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DESCRIPTIONThe use of computer-aided evaluation (CAE) is proposed to assist radiologists’ interpretation of contrast-enhanced magnetic resonance imaging (MRI) of the breast and to improve the accuracy of diagnosis of malignancy.
The use of computer-aided evaluation (CAE) is proposed to assist radiologists’ interpretation of contrast-enhanced magnetic resonance imaging (MRI) of the breast. MRI of the breast is suggested as an alternative or adjunct to mammography or other screening and diagnostic tests because of its high sensitivity in detecting breast lesions. However, it has a high false-positive rate because it is difficult to distinguish between benign and malignant lesions. MRI may be used to screen women at high risk of breast cancer or to look for more extensive disease in women diagnosed with breast cancer who are eligible for breast-conserving surgery; it is also being studied to gauge the impact of cancer treatment.
CAE systems reviewed in this policy are intended to improve the specificity of MRI in detecting or measuring malignant tissue, while maintaining the generally high sensitivity of MRI. Improved ability to identify MRI-detected lesions are almost certainly benign could potentially reduce biopsy rates. There is anecdotal information that MRI may also reduce re-operation rates among patients undergoing breast-conserving surgery by more clearly identifying the tissue that should be removed. CAE may also reduce the time needed to interpret breast MRI images, which currently takes longer than reading mammograms.
CAE systems for MRI provide an easier way to interpret patterns of contrast enhancement across a series of images, which in turn may help identify lesions and their likelihood of being malignant. Two key aspects of enhancement (also called kinetics) are examined: 1) Within the first minute or so, how quickly does the lesion enhance up to a certain threshold (e.g., 50% or 100% of the initial value; rapid enhancement [>90% in 90 seconds] suggests malignancy)? 2) What is the subsequent pattern of enhancement (ie, continues to increase [persistently ascending], plateaus, or declines [called washout, which is associated with malignancy])?
In contrast to computer-aided detection systems used with mammography, CAE for MRI is not primarily intended to identify lesions for consideration by a radiologist. Unlike the subtle appearance of lesions on mammography, most cancers enhance on MRI. The challenge is determining which lesions are benign and which are malignant. A large number of images are produced during MRI of the breast: images are taken at varying “depths” throughout each breast multiplied by the number of times the breast is imaged to capture different time points in the enhancement process; this can produce hundreds of images. Radiologists view the images to detect suspicious areas, and then pick a region of interest and look at the enhancement pattern. However, there may be variations across radiologists in the regions of interest selected and in the precise definition of the region of interest. CAE systems, in contrast, use color-coding and differences in hue to indicate the pattern of enhancement for each pixel in the breast image, thereby allowing radiologists to analyze enhancement patterns systematically.
Several CAE systems for use with MRI of the breast have 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). Some of these systems may have broader uses beyond breast MRI. Examples of FDA-cleared devices include:
POLICYThe use of computer-aided evaluation for interpretation of magnetic resonance imaging of the breast is considered investigational.
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 HISTORY05/09/2012: Policy added.
04/04/2013: Policy reviewed; no changes.
03/11/2014: Policy reviewed; no changes.
02/17/2015: Policy reviewed; description updated. Policy statement unchanged.
07/13/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number A.6.01.45 added. Investigative definition updated in Policy Guidelines section.
10/13/2016: Policy description updated regarding devices. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.45
This may not be a comprehensive list of procedure codes applicable to this policy.
Computer-aided detection, including computer algorithm analysis of MRI image data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation, breast MRI (List separately in addition to code for primary procedure)
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