Latest Review Date: July 2024

Category: Radiology/Medicine                                              

POLICY:

Ultrasonic evaluation of skin lesions is considered investigational.

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

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.

KEY POINTS:

The most recent update with literature review covers the period through July 25, 2024.

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. 

CURRENT CODING: 

CPT codes:     

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

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. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. National Comprehensive Cancer Network. Melanoma. Clinical practice guidelines in oncology, v2.2020.  Available online at: //www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. 
19. Nessi R, et al.  Skin ultrasound in dermatologic surgical planning, Journal of Dermatologic Surgical Oncology, 1991; 17: 38-42.
20. 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.
21. 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.
22. 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.
23. Ruocco E, Argenziano G, Pellacani G, et al.  Non-invasive imaging of skin tumors, Dermatol Surg 2004; 30(2 pt 2): 301-310.
24. 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.
25. 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.
26. Thiboutot D.  Dermatological applications of high-frequency ultrasound, www.bioe.psu.edu/labs/NIH/main_pub.html.
27. 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.
28. Vergilio, M. M., Monteiro E Silva, S. A., Jales, R. M., & Leonardi, G. R. (2021). High-frequency ultrasound as a scientific tool for skin imaging analysis. Experimental dermatology, 30(7), 897–910.
29. 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.

Medical Policy Group, August 2021 (5): Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, July 2022 (5): Minor update to Key Points. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, July 2023 (5): Updates to Key Points, Benefit Application, and References. No change to Policy Statement. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, July 2024 (5): Minor update to Key Points. No change to Policy Statement. 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.