Medical Policy: 02.01.14 

Original Effective Date: March 2003 

Reviewed: February 2021 

Revised: February 2021 

 

Notice:

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 Application:

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.

 

Description:

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.

 

Practice Guidelines and Position Statements

The American Academy of Orthopedic Surgeons

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.)

 

American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation

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) 

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.

 

Regulatory Status

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.

 

Prior Approval:

Not applicable

 

Policy:

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:

  • Carpal tunnel syndrome
  • Chronic neck pain
  • Chronic back pain
  • Shoulder impingement syndrome
  • Adhesive capsulitis
  • Osteoarthritis pain
  • Alopecia
  • Dental pain
  • Obesity
  • Bone regeneration/bone healing
  • Rheumatoid arthritis
  • Peripheral neuropathy
  • Wound healing, including diabetic ulcers
  • Heel pain (ie, Achilles tendinopathy, plantar fasciitis)
  • Lymphedema
  • Rosacea
  • Scar Treatment
  • For Body Memory Reset Therapy

 

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.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 17110 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; up to 14 lesions
  • 17111 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; 15 or more lesions
  • 17999 Unlisted procedure, skin, mucous membrane and subcutaneous tissue
  • 97039 Unlisted modality (specify type and time if constant attendance) 
  • 97139 Unlisted therapeutic procedure (specify)
  • 99199 Unlisted special service, procedure or report
  • S8948 Application of a modality (requiring constant provider attendance) to one or more areas; low level laser; each 15 minutes.
  • 0491T Ablative laser treatment, non-contact, full field and fractional ablation, open wound, per day, total treatment surface area; first 20sq cm or less
  • 0492T Ablative laser treatment, non-contact, full field and fractional ablation, open wound, per day, total treatment surface area; each additional 20 sq cm, or part thereof
  • 0552T Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional

 

Selected References:

  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Low-level laser therapy for carpal tunnel and chronic neck pain. TEC Assessments 2010; Volume 25, Tab 4.
  • American Academy of Orthopaedic Surgeons Clinical Practice Guideline on Treatment of Carpal Tunnel Syndrome. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2008. Guidelines re-issue statement September 2011. Accessed May 29, 2012.
  • Savigny P, Kuntze S, Watson P, et al. Low back pain: early management of persistent non-specific low back pain. National Collaborating Centre for Primary Care and Royal College of General Practitioners. 2009; Low back pain in adults: early management
  • Chang WD, Lee CL, Lin HY, et al. A Meta-analysis of Clinical Effects of Low-level Laser Therapy on Temporomandibular Joint Pain. J Phys Ther Sci. Aug 2014;26(8):1297-1300. PMID 25202201
  • Tchanque-Fossuo CN, Ho D, Dahle SE, et al. A systematic review of low-level light therapy for treatment of diabetic foot ulcer. Wound Repair Regen. 2016 Jan 7 [Epub ahead of print].
  • Peters S, Page MJ, Coppieters MW, et al. Rehabilitation following carpal tunnel release. Cochrane Database Syst Rev. 2016;2:CD004158.
  • American Academy of Orthopaedic Surgeons (AAOS). Management of Carpal Tunnel Syndrome Evidence-Based Clinical Practice Guideline. Published February 29, 2016. Accessed June 1, 2017.
  • National Institute for Health and Care Excellence (NICE). Low back pain and sciatica in over 16s: assessment and management [NG59]. 2016  
  • ECRI Institute. High-power Laser Therapy for Chronic Pain. Plymouth Meeting (PA): ECRI Institute; 2018 Aug 15. (Custom Rapid Review).
  • Wyszynska, J, and Bal-Bochenska, M. Efficacy of High-Intensity Laser Therapy in Treating Knee Osteoarthritis: A First Systematic Review. Photomed Laser Surg. 2018;36(7):343-353. PubMed 29688827
  • Choi HW, Lee J, Lee S, Choi J, Lee K, Kim BK, Kim GJ. Effects of high intensity laser therapy on pain and function of patients with chronic back pain. J Phys Ther Sci. 2017 Jun;29(6):1079-1081.
  • Bekhet AH, Ragab B, Abushouk AI, Elgebaly A, Ali OI. Efficacy of low-level laser therapy in carpal tunnel syndrome management: a systematic review and meta-analysis. Lasers Med Sci. 2017 Aug;32(6):1439-1448
  • Skelly AC, Chou R, Dettori JR,et al. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review. Comparative Effectiveness Review No. 209. AHRQ Publication No 18-EHC013-EF. Rockville, MD: Agency for Healthcare Research and Quality; June 2018.
  • Liu KH, Liu D, Chen YT, Chin SY. Comparative effectiveness of low-level laser therapy for adult androgenic alopecia: A system review and meta-analysis of randomized controlled trials. Lasers Med Sci. 2019;34(6):1063-1069.
  • Zadik Y, et al. Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Supportive Care in Cancer 2019 Jul 8, 27:3969–3983
  • Multinational Association of Supportive Care in Cancer (MASCC). Clinical practice guidelines for the management of mucositis secondary to cancer therapy. Last updated: July 2019.

 

Policy History:

  • February 2021 - Annual Review, Policy Revised
  • February 2020 - Annual Review, Policy Revised
  • February 2019 - Annual Review, Policy Revised
  • February 2018 - Annual Review, Policy Revised
  • February 2017 - Annual Review, Policy Revised
  • February 2016 - Annual Review, Policy Renewed
  • December 2015 - Interim Review, Policy Revised
  • March 2015 - Annual Review, Policy Revised
  • April 2014 - Annual Review, Policy Renewed
  • June 2013 - Annual Review, Policy Renewed
  • July 2012 - Annual Review, Policy Renewed
  • August 2011 - Annual Review, Policy Renewed

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.