National Coverage Analysis (NCA) Tracking Sheet

Infrared Therapy Devices

CAG-00291N

Issue

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.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/26/2006
Expected NCA Completion Date
10/24/2006
Public Comment Period
01/26/2006 - 02/26/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
07/26/2006
Proposed Decision Memo Public Comment Period
07/26/2006 - 08/25/2006
Decision Memo Released
10/24/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Karen Rinker
Maria Ciccanti
Lead Medical Officers
Beth Koller, MD, FACE

Medicare Benefit Category Determination Date

Actions Taken

January 26, 2006

CMS initiates an NCA on the use of infrared therapy for diabetic and non-diabetic neuropathy, wounds and ulcers, and similar or related conditions. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under consideration as well as comments on the appropriate benefit categories to which the technology should be assigned.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

July 26, 2006

CMS posts the proposed decision memorandum and invites public comment. The 30 day public comment period begins.

(View Comments [PDF, 4MB])

October 24, 2006