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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

01-96900-03

Original Effective Date: 03/15/03

Reviewed: 01/28/16

Revised: 02/15/16

Subject: Technologies for Evaluating Skin Lesions Suspected of Malignancy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Whole Body Photography

Whole body photography, also known as full-body photography, full-body screening, photographic surveillance or dermal screening, involves the taking of photographs of specific lesions or of the whole body, in order to identify suspicious areas which might be malignant melanoma, the most virulent form of skin cancer (causing 75% of all skin cancer related deaths) at the earliest possible stage. Whole body photography may be used for high-risk patients, while single-lesion pictures may be used for monitoring a particular mole or moles when biopsy does not seem warranted. High-risk patients include those with multiple ordinary moles (over 50), dysplastic nevi (moles that look different, e.g., due to irregular shape or color), or a personal or family history of melanoma. It is thought that the use of photography adjunctively with visual inspection will reduce unnecessary biopsies and provide an early detection for melanoma. Polaroid and regular film, as well as digital imaging, have all been used for this photography.

Dermatoscopy

Dermatoscopy is a noninvasive diagnostic tool that allows approximately 10x magnification for in vivo microscopic examination of skin lesions. This technology is also referred to as digital epiluminescence microscopy (ELM) (e.g., MoleMax II™), dermoscopy, skin surface microscopy, or incidence light microscopy. The MoleMax II™ is a dermatoscopy device that includes a microscopic camera, image digitizer, storage for retrieval of images, and computer-aided diagnostic tools. Clinically, dermatoscopy is used in combination with clinical assessment (e.g., direct visual inspection, review of photographs). Dermatoscopy is intended to help distinguish between benign and malignant pigmented skin lesions. The technique involves application of immersion oil to the skin. The oil 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 are visualized. A hand-held or stereomicroscope (skin-surface microscope) may be used for direct visual examination. Dermatoscopic images may be assessed by direct visual examination, or by review of standard or digitized photographs. Digitization of images, typically after initial visual assessment permits storage, facilitates retrieval of images, and is often used for comparison purposes if a lesion is being followed over time. Also, digitization of images (surface or dermatoscopic) may permit qualitative image enhancement for better visual perception, discrimination of certain features, or computer-assisted analysis.

Multispectral Digital Skin Lesion Analysis

A 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 to refer for biopsy. A multispectral digital skin lesion analysis device called MelaFind® (MELA Sciences, Irvington, NY) was approved by the U.S. Food and Drug Administration (FDA) in November 2011. Its intended use is to evaluate pigmented lesions with clinical or histologic characteristics suggestive of melanoma.

POSITION STATEMENT:

Partial and total body photography as adjuncts in melanoma screening are considered experimental or investigational for both high-risk and average-risk persons as there is insufficient published clinical data to support a benefit for those at high risk for melanoma, a lack of standardization of methods, and an absence of guidelines for when a lesion should be excised or monitored. There also exists a lack of evidence of improved patient outcomes, either by a reduction of unnecessary biopsies or an improvement in early detection of melanoma.

Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis, is considered experimental or investigational as there is insufficient clinical evidence to support the use of dermatoscopy as a technique to evaluate or serially monitor pigmented skin lesions. Although there are ongoing clinical studies on the use of dermatoscopy, there is still a lack of rigorous data that demonstrates the impact of this technology on clinical outcomes.

Multispectral digital skin lesion analysis (MSDSLA) is considered experimental or investigational in all situations including but not limited to evaluating pigmented skin lesions, serially monitoring pigmented skin lesions, and defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision. There are no studies conducted in a clinical setting that evaluate the utility of MSDSLA as a diagnostic tool in the initial evaluation of pigmented lesions. In addition, there are no studies conducted in clinical settings that compared patient management decisions and health outcomes with and without these devices.

BILLING/CODING INFORMATION:

CPT Coding:

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 (investigational)

96931

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report, first lesion (investigational)

96932

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, first lesion (investigational)

96933

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, first lesion (investigational)

96934

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report, each additional lesion (List separately in addition to code for primary procedure) (investigational)

96935

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, each additional lesion (List separately in addition to code for primary procedure) (investigational)

96936

Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, each additional lesion (List separately in addition to code for primary procedure) (investigational)

0400T

Multi-spectral digital skin lesion analysis of clinically atypical cutaneous pigmented lesions for detection of melanomas and high risk melanocytic atypia; one to five lesions (investigational)

0401T

Multi-spectral digital skin lesion analysis of clinically atypical cutaneous pigmented lesions for detection of melanomas and high risk melanocytic atypia; six or more lesions (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Digitization: a type of photography.

Dysplastic nevi: moles whose appearance is different from that of common moles (e.g., larger in size, irregular borders, color not uniform).

Melanoma: a form of skin cancer that comes from melanocytes, the cells that produce pigment; melanoma usually begins in a mole.

Nevi: benign growths on the skin; a mole is an example. The singular form is nevus.

Vivo microscopic examination: live microscopic imaging at and below the surface in living tissue. Digital images of cells appear in real time on the computer screen.

RELATED GUIDELINES:

None

OTHER:

Other names used to report dermatoscopy:

Note: 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.

Dermoscopy

Digital epiluminescence microscopy

Epiluminescence microscopy (ELM)

Incidence light microscopy

MelaFind® System

Melanomagram

Molemax II™

Skin surface microscopy

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.01.101, Multispectral Digital Skin Lesion Analysis, 12/15.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual 2.01.42, Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy, 10/15.
  3. Bono A, Tolomio E, Trincone S, et al; Micro-Melanoma Detection: A Clinical Study On 206 Consecutive Cases of Pigmented Skin Lesions With a Diameter < or = 3mm; Br J Dermatol. 2006 Sep; 155(3): 570-3.
  4. ECRI Hotline Response. Whole Body Photography for Diagnosis of Skin Cancer, (updated 08/29/06).
  5. Feit, N. E., Dusza, S. W. & Marghoob, A. A. (2004). Melanomas detected with the aid of total cutaneous photography. British Journal of Dermatology, 150(4), 706-714.
  6. Hanrahan, P. F., D’Este, C. A., Menzies, S. W., Plummer, T. & Hersey, P. (2002). A randomized trial of skin photography as an aid to screening skin lesions in older males. Journal of Medical Screening, 9, 128-132.
  7. HAYES Medical Technology Directory. “Photographic Surveillance for Early Detection of Malignant Melanoma”, (02/06/02; updated 10/17/07).
  8. Kanzler, M. H., & Mraz-Gernhard, S. (2001). Primary cutaneous malignant melanoma and its precursor lesions: Diagnostic and therapeutic overview. Journal of the American Academy of Dermatology, 45(2), 260-276.
  9. National Cancer Institute (NCI). Cancer.gov, melanoma home pageWebsite. What you need to know about moles and dysplastic nevi. NIH Publication No. 99-3133. Updated 09/16/02.
  10. National Comprehensive Cancer Network (NCCN), NCCN Clinical Practice Guidelines in Oncology: Melanoma, 10/10.
  11. National Institutes of Health (NIH). (1992). NIH Consensus Development Conference Statement Online. 88. Diagnosis and Treatment of Early Melanoma.
  12. Oliveria, S. A., Chau, D., Christos, P. J., Charles, C. A., Muslin, A. L. & Halpern, A. C. (2004). Diagnostic accuracy of patients in performed skin self-examination and the impact of photography. Archives of Dermatology, 140, 57-62.
  13. Oliveria, S. A., Dusza, S. W., Phelan, D. L., Ostroff, J. S., Berwick, M. & Halpern, A. C. (2004). Patient adherence to skin self-examination. Effect of nurse intervention with photographs. American Journal of Preventive Medicine, 26(2), 152-155.
  14. Rice, ZP, Utilization and Rationale for the Implementation of Total Body (Digital) Photography as an Adjunct Screening Measure for Melanoma, Melanoma Research, October 2010-Volume 20- Issue 5, pp 417-421.
  15. Risser, J, Pressley Z, Veledar E, et al. The Impact of Total Body Photography On Biopsy Rate in Patients From a Pigmented Lesion Clinic, Journal of the American Academy of Dermatology, Vol 57, Issue 3, pages 428-434, 09/07.
  16. Seidenari S, Longo C, Giusti F, Pellacani G, Clinical Selection of Melanocytic Lesions for Dermoscopy Decreases The Identification of Suspicious Lesions in Comparison with Dermoscopy Without clinical Preselection, Br J Dermatol. 2006 May; 154(5): 873-9.
  17. Terushkin V, Oliveria SA, et al, Use of and Beliefs About Total Body Photography and Dermatoscopy Among US Dermatology Training Programs: An Update, JAAD, Volume 62, Issue 5, pp 794-803, May 2010.
  18. Wang, S. Q., Kopf, A. W., Koenig, K., Polsky, D., Nudel, K. & Bart, R. S. (2004). Detection of melanomas in patients followed up with total cutaneous examinations, total cutaneous photography and dermoscopy. Journal of the American Academy of Dermatology, 50(1), 15-20.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/28/16.

GUIDELINE UPDATE INFORMATION:

03/15/03

New Medical Coverage Guideline.

07/01/03

Revision to guideline; added new code 0045T.

03/15/04

Annual review for investigational; no change.

03/15/05

Annual review for investigational; no change.

03/15/06

Enhanced annual review for investigational; no change.

01/01/07

2007 HCPCS update; added 96904, deleted 0044T, and 0045T.

02/15/07

Scheduled review; title revision; no change in coverage, references updated.

06/15/07

Reformatted guideline.

02/15/08

Annual review: position statement maintained; references updated.

02/15/09

Annual review: position statement maintained; references updated.

02/15/10

Annual review: position statement maintained; description section and references updated.

12/15/10

Annual review: position statement maintained and references updated.

05/11/14

Revision: Program Exceptions section updated.

01/01/16

Annual HCPCS/CPT update; codes 0400T and 0401T added.

02/15/16

Revision; title, description, position statements, coding, and references updated.

Date Printed: August 21, 2017: 07:40 PM