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DESCRIPTIONUltrasonographic evaluation of skin lesions refers to the use of ultrasound to provide information about the margins and depth of surface tumors or inflammatory skin conditions. Ultrasound transducers of at least 20 MHz are used to evaluate skin lesions.
High frequency ultrasound transducers (20-100 MHz), which have limited penetration but high resolution, have been extensively used in ophthalmology and as a component of endoscopic ultrasound. These same parameters make high frequency ultrasound suitable for evaluating skin lesions, where ultrasound can distinguish between the epidermis, dermis, and underlying connective tissue. Although widely used in Europe, ultrasonography evaluation of skin lesions has not been widely used in this country. The following applications have been proposed:
The U.S. Food and Drug Administration (FDA) has cleared numerous ultrasound systems that include skin ultrasound as one of many indications. In addition, several ultrasonic systems that specialize in imaging skin have been cleared for marketing by the FDA though the 510(k) process. The Episcan® I-200, Ultrasound System (Longport, Inc.), which uses either a 20 MHz or 30 MHz transducer, was cleared for marketing in November 2006. Its intended use is medical/surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic/reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention, and superficial musculoskeletal diagnosis. Another specialized system, the DermaScan™ C Ultrasonic System (Cortex Technology) was cleared in 1999. This 20 MHz transducer is intended to be used to visual the layers of the skin to make approximate measurement of dimensions of skin layers and blood vessels.
Also, see the Dermatoscopy medical policy.
POLICYUltrasonographic evaluation of skin lesions is considered investigational.
Ultrasonographic evaluation as a technique to assess photoaging or skin rejunvenation techniques is considered cosmetic in nature and therefore not medically necessary.
POLICY EXCEPTIONSFederal 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 GUIDELINESThis policy does not address the potential use of ultrasonographic detection for subcutaneous lesions including lipomas, epidermal cysts or ganglions or for detecting regional lymph nodes and subcutaneous metastases in patients with melanoma.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/18/2004: Approved by Medical Policy Advisory Committee (MPAC)
7/19/2005: Code Reference section completed
1/11/2008: Policy reviewed, no changes
04/14/2010: Policy description and guidelines updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
12/29/2010: Policy reviewed; no changes.
11/10/2011: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.59
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.