| Coverage Policy Manual | |
| Policy #: | 1997220 |
| Category: | Medicine |
| Initiated: | March 1993 |
| Last Review: | July 2023 |
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| Thermography and Infrared Dermal Thermometry | |
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| Description: |
Thermography
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 to use with a variety of conditions as a diagnostic tool, for treatment planning and to evaluate the effects of treatment.
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.
Background
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 ([CRPS], previously known as reflex sympathetic dystrophy), breast cancer, Raynaud’s 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’s syndrome, headaches, low-back pain, and vertebral subluxation.
Thermography may also assist in treatment planning and procedure guidance such as 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.
Regulatory Status
A number of thermographic devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA 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.
Thermography Devices Cleared by the U.S. Food and Drug Administration:
Coding
There are no specific CPT codes for these services. Effective 12/31/08, the CPT codes 93760 and 93762 that were specific to Thermography were deleted. Thermography would now be reported using the unlisted code 93799.
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Policy/ Coverage: |
Effective July 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of all forms of thermography does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of all forms of thermography is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Infrared dermal thermometry does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, infrared dermal thermometry is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2021
The use of all forms of thermography, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, the use of all forms of thermography is considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
Infrared dermal thermometry does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, infrared dermal thermometry is considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
Effective prior to July 2012
Thermography does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, thermography is considered investigational. Investigational services are contract exclusions in most member benefit certificates of coverage.
Effective March 1993 through April 2010
Thermography is not covered due to lack of medical data attesting to the effectiveness and is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
The American Medical Association, the American College of Radiology, the American Academy of Neurology, the American College of Obstetricians and Gynecologists (ACOG) and the Work Loss Data Institute have issued policy statements or other documents that specifically do not recommend or endorse thermography as a diagnostic technology.
No published studies demonstrate how the results of thermography can be used to enhance patient management and improve patient health outcomes. The studies identified tended to be small feasibility-type studies. They address the use of thermography in patients with a variety of clinical conditions. Several studies included patients with complex regional pain syndrome (CRPS). For example, a study by Kromova et al reported on skin temperature measurements in 22 patients with CRPS, 18 with non-CRPS pain, and 23 healthy controls (Kromova, 2008). Using long-term thermography, there was asymmetry in limb temperature in the CRPS group and to some extent in non-CRPS pain patients that was not seen in healthy controls. However, the significance of these results is uncertain. Some of the differences could be due to effects of medication, e.g., anti-seizure or antidepressant medications. In addition, the similarity of some findings between those with CRPS and non-CRPS pain limits applicability for use in diagnosis. A study, by Schurmann and colleagues, reported on imaging in 18 patients with CRPS type I (CRPS I) and 13 patients with an incomplete clinical picture (Schurmann, 2007). Based on the study, the authors concluded that imaging methods (e.g., three-phase bone scan, MRI, thermography) are not able to reliably differentiate between normal post-traumatic changes and changes due to CRPS I and that clinical findings remain the gold standard for diagnosis. They add that imaging procedures might serve as additional tools to establish the diagnosis in doubtful cases.
A study from Sweden, published in 2009, addressed the use of thermography for diagnosing foot problems in 65 diabetic patients (Roback, 209). They were examined with a liquid crystal thermography instrument, the SpectraSole (Linkoping, Sweden), immediately after a routine diabetic foot examination. No device with this name has been cleared by the FDA for use in the United States. The 65 patients underwent a total of 69 SpectraSole examinations; the authors did not report why some patients had more than one examination. The SpectraSole identified temperature differences between the right and left foot in 31 of the 69 examinations (45%). Forty-two physical examinations classified patients as having no or only minor problems. Of these, 11 were found to have temperature differences on the SpectraSole examination. The remaining 27 examinations classified patients as having several and/or large problem areas. Twenty of these were found to have temperature differences. The study did not include a gold standard comparison and the accuracy of the thermographic device was not evaluated.
Another recent study, conducted in Taiwan, evaluated thermography as an objective measurement for evaluating the effectiveness of treatment for coccygodynia (Wu, 2009). The study included 56 patients with a diagnosis of coccygodynia; data for 3 were incomplete leaving 53 patients in the analysis. Patients received manual treatments and short-wave diathermy. They underwent thermography (Telesis Spectrum 9000MD, United Integrated Services Co, Taiwan) prior to treatment and at the 12-week follow-up. The mean pain rating on a 0-to-10 scale decreased from 6.15 before treatment to 2.70 after treatment. The mean pericoccygeal surface temperature obtained by thermography decreased from 30.16 degrees C to 28.70 degrees C. There was a statistically significant correlation between the decrease in the pain score and the decrease in temperature. The clinical significance of this finding is unclear. The authors did not report other outcomes e.g., to what extent thermography could accurately categorize patients as improved or cured.
Thermography has also been considered in the diagnosis of breast cancer. In 2008, Arora and colleagues reported on the use of thermography on 92 patients who presented for a breast biopsy (Arora, 2008). When used in a screening mode (any positive reading was considered abnormal) for breast cancer, the sensitivity of thermography was 97% and specificity was 12%; when evaluated in a clinical mode (the lesion in question was used to determine an abnormal score), sensitivity was 90% and specificity was 44%. These results must be viewed as preliminary. As stated above, ACOG does not recommend thermography for breast cancer screening.
Summary
There is insufficient evidence to support the use of thermography for diagnosis. Studies are lacking that thermography can accurately diagnosis any condition or improve the accuracy of another diagnostic tool. Moreover, there are no published studies evaluating whether use of thermography in patient management, such as to select a treatment or determine treatment effectiveness, improves health outcomes.
Technology Assessments, Guidelines and Position Statements
American Medical Association: As of April 2010, their stated policy on thermography is: “1) 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…”
Council on Chiropractic Practice: In 2008, they issued an updated clinical practice guideline which includes the following recommendation on skin temperature instrumentation, “temperature reading devices employing thermocouples, infrared thermometry or thermography (liquid crystal, telethermography, multiple IR detectors, etc.) may be used to detect temperature changes in spinal and paraspinal tissues related to vertebral subluxation.” The recommendation was based on expert opinion and literature support in the form of observational, pre-post, and/or case studies but not controlled studies.
(RSD/CRPS): In 2002, they published a clinical practice guideline stating that there is no single laboratory test that can diagnose reflex RSD/ CRPS. They list the thermogram and bone scan as tests which can be useful for documenting the condition. Information on thermograms includes the following: “…An abnormal thermogram may be helpful when there are minimal objective findings for RSD / CRPS documented in the medical record. Furthermore, certain patterns of abnormal heat emission from the body (e.g. circumferential versus dermatomal changes) are more indicative of the existence of RSD / CRPS than others. The thermogram should be performed at a reputable medical facility. The quality of the test may vary among providers.”
2012 Update
This policy is being updated to include information on the use of infrared dermal thermometry. A search of the MEDLINE database through June 2012 did not reveal any new information that would prompt a change in the coverage intent for thermography or infrared dermal thermometry.
Infrared Dermal Thermometry
A retrospective review was conducted of 143 patients with type II diabetes mellitus who were divided into 3 subcategories (78 with peripheral sensory neuropathy, 11 with peripheral sensory neuropathy with foot ulcers, and 21 with peripheral sensory neuropathy with neuropathic fractures) (Armstrong, 1997). The skin temperature of the involved foot was recorded at 6 sites and compared with the same areas of the uninvolved foot. There were differences in skin temperature between the affected foot and the contralateral foot among the patients with Charcot’s arthropathy and the patients with neuropathic ulcers, with no difference identified among the patients with asymptomatic sensory neuropathy. Five patients with neuropathic ulcers experienced re-ulceration a mean of 12.2 months after initial healing, with a corresponding increase in skin temperature at the clinic visit immediately preceding re-injury.
The authors note the following limitations to their study: “The retrospective design limits truly uniform follow-up, particularly following resolution of ulceration or quiescence of Charcot’s arthropathy. All patients studied had adequate peripheral arterial perfusion. The role that ischemia plays in thermometric response to inflammation, therefore, cannot be discussed within the context of these data. Additionally, patients with bilateral neuropathic injuries were not evaluated. It may be inferred that patients with bilateral injuries will have commensurate inflammation and increased temperatures, thus diminishing the quality of the contralateral limb as a control and therefore the utility of dermal thermometry. Clearly, this subject warrants further investigation, prospectively monitoring large cohorts of patients with neuropathic or ischemic injuries before, during, and after ulceration and acute Charcot’s arthropathy.”
In 2007, Armstrong and colleagues conducted a randomized, controlled trial of 225 diabetic subjects to evaluate the effectiveness of home temperature monitoring to reduce foot ulcers. Subjects were randomized to either standard therapy (therapeutic footwear, diabetic foot education, regular foot care, and daily structured foot assessment) or dermal thermometry plus standard therapy. In the Standard Therapy Group, 12.2% of patients had ulceration compared to 4.7% ulceration in the Dermal Thermometry Group. In patients with ulceration, there was a 4.8 times greater temperature difference in the foot with ulceration compared to the opposite foot. The authors concluded, “High temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration”. Additionally, the authors report, “ it is unknown if the same outcomes and compliance would be observed in a multicenter clinical trial over an extended period of evaluation”.
In another randomized controlled trial, Lavery and colleagues studied 173 subjects with a previous history of diabetic foot ulceration. Subjects were randomized to either standard therapy, structured foot examination or enhanced therapy (infrared dermal thermometry) groups. Subjects in the enhanced therapy group were instructed to decrease their activity and contact the study nurse if they experienced a temperature difference of >4 degrees Fahrenheit between left and right corresponding sites. There were fewer foot ulcerations in the enhanced therapy group versus the standard therapy group (8.5% vs 29.3%).
Larger, multicenter trials are needed to assess the clinical utility of measuring skin temperature variations in the feet of diabetic patients.
2013 Update
A literature search conducted through June 2013 did not reveal any new information that would prompt a change in the coverage statement.
A 2013 systematic review identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard (Vreugdenburg, 2013). Six of the 8 studies, with sample sizes between 29 and 769 patients, included women scheduled for biopsy. The sensitivity of thermography in the individual studies ranged from 25% to 97% and specificity ranged from 12% to 85%. Study findings were not pooled.
A study published by Shada and colleagues addressed the use of infrared thermography for differentiating between a melanoma metastasis and benign cutaneous lesions (Shada, 2012). The study included 74 individuals with 251 palpable skin lesions. Thermographic images were taken of the lesions and diagnosis was confirmed by biopsy or clinical diagnosis. The sensitivity and specificity of thermography varied by lesion size. For lesions between 0 and 5 mm (n=40), the sensitivity was 39% and specificity was 100%. For lesions between 5 and 15 mm (n=46), the sensitivity was 0.58% and the specificity was 98%. Sensitivity and specificity were 95% and 100%, respectively, for lesions between 15 and 30 mm and 78% and 89%, respectively, for lesions above 30 mm.
The American College of Radiology (ACR), in their 2012 statement on breast imaging states that there is insufficient evidence to support the use of thermography for breast cancer screening (ACR, 2012).
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2013 study from Croatia by Kolaric et al in which 26 patients were evaluated with mammography and thermography before breast cancer surgery (Kolaric, 2013). The sensitivity and specificity of mammography were 85% and 84%, respectively, and of thermography were 100% and 79%, respectively. Limitations of the Kolaric study include its small sample size, unclear patient selection criteria, and unblinded analysis of test findings (Brkljacic, 2013).
Examples of other studies on thermography, all conducted outside of the United States, include evaluating the association between thermographic findings and postherpetic neuralgia in patients with herpes zoster (Han, 2010; Park, 2012)., surgical site healing in patients who underwent knee replacements,(Romano, 2012) ulcer healing in patients with pressure ulcers,(Nakagami, 2010) posttreatment pain in patients with coccygodynia,(Wu, 2009) evaluation of allergic conjunctivitis, (Hara, 2014) and early diagnosis of diabetic neuropathy (Balbinot, 2012).
Council on Chiropractic Practice: In 2013 issued an updated clinical practice guideline which includes the following recommendation on skin temperature instrumentation (Chiropractic, 2013), “Temperature reading devices employing thermocouples, infrared thermometry or thermography (liquid crystal, telethermography, multiple IR detectors, etc.) may be used to detect temperature changes in spinal and paraspinal tissues related to vertebral subluxation.” The recommendation remains unchanged from 2008. It was based on expert opinion and literature support in the form of observational, pre-post, and/or case studies but not controlled studies.
2015 Update
A literature search conducted through June 2015 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
In 2014 a diagnostic accuracy study was published by Rissiwala et al in India (Rassiwala, 2014). The study included 1008 women who were being screened for breast cancer. Following infrared breast thermography, 959 women were classified as normal (temperature gradient <2.5), 8 as abnormal (temperature gradient between 2.5 and 3) and 41 as potentially having breast cancer (temperature gradient greater than or equal to 3). Women who tested positive on thermography (n=49) underwent clinical, radiologic, and histopathologic examination. Forty-one of 49 women with positive thermograms were found to have breast cancer. The authors calculated the sensitivity of thermography to be 97.6% and the specificity to be 99.17%. The study was limited because women who had normal thermograms did not undergo radiologic reference tests, only clinical examination, and thus the false negative rate cannot be accurately calculated.
A 2014 systematic review by Sanchis-Sanchez evaluated the literature on thermography for diagnosis of musculoskeletal injuries (Sanchis-Sanchez, 2014). To be included in the review, studies needed to report on diagnostic accuracy and use findings from diagnostic imaging tests (eg, radiographs, computed tomography, magnetic resonance imaging, or ultrasound) as the reference standard. Six studies met the eligibility criteria; 3 included patients with suspected stress fractures, and the remainder addressed various other musculoskeletal conditions. Sample sizes of individual studies ranged from 17 to 164 patients. In the 3 studies on stress fracture, sensitivity ranged from 45% to 82% and specificity from 83% to 100%. Pooled specificity was 0.69 (95% confidence interval, 0.49 to 0.85); data on sensitivity were not pooled.
2017 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through June 2018. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of key identified literature.
Omranipour et al compared the accuracy of thermography and mammography in 132 patients in Iran who had breast lesions and were candidates for breast biopsy (Omranipour, 2016). The final pathologic result, which was used as the reference standard, indicated that there were 45 benign lesions and 87 malignant lesions. The diagnostic accuracy of thermography (67.7%) was lower than for mammography (76.9%; p values not reported). While the sensitivities of the 2 tests were similar (80.5% for mammography vs 81.6% for thermography), the specificity was higher for mammography (73.3%) than for thermography (57.8%). Both the positive and negative predictive values were lower with thermography than with mammography. The positive and negative predictive values were 85.4% and 66.0% for mammography, and 78.9% and 61.9% for thermography, respectively.
PRACTICE GUIDELINES AND POSITION STATEMENTS
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” (ESBI, 2017).
American College of Radiology
A 2013 American College of Radiology statement (republished 2016) concluded that there is insufficient evidence to support the use of thermography for breast cancer screening (ACR, 2013).
2019 Update
A literature search was conducted through June 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The only study to date to investigate the clinical utility of thermography compared with no thermography assessed diabetic foot ulcer incidence in 110 participants with a history of diabetic neuropathy and foot ulcers (Petrova, 2020). After 12 months followup, the study found no significant difference between use of monthly thermography versus no thermography and foot ulcer incidence (62% versus 56%; adjusted OR 0.55, 95% CI 0.21 to 1.40) or time to ulcer recurrence (adjusted HR 0.67, 95% CI 0.34 to1.3).
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A number of studies have assessed a range of potential thermography applications. To date, no randomized study has examined the impact of thermography on patient management decisions or health outcomes. Examples of other studies on thermography, mainly conducted outside of the U.S., include those evaluating the association between thermographic findings and post-herpetic neuralgia in patients with herpes zoster (Han, 2010; Park, 2012), surgical site healing in patients who underwent knee replacements (Romano, 2012), predicting pressure ulcers (Oliveira, 2017) and pressure ulcer healing (Nakagami, 2010; Bilska, 2020), posttreatment pain in patients with coccygodynia (Wu, 2009), evaluation of allergic conjunctivitis (Hara, 2014), evaluation of burn depth (Singer, 2016; Dang, 2021), association between thermographic findings and burn treatment (Martinez-Jimenez, 2018), detecting cervical lymph node metastasis from oral cavity cancer (Dong, 2018), monitoring lesions or inflammation in patients with scleroderma (Agazzi, 2018; Ranosz-Janicka, 2019), detection of vascular obstruction (Cruz-Segura, 2019) or perforator vessels during surgery (Unger, 2019; Chen, 2019), diagnosis of lower extremity cellulitis (Li, 2018), prediction of infrainguinal bypass surgery (Al Shakarchi, 2019), detection of melanoma (Magalhaes, 2019), detection of contact dermatitis during allergy patch testing (Anzengruber, 2019), and measuring disease activity in patients with rheumatoid arthritis (Umapathy, 2020; Jones, 2018).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A number of studies have assessed a range of potential thermography applications. To date, no randomized study has examined the impact of thermography on patient management decisions or health outcomes. Examples of other studies on thermography, mainly conducted outside of the U.S., include those evaluating the association between thermographic findings and post-herpetic neuralgia in patients with herpes zoster (Han, 2010; Park, 2012), surgical site healing in patients who underwent knee replacements (Romano, 2012), predicting pressure ulcers (Oliveira, 2017) and pressure ulcer healing (Nakagami, 2010; Bilska, 2020), posttreatment pain in patients with coccygodynia (Wu, 2009), evaluation of allergic conjunctivitis (Hara, 2014), evaluation of burn depth (Singer, 2016; Dang, 2021), association between thermographic findings and burn treatment (Martinez-Jimenez, 2018), detecting cervical lymph node metastasis from oral cavity cancer (Dong, 2018), monitoring lesions or inflammation in patients with scleroderma (Agazzi, 2018; Ranosz-Janicka, 2019), detection of vascular obstruction (Cruz-Segura, 2019) or perforator vessels during surgery (Unger, 2019; Chen, 2019), diagnosis of lower extremity cellulitis (Li, 2018), prediction of infrainguinal bypass surgery (Al Shakarchi, 2019), detection of melanoma (Magalhaes, 2019), detection of contact dermatitis during allergy patch testing (Anzengruber, 2019), diagnosis of acute appendicitis (Aydemir, 2021), and measuring disease activity in patients with rheumatoid arthritis, osteoarthritis, or other rheumatic diseases (Umapathy, 2020; Jones, 2018; Schiavon, 2021; Branco, 2022).
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| References: |
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