Latest Review Date: August 2024

Category: Physical Therapy                                                  

POLICY:

Monochromatic Infrared Energy System (Anodyne Phototherapy) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Monochromatic infrared energy (MIRE™) treatment is a therapy that uses infrared light therapy through contact with the skin for potential use in multiple conditions including cutaneous ulcers, diabetic neuropathy, and musculoskeletal and soft tissue injuries. 

Monochromatic infrared energy (MIRE) refers to light at a wavelength of 880 nm. MIRE can be delivered through pads containing an array of 60 superluminous infrared diodes emitting pulsed near-infrared irradiation. The pads can be placed on the skin, and the infrared energy is delivered in a homogeneous manner in a session lasting from 30–45 minutes.

MIRE devices have been investigated as a treatment of multiple conditions including cutaneous ulcers, diabetic neuropathy, musculoskeletal and soft tissue injuries, including temporomandibular disorders, tendonitis, capsulitis, and myofascial pain. MIRE devices are also being developed for the treatment of baldness and snoring. 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.

KEY POINTS:

The most recent literature update was performed through August 2024.

Summary of Evidence

The available literature regarding skin contact MIRE as a technique to treat various cutaneous conditions consists of small controlled trials and observational studies. MIRE has also been investigated for knee osteoarthritis.  The current evidence from the studies with the strongest methodology, i.e., sham-controlled trials with a between-group design, shows no improvement in outcomes for patients treated with MIRE. This evidence does not support the efficacy of this technology. Well-designed, prospective, RCTs with larger subject numbers are needed to determine with certainty whether MIRE is an effective treatment for cutaneous conditions. As a result, this technology is considered investigational.

Practice Guidelines and Position Statements

The 2010 Guidelines from the Association for the Advancement of Wound Care provides an A-level recommendation for infrared or monochromatic light for advanced or adjunctive treatment of pressure ulcers that are unresponsive to A-level management.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Monochromatic infrared energy (MIRE), Anodyne, diabetic neuropathy

APPROVED BY GOVERNING BODIES:

The Anodyne® Professional Therapy System is a MIRE device that received marketing clearance from FDA in 1994 through the 510(k) process. A device specifically for home use is also available. The labeled indication is for "increasing circulation and decreasing pain." The Clarimedix® system (Clarimedix), received 510(k) clearance in 2006 (K062635) listing the SMI™ SpectroPad (a.k.a. Anodyne® Therapy System) as a predicate device. Clarimedix is indicated for use for the treatment of chronic pain by emitting energy in the infrared spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. The HealthLight™ infrared therapy device (Bioremedi Therapeutic

Systems) received marketing clearance from FDA in 2011 (K101894) listing the SMI™ SpectroPad as a predicate device. The BioRemedi HealthLight™ System is available by prescription only and is indicated for heat therapy, ie, temporarily relieves minor pain, stiffness, and muscle spasm and temporarily increases local blood circulation.

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

CURRENT CODING: 

CPT codes:

HCPCS:                                 

REFERENCES:

1. Association for the Advancement of Wound Care. Association for the Advancement of Wound Care Guideline of Pressure Ulcer Guidlines. 2010. www.aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug1pdf.

2. Barclay Laura.  Anodyne therapy system effective in diabetic neuropathy, www.medscape.com/viewarticle/466606_print.

3. Burke Thomas J, Kochman Alan and Carnegie Dale.  Improved sensory perception in diabetics, (Abstract), www.infraredtherapy.net/rec1.asp.

4. Burke Thomas J.  Response:  The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: A double-blind, placebo controlled study. Diabetes Care, May 2006, Vol. 29, No. 5.

5. Clifft Judy K and Kasser Richard J. The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: A double-blind, placebo controlled study. Diabetes Care, December 2005, Vol. 28, No. 12.

6. Clifft Judy K , et al.  Response: The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: A double-blind, placebo controlled study. Diabetes Care, May 2006, Vol. 29, No. 5.

7. DeLellis SL, Carnegie DH, Burke TJ. Improved sensitivity in patients with peripheral neuropathy: effects of monochromatic infrared photo energy. J Am Podiatr Med Assoc 2005; 95(2):143-147.

8. Franzen-Korzendorfer H, Blackinton M, Rone-Adams S and 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 Manage, June 2008; 54(6): 16-31.

9. Harkless LB, DeLellis S, Carnegie DH and Burke TJ. Improved foot sensitivity and pain reduction in patients with peripheral neuropathy after treatment with mono chromatic infrared photo energy—MIRE. J Diabetes Complications, March-April 2006; 20(2): 81-87.

10. Horowitz CWS, Lon R, et al. Augmentation of wound healing using monochromatic infrared energy.  Advances in Wound Care, 1999, 12:35-40.

11. Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromatic infrared energy. Exploration of a new technology for wound management. Adv Wound Care 1999; 12(1):35-40.

12. Hsieh RL, Lo MT, Lee WC et al. Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study. J Orthop Sports Phys Ther 2012; 42(11):947-956.

13. InfraredTherapy.  What is Anodyne® therapy and what does it do?  www.infraredtherapy.net.

14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.

15. Ites KI, Anderson EJ, Cahill ML et al. Balance interventions for diabetic peripheral neuropathy: a systematic review. J Geriatr Phys Ther 2011; 34(3):109-116.

16. Kochman AB, Carnegie DH, Burke TJ. Symptomatic reversal of peripheral neuropathy in patients with diabetes. J Am Podiatr Med Assoc 2002; 92(3):125-130.  

17. Lavery LA, Murdoch DP, Williams J and 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, February 2008; 31(2): 316-321.

18. Leonard David R, Farooqi M Hamed and Myers Sara.  Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy. Diabetes Care, January 2004, Vol. 27, No. 1, pp. 168-172.

19. Li H, Nyland J, Shelton T. Effectiveness of the anodyne therapy system in treating diabetic peripheral neuropathy: a systematic review. Physical Therapy Reviews 2008; 13(6):395-404.

20. Nawfar SA, Yacob NB. Effects of monochromatic infrared energy therapy on diabetic feet with peripheral sensory neuropathy: a randomized controlled trial. Singapore Med J 2011; 52(9):669-672.

21. Ovington LG.  Wound care update: saying NO to diabetic ulcers, Podiatry Today; April 1999.

22. Powell MW, Carnegie DE, Burke TJ. Reversal of diabetic peripheral neuropathy and new wound incidence: the role of MIRE. Adv Skin Wound Care 2004; 17(6):295-300.

23. Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract 2004; 10(1):24-30.

24. Product information, Anodyne Therapeutics, Denver, CO.

25. Robinson CC, Klahr PDS, Stein C et al. Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials. Braz J Phys Ther 2017; 21(4):233-243.

26. Thomasson TL.  Effects of skin-contact monochromatic infrared irradiation on tendonitis, capsulitis, and myofascial pain. J Neuro Orthopedic Med Surg, 1997, 16:242-245.

27. Tripodi N, Feehan J, Husaric M, Sidiroglou F, Apostolopoulos V. The effect of low-level red and near-infrared photobiomodulation on pain and function in tendinopathy: a systematic review and meta-analysis of randomized control trials. BMC Sports Sci Med Rehabil. 2021 Aug 14;13(1):91. 

POLICY HISTORY:

Medical Policy Group December 2001

Medical Review Committee January 2002

Medical Policy Group February 2002

Medical Review Committee February 2002

Medical Policy Administration Committee March 2002

Available for Comment April 9-May 23, 2002

Medical Policy Group, March 2003

Medical Policy Administration Committee, March 2003

Medical Policy Group, March 2004

Medical Policy Group, March 2005 (1)

Medical Policy Group, March 2006 (1)

Medical Policy Group, March 2007 (1)

Medical Policy Administration Committee, March 2007

Available for comment March 23-May 7, 2007

Medical Policy Group, March 2008 (1): Key Points updated, references added

Medical Policy Group, March 2009 (1): Updated Key points, reference added

Medical Policy Group, March 2011 (3): Updated Description, Key Points & Governing Bodies

Medical Policy Group, December 2011 (3): Updated Key Points & References

Medical Policy Group, January 2013 (3): Update to Key Points & References; no change in policy statement

Medical Policy Panel, December 2013

Medical Policy Group, January 2014 (3):  2013 Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, December 2014

Medical Policy Group, February 2015 (3): Updates to Key Points and References. No change to policy statement.

Medical Policy Group, February 2015: Policy no longer available for regular literature updates

Medical Policy Group, July 2019 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, August 2021 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy. Removed “not medically necessary” statement from Policy Statement. No change in intent.

Medical Policy Group, August 2022 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, August 2023 (7): Reviewed by consensus. Update to Benefit Application and References. No change in Policy Statement.

Medical Policy Group, August 2024 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

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.