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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.
This 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
07/23/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
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.