BlueCross and BlueShield of Montana Medical Policy/Codes
Ultrasonographic Evaluation of Skin Lesions
Chapter: Radiology
Current Effective Date: March 16, 2011
Original Effective Date: March 16, 2011
Publish Date: March 16, 2011
Description

Ultrasonographic 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 used extensively in Europe, ultrasonographic evaluation of skin lesions has not been widely used in the United States. The following applications have been proposed:

  • To assess the margins and depth of melanoma and non-melanoma skin cancers to aid in surgical planning
  • To assess actinic keratoses to determine if cryosurgery is an appropriate therapeutic option
  • To follow the course of connective diseases of the skin, i.e., scleroderma, by evaluating the amount and location of collagen in the dermis
  • To assess inflammatory skin diseases, such as allergic reactions or psoriasis

Regulatory Status

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.

Related policy: Dermatoscopy

Policy

Cosmetic

Blue Cross and Blue Shield of Montana (BCBSMT) considers ultrasonographic evaluation as a technique to assess photoaging or skin rejunvenation techniques cosmetic in nature.

Investigational

BCBSMT considers ultrasonographic evaluation of skin lesions investigational.

Federal Mandate

Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP).  In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.

Policy Guidelines

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.

Rationale

Assessment of a diagnostic technology typically focuses on the following three parameters; 1) its technical performance; 2) diagnostic parameters (sensitivity, specificity, and positive and negative predictive values) in different populations of patients, such as those with inflammatory lesions or malignant melanoma; and 3) demonstration that the diagnostic information can be used to improve patient outcomes (clinical utility).

Ultrasonography is a longstanding technology, and its technical performance will not be considered further. The diagnostic performance of ultrasonography is typically compared to histological evaluation of specimens obtained by biopsy or excision, or clinical evaluation. If ultrasonography can accurately predict the thickness of melanotic lesions, it potentially could be used to assist in surgical planning and avoid repeated excisions. For example, the depth of recommended excision of melanoma is based on the thickness of the lesion (i.e., the Breslow index), as measured in the excisional biopsy; the recommended margin of excision is 1 cm for tumors with a Breslow index of 1 mm, 2 cm for those with an index between 1.01 and 4 mm, and 3 cm for those with an index over 4 mm. Therefore, some patients may have to undergo repeated excision if the original margin of excision is inadequate. For those with connective tissue diseases, such as scleroderma, progression of disease is typically assessed clinically. Ultrasonographic evaluation of the dermis could potentially provide a more objective and sensitive method of disease monitoring.

The policy was created with an initial literature search in 2003, at which time the literature was limited to studies evaluating diagnostic accuracy. The policy has been updated regularly with literature searches using MEDLINE®, most recently the literature was searched from July 2009 through August 2010. This section provides a summary of the literature.

A number of studies reporting diagnostic accuracy of ultrasound have been published in a variety of patient populations, primarily including patients with malignant melanoma, inflammatory lesions, or connective tissue disorders. Several studies examined the correlation of the thickness of melanotic lesions as assessed histologically and with ultrasonography. (1-10) In general, studies found a high degree of correlation, although some noted that the ultrasonographic assessment of the thickness of the lesion was often greater than that assessed histologically, perhaps due to shrinkage artifact in the histological specimen, or due to the inability of ultrasonography to distinguish an inflammatory reaction or normal nevus cells from malignant melanocytes. (6, 7) A 2009 systematic review by Machet and colleagues included 14 studies correlating high-resolution ultrasound with histological analysis in melanoma patients. The correlation coefficients in the studies ranged from 0.88 to 0.97 (median of 0.95). (11) Data on the ability of ultrasound thickness to predict adequate surgical margins were available from 7 of the studies, with a total of 860 lesions. The proportion of lesions in the individual studies that was well-classified by ultrasound ranged from 72% to 89%. In addition to the systematic review, Machet and colleagues conducted a prospective, single-center study in France that included 31 patients with suspected or confirmed primary cutaneous melanoma that had not been surgically removed. Average lesion thickness was 1.96 mm according to ultrasound and 1.95 mm by histology. The correlation between ultrasound and histological findings was 94% and it was possible to predict appropriate surgical margins in 84% of patients.

A study that included 57 patients assessed whether ultrasound biomicroscopy (50 MHz) could aid in the diagnosis of 8 non-melanocytic skin disorders. (12) There was a difference in thickness between lesional and normal skin for morphea, seborrheic keratosis, and psoriasis, and a correlation coefficient of 0.002 between the psoriatic area and severity index and ultrasound measurements. Dermal thickness could not be consistently assessed with ultrasound biomicroscopy for eczema, lichen planus, and seborrheic keratosis, and skin thickness was not different between port wine and normal skin.

A study published in 2009 investigated the optimal frequency of ultrasound machines for scanning thin melanocytic skin lesions (MSL). (13) The study included 37 patients with 50 suspicious MSL of maximal vertical tumor thickness less than 1 mm. Compared to histology, 100 MHz was more accurate than 20 MHz, although both overestimated tumor thickness (mean of 16 and 34 micrometer overestimation of tumor thickness, respectively). This study suggests that a higher frequency transducer may be more accurate than a 20-MHz transducer, which was used in many of the previously reported case series.

Several studies have evaluated the role of ultrasound in patient management among patients with skin lesions. A study by Jambusaria-Pahlajani and colleagues included 100 patients with biopsy-proven basal cell carcinoma or squamous cell carcinoma scheduled to undergo Mohs micrographic surgery. (14) Patients received a preoperative high-resolution (40 MHz) ultrasound scan after the surgeon initially drew a proposed surgical margin. The ultrasound technician identified any area of tumor that extended outside the proposed margin, and these areas were verified by histological examination. The sensitivity of ultrasound for correctly identifying areas of tumor extension beyond those proposed by the surgeon was low: 32% (95% CI: 15-54%). Ultrasound was more sensitive for the 43 larger tumors above the median of 1.74 sq cm than for the 41 smaller tumors (55% vs. 33%, respectively). The authors concluded that the sensitivity of high-frequency ultrasound was too low to be clinically useful. They noted, however, that the overall low sensitivity might be due in part from their decision to optimize the image of the dermis with greater resolution than the epidermis, thereby limiting the accuracy of imaging of the epidermis.

Wortsman and Wortsman conducted a retrospective single-center study in Chile. (15) The authors compared ultrasound diagnoses of 4338 skin lesions with clinical diagnosis, using histology as the reference standard. Of the 4338 lesions, 75 (2%) were malignant tumors and 677 (16%) were inflammatory or infectious lesions. (The majority of the skin lesions were benign nonvascular tumors such as enlarged lymph nodes and lipomas). All patients were referred to a department of radiology for further testing; specific reasons for referral were not provided. Clinicians did not have the ultrasound results available at the time of diagnosis, but they did have access to findings from laboratory tests. Ultrasound technicians were aware of the referring diagnosis. The referring diagnosis agreed with the histological diagnosis in 87% of the 75 malignant tumor cases and the addition of ultrasound findings increased the percentage to 91%. The referring diagnosis was correct in 77% of the inflammatory/infectious lesions and ultrasound increased this percentage to 99%. In both types of lesions, the increase in the proportion of correct diagnoses ultrasound was statistically significant (p<0.001). In 735 of the 4338 lesions (17%), including 3 malignant lesions, only ultrasound correctly identified the diagnosis. The authors said that the treatment plans were modified in all of these cases but did not provide details on the modifications. All ultrasound examinations were performed by the same physician which, although increasing the consistency of interpretation, may not be generalizable to findings by other clinicians. As noted above, the study was retrospective; prospective studies evaluating larger numbers of skin conditions relevant to this policy are needed.

An earlier study by Desei and colleagues compared the results from a 20 MHz scanner with clinically and histologically delineated margins for 50 superficial and nodular basal cell carcinomas, excluding those in locations difficult to image. (16) Ultrasound measurements were correlated (r >0.70) with clinical measurements prior to excision, with a mean 20% to 25% increase in size compared to naked eye measurements; 10% of ultrasound measurements showed clinical extension beyond the 4-mm margin. Limitations of this study include that the method for comparing ultrasound findings with preoperative clinical measurements was not clearly described and patient health outcomes were not evaluated.

Summary

The evidence is insufficient for determining whether the use of ultrasound leads to improved health outcomes in patients with skin lesions. No study identified examined whether the use of ultrasonography preoperatively resulted in improved health outcomes such as lower rates of disease recurrence or increased survival. Given the lack of sufficient high-quality evidence on the impact of ultrasound skin imaging on patient management, this technology is considered investigational. In addition, due to the cosmetic nature of the application, ultrasound skin imaging is considered not medically necessary to assess photoaging or skin rejuvenation techniques.

Technology Assessments, Guidelines and Position Statements

The National Comprehensive Cancer Network (NCCN) melanoma guideline does not mention use of ultrasonography for evaluating known or suspected melanomas. (17)

Medicare National Coverage

No National Coverage Determination found

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity.  BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions.  Providers are expected to make treatment decisions based on their medical judgment.  Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply, drug or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Coding

There is no specific CPT code describing ultrasonographic evaluation of skin lesions.

ICD-9 Codes
696.0 – 696.8, 710.0 – 710.9
Procedural Codes: 17999, 76999, 96999
References
  1. Kolbe L, Kligman AM, Schreiner V et al. Corticosteroid-induced atrophy and barrier impairment measured by non-invasive methods in human skin. Skin Res Technol 2001; 7(2):73-7.
  2. Cammarota T, Pinto F, Magliaro A et al. Current uses of diagnostic high-frequency US in dermatology. Eur J Radiol 1998; 27(suppl 2):S215-23.
  3. Vaillant L, Berson M, Machet L et al. Ultrasound imaging of psoriatic skin: a noninvasive technique to evaluate treatment of psoriasis. Int J Dermatol 1994; 33(11):786-90.
  4. Lassau N, Mercier S, Koscielny S et al. Prognostic value of high-frequency sonography and color Doppler sonography for the preoperative assessment of melanomas. AJR Am J Roentgenol 1999; 172(2):457-61.
  5. Harland CC, Bamber JC, Gusterson BA et al. High frequency, high resolution B-scan ultrasound in the assessment of skin tumours. Br J Dermatol 1993; 128(5):525-32.
  6. Semple JL, Gupta AK, From L et al. Does high-frequency (40-60MHz) ultrasound imaging play a role in the clinical management of cutaneous melanoma? Ann Plast Surg 1995; 34(6):599-606.
  7. Partsch B, Binder M, Puspok-Schwarz M et al. Limitations of high frequency ultrasound in determining the invasiveness of cutaneous malignant melanoma. Melanoma Res 1996; 6(5):395-8.
  8. Nessi R, Blanc M, Bosco M et al. Skin ultrasound in dermatologic surgical planning. J Dermatol Surg Oncol 1991; 17(1):38-42.
  9. Bessoud B, Lassau N, Koscielny S et al. High frequency sonography and color Doppler in the management of pigmented skin lesions. Ultrasound Med Biol 2003; 29(6):875-79.
  10. Bobadilla F, Wortsman X, Munoz C et al. Pre-surgical high resolution of facial basal cell carcinoma: correlation with histology. Cancer Imaging 2008; 8:163-72.
  11. Machet L, Belot V, Naouri M et al. Peroperative measurement of thickness of cutaneous melanoma using high-resolution 20 MHZ ultrasound imaging: a monocenter prospective study and systematic review of the literature. Ultrasound Med Biol; 2009; 35(9):1411-20.
  12. El-Zawahry MB, Abdel El-Hameed El-Cheweikh HM, Abd-El-Rahman Ramadan S et al. Ultrasound biomicroscopy in the diagnosis of skin diseases. Eur J Dermatol 2007; 17(6):469-75.
  13. Gambichler T, Moussa G, Bahrenberg K et al. Preoperative ultrasonic assessment of thin melanocytic skin lesions using a 100-MHz ultrasound transducer: a comparative study. Dermatol Surg 2007; 33(7):818-24.
  14. Jambusaria-Pahlajani A, Schmults CD, Miller CJ et al. Test characteristics of high-resolution ultrasound in the preoperative assessment of margins of basal cell and squamous cell carcinoma in patients undergoing Mohs micrographic surgery. Dermatol Surg 2009; 35(1):9-15.
  15. Wortsman X, Wortsman J. Clinical usefulness of variable-frequency ultrasound in localized lesions of the skin. J Am Acad Dermatol 2010; 62(2): 247-56.
  16. Desai TD, Desai AD, Horowitz DC et al. The use of high-frequency ultrasound in the evaluation of superficial and nodular basal cell carcinomas. Dermatol Surg 2007; 33(10):1220-7.
  17. National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology, v2.2010. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf . Last accessed September 1, 2010.
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Ultrasonographic Evaluation of Skin Lesions