Medical Policy: 02.01.14
Original Effective Date: March 2003
Reviewed: February 2021
Revised: February 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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.
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 called non-surgical or referred to as HILT, 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 have not been successful studies that consistently demonstrates benefit of the therapy.
The American Academy of Orthopedic 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. Limited evidence: Evidence from one or more "Low" quality studies with consistent findings or evidence from a single "Moderate" quality study for recommending for against the intervention or diagnostic or the evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention.)
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 (2011). The guideline notes LLLT is probably not effective for the treatment of this condition and is not recommended.
The Multinational Association of Supportive Cancer Care (MASCC) recently updated guidelines for preventing and treating OM.
The panel suggests the use of LLLT to reduce the incidence of OM and its associated pain in patients receiving high-dose chemotherapy or chemoradiotherapy before HCT if the treatment center is able to support the necessary technology and training, because LLLT requires expensive equipment and specialized training. Because of interoperative variability, clinical trials are difficult to conduct, and their results are difficult to compare; nevertheless, the panel is encouraged by the accumulating evidence to support LLLT.
A number of low-level lasers have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process for the treatment of pain. Data submitted for the MicroLight 830® Laser consisted of the application of the laser over the carpal tunnel 3 times a week for 5 weeks. The labeling states that the "MicroLight 830 Laser is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." In 2006, GRT LITE™ was cleared for marketing, listing the TUCO Erchonia PL3000, the Excalibur System, the MicroLight 830® Laser, and the Acculaser Pro as predicate devices. Indications of the GRTLITE™ for CTS are similar to the predicate devices: "adjunctive use in providing temporary relief of minor chronic pain." In 2009, the LightStream™ LLL device was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for adjunctive use in the temporary relief of pain associated with knee disorders treated in standard chiropractic practice. Many similar LLLT/cold-laser and high powered laser devices have received 510(k) clearance from the FDA including regionally advertised LanulaLaser and the LazrPulsr system.
Low-level laser therapy may be considered medically necessary for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis, including chemotherapy and/or radiotherapy, and/or hematopoietic cell transplantation.
Low-level laser treatment or cold laser treatment and high-powered, non-surgical lasers including infrared lasers are considered investigational for all applications outside of mucositis, 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 and durability.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.
*CPT® is a registered trademark of the American Medical Association.