CMS Reconsiders NCD for PTA

In light of recent data, the Centers for Medicare & Medicaid Services (CMS) is reconsidering the National Coverage Determination (NCD) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

The new data examines outcomes in patients for whom coverage is currently limited to participation in clinical trials and post approval studies.

CMS will examine whether coverage should be expanded to beneficiaries at high-risk for carotid endarterectomy (CEA) due to anatomic risk factors with asymptomatic carotid artery stenosis of less than or equal to 80 percent.

Under the current policy, patients at high-risk for CEA who have symptomatic carotid artery stenosis (CAS) less than 70 percent are covered for procedures performed using FDA approved CAS systems with embolic protection devices in facilities approved by CMS to perform CAS procedures. Patients at high-risk for CEA with symptomatic CAS between 50 percent and 70 percent and patients at high-risk for CEA with asymptomatic carotid artery stenosis less than or equal to 80 percent are covered in accordance with the Category B Investigational Device Exemption (IDE) clinical trials regulation (42, CFR 405.201) as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post approval studies (Medicare NCD Manual 20.7,B3).

PTA (with or without the placement of a stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary arteries. The procedure involves inserting a balloon catheter into a narrow or occluded blood vessel and inflating the balloon to recanalize and dilate the vessel. In doing this, blood flow through the diseased segment of a vessel is improved—the vessel patency is increased and embolization is decreased.

Symptoms of CAS include carotid transient ischemic attack (distinct focal neurological dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale greater than three with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). Patients who have had a disabling stroke (modified Rankin scale less than three) are not covered.

The determination that a patient is at high-risk for CEA and the patient’s CAS symptoms should be documented prior to performing any procedure.

The degree of CAS is measured by duplex Doppler ultrasound or carotid artery angiography and should also be recorded in the patient’s medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. Under the current NCD, if the stenosis is determined to be less than 70 percent by angiography, the CAS should not proceed.

The current NCD 20.7, which was only just issued Dec. 24, 2008 and went into effect Jan. 26 of this year, is available on the CMS Web site.


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