Low-Level Laser Therapy

POLICY NUMBER

A.2.01.56

DESCRIPTION

Low-level laser therapy (LLLT), also called photobiomodulation, is being evaluated to treat various conditions, including, among others, oral mucositis, myofascial pain, joint pain, lymphedema, and chronic wounds.

Oral Mucositis

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.

TreatmentTreatment 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 is 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. Low-level laser therapy (LLLT) has been used in cancer therapy-induced oral mucositis in individuals treated with radiotherapy and/or chemotherapy and hematopoietic cell transplantation.

Musculoskeletal and Neurologic Disorders

Musculoskeletal disorder describes a variety of conditions leading to chronic pain and decreased quality of life. 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, individuals experience marked sensory loss and significant functional impairment with thenar atrophy.

TreatmentSeveral modalities of treatment are used in the management of musculoskeletal pain including medications, immobilization, and physical therapy. The use of low-level laser therapy has been investigated for use in musculoskeletal pain conditions. In the case of carpal tunnel syndrome, mild-to-moderate cases are usually first treated conservatively with splinting and cessation of aggravating activities. Other conservative therapies include oral steroids, diuretics, nonsteroidal anti-inflammatory drugs, and steroid injections into the carpal tunnel itself. Individuals 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. Low-level laser therapy is also used to treat carpal tunnel syndrome.

Wound Care and Lymphedema

Chronic wounds are wounds that do not improve after 4 weeks or heal within 8 weeks. These include diabetic foot ulcers, venous-related ulcerations, non-healing surgical wounds, and pressure ulcers. They are often found on the feet, ankles, heels, calves, and on the hips, thighs, and buttocks of those who cannot walk.

Lymphedema is described as swelling in at least 1 leg and/or arm. It is commonly caused by the removal of a lymph node. The resulting blockage of the lymphatic system prevents lymph fluid from draining well, leading to fluid build-up and swelling. Other symptoms can include heaviness or tightness in the affected limb, restricted range of motion, aching or discomfort, recurring infections, and dermal fibrosis. Risk factors for developing lymphedema after cancer from cancer treatment or from other secondary causes can include older age, obesity, and rheumatoid or psoriatic arthritis.

Treatment

Chronic wound management involves ensuring adequate blood flow to the area, preventing the wound from drying, controlling infections, debriding scarred and necrotic tissue, and managing pain. The standard of care for diabetic foot ulcers includes debridement, dressings, offloading of pressure, infection management, and glycemic control. Lymphedema is typically managed with pneumatic compression, exercise, or complete decompression therapy. Use of low-level laser therapy has been investigated for the management of both chronic wounds and lymphedema.

Low-Level Laser Therapy

Low-level laser therapy is the use of red-beam or near-infrared lasers with a wavelength between 600 and 1,000 nm and power between 5 and 500 MW. By comparison, lasers used in surgery typically use 300 Watts. When applied to the skin, low-level laser therapy 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.

Low-level laser therapy is being evaluated to treat a wide variety of conditions, including soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, joint pain, and lymphedema.

Selected Low-Level Laser Therapy Devices Cleared by the U.S. Food and Drug Administration

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 (see table above). 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 GRT LITE for carpal tunnel syndrome are similar to the predicate devices: “adjunctive use in providing temporary relief of minor chronic pain.” In 2009, the LightStream™ Low Level Laser device was cleared for marketing by the FDA through the 510(k) process for adjunctive use in the temporary relief of pain associated with knee disorders treated in standard chiropractic practice. A number of clinical trials of LLLT are underway in the United States, including studies of wound healing. Since 2009, many more similar low-level laser therapy devices have received 510(k) clearance from the FDA.

Other protocols have applied low-level laser energy to acupuncture points on the fingers and hand. This technique may be referred to as "laser acupuncture."

POLICY

Low-level laser therapy may be considered medically necessary for the prevention of oral mucositis in individuals undergoing cancer treatment associated with increased risk of oral mucositis, including chemotherapy and/or radiotherapy, and/or hematopoietic cell transplantation (see Policy Guidelines).

Low-level laser therapy is considered investigational for all other indications including but not limited to:

• Carpal tunnel syndrome

• Neck pain

• Subacromial impingement

• Adhesive capsulitis

• Temporomandibular joint pain

• Low back pain

• Osteoarthritis knee pain

• Heel pain (ie, Achilles tendinopathy, plantar fasciitis)

• Rheumatoid arthritis

• Bell palsy

• Fibromyalgia

• Wound healing

• Lymphedema.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

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 cell transplant (HCT), the course of LLLT began between day -7 and day 0 and continued as long as day 14 or 15. In studies that began LLLT at day -7 or day -5 before hematopoietic cell transplant, the course of laser therapy ended at day -1 or day 0.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

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 HISTORY

7/2003: 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 A.2.01.56 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.

02/24/2017: Policy description updated. Policy statements unchanged. Policy guidelines updated to define medically necessary.

06/27/2018: Policy description updated regarding devices. Policy statements unchanged.

06/20/2019: Code Reference section updated to add new CPT code 0552T, effective 07/01/2019.

07/05/2019: Policy description updated regarding devices. Policy statements unchanged.

11/18/2020: Policy description updated regarding devices. Policy statements unchanged.

08/25/2021: Policy description updated regarding musculoskeletal disorders, neurologic disorders, wound care, and lymphedema. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

07/12/2022: Policy description and policy statement updated to change "patients" to "individuals." Policy Guidelines updated.

07/27/2023: Policy description updated. Policy statements unchanged.

12/21/2023: Code Reference section updated to add new 2024 CPT code 97037, effective 01/01/2024.

07/10/2024: Policy reviewed; no changes.

08/18/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.56

CODE REFERENCE

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

Investigational Codes 

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