Light Emitting Diode (LED) Therapy
DESCRIPTION
Light emitting diode (LED) therapy is proposed as a treatment of diabetic peripheral neuropathy, lymphedema, non-healing wounds and muscle pain. Treatment is based on the premise that LED therapy may cause an increase in nitric oxide concentrations that may lead to increased blood flow and promote vasodilatation.
LED therapy devices use one (monochromatic) or two wavelengths of infrared (invisible) light with or without red (visible) light. The light is measured in nanometers (880nm), with a higher nanometer number denoting a greater depth of tissue penetration. Treatment is administered several times a week over a period of weeks to months. LED therapy can be provided in an office or home setting.
LED therapy utilizes a device (e.g., Anodyne Therapy System, Pain-X-2000, BioScan, Light Force Therapy) that delivers light to targeted tissue through multiple super luminous infrared diodes located on a flexible pad that is in contact with the skin. LED therapy may also be referred to as monochromatic infrared energy (MIRE™), infrared energy therapy, infrared light therapy, or infrared heating pad system.
POLICY
Light emitting diode therapy for the treatment of conditions / diseases, including but not limited to diabetic peripheral neuropathy, lymphedema, non-healing wounds, tendonitis, capsulitis, and pain is considered investigational.
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
Scientific evidence in peer review literature regarding the safety and effectiveness of this technology on health outcomes is lacking.
SOURCES
Association for the Advancement of Wound Care (AAWC). (2014). Venous and pressure ulcer guidelines. Retrieved September 14, 2018 from https://www.o-wm.com/article/association-advancement-wound-care-aawc-venous-and-pressure-ulcer-guidelines.
Center for Medicare & Medicaid Services. CMS.gov. (2007, January). National Coverage Determination (NCD) for infrared therapy devices (270.6). Retrieved April 15, 2022 from https://www.cms.gov.
De Barros, A., Gonzaga, I., Fernandes, G.A., Lima, A., Cortelazzi, P., de Oliveira, R., & Nicolau, R. (2018). Low-intensity LED therapy (Λ 640 ± 20 nm) on saphenectomy healing in patients who underwent coronary artery bypass graft: a randomized, double-blind study. Lasers in Medical Science, 33 (1), 103-109. Abstract retrieved September 14, 2018 from PubMed database.
Hsieh, R., Lo, M., Lee, W., & Liao, W. (2012). Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study. Journal of Orthopaedic & Sports Physical Therapy, 42 (11), 947-956. (Level 1 evidence)
Jagdeo, J., Austin, E., Mamalis, A., Wong, C., Ho, D., & Siegel, D.M. (2018). Light-emitting diodes in dermatology: A systematic review of randomized controlled trials. Lasers in Surgery and Medicine, 50 (6), 613-628. (Level 1 evidence)
Lin, Y-P., Su, Y-H., Chin, S-F., RNa., Chou, Y-C., & Chia, W-T. (2020). Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses A single-center, double-blind, prospective, randomized controlled trial. Medicine, 99 (32), e21611. (Level 4 evidence)
Rastogi, A., Uppula, P., Saikia, U., & Bhansali, A. (2021). Effect of monochromatic infrared energy on quality of life and intraepidermal nerve fiber density in painful diabetic neuropathy: a randomized, sham control study. Neurology India, 69 (5), 1331–1337. (Level 2 evidence)
Robinson, C., Klahr, P., Stein, C., Falavigna, M., Sbruzzi, G., & Plentz, R. (2017). Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials. Brazilian Journal of Physical Therapy, 21 (4), 233–243. (Level 1 evidence)
U. S. Food and Drug Administration. (2006, December). Center for Devices and Radiological Health. 510(k) Premarket notification database K062635. Retrieved December 22, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2011, January). Center for Devices and Radiological Health. 510(k) Premarket notification database K101894. Retrieved December 22, 2015 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 12/1/2003
MOST RECENT REVIEW DATE: 10/10/2024
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