Medical Policy: 02.01.14
Original Effective Date: March 2003
Reviewed: February 2018
Revised: February 2018
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.
Low-level laser therapy, also known as cold laser therapy and sometimes called class III lasers, has been investigated as a conservative measure to treat a number of musculoskeletal disorders, soft tissue injuries including carpal tunnel syndrome (CTS) and other disorders such as Raynaud's disease and fibromyalgia. When applied to the skin, it has been hypothesized that the laser light penetrates the skin and stimulates cellular metabolism leading to temporary relief of hand and wrist pain. The exact mechanism of its effect is unknown.
The U.S. Food and Drug Administration classifies most LLLT devices as Class II devices as “lamp, non-heating, for adjunctive use in pain therapy”. Between 2002 and 2016, 44 such devices received 510(k) clearance for marketing for temporary pain relief: Including but not limited to Acculaser Pro Low Level Laser Therapy Device; Acculaser Pro4; Anodyne Therapy System, Axiom Biolaser LLLT Series-1; Axiom Biolaser LLLT Series-3; Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System; Collagentex Rx-1; Diobeam 830; Elite Electromed L.I.T.E. 4/1; Erchonia's Allay, Emerge, EML Laser, EML Laser; Evri, Mis-Ac Derma Scanner, Pl2000, Pi5000, Pi Touch, and TH1 Laser; Excalibur IV Light Therapy System Model SGEX4-001; Excalibur Light Therapy System Model SGLEX-04-001; GRT Lite Model 8-A; Lapex 2000; Laser Helmet, Lasertouchone; Lazrpulsr 4x; Ld-I 75 And LD-I 200; LEP2000 Therapy System; Lightstream Low Level Laser; Luminex LL Laser System; Lx-100 Hair Growth Stimulation System; Medx LCS Laser Series; Microlight 830 Laser System; NMA 1052 Console System With NMA 100 Laser Accessory; Omega Excel/XP Laser System; Power Laser 90; QLaser System; Quantum Light Therapy System; Sunetics Clinical Bio-Stimulation Laser; Theralase TLC-2000 Therapeutic Medical Laser System; Thor DDII 830CL3 Laser System; Tlc-2000 Therapeutic Medical Laser System; Trilumina Therapeutic Laser System, Vectra Genisys Laser System.
Carpal Tunnel Syndrom (CTS) is perhaps the most studied application of this type of laser therapy. CTS is an entrapment neuropathy caused by compression of the median nerve as it passes from the forearm to the palm beneath the transverse carpal ligament. Associated signs and symptoms include paresthesias; numbness and tingling in the sensory distribution of the median nerve for thumb, index, middle and radial side of the ring finger; Tinel sign; Plalen sign; nocturnal awakening; and sometimes hand weakness. The etiology of CTS is unknown; however, it occurs most commonly in workers involved in repetitive hand movements. Current standard treatments include conservative measures such as wrist splints and non-steroidal antiinflammatory drugs. Surgical release of the transverse carpal ligament may be performed when symptoms fail to respond to conservative measures.
Recently the use of higher powered, also non-surgical, lasers have been used for the treatment of the above mentioned musculoskeletal conditions, specifically peripheral neuropathy pain treatment. Sometimes these are referred to as Class IV lasers.
In November 2010, the BlueCross BlueShield Association Technology Evaluation Center (TEC) published a technology assessment of low-level laser therapy for carpal tunnel syndrome and chronic neck pain. For inclusion in the assessment studies had to: be published in a peer-reviewed journal; be randomized, sham-controlled trials and, if adjunctive therapies were used, they were applied to both groups; measure outcomes at least 2 weeks beyond the end of the treatment period; and, for neck pain studies, be studies of patients with chronic pain.
Four studies of carpal tunnel syndrome met the inclusion criteria. TEC concluded that the studies have serious limitations including limited follow-up, and no one study is so methodologically sound as to provide definitive results.
The TEC assessment included 6 trials of low-level laser therapy for chronic neck pain and found inconsistent results. The TEC assessment did comment on a systematic review and meta-analysis of randomized placebo or active-treatment controlled trials by Chow and colleagues and noted "some studied evaluated acute neck pain, some had insufficient follow-up beyond the period of treatment, one had no sham control…." Overall, TEC concluded that the studies are characterized by small sample sizes, limited statistical power, and limited long-term follow-up.
The use of infrared and/or near-infrared light and/or heat, including monochromatic infrared energy (MIRE), has not been shown to be beneficial, including symptoms such as pain arising from these conditions, of diabetic and/or non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of skin and/or subcutaneous tissues.
Laser therapy or low-level laser therapy, (LLLT) has been studied for a multiple number of other conditions. There has not been successful studies that consistently demonstrates benefit of the therapy.
The American Academy of Orthopaedic Surgeons (AAOS) published clinical practice guidelines on the treatment of carpal tunnel syndrome (AAOS, 2016). In the guidelines, regarding laser treatment, it is noted that, “ Limited evidence supports that laser therapy might be effective compared to placebo.” Strength of Recommendation: Limited Evidence.
An evidence-based guideline for the treatment of painful diabetic neuropathy published by American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation (Bril, et al., 2011). The guideline notes LLLT is probably not effective for the treatment of this condition and is not recommended.
Low-level laser treatment or cold laser treatment and high-powered, non-surgical lasers are considered investigational for all apllications, including but not limited to:
The available literature on low-level laser therapy as a treatment for pain of various etiologies and in a variety of anatomical sites presents inconsistent conclusions and methodologic weaknesses including a lack of follow-up evaluation, that prevent drawing firm conclusions regarding efficacy.
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.
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