Archived Policies - Medicine


Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

Number:MED201.023

Effective Date:05-15-2017

End Date:06-30-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Multispectral digital skin lesion analysis is considered experimental, investigational and/or unproven 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.

Reflectance confocal microscopy skin lesion analysis is considered experimental, investigational and/or unproven 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.

Description:

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 (i.e., <1.0 mm) localized stage I cancers the 5-year survival rate is over 90% and this decreases to 15% to 20% for metastatic stage IV cancers. (1) Thus, early detection of disease is important for increasing survival.

Differentiating 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.

One technique, reflectance confocal microscopy (RCM), is similar to dermatoscopy. It is a non-invasive imaging tool that uses a low-power laser to make available imaging of the epidermis and papillary dermis. RCM uses the natural reflectivity of different structures such as melanocytes to help differentiate between benign and malignant lesions; this enables the clinician to perform an examination of diagnostic features in skin lesions. RCM studies have been executed to assist in identifying the differences between melanocytic and nonmelanocytic neoplasms.

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 visible light on the suspicious lesion. The light is of 10 wavelengths, varying from blue (430 nm) and near infrared (950 nm). This 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 (i.e., high degree of morphologic disorganization) or negative (i.e., 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 the Regulatory Status section) is intended only for suspicious pigmented lesions on intact skin and for use by trained dermatologists.

Regulatory Status

In November 2011, MelaFind® (MELA Sciences, Irvington, N.Y., 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 (i.e., dermatologists) and only those who have successfully completed training on the MelaFind® device. 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).”

FDA product code: OYD.

A dermatoscopic device also cleared by the FDA is the VivaScope® System (Lucid, Inc.) (reflectance confocal microscopy [RCM]) approved in 2008, intended use is to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment. (17)

Rationale:

A search of the MEDLINE database was completed through March 31, 2017. This section has been substantially revised. Following is a summary of the key literature to date.

This policy refers to the use of multispectral digital skin lesion analysis (MSDSLA) and reflectance confocal microscopy (RCM) for the evaluation of lesions suspicious for malignancy.

No published evidence was identified on the use of MSDSLA for monitoring skin lesions or for evaluating cancerous lesions referred for surgery.

Use of MSDSLA devices is intended to inform decisions whether patients with pigmented lesions should undergo a biopsy. It is not clearly defined whether MSDSLA is intended to select patients for biopsy (rule in) or to select those who may undergo observation (rule out).

The evaluation of MSDSLA for diagnosis focuses on 3 main principles: 1) analytic validity (technical accuracy of the test in detecting the marker that is present or in excluding a marker that is absent); 2) clinical validity (diagnostic performance of the test [sensitivity, specificity, positive and negative predictive values] in detecting clinical disease or defining prognosis); and 3) clinical utility (i.e., a demonstration that the diagnostic or prognostic information can be used to improve patient health outcomes).

MSDSLA For Evaluating Pigmented Skin Lesions

Analytic Validity

No studies were identified on technical accuracy of MSDSLA methods for the evaluation of pigmented lesions suspicious for malignancy.

Diagnostic Accuracy

As with any diagnostic tool, assessment of MSDSLA technology involves a determination of its diagnostic accuracy compared with a reference standard and whether the results of the diagnostic tests are ultimately used to improve health outcomes. The reference standard for evaluation of pigmented skin lesions is excision with histologic diagnosis, in which, depending on the skill of the pathologist, sensitivity and specificity are considered near 100%. Clinically, noninvasive techniques such as MSDSLA would be used in combination with clinical assessment, either based on direct visual inspection or review of photographs. Therefore, the diagnostic performance of MSDSLA combined with clinical assessment should be compared with clinical assessment alone and then to the reference standard of histology. In addition, health outcomes in patients managed with MSDSLA versus standard care (clinical assessment alone, or clinical assessment and dermatoscopy) should be evaluated.

Most published studies to date on MSDSLA were industry-sponsored and/or coauthored by employees of or consultants for MELA Sciences, manufacturer of MelaFind.

A study published by Monheit et al. (2011) contained the data submitted to the U.S. Food and Drug Administration (FDA) for approval of the MelaFind device. (2) This prospective study included patients with at least 1 pigmented lesion scheduled for first-time biopsy. Lesions were between 2 mm and 22 mm in diameter. The following were exclusion criteria: anatomic site was not accessible to the device; lesion was not intact (e.g., open sores, ulcers, bleeding); lesion was on a palmar, plantar, or mucosal surface or under nails; lesion was in an area of visible scarring; and the lesion contained tattoo ink, splinter, or other foreign matter. In addition, lesions with a prebiopsy diagnosis of melanoma were excluded from analysis. Histologic diagnosis was used as the reference standard.

A total of 1393 patients with 1831 lesions were enrolled at major academic centers. Of the 1831 lesions, 1632 (90%) were eligible and evaluable. There were 165 lesions not evaluable for various reasons, including operator error, camera malfunction, and ineligibility after enrollment related to scarring. Histologic analysis determined that 127 (7.8%) of 1632 lesions were melanoma. The sensitivity of MSDSLA for recommending biopsy of the melanoma lesions was 98.2% (125/127 melanomas), with a 95% lower confidence interval (CI) bound of 95.6%. The average specificity (averaged over clinicians) of MSDSLA for melanoma was 9.5%. The accuracy of clinician diagnosis was determined by randomly selecting 25 melanoma cases and matching them with 25 nonmelanoma lesions. Clinicians were asked to classify lesions into 2 categories of melanoma: cannot rule out melanoma or not melanoma. The specificity of clinician diagnosis, as determined by the proportion of melanomas among the total number of lesions recommended for biopsy, was 3.7%, which was significantly lower than the specificity for MSDSLA (p=0.02). The Monheit study only included lesions previously examined clinically and determined to be sufficiently suspicious to warrant biopsy. The study did not include patients initially presenting with pigmented lesions to see whether MelaFind could enhance the accuracy of diagnosis based on clinical examination findings alone.

In 2016, Winkelman et al. reported on further analysis of the same 1632 lesions, to correlate MSDSLA classifier scores with histopathologic severity and clinical features of melanoma. (3) Mean classifier scores were higher for melanomas (3.5) than for high grade lesions (2.7; p=0.002), low-grade dysplastic nevi (7.1; p<0.001), nondysplastic nevi (1.6; p<0.001), and benign non-melanocytic lesions (2.0; p<0.001).

In 2015, Winkelmann et al. also reported on the diagnostic accuracy of MelaFind for evaluating suspicious lesions obtained from patients undergoing routine skin examination in a community practice. (4) Dermatologists identified suspicious lesions and selected them for biopsy. Prior to biopsy, the lesions were imaged with MelaFind (all met the FDA-approved indication for use of the device). (The study protocol did not involve reevaluation of images using MSDSLA findings.) Lesions were then biopsied and the diagnostic accuracy of MSDSLA for these lesions was determined and compared with histopathologic analysis of samples. A total of 137 consecutive lesions scheduled for biopsy were included in the study. MSDSLA categorized 21 of these lesions as having “low disorganization” (negative MSDSLA finding). All 21 of these lesions were histologically benign (11 mildly dysplastic nevi, 9 seborrheic keratosis, 1 compound nevus). The remaining 116 lesions were categorized by MSDSLA as having high disorganization (positive MSDSLA finding). Ninety-nine (85%) of these lesions were considered to be “true positives” (i.e., malignant melanoma, lesions with atypical melanocytic proliferation, moderately and severely dysplastic nevi). The study population included only 1 true melanoma and this was categorized by MSDSLA as having high disorganization. Advantages of this study were its prospective design and practice setting. However, as with the Monheit study, it did not evaluate the ability of MSDSLA to enhance the accuracy of biopsy decisions.

In 2016, Song et al. reported on a smaller study comparing the diagnostic accuracy of MDLSA with reflectance confocal microscopy (RCM) in the prebiopsy detection of melanoma in 55 atypical-appearing lesions from 36 patients undergoing biopsy. (5) MDSLA was performed with MelaFind and RCM was performed with VivaScope, by separate evaluators who were blinded to others’ evaluations. RCM was more sensitive than MDSLA (p=0.001). For the diagnosis of melanoma, MDSLA had a sensitivity of 71.4%.

Other studies have reported on the clinical performance of image-based classifiers other than MelaFind. In 2015, Ferris et al. reported on the training and validation of a novel classifier. (6) The classifier was trained on a malignant test set (105 melanomas, 29 high-grade dysplastic nevi, 23 basal cell carcinomas, 3 squamous cell carcinomas) and a benign training set (93 benign melanocytic lesions, 20 other benign lesions). In receiver operating characteristic curve analysis, with a threshold severity score of 0.4, the area under the curve was 0.818. The classifier’s performance was evaluated in a test set containing 39 melanomas, 11 basal cell carcinomas, 3 squamous cell carcinomas, and 120 benign lesions, all with available biopsy results, and 27 lesions considered not appropriate for biopsy by 2 dermatologists. The classifier’s sensitivity for melanoma was 97.4% (95% CI, 86.5% to 99.9%). Among the 120 benign lesions, 53 were correctly classified as benign (specificity, 44.2%; 95% CI, 35.1% to 53.5%); among the 27 unbiopsied lesions, 20 were classified as benign (specificity, 74.1%; 95% CI, 53.7% to 88.9%).

Section Summary: Diagnostic Accuracy

One prospective study has reported on the sensitivity and specificity of MelaFind, with high sensitivity. These results would have to be replicated in an independent sample, with appropriate confidence intervals.

Clinical Utility

Direct evidence of the clinical utility of MSDSLA would be demonstrated if its use leads to management changes that improve outcomes. This would ideally be evaluated in prospective randomized controlled trials (RCTs) examining health outcomes in patients presenting with pigmented lesions managed with and without the technology. RCTs would ideally compare MSDSLA to clinical examination and dermatoscopy. No studies of this type were identified.

Indirect evidence of clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

One RCT has been published; however, it was conducted over the internet rather than in a clinical setting and involved retrospective analysis of lesions. The trial was published by Hauschild et al. (2014) in Germany. (7) It included 215 board-certified dermatologists selected on a first-come basis after receiving invitations to participate. Each participant was presented with information on 130 pigmented lesions; 93% had been biopsied in a prior study. Half the lesions were melanomas and half were nonmelanomas. (The lesions were a subset of evaluable lesions from the Monheit trial (previously described). (2) All lesions met FDA indications for MelaFind.) Study participants were randomized to review clinical examination information and high-quality digital images only (n=108) or clinical information, high-quality digital images, and the MSDSLA results (n=107). After reviewing each case, participants completed a survey about their lesion management decision (e.g., recommendation for biopsy). A decision was considered correct if melanoma lesions were recommended for biopsy or if non-melanoma lesions were not recommended for biopsy. Before examining the cases, participants were shown an online slide presentation about MelaFind, including the devices performance data.

Among dermatologists in the arm without MSDSLA findings, the sensitivity and specificity of biopsy were 69.5% (95% CI, 64.3% to 76.0%) and 55.9% (47.3% to 60.5%), respectively. In the arm with MSDSLA findings, the sensitivity and specificity were 78.0% (95% CI, 73.9% to 83.5%) and 45.8% (38.1 to 50.8%), respectively. Differences in sensitivity and specificity between arms were statistically significant (p<0.001).

Some nonrandomized studies have evaluated whether the use of MSDSLA would hypothetically lead to management changes. (8, 9) These studies were not conducted in clinical settings and it is unclear whether selection of lesion types and study participants (dermatologists) were representative of actual practice.

Several industry-sponsored simulation exercises have also been conducted at professional conferences. For example, Winkelman et al. (2015) reported on 60 health care providers, 30 of whom were dermatologists, who participated in an exercise at a national dermoscopy conference. (10) Participants were shown images of 12 lesions previously analyzed by MSDSLA using the MelaFind device. They were asked 3 times whether they would biopsy the lesion: 1) based on clinical images alone; 2) with the addition of high-resolution dermoscopic images; and 3) with the addition of MSDSLA classifier scores. The 12 lesions consisted of 2 melanomas in situ, 3 invasive melanomas, and 7 low-grade dysplastic nevi. Diagnostic accuracy did not increase after being shown dermatoscopic images, but it did increase after getting MSDSLA scores. The proportion of dermatologists responding that they would biopsy all 5 malignant melanomas was 4% with clinical images alone, 10% after dermatoscopy, and 72% after MSDSLA. Proportions among nondermatologists were 13%, 6%, and 78%, respectively. Conversely, among dermatologists, the proportion of low-grade dysplastic nevi recommended for biopsy was 53% with clinical images alone, 60% after dermatoscopy, and 42% after MSDSLA. Among dermatologists, proportions were 53%, 66%, and 45%, respectively. The changes in biopsy recommendations after MSDSLA were statistically significant in all cases. Other studies conducted at conferences that used similar methodology had comparable results; biopsy decision accuracy increased significantly after clinicians were provided with MSDSLA findings. (11-13) Without health outcome data, studies of how physicians use medical tests, or how they may change behavior based on medical tests, do not provide significant additional data to inform clinical utility.

Section Summary: Clinical Utility

No direct evidence for the clinical utility of MSDSLA in the management of pigmented lesions was identified. In addition, given the absence of firm evidence about the clinical validity of MSDSLA, a chain of inference cannot be built to support conclusions about the magnitude of benefits and harms of the use of MSDSLA in practice. Therefore, conclusions cannot be made about the clinical utility of MSDSLA.

Summary of Evidence For MSDSLA

For individuals who have pigmented lesions being evaluated for melanoma who receive multispectral digital skin lesion analysis (MSDSLA), the evidence includes 2 prospective diagnostic accuracy studies of MelaFind and additional studies of other MSDSLA devices. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, other test performance measures, and change in disease status. The diagnostic accuracy study found that MSDSLA had a sensitivity of 98.2% for recommending biopsy of melanoma lesions (8% of the pigmented lesions were melanoma). The average specificity of MSDSLA was 9.5% compared with 3.7% among clinicians. However, the study only included lesions already determined by a clinician to be sufficiently suspicious to warrant excision. No studies conducted in a clinical setting have evaluated the utility of MSDSLA as a diagnostic tool in the initial evaluation of pigmented lesions. In addition, no studies conducted in clinical settings have compared patient management decisions and health outcomes with and without MSDSLA devices. In addition, given the absence of firm evidence about the clinical validity of MSDSLA, a chain of inference cannot be built to support conclusions about the magnitude of benefits and harms of MSDSLA use in practice. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements For MSDSLA

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on melanoma (v.1.2017) (14) do not address multispectral digital skin lesion analysis.

National Institute for Health and Care Excellence

National Institute for Health and Care Excellence guidance on the assessment and management of melanoma (15) does not address multispectral digital skin lesion analysis.

Ongoing and Unpublished Clinical Trials For MSDSLA

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Unpublished

NCT01700114a

Post-Approval Study of MelaFind

487

Mar 2016

(terminated)

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Reflectance Confocal Microscopy

Two review articles were examined. One from Edwards et al. (2017) which reviewed eleven studies that met the criteria to evaluate the diagnostic accuracy of the in vivo VivaScope© reflective confocal microscopy (RCM) system. This noninvasive technology was designed to provide a more accurate presurgical diagnosis, leading to fewer biopsies of benign lesions, or to provide greater accuracy for lesion margins. (19) The other review, from Edwards et al. (2016) examined sixteen studies in their article (20), to evaluate the clinical effectiveness and cost-effectiveness of VivaScope(®) 1500 (Caliber Imaging and Diagnostics, Rochester, NY, USA; Lucid Inc., Rochester, N.Y., USA; or Lucid Inc., MAVIG GmbH, Munich, Germany) and VivaScope(®) 3000 (Caliber Imaging and Diagnostics, Rochester, N.Y., USA) in the diagnosis of equivocal skin lesions, and VivaScope 3000 in lesion margin delineation prior to surgical excision of lesions. Both review articles noted the studies to be too heterogeneous to be combined by meta-analysis and both noted generalisability of the results to the UK population was unclear. The Edwards et al. (2016) review notes the following: High-quality RCTs are required in a UK population to assess the diagnostic accuracy of VivaScope in people with equivocal lesions (20).

Other articles reviewed for reflectance confocal microscopy included a retrospective analysis (23) and a small study. (24)

Summary of Evidence For RCM

In the two system review articles noted previously, the authors commented on the heterogenous aspect of the studies. As noted in one of the articles; high-quality RCTS are required to assess the diagnostic accuracy of VivaScope in people with equivocal lesions. At this time the evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements For RCM

National Institute for Health and Care Excellence (NICE)

In 2015, NICE (27) included in their recommendations that there was insufficient evidence to recommend the routine use of VivaScope 1500 and 3000 imaging systems for:

Deciding whether to biopsy and excise skin lesions in people with suspected melanoma (equivocal lesions), BCC, or Lentigo maligna, or

Defining margins of skin lesion s in people with lentigo maligna and BCC.

Ongoing and Unpublished Clinical Trials For RCM

As of March 31, 2017 the Clinical Trials.gov website located 22 studies for reflectance confocal microscopy.

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:

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

96931, 96932, 96933, 96934, 96935, 96936, 0400T, 0401T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


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.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. 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:

1. American Cancer Society. Melanoma Skin Cancer. Available at: <http://www.cancer.org> (accessed November 16, 2016).

2. Monheit G, Cognetta AB, Ferris L, et al. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. Feb 2011;147(2):188-194. PMID 20956633

3. Winkelmann RR, Rigel DS, Ferris L, et al. Correlation between the evaluation of pigmented lesions by a multi-spectral digital skin lesion analysis device and the clinical and histological features of melanoma. J Clin Aesthet Dermatol. Mar 2016; 9(3):36-38. PMID 27354886

4. Winkelmann RR, Rigel DS, Kollmann E, et al. Negative predictive value of pigmented lesion evaluation by multispectral digital skin lesion analysis in a community practice setting. J Clin Aesthet Dermatol. Mar 2015; 8(3):20-22. PMID 25852810

5. Song E, Grant-Kels JM, Swede H, et al. Paired comparison of the sensitivity and specificity of multispectral digital skin lesion analysis and reflectance confocal microscopy in the detection of melanoma in vivo: A cross- sectional study. J Am Acad Dermatol. Dec 2016; 75(6):1187-1192 e1182. PMID 27693007

6. Ferris LK, Harkes JA, Gilbert B, et al. Computer-aided classification of melanocytic lesions using dermoscopic images. J Am Acad Dermatol. Nov 2015; 73(5):769-776. PMID 26386631

7. Hauschild A, Chen SC, Weichenthal M, et al. To excise or not: impact of MelaFind on German dermatologists' decisions to biopsy atypical lesions. J Dtsch Dermatol Ges. Jul 2014; 12(7):606-614. PMID 24944011

8. Wells R, Gutkowicz-Krusin D, Veledar E, et al. Comparison of diagnostic and management sensitivity to melanoma between dermatologists and MelaFind: a pilot study. Arch Dermatol. Sep 2012; 148(9):1083-1084. PMID 22986873

9. Winkelmann RR, Farberg AS, Tucker N, et al. Enhancement of International dermatologists' pigmented skin lesion biopsy decisions following dermoscopy with subsequent integration of multispectral digital skin lesion analysis. J Clin Aesthet Dermatol. Jul 2016; 9(7):53-55. PMID 27672411

10. Winkelmann RR, Yoo J, Tucker N, et al. Impact of guidance provided by a multispectral digital skin lesion analysis device following dermoscopy on decisions to biopsy atypical melanocytic lesions. J Clin Aesthet Dermatol. Sep 2015; 8(9):21-24. PMID 26430487

11. Winkelmann RR, Tucker N, White R, et al. Pigmented skin lesion biopsies after computer-aided multispectral digital skin lesion analysis. J Am Osteopath Assoc. Nov 1 2015; 115(11):666-669. PMID 26501759

12. Winkelmann RR, Yoo J, Tucker N, et al. Assessment of a diagnostic predictive probability model provided by a multispectral digital skin lesion analysis device for melanoma and other high-risk pigmented lesions and its impact on biopsy decisions. J Clin Aesthet Dermatol. Dec 2014; 7(12):16-18. PMID 25584133

13. Rigel DS, Roy M, Yoo J, et al. Impact of guidance from a computer-aided multispectral digital skin lesion analysis device on decision to biopsy lesions clinically suggestive of melanoma. Arch Dermatol. Apr 2012; 148(4):541-543. PMID 22351788

14. National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: Melanoma. Version 1.2017. Available at: <https://www.nccn.org> (accessed November 16, 2016).

15. National Institute on Health and Care Excellence (NICE). Melanoma: assessment and management [NG14]. 2015; Available at: <https://www.nice.org.uk> (accessed November 16, 2016).

16. Multispectral Digital Skin Lesion Analysis. Chicago, Illinois: Blue Cross Blue Shield Association Medical policy Reference Manual. (2016 December) Medicine 2.01.101.

17. VivaScope® System (K080788) Department of Health and Human Services, U.S. Food and Drug Administration. Available at: <http://accessdata.fda.gov> (accessed March 31, 2017).

18. Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical policy Reference Manual. (2015 October) Medicine 2.01.42.

19. Edwards SJ, Osei-Assibey G1, Patalay R, et al. Diagnostic accuracy of reflectance confocal microscopy using VivaScope for detecting and monitoring skin lesions: a systematic review. Clin Exp Dermatol. 2017 Apr; 42(3):266-275. PMID 28218469

20. Edwards SJ, Mavranezouli I, Osei-Assibey G, et al. VivaScope® 1500 and 3000 systems for detecting and monitoring skin lesions: a systematic review and economic evaluation. Health Technol Assess. 2016 Jul; 20(58):1-260. PMID 27483991

21. Sponsored by Lucid Inc. VivaNet Study: a multicenter study of confocal reflectance microscopy in telemedicine (NCT01385943). Available at: <https://clinicaltrials.gov> (accessed March 22, 2017).

22. Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy (B-OSS) (NCT02285790). Available at: <https://clinicaltrials.gov> (accessed March 22, 2017).

23. Diaconeasa A, Boda D, Neagu M, et al. The role of confocal microscopy in the dermato-oncology practice. J Med Life. 2011 Jan-Mar; 4(1):63-74. PMID 21505576

24. Arzberger E, Komericki P, Ahlgrimm-Siess V, et al. Differentiation between balanitis and carcinoma in situ using reflectance confocal microscopy. JAMA Dermatol. 2013 Apr; 149(4):440-5. PMID 23325422

25. Rossi A. Improving Melanoma Detection: Reflectance Confocal Microscopy. Available at: <https://www.mskcc.org> (accessed March 31, 2017).

26. Farnetani F, Scope A, Braun R, et al. Skin Cancer Diagnosis with Reflectance Confocal Microscopy Reproducibility of Feature Recognition and Accuracy of Diagnosis. JAMA Dermatol. 2015; 151(10):1075-1080.

27. National Institute for health and Clinical Excellence (NICE). VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions. (Diagnostic guidance [DG19]) November 2015. Available at: < https://www.nice.org.uk> (accessed March 31, 2017).

Policy History:

Date Reason
5/15/2017 Document updated with literature review. The focus of the policy has changed to address only multispectral digital skin lesion analysis (MSDSLA) and reflectance confocal microscopy (RCM) skin lesion analysis. Coverage unchanged for MSDSLA and RCM.
7/1/2016 Document updated with literature review. Coverage unchanged.
1/1/2016 Document updated with literature review. In the Coverage section: including, but not limited to reflectance confocal microscopy was added to the following statement: Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis of whole or partial body photography including, but not limited to reflectance confocal microscopy is considered experimental, investigational and/or unproven as a technique to evaluate or serially monitor pigmented skin lesions.
4/1/2015 Reviewed. No Changes.
2/1/2014 Document title changed from Dermatoscopy. Document updated with literature review. A clarification was added to the first coverage statement to include indicating that dermatoscopy analysis of whole or partial body photography is considered experimental, investigational and unproven as a technique to evaluate or serially monitor pigmented skin lesions. An example was added to the second coverage statement of a computer-based optical imaging device e.g., multispectral digital skin lesion analysis. The following device was added to the third coverage statement: Computer-based optical imaging devices with additional clarification of the experimental investigational and unproven statement to include defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision.
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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