Medical Policy: 06.01.16 

Original Effective Date: November 1996 

Reviewed: January 2021 

Revised: January 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

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 geno typical men, deep vein thrombosis, complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy, vertebral subluxation, and others. Claims by those that provide thermography services state that various injuries and pathologies cause dilation of blood vessels, angiogenesis, and/or other sympathetic nervous system involvements. This results in temperature differences that can be mapped via thermography. Providers trained in thermography use precise temperature readings to detect or monitor different conditions in the body. Claims by providers state that thermography can:

  • Graphically display the subjective feeling of pain
  • Show combined effect of the autonomic nervous system and the vascular system, down to capillary dysfunctions
  • Monitor the effectiveness of therapies
  • And can present opportunity for early intervention

 

Available testing in the thermography field include breast scans, cranial/dental/thyroid scans, half body scans, full body scans, and scans to a specific region.

 

Infrared Dermal Thermometry

Infrared Dermal Thermometry (infrared skin temperature probe) measures an approximately 1.0 cm2 area of skin and is held approximately 0.5cm from the skin surface during measurement. The goal is to monitor the skin temperature of the foot in patients with diabetes mellitus to predict which patient may develop ulceration or neuropathic fracture, allowing for earlier intervention, possibly preventing ulceration or fracture.

 

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 patient's prognosis, and to study the plaque-stabilizing effects of different medications.

 

Practice Guidelines and Position Statements

The American Medical Association (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.

 

The ACR statement on imaging for myelopathy concluded that there is no high quality evidence to support the use of thermography in the evaluation of myelopathy (2015).

 

American College of Obstetritians and Gynecologists (ACOG)

ACOG’s Committee on Gynecologic Practice finds that current published evidence does not demonstrate meaningful outcome benefits with alternative screening modalities (e.g., breast tomosynthesis or thermography) in women with dense breasts who do not have additional risk factors. Evidence is lacking to advocate for additional testing until there are clinically validated data that indicate improved screening outcomes (Reaffirmed 2019).

 

The Society of Breast Imaging (SBI)

Position Statement: The Society of Breast Imaging does not currently support the use of thermography/infrared imaging of the breast as either a screening tool in the detection of breast cancer or as an adjunctive diagnostic tool. Breast thermography was approved by the FDA in 1982 only as an adjunct to mammography. A detailed background and review of the scientific data follows below. In summary, there are currently no studies supporting the use of thermography alone or thermography as an adjunct to mammography that show clear benefits of the technique. It is also unclear how the abnormal areas detected by thermography were aspirated or biopsied. No method was described to accurately transpose the thermographic location of the lesion to the mammogram and then to the actual location in the breast. Until there are more encouraging data available, the SBI cannot support the use of thermography/infrared imaging of the breast.

 

The Reflex Sympathetic Dystrophy Syndrome Association (RSD) and the International Research Foundation for RSD and Complex Regional Pain Syndrome (CRPS)

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.

 

European Society of Breast Imaging et al.

A 2017 position paper by the European Society of Breast Imaging and 30 national breast radiology bodies on screening for breast cancer stated, “screening with thermography or other optical tools as alternatives to mammography is discouraged.”

 

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. The greatest danger from thermography is that those who opt for this method instead of mammography may miss the chance to detect cancer at its earliest stage.

 

A number of medical authorities have concluded that thermography has no proven medical value, including the American Medical Association, the Office of Health Technology Assessment (OHTA), and the American Academy of Neurology. Based on a study by the OHTA, the Health Care Financing Administration (now the Center for Medicare and Medicaid Services) withdrew Medicare coverage of thermography.

 

United States Preventive Services Task Force (2016)

The U.S. Preventive Services Task Force recommendations on breast cancer screening do not mention thermography.

 

National Comprehensive Cancer Network (NCCN)

Breast Cancer Screening and Diagnosis (Version 1.2019)

Current evidence does not support the routine use of thermography or ductal lavage as screening procedures.

 

Regulatory Status

FDA (US Food and Drug Association)

The FDA (2019) is alerting women, health care providers, and people getting breast cancer screening, that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.

 

There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.

 

Summary of Problem and Scope

The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis.

 

The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make inaccurate, unsupported, and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.

 

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:

  • Infrared Sciences Breastscan IR System Infrared Sciences Feb-04 K032350 Telethermographic Camera, Series A, E, S, and P FLIR Systems Mar-04 K033967
  • Notouch Breastscan UE Lifesciences Feb-12 K113259
  • WoundVision Scout WoundVision Dec-13 K131596
  • AlfaSight 9000 Thermographic System Alfa Thermodiagnostics Apr-15 K150457
  • FirstSense Breast Exam® First Sense Medical Jun-16 K160573
  • Sentinel BreastScan II System First Sense Medical Jan-17 K162767
  • InTouchThermal Camera InTouch Technologies Feb-19 K181716

 

Prior Approval:

Not applicable

 

Policy:

Thermography (i.e. thermal imaging or digital infrared thermal imaging (DITI)) and temperature gradient studies are considered investigational for all indications, including but not limited to the following:

  • Breast Cancer Screening
  • Neuromuscular Conditions
  • Nervous System Disorders
  • Carpal Tunnel Syndrome
  • Trigger Points
  • Peripheral nerve injury/reflex sympathetic dystrophy (RSD)
  • Diabetes mellitus/Diabetic wound management
  • Metabolic disorders
  • Repetitive strain injuries
  • Headaches, neck and back problems.
  • Temporomandibular joint disease
  • Pain syndromes including vascular pain and inflammation
  • Arthritis
  • Soft tissue injuries including pressure ulcer detection
  • Stress fractures
  • Amputation complications
  • Ulcerative Colitis
  • Musculoskeletal Conditions
  • Cardiac Conditions
  • Allergy Testing
  • Herpes Zoster
  • Tumor Monitoring 
  • Diagnosis of Obstructive Sleep Apnea

 

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.

 

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. Therefore thermography should not be used as a substitute for mammograms.

 

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
  • 76498 Unlisted magnetic resonance procedure
  • 93799 Unlisted cardiovascular service or procedure

 

Selected References:

  • ECRI. Thermography for Detection of Breast Masses. Plymouth Meeting (PA): ECRI Institute 2007 December 26. 8p/ (ECRI Hotline Response).
  • 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.
  • 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
  • Rassiwala M, Mathur P, Mathur R, et al. Evaluation of digital infra-red thermal imaging as an adjunctive screening method for breast carcinoma: a pilot study. Int J Surg. Dec 2014;12(12):1439-1443. PMID 25448668
  • Hazenberg CE, van Netten JJ, van Baal SG, et al. Assessment of signs of foot infection in diabetes patients using photographic foot imaging and infrared thermography. Diabetes Technol Ther. Jun 2014;16(6):370-377.PMID 24690146
  • Sanchis-Sanchez E, Vergara-Hernandez C, Cibrian RM, et al. Infrared thermal imaging in the diagnosis of musculoskeletal injuries: a systematic review and meta-analysis. AJR Am J Roentgenol. Oct 2014;203(4):875-882. PMID 25247955
  • Work Loss Data Institute Neck and upper back (acute & chronic): 2011.
  • U.S. Preventive Services Task Force. Breast Cancer: Screening. 2016.
  • Burke-Smith A, Collier J, Jones I. A comparison of non-invasive imaging modalities: Infrared thermography, spectrophotometric intracutaneous analysis and laser Doppler imaging for the assessment of adult burns. Burns. 2015;41(8):1695-1707.
  • ACR Appropriateness Criteria®. ACR Appropriateness Criteria® myelopathy: 2015.
  • Omranipour R, Kazemian A, Alipour S, et al. Comparison of the accuracy of thermography and mammography in the detection of breast cancer. Breast Care (Basel). Aug 2016;11(4):260-264. PMID 27721713 
  • Oliveira AL, Moore Z, T OC, et al. Accuracy of ultrasound, thermography and subepidermal moisture in predicting pressure ulcers: a systematic review. J Wound Care. May 02 2017;26(5):199-215. PMID 28475447
  • Sardanelli F, Aase HS, Alvarez M, et al. Position paper on screening for breast cancer by the European Society of Breast Imaging (EUSOBI) and 30 national breast radiology bodies from Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Israel, Lithuania, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland and Turkey. Eur Radiol. Jul 2017;27(7):2737-2743. PMID 27807699
  • Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness Criteria Breast Cancer Screening. J Am Coll Radiol. Nov 2016;13(11s):R45-r49. PMID 27814813 
  • Neal, Colleen H. et al. Breast Imaging Outcomes following Abnormal Thermography, Academic Radiology , Volume 25 , Issue 3 , 273 – 278. 
  • Roback K, Johansson M, Starkhammar A.(2009) Feasibility of a thermographic method for early detection of foot disorders in diabetes. Diabet Technol Ther 2009; 11(10):663-7
  • Jones B, Hassan I, Tsuyuki RT, et al. Hot joints: Myth or reality? A thermographic joint assessment of inflammatory arthritis patients. Clin Rheumatol. 2018;37(9):2567-2571.
  • Hegedűs B. The Potential Role of Thermography in Determining the Efficacy of Stroke Rehabilitation. J Stroke Cerebrovasc Dis. 2018 Feb; 27(2):309-314.
  • de Melo DP, Bento PM, Peixoto LR, et al. Is infrared thermography effective in the diagnosis of temporomandibular disorders? A systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Sep 26. pii: S2212-4403(18)31190-8.
  • FDA 2019 Safety Communications. February 25, 2019.
  • Qaseem, A, Lin, JS, Mustafa, RA, Horwitch, CA, Wilt, TJ. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians. Ann. Intern. Med., 2019 Apr 9. PMID 30959525
  • Jaspers MEH, van Haasterecht L, van Zuijlen PPM, Mokkink LB. A systematic review on the quality of measurement techniques for the assessment of burn wound depth or healing potential. Burns. 2019;45(2):261-281.
  • Petrova NL, Donaldson NK, Tang W, et al. Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial. Diabet Med. 2019 Oct 19

 

Policy History:

  • January 2021 - Annual Review, Policy Revised
  • January 2020 - Annual Review, Policy Renewed
  • January 2019 - Annual Review, Policy Revised
  • January 2018 - Annual Review, Policy Revised
  • January 2017 - Annual Review, Policy Revised
  • January 2016 - Annual Review, Policy Revised
  • February 2015 - Annual Review, Policy Revised
  • March 2014 - Annual Review, Policy Revised
  • April 2013 - Annual Review, Policy Renewed
  • April 2012 - Annual Review, Policy Renewed
  • June 2011 - Annual Review, Policy Renewed

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.

 

*CPT® is a registered trademark of the American Medical Association.