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DESCRIPTIONMonochromatic infrared energy (MIRE) refers to light at a wavelength of 880nm. MIRE can be delivered through pads containing an array of 60 superluminous infrared diodes emitting pulsed near-infrared irradiation. The pads can be placed on the skin and the infrared energy is delivered in a homogeneous manner in a session lasting from 30-45 minutes. The Anodyne Professional Therapy System is a MIRE device that has received FDA approval in 1994 through the 510(k) process. A device specifically for home use is also available. 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. The proposed mechanism of action is not known, though some sort of photobiostimulation has been proposed, as well as increased circulation related to an increase in plasma of the potent vasodilator, nitric oxide.
Skin contact monochromatic infrared energy is considered investigational as a technique to treat cutaneous ulcers, diabetic neuropathy and musculoskeletal conditions, including but not limited to temporomandibular disorders, tendonitis, capsulitis and myofascial pain.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/2003: Approved by Medical Policy Advisory Committee (MPAC)
10/15/2004: Code Reference section updated, ICD-9 diagnosis code 707.0 deleted effective 9/30/2004, ICD-9 diagnosis code 707.0 5th digit effective 10/1/2004
3/19/2008: Policy reviewed, no changes
9/16/2008: Annual ICD-9 updates effective 10-1-2008 applied
8/14/2009: Policy reviewed, no changes
04/20/2011: Policy statement and description unchanged. FEP verbiage added to the Policy Exceptions section.
12/13/2011: Policy reviewed. Policy statement unchanged. Deleted outdated references from the Sources section.
03/13/2013: Policy reviewed; no changes.
03/10/2014: Policy reviewed; no changes.
08/31/2015: Medical policy revised to add ICD-10 codes. Removed the following ICD-9 diagnosis codes from the Code Reference section: 249.60, 249.61, 250.60, 250.61, 250.62, 250.63, 337.1, 357.2, 524.60, 524.61, 524.62, 524.63, 524.69, 707.00, 707.01, 707.02, 707.03, 707.04, 707.05, 707.06, 707.07, 707.09, 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.20, 707.21, 707.22, 707.23, 707.24, 707.25, 707.8, 707.9, 726.0, 726.11, 726.4, 726.5, 726.60, 726.61, 726.64, 726.71, 726.72, 726.79, 726.90, 727.82, and 729.1.
04/26/2016: Policy Guidelines updated to revise investigational definition.
06/07/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy #1.01.22
This may not be a comprehensive list of procedure codes applicable to this policy.