The infrared heating pad system (E0221) (e.g., Anodyne Therapy System) and any related accessories [e.g., replacement pad (A4639)] are considered experimental/investigational, and not eligible for reimbursement. Despite the fact that this system has received FDA approval, there is a lack of long-term studies demonstrating the efficacy of this device. A participating, preferred, or network provider can bill the member for the denied service.

Description

An infrared heating pad system, also known as a monochromatic infrared energy (MIRE) device, consists of a power source and a pad or pads containing mechanisms (e.g., luminous gallium aluminum arsinide diodes) that generate infrared or near infrared light. The labeled indication is for “increasing circulation and decreasing pain.” 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.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions, National Blue Cross Blue Shield Association Medical Policy 1.01.22

Augmentation of Wound Healing Using Monochromatic Infrared Energy, Advances in Wound Care, January/February 1999; 12(1):35-40

Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes, Journal of the American Podiatric Medical Association, Vol. 92, No. 3, March 2002

Neurogenic positional pedal neuritis, Common pedal manifestations of spinal stenosis,  J Am Podiatr Med Assoc, May 1, 2003; 93(3): 174-84

Improvement of sensory impairment in patients with peripheral neuropathy, Endocr Pract, January 1, 2004; 10(1): 24-30

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, January 1, 2004; 27(1): 168-72

Monochromatic infrared energy,  New hope for painful, numb feet?, Diabetes Self Manag, March 1, 2004; 21(2): 52, 54-6

Reversal of Diabetic Peripheral Neuropathy and New Wound Incidence: The Role of MIRE, Adv Skin Wound Care, July 1, 2004; 17(6): 295-300

CMS PUB 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 270.6

DME MAC Jurisdiction A L12873

Improved Sensitivity in Patients with Peripheral Neuropathy: Effects of Monochromatic Infrared Photo Energy. The Journal of the American Podiatric Medical Association, March-April 2005; 95(2):143-7

Management of Diabetic Peripheral Neuropathy, Clinical Diabetes, 2005, Vol. 23

The Effect of Monochromatic Infrared Energy on Sensation in Patients With Diabetic Peripheral Neuropathy: A double-blind, placebo-controlled study. Diabetes Care, Dec 2005; 28(12):2896-900
 
Improved Foot Sensitivity and Pain Reduction in Patients with Peripheral Neuropathy After Treatment with Monochromatic Infrared Photo Energy – MIRE, Journal of Diabetes and Its Complications, Mar-Apr 2006; 20(2):81-7

Harati Y. Diabetic Neuropathies: Unanswered Questions, Neurologic Clinics. Neurol Clin. 2007 Feb;25(1):303-17.

Nather A, Sim YE, Chew LLj, Neo SH. Anodyne therapy for recalcitrant diabetic foot ulcers: a report of four cases, J Orthop Surg (Hong Kong). 2007 Dec;15(3):361-4.

Lavery LA, Murdoch DP, Williams J, Lavery DC. Does Anodyne Light Therapy Improve Peripheral Neuropathy in Diabetes? A double-blind, sham-controlled, randomized clinical trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008 Feb;31(2):316-21.

Franzen-Korzendorfer H, Blackinton M, Rone-Adams S, McCulloch J. 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 Jun;54(6):16-31.