Multispectral Digital Skin Lesion Analysis

POLICY NUMBER

L.2.01.439

DESCRIPTION

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

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 (ie, <1.0 mm) 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.

DiagnosisDifferentiating 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 a more-detailed examination of suspicious skin lesions. The available evidence from prospective randomized controlled trials 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 could improve melanoma detection and outcomes is multispectral digital skin lesion analysis (MSDSLA). A U.S. Food and Drug Administration (FDA) approved MSDSLA device uses a handheld scanner to shine a 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 for biopsy. The FDA-approved system (see details below) is intended only for suspicious pigmented lesions on intact skin and for use by trained dermatologists.

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

In November 2011, MelaFind® (MELA Sciences, Irvington, NY, now Strata Skin Sciences, Horsham, PA), a multispectral digital skin lesion analysis device, was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. 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 (ie, dermatologists) and only those who have successfully completed training on the MelaFind® device. The FDA documents have further noted:

“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).”

POLICY

Multispectral digital skin lesion analysis is considered investigational in 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 surgical excision.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

03/17/2016: Approved by Medical Policy Advisory Committee.

06/01/2016: Policy number A.2.01.101 added.

01/16/2017: Policy description updated. Policy statement unchanged.

01/31/2018: Policy description updated regarding devices. Policy statement unchanged.

06/18/2018: Code Reference section updated to add new CPT code 0061U, effective 07/01/2018.

12/22/2020: Code Reference section updated regarding deleted CPT codes.

05/02/2023: Policy updated to change the policy number from "A.2.01.101" to "L.2.01.439." Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT codes 0400T and 0401T.

06/06/2024: Policy reviewed; no changes.

08/01/2025: Policy reviewed. Policy statement unchanged. Sources updated.

SOURCE(S)

1. Blue Cross Blue Shield Association policy # 2.01.101

2. Ilisanu MA, Moldoveanu F, Moldoveanu A. Multispectral Imaging for Skin Diseases Assessment-State of the Art and Perspectives. Sensors (Basel). 2023 Apr 11;23(8):3888. doi: 10.3390/s23083888. PMID: 37112229; PMCID: PMC10140977. Accessed. May 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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