Latest Review Date: October 2024

Category: Medicine                                                               

POLICY:

Multispectral digital skin lesion analysis is considered investigational for all situations including, but not limited to:

• Evaluating pigmented skin lesions
• Serially monitoring pigmented skin lesions
• Defining peripheral margins of skin lesions suspected of malignancy prior to excision.

DESCRIPTION OF PROCEDURE OR SERVICE:

Multispectral digital skin lesion analysis (MSDSLA) is a noninvasive approach to diagnosing skin lesions; the technique has 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.

Melanoma is a form of skin cancer that originates in the pigment-producing melanocytes. Most melanocytes produce melanin and the tumors are commonly pigmented brown or black. Melanoma is less common than basal and squamous cell skin cancer, but it is more likely to metastasize than other skin cancers. Prognosis is highly associated with stage of the disease at diagnosis, characterized by the depth of the tumor, the degree of ulceration and the extent of spread to lymph nodes and distant organs. For example, for thin (i.e., ≥1.0mm) localized stage 1 cancers the 5 year survival rate is over 90% and this decreases to around 15 to 20% for metastatic stage IV cancers. Thus, early detection of disease is important for increasing survival.

Diagnosis

Differentiating melanoma lesions from benign pigmented lesions in the clinical setting is challenging. Diagnostic aids such as the ABCDE rule have been developed to assist clinicians when they visually inspect suspicious lesions. The diagnostic accuracy of the ABCDE criteria varies depending on whether they are used singly or together. Use of a single criterion is sensitive but not specific, which would result in many benign lesions being referred or biopsied. Conversely, use of all criteria together is specific but not sensitive, meaning that a number of melanomas are missed.

There is interest in noninvasive approaches that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (also called dermoscopy) which enables the clinician to perform direct microscopic examination of diagnostic features in pigmented skin lesions. Devices consist of a 10x magnifier lens in combination with a liquid medium or polarized light to eliminate reflection and allow for more-detailed examination of suspicious skin lesions. 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.

Another technology that can potentially improve melanoma detection and outcomes is multispectral digital skin lesion analysis (MSDSLA). 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 (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 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.

In May 2017, the manufacturer of MelaFind® announced that it would no longer support or commercialize the device.

KEY POINTS:

The most recent literature update was performed through October 7, 2024.

Summary of Evidence

For individuals who have pigmented lesions being evaluated for melanoma who receive MSDSLA, the evidence includes two prospective diagnostic accuracy studies of MelaFind®, a retrospective analysis of MelaFind® in a clinical setting, and additional studies of other MSDSLA devices. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, other test performance measures, and change in disease status. The diagnostic accuracy study found that MSDSLA had a sensitivity of 98.2% for recommending biopsy of melanoma lesions (8% of the pigmented lesions were melanoma). The average specificity of MSDSLA was 9.5% compared with 3.7% among clinicians. However, the study only included lesions already determined by a clinician to be sufficiently suspicious to warrant excision. No prospective studies conducted in a clinical setting have evaluated the utility of MSDSLA as a diagnostic tool in the initial evaluation of pigmented lesions. In addition, given the absence of firm evidence about the clinical validity of MSDSLA, a chain of inference cannot be built to support conclusions about the magnitude of benefits and harms of MSDSLA use in practice. The manufacturer discontinued support and commercialization of the MelaFind® device in 2017. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on melanoma (v.1.2018)14 do not address multispectral digital skin lesion analysis.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence guidance on the assessment and management of melanoma does not address multispectral digital skin lesion analysis.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Digital skin lesion analysis, MelaFind, MSDSLA, pigmented skin lesions

APPROVED BY GOVERNING BODIES:

A multispectral digital skin lesion analysis device called MelaFind® (MELA Sciences, Irvington, NY, now Strata Skin Sciences, Horsham, PA) was approved by the U.S. Food and Drug Administration (FDA) in November 2011 Its intended use is to evaluate pigmented lesions with clinical or histologic 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 documents further note:

“MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e., not for use on nonpigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (i.e., nonulcerated or nonbleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or subungual areas).”

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

PREVIOUS CODING:

CPT Codes:

REFERENCES:

1. Aloupogianni E, Ishikawa M, Kobayashi N, Obi T. Hyperspectral and multispectral image processing for gross-level tumor detection in skin lesions: a systematic review. J Biomed Opt. 2022 Jun;27(6):060901. doi: 10.1117/1.JBO.27.6.060901. 
2. American Cancer Society. Melanoma Skin Cancer. www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-survival-rates-by-stage.
3. Ferris LK, Harkes JA, Gilbert B, et al. Computer-aided classification of melanocytic lesions using dermoscopic images. J Am Acad Dermatol. Nov 2015; 73(5):769-776.
4. Fink C, Jaeger C, Jaeger K, et al. Diagnostic performance of the MelaFind device in a real-life clinical setting. J Dtsch Dermatol Ges. Apr 2017; 15(4):414-419.
5. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): MelaFind. 2011; www.accessdata.fda.gov/cdrh_docs/pdf9/P090012b.pdf.
6. Hauschild A, Chen SC, Weichenthal M, et al. To excise or not: impact of MelaFind on German dermatologists' decisions to biopsy atypical lesions. J Dtsch Dermatol Ges. Jul 2014; 12(7):606-614.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Luttrell MJ, McClenahan P, Hofmann-Wellenhof R, et al. Laypersons' sensitivity for melanoma identification is higher with dermoscopy images than clinical photographs. Br J Dermatol. Nov 2012; 167(5):1037-1041.
9. MarketWatch. 10-Q: Strata Skin Sciences, Inc. 2017; www.marketwatch.com/story/10-q-strata-skin-sciences-inc-2017-05-15.
10. Monheit G, Cognetta AB, Ferris L, et al. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. Feb 2011; 147(2):188-194.
11. National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: Melanoma. Version 1.2017. https://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf.
12. National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: Melanoma. Version 1.2018. www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf.
13. National Institute on Health and Care Excellence (NICE). Melanoma: assessment and management [NG14]. www.nice.org.uk/guidance/ng14/chapter/1-Recommendations#assessing-melanoma-2.
14. 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.
15. Rogers T, Marino M, Dusza SW, et al. Triage amalgamated dermoscopic algorithm (TADA) for skin cancer screening. Dermatol Pract Concept. Apr 2017; 7(2):39-46.
16. Song E, Grant-Kels JM, Swede H, et al. Paired comparison of the sensitivity and specificity of multispectral digital skin lesion analysis and reflectance confocal microscopy in the detection of melanoma in vivo: A cross-sectional study. J Am Acad Dermatol. Dec 2016;75(6):1187-1192 e1182.
17. 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.
18. Winkelmann RR, Farberg AS, Tucker N, et al. Enhancement of International Dermatologists' Pigmented Skin Lesion Biopsy Decisions Following Dermoscopy with Subsequent Integration of Multispectral Digital Skin Lesion Analysis. J Clin Aesthet Dermatol. Jul 2016; 9(7):53-55.
19. Winkelmann RR, Rigel DS, Ferris L, et al. Correlation Between the Evaluation of Pigmented Lesions by a Multi-spectral Digital Skin Lesion Analysis Device and the Clinical and Histological Features of Melanoma. J Clin Aesthet Dermatol. Mar 2016; 9(3):36-38.
20. Winkelmann RR, Rigel DS, Kollmann E, et al. Negative predictive value of pigmented lesion evaluation by multispectral digital skin lesion analysis in a community practice setting. J Clin Aesthet Dermatol. Mar 2015; 8(3):20-22.
21. Winkelmann RR, Tucker N, White R, et al. Pigmented skin lesion biopsies after computer-aided multispectral digital skin lesion analysis. J Am Osteopath Assoc. Nov 2015; 115(11):666-669.
22. Winkelmann RR, Yoo J, Tucker N, et al. Assessment of a diagnostic predictive probability model provided by a multispectral digital skin lesion analysis device for melanoma and other high-risk pigmented lesions and its impact on biopsy decisions. J Clin Aesthet Dermatol. Dec 2014; 7(12):16-18.
23. Winkelmann RR, Yoo J, Tucker N, et al. Impact of guidance provided by a multispectral digital skin lesion analysis device following dermoscopy on decisions to biopsy atypical melanocytic lesions. J Clin Aesthet Dermatol. Sep 2015; 8(9):21-24.

POLICY HISTORY:

Medical Policy Panel, December 2015

Medical Policy Group, December 2015 (2) : Creation of new policy

Medical Policy Administration Committee, January 2016

Available for comment January 1 through February 14, 2016

Medical Policy Panel, December 2016

Medical Policy Group, December 2016 (7): 2016 Updates to Key Points, Approved by Governing Bodies, and References. No changes in Policy Statement.

Medical Policy Panel, December 2017

Medical Policy Group, December 2017 (7): 2017 Updates to Key Point and References. No change in Policy Statement. Policy Retired. Effective 12/20/17: Active policy but no longer scheduled for regular literature reviews and update.

Medical Policy Group, August 2021 (5): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, September 2022 (5): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points and References. No change to Policy Statement.

Medical Policy Group, September 2023 (5): Updates to Key Points and Benefit Application. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, October 2024 (5): Reviewed by consensus. Minor update to Key Points. No change to Policy Statement. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.