Policy #: 436 Latest Review Date: September 2016

Transcription

1 Name of Policy: Thermography Policy #: 436 Latest Review Date: September 2016 Category: Radiology Policy Grade: B Background: As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama 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. Page 1 of 9

2 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 a variety of conditions, e.g., complex regional pain syndrome, for treatment planning and to evaluate the effects of treatment. Thermography involves use of an infrared scanning device. 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 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 is also thought to 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. Thermography can include various types of telethermographic infrared detector images and heatsensitive cholesteric liquid crystal systems. Policy: The use of all forms of thermography does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Blue Cross and Blue Shield of Alabama 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. Blue Cross and Blue Shield of Alabama 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. Key Points: The most recent literature review was conducted through July 21, The following is a summary of the key literature to date. Page 2 of 9

3 Breast Cancer Breast cancer is the potential application of thermography with the most published literature. No studies have demonstrated how the results of thermography can be used to enhance patient management and/or improve patient health outcomes in breast cancer. 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. 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%. In addition, a 2013 systematic review by Vreugdenburg et al identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard. Six of the eight 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. In addition to the systematic reviews, in 2014 a diagnostic accuracy study was published by Rissiwala et al in India. 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), eight as abnormal (temperature gradient between 2.5 and 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 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. Section Summary: Breast Cancer Systematic reviews of studies evaluating the accuracy of thermography for diagnosing breast cancer found a wide range 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 Musculoskeletal Injuries A 2014 systematic review by Sanchis-Sanchez evaluated the literature on thermography for diagnosis of musculoskeletal injuries. To be included in the review, studies needed to report on diagnostic accuracy and use findings from diagnostic imaging tests (e.g., radiographs, computed Page 3 of 9

4 tomography, magnetic resonance imaging, or ultrasound) as the reference standard. Six studies met the eligibility criteria; three 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. 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. Miscellaneous Potential Indications A number of other studies have been published on a range of potential applications of thermography. None of these studies have 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, surgical site healing in patients who underwent knee replacements, ulcer healing in patients with pressure ulcers, post-treatment pain in patients with coccygodynia, evaluation of allergic conjunctivitis, early diagnosis of diabetic neuropathy or diabetic foot infection, evaluation of burn depth, and identifying patients with temporomandibular disorder. Section Summary: Miscellaneous Potential Indications There are 1or 2 preliminary studies each from outside of the U.S. on various miscellaneous potential indications for thermography. Most studies were on temperature gradients or the association between temperature differences and the clinical condition, and most were conducted outside of the United States. Studies did not adequately evaluate the diagnostic accuracy or clinical utility of thermography for any of these miscellaneous conditions. 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 accuracy and validity. Systematic reviews of studies evaluating the accuracy of thermography to screen and/or to diagnose breast cancer found a wide range 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 Page 4 of 9

5 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. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have miscellaneous conditions (e.g., pressure ulcers, herpes zoster, and 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 1or 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 have not adequately evaluated the diagnostic accuracy or clinical utility of thermography for any of these miscellaneous 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 2015 ACR statement on myelopathy states that there is no high-quality evidence in support of thermography. The 2012 ACR statement on breast imaging states that there is insufficient evidence to support the use of thermography for breast cancer screening. American College of Obstetricians and Gynecologists (ACOG) The 2015 practice bulletin on breast cancer did not address thermography as a screening option. Council on Chiropractic Practice In 2013 Council on Chiropractic Practice clinical practice guideline includes the following recommendation on skin temperature instrumentation, temperature reading devices employing thermocouples, infrared thermometry or thermography (liquid crystal, tele-thermography, multiple IR detectors, etc.) may be used to detect temperature changes in spinal and paraspinal tissues related to vertebral subluxation. Work Loss Institute Their 2011 guidelines include statements that thermography is not recommended for acute and chronic neck and upper back pain and that thermography is not recommended for treating chronic pain. U.S. Preventive Services Task Force Recommendations The 2016 U.S. Preventive Services Task Force recommendations on breast cancer screening do not mention thermography. Page 5 of 9

6 Key Words: Thermography, rolling thermal scan, Insight thermal scanner, Approved by Governing Bodies: In 2002, the Dorex Spectrum 9000 MD 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. In 2003, several telethermographic cameras (Series A, E, P and S) by Flir Systems (McCordsville, IN) was 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 FDA based on demonstrating substantial equivalence to existing products. 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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Coding: CPT Codes: Unlisted cardiovascular service or procedure References: 1. American Academy of Neurology. Assessment: Thermography in Neurologic Practice. Report of the American Academy of Neurology Therapeutics and Technology Assessment Subcommittee. Neurology 1990; 40(3 pt 1): American College of Obstetricians and Gynecologists (ACOG). Mammography and Other Screening Tests for Breast Problems Accessed August 10, American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening: ACOG practice bulletin; no Available online at: 4. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); Page 6 of 9

7 12 p. (ACOG practice bulletin; no. 42). The currency of the guideline was reaffirmed in American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); p. (ACOG practice bulletin; no. 42). The currency of the guideline was reaffirmed in American College of Radiology. ACR Appropriateness Criteria breast cancer screening: Available online at: 7. American College of Radiology. ACR Appropriateness Criteria for Myelopathy: Available online at: 8. American College of Radiology. Appropriateness Criteria for Acute Low Back Pain Radiculopathy. Radiology 2000; 215(suppl): American College of Radiology. Appropriateness Criteria for Suspected Lower Extremity Deep Vein Thrombosis American Medical Association (AMA) policy statement. H Thermography Update HTM. 11. Arora N, Martins D, Ruggerio D, et al. Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer. Am J Surg 2008; 196(4): 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): Brkljacic B, Miletic D, Sardanelli F. Thermography is not a feasible method for breast cancer screening. Collegium antropologicum 2013; 37(2): Council on Chiropractic Practice. Subluxation chiropractic practice Available online at: Council on Chiropractic Practice. Vertebral Subluxation in Chiropractic Practice: Available online at: Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J 2012; 125(1351): 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): Hara Y, Shiraishi A, Yamaguchi M et al. Evaluation of Allergic Conjunctivitis by Thermography. Ophthalmic research 2014; 51(3): 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): International Research Foundation for RSD/CRPS. Reflex sympathetic dystrophy/complex regional pain syndrome. Third ed. Tampa (FL): International Research Foundation for RSD/CRPS; Kolaric D, Herceg Z, Nola IA et al. Thermography--a feasible method for screening breast cancer? Collegium antropologicum 2013; 37(2): Krumova EK, Frettlöh J, Klauenberg S, et al. Long-term skin temperature measurements - a practical diagnostic tool in complex regional pain syndrome. Pain 2008; 140(1):8-22. Page 7 of 9

8 23. Nakagami G, Sanada H, lizaka S et al. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care 2010; 19(11): 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): 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): Roback K, Johansson M and Starkhammar A. Feasibility of a thermographic method for early detection of foot disorders in diabetes. Diabet Technol Ther 2009; 11(10): Romano CL, Logoluso N, Dell Oro F et al. Telethermographic findings after uncomplicated and septic total knee replacement. Knee 2012; 19(3): 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): Schurmann M, Zaspel J, Lohr P, et al. Imaging in early posttraumatic complex regional pain syndrome: a comparison of diagnostic methods. Clin J Pain 2007; 23(5): Shada AL, Dengel LT, Petroni GR et al. Infrared thermography of cutaneous melanoma metastases. J Surg Res 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 U.S. Preventive Services Task Force. Breast Cancer: Screening. inal/breast-cancer-screening1. Accessed August 10, 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): Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic) Available online at: Work Loss Data Institute. Neck and upper back (acute & chronic) Available online at: 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: 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): 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 Page 8 of 9

9 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. This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a caseby-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. Page 9 of 9