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DESCRIPTIONLow-level laser therapy, also called photobiomodulation refers to the use of red-beam or near-infrared lasers with a wavelength between 600 and 1,000 nm and power from 5–500 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 human 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 tissue healing is unknown; hypotheses have included improved cellular repair and stimulation of the immune, lymphatic, and vascular systems.
Low-lever laser therapy (LLLT) has been used to treat pain associated with a variety of conditions including soft tissue injuries, tendinopathies and osteoarthritis. LLLT has been used outside the United States to treat oral mucositis associated with radiation and chemotherapy, stimulate healing of chronic wounds, treat nerve injuries, and as an adjunct to antituberculosis drugs.
LLLT is also being evaluated in the treatment of carpal tunnel syndrome. 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 dorsally and laterally by the carpal bones and ventrally by the transverse carpal ligament. Through this contained space run the 9 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 hypesthesia, clumsiness, loss of dexterity, and weakness of pinch. In the most severe cases, patients experience marked sensory loss and significant functional impairment with thenar atrophy. 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. 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, using either an open or endoscopic approach.
A number of low-level lasers have received clearance for marketing from the U.S. Food and Drug Administration (FDA) specifically for the treatment of carpal tunnel syndrome. Data submitted to the FDA as part of the FDA 510(k) approval process for the MicroLight 830 Laser consisted of 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 used in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." In 2006, the FDA provided marketing clearance for the GRT LITE, which listed the Tuco Erchonia PL3000, the Excalibur System, the Microlight 830 Laser, and the Acculaser Pro as predicate devices. Indications of the GRT LITE for carpal tunnel syndrome are similar to the predicate devices: “adjunctive use in providing temporary relief of minor chronic pain.” The LightStream™ Low Level Laser device received 510(k) marketing clearance in 2009 for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice. As of October 2009, no devices have received FDA clearance for applications other than treatment of pain. A number of clinical trials of LLLT are underway in the United States, including studies of wound healing.
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."
POLICYLow-level laser therapy is considered investigational for all indications including but not limited to treatment of carpal tunnel syndrome.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/2003: Approved by Medical Policy Advisory Committee (MPAC)
3/15/2006: Policy reviewed, no changes
3/28/2007: Policy reviewed, description updated, no changes to policy statement
5/1/2008: Policy reviewed, no changes
06/22/2010: “As a Treatment of Carpal Tunnel Syndrome” was deleted from the policy title as the description and policy statement were expanded beyond carpal tunnel syndrome to include other musculoskeletal conditions and wound healing. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section. Added CPT code 97026.
04/20/2011: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
02/20/2013: Policy reviewed; no changes.
SOURCESBlue Cross Blue Shield Association policy # 2.01.56
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.