Laser therapy is the application of single-color light radiation over injuries or lesions to stimulate healing and relieve pain without sensation or side effects. The light can be delivered in a variety of methods including low- and mid-level irradiation lasers using wavelengths from 400 to 930 nanometers (nm). Laser therapy has been proposed as a treatment for multiple wound and skin conditions including:
Onychomycosis (i.e., nail fungus)
Onychomycosis is a common chronic fungal infection of the nail. Primary infectious agents include dermatophytes (eg, Trichophyton species), yeasts (eg, Candida albicans) and nondermatophytic molds. The current available treatments for nail fungus include systemic and topical antifungal medications. Laser treatments are proposed as another treatment option.
Multiple laser systems have been cleared by the FDA for the treatment of nail fungus (e.g., Hyperion Long Pulsed Nd:YAG Laser, PinPointe™ Foot Laser, GenesisPlus™, VARIABreeze™, JOULE ClearSense™, and Q-Clear™)
Note: This policy does not address the treatment of acne scarring.
Acne vulgaris or more simply ‘acne’ is a common disorder of the skin primarily affecting adolescents and young adults. It may be classified as inflammatory or noninflammatory. Treatment of active acne usually consists of skin care regimen, benzoyl peroxide, antibiotics, and retinoids. Active acne is distinct from acne scarring, which may occur from tissue damage after the inflammatory lesions subside.
Lasers therapy has been proposed to destroy the bacteria and reduce the inflammation as an alternative treatment for active inflammatory acne (e.g., Candela Smoothbeam™, Aura™ Laser, Clearlight™ Acne Treatment, Dermillume Pro Series, Radiancy ClearTouch™, MED Flash II and Ellispse I2PL)
Laser therapy for the treatment of the following is considered investigational:
Onychomycosis (i.e. nail fungus)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine lasting benefits of laser therapy for the treatment of active acne or onychomycosis as compared to conventionally accepted therapy.
American Academy of Dermatology. (May, 2016). Guidelines of care for the management of acne vulgaris. Received February 16, 2018 from www.aad.org.
American Academy of Pediatrics. (2013). Evidence-based recommendations for the diagnosis and treatment of pediatric acne. Retrieved July 9, 2013 from http://pediatrics.aappublications.org.
BlueCross BlueShield Association. Evidence Positioning System. (1:2019). Laser treatment of onychomycosis (2.01.89). Retrieved January 28, 2019 from http://www.evidencepositioningsystem.com. (13 articles and/or guidelines reviewed)
Bristow, I. R. (2014). The effectiveness of lasers in the treatment of onychomycosis: a systematic review. Journal of Foot and Ankle Research. 2014 (7), 34. (Level 1 evidence)
British Association of Dermatology. (2014). British Association of Dermatologists’ guidelines for the management of onychomycosis 2014. Retrieved March 23, 2017 from http://www.bad.org.uk.
Centers for Medicare and Medicaid Services. CMS.gov. NCD for laser procedures (140.5). Retrieved March 17, 2016 from: https://www.cms.gov.
Gupta, A.K., & Versteeg, S.C. (2017). A critical review of improvement rates for laser therapy used to treat toenail onychomycosis. Journal of the European Academy of Dermatology and Venereology, 2017 Mar 13. Doi: 10.1111/jdv.14212. [Epub ahead of print]
Karsai, S., Jäger, M., Oesterhelt, A., Weiss, C., Schneider, S.W., Jünger, M., & Raulin, C. (2017). Treating onychomycosis with the short-pulsed 1064-nm-Nd:YAG laser: results of a prospective randomized controlled trial. Journal of the European Academy of Dermatology and Venereology, 31 (1), 175-180. Abstract retrieved March 23, 2017 from PubMed database.
Kim, T.I., Shin, M.K., Jeong, K.H., Suh, D.H., Lee, S. J., Oh, I.H., & Lee, M.H. (2016). A randomized comparative study of 1064 nm Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser and topical antifungal treatment of onychomycosis. Mycoses, 2016 Jul 12: doi: 10.1111/myc.12534. [Epub ahead of print]. Abstract retrieved March 23, 2017 from PubMed database.
U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060653 (ThermaClear™ Device). Retrieved July 9, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2011, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K103338 (VariBreeze™). Retrieved July 9, 2013 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 5/12/2005
MOST RECENT REVIEW DATE: 3/28/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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