BlueCross and BlueShield of Montana Medical Policy/Codes
Skin Contact Monochromatic Infrared Energy Devices (MIRE)
Chapter: Durable Medical Equipment
Current Effective Date: September 24, 2013
Original Effective Date: May 01, 2006
Publish Date: September 24, 2013
Revised Dates: June 1, 2012; August 15, 2011; February 1, 2012; August 29, 2013
Description

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.

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.  Some sort of photo biostimulation has been proposed, along with an increase of the potent vasodilator nitric oxide, which could result in increased circulation.

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers Skin Contact Monochromatic Infrared Energy (MIRE) devices are considered experimental, investigational and unproven for any indication including (but not limited to):

  • Cutaneous ulcers,
  • Diabetic Neuropathy,
  • Musculoskeletal conditions (including but not limited to):
    1. Temporomandibular disorders,
    2. Tendonitis,
    3. Capsulitis,
    4. Myofascial pain.

Rationale

A search of the literature based on the MEDLINE database failed to identify any randomized controlled trials focusing on skin contact monochromatic infrared energy.  Several case series focusing on different clinical applications were identified.  These are reviewed below.

Thomasson reported on the outcomes of series of 563 patients treated with skin contact MIRE who were diagnosed with trapezius tendonitis, splenius capitus tendonitis, temporomandibular capsulitis, or myofascial pain.  Patients were treated with one to twelve sessions of skin contact MIRE.  The authors report an 88%–90% improvement rate within each diagnostic group. However, there was no control group nor 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.  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 six treatments, and all had improved sensation after twelve 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 five patients with venous or diabetic ulcers (four patients) and one patient with an ulcer related to scleroderma.  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.

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.  The lack of a control group limits interpretation of these studies.  Leonard and colleagues reported on the results of a placebo controlled randomized trial of 27 patients with diabetic peripheral neuropathy.  Patients essentially served as their own control as each limb was treated with either an Anodyne Professional Therapy System™ or a placebo device for two weeks, then both limbs were treated with the Anodyne Professional Therapy System™.  Outcomes were assessed with a Semmes-Weinstein monofilament.  While the authors reported improved sensitivity, less pain and better balance in limbs treated with the active device, larger studies with longer follow-up are required to confirm treatment efficacy

A search of the literature was completed through MEDLINE database for the period of October 2003 through September 2006.  No additional published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged.

Coding

Disclaimer for coding information on Medical Policies         

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.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

Refer to the ICD-9-CM manual.

ICD-10 Codes

Refer to the ICD-10-CM manual.

Procedural Codes: A4639, E0221
References
  1. Thomasson, T.L.  Effects of Skin-Contact Monochromatic Infrared Irradiation on Tendonitis, Capsulitis, and Myofascial pain.  Journal of Neurology and Orthopedic Medicine and Surgery (1996) 16:242-245.
  2. Horowitz, L. R., Burke, T. J., et al.  Augmentation of Wound Healing Using Monochromatic Infrared Energy.  Advances in Wound Care (1999 January-February) 12(1): 35-40. 
  3. Kochman, A. B., Carnegie, D. H., et al.  Symptomatic reversal of peripheral neuropathy in patients with diabetes.  Journal of the American Podiatric Association (2002 March) 92(3): 125-130.
  4. Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2003 April 29) Durable Medical Equipment: 1.01.22.
  5. Leonard, D.R., Farooqi, M.H., et al.  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 January) 27(1): 168-72.
  6. Prendergast, J.J., Mirando, G., et al.  Improvement of sensory impairment in patients with peripheral neuropathy.  Endocrine Practice (2004 January-February) 10(1): 24-30.
  7. Powell, M.W., Carnegie, D.E., et al.  Reversal of diabetic peripheral neuropathy and new wound incidence: the role of MIRE.  Advanced Skin Wound Care (2004 July-August) 17(6): 295-300.
  8. DeLellis, S. L., Carnegie, D.H., et al.  Improved sensitivity in patients with peripheral neuropathy effects of monochromatic infrared photo energy.  Journal of the American Podiatric Medical Association (2005 March-April) 95(2): 143-7.
  9. Powell, M.W., Carnegie, N.H., et al.  Reversal of diabetic peripheral neuropathy with phototherapy (MIRE) decreases falls and the fear of falling and improves activities of daily living in seniors.  Age and Aging (2006 January) 35(1): 11-6.
History
June  2011 Policy reviewed; updated description, policy, rationale, and references
February 2012 Policy Updated: Name changed from Anodyne and other Skin Contact Monochromatic Infrared Energy (MIRE) Therapies to Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions; no changes in policy statement
September 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions" to "Skin Contact Monochromatic Infrared Energy Devices (MIRE)".  Removed CPT code 97026.
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Skin Contact Monochromatic Infrared Energy Devices (MIRE)