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 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.
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:
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.
To report provider services, use appropriate CPT* codes, modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.