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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 hand-held 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 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 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 before surgical excision of skin tumors.
Computer-Based Optical Diagnostic Devices
An FDA-approved multispectral digital skin lesion analysis (MSDSLA) 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 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.
Dermatoscopic devices cleared by the FDA include:
One computer-based optical imaging device has been cleared by FDA. MelaFind® (MelaSciences Inc. Irvington, NY) was approved in November 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 (ie, 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). MelaFind is not designed to detect pigmented nonmelanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.”
Also, see the related medical policy, Ultrasonographic Evaluation of Skin Lesions.
POLICYDermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis, is considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.
Computer-based optical imaging devices e.g., multispectral digital skin lesion analysis, are considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.
Dermatoscopy and computer-based optical imaging devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision.
POLICY EXCEPTIONSFederal 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.
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 HISTORY11/2001: Approved by Medical Policy Advisory Committee (MPAC)
4/18/2002: Type of Service and Place of Service deleted
4/17/2003: Code Reference section updated
8/4/2005: Code Reference section updated, CPT code 0045T with effective date of 7/1/2003 added, CPT 0044T effective date of 7/1/2003 added, statement "Visual examination of skin lesions may be coded for by evaluation and management CPT codes." deleted Code Reference section
8/31/2006: Policy reviewed, no changes
12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
8/14/2009: Policy reviewed, description re-written, no changes in policy
12/30/2010: Link to related medical policy added to description. A new policy statement was added to indicated that dermatoscopy as a technique to define peripheral margins of basal cell carcinomas is considered investigational. The existing policy statement was changed from not medically necessary to investigational. FEP verbiage added to the Policy Exceptions section. Removed deleted codes 0044T and 0045T from the Code Reference section.
09/28/2011: Policy reviewed; no changes.
01/09/2013: Policy title changed from "Dermatoscopy" to "Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy" because the scope of the policy was changed to address dermatoscopy and computer-based optical imaging devices. Added the following policy statement: Computer-based optical imaging devices e.g., multispectral digital skin lesion analysis, are considered investigational as a technique to evaluate or serially monitor pigmented skin lesions. The last investigational policy statement was changed from "Dermatoscopy as a technique to define peripheral margins of basal cell carcinomas is investigational" to "Dermatoscopy and computer-based optical imaging devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision."
12/13/2013: Policy reviewed; no changes.
01/30/2015: Policy reviewed; description updated regarding devices. Policy statement unchanged.
08/03/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number L.2.01.423 added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.42
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.