Description:
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 MIRE^™ has been proposed as a therapy for multiple conditions, including cutaneous ulcers, diabetic neuropathy and musculoskeletal and soft tissue injuries.

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, randomized controlled trials 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.

Background
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 to 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.

Regulatory Status
The Anodyne^® Professional Therapy System is a MIRE device that received marketing clearance from the U.S. Food and Drug Administration (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 the 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, i.e., temporarily relieves minor pain, stiffness and muscle spasms and temporarily increases local blood circulation.

Related Policies
20156 Low-Level Laser Therapy

Policy:
Skin contact monochromatic infrared energy therapy, including, but not limited to, the Anodyne Therapy^™ system, is considered INVESTIGATIONAL as a technique to treat:

• Cutaneous ulcers.
• Diabetic neuropathy.
• Musculoskeletal conditions, including, but not limited to, temporomandibular disorders, tendonitis, capsulitis and myofascial pain.

Policy Guidelines:
There is no CPT code that specifically describes the use of skin contact MIRE therapy. However, when the technique is offered in a clinic or physical therapy session, the nonspecific CPT code 97026 (application of a modality to one or more areas, infrared) may be used. Devices may also be used in the home setting. In this situation, the HCPCS code E0221 (infrared heating and pad system) may be used.

Benefit Application
BlueCard/National Account Issues
State or federal mandates (i.e., the FEP) may dictate that all FDA-approved devices may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity. 

Rationale
This policy was originally created in 2003 and was updated regularly with searches of the MEDLINE database. The most recent literature review was performed through Nov. 11, 2014.

Assessment of efficacy for therapeutic interventions involves a determination of whether the intervention improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases, such as noncomparability of treatment groups, the placebo effect and variable natural history of the condition. Literature searches have identified six controlled trials of skin contact monochromatic infrared energy (MIRE) therapy and two systematic reviews of the technology. Following is a summary of the key literature to date.

Diabetic Peripheral Neuropathy
Systematic Reviews
A 2008 systematic review included all clinical studies, including retrospective and prospective experimental studies and case series, evaluating MIRE for the treatment of diabetic peripheral neuropathy.¹ Ten studies were identified, including four retrospective chart reviews, five studies with an experimental research design and two studies that used a prospective randomized, placebo-controlled design (discussed next). Six of the 10 studies had a sample size of 50 subjects or less. Although the studies suggested that MIRE had efficacy for improving lower-extremity sensation, balance, gait and decreasing fall risk, the systematic review concluded that poor study designs, small sample sizes, limited information regarding treatment volume or intensity, concomitant use of conventional physical therapy modalities and a lack of long-term follow-up decreased the validity of most of the studies.

A 2011 systematic review examined the use of physical therapy interventions for balance dysfunction in patients with diabetic peripheral neuropathy. MIRE was one of several interventions evaluated, and there was insufficient evidence to recommend MIRE as a treatment for balance dysfunction.² 

Sham-Controlled Trials
A double-blind RCT with 69 patients with diabetes and a vibration perception threshold between 20 and 45 V were randomized to active or sham treatment (seven d/wk for 90 days).³ Objective measures (Semmes-Weinstein monofilament testing, vibration perception threshold and nerve conduction velocity) did not improve in either group. The subjective Neuropathy-specific Quality-of-Life instrument showed at least as much improvement in the sham control as in the active group. 

Two additional sham-controlled RCTs found MIRE to be no more effective than sham stimulation in treating patients with diabetic peripheral neuropathy.^4,5 Clifft et al. reported a double-blind controlled trial with 39 subjects randomized to active or sham MIRE three times a week for four weeks.⁴ Both groups showed significant improvements in plantar sensation after four and eight weeks, with no significant difference between the active and sham groups. Nawfar and Yacob reported a single-blinded study with 30 feet from 24 patients randomized to 12 daily treatments of active or sham MIRE.⁵ There was no significant difference between active or sham treatment groups in current perception threshold measured at six weeks and three months following treatment. 

Patients served as their own controls in two studies (one limb treated with an active device and the other limb treated with a sham device). Franzen-Korzendorfer et al. conducted a clinical study in patients with diabetes and loss of protective sensation (1) to examine the effects of MIRE neuropathy protocol on sensation on the feet of patients with diabetes and a loss of protective sensation; (2) to determine the effects of a published MIRE neuropathy protocol on sensation of the feet of patients with diabetes and a loss of protective sensation; (3) to examine MIRE's effect on pain; and (4) to examine the relationship between transcutaneous oxygen levels and loss of protective sensation.⁶ Participants underwent a series of 12, 30-minute MIRE treatments two to four times per week for three to five weeks. No significant differences were observed between active and sham treatments for transcutaneous oxygen values, pain or sensation. Both active and sham MIRE-treated feet had significantly improved sensation when compared with pretest baseline scores. No statistical relationship was found between transcutaneous oxygen and sensation. 

Leonard et al. reported on the results of a sham-controlled randomized trial of 27 patients with diabetic peripheral neuropathy.⁷ Patients served as their own controls as each limb was treated either with an anodyne device or a placebo device for two weeks, then both limbs were treated with the anodyne device. Outcomes were assessed with a Semmes-Weinstein monofilament. The authors reported improved sensitivity, less pain and better balance in limbs treated with the active device. 

Observational Studies
Several retrospective or prospective case studies were identified that reported that MIRE treatment was associated with an improvement in peripheral neuropathy, as measured by changes in sensitivity recorded by the Semmes-Weinstein monofilament.^8,9,10 The lack of a control group limits interpretation of these studies. Thomasson reported on the outcomes of a series of 563 patients treated with skin contact MIRE who were diagnosed with trapezius tendonitis, splenius capitis tendonitis, temporomandibular capsulitis or myofascial pain.¹¹ Patients were treated with one to 12 sessions of skin contact MIRE. The authors report an 88 percent to 90 percent improvement rate within each diagnostic group. However, there was no control group or a discussion of how treatment response was assessed. Kochman et al. reported on the use of skin contact MIRE in the treatment of 49 patients with diabetic neuropathy.¹² The principal outcome was change in sensation, as measured with a Semmes-Weinstein monofilament. Four diode arrays were used, the first placed on the distal posterior aspect of the tibia, the second placed over the anterior distal tibia and the third and fourth placed on the dorsal and ventral surfaces of the foot, respectively. On the basis of Semmes-Weinstein monofilament values, 98 percent exhibited improved sensation after six treatments, and all had improved sensation after 12 treatments. However, the absence of a control group limits interpretation of these findings. Horwitz et al. investigated the use of skin contact MIRE as a technique to promote healing of five patients with venous or diabetic ulcers (four patients) and one patient with an ulcer related to scleroderma.¹³ Patients were instructed to use a skin contact MIRE device at home. While the ulcers improved in all patients, the small number of patients and the lack of a control group prevent scientific interpretation.

Section Summary
The available controlled trials are small and of short duration. In four of five sham-controlled trials identified to date, MIRE therapy provided no more improvement in peripheral sensation, balance, pain or quality of life than sham therapy in patients with peripheral diabetic neuropathy.

Knee Osteoarthritis
Randomized Controlled Trials
Hsieh et al. reported a double-blind randomized controlled trial of short-term MIRE for osteoarthritis (OA).¹⁴ Seventy-three patients with knee osteoarthritis received six 40-minute sessions of active or placebo MIRE (sham control) over the knee joints for a period of two weeks. Outcomes were measured weekly over four weeks with a number of validated questionnaires that assessed pain, functioning and quality of life. While some outcome measures showed improvement over time, there were no significant differences between the active and sham groups for any of the measured outcomes. 

Summary of Evidence
The available literature regarding skin contact monochromatic infrared energy (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, randomized controlled trials 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.¹⁵ 

U.S. Preventive Services Task Force Recommendations
Not applicable

References:

1. 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.
2. 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.
3. Lavery LA, Murdoch DP, Williams J, et al. Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008;31(2):316-321.
4. Clifft JK, Kasser RJ, Newton TS, et al. 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.
5. Nawfar SA, Yacob NB. Effects of monochromatic infrared energy therapy on diabetic feet with peripheral sensory neuropathy: a randomised controlled trial. Singapore Med J. Sep 2011;52(9):669-672. PMID 21947144
6. Franzen-Korzendorfer H, Blackinton M, Rone-Adams S, et al. 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. 2008;54(6):16-31.
7. 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.
8. 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.
9. 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.
10. Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract. 2004;10(1):24-30.
11. Thomasson T. Effects of skin-contact monochromatic infrared irradiation on tendonitis, capsulitis, and myofascial pain. J Neurol Orthop Med Surg 1996;16:242-245.
12. 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.
13. 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.
14. 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. PMID 22960644
15. Association for the Advancement of Wound Care. Association for the Advancement of Wound Care Guideline of Pressure Ulcer Guidlines. 2010; http://aawconline.org/wpcontent/ uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed November 11, 2014.
16. Centers for Medicare & Medicaid Services. Decision memo for infrared therapy devices (CAG-00291N). 2006; http://www.cms.gov/medicare-coverage-database/details/nca-decisionmemo. aspx?NCAId=176&ver=22&NcaName=Infrared+Therapy+Devices&bc=BEAAAAAAEAAA&&fromdb=true. Accessed November 24, 2014.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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