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Low-level laser therapy (LLLT), also called photobiomodulation, is being evaluated to treat various conditions including oral mucositis, myofascial pain, joint pain, lymphedema, and chronic wounds.
Low-level laser therapy refers to the use of red-beam or near-infrared lasers with a wavelength between 600 and 1,000 nm and power from 5MW and 500 MW. (In contrast, lasers used in surgery typically use 300 Watts.) When applied to the skin, LLLT produces no sensation and does 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. LLLT is being evaluated to treat a wide variety of conditions, including soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, and joint pain. LLLT has also been evaluated for lymphedema.
One of the disorders for which LLLT has been used is 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.
Another key disorder for which LLLT is being evaluated is cancer therapy-induced oral mucositis in patients treated by radiotherapy and/or chemotherapy and hematopoietic stem-cell transplantation. Oral mucositis describes inflammation of the oral mucosa and typically manifests as erythema or ulcerations that appear 7 to 10 days after initiation of high-dose cancer therapy. Oral mucositis can cause significant pain and increased risk of systemic infection, dependency on total parenteral nutrition, and use of narcotic analgesics. Treatment planning may also need to be modified due to dose-limiting toxicity. There are a number of interventions for oral mucositis that may partially control symptoms, but none are considered a criterion standard treatment. When uncomplicated by infection, oral mucositis is self-limited and usually heals within 2 to 4 weeks after cessation of cytotoxic chemotherapy.
A number of low-level lasers have been cleared for marketing from the U.S. Food and Drug Administration (FDA) through the 510(k) process for the treatment of pain. Data submitted 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. 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."
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 stem cell transplantation (see Policy Guidelines).
Low-level laser therapy is considered investigational for all other indications including but not limited to:
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
In the meta-analysis of 18 trials comparing low-level laser therapy (LLLT) to chemotherapy or chemoradiation for prevention of oral mucositis, the course of LLLT was generally from day 0 through treatment. In studies of hematopoietic stem cell transplant (HSCT), the course of LLLT began between day -7 and day 0 and continued as long as day 14 to 15. In studies that began LLLT at day -7 to day -5 before HSCT, the course of laser therapy ended at day -1 to day 0.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
03/05/2014: Policy reviewed; no changes.
02/06/2015: Policy reviewed; description updated regarding low-level laser therapy for oral mucositis. Policy statement unchanged.
07/31/2015: Code Reference section updated for ICD-10.
06/01/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
08/15/2016: Policy description updated. Added policy statement that low-level laser therapy may be considered medically necessary for prevention of oral mucositis in select patients. Investigational policy statement updated to state that low-level laser therapy is considered investigational for all other indications. Added additional investigational indications. Policy guidelines updated regarding trials. Code Reference section updated to change the code table from investigational to medically necessary. Added the following ICD-10 diagnosis codes: C00.0 - C96.9, D00.00 - D09.9, D37.01 - D48.9, and D49.0 - D49.9.
SOURCESBlue Cross Blue Shield Association policy # 2.01.56
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Medically Necessary Codes