|Subject:||Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy and Ultrasonography)|
|Document #:||MED.00004||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses the use of photographic, optical, video, and other imaging technologies for the evaluation of skin lesions.
Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those which are primarily intended to preserve or improve appearance.
Not Medically Necessary:
Dermatoscopy (also known as dermoscopy, epiluminescence microscopy [ELM], or digital epiluminescence microscopy [DELM], skin surface microscopy, skin videomicroscopy, or incidence light microscopy) using either direct inspection, digitization of images, or computer-assisted analysis is considered not medically necessary in all cases.
Investigational and Not Medically Necessary:
Whole body integumentary photography, including melanomagram, is considered investigational and not medically necessary in all cases.
Ultrasonography for the evaluation of skin lesions is considered investigational and not medically necessary.
Cosmetic and Not Medically Necessary:
Ultrasonographic evaluation of photoaging, intrinsic aging and skin rejuvenation techniques is considered cosmetic and not medically necessary.
While there is extensive literature regarding dermatoscopy, the literature is inconclusive regarding its clinical role in the management of pigmented skin lesions, i.e., as a technique to select or deselect lesions for excision. At this time, there is insufficient evidence to support the use of this technology to improve outcomes either by reducing the frequency of unnecessary biopsies or improving early detection of malignant melanoma.
The diagnostic performance of dermatoscopy combined with clinical assessment must be compared with clinical assessment alone and with the "gold standard," histology. There are three clinical scenarios in which dermatoscopy might be of benefit: (1) Use of dermatoscopy to evaluate a lesion with low pretest possibility of malignancy to determine if excisional biopsy is necessary. In this scenario, the negative predictive value is the most relevant diagnostic parameter; (2) Use of dermatoscopy to evaluate multiple suspicious pigmented lesions to determine which of the multiple lesions are most clinically suspicious and in need of excision. In this scenario, the positive predictive value of dermatoscopy is the relevant diagnostic parameter; and (3) Serial assessment of lesions over time, as a means to prompt excision when a lesion changes in character in an individual with multiple pigmented lesions, or for lesions in a location difficult to excise. In this scenario, both the positive and negative predictive values of the results of serial imaging and clinical assessment are relevant.
In one study, sensitivity, specificity, and positive and negative predictive values were reported as 79.2%, 71.8%, 16.1%, and 98.1%, respectively (Argenziano, 2006). These results are in conflict with earlier reports of negative predictive value of 85% (Carli, 2003). Additionally, there is little data addressing the use of dermatoscopy in eliminating the need for biopsy and histologic examination of the lesion for the definitive diagnosis. While there have been randomized controlled trials of dermatoscopy, this technology is considered to be an adjunct in the work-up of equivocal melanocytic lesions. Biopsy and histologic examination are still required for the definitive diagnosis.
Cristofolini (1994) reported a case series of 220 pigmented skin lesions in which the sensitivity and specificity of dermatoscopy alone, clinical assessment alone or dermatoscopy combined with clinical assessment were compared with the histologic "gold standard." The sensitivities of clinical assessment alone, dermatoscopy, and dermatoscopy combined with clinical assessment were 85%, 88%, and 95% respectively. The measured specificities for clinical assessment alone, dermatoscopy, and dermatoscopy combined with clinical assessment were 75%, 79%, and 72%. While this study showed a modest increase in sensitivity with the combined use of dermatoscopy and clinical assessment, it is unclear whether this improved sensitivity is statistically or clinically significant.
A study of digital dermoscopy by Wollina and colleagues reported on their findings in 1308 subjects with 3354 pigmented lesions (2007). The authors reported sensitivity between 90% and 95%, and specificity between 79.6% and 93.3%. This is an improvement upon previous reports involving non-digital dermatoscopic methods, but further investigation is needed to confirm these findings.
Moloney and colleagues conducted a study evaluating the impact of full-body examinations every 6 months supported by dermoscopy and total-body photography (TBP) on all subjects and sequential digital dermoscopy imaging (SDDI), when indicated, on detecting primary melanoma in an extreme-risk population. The study population consisted of 311 subjects who had a history of invasive melanoma and dysplastic nevus syndrome, or a history of invasive melanoma and at least 3 first- or second-degree relatives with prior melanoma, or a history of at least 2 primary invasive melanomas, or a known CDKN2A or CDK4 gene mutation. Out of the 311 subjects followed, 75 primary melanomas were detected, and of these 38% were detected using TBP and 39% with SDDI. The benign to malignant excision ratio was 1.6:1 for all lesions excised and 4.4:1 for melanocytic lesions. Cumulative risk of developing a novel primary melanoma was 12.7% by year 2, with new primary melanoma incidence during the final 3 years of follow-up half of that observed during the first 2 years (incidence density ratio 0.43, [95% confidence interval (CI), 0.25-0.74]; p=0.002). Unfortunately this study does not provide any data regarding comparative health outcomes vs. standard surveillance and follow-up methods.
There is no conclusive data regarding the role of serial dermatoscopic monitoring compared to serial clinical monitoring. In addition, there is insufficient data to assess the impact of dermatoscopy on skin cancer-related morbidity and mortality.
The body of evidence addressing the use of whole body integumentary photography (also known as whole body photography or TBP) is currently limited. Only three peer-reviewed articles discuss the results of clinical trials using TBP (Feit, 2004; Menon, 2006; Risser, 2007). The first two studies lack control groups, do not address specificity or sensitivity issues, and do not report any data regarding alterations in health outcomes as a result of the use of this technique. The third study, by Risser and colleagues retrospectively investigated the impact of TBP on the clinical treatment of individuals seen in a pigmented lesion clinic. The authors reviewed the charts of 64 subjects who had undergone TPB and 64 who had not. The authors report that TBP had no impact on the number of biopsies or on the number of dysplastic nevi diagnosed in the first year of the clinic. Further evidence from well-controlled trials is needed to properly evaluate the health benefits of total body photography.
Ultrasonography (US) has been proposed for use in the assessment of skin tumors. US has been described as a tool for differentiation of common benign pigmented skin lesions from melanoma. There are only a few small nonrandomized controlled studies currently available in the literature describing this technique. US has also been used in the preoperative measurement of melanoma thickness in preparation for lesion excision. The studies addressing this procedure have been small nonrandomized controlled studies and the impact of US assistance in melanoma excision planning was not addressed in relation to any potential decrease in repeat excisions or other outcome measures. Other studies have investigated the use of US in the assessment of inflammatory skin lesions and connective tissue diseases. The evidence is limited to small case series studies that do not evaluate the impact of US on health outcomes or on clinical management. In the absence of such evidence the use of ultrasonography cannot be recommended for use in evaluation of skin lesions.
Finally, the use of ultrasonographic evaluation of photoaging, intrinsic aging and skin rejuvenation techniques is considered cosmetic and not medically necessary. These techniques are used for the sole purpose of improving appearance and they have not been found to have any significant impact on health outcomes.
Of the three main types of skin cancer, melanoma is the most aggressive and accounts for approximately 75% of all skin cancer related deaths. Treatment of melanoma is highly successful if caught early. The gold standard for evaluation of pigmented skin lesions is excision with examination of the lesion under a microscope for diagnosis. The sensitivity and specificity is nearly 100% for a skilled pathologist. The early phase of malignant melanoma can be particularly difficult to identify since malignant melanomas of skin can share many clinical features with atypical birthmarks, moles, or other benign skin lesions. Because of this diagnostic difficulty, multiple tools have been proposed in order to improve the accuracy of diagnosis of malignancies in pigmented skin lesions and therefore improve health outcomes, without necessarily requiring biopsy or excision of lesions for testing.
Dermatoscopy, epiluminescence microscopy (ELM), and the other techniques mentioned in this document have been introduced as non-invasive aids in the visual examination of pigmented skin lesions in-vivo (on the individual's body). While dermatoscopy is extensively used in Western Europe, it has gained only limited acceptance in the U.S. It is considered to be an extraneous diagnostic step in the work-up of suspected melanoma.
In addition, the use of the dermatoscope requires adequate training and experience to use it effectively and studies have shown that its use by practitioners without adequate training actually decreases diagnostic accuracy below that obtained from clinical examination alone. The brand names of epiluminescence microscopes that are available include, but are not limited to, the NevoscopeÔ, the EpiscopeÔ, the DermascopeÔ, and MoleMax™.
Dermatoscopy and all its forms use magnification of in vivo skin lesions for better visualization of surface and subsurface structures without requiring excision. This diagnostic tool permits the recognition of morphologic structures not visible to the naked eye. The technique involves placing mineral oil, alcohol or water on the skin lesion and inspecting it using a hand-held lens, a hand-held scope, a stereomicroscope, a camera, or a digital imaging system. The magnifications of these various instruments range from 6x up to 100x. The most commonly used dermatoscope has a 10x magnification. The fluid placed on the lesion eliminates surface reflection and renders the hardened external layer translucent, thus allowing a better visualization of pigmented structures within the epidermis, the dermoepidermal junction and the superficial dermis. Moreover, size and shape of vessels of the superficial vascular plexus can be easily visualized by this procedure. Dermatoscopy is proposed to increase the accuracy of the clinical diagnosis of pigmented lesions and particularly to aid in the early recognition of malignant melanoma.
Whole body integumentary photography involves photographing an individual's entire body surface. Photographs may be taken using either conventional or digital photography. The purpose of this procedure is to attain a visual record of the skin with the hope of being able to compare with future examinations to assist in the identification of new or changed skin lesions. This technology has been proposed as a tool in the management of individuals at high risk for skin cancer.
Ultrasound (US) imaging is a method of obtaining images from inside the body through the use of high frequency sound waves. Sound waves are emitted by a handheld probe and penetrate the body without any discomfort or sensation. These sound waves are reflected by the structures inside the body and received by a receiver in the probe. The echoes are then processed by a computer and displayed as a real-time visual image on a monitor. The image that is displayed shows movement of internal structures of the body as they occur, including blood flow in the veins and arteries, aiding diagnosis of a variety of conditions. US for use in evaluating skin lesions has been proposed as a method to allow assessment of blood supply, thickness and depth of the growth into the skin.
Dermatoscope: A hand-held device used for the examination of the structures of the epidermis and epidermal-dermal junction using magnification of about 10x.
Dermatoscopy (Dermascopy, Dermoscopy, DS): A family of noninvasive techniques (skin videomicroscopy, epiluminescence microscopy [ELM], incident light microscopy, skin surface microscopy) that allow microscopic examination of skin lesions. These techniques are intended to help distinguish between benign and malignant pigmented skin lesions using a dermatoscope, stereomicroscope, camera, or a digital imaging system. The magnifications of these various instruments range from 6x to 40x and up to 100x.
Dermoscopy (DS): Another name for Dermatoscopy; see Dermatoscopy.
Digital epiluminescence microscopy (D-ELM): A version of dermatoscopy that involves using digital photography of the dermatoscopic images; the computerized digital images are stored for comparison of the skin lesion(s) at a later date.
Epiluminescence microscopy (ELM): Another dermatoscopic technique that allows microscopic examination of skin lesions directly on the person, without requiring excision.
Incidence or incident light microscopy: Another term sometimes used for dermatoscopy, dermoscopy or ELM.
Melanomagram: A whole-body image produced by using a digital-picture dermatoscope (MoleMax). A full set of digital computer images are evaluated for the presence of skin lesions and then digitally archived for future use. These images are used to do side-by-side comparisons of past and current images to determine changes in size, color, or other skin cancer risk factors.
Skin surface microscopy: Another name for dermatoscopy.
Ultrasonography: The diagnostic or therapeutic use of ultrasound, which uses sound waves to create two-dimensional images used for the examination and measurement of body structures and the detection of abnormalities.
Videomicroscope, videomicroscopy, or videodermatoscopy: A technique that uses a video-microscope linked to a computer that generates a melanomagram of the whole body or body region.
Whole body integumentary photography: A procedure where the entire skin surface of an individual is photographed. The purpose of this procedure is to provide a reference source of skin lesions over time; pictures may be conventional pictures or digital images stored electronically; also see melanomagram.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Not Medically Necessary:
|96999||Unlisted special dermatological service or procedure [when specified as dermatoscopy techniques such as dermoscopy, epiluminescence microscopy, or digital epiluminescence microscopy, skin surface microscopy, skin videomicroscopy, or incidence light microscopy]|
When services are Investigational and Not Medically Necessary:
|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|
|96999||Unlisted special dermatological service or procedure [when specified as ultrasonography of the skin for skin lesions]|
When services are Cosmetic and not medically necessary:
|96999||Unlisted special dermatological service or procedure [when specified as ultrasonography of the skin for evaluation of photoaging]|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Incident Light Microscopy
Mirror Body Mapping
Skin Surface Microscopy
Total Body Photography
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||05/05/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Reference section. Removed ICD-9 codes from Coding section.|
|Reviewed||05/07/2015||MPTAC review. Updated Rationale and Reference sections.|
|Reviewed||05/15/2014||MPTAC review. Updated Reference section.|
|Reviewed||05/09/2013||MPTAC review. Updated Reference section.|
|Reviewed||05/10/2012||MPTAC review. Updated Reference section.|
|Reviewed||05/19/2011||MPTAC review. Updated Reference section.|
|Reviewed||05/13/2010||MPTAC review. Updated Reference section|
|Reviewed||05/21/2009||MPTAC review. Updated Reference section|
|Reviewed||05/15/2008||MPTAC review. The phrase "cosmetic/not medically necessary" was clarified to read "cosmetic and not medically necessary." Updated Coding and Reference sections.|
|02/21/2008||The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.|
|Revised||05/17/2007||MPTAC review. Added investigational/not medically necessary statement regarding whole body photography. Updated Rationale, Reference Coding and Index sections.|
|01/01/2007||Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed CPT codes 0044T, 0045T deleted 12/31/2006.|
|Reviewed||06/08/2006||MPTAC annual review. References updated.|
|11/22/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organization||Last Date Reviewed||Document Number||Title|
|01/28/2004||MED.00004||Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy and Ultrasonography)|
|WellPoint Health Networks, Inc.||09/23/2004||2.02.03||Dermatoscopy|
|06/24/2004||4.02.02||Ultrasonographic Evaluation of Skin Lesions|