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Printer Friendly Version Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy

 

DESCRIPTION

Dermatoscopy describes a family of noninvasive techniques that allow in vivo microscopic examination of skin lesions, and is intended to help distinguish between benign and malignant pigmented skin lesions. The technique involves application of immersion oil to the skin, which eliminates light reflection from the skin surface and renders the stratum corneum transparent. Using a magnifying lens, the structures of the epidermis and epidermal-dermal junction can then be visualized. A hand-held or stereomicroscope may be used for direct visual examination. Digitization of images, typically after initial visual assessment, permits storage and facilitates their retrieval, often used for comparison purposes if a lesion is being followed over time.

A variety of dermatoscopic features have been identified that are suggestive of malignancy, including pseudopods, radial streaming, the pattern of the pigment network and black dots. These features in combination with other standard assessment criteria of pigmented lesions, such as asymmetry, borders and color, have been organized into algorithms to enhance the differential diagnosis of pigmented skin lesions. Dermatoscopic images may be assessed by direct visual examination, or by review of standard or digitized photographs. Digitization of images, either surface or dermatoscopic images may permit qualitative image enhancement for better visual perception and discrimination of certain features, or actual computer-assisted diagnosis.

Specialized clinics have been developed specifically to offer dermatoscopy. The evaluation may be marketed as a "melanomagram." The MoleMax II TM is a dermatoscopy device that includes a microscopic camera, image digitizer, storage and retrieval of images, and computer-aided diagnostic tools.

Dermatoscopic devices cleared by the FDA include:

  • EpiscopTM  (Welch Allyn, Inc.) approved in 1995, intended use is to illuminate body surfaces and cavities during medical examination.
  • NevoscopeTM  (TRANSLITE) approved in 1996, intended use is to view skin lesions by either illumination or transillumination.
  • DermascopeTM  (American Diagnostic Corp.) approved in 1999, intended use is to enlarge imagesfor medical puposes.
  • MoleMaTM  (Derma Instruments) approved in 1999, intended use is to enlarge images for medical puposes.

Dermatoscopy has been more widely investigated and adopted in Western Europe.

Dermatoscopy has also been used to assess other conditions including vascular structures and chronic psoriasis (to monitor effects of long-term topical steroid therapy) and nail pigmentations.

Also, see the related medical policy, Ultrasonographic Evaluation of Skin Lesions. 

 

POLICY

Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis, is considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.

Computer-based optical imaging devices e.g., multispectral digital skin lesion analysis, are considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.

Dermatoscopy and computer-based optical imaging devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

11/2001: Approved by Medical Policy Advisory Committee (MPAC)

4/18/2002: Type of Service and Place of Service deleted

4/17/2003: Code Reference section updated

8/4/2005: Code Reference section updated, CPT code 0045T with effective date of 7/1/2003 added, CPT 0044T effective date of 7/1/2003 added, statement "Visual examination of skin lesions may be coded for by evaluation and management CPT codes." deleted Code Reference section

8/31/2006: Policy reviewed, no changes

12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions

8/14/2009: Policy reviewed, description re-written, no changes in policy

12/30/2010:  Link to related medical policy added to description.  A new policy statement was added to indicated that dermatoscopy as a technique to define peripheral margins of basal cell carcinomas is considered investigational.  The existing policy statement was changed from not medically necessary to investigational. FEP verbiage added to the Policy Exceptions section. Removed deleted codes 0044T and 0045T from the Code Reference section.

09/28/2011: Policy reviewed; no changes.

01/09/2013:  Policy title changed from "Dermatoscopy" to "Optical Diagnostic Devices for Evaluating Skin Lesions Suspected of Malignancy" because the scope of the policy was changed to address dermatoscopy and computer-based optical imaging devices. Added the following policy statement:  Computer-based optical imaging devices e.g., multispectral digital skin lesion analysis, are considered investigational as a technique to evaluate or serially monitor pigmented skin lesions. The last investigational policy statement was changed from "Dermatoscopy as a technique to define peripheral margins of basal cell carcinomas is investigational" to "Dermatoscopy and computer-based optical imaging devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision."

 

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.42

 

CODE REFERENCE

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

Non-Covered Codes

Code Number

Description

CPT-4

96904

Whole body integumentary photography, for monitoring of high risk patient with dysplastic nevus syndrome or a history of dysplastic nevi, or patients with a personal or familial history of melanoma (new 1-1-2007)

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

 

HCPCS

 

 

 

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