Latest Review Date: August 2024

Category: Therapy     

POLICY:

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

High Intensity Laser Therapy (HILT) for treatment of Bell's palsy is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

KEY POINTS:

For individuals who have chronic musculoskeletal pain who receive HILT, the evidence includes RCTs and systematic reviews. Although systematic reviews of RCTs have demonstrated statistically and clinically significant improvements in pain and function in individuals receiving HILT, serious methodological limitations of the trials, along with heterogeneity in HILT parameters, cointerventions, and patient characteristics, decreases confidence in results and precludes drawing conclusions about the treatment's effectiveness. Additionally, there are no established practice guidelines on the use of HILT in chronic pain disorders and it is unclear where the technology fits in the clinical pathway. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have Bell's palsy who receive HILT, the evidence includes 1 RCT (N=48, in 3 groups of 17) comparing HILT, low level laser therapy, and facial expression exercise after 6 weeks of treatment. Significant improvements in recovery were seen in both laser therapy groups over exercise alone, with the greatest improvement seen with HILT, but study design limitations preclude drawing conclusions. Additionally, because Bell's palsy often improves within weeks and may resolve completely within months, it is difficult to isolate specific improvements from laser therapy over the natural resolution of the illness. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

North American Spine Society

The North American Spine Society (2020) Guidelines on Diagnosis and Treatment of Low Back Pain include the following relevant recommendations:

• It is suggested that the combination of laser therapy (low-level or high level) with exercise provides better short-term relief of pain than either exercise or laser therapy alone. Grade of Recommendation: B
• There is conflicting evidence that the combination of laser therapy with exercise provides better short-term improvement in function compared to exercise or laser therapy alone. Grade of Recommendation: I
• It is suggested that there is no short-term benefit of laser therapy (low-level or high level) when compared with exercise alone. Grade of Recommendation: B

U.S Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

High intensity laser therapy, HILT, Diowave, ESPT-3X, K-Laser, LCT-1000, LiteCure, OptonPro, Bell’s palsy, photobiomodulation

APPROVED BY GOVERNING BODIES:

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 FDA.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

Note: There is not a specific code for this procedure.

REFERENCES:

1. Alayat MS, Elsodany AM, El Fiky AA. Efficacy of high and low level laser therapy in the treatment of Bell's palsy: A randomized double blind placebo-controlled trial. Lasers Med Sci. Jan 2014; 29(1): 335-42.
2. Cai P, Wei X, Wang W, et al. High-intensity laser therapy on pain relief in symptomatic knee osteoarthritis: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023; 36(5): 1011-1021.
3. de la Barra Ortiz HA, Arias M, Liebano RE. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of high-intensity laser therapy in the management of neck pain. Lasers Med Sci. May 06 2024; 39(1): 124.
4. de la Barra Ortiz HA, Parizotto N, Arias M, et al. Effectiveness of high-intensity laser therapy in the treatment of patients with frozen shoulder: A systematic review and meta-analysis. Lasers Med Sci. Nov 20 2023; 38(1): 266.
5. Food & Drug Administration. Laser Products and Instruments. https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments.
6. Kim JH, Goo B, Nam SS. Efficacy of Laser Therapy on Paralysis and Disability in Patients with Facial Palsy: A Systematic Review of Randomized Controlled Trials. Healthcare (Basel). Aug 29 2023; 11(17).
7. North American Spine Society (2020). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis &Treatment of Low Back Pain. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf.
8. Starzec-Proserpio M, Grigol Bardin M, Fradette J, et al. High-Intensity Laser Therapy (HILT) as an Emerging Treatment for Vulvodynia and Chronic Musculoskeletal Pain Disorders: A Systematic Review of Treatment Efficacy. J Clin Med. Jun27 2022; 11(13).
9. Xie YH, Liao MX, Lam FMH, et al. The effectiveness of high-intensity laser therapy in individuals with neck pain: A systematic review and meta-analysis. Physiotherapy. Dec 2023; 121: 23-36.
10. Yılmaz M, Eroglu S, Dundar U, et al. The effectiveness of high-intensity laser therapy on pain, range of motion, functional capacity, quality of life, and muscle strength in subacromial impingement syndrome: A 3-month follow-up, double-blinded, randomized, placebo-controlled trial. Lasers Med Sci. Feb 2022; 37(1): 241-250.

POLICY HISTORY:

Medical Policy Panel, July 2024

Medical Policy Group, August 2024 (7): New medical policy. Available for comment September 1, 2024 through October 16, 2024. High power laser therapy previously non-covered per MP 495 Investigational Criteria.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members.  Our decisions concern coverage only.  The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient.  The plan administers benefits based on the member's contract and corporate medical policies.  Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients.  Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. 

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.