DESCRIPTION
Laser therapy has been proposed as a treatment for multiple skin conditions, including inflammatory acne and onychomycosis. As an alternative treatment for onychomycosis (common fungal infection of the nail), laser therapy uses the principle of selective photothermolysis, defined as the precise targeting of tissue using a specific wavelength of light. The aim of laser treatment for onychomycosis is to heat the nail bed to temperatures required to disrupt fungal growth and at the same time avoid pain and necrosis to surrounding tissues. Examples of FDA-cleared laser devices include Nd: YAG 1064-nm laser system, PinPointe™ FootLaser™, GenesisPlus™, VariaBreeze™, JOULE ClearSense™, GentleMax Family of Laser Systems, Nordlys, Dual-wavelength ND: YAG 1064 and 532-nm laser system, and Q-Clear™.
As an alternative treatment for acne, laser therapy is proposed to kill propionibacterium acnes (P. acnes) and reduce inflammation. Various types of laser devices have been cleared for marketing by the U.S. Food and Drug Administration. These include pulsed and non-pulsed devices and differing wavelengths of emitted light. Examples include Candela Smoothbeam™, CoolTouch®, Radiancy ClearTouch™, MED flash II, Ellispse I2PL, Aura™, Clearlight and Dermillume.
POLICY
Laser therapy for the treatment of the following is considered investigational:
Active acne
Onychomycosis (i.e., nail fungus)
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
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.
SOURCES
American Academy of Dermatology. (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. (1:2023). Laser treatment of onychomycosis (2.01.89). Retrieved September 21, 2022 from http://www.evidencepositioningsystem.com. (14 articles and/or guidelines reviewed)
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.
Bunyaratavej, S., Wanitphakdeedecha, R., Ungaksornpairote, C., Kobwanthanakun, W., Chanyachailert, P., Nokdhes, Y.N., et al. (2020). Randomized controlled trial comparing long-pulsed 1064-Nm neodymium: Yttrium-aluminum-garnet laser alone, topical amorolfine nail lacquer alone, and a combination for nondermatophyte onychomycosis treatment. Journal of Cosmetic Dermatology, 2020 Jan 10, doi: 10.1111/jocd.13291. [Epub ahead of print]
Centers for Medicare and Medicaid Services. CMS.gov. NCD for laser procedures (140.5). Retrieved March 17, 2016 from https://www.cms.gov.
Chalermsuwiwattanakan, N., Rojhirunsakool, S., Kamanamool, N., Kanokrungsee, S., & Udompataikul, M. (2021). The comparative study of efficacy between 1064-nm long-pulsed Nd:YAG laser and 595-nm pulsed dye laser for the treatment of acne vulgaris. Journal of Cosmetic Dermatology ,20 (7), 2108-2115. Abstract retrieved June 22, 2021 from PubMed database.
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, 31 (7), 1111-1118. Abstract retrieved January 16, 2020 from PubMed database.
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, 59 (12), 803-810. Abstract retrieved March 23, 2017 from PubMed database.
Ma, W., Si, C., Carrero, L.M.K., Liu, H.F., Yin, X.F., Liu, J., et al. (2019). Laser treatment for onychomycosis: a systematic review and meta-analysis. Medicine, 98 (48), e17948. (Level 1 evidence)
Zaki, A.M., Abdo, H.M., Ebadah, M.A., & Ibrahim, S.M. (2019). Fractional CO2 laser plus topical antifungal versus fractional CO2 laser versus topical antifungal in the treatment of onychomycosis. Dermatologic Therapy, 33 (1), e13155. Abstract retrieved January 16, 2020 from PubMed database.
ORIGINAL EFFECTIVE DATE: 5/12/2005
MOST RECENT REVIEW DATE: 11/9/2023
ID_BT
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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