Related Medicare Advantage Medical/Pharmacy Coverage Policies

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Related Documents

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Type Title ID Number Carotid Revascularization

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NCD
Percutaneous Transluminal Angioplasty (PTA)

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; which 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 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
• 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 most frequently involves the origin of the internal carotid artery and the common carotid artery bifurcation. Carotid artery disease may be described as extracranial or intracranial. Extracranial refers to the carotid and vertebral arteries outside of the skull. Intracranial refers to arteries inside or at the base of the skull.

Symptoms are the most important factor related to the risk for disabling stroke and the indication for revascularization. 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 (eg, paclitaxel, sirolimus) that is slowly released into surrounding tissue, via a drug delivery system, to prevent restenosis of a carotid artery.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for Percutaneous Transluminal Angioplasty (PTA).

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

Carotid Revascularization

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage