Humana Commercial Clinical Policy

Humana Skin Lesion Surveillance Technologies Form

Effective Date

12/14/2023

Last Reviewed

NA

Original Document

  Reference



Description

A skin lesion is a nonspecific term referring to any change in the integumentary system (skin surface). Skin lesions may have pigment (color), be raised, flat, large, small, fluid filled or exhibit other characteristics. A lesion may be benign, malignant or premalignant.

Skin cancers are often referred to as nonmelanoma or melanoma, with nonmelanoma skin cancers behaving less aggressively than melanoma. The two most common types of nonmelanoma skin cancer arise from cells in layers of the epidermis (skin) for which they are named. Basal cell skin cancer originates in the basal (lowest) layer of the epidermis, while squamous cell skin cancer starts in the squamous (outer) layer of the epidermis. Most skin cancers occur on skin that is regularly exposed to sunlight or other ultraviolet radiation.

Skin Lesion Surveillance Technologies

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 2 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Melanoma originates in the melanocytes and usually presents as a brown or black lesion (mole, nevus), but can appear as pink, tan, white or nonpigmented (no color). Melanoma can appear anywhere on the body and may be difficult to detect in early phases. Surgical removal of the lesion is the standard treatment for melanoma.

However, More than 90% of melanomas that arise in the skin can be recognized with the naked eye.14 Biopsy is necessary when there is a sufficient index of suspicion. Histopathologic examination remains the standard for diagnosing melanoma and nonmelanoma skin cancer.23

Surveillance technologies for early detection of skin cancer (especially melanoma) help identify malignant skin lesions without requiring a biopsy or lesion removal. Skin lesion surveillance technologies used alone or in combination include, but may not be limited to:

  • Artificial intelligence (AI) systems use algorithms and standardized skin images to purportedly autonomously diagnose skin cancers, including basal cell carcinoma, squamous cell carcinoma and melanoma. One example of an AI system, 3DermSpot, has been designated by the US Food & Drug Administration (FDA) as a breakthrough device.
  • Confocal laser scanning microscopy, also called reflectance confocal microscopy (RCM), uses a low-power laser beam projected through a lens on a specific point on the skin and then detects the light reflected from the focal point through a filter. The reflected light is transformed into an electrical signal, which is recorded as an image by a computer. RCM purports to noninvasively provide distinctions between benign, malignant or pre-malignant lesions, obviate the need for any further investigations or actions, or may facilitate planning further diagnostic or treatment interventions.2 One type of such technology is the VivaScope system.
  • Dermoscopy is a skin examination procedure that uses a dermoscope, a handheld magnification tool, to reveal structures and patterns in lesions that are invisible to the unaided eye. The dermoscope may allow 10x or higher magnification by using high intensity light. Oil may be applied to the surface of the lesion to make the skin more transparent, but may not be necessary if a polarized light source and lens are used.

Other terms for dermoscopy include, but may not be limited to: cutaneous surface microscopy, dermatoscopy, digital epiluminescence microscopy (DELM), magnified oil immersion diascopy and melanomography. One example of an FDA- approved dermoscope is the DermLite.

Digital dermoscopy combines the scope with cameras, software and computerized systems that save and store images. VisioMed with DermaGraphix is an example of a digital dermoscope and software system.

Electrical impedance spectroscopy measures a skin lesion's overall resistance to the flow of alternating electric currents of various frequencies, compared to normal skin tissue. One such device, the Nevisense generates an automated melanoma risk score, and is suggested for use as an adjunct tool for the evaluation of melanoma-suspected lesions prior to the decision to biopsy.

Fluorescent molecular imaging (molecular fluorescent imaging, skin fluorescent imaging) purports to detect the presence of tissue remodeling within a nevus, indicating the transformation of normal cells to atypical cells, which potentially become cancerous. A proprietary fluorescent biotag that binds to the mole is applied topically, and then wiped away. A handheld device uses near infrared light to excite the retained dye and to capture fluorescent images. Associated software displays and analyzes images and provides a probability score for the presence of tissue remodeling associated with the transition from benign to atypia.

Optical coherence tomography (OCT) uses back reflected near infrared light to produce high-resolution cross-sectional images of the skin layers (dermis, epidermis and dermoepidermal junction). It is suggested for diagnostic use as an adjunct to standard excisional biopsy and to guide interventional procedures.

Single lesion or total body integumentary photography or video (mole mapping) uses a digital camera to record and store images that can be compared over time to determine if lesions have changed. Some devices, such as the MoleMax systems have the capacity to record video images, referred to as video dermoscopy. Three-dimensional (3D) photography and mole mapping is a more recent development, with VECTRA WB360 being one example of this new technology.

Smart phone/mobile health applications (apps) offer information about skin cancer prevention and enable individuals to take and store photographs to assist in detecting new lesions or changes in the color or size of an existing lesion. Most applications rely on the individual to share the images with a health care professional during an exam. Some include additional features, such as compatibility with an over-the-counter (OTC) dermoscope or the capacity to have images reviewed through the app by an expert.

Skin Lesion Surveillance Technologies

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 4 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding mobile health (mHealth) apps, please refer to Digital Therapeutics Medical Coverage Policy.

Total body imaging combines a digital camera with a computer and software for storage and retrieval of images. Some systems also include a dermoscope and purport to have automated image analysis with capability of comparing previous photographs. This may also be referred to as a multispectral system, multispectral digital skin lesion analysis (MDSLA), multispectral imaging or multispectral image analysis.

For information about skin lesions/testing related to conditions not addressed in this policy, please see the following:

  • Actinic keratoses - Actinic Keratoses Treatments
  • Benign skin lesion removal - Cosmetic Surgery, Reconstructive Surgery, Scar Revision
  • Genetic testing for familial melanoma risk - Genetic Testing for Cancer Susceptibility
  • Pigmented lesion assay for aiding in melanoma diagnosis - Gene Expression Profiling for Cancer Indications

Coverage Determination

Humana members may NOT be eligible under the Plan for skin lesion surveillance technologies using artificial intelligence (AI) systems. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Skin Lesion Surveillance Technologies
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 5 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for skin lesion surveillance using any of the following technologies alone or in combination via standard or 3D technology:

  • Confocal laser scanning microscopy/reflectance confocal microscopy; OR
  • Dermoscopy:
    • Cutaneous surface microscopy; OR
    • Dermatoscopy; OR
    • Digital dermoscopy; OR
    • Digital epiluminescence microscopy (DELM); OR
    • Magnified oil immersion diascopy; OR
    • Melanomography; OR
  • Electrical impedance spectroscopy; OR
  • Fluorescent molecular imaging (molecular fluorescent imaging, skin fluorescent imaging); OR
  • Optical coherence tomography (OCT); OR
  • Single lesion or total body integumentary photography or video (videodermoscopy); OR
  • Total body imaging:
    • Mole mapping; OR
    • Multispectral digital skin lesion analysis (MDSLA); OR
    • Multispectral image analysis

These are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Skin Lesion Surveillance Technologies
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 6 of 10

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional information about lesions, moles or skin cancer may be found from the following websites:

Background
  • American Academy of Dermatology
  • American Cancer Society
  • National Library of Medicine
Medical Alternatives

Alternatives to skin lesion surveillance technologies include, but may not be limited to, the following:

  • Self-inspection complemented with examination by a health care professional

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Skin Lesion Surveillance Technologies

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 7 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

No code(s) identified

1. American Academy of Dermatology (AAD).

Guidelines of care for the management of primary cutaneous melanoma. https://www.aad.org. Published January 2019. Accessed November 16, 2023.

References
  • American Academy of Dermatology (AAD). Position Statement. Reflectance confocal microscopy. https://www.aad.org. Published April 28, 2018. Updated July 27, 2019. Accessed November 16, 2023.
  • American Academy of Pediatrics (AAP). Policy Statement. Ultraviolet radiation: a hazard to children and adolescents. https://www.aap.org. Published March 01, 2011. Accessed November 27, 2023.
  • American Society for Dermatologic Surgery. Position Statement. Position on the use of dermoscopy and other non-invasive diagnostic tools. https://www.asds.net. Published September 2016. Updated March 2023. Accessed November 16, 2023.
  • ECRI Institute. Emerging Technology Evidence Report. Computer-aided multispectral digital analysis (MelaFind) for assessing atypical skin lesions. https://www.ecri.org. Published June 27, 2012. Updated June 5, 2015. Accessed November 7, 2023.
  • ECRI Institute. Hotline Response (ARCHIVED). Dermoscopy for diagnosing melanoma and other malignancies. https://www.ecri.org. Published November 25, 2009. Updated December 29, 2011. Accessed November 22, 2022.
  • ECRI Institute. Hotline Response (ARCHIVED). Whole body and single lesion surveillance photography for diagnosis of skin cancer. https://www.ecri.org. Published November 25, 2009. Accessed October 3, 2012.
  • Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Electrical impedance spectroscopy for diagnosis of melanoma. https://evidence.hayesinc.com. Published August 9, 2021. Accessed November 9, 2023.
  • Hayes, Inc. Health Technology Assessment. Reflectance confocal microscopy for diagnosis of cutaneous melanoma. https://evidence.hayesinc.com. Published December 20, 2019. Updated March 7, 2023. Accessed November 9, 2023.
  • Hayes, Inc. Health Technology Brief (ARCHIVED). Dermoscopy for detection of melanoma. https://evidence.hayesinc.com. Published August 10, 2007. Updated August 6, 2009. Accessed November 9, 2023.
  • Hayes, Inc. Health Technology Brief (ARCHIVED). MelaFind (MELA Sciences, Inc.) for detection of malignant melanoma. https://evidence.hayesinc.com. Published December 17, 2012. Updated December 4, 2014. Accessed November 9, 2023.
  • Hayes, Inc. Medical Technology Directory (ARCHIVED). Photographic surveillance for early detection of malignant melanoma. https://evidence.hayesinc.com. Published March 30, 2011. Updated February 6, 2015. Accessed November 9, 2023.
  • MCG Health. Malignant melanoma and pigmented skin lesions. 27th edition. https://www.mcg.com. Accessed October 17, 2023.
  • National Cancer Institute (NCI). Skin cancer screening (PDQ) – health professional version. https://www.cancer.gov. Updated May 24, 2022. Accessed November 16, 2023.
  • National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Melanoma: cutaneous.

Skin Lesion Surveillance Technologies
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 9 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • National Comprehensive Cancer Network (NCCN). https://www.nccn.org. Updated October 27, 2023. Accessed November 28, 2023.
  • UpToDate, Inc. Dermoscopic algorithms for skin cancer triage. https://www.uptodate.com. Updated October 2022. Accessed November 9, 2023.
  • UpToDate, Inc. Dermoscopic evaluation of skin lesions. https://www.uptodate.com. Updated October 2023. Accessed July 5, 2023.
  • UpToDate, Inc. Dermoscopy of facial lesions. https://www.uptodate.com. Updated October 2023. Accessed November 17, 2023.
  • UpToDate, Inc. Dermoscopy of mucosal lesions. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Dermoscopy of nail pigmentations. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Dermoscopy of nonpigmented nail lesions. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Dermoscopy of pigmented lesions of the palms and soles. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Melanoma: clinical features and diagnosis. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Overview of dermoscopy. https://www.uptodate.com. Updated October 2023. Accessed November 9, 2023.
  • UpToDate, Inc. Screening for melanoma in adults and adolescents. https://www.uptodate.com. Updated October 2023. Accessed November 16, 2023.
  • US Preventive Services Task Force (USPSTF). Recommendation Statement. Screening for skin cancer. https://www.uspreventiveservicestaskforce.org. Published July 26, 2016. Accessed November 28, 2023.

Skin Lesion Surveillance Technologies
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0391-019
Page: 10 of 10

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.