Digital Epiluminescence Microscopy for the Diagnosis of Skin Lesions
Digital epiluminescence microscopy (e.g., MicroDERM®, MoleMax II™) is a noninvasive technique used for the early diagnosis of pigmented skin lesions and malignant melanoma. The procedure allows magnified visualization of pigmented skin lesions beyond what would be visible by the physician during a normal clinical examination. It is designed for small equivocal pigmented skin lesions. This technology may also be referred to as dermatoscopy, dermoscopy, skin surface microscopy, or incidence light microscopy.
POLICY
Digital epiluminescence microscopy for the diagnosis of skin lesions is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
The gold standard for evaluation of pigmented skin lesions is excision with histologic diagnosis.
Well-designed studies were not found in the published literatures that compare the diagnostic performance of digital epiluminescence microscopy combined with clinical assessment to clinical assessment alone.
SOURCES
Argenziano, G., Puig, S., Zalaudek, I., Sera, F., Corona, R., Alsina, M., et al. (2006). Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer. Journal of Clinical Oncology, 24 (12), 1877-1882. (Level 3 Evidence - Industry sponsored)
Argenziano, G., Zalaudek, I., Ferrara, G., Johr, R., Langford, D., Puig, S., et al. (2007). Dermoscopy features of melanoma incognito: Indications for biopsy. Journal of the American Academy of Dermatology, 56 (3), 508-513.
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010). Dermatoscopy (2.01.42.). Retrieved January 14, 2011 from BlueWeb. (22 articles and/or guidelines reviewed)
Engasser, H. C., & Warshaw, E. M. (2010). Dermatoscopy use by U. S. dermatologists: A cross-sectional survey. Journal of the American Academy of Dermatology, 63 (3), 412-419e2.
Fuller, S. R., Bowen, G. M., Tanner, B., Florell, S. R., & Grossman, D. (2007). Digital dermoscopic monitoring of atypical nevi in patients at risk for melanoma. Dermatologic Surgery, 33 (10), 1198-1206. (Level 3 Evidence - Independent study)
Haenssle, H. A., Krueger, U., Vente, C., Thoms, K. M., Bertsch, H. P., Zutt, M., et al. (2006). Results from an observational trial: Digital epiluminescence microscopy follow-up of atypical nevi increases the sensitivity and the chance of success of conventional dermoscopy in detecting melanoma. The Journal of Investigative Dermatology, 126 (5), 980-985.
Henning, S., Dusza, S. W., Wang, S. Q., Marghoob, A. A., Rabinovitz, H. S., Polsky, D., et al. (2007). The CASH (color, architecture, symmetry, and homogeneity) algorithm for dermoscopy. Journal of the American Academy of Dermatology, 56 (1), 45-52.
Malvehy, J., Puig, S., Argenziano, G., Marghoob, A. A., & Soyer, P. (2007). Dermoscopy report: Proposal for standardization. Results of a consensus meeting of the International Dermoscopy Society. Journal of the American Academy of Dermatology, 57 (1), 84-95.
Menzies, S. W., Kreusch, J., Byth, K., Pizzichetta, M. A., Marghoob, A., Braun, R., et al. (2008). Dermoscopic evaluation of amelanotic and hypomelanotic melanoma. Archives of Dermatology, 144 (9), 1120-1127.
National Cancer Institute. (2010, July). Screening for skin cancer. Retrieved January 14, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/skin/healthprofessional/allpages/print.
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Melanoma. (V.1.2011). Retrieved January 14, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf.
National Guideline Clearinghouse. (2008, July). Guidelines for the management of basal cell carcinoma. Retrieved January 14, 2011 from http://www.guidelines.gov.
Senel, E. (2011). Dermatoscopy of non-melanocytic skin tumors. Indian Journal of Dermatology, Venereology & Leprology, 77 (1), 16-22.
U. S. Food and Drug Administration. (2003, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040171. Retrieved January 14, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/k040171.pdf.
Wurm, E., Curchin, C. & Soyer, H. P. (2010). Recent advances in diagnosing cutaneous melanomas. F1000 Medicine Reports, 2, 46.
Zalaudek, I., Docimo, G., & Argenziano, G. (2009). Using dermoscopic criteria and patient-related factors for the management of pigmented melanocytic nevi. Archives of Dermatology, 145 (7), 816-826.
ORIGINAL EFFECTIVE DATE: 10/1/2000
MOST RECENT REVIEW DATE: 2/10/2011
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