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DESCRIPTIONUltrasonographic measurement of carotid intimal-medial thickness (CIMT) refers to the use of B-mode ultrasound to determine the thickness of the two innermost layers of the carotid artery wall, the intima and the media. Detection and monitoring of intimal-media thickening (atherosclerosis) may provide an opportunity to intervene earlier in the atherogenic disease and/or monitor disease progression.
Established major risk factors for coronary heart disease (CHD) have been identified by the National Cholesterol Education Program (NCEP) Expert Panel. These risk factors include elevated serum levels of low-density lipoprotein (LDL) cholesterol, total cholesterol, and high-density lipoprotein (HDL) cholesterol. Other risk factors include a history of cigarette smoking, hypertension, family history of premature CHD, and age. The third report of the NCEP Adult Treatment Panel (ATP III) establishes various treatment strategies to modify the risk of CHD, based in part on target goals of LDL cholesterol. Pathology studies have demonstrated that levels of traditional risk factors are associated with the extent and severity of atherosclerosis. However, at every level of risk factor exposure, there is substantial variation in the amount of atherosclerosis, presumably related to genetic susceptibility and the influence of other risk factors. Therefore, there has been interest in identifying a technique that can measure and monitor atherosclerosis that reflects the pathogenic endpoint of CHD risk factors. The carotid arteries can be well visualized by ultrasonography, and ultrasonographic measurements of the thickness of the carotid intimal medial (IMT) have been investigated as a technique to identify and monitor subclinical atherosclerosis.
B-mode ultrasound is most commonly used to measure CIMT. The intimal-medial thickness is measured and averaged over several sites in each carotid artery. Imaging of the far wall of each common carotid artery yields more accurate and reproducible IMT measurements than imaging of the near wall. Two echogenic lines are producted which represent the lumen-intima interface and the medica-adventitia interface. The distance between these two lines constitutes the IMT.
In February 2003, SonoCalc® (SonoMetric Health, LLC, Bountiful UT) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this software was substantially equivalent to existing image display products for use in the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems. Subsequently, several other devices have been approved through the 510(k) process.
POLICYUltrasonographic measurement of carotid artery intimal-medial thickness (IMT) as a technique of identifying subclinical atherosclerosis is considered investigational for use in the screening, diagnosis, or management of atherosclerotic disease.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY12/14/2006: Policy added.
3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
6/19/2009: Policy reviewed, policy statement re-written for clarity
07/16/2010: Policy description updated to add information about the FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
08/03/2011: Policy reviewed; no changes.
09/25/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.02.16
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.