452

May 2018

Patients with ischemic stroke within 8 hours of symptom onset who are ineligible for or who fail IV t-PA

Trevo® NXT ProVue Retriever (Stryker Neurovascular)

 

K210502

 

Aug 2021

 

Patients with acute ischemic stroke within 6 h of symptom onset who fail IVt-PA; patients with acute ischemic stroke within 8 h of symptom onset who are ineligible for or who fail IV t-PA; patients with smaller core infarcts may start therapy as late as 24 h after last seen well

 

IV: intravenous; tPA: tissue plasminogen activator.

Intracranial Stenosis

Two devices have received approval for atherosclerotic disease from the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) process. This form of FDA approval is available for devices used to treat conditions with an incidence of 4,000 or less per year; the FDA only requires data showing “probable safety and effectiveness.” Devices with their labeled indications are as follows:

Neurolink System® (Guidant, Santa Clara, CA)

“The Neurolink system is indicated for the treatment of patients 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 ≥50% stenosis and that are accessible to the stent system.”

Wingspan™ Stent System (Boston Scientific, Fremont, CA)

“The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥50% stenosis that are accessible to the system.”

Intracranial Aneurysms

In 2011, FDA granted premarket approval to the Pipeline® Embolization Device (Covidien/eV3 Neurovascular, Irvine, CA), an intracranial aneurysm flow diverter, for the endovascular treatment of adults (≥22 years of age) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments (P100018). Approval was based on the Pipeline for Uncoilable for Failed Aneurysms Study, a single-arm, open-label feasibility study that included 108 patients aged 30 to 75 years with unruptured large and giant wide-necked aneurysms.

In 2018, Surpass Streamline Flow Diverter (Stryker Neurovascular) was approved by the FDA through the premarket approval PMA process (P170024) for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.3 mm. The approval was based on one1-year results of the Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT) study. The SCENT study is continuing follow-up up to five5 years post-procedure as a post-approval study.

The following stents have received FDA approval through the Humanitarian Device Exemption (HDE) program for treatment of intracranial aneurysms.

Neuroform™ Microdelivery Stent System (Stryker, Kalamazoo, MI)

In 2002, based on a series of approximately 30 patients with six-month follow-up, the Neuroform Microdelivery Stent System was approved (HDE) for use with embolic coils for treatment of wide-neck intracranial aneurysms that cannot be treated by surgical clipping (H020002).

Neuroform™ Atlas Stent System

In 2019, the Neuroform Atlas Stent System (Stryker) was approved by the FDA through the PMA process (P190031) based on the pivotal ATLAS study including 201 patients with up to 12 months of follow-up. The approved indication is "for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients greater or equal to 18 years of age with saccular wide-necked (neck width greater or equal to 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of greater or equal to 2.0 mm and less than or equal to 4.5 mm." Product Code: QCA.

Enterprise™ Vascular Reconstruction Device and Delivery System (Cordis Neurovascular Inc., Miami Lakes, FL)

In 2007, based on a series of approximately 30 patients with six-month follow-up, the Enterprise Vascular Reconstruction Device and Delivery System (Cordis Neurovascular, Inc.) was approved (HDE) for use with embolic coils for treatment of wide-neck, intracranial, saccular or fusiform aneurysms (H060001).

The Low-Profile Visualized Intraluminal Support Device (LVIS™ and LVIS™ Jr.) (MicroVention, Inc., Tustin, CA)

In July 2014, the Low Profile Visualized Intraluminal Support Device received HDE approval (H130005) for use with embolic coils for the treatment of unruptured, wide neck (neck ≥ 4 mm or dome to neck ratio < 2), intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 4.5 mm. In 2018, the LVIS™ and LVIS™ Jr. were approved through the PMA process (P170013).

PulseRider Aneurysm Neck Reconstruction Device

In 2017, the PulseRider Aneurysm Neck Reconstruction Device (Pulsar Vascular, Inc.) was approved by the FDA through the HDE process (H160002) for use with neurovascular embolic coils for treatment of unruptured wide-necked intracranial aneurysms with neck width at least 4 mm or dome to neck ratio greater than 2.

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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. 

CURRENT CODING: 

CPT Codes:

CPT codes specific for intracranial angioplasty and stent placement:

61630

Balloon angioplasty, intracranial (e.g., atherosclerotic stenosis) percutaneous

61635

Transcatheter placement of intravascular stent(s), intracranial (e.g., atherosclerotic stenosis), including balloon angioplasty, if performed

CPT code for occlusion of a vascular malformation performed as part of the treatment of an aneurysm:

61624

Transcatheter permanent occlusion or embolization (e.g., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method; central nervous system (intracranial, spinal cord)

Diagnostic studies of cervico-cerebral arteries codes (e.g., 36221-36228) describe non-selective and selective arterial catheter placement and diagnostic imaging.

CPT code for mechanical embolectomy:

61645

percutaneous arterial transluminal mechanical thrombectomy and/or infusion for thrombolysis, intracranial, any method, including diagnostic angiography, fluoroscopic guidance, catheter placement, and intraprocedural pharmacological thrombolytic injection(s)

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  20. Ciccone A, Valvassori L, Nichelatti M et al. Endovascular treatment for acute ischemic stroke. N Engl J Med 2013; 368(10):904-13.
  21. Consoli A, Vignoli C, Renieri L, et al. Assisted coiling of saccular wide-necked unruptured intracranial aneurysms: stent versus balloon. J Neurointerv Surg. Jan 2016; 8(1):52-57.
  22. Coward LJ, McCabe DJ, Ederle J et al. Long-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis compared with medical treatment in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial.  Stroke 2007; 38 (5): 1526-30.
  23. de Havenon A, Sheth K, Johnston KC, et al. Acute Ischemic Stroke Interventions in the United States and Racial, Socioeconomic, and Geographic Disparities. Neurology. Dec07 2021; 97(23): e2292-e2303.
  24. Derdeyn CP, Chimowitz MI, Lynn MJ, et al. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. Jan 25 2014; 383(9914): 333-41.
  25. Diringer MN, Bleck TP, Claude Hemphill J, 3rd, et al. Critical care management of patients following aneurysmal subarachnoid hemorrhage: recommendations from the Neurocritical Care Society's Multidisciplinary Consensus Conference. Neurocrit Care. Sep 2011; 15 (2): 211-240.
  26. Ec Ic Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. Nov 7 1985; 313(19):1191-1200.
  27. English JD, Yavagal DR, Gupta R, et al. Mechanical thrombectomy-ready comprehensive stroke center requirements and endovascular stroke systems of care: recommendations from the Endovascular Stroke Standards Committee of the Society of Vascular and Interventional Neurology (SVIN). Interv Neurol. Mar 2016; 4(3-4):138-150.
  28. Food and Drug Administration. FDA Executive Summary General Issues: Meeting to Discuss the Evaluation of Safety and Effectiveness of Endovascular Medical DevicesIntended to Treat Intracranial Aneurysms.https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM598459.pdfAccessed March 3, 2022.
  29. FDA Summary of Safety and Probable Benefit. Neurolink System. Available online at www.accessdata.fda.cov/cdrH_doc/pdf/H010004b/pdf.  Accessed March 29, 2018.
  30. FDA Summary of Safety and Probable Benefit. Wingspan Stent System. Available online at: www.accessdata.fda.gov/cdrh_doc/pdf5/H500001b.pdf. Accessed March 29, 2018.
  31. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: PipelineTM Embolization Device. 2011; https: //www.accessdata.fda.gov/cdrh_docs/pdf10/P100018b.pdf. Accessed March 7, 2022.
  32. FDA Summary of Safety and Probable Benefit. Neurolink System. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf/H010004b.pdf.
  33. FDA Summary of Safety and Effectiveness (SSED). Accessed Feb 21, 2019.
  34. Food and Drug Administration (FDA). SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED): Neuroform Atlas Stent System (P180031). 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180031B.pdf Accessed March 9, 2022.
  35. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180031B.pdf Accessed Feb 25, 2020.
  36. Food and Drug Administration (FDA). SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED): Low Profile Visualized Intraluminal Support (LVIS) and LVIS Jr (P170013).2018. https: //www.accessdata.fda.gov/cdrh_docs/pdf17/P170013B.pdf. Accessed March 8, 2022.
  37. Food and Drug Administration. PMA P170024: Summary of Safety and Effectiveness (SSED). Intracranial Aneurysm Flow Diverter. 2018. https: //www.accessdata.fda.gov/cdrh_docs/pdf17/P170024B.pdf. Accessed March 4, 2022.
  38. Feng Z, Fang Y, Xu Y, et al. The safety and efficacy of low profile visualized intraluminal support (LVIS) stents in assisting coil embolization of intracranial saccular aneurysms: a single center experience. J Neurointerv Surg. Nov 2016; 8(11): 1192-1196.
  39. Fiorella D, Boulos A, Turk AS, et al. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal USLVIS trial. J Neurointerv Surg. Apr 2019; 11(4): 357-361.
  40. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: PipelineTM Embolization Device. 2011; https: //www.accessdata.fda.gov/cdrh_docs/pdf10/P100018b.pdf. Accessed March 7, 2022.
  41. Geyik S, Yavuz K, Yurttutan N et al. Stent-assisted coiling in endovascular treatment of 500 consecutive cerebral aneurysms with long-term follow-up. AJNR Am J Neuroradiol 2013; 34(11):2157-62.
  42. Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. Mar 12 2015; 372(11):1019-1030.
  43. Grech R, Schembri M, Thornton J. Stent-based thrombectomy versus intravenous tissue plasminogen activator in acute ischaemic stroke: A systematic review and meta-analysis. Interv Neuroradiol. Dec 2015; 21(6):684-690.
  44. Hetts SW, Turk A, English JD, et al. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. Apr 2014; 35 (4): 698-705.
  45. Hong KS, Ko SB, Lee JS, et al. Endovascular Recanalization Therapy in Acute Ischemic Stroke: Updated Meta-analysis of Randomized Controlled Trials. J Stroke. Sep 2015; 17(3):268-281.
  46. Hong Y, Wang YJ, Deng Z, et al. Stent-assisted coiling versus coiling in treatment of intracranial aneurysm: a systematic review and meta-analysis. PLoS One. 2014; 9 (1): e82311.
  47. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  48. Jankowitz BT, Hanel R, Jadhav AP, et al. Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort. J Neurointerv Surg. Aug 2019; 11(8): 801-806.
  49. Jovin TG, Chamorro A, Cobo E, et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. Jun 11 2015; 372(24):2296-2306.
  50. Jovin TG, Nogueira RG, Lansberg MG, et al. Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis. Lancet. Jan 15 2022; 399(10321): 249-258.
  51. Kahles T, Garcia-Esperon C, Zeller S, et al. Mechanical Thrombectomy Using the New ERIC Retrieval Device Is Feasible, Efficient, and Safe in Acute Ischemic Stroke: A Swiss Stroke Center Experience. AJNR Am J Neuroradiol. Jan 2016; 37(1):114-119.
  52. Kennedy SA, Baerlocher MO, Baerlocher F, et al. Meta-Analysis of Local Endovascular Therapy for Acute Ischemic Stroke. J Vasc Interv Radiol. Mar 2016; 27(3): 307-21.e2.
  53. Kim Y, Sharrief A, Kwak MJ, et al. Underutilization of Endovascular Therapy in Black Patients With Ischemic Stroke: An Analysis of State and Nationwide Cohorts. Stroke. Mar2022; 53(3): 855-863.
  54. Kiselev R, Orlov K, Dubovoy A et al. Flow diversion versus parent artery occlusion with bypass in the treatment of complex intracranial aneurysms: Immediate and short-term outcomes of the randomized trial. Clin Neurol Neurosurg. 2018 Sep; 172:183-189.
  55. Khoury NN, Darsaut TE, Ghostine J, et al. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol. Jun 2017; 44(3):198-202.
  56. Kidwell CS, Jahan R, Gornbein J et al. A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med 2013; 368(10):914-23.
  57. Kim Y, Sharrief A, Kwak MJ, et al. Underutilization of Endovascular Therapy in Black Patients With Ischemic Stroke: An Analysis of State and Nationwide Cohorts. Stroke. Mar2022; 53(3): 855-863.
  58. King B, Vaziri S, Singla A, et al. Clinical and angiographic outcomes after stent-assisted coiling of cerebral aneurysms with Enterprise and Neuroform stents: a comparative analysis of the literature. J Neurointerv Surg. Dec 2015; 7(12):905-909.
  59. Kulcsar Z, Goricke SL, Gizewski ER et al. Neuroform stent-assisted treatment of intracranial aneurysms: long-term follow-up study of aneurysm recurrence and in-stent stenosis rates. Neuroradiology 2013; 55(4):459-65.
  60. Lee KM, Jo KI, Jeon P, et al. Predictor and Prognosis of Procedural Rupture during Coil Embolization for Unruptured Intracranial Aneurysm. J Korean Neurosurg Soc. Jan 2016; 59(1):6-10.
  61. Liu YQ, Wang QJ, Zheng T, et al. Single-centre comparison of procedural complications, clinical outcome, and angiographic follow-up between coiling and stent-assisted coiling for posterior communicating artery aneurysms. J Clin Neurosci. Dec 2014; 21 (12): 2140-2144.
  62. Lutsep HL, Barnwell SL, Larsen DT, et al. Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis. Stroke. Mar 2015; 46(3):775-779.
  63. Lutsep HL, Lynn MJ, Cotsonis GA, et al. Does the Stenting Versus Aggressive Medical Therapy Trial Support Stenting for Subgroups With Intracranial Stenosis? Stroke. Nov 2015; 46(11):3282-3284.
  64. Marmagkiolis K, Hakeem A, Cilingiroglu M, et al. Safety and Efficacy of Stent Retrievers for the Management of Acute Ischemic Stroke: Comprehensive Review and Meta-Analysis. JACC Cardiovasc Interv. Nov 2015; 8(13):1758-1765.
  65. Martins SO, Mont'Alverne F, Rebello LC, et al. Thrombectomy for Stroke in the Public Health Care System of Brazil. N Engl J Med. Jun11 2020; 382(24): 2316-2326.
  66. Mattle HP, Arnold M, Lindsberg PJ et al. Basilar artery occlusion.  Lancet Neurol 2011; 10(11): 1002-14.
  67. Meyers PM, Schumacher HC, Higashida RT et al. Indications for the performance of intracranial endovascular neurointerventional procedures: a scientific statement from the American Heart Association Council on Cardiovascular Radiology and Intervention, Stroke Council, Council on Cardiovascular Surgery and Anesthesia, Interdisciplinary Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Circulation 2009; 119(16):2235-49.
  68. Mocco J, Zaidat OO, von Kummer R, et al. Aspiration thrombectomy after intravenous alteplase versus intravenous alteplase alone. Stroke. Sep 2016; 47(9):2331-2338.
  69. Muir KW, Ford GA, Messow CM, et al. Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial. J Neurol Neurosurg Psychiatry. Jan 2017; 88(1):38-44.
  70. Nogueira RG, Frei D, Kirmani JF, et al. Safety and efficacy of a 3-dimensional stent retriever with aspiration-based thrombectomy vs aspiration-based thrombectomy alone in acute ischemic stroke intervention: a randomized clinical trial. JAMA Neurol. Mar 1 2018; 75(3):304-311.
  71. Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. Jan 4 2018; 378(1):11-21.
  72. Nogueira RG, Lutsep HL, Gupta R et al. Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet 2012; 380(9849):1231-40.
  73. Pereira VM, Gralla J, Davalos A et al. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke 2013; 44(10):2802-7.
  74. Piotin M, Blanc R, Spelle L et al. Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216 consecutive aneurysms. Stroke 2010; 41(1):110-5.
  75. Powers WJ, Derdeyn CP, Biller J, et al. 2015 AHA/ASA Focused Update of the 2013 guidelines for the early management of patients with acute ischemic stroke regarding endovascular treatment: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. Jun 29 2015.
  76. Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. Mar 2018; 49(3):e46-e110.
  77. Qureshi AI, Chaudhry SA, Siddiq F, et al. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis. J Vasc Interv Neurol. Dec 2013; 6 (2): 34-41.
  78. Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke 2007; 38(3):967-73.
  79. Roaldsen MB, Jusufovic M, Berge E, et al. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. Jun 14 2021; 6:CD007574.
  80. Ryu CW, Park S, Shin HS, et al. Complications in stent-assisted endovascular therapy of ruptured intracranial aneurysms and relevance to antiplatelet administration: a systematic review. AJNR Am J Neuroradiol. Jul 2 2015; 36(9):1682-1688.
  81. Saposnik G, Lebovic G, Demchuk A, et al. Added Benefit of Stent Retriever Technology for Acute Ischemic Stroke: A Pooled Analysis of the NINDS tPA, SWIFT, and STAR Trials. Neurosurgery. Sep 2015; 77(3):454-461.
  82. Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. Jun 11 2015; 372(24):2285-2295.
  83. Saver JL, Jahan R, Levy EI et al. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomized, parallel group, non-inferiority trial. Lancet 2012; 380(9849):1241-9.
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POLICY HISTORY:

Medical Policy Group, February 2006 (4)

Medical Review Committee, February 2006

Medical Policy Administration Committee, June 2006

Available for comment July 5-August 18, 2006

Medical Policy Group, June 2009 (1)

Medical Policy Group, December 2010 (1): Coding update-Added change of verbiage to code 75960

Medical Policy Panel, May 2012

Medical Policy Panel Group, August 2012 (2): Policy extensively updated with literature review.  Policy statements changed to medically necessary for selected patients with intracranial aneurysms.  Added statement that transluminal angioplasty with and without stenting is investigational.  Title change, Description, Key Points, References updated to support policy changes. 

Medical Policy Administration Committee, September 2012

Available for comments September 18 through November 1, 2012

Medical Policy Group, September 2013 (4): 2013 Update to Key Points and References

Medical Policy Group, December 2013 (3):  2014 Coding Update – added existing code 61624; moved code 75960 to previous coding (deleted effective 01/01/2014)

Medical Policy Panel January 2014

Medical Policy Group January 2014 (4): All policy documentation in policy #298, “Mechanical Embolectomy for Treatment of Acute Stroke”, was added to this policy 263 and then policy 298 was archived. Title of this policy was changed to reflect the integration of policy 298. Update to Description, Key Points, Key Words, Approved Governing bodies, Coding and References related to intracranial and endovascular interventions; no change to policy statements or intention of coverage related to either procedure.

Medical Policy Panel June 2014

Medical Policy Group 2014 (4):  Added indication for flow-diverting stents to the policy section. updated Key Points & References.

Medical Policy Administration Committee August 2014

Available for comment August 8 through September 22, 2014

Medical Policy Panel, January 2015

Medical Policy Group, January 2015(4): Updates to Description, Key Points, Approved Governing Bodies, Key Words, Current Coding and References.  Added “with FDA approval for the treatment of intracranial aneurysms” and “AND are not amenable to surgical treatment or standard endovascular therapy” to the Intracranial flow diverting stents policy statement. 

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, and References.  Policy statement added, “The use of endovascular mechanical embolectomy with an FDA approved device for the treatment of acute ischemic stroke is considered medically necessary when certain criteria are met. Coding section updated. Removed CPT 35475 (error), removed code description for 37184-37186 (codes remain on policy).

Medical Policy Administration Committee October 2015

Available for comment October 2 through November 15, 2015

Medical Policy Group (4): Clarified policy statement that mechanical embolectomy does not meet for acute ischemic stroke when the above criteria are not met.  Further clarified by adding statement for “other endovascular interventions” are investigational.

Medical Policy Group, November 2015: 2016 Annual Coding Update; added new CPT code 61645 to current coding; moved CPT coding section 36221-36228 to previous coding section.

Medical Policy Panel, April 2016

Medical Policy Group, May 2016 (4): Updates to Description, Key Points, Coding, and References. No change to policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (4): Updates to Key Points, References, and Coding; Removed policy statements for dates of service November 1, 2012 through June 30th, 2014; Removed CPT code 75960 from Previous Coding section. It was deleted 01/01/2014.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (4): Updates to Key Points, Policy, Current Coding, and References.  Updated policy statement to include coverage for mechanical embolectomy within 24 hours with evidence of mismatch between specific clinical and imaging criteria.

Medical Policy Administration Committee: May 2018

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. Removed policy statements effective for dates of service on or after July 1, 2014 through September 30, 2015. Removed Previous Coding section stating prior to 2016, there were no specific codes for mechanical embolectomy.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (4): Updates to Description, Key Points, Approved by Governing Bodies, Key Words, and References.  No change to policy statements. Added key word Atlas Stent System.

Medical Policy Panel, April 2021

Medical Policy Group, May 2021 (3): Updates to Key Points and References. Added Policy Guidelines section. Policy statement updated to remove “not medically necessary,” no other changes to policy statement or intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (3): 2022 Updates to Key Points, Approved By Governing Bodies, References and Key Words added: Tigertriever™ and Tigertriever 17 Revascularization Devices, ZOOM Reperfusion Catheter, ZOOM™ 71 Reperfusion Catheter, Embotrap® III Revascularization Device, and Esperance™ Aspiration Catheter System. No change to policy statement or intent.

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.