Latest Review Date: September 2024                                                                      

Category: Radiology                                                             

POLICY:

The use of all forms of thermography is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Thermography is a noninvasive imaging technique that is intended to measure temperature distribution of 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.

Infrared radiation from the skin or organ tissue reveals temperature variations by producing brightly colored patterns on a liquid crystal display. 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.

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’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 by accomplishing the following tasks: 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.

KEY POINTS:

The most recent literature review was performed through July 26, 2024.

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, and test validity. Using histopathologic findings compared to the reference standard, a series of systematic reviews of studies have evaluated the accuracy of thermography to screen and/or diagnose breast cancer and reported wide ranges of sensitivities and specificities. To date, no study has 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 individuals with breast cancer. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have musculoskeletal injuries who receive thermography, the evidence includes diagnostic accuracy studies, a longitudinal prospective study, and a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing musculoskeletal injuries found moderate levels of accuracy compared with other diagnostic imaging tests. There is no consistent reference standard. This evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no high-quality or randomized studies on the impact of thermography on patient management or health outcomes for individuals with musculoskeletal injuries. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have temporomandibular joint disorder who receive thermography, the evidence includes a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing temporomandibular joint disorder found a wide variation in accuracy compared to other diagnostics. There is no consistent reference standard. The evidence does not permit conclusions as to 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 individuals with the temporomandibular joint disorder. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have miscellaneous conditions (e.g., pressure ulcers, herpes zoster, and diabetic foot) who receive thermography, the evidence includes primarily includes diagnostic accuracy studies. Outcomes in these studies are test validity, symptoms, and functional outcomes. Most studies assessed temperature gradients or the association between temperature differences and the clinical condition.Due to the small number of studies for each indication, diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography has only been considered in 1 study of diabetic foot ulcers. For other miscellaneous conditions, the clinical utility of thermography has not been investigated. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

European Society of Breast Imaging 

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 College of Obstetricians and Gynecologists

The American College of Obstetricians and Gynecologists (ACOG) practice bulletin for breast cancer risk assessment and screening in average-risk women do not mention the use of thermography for breast cancer screening.

American College of Physicians

The American College of Physicians (2019) issued a guidance statement for breast cancer screening in average-risk women that reviews existing screening guidelines. While the use of thermography was not mentioned in this statement, the authors conclude that evidence is insufficient to understand the benefits and harms of primary or adjunctive screening strategies in women who are found to have dense breasts on screening mammography.

American College of Radiology (ACR):

The American College of Radiology updated 2023 guidelines for breast cancer screeningdo not mention  the use of thermography for breast cancer screening.

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on breast cancer screening and diagnosis (v2.2024) states that “Current evidence does not support the routine use of thermography or ductal lavage as screening procedures.”

U.S. Preventative Services Task Force Recommendations

The 2024 U.S. Preventive Services Task Force recommendations on breast cancer screening do not mention thermography. Additionally, there is insufficient evidence for the use of adjunctive screening methods for breast cancer (ultrasonography or magnetic resonance imaging) in women identified to have dense breasts on a negative screening mammogram.

KEY WORDS:

Thermography, rolling thermal scan, Insight thermal scanner, Dorex Spectrum 9000MB Thermography System, Infrared Sciences Breastscan IR System, Notouch Breastscan, WoundVision Scout, FirstSense Breast Exam, Temperature Gradient Studies, Digital Infrared Thermal Imaging (DITI), Thermal Imaging

APPROVED BY GOVERNING BODIES:

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 shown in Table 1.

Table 1. Thermography Devices Cleared by the Food and Drug Administration

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CODING: 

CPT Codes:

  REFERENCES:

1. Agazzi A, Fadanelli G, Vittadello F, et al. Reliability of LoSCAT score for activity and tissue damage assessment in a large cohort of patients with Juvenile Localized Scleroderma. Pediatr Rheumatol Online J. Jun 18 2018; 16(1):37.
2. Al Shakarchi, JJ, Inston, NN, Dabare, DD, Newman, JJ, Garnham, AA, Hobbs, SS, Wall, MM. Pilot study on the use of infrared thermal imaging to predict infrainguinal bypass outcome in the immediate post-operative period. Vascular, 2019 May 9;1708538119847391.
3. American College of Radiology.  ACR Appropriateness Criteria® breast cancer screening: 2017. 
4. Anzengruber, FF, Alotaibi, FF, Kaufmann, LL, Ghosh, AA, Oswald, MM, Maul, JJ, Meier, BB, French, LL, Bonmarin, MM, Navarini, AA. Thermography: High sensitivity and specificity diagnosing contact dermatitis in patch testing. Allergol Int, 2019 Jan 2;68(2). 
5. Aydemir U, Sarıgoz T, Ertan T, et al. Role of digital infrared thermal imaging in diagnosis of acute appendicitis. Ulus TravmaAcil Cerrahi Derg. Nov 2021; 27(6): 647-653.
6. Bilska A, Stangret A, Pyzlak M, et al. Skin surface infrared thermography in pressure ulcer outcome prognosis. J WoundCare. Dec 02 2020; 29(12): 707-718.
7. Balbinot LF, Canani LH, Robinson CC et al. Plantar thermography is useful in the early diagnosis of diabetic neuropathy. Clinics (Sao Paulo) 2012; 67(12):1419-25.
8. Balbinot LF, Robinson CC, Achaval M, et al. Repeatability of infrared plantar thermography in diabetes patients: a pilot study. J Diabetes Sci Technol. Sep 2013; 7(5):1130-1137.
9. Branco JHL, Branco RLL, Siqueira TC, et al. Clinical applicability of infrared thermography in rheumatic diseases: Asystematic review. J Therm Biol. Feb 2022; 104: 103172.
10. Chen, RR, Huang, ZZ, Chen, WW, Ou, ZZ, Li, SS, Wang, JJ. Value of a smartphone-compatible thermal imaging camera in the detection of peroneal artery perforators: Comparative study with computed tomography angiography. Head Neck, 2019 Jan 13;41(5). 
11. Côrte, AA, Pedrinelli, AA, Marttos, AA, Souza, II, Grava, JJ, José Hernandez, AA. Infrared thermography study as a complementary method of screening and prevention of muscle injuries: pilot study. BMJ Open Sport Exerc Med, 2019 Jan 29;5(1). 
12. Cruz-Segura, AA, Cruz-Domínguez, MM, Jara, LL, Miliar-García, NANA, Hernández-Soler, AA, Grajeda-López, PP, Martínez-Bencomo, MM, Montes-Cortés, DD. Early Detection of Vascular Obstruction in Microvascular Flaps Using a Thermographic Camera. J Reconstr Microsurg, 2019 May 9. 
13. De Melo, DD, Bento, PP, Peixoto, LL, Martins, SS, Martins, CC. Is infrared thermography effective in the diagnosis of temporomandibular disorders? A systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol, 2018 Nov 30;127(2). 
14. Dang J, Lin M, Tan C, et al. Use of Infrared Thermography for Assessment of Burn Depth and Healing Potential: ASystematic Review. J Burn Care Res. Jun 12 2021.
15. Dong F, Tao C, Wu J, et al. Detection of cervical lymph node metastasis from oral cavity cancer using a non-radiating, noninvasive digital infrared thermal imaging system. Sci Rep. May 8 2018; 8(1):7219.
16. Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J 2012; 125(1351):80-91.
17. Gatt A, Falzon O, Cassar K, et al. The application of medical thermography to discriminate neuroischemic toe ulceration in the diabetic foot. Int J Low Extrem Wounds. Jun 2018;17(2):102-105.
18. Gatt A, Falzon O, Cassar K, et al. Establishing differences in thermographic patterns between the various complications in diabetic foot disease. Int J Endocrinol. 2018; 2018:9808295.
19. 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 Tech 2010; 16(2):198-201.
20. Hara Y, Shiraishi A, Yamaguchi M et al. Evaluation of Allergic Conjunctivitis by Thermography. Ophthalmic research 2014; 51(3):161-66.
21. 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.
22. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
23. Jones B, Hassan I, Tsuyuki RT, et al. Hot joints: myth or reality? A thermographic joint assessment of inflammatory arthritis patients. Clin Rheumatol. Apr 20 2018.
24. Li, DD, Dewan, AA, Xia, FF, Khosravi, HH, Joyce, CC, Mostaghimi, AA. The ALT-70 predictive model outperforms thermal imaging for the diagnosis of lower extremity cellulitis: A prospective evaluation. J. Am. Acad. Dermatol., 2018 Jul 14;79(6). 
25. Magalhaes, CC, Vardasca, RR, Rebelo, MM, Valenca-Filipe, RR, Ribeiro, MM, Mendes, JJ. Distinguishing melanocytic nevi from melanomas using static and dynamic infrared thermal imaging. J Eur Acad Dermatol Venereol, 2019 Apr 12. 
26. Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness Criteria Breast Cancer Screening. J Am Coll Radiol. Nov 2016; 13(11s):R45-r49.
27. Mainiero, MB, Moy, L, Baron, P, Didwania, AD, diFlorio, RM, Green, ED, Heller, SL, Holbrook, AI, Lee, SJ, Lewin, AA, Lourenco, AP, Nance, KJ, Niell, BL, Slanetz, PJ, Stuckey, AR, Vincoff, NS, Weinstein, SP, Yepes, MM, Newell, MS. ACR Appropriateness Criteria® Breast Cancer Screening. J Am Coll Radiol, 2017 Nov 6;14(11S). 
28. Martínez-Jiménez, MM, Ramirez-Garcia Luna, JJ, Kolosovas-Machuca, EE, Drager, JJ, González, FF. Development and validation of an algorithm to predict the treatment modality of burn wounds using thermographic scans: Prospective cohort study. PLoS ONE, 2018 Nov 15;13(11). 
29. Morales-Cervantes, A, Kolosovas-Machuca, ES, Guevara, E, Maruris Reducindo, MM, Bello Hernández, AB, Ramos García, M, González, FJ. An automated method for the evaluation of breast cancer using infrared thermography. EXCLI J, 2018 Dec 20;17:989-998. 
30. 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.
31. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. Version 2.2024; www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf.
32. Neal, CH, Flynt, KA, Jeffries, DO, Helvie, MA. Breast Imaging Outcomes following Abnormal Thermography. Acad Radiol, 2018 Mar;25(3):273-278.
33. Niell BL, Jochelson MS, Amir T, et al. ACR Appropriateness Criteria® Female Breast Cancer Screening: 2023 Update. J AmColl Radiol. Jun 2024; 21(6S): S126-S143.
34. 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.
35. 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.
36. Park J, Jang WS, Park KY et al. Thermography as a predictor of postherpetic neuralgia in acute herpes zoster patients: a preliminary study. Skin Res Technol 2012; 18(1):88-93.
37. Petrova NL, Donaldson NK, Tang W, et al. Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicenter controlled clinical trial. Diabet Med. Jan 2020; 37 (1): 95-104.
38. Practice Bulletin Number 179: Breast Cancer Risk Assessment and Screening in Average-Risk Women. Obstet Gynecol. Jul 2017; 130(1): e1-e16.
39. 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.Apr 16 2019; 170(8): 547-560. 
40. Ranosz-Janicka, II, Lis-ÅšwiÄ™ty, AA, Skrzypek-Salamon, AA, BrzeziÅ„ska-WcisÅ‚o, LL. Detecting and quantifying activity/inflammation in localized scleroderma with thermal imaging. Skin Res Technol, 2018 Jul 22;25(2). 
41. 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.
42. Romano CL, Logoluso N, Dell’Oro F et al. Telethermographic findings after uncomplicated and septic total knee replacement. Knee 2012; 19(3):193-7.
43. 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.
44. Sandi, S, Yusuf S, Kaelan C, et al. Evaluation risk of diabetic food ulcers (DFUs) using infrared thermography based on mobile phone as advanced risk assessment. Diabetes Res Clin Pract. Mar 2019; 149: 132-139.
45. 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.
46. 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. Nov/Dec 2016; 37(6):350-355.
47. Umpathy S, Thulasi R, Gupta N, et al. Thermography and colour Doppler ultrasound: a potential complementary diagnostic tool in evaluation or rheumatoid arthritis in the knee region. Biomed Tech (Berl). May 26, 2020; 65(3): 289-299.
48. Unger, MM, Markfort, MM, Halama, DD, Chalopin, CC. Automatic detection of perforator vessels using infrared thermography in reconstructive surgery. Int J Comput Assist Radiol Surg, 2018 Dec 7;14(3). 
49.  U.S. Preventive Services Task Force. Breast Cancer: Screening. 2024; www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening. 
50. Van Doremalen, RR, van Netten, JJ, van Baal, JJ, Vollenbroek-Hutten, MM, van der Heijden, FF. Validation of low-cost smartphone-based thermal camera for diabetic foot assessment. Diabetes Res. Clin. Pract., 2019 Feb 10;149:132-139. 
51. 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 2013; 137(3):665-676.
52. 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. 2015; 21:1485-1493.
53. 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 2009; 32(4):287-93.

POLICY HISTORY:

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medial Policy Group, December 2010 (2)

Medical Policy Group, June 2011 (3) Updated Key Points & References

Medical Policy Group, May 2012 (3): Updated Key Points & References

Medical Policy Panel, May 2013

Medical Policy Group, May 2013 (3):  2013 Updates to Key points & References; no change in policy statement

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (6):  Updates to Key Points and References; no change to policy statement

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (6): Updates to Key Points, U.S. Preventive Services Task Force Recommendations, Practice Guidelines, Summary and References. No change to policy intent.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Key Points, Governing Bodies, Practice Guidelines, Key Words and References.

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (3) Updates to Description, Key Points, References, and Key Words: added Temperature Gradient Studies, Digital Infrared Thermal Imaging (DITI), Thermal Imaging; Added code 93740. No change to policy statement or intent.

Medical Policy Panel, September 2019

Medical Policy Group, October 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Group, September 2020 (2): Updates to Description and Key Points. No change to Policy Statement.

Medical Policy Group, September 2021 (2): Updates to Key Points and References. Policy Statement updated to remove “not medically necessary.”

Medical Policy Panel, September 2022

Medical Policy Group, September 2022 (2): Updates to Description; no change to policy statement or intent.

Medical Policy Group, September 2023 (2): Updates to Key Points and Benefit Application. Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Panel, September 2024

Medical Policy Group, September 2024 (9): Update to Key Points, Approved By Governing Bodies and References; no change to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.