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Date Printed: June 24, 2017: 11:31 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-44

Original Effective Date: 08/15/03

Reviewed: 04/27/17

Revised: 05/15/17

Subject: Infrared Energy Therapy and Low Level Laser Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Infrared Energy Therapy

Monochromatic infrared energy (MIRE) is a therapy that uses pulsed infrared light at a wavelength of 880 nm through pads that contain an array of 60 superluminous infrared diodes. Use of skin contact MIRE has been proposed as a therapy for multiple conditions including cutaneous ulcers, diabetic neuropathy, and musculoskeletal and soft tissue injuries. The proposed mechanism of action is not known, although some sort of photobiostimulation has been proposed, as well as increased circulation related to an increase in plasma of the potent vasodilator nitric oxide.Several devices have received clearance for marketing from the U.S. Food and Drug Administration (FDA).

Low-level laser Therapy

Low-level lasers are also known as cold lasers, soft lasers, non-thermals, or laser acupuncture. Low-level lasers refer to the use of red-beam or near-infrared lasers with a wavelength between 600 and 1,000 nm and Watts from 5 – 500 milliWatts (MW). When applied to the skin, these lasers produce no sensation and do 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 may have 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. Numerous devices have received clearance for marketing from the FDA.

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. One of the primary disorders for which LLLT has been used is cancer therapy‒induced oral mucositis in patients treated by radiotherapy and/or chemotherapy and hematopoietic cell transplantation. 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. Treatment 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.

POSITION STATEMENT:

Low-level laser therapy meets the definition of medical necessity for prevention of oral mucositis in members undergoing cancer treatment associated with increased risk of oral mucositis, including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation.

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

Adhesive capsulitis

Bell palsy

Carpal tunnel syndrome

Fibromyalgia

Heel pain (ie, Achilles tendinopathy, plantar fasciitis)

Low back pain

Lymphedema

Neck pain

Osteoarthritic knee pain

Rheumatoid arthritis

Subacromial impingement

Temporomandibular joint pain

Wound healing.

The evidence is insufficient to determine the effects of the technology on health outcomes.

Skin contact monochromatic infrared energy (MIRE) is considered experimental or investigational as a technique for all indications including, but not limited to, treatment of cutaneous ulcers, diabetic neuropathy, and musculoskeletal conditions such as temporomandibular disorders, tendonitis, capsulitis and myofascial pain. The evidence is insufficient to determine the effects of the technology on health outcomes. (This includes the use of a home device.)

BILLING/CODING INFORMATION:

CPT Coding

97026

Application of a modality to one or more areas; infrared (investigational)

HCPCS Coding

E0221

Infrared heating pad system (new 2002) (investigational)

A4639

Replacement pad for infrared heating system, each (new 2003) (investigational)

S8948

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

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Infrared Therapy Devices (270.6) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Infrared Heating Pad Systems (L33825) located at cgsmedicare.com.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Therapy and Rehabilitation Services (L33413) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Physical Therapy (Physical Medicine), 01-97000-01

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) – Evidence Report/Technology Assessment #111 – “Wound-Healing Technologies: Low-Level Laser and Vacuum-Assisted Closure”, (12/04).
  2. American Academy of Orthopaedic Surgeons. Management of Carpal Tunnel Syndrome: Evidence-Based Clinical Guideline. 2016; located at aaos.org. American Diabetes Association, Executive Summary: Standards of Medical Care in Diabetes – 2008, Diabetes Care 31: S5-S11, 2008.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual – Low-Level Laser Therapy, 02/17.
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual – Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions, archived 12/15.
  5. Carrasco TG, Guerisoli LD, Guerisoli DM, et al. Evaluation of Low Intensity Laser Therapy in Myofascial Pain Syndrome, Cranio. 2009 Oct; 27(4): 243-7.
  6. Centers for Medicare & Medicaid (CMS), NCD for Infrared Therapy Devices (270.6), located at cms.gov.
  7. Centers for Medicare and Medicaid Services (CMS) Region C DMERC Local Coverage Determination (LCD) for Infrared Heating Pad Systems (L33825), located at cgsmedicare.com.
  8. ClinicalTrials.gov, Light Therapy In the Treatment of Leg Pain, sponsored by Samueli Institute for Information Biology & William Beaumont Army Medical Center, accessed 07/17/08.
  9. ClinicalTrials.gov, Assessment of Infrared Photobiotherapy for Improved Wound Healing, sponsored by University of Toledo Health Science Campus, accessed 04/12/10.
  10. ClinicalTrials.gov, Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery, sponsored by University of Toledo Health Science Campus, accessed 06/29/09.
  11. ClinicalTrials.gov, Low Level Laser Treatment and Breast Cancer Related Lymphedema, sponsored by Vanderbilt University, accessed 06/29/09.
  12. ClinicalTrials.gov, Near Infrared Light for the Treatment of Painful Peripheral Neuropathy, sponsored by Mayo Clinic, accessed 04/12/10.
  13. ClinicalTrials.gov, Non-Invasive Assessment of Wound Healing With Optical Methods, sponsored by Drexel University & coulter foundation, accessed 07/17/08.
  14. ClinicalTrials.gov, Treatment of Wounds Utilizing Light, sponsored by QRay Ltd., accessed 06/29/09.
  15. Dincer U, Cakar E, Kiralp MZ et al. The effectiveness of conservative treatments of carpal tunnel syndrome: splint ultrasound, and low-level laser therapies. Photomedicine and Laser Surgery 2009; 27(1): 119-125.
  16. ECRI Target Report Monochromatic Infrared Irradiation for Peripheral Neuropathic Pain”, (02/06).
  17. Emshoff R, Bosch R, Pumpel E, Schoning H, Strobl H, Low-Level Laser Therapy for Treatment of Temporomandibular Joint Pain: A Double-Blind and Placebo-Controlled Trial, Oral Surg Oral Med Pathol Oral Radiol Endod, 04/08; 105(4): 452-6.
  18. First Coast Service Options, Inc.(FCSO), LCD for Therapy and Rehabilitation Services (L33413), located at fcso.com.
  19. Franzen-Korzendorfer H, Blackinton M, Rone-Adams S, McCulloch J, The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a controlled, Double-Blind Randomized Clinical Study, Ostomy Wound Management, 2008 June; 54(6): 16-31.
  20. Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials. Acupunct Med. Oct 2016;34(5):328-341.
  21. Hayes Health Technology Brief, Anodyne® Therapy System (anodyne Therapy LLC) for Peripheral Neuropathy, 02/08.
  22. Hegedus B, Viharos L, Gervain M, et al. The Effect of Low-Level Laser in Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Trial, Photomed Laser Surg, 2009 Aug: 27(4): 577- 84.
  23. Kiritsi O, Tsitas K, Malliaropoulos N, Mikroulis G, Ultrasonographic Evaluation of Plantar Fasciitis After Low-Level Laser Therapy: Results of a Double-Blind, Randomized, Placebo-Controlled Trial, Lasers Med Sci, 2010 Mar; 25(2): 275-81.
  24. Konstantinovic LM, Kanjuh ZM, Milovanovic AN et al. Acute low back pain with radiculophaty: a double-blind, randomized, placebo-controlled study. Photomedicine and Laser Surgery 2010; 28(4): 553-560.
  25. Lavery LA, Murdoch DP, Williams J, Lavery DC, Does Anodyne Light Therapy Improve Peripheral Neuropathy in Diabetes? A Double-Blind, sham-Controlled, Randomized Trial to Evaluate Monochromatic Infrared Photoenergy, Diabetes Care, 2008 Feb; 31(2): 316-21.
  26. Li ZJ, Wang Y, Zhang HF, et al. Effectiveness of low-level laser on carpal tunnel syndrome: A meta-analysis of previously reported randomized trials. Medicine (Baltimore). Aug 2016;95(31):e4424.
  27. 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 Rheumatology, 01/16/10.
  28. Montes-Molina R, Madronero-Agreda MA, et al, Efficacy of Interferential Low-Level Laser Therapy Using Two Independent Sources in the Treatment of Knee Pain, Photomed Laser Surg, 2009, April.
  29. National Institute for Health and Care Excellence (NICE). Low back pain and sciatica in over 16s: assessment and management [NG59]. 2016; located at nice.org.uk/guidance.
  30. 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.
  31. Stergioulas A, Stergioula M, Aarskog R, Lopes-Marings RA, Bjordal JM, Effects of Low-Level Laser Therapy and Eccentric Exercises in the Treatment of Recreational Athletes with Chronic Achilles Tendinopathy, Am J Sports Med. 05/08; 36: 881-7.
  32. TrustSolutions “LCD for Infrared Heating Pad Systems” (L12932), 03/06.
  33. Tumilty S, Munn J, McDonough S et al. Low level laser treatment of tendinopathy: a systematic review with meta-analysis. Photomedicine and Laser Surgery 2010; 28(1): 3-16.
  34. Yeldan I, Cetin E, Ozdincler AR. The effectiveness of low-level laser therapy on shoulder function in subacrominal impingement syndrome. Disability and Rehabilitation 2009; 31(11): 935-940.
  35. Yousefi-Nooraie R, Schonstein E, HeidariK, Rashidian A, Pennick V, et al. Low Level Laser Therapy for Nonspecific Low-Back Pain, Cochrane Database of Systematic Reviews, 04/08.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

08/15/03

New Medical Coverage Guideline.

08/15/04

Scheduled annual review; S8948 added; no change in investigational status.

08/15/05

Scheduled annual review; no change in investigational status.

09/15/06

Scheduled annual review; no change in investigational status.

07/15/07

Scheduled review; investigational status maintained, added CPT code 97026; reformatted guideline, references updated.

09/15/08

Annual review: position statements maintained, description section and references updated.

08/15/09

Annual review: position statements maintained, description section and references updated.

06/15/10

Annual review: position statements maintained and references updated.

11/15/11

Revision; added laser therapy position statement and update references.

05/11/14

Revision: Program Exceptions section updated.

05/15/17

Revision: Guideline title, description, position statements, coding, and references updated.

Date Printed: June 24, 2017: 11:31 AM