Medical Policy: 02.01.50 

Original Effective Date: March 2013 

Reviewed: January 2021 

Revised: January 2021 



This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.


Benefit Application:

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. The US Food and Drug Administration (FDA), has approved seven 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. Although neodymium-doped:yttrium aluminum garnet (Nd:YAG) and diode lasers have emerged as treatment options for onychomycosis, data on the efficacy of these interventions are limited, and the mechanisms of action and optimal regimens for these treatments remain unclear. 


h3>Regulatory Status

A number of laser devices used to treat onychomycosis have received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for "the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)." Approved devices include, but are not limited to the:

  • PinPointe™
  • FootLaser™,
  • GenesisPlus™,
  • VARIABreeze™,
  • JOULE ClearSense™,
  • GentleMax Family of Laser Systems
  • Nordys™, and
  • Q-Clear™.


Prior Approval:

Not Applicable



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. Further study with randomized trials that compare laser devices with placebo and other onychomycosis treatments as well as long-term, follow-up studies will be useful for clarifying the efficacy, mechanisms, optimal regimens, and indications for laser therapy. 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


Selected References:

  • 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.  
  • Li DG, Mostaghimi A. Utility of Baseline Transaminase Monitoring During Systemic Terbinafine Therapy for Pediatric Onychomycosis. JAMA Dermatol 2018; 154:626
  • Karsai S, Jäger M, Oesterhelt A, et al. Treating onychomycosis with the short-pulsed 1064-nm-Nd:YAG laser: results of a prospective randomized controlled trial. J Eur Acad Dermatol Venereol 2017; 31:175.
  • Hollmig ST, Rahman Z, Henderson MT, et al. Lack of efficacy with 1064-nm neodymium:yttrium-aluminum-garnet laser for the treatment of onychomycosis: a randomized, controlled trial. J Am Acad Dermatol 2014; 70:911.
  • Sabbah L, Gagnon C, Bernier FE, Maari C. A randomized, double-blind, controlled trial evaluating the efficacy of Nd:YAG 1064 nm short-pulse laser compared with placebo in the treatment of toenail onychomycosis. J Cutan Med Surg. 2019; 23(5):507-512.
  • Yeung K, Ortner VK, Martinussen T, Paasch U, Haedersdal M. Efficacy of laser treatment for onychomycotic nails: a systematic review and meta-analysis of prospective clinical trials. Lasers Med Sci. 2019 Jun 29.  [Epub ahead of print]


Policy History:

  • January 2021 - Annual Review, Policy Revised
  • January 2020 - Annual Review, Policy Renewed
  • January 2019 - Annual Review, Policy Renewed
  • January 2018 - Annual Review, Policy Renewed
  • January 2017- Annual Review, Policy Renewed
  • 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.


*CPT® is a registered trademark of the American Medical Association.