Archived Policies - Medicine


Dermatoscopy

Number:MED201.023

Effective Date:08-01-2011

End Date:01-31-2014

Coverage:

Dermatoscopy by any method (e.g., by direct inspection, digitization of images, ultraviolet photography or computer-assisted analysis is considered experimental, investigational and unproven for any indication, including but not limited to:

  • evaluation or serial monitoring of pigmented skin lesions; or
  • defining peripheral margins of basal cell carcinomas.

Description:

Dermatoscopy (dermoscopy, epiluminescence microscopy, in vivo microscopy) 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 handheld or stereomicroscope may be used for direct visual examination.  Digitization of photographic images, typically after initial visual assessment, permits storage and facilitates their retrieval, and is often used for comparison purposes if a lesion is being followed up 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, digitized or ultraviolet 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.  Ultraviolet photography is a photographic process of recording images by using light from the ultraviolet (UV) spectrum only.

Specialized clinics have been developed specifically to offer dermatoscopy.  The evaluation may be marketed as a “melanomagram.”   Dermatoscopy has been more widely investigated and adopted in Western Europe.  It has also been used to assess other conditions, including melanoma, basal cell carcinoma, squamous cell carcinoma, cylindromas, dermatofibroma, angioma, keratosis, warts, fungal infections, alopecia areata, female androgenic alopecia, monilethrix, netherton syndrome, vascular structures,  and chronic psoriasis (to monitor effects of long-term topical steroid therapy) and nail pigmentation.

Dermatoscopic devices cleared by the U.S. Food and Drug Administration (FDA) include:

  • EpiScope™ (Welch Allyn, Inc., New York) approved in 1995, intended use is to illuminate body surfaces and cavities during medical examination.
  • Nevoscope™ (TransLite, Sugarland, Texas) approved in 1996, intended use is to view skin lesions by either illumination or trans-illumination.
  • Dermascope™ (American Diagnostic Corp.) approved in 1999, intended use is to enlarge images for medical purposes.
  • MoleMax™ (Derma Instruments, Austria) approved in 1999, intended use is to enlarge images for medical purposes.

Rationale:

As with any diagnostic tool, assessment dermatoscopy involves a determination of its sensitivity, specificity, and positive and negative predictive values in different populations compared to a gold standard, and whether the results of the diagnostic tests are ultimately used to benefit health outcomes.  The gold standard for evaluation of pigmented skin lesions is excision with histologic diagnosis, for which, depending on the skill of the pathologist, sensitivity and specificity are considered near 100%.  The relevant health outcome is early diagnosis of a malignancy.  Clinically, dermatoscopy is used in combination with clinical assessment, based on either direct visual inspection or review of photographs.  Therefore, the diagnostic performance of dermatoscopy combined with clinical assessment must be compared with clinical assessment alone and then compared to the gold standard of histology.  There are four general clinical situations in which dermatoscopy might be of benefit:

  • Many patients present with an individual pigmented skin lesion, and a decision must be made whether or not its clinical appearance suggests malignancy and thus whether or not the skin lesion should be excised.  Given the importance of early identification of melanoma and the relative ease of excision, most suspicious skin lesions will be excised.  However, in many cases excised lesions turn out to be benign, and thus the patient has undergone excision unnecessarily.  Therefore, when patients present with a lesion with a low pretest possibility of malignancy, dermatoscopy could potentially be used to determine which lesions did not require excision, (i.e., a deselection process).  In this clinical situation, the negative predictive value of dermatoscopy is the most relevant diagnostic parameter.
  • Some patients may present with multiple suspicious pigmented skin lesions such that excision of all or even some of them is not possible.  In this clinical situation, a determination must be made which of the lesions is most clinically suspicious and requires excision.  In this setting, the positive predictive value of dermatoscopy is the most relevant diagnostic parameter.
  • Serial assessment of lesions over time, as a technique to prompt excision when a lesion changes shape or color, is commonly performed in patients with multiple pigmented lesions, or for lesions in locations difficult to excise.  Serial conventional photography has been used for the follow-up of pigmented lesions.  In addition, the use of digital photography has facilitated the storage and retrieval of images.  Serial assessment using digitized dermatoscopic images has also been suggested.  Both the positive and negative predictive values of the results of serial imaging using clinical or dermatoscopic assessment are relevant.  For example, do dermatoscopic changes precede clinical changes, thus increasing the sensitivity and positive predictive value of clinical assessment?
  • Use in defining peripheral borders of basal cell cancers to guide surgery.  If dermatoscopy combined with clinical assessment is more accurate than clinical assessment alone in defining tumor borders, then it might be possible to excise the tumor with a narrower margin, thus preserving a larger amount of normal skin.

Dermatoscopy for selecting or de-selecting lesions for excision

A variety of studies have reported on the diagnostic parameters of dermatoscopy criteria compared to clinical assessment with histologic examination serving as the gold standard.

Unfortunately, most studies are retrospective and most compare clinical assessment only to dermatoscopic assessment of stored photographs instead of the more clinically relevant comparison of clinical assessment alone compared with combined clinical and dermatoscopic assessment.  In addition, the studies do not subcategorize lesions into varying levels of pretest probabilities.  There were no studies identified that specifically looked at the potential diagnostic advantages of digitization of images as opposed to conventional photography.  Moreover, there is a lack of consensus in the literature regarding the optimal dermatoscopic criteria for malignancy and the optimal method of using the criteria to assess malignancy.  For example, dermatoscopic images may be evaluated qualitatively, with semiquantitative scoring according to algorithms, evaluated using statistical methods to assess risk of malignancy or evaluated using artificial neural networks.  Dermatoscopic criteria for malignant melanoma have undergone multiple modifications, with questions raised regarding their validity and reproducibility.  As recently as 2009, even in papers that advocate for the widespread use of dermatoscopy, the accuracy of algorithms developed to differentiate between various types of pigmented lesions has been questioned.  This variety of methods obviously complicates the evaluation of the data.  Another important issue is that the majority of the studies report on the performance of clinicians who have extensive experience with dermatoscopic imaging, and it is not clear whether these results can be duplicated in a community setting or what kind of formal training would be required.  A 2010 article by Lee reiterates that the generalizability of study findings to the general practice setting is still not known.   In addition, the article mentions that studies may artificially inflate the sensitivity of dermatoscopy for several reasons, including that they generally compare dermatoscopy to naked eye evaluation of morphology, which does not reflect actual clinical assessment that also takes history and context, e.g., patient’s degree of sun damage, into consideration.

Published meta-analyses of studies on the diagnostic accuracy of dermatoscopy

A meta-analysis published in 2001 by Bafounta et al. identified eight studies involving 328 melanomas and 1,865 mostly melanocytic benign pigmented lesions found that, for experienced users, dermatoscopy is more accurate than clinical examination for the diagnosis of melanoma in a pigmented lesion.  However, the authors concluded that the roles of the number of lesions analyzed, the percentage of melanoma lesions, the instruments used, and dermatoscopy criteria used in each study could not be proved.

In a 2008 meta-analysis, Vestergaard et al. reviewed studies on the diagnostic accuracy of dermatoscopy for the diagnosis of melanoma compared with naked eye examination.  All of the studies were performed in an expert setting.  Nine studies met the inclusion criteria; two were randomized controlled trials; seven used a cross-sectional design.  The authors compared the diagnostic accuracy of dermatoscopy with naked eye examination using a reference test on consecutive patients with a defined clinical presentation.  Hierarchical summary receiver operator curve analysis was used to estimate the relative diagnostic accuracy for clinical examination with, and without, the use of dermatoscopy.  The pooled relative diagnostic odds ratio for melanoma, for dermatoscopy compared with naked eye examination, was found to be 15.6 (range: 2.9–83.7); removal of two small outlier studies changed this to 9.0 (range: 1.5–54.6). The authors concluded that dermatoscopy is more accurate than naked eye examination for the diagnosis of cutaneous melanoma in suspicious skin lesions when performed in the clinical setting.  The limitations of this meta-analysis include variability across the studies in the following study characteristics:

  • patient and lesion selections;
  • naked eye criteria for melanoma;
  • dermatoscopy criteria for melanoma; and
  • follow-up.

A 2009 meta-analysis by Rajpara et al. reviewed studies on dermatoscopy using a hand-held dermatoscope, as well as studies on digital dermatoscopy with computer-aided diagnosis (CAD,  [The latter technique was called artificial intelligence in the article]).  The studies could be prospective or retrospective, evaluated dermatoscopy performed by experts, and used histology of excised lesions as the reference standard.  Studies were not required to compare dermatoscopy to naked eye examination; thus, the study was not able to compare the diagnostic accuracy of dermatoscopy or digital dermatoscopy with CAD to clinical examination.  The investigators identified 30 studies; all but one, which was conducted in Iran, were studies from Europe.  A total of 9,784 melanoma lesions were included in the review; of these, 8,045 were analyzed by dermatoscopy and 2,420 by computer-aided diagnosis.  The investigators conducted pooled analyses of studies, grouping them by the type of algorithm used for diagnosis (e.g., pattern analysis, ABCD rule, etc.).  The pooled sensitivity for dermatoscopy (30 analyses) was 0.88 (95% confidence interval [CI]: 0.87-089) and the pooled specificity was 0.86 (95% CI: 0.85-0.86).  For digital dermatoscopy with CAD, the pooled sensitivity was (12 analyses) 0.91 (0.88-0.93), and the pooled specificity was 0.79 (95% CI: 0.77-0.81). The pooled specificity of the CAD diagnosis was significantly lower than the dermatoscopy analysis; pooled sensitivities did not differ significantly. There were no significant differences in overall diagnostic performance of different algorithms. The authors noted that, whereas dermatoscopy has been used by trained clinicians in a practice setting, computer-aided diagnosis has only been used in experimental settings using pre-selected lesions.

A representative review of the larger clinical studies

Binder and colleagues reported on a study of 240 pigmented skin lesions, photographed both with surface photography and with dermatoscopy.  (Both images were magnified 16 times). Histologic diagnosis was available for all.  The resulting 480 photographs were presented randomly and in an unpaired fashion to a group of six dermatoscopy experts and thirteen dermatologists who were not specifically trained in dermatoscopy.  Although not explicitly described, evaluation of the dermatoscopic images was presumably qualitative.  To assess intraobserver variability, 24 pairs of slides were presented twice.  The slides were arranged such that corresponding pairs of slides from an individual lesion were not presented sequentially, and thus the clinically relevant combined assessment of surface and dermatoscopic images for a single lesion was specifically excluded.  Among the 240 lesions, about 24% were malignant melanoma and 17.5% were histologically classified as a dysplastic nevus.  The rest were benign lesions.  Among the dermatoscopic experts, the intraobserver agreement was 0.57 for surface photography versus 0.56 for dermatoscopy.  The intraobserver agreement was 0.40 for surface microscopy versus 0.47 for dermatoscopy, indicating only a moderate degree of agreement for either technique.  The median sensitivity and specificity for surface microscopy in detecting malignant melanoma was 58% and 91%, respectively, compared to 68% and 91%, respectively, for dermatoscopy.  While the improvement in sensitivity from 58% to 68% was clinically significant (p=0.02), the more clinically relevant positive and negative predictive values were not reported.  In addition, the sensitivity of dermatoscopy among non-experts actually significantly decreased compared to surface photography.  A subsequent study by Binder reported that short-term formal training improves the diagnostic performance of dermatologists.

Cristofolini and colleagues reported on a series of 220 pigmented skin lesions in which the diagnostic parameters of clinical assessment, dermatoscopic assessment, and combined assessment were compared with histology.  The sensitivity and specificity of the techniques are summarized below:

Technique

Sensitivity (%)

Specificity (%)

Clinical Assessment Alone

85

75

Dermatoscopy

88

79

Combined

94

72

Nachbar and colleagues reported on a semiquantitative method of evaluation of 172 dermatoscopic images compared to a clinical assessment.  The ABCD rule of dermatoscopy was applied (asymmetry, border, color, differential structure) and those scoring above or below 5.45 were classified as malignant or benign, respectively.  The following results were reported:

Technique

Sensitivity (%)

Specificity (%)

Positive Predictive Value

Negative Predictive Value

Clinical

84

84

90

73

Dermatoscopy

83

91

96

85

As noted above, while dermatoscopy was associated with an improved negative predictive value, it is unlikely that a negative predictive value of 85% would be adequate to eliminate consideration of excision.  In addition, it is not known whether the improvement of the positive predictive value from 90% to 96% is statistically or clinically significant.

In 2000, Ascierto and colleagues reported on a series of 8,782 subjects with 15,719 skin lesions evaluated dermatoscopically.  Based on dermatoscopic assessment the lesions were further classified from very low to very high risk for malignant melanoma.  Excision was advised for all high-risk lesions.  In medium- and low-risk lesions, excision was justified for cosmetic or functional reasons.  The sensitivity and specificity of dermatoscopy were then compared to the histologic results of the 2,731 excised lesions.  For very high- and high-risk lesions, the positive and negative predictive value of dermatoscopy was 86.4% and 96.6%, respectively.  In the low-risk group, the positive and negative predictive values were 93.1% and 95.4%, respectively.  There are no data regarding the diagnostic performance of dermatoscopy compared to clinical assessment alone, or in combination with dermatoscopy.

A 2007 study by Annessi et al. compared dermatoscopy using three algorithmic methods with clinical diagnosis in 198 consecutive atypical macular melanocytic lesions.  Compared against the gold standard of histopathologic diagnosis, dermatoscopy with pattern analysis and the ABCD method had similar sensitivity (85% vs. 84%, respectively).  Specificity (79% vs. 75%, respectively) and positive predictive value (80% and 76%, respectively) were modestly higher for pattern analysis.  Results with the 7-point checklist were sensitivity of 78% and specificity of 65%.

Langley et al. conducted a study in 2007 to evaluate the diagnostic accuracy of confocal scanning laser microscopy (CSLM) compared to dermatoscopy in a prospective examination of benign and malignant melanocytic lesions.  Patients (n=125) with suspicious pigmented lesions were prospectively recruited to undergo a clinical, dermatoscopic and CSLM examination.  All patients had lesions studied; 88 melanocytic nevi and 37 melanomas.  Dermatoscopy had a sensitivity of 89.2%; specificity of 84.1%; positive predictive value of 70.2%; negative predictive value of 94.9%.  CSLM was found to have a sensitivity of 97.3%; specificity of 83.0%; positive predictive value of 70.6%; negative predictive value of 98.6%.  No melanomas were misidentified when both techniques were used together.  The authors concluded that CSLM had a relatively higher sensitivity than dermatoscopy.  However, they noted that, the specificity was similar with CSLM and dermatoscopy, suggesting that the two techniques are complementary.

Menzies et al. conducted a retrospective study in 2008 of lesions lacking significant pigment to determine the predictive dermatoscopic features of amelanotic and hypomelanotic melanoma.  A total of 105 melanomas (median Breslow thickness, 0.76 mm), 170 benign melanocytic lesions, and 222 non-melanocytic lesions lacking significant pigment (amelanotic, partially pigmented, and light colored) were imaged using glass-plate dermatoscopy devices and scored for 99 dermatoscopic features.  Diagnostic models were derived from and tested on independent randomly selected lesions.  The digital dermatoscopic images were predominantly hospital-based clinics from members of the International Dermoscopy Society on five continents.  The main outcome measures included odds ratios for individual features and models for the diagnosis of melanoma and malignancy.  The most significant negative predictors of melanoma were having multiple (greater than three) milia-like cysts (odds ratio [OR], 0.09; range: 0.01–0.64), comma vessels with a regular distribution (OR 0.10; 0.01–0.70), comma vessels as the predominant vessel type (OR 0.16; 0.05–0.52), symmetrical pigmentation pattern (OR 0.18; 0.09–0.39), irregular blue-gray globules (OR 0.20; 0.05–0.87), and multiple blue-gray globules (OR 0.28; 0.10–0.81).  The most significant positive predictors were having a blue-white veil (OR13; range: 3.9–40.0), scar-like depigmentation (4.4; 2.4–8.0), multiple blue-gray dots (OR 3.5; 1.9–6.4), irregularly shaped depigmentation (3.3; 2.0–5.3), irregular brown dots/globules (OR 3.2; 1.8–5.6), 5 to 6 colors (OR 3.2; 1.6–6.3), and predominant central vessels (OR 3.1; 1.6–6.0).  A simple model, based on eight criteria, distinguishing melanomas from all non-melanomas, had a sensitivity of 70% and a specificity of 56% in the test set.  In the training set, the sensitivity was 75% and specificity was 66%.  The authors concluded that, “Although the diagnostic accuracy of dermatoscopy for melanoma lacking significant pigment is inferior to that of more pigmented lesions, features distinguishing the former from benign lesions can be visualized on dermatoscopic evaluation.”   This study was based on morphology.  It did not include clinical information useful in formulating the diagnostic methods.  Such information may improve diagnostic accuracy for these lesions in clinical practice.  In addition, the study included selection biases.  Lesions were recruited from multiple centers, retrospectively, and may not have been consecutive patients at each institution.  The hypomelanotic lesions were not photographed, leading to missing data and a morphological bias.

In 2009, the International Dermoscopy Society began recruitment for a comparative study designed to identify features that are the most reproducible and diagnostically significant in the diagnosis of melanoma into a single dermatoscopic criteria algorithm.  Currently more than eight different methods are recognized for dermatoscopic analysis of melanocytic lesions.  The study will include 800 melanocytic lesions collected from ten centers around the world.  No expected completion date is available; patients continue to be recruited.

Serial Assessment of Lesions

Kittler and colleagues reported on 1,862 sequentially digitally recorded dermatoscopic images from 202 patients with multiple clinically atypical nevi.  Excision was recommended if substantial modifications in the dermatoscopic images were noted.  A total of 75 lesions from 52 patients were excised; 67 (89.3%) were histologically diagnosed as benign lesions.  The eight malignant lesions showed a change in size in addition to appearance of dermatoscopic structures that are associated with malignancy.  It is unclear from these data whether or not dermatoscopic evaluation can better target changing lesions for excision.  In addition, the study did not compare the use of serial dermatoscopy with serial surface photography.

A study published in 2009 by Menzies et al. aimed to evaluate whether short-term sequential digital dermatoscopy imaging (SDDI) (i.e., every three months) could reduce the rate of referral or biopsy compared to clinical examination alone.  The study was conducted in a general practice setting in Australia.  Participating physicians were trained in the use of dermatoscopy with SDDI by means of two-hour workshop and online training.  Seventy-four physicians completed the training and 63 of these (85%) then assessed 374 lesions (median of six lesions per physician). Based on clinical assessment with the naked eye alone, all 374 lesions were assessed as requiring excision or referral.  With dermatoscopy, lesions were triaged to three groups: 110 were received immediate referral or excision, 192 were assigned to close follow-up with SDDI, and 72 were assigned to observation for change.  The 192 SDDI lesions were re-evaluated three months later. At that time, 46 lesions were referred/excised, six were triaged to continue SDDI, and 140 were triaged to standard observation.  At the third visit (a total of six months from the initial visit), referral/excision was recommended for two of the six SDDI lesions, and the other four returned to standard care.  In addition, five of the lesions previously recommended for observation were triaged to referral/excision.  Thus, in this group of 374 lesions that would all have been recommended for referral/excision with clinical examination alone, the combined dermatoscopy and SSDI intervention reduced the number of referrals/excisions by about half, to 163 (44%) of lesions.  However, it is not known how many of the patients triaged to referral or excision would ultimately have had a biopsy.

Dermatoscopy for defining peripheral margins prior to surgery

One study was identified that evaluated dermatoscopy used to define peripheral borders of skin tumors to guide surgical excision.  This prospective study from Italy, published in 2010, included 200 consecutive patients with basal cell carcinoma.  In the study, 2-mm excision margins were used.  The margins were first marked using the naked eye only, and then the borders were confirmed using dermatoscopy.  There was concordance in the peripheral margins drawn using the naked eye and dermatoscopy in 131 of 200 (66%) cases.  In 69 cases, there was a larger margin with dermatoscopy, but this did not exceed 1-mm more than the clinical measurement in 55 (80%) of the 69 cases.  According to histological analysis, surgical excision using the 2-mm margin was found to be adequate in 197 of the 200 cases. After 10-30 months of follow-up, none of the 200 treated cases had signs or symptoms of recurrence.  Because surgery was performed using the margins drawn with dermatoscopy in all cases, the study could not compare margins drawn using naked eye (clinical) assessment plus dermatoscopy to clinical assessment alone.

In July 2007, the International Dermoscopy Society (IDS) embarked on creating a consensus document for the standardization and recommended criteria necessary to effectively convey dermatoscopic findings to consulting physicians and colleagues.  The final items included in the document are as follows:

  1. pertinent personal and family history (recommended);
  2. clinical description of the lesion (recommended);
  3. the two-step method of dermatoscopy differentiating melanocytic from non-melanocytic tumors (recommended);
  4. the use of standardized terms to describe structures (recommended);
  5. the dermatoscopic algorithm used (optional);
  6. information on the imaging equipment and magnification (recommended);
  7. clinical and dermatoscopic images of the tumor (recommended);
  8. a diagnosis or differential diagnosis (recommended);
  9. decision concerning the management (recommended);
  10. specific comments for the pathologist when excision and histopathologic examination are recommended (optional).

The National Comprehensive Cancer Network (NCCN) melanoma guideline does not mention dermatoscopy.  Biopsy is recommended for suspicious pigmented lesions.

Summary

Although the literature regarding dermatoscopy is extensive, it is insufficient for determining whether use of the technique (i.e., for selecting or deselecting lesions for excision) leads to improved health outcomes.  Two meta-analyses found that overall the diagnostic accuracy of dermatoscopy was higher than clinical assessment/naked eye examination.  However, definitive conclusions could not be drawn due to variability in the studies’ design, including patient selection criteria and diagnostic criteria.  Most studies were conducted outside the U.S. Moreover, there are insufficient data regarding the impact of serial dermatoscopic monitoring on health outcomes compared to serial clinical monitoring.  Thus, dermatoscopy to evaluate or serially monitor pigmented skin lesions is considered experimental, investigational and unproven.   There are insufficient data on the added value of using dermatoscopy for defining peripheral margins of basal cell carcinomas to guide surgical excision; thus, this application of dermatoscopy is considered experimental, investigational and unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None

CODING:

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

96904

HCPCS Codes

 

ICD-9 Diagnosis Codes

172.0, 172.1, 172.2, 172.3, 172.4, 172.5, 172.6, 172.7, 172.8, 172.9, 216.0, 216.1, 216.2, 216.3, 216.4, 216.5, 216.6, 216.7, 216.8, 216.9, V10.82

ICD-9 Procedure Codes

None

ICD-10 Diagnosis Codes

C43.0 – C43.9, D22.0 – D22.9, D23.0 – D23.9, Z85.820

ICD-10 Procedure Codes

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

Centers for Medicare and Medicaid (CMS) does not have a national coverage position.  Medicare coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Bahmer, F.A., Fritsch, P., et al.  Terminology in surface microscopy.  Journal of the American Academy of Dermatology (1990) 23:1159-62.

Nachbar, F., Stolz, W., et al.  The ABCD rule of dermatoscopy.  High prospective value in the diagnosis of doubtful melanocytic skin lesions.  Journal of the American Academy of Dermatology (1994) 30:551-9.

Cristofolini, M., Zumiani, G., et al.  Dermatoscopy: usefulness in the differential diagnosis of cutaneous pigmented lesions.  Melanoma Research (1994) 4:391-4.

Stanganelli, I., Burroni, M., et al.  Intraobserver agreement in interpretation of digital epiluminescence microscopy.  Journal of the American Academy of Dermatology (1995) 66:584-9.

Binder, M., Puespoeck-Schwarz, M., et al.  Epiluminescence microscopy of small pigmented skin lesion.  Short-term formal training improves the diagnostic performance of dermatologists. Journal of the American Academy of Dermatology (1997) 36:197-202.

Argenziano, G., Fabbrocini, G., et al.  Epiluminescence microscopy for the diagnosis of doubtful melanocytic skin lesions.  Comparison of the ABCD rule of dermatoscopy and a new 7-point checklist based on pattern analysis.  Archives of Dermatology (1998)134:1563-70.

Andreassi, L., Perotti, R., et al.  Digital dermoscopy analysis for the differentiation of atypical nevi and early melanoma: a new quantitative seminology.  Archives of Dermatology (1999) 135:1459-65.

Ascierto, P.A., Palmieri, G., et al.  Sensitivity and specificity of epiluminescence microscopy: evaluation on a sample of 2731 excised cutaneous pigmented lesions.  British Journal of Dermatology (2000) 142:893-8.

Kittler, H., Pehamberger, H., et al.  Follow up of melanocytic skin lesions with digital epiluminescence microscopy: patterns of modifications observed in early melanoma, atypical nevi, and common nevi.  Journal of the American Academy of Dermatology (2000) 43:467-76.

Bafounta, M., Beauchet, A., et al.  Is dermoscopy (epiluminescence microscopy) useful in the diagnosis of melanoma?  Results of a meta-analysis using techniques adapted to the evaluation of diagnostic tests.  Archives of Dermatology (2001) 137(10):1343-50.

Annessi, G., Bono, R., et al.  Sensitivity, specificity, and diagnostic accuracy of three dermoscopic algorithmic methods in the diagnosis of doubtful melanocytic lesions: the importance of light brown structureless areas in differentiating atypical melanocytic nevi from thin melanomas.  Journal of the American Academy of Dermatology (2007) 56(5):759-67.

Langley, R.G., Walsh, N., et al. The diagnostic accuracy of in vivo confocal scanning laser microscopy compared to dermoscopy of benign and malignant melanocytic lesions: a prospective study. Dermatology 2007; 215(4):365-72.

Malvehy, J., Puig, S., et al. International Dermoscopy Society Board members. Dermoscopy report: proposal for standardization. Results of a consensus meeting of the International Dermoscopy Society. J Am Acad Dermatol 2007; 57(1):84-95.

Menzies, S.W., Kreusch, J., et al. Dermoscopic evaluation of amelanotic and hypomelanotic melanoma. Arch Dermatol 2008; 144(9):1120-7.

Vestergaard, M.E., Macaskill, P., et al. Dermoscopy compared with naked eye examination for the diagnosis of primary melanoma: a meta-analysis of studies performed in a clinical setting. Br J Dermatol 2008; 159(3):669-76.

Argenziano, G., Ferrara, G., et al. Dermoscopy: the ultimate tool for melanoma diagnosis. Semin Cutan Med Surg 2009; 28(3):142-8.

Menzies, S.W., Emery, J., et al. Impact of dermoscopy and short-term sequential digital dermoscopy imaging for the management of pigmented lesions in primary care: a sequential intervention trial. Br J Dermatol 2009; 161(6):1270-7.

Rajpara, S.M., Botello, A.P., et al. Systematic review of dermoscopy and digital dermoscopy/artificial intelligence for the diagnosis of melanoma. Br J Dermatol 2009; 161(3):591-604.

Caresana, G., Giardini, R. Dermoscopy-guided surgery in basal cell carcinoma. J Eur Acad Dermatol Venereol 2010 Dec) 24(12):1395-9.

Lee, J.B., Hirokawa, D. Dermatoscopy: facts and controversies. Clin Dermatol 2010; 28(3):303-10.

Dermatoscopy.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual. (2010 Sept.) Medicine 2.01.42.

National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology, v1.2011. Available at www.nccn.org (accessed January 31, 2011).

Policy History:

8/1/2011          Document updated with literature review. The coverage position was revised as follows:  Dermatoscopy by any method (e.g., by direct inspection, digitization of images, ultraviolet photography or computer-assisted analysis is considered experimental, investigational and unproven for any indication, including but not limited to: evaluation or serial monitoring of pigmented skin lesions; or defining peripheral margins of basal cell carcinomas.  Rationale completely revised.

5/1/2008          Revised/Updated Entire Document

3/15/2006        Revised/Updated Entire Document

8/15/2003        New Medical Document

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