Pending Policies - Radiology
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The use of all forms of thermography is considered experimental, investigational and/or unproven.
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 as a diagnostic tool, for treatment planning, and for evaluation of treatment effects for a variety of conditions.
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 (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 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.
In 2002, the Dorex Spectrum 9000MB Thermography System (Dorex Inc., Orange, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in quantifying and visualizing skin temperature changes. Its indicated use is as an aid in diagnosis and follow-up therapy in areas such as orthopedics, pain management, neurology, and diabetic foot care. This type of device is also known as a telethermographic system. FDA product code: LHQ.
In 2003, several telethermographic cameras (series A, E, P, S) by Flir Systems (McCordsville, IN) were cleared for marketing by the FDA through the 510(k) process. Their intended use is as an adjunct to other clinical diagnostic procedures when there is a need for quantifying differences in skin surface temperature. Between 2006 and 2009, 3 new or updated thermography devices received 510(k) marketing clearance from the FDA based on demonstrating substantial equivalence to existing products. FDA product code: LHQ.
This policy was originally created in 1996 and has been updated regularly with searches of the MEDLINE database. The most recent literature review was conducted through July 21, 2016. Following is a summary of the key literature to date.
No studies have demonstrated how the results of thermography can be used to enhance management of breast cancer patients in a manner that would improve patient health outcomes in breast cancer.
Several systematic reviews of the published literature on diagnostic accuracy were identified. A 2013 systematic review by Vreugdenburg et al. identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard. (1) Six of the 8 studies, with sample sizes between 29 and 769 patients, included women scheduled for biopsy. The accuracy of thermography was highly variable. Sensitivity in the individual studies ranged from 25% to 97% and specificity ranged from 12% to 85%. Study findings were not pooled.
Previously, a 2012 systematic review by Fitzgerald et al. identified 6 studies, 1 study using thermography for breast cancer screening and 5 using thermography to diagnose breast cancer among symptomatic women or those with a positive mammogram. (2) In the screening study, more than 10,000 women were invited to participate, and sample sizes in the diagnosis studies ranged from 63 to 2625 subjects. The screening study found that, compared with mammography, thermography had a sensitivity of 25% and specificity of 74%. In the diagnostic studies, which all used histology as the reference standard, sensitivity ranged from 25% to 97% and specificity ranged from 12% to 85%.
Subsequent to the systematic reviews, a diagnostic accuracy study was published by Rissiwala et al. (2014) in India. (3) The study included 1008 women being screened for breast cancer. Following infrared breast thermography, 959 women were classified as normal (temperature gradient, <2.5), 8 as abnormal (temperature gradient range, 2.5-3), and 41 as potentially having breast cancer (temperature gradient, ≥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 false-negative rate could not be accurately calculated because women who had normal thermograms did not undergo radiologic reference tests, only clinical examination.
Section Summary: Breast Cancer
Systematic reviews of studies evaluating the accuracy of thermography for diagnosing breast cancer found wide ranges of sensitivities and specificities. In 1 large screening study included in a systematic review, the sensitivity and specificity of thermography were relatively low compared with mammography. Studies to date have not demonstrated that thermography is sufficiently accurate to replace or supplement mammography for breast cancer diagnosis. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with breast cancer.
A 2014 systematic review by Sanchis-Sanchez et al. evaluated the literature on thermography for diagnosis of musculoskeletal injuries. (4) To be included in the review, studies had to report on diagnostic accuracy and use findings from diagnostic imaging tests (e.g., 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 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 69% (95% confidence interval, 49% to 85%); data on sensitivity were not pooled.
Section Summary: Musculoskeletal Injuries
A systematic review of studies on thermography for diagnosing musculoskeletal injuries found moderate levels of accuracy compared with other diagnostic imaging tests. This evidence does not permit conclusions whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries.
A number of studies have assessed a range of potential applications of thermography. None has examined the impact of thermography on patient management decisions or health outcomes. 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, (5,6) surgical site healing in patients who underwent knee replacements, (7) ulcer healing in patients with pressure ulcers, (8) posttreatment pain in patients with coccygodynia, (9) evaluation of allergic conjunctivitis, (10) early diagnosis of diabetic neuropathy (11) or diabetic foot infection, (12) evaluation of burn depth, (13) and identifying patients with temporomandibular disorder. (14)
Section Summary: Miscellaneous Potential Conditions
There are 1 or 2 preliminary studies each from outside of the United States on various miscellaneous potential indications for thermography. Most studies were on temperature gradients or the association between temperature differences and the clinical condition. Studies did not adequately evaluate the diagnostic accuracy or clinical utility of thermography for any of these miscellaneous conditions.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in August 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
Summary of Evidence
For individuals who have an indication for breast cancer screening or diagnosis who receive thermography, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and test validity. Systematic reviews of studies evaluating the accuracy of thermography to screen and/or to diagnose breast cancer found wide ranges of sensitivities and specificities. Studies to date have not demonstrated that thermography is sufficiently accurate to replace or supplement mammography for breast cancer diagnosis. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with breast cancer. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have musculoskeletal injuries who receive thermography, the evidence includes diagnostic accuracy studies and a systematic review. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing musculoskeletal injuries have found moderate levels of accuracy compared with other diagnostic imaging tests. This evidence does not permit conclusions whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have miscellaneous conditions (e.g., herpes zoster, pressure ulcers, temporomandibular joint disorder) who receive thermography, the evidence includes diagnostic accuracy studies and a systematic review. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. There are 1 or 2 preliminary studies each from outside of the United States on various miscellaneous potential indications for thermography. Most studies assessed temperature gradients or the association between temperature differences and the clinical condition. Studies have not adequately evaluated the diagnostic accuracy or clinical utility of thermography for any of these conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
American College of Radiology (ACR)
The 2012 ACR statement on breast imaging concluded that there is insufficient evidence to support the use of thermography for breast cancer screening. (15)
The 2015 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. (16)
American College of Obstetricians and Gynecologists (ACOG)
The 2015 ACOG breast cancer screening recommendations did not address thermography as a screening option. (17)
Council on Chiropractic Practice (CCP)
The 2013 CCP clinical practice guideline included the following recommendation on skin temperature instrumentation (18): “Temperature reading devices employing thermocouples, infrared (IR) thermometry or thermography (liquid crystal, telethermography, multiple IR detectors, etc.) may be used to detect temperature changes in spinal and paraspinal tissues related to subluxation.”
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Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
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The following codes may be applicable to this Medical policy and may not be all inclusive.
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
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ICD-10 Diagnosis Codes
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ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Vreugdenburg TD, Willis CD, Mundy L, et al. A systematic review of elastography, electrical impedance scanning, and digital infrared thermography for breast cancer screening and diagnosis. Breast Cancer Res Treat. Feb 2013; 137(3):665-676. PMID 23288346
3. 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
4. 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
5. Han SS, Jung CH, Lee SC, et al. Does skin temperature difference as measured by infrared thermography within 6 months of acute herpes zoster infection correlate with pain level? Skin Res Technol. May 2010; 16(2):198-201. PMID 20456100
8. Nakagami G, Sanada H, Iizaka S, et al. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care. Nov 2010; 19(11):465-466, 468, 470 passim. PMID 21135794
9. Wu CL, Yu KL, Chuang HY, et al. The application of infrared thermography in the assessment of patients with coccygodynia before and after manual therapy combined with diathermy. J Manipulative Physiol Ther. May 2009; 32(4):287-293. PMID 19447265
10. Hara Y, Shiraishi A, Yamaguchi M, et al. Evaluation of allergic conjunctivitis by thermography. Ophthalmic Res. Mar 2014; 51(3):161-166. PMID 24603108
11. Balbinot LF, Canani LH, Robinson CC, et al. Plantar thermography is useful in the early diagnosis of diabetic neuropathy. Clinics (Sao Paulo). Dec 2012; 67(12):1419-1425. PMID 23295596
12. 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
13. Singer AJ, Relan P, Beto L, et al. Infrared thermal imaging has the potential to reduce unnecessary surgery and delays to necessary surgery in burn patients. J Burn Care Res. Dec 2015; 37(6):350-355. PMID 26720102
14. Wozniak K, Szyszka-Sommerfeld L, Trybek G, et al. Assessment of the sensitivity, specificity, and accuracy of thermography in identifying patients with TMD. Med Sci Monit. May 2015; 21:1485-1493. PMID 26002613
15. ACR Appropriateness Criteria®. ACR Appropriateness Criteria® breast cancer screening: 2012. Available at <https://www.guideline.gov> (accessed - 2015 March).
16. ACR Appropriateness Criteria®. ACR Appropriateness Criteria® myelopathy: 2015. Available at <https://www.guideline.gov> (accessed - 2016 August 10).
17. American College of Obstetricians and Gynecologists (ACOG). Mammography and Other Screening Tests for Breast Problems (2015). Available at <http://www.acog.org> (accessed - 2016 August 10).
18. Council on Chiropractic Practice. Subluxation chiropractic practice (2013). Available at <http://www.guideline.gov> (accessed - 2016 August 10).
19. U.S. Preventive Services Task Force. Breast Cancer: Screening (2016). Available at <http://www.uspreventiveservicestaskforce.org> (accessed - 2016 August 10).
20. Thermography. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 September) Radiology 6.01.12.
|4/15/2018||Reviewed. No changes.|
|3/1/2017||Document updated with literature review. Coverage unchanged.|
|2/15/2016||Reviewed. No changes.|
|2/1/2015||Document updated with literature review. Coverage unchanged.|
|9/1/2011||Document reviewed with literature review. Coverage unchanged, rationale and description updated.|
|2/15/2008||Revised/updated entire document|
|1/1/2006||Revised/updated entire document|
|10/24/2006||Revised/updated entire document|
|3/1/2005||CPT/HCPCS code(s) updated, medical policy unchanged|
|10/24/2003||Revised/updated entire document|
|11/1/1997||Revised/updated entire document|
|5/1/1996||Revised/updated entire document|
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