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DESCRIPTIONUltrasonographic measurement of carotid intima-medial (or intimal-media) 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 intima-medial thickening, which is a surrogate marker for atherosclerosis, may provide an opportunity to intervene earlier in the atherogenic disease and/or monitor disease progression.
Coronary heart disease (CHD) accounts for 27% of all deaths in the U.S. Established major risk factors for 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 reduced levels of 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, with emphasis 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. ATP III recommends use of the Framingham criteria to further stratify those patients with 2 or more risk factors for more intensive lipid management. 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 improve the ability to diagnose those at risk of developing CHD, as well as disease progression, particularly for those at immediate risk.
The carotid arteries can be well visualized by ultrasonography, and ultrasonographic measurement of the carotid artery intima-medial thickness (CIMT) has been investigated as a technique to identify and monitor subclinical atherosclerosis. B-mode ultrasound is most commonly used to measure CIMT. The intima-medial thickness (IMT) 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 produced which represent the lumen-intima interface and the medica-adventitia interface. The distance between these two lines constitutes the IMT.
In February 2003, SonoCalc® (SonoSite) 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 IMT of the carotid artery from images obtained from ultrasound systems. Subsequently, several other devices have been approved through the 510(k) process. Product code: LLZ.
POLICYUltrasonographic measurement of carotid artery intima-medial thickness (CIMT) 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
10/16/2013: Policy reviewed; no changes.
08/18/2014: Policy reviewed; description updated. Policy statement revised to change "intimal-medial" to "intima-medial." Intent of policy statement unchanged.
12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 93895.
07/23/2015: Code Reference section updated for ICD-10.
11/03/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
06/06/2016: Policy number A.2.02.16 added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.02.16
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to your policy.
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