Humana Low Level Laser Therapy and High Power Laser Therapy - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories LCD LCA LCD LCA Outpatient Physical and Occupational Therapy Services L33631 Billing and Coding: Outpatient Physical and Occupational Therapy Services A56566 Outpatient Physical and Occupational Therapy Services L34049 Billing and Coding: Outpatient Physical and Occupational Therapy Services A57067 Low Level Laser and High Power Laser Therapy Page: 2 of 7 J6 - National Government Services, Inc. (Part A/B MAC) JK - National Government Services, Inc. (Part A/B MAC IL, MN, WI CT, NY, ME, MA, NH, RI, VT J15 - CGS Administrators, LLC (Part A/B MAC) KY, OH Description Low Level Laser Therapy Low level laser therapy (LLLT), also known as cold laser or photobiomodulation therapy, refers to a wide variety of procedures involving several laser types and treatment methods. LLLT uses red beam or near infrared nonthermal lasers. When applied, the lasers penetrate the surface of the skin without a heating (burning) effect, produce no sensation and do not damage the skin. Purportedly due to the low skin absorption and no side effects, the laser light can penetrate deeply into tissues and reach the site of damage or injury. LLLT may be administered by a physician, physical therapist, occupational therapist or Doctor of Chiropractic (DC) in a provider’s office or other outpatient setting and requires no sedation or anesthesia. It is theorized that LLLT may cause a biostimulatory healing effect for the treatment of a range of conditions, including alopecia, arthritis, carpal tunnel syndrome, chronic pain, prevention of oral mucositis, temporomandibular joint disorders, tissue injuries (eg, tendinopathy, tendinitis) and wound healing. These devices are not the same as (or equivalent to) class IV surgical lasers. Examples of LLLT devices include, but may not be limited to, Bioptron 2, Bioptron MedAll, Bioptron Pro 1, Erchonia EVRL, Erchonia FX-635, Luminex Laser Therapy System, MicroLight ML830, RianCorp LTU-904, TerraQuant, Thor Laser System and Willow Curve. The TerraQuant device uses a combination of a super pulsed laser, pulsed infrared, red light and static magnetic field, which is purported to accelerate pain relief. The Willow Curve primarily uses dual dynamic photonic and dynamic thermokinetic energies proposed for treating musculoskeletal pain. High Power Laser Therapy High power laser therapy devices, also referred to as high dose laser therapy (HDLT) or high intensity laser therapy (HILT), (class IV therapeutic lasers) are purported to stimulate accelerated healing energy from Low Level Laser and High Power Laser Therapy Page: 3 of 7 superficial to deep levels (six to nine inches) over a larger surface treatment area. It is proposed for treating conditions such as arthritis, carpal tunnel syndrome, chronic pain, epicondylitis, sprains/strains, trigger points and various other musculoskeletal disorders. These devices are not the same as (or equivalent to) class IV surgical lasers. Examples of high power laser therapy devices that have received US Food & Drug Administration (FDA) approval are the AVI HP-7.5, AVI HPLL-12 and Diowave Laser System. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Low level laser therapy will not be considered medically reasonable and necessary. A review of the current medical literature shows that the evidence is insufficient to determine that this service is a standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.3,4 High level laser therapy (nonsurgical) will not be considered medically reasonable and necessary. A review of the current medical literature shows that the evidence is insufficient to determine that high power laser therapy (nonsurgical) is a standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management Summary of Evidence A systematic review (SR) with meta-analyses of nine randomized controlled trials (RCTs) and eight additional RCTs (not included in the SR) found that HILT alone or in combination with other treatments may reduce pain and improve function up to three months in some patients with chronic neck or back pain, the studies assessed too few patients per comparison and too few patients per pain etiology, and most studies include few patients. Additional studies are needed to confirm findings.5 Low Level Laser and High Power Laser Therapy Page: 4 of 7 A systematic review (SR) with meta-analysis of six randomized controlled trials (RCTs) and 1 additional RCT indicate that HILT alone or in combination with other treatments may reduce pain and improve function in some patients with knee OA up to three months after treatment, most studies in the SR are at high risk of bias and have high heterogeneity; additional RCTs are needed to validate these data.6