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MP 2.01.59 Ultrasonographic Evaluation of Skin Lesions

Medical Policy    
Section
Medicine
 
Original Policy Date
7/17/03
Last Review Status/Date
Reviewed with literature search/10:2012
Issue
10:2012
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


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. 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), 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. Lower frequency ultrasound transducers (12-15 MHz) have also been used to evaluate skin layers. Although used extensively in Europe, ultrasonographic evaluation of skin lesions has not been widely used in the United States.

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 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 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.


 Policy

Ultrasonographic 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 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.

There is no specific CPT code describing ultrasonographic evaluation of skin lesions. One of the following CPT codes might be used:

17999: Unlisted procedure, skin, mucous membrane, and subcutaneous tissue

76999: Unlisted ultrasound procedure

96999: Unlisted special dermatological service or procedure

This policy does not address the porential use of ultrasonographic detection for subcutaneous lesions including lipomas, epidermal cysts or ganglions or for detecting regional lymph nodes and subcutaneous metastases in patient with melanoma.

 


Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

 


Rationale

The policy was created with an initial literature search in 2003. The policy has been updated regularly with literature searches using the MEDLINE database; most recently the literature was searched from July 2011 through August 2012. A summary of the key literature is as follows.

Assessment of a diagnostic technology typically focuses on the following three parameters: 1) 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 management decisions or health outcomes (clinical utility).

Technical performance

Ultrasonography is a longstanding technology, and its technical performance will not be considered further.

Diagnostic accuracy

The diagnostic performance of ultrasonography is typically compared to histologic evaluation of specimens obtained by biopsy or excision, or clinical evaluation.

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. In general, studies found a high degree of correlation (1-4), 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 histologic specimen, or due to the inability of ultrasonography to distinguish an inflammatory reaction or normal nevus cells from malignant melanocytes. (5, 6)

A 2009 systematic review by Machet and colleagues included 14 studies correlating high-resolution ultrasound with histologic analysis in melanoma patients. The correlation coefficients in the studies ranged from 0.88 to 0.97 (median of 0.95). (7) 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 histologic 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. (8) The study included 37 patients with 50 suspicious melanocytic lesions 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 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 and colleagues in Slovenia preoperatively evaluated 69 patients with suspicious pigmented skin lesions with ultrasound (12-15 MHz). (9) 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 and colleagues 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. (10) 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. (11) 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 histologic examination. The sensitivity of ultrasound for correctly identifying areas of tumor extension beyond those proposed by the surgeon was low: 32% (95% confidence interval [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.

Another study on patient management using ultrasound was published in 2010 by Wortsman and Wortsman in Chile. (12) 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.

A 2012 review article on ultrasound in dermatology by Kleinerman and colleagues concluded that ultrasound is still being “fine-tuned” for dermatologic applications and remains in an experimental phase. (13) The authors noted that ultrasonic diagnosis requires a substantial amount of operator skill and training. They believe, though, that ultrasound has the potential to become a useful technique for dermatologic diagnosis in the future.

Summary

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. (14)

Medicare National Coverage

No National Coverage Determination found.

References:

  1. 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.
  2. Bobadilla F, Wortsman X, Munoz C et al. Pre-surgical high resolution ultrasound of facial basal cell carcinoma: correlation with histology. Cancer Imaging 2008; 8:163-72.
  3. 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.
  4. 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.
  5. 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.
  6. Semple JL, Gupta AK, From L et al. Does high-frequency (40-60 MHz) ultrasound imaging play a role in the clinical management of cutaneous melanoma? Ann Plast Surg 1995; 34(6):599-605; discussion 06.
  7. 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):1411-20.
  8. 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.
  9. 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):1105-8.
  10. 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.
  11. 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.
  12. 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.
  13. Kleinerman R, Whang TB, Bard RL et al. Ultrasound in dermatology: Principles and applications. J Am Acad Dermatol 2012; 67(3):478-87.
  14. National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology. V.1. 2013. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. Last accessed September, 2012.

 

Codes

Number

Description

CPT  17999  Unlisted procedure, skin, mucous membrane, and subcutaneous tissue 
  76999  Unlisted ultrasound procedure 
  96999  Unlisted special dermatological service or procedure 
ICD-9  696.0 – 696.8  Psoriasis and similar disorders code range 
  710.0 – 710.9  Diffuse diseases of connective tissue code range 
ICD-10-CM (effective 10/1/14)    Investigational or not medically necessary for all diagnoses  
  L40.0-L45 Papulosquamous disorders code range (includes psoriasis L40.x)  
  M30.0 – M36.8 Systemic connective tissue disorders code range (includes scleroderma)  
ICD-10-PCS (effective 10/1/14)      ICD-10-PCS codes are only used for inpatient services. There are no specific ICD-10-PCS codes for this type of testing. 

 


Index

Doppler Ultrasound, Skin
High-Frequency Ultrasonography, Skin
Ultrasonography, Skin
 


Policy History

Date Action Reason
07/17/03 Add policy to Medicine section New policy
11/9/04 Replace policy Policy updated with literature review; no change in policy; references added
08/17/05 Replace policy Policy updated with literature review; no change in policy
12/12/06 Replace policy Policy updated with literature review; reference numbers 12 and 13 added; no change in policy
12/13/07 Replace policy Policy updated with literature review; references 14 and 15 added; no change in policy statement.
10/06/09 Replace policy Policy extensively updated with literature review through July 2009; new reference numbers 10, 12, and 13 added; references renumbered, and some older references removed. No change in policy statements
10/08/10 Replace policy Policy updated with literature review through August 2010; reference numbers 11, 15 and 17 added. No change in policy statements.
10/04/11 Replace policy Policy updated with literature review through August 2011; reference numbers 9 and 10 added; other references renumbered or removed. No change in policy statements.
10/11/12 Replace policy Policy updated with literature review through August 2012; reference number 13 added; other references renumbered or removed. No change in policy statements.
    Archieved by TEC 2012 BCI to keep.