| Last Review: | December 26, 2018 | Related Policies |
| Next Review: | Policy Archived | |
| Issue: ARCHIVED | 12:2008 | |
| MONOCROMATIC ENERGY INFRARED CONTACT IN THE TREATMENT OF SKIN ULCERS, DIABETIC NEUROPATHY AND MUSCULOSKELETAL CONDITIONS | ||
| Summary | ||
| 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, ie, 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. | ||
| OBJECTIVE | ||
| DO NOT APPLY | ||
| POLICY STATEMENT | ||
| 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 | ||
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| 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 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 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, ie, temporarily relieves minor pain, stiffness, and muscle spasm and temporarily increases local blood circulation. | ||
| 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 November 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 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. | ||
| DO NOT APPLY | |
| 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. | |
| Medicare National Coverage | |
| The Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination on infrared therapy devices in 2006.16 CMS determined that there is sufficient evidence to conclude that the use of infrared devices is not reasonable and necessary for treatment of Medicare beneficiaries for diabetic and non-diabetic peripheral sensory neuropathy, wounds and ulcers, and similar related conditions, including symptoms such as pain arising from these conditions. The use of infrared and/or near-infrared light and/or heat, including MIRE, is not covered for the treatment, including symptoms such as pain arising from these conditions, of diabetic and/or nondiabetic peripheral sensory neuropathy, wounds and/or ulcers of skin and/or subcutaneous tissues in Medicare beneficiaries. | |
| REFERENCES | |
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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 and 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.
| CODES | ||
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| Codes | Number | Description |
| CPT | 97026 | Application of a modality to 1 or more areas; infrared |
| HCPCS | E0221 | Infrared heating pad system |
| | A4639 | Replacement pad for infrared heating system, each |
| ICD-10 CM (Effective date 10/01/2015) | 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 |
| ICD-10 CM (Effective date 10/01/2018) | M79.10 | Myalgia, unspecified site |
| | M79.11 | Myalgia of mastication muscle |
| | M79.12 | Myalgia of auxiliary muscles, head and neck |
| | M79.18 | Myalgia, other site |
| ICD-10 CM Termination date 9/30/2018) |
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| ICD-10-PCS (effective date 10/01/2015) | | ICD-10-PCS codes are for use on inpatient services. There is no specific ICD-10-PCS code for this therapy. |
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| Applicable Modifiers | ||
| Some | ||
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| POLICY history | |||||
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| Date | Action | Description | |||
| 12/26/2018 | Review (ICD-10 added) | ICD-10 CM (included and delete) 2018, New Format | |||
| 06/23/2016 | | | |||
| 12/11/2014 | | | |||
| 01/18/2012 | (ICD-10 added) | | |||
| 04/15/2008 | Created | New Policy | |||
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| payment POLICY guidelines | |||||
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| Applicable Specialties | Physical Therapy and other specialty | ||||
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| o YES | x NO | ||||
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| Preauthorization requirements | Do not apply | ||||
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| Place of Service | Office, Inpatient Hospital, On Campus-Outpatient Hospital, Ambulatory Surgical Center, Independent Clinic | ||||
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| Age Limit | No age limit | ||||
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| Frequency | One per day | ||||
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| Frequency Limit | As established in the policy | ||||
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| Gender | x Male | x Female | |||
| As established in the policy. | |||||
| Economical impact | |||||
| o YES | x NO | ||||
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| Description | | ||||
| INTERQUAL CRITeRiA | |
| o YES If Yes, describe the comparison between Interqual criteria and this Policy | x NO |
| describe the comparison between Interqual criteria and this Policy | |
| Policy Categorization | |
| o LOCAL If Local, specify Rationale | x BCBSA |
| Approved by: Date: |