Infrared Therapy for Lymphedema
From the Aetna Clinical Policy Bulletins
Subject: Infrared Therapy
Reviewed: November 22, 2005
This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in this Bulletin. The discussion, analysis, conclusions and positions reflected in this Bulletin, including any reference to a specific provider, product, process or service by name, trademark, manufacturer, constitute Aetna's opinion and are made without any intent to defame. Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information including correction of any factual error. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Aetna) for a particular member. The member's benefit plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website:
Aetna considers treatment with low-level infrared light (infrared therapy, Anodyne Therapy System) experimental and investigational for the treatment of chronic non-healing wounds, diabetic peripheral neuropathy, or lymphedema because of a lack of adequate evidence in the peer-reviewed published medical literature regarding the effectiveness of infrared therapy for these indications.
Infrared light treatment is considered medically necessary as a heat modality in physical therapy (see CPB 325 - Physical Therapy).
Aetna considers infrared coagulation medically necessary for members with grade I or grade II internal hemorrhoids that are painful or persistently bleeding. (See appendix for grading of internal hemorrhoids.)
Low-level Infrared Therapy:
Low-level infrared therapy is a type of low-energy laser that uses light in the infrared spectrum. The Anodyne Therapy System is a type of low-level infrared therapy, developed by Integrated Systems Physiology Inc. of Aurora, CO, that has been promoted for augmenting wound healing, for reversing the symptoms of peripheral neuropathy in people with diabetes, and for treating lymphedema. The manufacturer states that the Anodyne Therapy System increases circulation and reduces pain by increasing the release of nitric oxide.
Several meta-analyses have examined the evidence supporting the use of low-level (cold) lasers, including low-level infrared lasers, for treatment of chronic non-healing wounds. See CPB 363 - Cold Laser Therapy. These meta-analyses are unanimous in concluding that there is insufficient evidence to support low-level laser in the treatment of chronic venous ulcers or other chronic non-healing wounds.
There is no evidence that infrared light therapy is any more effective than other heat modalities in the symptomatic relief of musculoskeletal pain. Glasgow (2001) reported on the results of a randomized controlled clinical trial of low-level infrared therapy in 24 subjects with experimentally induced muscle soreness, and found no significant differences between treatment and placebo groups.
There are no published studies of the effectiveness of low-level infrared therapy for treatment of diabetic peripheral neuropathy. The case series presented by the manufacturer of the Anodyne System on its web site have not been published in a peer-reviewed medical journal.
Finally, there is no evidence in the published peer-reviewed medical literature on the effectiveness of infrared therapy for the treatment of lymphedema. The Canadian Coordinating Office of Health Technology Assessment (2002) found that “[t]here is little high quality controlled clinical trial evidence for these therapies.”
In a randomized, placebo-controlled study, Leonard et al (2004) examined whether treatments with the Anodyne Therapy System (ATS) would decrease pain and/or improve sensation diminished due to diabetic peripheral neuropathy (DPN). Tests involved the use of the 5.07 and 6.65 Semmes Weinstein monofilament (SWM) and a modified Michigan Neuropathy Screening Instrument (MNSI). Twenty-seven patients, 9 of whom were insensitive to the 6.65 SWM and 18 who were sensitive to this filament but insensitive to the 5.07 SWM, were studied. Each lower extremity was treated for 2 weeks with sham or active ATS, and then both received active treatments for an additional 2 weeks. The group of 18 patients who could sense the 6.65 SWM but were insensitive to the 5.07 SWM at baseline obtained a significant decrease in the number of sites insensate after both 6 and 12 active treatments (p < 0.02 and 0.001). Sham treatments did not improve sensitivity to the SWM, but subsequent active treatments did (p < 0.002). The MNSI measures of neuropathic symptoms decreased significantly (from 4.7 to 3.1; p < 0.001). Pain reported on the 10-point visual analog scale decreased progressively from 4.2 at entry to 3.2 after 6 treatments and to 2.3 after 12 treatments (both p < 0.03). At entry, 90 % of subjects reported substantial balance impairment; after treatment, this decreased to 17 %. However, among the group of 9 patients with greater sensory impairment measured by insensitivity to the 6.65 SWM at baseline, improvements in sensation, neuropathic symptoms, and pain reduction were not significant. The authors concluded that ATS treatments improved sensation in the feet of subjects with DPN, improved balance, and reduced pain.
There are a few drawbacks in this study. They include the small size of the study, and that it involved a single investigator group, arguing for the need to replicate this study. There is also no information about whether the improvements were durable. Furthermore, although the results are encouraging, more discreet quantitative sensory tests would be helpful in determining the exact degree of sensory improvement experienced after the administration of ATS treatments.
Infrared Coagulation for the Treatment of Hemorrhoids:
Infrared coagulation is one of the several non-surgical outpatient therapies in treating hemorrhoids. Linares et al (2001) examined the effectiveness of rubber band ligation (RBL) and infrared photocoagulation (IRC) in treating internal hemorrhoids in 358 patients with a total of 817 hemorrhoid. There was a follow-up period of 36 months. Two hundred ninety five of 358 patients were treated with RBL (82.4 %), this treatment being effective in 98 % of the patients after 180 days and very good after 36 months. There were 6/295 relapses at 36 months (2 %). All minor and major complications were observed within the first 15 days of treatment: rectal tenesmus in 96/295 patients (32.5 %), mild anal pain in 115/295 (38.9 %), self-limited and mild bleeding after the detachment of the bands in 30/295 (10 %), and febricula in one patient. Sixty three of 358 patients were treated with IRC (17.6 %). In this group, relapses were observed in 6/63 patients (9.5 %) at 36 months, all of them with grade III hemorrhoids that required additional treatment with RBL. All the complications (inherent to the technique) were observed within the first days: mild anal pain in 40/63 patients (63.4 %) and mild bleeding in 1/63 (1.6 %). The treatment with RBL or IRC depended on the number of hemorrhoids and the hemorrhoidal grade. No significant differences were found regarding the effectiveness between RBL and IRC for the treatment of grade I-II hemorrhoids, while RBL was more effective for grade III and IV hemorrhoids (p < 0.05). The authors concluded that RBL and IRC should be considered as a good treatment for all grades of hemorrhoids, due to its effectiveness, its cost-benefit and its small short and long-term morbidity.
In a randomized study, Gupta (2003) compared infrared coagulation and rubber band ligation in treating patients with early stages of hemorrhoids. One hundred patients with second degree bleeding piles were randomized prospectively to either rubber band ligation (n = 54) or infrared coagulation (n = 46). Parameters measured included post-operative discomfort and pain, time to return to work, relief in incidence of bleeding, and recurrence rate. Post-operative pain during the first week was more intense in the band ligation group (2 - 5 versus 0 - 3 on a visual analogue scale). Post-defecation pain was more intense with band ligation and so was rectal tenesmus (p = 0.0059). The patients in the infrared coagulation group resumed their duties earlier (2 versus 4 days, p = 0.03), but also had a higher recurrence or failure rate (p = 0.03). The authors concluded that band ligation, although more effective in controlling symptoms and obliterating hemorrhoids, is associated with more pain and discomfort to the patient. As infrared coagulation can be conveniently repeated in case of recurrence, it could be considered to be a suitable alternative office procedure for the treatment of early stage hemorrhoids.
The American Gastroenterological Association's technical review on the diagnosis and treatment of hemorrhoids (Madoff and Fleshman, 2004) stated that 1st degree and 2nd degree hemorrhoids (i.e., Grade I and Grade II hemorrhoids) can be treated with non-operative therapies such as infrared photocoagulation. Surgery is generally reserved for individuals who have large 3rd degree or 4th degree hemorrhoids, acutely incarcerated and thrombosed hemorrhoids, hemorrhoids with an extensive and symptomatic external component, or individuals who have undergone less aggressive therapy with poor results.
CPT Codes / ICD-9 Codes
CPT Code not covered for indications listed in the CPB:
Other CPT Code related to the CPB:
46934 Destruction of hemorrhoids, any method; internal
HCPCS Codes not covered for indications listed in the CPB:
A4639 Replacement pad for infrared heating pad system, each
E0221 Infrared heating pad system
ICD-9 Codes covered if selection criteria are met:
455.0 Internal hemorrhoids without mention of complication
455.1 Internal thrombosed hemorrhoids
455.2 Internal hemorrhoids with other complication
ICD-9 Codes not covered for indications listed in the CPB:
250.60 - 250.63 Diabetes with neurological manifestations
357.2 Polyneuropathy in diabetes
457.0 Postmastectomy lymphedema syndrome
457.1 Other lymphedema
757.0 Hereditary edema of legs
870.0 - 897.1 Open Wounds
998.31 - 998.32 Disruption of operation wound
998.83 Non-healing surgical wound
Original policy: March 19, 2002
Updated: May 13, 2003; November 22, 2005
Revised: October 26, 2004
The above policy is based on the following references:
Anodyne Therapy, LLC. Anodyne Therapy. Tampa, FL: Anodyne; 2004. Available at: http://www.anodynetherapy.com/
. Accessed September 15, 2004.
Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromatic energy. Adv Wound Care. 1999;12(1):35-40. Available at: http://www.fasterhealing.com/reports/wndpapr.pdf
. Accessed January 15, 2002.
Glasgow PD, Hill ID, McKevitt AM, et al. Low intensity monochromatic infrared therapy: A preliminary study of the effects of a novel treatment unit upon experimental muscle soreness. Lasers Surg Med. 2001;28(1):33-39.
Thomasson TL. Effects of skin-contact monochromatic infrared irradiation on tendonitis, capsulitis, and myofascial pain. J Neurol Orthop Med Surg. 1996;16:242-245. Available at:
. Accessed January 15, 2002.
Kocham AB, Carnegie D, Burke TJ. Symptomatic reversal of peripheral neuropathy in diabetic patients. Aurora, CO: Integrated Systems Physiology, Inc.; 2001. Available at:
. Accessed January 15, 2002.
Galeano M. Lymphedema case study. Tampa, FL: MedAssist Group; 2001.
Available at: http://www.fasterhealing.com/reports/lymphedema.pdf
. Accessed January 15, 2002.
Anodyne Therapy, LLC. Anodyne testimonials. Tampa, FL: Fasterhealing.com; 1998. Available at:
. Accessed January 15, 2002.
Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Review. In: The Cochrane Library, Issue 4, 2001. Oxford, UK: Update Software; 2001.
Beckerman H, de Ble R, Bouter L, et al. The efficacy of laser therapy for musculoskeletal and skin disorders: A criteria-based meta-analysis of randomized clinical trials. Physical Ther. 1992;72:483-491.
Schneider WL, Hailey D. Low level laser therapy for wound healing. Alberta Heritage Foundation for Medical Research (AHFMR). Edmonton, AB: AHFMR; 1999.
Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess. 2000;4(21):1-237.
Lagan KM, Clements BA, McDonough S, et al. Low intensity laser therapy (830nm) in the management of minor postsurgical wounds: A controlled clinical study. Lasers Surg Med. 2001;28(1):27-32.
Flemming KA, Cullum NA, Nelson EA. A systematic review of laser therapy for venous leg ulcers. J Wound Care. 1999;8(3):111-114.
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.
Gupta AK, Filonenko N, Salansky N, et al. The use of low energy photon therapy (LEPT) in venous leg ulcers: A double-blind, placebo-controlled study. Dermatol Surg. 1998;24(12):1383-1386.
Gogia PP, Hurt BS, Zirn TT. Wound management with whirlpool and infrared cold laser treatment. A clinical report. Phys Ther. 1988;68(8):1239-1242.
Lucas C, Stanborough RW, Freeman CL, De Haan RJ. Efficacy of low-level laser therapy on wound healing in human subjects: A systematic review. Lasers Med Science. 2000;15(2):84-93.
Canadian Coordinating Office of Health Technology Assessment (CCOHTA). Photonic stimulation for the treatment of chronic pain. Pre-assessment No. 11. Ottawa, ON; CCOHTA; November 2002.
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.
MacKay D. Hemorrhoids and varicose veins: A review of treatment options. Altern Med Rev. 2001;6(2):126-140.
Linares Santiago E, Gomez Parra M, et al. Effectiveness of hemorrhoidal treatment by rubber band ligation and infrared photocoagulation. Rev Esp Enferm Dig. 2001;93(4):238-247.
Accarpio G, Ballari F, Puglisi R, e al. Outpatient treatment of hemorrhoids with a combined technique: Results in 7850 cases. Tech Coloproctol. 2002;6(3):195-196.
Gupta PJ. Infrared coagulation versus rubber band ligation in early stage hemorrhoids. Braz J Med Biol Res. 2003;36(10):1433-1439.
Madoff RD, Fleshman JW; Clinical Practice Committee, American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology. 2004;126(5):1463-1473.
Simon A. Low level laser therapy for wound healing: An update. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); 2004.
Internal hemorrhoids are classified by the following grades:
Grade I: Bleeding without prolapse
Grade II: Prolapse with spontaneous reduction
Grade III: Prolapse with manual reduction
Grade IV: Incarcerated, irreducible prolapse
Infrared coagulation usually requires two sessions to eradicate the hemorrhoids.