This policy addresses low level laser therapy (LLLT), which uses laser devices producing laser beam wavelengths between 600 and 1000 nm and watts from 5–500 milliwatts (mW). This policy addresses the use of LLLT for all indications.

Note: For information related to other types of laser therapy for the treatment of acne vulgaris, see MED.00063 Treatment of Acne Vulgaris using Pulsed Dye Laser or Photodynamic Therapy.

Investigational/Not Medically Necessary:

The use of low level laser therapy, also referred to as cold laser therapy, is considered investigational/not medically necessary for all indications, including, but not limited to, carpal tunnel syndrome, Raynaud's phenomenon, fibromyalgia, other musculoskeletal disorders, chronic non-healing wounds, and neurological dysfunctions.

Rationale

The term “low level laser therapy” (LLLT), also referred to as “cold laser therapy,” refers to a wide variety of procedures involving several laser types and treatment methods.  This leads to difficulties in the consistency of the literature and in interpreting the body of evidence addressing this technology.  Several randomized controlled trials involving patients with lymphedema (Carati, 2003), fibromyalgia (Gur, 2002 [2 separate 2002 articles]), back pain (Gur, 2003), and post surgical wounds (Lagan, 2001) have failed to demonstrate any significant benefits to LLLT, when compared to standard treatment methods and placebo. 

The most studied application of LLLT is for the treatment of pain associated with carpal tunnel syndrome.  Relief of pain is a subjective outcome that is typically associated with a placebo effect.  Therefore, blinded and randomized controlled trials are required to control for the placebo effect and to determine its magnitude and whether any treatment effect provides a significant advantage over the placebo.  The technology must also be evaluated in different groups of patients.  In patients with mild to moderate symptoms of carpal tunnel syndrome, LLLT may be compared to other forms of conservative therapy, such as splinting, rest, non-steroidal anti-inflammatory drugs (NSAIDs), or steroid injection.  Secondly, in a group of patients who have exhausted conservative therapy, LLLT must be compared to surgical release of the carpal ligament.  Another relevant outcome measure for treatment of carpal tunnel syndrome is return to work.  It is difficult to analyze this outcome, because the criteria for return to work are often variable and job specific.

In February 2002, the MicroLight 830™ Laser System (MicroLight Corporation of America, Missouri City, TX) received 510(k) clearance for marketing from the U.S. Food and Drug Administration (FDA), specifically for the treatment of carpal tunnel syndrome.  In the data submitted to the FDA, the treatment consisted of applications of the laser over the carpal tunnel three times a week for five 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.”  As part of the FDA approval process, the manufacturer of the MicroLight device conducted a double blind, placebo-controlled study of 135 patients with moderate to severe symptoms of carpal tunnel syndrome who had failed conservative therapy for at least a month.  However, the results of this study have not been published in the peer-reviewed literature, and only a short summary is available in the FDA Summary of Safety and Effectiveness, which does not permit scientific conclusions. 

Naesar and colleagues published the results of a controlled study of 11 patients with mild to moderate carpal tunnel syndrome who received real and sham treatment of low level laser acupuncture and TENS therapy(Naeser, 2002).  This study is also too small to permit adequate scientific conclusions.  Additional small studies regarding other proposed treatment applications for LLLT, such as for joint pain associated with orthopedic/neuromuscular problems and also to stimulate wound healing, have failed to demonstrate the efficacy of LLLT, as compared with other treatment options (Bingol, 2005; Kopera, 2005).

Background/Overview

Carpal tunnel syndrome is the most common entrapment neuropathy and the most commonly performed surgery of the hand.  The syndrome is related to the bony anatomy of the wrist.  The carpal tunnel is bound by the carpal bones and the transverse carpal ligament.  Within this contained space are the nine flexor tendons and the median nerve.  Therefore, any space-occupying lesion can compress the median nerve and produce the typical symptoms of carpal tunnel syndrome—pain, numbness, and tingling in the distribution of the median nerve.  Symptoms of more severe cases include decreased sensitivity to touch or pain, clumsiness, loss of dexterity, and weakness of pinch.  In the most severe cases, patients experience marked sensory loss and significant functional impairment with atrophy of part of the hand (thenar).  A variety of etiologies have been associated with carpal tunnel syndrome.  Nonspecific flexor tenosynovitis is the most common cause and is, in turn, typically associated with occupationally associated repetitive motion.  A variety of space-occupying lesions can compress the median nerve, including benign tumors or anatomic anomalies.  Pregnancy has been associated with carpal tunnel syndrome, presumably as a result of hormone-mediated edema.  Carpal tunnel syndrome can also be one of the clinical manifestations of the following medical conditions:  rheumatoid arthritis, diabetes, post-traumatic wrist deformities, polymyalgia rheumatica, mucopolysaccharidoses, amyloidosis, myxedema, or acromegaly.  Finally, a causal link has been established between repetitive stress injuries and the development of carpal tunnel syndrome.  This can be seen in the high rate of carpal tunnel syndrome in individuals with repetitive hand and wrist-related tasks associated with their occupations, such as typing.

Mild to moderate cases of carpal tunnel syndrome are usually first treated conservatively with splinting and cessation of aggravating activities.  Other conservative therapies include oral steroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and steroid injections into the carpal tunnel itself.  Those patients who do not respond to conservative therapy or who present with severe carpal tunnel syndrome with thenar atrophy may be considered candidates for surgical release of the carpal ligament.  Recently, there has been interest in using low-level, non-thermal lasers, as a conservative alternative.

Low-level lasers refer to the use of red-beam or near-infrared non-thermal lasers with a wavelength between 600 and 1000 nm and watts from 5–500 milliwatts (mW).  In contrast, lasers used in surgery typically use 300 watts.  When applied to the skin, these lasers produce no sensation and do not burn the skin.  Because of the low absorption by skin, it is hypothesized that the laser light can penetrate deeply into the tissues where it has a photobiostimulative effect.  The exact mechanism of its effect on carpal tunnel syndrome is unknown; hypotheses have included improved cellular repair and stimulation of the immune, lymphatic, and vascular systems.  Other protocols have used low level laser energy applied to acupuncture points on the fingers and hand.  This technique may be referred to as “laser acupuncture.”

Definitions

Low level laser therapy: a form of therapy involving the use of low energy laser devices proposed for the treatment of various medical conditions

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

CPT

HCPCS

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Bensadoun RJ, Franquin JC, Ciais G, et al. Low-energy He/Ne laser in the prevention of radiation-induced mucositis. A multicenter phase III randomized study in patients with head and neck cancer. Support Care Cancer. 1999; 7(4):244-252. 
2. Bingol U, Altan L, Yurtkuran M. Low-power laser treatment for shoulder pain.  Photomed Laser Surg. 2005; 23(5):459-464.
3. Branco K, Naeser MA. Carpal tunnel syndrome: clinical outcome after low-level laser acupuncture, microamps transcutaneous electrical nerve stimulation and other alternative therapies – an open protocol study. J Altern Complement Med. 1999; 5(1):5-26.
4. Brosseau L, Wells G, Marchand S, et al.  Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand.  Lasers Surg Med. 2005a; 36(3):210-219.
5. Carati CJ, Anderson SN, Gannon BJ, Piller NB. Treatment of postmastectomy lymphedema with low-level laser therapy: a double blind, placebo-controlled trial. Cancer. 2003; 98(6):1114-1122. 
6. Gerritsen AA, de Krom MC, Struijs MA, et al. Conservative treatment options for carpal tunnel syndrome: a systematic review of randomised controlled trials. J Neurol. 2002; 249(3):272-280. 
7. Gur A, Karakoc M, Cevik R, et al. Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Lasers Surg Med. 2003; 32(3):233-238.
8. Gur A, Karakoc M, Nas K, et al. Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial. Rheumatol Int. 2002; 22(5):188-193. 
9. Gur A, Karakoc M, Nas K, et al. Efficacy of low power laser therapy in fibromyalgia: a single-blind, placebo-controlled trial. Lasers Med Sci. 2002; 17(1):57-61. 
10. Gur A, Sarac AJ, Cevik R, et al. Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomize-controlled trial. Lasers Surg Med. 2004; 35(3):229-235.
11. Hirschl M, Katzenschlager R, Francesconi C, et al. Low level laser therapy in primary Raynaud's phenomenon: results of a placebo controlled, double blind intervention study. J Rheum. 2004; 31(12):2408-2411.
12. Irvine J, Chong SL, Amirjani N, Chan KM.  Double-blind randomized controlled trial of low-level laser therapy in carpal tunnel syndrome.  Muscle Nerve. 2004; 30(2):182-187.
13. Kopera D, Kokol R, Berger C, Haas J.  Does the use of low-level laser influence wound healing in chronic venous leg ulcers?  J Wound Care. 2005; 14(8):391-394.
14. Lagan KM, Clements BA, McDonough S, Baxter GD. Low intensity laser therapy (830nm) in the management of minor postsurgical wounds: a controlled clinical study. Lasers Surg Med. 2001; 28(1):27-32. 
15. Naeser MA, Hahn KA, Lieberman BE, et al. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: a controlled study. Arch Phys Med Rehabil. 2002; 83(7):978-988.
16. Stergioulas A. Low-level laser treatment can reduce edema in second degree ankle sprains. J Clin Laser Med Surg. 2004; 22(2):125-128.
17. Weintraub MI. Noninvasive laser neurolysis in carpal tunnel syndrome. Muscle Nerve. 1997; 20(8):1029-1031.
18. Zinman LH, Ngo M, Ng ET, et al. Low-intensity laser therapy for painful symptoms of diabetic sensorimotor polyneuropathy: a controlled trial. Diabetes Care. 2004; (4):921-924.

Government Agency, Medical Society, and other Authoritative Publications:

1. Brosseau L, Gam A, Harman K, et al.  Low level laser therapy (Classes I, II and III) for treating osteoarthritis (Cochrane Review).  In:  The Cochrane Library, Issue 3, 2004.
2. Brosseau L, Robinson V, Wells G, et al.  Low level laser therapy (Classes I, II and III) for treating rheumatoid arthritis.  Cochrane Syst. Rev. 2005b; (4):CD002049. 
3. Centers for Medicare and Medicaid Services. National Coverage Determination:  Laser Procedures. NCD #140.5.  Effective May 1, 1997.  Available at:  http://www.cms.hhs.gov. Accessed on March 27, 2007.
4. Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management:  beds; compression; laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technology Assessment. 2001; Vol. 5, No. 9.
5. Flemming K, Cullum N.  Laser therapy for venous leg ulcers (Cochrane Review).  In:  The Cochrane Library, Issue 3, 2004.
6. Samson D, Lefevre F, Aronson N.  Agency for Healthcare Research and Quality (AHRQ). Wound-healing Technologies:  Low level laser and vacuum-assisted closure.    Evidence Report/Technology Assessment No. 111. AHRQ Publication No. 05-E005-2. Rockville, MD. December 2004. Available at:  http://www.ahrq.gov/downloads/pub/evidence/pdf/woundtech/woundtech.pdf.  Accessed on March 27, 2007.
7. Simon A.  Alberta Heritage Foundation for Medical Research.  Technology Assessment: Low level laser therapy for wound healing:  an update.  2004.  Available at:  http://www.ahfmr.ab.ca/.  Accessed on March 27, 2007.
8. U.S. Food and Drug Administration (FDA).  Center for Devices and Radiological Health. MicroLight 830™ Laser System. Approval letter: February 6, 2002.  Available at:    http://www.fda.gov/cdrh/pdf/k010175.pdf.  Accessed on March 27, 2007.
9. Vlassov VV, Pechatnikov LM, MacLehose HG.  Low level laser therapy for treating tuberculosis (Cochrane Review).  In:  The Cochrane Library, Issue 3, 2004.
   

Web Sites for Additional Information

1. National Institute of Neurological Disorders and Stroke. Carpal Tunnel Syndrome Fact Sheet.   Available at:  http://www.ninds.nih.gov/disorders/carpal_tunnel/detail_carpal_tunnel.htm Accessed on March 27, 2007.

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association