High Intensity Laser Therapy for Chronic Musculoskeletal Pain Conditions and Bell's Palsy

POLICY NUMBER

A.2.01.108

DESCRIPTION

High-intensity laser therapy (HILT) is a Class IV therapeutic non-surgical laser device with a power output >500 mW that is capable of transmitting energy beyond the skin to deep musculoskeletal tissues. HILT is proposed for use in the office setting for various indications including musculoskeletal disorders and Bell’s palsy.

High Intensity Laser Therapy

High-intensity laser therapy (HILT) is a Class IV therapeutic non-surgical laser device with a power output >500 mW that is capable of transmitting energy beyond the skin to deep musculoskeletal tissues. HILT is proposed for use in the office setting for various indications including musculoskeletal disorders and Bell’s palsy. The devices are intended to provide temporary relief of muscle spasms and minor muscle/joint pain by emitting energy in the infrared spectrum to provide topical heat and tissue temperature elevation which in turn promotes temporary muscle relaxation and increased local blood circulation.

The mechanism of action of HILT to treat chronic pain or Bell's palsy is not clearly understood. Proposed mechanisms of action include having anti-inflammatory effects through photobiomodulation mechanisms by altering inflammatory markers, photothermal effects leading to improved muscle relaxation and extensibility of connective tissue, or analgesic effects through neural inhibition or endorphin mechanisms.

Examples of lasers that have been cleared for marketing by the FDA through the 510(k) process include but are not limited to: Diowave Laser System (formerly Avicenna Laser Technology Inc. K031612; K121363; K091285), ESPT-3X (Lighthouse Technical Innovations, Inc. K083560), K-Laser (K-Laser, USA. K091497), LCT-1000 (LiteCure, LLC. K070400), and OptonPro (Zimmer MedizinSysteme. K141564).

HILT devices have a power output greater than 500mW and are classified as Class IV lasers by the FDA.

POLICY

High Intensity Laser Therapy (HILT) for treatment of chronic musculoskeletal pain is considered investigational.

HILT for treatment of Bell's palsy is considered investigational.

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.

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

03/01/2025: New policy added. Approved by the Medical Policy Advisory Committee.

08/27/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.108

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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