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Thermography is a noninvasive imaging technique that is intended to measure temperature distribution in organs and tissues. The visual display of this temperature information is known as a thermogram. Thermography has been proposed as a diagnostic tool, for treatment planning, and for evaluation of treatment effects for a variety of conditions.
Thermography involves the use of an infrared scanning device and can include various types of telethermographic infrared detector images and heat-sensitive cholesteric liquid crystal systems. Infrared radiation from the skin or organ tissue reveals temperature variations by producing brightly colored patterns on a liquid crystal display. Interpretation of the color patterns is thought to assist in the diagnosis of many disorders such as complex regional pain syndrome (previously known as reflex sympathetic dystrophy), breast cancer, Raynaud phenomenon, digital artery vasospasm in hand-arm vibration syndrome, peripheral nerve damage following trauma, impaired spermatogenesis in infertile men, degree of burns, deep vein thrombosis, gastric cancer, tear-film layer stability in dry-eye syndrome, Frey syndrome, headaches, low back pain, and vertebral subluxation.
Thermography may also assist in treatment planning and procedure guidance by identifying restricted areas of perfusion in coronary artery bypass grafting, identifying unstable atherosclerotic plaque, assessing response to methylprednisone in rheumatoid arthritis, and locating high undescended testicles.
In 2002, the Dorex Spectrum 9000MB Thermography System (Dorex Inc.; Orange, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in quantifying and visualizing skin temperature changes. Its indicated use is as an aid in diagnosis and follow-up therapy in areas such as orthopedics, pain management, neurology and diabetic foot care. This type of device is also known as a telethermographic system.
In 2003, several teletheromographic cameras (Series A, E, P and S) by Flir Systems (McCordsville, IN) were cleared for marketing by the FDA through the 510(k) process. Their intended use is as an adjunct to other clinical diagnostic procedures when there is a need for quantifying differences in skin surface temperature. Between 2006 and 2009, three new or updated thermography devices received 510(k) marketing clearance from the FDA based on demonstrating substantial equivalence to existing products.
The use of all forms of thermography is considered investigational.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
POLICY HISTORY7/1993: Issued
2/14/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
5/14/2002: Code Reference section completed
6/23/2004: Policy reviewed, Description section aligned with BCBSA policy # 6.01.12, Sources updated
8/25/2005: Code Reference section reviewed, no changes
3/5/2008: Policy reviewed, no changes
12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
3/30/2009: Policy reviewed, no changes
07/30/2010: Policy description updated regarding FDA status of devices. FEP verbiage added to the Policy Exceptions section. Removed deleted codes 93760 and 93762 from the coding section as they were deleted on 12/31/2008, and added 93799.
07/29/2011: Policy reviewed; no changes.
07/13/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
06/18/2014: Policy reviewed; description updated. Policy statement unchanged.
08/27/2015: Code Reference section updated to add ICD-10 codes.
09/25/2015: Policy reviewed; policy statement unchanged. Investigative definition updated in the Policy Guidelines section.
05/31/2016: Policy number A.6.01.12 added.
10/12/2016: Policy description updated. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.12
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.