Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2023 POLICY LAST REVIEWED: 01|07|2026

OVERVIEW There is interest in noninvasive devices that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (dermoscopy, epiluminescence microscopy, in vivo cutaneous microscopy), which enables the clinician to perform direct microscopic examination of diagnostic features in pigmented skin lesions. Another approach is computer-based light imaging systems. These techniques have the potential to improve diagnostic accuracy for suspicious skin lesions and may increase the detection rate of malignant skin lesions and/or reduce the rate of unnecessary biopsies. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans The following services are not covered as the evidence is insufficient to determine the effects of the technology on health outcomes: • Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis as a technique to evaluate or serially monitor pigmented skin lesions • Dermatoscopy for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision • Computer-based optical imaging devices, eg, multispectral digital skin lesion analysis, as a technique to evaluate or serially monitor pigmented skin lesions Note: Limited photography for documentation is considered part of record keeping and not separately reimbursed. Commercial Products The following services are not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes: • Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis as a technique to evaluate or serially monitor pigmented skin lesions • Dermatoscopy for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision • Computer-based optical imaging devices, eg, multispectral digital skin lesion analysis, as a technique to evaluate or serially monitor pigmented skin lesions Note: Limited photography for documentation is considered part of record keeping and not separately reimbursed. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage.
Medical Coverage Policy | Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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, is often used for comparator purposes if a lesion is being followed 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 dermatoscopy 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 (ABCD) structures 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 before surgical excision of skin tumors.

Computer-Based Optical Diagnostic Devices A U.S. Food and Drug Administration (FDA)‒approved multispectral digital skin lesion analysis device uses a handheld scanner to shine visible light on the suspicious lesion. The light is of 10 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 (ie, high degree of morphologic disorganization) or negative (ie, 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 to refer to biopsy. The FDA approved system (see details in the Regulatory Status section) is intended only for suspicious pigmented lesions on intact skin and for use only by trained dermatologists.

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 evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for computer-based optical diagnostic devices in patients who have lesions suspicious of melanoma includes several prospective diagnostic accuracy studies and a simulation study. Relevant

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. In the diagnostic accuracy study, 10% of samples were not evaluable and the simulation study had a number of potential biases. There are no studies comparing patient management decisions and health outcomes with and without these devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for dermatoscopy in patients who have pigmented lesions being monitored for suspicious changes consists of noncomparative studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The available does not clearly indicate that dermatoscopy results in better patient management decisions. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for computer-based optical diagnostic device in patients who have pigmented lesions being monitored for suspicious changes includes no published studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence for dermatoscopy and computer-based optical diagnostic devices in patients who have cancerous skin lesions referred for surgery includes 1 RCT and several observational studies. Relevant outcomes are overall survival, disease-specific survival, and treatment-related morbidity. The single RCT did not report superior outcomes using dermatoscopy compared with visual inspection or curettage. The published studies were all conducted outside of the United States and at least 2 did not use U.S. Food and Drug Administration‒approved devices. None addressed computer-based optical devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s), when performed with or without dermatoscopy, are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
96904 Whole body integumentary photography, for monitoring of high risk patients with dysplastic nevus syndrome or a history of dysplastic nevi, or patients with a personal or familial history of melanoma

There is no specific code for computer-based optical imaging devices. Claims should be filed with the following Unlisted CPT code(s): 96999 Unlisted special dermatological service or procedure

Whole body photography represents one component of dermatoscopy. CPT code 96904 may also be submitted to describe whole body photography without dermatoscopy.

RELATED POLICIES Unlisted Procedures

PUBLISHED Provider Update, March 2026 Provider Update, April 2025 Provider Update, April 2024 Provider Update, April 2023 Provider Update, June 2022

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

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

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.
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. 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
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. 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
11. 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.
12. 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
13. 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
14. 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
15. 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.
16. Caresana G, Giardini R. Dermoscopy-guided surgery in basal cell carcinoma. J Eur Acad Dermatol Venereol. 2010;24(12):1395-1399.
17. 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
18. 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-
19. 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. Sponsored by Lucid Inc. VivaNet Study: a multicenter study of confocal reflectance microscopy in telemedicine (NCT01385943). ClinicalTrials.gov. Accessed July 9, 2015.
22. Sponsored by MELA Sciences. Post-Approval Study of MelaFind (NCT01700114). www.clinicaltrials.gov. Accessed July 9, 2015.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

22. 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.
23. National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology, V3.2015. http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. . Accessed July 9, 2015.

24. American Acadey of Dermatology. Guidelines for the care and treatment of melanoma. 2011; http://www.aad.org/File%20Library/Global%20navigation/Education%20and%20quality%20care/guid elinetreatment-of-cutaneous-melanoma.pdf. Accessed July 9, 2015.

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS