Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Low-level Laser Therapy (LLLT)

Policy #:07.00.14f

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Low-level laser therapy is considered medically necessary, and, therefore, covered for prevention of oral mucositis in individuals who are undergoing cancer treatment that is associated with an increased risk of oral mucositis, for example, chemotherapy and/or radiotherapy and/or hematopoietic stem cell transplantation.

EXPERIMENTAL/INVESTIGATIONAL

Low-level laser therapy is considered experimental/ 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 (i.e., Achilles tendinopathy, plantar fasciitis)
  • Rheumatoid arthritis
  • Bell's palsy
  • Fibromyalgia
  • Wound healing
  • Lymphedema

BILLING REQUIREMENTS

Low-level laser therapy is described by Healthcare Common Procedure Coding System (HCPCS) code S8948 and should not be billed with any other code.

Using the Current Procedural Terminology (CPT) procedure code 97026 (infrared therapy) or any other code to report cold laser/low-level laser therapy is a misrepresentation of the actual service rendered. These services are subject to post-payment review and audit procedures.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, low-level laser therapy when used for the prevention of oral mucositis, is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met. However, services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous lasers approved by the FDA for low-level laser therapy.

Description

Low-level laser therapy (LLLT), refers to the use of polarized red-beam or near-infrared light to provide pain relief for various acute and chronic conditions. In contrast to more powerful surgical lasers, low-level laser light has low power, usually 5-500 milliwatts with wavelengths of 600-1000 nm. When applied to the skin, cold laser therapy does not burn and produces little or no sensation. While the exact mechanism of its effect is unknown, it is hypothesized that the cold laser light energy penetrates into tissues stimulating the cellular and extracellular systems (e.g., neurologic, vascular, immune, lymphatic) increasing serotonin levels with resultant pain relief and/or accelerated healing.

The evidence for LLLT in individuals who have increased risk of oral mucositis due to some cancer treatments (e.g., chemotherapy, radiotherapy) and/or hematopoietic stem cell transplantation includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related morbidity. Studies included patients undergoing various cancer chemotherapy regimens or hematopoietic stem cell transplantation. A recent systematic review of RCTs on LLLT for prevention of oral mucositis included 18 RCTs, generally considered at low risk of bias, and found statistically significantly better outcomes with LLLT than control conditions on primary and secondary outcomes. In addition, 3 double-blind RCTs published in 2015 found significantly better outcomes in patients undergoing LLLT than undergoing sham treatment prior to or during cancer treatment. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

The evidence for LLLT in individuals who have orthopedic pain (i.e., neck pain, osteoarthritis knee pain, low back pain, carpal tunnel syndrome) includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.

The evidence for LLLT in individuals who have shoulder conditions, heel pain, or temporomandibular joint pain includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.

The evidence for LLLT in individuals who have bone, ligament, and joint conditions (e.g., rheumatoid arthritis, fibromyalgia) includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.

The evidence for LLLT in individuals who have Bell's palsy includes an RCT. Relevant outcomes are change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Bell palsy may completely resolve within months and, thus, it is difficult to determine improvements from laser therapy over the natural resolution of the illness. The available RCT did not include a sham treatment; LLLT was superior to exercise only in this study. Sham-controlled studies are needed as well as additional studies comparing LLLT with alternative Bell's palsy treatments. The evidence is insufficient to determine the effects of the technology on health outcome.

The evidence for LLLT in individuals who have lymphedema includes RCTs, observational studies, and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment related morbidity. Systematic reviews of RCTs and observational studies found methodologic flaws in the available studies and have not consistently found better outcomes in patients receiving LLLT than in patients receiving a control condition treatment. The evidence is insufficient to determine the effects of the technology on health outcome.

The evidence for LLLT in individuals who have chronic wounds includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. The few existing RCTs tend to have small sample sizes and risk of bias. The evidence is insufficient to determine the effects of the technology on health outcome.
References


Abrisham SM, Kermani-Alghoraishi M, Ghahramani R, et al. Additive effects of low-level laser therapy with exercise on subacromial syndrome: a randomized, double-blind, controlled trial. Clin Rheumatol. 2011;30(10):1341-1346.

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. 2014;29(1):335-342.

American Academy of Orthopaedic Surgeons. Clinical practice guideline on the treatment of carpal tunnel syndrome. 2008; https://www.aaos.org/Research/guidelines/CTSTreatmentGuideline.pdf. Accessed January 25, 2019.

Bal A, Eksioglu E, Gurcay E, et al. Low-level laser therapy in subacromial impingement syndrome. Photomed Laser Surg. 2009;27(1):31-36.

Barbosa RI, Fonseca MC, Rodrigues EK, et al. Efficacy of low-level laser therapy associated to orthoses for patients with carpal tunnel syndrome: A randomized single-blinded controlled trial. J Back Musculoskelet Rehabil. Sep 25 2015.

Bjordal JM, Johnson MI, Lopes-Martins RA, et al. Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials. BMC Musculoskelet Disord. 2007;8:51.

Blue Cross and Blue Shield Technology Evaluation Center (TEC). Low-level laser therapy for carpal tunnel syndrome and chronic neck pain. TEC Assessment. Nov 2010;Volume 25, Tab 4.

Brosseau L, Robinson V, Wells G, et al. Low level laser therapy (Classes I, II and III) for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005(4):CD002049.

Calis HT, Berberoglu N, Calis M. Are ultrasound, laser and exercise superior to each other in the treatment of subacromial impingement syndrome? A randomized clinical trial. Eur J Phys Rehabil Med. Mar 2 2011;47(3):375-380.

Carcia CR, Martin RL, Houck J, et al. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. 2010;40(9):A1-26.

Carrasco TG, Guerisoli LD, Guerisoli DM, et al. Evaluation of low intensity laser therapy in myofascial pain syndrome. Cranio. 2009;27(4):243-247.

Chang WD, Lee CL, Lin HY, et al. A meta-analysis of clinical effects of low-level laser therapy on temporomandibular joint pain. J Phys Ther Sci. 2014;26(8):1297-1300.

Chang WD, Wu JH, Jiang JA, et al. Carpal tunnel syndrome treated with a diode laser: a controlled treatment of the transverse carpal ligament. Photomed Laser Surg. 2008;26(6):551-557.

Chen C, Hou WH, Chan ES, et al. Phototherapy for treating pressure ulcers. Cochrane Database Syst Rev. 2014;7:CD009224.

Chen J, Huang Z, Ge M, et al. Efficacy of low-level laser therapy in the treatment of TMDs: a meta-analysis of 14 randomised controlled trials. J Oral Rehabil. 2015;42(4):291-299.

Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. Oct 2007;147(7):478-491.

Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124(1-2):201-210.

da Cunha LA, Firoozmand LM, da Silva AP, et al. Efficacy of low-level laser therapy in the treatment of temporomandibular disorder. Int Dent J. 2008;58(4):213-217.

Doeuk C, Hersant B, Bosc R, et al. Current indications for low level laser treatment in maxillofacial surgery: a review. Br J Oral Maxillofac Surg. 2015;53(4):309-315.

Dogan SK, Ay S, Evcik D. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double-blind prospective study. Clinics (Sao Paulo). 2010;65(10):1019-1022.

Ekim A, Armagan O, Tascioglu F, et al. Effect of low level laser therapy in rheumatoid arthritis patients with carpal tunnel syndrome. Swiss Med Wkly. 2007;137(23-24):347-352.

Emshoff R, Bosch R, Pumpel E, et al. Low-level laser therapy for treatment of temporomandibular joint pain: a double-blind and placebo-controlled trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008;105(4):452-456.

Evcik D, Kavuncu V, Cakir T, et al. Laser therapy in the treatment of carpal tunnel syndrome: a randomized controlled trial. Photomed Laser Surg. 2007;25(1):34-39.

Ferreira B, da Motta Silveira FM, de Orange FA. Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial. Support Care Cancer. 2016;24(3):1035-1042.

Figueiredo AL, Lins L, Cattony AC, et al. Laser therapy in the control of oral mucositis: A meta-analysis. Rev Assoc Med Bras. Oct 9 2013.

Fikackova H, Dostalova T, Navratil L, et al. Effectiveness of low-level laser therapy in temporomandibular joint disorders: a placebo-controlled study. Photomed Laser Surg. 2007;25(4):297-303.

Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients-a randomized placebo controlled trial. J Photochem Photobiol B. 2015;144:51-56.

Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Effect of low-level laser therapy on patient reported measures of oral mucositis and quality of life in head and neck cancer patients receiving chemoradiotherapy--a randomized controlled trial. Support Care Cancer. 2013;21(5):1421-1428.

Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low Level Helium Neon Laser therapy for chemoradiotherapy induced oral mucositis in oral cancer patients - A randomized controlled trial. Oral Oncol. 2012;48(9):893-897.

Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients - A triple blinded randomized controlled trial. Radiother Oncol. 2012;104(3):349-354.

Gross AR, Dziengo S, Boers O, et al. Low level laser therapy (LLLT) for neck pain: a systematic review and meta-regression. Open Orthop J. 2013;7:396-419.

Huang Z, Chen J, Ma J, et al. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015;23(9):1437-1444.

Huang Z, Ma J, Chen J, et al. The effectiveness of low-level laser therapy for nonspecific chronic low back pain: a systematic review and meta-analysis. Arthritis Res Ther. 2015;17:360.

Irvine J, Chong SL, Amirjani N, et al. Double-blind randomized controlled trial of low-level laser therapy in carpal tunnel syndrome. Muscle Nerve. 2004;30(2):182-187.

Kiritsi O, Tsitas K, Malliaropoulos N, et al. Ultrasonographic evaluation of plantar fasciitis after low-level laser therapy: results of a double-blind, randomized, placebo-controlled trial. Lasers Med Sci. 2010;25(2):275-281.

Konstantinovic LM, Kanjuh ZM, Milovanovic AN, et al. Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study. Photomed Laser Surg. 2010;28(4):553-560.

Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120(10):1453-1461.

Macias DM, Coughlin MJ, Zang K, et al. Low-Level Laser Therapy at 635 nm for Treatment of Chronic Plantar Fasciitis: A Placebo-Controlled, Randomized Study. J Foot Ankle Surg. 2015;54(5):768-772.

Marini I, Gatto MR, Bonetti GA. Effects of superpulsed low-level laser therapy on temporomandibular joint pain. Clin J Pain. 2010;26(7):611-616.

Matsutani LA, Marques AP, Ferreira EA, et al. Effectiveness of muscle stretching exercises with and without laser therapy at tender points for patients with fibromyalgia. Clin Exp Rheumatol. 2007;25(3):410-415.

Meireles SM, Jones A, Jennings F, et al. Assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis: a randomized double-blind controlled trial. Clin Rheumatol. 2010;29(5):501-509.

Multinational Association of Supportive Care in Cancer (MASCC). Clinical Practice guidelines for the management of mucositis secondary to cancer therapy. May 15, 2014 Available at: http://www.mascc.org/assets/Guidelines-Tools/mascc%20isoo%20mucositis%20guidelines%20paper%206jun2014.pdf. Accessed January 25, 2019.

National Comprehensive Cancer Network (NCCN). Head and Neck CancersV.2.2018. [NCCN Web site]. 06/20/18. Available at: http://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf. [subscription required]. Accessed January 25, 2019.

Oberoi S, Zamperlini-Netto G, Beyene J, et al. Effect of prophylactic low level laser therapy on oral mucositis: a systematic review and meta-analysis. PLoS One. 2014;9(9):e107418.

Oton-Leite AF, Silva GB, Morais MO, et al. Effect of low-level laser therapy on chemoradiotherapy-induced oral mucositis and salivary inflammatory mediators in head and neck cancer patients. Lasers Surg Med. 2015;47(4):296-305.

Omar MT, Shaheen AA, Zafar H. A systematic review of the effect of low-level laser therapy in the management of breast cancer-related lymphedema. Support Care Cancer. 2012;20:2977-2984.

Omar MTA, Ebid AA, El Morsy AM. Treatment of post-mastectomy lymphedema with laser therapy: double blind placebo control randomized study. J Surg Res. 2011;165(1):82-90.

Page MJ, Green S, Kramer S, et al. Electrotherapy modalities for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014;10:CD011324.

Petrucci A, Sgolastra F, Gatto R, et al. Effectiveness of low-level laser therapy in temporomandibular disorders: a systematic review and meta-analysis. J Orofac Pain. 2011;25(4):298-307.

Ruaro JA, Frez AR, Ruaro MB, et al. Low-level laser therapy to treat fibromyalgia. Lasers Med Sci. 2014;29(6):1815-1819.

Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuum-assisted closure. Evid Rep Technol Assess (Summ). 2004(111):1-6.

Savigny P, Kuntze S, Watson P, et al. Low back pain: early management of persistent non-specific low back pain. National Collaborating Centre for Primary Care and Royal College of General Practitioners. 2009. Available at: https://www.nice.org.uk/guidance/cg88/documents/low-back-pain-draft-full-guideline2 . Accessed January 25, 2019.

Schubert MM, Eduardo FP, Guthrie KA, et al. A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Support Care Cancer. 2007;15(10):1145-1154.

Smoot B, Chiavola-Larson L, Lee J, et al. Effect of low-level laser therapy on pain and swelling in women with breast cancer-related lymphedema: a systematic review and meta-analysis. J Cancer Surviv. 2015;9(2):287-304.

Stergioulas A. Low-power laser treatment in patients with frozen shoulder: preliminary results. Photomed Laser Surg. 2008;26(2):99-105.

Stergioulas A, Stergioula M, Aarskog R, et al. Effects of low-level laser therapy and eccentric exercises in the treatment of recreational athletes with chronic achilles tendinopathy. Am J Sports Med. 2008;36(5):881-887.

Tascioglu F, Degirmenci NA, Ozkan S, et al. Low-level laser in the treatment of carpal tunnel syndrome: clinical, electrophysiological, and ultrasonographical evaluation. Rheumatol Int. 2012;32(2):409-415.

Tumilty S, McDonough S, Hurley DA, et al. Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial. Arch Phys MedRehabil. 2012;93(5):733-739.

Venezian GC, da Silva MA, Mazzetto RG, et al. Low level laser effects on pain to palpation and electromyographic activity in TMD patients: a double-blind, randomized, placebo-controlled study. Cranio. 2010;28(2):84-91.

Yeldan I, Cetin E, Ozdincler AR. The effectiveness of low-level laser therapy on shoulder function in subacromial impingement syndrome. Disabil Rehabil. 2009;31(11):935-940.

Yousefi-Nooraie R, Schonstein E, Heidari K, et al. Low level laser therapy for nonspecific low-back pain. Cochrane Database Syst Rev. 2008(2):CD005107.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.


HCPCS Level II Code Number(s)

S8948 Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

07.00.14f

03/13/2019

The policy has been reviewed and reissued to communicate the Company's continuing position on Low-Level Laser Therapy (LLLT)

03/14/2018

The policy has been reviewed and reissued to communicate the Company’s continuing position on Low-level Laser Therapy (LLLT).


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 10/14/2016
Version Issued Date: 10/14/2016
Version Reissued Date: 03/13/2019

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