Technologies for the Evaluation of Skin Lesions Suspected of Malignancy

Policy Number: MA-2.066

Effective Date: 2/1/2026

Policy

Whole body photography or digital dermatoscopy, without use of computer-assisted analysis, may be considered medically necessary when used to evaluate and monitor members with a history of primary melanoma and one of the following:

• greater than or equal to 25 nevi; OR
• presence of atypical/dysplastic nevi

Whole body photography or dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis, may be considered not medically necessary in all other situations. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these procedures.

Dermatoscopy and computer-assisted adjunctive devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these procedures.

The following technologies for the evaluation or monitoring of skin lesions are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with these procedures:

• electrical impedance devices (i.e., Nevisense)
• molecular fluorescent imaging
• multispectral image analysis (i.e., MelaFind)
• optical coherence tomography (OCT)
• reflectance confocal microscopy (RCM)

Cross-References

• MP 2.246 Genetic Testing for Familial Cutaneous Malignant Melanoma (CKDN2A, CDK4)
• MP 2.360 Gene Expression Profiling for Melanoma

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Dermatoscopy

Dermatoscopy, also known as dermoscopy, describes a family of noninvasive techniques that allow in vivo microscopic examination of skin lesions, and is intended to help distinguish between benign and malignant pigmented skin lesions. The technique involves application of immersion oil to the skin, which eliminates light reflection from the skin surface and renders the stratum corneum transparent. Using a magnifying lens, the structures of the epidermis and epidermal-dermal junction can then be visualized.

A handheld or stereomicroscope may be used for direct visual examination. Digitization of images, typically after initial visual assessment, permits storage and facilitates their retrieval, often used for comparison purposes if a lesion is being followed up over time.

A variety of dermatoscopic features have been identified that are suggestive of malignancy, including pseudopods, radial streaming, the pattern of the pigment network, and black dots. These features in combination with other standard assessment criteria of pigmented lesions, such as asymmetry, borders, and color, have been organized into algorithms to enhance the differential diagnosis of pigmented skin lesions. Dermatoscopic images may be assessed by direct visual examination or by review of standard or digitized photographs. Digitization of images, either surface or dermatoscopic images, may permit qualitative image enhancement for better visual perception and discrimination of certain features, or actual computer-assisted diagnosis.

Interpretation of dermatoscopic findings have evolved over time. Initially, lesions were evaluated using pattern analysis. More recently, several algorithms were developed, including the asymmetry, border, color, and dermatoscopic structures (ABCD) rule of dermatoscopy, the 3-point and 7-point checklists of dermatoscopy by Argenziano, the Menzies method, and the CASH algorithm. There remains a lack of consensus in the literature regarding the optimal dermatoscopic criteria for malignancy.

Dermatoscopy is also proposed in the serial assessment of lesions over time and for defining peripheral margins prior to surgical excision of skin tumors.

Computer-Based Optical Diagnostic Devices

A U.S. Food and Drug Administration (FDA)-approved multispectral digital skin lesion analysis (MSDSLA) device, also known as MelaFind, uses a handheld scanner to shine visible light on the suspicious lesion. The light is of ten wavelengths, varying from blue (430 nm) and near infrared (950 nm). The light can penetrate up to 2.5 mm under the surface of the skin. The data acquired by the scanner are analyzed by a data processor; the characteristics of each lesion are evaluated using proprietary computer algorithms. Lesions are classified as positive (i.e., high degree of morphologic disorganization) or negative (i.e., low degree of morphologic disorganization) according to the algorithms. Positive lesions are recommended for biopsy. For negative lesions, other clinical factors are considered in the decision of whether or not to refer to biopsy. The FDA-approved system is intended only for suspicious pigmented lesions on intact skin and for use only by trained dermatologists.

Electrical Impedance Spectroscopy

The Nevisense device is an electrical impedance spectrometer for melanoma detection. A handpiece connected to the tabletop device applies low current electrical signals to the skin and measures the impedance (resistance) to the flow of current in the tissue. The tip is placed on normal skin to measure baseline impedance and then on the suspicious lesion. The device screen then provides a score from 0 to 10 that reflects the degree of atypia in the lesion along with the positive and negative predictive value of the score. The device refers to lesions with scores up to 3.5 as “EIS negative” and scores from 3.5 to 10 as “EIS positives.”

Optical Coherence Tomography (OCT)

OCT is a noninvasive technique using an imaging technology based on light and optics. OCT uses eye-safe infrared light to obtain a 3D block of image at a higher resolution compared to other modalities. OCT is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This allows imaging of the tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of clinical conditions.

Reflectance Confocal Microscopy (RCM)

Reflectance confocal microscopy (RCM), also known as confocal scanning laser microscopy, is an imaging technology that allows the in vivo identification of cells and tissues of the epidermis and papillary dermis with nearly histologic resolution. RCM uses a low-power laser that emits near-infrared light (830 nm) that reflects off structures in the epidermis and creates a three-dimensional image, with resolution of approximately one micrometer comparable with standard histology at approximately 30x magnification. Melanin granules have a high refractive index, resulting in more light to be reflected back to the confocal microscope. Thus, areas of higher melanin concentration will appear as bright areas on a confocal image.

Molecular Fluorescent Imaging

The Orlucent^® system uses a proprietary biocompatible fluorescent peptide dye that binds to over expressed biomarker protein-receptors in the mole during advancement during tissue remodeling. The handheld imager uses near infrared light to excite the retained dye to capture the fluorescence from the target tissue delineating tissue remodeling as part of the transition process. The analysis software integrates tissue remodeling, including neoangiogenesis and tissue reorganization, with new characteristics (e.g., size, shape, and pigment) to create a probability score for the presence of tissue remodeling associated with the transition from benign to atypia. The Orlucent system identifies the presence of a biomarker preceding the structural changes that occur during transition from benign to atypia. This is unlike spectral imaging or impedance-based products that evaluate structural tissue reorganization.

Regulatory Status

Dermatoscopic devices cleared by the U.S. Food and Drug Administration (FDA) include:

• Episcope™ (Welch Allyn, Inc., Skaneateles Falls, NY) approved in 1995, intended use is to illuminate body surfaces and cavities during dermatoscopic examination.
• Neviscope™ (TRANSLITE, Sugar Land, TX) approved in 1996, intended use is to view skin lesions by either illumination or transillumination.
• Dermascope™ (American Diagnostic Corp., Hauppauge, NY) approved in 1999, intended use is to enlarge images for medical purposes.
• MoleMax™ (Derma Instruments, Austria) approved in 1999, intended use is to enlarge images for medical purposes.
  Product code: KZF.
• Demetra BDEM-01 (Barco N.V.), approved 2019, intended use to capture images of the skin and optimize the imaging and documentation workflow.
  Product code: PSN.
• MelaFind^® (MelaSciences Inc. Irvington, NY), a computer-based optical imaging device, was cleared by the FDA in November of 2011. Its intended use is to evaluate pigmented lesions with clinical or histological characteristics suggestive of melanoma. It is not intended for lesions with a diagnosis of melanoma or likely melanoma. MelaFind is intended for use only by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) and only those who have additionally successfully completed training on the MelaFind device.
  FDA product code: OYD.
• On December 7, 2015, FDA received a PMA (P150046) from SCIBASE AB for the Nevisense device, an electrical impedance spectrometer for melanoma detection. The Nevisense™ (Scibase AB, Stockholm, Sweden) received FDA PMA approval in June 2017.
  FDA product code: ONV.
• VivoSight™ is an OCT device that has received FDA-510(k) approval.

Rationale

Summary of Evidence

The evidence for dermatoscopy in patients who have lesions suspicious of melanoma includes a number of diagnostic accuracy studies and several meta-analyses. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The literature suggests that dermatoscopy is more accurate than naked eye examination when used in the expert clinical setting. The available evidence from prospective randomized controlled trials (RCTs) and other studies suggests that dermatoscopy used by specialists may lead to a decrease in the number of benign lesions excised and, when used by primary care physicians, may lead to fewer benign lesions being referred to specialists. The number of studies on the impact of dermatoscopy on patient management and clinical outcomes remains limited.

The American Academy of Dermatology in their 2019 Guidelines of Care for the Management of Primary Cutaneous Melanoma states that dermatoscopy can improve diagnostic accuracy and/or help direct optimal and adequate tissue sampling in the case of very large lesions.

The European Consensus-Based Interdisciplinary Guideline for Melanoma in their 2019 update states that whole-body photography with sequential examinations should be used for the early detection of melanoma in high-risk patients. They further state that sequential digital dermatoscopy can improve the early detection of melanoma and should be used in high-risk patients, with a high total nevus count.

NCCN, in their guideline for follow-up of patients with cutaneous melanoma, states that total-body photography and sequential digital dermoscopy may enhance early detection of new primary melanoma in patients with high mole count and/or presence of clinically atypical nevi.

Due to input from societal organizations, the evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

The evidence for dermatoscopy and computer-assisted adjunctive devices in defining peripheral margin of skin lesions suspected of malignancy prior to surgical excision is limited. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for technologies for the evaluation or monitoring of skin lesions includes several prospective diagnostic accuracy studies, case-studies, retrospective studies, and a simulation study. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The results of the current published literature for the evaluation of skin lesions lacks the data needed to conclude its clinical utility. The evidence is insufficient to determine the effects of the technology on health outcomes.

Definitions

Dermatoscope is an instrument used to perform dermatoscopy. Older dermatoscopes consist of a low-power (10×) magnifier, a nonpolarized light source, a transparent plate, and a light layer of mineral oil between the instrument and the skin. The mineral oil allows inspection of skin lesions without reflection from the skin surface. More recent dermatoscopes use polarized light to eliminate skin surface reflections.

Dermatoscopy refers to the examination of the skin using skin surface microscopy and is also called ‘epiluminoscopy’ and ‘epiluminescent microscopy.’ Dermatoscopy requires a high-quality magnifying lens and a powerful lighting system (a dermatoscope).

Dermoscopy another name for dermatoscopy.

Digital dermatoscopy is a version of dermatoscopy that involves using digital photography of the dermatoscopic images.

Melanoma is a malignant tumor of melanocytes that often begins in a darkly pigmented mole and can metastasize widely.

Non-invasive refers to a device or procedure that does not penetrate the skin or enter any orifice in the body.

Stratum corneum refers to the outermost horny layer of the epidermis.

Whole body photography is a procedure where the entire skin surface of an individual is photographed. The purpose of this procedure is to provide a reference for size of skin lesions over time; pictures may be convenient for comparison if dermatoscopic images are stored.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Investigational and therefore not covered:

Covered when medically necessary:

*If used for digital dermatoscopy

References

1. Kardynal A, Olszewska M. Modern non-invasive diagnostic techniques in the detection of early cutaneous melanoma. J Dermatol Case Rep. Mar 31, 2014; 8(1):1-8. PMID 24748903
2. Vestergaard ME, Macaskill P, Holt PE, et al. Dermoscopy compared with naked eye examination for the diagnosis of primary melanoma: a meta-analysis of studies performed in a clinical setting. Br J Dermatol. 2008;159(3):669-676. PMID
3. Rajpara SM, Botello AP, Townend J, et al. Systematic review of dermoscopy and digital dermoscopy/artificial intelligence for the diagnosis of melanoma. Br J Dermatol. 2009; 161(3):591-604.
4. Koelink CJ, Vermeulen KM, Kollen BJ, et al. Diagnostic accuracy and cost-effectiveness of dermoscopy in primary care: a cluster randomized clinical trial. J Eur Acad Dermatol Venereol. Nov 2014;28(11):1442-1449. PMID 25493316
5. Unlu E, Akay BN, Erdem C. Comparison of dermatoscopic diagnostic algorithms based on calculation: The ABCD rule of dermatoscopy, the seven-point checklist, the three-point checklist and the CASH algorithm in dermatoscopic evaluation of melanocytic lesions. J Dermatol. Jul 2014; 41(7):598-603. PMID 24807635
6. De Giorgi V, Grazzini M, Rossari S, et al. Adding dermatoscopy to naked eye examination of equivocal melanocytic skin lesions: effect on intention to excise by general dermatologists. Clin Exp Dermatol. 2011; 36(3):255-259
7. Rosendahl C, Tschandl P, Cameron A, et al. Diagnostic accuracy of dermatoscopy for melonocytic and nonmelanocytic pigmented lesions. J Am Acad Dermatol. 2011;64(6):1068-1073
8. Annessi G, Bono R, Sampogna F, et al. Sensitivity, specificity, and diagnostic accuracy of three dermoscopic algorithmic methods in the diagnosis of doubtful melanocytic lesions: the importance of light brown structureless areas in differentiating atypical melanocytic nevi from thin melanomas. J Am Acad Dermatol. 2007;56(5):759-767
9. Carli P, de Giorgi V, Chiarugi A, et al. Addition of dermoscopy to conventional naked-eye examination in melanoma screening: a randomized study. J Am Acad Dermatol. May 2004;50(5):683-689. PMID 15097950
10. Argenziano G, Puig S, Zalaudek I, et al. Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer. J Clin Oncol. Apr 20, 2006;24(12):1877-1882. PMID 16622262
11. Salerni G, Teran T, Puig S, et al. Meta-analysis of digital dermoscopy follow-up of melanocytic skin lesions: a study on behalf of the International Dermoscopy Society. J Eur Acad Dermatol Venereol. Jul 2013;27(7):805-814. PMID 23181611
12. Menzies SW, Emery J, Staples M, et al. Impact of dermoscopy and short-term sequential digital dermoscopy imaging for the management of pigmented lesions in primary care: a sequential intervention trial. Br J Dermatol. 2009;161(6):1270-1277
13. Asilian A, Momeni I. Comparison between examination with naked eye, curretage and dermoscopy in determining tumor extension before Mohs micrographic surgery. Adv Biomed Res. 2013;2:2. PMID 23930247
14. Suzuki HS, Serafini SZ, Sato MS. Utility of dermoscopy for demarcation of surgical margins in Mohs micrographic surgery. An Bras Dermatol. Jan-Feb 2014;89(1):38-43. PMID 24626646
15. Carducci M, Bozzetti M, de Marco G, et al. Preoperative margin detection by digital dermoscopy in the traditional surgical excision of cutaneous squamous cell carcinomas. J Dermatolog Treat. Apr 12, 2013;24(3):221-226. PMID 22390630
16. Carducci M, Bozzetti M, Foscolo AM, et al. Margin detection using digital dermatoscopy improves the performance of traditional surgical excision of basal cell carcinomas of the head and neck. Dermatol Surg. 2011;37(2):280-285
17. Caresana G, Giardini R. Dermoscopy-guided surgery in basal cell carcinoma. J Eur Acad Dermatol Venereol. 2010;24(12):1395-1399
18. Monheit G, Cognetta AB, Ferris L, et al. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. Feb 2011;147(2):188-194. PMID 20956633
19. Wells R, Gutkowicz-Krusin D, Veledar E, et al. Comparison of diagnostic and management sensitivity to melanoma between dermatologists and MelaFind: a pilot study. Arch Dermatol. Sep 2012;148(9):1083-1084. PMID 22986873
20. Rigel DS, Roy M, Yoo J, et al. Impact of guidance from a computer-aided multispectral digital skin lesion analysis device on decision to biopsy lesions clinically suggestive of melanoma. Arch Dermatol. Apr 2012;148(4):541-543. PMID 22351788
21. Malvehy J, Puig S, Argenziano G. Dermoscopy report: proposal for standardization. Results of a consensus meeting of the International Dermoscopy Society. J Am Acad Dermatol. 2007;57(1):84-95
22. National Comprehensive Cancer Network. Melanoma: cutaneous. Clinical practice guidelines in oncology, V2.2025
23. Swetter SM, Tsao H, Bichakjian CK, Curiel-Lewandrowski C, Elder DE, Gershenwald JE, Guild V, Grant-Kels JM, Halpern AC, Johnson TM, Sober AJ. Guidelines of care for the management of primary cutaneous melanoma. Journal of the American Academy of Dermatology. 2019 Jan 1;80(1):208-50.
24. Gerger A, Koller S, Kern T. Diagnostic applicability of in vivo confocal laser scanning microscopy in melanocytic skin tumors. J Invest Dermatol. 2005;124(3):493-498
25. Marghoob AA, Charles CA, Busam KJ, et al. In vivo confocal scanning laser microscopy of a series of congenital melanocytic nevi suggestive of having developed malignant melanoma. Arch Dermatol. 2005;141(11):1401-1412
26. Taber's Cyclopedic Medical Dictionary, 20th edition.
27. Cheng H, Guitera P. Systematic Review of Optical Coherence Tomography Usage in the Diagnosis and Management of Basal Cell Carcinoma. The British Journal of Dermatology. 2015;173(6):1371-1380.
28. US Food and Drug Administration (FDA). 501(k) Premarket Notification: number K192829. Demetra BDEM-01.
29. Swetter S, Geller AC. Melanoma: Clinical features and diagnosis. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated October 4, 2023. Literature review current through August 2025.
30. Marghoob A, Jaimes N. Overview of dermoscopy. In: UpToDate, Online Journal [serial online]. Waltham, MA: UpToDate; updated November 5, 2024. Literature review current through August 2025.
31. Dinnes J, Deeks JJ, Chuchu N, et al. Dermoscopy, with and without visual inspection, for diagnosing melanoma in adults. Cochrane Database of Systematic Reviews 2018, Issue 12. Art. No.: CD011902. DOI: 10.1002/14651858.CD011902.pub2
32. Deda LC, Goldberg RH, Jamerson TA, Lee I, Tejasvi T. Dermoscopy practice guidelines for use in telemedicine. NPJ Digit Med. 2022;5(1):55. Published 2022 Apr 27. doi:10.1038/s41746-022-00587-9
33. Tschandl P. Sequential digital dermatoscopic imaging of patients with multiple atypical nevi. Dermatol Pract Concept. 2018 Jul 31;8(3):231-237. doi:10.5826/dpc.0803a16. PMID: 30116670; PMCID: PMC6092075
34. Goodson AG, Florell SR, Hyde M, Bowen GM, Grossman D. Comparative analysis of total body and dermatoscopic photographic monitoring of nevi in similar patient populations at risk for cutaneous melanoma. Dermatol Surg. 2010 Jul;36(7):1087-98. doi:10.1111/j.1524-4725.2010.01589.x. PMID: 20653722; PMCID: PMC3025478.
35. Olsen CM, Carroll HJ, Whiteman DC. Estimating the attributable fraction for cancer: A meta-analysis of nevi and melanoma. Cancer Prev Res (Phila). 2010;3(2):233-245. doi:10.1158/1940-6207.CAPR-09-0108
36. Ferrante di Ruffano L, Takwoingi Y, Dinnes J, Chuchu N, Bayliss SE, Davenport C, Matin RN, Godfrey K, O'Sullivan C, Gulati A, Chan SA, Durack A, O'Connell S, Gardiner MD, Bamber J, Deeks JJ, Williams HC; Cochrane Skin Cancer Diagnostic Test Accuracy Group. Computer-assisted diagnosis techniques (dermoscopy and spectroscopy-based) for diagnosing skin cancer in adults. Cochrane Database Syst Rev. 2018 Dec 4;12(12):CD013186. doi:10.1002/14651858.CD013186. PMID: 30521691; PMCID: PMC6517147.
37. FDA Executive Summary Reclassification Panel Meeting on Skin Lesion Analyzers. Prepared for the Meeting of the General and Plastic Surgery Devices Advisory Panel. July 29, 2022.
38. Garbe C, Amaral T, Peris K, et al. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics - Update 2019. Eur J Cancer. 2020;126:141-158. doi:10.1016/j.ejca.2019.11.014
39. Quigley E. Atypical (dysplastic) nevi. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated August 12, 2025. Literature review current through August 2025.

Policy History

• MA 2.066
• 9/25/2025 Creation of policy.