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Medical Policy: 06.01.26
Original Effective Date: May 2008
Reviewed: September 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
The use of computer-aided detection (CAD) is proposed to supplement radiologists’ interpretation of contrast-enhanced magnetic resonance imaging (MRI) of the breast. MRI of the breast is suggested as an alternative to mammography or other screening and diagnostic tests because of its high sensitivity in detecting breast lesions, even among women—for example younger women and those with denser breasts—where mammography is less accurate. However, it has a high false-positive rate because of the difficulty in distinguishing between benign and malignant lesions. MRI is also being studied to look for more extensive disease in women diagnosed with breast cancer and to gauge the impact of treatment. The CAD 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. The use of CAD may also shorten the time needed to interpret breast MRI images, which currently takes much longer than reading mammograms.
CAD systems for MRI essentially provide easier ways of interpreting the patterns of contrast enhancement and washout across a series of images, which in turn may help identify lesions and their likelihood of being malignant. In contrast to CAD systems used with mammography, CAD for MRI is not aimed primarily at identifying 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 the number of time 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 they can select 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. CAD systems, in contrast, use color-coding and differences in hue to indicate the patterns of enhancement for each pixel in the breast image. They thereby may allow the radiologist to analyze the enhancement patterns systematically. Some CAD programs apparently incorporate morphological characteristics as well to estimate a probability of malignancy.
At the present time, it is not clear how CAD systems are to be used with MRI. In the case of CAD with conventional mammography, the radiologist reads the original films first, makes an interpretation, and then reviews the CAD results. Because CAD is not 100% sensitive, lesions detected both before the use of CAD and after viewing the CAD results may be worked up. In this way, CAD can add to the sensitivity of mammography, but not its specificity. With MRI of the breast, the sensitivity is already high and the focus is primarily on increasing the specificity. In some articles, it appears that CAD is intended as an adjunct to the initial MRI reading, just as with CAD and mammography. In other articles, it is proposed as a way of speeding up the MRI reading process, and the precise protocol to be followed in reading the MRI images is not clear.
A Technology Evaluation Center (TEC) Assessment published in 2006 summarized published articles and abstracts comparing the sensitivity and specificity of MRI of the breast interpreted with and without the use of CAD systems and reported on cancer detection based on histological results. Unfortunately, the literature on the use of CAD with MRI of the breast is sparse overall and few studies address the specific situations in which CAD with MRI may be used in the clinical setting. Many of the few articles and abstract reviewed by TEC calculated test characteristics on the basis of lesions and not the number of women or breasts. In the screening population, many women would not have any lesions. Including these women might alter the results. Given MRI’s lower sensitivity in detecting ductal carcinoma in situ (DCIS), the mix of DCIS versus masses would affect the calculations of sensitivity and specificity and might affect the impact of the CAD system.
Prospective, well-designed and executed studies that look specifically at the addition of CAD with MRI for the specific uses of interest are needed to determine whether or not the use of CAD provides a positive clinical benefit to these patients.
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Prior Approval:
Not applicable
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Policy:
The use of computer-aided detection (CAD) for interpretation of contrast-enhanced magnetic resonance imaging (MRI) of the breast is considered investigational.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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0159T Computer-aided detection, including computer algorithm analysis of MRI imaging data for lesion characterization, pharmacokinetic analysis, with further physician review for interpretation, breast MRI. (List separately in addition to code for primary procedure).
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Selected References:
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Blue Cross Blue Shield Association. Computer-aided detection of malignancy with magnetic resonance imaging of the breast. Blue Cross Blue Shield Association; 2006 Jun 1; vol. 21, no. 4.
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TARGET [database online]. Plymouth Meeting (PA): ECRI Institute; Computer-assisted detection (CAD) with magnetic resonance imaging (MRI) to detect breast cancer. TARGET report 944. Oct 2003.
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DeMartini WB, Lehman CD, Peacock S et al. Computer-aided detection applied to breast MRI: assessment of CAD-generated enhancement and tumor size in breast cancers before and after neoadjuvant chemotherapy. Acad Radiol 2005;12(7):806-14.
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Williams TC, DeMartini WB, Partridge SC, Peacock S et al. Breast MR Imaging: computer-aided evaluation program for discriminating benign from malignant lesions. Radiology 2007 Jul;244(1):94-103.
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Meeuwis C, van de Ven SM, Stapper G et al. Computer-aided detection (CAD) for breast MRI: evaluation of efficacy at 3.0 T. Eur Radiol. 2010 Mar; 20(3):522-8. Epub 2009 Sep 2.
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Arazi-Kleinman T, Causer PA, Jong RA et al. Can breast MRI computer-aided detection (CAD) improve radiologist accuracy for lesions detected at MRI screening and recommended for biopsy in a high-risk population? Clin Radiol. 2009 Dec; 64(12):1166-74. Epub 2009 Oct 21.
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Wang LC, DeMartini WB, Partridge SC et al. MRI-detected suspicious breast lesions: predictive values of kinetic features measured by computer-aided detection. AJR Am J Roentgenol. 2009 Sep; 193(3):826-31.
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Muralidhar GS, Bovik AC, Sampat MP et al. Computer-aided diagnosis in breast magnetic resonance imaging. Mt Sinai J Med. 2011 Mar-Apr; 78(2):280-90. doi: 10.1002.msj.20248.
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Dorrius MD, der Weide MC, van Ooijen PM et al. Computer-aided detection in breast MRI: a systematic review and meta-analysis. Eur Radiol. 2011 Aug;21(8):1600-8. Epub 2011 Mar 15.
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Cho N, Kim SM, Park JS et al. Contralateral lesions detected by preoperative MRI in patients with recently diagnosed breast cancer: Application of MR CAD in differentiation of benign and malignant lesions. Eur radiol 2011 Apr 15. [Epub ahead of print].
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Levrini G, Sghedoni R, Mori C et al. Size assessment of breast lesions by means of a computer-aided detection (CAD) system for magnetic resonance mammography. Radiol Med. 2011 Mar 19. [Epub ahead of print].
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Policy History:
Date Reason Action
September 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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