Skin contact monochromatic infrared energy therapy (MIRE) involves the use of superluminous infrared light  to topically treat various conditions.  This policy addresses the use of MIRE for all indications.

Investigational/Not Medically Necessary:

The use of skin contact monochromatic infrared energy therapy (MIRE), including, but not limited to, the Anodyne Therapy^TM system, is considered investigational/not medically necessary as a technique to treat all indications, including, but not limited to, musculoskeletal conditions, diabetic neuropathy, cutaneous ulcers, or lymphedema.

Rationale

The U.S. Food and Drug Administration (FDA) provided approval for the use of monochromatic infrared energy therapy (MIRE) in 1994 as a heating pad to provide heat therapy (e.g., temporarily relieve minor pain, stiffness and muscle spasm).  The medical literature for this indication is not strong; there have been no comparative trials of this device for this indication with other heat modalities such as electric heating pads, baths, or hot water bottles.  As such it is unclear if the use of this device provides any incremental benefits over other standard methods.

This MIRE technology has been investigated as a treatment of various musculoskeletal, peripheral nerve-related conditions, and others.  While there have been several case series studies published on the use of monochromatic infrared energy therapy for the treatment of diabetic neuropathy (Clifft, 2005; Harkless, 2006; Kochman, 2002; Leonard, 2004), chronic wounds and ulcers (Horwitz ,1999), temporomandibular joint dysfunction (Thomasson, 1996), tendonitis (Thomasson, 1996), myofascial pain (Thomasson, 1996) and other conditions, these studies have almost exclusively been limited to uncontrolled, non-blinded studies with small study populations.  One randomized placebo-controlled trial describing the use of this therapy for the treatment of diabetic neuropathy does indicate some promising benefits, but the small number of study participants (n= 27) and short duration of treatment and follow-up limits the generalizability and power of the findings (Leonard, 2004).  At this time, the existing evidence regarding the use of monochromatic infrared energy therapy for uses other than as a heating modality for physical therapy is insufficient to allow adequate assessment, and further investigation is required.

Background/Overview

Skin contact monochromatic infrared energy (MIRE) therapy, also referred to as near-infrared energy, involves the use of devices that deliver monochromatic infrared energy at a wavelength of 880 nanometers (nm).  The infrared energy spectrum encompasses light wavelengths from 750nm to 1mm and are capable of transmitting significant levels of heat to exposed surfaces.

It has been proposed that MIRE therapy triggers the release of nitric oxide from the hemoglobin in the blood and proteins in the tissues being treated.  Nitric oxide is a molecule produced by the body that is known to dilate arteries, veins and lymphatic vessels, improving circulation, decreasing swelling, and alleviating pain.  Additionally, the release of nitric oxide is believed to stimulate angiogenesis, or the process by which new blood vessels are created during healing and growth.  Based on these properties, MIRE therapy has been proposed for the treatment of a wide variety of conditions, including muscle soreness, diabetic neuropathy, tendonitis, lymphedema, myofascial pain, temporomandibular disorders, and chronic skin ulcers.

The Anodyne Professional Therapy System® is a MIRE device that received approval from the U.S. Food and Drug Administration in 1994 for local body heating and increasing circulation during physical therapy treatment.  This device emits infrared energy at a wavelength of 880nm via an array of 60 superluminous gallium aluminum diodes embedded in a flexible foam pad.  This pad can be applied to any portion of a patient’s body using straps.  Treatment sessions are usually 30-45 minutes in duration.

Definitions

Anodyne Therapy^TM: a device that is used to deliver monochromatic infrared light energy for use as a heating method in conjunction with physical therapy; other applications have been proposed

Chronic wounds: any injury where the continuity of the skin is broken and persists or progresses over time, despite medical therapy

Diabetic neuropathy: a condition where nerves become damaged and cease to function properly due to the long-term effects of diabetes

Heat modality: any method of applying heat as a means of increasing blood flow and relaxing muscles and soft tissues

Lymphedema: swelling of the subcutaneous tissues caused by obstruction of lymphatic drainage

Monochromatic infrared energy therapy: a medical therapy involving exposure to infrared light sources; also see Anodyne Therapy^TM

Musculoskeletal conditions: any condition related to dysfunction or injury to bones, muscles, or connective tissues

Myofascial: relating to the flat layers of connective tissue surrounding and separating muscles

Temporomandibular disorder: a condition related to inflammation or dysfunction of the joint where the lower jaw meets the skull

Tendonitis: a condition that causes a tendon to become inflamed and painful

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Clifft JK, Kasser RJ, Newton TS, Bush AJ.  The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy: a double-blind, placebo-controlled study. Diabetes Care. 2005; 28(12):2896-2900. 
2. Harkless LB, DeLellis S, Carnegie DH, Burke TJ. Improved foot sensitivity and pain reduction in patients with peripheral neuropathy after treatment with monochromatic infrared photo energy--MIRE. J Diabetes Complications. 2006; 20(2):81-87.
3. Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromactic infrared energy. Exploration of a new technology for wound management. Adv Wound Care. 1999; 12(1):35-40.
4. 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.
5. Leonard DR, Farooqi MH, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment. Diabetes Care. 2004; 27(1):168-172. 
6. Noble JG, Lowe AS, Baxter GD. Monochromatic infrared irradiation (890 nm): effect of a multisource array upon conduction in the human median nerve. J Clin Laser Med Surg. 2001;19(6):291-295.
7. Thomasson TL. Effects of skin-contact monochromatic infrared irradiation on tendonitis, capsulitis, and myofascial pain. J Neurol Orthop Med Surg. 1996; 16:242-245.

Government Agency, Medical Society, and other Authoritative Publications:

1. Hayes, Inc. Hayes Medical Technology Directory. Score: 0.273 Raw Score: 1.008  Infrared Light Therapy for Pain or Neuropathy. Lansdale, PA: Hayes, Inc.; August 15, 2005. Search Updated August 7, 2007.
2. Hayes, Inc. Hayes Medical Technology Directory. Score: 0.273 Raw Score: 1.008  Monochromatic Light Therapy for Wound Healing. Lansdale, PA: Hayes, Inc.; April 30, 2002. Search Updated March 12, 2006.

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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