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Ultrasonographic Evaluation of Skin Lesions

Policy Number: MP-144

Latest Review Date: July 2019

Category: Radiology/Medicine                                              

Policy Grade: Effective October 2012: Active Policy but no longer scheduled for regular literature reviews and updates.

Description of Procedure or Service:

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. Several ultrasound systems using transducers of at least 20 MHz have been approved by the Food and Drug Administration (FDA) for visualizing skin; lower frequency ultrasound transducers (12-15 MHz) have also been used.

High-frequency ultrasound transducers (20-100 MHz) have been used in ophthalmology, endoscopic imaging systems, and to evaluate skin lesions. High frequency scanning provides a high degree of axial and lateral resolution, but limited penetration. High-frequency ultrasound can distinguish between the epidermis, dermis, and underlying connective tissue. Lower frequency ultrasound transducers (12-15 MHz) have also been used to evaluate skin layers. It gives information on the morphology of the lesion, such as the size, shape, and depth of the skin lesion. However, it does not give information on the diagnosis of the lesion.

The following applications of ultrasonic evaluation of skin lesions have been proposed:

  • To assess the margins and depth of melanoma and non-melanoma skin cancers to aid in surgical planning.

  • To assess actinic keratosis to determine if cryosurgery is an appropriate therapeutic option.

  • To follow the course of connective tissue diseases of the skin, such as scleroderma, by evaluating the amount and location of collagen in the dermis.

  • To assess inflammatory skin diseases, such as allergy reactions, psoriasis, and lichen planus.

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.

Policy:

Ultrasonic evaluation of skin lesions is considered not medically necessary and investigational.

Ultrasonic evaluation as a technique to assess photoaging or skin rejuvenation techniques is considered not medically necessary.

Key Points:

The evaluation of a new diagnostic technology typically focuses on the following 3 parameters:  its technical performance, diagnostic parameters (sensitivity, specificity, positive and negative predictive value) in different populations of patients, and proof that the diagnostic information can be used to improve patient outcomes.

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. Generally studies found a high degree of correlation, although some noted that the ultrasonographic assessment of the thickness of the lesion was often greater that 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. 

A 2009 systematic review by Machet et al 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). 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 et al conducted a prospective, single-center study in France that included 31 patients with suspected to confirmed primary cutaneous melanoma that had not been surgically removed. Average lesion thickness was 1.96 mm by 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 published in 2009 investigated the optimal frequency of ultrasound machines for scanning thin melanocytic skin lesions (MSL). The study included 37 patients with 50 suspicious MSL of maximal vertical tumor thickness < 1mm. Compared to histology, 100 MHz was more accurate than 20 MHz, although both overestimated tumor thickness (mean of 16µm and 34µm 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 recent studies conducted outside of the United States have evaluated skin lesions using ultrasound machines with transducer frequencies lower than 20 MHz. In 2010, Music et al in Slovenia preoperatively evaluated 69 patients with suspicious pigmented skin lesions with ultrasound (12-15 MHz). There was a high correlation between ultrasound and histologic tumor thickness (correlation coefficient=0.82). Using histologic diagnosis as the reference standard, ultrasound had a sensitivity of 92% and a specificity of 92% for detecting melanoma with a thickness greater than 1 mm. In 2011, Kaikaris et al in Lithuania published findings from 100 patients with a clinical diagnosis of stage I-II cutaneous melanoma who underwent preoperative ultrasound examination with a 14-MHz transducer. There was a high correlation between ultrasound and histologic findings when melanoma lesions were thicker than 2 mm (correlation coefficient0.87). Histologic findings did not correlate well with ultrasound for thinner lesions (1-2 mm), correlation coefficient=0.28.

Clinical Utility

Several studies have evaluated the role of ultrasound in patient management among patients with skin lesions. A 2009 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. Patients received a preoperative high-resolution (40MHz) 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 histology. 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% versus 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.

Another study on patient management using ultrasound was published in 2010 by Wortsman and

Wortsman in Chile. In a retrospective single-center study, the authors compared ultrasound

diagnoses of 4,338 skin lesions with clinical diagnosis, using histology as the reference standard.

Frequencies of 14-15 MHz were used to observe skin layers. Of the 4,338 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 histologic 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 by ultrasound was statistically significant (p<0.001). In 735 of the 4,338 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.

Summary of Evidence

The evidence is insufficient for determining the clinical utility of ultrasonic evaluation of skin lesions. No published studies were identified that prospectively examined whether the use of ultrasonography resulted in improved health outcomes, such as higher treatment success rates, 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 and health outcomes, 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.

Practice Guidelines and Position Statements

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

Key Words:

Ultrasonography, ultrasound, skin lesions, melanoma, psoriasis, skin, Episcan I-200, DermaScan

Approved by Governing Bodies:

The 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., Glen Mills, PA), 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, Denmark) was cleared in 1999. This 20-MHz transducer is intended to be used to visualize the layers of the skin to make approximate measurement of dimensions of skin layers and blood vessels.

Benefit Application:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved. Will be reviewed for medical necessity.

Coding: 

CPT codes:     There are no specific CPT codes describing ultrasonographic evaluation of skin lesions.  These codes might be used.

17999

Unlisted procedure, skin, mucous membrane and subcutaneous tissue

76999

Unlisted ultrasound procedure

96999 

Unlisted special dermatological service or procedure

                      

           

References:

  1. Bakr M, et al.  Ultrasound biomicroscopy in the diagnosis of skin diseases.  Eur J Dermatol 2007; 17(6): 469-475.

  2. Bessoud B, Lassau N, Koscielny S, et al.  High frequency sonography and color Doppler in the management of pigmented skin lesions, Ultrasound Med Viol 2003; 29(6): 875-879.

  3. Blue Cross Blue Shield Association.  Ultrasonographic evaluation of skin lesions.  Medical Policy Reference Manual, November 2009.

  4. Bobadilla F, Wortsman X, et al.  Pre-surgical high resolution ultrasound of facial basal cell carcinoma:  Correlation with histology.  Cancer Imaging, September 2008; 8: 163-172.

  5. Cammarota T, Pinto F, Magliaro A et al. Current uses of diagnostic high-frequency US in dermatology. Eur J Radiol 1998; 27(suppl 2):S215-223.

  6. Desai TD, Desai AD, et al.  The use of high-frequency ultrasound in the evaluation of superficial and nodular basal cell carcinomas.  Dermatol Surg, October 2007; 33(10): 1220-1227.

  7. El-Zawahry MB, El-Hameed A, El-Cheweikh HM et al. Ultrasound biomicroscopy in the diagnosis of skin diseases. Eur J Dermatol 2007; 17(6):469-75.

  8. Gambichler T, Moussa G, et al.  Preoperative ultrasonic assessment of thin melanocytic skin lesions using a 100-MHz ultrasound transducer:  A comparative study.  Dermatol Surg, July 2007; 33(7): 818-824.

  9. Harland, et al.  High-frequency, high-resolution b-scan ultrasound in the assessment of skin tumors, British Journal of Dermatology, 1993; 128: 525-532.

  10. Jambusaria-Pahlajani A, Schmults CD, 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, January 2009; 35(1): 9-15.

  11. Kaikaris V, Samsanavicius D, Maslauskas K et al. Measurement of melanoma thickness- comparison of two methods: ultrasound versus morphology. J Plast Reconstr Aesthet Surg 2011; 64(6): 796-802.

  12. 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):73-77.

  13. Lassau N, et al.  Prognostic values of high-frequency sonography and color Doppler sonography for the preoperative assessment of melanomas, American Journal of Radiology, 1999; 172: 457-461.

  14. Machet L, Belot V, Naouri M, et al.  Preoperative 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):1411-1420.

  15. Mogensen M and Jemec GB.  Diagnosis of nonmelanoma skin cancer/keratinocyte carcinoma:  A review of diagnostic accuracy of nonmelanoma skin cancer diagnostic tests and technologies.  Dermatol Surg, October 2007; 33(10): 1158-1174.

  16. Music MM, Hertl K, Kadivec M et al. Pre-operative ultrasound with a 12-15 MHz linear probe reliably differentiates between melanoma thicker and thinner than 1mm. J Eur Acad Dermatol Venereol 2010; 24(9):1105-1108.

  17. National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology, v2.2020.  Available online at: //www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. 

  18. Nessi R, et al.  Skin ultrasound in dermatologic surgical planning, Journal of Dermatologic Surgical Oncology, 1991; 17: 38-42.

  19. Olsen L, and Serup J.  High-frequency ultrasound scan for non-invasive cross-sectional imaging of psoriasis, Acta Dermatology Venereol (Stock), 1993; 73: 185-187.

  20. 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): 395-398.

  21. Raju BI, Swindells KJ, Bonzalez S, et al.  Quantitative ultrasonic methods for characterization of skin lesions in vivo, Ultrasound Med Biol 2003; 29(6): 825-838.

  22. Ruocco E, Argenziano G, Pellacani G, et al.  Non-invasive imaging of skin tumors, Dermatol Surg 2004; 30(2 pt 2): 301-310.

  23. Semple J, Gupta AK, From L, et al.  Does high-frequency (40 – 60 mhz) ultrasound imaging play a role in the clinical management of cutaneous melanoma? Annals of Plastic Surgery, June 1995, Vol. 34, No. 6.

  24. Solivetti FM, Sidozzi A, et al.  Sonographic evaluation of clinically occult in-transit and satellite metastases from cutaneous malignant melanoma.  Radiol Med 2006; 111: 702-708.

  25. Thiboutot D.  Dermatological applications of high-frequency ultrasound, www.bioe.psu.edu/labs/NIH/main_pub.html.

  26. 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): 786-790.

  27. Wortsman X, Wortsman J.  Clinical Usefulness of variable-frequency ultrasound in localized lesions of the skin.  J Am Acad Dermatol 2010; 62(2): 247-256.

Policy History:

Medical Policy Group, November 2003 (1)

Medical Policy Administration Committee, December 2003

Available for comment December 16, 2003-January 29, 2004

Medical Policy Group, November 2005 (1)

Medical Policy Administration Committee, December 2005

Medical Policy Group, November 2007 (1)

Medical Policy Group, November 2009 (1)

Medical Policy Group, October 2010 (1) Updated Key Points and References, no policy statement change

Medical Policy Group, October 2011 (1) Updated Descriptions, Key Points and References; no change in policy statement

Medical Policy Group, January 2013: Effective October 2012 this policy will no longer be scheduled for regular literature reviews and updates.

Medical Policy Group, September 2016 (7): Reviewed by consensus. No new literature to add. Updated Key Words: added Episcan I-200 and DermaScan. No changes to Policy Statement.

Medical Policy Group, July 2019 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.