Infrared devices are used to treat an area of the skin and adjacent subcutaneous structures of a patient with infrared light energy, using an array of juxtaposed infrared diodes affixed to a flexible pad.  The pad holds the diodes in contact with the patient’s skin.  These devices can also produce local warming, though this may be a secondary effect.  These devices have been granted 510(k) clearance by FDA, based on the infrared lamp (ILY) predicate device.

The Centers for Medicare & Medicaid Services (CMS) is aware of assertions that these devices can be used to treat diabetic and non-diabetic peripheral neuropathy, wounds and ulcers, and similar or related conditions.  Based on meetings with various stakeholders, we believe that there is considerable controversy surrounding the adequacy of the scientific evidence to support these claims.

We have noted the recent publication in the peer-reviewed medical literature of the results of a double-blind placebo-controlled trial on the effect of monochromatic infrared energy (MIRE).  We have also noted FDA communication to a manufacturer of one such device, calling attention to multiple reports of burns as a result of using the device.

In accordance with Section 1862(l) of the Social Security Act, we have internally generated a national coverage determination request to determine if there is sufficient evidence that infrared devices are reasonable and necessary for the treatment of Medicare beneficiaries.