Subject:
Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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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.
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
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, ie, temporarily relieves minor pain, stiffness, and muscle spasm and temporarily increases local blood circulation.
Related Policies
- Low-Level Laser Therapy (Policy #074 in the Treatment Section)
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
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.
Medicare Coverage:
Per NCD 270.6, the Centers for Medicare & Medicaid Services has determined that the use of infrared and/or near-infrared light and/or heat, including monochromatic infrared energy, is non-covered for the treatment, (including the symptoms such as pain arising from these conditions), of diabetic and/or non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of the skin and/or subcutaneous tissues. Per Local Coverage Determination (LCD): Infrared Heating Pad Systems (L33825), there are no indications for which these devices have been demonstrated to have any therapeutic effect. The device and any related accessories will be denied as not medically reasonable and necessary. For additional information, refer to NCD 270.6 and LCD L33825 below.
National Coverage Determination (NCD) for Infrared Therapy Devices (270.6). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=315&ncdver=1&bc=AgAAgAAAAAAA&
Local Coverage Determination (LCD): Infrared Heating Pad Systems (L33825). Available: https:// https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33825&ver=10&Date=02%2f11%2f2019&SearchType=Advanced&DocID=L33825&bc=KAAAABgAAAAA&.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: This policy was originally created in 2002 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed through January 2018.
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.
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)
A recent systematic review in 2017 found "There was limited evidence that MIRE results in short-term improvement of tactile sensitivity probably not sustained over time. Limited evidence also suggested that MIRE does not provide relief for neuropathic pain. As quality of evidence is low, further studies are likely to change the estimated effect."17
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 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 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.
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.
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.
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 of Evidence
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.
SUPPLEMENTAL INFORMATION
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)
U.S. Preventive Services Task Force Recommendations
Not applicable.
Up to Date (January 2018)
Treatments regarded as probably not effective by the AAN were oxcarbazepine, lamotrigine, lacosamide, clonidine, pentoxifylline, mexiletine, magnetic field treatment, low-intensity laser therapy, and Reiki therapy.18]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions
Infrared Therapy
Anodyne Therapy System
Low-Level Infrared Therapy
Monochromatic Infrared Energy, Low-Level
MIRE
Clarimedix System
HealthLight™
BioRemedi HealthLight™ System
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 Guidlines. 2010. Available online at: http://aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Last 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.
17. Robinson CC, Klahr PDS, Stein C, Falavigna M, Sbruzzi G, Della Méa Plentz R. Effects of monochromatic infrared phototherapy in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials. Braz J Phys Ther. 2017 Jul-Aug; 21(4): 233–243.
18. Feldman EL, McCulloch DK. Treatment of diabetic neuropathy. Dashe JF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Accessed on January 25, 2018.)
19. Feldman EL, McCulloch DK. Treatment of diabetic neuropathy. Shefner JM, Nathan DM, Eichler AF, (eds). UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Accessed on February 11, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
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HCPCS
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
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