Medical Policy: 06.01.16
Original Effective Date: November 1996
Reviewed: January 2021
Revised: January 2021
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 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.
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:
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 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.
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.
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.
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).
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).
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), 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.
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.”
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.
The U.S. Preventive Services Task Force recommendations on breast cancer screening do not mention thermography.
Current evidence does not support the routine use of thermography or ductal lavage as screening procedures.
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.
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:
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:
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.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.