Laser Treatment for Onychomycosis Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 02|07|2017 POLICY LAST REVIEWED: 01|21|2026

OVERVIEW Onychomycosis is a common fungal infection of the nail. Currently, available treatments for onychomycosis, including systemic and topical antifungal medications, have relatively low efficacy and require a long course of treatment. Laser systems are proposed as another treatment option.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT Medicare Advantage Plans
Laser treatment of onychomycosis is considered not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products Laser treatment of onychomycosis is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessity benefits/coverage.

BACKGROUND Onychomycosis is a common chronic fungal infection of the nail. It is estimated to cause up to 50% of all nail disease and 33% of cutaneous fungal infections. The condition can affect toenails or fingernails but is more frequently found in toenails. Primary infectious agents include dermatophytes (eg, Trichophyton species), yeasts (eg, Candida albicans), and nondermatophytic molds. In temperate Western countries, infections are generally caused by dermatophytes.

Aging is the most common risk factor for onychomycosis, most likely due to decreased blood circulation, longer exposure to fungi, and slower nail growth. In addition, various medical conditions increase the risk of comorbid onychomycosis. They include diabetes, obesity, peripheral vascular disease, immunosuppression, and HIV infection. In certain populations, onychomycosis may lead to additional health problems. Although there is limited evidence of a causal link between onychomycosis and diabetic foot ulcers, at least 1 prospective study with diabetic patients found onychomycosis to be an independent predictor of foot ulcer. Moreover, onychomycosis, especially more severe cases, may adversely impact quality of life. Patients with onychomycosis have reported pain, uncomfortable nail pressure, embarrassment, and discomfort wearing shoes.

The diagnosis of onychomycosis can be confirmed by potassium hydroxide preparation, culture, or histology.
Treatments for onychomycosis include topical antifungals such as nail paints containing ciclopirox (ciclopiroxolamine), efinaconazole, tavaborole, or amorolfine (not available in the US), and oral antifungals such as terbinafine and itraconazole. These have low-to-moderate efficacy and a high relapse rate. Topical Medical Coverage Policy | Laser Treatment for Onychomycosis

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

antifungals and some long-available oral medications (eg, griseofulvin) require a long course of treatment, which presents issues for patient compliance. Moreover, oral antifungal medications have been associated with adverse effects such as a risk of hepatotoxicity.

Several types of device-based therapies are under investigation for treatment of onychomycosis, including ultrasound, iontophoresis, photodynamic therapy, and laser systems. A potential advantage of lasers is that they have greater tissue penetration than antifungal medication and thus may be more effective at treating infection embedded within the nail. Another potential advantage is that laser treatments are provided in a clinical setting in only 1 or several sessions and, thus, requires less long-term patient compliance.

Laser treatment of onychomycosis uses the principle of selective photothermolysis, defined as the precise targeting of tissue using a specific wavelength of light. The premise is that light is absorbed into the target area and heat generated by that energy is sufficient to damage the target area while sparing the surrounding area. The aim of laser treatment for onychomycosis is to heat the nail bed to temperatures required to disrupt fungal growth (approximately 40-6 degrees Celsius) and at the same time avoid pain and necrosis to surrounding tissues.

For individuals who have onychomycosis who receive treatment with laser therapy, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. Some of the available RCTs have reported improvements in clinical outcomes with laser treatment, but these trials have mixed results and methodologic limitations. Clinical and mycological outcomes sometimes differed in the trials, which may be due in part to lack of consistent blinding of outcome assessment. The published evidence to date does not permit determining whether laser treatment improves health outcomes in patients with onychomycosis. Additional well-designed, adequately powered, and well-conducted RCTs are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products There is no specific CPT code(s) for this treatment. It would likely be reported using an unlisted CPT code such as 17999 (Unlisted procedure, skin, mucous membrane and subcutaneous tissue) or 96999 (Unlisted special dermatological service or procedure).

RELATED POLICIES Foot Care and Nail Debridement Unlisted Procedures

PUBLISHED Provider Update, March 2026 Provider Update, March 2025 Provider Update, March 2024 Provider Update, March 2023 Provider Update, April 2022

REFERENCES

1. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. Feb 15 2001; 63(4): 663-72, 677-8. PMID 11237081
2. Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinicalinformation: the Seattle Diabetic Foot Study. Diabetes Care. Jun 2006; 29(6): 1202-7. PMID 16731996
3. Drake LA, Scher RK, Smith EB, et al. Effect of onychomycosis on quality of life. J Am Acad Dermatol. May 1998; 38(5 Pt1): 702-4. PMID 9591814
4. Elewski BE. Onychomycosis. Treatment, quality of life, and economic issues. Am J Clin Dermatol. 2000; 1(1): 19-26.PMID 11702301

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

5. Gupta A, Simpson F. Device-based therapies for onychomycosis treatment. Skin Therapy Lett. Oct 2012; 17(9): 4-9. PMID23032936
6. Bristow IR. The effectiveness of lasers in the treatment of onychomycosis: a systematic review. J Foot Ankle Res. 2014; 7:34. PMID 25104974
7. Meretsky CR, Friday BL, Schiuma AT. Efficacy of Laser Therapy in Comparison With Other Methods for the Treatment of Onychomycosis: A Systematic Review and Meta-Analysis. Cureus. May 2024; 16(5): e59720. PMID 38841013
8. Bunyaratavej S, Wanitphakdeedecha R, Ungaksornpairote C, et al. Randomized controlled trial comparing long-pulsed1064-Nm neodymium: Yttrium-aluminum-garnet laser alone, topical amorolfine nail lacquer alone, and a combination fornondermatophyte onychomycosis treatment. J Cosmet Dermatol. Sep 2020; 19(9): 2333-2338. PMID 31925917
9. El-Tatawy RA, Abd El-Naby NM, El-Hawary EE, et al. A comparative clinical and mycological study of Nd-YAG laserversus topical terbinafine in the treatment of onychomycosis. J Dermatolog Treat. Oct 2015; 26(5): 461-4. PMID 25669435
10. Hamed Khater M, Khattab FM. Combined long-pulsed Nd-Yag laser and itraconazole versus itraconazole alone in thetreatment of onychomycosis nails. J Dermatolog Treat. Jun 2020; 31(4): 406-409. PMID 31157575
11. Karsai S, Jäger M, Oesterhelt A, et al. Treating onychomycosis with the short-pulsed 1064-nm-Nd:YAG laser: results of aprospective randomized controlled trial. J Eur Acad Dermatol Venereol. Jan 2017; 31(1): 175-180. PMID 27521028
12. Kim TI, Shin MK, Jeong KH, et al. A randomised comparative study of 1064 nm Neodymium-doped yttrium aluminiumgarnet (Nd:YAG) laser and topical antifungal treatment of onychomycosis. Mycoses. Dec 2016; 59(12): 803-810. PMID2740246612.
13. Nijenhuis-Rosien L, Kleefstra N, van Dijk PR, et al. Laser therapy for onychomycosis in patients with diabetes at risk forfoot ulcers: a randomized, quadruple-blind, sham-controlled trial (LASER-1). J Eur Acad Dermatol Venereol. Nov 2019;33(11): 2143-2150. PMID 30920059
14. Sabbah L, Gagnon C, Bernier FE, et al. A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis. J Cutan Med Surg.2019; 23(5): 507-512. PMID 31296045
15. Xu Y, Miao X, Zhou B, et al. Combined oral terbinafine and long-pulsed 1,064-nm Nd: YAG laser treatment is moreeffective for onychomycosis than either treatment alone. Dermatol Surg. Nov 2014; 40(11): 1201-7. PMID 25322165
16. Nasif GA, Amin AA, Ragaie MH. Q-switched Nd:YAG laser versus itraconazole pulse therapy in treatment ofonychomycosis: A clinical dermoscopic and mycologic study. J Cosmet Dermatol. Jun 2023; 22(6): 1757-1763. PMID36716167i
17. García-Oreja S, Álvaro-Afonso FJ, Navarro-Pérez D, et al. Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial. Mycoses. Oct 2025; 68(10): e70121. PMID 41024682

18. Cai Q, Meng L, Liu X, et al. A randomised comparative study of 1064 nm Nd:YAG laser and Urea occlusion therapy with topical miconazole for the treatment of onychomycosis. Lasers Med Sci. Apr 27 2025; 40(1): 213. PMID 40287882

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