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Thermography and Temperature Gradient Studies

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 06.01.16 
Original Effective Date: November 1996 
Reviewed: February 2015 
Revised: February 2015 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

Thermography studies (i.e. thermal imaging or digital infrared thermal imaging (DITI)) are non-invasive imaging techniques that are intended to measure the skin surface temperature distribution of various organs and tissues. The infrared radiation from the tissues reveals temperature variations by producing brightly colored patterns on a liquid crystal display. Interpretation of the color pattern is thought to contribute to the diagnosis of many disorders including breast cancer, Raynaud's phenomenon, digital artery vasospasm, in hand-arm vibration syndrome, peripheral nerve damage following trauma, impaired spermatogenesis in infertile men, deep vein thrombosis, complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy, vertebral subluxation, and others.

 

The scientific evidence suggests that thermography may only confirm the presence of a temperature difference, and that other procedures are needed to reach a specific diagnosis. Thermography may add little to what doctors already know based on history, physical examination and other studies. A number of medical authorities have concluded that thermography has no proven medical value.

 

The FDA issued a safety communication in 2011 to alert the public, including women and health care providers, that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

 

Temperature Gradient Studies

In contrast to the skin surface thermography techniques used by some chiropractors and other providers, a newer invasive test called a temperature gradient study involves an intravenous catheter. The catheter is threaded into the coronary arteries to directly measure temperature differences on the inner artery walls. Researchers believe this information may be related to the presence of unstable coronary artery plaques and could be useful in diagnosing vulnerable patients.

 

Several coronary temperature mapping catheters are currently being developed and studied. These thermography methods may be used in the future to detect vulnerable plaques, potentially to determine patients prognosis, and to study the plaque-stablizing effects of different medications. 

 

Practice Guidelines and Position Statements

The American Medical Assocation (AMA) 

In view of the lack of sufficient proof of effectiveness, it is the policy of the AMA that the use of thermography for diagnostic purposes cannot be recommended at this time.  It should be noted that research protocols using thermography are continuing and data derived from these studies will require careful evaluation.

 

American College of Radiology (ACR)
ACR Appropriateness Criteria Breast Cancer Screening (2012)
There is insufficient evidence to support the use of other imaging modalities such as thermography, breast specific gamma imaging (BSGI), positron emission mammography (PEM), or optical imaging for breast cancer screening.

 

American College of Obstetritians and Gynecologists (ACOG)
Practice bulletin for breast cancer screening does not address thermography as a screening option. 

 

The Reflex Sympathetic Dystrophy Syndrome Association (RSD) and the International Research Foundation for RSD and Complex Regional Pain Syndrome (CRPS),  issued guidelines for the treatment of RSD and CRPS.  Each of these guidelines indicates thermography may be used to assist in the diagnosis of RSD/CRPS.  However, neither guideline has supporting evidence for its conclusion. 
 
American Cancer Society 
Thermography has been around for many years, but studies have shown that it’s not an effective screening tool for finding breast cancer early. Although it has been promoted as helping detect breast cancer early, a 2012 research review found that thermography was able to detect only a quarter of the breast cancers found by mammography. In other words, it failed to detect 3 out of 4 cancers that were known to be present in the breast. Digital infrared thermal imaging (DITI), which some people believe is a newer and better type of thermography, has the same failure rate. This is why thermography should not be used as a substitute for mammograms.


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Prior Approval: 

 

Not applicable


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Policy: 

Thermography (i.e. thermal imaging or digital infrared thermal imaging (DITI)) and temperature gradient studies are considered investigational for all indications.

 

The published, peer-reviewed literature and professional societies do not support the clinical utility of thermography and temperature gradient studies. The limited available studies are primarily in the form of case series, retrospective reviews or narrative reviews with small patient populations, lacking control groups and/or comparison to proven diagnostic studies. It has not been demonstrated how the results of thermography and temperature gradient studies can be used to enhance patient management and improve patient health outcomes. There is a lack of evidence in the peer-reviewed scientific literature to substantiate the accuracy of thermography. The role of thermography and temperature gradient studies in the diagnosis or management of any condition remains unproven and therefore is considered investigational.





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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes. 
  • 93740 Temperature gradient studies
  • 99429 Unlisted preventive medicine service

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Selected References: 

  • Leclaire RM, Esdaile JM, Jequier JC, Rossignol M, Bourdouxhe M. Diagnostic accuracy of technologies used in low back pain assessment.  Spine 1996 June; 1;21(11):1325-1330; discussion 1331.
  • Lai HS, Duh YC, Tsai WA, Sun WZ. Role of thermography in the diagnosis of undescended testes. European Urology 1998;33(2):209-213. 
  • Parisky YR, Sardi A, Hamm R, Hughes K, Esserman L, Rust S, Callahan K. Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions. AJR Am J Roentgenol. 2003 Jan;180(1):263-9.
  • Ogan K, Roberts WW, Wilhelm DM, Bonnell L, Leiner D, Lindberg G, Kavoussi LR, Cadeddu JA. Infrared thermography and thermocouple mapping of radiofrequency renal ablation to assess treatment adequacy and ablation margins. Urology. 2003 Jul;62(1):146-51.
  • ECRI. Thermography for Detection of Breast Masses. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 December 26. 8p/ (ECRI Hotline Response).
  • Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J. 2012 Mar 9; 125(1351):80-91.
  • Lovett KM, Liang BA Risks of online advertisement of direct-to-consumer thermography for breast cancer screening. Nat Rev Cancer. 2011 Dec; 11(12):827-8. 
  • Kontos M, Wilson R, Fentiman I. Digital infrared thermal imaging (DITI) of breast lesions: sensitivity and specificity of detection of primary breast cancers. Clin Radiol. 2011 Jun;66(6):536-9. Epub 2011 Mar 5.
  • Wishart GC, Campisi M, Boswell M et al. The accuracy of digital infrared imaging for breast cancer detection in women undergoing breast biopsy. Eur J Surg Oncol. 2010 Jun; 36(6):535-40. Epub 2010 May 10.
  • ECRI Institute. Thermography for detection of breast masses. Plymouth Meeting (PA): ECRI Institute; 2011 May 16.
  • Brennan M., Houssami N. Thermography in breast cancer diagnosis, screening, and risk assessment: systemic review. Breast Cancer Management 2013; 2(2) 163-172
  • Food and Drug Administration Safety Communication: Breast Cancer Screening Thermography is not an Alternative to Mammography. Date Issued June 2, 2011.
  • American Cancer Society (ACS), Mammograms and Other Breast Imaging Tests  and Experimental and Other Breast Imaging Methods.
  • Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Thermography (220.11).
  • National Guideline Clearinghouse, Work Loss Data Institute 2011, Pain (Chronic).
  • National Guideline Clearinghouse, ACR Appropriateness Criteria Breast Cancer Screening, 2012.
  • UpToDate. Screening for Breast Cancer: Evidence for Effectiveness. Suzanne W. Fletcher, M.D.. Topic last updated February 26, 2014.
  • UpToDate. Screening for breast Cancer: Strategies and Recommendations. Suzanne W. Fletcher, M.D.. Topic last updated February 26, 2014.
  • Canadian Agency for Drugs and Technologies in Health, Issues in Emerging Health Technologies, Infrared Thermography for Population Screening and Diagnostic Testing for Breast Cancer. Issue 118, March 2012

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Policy History: 

 

Date                                       Reason                                Action

June 2011                              Annual review                      Policy renewed

April 2012                              Annual review                      Policy renewed

April 2013                              Annual review                      Policy renewed

March 2014                            Annual review                      Policy revised

February 2015                        Annual review                      Policy revised


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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