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DESCRIPTION ........................................................................................................................................ 1
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1
BACKGROUND ...................................................................................................................................... 2
CLINICAL EVIDENCE........................................................................................................................... 3
U.S. FOOD AND DRUG ADMINISTRATION (FDA) .......................................................................... 7
APPLICABLE CODES ............................................................................................................................ 8
REFERENCES ......................................................................................................................................... 9
PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 12
DESCRIPTION
This policy describes the use of infrared light therapy for neuropathy and pain. The goal of infrared
light therapy is to reduce or reverse nerve damage and associated symptoms such as pain and loss of
sensation.
Infrared light therapy is not medically necessary for the management of pain or neuropathy including
conditions such as diabetic neuropathy, osteoarthritis, rheumatoid arthritis, ankle sprains, plantar
fasciitis, chondromalacia patellae, myofascial pain, musculoskeletal pain, fibromyalgia, tendonitis,
epicondylitis, and temporomandibular joint disorder due to inadequate clinical evidence of safety
and/or efficacy in published, peer-reviewed medical literature.
Effective for services performed on and after October 24, 2006, the Centers for Medicare & Medicaid
Services has determined that there is sufficient evidence to conclude the use of infrared therapy devices
and any related accessories is not reasonable and necessary under section 1862(a)(1)(A) of the Social
Security Act (the Act). 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.
For Medicare and Medicaid Service Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search.
BACKGROUND
Infrared light therapy involves the treatment of damaged tissues with light from a low-intensity
infrared laser. Since it is a noninvasive treatment, the applied light must travel through the skin and
any other overlying tissues to reach the site of damage. The infrared light must then be absorbed to
cause a biostimulatory, healing effect. Although the mechanism or mechanisms by which infrared light
therapy might reduce pain and promote healing have not been established, this modality has been
investigated as a treatment for a wide range of neuropathic, arthritic, and orthopedic disorders
including diabetic neuropathy, osteoarthritis, rheumatoid arthritis, ankle sprains, plantar fasciitis,
chondromalacia patellae, myofascial pain, musculoskeletal pain, fibromyalgia, tendonitis,
epicondylitis, and temporomandibular joint disorder.
In contrast to more powerful surgical lasers, low level laser light is low power, usually 5-500
milliwatts with wavelengths of 600-1000 nm. Infrared light therapy treatment protocols vary in many
respects. One significant aspect of variation is the light source, which is usually a single-beam infrared
laser. The light source could also be a cluster of laser sources or an array of infrared light-emitting
diodes. When performed with an array of light-emitting diodes, this procedure has been referred to as
monochromatic near-infrared photoenergy (MIRE) therapy. These light sources usually emit light at a
single wavelength. An example of MIRE therapy is the Anodyne Therapy release, cause local
vasodilation, improve circulation, and heal damaged nerves.
Diabetic Neuropathy:
In an RCT in which patients served as their own controls, Leonard et al. examined whether treatments
with the Anodyne Therapy System would decrease pain or improve sensation in 27 patients with
diabetic peripheral neuropathy. Each lower extremity was treated with sham (heat only) or active
monochromatic near-infrared photoenergy (MIRE) treatments for 2 weeks, followed by 2 weeks of
active treatment for all patients. After both 6 and 12 active MIRE treatments, the 18 patients who were
able to sense the 6.65 Semmes-Weinstein monofilament test (SWM) but not the 5.07 SWM at baseline
had improved sensation to the 5.07 SWM. Sham treatments did not improve sensation. Significant
reductions in neuropathic symptoms were also reported, as well as improvement in balance and
reduced pain. The 9 patients with greater sensory impairment measured by insensitivity to the 6.65
SWM at baseline, had no significant improvement in sensation, neuropathic symptoms, or pain
reduction. Study limitations included small sample size and the design did not measure pain reduction
or balance improvement in active compared to sham treatment of individual limbs. There was a lack
of objective measurement for balance impairment, and follow-up was limited to evaluation after 12
treatments, with no analysis of long-term durability.
Lavery et al. (2008) conducted a double-blind, randomized, sham-controlled clinical trial to determine
he efficacy of anodyne MIRE in-home treatments over a 90 day period to improve peripheral sensation
and self-reported quality of life in patients with diabetes. Sixty-nine patients with diabetes and a
vibration perception threshold (VPT) between 20 and 45V were randomized to an active or sham
treatment group. Sixty patients completed the study. The Anodyne units were used at home every day
for 40 minutes over 90 days. No significant differences in measures for were found in quality of life,
the Michigan Neuropathy Screening Instrument (MNSI), VPT, SWM, or nerve conduction velocities
in the active or sham groups (p>0.05).
There have been small case studies published that examined the Anodyne Therapy System (ATS) for
various uses (Kochman, et al., 2022) and Kochman (2004). These studies have been limited by small
size, as well as by a lack of control group, randomization, blinding and long-term follow-up. DeLessis
et al. (2005) and Harkless et al. (2006) reported on larger case series that examined MIRE for
peripheral neuropathy. These studies were limited by lack of randomization, a control group and
blinding. In addition, Harkless et al. (2006) a retrospective review of 2239 patient records, utilized the
records of patients who, after being treated with MIRE, had all exhibited improvement in their
symptoms.
Musculoskeletal Conditions:
A randomized, double-blind, placebo-controlled study of 40 patients found no significant differences
between four treatment groups with respect to all outcome parameters (p>0.05 and there were no
differences between laser and placebo laser treatments on pain severity and functional capacity in
patients with acute and chronic low back pain caused by lumbar disk herniation (Ay, et al., 2010). In
2008, Oken et al. reported on a randomized, controlled, single-blind trial of 59 patients that evaluate
the efficacy of light therapy compare to effects of brace or ultrasound (US) in lateral epicondylitis. No
significant difference was noted between the groups in terms of visual analog scale (VAS), grip
strength and global assessment at baseline and at follow-up assessments (p>.05). Limitations of the
study included the relatively small study size, lack of long-term follow-up and that activities of daily
living were not evaluated. Djavid et al. (2007) conducted a randomized, controlled trial of 61 patients
to evaluate light therapy for chronic low back pain. There was no between-group difference for any
outcome measure immediately after the six-week intervention. At 12 weeks, there was no difference in
the light therapy plus exercise compared with exercise group, while there was improvement noted that
in the light therapy plus exercise group when compared to the placebo laser therapy plus exercise
grouppain was reduced by 1.8 cm (95% CI 0.1 to 3.3, p=0.03), lumbar range of movement increased
by 0.9 cm (95% CI, 0.2 to 1.8, p<0.01) on the Shober Test and by 15 degrees (95% CI5 to 25, p<0.01)
of active flexion and disability reduced by 9.4 points (95% CI 2.7 to 16.0, p=0.03) on the Oswestry
Disability Index.
There are several systematic and technical reviews published regarding the use of light therapy for
musculoskeletal conditions. Bjordal et al. conducted a systematic review with meta-analysis of light
therapy in lateral elbow tendinopathy, with primary outcome measures of pain relief and/or global
improvement and subgroup analyses of methodological quality, wavelengths and treatment procedures.
The review included 13 randomized controlled trials (730 patients). The weighted mean difference for
pain relief was 10.2 mm (95% CI: 3.0 to 17.5). Trials which targeted acupuncture points reported
negative results, as did trials with wavelengths 820, 830 and 1064 nm. In a subgroup of five trials with
Yousefi-Nooraie et al. (2008) conducted a Cochrane review that included seven studies and examined
light therapy for nonspecific low-back pain. The authors concluded that based on the heterogeneity of
the populations, interventions and comparison groups, that there are insufficient data to draw firm
conclusion on the clinical effect of light therapy for low-back pain. In addition the authors note that
there is a need for further methodologically rigorous randomized, controlled trials to evaluate the
effects of light therapy compared to other treatments, different lengths of treatment, wavelengths and
dosage.
A review of evidence was conducted for the development of an American Pain Society /American
College of Physicians clinical practice guideline for diagnosis and treatment of low back pain (Chou
and Huffman, 2007). The review examined nonpharmacologic therapies for acute and chronic low
back pain and included only systematic reviews and randomized trials, with seven trials that included
light therapy, Four trials found laser therapy superior to sham for pain or functional status up to one
year after treatment, but another higher-quality trial found no differences between laser and sham in
patients receiving exercise. One lower-quality study reported found similar results for laser, exercise
and the combination of laser plus exercise for pain and back-specific functional status. It was noted
that optimal treatment parameters, wavelength, dosage, dose intensity are uncertain
Osteoarthritis:
There is inconclusive evidence that infrared light therapy is effective for osteoarthritis of the knee and
either insufficient evidence or lack of evidence of efficacy for osteoarthritis of the hands, fingers, and
neck. Gur et al. found that at 3 months follow-up, infrared laser treatment produced moderate,
statistically significant reductions in pain and improvements in mobility for patients with osteoarthritic
knees. Two other RCTs of infrared light therapy for knee osteoarthritis did not demonstrate a treatment
effect. These studies may have failed to reproduce the benefits obtained by Gur et al. due to differences
in the infrared light exposure protocol.
Ozdemir et al. randomized 60 patients to ten sessions of true or placebo infrared laser therapy for
cervical osteoarthritis. Infrared light treatment was associated with statistically and clinically
significant reductions in pain, range of motion, and Neck Pain Disability Scale scores relative to
baseline; however, in addition to lack of follow-up, the statistical significance of differences in
outcomes between the treatment and control groups was not reported.
A study of infrared light therapy for osteoarthritis of the fingers and hand reported that treatment did
not produce any statistically significant improvements in most of the measures of pain and function.
Rheumatoid Arthritis:
A Cochrane systematic review (Brosseau, et al., 2004) was performed for the purpose of reviewing the
literature regarding LLLT as treatment for osteoarthritis. The review included seven controlled clinical
trials, with 184 patients randomized to laser and 161 to an inactive laser probe. It was noted that the
main limitation of this systematic meta-analyses is the heterogeneity of clinical application, including
different dosages, wavelengths, and types of LLLT. The authors summarized the implications for its
practice as there is insufficient evidence to draw any firm conclusions regarding the use of LLLT for
treatment of osteoarthritis.
Lateral Epicondylitis:
The available studies do not present sufficient evidence to conclude that infrared light therapy is
effective for lateral epicondylitis. In one RCT, Haker and Lundeberg reported that infrared laser
treatment accelerated recovery of grip strength, with statistically significant improvements at 3 months
follow-up; however, these improvements were matched by spontaneous improvements in the control
group at 1 year follow-up. Moreover, at 3 months and 1 year follow-up, this study found that infrared
laser therapy had not reduced pain or improved outcomes in several other measures of function.
Similar results were obtained by Vasseljen et al. who found that at 4 weeks follow up, infrared laser
therapy was associated with statistically significant improvements in pain and grip strength; however,
the treatment group did not experience any statistically significant improvements in weight lifting or
flexion tests. Basford et al. reported that infrared light therapy failed to significantly reduce pain or
improve function for patients with lateral epicondylitis.
Myofascial Pain:
The available RCTs of infrared light therapy present promising but inconclusive evidence that it is an
effective treatment for myofascial and musculoskeletal pain. Gur et al. performed a study and reported
that for patients with chronic myofascial pain of the neck and shoulder girdle, infrared laser therapy
produced moderate, statistically significant reductions in number of trigger points and Neck Pain
Disability Scale scores; however, improvements in pain scores were not significant and this study
involved only 10 weeks of follow-up. Two other placebo-controlled randomized trials of infrared laser
therapy have reported that infrared laser therapy reduces neck and shoulder pain. Significant
shortcomings of these RCTs are their small size and lack of follow-up.
Fibromyalgia:
Another study evaluated infrared light therapy for fibromyalgia. Although this trial reported that the
treatment group had statistically significant improvements in pain, morning stiffness, fatigue,
depression, and Fibromyalgia Impact Questionnaire scores, the magnitude of these improvements was
relatively small, the study did not involve any follow-up, and there were no significant improvements
in muscle spasm, number of tender points, skinfold tenderness, or sleep disturbance.
Bingol et al. studied 40 patients with shoulder pain. Twenty patients were randomly assigned to low-
power laser treatment and 20 patients were part of the control group. The study results demonstrated
better results in palpation sensitivity and passive extension for the group treated with laser, but no
significant improvement in pain or active range in the laser treatment group compared to the control
group.
Summary:
Overall, studies do not provide sufficient evidence to conclude that infrared light therapy is effective
treatment for pain or neuropathy. Although some of these studies suggest that infrared light therapy is
relatively safe and might improve symptoms of neuropathy, limitations in study design hamper
interpretation of the evidence and therefore, no definitive conclusions can be drawn about long-term
health outcomes. Further study using randomized controlled clinical trials is needed.
Professional Societies/Organizations
MIRE for the treatment of peripheral neuropathy is not recognized as a standard of care by the
American Association of Clinical Endocrinologists, the American Diabetes Association, the American
Academy of Neurology, the American Medical Association, the American Orthopedic foot and Ankle
Society or the American Podiatric Medical Association.
U.S. Food and Drug Administration (FDA): Infrared lamps to perform phototherapy are regulated by the
FDA as Class II devices. A number of infrared light phototherapy devices have been approved by the FDA
through the 510(k) approval process (Searchable 510(k) database scanned for infrared lamp product code
ILY. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm).
APPLICABLE CODES
The codes listed in this policy are for reference purposes only. Listing of a service or device code in
this policy does not imply that the service described by this code is a covered or non-covered health
service. Coverage is determined by the benefit document. This list of codes may not be all inclusive.
CPT Codes Description
97026 Application of a modality to one or more areas; infrared
97039 Unlisted modality (specify type and time if constant attendance)
CPT is a registered trademark of the American Medical Association.
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low intensity Nd:YAG laser irradiation on lateral epicondylitis. Arch Phys Med Rehabil.
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Bingol U, Altan L, Yurtkuran M. Low-power laser treatment for shoulder pain. Photomed Laser Surg.
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Bjordal JM, Lopes-Martins RA, Iversen VV. A randomised, placebo controlled trial of low level laser
therapy for activated Achilles tendinitis with microdialysis measurement of peritendinous
prostaglandin E2 concentrations. Br J Sports Med. 2006 Jan;40(1):76-80; discussion 76-80.
Bjordal JM, Couppe C, Chow RT, et al. A systematic review of low level laser therapy with location-
specific doses for pain from chronic joint disorders. Aust J Physiother. 2003;49(2):107-116.
Bjordal JM, Lopes-Martins RA, Joensen J, Couppe C, Ljunggren AE, Stergioulas A, Johnson MI. A
systematic review with procedural assessments and meta-analysis of low level laser therapy in lateral
elbow tendinopathy (tennis elbow). BMC Musculoskelet Disord. 2008 May 29;9:75.
Brosseau L, Robinson V, Wells G, Debie R, Gam A, Harman K, Morin M, Shea B, Tugwell P. Low
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2005 Oct 19;(4):CD002049.
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Chow RT, Barnsley L, Heller GZ, Siddall PJ. A pilot study of low-power laser therapy in the
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DeLellis SL, Carnegie DH, Burke TJ. Improved sensitivity in patients with peripheral neuropathy. J
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Gur A, Sarac AJ, Cevik R, et al. Efficacy of 904 nm gallium arsenide low level laser therapy in the
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Date Action/Description
10/28/2010
Corporate Medical Affairs Committee
07/24/2009
The foregoing Health Plan of Nevada/Sierra Health & Life Healthcare Operations protocol has been
adopted from an existing UnitedHealthcare coverage determination guideline that was researched,
developed and approved by the UnitedHealthcare Coverage Determination Committee.