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MP 1.01.22

Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions


Medical Policy    
Section
Durable Medical Equipment
 
Original Policy Date
4/29/03

Last Review Status/Date
Reviewed with literature search/11:2012

Issue
11:20112
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

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.

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." 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. 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.


Policy

Skin contact monochromatic infrared energy is considered investigational as a technique to treat cutaneous ulcers, diabetic neuropathy, and 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 monochromatic infrared energy (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 1 or more area; infrared) may be used. Devices may also be used in the home setting. In this situation, the HCPCS code E0221 (infrared heating pad system) may be used. 


Benefit Application 

BlueCard/National Account Issues

State or federal mandates (e.g., 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 search was performed for the period of October 2011 through September 2012. Literature searches have identified 5 controlled trials of skin contact monochromatic infrared energy (MIRE) therapy and 2 systematic reviews of the technology. Following is a summary of the key literature to date:

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 4 retrospective chart reviews, 5 studies with an experimental research design, and 2 studies that used a prospective randomized, placebo-controlled design (discussed below). 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 randomized controlled trial (RCT) with 69 patients with diabetes and a vibration perception threshold between 20 and 45 V were randomized to active or sham treatment (7 days a week 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 (NeuroQoL) 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 3 times a week for 4 weeks. (4) Both groups showed significant improvements in plantar sensation after 4 and 8 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 6 weeks and 3 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 to 1) examine the effects of MIRE neuropathy protocol on sensation on the feet of patients with diabetes and a loss of protective sensation; 2) 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) examine MIRE's effect on pain; and 4) examine the relationship between transcutaneous oxygen levels and loss of protective sensation. (6) Participants underwent a series of twelve 30-minute MIRE treatments 2 to 4 times per week for 3 to 5 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 to pretest baseline scores. No statistical relationship was found between transcutaneous oxygen and sensation.

Leonard and colleagues 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 2 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.

Conclusion. The available controlled trials are small and of short duration. In 4 of 5 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.

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. (8-10) 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 1 to 12 sessions of skin contact MIRE. The authors report an 88–90% improvement rate within each diagnostic group. However, there was no control group or a discussion of how treatment response was assessed. Kochman and colleagues 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% exhibited improved sensation after 6 treatments, and all had improved sensation after 12 treatments. However, the absence of a control group limits interpretation of these findings. Horwitz and colleagues investigated the use of skin contact MIRE as a technique to promote healing of 5 patients with venous or diabetic ulcers (4 patients) and 1 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.

Summary

The available literature regarding skin contact MIRE as a technique to treat various cutaneous conditions consists of small controlled trials and observational studies. 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

None found.

Medicare National Coverage

No National Coverage Determination found.

References:

  1. Li H, Nyland J, Shelton T. Effectiveness of the anodyne therapy system in treating diabetic peripheral neuropathy: a systematic review. Phys Ther Rev 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):109-16.
  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):316-21.
  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):2896-900.
  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 2011; 52(9):669-72.
  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):168-72.
  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):143-7.
  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; 16:242-5.
  12. Kochman AB, Carnegie DH, Burke TJ. Symptomatic reversal of peripheral neuropathy in patients with diabetes. J Am Podiatr Med Assoc 2002; 92(3):125-30.
  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.

 

Codes

Number

Description

CPT  97026  Application of a modality to 1 or more area; infrared 
HCPCS  E0221  Infrared heating pad system 
  A4639  Replacement pad for infrared heating system, each 
ICD-9-CM diagnosis    Investigational for all diagnoses
ICD-10-CM (effective 10/1/14)    Investigational for all diagnoses
   E10.40-E10.49 Type 1 diabetes mellitus with neurological complications code range
   E10.620-E10.628 Type 1 diabetes mellitus with skin complications code range
   I70.231-I70.249 Atherosclerosis of native arteries of leg with ulceration code range
   M77.9 Enthesopathy, unspecified
  M79.1  Myalgia/Myofascial pain syndrome 
ICD-10-PCS (effective 10/1/14)    ICD-10-PCS codes are for use on inpatient services. There is no specific ICD-10-PCS code for this therapy.


Index

Anodyne
Infrared Heating Pad
Monochromatic Infrared Energy


Policy History

Date Action Reason
04/29/03 Add policy to Durable Medical Equipment section New policy
11/9/04 Replace policy Policy updated; no changes in policy statement
08/17/05 Replace policy Policy updated with literature search; references 4 through 7 added. No change in policy statement
12/12/06 Replace policy Policy updated with literature search; reference 8 added; no change in policy statement.
03/13/08 Replace policy  Policy updated with literature search; reference number 9 added; no change in policy statement
08/13/09 Replace policy  Policy reviewed with literature search from February 2008 through June 2009. The policy statement is unchanged; new reference number 10 added.
3/10/11 Replace policy Policy updated with literature search; rationale section extensively edited and updated; references reordered; no change in policy statement
11/10/11 Replace policy Policy updated with literature search through September 2011; references added; policy statement unchanged
11/08/12 Replacy Policy Policy updated with literature search through September 2012; reference 5 added and references reordered; policy statement unchanged