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L.6.01.422
Thermography is a noninvasive imaging technique that measures 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.
Infrared radiation from the skin or organ tissue reveals temperature variations by producing brightly colored patterns on a liquid crystal display. 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.
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 accomplishing the following tasks: identifying restricted areas of perfusion in coronary artery bypass grafting, identifying unstable atherosclerotic plaques, assessing response to methylprednisone in rheumatoid arthritis, and locating high undescended testicles.
A number of thermographic devices have been cleared for marketing by the Food and Drug Administration through the 510(k) process. Food and Drug Administration product codes: LHQ, FXN. Devices with product code LHQ may only be marketed for adjunct use. Devices with product code FXN do not provide a diagnosis or therapy. Examples of these devices are shown in the table below.
Thermography Devices Cleared by the U.S. Food and Drug Administration
Device Name | Manufacturer | Clearance Date | 510(k) No. |
Infrared Sciences Breastscan IR System | Infrared Sciences | Feb 2004 | K032350 |
Telethermographic Camera, Series A, E, S, and P | FLIR Systems | Mar 2004 | K033967 |
Notouch Breastscan | UE Lifesciences | Feb 2012 | K113259 |
WoundVision Scout™ | WoundVision | Dec 2013 | K131596 |
AlfaSight 9000 Thermographic System™ | Alfa Thermodiagnostics | Apr 2015 | K150457 |
FirstSense Breast Exam® | First Sense Medical | Jun 2016 | K160573 |
Sentinel BreastScan II System | First Sense Medical | Jan 2017 | K162767 |
InTouchThermal Camera | InTouch Technologies | Feb 2019 | K181716 |
Smile-100 System | Niramai Health Analytix Private Limited | Mar 2022 | K212965 |
ThermPix™ Thermovisual Camera | USA Therm | Apr 2022 | K213650 |
The use of all forms of thermography is considered investigational.
Federal 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.
7/1993: 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.
12/01/2017: Policy description updated regarding devices. Policy statement unchanged.
10/03/2018: Policy description revised. Policy statement unchanged.
10/21/2019: Policy description updated regarding devices. Policy statement unchanged.
10/13/2020: Policy reviewed; no changes.
12/29/2021: Policy reviewed; no changes.
11/21/2022: Policy reviewed; no changes.
10/11/2023: Policy description updated regarding devices. Policy statement unchanged.
03/01/2025: Policy updated to change medical policy number from "A.6.01.12" to "L.6.01.422." Policy description updated. Policy statement unchanged.
Blue Cross Blue Shield Association policy # 6.01.12
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description | ||
CPT-4 | |||
93799 | Unlisted cardiovascular service or procedure | ||
HCPCS | |||
ICD-9 Procedure | ICD-10 Procedure | ||
88.81, 88.82, 88.83, 88.84, 88.85, 88.86, 88.89 | Thermography | 4A0ZXKZ | Measurement of temperature, external approach (thermography) |
ICD-9 Diagnosis | ICD-10 Diagnosis |
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