Medical Policy: 02.01.50
Original Effective Date: March 2013
Reviewed: January 2016
Revised: February 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Onychomycosis is a fungal infection of the nail. The toenails are affected in 80% of all cases. The most common symptom of a fungal nail infection is the nail becomes thickened and discolored. Diagnosis consists of microscopic examination and culture of nail scrapings or clippings. Clinical appearance does not necessarily correlate with the causative organism. Onychomycosis should always be confirmed with microbiological evidence
Conventional treatment for this type of infection usually consists of oral anti-fungal and/or topical therapy and when required debridement of the nail(s). There is a low success rate and high relapse rate for all treatments.
Laser therapy is being investigated for the treatment of onychomycosis. Research suggests that fungi are sensitive to heat. Laser therapy heats the nail bed typically to 40-60 degrees celsius to disrupt fungal growth. As of January 2012, the US Food and Drug Administration (FDA), has approved four laser systems for the “temporary increase of clear nail onychomycosis”. The FDA has approved these devices on the basis of “substantial equivalence” to predictive devices with similar technical specifications and applications. Laser therapy appears to be promising alternative to traditional pharmacotherapy, but these systems have tested in limited clinical trials; therefore, it is not possible to compare their efficacy to the oral and topical drugs currently used in the treatment of onychomycosis.
Laser treatment is considered investigational for the treatment of nail fungus (onychomycosis).
The published evidence to date is insufficient to determine whether laser treatment improves health outcomes in patients with onychomycosis. Additional random controlled trials are needed that use FDA-cleared devices. There is an inability to draw conclusion of health benefits with the currently available information.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 17999 Unlisted procedure, skin, mucous membrane and subcutaneous tissue
- 96999 Unlisted special dermatological services or procedures
- MD Consult April 16, 2012, New Results Challenge Laser Effectiveness for Onychomycosis.
- Pub Med: J Am Podiatric Med Assoc 2012 Sept-Oct 102(5): 428-430 2012, Newly Approved Laser Systems for Onychomycosis.
- Pub Med: Dermatol Ther. 2012 Nov-Dec;25(6):574-81. Doi: 10.1111/j.1529-8019.2012.01519.x.
- New England Journal of Medicine, May 14, 2009, David de Berker, M.R.C.P., N Engl J Med 2009; 306:2108-2116 DOI:10.1056/NEJMcp0804878.
- Xu Y, Miao X, Zhou B, Luo D. Combined oral terbinafine and long-pulsed 1,064-nm Nd: YAG laser treatment is more effective for onychomycosis than either treatment alone. Dermatol Surg. 2014;40(11):1201-1207.
- Ortiz AE, Avram MM, Wanner MA. A review of lasers and light for the treatment of onychomycosis. Lasers Surg Med 2014; 46:117.
- Lim EH, Kim HR, Park YO, et al. Toenail onychomycosis treated with a fractional carbon-dioxide laser and topical antifungal cream. J Am Acad Dermatol 2014; 70:918.
- Ledon JA, Savas J, Franca K, et al. Laser and light therapy for onychomycosis: a systematic review. Lasers Med Sci 2014; 29:823.
January 2016 - Annual Review, Policy Renewed
February 2015 - Annual Review, Policy Revised
March 2014 - Annual Review, Policy Revised
March 2013 - New Policy
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.