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1 Clinical Policy Title: Infrared therapy Clinical Policy Number: 18.02.03 Effective Date: October 1, 2014 Initial Review Date: May 21, 2014 Most Recent Review Date: May 1, 2018 Next Review Date: May 2019 Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of infrared therapy to be clinically proven and, therefore, medically necessary when one of the following criteria is met (Davis, 2018; Qaseem, 2017): For treatment of early-stage (Stage I or II) internal hemorrhoids that are painful or persistently bleeding after conservative treatment (e.g., oral laxatives, local ointments, nonconstipating diets). As adjunctive treatment when used as a heat modality in physical therapy. Limitations: All other uses of infrared therapy are not medically necessary. Alternative covered services: Rubber band ligation. Sclerotherapy. Policy contains: Near-infrared light therapy. Far-infrared light therapy. Internal hemorrhoids. Physical therapy.

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Page 1: Clinical Policy Title: Infrared therapy · 2018. 11. 14. · Far-infrared therapy is a form of heat therapy delivered via heated saunas that exposes body tissues to slightly higher

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Clinical Policy Title: Infrared therapy

Clinical Policy Number: 18.02.03

Effective Date: October 1, 2014

Initial Review Date: May 21, 2014

Most Recent Review Date: May 1, 2018

Next Review Date: May 2019

Related policies:

None.

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of infrared therapy to be clinically proven and, therefore, medically

necessary when one of the following criteria is met (Davis, 2018; Qaseem, 2017):

For treatment of early-stage (Stage I or II) internal hemorrhoids that are painful or persistently

bleeding after conservative treatment (e.g., oral laxatives, local ointments, nonconstipating

diets).

As adjunctive treatment when used as a heat modality in physical therapy.

Limitations:

All other uses of infrared therapy are not medically necessary.

Alternative covered services:

Rubber band ligation.

Sclerotherapy.

Policy contains:

Near-infrared light therapy.

Far-infrared light therapy.

Internal hemorrhoids.

Physical therapy.

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Bipolar diathermy or cautery.

Surgical hemorrhoidectomy.

Background

Infrared light is electromagnetic radiation with longer wavelengths than those of visible light, extending

from the nominal red edge of the visible spectrum at 0.7 micrometers (µm) to 1,000 µm. This region is

further divided into near-infrared, middle-infrared, and far-infrared. Infrared therapy applies low-energy

light within the infrared spectrum. Although the exact mechanism is unclear, infrared therapy is believed to

promote photochemical, photophysical, and photobiological effects in cells and tissues, without causing

temperature to rise above 98°F (Anodyne, 2014).

Several devices are available to deliver infrared therapy, but they differ in their methods (wavelength, pulse

rate, intensity, etc.), design (total surface area), and application (handheld or attachable). Medical

applications for infrared therapy incorporate either near-infrared light using laser or light emitting diodes)

or far-infrared light applied in a sauna. Near-infrared light emitting diode devices are used to treat an area

of the skin and adjacent subcutaneous tissues of a patient by affixing infrared light emitting diodes to a

flexible pad to maintain skin contact.

Near-infrared laser (also referred to as low-energy, low-level, or cold laser) has low power with

wavelengths of 600–1,000 nanometers (nm) or greater in certain cases (Chung, 2012). When applied to the

skin, it does not burn and produces little or no sensation. Near-infrared laser is proposed for three main

purposes: to promote wound healing, tissue repair, and the prevention of tissue death; to relieve

inflammation and edema because of injuries or chronic diseases; and to be used as an analgesic. It is

proposed as a treatment for serious neurological conditions such as traumatic brain injury, stroke, spinal

cord injury, and degenerative central nervous system disease (Chung, 2012).

Far-infrared therapy is a form of heat therapy delivered via heated saunas that exposes body tissues to

slightly higher temperatures. Far-infrared reportedly heats the body and achieves similar effects as a

conventional sauna but at more tolerable lower temperatures. The rationale for using far-infrared is that

the heating gently increases blood flow by expanding capillary blood flow, increasing oxygenation and

regeneration of the blood, and detoxifying the blood to improve overall health. Its purported medical

benefits include treatment of health problems such as high blood pressure, congestive heart failure, and

rheumatoid arthritis (Mayo Clinic, 2014).

Regulatory status:

The U.S. Food and Drug Administration (FDA) reclassified several earlier infrared devices as heating pads,

and their approved indications reflect these roots. Now classified as infrared lamps, these interventions are

Class II Physical Medicine Therapeutic Devices (product codes IOB, ILY, NHN, ONH) that emit energy at

infrared frequencies of approximately 700 nanometers (nm) to 50,000 nm (21CFR890.5500). Product

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labeling varies, but generally these devices are intended for adjunctive use to provide relief of minor pain,

stiffness, and muscle spasm, and a temporary increase in local blood circulation.

In addition, the FDA has approved infrared lamps for stimulating hair growth (product code OAP), as

adjunctive treatment of post-mastectomy lymphedema (product code NZY), for electrosurgical cutting and

coagulation devices and accessories for tissue coagulation (product code GEI), and for laser treatment in

general and plastic surgery and dermatology (21CFR890.5500, 21CFR807.92, and 21CFR875.4400; FDA,

2014 using product code GEX). No devices using far-infrared have been approved for medical use, and at

least one warning letter was issued to a manufacturer of a far-infrared sauna for marketing its product in

the United States without marketing clearance or approval.

Searches

AmeriHealth Caritas searched PubMed and the databases of:

• UK National Health Services Centre for Reviews and Dissemination.

• Agency for Healthcare Research and Quality’s (AHRQ’s) National Guideline Clearinghouse and

other evidence-based practice centers.

• The Centers for Medicare & Medicaid Services (CMS).

We conducted searches on March 26, 2018. Search terms were: “Infrared Rays” (MeSH), “infrared therapy,”

and “Laser Therapy, Low-Level” (MeSH).

We included:

• Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and

greater precision of effect estimation than in smaller primary studies. Systematic reviews use

predetermined transparent methods to minimize bias, effectively treating the review as a

scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

• Guidelines based on systematic reviews.

• Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies

— which also rank near the top of evidence hierarchies.

Findings

Eleven systematic and narrative reviews were identified for this policy. Ten systematic reviews examined

the effectiveness of near-infrared light therapy for treating: internal hemorrhoids (Johanson, 1992); anal

canal intraepithelial neoplasia (Macaya, 2012); diabetic peripheral neuropathy (Ites, 2011; Hayes, 2009);

acne vulgaris (Hamilton, 2009; Hayes, 2009); musculoskeletal pain (Chow, 2005; Hayes, 2009); and restless

leg syndrome (Wilt, 2012), and also for preventing oral mucositis (Migliorati, 2013). One systematic review

examined the effectiveness of far-infrared sauna therapy for reducing cardiovascular risk factors (Beever,

2009). No economic analyses were identified for this policy.

Internal hemorrhoids:

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The Society for Surgery of the Alimentary Tract (2008) categorizes internal hemorrhoids as follows:

• Stage I: Bleeding only, no prolapse.

• Stage II: Prolapse that reduces spontaneously, with or without bleeding.

• Stage III: Prolapse that requires manual reduction, with or without bleeding.

• Stage IV: Irreducible prolapsed hemorrhoidal tissue.

There is sufficient evidence to support the use of infrared therapy (also called infrared coagulation) as a

treatment option for persons with early-stage (Stages I and II) internal hemorrhoids who have failed

conservative treatment (e.g., oral laxatives, local ointments, nonconstipating diets). The Standards Practice

Task Force of the American Society of Colon and Rectal Surgeons recommends rubber band ligation,

sclerotherapy, and infrared coagulation as effective treatment options for most patients with Stage I, II, and

III hemorrhoid disease based on moderate-quality evidence (Rivadeneira, 2011). The American

Gastroenterological Association states that second-degree, relatively small, and third-degree hemorrhoids

can be treated with nonoperative therapy, including infrared photocoagulation (Madoff, 2004).

Although the incidence of complications is low, perianal sepsis is a potential life-threatening complication

with all of the office-based procedures. Each procedure has a variable recurrence rate and each may

require repeated applications (Rivadeneira, 2011; Madoff, 2004). Previous reports on infrared coagulation

found high rates of recurrence with more advanced grades III and IV hemorrhoids. Rubber band ligation,

although more effective in controlling symptoms and obliterating grades I–III hemorrhoids than infrared

coagulation or sclerotherapy, is associated with more pain and discomfort to the patient. It can treat up to

three hemorrhoids in a single session, while infrared coagulation can treat up to six hemorrhoids per

session.

Because of the risk of postoperative hemorrhage, rubber band ligation should not be performed in patients

receiving anticoagulants (e.g., warfarin). Sclerotherapy and infrared therapy may be considered in patients

who are on anticoagulant therapy. Choice of treatment depends on several factors such as patient

symptoms, the number of hemorrhoids, the hemorrhoidal grade, bleeding tendency, surgical experience,

and patient preferences (Rivadeneira, 2011; Madoff, 2004).

Thermotherapy:

There is sufficient moderate-quality medical evidence to support the use of infrared therapy for acute or

chronic neck musculoskeletal pain. However, larger studies with long-term follow-up are needed to confirm

these findings and determine the most effective therapeutic parameters, sites, and modes of application.

One report found limited evidence of benefit for the use of low-level laser therapy for rheumatoid arthritis

using red or near-infrared light (Hayes, 2009). The Ottawa Panel Evidence-Based Clinical Practice Guidelines

Panel found moderate-to-good quality medical evidence from randomized controlled trials showing that

thermotherapy, including infrared, should be included as an intervention for the management of

rheumatoid arthritis, but they offered no preference for one type of thermotherapy over another. Their

findings and recommendations were consistent with other existing guidelines (Ottawa, 2004).

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For all other clinical indications, there is insufficient evidence to support the use of infrared therapy.

Policy updates:

In 2015, AmeriHealth Caritas identified no new systematic reviews, evidence-based guidance, or economic

studies for this update.

In 2016, we found new literature on near-infrared therapy: one small (10 patients) retrospective study for

treating traumatic brain injury (Morries, 2015) and a narrative review of Alzheimer’s disease and

Parkinson’s disease treatment (Johnstone, 2015). For treating traumatic brain injury, Alzheimer’s disease

and Parkinson’s disease, the research is in the pre-clinical or early stage and provides insufficient evidence

on which to determine the safety and efficacy of infrared. For far-infrared therapy, a small randomized

controlled trial (50 patients) found far-infrared therapy may improve needling pain and blood flow, but not

necessarily patency, of the arteriovenous shunt in patients on hemodialysis. The authors concluded that a

larger multicenter study is needed to evaluate the therapeutic effects.

In 2017, evaluations of new clinical indications for infrared therapy continue to emerge. Eight systematic

reviews and meta-analyses addressed the following clinical indications: orthodontic pain (Fleming, 2016);

tooth movement in orthodontics (de Almeida, 2016); neuropathic pain (de Andrade, 2016); chronic non-

specific low back pain (Glazov, 2016); androgenetic alopecia (Gupta, 2017); carpal tunnel syndrome (Li,

2016); improvement of exercise capacity and muscle performance during exercise (Nampo, 2016); and

nevus of Ota (Yu, 2016). For these new indications, the evidence is insufficient to support a role for infrared

therapy. No policy changes are warranted at this time.

In 2018, we identified one guideline update (Davis, 2018 replaces Rivadeneira, 2011) one new guideline

(Qaseem, 2017), and one best evidence synthesis (Baxter, 2017) for this policy. The new evidence is

consistent with the current policy, and no changes to the current policy are warranted.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Davis (2018) for the

American Society of Colon

and Rectal Surgeons

Clinical practice guidelines

for the management of

hemorrhoids

Key points:

Most patients with grade I and II and select patients with grade III internal

hemorrhoidal disease who fail medical treatment can be effectively treated with

office-based procedures, such as banding, sclerotherapy, and infrared coagulation.

Hemorrhoid banding is typically the most effective option. Grade of

Recommendation: Strong recommendation based on high-quality evidence, 1A.

Baxter (2017)

Low level laser therapy

(photobiomodulation

therapy) for breast cancer-

related lymphedema

Key points:

Best evidence synthesis of seven randomized controlled trials comparing low-level

laser therapy to sham laser, conventional therapy, or wait list control.

Overall quality: moderate to high.

Low-level laser therapy appears more effective than sham treatment for some

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Citation Content, Methods, Recommendations

outcome measures (e.g., limb circumference/volume reduction, short-term pain

reliev) in the short-term, but is not clearly superior to conventional therapy (e.g.,

compression or manual lymphatic drainage). Optimal treatment parameters are

unclear

Gupta (2017)

Low-level laser therapy for

androgenetic alopecia (hair

loss) in men and women

Key points:

Systematic review of nine trials, including five randomized controlled trials.

Overall quality: low, due to insufficient visual evidence and sample sizes and

variation in study designs.

Insufficient evidence.

Qaseem (2017) for the

American College of

Physicians

Guideline: noninvasive

treatments for acute,

subacute, and chronic low

back pain

Key points:

For chronic low back pain, low-level laser therapy is recommended as one of several

options based on low-quality evidence. (Grade: strong recommendation).

de Almeida (2016)

Low-level laser therapy to

induce dental movement

Key points:

Systematic review of six randomized controlled trials and meta-analysis of five

randomized controlled trials.

Overall quality: moderate-to-high.

Three of six randomized controlled trials found statistically significant differences in

induced movement for the maxilla in three months and, for the mandible, in one

month.

Inconclusive evidence.

de Andrade (2016)

Low-level laser therapy to

control neuropathic pain

Key points:

Systematic review of 10 experimental animal studies and four human studies.

Overall quality: low due to discrepancies in application parameters.

Inconclusive results. low-level laser therapy has positive effects on analgesia, but

high-quality studies are needed to define optimal treatment protocols.

Fleming (2016)

Non-pharmacological

interventions for alleviating

pain during orthodontic

treatment

Key points:

Systematic review and meta-analysis of 14 randomized controlled trials (931 total

participants), including four randomized controlled trials of low-level laser therapy.

Overall quality: low for low-level laser therapy.

Data from two randomized controlled trials (118 participants) suggest short-term pain

reduction with low-level laser therapy up to seven days; adverse effects not

measured.

Inconclusive evidence.

Glazov (2016)

Low-level laser therapy for

chronic non-specific low

back pain

Key points:

Meta-analysis of 15 randomized controlled trials (1,039 participants) using sham

controls and blinded assessment.

Overall quality: moderate.

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Citation Content, Methods, Recommendations

Low-level laser therapy at high dosage (at least 3 Joules per point) resulted in

significant immediate and short-term pain reduction (weighted mean difference -1.40

cm (95% confidence interval -1.91 to -0.88 cm) and improved global assessment in

persons with baseline pain <30 months’ duration.

Inconclusive evidence. Research using appropriate laser dosage needed.

Li (2016)

Low-level laser therapy for

carpal tunnel syndrome

Key points:

Meta-analysis of seven randomized controlled trials (270 wrists in the laser group,

261 wrists in the control group).

Overall quality: not reported, but high heterogeneity.

At 12 weeks, low-level laser therapy significantly improved hand grip, results on the

visual analog scale, and sensory nerve action potential, but no statistically significant

differences in the other parameters.

Insufficient evidence. High-quality studies are needed to confirm results.

Nampo (2016)

Low-level phototherapy to

improve exercise capacity

and muscle performance

Key points:

Systematic review and meta-analysis of 16 randomized controlled trials and cross-

over studies (297 total participants) using either light emitting diode therapy or laser

therapy.

Overall quality: not reported but authors stated “limited.”

Unlike light emitting diode therapy, laser therapy significantly improved number of

repetitions, time to exhaustion, lactate levels, and peak torque.

Inconclusive evidence. Results need confirmation.

Yu (2016)

Q-switched alexandrite

laser and Q-switched

Nd:YAG laser on nevus of

Ota

Key points:

Systematic review and meta-analysis of 13 studies (2,153 patients treated by Q-

switched alexandrite, 316 patients treated by Q-switched Nd:YAG.

Overall quality: not reported.

Insufficient evidence.

Migliorate (2013)

Prevention of oral mucositis

Key points:

Systematic review of one randomized controlled trial and multiple lower-level studies.

Randomized controlled trial had no major flaws and multiple lower-level studies

reported consistent positive results using similar laser parameters.

Low-level laser therapy at 650 nm wavelength reduced the severity of oral mucositis

and pain scores more than low-level laser therapy at 750 nm (p=0.06). low-level

laser therapy at 650 nm well tolerated and no adverse events noted but effects of

modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy

delivery, etc.) are unclear.

Macaya (2012)

Cochrane review:

anal cancer

Key points:

Systematic review of treatments for anal canal intraepithelial neoplasia; one

randomized controlled trial of medical treatment only.

Overall quality rated as poor.

Insufficient evidence.

Wilt (2012) for Agency for

Healthcare Research and

Key points:

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Citation Content, Methods, Recommendations

Quality

Restless leg syndrome

Systematic review of treatments for restless less syndrome, including one

randomized controlled trial of near-infrared light therapy.

Overall quality was rated as poor.

Insufficient evidence.

Ites (2011)

Diabetic peripheral

neuropathy

Key points:

Systematic review of six studies, including one randomized controlled trial of four

physical therapy interventions — monochromatic infrared energy therapy, vibrating

insoles, lower extremity strengthening exercises, and use of a cane.

Overall quality rated as poor.

Insufficient evidence.

Beever (2009)

Cardiovascular risk factors

Key points:

Systematic review of nine randomized controlled trials and observational studies of

far-infrared sauna therapy.

Overall quality rated as poor due to small sample sizes, short duration of study, and

use of non-validated symptom score assessments.

Inconclusive evidence.

Hayes (2009)

Acne vulgaris

Key points:

Systematic review of phototherapy, including one randomized controlled trial of near-

infrared laser.

Overall quality was rated poor with study designs that were considered flawed.

Blue light, red light (or a combination of the two), pulsed dye laser, and laser light

can reduce the severity of mild to moderate facial acne with no serious complications

in the short term.

Additional well-designed, longer-term randomized controlled trials needed.

References

Professional society guidelines/other:

Baxter GD, Liu L, Petrich S, et al. Low level laser therapy (Photobiomodulation therapy) for breast cancer-

related lymphedema: a systematic review. BMC Cancer. 2017; 17(1): 833. DOI: 10.1186/s12885-017-3852-x.

Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons

Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2018; 61(3): 284 – 292.

DOI: 10.1097/DCR.0000000000001030.

Madoff RD, Fleshman JW. American Gastroenterological Association technical review on the diagnosis and

treatment of hemorrhoids. Gastroenterology. 2004 May; 126(5): 1463 – 1473. DOI:

10.1053/j.gastro.2004.03.008.

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Ottawa Panel Evidence-Based Clinical Practice Guidelines for Electrotherapy and Thermotherapy

Interventions in the Management of Rheumatoid Arthritis in Adults. Phys Ther. 2004 Nov; 84(11): 1016 –

1043.

Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive Treatments for Acute, Subacute, and Chronic Low

Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;

166(7): 514 – 530. DOI: 10.7326/m16-2367.

Rivadeneira DE, Steele SR, Ternent C, et al. Practice parameters for the management of hemorrhoids

(revised 2010). Dis Colon Rectum. 2011 Sep; 54(9): 1059 – 1064. DOI: 10.1097/DCR.0b013e318225513d.

Society for Surgery of the Alimentary Tract (SSAT) Patient Care Guidelines: Surgical Management of

Hemorrhoids. Last approved October 13, 2008. SSAT website. http://www.ssat.com/cgi-bin/hemorr.cgi.

Accessed April 18, 2017.

Peer-reviewed references:

21CFR807.92

21CFR890.5500

21CFR875.4400

Beever R. Far-infrared saunas for treatment of cardiovascular risk factors: summary of published evidence.

Can Fam Physician. 2009 Jul; 55(7): 691 – 696. Available at:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2718593/pdf/0550691.pdf. Accessed March 26, 2018.

Choi SJ, Cho EH, Jo HM, et al. Clinical utility of far-infrared therapy for improvement of vascular access

blood flow and pain control in hemodialysis patients. Kidney Research and Clinical Practice. 2016; 35(1): 35

– 41. DOI: 10.1016/j.krcp.2015.12.001.

Chow RT, Barnsley L. Systematic review of the literature of low-level laser therapy (LLLT) in the

management of neck pain. Laser Surg Med. 2005 Jul; 37(1): 46 – 52. DOI: 10.1002/lsm.20193.

Chung H, Dai T, Sharma SK, et al. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012

Feb; 40(2): 516 – 533. DOI: 10.1007/s10439-011-0454-7.

de Almeida VL, de Andrade Gois VL, Andrade RN, et al. Efficiency of low-level laser therapy within induced

dental movement: A systematic review and meta-analysis. J Photochem Photobiol B. 2016; 158: 258 – 266.

DOI: 10.1016/j.jphotobiol.2016.02.037.

de Andrade AL, Bossini PS, Parizotto NA. Use of low level laser therapy to control neuropathic pain: A

systematic review. J Photochem Photobiol B. 2016; 164: 36 – 42. DOI: 10.1016/j.jphotobiol.2016.08.025.

Page 10: Clinical Policy Title: Infrared therapy · 2018. 11. 14. · Far-infrared therapy is a form of heat therapy delivered via heated saunas that exposes body tissues to slightly higher

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Fleming PS, Strydom H, Katsaros C, et al. Non-pharmacological interventions for alleviating pain during

orthodontic treatment. Cochrane Database Syst Rev. 2016; 12: Cd010263. DOI:

10.1002/14651858.CD010263.pub2.

Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: a meta-

analysis of randomised controlled trials. Acupunct Med. 2016; 34(5): 328 – 341. DOI: 10.1136/acupmed-

2015-011036.

Gupta AK, Foley KA. A Critical Assessment of the Evidence for Low-Level Laser Therapy in the Treatment of

Hair Loss. Dermatol Surg. 2017; 43(2): 188 – 197. DOI: 10.1097/dss.0000000000000904.

Hamilton FL, Car J, Lyons C, et al. Laser and other light therapies for the treatment of acne vulgaris:

systematic review. Br J Dermatol. 2009 Jun; 160(6): 1273 – 1285. DOI: 10.1111/j.1365-2133.2009.09047.x.

Hayes Inc., Hayes Medical Technology Report. Phototherapy for Acne Vulgaris. Lansdale, Pa. Hayes, Inc.;

February 2009.

Ites KI, Anderson EJ, Cahill ML, et al. Balance interventions for diabetic peripheral neuropathy: a systematic

review. J Geriatr Phys Ther. 2011 Jul – Sep; 34(3): 109 – 116. DOI: 10.1519/JPT.0b013e318212659a.

Johanson JF, Rimm A. Optimal nonsurgical treatment of hemorrhoids: a comparative analysis of infrared

coagulation, rubber band ligation, and injection sclerotherapy. Am J Gastroenterol. 1992 Nov; 87(11): 1600

– 1606.

Johnstone DM, Moro C, Stone J, Benabid A-L, Mitrofanis J. Turning On Lights to Stop Neurodegeneration:

The Potential of Near Infrared Light Therapy in Alzheimer’s and Parkinson’s Disease. Frontiers in

Neuroscience. 2015; 9: 500. DOI: 10.3389/fnins.2015.00500.

Li ZJ, Wang Y, Zhang HF, et al. Effectiveness of low-level laser on carpal tunnel syndrome: A meta-analysis of

previously reported randomized trials. Medicine (Baltimore). 2016; 95(31): e4424. DOI:

10.1097/md.0000000000004424.

Macaya A, Munoz-Santos C, Balaguer A, Barbera MJ. Interventions for anal canal intraepithelial neoplasia.

Cochrane Db Syst Rev. 2012; 12: CD009244. DOI: 10.1002/14651858.CD009244.pub2.

Migliorati C, Hewson I, Lalla RV, et al. Systematic review of laser and other light therapy for the

management of oral mucositis in cancer patients. Support Care Cancer. 2013 Jan; 21(1): 333 – 341. DOI:

10.1007/s00520-012-1605-6.

Morries LD, Cassano P, Henderson TA. Treatments for traumatic brain injury with emphasis on transcranial

near-infrared laser phototherapy. Neuropsychiatric Disease and Treatment. 2015; 11: 2159 – 2175. DOI:

10.2147/ndt.s65809.

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Nampo FK, Cavalheri V, Dos Santos Soares F, de Paula Ramos S, Camargo EA. Low-level phototherapy to

improve exercise capacity and muscle performance: a systematic review and meta-analysis. Lasers Med Sci.

2016; 31(9): 1957 – 1970. DOI: 10.1007/s10103-016-1977-9.

Wilt TJ, MacDonald R, Ouellette J, et al. Agency for Healthcare Research and Quality. November 2012.

Treatment for Restless Legs Syndrome. Comparative Effectiveness Review No. 86. (Prepared by the

Minnesota Evidence-based Practice Center under Contract No. 290-2007-10064-I.). Rockville, MD. Available

at: www.effectivehealthcare.ahrq.gov/reports/final.cfm. Accessed March 26, 2017.

Yu P, Yu N, Diao W, et al. Comparison of clinical efficacy and complications between Q-switched alexandrite

laser and Q-switched Nd:YAG laser on nevus of Ota: a systematic review and meta-analysis. Lasers Med Sci.

2016; 31(3): 581 – 591. DOI: 10.1007/s10103-016-1885-z.

CMS National Coverage Determination (NCDs):

270.6 Infrared Therapy Devices.

270.2 Noncontact Normothermic Wound Therapy (NNWT).

A54038 Infrared Coagulation (IRC) of Hemorrhoids Supplemental Instructions Article.

A52400 Outpatient Physical and Occupational Therapy Services Supplemental Instructions Article.

A53058 Physical Therapy for Home Health.

Local Coverage Determinations (LCDs):

L33571 Destruction of Internal Hemorrhoid(s) by Infrared Coagulation (IRC).

L34560 Home Health Occupational Therapy.

L34564 Home Health Physical Therapy.

L34422 Infrared Coagulation (IRC) of Hemorrhoids.

L34861 Infrared Photocoagulation (IRC) of Hemorrhoids.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not

an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill

accordingly.

CPT Code Description Comments

46930 Destruction of internal hemorrhoids by IR coagulation

97026 Application of a modality to 1 or more areas; IR

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ICD-10 Code Description Comments

K64.0 Hemorrhoids, first degree

K64.1 Hemorrhoids, second degree

M54.5 Low back pain

M54.9 Back pain

M79.1 Muscle pain

M79.601-

M79.603 Pain in arm

M79.604-

M79.606 Pain in leg

M79.609 Pain in unspecified limb

HCPCS

Level II Code Description Comments

N/A