MEDICAL POLICY

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DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

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

Number 1.01.22

Effective Date February 24, 2014

Revision Date(s) 02/10/14; 01/14/13; 01/06/12; 06/13/11; 10/13/09; 10/14/08; 02/13/07; 10/11/05; 12/14/04; 07/13/04; 08/12/03

Replaces N/A

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.

Related Policies

2.01.56

Low-Level Laser Therapy (LLLT)

2.02.17

End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

Policy Guidelines

Coding

No specific CPT code describes the use of skin contact monochromatic infrared energy (MIRE) therapy.

CPT

97026

Application of a modality to 1 or more areas; infrared

HCPCS

E0221

Infrared heating pad system

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.

Background

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 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

Some of the MIRE devices that received marketing clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) process are:

  1. 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."
  2. The Clarimedix system (Clarimedex, Inc.), received 510(k) clearance in 2006 (K062635) listing the SMI™ SpectroPad (a.k.a. Anodyne Therapy System) as a predicate device. Clarimedix’s indicated use is for the treatment of chronic pain by emitting energy in the infrared spectrum. The intended outcome is 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.
  3. 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, that is to temporarily relieves minor pain, stiffness, and muscle spasm and temporarily increase local blood circulation.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This policy does not apply to Medicare Advantage.

Benefit Application

N/A

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 through November 4, 2013. Literature searches have identified 6 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:

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 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 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 2 studies (1 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 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 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 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.

Section Summary

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% to 90% 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% 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 et al 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.

Knee Osteoarthritis

Randomized Controlled Trials. Hsieh et al reported a double-blind randomized controlled trial of short-term MIRE for osteoarthritis.(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 2 weeks. Outcomes were measured weekly over 4 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

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.

Practice Guidelines and Position Statements

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)

Medicare National Coverage

There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

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):109-16.
  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.
  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):947-56.
  15. Association for the Advancement of Wound Care. Association for the Advancement of Wound Care Guideline of Pressure Ulcer Guidelines. 2010. Available online at: http://aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Last accessed January 8, 2014.
  16. BlueCross BlueShield Association (BCBSA) Medical Policy Reference Manual, Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions. Policy No. 1.01.22, 2013.

Coding

Codes

Number

Description

CPT

97026

Application of a modality to 1 or more area; infrared

 

97039

Unlisted modality (specify type and time if constant attendance)

ICD-9 Procedure

   

ICD-9 Diagnosis

   

ICD-10-CM
(effective 10/01/14)

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 10/01/14)

   

HCPCS

A4639

Replacement pad for infrared heating system, each

 

E0221

Infrared heating pad system

 

S8948

Application of a modality requiring constant provider attendance to 1 or more areas; low-level laser; each 15 minutes

Type of Service

Durable Medical Equipment

 

Place of Service

Office

Outpatient

Home

 

Appendix

N/A

History

Date

Reason

08/12/03

Add to Durable Medical Equipment Section - New Policy

07/13/04

Replace policy - Policy reviewed. Rationale and references updated. No change in policy statement.

12/14/04

Replace policy - Policy reviewed. No change to policy statement.

10/11/05

Replace policy - Policy reviewed. References added. No change in policy statement.

05/26/06

Update Scope and Disclaimer - No other changes.

02/13/07

Replace policy - Policy updated with literature search; reference added. No change in policy statement.

10/14/08

Replace policy - Policy updated with literature search; no change to the policy statement. References added.

10/13/09

Replace policy - Policy updated with literature search; no change to the policy statement. References added.

06/13/11

Replace policy - Policy updated with literature search; rationale section extensively edited and updated; references reordered; no change in policy statement. ICD-10 codes added to policy.

01/06/12

Replace policy – Policy updated with literature search through September 2011; references added; policy statement unchanged.

03/22/12

Minor update, Related Policies updated with 1.01.16 and 1.01.22.

08/24/12

Update Related Policies – Remove 1.01.16 as it was archived. Update Coding Section – ICD-10 codes are now effective 10-01-2014.

01/29/13

Replace policy. Policy rationale updated based on a literature review through September 2012.Reference 5 added; others renumbered. Policy statement unchanged.

02/24/14

Replace policy. Policy updated with literature search through November 4, 2013; added info on knee OA study, added practice guideline. References 14, 15 added. Policy statement unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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