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.

When treatment using this device is offered in a clinic or physical medicine session (97026), the service is also considered experimental/investigational, and is not eligible for reimbursement.  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.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. The infrared heating pad system is considered an eligible service when determined medically necessary based on the patient’s condition.

PRN References

10/2003, Infrared heating pad systems

MPRM 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